Use Caution When Handling Controlled Substance Prescriptions

A regular patient visits a community pharmacy with a new prescription for buprenorphine/naloxone (Suboxone). The patient has been getting oxycodone for years and regularly talks with the pharmacy technician about everything from grandchildren to the weather. This time, however, the patient appears uncomfortable and does not talk much.

Technicians are at the forefront of drug distribution in community pharmacies across the United States and are often the first point of contact in the pharmacy for patients who have been prescribed a controlled substance. The responsibilities of accepting, processing, and assisting in the distribution of these prescriptions often falls to technicians. Therefore they play a vital role in preventing drug diversion, providing care for patients, and upholding the law. In addition, technicians handle prescriptions for drugs that treat opioid use disorder (OUD), such as buprenorphine, which are critical in fighting the continuing opioid epidemic in the United States.

Controlled Substances Act

The Drug Enforcement Administration (DEA) regulates controlled substances under the Controlled Substances Act (CSA) of 1971.¹ Drugs, certain chemicals used to make drugs, and substances are classified under 5 differ- ent schedules. Schedule I drugs, those with no accepted medical use in the United States, are not sold in pharmacies and have the highest level of regulation. Schedule V drugs have the fewest number of restrictions, as they are shown to have the lowest potential for abuse and addiction.¹

All hard copy prescriptions for controlled substances require the following, regardless of their schedule²:

• Patient’s full name and address
• Drug name, strength, dose form, and quantity prescribed • Adequate directions for use
• Prescriber’s signature and the date of issue
• Name, address, and DEA number of prescriber

Buprenorphine prescriptions have the same requirements as other controlled prescriptions, with the addition of a prescriber’s narcotic addiction DEA number (NADEAN), also known as a DATA 2000 waiver identification number (X-number).³ A technician should check that these prescriptions have a NADEAN in addition to the prescriber’s DEA to ensure they are for a valid medical purpose.

The CSA also details record-keeping requirements for controlled sub- stance prescriptions. In 2018, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act mandated the electronic prescribing of II, III, IV, or V controlled substances under Medicare Part D.⁴ However, exceptions do apply, so it is still import- ant for technicians to understand the requirements for both electronic and hard copy prescriptions.

Preventing Diversion

Pharmacists have a corresponding responsibility to ensure that prescriptions are for a legitimate medical purpose. Technicians serve as a first-line defense against drug diversion by identifying common red flags on forged or fraudulent prescriptions. Red flags may include an out-of-town prescriber, different handwriting or ink colors, directions that do not use acceptable standard abbreviations, handwriting that is too legible, or prescription paper that appears to be photocopied. Alerting the pharmacist when a prescription appears altered or false is a vital way that technicians can help prevent drug diversion.

Opioid Crisis

In 2019, 71,000 people died from drug overdose, with more than 70% of those deaths involving opioids. These can include dangerous synthetics, heroin, or prescription opioids.⁵ Although OUD is a pervasive issue in the United States, stigmas exist regarding patients with the condition. Technicians who are compassionate and empathetic toward patients create an environment that focuses on helping them get better. A regular patient, such as the man who was recently prescribed buprenorphine/naloxone, may be standoffish because of the stigma associated with OUD. Seeking treatment can be difficult for these patients. Individuals in treatment for OUD may be prescribed medication-assisted therapy, such as buprenorphine products, which can often be more highly stigmatized than other opioids. By upholding their compassion and sensitivity, technicians can play an important part in ending the opioid epidemic by empowering patients with OUD to continue their treatments.

Conclusion

Technicians already play a vital role in processing controlled prescriptions in community pharmacies but they can also care for patients affected by OUD. Additionally, by understanding the different regulatory requirements of controlled prescriptions and watching for red flags when accepting controlled prescriptions, they can prevent drug diversion. Further, patients often interact with technicians during their pharmacy visits, giving technicians the opportunity to reduce the stigma around OUD and the prescription drugs used to treat it. Appropriate handling of controlled substance prescriptions is the responsibility of all technicians, and gives them the potential to improve the lives of many patients.

James S. Wheeler, PharmD, is an assistant professor in the Department of Clinical Pharmacy and Translational Science at the University of Tennessee Health Science Center College of Pharmacy in Knoxville.

Erin R. Anderson is a PharmD candidate at the University of Tennessee Health Science Center College of Pharmacy in Knoxville.

REFERENCES

1. Title 21 United States (USC) Controlled Substance Act. US Department of Justice Drug Enforcement Administration. 2016. Accessed April 30, 2021. https://www.deadiversion.usdoj. gov/21cfr/21usc/
2. CFR – Code of Federal Regulations Title 21. FDA. Updated
   April 1, 2021. Accessed April 30, 2021. https://www. accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch. cfm?CFRPart=1306&showFR=1#:~:text=(a)%20All%20 prescriptions%20for%20controlled,registration%20number%20 of%20the%20practitioner
3. Buprenorphine. Substance Abuse and Mental Health Services Administration. Updated May 14, 2021. Accessed May 19, 2021. https://www.samhsa.gov/medication-assisted-treatment/ medications-counseling-related-conditions/buprenorphine
4. Medicare Program: electronic prescribing of controlled substances; request for information (RFI). Federal Register. August 4, 2020. Accessed April 30, 2021. https://www. federalregister.gov/documents/2020/08/04/2020-16897/ medicare-program-electronic-prescribing-of-controlled- substances-request-for-information-rfi
5. America’s drug overdose epidemic: putting data to action. CDC. Updated March 8, 2021. Accessed April 30, 2021. https://www.cdc. gov/injury/features/prescription-drug-overdose/index.html