Editorial: Should Patients Have the Ability to Authenticate Drugs?
Reading about the case of Maryland pharmacist Pamela Arrey, I was intrigued by a statement made by U.S. Attorney Rod J. Rosenstein of the U.S. Department of Justice (DoJ). I could be reading more into it than I should, but I find his statement noteworthy nonetheless.
The DoJ reported that Arrey was “sentenced to 57 months in prison followed by three years of supervised release for health care fraud, aggravated identity theft, and conspiracy to misbrand pharmaceuticals,” in a press release FDA posted to its site early this month (www.fda.gov/ICECI/CriminalInvestigations/UCM217938).
Much of Arrey’s scheme seems to involve filling prescriptions that, while authorized by doctors, were not requested by nor dispensed to customers. She then sought reimbursement through benefit programs using patients’ personal identifying information, claimed the press release.
In addition, according to the DoJ, Arrey “admitted that she filled prescription orders for pharmacy customers with misbranded pharmaceuticals, including Metformin, an oral diabetes medication used to help control blood sugar levels, and Gabapentin, an anti-epileptic medication used to treat seizures.”
Here is the quote that caught my eye: “When drugs are taken out of their original containers and relabeled, customers cannot verify their authenticity and expiration date,” said Rosenstein in the press release. “The sentence imposed on Ms. Arrey holds her accountable for committing fraud and putting at risk the health of her customers.”
Drugs are routinely removed from their original containers and repackaged into pharmacy vials. While no one would describe typical repackaging as fraudulent, it certainly does not give customers the ability to verify product authenticity and expiration dates themselves.
But should they be able to do so? I have argued before that manufacturer-provided tamper-evident unit-of-use packaging (either bottles or blisters) can provide reasonable assurance that their prescriptions have not been handled (or mishandled) by multiple parties before reaching their medicine cabinets.
Some readers, however, have told me that patients cannot be expected to authenticate products because they could be easily fooled by counterfeit packaging. Pharmacists should be the gatekeepers, and our faith in their role shouldn’t be shaken by a few rogue elements.
What do you think?