Risk Management Strategies for Prescribing Weight-Loss Medications
Laura M. Cascella, MA, CPHRM
Recent years have seen an explosion in patient demand for, and prescribing of, glucagon-like peptide-1 (GLP-1) receptor agonist drugs. These medications — which are branded under the names Ozempic®, Wegovy®, Zepbound®, and Mounjaro® — are in growing demand as a result of their efficacy, increased advertising, and social media prominence (including endorsements from celebrities and influencers).1
A recent survey of more than 300 healthcare practitioners found that almost 90 percent had reported seeing an increase in patients requesting GLP-1s, and more than 90 percent said they had written prescriptions for the medications in the past year. Further, almost 80 percent of survey respondents said that patients had unrealistic expectations of weight-loss medications due to celebrities and influencers.2
Although GLP-1s represent a pivotal advancement in obesity-related treatment, they also are costly, often are not covered by insurance, and may be vulnerable to supply shortages.3 Additionally, like any medication, these drugs can present risk management and patient safety concerns. Thus, healthcare providers should take a prudent approach to prescribing that relies on numerous safety strategies, such as the following:
- Be aware of evolving federal and state guidance and regulations related to on-label and off-label prescribing of medications for weight loss.
- Consult with your state medical and pharmacy boards to determine what standards and rules are in place in relation to prescribing GLP-1s. For example, does your state have requirements related to:
- Patient screening and assessment?
- Body mass index thresholds?
- Laboratory and diagnostic testing?
- Informed consent?
- Complementary weight-loss approaches?
- Documentation?
- Patient monitoring?
- Telehealth prescribing?
- Be mindful of payer requirements, including details related to coverage, prior authorization, documentation, etc. Carefully review billing and coding data and other documentation to avoid allegations of insurance fraud.
- Be knowledgeable about GLP-1s’ common side effects (e.g., nausea, diarrhea, vomiting, stomach pain, constipation, and dehydration) as well as other potential side effects (e.g., headaches, allergic skin reactions at the injection site, insomnia, dizziness, tachycardia, hypoglycemia, and indigestion).
- Stay abreast of emerging research on long-term and potentially serious side effects of GLP-1s (e.g., pancreatitis, gastroparesis, intestinal obstruction, biliary colic, diabetic retinopathy, thyroid cancer, severe allergic reactions, and mental health issues). Monitor for Food and Drug Administration alerts and drug safety-related labeling changes as well as evolving guidance from state medical and pharmacy boards and professional organizations.
- Be aware of and screen patients for GLP-1 contraindications (e.g., pregnancy, breastfeeding, pancreatitis, and renal impairment); additionally, screen patients for potential disorders that may be harmful in relation to taking medications for weight loss, such as body dysmorphic disorder and various eating disorders.
- Discuss with patients their expectations for taking weight-loss medications to determine whether they have realistic assumptions about the benefits of these drugs.
- Conduct comprehensive informed consent discussions with patients prior to prescribing weight-loss medications, including:
- Thoroughly discussing the benefits and risks of these medications as well as alternative treatment options.
- Educating patients about both short- and long-term side effects of GLP-1s, including potentially serious complications. (Note: Make sure patients are aware of potential red flags for serious side effects and when they should contact the healthcare practice or seek immediate help.)
- Providing patients with culturally appropriate, plain-language educational materials about weight-loss medications.
- Documenting the informed consent process and the provision of education and materials in each patient’s record.
- Work with patients to develop a holistic approach to weight management that includes nutrition, exercise, behavior modification, and behavioral health support (as applicable). Involve other healthcare practitioners and specialists as part of a multidisciplinary, team-based approach.
- Be aware of potential issues with compounded versions of some GLP-1s. Ensure due diligence of compounding pharmacies when entering into partnerships or contractual arrangements, or when referring patients to these pharmacies.
- Talk to patients about the risks associated with compounded versions of weight-loss medications, such as overdosing as a result of drawing up incorrect doses from multidose vials, safety issues with compounded versions that use semaglutide salts, and potential contamination issues.
- Develop standard protocols for monitoring patients who are taking weight-loss medications. Protocols might include frequency of assessment and blood/urine testing, parameters for tracking lab results and adjusting medications, and guidance for ongoing patient education.
- Notify your professional liability insurance company about your intention to prescribe GLP-1s to ensure adequate insurance coverage.
GLP-1s are a consequential advancement in the treatment of obesity, and they may help patients shed excess weight, reduce weight-related comorbidities, and improve quality of life. Yet, the interest and excitement surrounding these medications have led to growing demands for prescriptions and potentially unrealistic expectations about outcomes.
Practitioners who prescribe, or intend to prescribe, GLP-1s should implement strategies to maintain regulatory compliance, adhere to payer requirements, reduce prescribing risks and potential liability exposure, and ensure patient safety.
Endnotes
1 Balch, B. (2024, January 25). What doctors should know about popular weight-loss drugs. Association of American Medical Colleges. Retrieved from www.aamc.org/news/what-doctors-should-know-about-popular-weight-loss-drugs; Sermo. (2023, October 11). Sermo Barometer examines influencers’ impact on patient perceptions of weight loss medications & preventative care technologies. Retrieved from www.sermo.com/covid-19-press-releases/#post-15867
2 Sermo, Sermo Barometer examines influencers’ impact on patient perceptions of weight loss medications & preventative care technologies.
3 Balch, What doctors should know about popular weight-loss drugs; Burgess, B., Varond, A., Cohen, R. A., Brendel, A. M., & Schaefer, D. (2024, March 27). A changing regulatory and reimbursement landscape for weight-loss drugs. Goodwin. Retrieved from www.goodwinlaw.com/en/insights/publications/2024/03/alerts-lifesciences-hltc-changing-regulatory-reimbursement-weight-loss-drugs
