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Indian Journal of Pharmacy Practice
ijopp
Vol.2(3), Jul-Sep, 2009
EDITOR-IN-CHIEF
A
P
T
I
Dr. Shobha Rani R. Hiremath
[email protected]
ASSOCIATE EDITORS
Dr. G. Parthasarathi
[email protected]
Dr. Pramil Tiwari
[email protected]
ASSISTANT EDITORS
Mr. Jaiprakash S. Vastrad
[email protected]
Mr. Ramjan Shaik
[email protected]
EDITORIAL OFFICE
INDIAN JOURNAL OF PHARMACY PRACTICE
An Official Publication of Association of Pharmaceutical Teachers of India
H.Q.: Al-Ameen College of Pharmacy,
Opp. Lalbagh Main Gate, Hosur Road, Bangalore 560 027, INDIA
Mobile: +91 9845399431 | +91 9845659585 | +91 9878488050 | +91 9972588878
+91 9916069842 | Ph: +91 80 22107467; Fax: +91 80 22225834
www.ijopp.org || [email protected]
Indian Journal of Pharmacy Practice
ijopp
Vol.2(3), Jul-Sep, 2009
EDITORIAL ADVISORY BOARD
Dr. Anil Kumar, Chattisgarh
Dr. Atmaram P. Pawar, Pune
Dr. Claire Anderson, Nottingham,UK.
Dr. Dhanalakshmi Iyer, Mumbai
Prof. Ganachari M S, Belgaum
Dr. Geeta.S, Bangalore
Dr. Hukkeri V.I, Ratnagiri (Dist)
Dr. Krathish Bopanna, Bangalore
Prof. Mahendra Setty C.R, Bangalore
Dr. Miglani B D, New Delhi
Dr. Mohanta G.P., Annamalai Nagar
Dr. Nagavi B.G, Ras Al-Khaimah, UAE
Dr. Nalini Pais, Bangalore
Dr. Rajendran S.D, Hyderabad
Dr. Ramananda S.Nadig, Bangalore
Dr. Revikumar K G, Cochin
Dr. Sampada Patawardhan, Mumbai
Dr. Sriram. S, Coimbatore
Dr. Sreekant Murthy, Philadelphia, USA
Dr. Sunitha C. Srinivas, Grahamstown, RSA
Dr. Suresh B, Mysore
Dr. Tipnis H.P, Mumbai
Disclaimer: The editor-in-chief does not claim any responsibility, liability for
statements made and opinions expressed by authors
Indian Journal of Pharmacy Practice
ijopp
Vol.2(3), Jul-Sep, 2009
CONTENTS
Editorial
Review Articles
=
Obesity: Increased risk of chronic non-communicable diseases in South Africa and India
Sunitha C Srinivas, Natisha Dukhi, Wendy Wrench------------------------------------------------------------------1-7
l
Introducing Pharm. D. Programme in India: A Need of the Day
Patil J S, Kulkarni RV, Marapur SC, Dalavi VV---------------------------------------------------------------------8-12
=
Biochemical Tests in Pregnancy
Babitha K Vazhayil, Jayakrishnan SS------------------------------------------------------------------------------13-15
=
Introducing Pharm. D. Programme in India: A Need of the Day
Mahvash Iram, Shobha Rani R Hiremath--------------------------------------------------------------------------16-18
Research Articles
=
Retrospective Patient Data Analysis with Respect to Irresponsible Self-Medication in a Community
Pharmacy Setting in Taiping (Malaysia)
Sam A T, Naga Jothy Nagesvararao, Nager Devi Vampanan, Sharon T X X S, Arumugam D-----------------19-30
=
Impact on the outcome of pharmacotherapy of senior Indian inpatients: A pharmacist led intervention
Mandavi1, Padmavathi R, Mangu R, Pramil T, Vinay K----------------------------------------------------------31 -37
l
Impact of patient education on health related quality of life of dialysis patients
Ramani GK, Dholakiya RB, Patel GF------------------------------------------------------------------------------38-41
Indian Journal of Pharmacy Practice
ijopp
Vol.2(3), Jul-Sep, 2009
=
Safety and efficacy of amiodarone in arrhythmias – a prospective study in the South Indian population
Vasantha Janardhan, Kousalya K, Ramalakshmi S, Vanitha Rani N, Kannan G, Jyothsna G, Uma MRC----42 -47
=
Pharmacoeconomic evaluation of artesunate-amodiaquine and artesunate- mefloquine artemisininbased combination therapies.
Adepoju GKA-----------------------------------------------------------------------------------------------------------48-52
l
Utilization of Third Generation Cephalosporins in Multispeciality Teaching Hospital, Dehradun
Rekha Bisht, Bhattacharya S, Katiyar A--------------------------------------------------------------------------53-57
=
Effect of combination of steroids, antibiotic and emollient on atopic dermatitis lesions
Sabry EY---------------------------------------------------------------------------------------------------------------58-63
Case Report
=
Adverse drug reactions in geriatric patient with chronic asthma
Dixon T, Seeba Zachariah, Molly M, Vijaya RC-----------------------------------------------------------------64-66
Instructions to Authors ------------------------------------------------------------------------------------------67-70
Editorial
Dear Readers,
Greetings from the Editorial board of ijopp.
Although we received a good number of articles in the last six months, it was
very unfortunate that only less than fifty percent of the articles were of quality.
Thus we appeal to all the contributors to send us quality articles.
We also noticed that many of the contributors do not follow the norms while
preparing the manuscript especially with respect to titles, tables, figures and
references which becomes a huge problem while formatting. Contributors,
kindly take care of this.
Another major problem that we are facing is most of our reviewers are not
getting back to us with their comments on time. Also the authors are not
resubmitting the articles immediately after including the necessary corrections.
Due to these problems it is becoming difficult for us to meet the deadlines with
respect to publishing the journal.
Journal publication being a team work involving various stake holders such as
authors, reviewers and editors, co-ordination at all levels is required for the
prompt publication of the journal.
We once again appeal to all concerned to co-operate and follow the deadlines
for the smooth and timely publication of the journal.
Dr. Shobha Rani R.Hiremath
Editor-in-chief
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
APTI
ijopp
Obesity: Increased risk of chronic non-communicable diseases in
South Africa and India
Sunitha C Srinivas, Natisha Dukhi, Wendy Wrench
Faculty of Pharmacy, Rhodes University, Grahamstown, South Africa 6140
Address for Correspondence: [email protected]
Abstract
Although the incidence of chronic non-communicable diseases (CNCDs) is increasing, CNCDs were not included in
the United Nations Millennium Development Goals (2000) which focussed on the major global challenges of
communicable diseases, child and maternal health and poverty-related issues along with strengthening health
policies. Although some countries have since incorporated CNCDs into the MDGs, this has not happened globally, a
matter which requires urgent attention. Obesity and physical inactivity are risk factors for some CNCDs such as
cardiovascular disease and diabetes. The incidence of these risk factors is increasing in developing countries such
as India and South Africa with an increase in urbanization and the influence of Westernization playing an important
role. Cultural influences may also play a role in the increase in obesity e.g. in South Africa, being overweight or
obese is associated with affluence and happiness in some cultures. The World Health Assembly Global Strategy on
Diet, Physical Activity and Health (2004) provides guidelines to reduce global disease, deaths and CNCD risk
factors, with an emphasis on improvement of diet and physical activity promotion. To reduce the incidence of
CNCDs, these guidelines should be implemented using a multi-sectoral and multi-stakeholder approach.
Key words: Obesity, chronic non-communicable diseases, Millennium Development Goals.
Global health risks, the World Health Organisation's
upcoming report on global and regional mortality and
disease burden, identifies the following five leading risk
factors that account for one-quarter of all deaths in the
world and one-fifth of all disability-adjusted life years
(DALYs): being underweight in childhood, unsafe sex,
alcohol use, unsafe water and sanitation and high blood
pressure1. Global health is in a state of transition, with
Chronic Non Communicable Diseases (CNCDs) such as
cardiovascular diseases and diabetes, causing double the
number of deaths ascribable to infectious diseases2,3.
Exposure to unhealthy dietary habits and a sedentary
lifestyle, especially among indigent urban populations,
increases the risk of CNCDs4.
Unhealthy diet and physical inactivity risk factors are the
result of a complex interplay of various factors that
include irregular, unbalanced meals; aggressive fast food
marketing; sedentary lifestyles; adverse economic,
social and environmental conditions; urbanization;
industrialization and global trade5,6,7. During the 20th
century in most regions around the world, an extensive
range of demographic and socio-economic shifts has
resulted in major changes in diet and physical activity.
Indian Journal of Pharmacy Practice
Received on 21/08/200 9
Accepted on 23/12/2009 © APTI All rights reserved
There has been a steady increase in the consumption of
partially hydrogenated fats, refined carbohydrates, and a
substantial decrease in consumption of whole grains,
fibre, fruits and vegetables8,9. Also, increasingly, food is
seen by many people as a beauty and health tool or
emotional medication and not as providing nutritional
satisfaction10.
Physical activity has been greatly reduced by
urbanization, industrialization and mechanized forms of
transport9. Approximately 1.9 million deaths occur
among populations annually due to physical inactivity11.
People with lifelong habits of reduced physical activity
and unhealthy diets have an increased risk of obesity and
this in turn leads to adverse metabolic effects on blood
pressure, cholesterol, triglycerides and insulin
resistance12 which ultimately can cause cardiovascular
diseases (CVD), type 2 diabetes,
dyslipidemia,
osteoarthritis and some forms of cancer13,14. The CVD
burden is increasing rapidly in middle and low income
countries and affects young economically productive
people. If the overwhelming CNCD risk factors are
addressed adequately, quality of life may be increased15.
In the last five decades, unhealthy weight prevalence has
been increasing steadily, and obesity is reaching
epidemic levels in both developing and developed
countries16,17. Obesity has presented as the most prevalent
global nutritional problem over the last two decades,
1
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
eclipsing infectious diseases and under-nutrition as a
significant mortality and ill-health contributor. Globally
an estimated 1 billion adults are overweight, with 300
million of them being obese17. An estimated 155 million
obese children contribute to this epidemic18. Obese
children tend to become obese adults. Obesity-related
health problems occur in the early years of life and
progress into adulthood14.
Obesity results in some non-fatal but incapacitating
health problems such as respiratory difficulties, chronic
musculoskeletal problems, skin problems and infertility
but most significantly results in four main areas of lifethreatening health problems: CVDs; conditions
associated with insulin resistance such as type 2 diabetes;
certain types of cancers, especially the hormonally
related and large-bowel cancers; and gallbladder disease.
The World Health Report of 2002 highlighted that
globally, approximately 58% of diabetic cases, 21% of
ischaemic heart disease cases and 8-42% of certain
cancers were attributable to a body mass index (BMI)
above 21 kg/m2 (12) .
In 2005, 60% of all deaths in the world were attributed to
CNCDs, which caused an estimated 35 million of the 58
million global deaths. It has to be noted that CNCDs
account for double the number of deaths from all
infectious diseases (including HIV/AIDS, tuberculosis
and malaria), maternal and perinatal conditions, and
nutritional deficiencies combined3,19. It is equally
important to note that of the 60% global mortality, 80%
of CNCD related mortality rates occur in 23 middle and
low income countries, which include South Africa and
India20. These appalling statistics when viewed against
the popular misconception that CNCDs affect only
populations in high income countries, shows the major
challenges that countries like South Africa and India face
due to the double burden of infectious diseases along
with CNCDs.
In order to address the global health challenges, the Alma
Ata declaration of 'Health for all' was followed up by
Millennium Development Goals (MDGs)21,22. The UN
Millennium declaration was signed by 189 countries in
2000 and was developed into the MDGs23. The eight
MDGs emerged to assist in focusing attention on major
global challenges of communicable diseases, child and
maternal health and poverty-related issues along with
strengthening health policies24. While the public health
and medical communities can rejoice that three of the
eight MDG goals are specifically health focused, it is
extremely important to note that CNCDs have not been
included within the global MDG targets 1 5 , 2 4 .
Prioritization and investing in CNCD prevention as well
as management is misconceived to remove the emphasis
from communicable disease11,15. Countries with poor
health status are far from the health targets, are unlikely
to make any progress substantially, and are unlikely to
achieve the MDGs by 201523, especially in sub-Saharan
Africa25. As a way forward to deal with CNCDs which are
the major cause of adult illness and death, some countries
are adapting their MDG goals to incorporate CNCDs.
Countries such as the Czech Republic, Mauritius, Poland
and Thailand have included new indicators such as heart
disease prevalence and death rates to monitor their
MDGs while countries such as Hungary, Indonesia,
Jordan and Lithuania have started noting the importance
of chronic diseases in their countries' MDGs. This is an
important step forward in addressing this immense
challenge3.
South Africa:
Since 1996, after overcoming the Apartheid era, South
Africa has been investing resources in collecting
valuable data that informs the current situation,
highlights various health care challenges and paves the
path for addressing the enormous challenges in the area
of CNCDs along with other health related problems. A
few of the important strategies and studies are
highlighted below:
?
The introduction of the Outcome Based Education
(OBE) systems implemented at schools resulted in life
skills being integrated into the curriculum. In 1997
both HIV/AIDS and life skills education commenced
as part of the Department of Health's initiative26.
Stakeholders noted that communication as part of
information exchange in health education was
important and not only based on HIV/AIDS but
included various other health issues of importance27.
Health promotion activities in schools have been
recognized as an effective way of addressing health
related awareness in the community28.
?
The 1999 National Food Consumption Survey (NFCS),
documented the prevalence of being overweight at
17% and this increased concerns regarding the
nutrition transition, CNCDs and its association to
29
urbanization . CNCDs are the leading causal agents of
death in every region of the world except lowestincome countries and sub-Saharan Africa. While
HIV/AIDS is the leading cause of death in South
Africa, CVD is ranked first in women's burden of
15
disease .
2
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
?
According to data from the South African
Demographic and Health Survey (SADHS) in 1998, as
education levels increase so do unhealthy dietary
habits and physical inactivity due to urbanization and
other related factors30. This suggests that access to
education does not necessarily translate to a greater
awareness about healthy lifestyle.
?
Obesity emergence especially in Black African
women has been documented in studies over recent
years31.The 1998 SADHS revealed that 56% of women
and 29% of men were either overweight or obese.
Comparing urban and rural situations, 33% of urban
women and 25% of non-urban women were identified
as either overweight or obese32.
?
In 2000, a study of BMI contributing to an estimated
disease burden was conducted among the four
population groups of South Africa. This study
highlighted the similarity among Coloured, Indian and
White populations who subsisted on a diet high in fat
and sugar, and low in fibre and carbohydrate. This
study also reveals that while urban Black Africans tend
to consume a western diet, rural Black Africans tend to
follow a traditional diet high in carbohydrates and
fibre but low in simple sugars and fat32. Traditional
perceptions and culture regarding body size promote
the use of food rich in fat and sugar. In Black
communities, being overweight has positive
connotations and is considered a sign of happiness and
affluence33. Black women are feeling the pressure
mounting on them as they are subjected to the norms of
Westernization, whereas local tradition emphasizes
the desirability of a larger body size. Also, a thin figure
is associated with sickness and being HIV positive34.
?
In 2001, a South African report discussing 'Poverty
and chronic diseases' highlights that as people get
richer, obesity and hypertension emerge as risk
factors. Therefore it is important to protect poor
people from these risk factors because economic
progress and upward social mobility increases the risk
of major changes in diet and physical activity35.
?
In the 2002 National Youth Risk Behaviour Survey
with adolescents, overweight prevalence was
documented at 17% and postulated to be due to
increased energy-dense food consumption and low
physical activity levels. Nationally 37.5% of
adolescents have shown no or very little physical
activity and this confirms the decrease in physical
29
activity .
?
The 2003 SADHS was carried out as a follow up
survey to the 1998 SADHS. These surveys assist in
tracking changes in the population's health status,
identifying risk factors as well as in understanding if
health services are accessible and utilised by the
population. The 2003 SADHS survey highlights that
being overweight or obese has not changed since 1998
and remain particularly high for women. Fifty five%
of women and 30% of men aged 15 and above are
overweight or obese and the survey also points out that
currently there is considerable evidence of health
problems associated with excess bodyweight which
highlights the urgent need to initiate healthier
environments and lifestyles among all ages.
It is interesting to note that for the first time in the
SADHS, physical activity was measured compared to
other countries. It is not surprising that the survey shows
very high levels of inactivity, especially in urban
settings, with 48% of men and 63 % women in South
Africa being inactive. This data is extremely important to
set the trend in understanding the reasons behind this
behaviour and then setting agenda to change it so as to
avoid the resulting burden of diseases36.
In 2004, a Multi-sectoral National Health Lifestyle Task
Force was established and a strategy document was
drafted in 2005 which is currently in the advocacy stage.
In 2004, government and private sectors, NGOs and
tertiary institutions convened for the Youth Charter on
Physical Activity Sport Stakeholder Workshop, which
resulted in drafting the Youth Charter and constituting a
steering committee37. As part of the Healthy Lifestyle
initiative of the Department of Health, “Vuka South
Africa” was formed in 2005 with the intention of
expanding health education, identifying benefits of
fitness and promotion of physical activity. The Move for
Health core message is the encouragement of individuals
to participate in 30 minutes of moderate physical activity
as many times in a week as possible38.
In South Africa, although policies and guidelines for the
management and prevention of CNCDs have been
developed, their successful implementation at the
provincial and local levels has yet to be achieved39.
Inadequate staff and training, short consultation times,
infrequent use of clinical treatment guidelines, little
patient education in regard to self-care and low rates of
regular clinic attendance and adherence to medication
are some of the factors that constrain the management of
these chronic conditions40. In addition, attitudes of health
care professionals and patients may hinder optimal
prevention and management of CNCDs such as
hypertension and diabetes41,42.
3
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
India:
WHO Global info base, a data warehouse that collects,
stores and displays information on chronic diseases and
their risk factors for all WHO member states reports that
15.2% of females and 16.8% of males fall into the
overweight/obesity range = 25 kg/m² (43). In India, 1024.9% of women aged 30 and above fall into the
overweight range (BMI equal to or greater that 25 kg/m2)
whereas as in South Africa in 2005, more than 75% of
women fell into this category. It has been projected that
by 2015, the number of overweight women in India will
increase to 25-49.9% which will have dire consequences
w.r.t. the prevalence of CNCDs3. It is important to note
that overweight is more prevalent among female, urban
and high-socioeconomic-status (SES) groups44 and the
prevalence of diabetes, hypertension and coronary artery
disease is two- to threefold greater in the urban
population than in rural populations45.
A WHO report highlights that in 2005, projected death
rates from CVDs in India was 400 per 100,000 when
compared to less than 100 per 100,000 from HIV/AIDS,
TB and Malaria. This data highlights the myth that 'Low
and middle income countries should control infectious
diseases before chronic diseases'. CNCDs are
preventable and therefore it is important to adopt health
promotion strategies rather than wait until the challenges
of infectious diseases have been addressed. India has to
guard again another misunderstanding that 'Chronic
diseases affect old people'. The statistics show that
projected chronic disease death rates in 2005 for people
aged 30-69 years were close to 700 per 100,000 in India
whereas it was only 500 per 100,000 in China. A
common misunderstanding that 'Chronic diseases affect
men more than women' has to be reconsidered because
global statistics show that projected global coronary
heart disease deaths in 2005 affected not only 53% men
but also 47% women. In the light of all these statistics it is
important to consider that chronic disease prevention
strategies are cost-effective and have to be implemented
without delay3.
The WHO is estimating an increase of 42% in the number
of diabetics in the developed countries but an enormous
increase of 170% in developing countries by 2025.
Among the various regions that will be most affected by
this increase is the South East Asia region which is
expected to carry the maximum global burden of
diabetes46.
India requires urgent policy and regulatory
governmental interventions along with societal and
individual management of obesity and cardio vascular
diseases to sustain the economic boom with health
population to avert the growing epidemic due to
increased risk factors which range from urbanization to
possible genetic predisposition due to lipoprotein (a)
excess47. If urgent attention is not paid to these epidemic
health challenges, increasing trends of CNCDs such as
CVDs and diabetes will result in calamitous
consequences for developing countries like China, India
and the Russian Federation which are expected to lose
between $200 billion and $550 billion in national income
over the next 10 years3.
Way forward:
The World Health Assembly Global Strategy on Diet,
Physical Activity and Health (2004) provides guidelines
to reduce global disease, deaths and CNCD risk factors,
with improvement of diet and physical activity
promotion, resulting in effective preventative
interventions. The way forward is drafting and
implementing action plans and policies from global to
community levels48. As part of the CNCD action plan,
various responses are necessary at national level which
include: research capacity promotion; health-related
socio-economic, environmental and behavioural
policies; policies in public and private sectors; capacity
building; addressing health inequalities and burden of
disease monitoring 49 .This global strategy uses
experience, evidence and the best practices of countries
that are addressing CNCD prevention, along with health,
physical activity and nutrition knowledge from
developed and developing nations. Thus countries can
choose from a policy 'toolbox', with the strategy
emphasizing that a multi-sectoral and multi-stakeholder
approach to CNCD reduction is needed to decrease the
global disease burden4. Therefore the Global Strategy on
Diet, Physical Activity and Health must be implemented
at a national level11.
Scope exists for the dietary and environmental factors of
obesity prevalence to be better understood by
researchers. Many countries lack the necessary data,
particularly for children, as it is in this population group
that unhealthy diet and physical inactivity have
increased noticeably. Obesity co-morbidities and the
BMIs of the various ethnic groups need identification,
along with documentation of obesity high risk factors in
populations50. A grounded protocol that addresses the
major knowledge gaps needing to be filled with
emphasis on risk factors in all populations is an
4
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
For nutritious food selection, knowledge and support is
necessary for communities. Necessary healthy diet
messages must be creatively conveyed to target groups.
Where the resources of government are poor, effective
working partnerships between NGOs, schools, families,
health professionals, policy makers, corporate leaders,
key leaders, government stakeholders, faith-based
organizations and local communities are vital to initiate,
develop and implement intervention51,52,17. There is a need
for operational research to develop effective communitybased prevention programmes as part of interventions53.
Specifically, the Health and Education Departments, as
government stakeholders, play an important role in
facilitating the understanding of the contributing risk
factors for diet and decreased physical activity in
children and adults17. Interventions focusing on the risk
factors make CNCDs preventable and accomplish
improvement, which can reduce morbidity, mortality
and disability, leading to more positive health
outcomes54.
It is estimated that by the year 2020, lifestyle-related
CNCDs will account for 60% of the burden of disease,
and 70% of deaths worldwide, if adequate health
promotion intervention programs are not established. It
is possible to reduce mortality rates by 2% annually
during the 2006 - 2015 period if the global goal of CNCD
prevention is achieved. This achievement would avert 24
million deaths in the 23 middle and low-income
countries55.
To reduce the chronic disease burden, modification of
lifestyle, promotion of preventative measures in health
care systems, improved dietary habits and physical
activity, community-based interventions for all age
groups, and initiatives to create awareness of risk factors
in the most vulnerable sectors of the population are
vital56,20. It is important for health systems to be
developed to address all CNCDs together rather than in a
“disease by disease” vertical pattern15.
Although evidence indicates that there is feasibility in
unhealthy lifestyle prevention in both children and
adolescents, lack of information on intervention
development, implementation and content, leads to
inadequate intervention programme components being
determined57. Also, generally nutrition programs tend to
focus on children under five years of age, infants,
lactating and pregnant mothers. School-going children
are generally not included in these programs. This
neglected group presents an opportunity for constructive
intervention51. Nutrition education provided during
childhood enables this group to begin making informed
dietary behavior decisions. Thus, during these schoolgoing years, prevention of obesity is vital as juvenile
obesity often worsens or begins during this period of
accelerated growth58.
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7
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
APTI
ijopp
Introducing Pharm. D. Programme in India: A Need of the Day
Patil JS,*Kulkarni RV, Marapur SC, Dalavi VV
Department of Pharmaceutics, B.L.D.E.A's College of Pharmacy,
B.L.D.E University Campus, Bijapur-586 103, Karnataka
Author for Correspondence: [email protected]
Abstract
This article aims to focus on need of changes in the Pharmacy education in India and proposed role of clinical
Pharmacist in the healthcare system. A thorough search of literature was carried out and critically compared the
recently introduced Pharm. D. programme with the same of other countries especially United States of America. An
attempt was also made to identify the need of Pharm. D. programme, which is going to produce clinical Pharmacists
as per the requirement of our healthcare sector. This study made an attempt to narrate the role of Pharmacist in
clinical and biomedical research and also tried to focus on the scope of pharm. D. graduates across the world. This is
not the right time to say some thing on Pharm. D. programme, because it is in the stage of infancy. The Pharmacy
Council of India is appreciable for introducing this programme. Hence, the study critically reviewed and tried to
draw attention of our regulatory bodies to take attention for successfulness of this programme.The study also
identified some regulatory and upgradational suggestions to our government authorities and policy makers, which
may help in successful implementation of Pharm. D. programme in India.
Key words: Pharm. D. programme, Clinical pharmacy, Healthcare sector.
INTRODUCTION
Recently, Pharmacy Council of India decided to
introduce Pharm. D. course for the first time in the
country from the academic year 2008-09.Though the
Pharmacy profession is an ancient profession dedicated
to invention and development of drugs, it has been
relegated to backseat and the role of Pharmacy profession
in the healthcare system has not gained required
recognition. In India, Pharmacy education has initiated in
the year 1932 at Banaras Hindu University by Prof.
M.L.Schroff. Since those days the Pharmaceutical
education has developed to great extent and slowly
getting popularity as much as other professional courses.1
But the central and state governments of India have not
recognizing our profession even lot many employment
opportunities are available to Pharmacy graduates
especially in clinical and hospital pharmacy areas.
All over the world Pharmacy education has now grown
itself into a clinical profession, while in India the
Pharmacy programme has concentrated more on
industrial aspects. Since 1948, by producing B.Pharm.
graduates, the Pharmacy profession has been quite
useless in fulfilling the need of public healthcare sector.
We proved that we are producing the Pharmacist as a
“drug experts rather than health experts”. 2 By
Indian Journal of Pharmacy Practice
Received on 31/03/2009
Accepted on 12/01/2010 © APTI All rights reserved
considering all such limitations associated with our
profession, it is a right decision of the Pharmacy Council
of India to start the Pharm. D. programme which is based
on clinical pharmacy care for the fulfillment of the need
of public healthcare system. This decision also gives an
opportunity for a Pharmacist to involve actively in this
noble health care process. In this article, an attempt was
made to appreciate the decision of Pharmacy Council of
India and focus on need of this proramme and upgrade
our self to compete with global Pharmacy world.
Need of Pharm. D. programme in India
In the last consensus, India has crossed one billion
population with an exponentional rise of 30-40 million
population added every year. Most of the India's
population is rural based, illiterates with little or no
adequate basic emenities including healthcare facilities.
As a result majority of the population is suffering from
various health problems including mal-nutrition
disorders, maternal and infant deaths, in spite of various
government health programmes failed to provide net
results. While in the cities, people are little educated
having number of social habits such as smoking, drinking
etc., and becoming slaves and burden to the society.3 The
reasons for the above problem are numerous.
There are more than six hundred Pharmacy institutes in
India producing over 13,000 pharmacy graduates every
8
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
year, pharmacy practice experiences are more or less non
existent with particularly no emphasis on
phamacotherapeutics and clinical pharmacy, there may
be exceptions like Jadhavpur university and JSS college
of pharmacy.4
Presently, most of the people in India when they are
suffering from diseases rarely go to the doctors either
because of they are very poor or too busy and often rely
on local Pharmacist for medical advice. In the Indian
healthcare system the doctor diagnosis and prescribe the
medicines, a Pharmacist may explain how to take the
medicines. The people of India are more dependent on
pharmacist rather than a doctor. Along with these, some
other following reasons emphasize on the need of
pharmacist in health care system and focuses on the
development of clinical pharmacy in India.
1) Poor healthcare facilities in the rural areas of the
country.
2) Medical professionals not moving towards villages.
3) Increased work pressure on doctors necessitates
involvement of pharmacists.
4) Increased awareness of medicines in patients leading
to self medication habits.
5) Improper implementation of “rational drugs use”
policy.
6) Improper use of antibiotics, leading to serious
problems such as drug resistance.
7) Improper educational background of patients.
8) Unidirectional decision of medical people in
healthcare system.
9) Social and economic factors
10)Grave shortage of healthcare personnel in healthcare
sector.
These reasons necessitate revamping the conventional
role of Pharmacists in Indian health care sector. And
hence by producing the world competent Pharm. D.
graduates mainly having the knowledge of clinical
profession and pharmaceutical care, the above problems
can be solved at measurable extent.
In the rapidly changing healthcare system across the
world, the service of the Pharmacist is well accepted in
patient care. The concept of practice of pharmacy care in
the developed countries is well recognized the
pharmacist as health care professional. The world health
organization has given recommendations regarding roles
and responsibilities of pharmacists in community
pharmacies. But in most of the developing countries like
India, involvement of Pharmacist though important and
primary requirement is worse neglected. By considering
all these aspects, introduction of Pharm. D. programme
in India is utmost right decision of our apex body.
Figure.1: The scope for Pharm. D. graduates
Community practices
Services at hospital
pharmacy departments
Public service practice
Collaborative clinical
practices
Pharm.D.
Pharma industry
Graduates
Biomedical
research areas
Academic services
Managed-care
pharmacy services
9
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
The scope for Pharm. D. graduates
The Indian students choose the Pharm. D. course as their
career, because they have number of opportunities across
the world. These include community practices,
collaborative clinical practices, services at hospital
pharmacy departments, pharmaceutical industry, public
service practice, academic services, managed-care
pharmacy services and biomedical research areas as
shown in Figure 1.
Community practices
As the Pharmacists are easily accessible to the public,
they considered as healthcare professionals. They can
effectively counsel the patients, give precise drug
information, take pharmaceutical care, render health
screening services and work for public health promotion.
Hence, Pharm. D. graduates can have opportunities in
community practice area, such as work at independent
corporate pharmacies, neighborhood health clinics,
home healthcare services and consulting for nursing
homes.
Collaborative clinical practices
Always in the healthcare system, optimizing the clinical
outcomes solely depends on adequate management of
drug therapy. Hence the Pharm. D. graduates have
intense training and broad knowledge in the clinical
aspects, they can work with other healthcare
professionals to select and manage the drug therapy to
optimize the clinical outcomes of the specific cases.
Services at hospital pharmacy departments
As the hospital is a complex health care setup, involving
the services of different healthcare professional. As a
valued member of the healthcare team, hospital
pharmacist can involve in various activities such as drug
therapy management, health education, clinical studies,
administration and drug use evaluation.
Pharmaceutical industry
Pharm.D. graduates can also have broad scope in the area
of Pharma industries particularly in the manufacturing,
marketing, sales, clinical research, and regulatory
affairs.
Public service practice
The Pharm.D. graduates have options to have practices
in federal agencies such as food and drug administration
(FDA), Drug enforcement administration (DEA),
Airforce, Navy, Army, public health services, and the
department of veterans' affairs.
Academic services
Pharm.D. graduates can have opportunities in teaching
and administrations too.
Managed-care pharmacy services
Pharmacist with Pharm.D. degree can provide clinical
services and management services in a managed care
settings.
Biomedical research areas
As the Pharmacists have a broad base of knowledge in
pharmacology, pharmacokinetics, phamacodynamics,
p h a r m a c o g e n e t i c s , p h a r m a c o t h e r a p y, a n d
pharmacoeconomics along with good understanding of
human metabolism, transport and elimination, The
Pharm.D. graduates can significantly involve in the
translational/clinical research activities. Also the
Pharmacist has a multiple level knowledge related to
drug development and therapeutics; they can acquire
unique positions to conduct research towards achieving
the goal of individualized prescription drug therapy. As
the Pharm.D. graduates have the ability to envisage
translational endpoints; they can work as a valuable
component of the current biomedical research enterprise.
The Pharm.D. graduates offer biomedical research as
career field and can have perspectives to clinical
research, they can have scope in introducing and
integrating pharmacogenomic approaches and methods
to clinical trials in various disease areas. Further, the
Pharm.D. graduates can become bridge between clinical
investigators. The broad knowledge of physiology and
drug metabolism enables them to pursue research
interests in a range of therapeutics areas.
Comparison of Indian Pharm.D. programme with
other countries
If we have the glance on the overall curriculum of Indian
Pharm.D. programme, it can be noticed that, the subjects
and their content for first to third pharm.D. course is not
much differing from our current B. Pharm course. This
clearly indicates that much emphasize has neither been
made to make this programme more patient focused nor
clinical oriented concepts. Whereas, in other countries in
contrary have given more importance and focus on
subjects such as hematology, oncology, pain
management, special population, renal/pulmonary
diseases etc., along with the basic subjects such as
pharmacokinetics, pharmacotherapy, pharmaceutics,
pharmacology and medicinal chemistry. These subjects
will prepare the students for the practice of pharmacy as
these are focusing on disease state management aspects.
And most of the universities abroad are offering dual
degrees like Pharm.D. / MBA, Pharm.D./MS and
Pharm.D./Ph D. This kind of joint degree programme
permits the students to study concurrently for a Pharm.D.
and graduate degrees like MS and PhD in pharmaceutical
sciences. In such cases, students will learn about
literature evaluation, research design, career
opportunities and current issues in the healthcare.
In the Indian Pharm.D. programme, such subjects seem
to appear after completion of three years of the course.
10
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
But we hope in future in the up-gradation process of this
programme, our experts can tailor made to meet the
needs of Indian health care sector. We should emphasize
more on pharmaceutical care aspects rather than industry
oriented principles. As there is no clear statement about
global equality of this programme, it is being expressed
by different people in different meanings in media. But it
is yet to be clear that, whether Indian Pharm.D. graduates
whishing to serve at United States of America have to
appear for NAPLEX examination or it is not necessary?
Regulatory and upgradational suggestions
To start any new courses it may not take much pain but
maintaining and upgrading the same to meet the global
standards is the area where we Indians are lacking
behind. It is quite natural to feel very hard for any new
thing to begin but as time goes on, it must always become
easier to manage. In this context, to strongly establish the
Pharm.D. course here, there is a scope for establishment
of specific task force, charged with assessing the
Pharm.D. programme periodically. The task force may
given powers to define the career opportunities for
Pharm.D. graduates exploring the demand for Pharm.D.
graduates in the situations of competencies. It also may
have special powers to inspect the institutes to monitor
the quality of education. This task force may be having
vision and mission as that of the American association of
College of pharmacy- Clinical scientist's Task force
(AACP-CSTF). This kind of attempts may bring out
some collective changes and improvements in the
programme, which may prepare our graduates more
competent.
Better co-operation from medical faculty is an
ultimate need
Clinical pharmacy promotes rational drug use and plays
an important role in patient care. However, in developing
countries, clinical pharmacy is promoted as an isolated
single entity and not related to a stable population based
pharmaceutical system. Whereas, in the western
countries and United States the clinical pharmacy is well
established with stable drug distribution system in
hospitals and efficiently regulated by the authorities. But
it is really a challenge for the developing countries like
India to promote the Pharm. D programme based on
clinical pharmacy in the absence or nearly absence of
good governance of pharmaceuticals.
As this course is mainly hospital oriented, and Pharmacy
Council of India has made it compulsory that the college
wish to start Pharm.D. course must have an adjoined
hospital. This necessitates the pharmacists to work with
medical faculty and the better cooperation between each
other is required to run this programme, otherwise it
becomes absolutely meaningless. In the Pharm.D.
programme, students undergo extensive clerkship and
internship training including posting in especiality units.
Students should independently provide the clinical
pharmacy services to the allotted wards. As per the
Pharmacy Council of India curriculum, student must
work six months in general medicine department and two
months each in three other specialty departments. Every
student shall spend half a day in the morning hours
attending ward rounds on daily basis as a part of
clerkship. The student shall provide patient care in
cooperation with patients, prescriber and other member
of inter professional healthcare team. But presently the
pharmacy education in India is under the control of
private educational societies which may have their own
medical college hospital or may utilize government
hospitals.
The medical profession in India always suffering with a
superiority complex, they even not considering the
doctors practicing Indian medicine system as a health
care professionals, hence there is a big question mark on
the better cooperation of medical faculty in successful
run of pharm.D. programme. The cooperation from
medical faculty also depends on our sound therapeutic
principles, highly ethical and knowledgeful skills in
monitoring of therapeutic outcomes, as it is already
proved in JSS College of Pharmacy, where pharmacy
professionals are recognizing as other healthcare
professionals.
Modifications are needed in health policies of the central
government and all the state governments to give
respectful recognition of pharmacy profession and
pharmacist as the one of inter-professional health care
team. After modifying the policies, we hope that
pharmacy profession will overcome the limitations
associated with it and emerge stronger in function and
offer the concept of health for all.
Even in United States, to consider the pharmacy
profession as one of the potential health care team it took
years, now the simple drug dispensing pharmacist is
considering as a highly skilled clinical pharmacist. As
the Pharm.D programme was introduced first in United
State was done on prior arrangement and strengthening
of pharmacy practice system, that was useful for their
country, whereas in developing countries like India the
pharmacy practice system is seldom exists and the
conditions are worse where it is still fighting for
11
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
recognition with its own worth and reputation. In India,
pharmacy colleges running the basic degree in pharmacy
(B Pharm) are still suffering with inadequacy. Most of
the colleges are absolutely failed to fulfill the
requirements of apex bodies such as inadequate staff
profile, lack of advanced facilities and equipments etc.
The pharmacy colleges are in a debilitating state; their
curricula are devised by highly non-technical personnel
who have no idea about technical or clinical pharmacy
practice subjects. Many of the pharmacy colleges are
very busy in producing postgraduates and PhD holders
obviously in bulk. To avoid such types of manipulations
our apex bodies must be more cautious and required to
strictly monitor the quality of Pharm. D. education to
create a world class clinical pharmacist.
CONCLUSION
In the health care system, the requirement of controlling
the adverse drug reactions, patient compliance,
therapeutic drug monitoring, better drug dosage regimen
etc are few among many, which we need to achieve. The
drawbacks and limitations of our medical services to the
public of our nation, can overpower by training the
Pharm..D. graduates in ensuring patient compliance and
acceptability. And hence the emerging field of Pharm.D.
in India is the ultimate requirement and to achieve better
patient compliance which ultimately make us success in
achieving the concept of health for all. This may results
in increased recognition and respect to the Pharmacists.
REFERENCES
1. Mukharjee PK. Inclusion of pharmacy subject in
Indian civil service examinations. Ind J Pharm Edu
1999;33:141-145.
2. Adepu R, Nagavi BG. Community pharmacy
Practice-A Review. Ind J Pharm Edu 2003;37:14-27.
3. Kale S. Pharmacy education: current problems and
suggested solutions. Ind J Pharm Edu 2004;38:154160.
4. Parthasarathi G, Ramesh M, Nyfort H, Nagavi BG.
Clinical pharmacy in a South Indian teaching hospital.
Ann pharmacother 2002;36:927-932.
5. Babar ZU. Defining clinical pharmacy in Asia
(posting) Essential Drugs 2007. Available at:
http:/www.essential drugs.org/edrugs/archieve/2007.
12
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
APTI
ijopp
Biochemical tests in pregnancy
Babitha K. Vazhayil, Jayakrishnan.S.S#
Govt. College of Pharmaceutical Sciences, Medical College, Thiruvananthapuram, Kerala.
Author for Correspondence:[email protected]
Abstract
Pregnancy is a normal physiological phenomenon associated with marked hormonal and biochemical changes in
the maternal circulation which facilitates the metabolic, vascular and immunological adjustments necessary for the
fetus to thrive. Abnormal concentrations of these hormones or of other plasma constituents of fetoplacental origin
may indicate gestational pathology. The metabolic changes associated with pregnancy are relatively short lived and
thus are rarely harmful to the healthy mother. When pregnancy deviates from its normal course there are many
biochemical markers which can be used to assess these abnormalities. As biochemistry is only one part of obstetric
care the results should be interpreted in conjunction with clinical and medical imaging data.
Key words: human chorionic gonadotrophin, alpha fetoprotein
INTRODUCTION
Prior to the widespread availability of high resolution
ultrasound scanning, the diagnosis of early pregnancy
failure (such as spontaneous abortion and ectopic
pregnancy), of fetal malformation and fetal growth
disturbances relied solely on clinical evaluation backed
by blood tests on the maternal circulation. There are
certain biochemical markers which can be used to assess
maternal, placental and fetal health. They help to
diagnose maternal conditions such as gestational
diabetes and pre-eclampsia, placental conditions like
trophoblastic disease and fetal chromosomal
abnormalities like Down's syndrome.
Biochemical diagnosis of pregnancy:
Biochemical diagnosis of pregnancy is routinely made
by the detection of human chorionic gonadotrophin
(beta-hCG) using a latex agglutination technique
detecting concentrations >200 i.u/L while a monoclonal
antibody enzyme immunoassay will detect
concentrations as low as 50 i.u/L.
Also estimation of schavengershaftsprotein 1 (SPI) and
pregnancy associated plasma protein A (PAPPA) helps in
determining gestational age in early pregnancy.1
Biochemical monitoring of pregnancy:
Ectopic pregnancy
The incidence of ectopic pregnancy appears to be
increasing making accurate diagnosis of this condition
increasingly important. Even though definitive diagnosis
still depends on laparoscopy, use of additional tests may
help reduce the number of unnecessary laparoscopies.
Determination of urinary â -hCG and plasma monoclonal
Indian Journal of Pharmacy Practice
Received on 09/12/2009
Accepted on 15/01/2010 © APTI All rights reserved
antibody tests are the commonly employed tests for
diagnosis of ectopic pregnancy. When the test is positive
and an ectopic pregnancy is suspected a quantitative â hCG (0.15 – 0.8 i.u/L) may be advocated.
In ectopic pregnancies with normal hCG concentrations
PAPPA concentrations have been reported to be
consistently low. If these observations are confirmed
estimation of PAPPA may prove useful as an adjuvant test
in the diagnosis of ectopic pregnancy.
Spontaneous abortion
Many studies have reported low concentrations of
various hormones and placental proteins in cases of early
spontaneous abortion. Measurement of hCG is a valuable
adjunct in the evaluation of threatened abortion in the
first trimester. If less than 3000 i.u/24 hrs is excreted the
fetus is almost invariably dead. Also plasma
progesterone concentrations have been reported to be
low in such situations.1
Biochemical assessment of maternal health
Common maternal problems in pregnancy include
anemia, urinary tract infection, toxemia, gestational
diabetes and pre-eclampsia.
Anemias of pregnancy
Types of anemias that are more prominent in pregnancy
include iron deficiency anemia, hemoglobinopathies and
megaloblastic anemia. The last variety is quite unusual.
Examination of well prepared and well stained blood film
helps in the diagnosis of anemia.
Urinary tract infections in pregnancy
The urinary tract stasis and dilation, possible
instrumentation or catheterization, and the trauma of
childbirth all increase susceptibility of the woman to UTI
during or following pregnancy.
13
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
The periodic microscopic examination of the urine
sediment for white blood cells and bacteria as well as
screening procedures to detect significant bacteria helps
in the proper diagnosis.
Toxemia of pregnancy
Along with periodic measurement of blood pressure and
weight the check for proteinuria is a valuable screening
procedure for toxemia, because proteinuria and renal
impairment are prominent features of this disease.
Toxemia can progress to pre-eclampsia and frank
eclampsia (convulsions).²
Diabetes mellitus
Prevalence of gestational diabetes mellitus ranges from 1
to 14 % depending on the populations studied. Screening
for gestational diabetes can be carried out at 26-28 weeks
gestation. This enables early intervention which results
in significant improvements in both fetal and maternal
outcomes. The diagnosis can be confirmed by further
tests of fasting glucose concentration or 75 g oral glucose
tolerance test. These patients should be reassessed in post
partum period for evidence of diabetes. The woman's
glycated hemoglobin should be maintained in the normal
range to ensure optimal fetal outcome.³
Pre- eclampsia
Pre-eclampsia occurs typically in the third trimester and
affects 4-8 % of pregnancies. It constitutes a triad of
pregnancy associated hypertension, marked proteinuria
(>300 mg daily) and pathological edema. It is thus
critical to carry out dipstick testing for protein at each
antenatal visit together with blood pressure measurement
and careful examination for edema. Other findings
include rises in serum uric acid, urea and creatinine. Low
hemoglobin and platelet concentrations are informative
if the patient is suspected to have severe form of preeclampsia-haemolysis-elevated liver enzymes-low
platelets (HELLP).³
Biochemical assessment of placental health
Biochemical assessment of placental health is important
because it helps in diagnosing trophoblastic disease
(hydatidiform mole or choriocarcinoma).Maternal
serum human placental lactogen and serum or urinary
oestriol concentrations which were previously used
extensively in the assessment of placental function are
rarely used nowadays.
Physiologically serum hCG arising from trophoblastic
activity is elevated as early as eighth day after
implantation. Concentrations double every 2-3 days and
peak at approximately 10 weeks. They then decline and
plateau out at lower concentration until parturition.
In addition to confirming pregnancy hCG can be used as
a marker to assess various abnormalities in first trimester.
An elevated serum hCG level suggests the presence of
multiple pregnancies or gestational trophoblastic disease
such as chorionic carcinoma or hydatidiform mole. A
hydatidiform mole appears as snow storm on ultra sound.
Confirmatory biochemical tests include free â-hCG
concentrations because this form of hCG is secreted in
disproportionately high amounts. hCG can be used to
assess the effectiveness of therapy and monitor for
recurrence following surgery for gestational
trophoblastic disease. A rapid decline or disappearance of
serum hCG is to be expected after surgery.
After the second month of pregnancy the fetoplacental
unit becomes the major source of estrogen production in
the pregnant woman. These estrogens are excreted in the
urine and are proportional to the amount and type of
trophoblastic disease in the placenta as well as the blood
flow through the placenta. Mean excretion in the last 6
weeks is about 16 mg/day with a range of about 20 to 24
mg/day.
Level of urinary estriol less than 12 mg/day, during the
last weeks of pregnancy is associated with impending
fetal death. Levels below 4 mg/day almost indicate fetal
death. Sudden falls in estriol levels from above 12 mg to 4
or 6 mg indicate serious fetal difficulties and prompt
delivery must be considered.4
Biochemical assessment of fetal health
The major aim of fetal assessment is to ensure
satisfactory growths in utero.There are many factors
which can cause fetal growth retardation. These may
range from poor maternal nutritional state to placental
insufficiency and fetal abnormality. Fetal abnormalities
that can be detected using biochemical markers include
neural tube defects, Down's syndrome, hemolytic disease
of the newborn and lung immaturity.
Alpha fetoprotein
It is a fetal protein arising form the yolk sac and fetal liver.
It can be detected in maternal serum until 32 weeks of
normal gestation.
Neural tube defects
Neural tube defects are among the most common fatal
congenital malformations.
In neural tube defects such as spina bifida8 and
anencephaly, the concentration of alpha fetoprotein in the
maternal serum is unusually high in the first trimester
because cerebrospinal fluid leaks into the amniotic fluid.
As a marker of neutral tube defects maternal serum alpha
fetoprotein, ideally, should be measured between 15 and
18 weeks of gestation. Elevated maternal serum AFP
levels are seen in about 85% of open neural tube defects.
After maternal serum AFP is found to be elevated the
14
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
level of AFP in the amniotic fluid should be determined.
Elevated amniotic fluid AFP is about 95% sensitive for
open neural tube defects. Any suspicion of a neural tube
defect can be further assessed with ultrasound, usually at
18-20 weeks.5
Diagnosis of fetal genetic abnormality
Most of the fetal genetic disorders are diagnosed using
tissue sampling techniques, although majority of these
procedures are performed for fetal karyotyping. Tissue
sampling techniques that can be used for the diagnosis
are amniocentesis and chorionic villus sampling
(CVS).most commonly occurring fetal genetic
abnormality is Down's syndrome. Another procedure
used for screening of Down's syndrome is maternal
serum screening (triple test).
Chorionic villus sampling
As the fetus and the placenta both develop from the same
early blastocyst their genetic make-up is identical in the
vast majority of cases. Thus, chromosome and DNA
analysis of the placenta will provide information about
the fetus.
Amniocentesis
Traditionally amniocentesis has been performed at 16
weeks gestation and the result is available 2-4 weeks
later. As a result of the late gestation at which the result
becomes available earlier amniocentesis is currently
under investigation. This new technique can be
employed from 10 weeks gestation.
Down's syndrome
Down's syndrome is one of the common causes of fetal
growth retardation. It is the result of either partial or total
trisomy of chromosome 21 or a major obstetric concern,
particularly in older women. Important biochemical
markers include alpha fetoprotein, hCG, unconjugated
oestriol, pregnancy-associated plasma protein –a, serum
inhibin-a and free â -hCG. These markers are used in
various combinations and together with ultrasound to
increase the detection rate of Down's syndrome.
Between 11 and 13 weeks (that is late first trimester),
serum pregnancy-associated plasma protein-A. Free â hCG and ultrasound assessment of nuchal thickness (the
physiological space between the back of the neck and the
overlying skin of the fetus) are most commonly used in
the assessment of Down's syndrome.
In the second trimester screening for Down's syndrome
traditionally employs the triple test of maternal serum
hCG, serum unconjugated oestriol and alpha fetoprotein
at 15-18 weeks of gestation. Some laboratories also
measure serum pregnancy associated plasma protein -A.6
Fetal lung maturity
The lungs are among the last of the fetal organs to mature.
Thus, mature lungs usually indicate that the fetus is ready
for birth. Fetal lung maturity is evaluated by measuring
the amount of surfactant in the amniotic fluid. A
deficiency in surfactant leads to the development of
respiratory distress syndrome (RDS) in neonates.75
percent of the surfactant consists of phosphatidyl choline
(lecithin), 10 percent consists of phosphatidyl glycerol
and the remainder consists of various phospholipids and
sphingomyelin. Various assays can be used for measuring the concentration of various components of
surfactant. The most popular biochemical assay used to
assess FLM is the lecithin/sphingomyelin ratio.
Hemolytic disease of the newborn
In hemolytic disease of the newborn (HDN) the red blood
cells of the fetus are coated with maternal IGG antibody
and are destroyed in the infant's reticuloendothelial
system. Several blood group systems have been
associated with HDN, for example, the Rh system, the
ABO system, and other groups that form IgG antibodies.
At present there are no laboratory procedures that can
predict ABO hemolytic disease during the prenatal
period.
The objective of prenatal blood studies is to identify
women at risk for having babies affected with HDN.
Following studies can be done early in the pregnancy: 1)
ABO grouping; 2) Rh testing; and 3) screening for
unexpected antibodies (indirect coombs' test) 7.
CONCLUSION
Although ultrasound based bio-physical tests are
available for the diagnosis of early pregnancy failure,
fetal malformation and fetal growth disturbances,
biochemical assays still form an important part of the
screening of many pregnancies. These biochemical and
hormonal tests constitute only one aspect of obstetric
care and so the results should be interpreted in
conjunction with clinical findings and imaging,
particularly ultrasonography
REFERENCES
1. Clinical Biochemistry: Metabolic and Clinical-by
William.J.Marshall and S.K.Bungert, 413-418.
2. John AK, John FK. Textbook of clinical laboratory
approaches. pp. 343-354
3. http://www.australianprescriber.com/magazine/
29/2/48/52/
4. Ravel R. Textbook of clinical laboratory medicine. pp.
740-750
5. http://www.medsacpe.com/viewarticle/408805_9
6. http://www.geneticcounselling.eu/genetics4:html
7. Burtis CA, Ashwood ER. Tietz Textbook of Clinical
Chemistry. pp. 1736-1760.
15
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
APTI
ijopp
Pharmacoeconomics: Need for the day
Mahvash Iram*, Shobha Rani. R.Hiremath
Deaprtmentt of Pharmacy Practice, Al-Ameen College of Pharmacy, Bangalore-560027
Author for Correspondence: [email protected]
Abstract
Health economics shed's light on the concept of making decisions about resource allocations at the time of scarcity of
resources and increased demand, by evaluating the rationale of choices in terms of their cost and benefit.
Pharmacoeconomics is one of the strongest pillars of health economics to make the allocation decisions with respect
to the medicines and there by ensure that society allocates minimal health care resources wisely, fairly, and
efficiently. Two major components of any pharmacoeconomic evaluation are cost and consequences and using
pharmacoeconomic principles, methods and theories into practice, for quantifying the value of pharmacy products
and pharmaceutical care services utilized in real world environment is one of the major applications of
pharmacoeconomics. The key reason for studying pharmacoeconomics is to be able to estimate, understand and
interpret the complete impact of a drug therapy. Such an impact would be shown on individual's health, safety, their
use of health care services, cost of health care, quality of life, functional status and on society as a whole. The price of
drug therapy will be then justified based on its impact on broad range of outcomes.
Key words: Pharmacoeconomics, cost, consequences, health care, benefit
INTRODUCTION
In India because of growing pressure on the healthcare
budget, appropriate justification of current expenditures
and future investments in public healthcare are
becoming a priority. Pharmacoeconomic analyses are
one means of justifying and minimizing these
expenditures. Health care professionals must be able to
create a balance between the needs and desires of
individual patients with the needs and desires of society
at large. Comparing the expected benefits of a medical
intervention against the expected cost of that
intervention along with the health care benefits many
times is difficult to interpret, in such a scenario
pharmaco-economic studies helps to ensure that society
allocates minimal health care resources wisely, fairly,
and efficiently.
Cost and Consequences (Outcome)
Two major components of any pharmacoeconomic
evaluation are cost and consequences (outcome).Cost is
the total value of resource consumed for drug therapy of
interest or related services. Consequence is the outcome
of drug therapy of interest or related services.
Assessment of cost and consequence depends mainly on
two perspectives – Patient and Provider.1
In patient's perspective it will be the health care services
received where costs include co-payments,
Indian Journal of Pharmacy Practice
Received on 12/01/2010
Accepted on 23/01/2010 © APTI All rights reserved
transportation, loss of income and consequences include
relief of symptoms, cure, and quality of life. This outlook
is more subjective because it includes patient
preferences and less common in the empirical literature.
Provider's Perspective includes health care services
delivered. Costs here will be in terms of personnel,
supplies and consequences will be measured as length of
stay, mortality, morbidity. This perspective depends on
capitation and managed care penetration.2
To help decision making regarding a drug therapy, the
pharmacoeconomic evaluation should include an
assessment of the economic, clinical and humanistic
outcomes. (i.e., ECHO model). Sometimes the
consequences are grouped as positive and negative
where desired effect or efficacy of the drug will be a
positive outcome and adverse drug reaction or treatment
failure will be a negative outcome. 2
Pharmacoeconomic techniques
Cost-of-illness analyses: Identifies and measures the
costs of the illness itself but not treatment outcomes.
Cost-benefit analyses: Measures the costs of treating an
illness, along with monetary equivalents that provide the
same outcome, with the ultimate aim of identifying the
most economic option.
Cost-effectiveness analyses: Measures the costs of
treating an illness, by using clinical measurements which
involve the comparison of cost per standardized unit of
effectiveness, such as cost per life saved or cost per
16
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
hospitalization avoided for two or more interventions
that provide varying outcomes.
Cost-utility analyses: Measures the costs of treating an
illness in terms of their social value, expressed in
incremental measures or preference equivalents (QOL,
QALY) for the treatment's outcomes.
Cost-minimization analyses: Directly compares the
costs of treatment options for an illness, assuming
equivalence of their outcomes.
Using Pharmacoeconomic principles, methods and
theories into practice, to quantify the value of pharmacy
products and pharmaceutical care services utilized in real
world environment is major application of
Pharmacoeconomics.3
Modelling and sensitivity analysis
Lack of cost and consequences data for many
complicated health care interventions presents with
problems of interpretation, these problems can
sometimes be solved by using clinical and economic
modelling most common being decision trees and
Markov models. A decision tree maps out the alternative
being compared in as much detail as possible. Usually
starts with a decision node and subsequently probability
nodes show the chances of each possible consequence
occurring.
A range of interventions and their possible consequences
can be mapped out clearly in a decision tree. Once
4
options are clear, probabilities can be attached to them
either using new trial data or existing information.
Sensitivity analysis is the act of changing assumptions
about the value or probability of costs and consequences,
to determine whether the results of an evaluation are
Visit doctor
sensitive to such changes or not. Markov models are
helpful when decision trees are not sufficient such as in
case of chronic diseases and complex interventions
where same decisions recur constantly. 4
Limitations
Numerous limitations exist when pharmacoeconomic
studies are put into practice. Entire process may be biased
with respect to choice of comparator drug, assumptions
made or reporting of results. Since most studies are
conducted or funded by pharmaceutical companies who
are keen on the results, 5 there exists a publication bias
towards those studies favorable to sponsoring
companies. Pharmacoeconomics hence is misused
sometimes as a marketing tool.6
Similar problems may arise in studies funded by health
care payers (Insurance companies). Doctors may have
the tendency to equate pharmacoeconomics with cost
cutting, and hence reject on principle as unethical.
One of the major problems is ability to implement the
results of a study. Irrespective of how good a study is, and
how cost effective a therapy is when compared to
existing treatment, it may not be possible to achieve its
potential benefits because of the existing management
structures. Management authorities have a short term
outlook which limits the application of pharmacoeconomic evaluations showing long term savings for the
health service in return for increased spending.7 Many
budgets operate in isolation, and it is not easy to move
money between them and a new intervention may not be
affordable no matter how cost effective it might prove to be.
Gets better
p
p1 Alternative
treatment
p-1
Return to
Doctor
p1-1 diagnostic
Procedure
Disease/
Ailment
Gets better
q
q1 Chronic disease
Self Treatment
q-1
No-improvement
q1-1 emergency
medical care
17
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
SUMMARY
Various methodological advances have been
implemented to make available the tools that are
necessary to measure comprehensive outcomes; which
includes Strategies for collecting pharmacoeconomic
data. Using psychometric techniques, tools for
measuring changes in general and disease specific health
status have been developed and validated.8 Frequentist
and Bayesian approaches are preferred for designing as
well as analyzing of a clinical trial and observational data
to use in Pharmacoeconomic evaluations.
Individuals or organizations who are involved in health
care decision making such as, pharmaceutical
companies, medical device companies, consumers of
such products and health care providers9,10 should have a
through knowledge of various elements of
Pharmacoeconomic analysis to be able to understand the
interpretation in terms of result.
The key reason for studying pharmacoeconomics is to be
able to estimate, understand and interpret the complete
impact of a drug therapy. Such an impact would be shown
on individual's health, safety, their use of health care
services, cost of health care, quality of life, functional
status and on society as a whole. The price of drug
therapy will be then justified based on its impact on broad
range of outcomes.
Economic evaluations of drug therapy are increasingly
important in decision making. Health care providers
should welcome this as a means to promote efficiency
and effectiveness of prescribing, and aim to move the
debate away from pure cost to value for money in
prescribing. This tool can be effectively used in drug
evaluation & formulary decisions in hospitals, clinical
guidelines & drug use policy development, supporting
pricing decisions for new products, service or program
evaluation.
To improve upon the existing knowledge and practice of
pharmacoeconomics; more education has to be provided
and workshops to health professionals, decision makers
& medical representatives on should be conducted on:
Various pharmacoeconomic study designs, literature of
Pharmacoeconomic studies, modeling studies including
decision analysis, sensitivity analysis and markov
modeling, pharmacoeconomic courses incorporation in
the curriculum. Inspite of the complexicity of the subject
it is need for the day more so because the new age has
numerous drug therapies and devices being launched
everyday
REFERENCES
1. McGhan WF, Lewis NJ, Guidelines for Pharmacoeconomic studies. Clin Ther 1992;3:486-494.
2. Kozma CM, Reeder CE, Schulz RM. Economic,
clinical and humanistic outcomes: A planning model
for pharmacoeconomic research. Clin Ther
1993;15:1154-1176.
3. Guzman RA, Tosti A, Hay R. Pharmacoeconomics –
an aid to better decision-making. JEADV
2005;19(1):34–39.
4. Winfield AJ, Richards RME. Pharmaceutical
Practice. 3rd ed. Churchill Livingstone, 2004.
5. Walley T, Davey P. Pharmacoeconomics: a challenge
for clinical pharmacologists. Br J Clin Pharmacol
1995;40:199-202.
6. Hillman A, Eisenberg J, Pauly M et al. Avoiding bias
in the conduct and reporting of cost effectiveness
research sponsored by the pharmaceutical
companies. New Eng J Med 1991;324: 1362-1365.
7. Cull R, Wells N, Miocevick M Economic costs of
migraine Br J Med Econ 1992;5:103-115.
8. Maukskopf JA. Why Study Pharmacoeconomics?.
Expert Rev Pharmacoeconomics Outcome Res
2001;1(1) :1-3.
9. James S, Waddington C. Capacity building in health
economics opportunities for training in developing
countries.Health Economics 1996;5:473-8.
10. Heckman J, Smith J. Assessing the case for social
experiments. Journal of Economic Perspectives
1995;9(2):85-110.
.
18
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
APTI
ijopp
Retrospective Patient Data Analysis with Respect to Irresponsible SelfMedication in a Community Pharmacy Setting in Taiping (Malaysia)
Sam A T*, Naga Jothy Nagesvararao, Nager Devi Vampanan, Sharon T X X S, Arumugam D
Faculty of Pharmacy, AIMST University, Semeling-08100, Kedah, Malaysia.
Author for Correspondence: [email protected]
Abstract
This study was undertaken to determine the incidences of self-medication by means of patient data analysis in a
defined time period, in a community pharmacy in Taiping (Malaysia). This was a data format-based retrospective
study. A simple patient data analysis format was used. The details were filled in when the consumers (patients) came
to purchase medications. The inclusion criteria were those who purchased medications without a prescription. The
subjects intending to self-medicate were included. Age, gender, presenting complaints, medications purchased,
social history. A total of 65 cases were obtained. The most common age group that purchased non-prescription drugs
from the pharmacy counter falls in the age group 30-39. The number of smokers, non-smokers and alcoholics in the
study were (31 cases; 47.69%), (23 cases; 35.38%) and (3 cases; 4.6%) respectively. The most common presenting
complaints were headache (10 cases; 14.7%), fever (9 cases; 13.2%) and flu (10 cases; 14.7%). The proportion of
self-medication was almost equal in both the genders, with 34 females and 31 males. The ethnicity noted amongst the
cases were Malay (20 cases; 30.76%), Chinese (25 cases; 38.46%) and Indian (25 cases; 38.46%). The most
frequently purchased medications were antihistamines (15 cases; 23%). All the cases of self-medication were
inappropriate or irresponsible, in that the consumers were not at all aware of the risks associated with selfmedication. Most of them purchased the drug/s based on advices and suggestions from family members, friends and
peers. There was no stringent protocol for intervention regarding dispensing medications to these consumers. The
practice of self-medication was common and often irresponsible or inappropriate. Knowledge about the risks of selfmedication was poor. Health authorities must develop stringent protocols in regard to self-medication. Pharmacists
have a pivotal role in ensuring that each patient who self-medicates is aware of the risks associated. This can only be
achieved by appropriate intervention and counseling techniques
Key words: Over-The-Counter medications; Irresponsible self-medication; Polypharmacy, Patient data analysis.
INTRODUCTION
Rational use of drugs is 'the appropriate, timely use of
drugs, for an ailment, which is properly diagnosed and
prescribed by a physician, in the right dosage of a right
regimen and right duration of treatment.' Paracelsus
(1493 - 1541), the alchemist-physician, observed that 'all
drugs are poisons.' The availability of potent and
dangerous drugs has increased considerably since the
close of the 19th century. At the same time, expanding
availability of medical care exposes a large population of
people to drugs, leading to a greater number of toxic
reactions. Even certain prescription medications are
available to the lay person without the physician's
authorization. As people vary greatly in their sensitivity
to drugs, an appropriate dose for one person can be an
overdose for another. Even skilled physicians sometimes
Indian Journal of Pharmacy Practice
Received on 04/11/2009
Accepted on 06/02/2010 © APTI All rights reserved
fail to avoid such reactions. Thus, the lay person is illadvised in subjecting themselves to potentially
dangerous self-medication.
Today, over 7000 drugs and drug combinations have
been released for general use, and are sold directly to the
public as Over-The-Counter (OTC) remedies. A large
number of potent drugs are thus available to the
individual for self medication. There is an obvious
difference between drugs and other commodities of life.
The consumer, in most cases, has no way to judge the
efficacy of a drug or it's hazards, and therefore these
judgments have to be made for him / her by the
physicians.1
Self-Medication is defined as 'the use of medications,
whether modern or traditional, for self treatment.'
Studies done on self-medication reveal that it's a fairly
common practice, especially in economically-deprived
countries. It is a growing trend of self-care, which has
19
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
both positive and negative aspects.2 In several studies, it
has been found that inappropriate self-medication results
in wastage of resources, increases resistance to
pathogens and generally entails serious health hazards
such as Adverse Drug Reactions, prolonged sufferings
and dependence. 3
Self-medication usually involves common drugs which
are freely available. It is questionable whether the
benefits outweigh the potential hazards. They account for
poisonings, allergies, habituation, addictions and other
adverse reactions. Above all, their use often delays the
proper treatment of diseases. People often take medicines
on their own, for a small ailment, which can probably be
cured by simple measures or even by creating or
improving hygienic conditions. Easy access to
medicines, advertisements of drugs by pharmaceutical
companies, information from peers and friends and a
compelling desire to avoid going to the doctor drive
people to self-medication. Modern drugs are specific,
potent and have side effects which are not fully known to
people.
Nearly 805 of illness episodes and
complications have arisen only out of self-medication by
people. All this amounts to misuse and irrational use of
drugs. 1
Non-prescription drugs or OTC drugs are 'completely
compounded, packaged drugs and non-bulk chemicals,
not requiring a prescription order, which are sold,
offered, promoted and advertised by the manufacturer or
distributor to the general public.' 4
Categories of drugs which are misused [self
medicated]
?
Antibiotics (Penicillins, amoxicillin, tetracyclines,
erythromycin, ciprofloxacin, norfloxacin etc.).
?
Musculoskeletal drugs (Aspirin, ibuprofen, diclofenac,
nimesulide, etc.).
?
CNS drugs (Diazepam, lorazepam, fluoxetine,
barbiturates, etc.).
?
Alimentary system drugs (Laxatives, purgatives,
antidiarrhoeals, antiulcer drugs, etc.).
?
Respiratory system drugs (Bromhexine, salbutamol,
phenylpropanolamine, codeine, dextromethorphan,
antiallergenic drugs, etc.).
?
Hormones, vitamins, etc.5
Reasons why people self medicate
?
Easy accessibility to prescription drugs.
?
Easy access to OTC drugs.
?
Old prescriptions used again and again.
?
Overdose for quick relief.
?
Easy availability of 'prescription only' drugs without
physician's prescriptions due to inefficient control by
regulatory authorities.
?
Advice by friends, relatives on medicines (often
relating their own experiences).
?
Patient's social, economic and health factors, which
influence his / her decisions.
?
Choice by the patient whether or not to buy the
medications, even if they have the prescriptions. The
patients also decide what items are important and
worth buying.
?
Patient also decides on the dosage, whether and when
to take medicines, and if continuing the medication is
necessary, if side effects appear or symptoms
disappear.
?
Unethical marketing of drugs. Promotional, material
advertisements in the newspapers and the media by the
pharmaceutical companies. Drugs are distributes,
prescribed and used in ways that frequently do not
accord with rationality.
?
False, misleading claims and commercial promotions,
disguised as clinical trials.5
Patient data analysis
Patient safety is a new health care discipline that
emphasizes the reporting, analysis and prevention of
medical errors that often lead to adverse health care
events. Patient safety has emerged as a distinct health
care discipline supported by an immature yet developing
scientific framework. One of the key components of
pharmaceutical care is an in-depth understanding of the
data obtained from the patient, i.e. Patient data analysis.
The resulting patient safety knowledge continually
informs improvement efforts such as applying lessons
learned from practice, adopting innovative technologies,
educating providers and consumers, enhancing error
reporting systems and developing new economic
incentives.6
Recently, the profession of pharmacy has adopted
Pharmaceutical Care as it's mission, and thereby, extends
the responsibilities of the pharmacist. The goal is to
achieve optimal outcomes that improve the patient's
quality of life. In order for this to happen, the pharmacists
have to collaborate with the patients, patent's care givers,
physician, nurses and other health care personnel, to
i n i t i a t e , m o n i t o r, m o d i f y a n d d i s c o n t i n u e
pharmacotherapy (if needed). The aim is to resolve
medication-related problems. One of the primary
responsibilities of the pharmacists in order to achieve
successful outcomes is to collect essential patient data or
information.
20
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
Patient information is organised into three categories:
Lifestyle: daily activities; tobacco, alcohol & caffeine
use; dietary & exercise practice; compliance with current
therapy.
Demographic & Medical: age; gender; race; health
status; impairments / disabilities; current medical
problems.
Therapeutic: past therapies; prescription drugs use; nonprescription drugs use; allergies; ADRs; alternative
therapies.5
Data to be included in patient information
Core medical information: past medical problems; all
current acute & chronic diseases, including assessments
of their severity, prognosis and presenting complaints of
the patients.
Additional medical information: patient's immune status
when the selected drug therapy can cause further
immunosuppression.
Therapeutic information: name of prescription and nonprescription drugs used by the patient, frequency of use
and therapeutic indications.
Drug allergies, previous ADRs and intolerance are also
noted.
Lifestyle information: habits like smoking, alcohol,
which have some effects on the drugs administered.
Sexual history (to prevent recurrence of STDs).
Sources of information
Patient.
Patient's caregiver.
Patient profile (from the pharmacy).
Medical records.
Laboratories.
Physicians, nurses, etc.5
The purpose of this study is to perform an initial survey of
the incidences of self-medication in a specific location in
Malaysia, to asses the percentage of this phenomenon,
across various parameters and to note the pharmacy's
dispensing activities in relation to self medication.
OBJECTIVES
?
Retrospective analysis of patient self medication and
pharmacy dispensing activities.
?
Identification and review of patient profiles.
?
To identify the trends of self medication practices and
occurrence rates in Malaysia, and to compare it with the
existing data available.
?
Research studies into drug-related trends to aid in
improving pharmaceutical care.
?
To improve the researchers' competency levels with
respect to data collection and analyses.
MATERIALS AND METHOD
The sequential plan of work which was carried out:Stage-1: Collecting literature-based evidences from
books, journals and the internet.
Stage-2: Fixing or setting or preparation of a
standardized team for collecting patient data, with
priority assigned to age, gender, social status, presenting
complaints, past and current medication.
Stage-3: Obtaining permission from the community
pharmacists to perform the field study.
Stage-4: Collection of patient data from all the patients
who purchased drugs without prescription (selfmedication). This was done for a period of 8 weeks
Stage-5: Analysis of all the data obtained, comparison
with, and observing the trends with existing literature.
Subjects: Any customer / patient purchasing
medications without a prescription, with the sole
intention of self-medicating.
Setting: Retail pharmacy in Taiping (Malaysia).
RESULTS & DISCUSSION
Age:
We found that the highest incidences of self-medication
was in the age group 30-39
(20 cases, 30.8%). This was consistent with the study
conducted by Dr. P.R. Shankar et al (2002) on selfmedication practices amongst the population in Pokhara
valley (Nepal). They reported that 76 respondents (54%)
were aged between 20 – 39 years. Majority of the
respondents stayed within 30 minutes of a pharmacy
store. The most common reasons given for selfmedication were mild illness, previous experience of
treating a similar illness and non-availability of health
care personnel.6 Older people are more prone to fall ill
than younger persons, due to weaker body resistance.
They will also usually require more time to recover from
the illness. Dr. Pascal Goldschmidt (Duke University
Medical Center) and Duke researchers discovered that a
major outcome of aging is an unexpected failure of the
bone marrow to produce progenitor cells needed to repair
and rejuvenate arteries exposed to a genetically induced
risk of high blood pressure in the mouse. Stem cells are
immature cells produced in the bone marrow that have
the potential to mature into a variety of different cells.
The researchers demonstrated that an age-related loss of
these particular stem cells which reside in the marrow but
are also designed to repair arteries is critical to
determining the onset and progression of atherosclerosis,
which causes arteries to clog and become less elastic.7
Thomson W.M. et al (2006) surveyed the change in
medication use from ages 26 to 32. Nearly two-thirds
took at least one medication at each age, with medication
prevalence higher among women than among men.
Three-quarters of those taking at least one at age 26 were
doing so at 32. Over-the-counter medication prevalence
21
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
Figure.1: Age distribution of the patients
Age Group of subjects
25
No. of. subjects
20
20
17
15
12
10
7
3
5
3
2
1
0
1- 9
-19 0 -29 0 -39 0 -49 0 -59 0 -69 0 -79
10
2
3
4
5
6
7
Age group
increased from 35 to 43% between 26 and 32 years of
age. The prevalence of prescribed medications
decreased. Other categories showing major changes were
analgesics (increased), anti-asthma drugs (decreased),
antidepressants (increased) and antiulcer drugs
(increased). At 32, 82% of those taking analgesics, 85%
of those taking nutrient supplements, 71% of those taking
antihistamines and 33% of those taking antiulcer drugs
had self-prescribed them.8
Gender:
From the data's obtained, we found that more females
(34) purchased non prescription drugs from the
pharmacy than males (31) although there is just a small
gap difference.
Sex hormones like estrogen, and genes appear to play a
big part in how individuals' bodies, and emotions, react to
pain where higher estrogen levels made a difference in
the activation of the brain's natural painkiller system.
Researchers at the University of Michigan found that
variations in women's estrogen levels like those that
occur throughout the monthly menstrual cycle, or during
pregnancy regulate the brain's natural ability to suppress
pain. When estrogen levels are high, the brain's natural
painkiller system responds more potently when a painful
experience occurs, releasing chemicals called
endorphins or enkephalins that dampen the pain signals
received by the brain. But when estrogen is low, the same
system doesn't typically control pain nearly as
effectively.
In all 28 countries included in the database, analgesic use
was higher in girls than boys. Use of analgesics for
headaches increased by age, but medications for inability
to sleep or nervousness declined. Use of medications for
stomachache increased by age in girls, but decreased in
boys. The data revealed analgesic use for headache in
48.9% of boys and 65.9% of girls, with medication for
stomachache used in 20.5% of boys and 34.6% of girls,
while medications for sleeplessness or nervousness were
used in 10% or less.9
This finding was consistent with the result of an earlier
study done by Thomas et al, in which self medication
prevalence was higher among women.8
Figure.1: Gender distribution of the patients
31
34
Male
Female
22
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
Complaints:
From the datas collected, the most frequent complaints
from patients were headache (10 cases, 14.7%), fever (9
cases, 13.2%) and flu (10 cases, 14.7%).
This was found to be consistent with the findings in the
self-medication epidemiology studies conducted in
Ethiopia (2003), where headache, fever, cough and
diarrhea were the common illnesses that led to an
increased incidence of self-medication. [10]
Dr. Shankar et al (2002) conducted a study assessing the
self-medication patterns in Nepal. Their findings too
indicated that the commonest illnesses that led to selfmedication were usually self-limiting 'minor illnesses'
like headache, fever, cough, diarrhea and flu. Analgesics
and antipyretics were the medications most commonly
self-medicated. This corresponds well with headache,
fever and flu being the common indications. Analgesics
and antipyretics are used for headache, fever, body aches
and pains respectively. [11]
In the study by Henry James et al (2005) pertaining to
self-medication, the most common indications for selfmedication were to relieve the symptoms of headache
(70.9%), cough, cold and sore throat (53.7%),
stomachache (32.8%) and fever (29.9%). Analgesics
(81.3%) were the most common drugs used for selfmedication. The practice of self-medication was
appropriate in only 14.2% of cases. They concluded that
the knowledge about appropriate self-medication was
poor, attitude towards self-medication was positive, and
the practice of self-medication was common and often
inappropriate.[12]
Social history:
Based on the data collected from the research project, it
was found that most of the patients are smokers (31
people, 54%) and a few are alcoholics (3 people, 5.2%).
ALCOHOLICS
Many medications can interact with alcohol, leading to
increased risk of illness, injury, or death. For example, it
is estimated that alcohol-medication interactions may be
a factor in at least 25 % of all emergency room
admissions.13
Approximately 70% of the adult population consumes
alcohol at least occasionally, and 10% drink daily [14].
About 60% of men and 30% of women have had one or
more adverse alcohol-related life events.15 Alcohol can
influence the effectiveness of a drug by altering its
availability. Typical alcohol-drug interactions include
the following:
1) Inhibits a drug's metabolism by competing with the
drug for the same set of metabolizing enzymes and
enhances the drug's availability,
2) Activate drug-metabolizing enzymes, thus decreases
the drug's availability and diminishing its effects.
3) Enzymes activated by chronic alcohol consumption
transform some drugs into toxic chemicals that can
damage the liver or other organs.
4) Magnifies the inhibitory effects of sedative and
narcotic drugs at their sites of action in the brain.16
Figure.1: Graph showing the common presenting complaints by the patients
10
9
10
8
6
6
5
2
3
1
2
3
H
ea
da
ch
e
Fl
Fe
e/
ru
ve
Pa
nn
r
in
in
g
(le
no
g,
se
ba
ck
bo
dy
)
C
ou
gh
So
re
th
ro
at
D
ia
rrh
oe
a
D
ia
be
te
s
So
re
ey
H
es
yp
er
te
ns
io
n
Ec
D
ys
ze
as
m
a/
ia
ps
or
ia
si
s
As
th
m
a
3
Complaint
23
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
Some specific interactions
Narcotic pain reliever (codeine): These drugs are
prescribed for moderate to severe pain. The combination
of opiates and alcohol enhances the sedative effect of
both substances, increasing the risk of death from
overdose. [17]
Non-narcotic pain relievers: Aspirin and similar
nonprescription pain relievers are most commonly used
by the elderly. Some of these drugs cause stomach
bleeding and inhibit blood from clotting; alcohol can
exacerbate these effects.[18] Older persons who mix
alcoholic beverages with large doses of aspirin to selfmedicate for pain are therefore at particularly high risk
for episodes of gastric bleeding. In addition, aspirin may
increase the availability of alcohol, heightening the
effects of a given dose of alcohol. [19]
Antihistamines: Drugs such as diphenhydramine
(Benadryl and others) are available without prescription
to treat allergic symptoms and insomnia. Alcohol may
intensify the sedation caused by some antihistamines. [20]
These drugs may cause excessive dizziness and sedation
in older persons; the effects of combining alcohol and
antihistamines may therefore be especially significant in
this population.
Smoking
Tobacco smoking is associated with many drug
interactions. Drug interactions can occur via
pharmacokinetic and pharmacodynamic mechanisms.
Pharmacokinetic interactions may cause smokers to
require larger doses of certain drugs through an increase
in plasma clearance, a decrease in absorption, enzyme
induction or a combination of these factors.
Pharmacodynamic interactions may increase the risk of
adverse events (for example, in smokers with
cardiovascular disease, and in women who smoke and
use oral contraceptives).
Below are the possible interactions of analgesics,
antihistamines and NSAIDs due to smoking
Analgesics – less effective as analgesics in smokers than
in nonsmokers
Anti-inflammatory drugs – greater clearance in
smokers than in non-smokers.
H2 Blockers – reduced plasma levels and reduced
nicotine clearance in non-smokers.
Drugs purchased:
Based on the datas collected from the research project,
we found that the most frequently purchased drugs are
the Antihistamines (15 cases, 23%) and NSAIDs (13
cases, 20%)
A histamine antagonist is an agent that serves to inhibit
the release or action of histamine. Antihistamine can be
used to describe any histamine antagonist, but it is
usually reserved for the classical antihistamines that act
upon the H1 histamine receptor. Antihistamines are used
as treatment for allergies. There are 2 types of
antihistamine, one acting on the H1 receptors and the
[21]
other on H2 receptors.
Figure.1: Graph showing the social history of the patients
23
31
3
Smoker
Non-smoker
Alcoholic
24
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
Table. 1: Drugs purchased by the patients
Drugs
Classification of drugs
No. of Patients
Famotidine 20 mg, Cimetidine
H2 receptor antagonist
2
Cetrizine 10mg, Orphenadrine citrate, Benatussil
expectorant, Loratadine, Dimenhydrinate, Triprolidine
HCL 2.5mg, Cetrizine, Betahistine HCL
Antihistamine
15
Norethisterone 10mg, Evening Primrose oil capsules
Hormonal contraceptives
2
Ambroxol HCL 30 mg, Cylindrol-mucoflux syrup 5ml,
Bromhexine HCL 8mg
Mucolytics
4
Lyzozyme HCL 200mg, Serratiopeptidase
Anti inflammatory
4
Metformin 850mg, Metformin HCL, Glibenclamide
5mg, Gliclazide
Antidiabetics
3
Calcium dodesilate monohydrate 500mg
Anti haemorrhagic
2
Naproxen sodium 275mg, Diclofenac sodium, PCM,
Etoricoxib, Naproxen Serratiopeptidase, Rofecoxib
NSAIDs
13
Prime edema, Macrogol 400
Laxatives
3
Fungazol 10's, Clotrimazole lotion
Broad spectrum antifungal
1
Loperamide
Opioid receptor antagonist
2
Clobetasol propionate ointment, Prednisolone
Corticosteroids
2
Charcoal
Antidiarrheals
2
Fusic acid, Na fusidate, Ceturoxime axetil
Antibiotics
1
Losartan potassium
Antihypertensives
2
Dextromethorphan
Antitussives
2
NSAIDs are usually indicated for the treatment of acute
or chronic conditions where pain and inflammation are
present. For example, NSAID can be used for treatment
of the following:
· Rheumatoid arthritis, Osteoarthritis, Acute gout
· Inflammatory arthropathies (e.g. ankylosing
spondylitis, psoriatic arthritis, Reiter's syndrome)
· Dysmenorrhoea, Metastatic bone pain, Headache and
migraine, Postoperative pain, Mild-to-moderate pain,
Pyrexia, Ileus and Renal colic[22]
Aspirin, the only NSAID able to irreversibly inhibit
COX-1, is also indicated for inhibition of platelet
aggregation. This is useful in the management of arterial
thrombosis and prevention of adverse cardiovascular
events. Aspirin inhibits platelet aggregation by inhibiting
the action of thromboxane -A. Aspirin does have certain
drawbacks. It can irritate the stomach lining, causing
heartburn, pain, or nausea. Coating aspirin capsules helps
reduce this irritation by preventing the release of the
aspirin until it has passed through the stomach and into
25
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
the small intestine; however, coating also slows the
absorption of aspirin and increases the amount of time
before it starts to work. Other side effects include the fact
that high doses of aspirin may cause ringing in the ears.
Aspirin shouldn't be given to children under the age of
twelve or to pregnant women, especially during the last
three months of pregnancy since it could cause
complications during delivery. [23]
Taking more than the prescribed dose of NSAIDs can
increase the risk of gastrointestinal upset and ulcers. A
study (2002) involving 138 patients showed that taking
multiple NSAIDs – either intentionally or inadvertently –
can adversely affect a person's overall health. The results
showed that 26 percent of participants were dual users,
meaning that they reported taking at least two NSAIDs
(multiple prescriptions, OTC, or both) during the
previous month. Using multiple NSAIDs was found to be
associated with worse scores on the physical health
component of the survey. Little is known about patients
who take multiple NSAIDs, whether multiple
prescriptions or OTC NSAIDs. As OTC use is difficult to
track, few studies have evaluated it. In addition, OTC
medication is often not discussed during doctor visits,
even though taking high doses of NSAIDs raises safety
concerns. [24]
Polypharmacy
From our findings, we discovered that polypharmacy is
quite common among Malaysian patients accounting for
about 29 cases (44.6%).
The term 'Polypharmacy' is derived from the Greek
words polus (many) and pharmakon (drugs / poisons),
and literally means 'many drugs' [25].The intent of
co-pharmacy is to produce a drug-drug interaction that
will have beneficial consequences for the patient.
Generally, the goal is to produce a pharmacodynamic
interaction in which the effect of one drug accentuates or
diminishes the effect of another. Alternatively, the goal
could also be to produce a pharmacokinetic interaction in
which one drug alters the absorption, distribution,
metabolism, or elimination of another. Polypharmacy
occasions greater concern because each drug that is
added to the patient's regimen increases the likelihood of
an adverse outcome and the expense of the treatment.
A study by Dr. Barkley et al (2006) revealed that one of
the major contributing factors to polypharmacy is selfmedication by the patient. Surveys show that 73% of
Americans would rather treat themselves at home than
see a doctor and 96% are confident about their ability to
make their own healthcare decisions. This decreases the
ability of healthcare providers to properly monitor
potentially dangerous interactions. Patients' ability to
start their own regimens without input from a healthcare
provider is increasing as more medications make the
switch to over-the-counter (OTC) status. According to
Dr. Barkley, there are more than 700 products available
OTC today that were prescription-only less than 30 years
ago. Elderly patients are certainly at high risk for
polypharmacy -- seniors consume 34% of all prescription
drugs, 33% of all over the counter drugs and 6.5 million
use 1 of 33 inappropriate prescription drugs. But, the
possibility should not be discounted in other patients.
Patients with co-morbidities, with multiple healthcare
providers, and those who fill prescriptions at more than
one pharmacy are at increased risk. [26]
Figure.1: Graph showing different class of drugs purchased by the patients
15
13
4
2
2
4
3
2
3
1
2
2
2
1
2
2
H
2
re
ce
pt
or
an
H
ta
or
An go
m
on
t ih nis
t
al
is
ta
co
m
nt
ra ine
ce
pt
iv
es
M
uc
An
ol
ti
y
in
fla tics
m
m
at
An
t id ory
An
ia
ti
be
ha
em tic
or s
rh
ag
ic
Br
N
oa
SA
d
ID
sp
s
O
ec Lax
pi
tru
at
oi
iv
d
es
re m a
ce
nt
ifu
pt
or
n
an gal
ta
C
go
or
n
tic
os ist
An tero
id
t id
s
ia
rrh
ea
ls
An An
t ib
t ih
io
yp
tic
er
s
te
ns
i
An
v
t it es
us
si
ve
s
16
14
12
10
8
6
4
2
0
26
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
According to the WHO – among the populations most
impacted by the challenges of polypharmacy are the
elderly. In the U.S., the elderly consume more than 1/3rd
of all pharmaceutical drugs. Polypharmacy is
problematic for elderly because it is the greatest risk for
adverse drug reactions, drug interactions, etc. The same
report also reveals increasingly high levels of medication
use among the elderly. 66% of men and 88% of women
consume atleast one medication per week. When OTC
drugs are included, the percentage rises significantly to
89 % men and 94% women. [27]
The criteria for rational co-pharmacy are:
1. Knowledge that the combination has a positive effect
on the pathophysiology or
pathoetiology of the
disorder.
2. Convincing evidence that the combination is more
effective, including more cost-effective, than
monodrug therapy
3. The combination should not pose significantly
greater safety or tolerability risks than monotherapy
-Drugs should not have narrow therapeutic indices.
-Drugs should not have poor tolerability profiles.
4. Drugs should not interact both pharmacokinetically
and pharmacodynamically.
5. Drugs should have mechanisms of action that are
likely to interact in a way that augments response.
6. Drugs should have only one mechanism of action.
7. Drugs should not have a broad-acting mechanism of
action.
8. Drugs should not have the same mechanism of action.
9. Drugs should not have opposing mechanisms of
action.
10. Each drug should have simple metabolism.
11. Each drug should have an intermediate half-life.
12. Each drug should have linear pharmacokinetics. [28]
Distribution of patients according to
the race
Indian,
25
Malay,
20
Chinese,
25
CONCLUSION
This retrospective survey shows that a significant
proportion of the general population (65 cases) in the
span of 14 weeks opted for self medication. Most of the
consumers had a foreknowledge of the medications they
had to purchase based on previous prescribed medication
regimen, old prescriptions, and suggestions from friends,
family and peers. All of them were not aware of the side
effects and the risks posed by the medications that they
purchased without prescription. The practice of selfmedication in this survey period was common and
inappropriate or irresponsible. As no clear-cut protocols
exist regarding self medication and dispensing to such
patients, the pharmacists had no other alternative, but to
dispense the medication. It would have been beneficial
to these consumers if counselling was provided on a
regular basis.
Self-medication must be accompanied by appropriate
health information. Responsible self-medication can
help prevent and treat ailments that do not require
medical consultation and provides a cheaper alternative
for treating common ailments. Self-medication is an area
where governments and health authorities need to ensure
that it is done in a responsible manner, ensuring that safe
drugs are available over-the-counter and the consumer is
given adequate information about the use of drugs and
when to consult a doctor. Unlike other aspects of selfcare, self-medication involves the use of drugs, and drugs
have the potential to do good as well as cause harm. In
this context, the pharmacists have a pivotal role in
ensuring responsible self-medication.
27
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
Retrospective patient data analysis with respect to irresponsible self medication in
community pharmacy setting
PATIENT CHARACTERICTICS
Name :
Age :
Education
Sex :
File No. :
Date :
Social History
Primary (<6)
Smoker
Alcoholic
Secondary (6-12)
Tobacco
Betel Nut
Graduates and above (>12)
Snuff
Marital Status :
M
UM
Know Allergies :
House hold Income :
C/O :
Past Medical History :
Past Medication History :
No of drugs prescribed :
0-1
2-4
>5
For Treatment Of :
DRUGS PROCURED
No Drugs
Tr. Name
Gen. Name
Route of
Administration
Dose
No of days
1
2
3
4
5
6
7
8
9
10
28
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
Recommendations for future research
Self medication is defined as 'the use of medication,
whether modern or traditional, intended for the sole
purpose of self treatment. Studies assessing self
medication reveal that it is a fairly common practice,
especially in economically deprived countries. Self
medication moves patients towards greater
independence in making decisions about management of
minor illnesses, thereby promoting empowerment. Self
medication also has advantages for healthcare systems,
as it facilitates better use of clinical skills; increases
access to medication and may contribute to reducing
prescribed drug costs. However, irresponsible self
medication is associated with risks such as misdiagnosis,
use of excessive drugs, and prolonged duration of action,
drug interactions and polypharmacy. The latter may be
particularly problematic in the elderly. Monitoring
systems, a partnership between patients, physicians and
pharmacists, and the provision of education and
information to all concerned on safe self medication, are
proposed strategies for maximizing benefit and
minimizing risks.2
This research work can, provided the time frame is
increased, delve deeper into this aspect, by assessing
many more patients, include successive stages (namely
pharmacists' intervention, counselling and evaluation of
the efficacy process and patient compliance). Close
coordination with the pharmacists can ensure, over a
period of time, improved counselling sessions with the
patients. Furthermore, evaluation of the counselling
process as well as compliance can be done through
regular follow customers. The pharmacist's attitude
towards self medication with respect to dispensing and
counselling can also be evaluated.
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30
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
APTI
ijopp
Impact on the outcome of pharmacotherapy of senior Indian
inpatients: A pharmacist led intervention
1
2
3
4*
5
Mandavi , Padmavathi R , Mangu R , Pramil T , Vinay K
1,2,3,4
Department of Pharmacy Practice, National Institute of Pharmaceutical Education and Research, S.A.S. Nagar,
Punjab, INDIA, 5Department of General Medicine, Government Medical College & Hospital, Chandigarh, INDIA
Author for Correspondence: [email protected]
Abstract
It is well known that due to physiological changes, elderly patients are prone to suffer from Drug-Related Problems
(DRPs). By the year 2040, the elderly will account for 14% of total global population. Since the elderly population
will increase, it is expected that the DRPs will also increase. To determine the potentially inappropriate
prescription(s), understand risk factors and study the impact of providing regular feedback to the clinicians on the
inappropriate medications prescribed to the elderly inpatients using the Modified Updated Beers Criteria 2003. A 3
year long term prospective interventional study included 1972 elderly inpatients (60yrs or above) at a public
teaching hospital. Regular feedback was provided to the clinicians and the changes effected in the therapy were
documented. The average age of the patients was 68.03±0.16 yrs. On an average, each patient had 2 diagnoses &
was prescribed 7 drugs. Of 1972 patients, 285 (15%) patients were identified to have at least one inappropriate
medication. The most common inappropriate drugs were administration of anticoagulant therapy with aspirin or
Clopidogrel (22.2%), Amitriptyline (18.5%), Digoxin (9.8%), Amiodarone (8.7%) and Chlorphenaramine (7.3%),
followed by Promethazine & Ferrous Sulfate (4.9%). The risk factors for the inappropriate prescription were age
over 70 yrs, more than 5 medications prescribed, longer stay in the hospital and multiple diagnoses. The extent of
inappropriateness in the first, second and third year of the study was 19%, 18% and 7%, respectively. There was a
significant improvement in the inappropriateness in third year, when compared from the first 2 years of the study.
Some illustrative instances where the drug(s) was discontinued or the use decreased, in the third year, are
anticoagulant therapy with Aspirin or Clopidogrel (4.6% to 0.46%), Amitriptyline (3.3% to 1.3%), Digoxin (2.1% to
Nil), Promethazine (1.05% to Nil), and use of Anticholinergic agents in obstructed bladder (0.52% to Nil). These
results have demonstrated that it is possible to reduce inappropriateness of pharmacotherapy in elderly patients
through provision of relevant unbiased information to healthcare professionals. Reinforcement of the feedback is a
possible route to sustain the improvement.
Key words: Elderly; Inappropriate drugs; Beers criteria 2003, India
INTRODUCTION
By 2040, the world is projected to have 1.3 billion older
people—accounting for 14% of the total. [1, 2] According
to the data projected by United Nation, the Indian elderly
population will rise to 21.2% of total by 2050 from 7.2%
estimated in 1995. Globally, this will witness a rise to
only 16.5% in 2050 from 12.4% in 1995. [3]
The elderly, often, have chronic medical conditions and
they require multi-drug treatment. Because of the
unfavorable anatomic and physiologic function changes,
elderly patients are prone to suffer from drug-related
problems. The advancement in medical technology has
added extra length in life as well as improved the quality
of healthcare. However, the problems associated with
Indian Journal of Pharmacy Practice
Received on 19/11/2009
Accepted on 23/01/2010 © APTI All rights reserved
pharmacotherapy have also increased. [4]
Inappropriate medication use in elderly population has
long been an issue of healthcare quality along with over
and under use of medication. The major factors which
contribute to changes in the drug use patterns among
elderly are increasing age, availability of new classes of
drugs, and changes in physicians' prescribing habits.
The findings from United States and other countries
showed a higher prevalence rate (up to 49%) for
[5, 6]
inappropriate medication among elderly.
Like their
counterparts in other countries, Indian elderly are also
not immune from receiving potentially inappropriate
medications. The earliest study from the country has
reported 18% inappropriateness among Indian elderly
patients.[7] Although the reported prevalence is lower
31
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
when compared to other countries, this is one of major
issues of concern. It was, therefore, relevant to conduct a
long term study to determine the potentially
inappropriate prescription(s), understand risk factors and
study the impact of providing regular feedback to the
clinicians on the inappropriate medications prescribed to
the elderly inpatients.
METHODOLOGY
Participants and Data source: This prospective study
was conducted at a public teaching hospital for a period
of three years. The patients admitted to three medicine
wards and one cardiac care unit were randomly enrolled
in this study and followed until discharge. The patients
recruited in the study were 60 yrs. or more and were
prescribed drugs for duration of five days or more. For
each patient, a study form was completed at admission
and updated daily until the discharge from the hospital.
The information on age, sex, diagnosis, prescribed drugs,
dose, formulation, route of administration, frequency and
duration of therapy was obtained from the case records.
Spread over the three consecutive years, a total of 2037
prescriptions were captured. However, 65 records did
not match the inclusion criteria and the results are
based on the prescriptions of 1972 patients.
Problem Identification: The potentially inappropriate
medications were identified according to the Modified
Updated Beers Criteria 2003.[8] The Updated Beers
criteria 2003 is applicable to the general population
above 65 yrs. of age, regardless of level of frailty or
place of residence. However, in this study, the cutoff
age was 60 yrs. and, hence, the criteria was termed
“Modified Updated Beers Criteria 2003” (now
onwards, Beers Criteria 2003). This tool is an
internationally accepted criteria for assessment of
inappropriate prescribing practices in the elderly
patients. [9,10] Finally, the International Classification of
Disease (ICD-10) [11] was used to code the diagnosis.
Regular feedback was provided to the clinician(s) for
every identified inappropriateness to resolve the
problem and improve the pharmacotherapy.
Statistical analysis: The results are presented as
average±SEM & percentages. The variables such as age,
number of drugs and number of diagnosis were expressed
as frequency and percentage of the respective totals. The
potential risk factors in the logistic regression equation
were age, gender, number of medications prescribed,
number of diagnosis and duration of treatment in the
hospital. Odds Ratio was used to determine the risk factor
for the inappropriate prescriptions. Statistical
significance was determined at 95% level of confidence.
The data was analyzed using Sigma Stat version (2)
software. [12]
RESULTS
The results were based on the data of 1972 patients. The
male and female patients were in ratio of 3:2
{(n=1206):(n=766)}. The average age of the patients was
68.03±0.16 yrs. The demographic profile of patients is
given in table I.
On an average each patient had 2 diagnoses & was
prescribed 7 drugs. Nearly one third (34%) of the patients
received less than five medications; about half of the
patients (54%) received medications between 6-10 and
approximately 12% of patients received more than ten
medications concurrently. It should be noted that the
distribution of the number of drugs prescribed to patients
in this study followed a normal gaussian distribution.
The number of the patients suffering from multiple
disorders was 61%. The most commonly noted disorder
among elderly, classified on the basis of ICD-10, was the
'circulatory system disorders' (66.6%). This was
followed by 'endocrine disorders' in the second rank
(28.2%) & 'respiratory system disorder' in the third place
(18.3%) (Table II).
Prescribing of Potentially Inappropriate Medication:
Of 1972 patients, 285 (15%) patients were identified to
have at least one inappropriate medication. The Beers
Criteria 2003 classifies two types of inappropriateness
with respect to drugs. The first one is the prescription of
drug(s) which should be avoided, in general, to the
elderly because of the risk of adverse effect and second is
the use of the prescription drugs whose dose is
considered as higher than normal for elderly & those
drugs avoided in specific disease condition. The most
common inappropriate drugs identified in 285 cases
(who were prescribed inappropriate drugs according to
the first list of Beers criteria 2003) were Amitryptiline
(18.5%), Digoxin (9.8%) and Amiodarone (8.7%). The
recommended dose of Digoxin for elderly patients in
Beers criteria is 0.125mg. But, it was observed that the
dose in use was nearly four times the recommended dose
(i.e. 0.5mg) in patients. In several instances, the clinician
chose to revise the dose based upon the feedback
provided by the investigator. The rank order of
inappropriateness in descending order was:
Chlorphenaramine>Promethazine>Iron>Clindinium>Fl
uxetine>Dicylamine>Diazepam>Diphenhydramine>Pe
ntazocine>Indomethazine>Doxazosine>Piroxicam>Thi
oridazine>Biscodyl Hydroxyzine>Oybutyrine.
The second kind of inappropriateness depends upon the
32
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
Table I: Age and Gender Wise Distribution of Patients
Sl.no
1
Characteristics
Number of patients (n=1972)
60-69 yrs
Age
1166 (59.1%)
70-79 yrs
608 (30.8%)
80-89 yrs
173 (8.7%)
90-99 yrs
23 (1.2%)
Over 99 yrs
2
2 (0.1%)
Male
Gender
1206 (61.2%)
Female
766 (38.8%)
Table II: Top Five Disorders on the basis of ICD-10
Sl.no
Class of Disease
Number of patients & proportion (%)
1
Circulatory System Disorder
1301 (66.6%)
2
Endocrine Disorder
555 (28.2%)
3
Respiratory System Disorder
361 (18.3%)
4
Digestive System Disorder
333 (16.8%)
5
Genitourinary System Disorder
234 (11.9%)
% o f In a p p ro p ri a te M e d i c a ti o n U s e
Figure I: Changes in prescribing-Impact of provision of regular feedback
25%
20%
19%
18%
15%
10%
5%
0%
2004
7%
2005
2006
2007
Year
33
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
Table III: Prevalence of inappropriate drug use (IDU) by sample characteristics
Sl.no
Variable
1
All
2
Age
60-69 yrs
3
4
5
6
Total no. of
patients
1972
1166
Patients
with IDU
Prevalence of
without IDU
Odds ratio (95% confidence
interval)
285
1687
15%
145
1021
1(reference)
70-79 yrs
608
102
506
1.42 (1.07-1.89)
(0.98-2.05) (p=.008)
80 yrs
198
38
160
1.61 (1.11-2.52)
(.98-2.85) (p=0.009)
Men
1206
165
1041
1(reference)
Women
766
120
646
1.17 (.90-1.52)
(.83-1.65) (p=.12)
1- 5
684
56
628
1(reference)
6-10
1061
156
905
1.93 (1.38-2.7)
(1.25-2.9) (p=0)
11 or more
227
73
154
5.32 (3.53-8.0)
(3.13-9.04) (p=0)
5 days
1211
166
1045
1(reference)
6-10 days
636
99
537
1.16 (-88-1.53)
(.81-1.67) (p=0.15)
11 days
125
20
105
1.20 (.7-2.04)
(.6-2.37) (p=.27)
Single
763
91
672
1(reference)
Double
738
109
629
1.28 (.94-1.74)
(.86--91) (p=0.061)
Triple
385
68
317
1.52 (1.11-2.26)
(1-2.51) (p=0.006)
Multiple
86
17
69
1.82 (.98-3.34)
(.83-3.96) (p=0.034)
Sex
No. of medication
Length of treatment
No of Diagnosis
34
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
the diagnosis or conditions. The most frequently
encountered instance was administration of
anticoagulant therapy with aspirin or using a
combination of Aspirin and Clopidogrel (22%). It was
observed that the prescribed dose of aspirin was higher
than recommended in patients; hence, it was revised to
the recommended level by the physician. It was also
found that in a few patients, the inappropriate
administration of anticoagulants caused bleeding.
Another common situation noted was the use of
anticholinergic agent in patients having bladder outflow
obstruction. Some other less common instances were use
of metoclopromide in parkinson's patients, use of
prazosin in incontinence and use of sodium chloride in
heart failure.
Out of total inappropriate prescription, 241 prescriptions
identified as potentially inappropriate prescriptions had a
“high severity” potential as defined by the Beers Criteria
2003.
Risk Factors: The risk factors responsible for the
inappropriate prescriptions were also studied.
Inappropriate drug use was more common in the patients
of more advanced age (over 70 yrs) as compared to the
patients of age group 60-69 years (p=0.008). A higher
prevalence was detected in the elderly patients with
increasing number of medications and longer hospital
stay. Fourthly, the inappropriate drug use was more
prevalent in the patients having multiple diagnoses. The
effect of variables on the inappropriate drug use is
depicted in Table III.
Impact of Provision of Regular Feedback: The extent
of inappropriateness in the first, second and third year of
the study was 19%, 18% and 7%, respectively (fig I).
There was a significant improvement in the
inappropriateness in third year, when compared from the
first 2 years of the study. This demonstrated that the
feedback provided by the investigator(s) was being
pursued and the clinicians were certainly cautious in
prescriptions to elderly.Some noteworthy examples of
the changes in clinical practice are as follows:
Anticoagulant therapy with Aspirin or Clopidogrel
(reduced from 4.6% to 0.46%), Amitriptyline (use
decreased from 3.3% to 1.3%), Digoxin (from 2.1% to
Nil), Promethazine (changes from 1.05% to negligible),
and use of Anticholinergic agents in obstructed bladder
(from 0.52% to Nil).
DISSCUSSION
This 3 year study has confirmed that the prevalence of
inappropriate drug prescribing among Indian elderly
patients is not very high. Only 15% of 1972 patients
prescriptions were found to be inappropriate according to
the modified updated beers criteria 2003. This finding
matches very well with reports from other
countries.[13,14,15] The level of inappropriateness identified
in similar studies from France[16], Finland[17] , Croatia [18]
Cuyahoga [19] and Taiwan[20] ranges between 21-40%
which is certainly alarming. The results of a retrospective
study on 493,971 patients in USA has shown an increased
inappropriate prescribing to the tune of 49%.[ 5]
It is not wise to compare the extent of inappropriateness
on a head to head statistical basis. This reasoning is based
upon fact that there is possibility of variation in
prescribing pattern(s), availability of drug(s) in hospital
formulary, morbidity profile(s), sickness of patient(s)
and physician(s) prescribing behaviour. The most
common instances contributing to inappropriate usages
were administration of anticoagulant therapy with
aspirin or Clopidogrel (22.2%), Amitriptyline (18.5%),
Digoxin (9.8%), Amiodarone (8.7%) and Chlorphenaramine (7.3%), followed by Promethazine (4.9%)
& Ferrous Sulfate (4.9%) . This pattern is in agreement
with the results from other countries. [20,21]
The use of dugs like propoxyphen[22,23,24], ticlopidine[25,9],
long acting benzodiazapenes[26,27], muscle relaxants,
calcium channel blockers[28] was not so common in the
patients of this setting. This is an important difference in
the pattern of inappropriateness between Indian elderly
inpatients and patients from other countries.
This study did not only determine the extent of
inappropriateness but also the responsible risk factors.
The finding of this study shows similarity with other
published results in connection to the risk factors (older
age, increased number of medication, longer hospital
stay and multiple numbers of diagnoses) identified for
the inappropriate prescribing.[10,18] The result of this study
demonstrated that as the number of medications in the
regimen increased the likelihood of an unnecessary
medication also increased (Odds Ratio: 5.32; CI: 3.53-8).
This finding is consistent with study which showed
association of polypharmacy with the inappropriate
prescribing. [29]
One of the most important objectives of this study was to
assess the impact of providing regular feedback to the
clinicians on the inappropriate medications prescribed to
the elderly patients, based on Modified Beers Criteria
2003.The inappropriate drug use in the first, second and
third year of the study was 19%, 18% & 7% respectively.
35
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
While the first two years had a nearly matching
inappropriate drug use, the third year study registered a
steep decline in inappropriate prescribing (18%
compared to 7%). The steep decline in the inappropriate
drug use can be very well understood because the
intervention applied was purely educational in nature. It
can be argued that the first two years were largely utilized
for sensitization of the clinicians. And, this sensitization
started bearing fruit in the third year of the study. This
observation also reiterates the fact that the clinicians had
started pursuing the feedback provided by the
investigators on individual inappropriate drug use.
In essence, this study has provided evidence for a
pharmacist led intervention producing a beneficial
impact on the outcome of pharmacotherapy of Indian
elderly inpatients.
CONCLUSIONS
These results have demonstrated that it is possible to
reduce inappropriateness of pharmacotherapy in elderly
patients through provision of relevant unbiased
information to healthcare professionals. Reinforcement
of the feedback is a possible route to sustain the
improvement.
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2. Soneja S. Abuse of elders, in: Country report
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3. United Nation, World Population Prospects:
Estimates and Projection Revised in 1998.
4. Chang CM, Liu PY, Yang HK. Potentially
Inappropriate Drug Prescribing Among First Visit
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5. Rothberg MB, Pekow PS, Liu F. Potentially
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Elders. J Hosp Med 2008; 3(2):91-102.
6. Hamilton HJ, Gallagher PF, Mahony D.
Inappropriate prescribing and adverse drug events in
older people. BMC Geriatric 2009; 5.
7. Mandavi, Tiwari P, Kapur V. Inappropriate drug
prescribing identified among Indian elderly
hospitalized patients. Int J Risk Safety Med 2007;
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8. Fick DM, Copper JW, Wade WE,et al. Updating the
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Niwata S, Yamada Y, Ikegami N. Prevalence of
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2006; 6:1-7.
H. Viswanathan , M. Bharmal , J.Thomas,
Prevalence and correlates of potentially
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patients in the year 2001: comparison of three
explicit criteria, Clin Ther 2005; 27: 88-99.
International classification of disease, in:
International Statistical Classification of Diseases
and Related Health Problems 10th Revision. 2003.
Sigma Stat software Version 2.0: Microsoft
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Lechevallier MN, Gautier BM, Alperovitch A, et al.
Frequency and Risk Factors of Potentially
Inappropriate Medication Use in a CommunityDwelling Elderly Population: Results from the 3C
Study. Eur J Clin Pharmacol 2005; 60:813-819.
Klarin I, Wimo A, Fastbom J. The Association of
Inappropriate Drug Use with Hospitalization and
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Old. Drugs Aging 2005; 22:69-82.
Brekke M, Rognstad S, Straand J, et al.
Pharmacologically inappropriate prescriptions for
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Baseline data from The Prescription Peer Academic
Detailing (Rx-PAD) study. Scand J Prim Health Care
2008; 26(2): 80-5.
Prudent M, Dramé M, Jolly D, et al. Potentially
Inappropriate Use of Psychotropic Medications in
Hospitalized Elderly Patients in France: CrossSectional Analysis of the Prospective, Multicentre
SAFEs Cohort. Drugs Ageing 2008; 25(11): 933-46.
Hosia-Randell HM, Muurinen SM, Pitkälä KH.
Exposure to potentially inappropriate drugs and
drug-drug interactions in elderly nursing home
residents in helsinki, Finland: a cross-sectional
study. Drugs Ageing 2008; 25(8): 683-92.
Radoseviæ N, Gantumur M, Vlahoviæ-Palcevski V.
Potentially inappropriate prescribing to hospitalized
patients. Pharmacoepidmiol Drug Saf
2008;17(7):733-7.
Nixdorff N, Hustey FM, Brady AK, et al. Potentially
inappropriate medications and adverse drug effects
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697-700.
Lin HY, Liao CC, Cheng SH, et al. Association of
potentially inappropriate medication use with
adverse outcomes in ambulatory elderly patients
with chronic diseases: experience in a Taiwanese
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medical setting. Drugs Ageing 2008; 25(1): 49-59.
21. Aparasu RR, Mort JR. Prevalence, Correlates, and
Associated Outcomes of Potentially Inappropriate
Psychotropic Use in the Community-Dwelling
Elderly. Am J Geriatr Pharmacother 2004;2:102-111.
22. Fredric MH, Nicole W, Jonathan M. Inappropriate
prescribing in an older ED population. Am J Emerg
Med 2007; 25:804–807
23. Andrea MW, Paul JN, Ruth GJ, et al. Inappropriate
Medication Use in the Elderly: Results from a Quality
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Am J Geriatr Pharmacother 2008; 6:21-27.
24. Bahl SK, Stuart BC, MH Beers. National Trends in
and Predictors of Propoxyphene Use in CommunityDwelling Older Adults. AmJ Geriatr Pharmacother
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25. Martins SO, Soares MA, Foppe van Mil JW , et al.
Inappropriate Drug Use by Portuguese elderly
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World Sci 2006;28: 296-301.
26. Brekke M, Rognstad S, Straand J, Furu K, Gjelstad S,
Bjørner T, Dalen I. Pharmacologically inappropriate
prescriptions for elderly patients in general practice:
How common. Scand J Prim Health Care.
2008;26:2,80-85
27. Laroche ML, Charmes JP, Nouaille Y, et al. Is
inappropriate medication use a major cause of
adverse drug reactions in the elderly? Br J Clin
Pharmacol 2006; 63:2 177–186
28. Lindblad CI, Artz MB, Pieper CF, et al. Potential
Drug Disease Interaction in Frail, Hospitalized
Elderly Veterans. Ann Pharmacother 2005; 39: 41217.
29. Gallagher PF, Barry PI, Ryan C, et al. Inappropriate
prescribing in an acutely ill population of elderly
patients as determined by Beers' Criteria. Age
Ageing 2008; 37: 96–101
30. Joshi K, Kumar R, Avasthi A. Morbidity profile and
its relationship with disability and psychological
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37
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
APTI
ijopp
Impact of patient education on health related quality of life of
dialysis patients
1*
2
3
Ramani G.K. , Dholakiya R.B. , Patel G.F
Shree Dhanvantary Pharmacy College, KIM
Near railway station, Kudsad Road, Kim-394110
Author for Correspondence: [email protected]
Abstract
The Dialysis patients require life time treatments which may cause side effects that impair their quality of life.
Studies have shown that when pharmacists were involved in the care of dialysis patients, significant improvements in
patients' HRQoL were achieved. This study aimed to assess the impact of patient education on HRQoL of Dialysis
patients. This was a prospective, open comparative study. This study was approved by the ethics committee of KIMS
Hospital, Bangalore. Patients were kept under observation for a period of one month. We assessed the HRQoL before
and after providing them patient education. We provided patient education regarding the disease, medication,
storage of medication, OTC drugs, diet, exercise, dressing, emotion sharing, and problems occurring during and
after dialysis. The HRQoL of the patients was assessed using SF-36 Questionnaire. After the patient education the
improvement in HRQoL of dialysis patients was significant (p<0.05). At the end of study patients had significantly
(P<0.05) higher HRQoL score as compared to their scores before receiving patient education. Our study concludes
that patient education can play an important role in the improving the HRQoL of patients on Dialysis.
Key words: Dialysis, HRQoL, OTC drugs
INTRODUCTION
The incidence and prevalence of chronic renal failure
(CRF) and consequently end –stage renal disease
(ESRD) has steadily increased in the last two decades.1
Chronic kidney disease (CKD) is a worldwide public
health problem with significant co morbidity and
mortality. Improving quality of life and survival of CKD
patients necessitates a large number of preventive and
therapeutic interventions. To resolve these issues several
organizations have developed guidelines.2
One of the main reasons for the rapid growth in Health
Related Quality of Life (HRQoL) measurement is the
reorganization of the importance of a better
understanding of the impact concerning the health care
interventions on the life of the patient.12 Over this period,
the treatment of patients in end stage renal disease or on
dialysis has also changed dramatically with
development of newer, but expensive renal replacement
techniques, while there is a greater acceptance of higher
risk patients, like diabetics, elderly and those with many
cardiovascular problems.3
Chronic renal failure is the progressive, irreversible
deterioration of renal function usually resulting from
long standing disease. It some time derives from Acute
Indian Journal of Pharmacy Practice
Received on 17/06/2009
Accepted on 20/09/2009 © APTI All rights reserved
Renal Failure (ARF) that does not respond to treatment.4
In medicine, Dialysis is the removal of toxic substances
from the blood by diffusion through a semi-permeable
membrane in an artificial kidney machine, used in cases
of kidney failure when a transplant is not available. It is a
life support treatment and does not treat any kidney
diseases.5
In last two decades, quality of life has become an
increasingly important outcome measure in medicine3.
One of the main reasons for the rapid growth in Health
Related Quality of Life (HRQoL) measurement is the
reorganization of the importance of a better
understanding of the impact concerning the health care
interventions on the life of the patient.6
As per World Health Organization (WHO, 1947) the
Health Related Quality Of Life is defined as “a complete
state of physical, mental, and social well-being and not
merely the absence of disease or infirmity”.3 This
definition identified key dimensions of health that
should be included, such as physical, social, and
psychological domains. Identification of these domains
expanded the construct of HRQoL and led to a set of
principles which guided its measurement.7
The Short Form health survey SF-36 [Short Form with
36 questions] with 36 questions is a well-documented
38
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
scoring system that has been widely used and validated as
a HRQoL assessment tool for the general population as
well as patients on Dialysis. SF-36 consists of 36
questions, 35 of which are compressed into eight multiitem scales: (1) physical functioning; (2) role-physical;
(3) bodily pain; (4) general health; (5) vitality; (6) social
functioning; (7) role-emotional; and (8) mental health.
Hence, in the SF36 scoring system, the scales are
assessed quantitatively, each on the basis of answers to
two to ten multiple choice questions, and a score between
0 and 100 is then calculated on the basis of well-defined
guidelines, with a higher score indicating a better state of
health7.
MATERIALS AND METHODS
The study was conducted at the dialysis centre of KIMS
hospital and Research Center, a 1000 bedded hospital in
Bangalore, Karnataka. It was a hospital based
prospective study designed as an open comparative
study. Informed consent forms were obtained from the
patients recruited for this study. 53 patients of either sex
who were above the age of 18 years and with co
morbidities were provided with patient education to
assess the impact of patient counseling on the Health
Related Quality of Life in dialysis patients. The patient
education consisted of tips regarding the disease,
medication, storage of medication, OTC drugs, diet,
exercise, dressing, emotion sharing, and problems
occurring during and after dialysis.
Demographic and lab data were recorded for all patients
from the patient's case sheet, direct patient and their care
givers' interviews, and dialysis charts. It included age,
sex, marital status, education, occupation, income level,
diagnosis. To assess the HRQoL we used a SF-36
questionnaire. This is a WHO validated questionnaire. In
our study we used English and Kannada version of SF-36
questionnaire. We converted this questionnaire in to
Kannada version and validated as per the standard
procedure mentioned in Linguistic Validation of SF-36.
The baseline SF-36 scores were obtained from the
patients before they were given patient education. After
collection of the SF-36 scores on day 1, they were given
patients counseling. After 15 days of them being
recruited for the study, they were counseled again
regarding their dialysis, disease, medication, and the life
style modifications required to improve their HRQoL.
The follow up SF-36 scores were then collected after a
month from the patients.
The total SF-36 scores were assessed from the Physical
and Mental health scores.
Analysis
We used Paired –t test to analyze and compare the study
data.
RESULTS AND DISCUSSION
The comparison of the Scores of different parameters
before and after counseling
One of the main objective of the study was to measure the
impact of patient education on the HRQoL in dialysis
patients.
Measuring Quality of Life in Dialysis patients has special
significance. Dialysis therapy has been associated with
side effects and impairment of quality of life which are
the major reason of reduced quality of life in dialysis
patients.
The improvement seen can be explained as follows: at
before counseling all patients had SF-36 score below 50.
The lower score of SF-36 indicates lower HRQoL. While
lab data also showing higher values which indicating that
health is not well.
Our result shows the mean score and standard deviation
[std dev] of lab data such as hemoglobin, serum creatinin,
Blood urea, electrolytes (sodium, potassium, chloride),
total counts of the pre and post dialysis weights and the
mean score and std deviation of physical health, mental
health and total SF-36 before and after counseling. The
mean score and standard deviation for the same
parameters after counseling shows significant difference
(P<0.05). The data shows a significant improvement
after counseling. The greater improvement seen in the
test group can be attributed to the fact that they received
pharmaceutical care in addition to a regular physicians
care. Our data shows that when we correlate lab data and
QoL its shows that both the lab data and the QoL have
improved, so the lab data and the QoL can be correlated
with each other.
These findings suggest that pharmacist who provides
patient education can have a positive impact on the
HRQoL of Dialysis patients.
CONCLUSION:
Health related QoL is increasingly viewed as a
therapeutic outcome and is gradually gaining the same
level of importance as clinical or physiological outcome
parameters. This study aimed to assess the impact of
patient education provided on HRQoL in dialysis
patients. At before patient education all patients had very
poor HRQoL. This was reflecting in their SF-36 score
below 50.
At the end of the study period, the patients who had
received extensive patient education regarding dialysis,
life style, exercise and its management from a pharmacist
showed a greater improvement in HRQoL.
Our study confirm that improvement in knowledge of the
39
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
Table-1 Comparison of Different Parameters in Dialysis Patients.
Parameter
Duration
Mean
Std Dev
Physical Health
On 1st day
40.97
20.25
th
Mental Health
Total SF36 Score
On 30 day
51.69
26.90
On 1st day
45.83
18.10
On 30th day
56.25
25.13
On 1st day
43.86
18.80
th
Hemoglobin
On 30 day
55.38
26.09
On 1st day
9.65
1.45
th
Creatinine
Blood Urea
On 30 day
10.32
1.73
On 1st day
7.12
13.35
On 30th day
6.81
13.51
On 1st day
101.55
53.85
th
FBS
Sodium
On 30 day
95.81
53.63
On 1st day
178.10
35.74
On 30th day
164.57
27.00
On 1st day
142.63
6.39
th
Potassium
On 30 day
144.31
6.25
On 1st day
4.81
0.63
th
Chloride
T.C
On 30 day
4.88
0.59
On 1st day
96.52
9.45
On 30th day
98.21
8.81
On 1st day
5276.09
1512.05
Mean
Difference
T
P-value
-10.717
-4.857
<0.001*
-10.416
-4.630
<0.001*
-11.518
-4.924
<0.001*
-0.672
-5.919
<0.001*
0.309
2.836
0.006*
5.736
3.262
0.002*
13.524
4.118
0.001*
-1.688
-3.218
0.002*
-0.069
-1.649
0.106
-1.688
-3.864
<0.001*
-150.000
-4.011
<0.001*
40
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
disease and its management, improves HRQoL, which in
turn has a positive impact on treatment outcomes and
QoL of Dialysis patients. This study also emphasis the
potential of the pharmacist to plat an important role, as a
patient educator, in the management of Dialysis patients.
ACKNOWLEDGEMENT
Authors specially acknowledge to Visveswarpura
Institute of Pharmaceutical Science and KIMS Hospital
and Research Centre, Bangalore for allow me to carry out
ma research work. Also thanks to Mrs. Geetha K. for
guiding me in my research work.
REFERENCES
1. Arogundade FA, Abd-Essamie MA, Barsoum RS.
Health Related Quality of Life in Emotionally Related
Kidney Transplantation: Deductions from a
Comparative Study. Saudi J Kidney Dis Transpl
2005;16: 311-320.
2.Vanbelleghem H, Vanholder R; Levin NW, Becker G,
Craig JC, Ito S, Lau J.et al. The Kidney Disease:
Improving Global Outcomes Website: Comparison of
Guidelines as a Tool for Harmonization. Kidney Int.
2007; 71(10):1054-1061.
3.Gokal HR. Nephrol 2002; 14 (Supplement 1): 170 173.
4. Shargel L. Chronic Renal Failure, Comprehensive
Pharmacy Review. 2 nd Edition, Philadelphia,
Baltimore, Hong Kong, London, Munich. Harwal
Publishing.1994. pp.819.
5. http://www.allwords.com/query.php?SearchTyp
e=0&Keyword=dialysis&goquery=Find+it%21&
Language=ENG
6.Modi AC, Quittner AL. Validation of a DiseaseSpecific Measure of Health-Related Quality of Life for
Children with Cystic Fibrosis. Journal of Pediatric
Psychology 2003;28(8):535-546.
7. Kalantar-Zadeh K, Kopple JD, Block G, Humphreys
MH. Association Among SF36 Quality of Life
Measures and Nutrition, Hospitalization, and
Mortality in Hemodialysis. J Am Soc Nephrol 2001;
12:2797-2806.
41
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
APTI
ijopp
Safety and efficacy of amiodarone in arrhythmias – a prospective
study in the South Indian population
*Vasantha Janardhan, Kousalya K, Ramalakshmi S, Vanitha Rani N,
Kannan G, Jyothsna G, Uma M R C
Department of Pharmacy Practice, Faculty of Pharmacy, Sri Ramachandra University, Porur, Chennai-600 116
Author for Correspondence: [email protected]
Abstract
To study the cardiac and non-cardiac safety of amiodarone and measure the efficacy of amiodarone in restoring and
maintaining sinus rhythm. 35 patients on amiodarone therapy were examined for its safety and efficacy during a
period of 6-months. The dosing schedule of amiodarone in the study population was as follows: I.V. loading doses of
150-300 mg bolus over 30 minutes, followed by 1 mg per minute for 6 hours, followed by daily oral maintenance dose
of 100-400 mg; I.V. + oral loading dose of 800-2320 mg per day, to a total dose of up to 10 gm, followed by daily oral
maintenance dose of 100-400 mg; Oral loading dose of 200 mg T.D.S. for 5 days followed by 200 mg B.D. for 5 days
and a daily oral maintenance dose of 100-200 mg O.D. Out of 35 patients, only 2 patients developed severe ADR
(hypothyroidism) and discontinued amiodarone therapy. Amiodarone could restore rhythm in 15 (83.33%) out of 18
patients with Ventricular Tachyarrhythmias (VT) and in 10 (83.33%) patients out of 12 patients with Atrial
Fibrillation (AF). In other types of arrhythmias (Supraventricular Tachycardia (SVT), Ventricular Tachycardia
(VT), Ventricular Premature Complexes (VPCs) & Supraventricular Premature Complexes (SVPCs), amiodarone
could restore rhythm in 5 (100%) out of 5 patients. Amiodarone was found to be safe and effective in treating all types
of arrhythmias.
Key words: amiodarone; arrhythmias; efficacy
INTRODUCTION
An arrhythmia is any abnormality in rate, regularity, or
site of origin or a disturbance in conduction that disrupts
the normal sequence of activation in the atria or
ventricles.1 Arrhythmias may indicate an underlying
abnormality of the heart muscle, valves or arteries. When
the normal sequence of impulse initiation and
propagation is perturbed, an arrhythmia occurs. Failure
of impulse initiation may result in slow heart rates
(bradyarrhythmias), whereas failure of impulses to
propagate normally from atrium to ventricle results in
dropped beats or "heart block" that usually reflects an
abnormality in either the AV node or the His-Purkinje
system. These abnormalities may be caused by drugs or
by structural heart disease; in the latter case, permanent
cardiac pacing may be required.2 Arrhythmia may be
classified by rate (normal, tachycardia, bradycardia), or
mechanism (automaticity, reentry, fibrillation). 3
Lidocaine, procainamide, amiodarone, verapamil and
isoproterenol are the various anti-arrhythmic agents
used widely.4 Among these, amiodarone has become the
most widely prescribed anti-arrhythmic because of its
Indian Journal of Pharmacy Practice
Received on 01/ 12/2009
Accepted on 05/01/2010 © APTI All rights reserved
wide spectrum of efficacy and relative safety in patients
with structural heart disease.5
Amiodarone
Structure
Systematic (IUPAC) name:
(2-butyl-1-benzofuran-3-yl)-[4-(2-diethylaminoethoxy)-3,5-diiodophenyl]methanone.
Amiodarone is indicated for acute termination and
maintenance of ventricular fibrillation, ventricular
tachycardia (pulse less or with a pulse), atrial fibrillation
and atrial flutter.6 It is effective in the maintenance of
direct current cardioversion in patients with atrial
fibrillation and in the termination of reentrant
42
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
arrhythmias, including the WPW (Wolff-ParkinsonWhite) syndrome.7 Intravenous amiodarone is also
effective in suppressing ventricular arrhythmias, and oral
amiodarone appears to decrease cardiac mortality after
MI.1z
Amiodarone is a unique drug with a combination of
pharmacological properties that are effective in treating a
variety of arrhythmias.8,9,10 This medication is a class III
antiarrhythmic that blocks potassium channels and thus
prolongs the action potential and refractory period in
myocardial cells, thereby decreasing membrane
excitability. Unlike other class III antiarrhythmic agents,
amiodarone maintains this prolonged myocardial action
potential despite faster heart rates, a characteristic that
explains its effectiveness in treating tachycardias.11
Amiodarone also acts as a weak sodium channel blocker,
causing a decline in the rate of membrane depolarization
and impulse conduction.12 As a calcium channel blocker,
Amiodarone can cause significant AV nodal block and
bradycardia.13,14 These properties cause smooth muscle
relaxation as indicated by dilatation of coronary and
peripheral arteries, thereby increasing coronary blood
flow and reducing systemic blood pressure and
afterload.11,15
Adverse effects are very common in patients using
amiodarone. 1 6 Adverse reactions affecting the
cardiovascular, central nervous, endocrine,
gastrointestinal, hepatic, neuromuscular, skeletal and
respiratory systems can occur with large doses (>400
17
mg/d).
The aim of the study is to evaluate the safety and efficacy
of amiodarone in various arrhythmias.
MATERIALS AND METHODS
This prospective study was conducted in the cardiology
in-patient and out-patient departments of a tertiary care
teaching hospital, with the approval of the Institutional
ethics committee and informed consent of the patients.
35 patients prescribed with Amiodarone for a period of
six months (September 2007 to March 2008) were
included in the study.
Patients prescribed with a daily dose of not less than
200mg of amiodarone either orally and/or parenterally
(I.V.) were included in the study. Children, pregnant and
breast-feeding women and patients prescribed with
amiodarone of a daily dose less than 200mg were
excluded from the study.
The dosing schedule of amiodarone in the study
population was as follows:
I.V. loading doses of 150-300 mg bolus over 30 minutes,
followed by 1 mg per minute for 6 hours, followed by
daily oral maintenance dose of 100-400 mg I.V. + oral
loading dose of 800-2320 mg per day, to a total dose of up
to 10 gm, followed by daily oral maintenance dose of
100-400 mg.
Oral loading dose of 200 mg T.D.S. for 5 days followed
by 200 mg B.D. for 5 days and a daily oral maintenance
dose of 100-200 mg O.D.
Patient data were collected in specially designed forms
which included patient demographics (age and sex),
History of present illness, past medical and medication
history, social history, general and systemic examination,
clinical and cardiac investigations, lab investigations,
diagnosis, disease condition for which amiodarone was
prescribed, dose, route, dosing interval and duration of
therapy. diagnosis of these patients were made by the
cardiologist based on clinical signs and symptoms,
history of illness along with the results of cardiac
investigations like E.C.G., echo and Holter monitoring if
required.
The drug-charts were reviewed for prescribing patterns
of amiodarone such as dose, route of administration and
dosing intervals. Adverse drug reactions of amiodarone
reported by the study group were also analyzed. The
safety and effectiveness of amiodarone in the study group
was determined by comparing dose and duration of
amiodarone with the incidence of ADRs and outcome of
the treatment. Statistical analysis was carried out using
software Graph pad (Instat, Version 3.05).
RESULTS
A total of 35 patients who were diagnosed to have
arrhythmias and prescribed with amiodarone not less
than 200 mg daily dose were enrolled in the study.
Table 1 summarizes the patient demographics, duration
of therapy, distribution of arrhythmias and severity of
arrhythmias. Among 18 patients with Ventricular
Tachycardia, the underlying cause was found to be
Myocardial Infarction (MI) in 50% (n=9) of the patients.
Of the 35 enrolled patients, loading dose was given for
91.43% (n=32), of which, 46.88% (n=15) were given I.V.
+ Oral loading dose (mean dose of 6670mg), 31.25%
(n=10) patients were given only oral loading dose (mean
dose of 6180mg) and 21.87% (n=7) were given only I.V.
loading dose (mean dose of 1150mg). 3 patients were
cases of Ventricular and Supra Ventricular Premature
Complexes and they required only maintenance doses for
regular rhythm. Oral maintenance dose of 100-200 mg
O.D. were given for all the patients except two, as the
drug was withdrawn for them due to adverse drug
reactions (ADRs).
43
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
Table 1: Baseline characteristics
Characteristics
No. of patients (n=35)
%
Male
26
74.29
Female
9
25.71
Smoking
6
17.14
Both smoking & alcohol
2
5.71
Tobacco
1
2.86
< 1 week
4
11.43
< 6 months
15
42.86
6 months – 1 year
9
25.71
> 1year
7
20
Stable
10
28.57
Unstable
25
71.43
AF
12
34.29
VT
18
51.43
SVT
2
5.71
VPCs, SVPCs
3
8.57
Sex:
Social History:
Duration of Therapy:
Severity of arrhythmias:
Distribution of arrhythmias:
Safety
Out of 35 patients enrolled for the study, 5 patients
(14.29) developed mild ADR like hypotension (n=3) and
bradycardia (n=2). Only 2 patients (5.71%) developed
severe ADR (hypothyroidism) and discontinued
amiodarone therapy. Hence the rest continued
amiodarone therapy and ADRs did not affect treatment in
94.29% of the patients. The mild ADR was cardiac and
severe ADR was non-cardiac. The distribution of ADR is
summarized in Table 2.
44
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
Efficacy
Of the 35 patients enrolled, sinus rhythm was restored in
all the 10 patients on oral therapy (n=10), 14 patients with
I.V + oral therapy (n=15) and in 5 patients on I.V
amiodarone therapy (n=7). Amiodarone restored rhythm
in 15 (83.33%) out of 18 patients with VT and in 10
(83.33%) patients out of 12 patients with AF. In other
types of arrhythmias (SVT, VPCs & SVPCs),
amiodarone restored rhythm in all 5 (100%) patients.
Table 3 summarizes the rate of 'P' wave in atrial
fibrillation and QRS duration in Ventricular Tachycardia
of ECG before and after administration of amiodarone.
Table 2: Distribution of ADRs
ADRs
No. of patietns (n=35)
Mild (n=5)
Hypotension (n=3, 8.57%)
Bradycardia (n=2, 5.71%)
Severe (n=2)
Hypothyroidism (n=2, 5.71%)
-
Table 3: paired “t”test for comparision of rate of “p” wave in atrial fibrillation and
“qrs” duration in ventricular tachycardia before and after administration of
amiodarone
Rate
n
Mean ± S.D
Before treatment
12
408.42 ± 6.11
After treatment
12
124.33 ± 80.62
Before treatment
18
134.47 ± 5.57
After treatment
18
91.53 ± 14.5
p value
Rate of P Wave:
0. 0001
Rate of QRS Complex:
0.0001
45
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
DISCUSSION
Amiodarone is indicated for acute termination &
maintenance of stable (or) unstable Ventricular
Tachycardia, Ventricular Fibrillation, Atrial Fibrillation
and Atrial Flutter. It is effective in the maintenance of
sinus rhythm in patients with Atrial Fibrillation and also
in the termination of reentrant arrythmias.
The present study indicated suppression of Incessant VT
or VF with amiodarone, in 70% of patients. In the other
20%, amiodarone was accompanied by Adenosine/
Lidocaine /DC shock for suppression. Overall amiodarone played a role in 90% of patients in the suppression
of incessant VT or VF. The report of the present study is
in accordance with the study conducted by Rosenbaum et
al (1976) where total suppression of arrhythmias was
observed in 72% of patients.18
In the present study, 100% of amiodarone patients were
observed to have almost complete suppression of VPCs
and non-sustained VT. This study report is similar to that
of Canadian Amiodarone Myocardiac Infarction
Arrhythmia trial (CAMIAT) pilot study in which almost
complete suppression of asymptomatic VPCs were
observed in 86% of the enrolled patients.19
Amiodarone exhibited excellent results in 15 of 18
patients (83.33%) with symptomatic VT or VF in the
current study. These results are in accordance with the
study done by Rosenbaum et al (1976) where they
reported excellent results in 82% with symptomatic
VT/VF.18
In the present study, amiodarone was given in 3 different
doses of 960mg (group 1), 1050 mg (group 2) and
1200mg (group 3) over 24 hours for incessant VT or VF.
There was no recurrence of VT/VF with in or after 24
hours in group 1 and 3 where as 50% recurrence was
observed in group 2. The present report has no correlation
with the study done by Scheinman MM et al where the
reports were 32%, 45% and 53% of recurrence in low,
medium and high dose groups respectively20.
Conversion of sinus rhythm (SR) with I.V. amiodarone
was achieved in 10 of 12 (83.33%) patients. This result
was similar to that of the randomized controlled study
conducted by Panos E.Vardas et al. They reported that
conversion to SR with I.V. amiodarone was achieved in
80.05% of patients21.
In the present study, loading and maintenance doses were
found to have no significant effect on restoration and
maintenance of SR in patients with AF. Maintenance of
SR in patients with AF was achieved in 9 of 10 (90%)
patients. The results were different from the reports of the
study conducted by O’keefe et.al. where the maintenance
of SR was 32.5% at 1 month.22
In the present study, the incidence of spontaneous
marked QT prolongation resulted in polymorphic VT
was observed in 2 of 35 patients (5.71%) in contrast to the
reports of studies conducted by Greene HL et al where the
incidence was found to be < 0.5%.23
Amiodarone induced torsade de pointes was absent in the
present study.
A meta analysis of double blind study on amiodarone
reported 1 year net risk of events as Pulmonary toxicity in
1%, hepato toxicity in 0.6%, peripheral neuropathy in
0.3% and hyper thyroidism was found in 0.7%.24 None of
the above toxicities were observed in the present study.
Amiodarone exhibited excellent results in the control of
symptomatic VT/VF. It is effective in the suppression of
incessant/ recurrent Ventricular Tachyarrhythmias and
asymptomatic or symptomatic VPCs, SVPCs and nonsustained VT and SVT. It is effective in termination of
AF, restoration and maintenance of SR in AF patients.
Amiodarone exhibits good safety for other cardiac and
non-cardiac ADRs in the treatment of various
arrhythmias.
Hence it was observed that effective restoration and
maintenance of sinus rhythm was achieved in patients
after treatment with amiodarone. The improvement in
cardiac condition was found to be higher. Only 2 ADRs
were severe requiring discontinuation of the drug. The
others were not serious and did not lead to any
compromise in normal life-style.
Limitations of the Study
The time period was very less and hence the number of
subjects was minimal. The same study can be carried out
in a larger population.
ACKNOWLEDGEMENT
We sincerely thank Dr.Ramesh, Professor, Department of
Cardiology, Sri Ramachandra University, Chennai, for
his valuable guidance and encouragement throughout the
study.
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book of Therapeutics - Drug and Disease
Management, Eighth Edition, Lippincott Williams &
Wilkins, 2006. p. 534- 568.
2. Keating MT, Sanguinetti MC. Molecular and cellular
mechanisms of cardiac arrhythmias. Cell 2001,
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3. Velebit V, Podrid P, Lown B, Cohen BH, Graboys TB.
Aggravation and provocation of ventricular
arrhythmias by antiarrhythmic drugs. Circulation
1982; 65:886-894.
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4. Hanaki Y, Sugiyama S, Hieda N, Taki K, Hayashi H,
Ozawa T. Cardioprotective effects of various class I
antiarrhythmic drugs in canine hearts. J Am Coll
Cardiol 1989;14:219-224.
5. Karin H Humphries, Charles R Kerr, Michael S, Paul
D, and for The Canadian Registry of Atrial
Fibrillation (CARAF) Investigators. Limitations to
antiarrhythmic drug use in patients with atrial
fibrillation. CMAJ 2004 September 28;171(7):
741–745.
6. Rae AP, Hutton I. Cardiogenic shock and the
haemodynamic effects of arrhythmias. Br J Anaesth
1986; 58:151-168.
7. Indranill BR. Atrial Fibrillation: Present Treatment
Protocols by Drugs and Interventions. JIACM 2003;
4(3):213-227.
8. Maisel WH, Rawn JD, Stevenson WG. Atrial
fibrillation after cardiac surgery. Ann Intern Med
2001; 135:1061–1073.
9. Aranki SF, Shaw DP, Adams DH et al. Predictors of
atrial fibrillation after coronary artery surgery:
current trends and impact on hospital resources.
Circulation 1996; 94:390–397.
10.Maras D, Boskovic SD, Popovic Z et al. Single-day
loading dose of oral amiodarone for the prevention of
new-onset atrial fibrillation after coronary artery
bypass surgery. Am Heart J 2001;141:E8.
11. Katzung B. Basic and Clinical Pharmacology. 8th ed,
New York, McGraw-Hill 2001.
12. Podrid PJ. Amiodarone: reevaluation of an old drug.
Ann Intern Med 1995;122:689–700.
13. Marshall. Pharmacology of Cardiac Rhythm. In:
David E. Golan, Armen H Tashjiam, Ehrin J
Armstrong and April W Armstrong, editors.
Principles of Pharmacology: The Pathophysiologic
Basis of Drug Therapy. 2nd Edition, Wolters
Kluwer/Lippincott Williams & Wilkins, 2008.
pp.321-322.
14. Sanguinetti MC, Jurkiewicz NK. Two components of
cardiac delayed rectifier K+ current: differential
sensitivity to block by class III antiarrhythmic agents.
J Gen Physiol 1990, 96:195-215.
15. Pollak PT. Oral amiodarone: historical overview and
development. Pharmacotherapy 1998; 18(6 pt
2):121S–126S.
16. Greene HL, Graham EL, Werner JA et al. Toxic and
therapeutic effects of amiodarone in the treatment of
cardiac arrhythmias. J Am Coll Cardiol 1983; 2:1114.
17. Stelfox HT, Ahmed SB, Fiskio J, Bates DW.
Pharmacoepidemiology and Drug Utilization;
Monitoring amiodarone's toxicities:
Recommendations, evidence, and clinical practice.
Clin Pharm Ther 2004; 75:110-122.
18. Rosenbaum MB, Chiale PA, Haedo A, Lázzari JO,
Elizari MV. "Ten years of experience with
amiodarone". Am. Heart J 1983;106(4 Pt 2):
957–964.
19. The CAPS Investigators. The cardiac arrhythmia
pilot study. Am J Cardiol 1986; 57:91-95.
20. Scheinman MM, Levine JH, Cannom DS. Doseranging study of intravenous amiodarone in patients
with life-threatening ventricular tachyarrhythmias.
Circulation 1995; 92:3264-3272.
21. Vardas PE, Kochiadakis GE, Igoumenidis NE,
Tsatsakis AM, Simantirakis EN, Chlouverakis GI.
Amiodarone as a First-Choice Drug for Restoring
Sinus Rhythm in Patients with Atrial Fibrillation.
Chest 2000; 117(6):1538-1545.
22. O'Keeffe DB, Nicholls DP, Morton P, Murtagh GJ,
Scott ME. Maintenance of sinus rhythm after
elective cardioversion from chronic stable atrial
fibrillation: amiodarone compared with quinidine.
Br Heart J 1984; 51:103.
23. Greene HL, Graham EL, Werner JA. Toxic and
therapeutic effects of amiodarone in the treatment of
cardiac arrhythmias. J Am Coll Cardiol 1983;
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25. Vorperian VR, Havighurst TC, Miller S, January CT.
Adverse Effects of Low Dose Amiodarone: A MetaAnalysis. J Am Coll Cardiol 1997; 30(3):791-798.
47
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
APTI
ijopp
Pharmacoeconomic evaluation of artesunate-amodiaquine and
artesunate- mefloquine artemisinin-based combination therapies.
Adepoju G.K.A.
Department of Clinical Pharmacy & Biopharmacy, Faculty of Pharmacy, Olabisi Onabanjo University, Sagamu,
Ogun State, Nigeria.
Address for Correspondence: [email protected]
Abstract
These two artemisinin-combination therapies (ACTs) have been found to be rarely prescribed due to various reasons
relating to both clinical and marketing promotional considerations. This study aims at uniting these factors by
evaluating the pharmacoeconomic considerations on the choice of these two drugs. Published data on efficacy/
effectiveness trials were reviewed from where the data for this study were extracted. A pharmacoeconomic analysis
was carried out using the various tools of pharmacoeconomics. It was found out that clinically derivable utilities and
health outcomes (Side-effects and, probably, convenience of dosage regimen) did not favour the frequent choice of
these drugs. Side effects and, probably, convenience of dosage regimen mainly affected the choice of these
drugs.Clinical cure should not be the only health outcome to be guided in therapy. Other unfavourable health
outcomes should be considered also. Disability/Distress to the patients should be considered also. However,
Artesunate-Amodiaquine (AAQ) has a superior pharmacoeconomic advantage over Artesunate-Mefloquine (AM) in
terms of cost and cost utility. Artesunate-Mefloquine (AM) has a higher cost-benefit than AAQ but this is rarely used
in health considerations. Side effects of these drugs limit their choice as antimalarials. in effective in treating
uncomplicated Plasmodium falciparum malaria
Key words: Pharmacoeconomics; health outcomes; disability/distress scale; recrudescence; health utility;
sensitivity analysis; effectiveness-efficacy data
INTRODUCTION
Pharmacoeconomics has become a subject of great
interest. Riding the wave of managed care-and the
increased cost consciousness of government, employers,
insurers, and patients, pharmacists, providers, and
pharmaceutical companies use economic models to
prove the value of their drugs and therapeutic
interventions.1 This must include the use and cost of
laboratory and diagnostic services, physician and
ambulatory visits, hospitalizations, and other resources
consumed; more importantly, they must now include the
costs and benefits to the patients, their families and to the
society.The utility of a particular health state is a cardinal
measure of the strength of one's preference for a health
state. 2 ,3 The time spent in various health states by an
individual, weighted by the utility values assigned by this
individual, represents the health-related quality of life for
this individual as measured in Quality-adjusted life years
(QALYs).
The gains in QALY for an individual or a group of
Indian Journal of Pharmacy Practice
Received on 17/11/2009
Accepted on 28/01/2010 © APTI All rights reserved
individuals due to a health programme can be used as a
measure of that programme's effectiveness. When
changes in cost before and after the implementation of
the programme, are calculated and matched with the
gains (or losses) in QALY due to the programme, the
resulting ratio is the cost-utility ratio of that programme.
It should be recognized that a number of researchers have
been working in the area of measurement of health state
utilities and changes in QALY as a measure of
effectiveness of health programmes.2,4,5 The results of
Torrance showed varying utility values of 1.00 for health
and 0.00 for dead as reference states.2 The health states
with negative values are viewed as worse than death. The
Rosser and Watts Matrix (Table 1) also provide another
index for utility values.6 It should be recognized that
measures of improvement in health states due to any
programme or treatment simply provide data that may be
used by pharmacists and other healthcare professionals to
improve their decisions. They do not provide definitive
answers nor do they make decisions for us. The study,
therefore, aims at evaluating the Pharmacoeconomic
basis for guiding the choice of the Artemisinin-based
combination therapies (ACTs), particularly focusing
48
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
on Artesunate-Amodiaquine (AAQ) with Artesunate Mefloquine (AM) as antimalarial drugs.
METHODOLOGY
Literature search was carried out on the effectiveness and
other health related parameters of these WHO approved
ACTs. Thus, it was the efficacy data obtained from
randomized clinical trials that were applied in this
pharmaco-economic analysis whose aim was to
determine the relative PE data of these drugs and use
them in their ratings for real life situations.
Artesunate-Amodiaquine (AAQ) and Artesunate Mefloquine (AM) are two Artemisinin-based
combination therapies (ACTs) that have been widely
used for the treatment of uncomplicated malaria across
the sub-Saharan Africa. The efficacy of these two
regimens is well established. 7-12
Aside from their efficacy, no convincing evidence of
artemisinin neurotoxicity has been demonstrated during
routine clinical use in humans. 7 The absence of
longitudinal studies limits the prospective areas of study.
The major pharmacoeconomic evaluation tools are Cost
Minimisation Analysis (CMA); Cost-Effectiveness
Analysis (CEA) Cost-Utility Analysis (CUA) and CostBenefit Analysis (CBA). 19-24
Cost Minimization Analysis (CMA)
The average prices of AAQ and AM in retail pharmacies
in Nigeria are respectively N800 and N1050. The too
ACTs produce a very rapid therapeutic response, 25 no
resistance to them has been reported 26-29 and the outcomes
are the same--cure to malaria episodes. Hence, only the
costs of the drug are considered more so as the other costs
are equal for the interventions. Since CMA identifies the
intervention with the lowest possible costs bearing in
mind that the outcomes are the same, it is glaring that
AAQ has a lower cost than AM. Hence, AAQ is the drug
of choice under this evaluation tool as only the cost
differences are the main determinants of the decision
about the choice of therapy.
Cost Benefit Analysis
Under this tool, it is the benefit that arises as a result of
applying the intervention that is considered relative to the
cost and this parameter is measured in monetary values. 30
The studies by Bukirwa et al, 8 Mattenson et al 10 and van
der Broek 31 showed AL as the 'gold standard' being the
most effective of all the ACTs followed by AM. Hence,
AM is more efficacious than AAQ in the treatment of
malaria episodes. Hence the net cost of using AAQ is
higher than the net cost of using AM (alternatively, the
net benefit of using AAQ is less than that of AM). The
pharmaco-economic decision rule to choose the drug
with the higher net benefit (of the two) favours AM.
Hence, in terms of CBA, AM will be drug of choice.
Cost-Effectiveness, Analysis
Outcomes to be compared are efficacy, side effects,
productivity cost and all patient and family costs etc.
Although AM has been widely studied in Asia, data are
limited in malaria-endemic areas in Africa. 32- 34 Stoher et
al 35 has shown the excellent efficacy and tolerability of
AL and AM in Northern Laos while that of Hutagalung et
36
37
al and Sagara et al showed that AM was well tolerated
and is as effective as AL for the treatment of Plasmodium
falciparum malaria. The two drugs remained highly
effective and resulted in equivalent therapeutic responses
and prevented more new infections. Hence, AM is more
effective and well tolerated than AAQ. Therefore, in
effectiveness ratio, AM has a higher cost-effectiveness
than AAQ. This was confirmed by the studies by
Mattenson et al, 10 and Bukirwa et al, 8 that compared AL
to AAQ (an effectiveness study in Tanzania and an
efficacy trial in Burundi). AL resulted in fewer failures
and fewer parasitological failures. Thus AL provided
greater protection against re-infection compared with
AAQ. AL was superior to AAQ in preventing new
infections. 8 Therefore, since AM and AL were found to
be highly efficacious and equivalent in there therapeutic
responses and AL was found to be superior to AAQ,
hence AM is superior to AAQ.
It should be noted that CEA is not useful to decision
makers in deciding among programmes with different or
multiple health effects involving morbidity and
mortality. It does not provide an overall measure of
healthcare programmes.
Cost-Utility Analysis (CUA)
Here the consequences are expressed in utilities such as
the quality-adjusted life years (QALY) as opposed to
natural units in CEA - recrudescence, re-infection and
treatment-related adverse events are variables that affect
the QALY measurements. Ndiaye et al, (2009) showed
that these adverse events are milder in AAQ (insomnia,
somnolence and gastro-intestinal system disorders)
when compared with AM (neuropsychiatric reactions
cardiac conduction disorders, circulatory disorders etc).
(www.lariam.com). Other reported effects of Mefloquine
included bad dreams, ringing in the ears, emotional
instability, numbness, rashes and itching. Recrudescence
was higher in AAQ than AM.
38
49
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
Table 1 shows the DDS for these drugs using the Rosser
and Watts Disability/Distress Scale. From this Table,
AAQ has 0.973 and 0.956 value for AM. The cost per
QALY gained is calculated as: (Cost B – Cost A)/(QALY
of B – QALY of A).
Table 1: Showing the Rosser and Watts Disability/Distress Scale for these drugs
Drug
Disability
Distress
AAQ
Slight social disability
0.978
AM
Severe social disability
0.956
Table 2: Showing the cost per QALY for the Drugs
Drug
AAQ
AM
AAQ
-
-14705.88
AM
-14705.88
-
Table 2 showed that substituting either of these drugs for
the other cost - #14705.88 per QALY. Hence, neither is
cost effective over the other in treating P. falciparum
malaria. The cost /QALY surpassed the cut-off threshold
for cost-effectiveness by this value. Hence, it is not cost
effective to use these drugs where an alternative ACT is
available.
Sensitivity Analysis
Increasing the DDS for AM to 0.995 made the drugs to
become alternative cost-effective replacement therapy
for each other (Table 3).
Table 3: Showing the Sensitivity Analysis
Drug
AAQ
AM
AAQ
-
-11363.64
AM
-11363.64
-
It cost N11, 363.64 above the cut-off threshold for costeffectiveness per QALY gained for either therapy 9 Table
3). Hence, it is not cost-effective using AM in place of
AAQ. Reducing the price of AM by 20% (N840) while
maintaining the DDS of 0.973, increased the cost per
QALY gained by # 2392.94 above the cut-off threshold
this discounting reduced the cost/QALY gained but none
is cost-effective over the other. Again, the drugs are
equally cost-effective over each other.
Conclusion:
Apart from being of a lower cost, AAQ has superior
advantage over AM in terms of CUA. AM has higher
CBA, and CEA than AAQ while they are equally costeffective over each other. Side effects of these drugs
(particularly AM) limit their choice as anti-malarial.
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52
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
APTI
ijopp
Utilization of Third Generation Cephalosporins in Multispeciality
Teaching Hospital, Dehradun
Rekha Bisht1*, Bhattacharya S1, Katiyar A2
1
Shri Guru Ram Rai Institute of Technology and Science, Patel Nagar, Dehradun (Uttarakhand)
2
Ranbaxy Laboratory (Ltd), Paonta Sahib, Himachal Pradesh
Address for correspondence: [email protected]
Abstract
Antibiotic resistance has become a major clinical and public health problem within the life time of most people living
today. The liberal use of third-generation cephalosporins in hospitals has been associated with the emergence of
extended-spectrum beta- lactamases presenting concerns for bacterial resistance in therapeutics. The present study
was carried out to identify the utilization of third generation cephalosporins in tertiary care teaching hospital in
Dehradun. Total 250 inpatients were interviewed by using a data collection form. The study revealed that out of 250
patients, 213 were prescribed third generation cephalosporins. Ceftriaxone (46%) was most widely prescribed drug
followed by cefixim (20.18%), ceftazidime (12.25), cefotaxime (8.92) and cefpodoxime (5.63).The maximum use of
third generation cephalosporins was in medicine ward (39%) followed by patients in surgical (59, 28%), gynecology
(36, 17%), orthopedic (18, 8%) and pediatric ward (9, 4%). The most common reasons for administration of third
generation cephalosporins were high grade fever and gastrointestinal infections (26.29%) followed by respiratory
tract infections (33,15.49%), injury cases (43, 20.19%), urinary tract infection (35,16.43%), skin and soft tissue
infection (19,8.9%) and septicemia (04, 1.88%) and maximum patients were between the age group of 41-50
(23.47%) who were prescribed third generation cephalosporins.
Key words: Antibiotic, Resistance, Third generation cephalosporins, Prescription, infections
INTRODUCTION
Appropriate use of antibiotics is central to limiting the
development and the spread of resistant bacteria in
hospitals and communities. Use of broad-spectrum
antibiotics, in particular the third generation
cephalosporins in nosocomial infections have been
linked to the emergence of antibiotic resistance and
increase in costs.1 The emergence and spread of
resistance are also threatening to create species resistant
to all currently available agents.2 The hospital setting is
particularly conducive to the development of antibiotic
resistance as patients who are severely ill, immunocompromised or have devices and/or implants in them
are likely to receive frequent courses of empirical or
prophylactic antibiotic therapy.3 Furthermore, the
absence of guidelines for antibiotic use, protocols for
rational therapeutics and infection control committees
have led to overuse and misuse of antibiotics in different
specialized units in hospitals.1
Overuse and misuse of antibiotics influences the
Indian Journal of Pharmacy Practice
Received on 25/11/2009
Accepted on 29/01/2010 © APTI All rights reserved
prevalence and distribution of antibiotic resistance in
common pathogens. Antibiotic usage is the only form of
medical treatment where the choice of therapy for one
patient can affect diseases suffered in the future by
another, through the selection of resistant organisms
followed by cross-infection to the new host.4 Multiple
drug resistance (MDR) mediated through R plasmids
among Gram-negative bacteria has become a major
nosocomial problem worldwide.5 Due to multiple drug
resistance to â-lactams, aminoglycosides and
quinolones, antibiotic treatment of nosocomial
infections caused by these bacteria is compromised.6
Among the â-lactams, third generation cephalosporins,
such as ceftazidime, cefotaxime, and ceftriaxone are
routinely used in our clinical settings, and resistance to
these drugs, due to â-lactamase production, is rampant.7
The increasing resistance to third generation
cephalosporins accompanied by an increasing cost
burden has raised concerns about the detection,
prevalence, and clinical implications of infections with
Escherichia coli and Klebsiella spp. An important source
of this resistance results from the production of extendedspectrum beta-lactamases (ESBLs) by bacteria.
53
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
ESBLs are modified beta-lactamase enzymes mainly
derived from the ubiquitous TEM1/2 and SHV-1
plasmidmediated enzymes, which hydrolyse expanded
spectrum cephalosporins to varying degrees. Many betalactamases result in resistance to third generation
cephalosporins in Enterobacteriaceae. Genera such as
Enterobacter, Citrobacter and Serratia posses
chromosomal broad spectrum beta-lactamases which are
normally repressed, and when induced result in
resistance to third generation cephalosporins. Klebsiella
and E. coli usually have the SHV- or Temtype betalactamases and key mutations in these results in true
"ESBLs". ESBLs have received attention in the last
decade because although penicillins, cephalosporins, or
aztreonam appear to be susceptible in vitro, ESBL
producing E. coli or Klebsiella spp. may demonstrate
clinical resistance to these antibiotics leading to
treatment failures. Liberal use of the third generation
cephalosporins antibiotics has resulted in the ESBLs
conferring resistance among Enterobacter 8 and
Enterobacteriacae worldwide 9-11 compromising their
clinical use.
In order to identify the utilization of third generation
cephalosporins, an audit of prescriptions of inpatients
was undertaken at Shri Mahant Indresh Hospital, a
multispecialty teaching hospital in Dehradun,
Uttarakhand.
MATERIAL AND METHODS
Study Site
The present study was carried out at Shri Mahant Indresh
Hospital, Dehradun, which is a multispecialty teaching
hospital providing both inpatient and outpatient services
to people in and around Dehradun district.
Study setting
The study was performed using prescriptions of 250
inpatients. The study was carried out in between June to
August 2009. Various age group patients admitted in
different wards of hospital were selected for the study.
The prospective study in various patients was conducted
who had received one or more course of treatment with
one of the third generation cephalosporin. Patient's data
such as the age, name, gender and data on prescribed
drugs that include name of drug, dosage form, route of
administration, most widely prescribed drugs and so on.
Patient's characteristics, clinical data and laboratory
investigations were obtained from the hospital records.
Specific data on the category of service, concomitant
disease and drug therapy, organ system with infection
and third generation cephalosporins used were collected
by using a customized data collection sheet in an
approved manner.
RESULTS
Out of 250 patients studied during study period, 213 were
prescribed cephalosporins either alone or in combination
with other antibiotics. Gender wise distribution of
patients showed that, 109 patients were male and 104
patients were female accounting for 51.17% and 48.83%
of total population who were prescribed cephalosporins
respectively. The maximum number of patients who
were prescribed 3rd generation cephalosporins were
between the age groups of 41-50 (50, 23.47%) and 51-60
(47, 22.07%) followed by 31-40 ( 45, 21.13%) and 21-30
( 26, 12.21%). (Table-1). During the study it was found
that the use of third generation cephalosporins was
highest in medicine ward (83, 38.97%) followed by
patients in surgical (59, 27.7%), gynaecology (36,
16.90%), orthopedic (18, 8.45%) and pediatric ward (9,
4.22%). Table-2 shows the distribution of patients
according to the wards in which they were admitted.
Amongst the various reasons for administration of 3rd
generation cephalosporins, the maximum reasons were
of high grade fever and gastrointestinal infections (56,
26.29%) followed by respiratory tract infections (33,
15.49%), injury cases (43, 20.19%), urinary tract
infection (35, 16.43%), skin and soft tissue infection (19,
8.9%) and septicemia (04, 1.88%). (Table-3)
By interpretation of data collected during study, it was
found that ceftriaxone (98, 46%) was the most widely
prescribed antibiotic amongst all 3rd generation
cephalosporins followed by prescriptions of cefixim (43,
20.18%), ceftazidime (26, 12.25%), cefotaxime (19,
8.92%), cefpodoxime (12, 5.63%).(Table-4)
DISCUSSION
The increasing frequency with which antibiotic resistant
microorganisms are recovered from patients in hospital
and community setting has been commented widely in
recent years.12,13,14 The major selective pressure driving
changes in the frequency of resistance is in each case, the
volume of antibiotics use.15
The increasing resistance problems of recent years are
probably related to the overuse of broad spectrum agents
such as cephalosporins.16 The extensive use of third
generation cephalosporins has caused the emergence of
extended spectrum beta lactamases in gram negative
bacteria worldwide. 1 More third generation
cephalosporins are being widely used in hospitals for
empirical and prophylactic therapy and as their use
extends across the board, more organisms will develop
54
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
Table. 1: Age wise distribution of inpatients that were prescribed 3GCs
Age Group ( years)
Male
Female
Total
(%)
1-10
5
4
9
4.22
11-20
11
10
21
9.86
21-30
12
14
26
12.21
31-40
19
26
45
21.13
41-50
28
22
50
23.47
51-60
25
22
47
22.07
61-70
09
06
15
7.04
Total
109
104
213
100
Table. 2: Ward wise distribution of patients that were prescribed 3GCs
Hospital Ward
Number of Patients (n=213)
Percentage (%)
Medicine
83
38.97
Surgery
59
27.7
Gynaecology
36
16.90
Orthopedics
18
8.45
Pediatrics
09
4.22
Other
08
3.76
n= Number of patients that were prescribed third generation cephalosporins
Table. 3: Reasons for administration of 3GCs
Reasons
Number of Patients
(Percentage) %
Fever/ GIT infection
56
26.29
Respiratory tract infection
33
15.49
Injury
43
20.19
Urinary tract infection
35
16.43
Skin and soft tissue infection
19
8.92
Septicemia
04
1.88
Others
23
10.80
Total
213
100
55
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
Table. 4: Distribution of prescriptions according to widely prescribed 3GCs
Third Generation Cephalosporins
Number of Prescription n= 213
Percentage (%)
Ceftriaxone
98
46.00
Cefixime
43
20.18
Ceftazidime
26
12.25
Cefotaxime
19
8.92
Cefpodoxime
12
5.63
Ceftriaxone + Salbactun
7
3.28
Cefixime + Salbactum
5
2.34
Cefotaxime + Salbactum
3
1.40
n= Number of patients that were prescribed third generation cephalosporins
resistance to them presenting the threat of antibiotic
ineffectiveness in life threatening infections.
Various literatures have been reported the inappropriate
use of third generation cephalosporins. Inappropriate
antibiotics use has been reported from teaching hospitals
in New York17 in the surgical practice, in China18 where
inappropriate third generation cephalosporins use was an
independent risk factor for significant high mortality, in
Malaysia19 for patients in medical wards and in South
Africa20 for patient in gynaecology ward. In our study we
found that out of 250 patients, 213 were receiving third
generation cephalosporins, which was quite
inappropriate. The result of the study revealed the higher
inappropriate use of ceftriaxone when used as single
agent rather than in combination therapy with other
antibiotics. We believe this practice may have followed
from the convenience of a single daily dose by
intramuscular injection particularly for ceftriaxone,
which was the most frequently used third generation
cephalosporin.
CONCLUSION
Antibiotic resistance is rapidly increasing global
problem. It contributes to health and economic losses
world wide. As antibiotics have important role in clinical
care, thus efforts should be made to reduce the volume of
unnecessary antibiotic prescribing. The present study
shows the high proportion of hospitalized patients who
receive antibiotics particularly broad spectrum agents
like cephalosporins. In addition to their broader spectrum
activity, third generation cephalosporins are widely used
for empirical treatment of severe or complicated
infections and for direct treatment of otherwise resistant
organisms. The expanding use of these agents can
promote escalating antibiotic resistance within both
individual and communities. As a result, the medical
profession is losing some of its most potent therapies for
patients with greatest need.
REFERENCES
1. Pereira LMP, Phillips M, Ramlal H, Teemul K,
Prabhakar P. Third generation cephalosporins use in a
tertiary hospital in Port of Spain, Trinidad: Need for an
antibiotic policy. BMC Infect Dis 2004; 4:59.
2. Okesola AO, Makaanjoula O. Resistance to third
generation cephalosporins and other antibiotics by
Enterobacteriaceae in Western Nigeria. Am J Infect
Dis 2009; 5(1):17-20.
3. Patterson JE. Antibiotic utilization: Is there an effect
on antimicrobial resistance?. Chest 2001;119(2):426430.
4. Gupta V, Datta P, Agnihotri N, Chander J. Comparative
in vitro activities of seven new â-lactams alone and in
combination with â-lactamase inhibitors, against
clinical isolates resistant to third generation
cephalosporins. Braz J Infect Dis 2006;10(1):22-25.
5. Ram S, Gupta R, Gaheer M, Uppal S. Prevalence of
multiple drug resistant organisms in an intensive care
burn unit. Indian J Med Res 2000;111:118-120.
6. Gales AC, Jones RN, Turnidge J. Characterization of
Pseudomonas aeruginosa isolates: occurrence rates,
antimicrobial susceptibility patterns and molecular
typing in the global SENTRY antimicrobial
surveillance program 1997-1999. Clin Infect Dis
2001;32(2):146-155.
7. Mahapatra A, Samal B, Pattnaik D, et al. Antimicrobial
susceptibility pattern of clinical isolates of nonfermentative bacteria. Indian J Pathol Microbiol
2003;46(3):526-527.
56
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
Cosgrove SE, Kaye KS, Eliopoulous GM, Carmeli
Y. Emergence of third-generation cephalosporin
resistance in Enterobacter species. Arch Intern Med
2002;162:186-190.
Sanders CC, Sanders WE. Beta-lactam resistance in
Gram negative bacteria: global trends and clinical
impact. Clin Infect Dis 1992;15:824-839.
Pfaller MA, Jones RN, Doern GV, Salazar JC.
Multicenter evaluation of antimicrobial resistance to
six broad spectum â- lactams in Colombia:
Comparison of data from 1997 and 1998 using E test
method. Diagn Microbiol Infect Dis 1999;35:235241.
Goossens H. MYSTIC (Meropenam yearly susceptibility test information collection) results from
Europe: comparison of antibiotic susceptibilities
between countries and centre types. MYSTIC Study
Group (European centers only). J Antimicrob
Chemother 2000;46:39-52.
Cohen ML. Science 1992;257:1050-1055.
Neu HC. Science 1992;237:1064-1073.
Greenwood D. Lancet 1995;345:1371.
Austin DJ, Kristinsson KG, Anderson RM. The
relationship between the volume of antimicrobial
consumption in human community and the
frequency of resistance. Proc Natl Acad Sci
1999;96:1152-1156.
Antimicrobial resistance- is a major threat to public
health. BMJ 1998; 317:609-610.
Gorecki P, Schein M, Rucinski JC, Wise L.
Antibiotic administration in patients undergoing
surgical procedure in a community teaching
hospital: the chaos continues. World J surg 1999;23:
429-432.
Du B, LongY, Chen D, Liu D, Xu Y, Xie X. Extented
spectrum beta-lactamase producing Escheria Coli
and Klebsiella Pneumoniae blood stream infection:
risk factors and clinical outcome. Intensive care Med
2002;28:1718-1723.
Hoopi PY, Yong CM, Cheong I. A study of the
appropriateness of antibiotic use in the medical
wards of a tertiary teaching hospital in Malaysia. Int
J Clin Pract 2001;55:272-274.
Till B, Williams L, Oliver SP, Pillans PI. A survey of
inpatient antibiotic use in a teaching hospital. S Afr
Med 1991;8017-20.
57
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
APTI
ijopp
Effect of combination of steroids, antibiotic and emollient on atopic
dermatitis lesions
Sabry E.Y
Allergy Unit- College of Medicine and Medical Sciences - Taif University, Taif - Kingdom of Saudi Arabia.
Address for correspondence: [email protected]
Abstract
Topical steroids are the mainstay of therapy in atopic dermatitis. However, as massive colonization of lesional and
non-lesional skin of atopic dermatitis patients with staphylococcus aureus had been proved to exist and aggravate the
skin lesions, thus topical antibiotics seem necessary to be added. New combined topical antibiotics and steroid
formula eliminate forcefully the organism. Moreover, as topical medication penetrates a moist stratum corneum more
effectively than it will penetrate a dehydrated stratum corneum. Thus combining two and not one moderately potent
topical steroids, a topical antibiotic with an emollient, in rapidly and effectively controlling atopic dermatitis lesions
was the aim of this study. Twenty females with non facial non extensive forms of atopic dermatitis were included in this
study. Atopic dermatitis severity scoring was performed using the SCORAD index. Three weeks after the start of
therapy (second visit), marked improvement of the treated lesions were observed, especially erythema,
oozing/crusting and oedema/papules, with minimization of pruritus and sleep disturbance. These three signs
disappeared on the third visit, six weeks after start of therapy, only minimal dryness was detected with no more
personal complaints, thus patients were shifted to maintenance therapy with an emollient. The combined topical
therapy was effective and safe in rapidly controlling treated lesions.
Key words: atopic dermatitis; combined therapy; emollient; topical antibiotics; topical steroids
INTRODUCTION
Atopic dermatitis (AD) remains a therapeutic challenge,
and topical corticosteroids continue to have an important
role. There are a large number of topical corticosteroids
available, classified according to potency (mild,
1,2
moderate, potent or very potent).
In 1974, Leyden et.al. showed that 90% of patients with
atopic dermatitis have their skin colonized with
staphylococcus aureus (SA).3 Thereafter, many studies
proved the increased carrier state of SA in both involved
and uninvolved skin in atopic dermatitis(AD).4-8
Moreover, as SA produces superantigens that perpetuate
the eczema, thus it was presumed that combining
moderately potent topical corticosteroid and an antibiotic
could tackle AD more effectively than steroids alone.9,10
Dry skin is a common skin condition as well as a key
aspect of a number of diseases such as atopic dermatitis.
Dry skin has an impact on the patient in terms of
discomfort, pruritis and impaired quality of life. Within
the overall treatment regimen for these diseases, the use
of emollients to manage dry skin plays a considerable
Indian Journal of Pharmacy Practice
Received on 17/11/2009
Accepted on 03/01/2010 © APTI All rights reserved
role in managing skin conditions, to an extent that
emollients are considered the mainstay of maintenance
therapy for atopic dermatitis.11-14
Hence, the primary goal of this study was to evaluate the
role of combining two moderately potent topical steroids,
a topical antibiotic and an emollient, in effectively and
rapidly controlling AD.
Patients and methods
Patients
A total of thirty one patients with atopic eczema were
recruited for this study from "Allergy Unit" at Taif
University. All the patients satisfied the diagnostic
criteria of Hanifin and Rajka for atopic eczema.15 All
patients provided their verbal consent and approval and
were voluntarily included in this research study. The
study was performed in accordance with the Declaration
of Helsinki (South Africa, 1996 amendment) and Good
Clinical Practice guideline.
Patients were ineligible for the study if they had only
periorbital and /or facial eczema (four cases) or
extensively generalized eczema (seven cases) for fear of
side effects from the use of two topical steroids on
delicate skin or on a large body area. Thus a total of 20
cases were actually included in this study, (age range, 1926 years; mean age 22.1± 2.07 years; all were females).
58
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
Assessments
Six clinical signs were recorded: erythema,
oedema/papulation, oozing/crusting, excoriations,
lichenification and dryness. These clinical signs are the
most widely used and validated in atopic eczema
currently available scoring system: Scoring of Atopic
Dermatitis (SCORAD) index, The SCORAD used;
scored the extent, six intensity criteria, and subjective
symptoms of AD.16 Disease extent was measured using
the rule of nines. The average intensity of each clinical
sign was graded on a scale from 0 to 3 (0=absent, 1=mild,
2=moderate, and 3=severe) at a representative body site,
per the SCORAD protocol. Subjective symptoms,
pruritus, and sleep loss were evaluated with regard to the
last 3 days and nights, and all were scored by the patients.
Both subjective items can be graded on a 10-cm visual
analogue scale. The SCORAD index formula is: A/5 +
7B/2 + C. In this formula A is defined as the extent
(0–100), B is defined as the intensity (0–18) and C is
defined as the subjective symptoms (0–20). The
maximum SCORAD score is 103.
Mometasone furoate 0.1% and fusidic acid 2% with
betamethasone valerate 0.1% were mixed in a glass jar
with petroleum jelly (50gm) and were applied on the
lesions twice daily. To those with hand and feet eczema,
cotton gloves and socks were recommended to be worn
respectively following mixture application.
Participant flow and follow up
Participants were first seen at baseline (week 0) when
they were assessed for eligibility, provided their verbal
consent. All patients who met eligibility criteria started
therapy. Participants had clinical assessments at week 3
and week 6. A detailed history was obtained at baseline
and SCORAD assessment was also performed at each
visit. The primary outcome measure was effective and
rapid control of eczematous lesions.
Statistical analysis
Using the t- test, baseline values were compared with
visit 2 (week 3) and visit 3 (week 6) values and values of
visit 2 (week 3) and visit 3 (week 6) were compared
together.
Results
Twenty female patients with atopic dermatitis and an age
range of 19-26 years (mean age 22.1±2.07) were
included in this study. At baseline, prevalence rate of
other allergic problems (Table1) and thorough clinical
assessment were done with the determination of the
SCORAD score to each case. Thereafter, their
eczematous lesions were treated with the combined
topical therapy of two steroids, an antibiotics and
petroleum jelly.
At baseline, all except one case had had severe form of
AD as estimated by the SCORAD index. At the second
visit (3 weeks latter) (Table 2), erythema, oozing/crusting
and oedema/papules in studied cases showed much more
rapid improvement or even disappearance than
excoriation, lichenification and dryness, with complete
disappearance at the third visit (6 week latter( (Table3,4).
However, patients were still complaining of minimal
pruritus causing slight sleep disturbances.
On visit 3 (week 6), clinical examination revealed
minimal dryness with no more personal complaints, thus
patients were shifted to maintenance therapy with an
emollient.
It was observed that all comparative parameters showed
statistically significant difference (P < 0.000) at visit 2
and visit 3 (P < 0.000) when compared to baseline values
and when compared with each other (P < 0.000).
During the study period, no local side effects were ever
reported by any of the studied cases.
Discussion
Topical corticosteroids have been the mainstay of
treatment for AD over the past 40 years.17 Currently, there
is no standard therapeutic regimen for the long-term
management of moderate to severe atopic dermatitis but
most regimens include a topical steroid and an
emollient. 1 8 Topical applications containing
corticosteroid compounds vary greatly in potency. In
general the more potent ones are associated with the
greater risk of adverse effects.19
Mometasone furoate; is a highly effective topical
corticosteroid with a less systemic absorption and a low
potential for local and systemic side effects.20,21 Oncedaily use of mometasone furoate was found to result in a
greater percentage improvement in total atopic
dermatitis scores compared with twice-daily
betamethasone valerate in one study, and an
improvement in pruritus only in another study compared
with twice-daily hydrocortisone 17-butyrate.22,23
The frequency of application is a key clinical issue when
prescribing topical corticosteroids. Topical
corticosteroids are available for application one to four
times per day. Although there are few empirical data to
assess the patterns of prescribing with respect to
frequency of application, it is generally accepted that a
twice-daily regimen is the most widespread approach to
the use of topical corticosteroids in atopic eczema.20
59
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
Table 1: Demographics and percentage of associated allergies in studied cases
Age in years
Number of patients with history of
Range (mean) 19-26 years (22.1± 2.07 years)
Asthma: 10 (50%)
Allergic rhinitis: 19 (95%)
Urticaria: 16 (80%)
Food allergy: 8 (40%)
Allergy to animals: 2 (10%)
Allergy to insects:2 (10%)
Latex allergy: 2 (10%)
Values indicate number of patients (%)
Table.2: Statistical comparison of SCORAD index score at baseline and after 3 weeks (second visit)
Baseline
Second visit
t
p
48.99±5.01
26.48±4.36
50.163
0.000
Table.3: Statistical comparison of SCORAD index score at baseline and after 6 weeks (third visit)
Baseline
Third visit
t
p
48.99±5.01
10.98±2.41
37.489
0.000
Table.4: Statistical comparison of SCORAD index score at the second and third visits
Second visit
Third visit
t
p
26.48±4.36
10.98±2.41
18.914
0.000
60
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
Guidelines from the British Association of
Dermatologists suggest that the use of topical
corticosteroids should be limited to a few days to a week
for acute eczema and for periods of up to 4–6 weeks to
gain initial remission for chronic eczema.24
Staphylococcus aureus has a peculiar ability to colonize
the skin of patients with eczema and AD and is
consistently found in eczematous skin lesions in these
patients. The skin lesions of 80–100% of patients with
eczema and AD are colonized with S. aureus. In contrast,
S. aureus can be isolated from the skin of only 5–30% of
normal individuals, mainly from intertriginous areas.8,25,26
A correlation between the severity of the eczema and
colonization with S. aureus has been demonstrated, and it
has been determined that bacterial colonization is an
26,27,28
important mechanism aggravating skin lesions.
Hence the eradication of S. aureus may lead to a steroidsaving effect.25,29,30 Moreover, aside from an antiinflammatory effect, treatment with topical steroids
contributes to a reduction of skin colonization with S.
aureus and therefore might affect a further trigger of
AD.31,32 Therefore, a combination topical treatment with
antibacterial and corticosteroid agents has been
recommended.33-36
Topical fusidic acid proved to reduce the prevalence and
population density of S. aureus without increasing
fusidic acid-resistant S. aureus.37 Moreover, the new
combined fusidic acid-betamethasone lipid formulation
showed more strength in eliminating bacteria originally
present in these skin lesions, and relieved the dryness of
38,
atopic dermatitis skin. 39
Therapies directed towards restoring the impaired barrier
function of the epidermis seem to be of significant
importance in AD. Emollients, which reconstruct
integrity and continuity of stratum corneum, may
blockade penetration of air-borne allergens across
damaged skin barrier and prevent AD flares.40 Studies
proved that combined steroids with emollients could
reduce the total high potency topical corticosteroid
consumption, resulted in significantly greater
improvement of disease severity, pruritus and skin
dryness compared to corticosteroid treatment alone,
decreased the risk of irritant contact dermatitis in AD and
significantly improved skin dryness and enabled to
maintain the achieved remission in the majority of
patients.41-44
In this study, AD lesions were effectively and rapidly
controlled after the six weeks therapy with the topical
combination, suggesting that the idea of benefiting from
the results of previous studies that showed that the use of
combined topical steroids and antibiotics or topical
steroids and emollients were much better than topical
steroids alone in managing AD. Thus combining all these
topical therapy together in a single combination
containing two and not one topical steroids; one known
of its high efficacy and another that potentiates the action
of the used topical antibiotics, with an emollient known
for its action in skin barrier repair and thus enhancing the
rate of local drug absorption, all this combined together
proved their efficacy in controlling non-facial, non
extensive AD in a short period of time (six weeks), thus
guarding against the hazards of prolonged use of topical
steroids, the mainstay of therapy in AD, and emergence
of resistant S.aureus strains.
However, no control group was included; as this was not
the goal of the study because the efficacy of combined
therapy of a single topical steroid with antibiotics or with
emollient in AD had been studied extensively and proved
its effect, but this new combination idea aimed at finding
a rapid and effective control of AD lesions with to assure
better compliance of patients and to guard against any
side effects.
In spite of the fact that the quality of life indices were not
studied, but the great improvement in patients' clinical
status are expected to be good solid proof of the
improvement of the quality of life of such patients.
Conflict of interest
The author declares that there is no conflict of interest
and there that this study was not funded.
Acknowledgement
I would like to thank all those who had helped in the
establishment of the "Allergy Unit'. The first Allergy Unit
in all Saudian Universities.
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RA. et.al. International Consensus Conference on
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17.Williams H. New treatments for atopic dermatitis.
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21.Kerscher MJ, Hart H, Korting HC, Stalleicken D. In
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63
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APTI
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Adverse drug reactions in geriatric patient with chronic asthma
*Dixon T, Seeba Zachariah, Molly M, Vijaya R.C
Malik Deenar College of Pharmac, Bela Post, Kasaragod, Kerala, India 671321
Address for Correspondence: [email protected]
Abstract
A 70 year old male with chronic asthma was presented to the hospital pharmacy in a primary health center in
Kannur, India. The patient was unable to walk without help was tired and was experiencing wheezing with his
breathing. He had severe itching, bruises, thinned skin, and gastrointestinal bleeding as observed by the
pharmacist. He was diagnosed by his physician as having uncontrolled asthma, gastrointestinal bleeding and
Stevens-Johnson syndrome. The patient had taken Salbutamol, Diclofenac and Betamethasone for three years
without valid prescription. It was a case of problem due to self medication by the patient and community pharmacist
dispensinging the medication without a prescription.
Key words: Self Medication , asthma, salbutamol, pharmacist
INTRODUCTION
A 70 year old male with chronic asthma was presented to
the hospital pharmacy in a primary health center in
Kannur, India. The patient was unable to walk without
help, was tired and was experiencing wheezing with his
breathing. He had severe itching, bruises, thinned skin,
and gastrointestinal bleeding as observed by the
pharmacist. He was diagnosed by his physician as having
uncontrolled asthma, gastrointestinal bleeding and
Stevens-Johnson syndrome. The patient had taken
Albuterol, Diclofenac and Betamethasone for three years
without valid prescription. It was a case of serious
medication error by the patient and the community
pharmacist gave medicines without a prescription.
The patient was referred to an intensive care unit of
tertiary care hospital by the physician. The patient scored
40% on Australia-modified Karnofsky Performance
Status Scale (AKPS).1
The patient had started some of the standard treatment of
asthma years prior with inhalers for routine use. As the
patient became older and unemployed, he had to restrict
his treatment for asthma to inexpensive medicines such
as tablets. The patient had no health insurance either.
The patient lives in a rural village from where it is a two
hour journey to the tertiary care hospital where he was
originally prescribed by his physician for the following
medications for his shoulder pain and asthmatic
symptoms.
Tab. Asthalin (Salbutamol) 4mg three times a day
Indian Journal of Pharmacy Practice
Received on 03/12/2009
Accepted on 20/01/2010 © APTI All rights reserved
Tab. Voveran (Diclofenac) 50mg two times a day
Tab. Betnesol (Betamethasone) 0.5 mg three times a day2
It is a lengthy process in the hospital so the patient is
hesitant to go to the hospital even though it is necessary.
The patient reported the hospital pharmacist that he was
not cared properly by his children at home. He added that
once he lost the prescription mentioned above, his local
community pharmacist who used to dispense medicines
for few refills of the prescription wrote a duplicate copy
of the prescription on his notebook and given it to the
patient.
No staff from the local community pharmacy referred the
patient to any physician even after the prescription was
lost.
Patient purchased those medications whenever possible
and consumed them for his satisfaction. It is not clear as
to whether the patient was taking any other medications
for the protection of gastrointestinal mucosa. Each time
when patient produce his note book contains the above
mentioned medications, pharmacist used to give the
medication for one month and this continued for three
years. At times, the rural pharmacy was staffed with an
unqualified pharmacist. This is not uncommon in India
where the system of pharmacy health care is very much
malfunctioning especially in rural parts.
The practice of local community pharmacy showed no
respect to valid prescriptions, drug interaction checking
or adverse drug reaction monitoring.
ASTHMA AND ITS MANAGEMENT
National asthma education and prevention program
(NAEPP) reports define asthma as a lung disease with the
following characteristics:
64
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
1.Airway obstruction that is reversible (but not
completely so in some patients) either spontaneously
or with treatment.
2. airway inflammation; and
3. Increased airway responsiveness to a variety of
stimuli.3
The goals of chronic asthma treatment are;
1. Prevent or minimize symptoms
2. Maintain normal or near normal pulmonary function
3. Maintain normal activity (including exercise)
4. Prevent exacerbations; minimize need for emergency
visits or hospitalizations
5. Provide optimal pharmacotherapy with minimal or no
adverse effects
6. Meet patients' and families' expectations of and
satisfaction with asthma care. 4
The pharmacotherapy of asthma employs drugs aimed at
reducing airway inflammation (i.e., anti-inflammatory
agents) and drugs aimed more directly at decreasing
bronchospasm (i.e., bronchodilators).5
DRUG INTERACTION
Interactions between betamethasone and diclofenac
(Moderate Drug-Drug Interaction)
The combined use of oral corticosteroids and
nonsteroidal anti-inflammatory drugs (NSAIDs) may
increase the potential for serious gastrointestinal (GI)
toxicity, including inflammation, bleeding, ulceration,
and perforation. In a large, case-control study of elderly
patients, those who used corticosteroids and NSAIDs
concurrently had an estimated relative risk (RR) for
peptic ulcer disease and GI hemorrhage of 14.6
compared to those who used neither. Oral corticosteroid
use was associated with a doubling of the risk (estimated
RR = 2.0), but the risk was confined to those who also
used NSAIDs. It is possible that both categories of agents
are ulcerogenic and have additive effects on the GI
mucosa during co administration. Some investigators
have also suggested that the primary effect of
corticosteroids in this interaction is to delay healing of
erosions caused by NSAIDs rather than cause de novo
ulcerations.
Caution is advised if oral corticosteroids and NSAIDs are
used together, especially in patients with a prior history
of peptic ulcer disease or GI bleeding and in elderly and
debilitated patients. During concomitant therapy,
patients should be advised to take the medications with
food and to immediately report signs and symptoms of GI
ulceration and bleeding such as severe abdominal pain,
dizziness, lightheadedness, and the appearance of black,
tarry stools. The selective use of prophylactic anti-ulcer
therapy (e.g., antacids, H2-antagonists) may be
considered.6
DICLOFENAC
Diclofenac is a prototypical Non-Steroidal AntiInflammatory Agent (NSAIA) that also exhibits
analgesic and antipyretic activity.
Dermatologic and sensitivity reactions of diclofenac
include rash or pruritus occurs in up to 10% of patients
receiving diclofenac. Other adverse dermatologic
reactions including alopecia, photosensitivity, and
excessive perspiration have occurred occasionally.
Bullous eruption, Stevens-Johnson syndrome, erythema
multiform, exfoliation dermatitis, toxic epidermal
necrolysis, urticaria and angioedema have occurred
rarely. Sensitivity reaction, asthma, bronchospasm, chest
tightness, wheezing and anaphylactoid reactions are also
reported. Potentially severe hypotension may also be
produced. Fever, infection and sepsis have occurred in
patients receiving diclofenac.
Usual doses of diclofenac sodium reportedly produce
fever adverse gastro intestinal (GI) effects than usual
anti-inflammatory dosages of aspirin and naproxen. GI
bleeding was determined by fecal blood loss. There is no
consistent evidence that use of low dose aspirin mitigates
the increases risk of serious cardiovascular events
associated with NSAIAs.
Many of the spontaneous reports of fatal adverse GI
effects in patients receiving NSAIAs involve geriatric
individuals. NSAIAs including diclofenac should be
used with caution in geriatric patients 65 years of age or
older.
SALBUTAMOL
The most frequently reported adverse GI effect of
Salbutamol is nausea. Nausea was reported in 9 or 10 %
of patients receiving Salbutamol of Salbutamol sulfate
oral inhalation aerosol respectively. Salbutamol sulfate
may be associated with clinically important
cardiovascular effects, including tachycardia, increased
or decreased blood pressure and related symptoms.
Bronchospasm has been reported in 8 %, and wheezing in
1%, of patients receiving Albuterol sulfate inhalation.
Extensive or prolonged use of some sympathomimetic
amine aerosols can lead to tolerance. Failure to respond
to a previously effective dosage of Salbutamol may
indicate seriously worsening asthma. Fatalities may
result from severe, acute asthmatic crisis and hypoxia
followed by cardiac arrest.
Geriatric precautions; Data on the use of Salbutamol
inhalation aerosol in geriatric patients 65 years of age or
older are limited and are insufficient to determine
65
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
whether the efficacy and safety of Salbutamol are
different in geriatric patients versus young patients.7
DISCUSSION
There is an important moderate drug interaction
happening between betamethasone and diclofenac
increasing the GI risk of the patient. Serious adverse drug
reactions such as GI bleeding and Stevens-Johnson
syndrome were observed on the patient. GI bleeding was
caused by the combined effect of betamethasone and
diclofenac. It was unclear that which drug cause StevensJohnson syndrome as both diclofenac and albuterol have
the potential to cause Stevens-Johnson syndrome. There
was no gastrointestinal protective agent included in the
list of medications for the patient. The patient remained
medically illiterate on asthma management even after
getting treated for many years. It shows the lack of crucial
patient counseling essential for the management of
asthma. It was a case of serious medication error by the
private pharmacist or pharmacy in charge of the patient
for the past three years. Medications were dispensed
without valid prescription and the pharmacy was
concentrating only on the sale of the medications. The
medically illiterate patient was uncared by the pharmacy
as well as family setup. Patient was very sick with
asthmatic conditions as the combination of medications
are no more working for the patient, but only to harm.
CONCLUSION
Poverty, lack of quality health care facilities and
noncompliance lead patient more in to self medication
which causes adverse drug reactions. In this case patient
suffered from Stevens-Johnson syndrome, GI bleeding
and uncontrolled asthma due to irrational use of
medications.
REFERENCES
1. Abernethy AP, Tania SJ, Belinda FS, David W, David
CC, The Australia-modified Karnofsky Performance
Status (AKPS) scale: a revised scale for
contemporary palliative care clinical practice. BMC
Palliat Care 2005;4:7.
2. Indian Drug Review, CMO Medica India Pvt. Ltd.,
Bangalore, 2009;3(127):165-256.
3. A m e r i c a n p h a r m a c e u t i c a l a s s o c i a t i o n ,
Nonprescription products: patient assessment hand
book, Washington DC, 1997, 11th ed., 104-117.
4. Koda-Kimble MA, Yee YL, Wayne KA, Joseph GB,
Brian AK, Robin CL, Handbook of Applied
Therapeutics, Wolters Kluwer Health (India) Pvt.
Ltd., New Delhi, 2007, 11th Ed. 22.3
5. Laurence BL, Keith PL. Goodman and Gilman's
Manual of Pharmacology and Therapeutics,
McGraw-Hill Companies, Inc., New York, 2008;
462-474.
6. Drugs.com Drug Information Online, Interaction
Checker, Accessed on 29 Sep. 2009, http://www.
drugs.com/drug_interactions.php
7. AHFS Drug Information, ASHP, Bethesda 2008;
1340-2092.
66
Indian J. Pharm. Pract. 2(3), Jul-Sep, 2009
INSTRUCTIONS TO AUTHORS -2009
INDIAN JOURNAL OF PHARMACY PRACTICE (ijopp)
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Kimura J, Shibasaki H, editors. Recent advances in
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Amsterdam: Elsevier; 1996.
Dissertation
Kaplan SJ. Post-hospital home health care: the elderly's
access and utilization [dissertation]. St. Louis (MO):
Washington Univ.; 1995.
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Patent
Larsen CE, Trip R, Johnson CR, inventors; Novoste
Corporation, assignee. Methods for procedures related to
the electrophysiology of the heart. US patent 5529 067.
1995 Jun 25.
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British Journal of Pharmacology and Chemotherapy(Brit J Pharmacol)
Canadian Journal of Pharmaceutical Sciences- (Can J
Pharm Sci)
Clinical Pharmacokinetics- (Clin Pharmacokinet)
Drug Development and Industrial Pharmacy- (Drug
Develop Ind Pharm)
Helvitica Chimica Acta- (Helv Chim Acta)
Indian Journal of Medical Sciences- (Indian J Med Sci)
Indian Journal of Pharmaceutical Sciences- (Indian J
Pharm Sci)
Journal of the American Chemical Society, The- (J Amer
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Journal of Biological Chemistry- (J Biol Chem)
Journal of Organic Chemistry, The- (J Org Chem)
Journal of Pharmacology and Experimental
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New England Journal of Medicine- (N Engl J Med)
Pharmaceutical Journal, The (Pharm J)
PharmacologicalResearch Communications(Pharmacol Res Commun)
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