Building a team to support best practices, medication safety, and staff education will reduce risks.
Opportunity for diversion of controlled substances occurs at all steps in medication management. Health systems face many risks associated with diversion, including financial, legal, patient injury, and reputational.1,2 Affected parties include coworkers, patients, pharmacy staff members, and providers. To secure an effective diversion prevention program, pharmacy leaders should proactively engage essential interdisciplinary stakeholders, including individuals in charge of storing or disposing of controlled substances, the executive team, operating room staff, and patient care units. Input and shared decision-making with staff members should include discussions on decreased documentation burden, ways to lower diversion risk, peer oversight, and program value.3
The American Society of Health-System Pharmacists (ASHP) Guidelines on Preventing Risk Diversion identify where in the supply chain diversion is most likely. These are the 5 essential phases where pharmacists should focus their efforts4:
• Drug procurement phase: There is an opportunity for staff members to alter or delete records, gain unauthorized access to electronic controlled-substance ordering system and Drug Enforcement Administration (DEA) forms 222, or compromise a product container.
• Preparation and dispensing phase: Staff members might divert overfill, remove volume from a solution, replace one product with another, or replace a prepared drug with another product.
• Prescribing phase: Prescription pads could be targeted; prescribers might self-prescribe or prescribe controlled substances for family or friends. Issues with illegitimate or nonauthorized verbal orders may arise. Also, patients might alter written prescriptions. E-prescriptions have helped but do not eliminate risk.
• Medication administration phase: Products could be removed for a discharged patient, medications might be documented as administered but not provided to patients, or substitute drugs might be administered in place of the product.
• Waste and removal phase: Controlled-substance waste might be removed from unsecured waste containers, expired products might be diverted from holding areas, and waste in syringes might be replaced with saline.
Focusing on these risk points identified by the ASHP is important to ensure supply chain integrity.4 A comprehensive plan addressing all 5 phases with financial stewardship is important to assure adequate oversight.
Elements of a Good Prevention Program
First, administrative checks and balances help provide oversight and accountability. This includes the development of drug diversion teams. Teams should meet at set intervals to certify that controlled substance legal and regulatory requirements are met. Oversight should include general and random screens for handling of all controlled substances. The teams should ensure prompt audits and investigations, and results should be taken seriously. Automated intelligence provides teams with additional information with standard deviations to analyze efforts.
Second, teams should engage in health system–wide processes. This involves addressing components of human resources management (2 witnesses for medication waste), automation and technology (appropriate policy and procedures, including sign-outs), ensuring prompt event reporting and investigation, proactive monitoring (including scheduled and random counts), and camera surveillance. A good program makes it difficult to divert controlled substances while ensuring patient care.
Third, pharmacists should establish adequate user competencies, oversight, and training around chain of administration, custody, disposal, internal pharmacy supply chain, prescribing, returns, security and storage, and waste. An avenue for providing feedback and shared decision-making for these processes should be used.
A culture of collaboration in team efforts should include a variety of departments, including anesthesiology, human resources, medicine, nursing, and pharmacy, with support from the executive team. Ensuring transparent communication, goals, and perceived value with other disciplines is crucial to efficient controlled-substance management.
Diversion and waste are significant prob- lems, especially in areas where there
is high use of drug products. The more waste produced, the greater the prospect for medication diversion. Reducing waste reduces diversion risk. The Third Consensus Development Conference on the Safety of IV Delivery Systems has a list of 10 items to ensure safe handling and reduce waste of intravenous products.5 Best practices include competencies, formal education, interdisciplinary efforts, legislative and regulatory frameworks, standardizing packaging sizes, training, and use of automation and technology where possible with appropriate policy and oversight.4 The DEA’s 2014 Final Rule on Disposal of Controlled Substances discusses disposal of a DEA registrant’s inventory. But it does not discuss disposal by health care facilities of partially administered syringes or single-dose vials (eg, medication waste) or how household users should handle waste disposal.6 The Environmental Protection Agency amended the Resource Conservation and Recovery Act in 2020 to require staff members to render wasted medication irretrievable. Product can no longer be poured down the sink into wastewater. This is now an added consideration.7
Pharmacists should identify institutional practices supporting best practices, medication safety, and staff education to minimize drug diversion risks. Engaging key interdisciplinary stakeholders to gain support and improve the institution’s controlled-substance stewardship program are the goals essential to reducing the opportunity for diversion and ensuring a successful program.
About The Authors
Craig Kimble, PharmD, MBA, MS, BCACP, is an associate professor of pharmacy practice, administration, and research, director of experiential learning, and manager of clinical support services at Marshall University School of Pharmacy in Huntington, West Virginia.
Tiffany Davis, PharmD, is a clinical assistant professor at Marshall University School of Pharmacy in Huntington, West Virginia.
Chris Booth, PharmD, is a clinical associate professor at Marshall University School of Pharmacy in Huntington, West Virginia.
Ken Maxik, MBA, BSPharm, is vice president of pharmacy operations at Health Trust Supply Chain in Largo, Florida.
1. ISMP safe practice guidelines for adult IV push medications. Institute for Safe Medication Practices. 2015. Accessed June 16, 2022. org/sites/default/files/attachments/2017-11/ISMP97-Guidelines-071415-3.%20 FINAL.pdf
2. Guidelines for safe preparation of compounded sterile preparations. Institute for Safe Medication Practices. Updated 2016. Accessed June 16, 2022. org/sites/default/files/attach- ments/2017-11/IVCGuidelines.pdf
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4. Brummond PW, Chen DF, Churchill WW, et al. ASHP guidelines on preventing diversion of controlled substances, Am J Health Syst Pharm. 2017;74(5):325-348. doi:10.2146/ajhp160919
5. Gabay M, Hertig JB, Degnan D, et al. Third Consensus Development Conference on the safety of IV delivery systems-2018. Am J Health Syst Pharm. 2020;77(3):215-220. doi:10.1093/ajhp/zxz277
6. Brechtelsbauer E, Shah S. Update on pharmaceutical waste disposal regulations: strategies for success. Am J Health Syst Pharm. 2020;77(7):574-582. doi:10.1093/ajhp/zxz360
7. Resource Conservation and Recovery Act (RCRA) laws and regulations. United States Environmental Protection Agency (EPA). Updated March 9, 2022. Accessed May 19, 2022.