Amy Boring

As prescription drug abuse has grown into the “opioid epidemic” we are currently faced with, the Drug Enforcement Administration and state regulatory and law enforcement authorities have significantly ramped up their enforcement efforts across the entire pharmaceutical supply chain. For pharmacists, there has been an increased focus on a pharmacist’s “corresponding responsibility” to prevent the abuse and/or diversion of controlled substances. Indeed, in the last 10 years, DEA and other authorities have brought a number of administrative, civil and criminal actions against independent and chain pharmacies relating to allegations that pharmacists failed to exercise their corresponding responsibilities before dispensing a controlled substance. In practice, the concept of corresponding responsibility is generally approached in terms of a list of “red flags” that pharmacists are advised to consider before dispensing a controlled ­substance.

Stephen Cummings

The emergence of another epidemic, COVID-19, has led to significant changes in the way controlled substances are being prescribed and dispensed, some of which directly impact a pharmacist’s ability to evaluate the traditional list of red flags. However, DEA has clearly stated that the current circumstances do not excuse pharmacists from the obligation to fulfill their corresponding responsibility. This article explores the challenges pharmacists are now facing in ensuring that a controlled substance prescription is being filled for a legitimate medical purpose.

Corresponding responsibility and red flags

Federal and state laws provide for a comprehensive regulatory scheme that allows for the distribution, dispensing or administration of controlled substances only for a legitimate medical use. Specifically, 21 C.F.R. 1306.4. states that “[a] prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” The regulation puts the “responsibility for the proper prescribing and dispensing of controlled substances upon the prescribing practitioner” but says a “corresponding responsibility rests with the pharmacist who fills the prescription.” Id.

A pharmacist who “knowingly” fills an improper prescription is subject to penalties for violating the Controlled Substances Act. Id. To prove a pharmacist or pharmacy acted knowingly, the DEA must show, “either that the pharmacist filled a prescription (1) notwithstanding his/her actual knowledge that the prescription lacked a legitimate medical purpose or (2) being willfully blind to (or deliberately ignorant of) the fact that the prescription lacked a legitimate medical purpose.” Many actions do not attempt to prove actual knowledge, but instead allege “willful blindness,” which has been interpreted to mean that (1) the pharmacist subjectively believed there is a high probability that a fact exists and (2) the pharmacist took deliberate actions to avoid learning that fact. Id. DEA agency decisions have found that a pharmacist’s failure to consider or clear red flags that signal potential diversion when filling a prescription can support a finding that the pharmacist acted with willful blindness.

The DEA regulations do not provide a comprehensive list of red flags — or refer to the red flag concept at all — but DEA has provided various non-exhaustive lists through informal guidance, industry materials and case law. Pharmacies have devoted significant resources in both time and money to train pharmacists to identify and evaluate red flags to determine whether a controlled substance prescription should be filled. Some of the generally accepted red flags included the following:

• Customers paying cash for a prescription, especially patients that have insurance.

• Prescriptions written by practitioners that write significantly more prescriptions or in larger quantities compared to other prescribers in the area.

• Customers switching practitioners or using multiple ­practitioners.

• Prescriptions being presented for drug cocktails, such as depressants and stimulants, at the same time.

• Prescriptions written by emergency room or urgent care practitioners.

• Multiple customers who appear simultaneously, or within a short time, all bearing similar prescriptions from the same physician.

• Prescriptions being picked up by someone other than the customer.

• Suspicious behavior that may indicate abuse or diversion by the customer at drop-off or pickup.

• Customers who appear to be returning too frequently (i.e., prescriptions that should last for a month are being refilled on a more frequent basis).

• Customers that present prescriptions written by out-of-state prescribers.

• People who are not residents of the community showing up with prescriptions from the same physician.

DEA remains focused on corresponding responsibility

DEA has recognized the impact of COVID-19 on prescribers, patients and pharmacies and has announced temporary exceptions to certain controlled substance regulations in light of the nationwide public health emergency. For example, in late March, as cities and states sought to encourage their residents to shelter-in-place and minimize in-person transactions, the DEA announced exceptions to certain of the requirements for oral (by telephone or other form of verbal communication as opposed to written or electronic) Schedule II prescriptions. DEA has also granted an exception to the requirement that a practitioner have a separate DEA registration in each state to allow practitioners to temporarily work in hard-hit locations under state licensing reciprocity. The registration exception also allows practitioners to prescribe controlled substances via telemedicine for a patient located in another state.

Even when granting these regulatory exemptions, DEA has clearly indicated that the corresponding responsibility standard has not been changed. The letter announcing the Schedule II emergency oral prescription exceptions affirmatively stated that “[r]egardless of any exceptions that DEA has made in response to COVID-19, pharmacists continue to have a corresponding responsibility to ensure that any controlled substance prescription for the fill was issued for a legitimate medical purpose by a practitioner acting in the usual course of his/her professional practice.” DEA included a similar mandate in the letter providing guidance on refilling Schedule III-V controlled substances in accordance with state orders authorizing early refills during the COVID-19 emergency, stating “[i]n all cases, it bears repeating that every prescription for a controlled substance must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice and that a pharmacist bears a corresponding responsibility for the proper dispensing of controlled substances.”

Yet, what the guidance does not provide is any strategies or guiding principles to address how pharmacists can evaluate the legitimacy of prescriptions when the red flags they have been trained to look for may be less meaningful in light of the current health emergency.

Challenges presented by COVID-19

COVID-19 has made it increasingly difficult for pharmacists to apply the red flag analysis to determine if a controlled substance prescription is legitimate. Indeed, some of the same behaviors that were identified as red flags have now become potentially explainable and even reasonable behaviors in light of the ongoing pandemic. The following is just a small sample of how COVID-19 may adversely impact a pharmacist’s ability to determine whether red flag versus what are changes in behavior necessitated by COVID-19:

• There may be increase in the number of prescriptions being paid for in cash because many customers have lost their jobs and corresponding ­insurance.

• With some practitioners’ office being closed or limited in what services they provide, there has been an uptick in some areas of a handful of practitioners writing a larger percentage of controlled substance prescriptions than is usual.

• Customers are changing practitioners, sometimes more than once, to account for office closures and limited availability of their physician of record.

• Patients are having to go to emergency rooms or urgent care facilities for treatment more frequently due to the inability to get an appointment with their usual doctor.

• Customers are more frequently presenting prescriptions for more than one medication at a time due to customers and/or prescribers wanting to limit office visits.

• Practitioners are more frequently writing prescriptions for more than one month’s supply because it may be difficult for patients or doctors to make appointments.

• Early refills in some states.

• Some customers are reluctant to go to a pharmacy, so they are sending family members or friends to pick up their prescriptions.

• Customers are frequently wearing masks making it harder to identify potential identity theft and physical signs of addiction and/or abuse.

• Some customers have isolated themselves in locations other than their homes, so prescriptions are more frequently being presented by out-of-state customers and out of state ­practitioners.

In addition, some pharmacies are experiencing staffing challenges, which is making it harder for pharmacists to investigate and clear potential red flags. For example, since many practitioners are working remotely and/or have reduced office hours it can be more difficult for pharmacists to timely contact practitioners or their staff to confirm the accuracy and/or medical necessity of controlled substance prescriptions. Moreover, some pharmacies are experiencing disruptions in training cycles because of staffing or resource limitations or because of the need to train pharmacy staff on operational changes resulting from increased health and safety requirements, which means pharmacists may not be getting as frequent training or updates on potential indicators of abuse or division.

The challenges described above are just some of the additional burdens that pharmacists are currently facing in light of COVID-19. As a result, pharmacists must continue to remain vigilant in looking for potential signs of abuse or diversion in what is an increasingly challenging environment.

Stephen Cummings is a counsel and Amy Boring is an associate in the Atlanta office of King & Spalding LLP; they can be contacted at [email protected] and [email protected].