On May 8th, 2018, the FDA’s Center for Drug Evaluation and Research (CDER) sponsored a webinar titled: “Protecting Patients – Pharmacist Requirements Under the Drug Supply Chain Security Act (DSCSA).” This webinar was co-presented by Dr. Ilisa Bernstein, Deputy Director of the Office of Drug Compliance for CDER and Dr. Connie Jung, Senior Advisor for Policy in the Office of Drug Security, Integrity, and Response in CDER’s Office of Compliance. The webinar focused on the steps pharmacists need to take to protect patients within the context of DSCSA. To date, much of the FDA’s outreach surrounding DSCSA has focused on drug manufacturer and wholesaler requirements; this webinar was one of their first public outreach activities focused on dispensers (pharmacists). The pharmacy community has asked FDA in public meetings, and a recent report by the OIG has recommended, that FDA spend more time clarifying and explaining Dispenser responsibilities under the Act.
Although the US Drug Supply Chain is one of the safest in the world, there continues to be cases where counterfeit drugs reach patients. Rather than leave you to sift through the broad framework of the webinar, we break down the three primary takeaways the FDA wanted dispensers to focus on: confirm the entities you do business with are registered and licensed; receive, store and provide product tracing documentation; investigate and properly handle suspect and illegitimate drugs.
- Confirm that the entities you do business with are registered and licensed
Most drug purchases in the United States are processed through the nation’s three largest wholesale distributors. However, as drug product becomes more specialized and direct shipments more frequent, proper vetting of new suppliers and distributors becomes more and more important. The FDA has made available several online tools for pharmacists to perform supplier verification. Click here for FDA manufacturer certifications http://bit.ly/FDA_DECRS , here for FDA distributor certifications http://bit.ly/FDA_WDDL , and here for The Association of Boards of Pharmacy site on wholesaler certification https://nabp.pharmacy/programs/vawd/vawd-accredited-facilities/.
- Receive store and provide product tracing documentation
The second takeaway the FDA emphasized for pharmacists focused on receiving, storing and providing product tracing information at a manufacturing lot level. Tracing transactions from a manufacturer to the pharmacy facility for drug pedigree data is known as collecting T3 information. T3 data is comprised of: the transaction information (TI), transaction history (TH) and a transaction statement (TS). The DSCSA requires that product should not be accepted unless the T3 information is provided and verified. Additionally, pharmacists are also responsible for maintaining six years of product tracing information (T3) beginning in 2015. Finally, pharmacists need to be able to respond to a request by the Agency within two days (48 hours) of an inquiry during an investigation or recall.
- Investigate and properly handle suspect and illegitimate drugs
The final takeaway the FDA wanted to emphasize concerns handling a drug product that is potentially suspect or illegitimate. FDA defines “suspect” as having a reason to believe that the product is counterfeit, diverted, stolen, subject to a fraudulent transaction, intentionally adulterated or otherwise not fit for use. FDA’s definition of “illegitimate” involves the same criteria as mentioned above but instead of having, “A Reason to Believe” you instead have, “Credible Evidence” that the product is suspect.
The remediation of identification of a suspect or illegitimate drug product is the same. If a pharmacist identifies that a drug product is suspect or illegitimate they should investigate, quarantine and report it to FDA using FDA form 3911 within 24 hours of discovering the suspect or illegitimate product. The following is a link to FDA’s Form 3911. http://bit.ly/FDAForm3911
Pharmacies are the last line of defense to ensure the US Drug Supply Chain is safe and secure. Dr. Scott Gottlieb, the current FDA commissioner, recently made public statements that DSCSA is an Agency priority. The FDA’s final recommendation for pharmacists is to be vigilant and diligent in protecting patients in their care.
A replay of this webinar is available on FDA’s website: http://bit.ly/FDADrugTopic582018
Join RXTransparent on June 27th for a free webinar reviewing these three points and recent enhancements we have made to the RXTransparent platform based on FDA’s recommendations from their webinar.
DSCSA Regulatory Update
June 27th @ 2 P.M. Eastern Time