RULES AND REGULATIONS
Title 49—PROFESSIONAL AND VOCATIONAL STANDARDS
STATE BOARD OF PHARMACY
[ 49 PA. CODE CH. 27 ]
Standards of Practice and Prospective Drug Review and Patient Counseling
[48 Pa.B. 7404]
[Saturday, December 1, 2018]The State Board of Pharmacy (Board) amends §§ 27.18 and 27.19 (relating to standards of practice; and prospective drug review and patient counseling) to read as set forth in Annex A.
Background and Purpose
Beginning January 10, 2018, Governor Tom Wolf has signed Statewide disaster declarations to address the heroin and opioid abuse crisis. One of his initiatives is to increase access to naloxone and to ''allow pharmacists to partner with other organizations, including prisons and treatment programs to make naloxone available to at-risk individuals upon discharge from these facilities.'' Naloxone, a noncontrolled prescription drug, is an opioid antagonist used to reverse opioid overdose.
As recently as April 5, 2018, the United States Surgeon General issued an advisory that more Americans should carry the opioid overdose-reversing drug, naloxone, noting that the drug can very quickly restore normal breathing in someone suspected of overdosing on opioids, including heroin and prescription pain medications. The Surgeon General stated that ''[r]esearch shows that when naloxone and overdose education are available to community members, overdose deaths decrease in those communities.'' See, https://www.surgeongeneral.gov/priorities/opioid-overdose-prevention/naloxone-advisory.html.
''The risk of death from overdose is greatly increased in the weeks following release from prison. A pre-release program of overdose prevention education, including naloxone prescription, for inmates with a history of opiate addiction would likely prevent many overdose deaths.'' Wakeman, SE, et al., Preventing Death Among the Recently Incarcerated: An Argument for Naloxone Prescription Before Release, Journal of Addiction Disease, 2009;28(2): 124.
Correctional facilities, prisons and jails often identify inmates who are pending release, and residential drug treatment facilities identify patients pending discharge, who are at-risk for opioid abuse and overdose. Some of these facilities are large enough to maintain their own medical clinic and pharmacy, while others do not, but instead contract with medical practitioners. For the larger facilities, the in-house pharmacy or physician may dispense directly to the individual. It is the smaller correctional facilities, prisons, jails and residential drug treatment facilities that wish to allow outside pharmacies to deliver naloxone to the facility for the individual pending release.
There are two potential regulatory impediments. The first is § 27.18(e), which limits the pharmacy's ability to ''enter into an arrangement or agreement with a nonlicensed person [facility employee] whereby. . .prescription drugs. . .may be regularly. . .delivered. . . .'' The proposed change would provide an exception for naloxone delivered to a facility for an identified individual.
The second potential impediment is § 27.19. This section requires pharmacists to perform a prospective drug review (PDR) prior to dispensing or delivering a new prescription. The purpose of the PDR is to help assure that a drug dispensed is not likely to have an adverse medical result and involves a pharmacist's review of a patient profile maintained in the pharmacy. It is likely that although the facility requesting delivery of naloxone will provide the individual's name to the pharmacy, the pharmacy will not have a current profile for that person, and the pharmacist will not have the necessary information, including medical and prescription history, the ability to create a profile.
Section 27.19(c)(3) provides four exceptions to the PDR requirement. This final-omitted rulemaking would provide an additional exception for naloxone delivered to a facility for an identified individual.
Omission of Proposed Rulemaking
Under section 204(3) of the Commonwealth Documents Law (CDL) (45 P.S. § 1204(3)), the Board is authorized to omit the procedures for the proposed rulemaking in sections 201 and 202 of the CDL (45 P.S. §§ 1201 and 1202) if the Board finds that the specified procedures are impracticable, unnecessary or contrary to the public interest.
Publication of the proposed rulemaking is contrary to the public interest under the circumstances previously set forth because the final-omitted rulemaking is needed to fulfill an urgent and immediate need to provide this potentially life-saving drug to individuals identified as at risk for overdose and death upon their release from incarceration or their discharge from a residential drug treatment facility, consistent with the Governor's Proclamation of Disaster Emergency.
Statutory Authority
Section 6(k)(9) of the Pharmacy Act (act) (63 P.S. § 390-6(k)(9)) authorizes the Board to promulgate rules and regulations to effectuate the purposes of the act and to regulate the distribution of drugs and devices and the practice of pharmacy for the protection and promotion of the public health, safety and welfare.
Fiscal Impact and Paperwork Requirements
There is no fiscal impact and no paperwork requirements are associated with this final-omitted rulemaking.
Regulatory Review
Under section 5.1(c) of the Regulatory Review Act (RRA) (71 P.S. § 745.5a(c)), on October 10, 2018, the Board submitted copies of the final-omitted rulemaking to the Independent Regulatory Review Commission (IRRC), the Senate Consumer Protection and Professional Licensure Committee and the House Professional Licensure Committee. On the same date, the Board submitted a copy of the final-omitted rulemaking to the Office of Attorney General under the Commonwealth Attorneys Act (71 P.S. §§ 732-101—732-506).
Under sections 5.1(e) and (j.2) of the RRA (71 P.S. § 745.5a(e) and (j.2)), the amendment was deemed approved by the House Professional Licensure Committee on November 14, 2018, deemed approved by the Senate Consumer Protection and Professional Licensure Committee on November 14, 2018, and approved by IRRC on November 15, 2018.
Additional Information
For additional information about this final-omitted rulemaking, submit inquires to Melanie Zimmerman, RPh, Executive Secretary, State Board of Pharmacy, P.O. Box 2649, Harrisburg, PA 17105-2649, ST-PHARMACY@pa.gov.
Findings
The Board finds that:
(1) Public notice of the Board's intention to amend its regulations under the procedures in sections 201 and 202 of the CDL (45 P.S. §§ 1201 and 1202) has been omitted under section 204 of the CDL (45 P.S. § 1204) because publication of proposed rulemaking is contrary to the public interest under the circumstances previously set forth because the final-omitted rulemaking is needed to fulfill an urgent and immediate need to provide this potentially life-saving drug to individuals identified as at risk for overdose and death upon their release from incarceration or their discharge from a drug treatment facility, consistent with the Governor's Proclamation of Disaster Emergency.
(2) The amendment of the Board's regulations in the manner provided in this order is necessary and appropriate to effectuate the purposes of the act and to regulate the distribution of drugs and devices and the practice of pharmacy for the protection and promotion of the public health, safety and welfare.
Order
The Board, acting under its authorizing statute, orders that:
(a) The regulations of the Board hereby are amended by amending §§ 27.18 and 27.19 to read as set forth in Annex A.
(b) The Board shall submit this order and Annex A to the Office of General Counsel and the Office of Attorney General for approval as to form and legality as required by law.
(c) The Board shall submit this order and Annex A to the IRRC, the Senate Consumer Protection and Professional Licensure Committee, and the House Professional Licensure Committee as required by law.
(d) The Board shall certify this order and Annex and deposit them with the Legislative Reference Bureau as required by law.
(e) This order shall take effect upon publication in the Pennsylvania Bulletin.
JANET GETZEY HART, RPh,
Chair(Editor's Note: See 48 Pa.B. 7494 (December 1, 2018) for IRRC's approval order.)
Fiscal Note: 16-5431. No fiscal impact; (8) recommends adoption.
Annex A
TITLE 49. PROFESSIONAL AND VOCATIONAL STANDARDS
PART I. DEPARTMENT OF STATE
Subpart A. PROFESSIONAL AND OCCUPATIONAL AFFAIRS
CHAPTER 27. STATE BOARD OF PHARMACY
STANDARDS § 27.18. Standards of practice.
* * * * * (e) No pharmacist may enter into an arrangement or agreement with a nonlicensed person whereby prescription orders or prescription drugs and devices may be regularly left with, picked up from, solicited by, accepted by or delivered to the nonlicensed person or whereby a pharmacist pays or has an arrangement or agreement with the nonlicensed person to perform these functions. Nothing in this section shall prohibit a licensee from picking up a prescription or delivering a prescription drug or device, at the request of the patient, at the office or home of the prescriber or patient, at an institution in which a patient is confined, at another place as the patient designates for his safety and convenience, or by means of an employe, the mails or common carrier. Nothing in this section shall prohibit a licensee from delivering naloxone to an identified employee of a Pennsylvania correctional facility, prison, jail or residential drug treatment facility under a prescription and for an identified individual who is pending release or discharge from the correctional facility, prison, jail or residential drug treatment facility.
* * * * * § 27.19. Prospective drug review and patient counseling.
* * * * * (c) Scope.
* * * * * (3) The following are examples of situations in which a PDR is not required:
* * * * * (iv) A pharmacist dispenses a drug to a medical practitioner which the practitioner will administer to a patient.
(v) A pharmacist delivers naloxone to an identified employee of a Pennsylvania correctional facility, prison, jail or residential drug treatment facility under a prescription and for an identified individual who is pending release or discharge from the correctional facility, prison, jail or residential drug treatment facility.
* * * * *
[Pa.B. Doc. No. 18-1857. Filed for public inspection November 30, 2018, 9:00 a.m.]
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