Wednesday, February 4, 2015

Contemplating a Comprehensive Medicines Management Policy Framework for Tertiary Care Hospitals


Inefficient and irrational use of medicines is a widespread problem at all levels of health care throughout India. Lack of discretely documented policies and procedures in respect of medicines management in a hospital is unnecessarily straining the already meager resources resulting into poor inflow of benefits to the patients. Per capita wastage from inefficiencies and irrational use tends to be greatest in hospitals. Many of these sources of wastage could be reduced if some basic principles of drug management and use are followed and a proper drug management policy is developed for each hospital. The effectiveness of the medicines management system in a hospital depends on adherence to policies (broad, general statements of philosophy) and procedures (detailed guidelines for implementing policy). For this to happen evidence on current medicine management practices needs to be generated first followed by development of a robust policy framework that can then be translated into practice for efficient utilization of resources.
 
An effective medicines management system ensures the availability of the right drugs in the right quantities, at reasonable prices, and at recognizable standards of quality. Problems can often be encountered if medicines management in a hospital is carried out without such a systematic process, for instance the needed medicines may be out of stock, overstocks and wastage of resources besides purchase of low quality products. Most of the tertiary care hospitals of J&K state do not have any well documented medicines management policy and any policy and procedures manual to guide the usage and management of its medicines supply within the hospital quite often resulting in unorganized, unscientific and non-systematic selection, quantification, procurement, quality assurance, storage, distribution and use of medicines besides wastage of limited resources for medicines. Therefore there is need to design a comprehensive medicines management policy for tertiary care hospitals that would lay out a concrete policy framework for its drug selection, quantification, procurement, storage, distribution, dispensing and use. This would help these hospitals make the best use of their available resources for making quality medicines accessible and affordable to their patients. This paper aims at laying the foundation for design and development of a comprehensive medicines management policy framework for tertiary care hospitals of the region.

Evaluation of the Prescribing Patterns of Antihypertensive Drugs in Patients of Hypertension with Associated Co-Morbidities at a Tertiary Care Hospital


This study was an attempt to analyze and evaluate the prescribing patterns of antihypertensives and their adherence with published treatment guidelines in patients diagnosed of hypertension with co-morbidities like diabetes, cardiovascular diseases, renal diseases etc at a tertiary care hospital. A prospective, observational, cross-sectional study was conducted in all patients with hypertension and co-morbidities presenting to one of the polyclinics of Internal Medicine OPD of a tertiary care hospital during the study period. Drug utilization data of anti-hypertensives in patients with co-morbidities was collected through daily monitoring of prescriptions and by personally interviewing the patients meeting the inclusion criteria. Confirmed patients were analyzed for social, demographic and clinical variables.
 
A total of 120 hypertensive patients fulfilled the criteria for inclusion in the present study. Monotherapy was used more commonly than combination therapy (53.7% vs 46.3%). From the monotherapy category, various classes of drugs used included calcium channel blockers (48.3%), angiotensin II receptor blockers (32.75%), ACE inhibitors (12.06%) followed by beta-blockers (3.44%). As for individual drugs, Amlodipine (48.3%) was most commonly prescribed. Among the combination therapies, 2-drug treatment was preferred for 76.2% of the hypertensive patients with ACEIS/ARBS+DIURETICS being the most frequent drug combination (62.0%) prescribed. Also T2DM (27.5%) was found to be the most common co-morbid condition associated with hypertension followed by hypothyroidism (17.6%).
 
Effective control of BP was found in 53.3% of patients. Though Telmisartan (ARB) was the most frequently prescribed drug in combination therapy, it did not exist in the hospital formulary and was not provided at the hospital pharmacy. The general pattern of antihypertensive utilization seems to be in accordance with the international guidelines for management of hypertension, but, diuretics were not prescribed as monotherapy. The prescription of branded drugs often results in noncompliance due to poor economic status of a large proportion of hypertensive patients ultimately leading to poor blood pressure control and hence treatment failure. Therefore the set guidelines need to be strictly adhered to so that effective management and treatment is ensured and the risks of cardiovascular morbidity and mortality get minimized.

Tuesday, February 3, 2015

Five Years of Pharmacy Practice Education and Research in Jammu and Kashmir state - an overview


Department of Pharmaceutical Sciences, University of Kashmir is the only educational institution in the entire state of J&K that has been offering an under-graduate degree programme in Pharmacy over the past thirty years. In 2009 this Department commenced post-graduate degree programmes in five different specializations of Pharmaceutical Sciences including Pharmacy Practice. Introduction of Masters Degree Programme in Pharmacy Practice has given a new orientation to the pharmacy education in J&K state with focus gradually shifting from a pharmaceutical product to a patient and from laboratory bench side to the hospital bed side.
 
Over the past five years main focus of Pharmacy Practice education has been on Clinical Pharmacy, Pharmacokinetics and Toxicology; Applied Pharmacotherapeutics and Pathophysiology; Hospital and Community Pharmacy whereas the main focus of Pharmacy Practice Research has been on Designing a Pharmaceutical Care service model for the patients of respiratory medicine; Evaluating prescribing patterns of hormone replacement therapy in pre- and post-menopausal women; Assessing availability, affordability and pricing of essential medicines in hospitals of Kashmir division; Assessing availability and affordability scenario of maternal and child health essential commodities in hospitals of Kashmir division; Drug utilization studies of statins in patients of Diabetes mellitus; Prescribing patterns of antihypertensive drugs in patients with comorbidities at a tertiary care hospital and Design and development of a comprehensive medicines management policy framework for a tertiary care hospital.
 
Thus all the three core areas of Pharmacy Practice viz., hospital, community and clinical pharmacy practice have been addressed while formulating the research design in this programme. Care has been taken to accord top priority to the most intriguing issues facing patient care in the region and the outcome of research has so far been not only interesting and encouraging but thought-provoking too. In spite of some difficulties faced in running the programme smoothly, department has been relentlessly marching ahead over the past four years towards establishment of Clinical Pharmacy Practice as a fullfledged and well recognized profession in the state. The programme is aimed at carving a niche for the qualified pharmacists of the state and establish them as an inherent part of the healthcare team that so far comprised of only doctors and nurses. This paper discusses the overall design of education and research in Pharmacy Practice and the outcome of research work carried out so far by a team of six post-graduate and one doctoral students in the subject.

Prices, Availability and Affordability of Essential Medicines in Public and Private Sectors of Kashmir Province

In low- and middle-income countries, large proportions of the population have limited access to medicines, either because of poor availability or because patients have to pay for their prescriptions which often they not able to do. The price and availability of medicines are key components in determining access to effective treatments. Data on prices and availability of common medicines in public and private sector in different Districts of Kashmir are scarce. Hence, a survey was undertaken in ten districts of Kashmir division to evaluate these metrics. This study used standard World Health Organization and Health Action International methodology in ten districts of Srinagar, Anantnag, Pulwama, Shopian, Ganderbal, Budgam, Baramulla, Kupwara, Bandipora and Kulgam.
 
Data was collected from the public as well as private sector pharmacies. Public sector consisted of a total of 51 district and divisional level govt health institutions whereas private sector comprised of 28 private retail pharmacies where people have to pay full cost of the medicines to the retailer. A core list of 31 drugs was prepared apart from a supplementary list of 16 drugs for the sake of assessment of accessibility and affordability. For each medicine, data was collected for the Innovator Brand (IB), Most Sold Generic (MSG), and Lowest Priced Generic (LPG) at randomly selected public and private facilities in each site surveyed. Prices were compared to an international reference price published by Management Sciences for Health, USA.
 
Study revealed that district hospitals, SDHs, PHCs, allopathic dispensaries and CHCs had the lowest average availability (7.13%) compared to the private sector (54.62%). In the private sector it was observed that, highest as well as lowest priced medicines were more expensive than their international reference price comparisons. Treatments were unaffordable, costing as much as 5 days wages’ of an unskilled worker to cure respiratory tract infections. The procurement price of medicines in the public sector was very low. Although a few innovator brands were more expensive, no difference was observed between the prices of the most sold generic (MSG) and the lowest priced generic (LPG) available at the facilities. The survey revealed low procurement prices and poor availability in the public sector. Thus, the majority of the population purchased medicines from private pharmacies, where generics were sometimes available although prices of certain medicines were high. Robust and specified policy measures could increase the availability and accessibility of medicines for the population.

Accessibility, Availability and Affordability of Life-Saving Commodities for Maternal and Child Health in Public and Private Sectors of Kashmir Province


Several World Health Organization (WHO) and UN initiatives aim to improve the accessibility, availability and affordability of maternal and child health commodities. A first step in achieving this goal is to obtain a baseline measure of access to such essential medicines. The objective of this study was to measure the accessibility, availability and affordability of maternal and child health commodities in primary and secondary health centers at ten districts of Kashmir division. An adaption of the standardized methodology developed by WHO and Health Action International (HAI) was used to conduct a cross sectional survey to collect data on accessibility, availability and affordability of maternal and child health commodities in public hospitals and  private sector medicine outlets between June, 2012 to July, 2013.
 
In this study, data was collected on the availability, affordability and prices of thirteen essential commodities from the core list that includes 3 maternal, 4 new born, 3 childhood and 3 reproductive health commodities and 27 essential commodities from the supplementary list published by UN Commission on Life-saving Commodities for Women and Children in 2012, in both public and private sectors within ten districts of the Kashmir province. In each district, a sample of health centres and medicine outlets were surveyed systematically that included a total of 10 district hospitals, 10 sub-district hospitals (SDH), 15 Maternal and Child Health (MCH) centres, 14 Primary Health Centres (PHC), 4 Allopathic Dispensaries and all GMC associated hospitals and a total of 20 licensed pharmacies in the private sector.
 
Study revealed that district hospitals, SDH, PHCs, allopathic dispensaries and CHCs had the lowest average availability (40%) compared to the private sector (65%). In DHs availability was (55%), in SDHs it was (45%), in PHCs it was (20%) and in MCHs it was (60%). In the private sector, highest as well as lowest priced medicines were more expensive than their international reference price comparisons. Treatments were generally unaffordable, costing as much as 15 day wages for a course of Ceftriaxone. In our state, this is the first kind of study conducted on accessibility, availability and affordability of maternal and child health commodities. The findings of this study can be used to structure policies to improve the accessibility, availability and affordability of maternal and child health commodities in Kashmir and help the country meet Millenium Development Goals - MDG4 and MDG5 by the year 2015.



DEVELOPING INNOVATIVE AND EFFECTIVE STRATEGIES AND DEVISING POLICIES TO IMPROVE AVAILABILITY, AFFORDABILITY AND USE OF MEDICINES IN INDIA WITH SPECIAL REFERENCE TO JAMMU AND KASHMIR STATE

According to World Medicines Situation Report published by World Health Organization, an estimated 2.1 billion people worldwide, that comprises one third of global population, do not have access to medicines.  As per this report, within India, an estimated 499-649 million people comprising 50% to 65% of the population, do not have regular access to essential medicines in spite of the fact that the Indian pharmaceutical industry currently ranks third in terms of volume of pharmaceutical production (10% of global share) and is the 14th largest by value (1.5%) worldwide. Its annual turnover has grown from a mere $0.3 billion in 1980 to about $21.73 billion in 2009-10.  India is a world leader in the manufacture and sale of generic medicines to the extent that it is often referred as “the pharmacy of developing world”. However, surprisingly, in spite of such phenomenal growth, India’s own people continue to suffer for want of medicines. There is a clear dichotomy in the progress made by pharmaceutical industry and in securing access of quality medicines to people across the board.
 
Further as per WHO estimates, worldwide half of all the medicines (50-60%) are inappropriately prescribed, dispensed or sold and the situation seems even worse within India. Apart from grim access to quality medicines, Indian pharmaceutical market is also dogged by many issues relating to inappropriate use of medicines like spurious and substandard drugs, sale of prescription drugs over the counter, unethical marketing and prescribing of drugs etc. Within the state of Jammu and Kashmir, an estimated 24.21 lakh people (21.63% population) live below poverty line who cannot afford costly branded medicines. Globally various strategies to enhance access and improve use of medicines have been suggested like promoting use of generic medicines, providing universal health coverage, allowing government subsidies on medicines, making medicines a zero mark-up sector, enforcing micro-insurance schemes etc. However, given the unique circumstances, regulatory framework and constitutional barriers within India where health is a state subject, it becomes highly imperative to develop innovative and effective strategies and to devise pharmaceutical policies at the national as well as state levels in order to overcome the disparities between pharmaceutical production and access to medicines and to improve their use in public as well as private sectors.

Knowledge, attitude and prescribing practices of doctors in ten districts of Kashmir division towards hormone replacement therapy in pre- and post menopausal women


This study was carried out to assess the knowledge, attitude and prescribing practices of doctors in ten districts of Kashmir division towards hormone replacement therapy in pre- and post menopausal women. A total of 102 pre-validated questionnaires were distributed among practitioners at 31 public health facilities and 28 private clinics in these districts over a period of almost one year, out of whom 87 responded back.  Overall pattern of HRT prescribing was found to be dismal. Majority of the doctors did not prefer to prescribe HRT for several reasons and a majority of them did not possess adequate knowledge about the international trials favouring HRT using amongst select group of pre and post menopausal women.
 
Nowadays, HRT is being reserved by most of the gynaecologists for treatment of menopause symptoms and not as a preventive measure against future complications of heart disease and osteoporosis. Despite the results of many clinical trials against HRT use most gynaecologists who participated in this study continued prescribing HRT; however, some of those who continued prescribing HT later changed their prescriptions and now they are also in support of alternative therapies for menopause management. It has been observed that HRT is being prescribed for immediate relief of hot flashes and mood swings. However, in some cases of poor compliance with HRT, alternative therapy was considered a safer option. There is a need for greater awareness among gynaecologists regarding HRT use during early menopause for a short duration to counter some of the disorders associated with post-menopausal syndrome.

FREQUENCY, TYPES, SEVERITY, PREVENTABILITY AND COSTS OF ADVERSE DRUG REACTIONS AT A TERTIARY CARE HOSPITAL OVER A NINE MONTH PERIOD

Background:
Prior to this study, there were no pharmacovigilance centres or any other ADR monitoring framework available in any of the leading hospitals of the Indian state of Jammu and Kashmir.
Objective/Aim:
To assess the frequency, preventability, types, severity, causality and costs of drug-related adverse effects in Kashmiri patients at a tertiary care hospital.
Methods:
A prospective, observational, cohort, ADR monitoring study was conducted on adult patients admitted in Internal Medicine IPD, presenting to the Internal Medicine OPD and those visiting the Accident and Emergency Department of a tertiary care hospital during a 270 day period. A total of 5482 patients belonging to both the sexes were screened and monitored on a daily basis for the occurrence of any ADRs. WHO definition of ADRs was used and causality of suspected ADRs was determined using Naranjo’s algorithm whereas severity was assessed using modified Hartwig’s Scale and preventability was determined using Hallas methodology. Cost of ADRs was calculated as per the protocols suggested by Lagnaoui et al and Nicholas et al (extension in hospital stay).
Results:
ADRs accounted for 6.23% of adult Kashmiri patients visiting a tertiary care hospital, either for referral or hospitalization, with the majority (81.57%) of these ADRs being preventable; 23.68% of patients had mild ADRs, 69.29% had ADRs of moderate severity, and 7.01% had severe ADRs. The 4 classes of drugs most frequently suspected in admissions due to ADRs were anti-infective agents (40.92%) including anti-tubercular drugs (13.15%), steroids (14.03%), anti-coagulants (8.77%), and NSAIDs (7.89%). Increasing age and female gender were identified as risk factors. The total cost to the hospital due to hospitalization of patients presenting with ADRs over the 9-month period in the internal medicine IPD was USD 22469.
Conclusion:
The present work is the maiden pharmacovigilance study conducted on Kashmiri patients, especially at a tertiary care teaching hospital that has provided baseline information about the prevalence of ADRs and their distribution among different age groups, genders, organ systems affected, and therapeutic classes of medicines. The data collected will be useful in future for more extensive ADR monitoring on Kashmiri patients and will also be useful in framing policies toward the rational use of drugs. This study led to the establishment of a full-fledged pharmacovigilance centre and initiation of pharmaceutical care services at the study hospital.

Improvements in drug policy of Indian state of J&K through persistent advocacy and logical interventions by Civil Society Forum

Background:
Draft drug policy of the Indian state of Jammu and Kashmir was made available on its official website in the year 2009 by the Ministry of Health and Family Welfare. On studying the draft it was found to be deficient in many important aspects. Hence a sustained campaign was launched by Civil Society Forum, a group of activists drawn from diverse sectors like health, education, media, trade, industry, politics etc in order to incorporate necessary changes in the draft policy.
Objective/Aim:
To emphasize upon the importance of civil society interventions and involvement in policy making process and decisions, with a view to bring changes in government drug policies, necessary to ensure quality, safety, efficacy, availability and affordability of medicines.
Methods:
Through sustained lobbying, persistent advocacy, persuasive pressure, wide consultations and logical interventions, Civil Society Forum Kashmir got some significant changes incorporated in the draft drug policy of J&K state, introducing some fresh policy initiatives and novel approaches to tackle common problems of drug use in the society like spurious drugs, drug abuse, misuse of drugs belonging to Indian Systems of Medicines, over-the-counter sale of prescription drugs, recall and disposal of unwanted drugs etc.
Results:
Draft drug policy formulated by the J&K govt. in 2009 was mainly focussed on selection, procurement, storage and rational use of drugs particularly in govt health facilities. However it was totally deficient in vital policy provisions related to spurious drugs control, AYUSH drugs control, control of prescription drug abuse, recall and disposal of uwanted drugs, drug licensing regulation, control of unethical promotion of drugs, drug prosecution, hospital and clinical pharmacy services, pharmacy education regulation, drug price control, medical financing/health insurance, blood banking and transfusion etc. Through civil society interventions some of these provisions were accepted by the J&K govt. for incorporation in the modified draft whereas few others were rejected. Net outcome of interventions was that qualitatively a better draft could be evolved.
Conclusion/Discussion:
Taking cue from the Indian state of Jammu and Kashmir, this paper demonstrates the need and importance of inclusion of civil society in policy making process and decisions for achieving the overall goal of making drugs of standard quality, good efficacy and reasonable safety available to common masses, particularly at govt. health centres. Experiences gained from J&K emphasize upon the need to replicate such activism in other Indian states too.

SWOT ANALYSIS OF THE POST-GRADUATE PROGRAMME IN PHARMACY PRACTICE LAUNCHED AT THE DEPT. OF PHARMACEUTICAL SCIENCES, UNIVERSITY OF KASHMIR IN 2009

An innovative post-graduate programme in Pharmacy Practice was launched at the Department of Pharmaceutical Sciences (DOPS), University of Kashmir in the year 2009. Course was introduced with an aim of introducing clinical pharmacy, community pharmacy and modernized hospital pharmacy services at a tertiary care hospital with whom DOPS has signed a Memorandum of Understanding (MoU) under which the hospital has been providing necessary assistance to our students for undertaking practical classwork and research studies at its various inpatient and outpatient departments.
 
Main objectives of the course were to shift the focus of graduating pharmacists from bench side to bed side, from product to patient so that they are adequately skilled and properly trained to offer patient oriented services like patient counseling, drug information services, pharmacovigilance and drug safety monitoring services, prescription audit and drug utilization studies, hospital formulary and drug management services, community education services, pharmaceutical care services etc. This way pharmacy practitioners will become a part and parcel of the healthcare delivery team which hitherto comprised of only doctors and nurses. Thus this course marks the beginning of a new era of clinical pharmacy practice in the state.

During the past five years of this programme one research project involving design, implementation and evaluation of pharmaceutical care services to the patients of respiratory medicine at the Internal Medicine ward of the tertiary care hospital was completed successfully apart from two more research projects on drug utilization evaluation. During the course of their research and practical work, trainee pharmacy practitioners took part in ward rounds, offered patient counseling and education services, undertook case studies of patients, prepared clinical manuals of various diseases and exposed themselves thoroughly to the drug and disease management techniques in clinical settings at various wards of the tertiary care hospital.
This paper discusses the journey and experience of the author with this innovative programme over the past five years and throws light upon the various strengths, weaknesses, opportunities and threats (SWOT ANALYSIS) encountering the programme so that the future policy and planning of this course becomes better that shall pave way for a smooth and successful conduct of this course in days to come.  Primary needs and special requirements of the course to fulfill its basic objectives are also discussed.

Resurgence of renewed interest in the use of HRT in pre- and post-menopausal women

Menopause is that time in the reproductive phase of a woman where by the levels of circulating estrogen diminishes to such low levels as to cause physical, psychological and sexual disturbances. At or around menopause (between 48 to 52 years) there is a decline in the ovarian functions and in the amounts of hormones produced by hypothalamus-FSH and LH which results in decrease in the ovarian hormones. While cessation of periods can be welcome to many a women, the wide ranging effects of lack of estrogen can be discomforting to an equal many. One alternative to overcome the hazards of menopausal syndrome is the use of Hormone Replacement Therapy (HRT).
 
Many trials on the use of hormone replacement therapy (HRT) during the past one decade have provided contradictory results on its risks and benefits in post-menopausal women that has consequently put the medical community in quandary in decision making about use of HRT. The use of HRT declined globally following publication of the first data from the Women’s Health Initiative (WHI) trial in 2002, with the revelation that there was an increased risk of breast cancer and coronary heart disease (CHD) in postmenopausal women taking HRT. Following this, Heart and Estrogen/Progestin Replacement Study & its follow-up (HERS I & II), WHI Memory Study (WHIMS), Women’s international study of long duration oestrogen after menopause (WISDOM) and the Million Women Study (MWS) published results that were consistent with the findings of the WHI study. This reduced enthusiasm for HRT use, and many health professionals and patients considered the use of such hormones as ‘unsafe’, leading to reduction in HRT prescribing.

However, recent publications from the International Menopause Society indicate that HRT is the first-line and most effective treatment for menopausal symptoms.  Moreover when the full results of the WHI trial were subsequently published it appeared that HRT may confer benefit for CHD prevention below age 60. The consensus statements from the British Menopause Society and the International Menopause Society (IMS) published in 2008 also supported this opinion. These revelations renew interest in realms of HRT use. This paper analyzes the current status of HRT use in post-menopausal women vis-à-vis effects of combination versus unopposed HRT on, osteoporosis, breast and CHD, endometrial cancer induction, venous thromboembolic disease, on lipids and lipoproteins, neuroprotection and cognitive function, in post-menopausal women.
 
The differences in age at initiation and the duration of HRT are key points. The intention dose and regimen of HRT need to be individualized based on the principle of choosing the lowest appropriate dose in relation to the severity of the symptoms and the time and age. HRT appears to decrease coronary artery disease in younger women, near menopause yet, in older women, HRT increases risks of coronary event.

INTENSIVE HOSPITAL-BASED ADVERSE DRUG REACTION MONITORING STUDIES ON 5482 PATIENTS OF KASHMIRI ORIGIN AT A TERTIARY CARE HOSPITAL

Problem Statement: Prior to this study there was no provision for monitoring drugs for their adverse effects in any of the leading hospitals of Kashmir division of the J&K state.
Objectives: Present study was undertaken to assess the prevalence, preventability, category, costs and severity of drug-related adverse effects in Kashmiri patients at a Srinagar-based tertiary care hospital.
Design: Prospective, observational, cohort study with follow-up
Setting: All adult patients admitted in Internal Medicine IPD, presenting to the Internal Medicine OPD and those visiting the Accident and Emergency Department of the study hospital, over a 270 day period were included in the study.
Study Population: A total of 5482 patients, of both sexes were screened and monitored on a daily basis for the occurrence of any ADRs.
Intervention: Data was recorded using structured forms and then scrutinized for various assessment parameters by a multi-disciplinary medical team of a senior consultant in medicine, a clinical pharmacologist and a pharmacist. Interventions relating to detection and management of ADRs were undertaken on case-to-case basis. Study led to the establishment of a full-fledged Pharmacovigilance Centre in the hospital.
Policies: No hospital drug policy or ADR monitoring policy/framework was available in the study hospital at the time of this study.
Outcome Measures: Causality assessment, severity assessment, preventability assessment, extension of hospital stay and cost due to ADRs.
Results: ADRs account for 6.23% Kashmiri patients visiting a tertiary care hospital, either for referral or hospitalization and a majority (81.57%) of these ADRs were preventable. 23.68% patients had mild ADRs while 69.29% patients had ADRs of moderate severity and 7.01% patients had severe ADRs. The four classes of drugs most frequently suspected in admissions due to ADRs were anti-infective agents (40.92%) including anti-tubercular drugs (13.15%), steroids (14.03%), anti-coagulants (8.77%) and NSAIDs (7.89%). Increasing age and female gender were identified as risk factors. The organ-systems most commonly affected were gastrointestinal (81%), dermatological (43%), central nervous (40%), hematological (34%), metabolic (33%), cardiovascular (22%), urinary (18%), ENT (18%), immunological (11%) and respiratory (10%) systems. The total cost to the hospital due to hospitalization of patients presenting with ADRs over the 9 month period in the IPD of Internal Medicine at the study hospital was USD 22469.
Conclusion: Present work is the maiden pharmacovigilance study conducted on Kashmiri patients, moreso at a tertiary care teaching hospital that has provided base line information about the prevalence of ADRs and their distribution amongst different age groups, genders, organ systems affected and therapeutic classes of medicines. The data collected will be useful in future for long term and more extensive ADR monitoring on Kashmiri patients and will also be useful in framing policies towards the rational use of drugs.

DESIGN, IMPLEMENTATION AND EVALUATION OF PHARMACEUTICAL CARE SERVICES TO THE PATIENTS OF RESPIRATORY MEDICINE AT A TERTIARY CARE HOSPITAL


BACKGROUND:
Clinical Pharmacy is in its infancy in the state of Jammu and Kashmir and the concept of Pharmaceutical Care is completely new to most of the physicians, nurses and even pharmacists presently working in our government health facilities. Present study being the first of its kind in the state will pave way for more advanced, systematic and coordinated pharmaceutical care services in future.
OBJECTIVES: 
To assess the design and implementation of a pharmaceutical care model for respiratory medicine patients  focusing on identification, resolution and prevention of drug related problems and optimization of therapy outcomes.
STUDY DESIGN: 
Prospective, interventional, cohort study.
SETTING:
Medication review in all respiratory medicine patients.
STUDY POPULATION: 
A total of 182 patients of all age groups, of which 121 (66.48%) were males and 61 (33.51%) were females, with respiratory disorders admitted to the Internal and Pulmonary Medicine ward of a tertiary care hospital over a period of six months.
METHODS:
Medication use data was collected and reviewed by the pharmacy practitioner. Drug-related needs and problems of patients were assessed. Pharmaceutical care plans were formulated and medication interventions proposed.
OUTCOME MEASURES:
Pharmaceutical care services, Drug-related problems, interventions, therapy outcomes
RESULTS:
A total of 388 Drug Therapy Related Problems/ Pharmaceutical Care issues with an average of 2.29 DRPs per patient were identified and a total of 233 interventions were made, besides imparting patient education and counselling to 177 patients. Pharmaceutical Care Services offered to the study patients proved beneficial in terms of better patient compliance, their improved health-related quality of life, optimized therapeutic outcomes.
CONCLUSION:
Design, implementation and evaluation of pharmaceutical services has proved to be fruitful in all respects among the study patients. There is need to replicate this model to all other wards of the tertiary care hospital for the benefit of patients.


NEED FOR FRESH POLICY INITIATIVES AND NOVEL APPROACHES IN THE FORMULATION OF STATE MEDICINES POLICIES FOR VARIOUS INDIAN STATES


BACKGROUND:
Healthcare is a state subject in India. Most of the state medicines policies of Indian states contain provisions relating to selection, procurement, storage, distribution and rational use of medicines but there is lack of uniformity in policy components and many state medicines policies lack vital provisions relating to spurious drugs, drug abuse, unethical promotion and prescribing, drug licensing, drug recall, AYUSH drugs control, drug safety monitoring etc.
OBJECTIVES:
To make a comparative analysis of policy components of the state medicines policies of six Indian states, make necessary interventions for fresh policy initiatives in the formulation of maiden drug policy for the state of Jammu and Kashmir (J&K) and suggest new policy initiatives for other Indian states.
STUDY DESIGN:
Policy evaluation study of state medicines policies of six Indian states.
SETTING:
Study examines the various policy components of the medicines policies of six Indian states.
STUDY POPULATION:
Drafts of state medicines policies of six Indian states were randomly selected for the comparative analysis based on their availability on worldwide web.
METHODS:
State medicines policies of six Indian states viz., Chattishgarh, Delhi, Madhya Pradesh, Orissa, J&K and West Bengal were retrieved from the internet and analyzed for presence or absence of various policy components. Subsequently, necessary interventions were made to evolve fresh policy initiatives in the formulation of first drug policy of J&K state.
OUTCOME MEASURES:
Fresh policy initiatives and novel approaches in state medicines policies.
RESULTS:
Many policy initiatives suggested were accepted and some rejected by the govt. of J&K state and qualitatively, a better policy could be evolved for the state.
CONCLUSION:
Paper demonstrates the need for fresh policy initiatives and novel approaches in the medicines policies of various Indian states through sustained lobbying, persistent advocacy and logical interventions.

Knowledge, perception and attitude of the healthcare staff in a ward of internal medicine of a tertiary care hospital towards Pharmaceutical Care services


Pharmaceutical Care is, “the responsible provision of pharmacotherapy for the purpose of achieving definite outcomes that improve or maintain a patient’s quality of life. It involves four major functions by a pharmacy practitioner on behalf of the patient viz., identifying potential and actual drug-related problems; addressing needs and resolving actual drug related problems; preventing potential drug-related problems and optimizing patient therapy outcomes. Clinical Pharmacy on the whole is in its infancy in the state of Jammu and Kashmir and the concept of Pharmaceutical Care is completely new to most of the physicians, nurses and even pharmacists presently working in our government health facilities. Main objective of this study was to assess the knowledge, perception and attitude of the health care staff towards pharmaceutical care services  

A questionnaire-based assessment involving doctors, pharmacists and nurses of the study department was carried out to assess their knowledge, perception and attitude towards the pharmaceutical care services. From the total number of questionnaires which were distributed to doctors pharmacists and nurses 69% doctors 72% of pharmacists and 75% of  nurses responded . 38.8% of doctors, 32.8%of pharmacist and 24.3% of nurses answered correctly to the first section of questionnaire which was intended to assess the knowledge regarding pharmaceutical care. In second section of the questionnaire which was for assessment of perception in doctors 73.3% agreed and 20%stongly agreed that pharmaceutical services provided by clinical pharmacist can improve the quality of patient care in hospital settings.66.6% agreed and 26.6%stongly agreed that clinical pharmacist as a part of medical team will minimize medication errors.73.3% agreed and 13.3% strongly agreed that clinical pharmacists can educate patients about their safe and appropriate medication use. 73.3% agreed and 20% disagreed that clinical pharmacists can monitor patients response to drug therapy.73.3%agreed and 20% disagreed that doctors can allow pharmacists to be available with them during ward rounds.
 
In third section of the questionnaire which was for assessment of attitude in doctors 66.6% of doctors agreed and 20%disagreed that pharmacists are reliable source of drug information.73.3%agreed and 20% disagreed that pharmacists can inform doctors if patient has experienced some problems with his medications. A separate questionnaire distributed in pharmacists only to assess various services offered by pharmacists to the in-patients revealed that patient education and counseling, Detecting and preventing drug related needs and problems,drug utilization studies were never offered where as QC testing of drugs seldom offered and services like distribution of drugs to wards, dispensing of drugs at pharmacy counters and drug inventory management at stores are regularly offered

Key words:pharmaceutical care,outcome pharmacotherapy,questionnaire,

DEVELOPMENT OF AN INDICATOR-BASED TOOL FOR THE ASSESSMENT OF MEDICINE MANAGEMENT PRACTICES OF A TERTIARY CARE HOSPITAL


A well functioning medicines management system is vital in assuring an uninterrupted supply of   medicines that are efficacious and of good quality, physically and financially accessible and used rationally. In an era of evidence-based medicine and policy, high-quality research evidence is essential for the development of effective pharmacist-led services and hospital policies. Inefficient and irrational use of medicines is a widespread problem at all levels of health care throughout India. Lack of discretely documented policies and procedures in respect of medicines management in a hospital is unnecessarily straining the already meagre resources resulting into poor inflow of benefits to the patients. Per capita wastage from inefficiencies and irrational use tends to be greatest in hospitals. Many of these sources of wastage could be reduced if some simple principles of drug management and use are followed and a proper drug management policy is developed.

Development of medicine management indicators is important for reliably assessing the components of good pharmacy practices (GPP), including quality of care. Hence, there is a need to develop, adopt and enforce minimum standards for GPP as well as the means to assess pharmacy practice in hospital settings. In the light of the above, an attempt is made to develop a standard indicator tool which can be used to carry out an in-depth assessment  of  the  system  and will help in providing  information  for  targeted  interventions  in strengthening the  system and current practices. The tool comprises of a set of structural, process and outcome indicators covering five essential components; selection, quantification, procurement, storage and dispensing. These indicators would be further developed refined and validated through Delphi technique and later used for developing the medicine management policy frame work. This would help our tertiary care hospitals make the best use of its available resources for making quality medicines available and affordable to its patients throughout the year without any stock-outs.
 
Key Words: Indicator, Selection Quantification, Procurement, Storage, Dispensing, Delphi technique

Analysis and review of new drugs approved for marketing and use in India by CDSCO over a five year period

The Central Drug Standards Control Organization (CDSCO) headed by the Drugs Controller General (India) is the Central Authority for regulating the quality of drugs marketed in India under the Drugs and Cosmetics Act, 1940.  It is the regulatory body within India that is responsible for approval of new drugs, clinical trials, laying down the standards for drugs, control over the quality of imported drugs, coordination of the activities of state drug control organizations and providing expert advice with a view to bring about the uniformity in enforcement of various provisions of the Drugs and Cosmetics Act, 1940 and Rules thereunder. Regulation of manufacture, sale and distribution of drugs is however primarily the concern of the state drug controlling authorities. A total of 1125 new drugs have been approved for marketing and use within India by CDSCO between January, 1961 and January, 2013 that includes single ingredient as well as combination formulations.

Among the combination drug formulations largest number of drugs have been approved for acute pain, inflammation, musculoskeletal spasm (52); hypertension (46); nutritional disorders (40); RTI, UTI, ENT infections (29). Among the single ingredient formulations largest number of drugs have been approved for Cancers (56); acute pain, inflammation, musculoskeletal spasm (39); GIT disorders (24); RTI, UTI, ENT infections (22). Therefore these are the areas inviting maximum attention of the regulatory authorities within India with respect to approval of new drugs over the past five years. Still a vast number of other areas remain unattended and there is need to diversify the types of drugs being approved in India with special attention to Orphan diseases. Further the approval process itself needs to be made more stringent as pointed out by a parliamentary panel appointed by the Govt. of India for the purpose of investigating the process of approval of new drugs by Central Drug Standards Control Organization of India.

Analysis and review of adverse drug reactions, safety alerts and drug recalls recorded by Health Canada MedEffect Programme over a period of one year

Adverse reactions (AR) are undesirable effects to health products. Health products include drugs, medical devices and natural health products. Drugs include both prescription and nonprescription pharmaceuticals; biologically-derived products such as vaccines, serums, and blood derived products; cells, tissues and organs; disinfectants; and radiopharmaceuticals. The Food and Drug Regulations define an adverse drug reaction as a noxious and unintended response to a drug which occurs at doses normally used or tested for the diagnosis, treatment or prevention of a disease or the modification of an organic function. A serious adverse drug reaction requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death.

Adverse Drug Reactions may occur under normal use conditions of the product. Reactions may be evident within minutes or years after exposure to the product and may range from minor reactions like a skin rash to serious and life-threatening events such as a heart attack or liver damage. Patients, health professionals, manufacturers and health product regulatory authorities need to work together to detect and monitor ARs. Voluntary reporting by health professionals and consumers of suspected reactions is the most common way to monitor the safety and effectiveness of marketed health products to obtain information regarding ARs.

Health Canada suggests that prevention and health promotion can hold health care costs down and improve quality of life in the long term. MedEffect e-Notice is a free service that sends health product alerts right to your e-mail inbox. MedEffect Canada uses a variety of mechanisms to share information and to help patients stay informed about advisories and recalls that are issued by Health Canada, as well as by Industry, for health products, such as pain relievers, cold medicines, prescription drugs, medical devices, vaccines and natural health products.

This paper consolidates analyses and reviews various adverse drug reactions, safety alerts and drug recalls reported over the past one year by Health Canada-MedEffect Programme. The goal of this short study is to raise awareness and provide facts and safety information about marketed health products and reported adverse reactions that are suspected of being associated with specific health products. Idea is to sensitize people about the importance of reporting adverse drug reactions to regulatory authorities for generating safety alerts, labeling changes and drug recalls in the interest of safety of patients.
 
Key Words: Adverse Drug Reactions; Safety Alerts; Drug Recalls; Health Canada; MedEffect

Role of Clinical Pharmacist in Disease and Drug Therapy Management at a Tertiary Care Hospital - Few Case Studies


Objective: To highlight the role and responsibilities of a Clinical Pharmacist in disease and drug therapy management at a tertiary care hospital.

Background: With recent advancements in drug therapy management and increasing volume of new information continuously pouring in areas of pharmaceutical formulations, pharmacokinetics, dosing, pharmacodynamics, adverse effects, drug interactions, patient compliance, pharmacogenomics and pharmacoeconomics, new challenges are being posed to the healthcare personnel for optimizing clinical outcomes of pharmacotherapeutics among patients. With this very objective this paper presents observations, interventions and outcomes of a clinical pharmacist led initiatives in a few wards of a tertiary care hospital during the course of his routine practical training work and highlights the benefits that such services can yield to the patients by way of assistance offered to the other partners of healthcare system.

Methodology: The study was carried out in four different wards of a tertiary care hospital over a period of four months. A total of 12 cases were selected out of which 3 were from Cardiology, 3 from General Medicine 2 from Gastroenterology and 4 from Accident and Emergency wards. Data was collected from patient record files by examining the patients' demographic data, past medical and medication history, laboratory investigations. Data was also collected from treatment charts and individual patient interviews. During the entire period of study, selected cases in the respective wards were continuously monitored for patients’ drug related needs and problems and all cases were followed up till their discharge from the hospital.

Results: Present study revealed that total no. of drugs prescribed  to these 12 patients under study were 85 and average no. of drugs prescribed per patient was 7 out of which most frequently prescribed therapeutic class of drugs was antibiotics (16), followed by Proton Pump Inhibitors (12), vitamins and supplements(12), antihypertensive (08), anticoagulants (5), steroids (4) and others (28). No. of injectables prescribed were 42 out of a total of 85 drugs. Other parameters like total no. of drug related problems, patients related needs, no. of patients counselled, no. of drug interactions identified are discussed in detail.

Conclusion:  Hospitalized patients in medicine-related wards have a wide range of diseases and are frequently prescribed with large number of drugs which makes drug therapy complex. Therefore Clinical Pharmacy services can help in monitoring of drug therapy and addressing the patients’ actual drug related needs and problems. This paper underlines the need to include a clinical pharmacist in daily ward rounds and seek his assistance is making the best possible pharmacotherapeutic options available to the patients and thereby minimize unwanted effects and improve his health related quality of life.
 
Key Words: Drug therapy management; Disease management; Clinical Pharmacy Services; Tertiary care hospitals; Drug related problems; Drug related needs

Design and development of a Universal Health Coverage policy framework for the state of Jammu and Kashmir

Access is defined as having medicines continuously available and affordable at public or private health facilities or medicine outlets that are within one hour’s walk from the homes of the population. Access to essential medicines has been viewed as an integral component of the right to health, which is a basic human right. Inequity in medicines access is widely perceived as symptomatic of weaknesses in the health-care system and represents a failure on the part of national governments to fulfill their obligations towards their citizens in terms of their right to health. Ensuring equitable access to quality pharmaceuticals is thus a key development challenge and an essential component of health system strengthen­ing and primary health care reform programmes throughout the world.
 
WHO Director General Margaret Chan’s assertion that universal health coverage is “the single most powerful concept that public health has to offer”, attests to the increasing worldwide attention given to universal coverage— even for less affluent countries—as a way to reduce financial impoverishment caused by health spending and increase access to key health services. Public sector in India is in a state of neglect and has traditionally been poorly funded. Public expenditure on health stood at around 1.04% of GDP in 2012, one of the lowest in the world. Consequently, large sections of the population depend on a poorly regulated private sector, increasingly dominated by networked corporate hospital chains, which have an infamous track record of unethical practices.  Out-of-pocket expenditure on health care (approximately 70% of households’ health care expenses) contributes to widespread poverty in India.
 
As per available statistics every fifth citizen of the state of Jammu and Kashmir is falling Below Poverty Line (BPL). A total of 24.21 lakh people are living under BPL category which includes 22 lakhs in rural areas and 7.96 percent residing in urban areas of state. With a total GSDP of INR 8731872 lakhs recorded in the year 2013-2014 and the total budgetary allocation for drugs and instruments earmarked at INR 5750 lakhs, state government spends 0.065% of its GSDP on drugs and devices. Even though healthcare indicators of Jammu and Kashmir are improving considerably, there is much more which needs to be done to rejuvenate it. Government of Jammu and Kashmir needs to take substantive measures towards ensuring equitable access to healthcare and rational use of medicines in the state. Formulating a comprehensive and robust policy framework for providing Universal Health Coverage to its citizens is the primary step that the state government needs to take.
 
This study is an attempt to analyze the situation on ground vis-a-vis availability, financial accessibility, geographical accessibility, affordability and acceptability of healthcare services particularly essential medicines at public health facilities of the state with an aim to identify the gaps, barriers, prospects and challenges towards adopting and implementing universal health coverage. Subsequently a comprehensive policy framework covering all relevant aspects concerning UHC including health service delivery, health workforce, health information systems, access to essential medicines, health systems financing, leadership and governance shall be developed that shall lay a roadmap for future policy direction of the state government towards implementing Universal Health Coverage scheme in the state.

Drug Utilisation patterns, cost effectiveness and patient compliance of statins among patients of diabetes mellitus at a tertiary care hospital


OBJECTIVE: The objective of this study was to determine the drug utilization patterns and cost-effectiveness of statin therapy in diabetic patients as well as their compliance towards the prescribed statin.
DESIGN: Prospective observational cross-sectional study
SETTING: 700 bedded tertiary care hospital.
PARTICIPANTS: A total of 120 diabetic patients, involving both sexes and all ages, admitted to endocrinology ward or attending one of the endocrinology OPD clinics for a period of 4 months were included in the study
RESULTS: Out of 120, a total of 57 patients had a statin being prescribed in their prescription. Statin prescription was restricted to Atorvastatin and Rosuvastatin only with Atorvastatin being prescribed in 50.87% patients and Rosuvastatin in 49.11% patients. The average per month expenditure of statins varied considerably among the different brands of statins being prescribed. There was 1061% variation between the monthly expenditure of lowest cost generic available and highest cost branded form of Atorvastatin 10 mg; in case of Atorvastatin 20 mg the percentage variation in the monthly expenditure of lowest cost generic and highest cost branded form was 841.3%. Out of 57 patients, a total of 40.35% patients were highly adherent to their prescribed statin, while as 47.36% patients had medium adherence and 12.28%  patients were poorly adherent to prescribed statin. 23.52% patients gave non-affordability as the reason for decreased adherence to statins, similarly in 43.75% patients, lack of proper education was the reason of non-adherence, 20.58% patients had polypharmacy and 14.70% patients gave myopathy as the reason for non-adherence to statins.
CONCLUSION: Statin use matches the established standards of care. Statins belong to one of the expensive class of drugs meant for chronic use and one of the reasons responsible for patient non-compliance to statins is their price in a higher range, therefore there is a considerable need for extensive generic prescribing or prescribing low cost brands keeping the fact in mind that more than 60% of people in India do not have access to medicines. Patient counseling and education is an important area which needs considerable attention since it has a direct impact on patients’compliance to prescribed drugs.

Role of computer-based, multimedia-enriched, e-content modules in patient education and pharmaceutical care – a pilot study


Patient education involves the transfer of health-related knowledge from various healthcare sources to the patients. Its value in clinical practice is undisputed. Computer-based patient education is an effective strategy for presenting information, enhancing awareness and improving clinical outcomes among hospitalized patients. Self-care behaviors and patient satisfaction are improved by such a practice for patients with chronic diseases like hypertension and peptic ulcer. Findings have shown computer-based education to be effective for people across the age continuum since it can be tailored to the individual's specific literacy level. The basic underlying assumption for such learning modules is that engagement into informal learning activities while at hospital can have a beneficial effect on the emotional as well as physical recovery of hospitalized patients.
 
Clinical pharmacists have long played a major role in the design, development, and implementation of innovative approaches to patient education. Computer technologies, like multimedia-enabled, e-content modules, are a very useful tool for use as an educational delivery mode in the healthcare settings. Computer-based learning interventions support real-time learning when the patient is ready or has time to access the computer. Such e-contents need to be simple, lucid, illustrative and interesting for patients to understand the basic underlying principles of the disease and its treatment.

Two such e-content modules describing pathophysiology and pharmacotherapy of peptic ulcer and hypertension were developed in collaboration with Educational Multimedia Research Centre of the University of Kashmir and used to educate a select group of patients at a tertiary care hospital with a view to increase patient awareness about these two diseases that in turn enhanced patient compliance to the prescribed medication, maximized the therapeutic outcomes and improved patients’ health-related quality of life. These e-content modules employed multimedia technology to promote and consolidate theoretical understanding about the diseases. Such e-content modules are expected to improve patient self-care, and in the long-term reduce the incidence of various complications as well as their associated costs.