35 Pa.C.S. Ch. 52

in effect

35 Pa.C.S. § 52A01 Definitions.

The following words and phrases when used in this chapter shall have the meanings given to them in this section unless the context clearly indicates otherwise: "Authorized adult." An adult who has a valid health care proxy to consent to the minor's medical treatment. "Bureau." The Bureau of Professional and Occupational Affairs. "Controlled substance." A drug, substance or immediate precursor included in Schedules II, III, IV and V of section 4 of the act of April 14, 1972 (P.L.233, No.64), known as The Controlled Substance, Drug, Device and Cosmetic Act. "Licensing board." A Commonwealth board which licenses, registers or certifies a prescriber. "Medical emergency." A situation which, in a prescriber's good faith professional judgment, creates an immediate threat of serious risk to the life or physical health of a minor. "Minor." An individual under 18 years of age. The term excludes an individual who is emancipated by: (1) marrying; (2) entering the armed forces of the United States; (3) being employed and self-sustaining; or (4) otherwise being independent from the care and control of the individual's parent, guardian or custodian. "Opioid." Any of the following: (1) A preparation or derivative of opium. (2) A synthetic narcotic that has opiate-like effects but is not derived from opium. (3) A group of naturally occurring peptides that bind at or otherwise influence opiate receptors, including opioid agonist. "Prescriber." A person that is licensed, registered or otherwise authorized to distribute, dispense or administer a controlled substance, other drug or device in the course of professional practice or research in this Commonwealth. The term does not include a veterinarian.

35 Pa.C.S. § 52A02 Administration.

(a) Licensing boards.--A licensing board shall administer this chapter as to prescribers under its jurisdiction. (b) Bureau.-- (1) The bureau shall, in cooperation with the licensing boards, prescribe the form under section 52A04(a)(3) (relating to procedure). (2) The bureau shall transmit notice of the availability of the form to the Legislative Reference Bureau for publication in the Pennsylvania Bulletin. Cross References. Section 52A02 is referred to in section 52A04 of this title.

35 Pa.C.S. § 52A03 Prohibition.

(a) Proscription.--A prescriber may not do any of the following: (1) Prescribe to a minor a controlled substance containing an opioid unless the prescriber complies with section 52A04 (relating to procedure). (2) Except as set forth in subsection (b) and subject to section 52A04(c)(1), prescribe to a minor more than a seven-day supply of a controlled substance containing an opioid. (b) Exception.--Notwithstanding subsection (a)(1), a prescriber may prescribe to a minor more than a seven-day supply of a controlled substance containing an opioid if any of the following apply: (1) In the professional medical judgment of the prescriber, more than a seven-day supply of a controlled substance containing an opioid is required to stabilize the minor's acute medical condition. In order for this paragraph to apply, the prescriber must: (i) document the acute medical condition in the minor's record with the prescriber; and (ii) indicate the reason why a non-opioid alternative is not appropriate to address the acute medical condition. (2) The prescription is for: (i) management of pain associated with cancer; (ii) use in palliative or hospice care; or (iii) management of chronic pain not associated with cancer. Effective Date. Section 2(2) of Act 125 of 2016 provided that section 52A03 shall take effect upon publication of the notice under section 52A02(b)(2). The notice was published February 4, 2017, at 47 Pa.B. 671. Cross References. Section 52A03 is referred to in section 52A04 of this title.

35 Pa.C.S. § 52A04 Procedure.

(a) Requirements.--Except as set forth in subsection (b), before issuing a minor the first prescription in a single course of treatment for a controlled substance containing an opioid, regardless of whether the dosage is modified during that course of treatment, a prescriber shall do all of the following: (1) Assess whether the minor has taken or is currently taking prescription drugs for treatment of a substance use disorder. (2) Discuss with the minor and the minor's parent or guardian or with an authorized adult all of the following: (i) The risks of addiction and overdose associated with the controlled substance containing an opioid. (ii) The increased risk of addiction to controlled substances to individuals suffering from mental or substance use disorders. (iii) The dangers of taking a controlled substance containing an opioid with benzodiazepines, alcohol or other central nervous system depressants. (iv) Other information in the patient counseling information section of the labeling for controlled substances containing an opioid required under 21 C.F.R. 201.57(c)(18) (relating to specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1)) deemed necessary by the prescriber. (3) Obtain written consent for the prescription from the minor's parent or guardian or from an authorized adult. The prescriber shall record the consent on the form under section 52A02(b)(1) (relating to administration). The following apply: (i) The form must contain all of the following: (A) The brand name or generic name and quantity of the controlled substance containing an opioid being prescribed and the amount of the initial dose. (B) A statement indicating that a controlled substance is a drug or other substance that the United States Drug Enforcement Administration has identified as having a potential for abuse. (C) A statement certifying that the prescriber engaged in the discussion under paragraph (2). (D) The number of refills authorized by the prescription under section 52A03(b) (relating to prohibition). (E) The signature of the minor's parent or guardian or of an authorized adult and the date of signing. (ii) The form shall be maintained in the minor's record with the prescriber. (b) Exception.--Subsection (a) does not apply if the minor's treatment with a controlled substance containing an opioid meets any of the following criteria: (1) The treatment is associated with or incident to a medical emergency as documented in the minor's medical record. (2) In the prescriber's professional judgment, complying with subsection (a) with respect to the minor's treatment would be detrimental to the minor's health or safety. The prescriber shall document in the minor's medical record the factor or factors which the prescriber believed constituted cause for not fulfilling the requirements of subsection (a). (3) The medical treatment is rendered while the minor remains admitted to a licensed health care facility or remains in observation status in a licensed health care facility. (4) The prescriber is continuing a treatment initiated by another member of the prescriber's practice, the prescriber who initiated the treatment followed the procedures outlined in subsection (a) and the prescriber who is continuing the treatment is not changing the therapy in any way other than dosage. (c) Limited prescription.--If the individual who signs the consent form under subsection (a)(3) is an authorized adult, the prescriber: (1) may prescribe not more than a single, 72-hour supply; and (2) shall indicate on the prescription the quantity that is to be dispensed pursuant to the prescription. (Oct. 24, 2018, P.L.650, No.93, eff. 60 days) 2018 Amendment. Act 93 amended subsec. (b). Effective Date. Section 2(2) of Act 125 of 2016 provided that section 52A04 shall take effect upon publication of the notice under section 52A02(b)(2). The notice was published February 4, 2017, at 47 Pa.B. 671. Cross References. Section 52A04 is referred to in sections 52A02, 52A03 of this title.

35 Pa.C.S. § 52A05 Penalties.

A violation of this chapter subjects a prescriber to administrative sanctions by the prescriber's licensing board under the applicable statute. Effective Date. Section 2(2) of Act 125 of 2016 provided that section 52A05 shall take effect upon publication of the notice under section 52A02(b)(2). The notice was published February 4, 2017, at 47 Pa.B. 671.

35 Pa.C.S. § 52B01 Definitions.

The following words and phrases when used in this chapter shall have the meanings given to them in this section unless the context clearly indicates otherwise: "Acute pain." Pain that comes on quickly, may be severe, but lasts a relatively short time and is provoked by a specific condition or injury. "Baseline test." The initial assessment through a urine drug test to: (1) identify the presence of an illegal substance prior to prescribing a controlled substance; or (2) assess the presence or absence of a prescribed drug or drug class. "Chronic pain." Pain that persists or progresses over a period of time that may be related to another medical condition and is resistant to medical treatment. The term does not include acute pain. "Controlled substance." A drug, substance or immediate precursor included in Schedules II through V of section 4 of the act of April 14, 1972 (P.L.233, No.64), known as The Controlled Substance, Drug, Device and Cosmetic Act. "Definitive drug test." A qualitative or quantitative urine drug test used to identify specific drugs, specific drug concentrations and associated metabolites. "Department." The Department of Health of the Commonwealth. "Individual." An individual who is at least 18 years of age. "Medical emergency." A situation that, in the good faith professional judgment of the prescriber, creates a time sensitive threat of serious risk to the life or physical health of a person. The term includes treatment received in an emergency department or urgent care center under the act of November 2, 2016 (P.L.976, No.122), known as the Safe Emergency Prescribing Act. "Opioid." Any of the following: (1) A preparation or derivative of opium. (2) A synthetic narcotic that has opiate-like effects but is not derived from opium. (3) A group of naturally occurring peptides that bind at or otherwise influence opiate receptors, including an opioid agonist. "Periodic test." A urine drug test that screens for a selection of drugs. "Prescriber." As defined in the act of October 27, 2014 (P.L.2911, No.191), known as the Achieving Better Care by Monitoring All Prescriptions Program (ABC-MAP) Act. "Presumptive positive drug test." A urine drug test that is used to identify suspected possible use or nonuse of drugs or a drug class that may be followed by a definitive test to specifically identify drugs or metabolites. "Targeted test." A urine drug test ordered at the discretion of a prescriber, based on observation of the prescriber and related circumstances that enhance clinical decision making. "Treatment agreement." A document signed by a prescriber and individual that contains a statement to ensure that the individual understands: (1) Treatment responsibilities. (2) The conditions of medication use. (3) The conditions under which the treatment of the individual may be terminated. (4) The responsibilities of the prescriber.

35 Pa.C.S. § 52B02 Procedure.

(a) Prescriber requirements.--Except as specified in subsection (d), before issuing an individual the first prescription in a single course of treatment for chronic pain with a controlled substance containing an opioid, regardless of whether the dosage is modified during that course of treatment, a prescriber shall: (1) Assess whether the individual has taken or is currently taking a prescription drug for treatment of a substance use disorder. (2) Discuss with the individual: (i) The risks of addiction and overdose associated with the controlled substance containing an opioid. (ii) The increased risk of addiction to a controlled substance if the individual suffers from a mental disorder or substance use disorder. (iii) The dangers of taking a controlled substance containing an opioid with benzodiazepines, alcohol or other central nervous system depressants. (iv) Other information deemed appropriate by the prescriber under 21 CFR 201.57(c)(18) (relating to specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1)). (v) The nonopioid treatment options available for treating chronic noncancer pain, if applicable, that are consistent with the best practices per the Pennsylvania Opioid Prescribing Guidelines. (3) Review and sign a treatment agreement form that includes: (i) The goals of the treatment. (ii) The consent of the individual to a targeted test in a circumstance where the physician determines that a targeted test is medically necessary. The treatment of chronic pain shall be consistent with the Pennsylvania Opioid Prescribing Guidelines. (iii) The prescription drug prescribing policies of the prescriber, which policies include: (A) A requirement that the individual take the medication as prescribed. (B) A prohibition on sharing the prescribed medication with other individuals. (iv) A requirement that the individual inform the prescriber about any other controlled substances prescribed or taken by the individual. (v) Any reason why the opioid therapy may be changed or discontinued by the prescriber. (vi) Appropriate disposal methods for opioids that are no longer being used by the individual as specified in a consultation with the prescriber. (4) Obtain written consent for the prescription from the individual. The prescriber may utilize electronic methods to obtain the written consent of the individual. (5) Record the consent under paragraph (4) on the treatment agreement form under paragraph (3). (b) Treatment agreement form requirements.--The treatment agreement form under subsection (a)(3) shall be maintained by the prescriber in the medical record of the individual and include: (1) The brand name or generic name, quantity and initial dose of the controlled substance containing an opioid being prescribed. (2) A statement indicating that a controlled substance is a drug or other substance that the United States Drug Enforcement Administration has identified as having a potential for abuse. (3) A statement certifying that the prescriber engaged in the discussion under subsection (a)(2). (4) The signature of the individual and the date of signing. The prescriber may utilize electronic methods to obtain the signature of the individual and the date of signing. (c) Urine drug testing.-- (1) A baseline test, periodic test or targeted test shall be used to establish a general assessment for an individual new to treatment for chronic pain and in monitoring adherence to an existing individual treatment plan, as well as to detect the use of a nonprescribed drug. (2) A baseline test shall be required prior to the issuance of the initial prescription for chronic pain and shall include confirmatory or quantitative testing of presumptive positive drug test results. (3) An individual who is treated for addiction or an individual who is considered moderate or high risk by the prescriber shall be tested at least once annually or as frequently as necessary to ensure therapeutic adherence. (d) Exception.--Subsection (c) shall not apply if the treatment of an individual with a controlled substance containing an opioid is associated with or incident to: (1) A medical emergency documented in the medical record of the individual. (2) The management of pain associated with cancer. (3) The use in palliative or hospice care. (4) The professional judgment of the prescriber under subsection (a)(1) and (2). (e) Documentation of exception.--If subsection (d) applies, the prescriber shall document in the individual's medical record the factor under subsection (d) that the prescriber believes applies to the individual.

35 Pa.C.S. § 52B03 Regulations.

(a) Promulgation.--The department shall promulgate temporary regulations within 90 days of the effective date of this subsection. The temporary regulations shall not be subject to: (1) Sections 201, 202, 203, 204 and 205 of the act of July 31, 1968 (P.L.769, No.240), referred to as the Commonwealth Documents Law. (2) Sections 204(b) and 301(10) of the act of October 15, 1980 (P.L.950, No.164), known as the Commonwealth Attorneys Act. (3) The act of June 25, 1982 (P.L.633, No.181), known as the Regulatory Review Act. (b) Expiration.--The temporary regulations under subsection (a) shall expire on the promulgation of final-form regulations, or two years following the effective date of this section, whichever is later.

35 Pa.C.S. § 52B04 Penalties.

A violation of this chapter by a prescriber shall be subject to sanctions under the prescriber's professional practice act and by the appropriate licensing board.

35 Pa.C.S. § 5201 Scope of chapter.

This chapter relates to patient voluntary nonopioid directives.

35 Pa.C.S. § 5202 Definitions.

The following words and phrases when used in this chapter shall have the meanings given to them in this section unless the context clearly indicates otherwise: "Controlled substance." As defined in the act of April 14, 1972 (P.L.233, No.64), known as The Controlled Substance, Drug, Device and Cosmetic Act. "Department." The Department of Health of the Commonwealth. "Health care facility." A health care facility as defined in section 103 of the act of July 19, 1979 (P.L.130, No.48), known as the Health Care Facilities Act, or any other facility or institution licensed, registered or otherwise permitted to distribute, dispense, conduct research with or prescribe or administer a controlled substance containing an opioid or other controlled substance in the course of professional practice or research in this Commonwealth. "Licensing board." The term shall include the following: (1) The State Board of Medicine as set forth in the act of December 20, 1985 (P.L.457, No.112), known as the Medical Practice Act of 1985. (2) The State Board of Osteopathic Medicine as set forth in the act of October 5, 1978 (P.L.1109, No.261), known as the Osteopathic Medical Practice Act. (3) The State Board of Nursing as set forth in the act of May 22, 1951 (P.L.317, No.69), known as The Professional Nursing Law. (4) The State Board of Podiatry as set forth in the act of March 2, 1956 (1955 P.L.1206, No.375), known as the Podiatry Practice Act. (5) The State Board of Dentistry as set forth in the act of May 1, 1933 (P.L.216, No.76), known as The Dental Law. "Opioid." Any of the following: (1) A preparation or derivative of opium. (2) A synthetic narcotic that has opiate-like effects but is not derived from opium. (3) A group of naturally occurring peptides that bind at or otherwise influence opiate receptors, including an opioid agonist. "Patient." An individual who is under the medical care of a practitioner. "Practitioner." A health care practitioner as defined in section 103 of the act of July 19, 1979 (P.L.130, No.48), known as the Health Care Facilities Act. "Secretary." The Secretary of Health of the Commonwealth. "System." The Achieving Better Care by Monitoring All Prescriptions Program electronic prescription monitoring system with a database component as established under the act of October 27, 2014 (P.L.2911, No.191), known as the Achieving Better Care by Monitoring All Prescriptions Program (ABC-MAP) Act. "Voluntary nonopioid directive." A written instruction form executed by a patient evidencing the named patient's request not to have a controlled substance containing an opioid offered, supplied, prescribed or otherwise administered to the named patient by a practitioner.

35 Pa.C.S. § 5203 Voluntary nonopioid directive.

(a) Duty of department.-- (1) In consultation with a Statewide professional organization representing physicians licensed to practice medicine in all its branches, Statewide organizations representing nursing homes, registered professional nurses, emergency medical systems and a Statewide organization representing health care facilities, the department shall develop and publish a uniform voluntary nonopioid directive form which may be used by a patient to deny or refuse the administration or prescribing of a controlled substance containing an opioid by a practitioner. (2) The voluntary nonopioid directive form developed by the department in accordance with paragraph (1) shall indicate to all prescribing practitioners and health care facilities that the named patient shall not be offered, prescribed, supplied with or otherwise administered a controlled substance containing an opioid. (3) The voluntary nonopioid directive form shall be posted in a downloadable format on the department's publicly accessible Internet website. (b) Execution of form.--The following shall apply: (1) A patient may execute and file a voluntary nonopioid directive form with a practitioner or other authority authorized by the secretary to accept the voluntary nonopioid directive form for filing. Each practitioner or other person authorized by the secretary to accept a voluntary nonopioid directive form for filing shall date and affix his signature to the form in the presence of the patient as evidence of acceptance and shall provide a signed copy of the form to the patient. (2) The patient executing and filing a voluntary nonopioid directive form with a practitioner shall sign and date the form in the presence of the practitioner, a designee of the practitioner or other person authorized by the secretary to accept a voluntary nonopioid directive form for filing. In the case of a patient who is unable to execute and file a voluntary nonopioid form, the patient may designate a duly authorized guardian or health care proxy to execute and file the form in accordance with paragraph (1). (3) A patient may revoke the voluntary nonopioid directive form for any reason and may do so by written or oral means. (4) Notwithstanding paragraph (1), before signing a voluntary nonopioid directive form a practitioner may, if deemed appropriate, assess the patient's personal and family history of alcohol or drug abuse and evaluate the patient's risk for medication misuse or abuse. In evaluating such risks, the practitioner shall access the system to determine whether an unusual or suspect pattern for the prescribing of controlled substances containing opioids to the patient has been reported to the system. If a practitioner reasonably believes that a patient is at risk for substance misuse or abuse or a practitioner believes in the practitioner's expert medical opinion that for any other reason the nonopioid directive is appropriate, the practitioner shall sign the form. The practitioner signing the nonopioid directive form shall note doing so in the patient's medical record.

35 Pa.C.S. § 5204 Guidelines.

(a) Adoption of guidelines.--The department shall adopt and publish guidelines for the implementation of the voluntary nonopioid directive form. The guidelines shall include, but not be limited to: (1) A standard form for the recording and transmission of the voluntary nonopioid directive form, which shall include verification by the patient's practitioner and which shall comply with the written consent requirements of the Public Health Service Act (58 Stat. 682, 42 U.S.C. § 290dd-2(b)) and 42 CFR Pt. 2 (relating to confidentiality of alcohol and drug abuse patient records), provided that the voluntary nonopioid directive form shall also provide the basic procedures necessary to revoke the voluntary nonopioid directive form. (2) Procedures to record the voluntary nonopioid directive form in the patient's medical record or, if available, the patient's interoperable electronic medical record and in the system. (3) Requirements and procedures for a patient to appoint a duly authorized guardian or health care proxy to override a previously filed voluntary nonopioid directive form and circumstances under which an attending practitioner may override a previously filed voluntary nonopioid directive form based on documented medical judgment which shall be recorded in the patient's medical record. (4) Procedures to ensure that any recording, sharing or distributing of data relative to the voluntary nonopioid directive form complies with all Federal and State confidentiality laws. (5) Appropriate exemptions for practitioners and other health care providers and emergency medical personnel to prescribe or administer a controlled substance containing an opioid when, in their professional medical judgment, a controlled substance containing an opioid is necessary. (b) Publication.--The department shall publish the guidelines in the Pennsylvania Bulletin and on its publicly accessible Internet website. (c) Written prescriptions.--A written prescription that is presented at an outpatient pharmacy or a prescription that is electronically transmitted to an outpatient pharmacy shall be presumed to be valid for the purposes of this section, and a pharmacist in an outpatient setting shall not be held in violation of this section for dispensing a controlled substance containing an opioid or other controlled substance in contradiction to a voluntary nonopioid directive form, except upon evidence that the pharmacist acted knowingly against the voluntary nonopioid directive form. Cross References. Section 5204 is referred to in section 5205 of this title.

35 Pa.C.S. § 5205 Exemption from liability.

(a) Practitioner exemption.--No practitioner or employee of a practitioner acting in good faith shall be subject to criminal or civil liability or be considered to have engaged in unprofessional conduct for failing to offer or administer a prescription or medication order for a controlled substance containing an opioid under the voluntary nonopioid directive form. (b) Representative exemption.--No person acting as a representative or an agent under a health care proxy shall be subject to criminal or civil liability for making a decision under section 5204(a)(3) (relating to guidelines) in good faith.

35 Pa.C.S. § 5206 Licensing boards.

Notwithstanding any other provision of law or regulation, a licensing board may limit, condition or suspend the license of or assess a fine against a practitioner who recklessly or negligently fails to comply with a patient's voluntary nonopioid directive form.

Source: Open US Law by Vaquill AI (CC BY 4.0)URL: https://www.palegis.us/statutes/consolidated/view-statute?txtType=HTM&ttl=35Fetched: 10/16/2026