Pennsylvania § 52A04 - Procedure.

§ 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.