Principal aim of drug utilization research is to
facilitate safe, effective and rational use of drugs in populations. Without
knowledge of how medicines are being prescribed and used, it is difficult to
make necessary interventions for promoting rational drug use in the society.
Therefore drug utilization studies are carried out to ensure that the drugs are
prescribed, dispensed and used appropriately, in tune with established
guidelines with a view to improve patient’s health related quality of life. Results
of four drug utilization studies carried out by the authors over the past few
years including drug utilization evaluation of statins in patients of diabetes
mellitus at a tertiary care hospital; Evaluation of the prescribing patterns of
anti-hypertensive drugs in patients of hypertension with associated
co-morbidities at a tertiary care hospital; Drug utilization patterns and risk
assessment for primary and secondary prevention of cardiovascular disease at a
tertiary care hospital and drug utilization patterns and risk assessment for
renal impairment patients at a tertiary care hospital shall be presented. Besides,
aim and objectives of three more drug utilization studies to be taken up this
year including drug utilization studies among neonatal and pediatric
in-patients at a tertiary care hospital; drug utilization studies among
geriatric patients at an internal medicine unit of a tertiary care hospital and
Hospital and community-based drug utilization evaluation and assessment of the
quality of pharmaceutical care among pregnant women of Kashmiri origin shall
also be discussed. With the completion of these studies a baseline of vital
information shall be generated on the overall drug utilization patterns among different
categories of Kashmiri patients that shall very well serve the objectives of
National Drug Utilization Programme launched by the Indian Council of Medical
Research (ICMR) this year and improve the quality of drug use among the local population.
Monday, August 24, 2015
Community and hospital-based drug utilization study in Kashmiri population using WHO devised methodology
Introduction:
Essential medicines are one of the vital tools needed to improve and maintain health. However, for too many people throughout the world medicines are still unaffordable, unavailable, unsafe and improperly used. An estimated one-third of the world’s population lacks regular access to essential drugs, with this figure rising to over 50% in the poorest parts of Africa and Asia. When available, the medicines are often used incorrectly: around 50% of all medicines are prescribed, dispensed or sold inappropriately, while 50% of patients also fail to take their medicines appropriately. This often leads to problems such asineffective treatment, health risks, patient non-compliance, decreases the quality care of population andincreases morbidity and mortality besides leading to excessive spending onpharmaceuticals and wastage of financial resources by patients as well ashealth care system1. Published literature suggests that drug wastages may be dueto excessive and irrational prescribing and dispensing, or due to lack of controlupon the sales of prescription medications in the community pharmacies andpoor compliance of the patients.2-3 For these reasons,World Health Organization has evolved the concept of Drug Utilization Research (DUR)whose primary aim is to facilitate the rational use of drugs in populations.DUR involves study of marketing, distribution, prescription, dispensing and use of drugs in a society with special emphasis on the resulting medical, social and economic consequences4. DURstudies are a very important tool to obtain such information so that it helps in universal access to medicines and their rational use.
Novelty:
In the state of J&K, barring a couple of hospital based DUE studies by Jan et al5 and Tandon et al6, no community or hospital-based DUEstudies have been conducted. However newspaper reports suggest large scale use of medicines by the locals. Self-medication and over-the-counter dispensing of prescription drugs by mostly unqualified retail pharmacists seem to be rampant. There is acute paucity of literature about DUE studiesfrom J&K. Therefore there is need to conduct a study which can reveal the picture of how drugs are being prescribed, dispensed and used in households of our community as well as at primary/community health centres.
Applicability:
This study shall provide an idea about the present utilization practices of medicines in the community and associated hospitals, the problems encountered by people related to the medicine use including the channels through which people treat their ailments, obtain their medicines, medicine affordability and accessibility problems and the extent to which rational drug use concept exists in the community. This study shallalso generate sufficient data for both state and centralgovernments which can then help in policy making for promoting universal access to medicines as well as their rational use since no such data is available from J&K at present.
Methodology:
The study mainly comprises of two parts -the household part and the hospital part. In households the method of data collection will make use of a pre-validated, self-administered structured questionnaire. The study design will be a cross sectional baseline study based on the methods contained in WHO manual "How to investigate the use of medicines by consumers”7 and WHO methodology on Drug Utilization Research as outlined in WHO guide “Introduction to drug utilization research”8.
The structured household interview questionnaire will include information on the socio-demographic data of interviewed households, their common chronic diseases, use of traditional remedies, medicines available on the day of the visit, their therapeutic uses and by whom they were used, various modalities through which people in the households treat and obtain their medicines and the reasons for choosing them, various storage places and practices of the stocked medicines, expiry dates of the stocked medicines, and the left-over medicines and how households deal with them, adequacy of labels for the stocked medicines, households' knowledge of the correct dosage regimen and route of administration of stocked medicines, the adherence of patients towards their prescribed medications using Morrisky’s patient adherence questionnaire9, approximate expenditure on healthcare services and its impact on the overall economy of the household, the Daily Defined Dose and Anatomical Therapeutic Classification of the prescribed drugs for chronic use etc.
Second part of the study shall be conducted in the primary/community health centers as well as the private retail pharmacists in the vicinity of the selected hospitals. This will involve the assessment of prescribing practices of the healthcare prescribers and dispensing practices of pharmacists. Data from a random sample of 20-25 prescription slips per facility shall be captured on the day of the facility visit to study prescribing practices, using WHO drug use indicators like number of medicines per prescription, medicines prescribed by generic name, medicines prescribed from essential medicines list, usage of antibiotics, injections, syrups, fixed dose combinations etc.
Knowledge, attitude and dispensing practices of pharmacists will also be ascertained using a pre-validated, structured questionnaire. This will include the information on qualification and experience of the retail pharmacists, overall drug dispensing and storage practices by retail pharmacists, involvement of pharmacist in patient counseling, promotional schemes from manufacturers, pharmacists’ knowledge and attitude about legal and rational drug use.
Selection of Districts, Households and Health Facilities:
Sampling of districts and health facilities shall be done in a systematic manner in accordance with PPS (probability proportional to size) approach so as to ensure that the findings are representative of the entire Kashmir province of Jammu and Kashmir state. Accordingly districts, households, retail chemists and study hospitals shall be sampled in such a manner so as to represent the whole geography of Kashmir province. In each of the 06 districts selected three blocks, one primary health centre or community health centre in each block, three retail chemists in each block and thirty households in each block shall be selected randomly for the data collection. Thus, data shall be collected from a total of 18 blocks, 18 primary/community health centres, 54 retail chemists and 540 households.
Feasibility:
The health sector in Jammu and Kashmir is unique Indian state beset by many challenges. A combination of weak institutional capacity, limited access to modern equipment and infrastructure, and shortage of healthcare personnel has limited the effectiveness of health service delivery in the State. The healthcare system in J&K is primarily run by the State Government. The private sector plays a smaller part in health service delivery. The non-governmental sector is largely absent.We don’t have qualified and trained pharmacy graduates working as pharmacists either in government or in private sector. In government hospitals Medical Assistants with one year multi-purpose health worker type diploma in their hands are employed as pharmacists whereas in private sector matriculates with some experience in sale of medicines at a retail counter have been registered as pharmacists and granted drug sale licenses as per a redundant and obsolete piece of legislation known as the J&K Pharmacy Act, 2011 (samvat) that has been framed more than sixty years back and amended only once to include matriculates as registered pharmacists. Consequently patients are deprived of good counseling services on the use of medicines. On top of that patients largely prefer to consult these very Medical Assistants or so-called pharmacists over registered medical practitioners for choosing medicines and curing their ailments. However the reasons for and consequences of such a drug utilization pattern have not been documented anywhere in the literature.
Outcome:
Jammu and Kashmir government has drafted and approved its maiden state drug policy in the year 2012 that has several provisions related to promotion of rational use of medicines including pharmacovigilance activities and drug utilization research. However drug policy has not been implemented. There is paucity of literature on existing drug related problems in the community. Therefore this study will significantly improve implementation of the approved drug policy by generating data on various drug related problems existing in the community and documenting various prospects and challenges towards improving drug use. One such study sponsored by Public Health Foundation of India (PHFI), New Delhi has already been conducted by us in the year 2014 and report submitted to PHFI. This study is also feasible and viable in the local settings. Prior permission from government authorities shall be obtained before starting the study.
This study is expected to throw some light upon the below mentioned research questions:
ü What are the most frequent categories of medicines being used by the surveyed households and by whom they are used?
ü What are the preferences people rely on treating their ailments and obtaining medicines?
ü What are the reasons for choosing the source of treatment (such as health facility, pharmacist, traditional healer, self-medication etc)?
ü What are the alternate modes of treatment used by the patients?
ü How far are patients adherent to the prescribed medications?
ü How well versed are patients with their prescribed medications?
ü What are the prescribing practices of healthcare prescribers in the primary care hospitals?
ü What are the daily defined doses (DDD) per 1000 inhabitants on the basis of Anatomical therapeutic classes (ATC) of the prescribed drugs?
ü What are the knowledge, attitude and dispensing practices of community/retail pharmacists?
ü What is the overall satisfaction level of people towards the healthcare facilities and prescribed medications?
ü What is the economic impact of healthcare expenditures in general and expenditures on medicine in particular on households?
References:
1. WHO (2002). Promoting rational use of medicines: core components. WHO Policy Perspectives on Medicines, No.5. Geneva, World Health Organization.
Essential medicines are one of the vital tools needed to improve and maintain health. However, for too many people throughout the world medicines are still unaffordable, unavailable, unsafe and improperly used. An estimated one-third of the world’s population lacks regular access to essential drugs, with this figure rising to over 50% in the poorest parts of Africa and Asia. When available, the medicines are often used incorrectly: around 50% of all medicines are prescribed, dispensed or sold inappropriately, while 50% of patients also fail to take their medicines appropriately. This often leads to problems such asineffective treatment, health risks, patient non-compliance, decreases the quality care of population andincreases morbidity and mortality besides leading to excessive spending onpharmaceuticals and wastage of financial resources by patients as well ashealth care system1. Published literature suggests that drug wastages may be dueto excessive and irrational prescribing and dispensing, or due to lack of controlupon the sales of prescription medications in the community pharmacies andpoor compliance of the patients.2-3 For these reasons,World Health Organization has evolved the concept of Drug Utilization Research (DUR)whose primary aim is to facilitate the rational use of drugs in populations.DUR involves study of marketing, distribution, prescription, dispensing and use of drugs in a society with special emphasis on the resulting medical, social and economic consequences4. DURstudies are a very important tool to obtain such information so that it helps in universal access to medicines and their rational use.
Novelty:
In the state of J&K, barring a couple of hospital based DUE studies by Jan et al5 and Tandon et al6, no community or hospital-based DUEstudies have been conducted. However newspaper reports suggest large scale use of medicines by the locals. Self-medication and over-the-counter dispensing of prescription drugs by mostly unqualified retail pharmacists seem to be rampant. There is acute paucity of literature about DUE studiesfrom J&K. Therefore there is need to conduct a study which can reveal the picture of how drugs are being prescribed, dispensed and used in households of our community as well as at primary/community health centres.
Applicability:
This study shall provide an idea about the present utilization practices of medicines in the community and associated hospitals, the problems encountered by people related to the medicine use including the channels through which people treat their ailments, obtain their medicines, medicine affordability and accessibility problems and the extent to which rational drug use concept exists in the community. This study shallalso generate sufficient data for both state and centralgovernments which can then help in policy making for promoting universal access to medicines as well as their rational use since no such data is available from J&K at present.
Methodology:
The study mainly comprises of two parts -the household part and the hospital part. In households the method of data collection will make use of a pre-validated, self-administered structured questionnaire. The study design will be a cross sectional baseline study based on the methods contained in WHO manual "How to investigate the use of medicines by consumers”7 and WHO methodology on Drug Utilization Research as outlined in WHO guide “Introduction to drug utilization research”8.
The structured household interview questionnaire will include information on the socio-demographic data of interviewed households, their common chronic diseases, use of traditional remedies, medicines available on the day of the visit, their therapeutic uses and by whom they were used, various modalities through which people in the households treat and obtain their medicines and the reasons for choosing them, various storage places and practices of the stocked medicines, expiry dates of the stocked medicines, and the left-over medicines and how households deal with them, adequacy of labels for the stocked medicines, households' knowledge of the correct dosage regimen and route of administration of stocked medicines, the adherence of patients towards their prescribed medications using Morrisky’s patient adherence questionnaire9, approximate expenditure on healthcare services and its impact on the overall economy of the household, the Daily Defined Dose and Anatomical Therapeutic Classification of the prescribed drugs for chronic use etc.
Second part of the study shall be conducted in the primary/community health centers as well as the private retail pharmacists in the vicinity of the selected hospitals. This will involve the assessment of prescribing practices of the healthcare prescribers and dispensing practices of pharmacists. Data from a random sample of 20-25 prescription slips per facility shall be captured on the day of the facility visit to study prescribing practices, using WHO drug use indicators like number of medicines per prescription, medicines prescribed by generic name, medicines prescribed from essential medicines list, usage of antibiotics, injections, syrups, fixed dose combinations etc.
Knowledge, attitude and dispensing practices of pharmacists will also be ascertained using a pre-validated, structured questionnaire. This will include the information on qualification and experience of the retail pharmacists, overall drug dispensing and storage practices by retail pharmacists, involvement of pharmacist in patient counseling, promotional schemes from manufacturers, pharmacists’ knowledge and attitude about legal and rational drug use.
Selection of Districts, Households and Health Facilities:
Sampling of districts and health facilities shall be done in a systematic manner in accordance with PPS (probability proportional to size) approach so as to ensure that the findings are representative of the entire Kashmir province of Jammu and Kashmir state. Accordingly districts, households, retail chemists and study hospitals shall be sampled in such a manner so as to represent the whole geography of Kashmir province. In each of the 06 districts selected three blocks, one primary health centre or community health centre in each block, three retail chemists in each block and thirty households in each block shall be selected randomly for the data collection. Thus, data shall be collected from a total of 18 blocks, 18 primary/community health centres, 54 retail chemists and 540 households.
Feasibility:
The health sector in Jammu and Kashmir is unique Indian state beset by many challenges. A combination of weak institutional capacity, limited access to modern equipment and infrastructure, and shortage of healthcare personnel has limited the effectiveness of health service delivery in the State. The healthcare system in J&K is primarily run by the State Government. The private sector plays a smaller part in health service delivery. The non-governmental sector is largely absent.We don’t have qualified and trained pharmacy graduates working as pharmacists either in government or in private sector. In government hospitals Medical Assistants with one year multi-purpose health worker type diploma in their hands are employed as pharmacists whereas in private sector matriculates with some experience in sale of medicines at a retail counter have been registered as pharmacists and granted drug sale licenses as per a redundant and obsolete piece of legislation known as the J&K Pharmacy Act, 2011 (samvat) that has been framed more than sixty years back and amended only once to include matriculates as registered pharmacists. Consequently patients are deprived of good counseling services on the use of medicines. On top of that patients largely prefer to consult these very Medical Assistants or so-called pharmacists over registered medical practitioners for choosing medicines and curing their ailments. However the reasons for and consequences of such a drug utilization pattern have not been documented anywhere in the literature.
Outcome:
Jammu and Kashmir government has drafted and approved its maiden state drug policy in the year 2012 that has several provisions related to promotion of rational use of medicines including pharmacovigilance activities and drug utilization research. However drug policy has not been implemented. There is paucity of literature on existing drug related problems in the community. Therefore this study will significantly improve implementation of the approved drug policy by generating data on various drug related problems existing in the community and documenting various prospects and challenges towards improving drug use. One such study sponsored by Public Health Foundation of India (PHFI), New Delhi has already been conducted by us in the year 2014 and report submitted to PHFI. This study is also feasible and viable in the local settings. Prior permission from government authorities shall be obtained before starting the study.
This study is expected to throw some light upon the below mentioned research questions:
ü What are the most frequent categories of medicines being used by the surveyed households and by whom they are used?
ü What are the preferences people rely on treating their ailments and obtaining medicines?
ü What are the reasons for choosing the source of treatment (such as health facility, pharmacist, traditional healer, self-medication etc)?
ü What are the alternate modes of treatment used by the patients?
ü How far are patients adherent to the prescribed medications?
ü How well versed are patients with their prescribed medications?
ü What are the prescribing practices of healthcare prescribers in the primary care hospitals?
ü What are the daily defined doses (DDD) per 1000 inhabitants on the basis of Anatomical therapeutic classes (ATC) of the prescribed drugs?
ü What are the knowledge, attitude and dispensing practices of community/retail pharmacists?
ü What is the overall satisfaction level of people towards the healthcare facilities and prescribed medications?
ü What is the economic impact of healthcare expenditures in general and expenditures on medicine in particular on households?
References:
1. WHO (2002). Promoting rational use of medicines: core components. WHO Policy Perspectives on Medicines, No.5. Geneva, World Health Organization.
2. Potter M. Medication compliance - a
factor in the drug wastage problem. Nurs times. 1981; 77 (suppl 5):17-20.
3. Nasser AN. Prescribing patterns in
primary health care in Saudi Arabia. DICP.
1991; 25:90-93.
4. Serradell
J, Bjornson DC &Hartzema AG. Drug Utilization Study Methodologies: National
and International Perspectives. Drug Intelligence and Clinical Pharmacy. 1987;
21(12, December):994-1001.
5. Jan A et al. Drug Utilization At SKIMS–A Tertiary Care Hospital.JK- Practitioner 2013;18(1-2):35-40.
6. Tandon R et al. Antihypertensive drug prescription
patterns, rationality, and adherence to Joint National Committee-7 hypertension
treatment guidelines among Indian postmenopausal women. J Midlife Health.
2014; 5(2): 78–83.
7. Chetley
A, Hardon A, Hodgkin A, Haaland A, Fresle D. How to investigate the use of
medicines by consumers.(WHO/PSM/PAR/2007.2) Geneva: World Health Organization,
2007.
8. WHO. Introduction to drug utilization
research/WHO International Working Group for Drug Statistics Methodology, WHO
Collaborating Centre for Drug Statistics Methodology, WHO Collaborating Centre
for Drug Utilization Research and Clinical Pharmacological Services 2003.
9. Morisky
DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported
measure of medication adherence. Med Care1986;24:67-74.
Hospital and community-based drug utilization evaluation and assessment of the quality of pharmaceutical care among pregnant women of Kashmiri origin
Pregnancy is a special physiological condition where
drug treatment presents a special concern because the physiology of pregnancy
affects the pharmacokinetics of medications used and certain medications can
reach the fetus and cause harm. Careful consideration of the benefits to the
mother and the risks to the foetus is required while prescribing drugs during
pregnancy and lactation.
The use of drugs during pregnancy calls for special attention because in this
case in addition to the mother, the health and life of her unborn child is also
at stake.
Due to ethical constraints whenever a new drug hits
market, it is almost never tested in pregnant women and hence its effect on the
fetus and newborn remains uncertain. Most of the drugs therefore are labelled
as ‘not to be used in pregnancy'. These constraints put pregnant women and
their physicians in a difficult situation worldwide. Furthermore in case of unplanned pregnancies most of
the fetuses are exposed to drugs before even being aware of pregnancy.
World Health Organization (WHO) has reported
that 50% of all medicines are prescribed, dispensed or sold inappropriately,
while 50% of patients also fail to take their medicines appropriately. This
often leads to problems such as ineffective treatment, health risks, patient
non-compliance, decreases the quality care of population and increases
morbidity and mortality besides leading to excessive spending on pharmaceuticals
and wastage of financial resources by patients as well as health care system. For these reasons, WHO has evolved the concept of Drug
Utilization Evaluation (DUE) whose primary aim is to facilitate the rational
use of drugs in populations.
Methodology:
The
study design will be a cross sectional baseline study based on the methods
contained in WHO manual "How to investigate the use of medicines by
consumers” and WHO
methodology on Drug Utilization Research as outlined in WHO guide "Introduction
to drug utilization research."
Study
will be conducted at all the three levels of primary, secondary and tertiary
care hospitals including both government and private antenatal clinics. Study
units shall include a leading government, tertiary care gynecological hospital
based at Srinagar, the capital city of J&K state, few community health
centres and primary health centres spread across Kashmir valley and a few
private antenatal clinics. Sampling of health facilities shall be done on the
basis of their geographical distribution in accordance with PPS (probability
proportional to size) approach so as to ensure that the findings are
representative of the entire Kashmir province.
Data shall be
collected using a self-administered, pre-designed and pre-tested questionnaire
after obtaining necessary ethical clearance. Pregnant women reporting at study
units during the study period shall be interviewed in local language, after obtaining
their informed consent. Their statements shall be corroborated with the written
records and medicines that are available with them. All prescriptions during
the study period shall be audited for drug utilization and cost analysis. Information
shall be collected and analyzed for various study parameters including
demographic and anthropometric details, duration of pregnancy, family per
capita income per month, number of antenatal visits, self-medication practices,
number of drugs used, number of herbal/homeopathic drugs used etc. All drugs
used during the first (first 12 weeks), second (13th to 24th week) and third
(24th week onwards) trimester of pregnancy shall be classified into category-A,
category-B, category-C, category-D and category-X, as per the classification
for drug use during pregnancy, given by the US Food and Drug Administration
(FDA). ATC-DDD classification of drugs as prescribed by WHO shall be used
wherever necessary.
Main objective
of the study shall be as under:
Ø To
evaluate the prescribing patterns of doctors among the pregnant women
presenting to antenatal clinics of a gynecological hospital, primary and
community health centres and those reporting at private gynecological clinics.
Ø To
ascertain the choice, strength, dosage forms and duration of treatments
prescribed to the pregnant women at study units and stratify them as per WHO
ATC/DDD methodology wherever applicable.
Ø To
perform cost analysis of drugs prescribed to pregnant women.
Ø To
evaluate the prescribing patterns using WHO drug use indicators among the study
population.
Ø To
evaluate the pharmaceutical care services including patient counseling, drug
information and pharmacovigilance services available to patients at the study
hospital.
Ø To
assess prescribing practices of the prescribers and dispensing practices of
pharmacists.
Ø To
assess the use of traditional remedies by the pregnant women.
Ø To
evaluate the adherence of patients towards their prescribed medications using
Morrisky’s patient adherence questionnaire.
Data from a random
sample of prescription slips shall be captured on the day of the facility visit
(roughly 20-25 slips per facility). Prior consent of the respective medical
heads of the facilities shall be sought in addition to the oral consent of the
patients. Analysis of prescription slips is required to contribute towards
understanding the level and pattern of irrational prescription practices, if
any.
Feasibility:
Information on the use of drugs during pregnancy is
scarce and rather anecdotal. Careful consideration of the benefit to the mother
and the risk to the fetus is required when prescribing drugs during pregnancy. Total
avoidance of pharmacological treatment in pregnancy is not possible and may be
dangerous because some women enter pregnancy with medical conditions that
require ongoing and episodic treatment (e.g. asthma, epilepsy, hypertension).
Also during pregnancy new medical problems can develop and old ones can be
exacerbated (e.g. migraine, headache) requiring pharmacological therapy. The
fact that certain drugs given during pregnancy may prove harmful to the unborn
child is one of the classical problems in medical treatment.
Drug utilization studies on pregnant women focus on
the potential teratogenic effects traditionally. However drugs can influence
foetus during entire time of pregnancy. Furthermore toxic manifestations of
intra uterine drug exposure may not be revealed many years after the time of
birth. The potential long term consequences of intra uterine exposure to drugs
emphasise the importance of studying drug exposure during pregnancy and
prolonging follow up beyond the time of birth.
The health sector in Jammu and Kashmir is unique
Indian state beset by many challenges.
A combination of weak institutional
capacity, limited access to modern equipment and infrastructure, and shortage
of healthcare personnel has limited the effectiveness of health service
delivery in the State. Patients
are deprived of good pharmaceutical care services on the use of medicines like
patient counseling services, drug information services, adverse drug reaction
monitoring services etc due to non-availability of qualified clinical
pharmacists in either government or private sector. However the reasons for and
consequences of such a drug utilization pattern have not been documented
anywhere in the literature.
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