Natalia Mazina, Emily Do, Eman Kirolos
This year’s American Society for Pharmacy Law (ASPL) conference was as always full of opportunities to connect with pharmacy leaders, superb lawyers, and government representatives. The lineup of presentations featured a range of topics from the key Supreme Court decisions impacting pharmacies to animal drug compounding (with many more in between). A few sessions were focused on dispensing and handling controlled substances. While the most recent wave of increased DEA audits and enforcement actions has passed (or at least it seems so), this topic is as relevant today as ever.
In fact, the day after the conference, I received an email announcing an indictment of a man who purchased cocaine and fentanyl for his two girlfriends while they were out in San Francisco. One of the women died due to the interaction between the two substances, while the other woman is still hospitalized. These cases are still happening on a daily basis and while this specific situation did not involve a pharmacy, purchasing illegal substances online or on the streets still kills people.
One of the presentation at the ASPL conference focused on DEA’s efforts to curb illegal distribution of controlled substances. Joel A. Ferre (Assistant United States Attorney, District of Utah) discussed pharmacy enforcement cases. Although Mr. Ferre had explained that intent or “knowingly” requirement must be present, my firm had several cases where the DEA had lowered the threshold of what constitutes “knowingly” dispensing controlled substances in violation of the Controlled Substances Act (CSA). Dispensing without resolving (and documenting) all the red flags was enough for the DEA to commence administrative and civil actions. For example, in one of the cases, we presented ample evidence that the dispensing pharmacist personally knew his patients (it was a rural community), their diagnoses, and discussed treatment plans with the prescribers. Nevertheless, the DEA imposed a very large monetary penalty because the patients were taking “suspicious” combinations of controlled substances, which the pharmacist should have resolved with prescribers and properly documented reasons for these combinations.
A good resource, mentioned during the presentation, is the “Pharmacist’s guide to Prescription Fraud,” available at https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-002R1)(EO-DEA009R1)_RPH_Guide_to_RX_Fraud_Trifold_(Final).pdf
Some recent pharmacy cases highlighted during Mr. Ferre’s presentation are:
WeCare Pharmacy (Florida) case resulted in a temporary restraining order against the pharmacy and its pharmacist-in-charge for not resolving red flags while dispensing controlled substances.
A very similar case but in Ohio resulted in $375,000 civil penalty and a consent judgment to cease dispensing certain opioid prescriptions, including combinations of opioid and benzodiazepine prescriptions (Toledo Pharmacy case).
And a case on almost identical facts but in North Carolina resulted in $600,000 as civil penalty and a consent judgment and permanent injunction against the corporation and its pharmacist prohibiting them for ever again dispensing or handling controlled substances. (Farmville Discount Drug, Inc).
As you can see from the above examples, depending on the DEA district, penalties and enforcement actions vary greatly. The DEA is equipped with various tools of enforcing the CSA and sometimes uses them creatively. Our firm is in the San Francisco (Bay Area) DEA district, which, for example, uses civil penalties as the most preferred mechanism against pharmacies.
Two more presentations at the ASPL’s conference focused on controlled substances, such as “Distribution, Dispensing, and Digital Health” (presented by Cory Kopitzke and Libby Baney), discussing online dispensing of controlled substances, and “Recent DEA Rules Every Pharmacist Should Know” presented by Jonathan A. Keller.
Another notable presentation discussed where the DEA stands with rescheduling cannabis “A Detailed Review of DEA’s Proposed Rescheduling of Marijuana” presented by Karla Palmer and Kalie Richarson, which was another insightful presentation of a hot topic.
The amount of sessions on controlled substances stresses the need for vigilance and thorough review of DEA updates, recent cases, and state actions regarding controlled-substances dispensing. That leads me to my usual mantra that I teach in DEA seminars: “resolve and document all red flags.” And if you want to stay abreast of the developments in pharmacy law, the ASPL annual conference is a great place to start. Hope to see you there next year.