HB 159-OPIOIDS;PRESCRIPTIONS;DATABASE;LICENSES  3:03:59 PM CHAIR SPOHNHOLZ announced that the first order of business would be HOUSE BILL NO. 159, "An Act relating to the prescription of opioids; establishing the Voluntary Nonopioid Directive Act; relating to the controlled substance prescription database; relating to the practice of dentistry; relating to the practice of medicine; relating to the practice of podiatry; relating to the practice of osteopathy; relating to the practice of nursing; relating to the practice of optometry; relating to the practice of veterinary medicine; related to the duties of the Board of Pharmacy; and providing for an effective date." 3:04:59 PM JAY BUTLER, MD, Chief Medical Officer/ DPH Director, Central Office, Division of Public Health, Department of Health and Social Services, stated that there had been a fourfold increase in the number of opioid associated deaths in the past 20 years. He declared that this was an opioid epidemic, pointing out that no other cause of death had increased so remarkably over such a short period of time. He reported that there was also an increase in the rates of Hepatitis C, as well as other burdens on the health care system associated with increased use of opioids, both legal and illicit. He said that there were many things that had to be done, which would require a multi-faceted approach. He declared that it was necessary to address the needs of people who were currently struggling with addiction, and to prevent addiction through more evidence based prescribing practices, control the flood of prescription opioids in the community, and address the access to treatment and the de- stigmatization by improving provider knowledge. He reported that there had been an increase in illicit opioid use, beginning with heroin in the past five years, and more recently with fentanyl and other synthetic opioids. He noted that 80 percent of heroin users started opioid use with prescription painkillers. He said that HB [159] aligned with many prescribing guidelines delivered to the legislature from the health care boards through Senate Bill 74 in 2016, as well as the Centers for Disease Control and Prevention pain management guidelines, and the Surgeon General's report on alcohol, drugs, and health. He added that recent statements from the American Medical Association and the American Dental Association, as well as recommendations for evidence based improvement and prescription drug monitoring from the PEW Charitable Trust also supported these guidelines. DR. BUTLER offered to outline the proposed bill for three particular areas: patients, providers, and the prescription drug monitoring program. He said that proposed HB [159] empowered patients in two ways, it provided an option for those who did not wish to be prescribed opioids to communicate that preference to the providers by way of a voluntary revocable opioid advanced directive which could be placed on the medical record. He shared that this had been a request from the recovery community, describing the challenges they faced in interactions with the health care system when a provider was unaware that the patient was in recovery. He shared that the second way was that it allowed patients to request that the pharmacist dispense less than the total prescribed amount. He said that a partial fill was authorized under federal law, with a goal to affirm the rights of the patient and the authority of the pharmacist. He said that a portion of the continuing professional education that health care providers must receive would include a section of at least two hours designated on pain management and the basics of addiction medicine. He explained that the renewal of a medical license required at least 40 hours of continuing medical education credit. He said that the second component for providers was a setting of dispensing limits for the initial opioid prescription to no more than 7 days. He added that the proposed bill did allow exceptions, when in the professional judgment of the provider, a longer supply was necessary due to chronic pain, severe acute pain, cancer pain, or palliative care, or when a longer supply was necessary due to travel or other logistical barriers. The third component was for changes to the prescription drug monitoring program, a data base accessible to prescribers and dispensers, in order to share information about controlled substances. He declared that the data base was secure and confidential, and met the requirements of the Health Insurance Portability and Accountability Act (HIPAA). He added that this database was not openly available to law enforcement without appropriate search warrant authority. DR. BUTLER said that the proposed bill authorized the pharmacy board to issue routine periodic confidential reports to prescribers to provide feedback on their prescribing practices relative to those of their peers. These "report cards" were a good way to provide feedback for providers for their own prescribing habits. He said that this had been proven effective in other states for reducing the number of excessive prescriptions with other substances. He stated that the second component of the changes to the prescription drug monitoring program (PDMP) was for clarification to include veterinarians who prescribe opioids to register and use the monitoring program. He referenced recent media reports regarding attempts to get opioid medications from veterinarians. He explained that the third component was to make the PDMP a more useful tool by providing that pharmacists update the data on a daily, rather than weekly, basis. He stated that the proposed bill had a zero-fiscal note from the Department of Health and Social Services and the Department of Corrections, and a one-time cost of $27,500 from the Department of Commerce, Community & Economic Development to cover legal costs to amend the regulations and for printing. He directed attention to a letter of support from the Alaska Dental Society. REPRESENTATIVE TARR asked if there had been a response from pharmacists regarding the more frequent updating of PDMP. DR. BUTLER said that there had been this discussion with the pharmacists and that DHSS shared concern for any increased burden on the smaller pharmacies. He explained that there could be a delay for this requirement to take effect. He pointed out that some of the larger, more automated pharmacies already updated more frequently than currently required by law. 3:16:58 PM CHAIR SPOHNHOLZ asked about the option for patients to decline the full prescription amount, as it seemed counter intuitive to ask permission to accept less medicine than prescribed. She asked if that was not currently possible. DR. BUTLER offered his belief that "it depends on who you ask" and that federal law had recently changed, which clarified that pharmacists could do a partial fill at the request of the patient. REPRESENTATIVE KITO pointed out that there were certain medications which required the full regimen to be effective, which could lead to some confusion. DR. BUTLER acknowledged and stated that the law specified for federally designated Schedule 2 controlled substances. He said that this use for full regimen may have inadvertently lead to patient confusion with opioid prescriptions. 3:19:16 PM DR. BUTLER paraphrased from the Sectional Analysis [Included in members' packets], which read: Sec. 1 Adds a new Chapter 55, Voluntary Nonopioid Directive Act, to AS 13, Decedents' estates, guardianships, transfers, trusts, and health care decisions, that provides an option for patients to execute a Voluntary Nonopioid Directive that would allow a person in recovery (or for other reasons) to make clear the person's desire not to be administered an opioid. A person, guardian, conservator or other appointed person may revoke a directive at any time. The person would provide this confidential information to a health care provider or hospital on a form provided by the Department of Health of Social Services. The department would promulgate regulations on procedures, confidentiality, and exemptions for emergency or substance misuse treatment. Providers are not liable for following a directive. Prescriptions are assumed to be valid; pharmacists are not liable for dispensing a controlled substance in contradiction to a directive. The directive does not alter an advance health care directive, limit opioid overdose drugs, or limit treatment for substance abuse or opioid dependence. Sec. 2-25 Amend AS 08, Business and Professions, for the Boards of Dentistry, Medicine, Nursing, and Optometry to • Require two (2) hours of pain management and opioid misuse and addiction instruction; • Disciplinary actions for prescribing or dispensing an opioid in excess of the maximum dosage allowed by law or violated a law related to drugs, regardless of any criminal action; • Set the maximum dosage for initial opioid prescriptions at a seven-day supply unless, in the practitioner's professional judgment, it is necessary for chronic pain management or a patient is unable to access a practitioner in time to refill the prescription; and • Require, for a minor under 18 years of age, the practitioner discuss with the parent or guardian why the prescription is necessary and the risks associated with opioid use. Sec. 26-27 Amend AS 08.80 for the Board of Pharmacy to • Register with the Prescription Drug Monitoring Database (PDMP) with or without a federal Drug Enforcement Administration registration number; and • Allow pharmacists to dispense less than the prescribed amount of a schedule II or III controlled substance at a person's request; the pharmacists would inform the prescribing practitioner and the Prescription Drug Monitoring Database. Sec. 28 Amends AS 08.98 for the Board of Veterinary Medicine to • Register with the Prescription Drug Monitoring Database if the veterinarian has a federal Drug Enforcement Administration number; and • Identify resources and educational materials for veterinarians to identify clients at risk for opioid misuse or diversion of prescribed opioids. Sec. 29-36 Amend AS 17.30, Controlled Substances, to change the frequency pharmacists report to the Prescription Drug Monitoring Database from weekly to daily; remove the prohibition on sharing information with the federal government. The pharmacy board may provide a confidential unsolicited notification in summary form to a practitioner's licensing board which includes the basis for the notification. The notification must be provided to the practitioner as well. Sec. 37 Directs the Department of Health and Social Services to draft regulations to implement the Voluntary Nonopioid Directive Act. Sec. 38 Repeals sunset dates in sections 52 and 73 of Ch. 25, SLA 2016 (SB 74). Sec. 39-40 Set an immediate effective date and provide an effective date for regulations. 3:28:24 PM REPRESENTATIVE EASTMAN asked for the type of information on the report cards and whether the confidentiality was discoverable in any legal action. DR. BUTLER explained that the report cards, as used in other states, would compare the usage over the previous 12 months with other providers. He replied that he did not know if this was discoverable in a legal situation. REPRESENTATIVE EASTMAN directed attention to page 7, [lines 8 - 9] of the proposed bill, and questioned whether there should be sanctions "regardless of whether there has been a criminal action or patient harm." He expressed his concern, as there was the possibility of easily breaking one of many, many laws. He asked if this was opening up the providers to liability. Although he was unsure of the implications, he suggested this might require the hiring of extra staff to deal with potential technical violations, or the increasing of insurance coverage. He asked for the reason behind this language. DR. BUTLER offered his understanding that this language was not new in this bill. REPRESENTATIVE TARR directed attention to page 28, Section 36, of the proposed bill, and stated that she was supportive of the idea that providers be responsible, benchmark their practice against others, and adjust their own prescribing practices accordingly. She pointed out that the language was permissive and not required, and asked if this should be required. She declared that providers were part of the solution, as they recognized that there were alternative options for their patients to address health care needs. DR. BUTLER explained that the primary goal of Section 36 of the proposed bill was to provide authority to the Board of Pharmacy to issue the report cards, and whether or not it was a mandate was a matter of ideology. He said that, as the issuance of these types of report cards was not currently allowed under Alaska law, the desire was to establish the authority to do so. REPRESENTATIVE TARR asked if the board had a better understanding for whether this would be voluntary. She asked if these were the recommendations from the task force. DR. BUTLER, in reference to the Alaska Opioid Policy Task Force, said that a number of its recommendations were used in the bill. 3:35:28 PM CHAIR SPOHNHOLZ said that the bill would be held over.