For a country said to be producing in excess of 65,000 drugs, it comes as a surprise to note that only for 5 per cent of the drugs does there exist some sort of a study on Adverse Drugs Reactions (ADRs). ADRs said to be one of the leading causes of morbidity and mortality in health care.
While impediments such as lack of awareness, limited access to ADR monitoring centres/regions, uncertainty about causality, guilt and fear of being ridiculed seem to be the obvious reasons, the most worrying factor for cases being unreported is the reluctance on part of the clinicians in taking part and reporting such events to the ADR monitoring committee, according to experts who spoke on the workshop on 'Pharmacovigilance: From Identification to Reporting' at the KEM hospital here recently.
According to Dr Santosh Bavdekar, professor, dept of paediatrics, KEM Hospital, for any new drug that was being studied, there was an urgent need on behalf of the clinicians to be vigilant due to factors such as it being tested in a limited number of patients, only common reactions being identified, availability of limited data on drug interaction and all population were not properly included.
According to Sten Olsson, Uppsala Monitoring Centre, Sweden, factors such as shortage of time, filling intricate forms, corresponding with the ADR centre, consultation with the company representative and providing clarification and additional information to regulators could further detract the clinicians in providing additional ADR information. Further, lack of adequate ADR centres prevents the clinicians from coming to the fore and reporting ADR cases to the concerned authorities. For this, Sten suggested the model being followed by China, which currently has one ADR centre in each region/state in the country.
According to Sten, some of the methods for stimulating ADR reporting would be to facilitate access to reporting forms, including the Yellow Form (EU norms) and Medwatch (USFDA); acknowledge receipt of reporting as is being done abroad; publicize in medical journals; include ADR monitoring in the curricula; engage drug/therapeutic committee; involve professional associations and most importantly set up regional centres in every state throughout the country.