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Recognizing Medical Affairs as pharmacy practice

By Dennis Tribble posted 28 days ago

  

I had a chance to view an article by Bastow and Greszler in the American Journal of Pharmaceutical Education about the value of including exposure to Industrial Medical Affairs in pharmacy education and residencies. It is gratifying to see discussion of industrial practice as something other than "going to the dark side". I am grateful both to Samantha and Craig for their excellent article, and to the American Journal of Pharmaceutical Education for publishing it.

It is important to understand that Medical Affairs practice exists because regulatory bodies need a group of professionals and scientists within the pharmaceutical and medical device industries who are not directly compensated by the sale of products, and who can reliably speak to them, and to the healthcare provider community free of commercial interest. This places significant constraints on what a Medical Affairs professional may discuss such as constraints against promoting their company or their products in any material way.

Indeed, Medical Affairs practitioners, and their Healthcare Economics and Outcomes Research (HEOR) partners are the only individuals in these industries who are permitted to discuss off-label use of their products, and even then, may only do so if that information is solicited by practicing providers (they may not do so unsolicited), is based on published evidence and is non-promotional in nature. This distinguishes Medical Affairs pharmacists from industry pharmacists who are engaged in commercial activities (such as sales, sales support and installation) who are constrained by law and regulation to limit their conversations to approved indicated uses of the products they sell or support and to information about the use of those products to that described in their official product literature.

It is probably worth noting that positions for newly graduated pharmacists in Medical Affairs may be hard to acquire. In my experience, our value in a Medical Affairs role arises from extensive experience in a variety of practice settings, a history of publication, knowledge of the regulatory environment, and an established network of key opinion leaders (KOL's) that a new graduate might struggle to acquire. To be a Medical Affairs pharmacist, one must first have been a practicing pharmacist.

That being said, eventually practicing in industrial Medical Affairs is a worthy goal for a pharmacist, in my experience. It is a role that permits the pharmacist to be actively engaged on behalf of the profession in the creation and design of products, as well as in working relationships with professional colleagues in practice to influence thought and perform research. In a Medical Affairs role, a pharmacist gains a broader view of professional practice than they could achieve in traditional practice, in part by virtue of those relationships and in part by working with people one would never encounter in traditional practice. I have found it to be quite rewarding.

I first participated in a Medical Affairs organization when my then current employer was purchased by a large medical supply company. What was most amazing to me was that my Medical Affairs colleagues in that new organization were physicians and nurses who actively performed their own research, presented frequently in their professional meetings, and published regularly. Their work (and mine when it could occur) was carefully vetted by legal, quality and regulatory organizations within those companies to ensure that none of it strayed into areas that could be considered promotional. 

This was in stark contrast to pharmacy whose organizations appeared to paint all pharmacists in industry with the same brush, to fail to recognize the distinction between promotional and non-promotional speech, roles and activity, and who would only permit us to present or publish when they couldn't find anyone else who knew anything about a subject of interest. ASHP Sections and this blogosphere are notable exceptions to this experience.

It is not that we could never present or publish; but it became increasingly difficult to do so. The need to control apparent conflicts of interest is clear and understandable. But do we really believe that only pharmacists employed within industry own stock in, or perform paid services for these companies? Are pharmacists who were once celebrated practitioners suddenly anathema because they now work with or for industry? Should we not rather judge a pharmacist by the impartial and scholarly quality of their words than by the name of their employer?

Samantha and Craig's article gives me hope that some of that may be changing.

I am very grateful that ASHP has permitted me to blog for the last 14 years, as well as to those who comments have corrected and encouraged me. This is not a swan song, but it is an expression of gratitude that is long overdue. I am also grateful for the opportunities I was given to speak and publish.

My point is that, as we see movement of experienced and once-valued pharmacists  (and pharmacy technicians) into industry, I would like to see the profession adopt a better-informed position on the non-promotional roles a pharmacist might adopt in industry, and permit those non-promotional pharmacists to contribute their view and expertise to the body of professional knowledge to the same degree as their traditionally-practicing colleagues.

What do you think?

Dennis A. Tribble, PharmD, FASHP

Retired

tribbledennis@gmail.com

Ormond Beach, Florida

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