The Indian Pharmacopoeia Commission (IPC) in association with the Indian Medical Association (IMA) has launched a Continuing Medical Education (CME) programme on pharmacovigilance for the doctors. To kick-start the CME initiative on Pharmacovigilance Programme of India (PvPI) in the national level, a training programme was conducted in Chennai on February 22 by the Tamil Nadu unit of IMA, supported by the IPC.
Inaugurating the CME, the national scientific coordinator for the PvPI, Dr Yogendra Kumar Gupta said the term ‘drug safety’ is more comfortable than ‘pharmacovigilance’ which is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. Hailing Tamil Nadu as the most advanced state in India for healthcare services, Dr Gupta said the state unit of the IMA is the first medical association in the country to come forward to host the training program on PvPI for its members. He said all the state branches of IMA would be involved in the pharmacovigilance activity and wanted the doctors to become ambassadors of drug safety.
He said all the drugs have benefit and risk factors. The risk factors cause side effects and to prevent such adverse effects, the country needs accurate efficacy and safety data of drugs. Countries like US and Europe have the safety data of all drugs which are generated from the reporting of physicians, nurses and pharmacists. The data will help prevent side effects of the drugs, both of the new ones and of the existing.
Risk identification, risk assessment and risk minimization are the prime objectives of the pharmacovigilance. Physicians, industry, patients and the regulators form the stakeholders of data generation/ADR reporting. The data created on the side effects of a particular drug is generated not from one person or place, but from all the stakeholders across the country. Dr Gupta pointed out that it was the primary responsibility of the doctors to monitor and report the side effects of the drugs they prescribe to their patients. However, he said the government of India has not invested enough money for pharmacovigilance programme of the country.
Delivering the presidential address, the state president of TN IMA, Dr M Balasubrahmaniam said henceforth his association will be more vigilant on the side effects of drugs and all the doctors will be alerted on the issue.
Dr Vijay Venkitaraman, managing director of Oviya MedSafe, Coimbatore, who coordinates the CME on PvPI in Tamil Nadu, said there are two stages for pharmacovigilance, pre-marketing and post-marketing of drugs. The former is based on monitoring the safety issues during clinical trials and the latter is the safety monitoring after launch of the drugs. He, further said, drug safety programmes will enhance patient care and patient safety in relation to the use of medicines.
Dr Bikash Medhi, Dr V Kalaiselvan, national coordinator for PvPI, Dr S Gunasekharan, Dr T Senthamil Pari and TN IMA secretary Dr C N Raja spoke on various subjects of the program. According to sources, there are nine ADR reporting centres in Tamil Nadu, all of them are attached with medical colleges.
Commenting on the IPC’s pharmacovigilance programme, some leaders of various pharmacist associations said the authorities should consider the Pharm D graduates while implementing the programme as they have studied in detail the adverse reactions of the drugs, whereas the subject is a new one to the doctors.