Pharmacy Alert: Recognizing and Resolving Red Flags when Dispensing Opioids
The opioid epidemic has plagued the U.S. for the better part of two decades, leading to catastrophic numbers of opioid addiction and overdose-related deaths. In response, lawmakers, government agencies, and nonprofit organizations have taken swift action to implement the necessary changes to end the opioid crisis. Specifically, healthcare providers have been tasked with significant responsibility to prevent instances of opioid misuse and diversion, which, in turn, directly contribute to the skyrocketing addiction and overdose statistics. As highlighted by recent Department of Justice (“DOJ”) enforcement[1], pharmacies are amongst the healthcare providers that must be cognizant of their legal duties and the role they play in combating the opioid epidemic. Moreover, a pharmacy’s failure to adhere to its legal obligations when dispensing opioids can lead to significant penalties, including, but not limited to, administrative, civil, and/or criminal exposure.
Pharmacy Responsibilities when Dispensing Opioids
The recent imposition of responsibility upon a pharmacy to prevent potentially dangerous provisions of opioids should not be understated. Years ago, pharmacists and pharmacies had no duty to warn patients of potentially dangerous drugs or combinations of drugs. Instead, the pharmacy’s sole responsibility was to accurately dispense medication in accordance with the corresponding prescription. Today, however, and specifically when dispensing opioids, federal law makes clear that “the responsibility for the proper prescribing and dispensing of [opioids] is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription.”[2] Although the extent of the pharmacy’s responsibility is not defined, the DOJ and DEA have interpreted this provision as prohibiting a pharmacy from filling a prescription for opioids when there is reason to know that the prescription was not written for a legitimate medical purpose.
To illustrate, in a recent December 2021 DEA order (the “December Order”), a Florida pharmacy lost its DEA registration after filling prescriptions for opioids without regard for multiple “red flags.”[3] To make matters worse, the December Order recommended that any future application for DEA registration on behalf of the pharmacy be denied. The DOJ has previously clarified that “red flags” are indications that a prescription may be invalid or illegitimate. Further, since pharmacies are often the final gatekeeper before putting potentially dangerous opioid prescriptions in the hands of patients, pharmacies are tasked with resolving any existing red flags before dispensing opioids.
What are the Red Flags?
Although neither the DEA nor the DOJ has issued an exhaustive list of red flags that pharmacies must be aware of, in the December Order, the DEA stated that red flags “are circumstances surrounding a prescription that cause a pharmacist to take pause, including signs of diversion or the potential for patient harm.”[4] The December Order also provides a detailed overview of some of the most common red flags.
Cocktail Medications
A common red flag of drug abuse or diversion is present when a practitioner prescribes “cocktail medications.” Cocktail medications are combinations of controlled substances, including opioids, that are widely known to be abused or diverted, and when taken together, significantly increase a patient’s risk of death or overdose.[5] Cocktail medications are most commonly seen when a prescription for opioids is combined with orders for other central nervous system depressants or muscle relaxants.
Improper Dosing for Pain Management
DEA experts have stated that when a patient receives treatment using both long-acting and short-acting opioids, the proper dosing for pain management is to use larger doses of long-acting opioids with smaller, as needed doses of the short-acting opioid for breakthrough pain.[6] According to the DEA, orders for large doses of short-acting opioids not only lack pharmacologic justification but are also a red flag of abuse and diversion.[7]
Patients Traveling Long Distances
In the December Order, the pharmacy at issue routinely filled prescriptions for patients who traveled over forty (40) miles to receive their medication from the Pharmacy. According to the DEA, if a patient is traveling long distances to obtain or fill a prescription for controlled substances, it is indicative of diversion or abuse.[8]
Cash Payments
Another common red flag is when patients routinely opt to pay for their opioid prescriptions with cash, rather than through insurance. Since insurance companies typically reject suspicious claims for controlled substances, patients may try to avoid the rejection by paying with cash.
Price Gauging
Finally, the DEA made it clear that it is a significant red flag[9] when a pharmacy charges patients higher than market value for controlled substances and/or opioids. Not only does a patient’s willingness to pay higher rates at a specific pharmacy present a red flag, but the pharmacy’s willingness to charge a patient higher rates for controlled substances also provides evidence of the pharmacy’s knowledge that there are suspicious circumstances surrounding the prescription and the patient in question.
Resolving Red Flags
Where red flags are present, a pharmacy must resolve the red flag before dispensing the prescription in question. As highlighted by recent DOJ actions, a failure to do so could subject pharmacies to discipline such as losing the ability to dispense opioids and other controlled substances. In determining whether red flags persist and/or whether the red flags have been resolved, pharmacies must use sound professional judgement. Pharmacies must also ensure that they are keeping proper records and documentation which indicate the pharmacy’s recognition of a red flag and the proactive measures it took to resolve red flags.
In situations where pharmacies have doubts as to the authenticity of a prescription for controlled substances, the pharmacy should refrain from dispensing the medication in question until all red flags are resolved. Critically, since federal regulations require pharmacies to only fill orders for controlled substances pursuant to valid prescriptions, a pharmacy is well within its rights to refuse to fill a prescription until it can establish the validity of the prescription. Once a pharmacy is able to resolve any existing red flags, for example by contacting the prescriber, the pharmacy should mark the prescription label to indicate the red flag has been resolved and keep internal documentation to support the resolution of the red flag.
Finally, the Centers for Disease Control and Prevention (“CDC”) issued Proposed 2022 Practice Guidelines for Prescribing Opioids updating and expanding the 2016 Guideline for Prescribing Opioids for Chronic Pain. Although directed at physicians and prescribers, the CDC guidelines provide several recommendations that pharmacies should be aware of to ensure that opioid treatment is legitimate and proper for a given patient. Specifically, these guidelines include, but are not limited to: (i) prescribing immediate-release opioids instead of extended release; (ii) prescribing the lowest possible dose to achieve the expected effect; (iii) appropriately tapering patients off of opioids; and (iv) exercising extreme caution before prescribing opioids with other central nervous system depressants.[10]
How Frier Levitt Can Help
As enforcement efforts increase, pharmacies and pharmacists must ensure that they are complying with federal regulations and are properly identifying and resolving red flags when filling prescriptions for opioids or other controlled substances. The best way for pharmacies to protect themselves from potential liability is to adopt and implement a robust opioid compliance plan. Frier Levitt’s attorneys have the in depth knowledge and experience to provide your pharmacy with thorough compliance procedures that will assist you in identifying and resolving red flags. Contact us to better protect your pharmacy from potential liability.
[1] See Federal Court Restrains Tampa Pharmacy and Two Individuals from Dispensing Opioids or Other Controlled Substances, Department of Justice, January 29, 2021; available at https://www.justice.gov/opa/pr/federal-court-restrains-tampa-pharmacy-and-two-individuals-dispensing-opioids-or-other.
[2] 21 C.F.R. § 1306.04(a) (emphasis added).
[3] 86 Fed. Reg. 72694, 72703 (Dec. 22, 2021).
[4] 86 Fed. Reg. 72694, 72703 (Dec. 22, 2021).
[5] Id., at 72695.
[6] Id.
[7] Id.
[8] Id., at 72696.
[9] Id.
[10] See Larry K. Houck, CDC Proposes Updating Practice Guideline for Prescribing Opioids, Warning Against Continued Misapplication, March 18, 2022; available at https://www.thefdalawblog.com/2022/03/cdc-proposes-updating-practice-guideline-for-prescribing-opioids-warning-against-continued-misapplication/.
