Adverse drug reaction monitoring in India.

Adverse drugs reactions (ADRs), put simply, are noxious, unintended, and undesirable effects that occur as a result of drug treatment at doses normally used in man for diagnosis, prophylaxis, and treatment. Although there are many terms indicating the harmful and undesirable effects of drug treatment, the term ‘adverse drug reaction’ describes them best. During the course of treatment, drugs prescribed to patients produce certain effects other than the desired or expected effects. These cause concern both to the physician and the patient. They not only add to spiralling costs of medical treatments, but also cause a great deal of morbidity and mortality. These are generally referred to as ‘side effects’. People usually attribute these abnormal effects to either overdose or inappropriate medications prescribed by the doctor or the attending specialists. The unwanted effects are categorised into many types such as toxic effects, side effects, adverse reactions, and adverse drug events etc., depending upon the taxonomic classification used. Worldwide, studies have shown them to be a major cause of morbidity and mortality. Though Indian studies in this regard are very few, the pattern of reactions seems to be similar. Moreover, we have certain peculiarities of drug use such as: large number of patients, poor doctor-patient ratio, self-medication, drugs of alternative systems of medicine, malnutrition, widespread anaemias, presence of counterfeit drugs, and presence of the highest number of drug combinational products in the world. Therefore, incidence of the adverse drug reactions is likely to be same as that of the West, or more. Unfortunately, inspite of presence of five wellorganised centres for drug monitoring in the country, the number of reports sent annually are dismal. Most of the adverse drug reactions are, fortunately, preventable. This calls for the urgent need to reinforce the monitoring of adverse reactions to drugs; public education against self-medication, inclusion of reaction monitoring, and an introduction to drug-safety in the curriculum of medical undergraduates, and systemic and periodic continuing medical education of health professionals. This multi-pronged strategy can lead to reduction in the incidence of adverse drug reactions. The gem cannot be polished without friction, nor medicines perfected without trials. – Chinese proverb. The Joint Commission on the Accreditation of Healthcare Organisations (JCAHO) defines an adverse drug reaction (ADR) as an undesired effect of a medication that either increases toxicity, decreases desired therapeutic effect, or both. This term covers drug reactions of all degrees of severity and is used with a fair degree of uniformity throughout the world. However, for convenience, other commonly used terms are also described. In European countries, adverse drug monitoring is commonly referred to as pharmacovigilance. The Americans use this term in a broader sense and call it, pharmacoepidemiology. Following the thalidomide disaster of 1961, when Dr. McBride of Australia reported increased frequency of birth defects (seal limbs) that left 10,000 babies disabled for life, monitoring centres were started the world over. A 1998 report estimated that 1,06,000 Americans die each year as a result of adverse reactions to prescription medications. This figure represents three times the number of people killed by automobiles and is the fourth leading cause of death in the United States. Only heart disease, cancer, and stroke kill more people than adverse reactions to drugs. This staggering figure does not include drugs administered in error, nor those taken as a suicidal intent. ADRs increase health care cost by an estimated US $ 1,900 per case. If medication errors were included in this statistic, the death toll would probably be as high as 1,40,000 deaths per year. As a result of 39 separate studies in the USA, it was found that 3.2 out of every 1,000 hospitalised patients die each year as the result of adverse reactions to prescription drugs. Why is the number of ADRs so high? There are several reasons why the number of adverse drug reactions is so high. These include: 1) the number of drugs prescribed are high; 2) the ever-increasing number of new drugs in the market; and, 3) the lack of a formal system for monitoring adverse drug reactions. While the exact epidemiology remains to be known in JIACM 2004; 5(1): 27-33