Spontaneous reporting and a system of post-marketing observational studies is the core of pharmacovigilance (PV) and this prevents unwarranted adverse drug reactions (ADR) in patients. Therefore, pharmacovigilance departments across the world need to recognize a mistake when it is small, fix it, monitor and learn from it. This was the only way to improve patient safety and to reduce costs, concurred a panel of experts.
The current global safety reporting requirements for prescription and over-the-counter drugs need to be further strengthened. There is need for a constant interaction between pharmacovigilance professionals across the world to discuss new pragmatic approaches and exchange regulatory agency clinical safety aspects of PV inspection programmes in the US, Europe, and Japan. Further, there is need to identify best practices for quality assurance in post marketing pharmacovigilance and clinical safety, stated experts who deliberated at the pharmacovigilance conference titled 'New Insights into Current Pharmacovigilance Challenges', organised by the Drug Information Associates (DIA) India.
Providing a regional update in his key note address, Dr Stewart Geary, chief medical officer, Eisai Co., Ltd. Tokyo, Japan highlighted the System of post-marketing observational studies which are laid out in the Japan Risk Management Plan. Early Phase Post-marketing Vigilance (EPPV) is essential for all new drug approvals. There is need to maintain both individual reports and periodic reports.
The Risk Management Plan in Japan includes both routine and Early Phase Post-marketing Vigilance. There is need to collect and evaluate new safety information and risk minimization with a periodic reminder of correct use, he said.
Serious ADR incidents need to be immediately reported after commencement of marketing of new drugs. There is also need to encourage the health care professionals to understand profile of drugs, and to be aware of appropriate drug use. Only these initiatives will enhance the safety monitoring to detect significant safety risk in the early stage. In Japan Early Phase Post-marketing Vigilance system is unique. The purpose is to promote appropriate use and speed reporting of new serious reactions. Therefore it is crucial that every pharmaceutical company must repeatedly inform health professionals about the proper use of the new drug and collect information on serious adverse reactions. There should be a concentrated period of vigilance during first six months after marketing, pointed out Dr Geary.
According to Dr Vishwas Sovani, country manager, Revogenex Inc., a new set of guidelines on Good PV Practice (GVP)for the conduct of pharmacovigilance in the EU is under development. These guidelines are made into 16 modules and it is the first seven GVP modules which came into force on July 2, 2012.
Delving on the Periodic Benefit-Risk Evaluation Report, Dr Sibin Kurien, head, Medical Safety, Novartis Healthcare Limited emphasized on the need for proactive and documented risk management planning. He called for balancing the new evidences of risk against documented benefits of the drug.
Challenges in Periodic Benefit-Risk Evaluation Report include providing information in a correct manner and format which most often is not straight forward as the standard operating procedures suggest. Errors in reporting occur because of fluctuation in workload, disturbances or interruptions, fatigue, multi-tasking, failure to follow up, ineffective communication and not adhering to protocol, said Manoj Sharma, Global Pharmaceutical Division, Panacea Biotec Limited.