Tackle Tampering Now

On its Web site, FDA lists several “opportunities for collaboration” under its Safe Use Initiative. These include potential changes to consumer medication information, over-the-counter drug dosing tools, and medication in vials, among other issues. But after several recent instances of drug tampering by healthcare workers, I’d like to suggest another opportunity: wider use of tamper-evident packaging or labeling for prescription drugs.

In February, a former scrub technician was sentenced to 30 years in federal prison for crimes including tampering with syringes and exposing patients to blood-borne pathogens. In July 2009, we reported in our PMP News Insider blog that Kristen Parker, a former Rose Medical Center surgery scrub technician, was “accused of stealing fentanyl from surgery prep tables, injecting herself with the syringe containing the narcotic, filling the used syringe with saline, and putting it back on the surgical tray.” Parker was infected with Hepatitis C, and at least 35 patients were identified as matching the genotype associated with Parker, according to her September 2009 plea agreement. After sentencing, U.S. Attorney David Gaouette in Colorado said that the “sentence should truly send a message that there are very serious consequences for these types of actions.”

Will 30 years be enough of a deterrent? I sincerely hope so, but I also wonder whether additional steps should now be taken to ensure that such tampering does not go unnoticed before other patients are infected.

In a later blog post, we reported that tamper-evident packaging is not required for prescription drugs, which would include those packaged in prefilled syringes.

But should it be for certain high-risk drugs?

Tamper evidence could give both patients and healthcare workers peace of mind. As Parker’s September 2009 plea agreement and statement of facts relevant to sentencing states, “as a scrub tech, the defendant was a person in a position of trust relative to the hospital and its patients.” These patients in particular “had a diminished capacity due to their medical condition.” The number of potentially exposed patients was significant. According to the statement of facts, nearly 6000 patients were contacted by the two healthcare facilities that employed Parker.

FDA may be reluctant to issue sweeping rules for instituting prescription drug tamper evidence. And it may need legislation to do so. But for now, it could certainly begin collaborating with industry on encouraging voluntary efforts. I also wonder whether FDA could take action under its draft guidance for Risk Evaluation and Mitigation Strategies (REMS).

Waiting for legislation or FDA action may not be prudent. A Google search shows that medical malpractice lawyers around the country have been blogging about the Parker case and others.

Can you employ packaging and labeling technologies to help alert healthcare practitioners to drug tampering? Hospitals may soon demand such assistance.

Daphne Allen, Editor
daphne.allen@cancom.com