SB2271

SECTION 1. The legislature finds that the United States opioid epidemic has persisted. According to data from the federal Centers for Disease Control and Prevention, drug overdose deaths nearly tripled from 1999 to 2014. Among the 47,055 drug overdose deaths that occurred in 2014 in the United States, sixty-one per cent involved an opioid. During 2015, drug overdoses accounted for 52,404 deaths in the United States, including 33,091 deaths that involved an opioid. Illicit opioids are contributing to the increase in opioid overdose deaths. While data indicates that there has been progress in preventing methadone deaths, rates of deaths involving other opioids, specifically heroin and synthetic opioids other than methadone (likely driven primarily by illicitly manufactured fentanyl), increased sharply overall and across many states.

According to the Centers for Disease Control and Prevention, overdoses involving prescription painkillers are at epidemic levels. However, deaths caused by opioids are often preventable via timely administration of an opioid antagonist, such as naloxone hydrochloride. Opioid antagonist use has been approved by the federal Food and Drug Administration and used for more than forty years by emergency medical services personnel to reverse opioid overdose. Opioid antagonists have no psychoactive effects and do not have any potential for abuse, and first responders and family members with no medical training can learn to administer them safely. Furthermore, research has shown that the increased availability of opioid antagonists does not encourage people to use more drugs or engage in riskier behavior.

The legislature additionally finds that chapter 329E, Hawaii Revised Statutes, provides immunity for licensed physicians, physician assistants under the authority and supervision of a physician, and advanced practice registered nurses with prescriptive authority who prescribe, dispense, and distribute an opioid antagonist directly or by standing order to an individual at risk of experiencing an opioid-related drug overdose, another person in a position to assist an individual at risk of experiencing an opioid-related drug overdose, or a harm reduction organization. A standing order is a prescription order for an opioid antagonist that is not specific to and does not identify a particular patient and may be applicable to more than one patient. Chapter 329E, Hawaii Revised Statutes, similarly provides immunity from criminal or civil liability for pharmacists who prescribe, dispense, or distribute an opioid antagonist under certain conditions but not explicitly pursuant to a standing order or without any other prescription.

Recently, the Utah State Legislature passed legislation that authorized licensed pharmacists to dispense an opioid antagonist, without a prior prescription, to anyone at increased risk of experiencing an opioid overdose pursuant to a standing order. The purpose of this legislation was to increase access to an opioid antagonist for those who might be at risk of an overdose and thus, decrease the rate of opioid overdose deaths.

The purpose of this Act is to:

(1) Authorize a registered pharmacist to dispense an opioid antagonist pursuant to a standing order issued by a health care professional without any other prescription;

(2) Require the standing order issued by an authorized health care professional to limit the dispensing of an opioid antagonist to certain individuals or a harm reduction organization;

(3) Establish that the practice of pharmacy includes the dispensing of an opioid antagonist by a pharmacist pursuant to a standing order; and

(4) Require the board of pharmacy to identify pharmacists by license who are authorized to dispense an opioid antagonist pursuant to a standing order and annually review the dispensing practices of pharmacists who dispense the opioid antagonist pursuant to a standing order.

SECTION 2. Chapter 329E, Hawaii Revised Statutes, is amended by adding a new section to be appropriately designated and to read as follows:

"§329E- Standing order; pharmacists; dispensing of an opioid antagonist. (a) Notwithstanding any other law to the contrary, a pharmacist may dispense an opioid antagonist:

(1) Pursuant to a standing order in accordance with subsection (b);

(2) In accordance with procedures relating to dispensing an opioid antagonist under the definition of "practice of pharmacy" in section 461-1; and

(3) Without any other prescription order from a health care professional otherwise authorized to prescribe an opioid antagonist.

(b) A health care professional may issue a standing order that authorizes a pharmacist to dispense an opioid antagonist pursuant to subsection (a); provided that the standing order shall limit the dispensing of an opioid antagonist to:

(1) An individual at risk of experiencing an opioid-related drug overdose;

(2) Another person in a position to assist an individual at risk of experiencing an opioid-related drug overdose; or

(3) A harm reduction organization.

(1) Identify the pharmacists by license issued in accordance with section 461-6 who are authorized to dispense the opioid antagonist pursuant to a standing order; and

(2) Annually review the dispensing practices of pharmacists who dispense the opioid antagonist pursuant to a standing order."

SECTION 3. Section 461-1, Hawaii Revised Statutes, is amended by amending the definition of "practice of pharmacy" to read as follows:

""Practice of pharmacy" means:

(1) The interpretation and evaluation of prescription orders; the compounding, dispensing, and labeling of drugs and devices (except labeling by a manufacturer, packer, or distributor of nonprescription drugs and commercially legend drugs and devices); the participation in drug selection and drug utilization reviews; the proper and safe storage of drugs and devices and the maintenance of proper records therefor; the responsibility for advising when necessary or where regulated, of therapeutic values, content, hazards, and use of drugs and devices;

(2) Performing the following procedures or functions as part of the care provided by and in concurrence with a "health care facility" and "health care service" as defined in section 323D-2, or a "pharmacy" or a licensed physician or a licensed advanced practice registered nurse with prescriptive authority, or a "managed care plan" as defined in section 432E-1, in accordance with policies, procedures, or protocols developed collaboratively by health professionals, including physicians and surgeons, pharmacists, and registered nurses, and for which a pharmacist has received appropriate training required by these policies, procedures, or protocols:

(A) Ordering or performing routine drug therapy related patient assessment procedures;

(B) Ordering drug therapy related laboratory tests;

(C) Initiating emergency contraception oral drug therapy in accordance with a written collaborative agreement approved by the board, between a licensed physician or advanced practice registered nurse with prescriptive authority and a pharmacist who has received appropriate training that includes programs approved by the American Council of Pharmaceutical Education (ACPE), curriculum-based programs from an ACPE-accredited college of pharmacy, state or local health department programs, or programs recognized by the board of pharmacy;

(D) Administering drugs orally, topically, by intranasal delivery, or by injection, pursuant to the order of the patient's licensed physician or advanced practice registered nurse with prescriptive authority, by a pharmacist having appropriate training that includes programs approved by the ACPE, curriculum-based programs from an ACPE-accredited college of pharmacy, state or local health department programs, or programs recognized by the board of pharmacy;

(E) Administering:

(i) Immunizations orally, by injection, or by intranasal delivery, to persons eighteen years of age or older by a pharmacist having appropriate training that includes programs approved by the ACPE, curriculum-based programs from an ACPE-accredited college of pharmacy, state or local health department programs, or programs recognized by the board of pharmacy; and

(ii) Vaccines to persons between fourteen and seventeen years of age pursuant to section 461-11.4;

(F) As authorized by the written instructions of a licensed physician or advanced practice registered nurse with prescriptive authority, initiating or adjusting the drug regimen of a patient pursuant to an order or authorization made by the patient's licensed physician or advanced practice registered nurse with prescriptive authority and related to the condition for which the patient has been seen by the licensed physician or advanced practice registered nurse with prescriptive authority; provided that the pharmacist shall issue written notification to the patient's licensed physician or advanced practice registered nurse with prescriptive authority or enter the appropriate information in an electronic patient record system shared by the licensed physician or advanced practice registered nurse with prescriptive authority, within twenty-four hours;

(G) Transmitting a valid prescription to another pharmacist for the purpose of filling or dispensing;

(H) Providing consultation, information, or education to patients and health care professionals based on the pharmacist's training and for which no other licensure is required; or

(I) Dispensing an opioid antagonist in accordance with a standing order pursuant to section 329E- and a written collaborative agreement approved by the board, between a licensed physician and a pharmacist who has received appropriate training that includes programs approved by the American Council on Pharmaceutical Education (ACPE), curriculum-based programs from an ACPE-accredited college of pharmacy, state or local health department programs, or programs recognized by the board; and

(3) The offering or performing of those acts, services, operations, or transactions necessary in the conduct, operation, management, and control of pharmacy."

SECTION 4. This Act does not affect rights and duties that matured, penalties that were incurred, and proceedings that were begun before its effective date.

SECTION 5. New statutory material is underscored.

SECTION 6. This Act shall take effect upon its approval.

INTRODUCED BY:	_____________________________

THE SENATE	S.B. NO.	2271
TWENTY-NINTH LEGISLATURE, 2018
STATE OF HAWAII