Three months into the FDA-granted one-year stabilization period for drug supply chain stakeholders to comply with the Drug Supply Chain Security Act (DSCSA), implementation by dispensers (i.e., pharmacies) is off to a slow start, but interest in implementing is high. A new American Pharmacists Association (APhA) survey of pharmacists reveals that 86% of the 81 respondents are aware of the DSCSA requirements; however, only 14% of the dispensers report having fully implemented and stabilized systems and processes for the newly required enhanced traceability of prescription drugs in the supply chain. Almost 50% of dispensers report that they are working on implementation with their wholesaler or third-party vendor. A majority of the respondents were from independent community pharmacies.
“Although implementation of the new drug security requirements is progressing, pharmacies and pharmacists are focusing on providing patient care amid the economic crisis facing pharmacies across the country,” said Ilisa Bernstein, PharmD, JD, FAPhA, APhA’s Senior Vice President for Practice, Policy, and Partnerships.
Over half of the respondent independent dispensers identified cost, time to implement, and understanding what needs to be implemented as significant challenges. This is not surprising given that pharmacies across the country are dealing with significant economic challenges due to new Centers for Medicare & Medicaid Services (CMS) regulatory requirements and pharmacy benefit manager (PBM) business practices that went into effect on January 1, 2024. These challenges are so great that pharmacies are closing at a disheartening rate throughout the country, and it is a struggle to keep pharmacy doors open.
APhA shared these findings with FDA in a letter submitted in response to a recent FDA request for information related to implementation of new DSCSA requirements. APhA noted that universal interoperability and stabilization in the dispenser sector will only be realized after the upstream supply chain has implemented and stabilized their connections and systems, which is still a work in progress.
“We share FDA’s goal of improving the safety and security of the drug supply chain, and call on FDA to work more closely with stakeholders and bolster and intensify the level of outreach and education for drug supply chain interoperability to be stabilized by November 27, 2024,” said Bernstein. APhA recommended that FDA focus on phased targeted outreach, clear and concise messaging, increased outreach to boards of pharmacy, and heightened two-way communication with stakeholders.
APhA’s survey was conducted January 25, 2024, to February 5, 2024 and the letter describing the results can be found here.
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