Legislature(2015 - 2016)CAPITOL 106
01/26/2016 03:00 PM HEALTH & SOCIAL SERVICES
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SB 23-IMMUNITY FOR PROVIDING OPIOID OD DRUG 3:02:26 PM CHAIR SEATON announced that the first order of business would be CS FOR SENATE BILL NO. 23(JUD), "An Act relating to opioid overdose drugs and to immunity for prescribing, providing, or administering opioid overdose drugs." 3:04:19 PM SENATOR JOHNNY ELLIS, Alaska State Legislature, shared that the proposed bill represented life or death. He explained that many presidential nominees from both parties had been discussing this issue of opioid addiction. He reported that fatal drug overdoses had increased by more than six times in the past three decades, and now killed more than 36,000 Americans every year. In Alaska, heroin use and fatal drug overdose now claimed more lives than traffic fatalities. The Alaska State Troopers had identified the increase in heroin abuse and the continued use of other opiates as a significant concern. This abuse epidemic was largely driven by the addiction to prescription opioids, and, as these were now more difficult to obtain, the use of heroin was increasing. He referenced an article he had read many years ago, forecasting that the biggest drug problems in the U.S. would be abuse of prescription drugs, with a subsequent switch to "black tar heroin." He pointed out that there has not been much funding for methadone clinics to attempt to wean people off heroin. 3:08:15 PM SENATOR ELLIS stated that heroin abuse had exploded in the last decade, "had moved from the inner city and people of color, low income folks," and was now in the white, affluent suburbs and rural areas. He lamented that it had taken this demographic change for the problem to get attention. Between 2006 and 2013, the number of first time heroin users nearly doubled, with almost 80 percent of heroin users stating that they had previously abused prescription opioids. He reported that heroin and other opioid abuse had reached epidemic levels in Alaska, pointing out that this was not an urban phenomenon. Drug seizures and overdoses had occurred throughout Alaska. He relayed the police claim that thefts and prostitution were increasing because of heroin use. He reported that data in 2011 from the Centers for Disease Control and Prevention Youth Risk Behavior Survey showed that 15.8 percent of Alaska students reported use of prescription pills for pain medication that they stole from parents. These pills were more popular than alcohol, tobacco, or marijuana. He shared that opioid overdose was typically reversible through the timely administration of the medication, Naloxone, and the provision of emergency care. However, Naloxone is often not available when needed as overdose most often occurs with friends or family. He shared that medical professionals were wary of prescribing Naloxone, without any relief from potential civil liability, and lay persons were wary of administering it. He stated that proposed SB 23 would remove the civil liability from a doctor who prescribes and a lay person who administers Naloxone in those cases of an opioid overdose. He noted that Alaska would be the 43rd state to pass this bill. He called this a "life or death step forward." He noted that the proposed bill was supported by, among others, the Alaska State Medical Association, the Alaska Police Department Employee's Association, the Advisory Board on Alcoholism and Drug Abuse, the Alaska Mental Health Board, and the Alaska Mental Health Trust Authority. He stated that there was not any known opposition. 3:12:40 PM SENATOR ELLIS suggested two amendments for consideration, stating that the first amendment would add language to the proposed bill that any pharmacist who dispenses an opioid overdose drug must educate and train each person to whom the overdose drug was dispensed on how to administer the drug. The second proposed amendment would allow pharmacists in Alaska to prescribe an opioid overdose drug once the pharmacist had completed an opioid overdose drug training program. 3:13:56 PM SARAH EVANS, Staff, Senator Johnny Ellis, Alaska State Legislature, shared that heroin had wreaked havoc on her hometown of Dillingham. She reported that many states across the country had enacted laws that increased access to treatment for opioid overdose as a means to combat increasing overdose rates. She declared that proposed SB 23 provided immunity from civil liability to health care providers who prescribe and to by-standers who administer opioid overdose drugs, such as Naloxone, in cases of overdose. She described Naloxone as an opioid antagonist, which was used to counter the effects of opioid overdoses. She declared that Naloxone was extremely safe and effective at reversing these overdoses. She discussed the use of Naloxone in treatment of opioid overdose, stating that it allowed an overdose victim to breathe normally. She reported that Naloxone was not a controlled substance, and had no abuse potential. It would have zero effect if administered to someone with no opiates in their system. Naloxone was available as a nasal spray or as an injectable into a muscle or vein. The efficiency was time dependent, as death from overdose typically occurred from one to three hours, leaving this brief window for intervention. Naloxone takes effect immediately and would last between 30 to 90 minutes. She stated that Naloxone had been used by emergency medical professionals for more than 30 years to reverse overdoses, and was regularly carried by medical first responders. She noted that it could be administered by ordinary citizens with little to no formal training. She referenced data from recent pilot programs which demonstrated that lay persons were consistently successful at safely administering Naloxone. She pointed out, however, that family and friends were most often the actual first responders, and were in the best position to intervene within an hour of the overdose. She shared that New Mexico had amended its laws in 2001, the first state to do so, to make it easier for medical professionals to prescribe and dispense Naloxone without liability concerns, and for lay administers to use it without fear of legal repercussions. At the urging of many organizations, which included the U.S. Conference of Mayors and the American Medical Association, a number of states had addressed the issue by removing legal barriers to the timely administration of Naloxone. She explained that there had been two approaches to this: the first, made by 41 states and the District of Columbia, encouraged the wide prescription and use of Naloxone by removing the possibility of negative legal action against prescribers and administers of the drug to reverse an overdose; the second encouraged bystanders to become Good Samaritans by summoning emergency responders without any fear of arrest or other negative legal consequences. She relayed that House Bill 369 had been passed previously, similar to legislation passed in 33 other states. She reported that currently 188 community based overdose prevention programs now distributed Naloxone, and had provided training in Naloxone use to more than 150,000 people, resulting in more than 26,000 overdose referrals. She declared that proposed SB 23 was not a replacement for substance abuse treatment, drug enforcement, or rehabilitation, as these were also critical components to fight addiction. The proposed bill allowed bystanders and doctors the peace of mind to not be held civilly liable for doing the right thing, providing a lifesaving tool for an opioid overdose. 3:19:13 PM MS. EVANS paraphrased from the Sectional Analysis for SB 23, which read: Section 1. Amends AS 09.65 by adding a new section (09.65.340) to give immunity for prescribing, providing, or administering an opioid overdose drug Subsection (a) exempts a person from civil liability if providing or prescribing an opioid overdose drug if the prescriber or provider is a health care provider or an employee of an opioid overdose program and the person has been educated and trained in the proper emergency use and administration of the opioid overdose drug Subsection (b) except as provided in (c) exempts a person who administers an opioid overdose drug to another person who the person reasonably believes is experiencing an opioid overdose emergency if the person 1. Was prescribed or provided the drug by a health care provider or opioid overdose program and 2. Received education and training in the proper emergency use and administration 3:20:50 PM REPRESENTATIVE WOOL, in reference to the drug being provided during overdose, asked whether immunity was granted to an administering individual who was not trained. MS. EVANS replied that, under the current iteration of the proposed bill, immunity was not included for anyone not given the proper training, but there had been a discussion to re-write the proposed bill to cover more administers. CHAIR SEATON directed attention to the proposed bill, page 2, line 12. He asked to broaden the health care provider definition, to include all formats to be used in clinical settings. He acknowledged that this was not quite the same as the question posed by Representative Wool, and he asked that the discussion of the proposed bill include the use of both epipens and nasal sprays. 3:24:06 PM REPRESENTATIVE STUTES asked that the proposed bill be amended to include anyone who was present and knew there was an option for Naloxone. MS. EVANS acknowledged that a change to the language of the proposed bill was necessary, and asked to include that the training was more widely available. She stated that Naloxone was easy to administer, and that the training only took between 3 to 15 minutes to learn to administer and the subsequent steps. She reported that the top three things to look for in an overdose were blue lips and blue fingernails, no verbal recognition, and no response to a physical shake. 3:26:00 PM SENATOR ELLIS noted that the U.S. Food and Drug Administration (FDA) had just approved administration of Naloxone through nasal spray. He offered his belief that the existing language of the proposed bill already covered the different means for administration of the drug. 3:26:43 PM REPRESENTATIVE VAZQUEZ asked whether subsection (a) also offered regulatory liability. SENATOR ELLIS replied that he was not familiar with the difference between civil and regulatory liability and he asked for legal advice. 3:27:58 PM REPRESENTATIVE TARR asked whether a standard follow-up procedure to an overdose included a discussion with the family for this option. MS. EVANS replied that some doctors did prescribe this to family members of addicts. SENATOR ELLIS clarified that this was not a standard or required procedure. 3:29:20 PM REPRESENTATIVE WOOL asked for clarification whether an administrator was protected for liability if there was not an opioid overdose and Naloxone was administered. He asked if the drug could cause other problems. MS. EVANS replied that Naloxone was "extremely safe," even if there were not any opiates in the body. 3:30:27 PM MS. EVANS moved on and paraphrased from Subsection (c) of the proposed bill, which read: Subsection (c) does not preclude liability for civil damages that are a result of gross negligence or reckless or intentional misconduct MS. EVANS stated that the remainder of the proposed bill are definitions. 3:31:16 PM REPRESENTATIVE STUTES expressed some confusion about subsection (c), as Ms. Evans had just declared that the drug was totally safe and would not cause any reaction, regardless of whether there were any drugs in a person's system. MS. EVANS offered her belief that subsection (c) had been included for legal purposes. She reaffirmed that Naloxone was "a very safe drug." CHAIR SEATON suggested that this had been included to cover the possibility that "somebody is mad at somebody else and sticks them in the neck with an epipen," an action of intentional misconduct which would not be waived. REPRESENTATIVE STUTES responded that this was difficult for her to perceive and she would like to hear a legal response. REPRESENTATIVE VAZQUEZ directed attention to page 2, and read: "this section does not preclude liability for civil damages that are the result of gross negligence or reckless or intentional misconduct." 3:34:10 PM MEGAN WALLACE, Attorney, Legislative Legal and Research Services, Legislative Affairs Agency, responded that the exceptions to an immunity statute for gross negligence or reckless or intentional misconduct allowed for civil damage suits to move forward. She described, during an act when someone had intentionally hurt someone else, this subsection would allow the action for damages to move forward. REPRESENTATIVE VAZQUEZ asked whether the proposed bill allowed pharmacists to dispense Naloxone to family members, friends, care givers and personal physicians. MS. EVANS explained that currently a pharmacist could not prescribe the drug, but could fill a prescription from a doctor. She stated that an upcoming proposed amendment would allow for a pharmacist to prescribe the drug. She referenced an earlier bill, Senate Bill 71, that changed the procedure allowing a pharmacist to administer vaccine. REPRESENTATIVE VAZQUEZ suggested that an amendment was necessary to allow for third party prescription. 3:38:04 PM CHAIR SEATON directed attention to page 3, line 1, of the proposed bill, and offered his belief that should a physician "wish to put a prescription out for a standing order, the entire family could be trained" by the pharmacist. REPRESENTATIVE WOOL asked whether any states had this drug available without prescription, comparing Maloxone to a defibrillator which could be maintained at home. MS. EVANS offered her belief that all states mandated the need for a prescription, although this would change with the upcoming proposed amendment which would allow pharmacists to dispense the drug without a prescription. SENATOR ELLIS reported that Italy did not require a prescription. MS. EVANS added that the drug has been sold over the counter in Italy "since the 1980s with zero issues ever." SENATOR ELLIS noted that all states require prescriptions. REPRESENTATIVE VAZQUEZ pointed out that in one of the articles [included in members' packets] the drug was now offered without a prescription in selected Rhode Island pharmacies, and that another state had provided Naloxone to all of its police departments. MS. EVANS stated that it is common for police officers, emergency medical technicians, and fire fighters to carry Naloxone, even in Alaska. 3:43:16 PM BRADLEY GRIGG, Treatment & Recovery Section Manager, Division of Behavioral Health, Department of Health and Social Services, in response to a question by Representative Vazquez regarding regulatory liability, he asked to defer to Dr. Butler. 3:45:44 PM MICHELE STUART MORGAN, Juneau Stop Heroin Start Talking, shared a story about softball players in Juneau who had died of heroin overdoses. She reported that the Juneau Police Department estimated that 200 - 400 people were taking heroin every day in Juneau, and offered an analogy of the proposed bill to a fire extinguisher that could save another person. REPRESENTATIVE TARR asked about the origin of the drugs, as well as any recognition by parents, in order to better understand this problem. MS. MORGAN discussed the cost and the marketing of heroin in Juneau. She remarked that the use of the drugs, with the resulting addiction, often start as a result of sports injuries. 3:51:02 PM PAULA COLESCOTT, M.D., reported that she is a substance abuse physician and has dealt primarily in addiction since 2007, and the majority of her practice is with individuals who are heroin or opioid dependent. Within her review of the data and the literature regarding Alaska, she noted that between 2008 and 2012 there were 72 drug overdoses, and it does not include the 23 overdoses in 2013. She said her work in a substance abuse center where they do partial hospitalization, intensive outpatient care, and outpatient care and do provide either Vivitrol, which is an injectable, long acting agent called Naltrexone, as well as supplying Suboxone. She shared instances of overdoses as related to her by other addicts. She said that many users know about the overdose reversal drugs, noting that she currently had two patients on long term injectable reversal agents. She expressed concern for the current overdose deaths as there was now a transition from opium analgesics to heroin, and that the purity of heroin was now erratic, hence even more deadly. She relayed that there were synthetic drugs now available that were very dangerous. She reported that there were often cases where she gave intravenous overdose reversal drugs for restoring respiration that were double the dosage of the nasal sprays. She reported that these reversal drugs acted immediately and were lifesaving. She mused that she could not visualize that there would be any legal implication, as any physician offering appropriate medication for the appropriate reason will not be affected by a medical board investigation. She stated that opiate withdrawal does not kill people, it was the opiate that kills. She expressed her support for the proposed bill. 3:59:58 PM REPRESENTATIVE WOOL asked about blocking agents and reversing agents, and whether Naloxone had a wide application of blockage to opioids. DR. COLESCOTT explained the treatment procedures for an overdose, and answered that it is a reversal agent for any of the opiates. REPRESENTATIVE TARR asked about the increase in use. DR. COLESCOTT said that the increased use of prescription drugs has increased this dependence on opiates. She reported that 29 percent of the substance abuse assessments at her clinic were opiate related, and included many patients using a mixture of opiates. DR. COLESCOTT, in response to Representative Tarr, said that an extended use pattern was common, and she offered some examples. 4:08:31 PM SARAH SPENCER, Medical Doctor, South Peninsula Hospital, said she is board certified in addiction medicine and that she offers treatments to people with addictions. She reported that she distributes Naloxone rescue kits to her patients, starting about six months prior. She stated that these rescue kits are also kept in stock in the emergency room, although only one in five people would seek treatment for their addiction. She pointed out that the EMS response time could be prolonged and this was the time period these medicines could be most helpful. She relayed there were not many medications that allowed for "third party prescribing." She compared these prescriptions to sexually transmitted diseases, for which she would give prescriptions to individuals to share with their partners. She noted that she was not able to legally give the Naloxone except to the individual. She suggested community education seminars as a means to spread the programs for people to learn how to use the medication, as well as to sometimes be enabled to receive the prescription. She noted that in some states, pharmacists are allowed to write the prescriptions. She lauded the proposed bill as a way to allow for these distributions. She pointed out that the places with the highest distribution of Naloxone had a reduction in overdose death rates of 50 - 80 percent, without any change in the use of opiates. She declared that the medication has been shown to be incredibly safe, with no increase in risk taking behavior. She shared that there has not been any deaths among those patients that had refused to be taken to the hospital after receiving Naloxone. She declared there was almost unanimous support for increased access to Naloxone by almost every major medical association in the United States. DR. SPENCER, in response to Chair Seaton, offered her belief that the language in the proposed bill would work in all the situations she had described. She pointed out that a person overdosing is not able to give themselves the medication, so it is necessary for someone else to be involved; therefore, the medication should be available to anyone around a user. CHAIR SEATON asked to ensure that the medical community was secure with making these prescriptions. He stated that it was necessary to ensure a protocol or a standing order which gave the statutory authority and the comfort level to doctors. He wanted to know what language was sufficient for the medical community. DR. SPENCER offered her belief that the language of the proposed bill covered the needs. She suggested that an amendment allowing a pharmacist to prescribe would be welcome, would allow the pharmacist to counsel its use, and would increase access, especially for those without insurance. 4:21:24 PM REPRESENTATIVE WOOL asked what the mechanism would be for distribution by a pharmacist. 4:21:56 PM REPRESENTATIVE VAZQUEZ relayed that the literature indicates a blanket prescription is available, although she was unsure whether any statutory changes were necessary. CHAIR SEATON spoke about the possibility of a protocol or a standing order. 4:22:40 PM DANIEL NELSON, Alaska Pharmacist Association, offered support to the proposed bill by the Alaska Pharmacist Association and opined that pharmacists everywhere would also support this bill. He shared that this was a national epidemic and pharmacists are doing their best "to become part of the solution and not furthering the problem." He reported that although there are risks associated with many drugs dispensed from pharmacies, there is not any risk with Naloxone. He offered his belief that this is a great service to the community and creates a win - win situation. He explained that a standing order is a communication between a licensed medical practitioner and a health care provider that allowed for the prescription. This would be under the supervising physician's license, although the supervising physician would not need to have a direct interaction with the patient. CHAIR SEATON asked to clarify that, as a pharmacist, the language in the proposed bill is enough to make him comfortable to exercise the established protocol. DR. NELSON replied that the proposed amendment does make the standing order no longer necessary as a requirement. He spoke in support of the elimination of another unnecessary, artificial barrier that did nothing to protect patient safety. CHAIR SEATON asked what sort of training, if any, regarding administering Naloxone should be included in the proposed bill. DR. NELSON offered his belief that the Board of Pharmacy could clarify any necessary training, and it could be satisfied with a video teleconference, webinar, or something similar with a competency test at the conclusion. He opined that it is not important for this to be done in-person. CHAIR SEATON directed attention to page 2, line 3 of the proposed bill, which read: "educated and trained in the proper emergency use and administration of the opioid overdose drug." He asked to ensure that pharmacists are comfortable that this statutory language gives them the authority to use technology to provide training to the person receiving the prescription. DR. NELSON expressed his agreement and reiterated his strong support of the bill and the [upcoming] proposed amendment. 4:30:35 PM DR. JAY BUTLER, Chief Medical Officer/Director, Division of Public Health, Central Office, Department of Health and Social Services, reported that, in 2015, 54 Alaskans died of prescription pain reliever overdose, and 33 more died of heroin overdose. He shared that he rarely used the term "epidemic," defined by the Centers for Disease Control and Prevention (CDC) as "an increase, often sudden, in the number of cases of a disease above what is expected." He expressed his agreement that the data on the health effects of opioid use in Alaska now reflected "an epidemic of disability and death caused by heroin and non-medical use of prescription opioid pain relievers." To address this epidemic, he proposed a three pronged strategy: prevent, reduce, and reverse. He relayed that opioid dependency could be prevented by ensuring safe and appropriate use of prescribed opioids for their important role in managing acute pain and providing comfort care. He stated that the majority of people using heroin first began by using opioids in the form of prescription pain relievers. He expressed his agreement that there are economic drivers increasing the use of heroin throughout Alaska and the rest of the country. He stated that dependency could be reduced by recognizing this as a medical condition requiring medication assisted treatment and counseling. He declared that respiratory depression, the mechanism of death in opioid overdose, could be reversed through timely administration of Naloxone. He reported that a major problem from opioid use is tolerance, as a higher dose is needed over time; therefore, the margin of safety becomes narrower at higher doses. He stated that Naloxone needs to be administered as soon as possible after an overdose to be effective. He shared that a number of states have instituted measures to increase access to Naloxone so that it could be administered by any bystander, as soon as the overdose is recognized, while waiting for the arrival of emergency medical treatment. He declared that proposed SB 23 seeks to remove barriers to Naloxone use in Alaska, while providing protection against civil liability. He commented that there are a number of good on-line public training materials for administering Naloxone. 4:35:56 PM CHAIR SEATON asked for clarification to the possibility of the state medical officer offering a broad license [to pharmacists] throughout the state. DR. BUTLER replied that Rhode Island has this system, and that he would follow up on this possibility. CHAIR SEATON expressed his appreciation for the support in finding something safe, effective, and available throughout the state. 4:37:10 PM GARY MILLER shared an anecdote of the drug overdose death of his daughter, and declared that the proposed bill offered an opportunity to save other lives. 4:38:55 PM TRACY WIESE, Family Nurse Practitioner, Alaska Nurse Practitioner Association, stated that the Alaska Nurse Practitioner Association was "absolutely in support of the bill." The Association encourages that registered nurses be specifically included within the bill language. She said that as a prescriber, the proposed bill would make her feel better from a liability perspective. 4:40:42 PM LYNN HARTZ, Family Nurse Practitioner, Alaska Nurse Practitioner Association, spoke in support of the proposed bill, noting that the number of deaths from opioid pain reliever overdose had surpassed the number of deaths from motor vehicle accidents. She offered her belief that all of the health care programs in this area would benefit from SB 23. 4:42:22 PM KATIE BOTZ shared an anecdote of the loss of a friend and co- worker by overdose. She offered her belief that this would help friends to help friends. 4:45:15 PM JANEY HOVENDEN, Director, Division of Corporations, Business, and Professional Licensing, Department of Commerce, Community & Economic Development, was available for questions. 4:45:28 PM SARA CHAMBERS, Operations Manager, Division of Corporations, Business, and Professional Licensing, Department of Commerce, Community & Economic Development, was available for questions. CHAIR SEATON noted that the committee had been discussing civil liabilities and regulatory liability, asked whether they had any answers regarding regulatory liability, how it would be affected, or not affected, by this bill, and what that would mean. MS. HOVENDEN answered said that she would respond by e-mail to the questions for regulatory liability. MS. CHAMBERS replied they would want to consult with the State Medical Board, the Board of Pharmacy, and the Board of Nursing to better provide a comprehensive response. CHAIR SEATON agreed. He said he wanted it on the record that he will be looking for the email and hard copy response to put before the committee for discussion. REPRESENTATIVE VAZQUEZ noted that the current draft of the bill exempts individuals from civil liability, but it does not address the possibility of regulatory action by the Board of Pharmacy or the Board of Nursing, and so forth. 4:47:36 PM CHRISTINA LOVE, Advocate and Recovery Coach, AWARE, shared that she had once had an unintentional overdose, noting that an unintentional overdose is the leading cause of preventable death in the U.S. She declared that many opioid users do not have family or health care, and that there is not a 24 hour pharmacy in Juneau. She stated that expanded access to this drug would "send a statement to the public," "We are worth it, and every life matters." She declared that "the only side effect to this drug is life." She mused that many lives would have been saved, had the proposed bill been passed in the last year. 4:49:37 PM JANET MCCABE, Chair, Partners For Progress, stated that her organization is in full support of proposed SB 23, and expressed her support for this early session hearing for the bill. She declared that untreated overdoses are taking lives in rural and urban communities. She shared an update regarding the work by her organization with a family nurse practitioner for use of an injectable opioid antagonist drug to help cut the craving for opioids, as well as alcohol. She offered her belief that it was best for those with a record of being serious addicts to use this drug before release from prison, so that it was not necessary to detox. She opined that this could save a lot of money as it would reduce the incidence of recidivism. CHAIR SEATON asked about the length of action for this drug. MS. MCCABE replied that it was injected every month, and that its cost was covered by Medicaid. 4:53:49 PM CHAIR SEATON closed public testimony after ascertaining that no one further wished to testify. He advised that SB 23 would be held over. CHAIR SEATON declared that this proposed bill is an opportunity to step up to prevention, and keep people from dying. He stated that there would be an additional investigation into changing the opioid prescriptions data base to require the immediate posting of opioid prescriptions, instead of the currently required monthly posting. He pointed out that there is not even a requirement to check the database before prescribing. He suggested that there be a "push system" and a civil penalty administered through the occupational licensing boards for not checking the database prior to prescriptions. He allowed that over prescription of opioids was a problem with severe consequences. 4:58:09 PM REPRESENTATIVE WOOL reflected on the approximately 80 overdoses in the past year, noting that there were almost 60 overdoses from prescription drugs. He declared that prescription drugs are still part of the equation, and opined that over prescription and lack of training all fit together "as far as prevention." [SB 23 was held over.]