While agreeing that the great potential of the Pharm D graduates will be a supporting asset for the pharmacovigilance programme of India (PvPI), the national scientific coordinator of the programme, Dr Yogendra Kumar Gupta said the highly qualified pharmacists will be absorbed into it for the success of the ADR reporting.

“I think the Pharm D graduates will have better understanding, sufficient time, and most importantly they can think of building careers in medicine safety. So, to ensure continuous interest of graduates of Pharm D in the PvPI, and for the growth of the programme, we must create better job opportunities, career growth/ promotional avenues and higher level positions,” Dr Gupta told Pharmabiz.

According to him, ADR reporting requires high degree of motivation. The culture of ADR reporting in doctors in the country has just started and yet to mature. Busy schedule, lack of time, lack of incentives, fear of adverse publicity and lack of understanding as to what to report, where to report and how to do causality assessment, etc. are the bottlenecks in reporting by the doctors.

He said even though 150 PvPI centres are operating in India now, the number of ADR reports is less compared to the efforts and the manpower exerted. The national co-ordinator said he will definitely hold brainstorming sessions with different stakeholders, especially with the key opinion leaders of Pharm D for their suggestions and guidance in the matter.

Dr Gupta hoped that with greater involvement of Pharm D students, the number of ADR reporting would go up and the quality of reporting would improve. The causality assessment will be more reliable and in time. Regarding reporting of ADR he commented that it was a team work consisting of doctors and pharmacists, which would create a win-win situation.

“Pharm D students have more training in pharmacovigilance, time limitation may not be the limiting factor for them. Work on medicine safety will become the primary job of the Pharm D graduates who specialize in pharmacovigilance. So I will have no hesitation that Pharm D will make a better case. But it does not undermine the role of medical doctors as they are the first one to see the ADR and can better do the causality assessment,” Dr Gupta added.

When asked whether the doctor or the pharmacist is more suitable for ADR monitoring, he said both of them are suitable and important, no one is inferior. The only problem with the doctors is lack of time. In India, the doctor-patient contact time is much less than in developed countries.

Currently, PvPI is now functional in nearly 150 medical colleges covering almost all the states. Some corporate hospitals have joined recently. Indian Medical Association (IMA) is now showing keen interest. More centres will be established soon in the rest of the medical colleges in the country, both in the private sector and in the government sector, he said.

But, Dr Gupta said an important issue that demands attention and needs to be addressed is with regard to periodic safety update reports (PSURs) from industries. This is very huge and professionally collected medicine safety data needs to be integrated with pharmacovigilance data.

Further, he pointed out that in order to sustain the enthusiasm of pharmacovigilance professionals, a career growth option has to be thought of in consultation with government, regulators and industry.