RESEARCH HIGHLIGHTS OF THE DRUG UTILIZATION RESEARCH GROUP OF DEPARTMENT OF PHARMACEUTICAL SCIENCES, UNIVERSITY OF KASHMIR

Drug utilization is defined by the World Health Organization (WHO) as the “marketing, distribution, prescription, and use of drugs in society, with special emphasis on the resulting medical, social, and economic consequences [1]. A drug utilization evaluation (DUE) is therefore a study designed to describe-quantitatively and qualitatively-the population of users of a given drug or class of drugs and the conditions of their use (for example, indications, duration of treatment, dosage, previous or associated treatments and compliance) [2]. Drug utilization evaluation has created a broad arena for the development of innovative approaches to improve drug use. That is why WHO has recommended that more recognition and support should be given to Drug Utilization Studies and related work and governments should be made aware of the importance of such studies [3]. For the individual patient, the rational use of a drug implies the prescription of a well documented drug at an optimal dose, together with the correct information, at an affordable price. DUE  can play a key role in helping the healthcare system to understand, interpret and improve the prescribing, administration and use of medications [4,5]. These studies are powerful exploratory tools to ascertain the roles of medicines in society. They create a sound socio-medical and health economic basis for healthcare decision making [6]. Thus overall objectives of drug utilization research are to ascertain and ensure rational prescribing, rational dispensing and rational use of safe, efficacious and standard quality drugs in the society.

 

In the year 2009, Department of Pharmaceutical Sciences started post-graduate degree programmes in five different specializations of Pharmaceutical Sciences, one of them being M.Pharm. (Pharmacy Practice). Introduction of Masters Degree Programme in Pharmacy Practice has given a new orientation to the pharmacy education and research 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. The programme is aimed at carving a niche for the qualified pharmacists of the state and incorporate them as an inherent part of the healthcare team that so far comprised of only doctors and nurses. Over the past five years main focus of Pharmacy Practice Research group has been on Drug Utilization Research in this part of the globe. During this period a series of drug utilization studies have been conducted to ascertain the pattern of drug prescribing, dispensing and usage among Kashmiri population attending various tertiary care hospitals of the state with a view to generate data on baseline assessment of the situation on ground that has not been documented so far in the published literature.

 

In the year 2014, Public Health Foundation of India (PHFI) conducted a “baseline study to assess the access to medicines situation in India” across nine Indian states including the state of J&K. In J&K state, PHFI partnered with our research group to undertake the study. The study was fully funded by PHFI, New Delhi and was successfully completed in time and the report submitted to PHFI for onward submission to the Govt. of India. Project was aimed at undertaking situational analysis vis-à-vis medicines access with a view to generate baseline data and scale up medicines access across India including J&K in anticipation of Govt. of India’s scheme to provide free medicines for all at govt. health institutions. Ministry of Health and Family Welfare, Govt. of India had given its clearance for the study and necessary permission was also obtained from the Ministry of Health, F.W and Medical Education, Govt. of J&K for conducting the study in J&K state.

 

In the coming days this research group intends to conduct a study on “Hospital and community based drug utilization study among Kashmiri population using WHO devised methodology”, with financial support expected from ICMR, New Delhi. This study, which is the first of its kind in J&K state shall generate data on prescribing practices of doctors and dispensing practices of pharmacists in primary/community health centres and on drug utilization patterns of community households in selected districts of Kashmir province so as to pave way for development and effective implementation of a comprehensive policy framework necessary for promoting equitable access and ensuring rational use of medicines in the community. Two more studies are currently underway on drug utilization patterns among pediatric and geriatric patients at two Srinagar-based speciality care centres. A gist of the ongoing and completed studies of the research group is given as under.

 Ongoing and Completed Research Projects:

 

1.         Drug utilization studies of statins in patients of diabetes mellitus at a tertiary care hospital  (completed).

2.         Evaluation of the prescribing patterns of anti-hypertensive drugs in patients of hypertension with associated co-morbidities at a tertiary care hospital (completed).

3.         Drug utilization patterns and risk assessment for primary and secondary prevention of cardiovascular disease at a tertiary care hospital (nearing completion).

4.         Drug utilization patterns and risk assessment for renal impairment patients at a tertiary care hospital (nearing completion).

5.         Drug utilization studies with special reference to off-label use of drugs among pediatric patients at a tertiary care hospital (ongoing).

6.         Drug utilization studies among geriatric patients at an internal medicine unit of a tertiary care hospital (ongoing).

7.         Prospective adverse drug reaction monitoring studies in Kashmiri population (completed; funded by University Grants Commission, New Delhi to the tune of Rs. 1.8 lakhs).

8.         Design, development and implementation of Pharmaceutical Care services to patients of respiratory medicine (completed).

9.         Baseline evaluation of access to medicines across eight Indian states (completed; funded by Public Health Foundation of India (PHFI), New Delhi to the tune of Rs. 5.8 lakhs).

10.       Knowledge, attitude and prescribing patterns of doctors towards hormone replacement therapy in pre- and post-menopausal women of Kashmir region (completed).

11.       Evaluation of availability, prices and affordability of essential medicines as per WHO-HAI methodology across ten districts of Kashmir province (completed).

12.       Evaluation of availability and affordability of essential commodities required for maternal, neonatal, reproductive and child health across ten districts of Kashmir province (completed).

13.       Design and development of a comprehensive medicines management policy framework for tertiary care hospitals (ongoing).

14.       Anti-genotoxic potential of some essential oils using mouse bone-marrow test system (completed).

 

Research Publications of the group (2010-2013):

 

1.                  Geer, M. I. Mushrooming of medical stores in J&K state–reasons and solutions. Physicians Academy 2010;4(7);75-76.

2.                  Geer, M. I. Deficiencies in the draft Drug Policy of J&K government. Physicians Academy 2011; 5(2): 16-19.

3.                  Geer, M. I., Mir J.I., Koul P. A. Optimizing Clinical Outcomes through Pharmaceutical Care. Physicians Academy 2011;5(9): 117-121.

4.                  Geer M.I., Tasaduq H., Mir J.I., Mohsin B.M. Risk-benefit analysis of combination versus unopposed HRT in post-menopausal women. International Journal of User-driven Health 2011;1(4): 61-76.

5.                  Geer M.I. Magnitude of spurious drug trade in J&K – Mountain or a molehill? Physicians Academy 2012; 6(1):2-9.

6.                  Geer M.I. Approved drug policy of J&K government – A Review. Physicians Academy 2012;6(2): 27-37.

7.                  Geer M.I. Generic Drug Prescribing in J&K - Boone or bane? Physicians Academy 2012; 6(5): 82-87.

8.                  Geer M. I. Improvements in Drug Policy of Indian state of J&K through persistent advocacy and logical interventions by Civil Society Forum. Drug Safety 2012; 35(10): 938. [Impact Factor = 3.4]

9.                  Mir J.I., Geer M. I., Koul P.A. Identification and resolution of Drug-related Problems in respiratory medicine patients at a tertiary care hospital. Drug Safety 2012; 35(10): 941. [Impact Factor = 3.4]

10.              Geer M.I., Koul P.A., Tanki S.A., Shah M.Y. Incidence, category, severity, avoidability, extension of hospital stay and costs of drug related adverse effects among Kashmiri population at a tertiary care hospital. Jour of Pharmacol and Toxicol Methods 2013; 68(1): e19. [Impact Factor = 2.15]

 

References:

 

1.      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.

2.      Hartzema AG, Porta M, Tilson HH. Pharmacoepidemiology: An Introduction, 3rd Edition. 1998. Cincinnati: Harvey Whitney Books.

3.      WHO drug utilization research group. Report of the meeting held at Cologne, 7-8 November 1985.

4.      American Society of Hospital Pharmacists. ASHP guidelines on Medication Use Evaluation, 1996.

(Available at http://www.ashp.org/DocLibrary/BestPractices/FormGdlMedUseEval.aspx, Accessed on 04.03.2015)

5.      Sathvik BS. Drug utilization review/evaluation, in Parthasarathi G, Nyfort-Hansen K, Nahata MC (eds), A textbook of Clinical Pharmacy Practice. 1^st ed., Orient Longman, India, pp 362-375, 2004.

6.      Baksaas I, Lunde PKM. National drug policies: the need for drug utilization studies. Trends Pharmacol Sci 1986;7:331-34.

Generic Drug Prescribing - a step towards Universal Health Coverage

To begin with here is an excerpt from the World Health Report, 2010 on Universal Health Coverage published by World Health Organization. “Promoting and protecting health is essential to human welfare and sustained economic and social development. This was recognized more than 30 years ago by the Alma-Ata Declaration signatories, who noted that Health For All would contribute both to a better quality of life and also to global peace and security. Not surprisingly, people also rate health as one of their highest priorities, in most countries behind only economic concerns, such as unemployment, low wages and a high cost of living. There are many ways to promote and sustain health. Some lie outside the confines of the health sector like education, housing, food and employment that all significantly impact upon health. But timely access to health services that is a mix of promotion, prevention, treatment and rehabilitation is highly critical. This cannot be achieved, except for a small minority of the population, without a well-functioning health financing and well–organized supply chain management system of which making quality generic drugs available to patients visiting government health facilities is an integral and important component. Recognizing this, Member States of the World Health Organization (WHO) committed in 2005 to develop their health financing systems so that all people have access to services and do not suffer financial hardships paying for them. This very goal was defined as universal health coverage.”

“Access to Medicines” 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, guaranteed not only under Article 21 of the Indian Constitution but also under Section 24 of the Constitution of Jammu and Kashmir. Ensuring equitable access to quality pharmaceuticals is a key development challenge and an essential component of health system strengthening and primary health care reform programmes throughout the world. Providing access to affordable essential medicines in developing countries has become one of the Millennium Development Goals outlined by United Nations Organization i.e. MDG 8E, Target 17, Indicator 46. One of the major impediments in more rapid movement towards universal coverage is the inefficient and inequitable use of resources. At a conservative estimate, 20–40% of health resources are being wasted worldwide. Reducing this wastage would greatly improve the ability of health systems to provide quality services and improve health. Procuring costly branded medicines instead of cheap generic versions has been counted as one of the factors resulting into wastage of limited resources of low and middle income countries.

High prices and low govt. spending on medicines are major barriers to the use of medicines, better health and improved quality of life. Average per capita spending on pharmaceuticals in high-income countries is 100 times higher than in low-income countries – about US$ 400 compared with US$ 4. Up to 90% of the population in developing countries purchases medicines through out-of-pocket payments, which means from income, domestic savings, borrowing, or the sale of assets. Over 80% of India’s health financing is in this form. The share that goes into medicines is 74.72% which should come down to around 20%. In some countries, up to 11% of the population suffers this type of severe financial hardship each year, and up to 5% is forced into poverty.  Imagine if a person hailing from some remote village of Kokernag has to pay whopping 80,000 dollars for newly developed branded drug therapy of Sofosbuvir for his Hepatitis C disease. Can he ever afford that medication? Of course, never.

Due to out-of-pocket spending of their income in medicines and healthcare services, about 3.2 percent of India’s population will fall below the poverty line as per a WHO sponsored study. Public expenditure in India on health stood at around 1.04% of GDP in 2012, one of the lowest in the world that has to be increased upto 6%. As per Economic Survey 2011-2012, every fifth citizen of the state of Jammu and Kashmir falls below poverty line. J&K’s 21.63 percent population, comprising of 24.21 lakh people is falling under BPL category which includes 26.14 percent rural population and 7.96 percent urban. Per capita expenditure on drugs in J&K in the year 2010-2011 was Rs. 39.2 (against all India average of 43) that has increased to Rs. 45.84 in the year 2013-2014 whereas drug expenditure as percentage of health expenditure was 4.3% as against all India average of 13%. With a total GSDP of Rs 87318 crores recorded in the year 2013-2014 and the total budgetary allocation for drugs and instruments earmarked at Rs 57.50 crores, state government spends 0.065% of its GSDP on drugs and devices which is very low by any standards.

Jammu and Kashmir government adopted state drug policy in the year 2012 but no concrete steps were taken towards its enforcement and implementation over the past three years. The policy was pushed under the carpet for fear of backlash from pharmaceutical traders and corporate lobby. Main bone of contention was the provision relating to prescribing of drugs on generic names rather than brand names within government health centres. Generic drug prescribing is the first step towards achieving the goal of equitable access through Universal Health Coverage since it allows maximum value for money in states like ours having limited resources at their disposal for bearing healthcare and more particularly medicine expenditures on behalf of the common masses. Generic drugs are those that have gone off the patent protection, are sold on the name of their active ingredients and are the same as that of their branded counterparts in terms of dosage, safety, strength, purity, stability, quality, performance, route of administration and intended use. Most of the apprehensions related to generic drug prescribing in government health facilities of J&K pertain either to quality and efficacy of generic medicines or its impact on local pharmaceutical trade. However fact of the matter is that if the govt. follows standard guidelines of pre-qualification and post-qualification of suppliers while tendering and strictly adheres to the technical specifications for quality assurance as has successfully happened in case of Tamil Nadu Medical Supplies Corporation, there is no reason why govt. can't procure good quality drugs. If India can supply quality generic medicines to the extent of 22% of entire global generic market and if highest number of USFDA approved generic manufacturing units outside USA are based in India, what makes it impossible to procure world class quality generics from such approved companies within India? It all depends upon the will and intent of procurement and enforcement agencies of the govt. as to what quality standards they can maintain for generics.

Before necessitating prescribing of generic drugs within hospitals in public sector, government has to ensure availability of standard quality generic medicines at hospital drug counters throughout the year without letting any stock-outs to take place anytime because inherent design of the state drug policy is such that none of the prescriptions written inside the hospitals should go out to private retail chemists for dispensing. Instead, all drugs prescribed on generic names within the hospital must be available and dispensed on the hospital drug counters round the clock. This seems to be a lofty goal given the fact that government has to meet two significant challenges of maintaining continuous supply as well as their quality throughout the year before asking its doctors to prescribe on generic names. This is how generic drug prescribing works in many other Indian states like Tamil Nadu where it has been practiced successfully with excellent results. This requires robust drug procurement or supply chain management mechanism and a foolproof quality assurance system failing which generic drug prescribing can just prove to be a money-minting method for the unqualified and untrained pharmacists working in our retail sector.

It is saddening that even after fifteen years of formation of our own J&K Pharmacy Council which is not an offshoot of Pharmacy Council of India unlike other states, 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.

Only pharmacy graduates are suitably trained to offer professional pharmacy services to patients alongwith necessary couselling about the use and side effects of drugs. Government of India has notified Pharmacy Practice Regulations, 2015 in its official Gazette in January this year but our state is lagging far behind in adopting these regulations. Our patients continue to be at the mercy of unqualified pharmacists for receiving medicines and medicine information. Under these circumstance any step that empowers these unqualified pharmacists to choose a drug formulation for the patient can have disastrous economic and health related consequences for the patients. As such, doctors’ apprehensions of their reputation taking a serious jolt if the prescribed therapy fails to produce its desired therapeutic response are not baseless or unfounded. Government needs to take up first things first and move in a sequential and scientific manner rather than taking arbitrary and hasty decisions and ruining the entire concept of generic drug prescribing by faulty decision-making and misplaced priorities.

Of course it will take some time to establish new drug testing laboratories in the state. Till then government can empanel other government and private, licenced, accredited laboratories existing outside the state for quality assurance of its drug supplies. Immediate concern of the government should be to devise robust drug procurement and supply chain mechanism that was left in doldrums when the draft drug policy was adopted by the erstwhile government in 2012. Our existing quality control mechanism is the same for branded as well as generic medicines. If substandard or spurious generic medicines can sneak into our existing drug procurement system so can happen with branded medicines. Therefore the argument that generic medicines will promote substandard quality medicines does not hold much water. Our level of surveillance and alertness is same, as of today, for branded as well as generic medicines. Once the mechanism is strengthened quality of both generic as well as branded medicines will improve simultaneously. Remember all the medicines that have been tested as spurious or substandard so far by our drug testing laboratories were mostly branded medicines and not generics.

On the analogy of Tamil Nadu Medical Services Corporation, J&K State Medical Supplies Corporation has to be strengthened, empowered and made fully functional with adequate funding, manpower, infrastructure, transportation and other logistics. All the budgetary allocations for drugs lying scattered at present with various units like Directorate of Health Services, Jammu, Srinagar, Government Medical College, Jammu, Srinagar, Controller Provincial Medical Stores, Jammu, Srinagar need to be pooled centrally and utilized in a unified systematic manner that is a pre-requisite for Universal Health Coverage too. Drug procurement has to be centralized through JKMSC making use of an autonomous, constraint-free mechanism that will function in a completely transparent fashion and will be devoid of any political interference in decision-making. On the contrary drug distribution has to be decentralized through district-level warehouses that need to be established on priority basis with dedicated transportation facilities for timely drug delivery. Government expenditure on medicines has to be drastically increased to cater to the annual demands created after generic drug prescribing starts. Proper demand estimation has to be done on scientific lines so that there are no stock-outs in any part of the year. Only then can generic drug prescribing achieve its goals of enhancing access to medicines and earning trust of patients on the quality of generics. Thus generic drug prescribing can prove to be a boon or a bane for the patients depending upon how it is enforced and implemented. Sometimes a well intentioned move based upon a universally accepted concept can prove to be a disaster if executed in a wrong manner. That is where we need to be cautious.

Generic Drug Prescribing in J&K - Boon or bane?

Government decision to mandate generic drug prescribing within government hospitals has once again stirred the hornet’s nest and created furore among a section of the medical fraternity who believe that such a move will pave way for sale of drugs by unqualified and inadequately trained pharmacists on profit margin considerations in absence of a stringent quality control mechanism. Draft Drug Policy was approved and adopted by the J&K state legislative assembly way back in 2012 but erstwhile state government miserably failed to implement the same and relegated it to cold storage after there was agitation and resentment among pharmaceutical traders on this very generic drug prescribing clause of the drug policy. Quite surprisingly previous government never bothered to implement other relevant provisions of the drug policy to which nobody had ever expressed any objection and that were aimed at rationalizing drug use, improving prescribing and dispensing practices and ensuring quality, safety and efficacy of drugs procured by government agencies nor did it take any measures to streamline the drug procurement mechanism that was left in doldrums in the state drug policy owing to strong opposition by pharmaceutical corporate lobby.

 

After the spurious drug scam surfaced erstwhile state and central governments repeatedly pledged to upgrade the existing drug testing facilities in the state with a view to silence the huge public dissent against the debacle and had also promised to establish a new, fully equipped and sophisticated state-of-art drug testing laboratory in the state. But again no breakthrough could be achieved on those fronts too till their respective terms ended. Promises to this effect that proved to be hollow were made publicly by none lesser than the Drugs Controller General of India himself. However previous government announced formation of J&K Medical Supplies Corporation which again proved to be a non-starter, a damp squib. Even after a couple of years of its formation it kept craving for funds, manpower, infrastructure, transportation facilities and other necessary logistics without any substantial attention from the powers that be. Contrary to the provisions of the approved drug policy, previous government completely failed to establish intelligence cum legal cells to bust spurious drug rackets, to establish pharmacovigilance and drug information centres, to formulate standard treatment guidelines, to establish Drugs and Therapeutics Committees and to publish customized Essential Drug Lists in all premier health institutions of the state. No warehouses for drug storage were set up at district level nor any dedicated transportation facilities were made available for timely delivery of drug supplies.

 

Soon after new government and new health minister took charge an order was issued banning prescription of branded drugs within government health centres. Though the decision seemed well intentioned to benefit the patients and in accordance with national/international guidelines as well as provisions of the approved drug policy of the state, yet the manner in which order was abruptly issued without taking above mentioned deficiencies into consideration and without laying out a well-organized scientific mechanism towards maintaining unhindered availability of drugs in govt. hospitals throughout the year, fool-proof quality assurance mechanism to ensure quality standards of the drug supplies and robust procurement mechanism to prevent any stock-outs, it has raised many eyebrows forcing people to question the government move. Apprehensions expressed by doctors only get compounded by the fact that we don’t have qualified pharmacy graduates either in public or in private sector. In public sector Medical Assistants having one year MPHW diploma in hand are serving as pharmacists and in private sector matriculates have been registered as pharmacists by the J&K Pharmacy Council on the basis of their experience in drug trade. It is only trained pharmacy graduates who can dispense quality generic drugs alongwith professional counseling services to patients.

 

Fact of the matter is that generic drug prescribing is a need of the hour in order to march slowly towards universal health coverage wherein people at large do not have to pay out of pocket towards medical expenses and consequently face impoverishment on account of catastrophic health expenditures as has been well established in published literature. It is a fact that 78-80% of total health expenditure in India is borne upon medicines alone and out of that around 75% is borne by the people out of pocket since government’s per capita expenditure on drugs in public sector is less than one dollar which is peanuts as compared to what developed nations spend. Therefore making quality generic drugs available throughout the year within government hospitals is a must in order to enhance access to medicines among the 65% population (within India) who as per WHO World Medicines Situation Report lack adequate access at present. Such measures like generic drug prescribing have been hailed and strongly advocated by WHO, UNITAID and other international bodies as a positive step towards achieving Universal Health Coverage. However it is extremely important how generic drug prescribing and other measures envisaged in the drug policy are enforced and implemented. Sometimes a very good move executed in a wrong manner can prove to be a disaster leaving no scope for its revival in future.

 

Generic drugs are those that have gone off the patent protection and are sold on the name of their active ingredients but are the same as that of their branded counterparts in terms of dosage, safety, strength, purity, stability, quality, performance, route of administration and intended use. An estimated 24.21 lakh people (21.63% population) in J&K state live below poverty line and it is these people who cannot afford costly branded medicines. Price difference between generic and branded drugs ranges anywhere between 10% to 5000%.That is why National Human Rights Commission, World Health Organization, several expert committees and the National Commission for Macroeconomics and Health have unanimously advocated use of generic medicines in government hospitals.  Most of the apprehensions related to generic drug prescribing in government health facilities of J&K pertain either to quality and efficacy of generic medicines or its impact on pharmaceutical trade. However fact of the matter is that if the govt. follows standard guidelines of pre-qualification and post-qualification of suppliers and strictly adheres to the technical specifications as has successfully happened in case of Tamil Nadu Medical Supplies Corporation, there is no reason why govt. can't procure good quality drugs. If India can supply quality generic medicines to the extent of 22% of entire global generic market and if highest number of USFDA approved generic manufacturing units outside USA are based in India, what makes it impossible to procure world class quality generics from such approved companies within India? It all depends upon the will and intent of procurement and enforcement agencies of the govt. as to what quality standards they can maintain for generics.

 

It is quite possible for the state government to ensure standard quality of generic medicines by having stringent quality control measures, foolproof quality assurance mechanism, well-defined, transparent procurement and tendering policy, by adopting efficient technical specifications, pre-qualification and post-qualification criteria for drug supplier selection, by having in-house quality control cells in all major hospitals, by ensuring pre-shipment as well as post-shipment analysis of drug consignments, by taking samples randomly from all warehouses for testing, by having an effective drug problem reporting and recording mechanism, by making onsite periodic surprise inspections of manufacturing premises, by decoding the drug samples before sending them to government and private empanelled laboratories for testing, by validating the testing quality of these laboratories, by blacklisting the suppliers whose drug samples fail upon testing and putting their names on official website of the health ministry, by adopting a perpetual and seamless quality assurance mechanism in all healthcare institutions of the state.

 

Concept of Essential Drug List can minimize the number of drugs to be procured to just 348 and can thereby ensure economies of scale so that all necessary medicines of standard quality can be made available throughout the year within hospital pharmacies. However for that to happen, an efficient procurement and stringent quality control mechanism has to be in place. Drugs have to be procured through an autonomous, constraint-free mechanism that will function in a completely transparent fashion and will be devoid of any political interference in decision-making. Tamil Nadu Medical Supplies Corporation Model has shown the way how it can be achieved and that is the reason why this model has been appreciated, approved and recommended for all Indian states not only by the Government of India but also by the World Health Organization.

 

Further it is feared that generic drug prescribing will disempower qualified physicians from exercising a choice of brands and empower unqualified chemists to substitute prescribed generics with generics of their own choice on profit basis. However, inherent design of the new drug policy is such that all generic medicines listed in the Essential Drugs List will have to be kept available for distribution among patients on hospital pharmacy counters within all govt. health facilities throughout the year without allowing any stock-outs to occur at any point of time, so that all the prescriptions whether belonging to in-patients or out-patients can be dispensed within the hospitals and there is no need for the patients to purchase branded or generic medicines from outside the hospitals.

 

Bottom-line is that for successful enforcement of generic drug prescribing within government health institutions efficient procurement mechanism is necessary and maintenance of quality standards is extremely important without which this decision can boomerang and adversely affect patients’ health and welfare. Standard quality generic drugs have to be made available at all government health centres throughout the state throughout the year without any stock-outs, failing which prescriptions might be filled by retail chemists as per their own monetary considerations rather than quality parameters. Therefore it is high time that the state government takes adequate measures to streamline drug procurement mechanism in tune with well accepted norms and to upgrade quality control mechanism besides employing qualified and adequately trained pharmacy graduates in all hospitals of the state. All this can be achieved in a time-bound manner following which generic drug prescribing could be made mandatory across the state. Putting the cart before the horse will not serve any purpose other than generating yet another spell of agitation and furore among the medical fraternity and traders community thereby killing the entire spirit of a well-meaning drug policy of the state. At the same time doctors and pharmaceutical traders need to be pro-patient and welcome the generics wholeheartedly once the deficiencies are suitably addressed by the government.