ASHP Advises FDA On Drug Supply Systems

Main Category: Pharmacy / Pharmacist
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 22 May 2008 - 5:00 PDT

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ASHP offered its perspective to the Food and Drug Administration (FDA) on two important issues related to protecting the integrity of the prescription drug supply chain against counterfeit and adulterated medications.

The FDA sought comments on standardizing systems for tracing drugs as well as effective technologies that should be used for this purpose.

Standardizing Systems

ASHP expressed concern about current lack of interoperability of all data that identifies drug products. The Society urged the agency to adopt a universal, standard numerical identifier to properly verify medications in the distribution system and enhance patient safety. The identifier should be unique, permanent, readable by humans and machines, readily updated when drugs enter the market, and administered by a central authority to prevent duplication.

ASHP cited members' struggles with one identifier, the National Drug Code, when used with barcode point-of-care, clinical information, and financial systems. The code numbers aren't descriptive enough, and require significant public infrastructure for reasonable clinical and research purposes, ASHP says.

Once final, the standards could be adopted by state boards of pharmacies to require pedigree processes in which pharmacists and pharmacy technicians would be required to assess the integrity of medications. The standard numerical identifier for tracing drugs in the supply chain is to be established by 2010.

Appropriate Technologies

ASHP recommended effective technologies that the FDA should consider to trace medications, including radiofrequency identification systems. ASHP also pointed out the necessity that all electronic systems in the medication-use process use one unique numerical identifier to ensure patient safety and system interoperability. The Society also noted that all prescription drug-related communications should be encrypted so drugs aren't compromised by a source outside the supply chain.

Click here for ASHP's comments on the standards.
Click here for ASHP's comment on the technologies.

American Society of Health-System Pharmacists