Pharmacist-Led Opioid Stewardship Program Critical for Safety in Cancer Care, Despite Regulatory Exemptions

In a setting often overlooked by standard regulations, the University of Texas MD Anderson Cancer Center has successfully developed and implemented a pharmacist-led opioid stewardship program to ensure patient safety. Matthew D. Clark, PharmD, a clinical pharmacy specialist in palliative care and opioid stewardship, discussed the critical motivation, successful strategies, and essential steps for implementing such a program within oncology institutions.

Motivation Beyond Regulation

Dr. Clark emphasized that most state and federal opioid regulations, including those from the Joint Commission or Medicare, exempt patients prescribed opioids for terminal illness or those in hospice and palliative care. However, he stressed that this exemption does not remove the ethical and clinical duty to ensure safe prescribing practices.

The primary motivation for MD Anderson’s program was a noticeable and steep incline in inappropriate opioid behaviors—particularly after the COVID-19 pandemic. The spike in discrepancies and risk factors for opioid misuse among the patient population necessitated a dedicated team.

“Just because we’re not regulated… that does not exempt us from safely prescribing opioids. We still owe that to the patient, and we still owe that to our institution, despite the lack of regulations.” — Matthew D. Clark, PharmD

The program’s core goal is to provide the safest care, which includes crucial measures such as:

Ensuring patients have naloxone (an opioid overdose reversal agent) readily available.
Monitoring patients to ensure they are abstaining from illicit substances.
Creating strategies to wean patients off opioids who show no evidence of disease and no longer require them for pain management.

The Pivotal Role of the Pharmacist

The involvement of a clinical pharmacist has been instrumental in the program’s success, primarily by becoming the recognized point person for complex cases. The pharmacist’s presence has led to overall safer opioid prescribing by:

Consultation and Treatment Planning: Team members (physicians, physician assistants, nurse practitioners) know to contact the pharmacist and the opioid stewardship team when encountering high-risk patients or those with discrepancies and active misuse. The team then collaborates to develop a specific treatment plan.
Education: Pharmacists leverage their in-depth knowledge of opioid pharmacology, pharmacokinetics, and the risks of these medications to provide valuable education to both patients and the entire healthcare team through lectures and academic detailing.
Monitoring: The pharmacist is uniquely positioned to monitor prescribing patterns and patient adherence, contributing significantly to improved safety and proactive intervention.

Practical Steps for Program Implementation

Dr. Clark offered key practical advice for other cancer institutions considering establishing a similar opioid stewardship program, stressing that success hinges on a structured, data-driven approach:

Collect Data (Data is Truth): Institutions must first identify the extent of the problem by gathering concrete data on metrics such as:
- Uptick in opioid misuse.
- Appropriate versus inappropriate prescribing.
- Naloxone prescribing rates.
- Urine drug screen monitoring.
Establish a Team Structure: Opioid stewardship cannot be managed by one person. A successful program requires a multidisciplinary team, including a medical director and team members such as physician assistants, nurses, nurse practitioners, physicians, and clinical pharmacists.
Propose a Plan: Based on the collected data, a comprehensive blueprint should be presented to the governing body, clearly demonstrating the need for the program, the metrics it will tackle, and the unique contributions of each team role.
Network Extensively: Dr. Clark strongly advised pharmacists to network with other institutions—such as Dana-Farber, Memorial Sloan Kettering (MSK), and the Cleveland Clinic—that are also developing stewardship programs. Sharing metrics and lessons learned is crucial for building and sustaining effective, high-quality programs.

By prioritizing patient well-being and safe practices, even without regulatory mandate, MD Anderson’s program serves as a model for how specialized cancer centers can proactively address the complexities of opioid use in oncology.