The dispensing of opioid antagonists approved by the FDA for use in treating an overdose must be reported to the CSMP. You must work with your software, or, if need be, work with your software provider, to include naloxone as a reportable item.
West Virginia Board of Pharmacy
Protocol for Pharmacist or interns Furnishing
Opioid Antagonist Naloxone Hydrochloride
Developed in Consultation with the DHHR Bureau for Public Health
A pharmacist or intern furnishing an opioid antagonist, naloxone hydrochloride, pursuant to West Virginia Code § §16-46-3a shall satisfy the requirements of this protocol.
(a) As used in this protocol:
(1) “Recipient” means the person to whom naloxone hydrochloride is furnished.
(b) West Virginia Code § 16-46-3a provides that a pharmacist or pharmacy intern under the supervision of a pharmacist may dispense an opioid antagonist without a prescription pursuant to a protocol developed by the Board of Pharmacy in consultation with the Bureau for Public Health. As set forth in subsection (b) of section 16-46-3a,
A pharmacist or intern or pharmacy intern who dispenses [naloxone hydrochloride] without a prescription under this [protocol] shall provide patient counseling to the individual for whom the opioid antagonist is dispensed regarding, but not limited to, the following topics: (1) The proper administration of the opioid antagonist; (2) the importance of contacting emergency services as soon as practicable either before or after administering the opioid antagonist; and (3) the risks associated with failure to contact emergency services following administration of an opioid antagonist. The patient counseling described in this section is mandatory and the person receiving the opioid antagonist may not opt out.
Further, subsection (d) provides: “All pharmacists or pharmacy interns who dispense an opioid antagonist under this section shall provide educational materials to any person receiving such an opioid antagonist on opiate-related overdose prevention and treatment programs, as well as materials on administering the opioid antagonist.” Following is the protocol developed to meet these requirements.
The law clearly requires only a protocol issued by the Board in consultation with the Bureau for Public Health for pharmacists to dispense Naloxone without any prescription from any practitioner. However, although not required, a pharmacy may choose to have a prescribing practitioner sign the protocol set forth in subsection (c) below to treat it as a standing order.
(c) Protocol for Pharmacist or Interns Furnishing Naloxone Hydrochloride.
(1) Before providing an FDA-approved naloxone hydrochloride product, the pharmacist or intern shall screen the potential recipient by asking whether the person to whom the naloxone hydrochloride would be administered has a known hypersensitivity to naloxone. (If the recipient answers yes, the pharmacist or intern may not provide naloxone. If the recipient responds no, the pharmacist or intern may continue.)
(2) When naloxone hydrochloride is furnished:
(A) The pharmacist or intern shall provide the recipient with appropriate counseling and information on the product furnished, including dosing, effectiveness, adverse effects, storage conditions, shelf---life, and safety. The recipient is not permitted to waive the required consultation.
(B) The pharmacist or intern shall provide the recipient with the number to talk with someone about available substance abuse treatment and recovery services near them, 1-844-HELP-4-WV, if the recipient indicates interest in addiction treatment or recovery services at this time.
(C) The pharmacist or intern shall answer any questions the recipient may have regarding naloxone hydrochloride.
(3) Product Selection: A pharmacist or intern may supply naloxone hydrochloride in any FDA- approved product form.
(4) The dispensing shall be documented and labelled as a prescription dispensed per this protocol.
(5) Fact Sheet: The pharmacist or intern shall provide the recipient
(A) a copy of the current Naloxone Administration Tri-fold “I Have Narcan” created and maintained by the West Virginia Department of Health & Human Resources, Bureau for Public Health, Office of Emergency Medical Services (OEMS): http://www.wvoems.org/medical-direction/naloxone-information; or other appropriate patient information for the FDA-approved product dispensed; and
(B) the Naloxone Tri-fold Brouchure concerning recognition of signs of an overdose and other information created and maintained by the OEMS: http://www.wvoems.org/medical-direction/naloxone-information.
(6) Privacy: All pharmacist or interns furnishing naloxone hydrochloride in a pharmacy or health care facility shall operate under the pharmacy or facility’s policies and procedures to ensure that recipient confidentiality and privacy are maintained.
(7) Although not required, a pharmacy may choose to have a prescribing practitioner sign the protocol to treat it as a standing order.