RM Alert: Opioid Cases Continued – Suggestions for Pharmacy Owners

Don R. McGuire Jr., General Counsel, BS Pharmacy, JD

Another court ruling involving pharmacists' duties in the dispensing of opioid prescriptions has been issued. Like the Ohio case referenced in September 2020, the latest ruling involves the idea of Red Flags and pharmacists' duty to resolve them. Shortly after the Ohio decision, Walmart filed suit against the Department of Justice (DOJ) in the Eastern District of Texas seeking a declaratory judgment on the obligations of pharmacies and pharmacists under the Controlled Substances Act and its regulations. The basis of Walmart's claim was that the Drug Enforcement Administration (DEA) was seeking to penalize pharmacists based upon a collective knowledge theory even when the individual pharmacist filling the prescription in question had no actual knowledge of any fraud. This idea of aggregating the knowledge of employees across the company is very similar to the ideas outlined by the judge in Ohio.

On February 22, 2021, the judge dismissed Walmart's case because of a lack of subject matter jurisdiction. This dismissal leaves all of the questions regarding a pharmacy's and pharmacist's duties when presented with an opioid prescription unanswered. Part of the court's basis for the dismissal was that Walmart did not identify any specific agency action against them that adversely affected Walmart. While this was true when Walmart filed their case, the DOJ did file suit against Walmart on December 22, 2020. That case is ongoing. Walmart appealed the dismissal of their case on March 5, 2021.

Even if Walmart's appeal is not upheld, most of these unanswered questions will hopefully be answered by a substantive decision in the case filed by the DOJ. While this leaves pharmacists living in a gray area, there are reasonable risk management lessons for all pharmacy owners.

• The Corresponding Responsibility regulation does specifically cite pharmacists. However, pharmacies are registrants too. As an owner, you should provide assistance to the front line pharmacists as they make their judgments on the validity of a controlled prescription.
• Pharmacy owners should regularly share information they have with their staff. If an owner knows, for example, that a prescriber's DEA license has been suspended, he/she should share that information with the staff.
• Owners and staff should have regularly scheduled meetings to share observations and information regarding dispensing of controlled substances. Patterns indicating diversion or misuse are more difficult to discern if individual pharmacists are not on duty during all of the pharmacy's hours.
• Pharmacy owners need to be clear with their staff about diversion and addiction prevention. Establishing a culture of judicious and sensible dispensing of controlled substances starts with owners and managers of the pharmacy. Owners who concentrate on volume will get less discernment from their staff pharmacists as they will likely feel pressure to fill all controlled prescriptions.
• Pharmacy owners should have a written diversion policy that gets audited on a regular basis to make sure the plan is working. This policy and the follow up actions create a very strong defense if the pharmacy is sued.
• The law is evolving and pharmacists are not merely order takers for the physician. Pharmacists have an independent duty to the patient. Following the physician's orders is no longer a sufficient defense when a patient is harmed by a prescription when the pharmacist could have intervened.

For additional information, please contact us at riskmgmt@phmic.com.