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Telerx Blog: Drug Safety Stress Tests

In the world of banking and finance, the US government and the EU have been doing “stress tests” on banks ever since the 2008 financial crises.

These are defined, on Wikpedia, as:

“Regulators devise hypothetical future adverse economic scenarios to test banks. These established scenarios are then given to the banks in their jurisdiction and tests are run, under the close supervision of the regulator. They evaluate if the bank could endure the given adverse economic scenario, survive in business, and most importantly, continue to actively lend to households and business. If it is calculated that the bank can absorb the loss, and still meet the minimum bank capital requirements to remain in active business, they are deemed to have passed.”

The concept is worth considering in drug safety and pharmacovigilance (PV), though referring to various extreme business and health scenarios (not financial ones) that might occur but are unlikely.

To put this into our world: Could your drug safety department withstand a crisis or a “perfect storm” that puts severe stress on your department and company?

Stresses on Drug Safety/Pharmacovigilance from a Company or a Regulator’s point of view:

What To Do

Some stresses cannot be predicted. These are “unknown unknowns” or “black swans” (“a metaphor that describes an event that comes as a surprise, has a major effect, and is often inappropriately rationalized after the fact with the benefit of hindsight.” From Wikipedia. Read Nassim Nicholas Taleb’s book the Black Swan for more on this.).

Normally then, one cannot prepare for these black swans in advance. Other stresses can be predicted and mechanisms should be put in place to minimize the stresses, problems, volumes, etc. To do this, the DS/PV department should stay up to date on corporate, regulatory, research, marketing and other events that will touch upon them. This is broadly described as “DS/PV Intelligence.” This means reading the internet, the trade websites and journals, attending conferences, keeping politically in tune within and outside the company etc.

The DS/PV department should function well in normal times. This should be ascertained by regular internal (and/or external third party) PV audits. Any CAPAs that need to be put in place should be done so and completed rapidly. SOPs should be reviewed and revised as needed. Training should keep everyone up to date.

There should be a business continuity/crisis management SOP that, at the very least, recognizes that crises occur and a mechanism will be invoked, at a moment’s notice, to respond in a rational way. A spreadsheet of key players who can be immediately contacted should be maintained and kept up to date and owned by someone.

As in war, detailed plans may be drawn up in advance, but when the crisis does hit, there is a lot improvisation that will be needed. The best one can do is put all the mechanisms in place to be invoked when the blow does hit. Or to put it in the terms at the beginning of this posting, if you can, do a stress test. Periodically, say yearly or every 6 months, hold a meeting or two with the key stakeholders to anticipate stresses and problems that may occur and outline a response.

Do a thought experiment seeing how the company and the department would react to each of the stresses listed here or other stresses you devise yourself. If the response seems reasonable and doable, fine. If there seem to be gaps, they should be filled.

This list is not meant to be complete. There are many other stresses that can befall the DS/PV folks. If you have any that do not fall into the above categories, by all means drop us a note and add to this list. And if you have any wisdom or advice to add, by all means let us know!




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