E-DRUG: Post-Marketing Surveillance and ADR Monitoring in India (2)
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[From the Editor's Desk, Monthly Index of Medical Specialities (MIMS), Vol. 23, Number 2 (February 2003). Copied as fair use. WB]
Screening Side Effects: Let the Head Rule Over the Heart
The importance of post-marketing screening of adverse drug reactions (ADRs) can hardly be over-emphasized. Before a drug is introduced into the market, it is usually tested in no more than a thousand patients. Adverse reactions that occur in 1 in 1,000 or more cases cannot be detected prior to marketing. Side effects are always a serious challenge. In the United States, 3 to 5 per cent of all hospital admissions are due to drug reactions. While every country would like to monitor ADRs, presently only a few have the competence, capacity and infrastructure required to do so.
Doctors alone cannot assess side effects on their own. Several institutions and experts are required to do so: drug regulatory authorities, doctors, pharmacologists, pharmacists, dentists, epidemiologists, statisticians and an efficient infrastructure. Do we have all these elements in place?
Indias contribution to worldwide collection of data on drugs side effects is dismal. One has just to go through the four issues of WHO Pharmaceutical Newsletter published in 2002 to realize that the safety information of not even one drug was internationally amended based on Indian input. Since the safety of nimesulide is currently under cloud, let us look at the adverse reaction data submitted by a few countries on this controversial drug (name of the country, population, number of ADRs reported):
Ireland 4 million 25
Switzerland 7 million 33
Belgium 10 million 83
Finland 5.5 million 109
Italy 57 million 225
India 1000 million 0
On another drug, Sildenafil, Australia with a population of 18 million has reported 741 ADRs while we have reported none. Why is it so?
Firstly, medical students are not taught the art of monitoring ADRs. Secondly, a huge majority of doctors do not maintain records on their patients. They do not even seek information required to determine side effects such as weight, use of medications including OTC products taken during the past three months with dose, date of starting & stopping and the condition for which they were taken. Without this basic information, ADRs cannot be determined. Finally, most doctors do not know to whom they should report side effects. Over 80 per cent of Indian population is dependent on private practitioners. Unless family doctors, now numbering over 206,000 are actively involved in ADR monitoring, no worthwhile outcome is likely. In Ireland, for example, 50 per cent of ADRs are reported by family doctors, 25 per cent by drug companies, 13.6 per cent by specialists, 10 per cent by pharmacists, 1 per cent by nurses and 0.2 per cent by dentists.
Assessing ADRs is not an easy task. Even in the United States, no more than 10 per cent of side effects are recorded. The situation in Britain, Canada, Denmark, Sweden and New Zealand is somewhat better because ADR reporting is legally mandatory in these countries.
Medicines know no boundaries. Even if we have our own drug surveillance system, ADR findings from developed countries will continue to play a decisive role. In the absence of locally reported ADRs, we may not prohibit the sale of a globally discarded drug but it will die a natural death sooner or later. Prescribers will simply switch to non-controversial alternatives.
In the near term there is no option but to accept the ADR findings reported from credible western sources. In the larger interest of patients, it is time we permit our head to rule over our heart, at least for the time being.