N.Y. Comp. Codes R. & Regs. tit. 10 § 80.138

Current through Register Vol. 46, No. 45, November 2, 2024

Section 80.138 - Opioid overdose prevention programs

(a)Definitions.

(1)Opioid means an opiate as defined in section 3302 of the Public Health Law.

(2)Opioid antagonist means a drug approved by the Food and Drug Administration, that, when administered, negates or neutralizes in whole or in part the pharmacological effects of an opioid in the body. The opioid antagonist is limited to naloxone or other medications approved by the department for this purpose.

(3)Opioid Overdose Prevention Program means a program the purpose of which is to train individuals to prevent a fatal opioid overdose in accordance with these regulations.

(4)Opioid overdose prevention training curriculum refers to any set of instructions, consistent with guidance from the department, which provides a person encountering a suspected opioid overdose with the steps to take for preventing a fatality, including contacting emergency medical services, administering an opioid antagonist and, where appropriate, providing resuscitation.

(5)Registered provider for the purposes of this section shall mean any of the following that have the services of both a program director and a clinical director and that have registered with the department pursuant to subdivision (b) of this section:

(i) a health care facility licensed under the Public Health Law;

(ii) a physician, physician assistant, or nurse practitioner who is authorized to prescribe the use of an opioid antagonist;

(iii) a drug treatment program licensed under the Mental Hygiene Law;

(iv) a not-for-profit community-based organization incorporated under the Not-for-Profit Corporation Law;

(v) a local health department, public safety agency, or other local or State government agency;

(vi) an institution of higher education, recognized and approved by the regents of the university of the State of New York, which provides a course of study leading to the granting of a post-secondary degree or diploma;

(vii) a business, trade, technical or other occupational school approved as such by the regents of the university of the State of New York or accredited by a nationally recognized accrediting agency or association accepted as such by the regents of the State of New York; and

(viii) a pharmacy registered in accordance with the article 137 of the Education Law.

(6)Program director means an individual who is identified to manage and have overall responsibility for the Opioid Overdose Prevention Program.

(7)Clinical director means a physician, physician assistant or nurse practitioner who is designated in an Opioid Overdose Prevention Program's registration for prescribing an opioid antagonist to individual or an identifiable pool of trained overdose responders and who provides oversight of the clinical aspects of the Opioid Overdose Prevention Program. This oversight includes serving as a clinical advisor and liaison concerning medical issues related to the Opioid Overdose Prevention Program, providing consultation on training and reviewing reports of all administrations of an opioid antagonist.

(8)Affiliated prescriber means a physician, physician assistant or nurse practitioner, who, in addition to the clinical director, is designated in an Opioid Overdose Prevention Program's registration for prescribing an opioid antagonist to individual or an identifiable pool of trained overdose responders.

(9)Trained overdose responder means any individual not otherwise permitted by law to administer an opioid antagonist, who is either:

(i) an opioid antagonist recipient as defined in PHL section 3309 who has successfully completed an opioid overdose prevention training curriculum offered by an authorized opioid overdose prevention program and has been authorized by a registered provider to possess the opioid antagonist;

(ii) a public safety officer who has completed a curriculum approved by the division of criminal justice services for purposes of intervening in opioid overdoses prior to the arrival of emergency medical services; or

(iii) a firefighter who has completed a comparable curriculum approved by the department.

(b)Registration.

(1) Registered providers may operate an Opioid Overdose Prevention Program if they obtain a certificate of approval from the department authorizing them to operate an Opioid Overdose Prevention Program and otherwise comply with the provisions of this section.

(2) Providers eligible to register to operate an Opioid Overdose Prevention Program that are in good standing may apply to the department to operate an Opioid Overdose Prevention Program on forms prescribed by the department which must include, at a minimum, the following information:

(i) the provider name, address and operating certificate or license number where appropriate;

(ii) the name, address, telephone number, fax number, e-mail address and signature of the program director;

(iii) the name, address, telephone number, fax number, e-mail address, license type, license number and signature of the clinical director;

(iv) the name, license type and license number of the affiliated prescribers, if any;

(v) the name and address of the sites at which the Opioid Overdose Prevention Program will be conducted; and

(vi) a description of the targeted population to be served and recruitment strategies to be employed by the Opioid Overdose Prevention Program.

(c)Program operation.

(1) Each Opioid Overdose Prevention Program shall have a program director who is responsible for managing the Opioid Overdose Prevention Program and shall, either directly or through a designee, at a minimum:

(i) identify a clinical director to oversee the clinical aspects of the Opioid Overdose Prevention Program;

(ii) establish the content of the program's opioid overdose prevention training cirriculum consistent with guidance from the department;

(iii) identify and train other program staff;

(iv) select and identify persons as trained overdose responders;

(v) issue certificates of completion to trained overdose responders who have successfully completed the program's opioid overdose prevention training curriculum however, certificates of completion of curriculum under subparagraphs (a)(9)(ii) and (iii) of this section are not required for public safety or firefighting personnel;

(vi) establish and maintain the Opioid Overdose Prevention Program's mandated recordkeeping system;

(vii) ensure that all trained overdose responders successfully complete the program's opioid overdose prevention training curriculum;

(viii) provide liaison with local emergency medical services and emergency dispatch agencies, where appropriate;

(ix) assist the clinical director with review of reports of all overdose responses, particularly those involving administration of an opioid antagonist;

(x) report all administrations of an opioid antagonist on forms prescribed by the department; however, public safety and firefighting personnel are required to report administrations of an opioid antagonist directly, or through their department or agency, to the department; and

(xi) report the number of trained overdose responders and the number of doses of an opioid antagonist provided on a quarterly basis on forms prescribed by the department.

(2) Each Opioid Overdose Prevention Program shall have a clinical director who is responsible for clinical oversight and liaison concerning medical issues related to the Opioid Overdose Prevention Program and, at a minimum, shall:

(i) provide clinical consultation, expertise, and oversight;

(ii) serve as a clinical advisor and liaison concerning medical issues related to the Opioid Overdose Prevention Program;

(iii) provide consultation to ensure that all trained overdose responders are properly trained;

(iv) adapt and approve opioid overdose prevention training curriculum content and protocols;

(v) review reports of all administrations of an opioid antagonist; and

(vi) designate individuals, either by name or by description, who are authorized to dispense or furnish an opioid antagonist to trained overdose responders and/or individuals who are responsible for ensuring orderly, controlled, shared access to an identifiable pool of trained overdose responders pursuant to a non-patient specific prescription.

(3) The trained overdose responders shall:

(i) complete an initial training consistent with the program's opioid overdose prevention training curriculum;

(ii) complete a refresher training consistent with the opioid overdose prevention training curriculum at least every two years or otherwise demonstrate competence in opioid overdose recognition and response to the satisfaction of the opioid overdose prevention program director or to someone designated by the program director;

(iii) ensure that emergency medical service has been contacted when encountering a victim of a suspected drug overdose and advise responding emergency medical services personnel if an opioid antagonist has been used;

(iv) comply with protocols for response to victims of suspected drug overdose consistent with the program's opioid overdose prevention training curriculum, or, in the case of responders who are public safety or firefighting personnel, comply with policies developed by their local public safety agency or fire department; and

(v) report all responses to victims of suspected drug overdose to the Opioid Overdose Prevention Program director or to someone designated by the program director.

(4) The opioid antagonist shall be provided or furnished to the trained overdose responder in accordance with all applicable laws, rules and regulations.

(5) The Opioid Overdose Prevention Program will maintain and provide response supplies consistent with its policies and procedures; however, these supplies must include:

(i) a mask or other barrier where rescue breathing is part of the curriculum;

(ii) an agent to prepare skin before injection where an injectable form of an opioid antagonist is used; and

(iii) instructional material required by the department, including information on how to recognize symptoms of an opioid overdose; the steps to be taken in responding to an overdose; and how to access the Office of Alcoholism and Substance Abuse Services through both a toll free number and its website.

(6) The Opioid Overdose Prevention Program's recordkeeping system must include, at a minimum, the following elements:

(i) the names of trained overdose responders, the dates they were trained, and the dates they were furnished naloxone; however, where an opioid antagonist is furnished or dispensed by an opioid overdose prevention program pursuant to a non-patient specific prescription, the program must also maintain records on who has issued the non-patient specific prescription and which designated program staff have dispensed or furnished the opioid antagonist and/or are responsible for ensuring orderly, controlled, shared access to an identifiable pool of trained overdose responders;

(ii) program policies and procedures;

(iii) copy of the contract/agreement with the clinical director, if appropriate;

(iv) opioid antagonist administration usage reports and forms;

(v) documentation of review of administration of an opioid antagonist; and

(vi) an inventory of overdose response supplies.

(7) The Opioid Overdose Prevention Program will establish a procedure by which any administration of opioid antagonist to another individual by a trained overdose responder affiliated with an Opioid Overdose Prevention Program, shall be reported on forms prescribed by the department.

(8) Approval obtained pursuant to this section shall consist of a certificate of approval provided by the department that shall remain in effect for two years or until receipt by the authorized provider of a written notice of termination of the program from the department, whichever shall first occur. The department may renew a certificate of approval for a subsequent two-year period if the registered provider is in good standing with all applicable State and Federal licensing agencies and such provider is found to have complied with the requirements of this section.

(9) Pursuant to Public Health Law section 3309(2), the purchase, acquisition, possession or use of an opioid antagonist by an Opioid Overdose Prevention Program or a trained overdose responder in accordance with this section shall not constitute the unlawful practice of a professional or other violation under title 8 of the Education Law or article 33 of the Public Health Law.

(10) Trained overdose responders may have shared access to, and use of, an opioid antagonist so long as the following conditions are met:

(i) they are trained in accordance with these regulations;

(ii) they have a common organizational or workforce bond; and

(iii) there are policies and procedures in place within that organization or workforce that ensure orderly, controlled access to an opioid antagonist by an identifiable pool of trained overdose responders.

(11) Clinical directors and affiliated prescribers of registered providers are authorized to direct the furnishing or dispensing of an opioid antagonist to trained overdose responders pursuant to a patient-specific prescription or a non-patient specific prescription.

(12) All dispensing or furnishing of an opioid antagonist pursuant to a non-patient-specific prescription shall be to individuals who have been trained in opioid overdose recognition and response and be accompanied by documentation indicating:

(i) that the opioid antagonist has been furnished pursuant to a non-patient specific prescription;

(ii) the name of the prescriber;

(iii) the opioid antagonist being prescribed;

(iv) the date of the dispensing or furnishing; and

(v) the name of the person (or identification of the pool under subparagraph [10][iii] of this subdivision) receiving the opioid antagonist.

(d) Nothing in this section shall prevent a health care practitioner from issuing a patient-specific prescription for an opioid antagonist as otherwise permitted by law.

N.Y. Comp. Codes R. & Regs. Tit. 10 § 80.138

Amended, New York State Register, Volume XXXVI, Issue 30, effective 7/30/2014

Amended New York State Register May 6, 2015/Volume XXXVII, Issue 18, eff.5/6/2015