Can Tamper Evidence Reduce Risk?

Recent cases of syringe tampering have made me wonder: Should prefilled syringes carry tamper evidence as part of a risk-mitigation strategy?

Tamper-evident packaging is not required for prescription drugs. According to an FDA spokesperson, “the regulation that requires tamper-evident packaging (21 CFR 211.132) applies only to over-the-counter drugs, not prescription drugs.” Explained another: “The intent of tamper-evident packaging regulations is to assure the integrity, safety, and efficacy of OTC drugs that are at risk for tampering because of public access and limited security while held for retail sale. In contrast, prescription drugs are controlled by licensed healthcare practitioners and are therefore not required to be packaged in tamper-evident packaging.”

The public isn’t the only source of risk, however. Sadly, there have a been a few cases in which “licensed healthcare practitioners” have tampered with prescription drugs. Couldn’t tamper evidence protect patients by alerting the administering healthcare practitioner to suspicious activity?

I wonder whether FDA may not arrive at this conclusion as it implements its Safe Use Initiative. In a November 4 document, FDA states that “intentional misuse and abuse of medications, as well as attempts at self-harm, are significant sources of drug-related risks in the United States. Although such acts are not 100 percent preventable, concerted risk management efforts across stakeholder communities could help reduce these risks.”

FDA says it can now better address such problems thanks to the FDA Ammendments Act of 2007 (FDAAA). FDA can now require Risk Evaluation and Mitigation Strategies (REMS) for drugs with particular safety issues. So is syringe tampering enough of a risk? FDA itself says that intentional misuse is a significant problem.

Could one REMS be use of tamper-evidence unit packaging? Or should use of tamper evidence remain voluntary, employed only when the drug manufacturer decides the benefit is worth the added investment?

I’d love your input!

Daphne Allen