Published April 5, 2024 APhA Addressing Red Flags With Controlled-Substance Prescriptions Mark Garofoli, PharmD, MBA, BCGP, CPE, CTTS, is the director of experiential learning, clinical assistant professor, and a clinical pain management pharmacist at the West Virginia University School of Pharmacy and Medicine. During his session titled “Communicating Through Controlled Substance Concerns,” he discussed ways to recognize and address red flags in the pharmacy practice, stigma-free communication strategies to use when a patient with red flags are identified, and best practices for documenting related to the pharmacist’s corresponding responsibilities.Dr. Garofoli began by explaining the history of documenting red flags. Prior to 2022, the Drug Enforcement Agency (DEA) documented red flags within court room documents, and these could only be accessed via a membership. In 2022, Dr. Garofoli worked with Med Central to publish an article that addressed red flags with general controlled-substance concerns. Then in 2023, the National Opioid Settlement (NOS) was introduced. Dr. Garofoli listed some of the DEA red flags for prescribers as out-of-area patients, out-of-pocket-only paying patients (also known as cash pay), prescribing the same (high) quantities of controlled substances to most/every patient, high number of prescriptions in general issued per day, and prescribing of the same combination of highly abused drugs.He added that the DEA red flags for dispensers are: dispensing a high ratio of controlled to noncontrolled drugs; dispensing high volumes of controlled substances generally; dispensing identical prescriptions prescribed by the same prescriber to many patients; dispensing to out-of-area patients; dispensing to multiple patients with the same last name or address; filling sequentially numbered controlled substance prescriptions from the same prescriber; filling prescriptions for controlled substances for one patient from multiple practitioners; and dispensing for patients seeking early prescription fills/refills.Several concerns for dispensers regarding controlled substances include:• Patient utilized multiple pharmacies (beyond cost-savings strategies)• Patient presents various prescriptions, such as a controlled substance and an antibiotic, but only wants the controlled substance • Patient presents a controlled substance prescription for someone else (without verified justification)• Prescription is outside the scope of a prescriber’s practice• Prescriber’s state license is expired or the prescriber’s DEA Registration is suspended/revoked• Papyrus prescription appears to be altered or forged• Other pharmacy/pharmacies refused to fill prescription for verified justification.He noted that, according to the NOS, “A red flag shall not automatically mean that a prescription is illegitimate yet must be resolved.” He noted that this takes time to resolve. A “resolution” occurs when a pharmacist believes that the diagnosis and scope of the prescription are legitimate. He added that all resolutions and prescription rejections must be documented properly. Some red flags according to the NOS include a class II controlled substance that is filled too soon by >3 days, a controlled substance that has been written by >4 previous prescribers of separate practices over 6 months, distance between the patient’s residence and pharmacy is >50 miles, distance between the patient’s residence and prescriber is >100 miles, three or more patients appear for the same type of controlled substance at time of fill, and the patient appears visibly altered, intoxicated, or incoherent. Additional red flags are that the prescriptions fail to meet law requirements, have misspellings or atypical abbreviations, there are multiple ink colors or handwritings, or the prescriber utilizes preprinted or stamped prescription pads.Dr. Garofoli then introduced the Pharmacist Patient Care Process (PPCP) to help with best practice by collecting information, assessing that information, forming a plan, implementing that plan, and providing follow-up for every patient scenario. He advised that PPCPs can utilize state-wide prescription drug monitoring programs that are available in each state; however, he noted that these programs are not part of a singular shared system and vary state-by-state. He noted that when pharmacists are suspicious, he advises using “emotional intelligence.” This includes eliminating personal or judgmental biases; approaching the situation calm, collected, and well researched; and having a conversation with the respective prescriber/dispenser and then with the patient. If suspicion is confirmed, he suggested patient counseling using “scripting” that ensures universal respect between all parties, while upholding federal/state laws. Scripting entails speaking without stigmatic terminology (e.g., “abuser” or “addict”). If the pharmacist feels that there are legitimate concerns, they can report their findings to the DEA by calling 1-877-RX-ABUSE (1-877-792-2873). The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.