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
- SOP & Work Instruction Review: All companies must have written SOPs as part of their Quality Systems. If your company doesn’t have any or if there are some areas that need SOPs or Work Instructions (or both), now is the time to write them.It is also a good time to review the current procedural documents to see which ones need updating. Most companies have a procedure requiring formal review and updating where necessary. This is usually yearly or at most every two years. It is definitely worth reviewing the procedural documents in place and speaking to the teams and personnel who work with the SOPS and WIs to see if they feel the documents are adequate, up to date and reflect the reality of how things are done. If feedback suggests that some of the documents need to be redone, now is the time to either revise the documents or to be sure that they get on the schedule for review and rewriting.Procedural documents are always a key focus of an audit or governmental inspection. They really must be up to date and defensible during the inspection. Inadequate documents can lead to major or even critical inspection findings.
- Audits, Inspections and CAPAs: As noted above, although your company’s auditors and health agencies’ personnel may also take summer vacations, audits and inspections do not stop and the possibility of a PV inspection (FDA inspections are unannounced in the US usually) always remains. You should be sure you will be able to handle the inspection with the personnel on hand. If you have to call someone back from vacation (ugh) or at least be able to do telephone or webinar/Facetime communication, this should be possible if you can immediately locate everyone. A spreadsheet with everyone’s schedule and contact information should be kept.Be sure that any open Corrective Action, Preventive Action plans (CAPAs) are known and being performed. This work does not stop during the summer if it has been promised to the FDA or another agency unless a “timeout” is built into the CAPA schedule. In the same vein, it is worth rereading your SOP on audits to make sure it is still correct and ready to invoke upon the arrival of the inspectors.
- Expected Launches or Volume Increases: This actually should be examined in the months before summer arrives. By this, we mean that if FDA or EMA approval is expected in July (e.g. the NDA was submitted in December to get it in before the end of the previous year) then approval and launch may be expected in June or July. Companies will often want to launch immediately. The well-known Weber effect of increased AEs/SAEs during and for the several months after a new launch is to be expected. So you may see an increase in SAEs just when the staff is at its lowest. This may be predictable and the appropriate arrangements need to be put in place.If your drugs are seasonal and you have expected volume increases during the summer, this too should be built into PV planning.
- Hiring New Personnel: Although hiring (and I suppose layoffs and firing) can occur at any time, usually things slow down during the summer. The procedure for evaluating candidates for PV positions, usually involves interviews with up to a dozen people over two or even three visits to the prospective employer. It is usually difficult, if not impossible, to get everyone in place for the interviews if 4 or 6 people need to interview the candidate during the visit. These interviews may be deferred till September or later.So if you are looking to hire (or are looking to change jobs) expect things to slow down during the summer. You may not be able to get new full time personnel or even temps and contractors during the summer.If you’re in job-hunting mode during the summer, it might be a good time also to update your CV and resumé. You may also want to update your LinkedIn profile and memberships in groups as well as any other social media sites you use.
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.