¶ … Product Accountability This failure in drug accountability is an issue. One of the purposes of a closeout visit is to determine that all of the investigational product is accounted for, so when ten pills are missing, that means that not all of the product is accounted for. Unused supplies need to be destroyed or returned, and in either case there should be an accounting for that. Whatever happened to these ten pills should have been recorded, and apparently this is not the case, so nobody knows what happened to the pills.

This is as pertains to 21 CFR 312.57, which states that "a sponsor shall maintain adequate records showing the receipt, shipment or other disposition of the investigational drug." Furthermore, 21 CFR 312.59 states that "the sponsor shall assure the return of all unused supplies of the investigational drug from each individual investigator whose participation in the investigation is discontinued or terminated." There are further provisos with respect to the disposition of the drug. This is all part of good clinical practice. The rules regarding the closeout visit, and the accounting of each pill of a drug, are unequivocal. As a result, there is no question that in this instance the ten missing pills are a problem, and there is a responsibility to find out what happened to those pills, why there was no paperwork filed on them, and to determine who bears responsibility for this incident.

There are several actions that could be taken during the trial to reduce the risk of pills going missing. This can only be analyzed in general because...

First, there needs to be records of all pills that are produced, shipped, returned or disposed. Every single pill needs to be accounted for. Training all people who might handle such pills on this point is essential -- they need to understand the risks and consequences of failing to account for each pill. There also needs to be an organizational culture that ensures everybody bears responsibility for any missing pills. Such a culture encourages employees to be accountable to each other, as well as to the supervisors and regulators, and it is less likely that pills will go missing where such a culture exists.
There are also several functional steps that can reduce the risk of pills going missing. All handling of drugs should be done by designated individuals who have specifically been trained on drug handling, and on adequate record-keeping. This will ensure that there are records kept for all handling and movements of these drugs.

Furthermore, the records themselves need to be of adequate standard. The drugs need to be assigned batch numbers, serial numbers, and records need to be kept with dates, quantities and individuals responsible for each handling of the drug. Essentially, there should be a paper trail for each pill that shows when, where and by whom it was handled. If there are no gaps, this makes it less likely that there is the possibility of drugs going missing.

It is also important to ensure that there are best practices in storage at all…