With a view to help the pharmaceutical companies’ efforts in pharmacovigilance activities by enabling them outsource trained people for assessing the risks and benefits of medicines, the Tamil Nadu Pharmaceutical Sciences Welfare Trust (TNPWT) has decided to hold training programmes for Pharm D graduates in pharmacovigilance.
With this, the industry as well as clinical research organisations (CROs), can utilize the potential of the trained Pharm D graduates in collecting new information about benefits and risks associated with drugs, newly developed and already in the market. The manufacturers can, either recruit them for setting up their own pharmacovigilance programmes (PvP) or they can outsource them on contract basis.
The Trust office-bearers, who belong to various segments in the pharmacy profession, industry and regulatory agencies, find that graduates with Pharm D qualification are appropriate candidates to identify, assess, monitor, report and document the adverse reactions of a drug (ADR). So, they have selected 50 Pharm D graduates passed out from ten pharmacy colleges in the state to be trained for pharmacovigilance activities.
The first batch of the training programme was started at the Trust office on August 3 and culminated on August 5. The chairman of the Trust, SV Veeramani inaugurated the first training programme.
“Since the Pharm D graduates have expert knowledge on patients’ health conditions, disease state, therapeutic knowledge and evidence based practice compared to graduates of B Pharm or any others, they can take active roles in pharmacovigilance. The trained personnel can be hired by each manufacturing company for their PvP activities or appoint them in their independent pharmacovigilance centre,” said SV Veeramani, chairman of TNPWT.
He said a pharmaceutical company can meet its pharmacovigilance obligations either by setting up in-house systems for pharmacovigilance or can enter into contractual arrangements with contract research organizations specializing in pharmacovigilance function.
According to sources from the Pharmaceutical Welfare Trust, the selected Pharm D graduates will be given hands-on training in ‘Terminology & involving pharmacovigilance and methods of adverse event reports, role of healthcare professionals including pharmacists in PvP, effective communication setting up of pharmacovigilance system, transcription of data case study to reporting form, ADR/AE and its clinical relevance, logistic methodology of causality of assessment, pharmacovigilance programme in India & its regulatory implication, regulatory aspect of pharmacovigilance, role of CDSCO in PvP and integration of national health programmes in PvP.
While speaking to Pharmabiz, Veeramani, who is the immediate past president of the Indian Drugs Manufacturers Association (IDMA), said, in compliance with the recent amendment to Schedule Y of the Drugs & Cosmetics Rules, 1945, vide Gazette notification No.GSR 287 (E) dated March 8, 2016, pharmacovigilance has become mandatory for marketing authorization holders (MAHs) in India. To ensure the effective implementation, there is an urgent need for the MAHs (manufacturers & importers) to set up a pharmacovigilance system in their sites.