Safety bypassed

Drug safety monitoring has been the subject of many a heated debates and despite much having written about it, certain reporting practices in the country call for greater attention. Recently, at a pharmaco-vigilance seminar in Mumbai, a senior official from a multinational drug maker admitted that the company reports Adverse Drug Reactions (ADR) to its headquarters directly and not to the Union Health Ministry, a disclosure which immediately elicited sharp criticism from the World Health Organisation (WHO) representatives present. The company said, due to reasons it did not want to elaborate, ADRs are reported to its headquarters, and get back information for follow up action including changing labels. A senior official from the WHO Collaborating Centre for International Drug Monitoring, the Uppsala Monitoring Centre in Sweden, said, bypassing the local government and sending ADR reports to the company's headquarters or to an international body, was not proper as it would be going everywhere except to the people who require it. A top Health Ministry official, when asked about it, said these might not be very serious reactions and that the company could be doing so for academic purposes. One cannot always be critical, the official added. Certainly one cannot. But considering the present lack of an accurate estimate of casualties due to adverse reactions, lack of awareness and the presence of counterfeit drugs, a more cautious approach would be desirable.

Despite all the safety measures, adverse drug reactions occur often even in the best-regulated countries. According to WHO figures, negative effects from medicines were estimated to be between the fourth and sixth largest cause of death in the United States. In Europe, adverse drug reactions are the cause of up to 15 per cent of hospital admissions. The reasons are as varied as inappropriate prescription of medicine and dosage to substandard quality.

The WHO's Programme for International Drug Monitoring is supported by a massive database containing almost three million recorded ADR cases and functions as an alert and response mechanism. Member countries in which adverse drug reactions have been reported, send information to Uppsala, where the pooled data from all countries are analysed and if a significant number of similar reports are detected, a 'signal' is issued alerting all drug regulatory authorities. Countries can take a medicine off the market if the risks outweigh the benefits. When companies are not forthcoming in reporting adverse events to the local government, the precious time for decision-making and appropriate action is lost. This is particularly of concern as in the product patent regime, the introduction of newer drugs would warrant greater vigilance. The government's WHO-funded national pharmaco-vigilance programme is to take off in January 2004. The government also has to ensure transparency on the part of drug makers in handling ADR data besides fixing and demarcating the responsibility for its reporting among the drug maker, the physician, the pharmacist and the patient.

gireeshcprasad@express2. indexp.co.in