HOPE Legislation, the DEA and Pharmacists Second-Guessing Doctors?

February 24, 2016

As of this writing, the second wave of HOPE agenda bills is just about through the legislature and enactment seems imminent. HOPE, which stands for Heroin, Opiate Prevention and Education, is a series of efforts aimed at stemming the growing problem of heroin and opiate addiction. Prior HOPE bills included measures requiring proper identification when picking up certain medications, Naloxone and Narcan training for first responders, immunity for individuals reporting overdoses, and funding for recovery efforts.

The current wave addresses healthcare professionals more directly. Among other things, the bills do the following:

(1) Create a Prescription Drug Monitoring Program;

(2) Define the practice of pain medicine;

(3) Create certain reporting requirements for pain clinics;

(4) Require the Medical Examining Board to issue guidelines for best practices in prescribing controlled substances.

The Wisconsin legislature, however, is not the only governing entity looking for new ways to combat opiate-abuse practices. The Drug Enforcement Agency (DEA) has identified prescription drug abuse as a growing problem and stepped up its regulatory enforcement activities, which leaves pharmacies under a new and surprising level of scrutiny. This was brought home in a recent case out of the D.C. Court of Appeals (which has original jurisdiction for appeals of DEA Orders), The Medicine Shoppe v. Lynch, et al..

Briefly, the Medicine Shoppe was a small pharmacy in Texas that had been filling prescriptions for a physician, who it turned out was under investigation for possible drug diversion. Upon being presented with prescriptions that the DEA termed the “holy trinity drug cocktail,” the pharmacy dutifully contacted the physician’s office for verification of the prescriptions before filling them and was assured they were for valid medical purposes. This step had always been considered sufficient to fulfill a pharmacist’s duty to “verify the validity and authenticity of a prescription” consistent with state and federal law, as well as DEA decisional history.

The DEA did not see things that way and took steps to revoke the Medicine Shoppe’s Certificate of Registration. It cited the pharmacy’s corresponding responsibility with the physician to assure that prescriptions were for legitimate medical purposes. Fearing this interpretation required pharmacists to second-guess physicians – a task they argued was beyond their scope of training and expertise as well as their licensure – the Medicine Shoppe challenged the DEA’s interpretation. The DEA maintains pharmacies must resolve “all red flags” before filling prescriptions. If they know, or should have known, that a prescription was issued for an improper purpose, they will face consequences for filling it.

The D.C. Circuit Court denied the Petition for Review without comment. This left open an important question about whether the federal government can effectively expand the duties of pharmacists beyond that set under state laws.

How this uncertainty will play out against the new requirements of the HOPE legislation will present a thorny question. Will a pharmacist’s compliance with the Prescription Drug Monitoring Program be seen as adequate? Under what situations must a pharmacist question a physician regarding medical decision-making if the physician is complying (or deviating) from MEB sanctioned best practices? What are “red flags” and if the pharmacist confers and is convinced by a physician that a prescription is legitimate, can they even refuse to fill it? What are a physician’s responsibilities if they are questioned by a pharmacist?

This area of the law will develop over the next few years, potentially at the expense of practitioners on both sides of the prescription pad. If you have questions concerning this or other regulatory matters, feel free to contact the Health Care attorneys at Axley Brynelson for up-to-date guidance.