Pharmacy Alert: Prescription “Red Flags” for Pharmacies

Combatting opioid diversion remains a top priority for regulators and enforcement agencies.  In that vein, there continues to be enhanced scrutiny on healthcare professionals over opioid prescriptions.  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. 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.

The U.S. Drug Enforcement Administration (“DEA”) and some courts have interpreted the “corresponding responsibility” of a pharmacist as due diligence, even vigilance, to be exercised in preventing the dispensing of prescriptions issued for nonmedical purposes. That means recognizing and resolving “red flags” before filling controlled substance prescriptions. When a pharmacist acts outside of his or her “corresponding responsibility” of dispensing controlled substances, such failure could result in severe enforcement action including the revocation of a pharmacy’s registration and/or criminal liability. Although neither the DEA nor the DOJ has issued an exhaustive list of red flags for pharmacies, it is generally recognized to include:

• Pattern prescribing – multiple individuals presenting prescriptions for the same drugs, for the same or similar quantities, and from the same prescriber
• Distance anomalies (e.g., patient and prescriber are in different locations from one another)
• Shared addresses by customers presenting the same prescriptions from the same provider on the same day
• Family members receiving the same prescription from the same prescriber or high number of family members in a pain management practice
• Patients presenting prescriptions for antagonistic drugs, such as depressants and stimulants, at the same time
• Payment in cash
• Signs of forged prescriptions (e.g., Quantities, directions, or dosages that differ from standard medical usage; prescriptions that appear photocopied)

DEA has made it clear that a “pharmacist or pharmacy may not dispense a prescription in the face of a red flag (i.e., a circumstance that does or should raise a reasonable suspicion as to the validity of a prescription) unless he or it takes steps to resolve the red flag and ensure that the prescription is valid.”[2]  Therefore, pharmacies and pharmacists must implement policies designed to identify red flags.

How Frier Levitt Can Help

Frier Levitt has a long history of defending pharmacies and prescribers in criminal, civil and administrative actions relating to opioids and controlled substances, as well as counseling them on proper practices under federal and state laws and regulations. Contact Frier Levitt to speak to an experienced attorney regarding proper compliance or defense in investigations and prosecutions.

[1] Pharmacist and Pharmacy Owner Sentenced to Prison for Unlawfully Distributing Opioids, the United States Department of Justice, available at: https://www.justice.gov/opa/pr/pharmacist-and-pharmacy-owner-sentenced-prison-unlawfully-distributing-opioids

[2] Holiday CVS, L.L.C. d/b/a CVS/Pharmacy Nos. 219 and 5195; Decision and Order, 77 Fed. Reg. 62,316, 62,341 (Oct. 12, 2012) (quoting Bob’s Pharmacy & Diabetic Supplies; Revocation of Registration, 74 Fed. Reg. 19,599, 19,601 (Apr. 29, 2009)); see Jones Total Healthcare Pharmacy, L.L.C. and SND Health Care, L.L.C.; Decision and Order, 81 Fed. Reg. 79,188, 79,218-19 (Nov. 10, 2016); East Main Street Pharmacy; Affirmance of Suspension Order, 75 Fed. Reg. 66,149, 66,150 (Oct. 27, 2010).