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Summer Pharmacovigilance

Now what in heaven’s name do we mean by “summer pharmacovigilance”?

By this I am referring to July and August (in the northern hemisphere) when things often slow down, the weather heats up and folks go on vacation. Sometimes, though not always, drug safety and pharmacovigilance efforts slow down too.

Why is this?

Many reasons. Sometimes there is less drug use during the summer and thus fewer reported AEs; there may be fewer new launches; patients and health care professionals are on vacation and may not report as many AEs; seasonal drug use may decrease (e.g. flu products) though others may increase (sun prevention products, dehydration products). Management may also be on vacation so that the demanding boss may trouble you less – though with 24/7 iPhones and such, that may not always happen.  FDA and other health agencies also may take their vacations and slow down on audits – though I once had an audit that began July 3 and another that began the Friday before Labor Day weekend…

So there are several things to think about as the summer slow season rolls around that you may want to consider doing if you have a lighter load or even some free time (yes, I hear the skeptical comments out there…).  Some relate to operational or “housekeeping” items whereas others include review of various medical or signaling issues and other direct safety related items.

Operational & Housekeeping

Unfortunately, drug safety crises can occur anytime including the summer.  Sometimes they pop up suddenly but very often they build up slowly reaching a crescendo when action must be taken.  This can occur in the summer and I have personally experienced several that were very difficult to manage because the key personnel (including senior management) were not available.  Note also that lawsuits and class action suits may be filed anytime.  The lawyers may try to file when the company is less able to mobilize and rapidly respond.  On-going lawsuits may have court dates or depositions also scheduled for the summer.

There is, of course, no way to predict this so all that one can do is to be sure you are able to mobilize when necessary.  The spreadsheet with personnel, schedules and contact information must be kept up to date.

Medical Issues and Signaling

Summer may be the ideal time to review the ongoing signals.  Usually the key signals are well-followed but the less critical or lower priority signals often get put aside for review “at a later date”.  The summer may be a fine later date.

PSURs, DSURs and Other Periodic Reports

There is really no excuse to be caught unprepared during the summer for scheduled periodic reports.  These dates are known well in advance, usually at the time of NDA/MA approval, and the procedures and personnel should be available to ensure that the reports are done correctly and submitted on time.

Medical Literature Review

Again, another scheduled process that should not surprise. Whether your requirements are for weekly review of marketed drugs (in the EU) or less frequently, this should be a smooth running procedure that continues year round.  If not, fix it during the summer.


Many companies now out-source PV functions.  It is always wise, particularly as part of the required Quality Management System, to track your vendors and out-source companies to be sure that the work is done correctly and on time.  This continues during the summer when the vendors and out-sourcers are on vacation too. Keep in mind that in Europe the tradition of August vacations often leaves skeletal staff at many companies and institutions. This can make case follow up and other required functions hard to do during August. So pay attention during the summer.

Planning for Fall and Winter

Are there any items such as expected launches, arrival of new products, mergers/acquisitions, interactions with partners or other companies for joint PV handling or clinical trial safety, new regulations going into effect (e.g. new EU PV module updates) that will pick up in September or beyond?  If there is any planning that can be done now, it would be a good idea to start.


If you are involved in the budgeting process or handle spending or payments, it is a good idea to see what is due to be paid or disbursed during the summer.  Sometimes you may need a little more time to get vendors paid if the finance folks are also on vacation.

Find out when your fiscal year ends and when budgets are due.  A not uncommon phenomenon is for your finance folks to call you about 6 or 8 weeks before the fiscal year ends telling you to spend all your allotted funds or you may lose them next year!  If this is due to occur in the summer, you may have trouble getting an invoice from the vendor quickly enough to have the payment issued before the fiscal year ends.  Usually finance wants weeks to a couple of months notice to cut a check for payment (no one is ever in hurry to pay bills nowadays).

So these are a few suggestions for those of you who are lucky enough to have some free time during the summer. I realize that many, if not most, folks actually don’t have more free time as organizations become leaner.



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