Let’s test your knowledge of prescribing controlled substances.
A specialist practicing on the west coast makes frequent visits to her country of origin – Brazil. During such visits, she often performs charity work, diagnosing and treating patients. She keeps records of the visits.
On one such trip to Brazil, the specialist diagnosed an elderly woman with severe osteoarthritis. The specialist prescribed typical treatments – but, over time, such treatments did not help.
The patient’s son is a doctor living in the same community as the specialist. He said his mother was getting worse, and he wondered whether the specialist would prescribe something stronger.
Sure. As luck would have it, the son was traveling to Brazil to visit his mother. The specialist handed the son a prescription (in the name of the patient) for Percocet, a controlled substance. The son filled the prescription, intending to bring the medicine to his mother on his next trip, scheduled a few days later.
Next, the DEA paid a visit to the specialist. They explained that in spite of acting as a Good Samaritan, she broke the law. They continued that it is illegal to prescribe controlled substances to a patient in another country, if that prescription will be filled by a surrogate in the US. The penalty – relinquish your license to prescribe Schedule 2 drugs for a long time. This penalty was negotiated down to a shorter time frame. The “negotiation” process was hardball. For two hours the DEA agent remained in the specialist’s office. The specialist felt pressured to sign a document peppered with legalese with no lawyer present.
How many of you are familiar with these rules? The specialist was not running a pill mill. She filled out one prescription for an elderly woman. We used this case to query the DEA about their policies on prescribing to patients overseas. It’s relevant because we live in a global economy. Patients from around the world come to the US. And doctors go overseas to treat patients. Illness, treatment, and charity often do not observe geopolitical boundaries.
Barbara Carreno, Public Affairs Officer for the DEA recently gave us the following clarification.
The CSA [Controlled Substances Act] and its implementing regulations do not apply to practitioners writing prescriptions for Schedule II medications for residents of other countries while they (the residents) are in their country; such activity is outside our purview. The law of the recipient’s country applies to the patient there, not our law. Thus, if a doctor wants to fax a script for a Schedule II medication to someone in another country that allows a script from a foreign doctor to be filled, the doctor can do so. But the physician cannot give that script to a third party, even another doctor, to fill and to carry to the patient in another country, because 21 CFR 1301.26(b)(1) specifies that controlled substances medication carried out of the country must be for the personal use of the person carrying it or an animal traveling with that person.
So, the specialist was at the mercy of the son, who filled the prescription. Had the son merely served as a conduit for the paper, all would have been well.
Another DEA representative explained further:
The prescription that the doctor writes is supposed to be given to the patient not to a family member … unless the family member is in the doctor’s office with the patient. The liability comes from when the doctor trusts the son to give it to his mother. Anything could happen between giving it to his son and giving it to his mother. Besides the fact he can’t take controlled substances out of the country in the name of his mother.
Finally, we asked about whether a family member can pick up a prescription for a patient. In this scenario, everyone is in the U.S. and the patient may be too sick or unable to drive to the pharmacy. Here, the DEA said that although the doctor must take pains to make sure the filled-prescription goes to the actual patient, they do make accommodations for family members picking up prescriptions for controlled substances at a US pharmacy for use by a patient in the U.S.
Putting this all together, to us, this seems like Russian Rx Roulette. Write a script for your patient residing in another country and see where it’s filled–in Brazil you’re safe–in the U.S. you lose your DEA license. Unless the patient actually is in the U.S. What do you think of this policy? Shouldn’t there be an easier way to know the answer rather than a Talmudic parsing of 21 CFR 1301.26(b)(1)?