Pharmacists should take a second (and third) look before filling prescriptions for large quantities of controlled substances. Recent criminal prosecutions demonstrate that law enforcement officials are now targeting pharmacies that fill scripts for large amounts of controlled substances. Previous investigations have focused on the individuals who abuse controlled substances and the doctors who prescribe those substances. Recent efforts, however, have expanded the scope of these investigations to include pharmacists and pharmacy technicians. One challenge faced by pharmacies involves determining whether scripts are written by doctors with a “legitimate medical purpose” as required by the Controlled Substances Act (CSA). Making this determination may not be as simple as it would seem.
The CSA makes it unlawful, except under certain circumstances, to distribute controlled substances. Physicians, pharmacists, and those assisting them may nevertheless distribute controlled substances so long as the prescriptions are “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.”
The regulations make clear that the responsibility for the proper prescribing and dispensing of controlled substances rests not only with the prescribing practitioner, but also with the pharmacist who fills the prescriptions. Two questions arise: first, what is meant by the phrase “legitimate medical purpose,” and second, when is a practitioner “acting in the usual course of his professional practice”?
For a pharmacist or pharmacy technician, the second question may be easier to answer. Although not defined by statute, a pharmacist acting in the usual course of pharmaceutical practice does so when he or she abides by generally accepted standards of pharmaceutical practice. These standards would include following state rules and regulations governing the operation of the pharmacy and the dispensing of controlled substances.
The more difficult question concerns the meaning of a “legitimate medical purpose.” Take the following example. A customer walks into a pharmacy. The pharmacist knows the customer, having served the customer for many years. The customer presents a script written by an out-of-state physician for a large quantity of controlled substances. The customer claims to suffer from serious back pain (or perhaps cancer). The pharmacist verifies the license of the prescribing physician and even calls the physician’s office to confirm the accuracy of the script. No state law or regulations prohibit the filling of out-of-state scripts. Nothing immediately puts the pharmacist on notice that the script is written for an illegitimate purpose. Filling the script may nevertheless subject the pharmacist to liability under the CSA.
What is a pharmacist to do? Some pharmacies have begun refusing to fill all out-of-state scripts. Others have taken less drastic measures and rely on their own observations in their dealings with customers. Is the script written for an unusually large quantity of controlled substances? Is the customer paying in cash or is the medication covered by insurance? Is the customer requesting refills of the substance before the scheduled refill date? Does the customer appear to suffer from the actual condition which he or she claims? Is there some reason the customer must travel to another state to see a physician for the particular ailment? These questions may help a pharmacist decide whether the script was issued for a legitimate medical purpose.
Of course, making the “legitimate medical purpose” determination is considerably more difficult for pharmacy technicians lacking the skill and training of registered pharmacists. For this reason, pharmacy technicians should never fill a script for a controlled substance without obtaining the approval of the pharmacist-on-duty.
In the end, taking multiple looks at that questionable script may help pharmacists and pharmacy technicians avoid prosecution.
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