HOUSE OF REPRESENTATIVES STAFF ANALYSIS BILL #: HB 725 Nonopioid Alternatives Educational Materials SPONSOR(S): Plakon TIED BILLS: IDEN./SIM. BILLS: SB 530 REFERENCE ACTION ANALYST STAFF DIRECTOR or BUDGET/POLICY CHIEF 1) Professions & Public Health Subcommittee 15 Y, 0 N Grabowski McElroy 2) Health & Human Services Committee 18 Y, 0 N Grabowski Calamas SUMMARY ANALYSIS Substance abuse affects millions of people in the U.S. each year. Drug overdoses have steadily increased and now represent the leading cause of accidental death in the U.S., the majority of which involve an opioid. In Florida, opioids (licit and illicit) were responsible for more than 6,000 deaths in 2019. The National Institute of Health reports that the majority of heroin users first misused a prescription opioid. The Department of Health (DOH) publishes an educational pamphlet regarding the use of non-opioid alternatives to treat pain on its website. Current law requires health care practitioners, except pharmacists, to discuss non-opioid alternatives with a patient or the patient’s representative prior to prescribing, ordering, dispensing, or administering opioids. A health care practitioner must also provide a printed copy of the DOH- developed pamphlet to a patient or the patient’s representative and document the discussion in the patient’s medical record. The law exempts emergency and hospice care from these requirements. HB 725 modifies the existing requirements by allowing practitioners to provide each patient with an electronically transmitted copy of the DOH pamphlet as an alternative to a printed pamphlet. The bill has no fiscal impact on state or local government. The bill provides an effective date of July 1, 2021. This document does not reflect the intent or official position of the bill sponsor or House of Representatives . STORAGE NAME: h0725c.HHS DATE: 3/9/2021 FULL ANALYSIS I. SUBSTANTIVE ANALYSIS A. EFFECT OF PROPOSED CHANGES: Present Situation Substance Abuse Substance abuse refers to the harmful or hazardous use of psychoactive substances, including alcohol and illicit drugs.1 Substance abuse disorders occur when the chronic use of alcohol or drugs causes significant impairment, such as health problems, disability, and failure to meet major responsibilities at work, school, or home.2 Repeated drug use leads to changes in the brain’s structure and function that can make a person more susceptible to developing a substance abuse disorder.3 Brain imaging studies of persons with substance abuse disorders show physical changes in areas of the brain that are critical to judgment, decision making, learning and memory, and behavior control.4 According to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, a diagnosis of substance abuse disorder is based on evidence of impaired control, social impairment, risky use, and pharmacological criteria.5 The most common substance abuse disorders in the United States are from the use of alcohol, tobacco, cannabis, stimulants, hallucinogens, and opioids.6 Opioid Abuse Opioids are psychoactive substances derived from the opium poppy, or their synthetic analogues.7 They are commonly used as pain relievers to treat acute and chronic pain. An individual experiences pain as a result of a series of electrical and chemical exchanges among his or her peripheral nerves, spinal cord, and brain.8 Opioid receptors occur naturally and are distributed widely throughout the central nervous system and in peripheral sensory and autonomic nerves.9 When an individual experiences pain, the body releases hormones, such as endorphins, which bind with targeted opioid receptors.10 This disrupts the transmission of pain signals through the central nervous system and reduces the perception of pain.11 Opioids function in the same way by binding to specific opioid receptors in the brain, spinal cord, and gastrointestinal tract, thereby reducing the perception of pain. 12 Opioids include:13 Buprenorphine (Subutex, Suboxone); 1 World Health Organization, Substance Abuse, available at http://www.who.int/topics/substance_abuse/en/ (last visited February 23, 2021). 2 Substance Abuse and Mental Health Services Administration, Mental Health and Substance Use Disorders, (last rev. April 2019), available at http://www.samhsa.gov/disorders/substance-use (last visited February 23, 2021). 3 National Institute on Drug Abuse, Drugs, Brains, and Behavior: The Science of Addiction, available at https://www.drugabuse.gov/publications/drugs-brains-behavior-science-addiction/drug-abuse-addiction (last visited February 23, 2021). 4 Id. 5 Supra note 2. 6 Id. 7 World Health Organization, Information Sheet on Opioid Overdose, (Aug. 2018), available at http://www.who.int/substance_abuse/information-sheet/en/ (last visited February 23, 2021). 8 National Institute of Neurological Disorders and Stroke, Pain: Hope through Research, (last rev. Aug. 13, 2019), available at https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Hope-Through-Research/Pain-Hope-Through-Research (last visited February 23, 2021). 9 Gjermund Henriksen, Frode Willoch; Brain Imaging of Opioid Receptors in the Central Nervous System, 131 BRAIN 1171-1196 (2007), available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2367693/ (last visited February 23, 2021). 10 Id. 11 Id. 12 Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, SAMHSA Opioid Overdose Prevention Toolkit: Facts for Community Members (2013, rev. 2014) 3, available at https://www.integration.samhsa.gov/Opioid_Toolkit_Community_Members.pdf (last visited February 23, 2021). 13 Florida Department of Law Enforcement, Medical Examiners Commission, Drugs Identified in Deceased Persons by Florida Medical Examiners 2019 Annual Report, (Nov. 2020), available at http://www.fdle.state.fl.us/MEC/Publications-and-Forms/Documents/Drugs-in- Deceased-Persons/2019-Annual-Drug-Report.aspx (last visited February 23, 2021). STORAGE NAME: h0725c.HHS PAGE: 2 DATE: 3/9/2021 Codeine; Fentanyl (Duragesic, Fentora); Fentanyl Analogs; Heroin; Hydrocodone (Vicodin, Lortab, Norco); Hydromorphone (Dilaudid, Exalgo); Meperidine; Methadone; Morphine; Oxycodone (OxyContin, Percodan, Percocet); Oxymorphone; Tramadol; and U-47700. Opioids are commonly abused, with an estimated 15 million people worldwide suffering from opioid dependence.14 Opioids can create a euphoric feeling because they affect the regions of the brain involved with pleasure and reward, which can lead to abuse.15 Continued use of these drugs can lead to the development of tolerance and psychological and physical dependence.16 This dependence is characterized by a strong desire to take opioids, impaired control over opioid use, persistent opioid use despite harmful consequences, a higher priority given to opioid use than to other activities and obligations, and a physical withdrawal reaction when opioids are discontinued.17 Nearly 80 percent of people who use heroin first misused prescription opioids.18 An overabundance of opioids in the body can lead to a fatal overdose. In addition to their presence in major pain pathways, opioid receptors are also located in the respiratory control centers of the brain.19 Opioids disrupt the transmission of signals for respiration in the identical manner that they disrupt the transmission of pain signals. This leads to a reduction, and potentially cessation, of an individual’s respiration. Oxygen starvation will eventually stop vital organs like the heart, then the brain, and can lead to unconsciousness, coma, and possibly death.20 Within three to five minutes without oxygen, brain damage starts to occur, soon followed by death.21 However, this does not occur instantaneously as people will commonly stop breathing slowly, minutes to hours after the drug or drugs were used.22 An opioid overdose can be identified by a combination of three signs and symptoms referred to as the “opioid overdose triad”: pinpoint pupils, unconsciousness, and respiratory depression.23 The drug overdose death rate involving opioids has increased by 200% since 2000 and has now become the leading cause of accidental deaths in the United States.24 Opioid-involved overdoses accounted for 69 percent of drug overdose deaths in 2018.25 Nationwide, in 2017, there were 47,600 14 Supra note 7. 15 National Institute on Health, National Institute on Drug Abuse, Misuse of Prescription Drugs: What Classes of Prescription Drugs Are Commonly Misused?, (rev. Dec. 2018), available at https://www.drugabuse.gov/publications/research-reports/misuse-prescription- drugs/which-classes-prescription-drugs-are-commonly-misused (last visited February 23, 2021). 16 Supra note 9. 17 Supra note 7. 18 National Institute on Health, National Institute on Drug Abuse, Prescription Opioids and Heroin: Prescription Opioid Use Is a Risk Factor for Heroin Use, (rev. Jan. 2018), available at https://www.drugabuse.gov/publications/research-reports/relationship-between- prescription-drug-heroin-abuse/prescription-opioid-use-risk-factor-heroin-use (last visited February 23, 2021). 19 K.T.S. Pattinson, Opioids and the Control of Respiration, BRITISH JOURNAL OF ANAESTHESIA, Volume 100, Issue 6, pp. 747-758, available at http://bja.oxfordjournals.org/content/100/6/747.full (last visited February 23, 2021). 20 Harm Reduction Coalition, Guide to Developing and Managing Overdose Prevention and Take-Home Naloxone Projects (Fall 2012), http://harmreduction.org/wp-content/uploads/2012/11/od-manual-final-links.pdf (last visited February 23, 2021). 21 Id. at 9. 22 Id. at 9. 23 Supra note 7. 24 Rose Rudd, MSPH, et. al., Increases in Drug and Opioid Overdose Deaths – United States, 2000-2014, Morbidity and Mortality Weekly Report (MMWR) 64(50); Jan. 1, 2016, at 1378-82, available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6450a3.htm?s_cid=mm6450a3_w (last visited February 23, 2021). 25 Centers for Disease Control and Prevention, Drug Overdose Deaths, (last rev. Mar 19, 2020), available at https://www.cdc.gov/drugoverdose/data/statedeaths.html (last visited February 23, 2021). STORAGE NAME: h0725c.HHS PAGE: 3 DATE: 3/9/2021 deaths that involved an opioid (licit or illicit), and 17,029 people died from overdoses involving prescription opioids.26 In 2019, Florida had the following opioid-involved deaths:27 Opioid Caused Death Present at Death Oxycodone 510 671 Hydrocodone 165 393 Methadone 174 144 Morphine 984 871 Fentanyl 3,244 411 Fentanyl Analogs 922 496 Heroin 809 145 Controlled Substance Prescribing in Florida: Chronic Pain Every physician, podiatrist, or dentist, who prescribes controlled substances in the state to treat chronic nonmalignant pain,28 must register as a controlled substance prescribing practitioner and comply with certain practice standards specified in statute and rule.29 Before prescribing controlled substances to treat chronic nonmalignant pain, a practitioner must:30 Complete a medical history and a physical examination of the patient which must be documented in the patient’s medical record and include: o The nature and intensity of the pain; o Current and past treatments for pain; o Underlying or coexisting diseases or conditions; o The effect of the pain on physical and psychological function; o A review of previous medical records and diagnostic studies; o A history of alcohol and substance abuse; and o Documentation of the presence of one or recognized medical indications for the use of a controlled substance. Develop a written plan for assessing the patient’s risk for aberrant drug-related behavior and monitor such behavior throughout the course of controlled substance treatment; Develop a written individualized treatment plan for each patient stating the objectives that will be used to determine treatment success; Discuss the risks and benefits of using controlled substances, including the risks of abuse and addiction, as well as the physical dependence and its consequences with the patient; and Enter into a controlled substance agreement with each patient that must be signed by the patient or legal representative and by the prescribing practitioner and include: o The number and frequency of prescriptions and refills; o A statement outlining expectations for patient’s compliance and reasons for which the drug therapy may be discontinued; and o An agreement that the patient’s chronic nonmalignant pain only be treated by a single treating practitioner unless otherwise authorized and documented in the medical record. A prescribing practitioner must see a patient being treated with controlled substances for chronic nonmalignant pain at least once every three months and must maintain detailed medical records relating to such treatment.31 Patients at special risk for drug abuse or diversion may require 26 L. Scholl, et. al. Drug and Opioid-Involved Overdose Deaths – United States, 2013-2017, Morbidity and Mortality Weekly Report (MMWR) 64(50); Jan. 4, 2019, at 1378-82, available at https://www.cdc.gov/mmwr/volumes/67/wr/mm675152e1.htm?s_cid=mm675152e1_w (last visited February 23, 2021). 27 Supra note 13. “Caused death” means that the medical examiner determined the drug played a causal role in the death. “Present at death” means the medical examiner determine that the drug is present or identifiable but may not have played a causal role in the death. 28 “Chronic nonmalignant pain” is defined as pain unrelated to cancer which persists beyond the usual course of disease or the injury that is the cause of the pain or more than 90 days after surgery. Section 456.44(1)(e), F.S. 29 Chapter 2011-141, s. 3, Laws of Fla. (creating s. 456.44, F.S., effective July 1, 2011). 30 Section 456.44(3), F.S. 31 Section 456.44(3)(d), F.S. STORAGE NAME: h0725c.HHS PAGE: 4 DATE: 3/9/2021 consultation with or a referral to an addiction medicine physician or a psychiatrist.32 The prescribing practitioner must immediately refer a patient exhibiting signs or symptoms of substance abuse to a pain management physician, an addiction medicine specialist, or an addiction medicine facility.33 Controlled Substance Prescribing in Florida: Acute Pain The Boards of Dentistry, Medicine, Nursing, Optometry, Osteopathic Medicine, and Podiatric Medicine, have adopted rules for prescribing a controlled substance to treat acute pain.34 Under these rules, a health care practitioner must:35 Conduct a medical history and physical examination of the patient and document the patient’s medical record, including the presence of one or more recognized medical indications for the use of a controlled substance; Create and maintain a written treatment plan, including any further diagnostic evaluations or other treatments planned including non-opioid medications and treatments; Obtain informed consent and agreement for treatment, including discussing the risks and benefits of using a controlled substance; expected pain intensity, duration, options; and use of pain medications, non-medication therapies, and common side effects; Periodically review the treatment plan; Refer the patient, as necessary, for additional evaluation and treatment in order to meet treatment goals; Maintain accurate and complete medical records; and Comply with all controlled substance laws and regulations. A health care practitioner who fails to follow the guidelines established by the appropriate regulatory board is subject to disciplinary action against his or her license. Continuing Education on Controlled Substance Prescribing All health care practitioners who are authorized to prescribe controlled substances must complete a