HB 344-DRUG PRESCRIPTION DATABASE  3:48:31 PM CHAIR SEATON announced that the next order of business would be HOUSE BILL NO. 344, "An Act relating to the controlled substance prescription database; and providing for an effective date." 3:48:48 PM REPRESENTATIVE VAZQUEZ moved to adopt the proposed committee substitute (CS) for HB 344, labeled 29-LS1378\N, Bruce, 3/14/16, as the working draft. CHAIR SEATON objected for discussion. 3:49:25 PM TANEEKA HANSEN, Staff, Representative Paul Seaton, Alaska State Legislature, stated that this version added a seven day limit to initial opiate prescriptions; it limited the prescription drug monitoring program to only Schedule II, III, and IV drugs; changed the reporting requirement for the database from "near real time" to "at least weekly;" changed the mandatory review of the database from only dispensers to include dispensing, prescribing, or administering of controlled substances, with some exceptions; restricted the delegation of authority or access or the ability to submit information to the database to only licensed or registered employees; directed the Department of Commerce, Community & Economic Development to establish registration fees to cover the costs of data base operation, if no federal grants are established; and changed transition language to give regulatory authority to the Department of Commerce, Community & Economic Development, with a more immediate effective date. She paraphrased from the "Summary of Changes: Version H to Version N" [included in members' packets], which read: Title On lines 2- 4 the title has been expanded to include 'relating to the prescription f opiates; relating to the practice of dentistry; relating to the practice of medicine; relating to the practice of nursing; relating to the practice of optometry; relating to the practice of veterinary medicine' to reflect the inclusion of seven day prescription restriction. Section 1-12 New sections 1-12 were added to limit opiate prescriptions under the following boards; dentistry, medicine, nursing, and optometry. Under each board, an initial opiate prescription is limited to seven days unless the practitioner documents a logistical or medical need for a longer supply, and prescriptions in excess of the dosage without documented reasons can be grounds for disciplinary action. Additional language was added to section 1 (Board of Dental Examiners), section 7 (Board of Nursing), and section 10 (Board of Optometry) allowing disciplinary action if drugs are dispensed, prescribed or sold drugs in violation of law regardless of whether there has been criminal actions. This mirrors existing language in the State Medical Board (section 4). 3:53:32 PM REPRESENTATIVE WOOL asked why the Board of Veterinary Medicine had been included. MS. HANSEN explained that the adult seven day limit had not been added to Board of Veterinary Examiners, although the disciplinary language had been added because, as all practitioners were required to submit information on controlled substances to the boards, this included the Board of Veterinary Examiners as they are able to provide opiates. She relayed an anecdote about the increase in opiates being prescribed for animals. CHAIR SEATON referenced the maximum dosage and asked whether this was for the number of pills prescribed or for a milligram limitation. MS. HANSEN replied that the limitation was for the number of pills, and not for the dosage level. CHAIR SEATON reported that, although some states had limited the milligrams per pill as recommended by the CDC, the focus of the proposed bill was a concern for opioid addiction and the duration of the prescriptions. 3:56:54 PM MS. HANSEN moved on to address Section 13 and Section 14, which read: Section 13 This new section adds language to the Board of Veterinary Examiners allowing disciplinary action if drugs are dispensed, prescribed or sold drugs in violation of law regardless of whether there has been criminal actions. This mirrors existing language in the State Medical Board (section 4). Section 14 Language referencing the state controlled substance schedules and federal schedules I and V has been removed; this will limit the database to only drugs in the federal schedules II, III, and IV. Language regarding the Department of Commerce, Community, and Economic Development assisting the board of pharmacy with implementing the database has been moved to a later section. 3:57:44 PM MS. HANSEN discussed Section 15 and Section 16, which read: Section 15 Language referencing the state controlled substance schedules and federal schedules I and V has been removed; this means the database will only be accessed for drugs in the federal schedule II, III, and IV. The reporting requirement in this section has changed, from near-real-time to at least weekly. Section 16 AS 17.30.200(d)(3) has been amended to state that a licensed or registered practitioner with prescription authority is allowed access to the database. This is intended to capture practitioners in federal facilities that are not required to be licensed with the state but that may be registered. 3:59:04 PM MS. HANSEN addressed Section 19, which read: Section 19 Language directing dispensers to access the database prior to dispensing and to report the prescription at near real time has been deleted and replaced with subsections k (3), k (4), and k (5) requiring all practitioners to check the database prior to dispensing, prescribing, or administering schedule II, III, or IV controlled substances but creating exemptions for emergent situations, surgery or medical procedures. This section also creates alternate procedures for practitioners with technological barriers, previously included in a later section. 4:00:36 PM MS. HANSEN directed attention to Section 20, which read: Section 20 The language previously in subsection (o), creating a technology exemption, has been moved to section 18. The remaining subsections have been reordered. Subsection (p) (previously subsection q) has been amended to reflect that the database has been limited to only schedule II, III, or IV controlled substances. A new subsection (q) has been added to state that a practitioner may only delegate database access or information submittal to an agent or employee who is who is licensed or registered in the state. Subsection (r) directs the Department of Commerce, Community, and Economic Development to notify each board when a practitioner registers with the database (previously required of the Board of Pharmacy). The Board of Veterinary Examiners was added to assist the Board of Pharmacy in implementing this section, language that was previously under AS 17.30.200(a). Additionally, the department shall establish regulations for registration with the database, which will cover the cost of the database minus all federal funds. 4:02:01 PM MS. HANSEN discussed Section 21, which read: Section 21 The transition regulatory authority has been expanded from just the Board of Pharmacy to now include the Department of Commerce, Community, and Economic Development and each board whose licensees will be required to register. 4:02:24 PM MS. HANSEN paraphrased Section 22, the new Subsection 23, and Section 24, which read: Section 22 The transition language has been amended to require the Board of Pharmacy to provide information and training on this act to the other boards. Subsection (b) has been deleted. New Subsection 23 New subsection 23 has been added which will enact AS 17.30.200(r) in September 1, 2016. This is the section the Department to establish registration fees. Section 24 The effective date (relating to transition language) has been amended to take effect immediately. 4:03:42 PM MS. HANSEN concluded with Section 25, which read: Section 25 The effective date of the bill has been amended to July 1, 2017. MS. HANSEN, in response to Representative Wool, said that previously all state and federally controlled substances were included, whereas now it was limited to Schedule II, III, and IV drugs of the federal schedule. She stated that all the drugs in the federal Schedule I were illegal, and Schedule V drugs included cough medicine and Tylenol with Codeine. CHAIR SEATON relayed that Schedule IV included benzodiazepine, whereas Ritalin was a Schedule II drug. REPRESENTATIVE WOOL asked for clarification that benzodiazepine was previously on the database requirement, pointing out that earlier testimony had indicated that it, in combination with opiates, "was a very bad combination." He asked if many of these drugs would fall into the category for an initial 7-day limit to the prescriptions. MS. HANSEN relayed that the 7-day limit was specific to opiates; however, reporting to the database included all controlled substance in Schedules II, III, or IV. She pointed out that the 7-day limit would not apply to any refill for a chronic illness. REPRESENTATIVE VAZQUEZ asked how the 7-day limit would work in the rural villages. MS. HANSEN directed attention to Section 2 of the proposed CS, Version N, which described the maximum dosage for opiate prescriptions. Pointing to page 3, line 27, she read: a patient who is unable to access a practitioner within the time necessary for a refill of the seven- day supply because of a logistical or travel barrier; the licensee may write a prescription for an opiate for the quantity needed to treat the patient for the time that the patient is unable to access a practitioner. MS. HANSEN relayed that, for an adult, this would just apply to the initial prescription, and if diagnosed with a chronic issue requiring a longer prescription, the refills would not have this same requirement. 4:09:01 PM SUSIE EDWARDSON, Staff, Representative Paul Seaton, Alaska State Legislature, reported on the recommendations from Centers for Disease Control and Prevention (CDC), which included that 3 days or less was sufficient for opiate prescriptions, while more than 7-days would rarely be necessary. She shared that a recent bill in Massachusetts limited initial opioid prescriptions to a 7-day supply, while also requiring practitioners to check the database for drugs which have a high potential for abuse, and that Maine was working on a similar bill which would set a 3-day limit. She stated that another CDC recommendation was for clinicians to review a patient's history for controlled substance prescriptions. She noted that a CDC recommendation not included in the proposed bill was to limit dosage to 5 morphine milligram equivalent (MME) daily, while limiting any increase of dosage to 90 MME. CHAIR SEATON pointed out that, although CDC had also recommended that any dosage over 90 MME should be noted on the prescription, the proposed bill did not include this recommendation. REPRESENTATIVE WOOL suggested that the prescription for a horse may exceed this. CHAIR SEATON added that federal practitioners were not required to be licensed in Alaska, hence the addition of "registered" to the proposed bill. 4:12:54 PM CHAIR SEATON removed his objection. There being no further objection, the proposed committee substitute Version N was adopted as the working draft. 4:13:45 PM CHAIR SEATON moved to adopt proposed Amendment 1, labeled 29- LS1378\N.1, Bruce, 3/14/16, which read: Page 13, lines 18 - 19: Delete "database at least weekly [BOARD]" Insert "board, at least weekly" Page 13, line 20: Delete "[FOR INCLUSION IN THE DATABASE]" Insert "for inclusion in the database" Page 18, following line 3: Insert a new subsection to read: "(s) The board shall, on a weekly basis, update the database with the information submitted to the board under (b) of this section." REPRESENTATIVE VAZQUEZ objected for discussion. 4:13:59 PM MS. HANSEN explained the proposed amendment, stating that it clarified that practitioners and dispensers would submit information to the board at least weekly, and that the board was required to update the database with the submitted information at least weekly. 4:15:10 PM The committee took an at-ease from 4:15 p.m. to 4:17 p.m. 4:17:11 PM REPRESENTATIVE VAZQUEZ removed her objection. There being no further objection, Amendment 1, labeled 29-LS1378\N.1, Bruce, 3/14/16, was adopted. MS. HANSEN explained that some of the written testimony had mentioned that the requirement for a mandatory review for all controlled substances could be onerous for some practitioners. There had been a suggestion to limit the review of Schedule IV to just benzodiazepine because of its aforementioned interaction with other drugs, although further review had indicated that other Schedule IV drugs had adverse interactions with opiates. CHAIR SEATON declared that he wanted to ensure that the public comments had been considered. He offered his belief that it was better, and less confusing, to include all the Schedule II, III, and IV drugs. REPRESENTATIVE WOOL asked to hear from the Alaska Pharmacists Association, noting that some of the drugs in and of themselves were not dangerous. He expressed the need for a database for opiates. CHAIR SEATON said that public testimony would be opened up again. He stated that he wanted to get the issues on the record for consideration prior to public testimony. MS. HANSEN suggested that the proposed bill state that the database must be reviewed prior to dispensing, prescribing, or administering a controlled substance. The regulation must provide that the practitioner is not required to review the information in the database before dispensing, prescribing, or administering a controlled substance for less than a 3-day supply. She stated that this would include all controlled substances, and should alleviate some of the concerns for the burden. CHAIR SEATON reflected that a 3-day supply was enough for most people, and asked whether doctors would prescribe the lesser amount. He offered his belief that the issue was a result of too long a course for opioid prescriptions. He asked for input from the committee. REPRESENTATIVE WOOL mused that some drugs were stronger than others, and, as not all drugs were measured in MME, it was difficult to micromanage the prescriptions. CHAIR SEATON pointed out that this was an exception and, by controlling the initial prescription, was an attempt to limit opioid addiction in the state. REPRESENTATIVE VAZQUEZ asked for testimony from Dr. Butler. 4:28:16 PM JAY BUTLER, MD, Chief Medical Officer/DPH Director, Central Office, Division of Public Health, Department of Health and Social Services, opined that it was a difficult issue to maintain access to appropriate care for pain yet prevent misuse of the drugs, with the unintentional risk for overdose. He suggested an additional exemption for a supply of less than x number of days, pointing out that the CDC guidelines for 3-days or less were often sufficient, whereas more than 7-days was rarely needed. This exemption for less than 7-days could be more acceptable to many providers, while not creating any unintentional barriers to the treatment of pain. CHAIR SEATON mused that the proposed bill stated that the initial prescription could not be longer than 7-days, and asked if anything under 7-days should be exempt. DR. BUTLER relayed that he was speaking specifically to the requirement for the review of the database. He acknowledged that this could be for a shorter time frame, although he was trying to strike a balance for not being overly burdensome or creating barriers to treatment for acute pain. He said that it was not entirely clear for prescriptions to outpatient procedures in advance of the procedure. CHAIR SEATON suggested that this would be covered under a less than 3-day exemption. REPRESENTATIVE VAZQUEZ asked for clarification, was this less than 3 days, or 3 days or less. DR. BUTLER replied that there was nothing really magic in either, that the reference had been to the CDC guidelines, which read, 3 days or less will often be sufficient in treatment of acute pain. CHAIR SEATON pointed out that this only applied to the initial prescription for 7-days, not to renewals. He reported that the prescriptions for 3-days or less without refills could also be an issue. He stated that the exemption was not intended to allow for open ended prescription refills of 3-days or less. REPRESENTATIVE WOOL asked whether to include Schedule IV drugs for the mandatory database review. DR. BUTLER reminded the committee that there was an increased risk of fatal overdose when opioids and benzodiazepine were co- administered. He shared that many prescribers had stated they prescribed Schedule IV drugs more frequently than Schedule II drugs. He reported that the 2015 annual report had listed 238,000 prescriptions for Schedule II and III drugs, with 429,000 for Schedules II, III, and IV in the Prescription Drug Monitoring Program (PDMP), even as the PDMP was fairly incomplete. CHAIR SEATON asked for clarification that the medical recommendations was for Schedules II, III, and IV. DR. BUTLER stated that this was a difficult question. If the outcome were solely to reduce the risk of overdose, including the Schedule IV drugs made a lot of sense; however, in looking at the practicality of what could actually be done and what providers would adopt and do, there were some reservations for this. REPRESENTATIVE WOOL asked if all the Schedule IV drugs, such as Robitussin for a cough or Tylenol with codeine, would have to be entered into the database. He asked whether it would be best to include all of them, or limit it to select drugs, in order to decrease the possible burden. DR. BUTLER clarified that Robitussin was a Schedule V drug, as was gabapentin which was used for chronic pain syndrome as it had a very low abuse potential, and both of these were excluded. CHAIR SEATON questioned whether 3-days or less, without refills and exempt from the requirements, would be beneficial to the practice of medicine. He asked about the risk for overdoses. DR. BUTLER replied that this would be less burdensome on providers. He stated that a situation where a very small quantity was prescribed had a lower risk for overdose or addiction. 4:42:00 PM CHAIR SEATON opened public testimony. 4:42:17 PM BARRY CHRISTENSEN, Pharmacist, Alaska Pharmacists Association, reported that he was also the co-chair of the Legislative committee for the Alaska Pharmacists Association. He said the association represented over 200 pharmacists and pharmacy technicians in the state. He declared that proposed HB 344 was a "step in the right direction for helping opiate abuse and prescription drug abuse in the State of Alaska." He applauded the change from real time to weekly down loads as being more cost effective and technologically available. He expressed agreement that all users of the database should be licensed, pointing out that all the pharmacy technicians working around medications were licensed. He expressed concern that the requirement for both prescribers and pharmacists to check the database prior to every controlled substance prescription was duplicative and time consuming. He pointed out that the PDMP was only one tool used by pharmacists when trying to rule out possible narcotic abuse. He pointed out that this would have a big impact. He reported that real time prescription insurance data checks were performed when processing prescriptions, as almost 90 percent of prescriptions were done through insurance. He stated that the 3-day prescription may have some merit. REPRESENTATIVE WOOL asked for clarification for the statement that it was duplicative for both the prescriber and the dispenser to check the PDMP database. He offered his belief that this was a good safe guard. MR. CHRISTENSEN replied that the pharmacists have been using the database since its onset, but that the best time to utilize the database was before a prescription was written. He acknowledged that there were instances when both should be checking the database, but that professional judgement should dictate when. REPRESENTATIVE WOOL asked which end of the database check to make optional. MR. CHRISTENSEN offered his belief that the pharmacist end should be optional, as "it makes sense that it be dealt with before the prescription is written rather than after in terms of checking for potential abuse by the patient." He allowed that it should be possible for pharmacists to double check when "we do have warning flags come up." CHAIR SEATON asked if the option for the pharmacist to delegate the database check would alleviate the situation. MR. CHRISTENSEN expressed appreciation for the option, and although it did help the situation, it still affected work flow. REPRESENTATIVE VAZQUEZ asked when it made sense for the pharmacist to review the database. MR. CHRISTENSEN replied that there were several times, including when there was a new patient, multiple prescriptions for narcotics, or a large quantity of narcotics. He added that patient refusal to use insurance also raised concerns. CHAIR SEATON shared the concern that availability of the database, without any requirement to check it, had not been sufficient to stop the availability of many prescription medications. He reported that the proposed bill was also an attempt to include the prescribers. REPRESENTATIVE VAZQUEZ asked for his opinion about the 3-day or less exemption. MR. CHRISTENSEN relayed that, although this would ease the burden "on a certain number of prescriptions," he was unsure for how much it would decrease the work load. He pointed out that they would most likely have not looked at the database for those prescriptions anyway. REPRESENTATIVE WOOL asked if the aforementioned "flags" were in the database. MR. CHRISTENSEN replied that most flags were through the insurance system, reiterating that almost 90 percent of the prescriptions were processed on-line at the time of dispensing. He agreed that those flags would also show up on the PDMP database. 4:54:59 PM JERRY BROWN, Pharmacist, echoed some of the earlier comments, including the removal of pharmacists for the mandatory requirement to check the database for every narcotic prescription. He offered his belief that it was not necessary to be checked every time. He stated that he had problems with the 7-day and the 3-day quantity, as prescribers would not check the database. He suggested to use a 5-day supply instead. He declared that there would always be a flag when checking the data base because of the limited initial prescription amount, and that additional time would be spent making a determination for whether this was overprescribing or a restriction on the prescription. He reported that, under Medicaid, the first pharmacist was paid a dispensing fee for the first prescription, but a second pharmacy did not receive any dispensing fee, thereby being placed at a greater financial disadvantage. He pointed to the difficulties presented by shorter initial prescriptions when living in a remote area. He suggested that 5-day prescriptions were not so onerous for the patient. MR. BROWN said that exempting emergency rooms and the prescribers for a 3-day or 5-day supply would remove the database checks. He stated that the proposed bill was micro managing the professions of medicine and pharmacy, but it did not help for the actual problem, the writing of the prescription. He stated that the proposed bill actually exempted that group from compliance for checking the database, which was its purpose. 5:02:31 PM DANIEL NELSON, President, Alaska Pharmacists Association, Tanana Chiefs Conference, echoed the earlier comments, stating that the requirement for mandatory PDMP queries by pharmacists and prescribers was overly onerous and micro managing the practice of medicine and pharmacy. He recommended that the language be removed from the proposed bill. He stated that this was a duplicative process, and there was not any rationale for the pharmacist to check after the prescriber had done so. He stated that 10 - 12 percent of prescriptions written were for controlled substances. He estimated that it would take two to three minutes per query, which was 3 - 4.5 hours daily in his pharmacy. He reported that Alaska had one of the lowest per capita prescriptions of opioids in the United States. 5:05:49 PM CHAIR SEATON closed public testimony on HB 344 after ascertaining no one further wished to testify. [HB 344 was held over.]