§ 18.158. Prescribing and dispensing drugs, pharmaceutical aids and devices.

 (a)  Prescribing, dispensing and administration of drugs.

   (1)  The supervising physician may delegate to the physician assistant the prescribing, dispensing and administering of drugs and therapeutic devices.

   (2)  A physician assistant may not prescribe or dispense Schedule I controlled substances as defined by section 4 of The Controlled Substances, Drug, Device, and Cosmetic Act (35 P. S. §  780-104).

   (3)  A physician assistant may prescribe a Schedule II controlled substance for initial therapy, up to a 72-hour dose. The physician assistant shall notify the supervising physician of the prescription as soon as possible, but in no event longer than 24 hours from the issuance of the prescription. A physician assistant may write a prescription for a Schedule II controlled substance for up to a 30-day supply if it was approved by the supervising physician for ongoing therapy. The prescription must clearly state on its face that it is for initial or ongoing therapy.

   (4)  A physician assistant may only prescribe or dispense a drug for a patient who is under the care of the physician responsible for the supervision of the physician assistant and only in accordance with the supervising physician’s instructions and written agreement.

   (5)  A physician assistant may request, receive and sign for professional samples and may distribute professional samples to patients.

   (6)  A physician assistant authorized to prescribe or dispense, or both, controlled substances shall register with the Drug Enforcement Administration (DEA).

 (b)  Prescription blanks. The requirements for prescription blanks are as follows:

   (1)  Prescription blanks must bear the license number of the physician assistant and the name of the physician assistant in a printed format at the heading of the blank. The supervising physician must also be identified as required in §  16.91 (relating to identifying information on prescriptions and orders for equipment and service).

   (2)  The signature of a physician assistant shall be followed by the initials ‘‘PA-C’’ or similar designation to identify the signer as a physician assistant. When appropriate, the physician assistant’s DEA registration number must appear on the prescription.

   (3)  The supervising physician is prohibited from presigning prescription blanks.

   (4)  The physician assistant may use a prescription blank generated by a hospital provided the information in paragraph (1) appears on the blank.

 (c)  Inappropriate prescription. The supervising physician shall immediately advise the patient, notify the physician assistant and, in the case of a written prescription, advise the pharmacy if the physician assistant is prescribing or dispensing a drug inappropriately. The supervising physician shall advise the patient and notify the physician assistant to discontinue using the drug and, in the case of a written prescription, notify the pharmacy to discontinue the prescription. The order to discontinue use of the drug or prescription shall be noted in the patient’s medical record by the supervising physician.

 (d)  Recordkeeping requirements. Recordkeeping requirements are as follows:

   (1)  When prescribing a drug, the physician assistant shall keep a copy of the prescription, including the number of refills, in a ready reference file, or record the name, amount and doses of the drug prescribed, the number of refills, the date of the prescription and the physician assistant’s name in the patient’s medical records.

   (2)  When dispensing a drug, the physician assistant shall record the physician assistant’s name, the name of the medication dispensed, the amount of medication dispensed, the dose of the medication dispensed and the date dispensed in the patient’s medical records.

   (3)  The physician assistant shall report, orally or in writing, to the supervising physician within 36 hours, a drug prescribed or medication dispensed by the physician assistant while the supervising physician was not physically present, and the basis for each decision to prescribe or dispense in accordance with the written agreement.

   (4)  The supervising physician shall countersign the patient record within 10 days.

   (5)  The physician assistant and the supervising physician shall provide immediate access to the written agreement to anyone seeking to confirm the physician assistant’s authority to prescribe or dispense a drug. The written agreement must list the categories of drugs which the physician assistant is not permitted to prescribe.

 (e)  Compliance with regulations relating to prescribing, administering, dispensing, packaging and labeling of drugs. A physician assistant shall comply with § §  16.92—16.94 (relating to prescribing, administering and dispensing controlled substances; packaging; and labeling of dispensed drugs) and Department of Health regulations in 28 Pa. Code § §  25.51—25.58 (relating to prescriptions) and regulations regarding packaging and labeling dispensed drugs. See §  16.94 and 28 Pa. Code § §  25.91—25.95 (relating to labeling of drugs, devices and cosmetics).

Authority

   The provisions of this §  18.158 issued under sections 8, 13 and 36 of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.13 and 422.36).

Source

   The provisions of this §  18.158 adopted August 13, 1993, effective August 14, 1993, 23 Pa.B. 3780; amended November 17, 2006, effective November 18, 2006, 36 Pa.B. 7009. Immediately preceding text appears at serial pages (222930) to (222933).

Cross References

   This section cited in 49 Pa. Code §  18.122 (relating to definitions); and 49 Pa. Code §  18.151 (relating to role of physician assistant).



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