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The Liabilities of Pharmacovigilance Activities
Posted on June 21st, 2017 by J.-P. Clement MD in Pharmacovigilance
There is always a risk that any Pharmacovigilance (PV) activity, even executed with the highest business and ethical standards, and with the highest compliance results, could be challenged, sometimes many years later. As a member of a PV team, you may have to one day justify your actions in front of a group of plaintiff’s lawyers, because of a claim that the company you worked for did not fulfill its mandate on patient safety. Without any consideration to the claim’s merit, when this time comes, how much of your current behavior and business activities will influence the outcome of such discussions and your comfort in handling such a situation? Legal context apart, some good business rules are good to keep in mind.
It is all about being professional
In this age of intense social media exchange, every piece of your communications leaves an everlasting track. Everything can become discoverable material from a legal standpoint, even your personal notes, years after, whether from internal company emails, chat groups or Facebook. Inside and outside the business world, you should always control your communication and avoid your message to be too easily and incorrectly distorted or misinterpreted, now and in the future. You are a professional day and night, at work and outside work.
Fact based rather than emotion based communication
In almost every job, our responsibility is to get the job done. If there is a problem, we are expected to find the solution and/or execute a remediation plan, and move to the next step. If the problem is frustrating, if the solution does not come fast enough or we feel that our efforts are not productive enough, the emotions can become excessive and pollute the intent of what we want to communicate. Never let the emotions get the best of you, and resist sharing your excessive emotions with others. Otherwise, this will always end up working against you (not only with lawyers, but with HR, your colleagues…). If you feel emotional while drafting a message, wait an hour or a night before sending the email or the chat. And when the emotions become overwhelming, go to your car, close the windows, yell out loud for some time, and get back to work with a refreshing approach to problem solving… It is all about restraint and professionalism.
100% Compliance is a goal, process improvement is a permanent effort
Years later, any mention of non-compliance of any type in your department meeting slides may be read as a sign that your organization was not able to fulfil its regulatory obligations. Likewise, process improvement efforts might be later read as a proof that the organization was deficient prior to enhancing the processes. Both are inadequate interpretations which can be debunked, but this is another strong driver for always stick to facts, goals and purposes in internal communications, rather than being judgmental, emotional or describe a potential risk with excessive words.
Truth and honesty are key
Do your job with honesty and integrity, speak up when needed, disagree and alert the appropriate hierarchy if you think that there is a potential ethical or business issue. Ensure that what you say and write are an accurate reflection of the facts and issues. Keep communicating as per your business needs without unnecessary emotional tones. All these will always have a positive impact on your current and future life.
Being involved in a lawsuit is an inherent risk for any pharmacovigilance role, especially but not only in the US. The best preparation for this challenge is to keep making the right decisions for the patients, accurately document activities and discussions, avoid ambiguity and potential misinterpretation in communications, and stay truthful to your principles and ethical values.
All opinions shared in this post are the author’s own.
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J.-P. Clement MD
Executive Pharmacovigilance Consulting
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