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.