For those of you who may have missed this (like I did), over a year ago the Office of the Inspector General (OIG) performed a
study on the ability of the current compliance mechanisms for the Drug Supply Chain Security Act by tracing the movement of 44 drug products they characterized as high-risk "billed to Medicare Part D by high-risk dispensers" by reviewing tracing documents to "determine whether the information necessary to trace drugs was present and accurate". I recommend the document to your review. It is most enlightening.
The observations were interesting:
- Ownership was traceable for 37 of the 44 selected drug products - the remaining 7 were not traceable because (a) data elements were missing or mismatched - including being missing from the manufacturer's documents, and (b) because one wholesaler refused to provide drug tracing information.
- Of the 37 traceable drug products, 23 had missing or mismatched data including strength, dosage form, and transaction date.
- Physical movement of drugs through the supply chain could not be traced because physical storage and shipping information is not required by DSCSA. The report asserts "Knowing a drug's physical movement through the supply chain expedites investigations by FDA, State and other investigators and helps them ensure that adulterated or mishandled drug products do not end up in the drug supply."(1) It also cites FDA testimony before congress before the passage of DSCSA describing the effort the FDA must expend to recreate the physical movement path which "... delays these drugs from being removed from the supply chain".
- As DSCSA is currently written, third party logistics providers are not required to participate in DSCSA documentation because they do not take ownership of the drugs that they handle. Of the 44 drug products being traced, 15 were stored and handled by third-party logistics providers.
The report provides three conclusions/recommendations:
- FDA should follow up with the one wholesaler who did not provide tracing information to OIG.
- FDA should provide educational outreach to ensure that trading partners are aware of their responsibilities to supply complete and accurate information to their trading partners.
- FDA should seek legislative authority to require traceability information including the physical path a drug product took through the supply chain.
The report includes FDA's response to these recommendations; the FDA concurred with all three recommendations
I believe this should be of interest to our practice because these omissions may require our practice to perform extra steps to verify the missing information, and may compromise our ability to actually perform verifications required of us as dispensers under DSCSA.
What do you think?
The ideas expressed herein are my own, and are not necessarily those of ASHP, or my employer, BD.
Dennis A. Tribble, PharmD, FASHP
Ormond Beach, FL
datdoc@aol.com
[1] Ownership – But Not Physical Movement – of Selected Drugs Can Be Traced Through the Supply Chain US Department of Health and Human Services, Office of Inspector General – Report OEI-15-17-00460 available at https://oig.hhs.gov/oei/reports/oei-05-17-00460.asp viewed 5/18/2021