From an FDA Perspective: The US Drug Supply Chain and Patient Safety

On the website of the U.S. Food and Drug Administration, Ilisa Bernstein, Deputy Director of FDA's Center for Drug Evaluation and Research's Office of Compliance, shares her thoughts on the important role drug supply chain integrity plays in patient safety and quality care. Ilisa Bernstein is focusing on three key areas:

1.) Protecting the drug supply chain

With the Drug Supply Chain Security Act (DSCSA) and the related implementation plan, new requirements were defined in the USA which aim at improving the traceability of prescription drugs within the supply chain.

The DSCSA is focussing on each step in the supply chain, tracking the different stages on the way to the pharmacist.

Under the DSCSA, doctors will be are required to purchase their prescription drugs only from authorized trading partners licensed by or registered with the state or federal government.

When products occur from outside the legitimate supply chain, FDA will issue letters to doctors informing them that they may have obtained counterfeit or unapproved drugs.

2.) Purchasing decisions and patient health

Ilisa Bernstein  says that she has "seen a growing trend of health care professionals and medical practice administrators who purchase prescription drugs from rogue wholesale drug distributors outside of the legitimate supply chain."

Drugs sold by rogue distributors may be counterfeit, adulterated or may not have been evaluated by FDA for safety and effectiveness. Because FDA has not evaluated these products, there is no way of knowing if these drugs were made using quality manufacturing practices, contain harmful ingredients, or if they were stored under proper conditions.  For these reasons and more, it is important that health care professionals know the source of their drugs.

3.) Buyer beware

In this context, she emphasizes "if an offer sounds too good to be true - it probably is. And that "deep discounts may indicate that the products are stolen, counterfeit, or unapproved".

To be on the safe side, doctors should ensure they are receiving FDA-approved prescription drugs. After being received, checks of packaging, labels and safety information should be performed.

She also recommends listening closely to patient feedback. "If several patients report that they are experiencing a new side effect or lack of therapeutic effect from the same product, consider that the drug may be substandard or counterfeit. Health care professionals and patients should report adverse events related to the use of a suspect product and drug quality issues to FDA's MedWatch Safety Information and Adverse Event Reporting Program."

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