It was not until the disaster caused by thalidomide in 1961 that the first systematic international efforts were initiated to address drug safety issues. The Erice Declaration of 19971 called for all the players in healthcare including public health administration, health professionals, the pharmaceutical industry, government, drug regulators, the media and the consumers to strive towards the highest ethical, professional and scientific standards in protecting and promoting safe use of medicines and in establishing a new culture of transparency, equity and accountability in communicating drug safety information. Of late, sustained efforts in this area have led to the advent of a new discipline named Pharmacovigilance which means the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems. Recently its concerns have been widened to include herbals, traditional and complementary medicines, blood products, biologicals, medical devices, diagnostic products and vaccines.2,3,4 Pharmacovigilance is needed for the prevention of drug-induced human sufferings and to avoid financial risks associated with unexpected adverse effects.
Its major objectives are:5,6
• Early detection of hitherto unknown adverse reactions and interactions.
• Detection of increases in frequency of known adverse reactions.
• Identification of risk factors and possible mechanisms underlying adverse reactions.
• Estimation of quantitative aspects of benefit/risk analysis and dissemination of information on the need to improve drug prescribing and regulation.
Pharmacovigilance activities are specifically aimed to improve patient care and safety in relation to the use of medicines and all medical and paramedical interventions, contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective (including cost-effective) use, and promote understanding, education and clinical training in pharmacovigilance and its effective communication to the public.1
Sher-i-Kashmir Institute of Medical Sciences (SKIMS), Srinagar is a 500-bedded teaching-cum-service referral centre, offering primary, secondary and tertiary care facilities. During the year, 2002, a total of 3,11,182 patients attended different speciality poly- and referral clinics at SKIMS;6,129 patients were admitted by super speciality disciplines for various surgical procedures;529 patients were admitted in surgical intensive care unit for life support and intensive monitoring.7 Calculating between the period 1996 to 2002, at an average, over twenty four thousand patients get admitted, 1.7 lack patients attend referral clinic, over seventy thousand patients attend polyclinic and over thirty thousand patients attend emergency department at SKIMS every year. Considering the fact that SKIMS has been established towards the end of 1982, it is estimated that during its life span of 20 years up to ending 2002, it might have admitted about 5 lac patients, treated over 30 lack patients at its referral clinic, over 14 lac patients at its polyclinic and over 6 lac patients at its emergency department.
However this huge inflow of patients does not run commensurate to the information and data collected/available on the pattern of adverse drug reactions (ADRs) and interactions in Kashmiri population or on drug utilization patterns at SKIMS. This becomes evident from the fact that upon literature search for published ADR reports and drug utilization patterns using various database resources like Medline, Toxline, Chemical, Biological and Pharmaceutical Abstracts between 1966 to 2004, reports not exceeding a two-digit figure in number from entire Kashmir could be retrieved depicting a very grim scenario of ADR monitoring and reporting from the valley. It is astonishing to know that even such a large population of patients catered by SKIMS over the past twenty years could not be utilized for collection of some valuable information on how drugs behave in this part of the globe or on what drug utilization patterns at SKIMS are like, due to the lack of any systematic pharmacovigilance activities.
The need for pharmacovigilance activities within Kashmir valley is emphasized by the fact that there are differences between countries and even regions within countries in the occurrence of ADRs and other drug related problems. This may be due to differences in drug production, distribution and use, genetics, diet, traditions of the people, pharmaceutical quality and composition of locally produced pharmaceutical products, use of non-orthodox drugs like herbal remedies which may pose special toxicological problems when used alone or in combination with other drugs, prescribing and dispensing practices etc.8,6 As such it is most likely that drugs having been used successfully elsewhere may prove detrimental and dangerous to the population here. Moreover as a result of complete dearth of any sustained efforts in the valley, several drugs that have been either banned abroad or several ADR reports on their use continue to pour in from across the globe, are being used unabated without any monitoring. Some of these drugs include Phenylbutazone, Phenacetin, Cefloridine, Analgin etc. Drugs belonging to Quinolone group that are not recommended for use below 18 years of age, are routinely being prescribed without any proper monitoring of their adverse drug reactions. Similarly a number of drugs to be used with greater caution in pregnancy (Class C, D or X) are being used either advertantly or inadvertantly. Further the data derived from within the valley may have greater relevance and educational value. Information obtained from other parts of the country or the world may not be relevant to this part where above-mentioned factors differ.
Drug and Pharmacy department of SKIMS dispenses around 1000 prescriptions daily for in- and out-patients and around 200-250 prescriptions for employees per day making an annual sale of drugs/surgicals to the tune of approx. Rs. 1.5 crore7 and thereby taking the total number of prescriptions dispensed per year to over four lacks. Given this rate, it is estimated that over 80 lack prescriptions might have been handled by the Drug and Pharmacy department over the past 20 years but sadly so, not even 80 reports of adverse events at the rate of a mere ten reports per year are available in the literature from entire SKIMS though this figure of dispensed prescriptions represents only a small fraction of total number of prescriptions actually written by the physicians at SKIMS due to the fact that majority of prescriptions get filled from outside in open drug markets. Does it mean that drugs do not show any usual or unusual adverse drug reactions here? Surely the answer is in negative, for, the harm caused by medicines has been shown to be significant. Morbidity and mortality from drug-induced diseases have been recognized as an important item on the public health agenda in developed and developing countries. Recent studies have shown that ADRs are responsible for 11.5% of hospital admissions in Norway, 13% in France and 16% in UK9,10,11;6.5% of hospital patients suffer serious ADRs12 and 0.1-0.3% of hospital patients suffer fatal ADRs.13 Situation becomes even more grievous in view of the fact that even medicines that do not need a prescription (over-the-counter medicines) can cause problems. Vaccines, health foods and herbal products may also cause adverse reactions.14 The reasons for non-reporting from Kashmir valley are non-existence of systematic and organized pharmacovigilance and drug information services/activities within SKIMS or any other hospital. Since there is no dearth of well-qualified pharmacy professionals working under the immediate supervision of an experienced hand at SKIMS, the respective section too needs to be encouraged and promoted to actively participate and contribute through their expertise in this field.
The huge inflow of patients makes SKIMS an ideal case for immediate initiation of pharmacovigilance activities in order to ensure safe, rational and effective drug therapy to its patients. Recently Central Drug Standards Control Organization (CDSCO), Government of India has taken up a project in association with and under the financial assistance of W.H.O, wherein national, zonal and regional pharmacovigilance centres are to be established throughout India. SKIMS could well provide a centre under this scheme. In this direction, Dept. of Clinical Pharmacology can serve as the epicenter of all drug safety monitoring studies/programs and can provide all necessary inputs for launching of a Pharmacovigilance center in collaboration with the Dept. of General Medicine and some other institute/department outside SKIMS like Department of Pharmaceutical Sciences, University of Kashmir. Such a centre could play an important role through training, teaching, research, policy development, clinical research, ethics committees, and other related clinical services. It is advisable to appoint an ADR advisory committee comprising amongst others of independent experts in general medicine, epidemiology, pediatrics, pathology and clinical pharmacology.
Some other issues of relevance to pharmacovigilance include substandard medicines, irrational drug use, overdoses, medication errors, lack of efficacy reports, increasing self-medication practices, increasing use of traditional and herbal medicines with other medicines, illegal sale of medicines, use of medicines for indications that are not approved and for which there is inadequate scientific basis, case reports of acute and chronic poisoning, assessment of drug-related mortality, abuse and misuse of medicines, polypharmacy and adverse interactions of medicines with chemicals, other medicines, and food. There are other aspects of drug safety that should be included in monitoring latent and long-term effects of medicines. These include detection of drug interactions, measuring the environmental burden of medicines used in large populations, assessing the contribution of ‘inactive’ ingredients (excipients) to the safety profile etc.5
The entire cost of a pharmacovigilance system, compared with the national expenditure on medicines or the cost of ADRs to the nation is very small.15 Moreover, keeping in view the fact that about 30-80% of ADRs may be preventable,16 comprehensive ADR monitoring, evaluating and reporting programs need to be undertaken that should focus on the assessment of incidence, prevalence, category, severity, preventability, costs and burdens of ADRs. This would help ensure that patients receive safe medicines and mortality/morbidity due to ADRs is considerably reduced.17 By way of pharmacovigilance, healthcare practitioners could make good use of their patients’ positive and negative experiences of treatment and thereby contribute to the medical sciences and towards an improved understanding of disease and of the medicines.
REFERENCES
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