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Explaining Drug Safety & PV

In the course of many years in pharma heading drug safety groups and now consulting, training and doing outreach to the public, I continue to be amazed and humbled by the lack of knowledge by the public about drug safety and what those little pills you pop in your mouth can do.

Except for our small group of drug safety people, very few in the pharmaceutical companies, and even fewer in the medical world (MDs, nurses, dentists and to some degree pharmacists), have any idea about the safety of medicines. The public has no idea whatsoever about the safety of medicines.

I preface this because I was once again shocked this month when I delivered a talk at a Science Café session sponsored by our local university entitled: Medications, Drug Safety and Side Effects: Great Expectations or Bleak House. (See ScienceCafes.org for information about the wonderful Science Cafés around the country. These are talks by scientists for the lay public often sponsored by local universities or science societies on current and interesting science topics. Often held in a restaurant or bar – the concept of hearing a science lecture with a beer in your hand munching on hot wings is wonderful).

The audience was non-medical but bright, educated and interested. I reviewed briefly the concepts of ADME (absorption, distribution, metabolism and elimination/excretion), how a drug is approved by FDA (pre-clinical, phase I-IV studies, post-marketing PV), what “side effects” are, how causality is done (or not done), drug interactions and how we cannot predict them too well, etc. The talk was very well received but was somewhat shocking and even upsetting to people who now realized that “safe and effective” means the benefits outweigh the risks in the appropriate patient population at the appropriate dose, etc. and not a blanket guarantee of great efficacy no side effects.

So that made me think again about how to convey the ideas and concepts about DS/PV to different audiences: The first is the group of people who don’t know about the pharma world or industry at all: the public. The second is those in the pharma world who don’t do DS/PV and have only a vague idea at best of our functions and duties.

First, to the public:

It may be the best policy to assume that this audience (whether you are speaking to them at a meeting or writing or using social media, etc.) does not have any idea about where their pills and medicines come from. They have no idea what the FDA is, who works there, how drugs get to the market, what “safe and effective” really means and how “side effects” are collected.

Some points to make include:

Second, to our pharma colleagues not in DS/PV:

Avoid excess jargon, abbreviations and acronyms, particularly with non-medical folks (lawyers, marketing, sales, etc.). Depending upon the audience and time available, you may want to do a brief review of why DS/PV must be done, drug risks, how we do PV and possible consequences of safety issues (even when PV is done totally correctly).

Things you can point out:

Bottom Line:

DS/PV needs continual outreach both to the public and within companies for multiple reasons. You should be prepared for this.



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