The proposed ADR monitoring system by setting up pharmacovigilance centers across the country may not work as expected unless the clinicians are well-trained and adequately rewarded, says clinical and industry experts.

Even as the Central Drugs Standard Control Organization (CDSCO) is hoping to put in place a workable adverse drug reaction (ADR) monitoring system through a network of 40 pharmacovigilance centers across the country, doubts are arising from various quarters on the participatory role of the clinicians in the latest experiment.

The experts are of the opinion that a massive education programmes to sensitize the doctors are needed before the launch of any such programme. According to Dr S K Gupta, chief, National Pharmacovigilance Centre, the failure of the existing attempts to conduct ADR monitoring even in a small scale was the unavailability of the doctors for such a project. "One cannot blame the doctors alone for not being able to cooperate with the centre as they are overloaded with their practice. We have been trying in futile all these years to get them involved. I would like to wait and watch how the new system works", he said.

There are other reasons like medico-legal issues, which prevent the doctors from reporting adverse drug reactions. Dr Gupta believes that any system modeling on the pattern practiced in other countries cannot be adapted in India. "We need to develop our own system where the doctors are trained, educated and rewarded for reporting ADRs," he adds.

Elaborating on the AIIMS experiment, he said that the centre used to depute their experts to sit with the doctors and carry out ADR monitoring. "We cannot have people for each and every doctor. Nor is it advisable to go about in a generalized manner. With our limited strength and capacities, we should focus on specific drugs and try to generate data on them," he said.

According to him, the drugs which were followed up recently were Amoxycillin + clavulanic acid, Astemizole, Celecoxib, Cisapride, Clomipramine, Clozapine, Doxycycline, Fexofenadine, Fluroquinolones, Ibuprofen, Itraconazole, Meloxicam, Methotrexate, Nimesulide, Olanzapine, Phenylpropanolamine, Phenytoin, Rofecoxib, Statins and Zidovudine. The centre's observation on Nimesulide use in adults was that it was as good or bad as any other drugs used for similar purpose.

Even though the National Centre at AIIMS were supposed to be the nodal centre for the whole country, most of the studies carried out here were within the institute. If the Centre's plans are to be materialized, the AIIMS centers will continue to exist as a zonal centre and the national nod would move to the office of the Drugs Controller General of India. The national centre will have a full time special officer given responsibilities of monitoring the pharmacovigilance activities in the country.

As per the centers programme, all new drugs cleared during the last four years will be specifically monitored for adverse drug reactions by these centers, proposed in both government and private medical institutions.

The activities of the centers would be monitored and coordinated by six regional centers, two zonal centers and a supreme control nod at the CDSCO Headquarters in Delhi.

The project is to be aided by the Word Bank for the first five years. It is known that the government has earmarked Rs 55 lakh for the initial year for having the national pharmacovigilance system in place.

The CDSCO is to give specific targets to each of these centres. The targets would depend upon the number of patients handled by the medical institutions. While a peripheral center will have to forward a minimum of 30 adverse events (AE) in a month, the regional centers, all 1000-bedded hospitals, would be asked to forward 120 to 150 Aes during the period. There would be standard operating procedures (SOP) for AE recording. The clinicians in these centers would be briefed about the requirements and necessary documentation would be expected from them, it is learnt.