Student’s Discussion:
Utah Healthcare Policy
Bill SB0266 Medical Amendments (2024) “authorizes a healthcare system to create a pilot program for certain drugs.” The bill authorizes the use of psilocybin or methylenedioxymethamphetamine (MDMA) that is in federal Food and Drug Administration (FDA) Phase 3 for behavioral health treatment as a testing for an investigational drug (SB0266, 2024). This bill does not take effect until May of 2024. This bill reads “a healthcare system may develop a behavioral health treatment program that includes a treatment based on a drug that the healthcare system determines is supported by a broad collection of scientific and medical research” (SB0266, 2024).
Bill SB0266 is specific about who can oversee the drug administration and who can take the drug for testing purposes. The drug can only be used by a patient under direct supervision of the healthcare systems providers licensed under the title and above 18 years of age (SB0266, 2024). The medication cannot be used before July 1, 2026, without a written report to the Health and Human Services Interim Committee (SB0266, 2024).
Implications
Psilocybin and MDMA are being tested for behavioral health treatment, but the policymaking is the same for any drug being trialed for population use later. This bill will also be applicable to primary care providers working with mental health patients and needing to prescribe these medications in the future.
There was a total of eight studies done on MDMA and six on psilocybin by the Australian & New Zealand Journal of Psychiatry (2023). The outcome was substantial with the medications being “equally as effective as escitalopram in long-standing depression for the primary study outcome and superior for most of the secondary outcomes in analyses uncorrected for multiple comparisons” (Kisely et al., 2023). There were listed limitations that need to be closely monitored in further studies.
The studies were done on patients with “post-traumatic stress disorder, long-standing/treatment-resistant depression, obsessive-compulsive disorder, social anxiety in adults with autism, and anxiety or depression in life-threatening disease” (Kisely et al., 2023). Both psychotropic medications were well tolerated and show promising results in selected populations when administered “in closely supervised settings and with intensive support” (Kisely et al., 2023).
Stakeholders
The stakeholders are the roles that contribute to managing population health with each requiring a set of skills and knowledge to work together for the common goal (Nash et al., 2021). The key stakeholders in this bill include the pharmaceutical companies trialing the psilocybin or MDMA, the providers who want to participate in any program, and the patients above 18 years of age that want to participate in the trials of this medication.
Public and Private Interests
Public interests belong to the Federal and State governments. The state was able to issue this new bill because of the FDA approved guidance for considerations. The FDA issued guidance to provide general considerations to sponsors developing psychedelic drugs including psilocybin and lysergic acid diethylamide (LSD), and MDMA (U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research, 2023). The considerations for an FDA proposal need to include chemistry, manufacturing, and controls information, proper identification, quality, purity, and strength of the investigational drug substance and drug product, pharmacokinetics and/or pharmacodynamics, abuse potential of a drug product, and adequate and well-controlled (AWC) clinical studies (U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research, 2023).
Private interests from patients and providers include excitement for an alternative treatment for therapy to treat mental health disorders (Gill et al., 2020). “Available evidence indicates that psychedelics may offer a single-dose, rapid effect model that have robust effects with treatment-resistant mental disorders and a unique advantage as a possible monotherapy for mental illness” (Gill et al., 2020).
References
Gill, H., Gill, B., Chen-Li, D., El-Halabi, S., Rodrigues, N. B., Cha, D. S., Lipsitz, O., Lee, Y., Rosenblat, J., Majeed, A., Mansu, R., Nasri, F., Ho, R., & McIntyre, R. S. (2020). The emerging role of psilocybin and MDMA in the treatment of mental illness. Expert Review of Neurotherapeutics, 20(12), 1263–1273. https://doi.org/10.1080/14737175.2020.1826931
Kisely, S., Connor, M., Somogyi, A., A, Siskind, D., (2023). A systematic literature review and meta-analysis of the effect of psilocybin and methylenedioxymethamphetamine on mental, behavioural or developmental disorders. Australian & New Zealand Journal of Psychiatry. 57(3), 362-378. https://doi.org/10.1177/00048674221083868
Nash, D. B., Fabius, R. J., Skoufalos, A., & Oglesby, W. H. (2021). Population health: Creating a culture of wellness (3rd ed.) Jones & Bartlett Learning.
SB0266. (2024). Medical amendments. Retrieved from: https://le.Utah.Gov/~2024/bills/static/SB0266.Html#63i-1-258
U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (2023). Psychedelic drugs: Considerations for clinical investigations guidance for industry. Retrieved from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/psychedelic-drugs-considerations-clinical-investigations
DIrections for Response:
Respond to two other students in reply posts of 100-150 words with a minimum of 1 reference per reply post to answer this question, “How might policies other than those directly concerning health care influence the health of a population?”
