[india-drug] ADR monitoring in India

["Dr. Gulhati" <mims@del2.vsnl.net.in>]

ADR monitoring in India
-----------------------


The importance of post-marketing screening of adverse drug reactions
(ADRs) can hardly be over-stated. 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?

India?s 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 boundries. 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.

Dr. Chandra M. Gulhati, 
Editor,
MIMS INDIA.




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