What Pharmacists Need to Know About Drug Supply Chain Law

The federal Drug Quality and Security Act (DQSA) was signed into law in 2013 with the expressed intent to hold pharmacy stakeholders accountable for identifying suspect drug products and reporting related issues.

The supply chain security and compounding components of this law were key points of discussion at the American Society of Health-System Pharmacists (ASHP) 2015 Summer Meetings and Exposition in Denver.

During a policy session, ASHP director of federal regulatory affairs Chris Topoleski told attendees that the DQSA creates a framework through which “trading partners” defined as drug manufacturers, repackagers, wholesale distributors, and dispensers—including both retail and hospital pharmacies—can “identify suspected products and report illegitimate products.”

Under the law, suspect products are those believed to be:

1) Counterfeit, diverted, or stolen

2) Intentionally adulterated

3) Subject of a fraudulent transaction

4) Otherwise unfit for distribution

Under the DQSA’s track-and-trace portion, the Drug Supply Chain Security Act (DSCSA), pharmacies were required to have verification systems in place to handle suspect or illegitimate products by January 1, 2015. By July 1, they must be equipped to produce lot-level product tracing information, such as transaction information and history, for a 6-year period.

“And by 2023,” Topoleski added, “everything needs to be in place in terms of interoperability” with respect to DSCSA monitoring system requirements.

To accomplish this, Topoleski advised attendees to contact their wholesale distributor and ask questions like “How are [you] maintaining product tracking information?” and “Is software available to allow access to track-and-trace product data?”

In an exclusive interview with Pharmacy Times, Institute for Safe Medication Practices (ISMP) president Michael R. Cohen, RPh, MS, ScD (hon.), DPS (hon.), FASHP, described situations in which a supply chain error caused “real tragedy.”

“We’ve had several situations in which demonstration products were given to patients,” Cohen explained. This January, “what looked like 0.9% sodium chloride in IV bags was actually a demonstration product—and it was never sterilized,” he said.

Cohen said the ISMP knows of at least 40 patients who received this unsterile demonstration product.

“Of those patients, 26 were hospitalized, and 2 of them actually died,” he sympathized.

Cohen said this scenario and others like it highlight that the potential for product error is “something pharmacists need to be paying attention to in all fields, at all times, no matter what.”

With respect to compounded drugs, in particular, Topoleski told Pharmacy Times in an exclusive interview that pharmacists should “take a critical look at in-house processes. Really examine what they’re doing to compounded medicine within the hospital or health-system to make sure that it meets all levels of…compliance.”

When health-systems outsource their compounding operations, they should “really critically look at their vendors,” Topoleski advised. “You really need to do your due diligence.”

One of the ways to do so is purchasing products from 503B outsourcing facilities, which are “registered voluntarily with the FDA and are inspected by the FDA,” Topoleski explained.

He also noted ASHP provides a contractor assessment tool that helps dispensers determine whether or not they can feel confident in working with a contractor on compounding sterile medications.