Study samples expiration dating
The IRB reserves the right to make exceptions to this policy, and inclusion/exclusion of any research project under this procedure will be at the IRB’s discretion.During the extended approval period, principal investigators retain responsibility for all regulatory requirements including submission of modifications, reportable events, suspension and/or terminations.
Of the 12,581 drug packages and boxes we inventoried in 10 sample closets, 14% of medications were expired.
Sample closets varied widely in their organization; the range of expired medications in the 10 closets was 0% to 28%.
Members of the Regulatory Affairs Division will periodically monitor a random sample of studies to confirm continued eligibility for the three year approval period.
Studies found to not meet the criteria will be subject to annual review.
In offices that had few expired medications, we were unable to quantify the number of medicines removed before our inventory.
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It is likely that our tally underestimates medication waste because some practices dispose of medications on a regular basis.We hypothesize that there are 2 main reasons sample closets contain substantial numbers of expired medications.First, the presence of expired medications may be because of the absence of a reliable inventory system in most practices.Of these, only aspirin and amphetamine had deteriorated below generally recognized minimum acceptable potency.One other, phenacetin, showed a concentration of less than 60% when tested in one medication, but 110% in another.The group tested eight-decades-old prescription medications unearthed in a retail pharmacy and found that 12 of the 14, or 86%, of the compounds tested in the drugs retained at least 90% of their potency 28 to 40 years after their expiration dates.1 Those results came as no surprise to those involved in the Do D/U. Food and Drug Administration Shelf Life Extension Program (SLEP), which has been testing pharmaceuticals for more than 25 years to estimate when drugs actually will lose their potency.The medications tested by Cantrell and colleagues contained several common ingredients.Two closets had no expired medications on the day we inventoried.In this study, 14% of sample medications were expired.When continuing review occurs annually and the IRB performs continuing review within 30 days before the IRB approval period expires, the IRB may retain the anniversary date as the date by which the continuing review must occur.Certain types of non-exempt research may be granted a three year approval.