It gives me utmost pleasure to connect with you through this June 2022 edition of Oviya MedSafe‘s newsletter (the 117th in the series since April 2012), especially following the phenomenal reception you extended to our most recent issue in which I wrote about Oviya MedSafe’s Pharmacovigilance Business Pearls and how we intend to share them with you periodically! Today, I wish to dig deeper into and address a popular misconception many clients have: a Pharmacovigilance database is the same as a Pharmacovigilance system.
Those of us who have known Pharmacovigilance only from the viewpoint of top notch organizations may wonder if such naive clients could exist. But, it is a fact that all pharma/biotech companies go through a growth cycle and Pharmacovigilance as a business requirement comes quite late in the picture. In the case of small niche innovators, the necessity to get involved in clinical trials gives them at least some idea of Pharmacovigilance but when we consider large generic manufacturers, the lack of awareness is quite widespread and deep-rooted. Moreover, whether these companies operate in regulated countries/regions or only in emerging markets is also a key determinant of their level of understanding. Given that there are thousands of companies which have limited exposure to Pharmacovigilance compared to a few hundred companies which know what they need to do, this is not surprising.
It is an open secret that companies carry out Pharmacovigilance activities only when they experience regulatory pressure. Hence, the managements of such companies in which Pharmacovigilance is in its early stages invariably wake up to the reality either when they find out that Pharmacovigilance is a pre-requisite for their planned business expansion to bigger markets or in the unfortunate scenario of an unexpected Pharmacovigilance audit/inspection coming their way. The biggest challenge for many companies in such situations is their inability to identify and/or explain what exactly they need in Pharmacovigilance. Thanks to the inputs from their peers in other organizations and their limited knowledge of the subject, they tend to misconstrue the term ‘Pharmacovigilance system’ as a software database product which when procured and installed will solve all their problems.
However, a database is merely a part of the system and these terms are not synonymous with each other. A Pharmacovigilance system essentially consists of written procedures that define how data pertaining to suspected adverse drug experiences are collected, analyzed, processed, quality-checked, reviewed, reported and archived. The qualifications and training requirements for the Pharmacovigilance staff are defined in the system and fulfilment of these is mandatory for ensuring robust Pharmacovigilance coverage. Of course, a system is successful only when it achieves its purpose which in the case of a Pharmacovigilance system is compliance (with internal as well as external obligations including but not limited to regulatory). To make all these happen, sufficient Pharmacovigilance expertise is necessary and this when practised over a period of time results in a mature Pharmacovigilance system. By Pharmacovigilance database, what we mean is the organized documentation of the data points in line with the criteria laid out by the Pharmacovigilance system, with the ability of proper retrieval in future. All databases are not necessarily software-driven and some companies still use paper/spreadsheet databases for Pharmacovigilance, albeit it is true that there is global regulatory insistence to use software-driven databases that conform to accepted standards. In this era of digital revolution, technology may be an almost indispensable aide but strength in the subject is always the master.
On a related note, I wanted to share with you a video recording of my invited speech at the Global Pharmacovigilance Congress 2022 organized by the ADR Monitoring Centre, MKCG Medical College & Hospital, Berhampur, Odisha, India, in collaboration with the Indian Pharmacopoeia Commission and the Global Pharmacovigilance Society. I chose the topic “Pharmacy of the World & Pharmacovigilance for the World: Leveraging India’s Unique Advantage” as I believed it had quite a lot of scope for me to share some pearls not only from the Pharmacovigilance perspective but also for the entire Indian Pharmaceutical Industry. To watch the presentation on YouTube, please click on https://youtu.be/2Zicp476XDc and do feel free to comment.
While I do understand I have already taken quite a lot of your time, I still wish to share with you another update before closing this bulletin: I enjoyed delivering a guest lecture “Evolution of Pharmacovigilance as a Multidisciplinary Medical Specialty” to 2nd Year MBBS students, thanks to the kind invitation of my former colleague and always my good friend Dr Ponnuswamy Kameswaran, Professor & Head of the Department of Pharmacology, Karpagam Faculty of Medical Sciences & Research, Coimbatore! Thanks to his team for these memorable pictures. Making Pharmacovigilance an attractive and intriguing career choice for doctors has always been my one of my relentless pursuits as a passionate Pharmacovigilance physician and entrepreneur. I hope that the young medicos will remember this occasion and some of them will become Drug Safety Physicians in the future 😊
Eager to get in touch with you soon with our July 2022 newsletter,
With thanks & regards,
Dr J Vijay Venkatraman
MBBS, F. Diab., MBA, FPIPA (UK)
Managing Director & CEO,
Oviya MedSafe Pvt Ltd,
Oviya MedSafe UK Ltd,