Asia Focus: Top 5 Challenges around Pharmacovigilance

Deepa Arora

There are several challenges around pharmacovigilance in Asia and perspectives are different for Industry, regulatory authorities, academia and healthcare professionals. Dr Deepa Arora MD, Global Head, Drug Safety & Risk Management at Lupin Limited, tells Pharma IQ what she considers to be the Top 5 most common challenges around pharmacovigilance in Asia.

Challenge 1: Poor availability of trained manpower and lack of systematic material to learn about pharmacovigilance are major issues faced in all sectors. The situation is consistently improving over thelast few years as some big projects have been awarded by MNCs to BPOs based in Asia, therefore, these BPOs have hired and trained staff in PV. Several institutes are also offering training courses in PV for beginners. 

Challenge 2: The pharma industry in Asia expects detailed guidance from regulators and better harmonisation of regulations for pharmacovigilance. As regulatory authorities don’t have necessary manpower, this in turn leads to poor implementation of regulations, delays in planning and regulatory action.

Challenge 3: The safety of herbal drugs / allied medicine-herbal and herbo-mineral drugs are a challenge more specific to Asia than other regions due to the extensive usage of these drugs. Efforts are on-going to define the methodology for monitoring the safety of such drugs. Several regulatory-academia-industry workshops have been organised and extensive work has been done in collaboration with WHO.    

Challenge 4: Like Western countries, challenges faced by the industry in Asia include poor reporting and poor quality of spontaneous reports.  A lack of awareness regarding PV amongst healthcare professionals and consumers is a major issue and probably the most important target for improvement, as growing awareness amongst healthcare professionals and consumers is likely to result in a significant improvement in overall implementation of PV by all sectors, especially regulatory authority and Pharma industry.

Challenge 5: Medication errors are an important cause of adverse reactions resulting in significant morbidity and mortality. Due to poor reporting, it is quite difficult to estimate the extent of medication errors in Asian countries. Various forums are being used to increase the awareness of HCPs regarding the importance of collection of ADR data.

These responses are based on my experience and opinion and may not reflect the current processes followed at Lupin.