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Oviya MedSafe - Uniting Physicians for Pharmacovigilance

Dear Well-wishers,

With immense trust that the year 2019 is indeed treating you well, I am heartened to connect with you through this January 2019 edition of Oviya MedSafe‘s newsletter!

Although the word ‘treat‘ has quite a few meanings, its usage in the context of ‘medical treatment‘ assumes the greatest significance for patients and physicians alike. A physician may occasionally become a patient by chance but physicians are necessitated by design to play one of the following roles:

(i) the Prescribing Physician (clinician) that prescribes medicinal products in order to provide medical care to the patient; or

(ii) the Drug Safety Physician (pharmacovigilance professional) that assesses the benefit-risk balance of the prescribed medicinal products on an ongoing basis in the best interest of the patient.

While prescribing physicians usually work in clinics or hospitals, drug safety physicians work not only in the pharmaceutical industry but also in governmental/international health agencies and academic institutions. Being key people on either side of the spectrum, physicians deal with quite a few issues pertaining to pharmacovigilance on a day-to-day basis. In this edition, I wish to share some of my thoughts on the divergent roles that are currently being played by physicians in pharmacovigilance and on why physicians have to come forward to unite for pharmacovigilance.

For a prescribing physician, the priority would be treating the patient’s medical condition and therefore, a suspected Adverse Drug Reaction (ADR) is of importance only to the extent of its impact on the patient’s compliance with the prescribed treatment. However, for a drug safety physician, a suspected ADR is of primary importance as their mission is to ensure that the maximal therapeutic benefit of a prescribed treatment is passed on to the consumer, at the least risk. Having said so, we must remember that serious ADRs (especially fatal/life-threatening ones) critically affect prescribing physicians as they directly interact with patients and are expected to overcome the associated professional relationship issues and at times, medico-legal challenges also. On the other hand, drug safety physicians are seldom required to establish direct communication with consumers and they are in a position to critically analyze a wide range of ADR reports received from several prescribing physicians from different locations over an extended period of time. While a prescribing physician’s approach to the occurrence of a suspected ADR would be focused on providing appropriate medical treatment to the patient, a drug safety physician would try to understand why the suspected ADR occurred in the first place. In other words, a prescribing physician strives to “correct” while the drug safety physician aspires to “prevent“.

The dissimilarities in the worlds of the prescribing physicians and the drug safety physicians often lead to the unfortunate scenario of one not fully understanding the professional goals, practical problems, regulatory/statutory obligations and so on of the other, thereby making ‘working in silos‘ the norm, in spite of the fact that both these physicians work for the benefit of the patient. The root cause for the development of this gap appears to be a lack of regular interactions between prescribing physicians and drug safety physicians rather than anything else. Although some amount of communication happens between these two physicians during the initial reporting and the follow-up seeking stages of specific cases for purposes of regulatory compliance of the pharmaceutical industry, it does not reflect the plethora of pharmacovigilance benefits that the community could harvest if such interactions were more mainstream and possibly mandated by statutory bodies ably facilitated by physicians’ associations.

In this context, I am delighted to share with you that I have been unanimously nominated as the Chairman of the Pharmacovigilance Standing Committee of the Indian Medical Association – Tamil Nadu State Branch (IMA TNSB) for the year 2019. While I did hold the position for 2018 in which year the committee was first established, my first term was well spent in creating awareness of pharmacovigilance among the state and national office-bearers of IMA, thanks to my legacy of having been a proponent of pharmacovigilance on several state and national platforms of IMA since 2010. I trust that my second term will help me go beyond the cream of the medical fraternity and induce the adoption of pharmacovigilance as an integral part of medical practice across all doctors in the state, with the co-operation of the highly experienced members of the committee. I hope IMA TNSB Pharmacovigilance Standing Committee would evolve into the first-of-its-kind platform for facilitating dialogue between prescribing physicians and drug safety physicians, which could, in turn, pave way for more productive pharmacovigilance mechanisms to be derived in the long run.

As far as Oviya MedSafe is concerned, both ‘Physicians for Pharmacovigilance‘ and ‘Pharmacovigilance for Physicians‘ have been our goals since a long time. As a company, we at Oviya MedSafe are privileged to state that all our directors are seasoned medical professionals. Further, we have been vocal of our Expert Clinician Panel which was added as a specialty offering to Oviya MedSafe’s portfolio of services as early as in June 2014. Oviya MedSafe has played key roles in the conduct of quite a few customized pharmacovigilance awareness programmes for prescribing physicians, apart from supporting some advocacy initiatives organized under the aegis of IMA. Above all, the formal launch of Oviya MedSafe held at Coimbatore on 23-Feb-2013 had the then Honorary President and the Honorary Secretary of IMA TNSB as dignitaries among others, as a token of the medical fraternity’s compliments for the promising organization we were even at a time when we were just sprouting. In reciprocation, we at Oviya MedSafe take pride in re-dedicating ourselves to continue empowering physicians with our pharmacovigilance expertise, as our solemn commitment to the medical fraternity, beyond our business interests in pharmacovigilance.

Having articulated these points in favour of my argument for uniting physicians for pharmacovigilance, I believe reading this note was worth your time and I am eager to hear your feedback on my views, if possible, in person. It will be my pleasure to catch up with you at Mumbai (India) on the 5th and 6th of April 2019 at the DIA India 7th Pharmacovigilance Conference which has given me the special honour of being the Session Chair for the first session of the first day (following the keynote address), thanks to my consecutive involvement as a Member of the Program Committee for this annual conference since 2016. I will again be in Mumbai on 26th July 2019 as the Chair of the Indian Pharmacovigilance Day 2019 conference (the 4th in the annual series under my Chairmanship), the agenda of which is still under development. Please keep watching the conference website for information on the venue, topics and the speakers.

Before concluding this bulletin, I am pleased to announce that I will be an Invited Speaker at the International Pharmacovigilance Day 2019 conference that is to be held in Barcelona (Spain) on the 12th and 13th of June 2019. I believe this will be an opportunity not only for me to meet my friends in Europe but also for our Oviya MedSafe team to formally connect with prospective business collaborators in the region. We will be delighted to accept meeting invitations from potential clients not only in Spain but in other European countries as well and include their locations too in our itinerary. Please do contact us if you are interested to hear about our global pharmacovigilance offerings which have been successfully availed by more than 50 delighted clients of ours since Oviya MedSafe’s inception in 2012.

Looking forward to connecting with you shortly through our February 2019 newsletter,

With thanks & regards,
Dr J Vijay Venkatraman
MBBS, F. Diab., MBA, FPIPA (UK)

Managing Director & CEO,
Oviya MedSafe Pvt Ltd,
Coimbatore, India
Phone: +91-422-2444442

Director,
Oviya MedSafe UK Ltd,
London, UK
Phone: +44-8452-733839

Web: www.oviyamedsafe.com
Mail: info@oviyamedsafe.com
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