The law requires pharmacists to ensure that prescriptions for controlled substances are legitimate and for a true medical purpose.
Recent news regarding the suspension of pharmacists reminded me of Title 21 of the Code of Federal Regulations Part 1306 (see box), the very important regulation regarding a pharmacist’s corresponding responsibility when filling prescriptions for controlled substances.
The laws and regulations that cover this provide for at least 2 gatekeepers. First, the prescriber has guidelines regarding prescribing a controlled substance. It must be issued for a legitimate medical purpose by a practitioner acting in the usual course of his or her professional practice. In other words, the prescription must be written for solid medical reasons that the practitioner could adequately defend if needed.
The second gatekeeper is the registered pharmacist. Assuming that a pharmacist is filling the prescription and the prescriber is not dispensing the drugs himself or herself, the pharmacist has the corresponding responsibility to make sure the prescription is valid and for a true medical purpose. This may mean a phone call to the prescriber to discuss any concerns that a pharmacist has about the legitimacy of the written prescription.
If the communication with the prescriber quells all the pharmacist’s concerns, then filling the prescription is usually appropriate. However, in some cases, the pharmacist may know of patient issues that could include a known drug addiction, altering or changing prescriptions, doctor shopping, and even drug trafficking. Of course, the prescriber should be advised of any of these.
At times, even after a pharmacist has explained any concerns, the prescriber still wants to fill the prescription. Does this relieve the pharmacist of the corresponding responsibility? If the pharmacist fills the prescription, no matter how egregious the circumstances, is that pharmacist off the hook?
In my experience, absolutely not. The power of refusing to fill a controlled substance prescription is given to the pharmacist for a very good reason, and that is to be the second gatekeeper and help ensure that the prescription is for a legitimate medical purpose.
Pharmacies have sometimes decided not to fill any prescriptions for a certain prescriber and/or an entire medical practice. The reason is typically strong suspicion of engaging in an active pill mill or other illegal activity in the prescriber’s facility. This is usually based on a considerable amount of evidence that past prescriptions were not legitimate.
If pharmacists fill orders that they suspect are not legitimate, they open themselves up to not only possible criminal and regulatory charges but also civil recourse by the families of addicts who overdose and die after the drugs were dispensed (see page 60 for details on a related case).
Pharmacists can certainly be duped, as can prescribers. The individuals who scam the prescription drug systems are very good at what they do, and a pharmacist may certainly be scammed on occasion. Pharmacists should do due diligence when a prescription does not seem right to avoid filling bogus prescriptions and safeguard their pharmacy licenses.
Cmdr. John Burke is a 40-year veteran of law enforcement, the past president of the National Association of Drug Diversion Investigators, and the president and cofounder of the International Health Facility Diversion Association.