Question

If the product is borrowed for immediate patient need, what documentation or proof does DSCSA require my pharmacy to provide?

Answer

The law states that when product changes ownership, compliance documentation must be exchanged. This includes both traditional sales situations - when drugs are bought from a distributor, for instance, or sold for cash to another dispenser – as well as when the product is borrowed or loaned.

One of the key exemptions to this, though, is in cases of “specific patient need”. If a pharmacy or hospital transfers product from their business to an unaffiliated dispenser in order to fill a prescription for an identified patient, the law stipulates that a Transaction History, Information, and Statement (T3) do not need to be provided. The obvious next question for many dispensers, then, is how do we prove it?

The law provides no additional information on if or how you should document a case of specific patient need. Because of that, how you choose to do so becomes more of an operational decision than a compliance one. Even though the law doesn’t mandate that you provide proof, that doesn’t guarantee that a government official won’t ask for details if your facility, or the pharmacy to whom you sent the product, is inspected. From a business or liability perspective, what sort of documentation would you want to have on hand in the event of an inquiry?

Consider noting in your pharmacy system that the product was transferred for an identified patient need; the date of transfer; the dispenser to whom you sent it; and your specific contact at that pharmacy. The dispensing pharmacy may or may not provide you with the name of the patient. If they do, you can notate that in your pharmacy system, as well, since there typically aren’t HIPAA-related concerns around patient data entered in patient-facing systems.

Next week, we may very well answer your DSCSA question! Send it to us at questions@tracelink.com and stay tuned for our next dispenser answer.