Jeffrey Fudin, PharmD, DAIPM, FCCP, FASHP
Dr. Jeff Fudin graduated from Albany College of Pharmacy & Health Sciences with a BS and PharmD. He is a Diplomate to the Academy of Integrative Pain Management, a Fellow to ACCP, ASHP, & FSMB, a member of several other professional organizations. He is CEO of Remitigate (remitigate.com), an opioid safety software development LLC. Dr. Fudin is a section editor for Pain Medicine & Co_Editor-A-Large for Practical Pain Management. He practices as a clinical pharmacy specialist (WOC) and director of PGY-2 pharmacy pain residency programs at the Stratton Veterans Administration Medical Center in Albany, New York and has academic affiliations with Western New England University and Albany Colleges of Pharmacy.
But there is a delicate balance between deterring individuals who may be seeking controlled substances for illegitimate reasons and helping patients who need these prescriptions to manage pain and in pursuit of an improved quality of life.
As the opioid epidemic in the United States continues to spiral out of control, physicians and other prescribers have been held criminally liable for overdose-related deaths. Pharmacists are not exempt from liability in this setting and have been held legally and criminally liable for patients' overdose deaths. The Board of Pharmacy in states such as California have been increasing the number of investigations against pharmacies, pharmacists, pharmacy technicians, intern pharmacists, and associate staff members for not carrying out “corresponding responsibility” or addressing “red flags." In 2013, the California Pharmacy Board revoked the licenses of Pacifica Pharmacy and pharmacist Thang Q. Tran for multiple failures to address red flags.1 In 2015, the West Virginia Supreme Court ruled that substance abusers, even those who knowingly engage in illegal activities, such as doctor shopping and misleading providers, can sue the prescriber and pharmacists who dispensed the medications. A bill was subsequently approved by the West Virginia governor in 2016 to prohibit anyone engaging in illegal activities from suing prescribers and pharmacists.1
Pharmacists have an important legal and ethical role in addressing prescription drug abuse. Under Title 21 Code of Federal Regulations Part 1306.04 (21 C.F.R. § 1306.04), “the responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription.”2 The extent and magnitude of the “corresponding responsibility” remains largely misunderstood and undefined. There have been several cases where pharmacists and pharmacies were held criminally liable for failing to exercise their corresponding responsibility.
With pharmacists and pharmacies susceptible to investigations and corresponding liability, it is important that pharmacies establish due diligence policies, which include checking state prescription drug monitoring programs (PDMPs) and identification of red flags. Red flags are warning signs that may indicate a controlled substance prescription is not being obtained for legitimate medical purpose but rather for diversion or abuse. It is the pharmacist’s job to evaluate and interpret the seriousness of these warning signs.
Listed below are the red flags that pharmacists should recognize based on a document released by the National Association of Boards of Pharmacy titled, “Stakeholders’ Challenges and Red Flag Warning Signs Relate to Prescribing and Dispensing."3
Presentation of the Prescription
· Patients travel in groups and/or have unexplainable common factors in their relationships with each other. For example, groups of patients present prescriptions for the same controlled substance(s) from the same prescriber or multiple family members or patients living at the same address present similar controlled-substance prescriptions to the pharmacy on the same day.
· A patient presents prescriptions for controlled substances written in the names of other people. This does not apply to designated caregivers presenting prescriptions for patient.
· A patient presents a prescription for a controlled substance that the pharmacist knows or reasonably believes that another pharmacy refused to fill.
· A handwritten prescription is presented at the pharmacy, looking altered or flawlessly thorough (contains patient address, quantity spelled out, patient's date of birth, multiple provider identifiers, lacks common abbreviations, etc.).
· The pharmacist becomes aware that the prescriber’s Drug Enforcement Agency (DEA)registration has been previously suspended or revoked or is pending suspension or revocation.
· The patient pressures the pharmacist to dispense the controlled substance by making implied or direct threats.
· The patient shows physical signs associated with controlled-substance abuse, such as appearing sedated, confused, intoxicated, or exhibiting withdrawal symptoms.
· The patient obtains the same or a similar controlled-substance prescription from multiple health care practitioners without disclosing those existing controlled-substance prescriptions.
· The patient obtains controlled-substance medications from 1 pharmacy, while having received the same or similar controlled substance(s) from another pharmacy or other pharmacies, without disclosing those existing controlled-substance prescriptions.
· The patient presents prescriptions for highly abused controlled-substance medications, which may vary by region. The pharmacist should be aware of abuse trends in their area.
· The patient presents several prescriptions written for controlled and non-controlled substances but only wants the controlled-substance medication(s) dispensed.
· The patient has a history of untruthfulness when filling controlled-substance prescriptions.
· The patient presents prescriptions for large quantities or large numbers of prescriptions for controlled substances.
· There is therapeutic duplication for 2 or more long-acting and/or 2 or more short-acting opiates.
· The patient presents prescriptions for highly abused “cocktails” (combination of opiate, benzodiazepine, and muscle relaxant) of controlled-substance medications.
· The patient indicates that drugs will be shared with others or sold.
· The prescriber’s DEA registration or state license has expired or been suspended or revoked.
· The patient presents a prescription from a prescriber who is prescribing outside the scope of his/her practice, as defined by state law.
· The patient alters, forges, sells or rewrites prescriptions.
· The patient is diverting/selling medication or getting drugs from others.
After recognizing red flag(s), pharmacists should begin applying due diligence to the situation. This includes checking the patient’s PDMP report, contacting the prescribing physician for a confirmation, and in a respectful manner, asking the patient to explain his or her situation. Documentation of the due diligence applied to prescriptions is a good habit to practice in case of audits or investigations. In the case that a prescription’s legitimacy cannot be verified, taking the time to explain the circumstance to the patient is necessary to avoid miscommunication.
Of late, some community pharmacy chains have changed policies that have been developed around the pretext of patient safety.4 Such policies include limited-day supply of opioids for acute pain. However, this may present a bitter inconvenience for patients who legitimately require opioids for a major acute injury and also maximizes the profitability associated with multiple copays and dispensing fees for drugs that cost pennies. To our knowledge, there is no evidence to support that limited supplies for legitimate patients improves safety or mitigate risk. In fact, there is sufficient data to support that placing such barriers, at least for patients requiring long-term opioids, may actually contribute to the heroin epidemic.5 Nevertheless, for minor acute injuries, we certainly don’t advocate for large supplies of short-acting opioids. Discretion should be left to the prescriber, based on presumed healing, and the number of units to be dispensed should be based on a responsible assessment with appropriate follow-up. Overshadowing such policies should be a requirement that pharmacists counsel every patient receiving opioids for new fills and renewed prescriptions and should include the attributes, adverse effects, and secure storage. Irrespective of how many times a patient hears these things, counseling should be a repetitive priority similar to the safety checks we hear each time we board an airplane.
In summary, an interdisciplinary approach that works fluidly is imperative to ensure that the right medication ends up in the right hands. All health care professionals share 1 goal, which is to help patients. Prescribers have the duty of appropriate prescribing for a legitimate medical purpose, followed by monitoring to ensure adherence and appropriate continuation of therapy. Pharmacists have an equal and corresponding responsibility to ensure that patients are receiving controlled substances for a legitimate medical purpose and should engage patients in related counseling conversations routinely. Pharmacists should serve as a continuum of patient care and are some of the most accessible members of the health care team. Pharmacists are the last line of defense in preventing a controlled substance from ending up in the wrong hands and have a duty to patients and the community.
This commentary was collaboratively written with Kangni (Connie) Wang and Dr. Mena Raouf.
Kangni (Connie) Wang is a 2018 PharmD candidate at Albany (New York) College of Pharmacy and Health Sciences and is a pharmacy intern at CVS.
Mena Raouf is PGY-2 pain and palliative care resident at the Stratton VA Medical Center in Albany, New York. He completed his PGY-1 residency at the VA Tennessee Valley Healthcare System in Nashville and received his PharmD from the Albany (New York) College of Pharmacy and Health Sciences.
This article is the sole work of the authors, and the stated opinions or assertions do not reflect the opinions of employers, employee affiliates, or any pharmaceutical companies listed. It was not prepared as part of the authors’ duties as federal employees.
1. Ault, Alicia. Pharmacists may be legally liable for opioid overdoses. medscape.com/viewarticle/882358]. Published June 30, 2017. Accessed October 18, 2017.
2. Department of Justice, Drug Enforcement Agency, Diversion Control Division. §1306.04 purpose of issue of prescription. deadiversion.usdoj.gov/21cfr/cfr/1306/1306_04.htm. Accessed October 18, 2017.
3. Stakeholders’ challenges and red flag warning signs relate to prescribing and dispensing. nabp.pharmacy/wp-content/uploads/2016/07/Red-Flags-Controlled-Substances-03-2015.pdf. Accessed October 18, 2017.
4. CVSHealth. Fighting national opioid abuse epidemic with enterprise initiatives. cvshealth.com/newsroom/press-releases/cvs-health-fighting-national-opioid-abuse-epidemic-with-enterprise-initiatives. Published September 21, 2017. Accessed October 18, 2017.
5. Anson P. Survey Finds CDC opioid guidelines harming patients. painnewsnetwork.org/stories/2017/3/13/survey-finds-cdc-opioid-guidelines-harming-patients. Published March 15, 2017. Accessed October 18, 2017.