Section 21.284b. Prescribing, administering and dispensing controlled substances

(a) A CRNP authorized to prescribe or dispense, or both, controlled substances shall register with the Drug Enforcement Administration.

(b) A CRNP shall carry out the following minimum standards when prescribing, administering or dispensing controlled substances:

(1) Initial evaluation. In a health care facility regulated by the Department of Health, the Department of Public Welfare or the Federal government, an initial medical history shall be taken and an initial physical examination shall be conducted to the extent required by the Department of Health in 28 Pa. Code (relating to health and safety) or Department of Public Welfare in 55 Pa. Code (relating to public welfare) or the Federal government in appropriate Federal regulations, whichever is applicable, and bylaws of the health care facility and its medical staff. In other practice settings, before commencing treatment that involves prescribing, administering or dispensing a controlled substance, an initial medical history shall be taken and an initial physical examination shall be conducted unless emergency circumstances justify otherwise. Alternatively, medical history and physical examination information recorded by another health care provider may be considered if the medical history was taken and the physical examination was conducted within the immediately preceding 30 days. The physical examination must include an evaluation of the heart, lungs, vital signs, pain level, and body functions that relate to the patient’s specific complaint.

(2) Reevaluations. Among the factors to be considered in determining the number and frequency of follow-up evaluations that should be recommended to the patient are the condition diagnosed, the controlled substance involved, expected results and possible side effects. For chronic conditions, periodic follow-up evaluations shall be recommended to monitor the effectiveness of the controlled substance in achieving the intended results.

(3) Patient counseling. Appropriate counseling shall be given to the patient regarding the condition diagnosed and the controlled substance prescribed, administered or dispensed. Unless the patient is in an inpatient care setting, the patient shall be specifically counseled about dosage levels, instructions for use, frequency and duration of use and possible side effects.

(4) Medical records. In a health care facility regulated by the Department of Health, the Department of Public Welfare or the Federal government, information pertaining to the prescription, administration or dispensation of a controlled substance shall be entered in the medical records of the patient and the health care facility under 28 Pa. Code or 55 Pa. Code or appropriate Federal regulations, whichever is applicable, and bylaws of the health care facility and its medical staff. In other practice settings, certain information shall be recorded in the patient’s medical record on each occasion when a controlled substance is prescribed, administered or dispensed. This information must include the name of the controlled substance, its strength, the quantity and the date it was prescribed, administered or dispensed. On the initial occasion when a controlled substance is prescribed, administered or dispensed to a patient, the medical record must also include a specification of the symptoms observed and reported, the diagnosis of the condition for which the controlled substance is being given and the directions given to the patient for the use of the controlled substance. If the same controlled substance continues to be prescribed, administered or dispensed, the medical record must reflect changes in the symptoms observed and reported, in the diagnosis of the condition for which the controlled substance is being given and in the directions given to the patient.

(5) Emergency prescriptions. In the case of an emergency contact by a known patient, a prudent, short-term prescription for a controlled substance may be issued. Neither a refill nor a consecutive issuance of this emergency prescription may be given unless a physical examination and evaluation of the patient are first conducted. The results of this examination and evaluation must be set forth in the patient’s medical record together with the diagnosis of the condition for which the controlled substance is being prescribed. An emergency oral prescription for a Schedule II controlled substance shall be covered by a written prescription delivered to the pharmacist within 72 hours. In certain health care facilities regulated by the Department of Health, the Department of Public Welfare and the Federal government, an order for the immediate, direct administration of a Schedule II controlled substance to a patient is not considered a prescription and is, therefore, not subject to the requirements in this paragraph. Further information regarding this exclusion can be found in The Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. § § 780-101—780-144) and 28 Pa. Code Chapter 25 (relating to controlled substances, drugs, devices, and cosmetics).

(c) This section establishes minimum standards for the prescription, administration and dispensation of controlled substances by a CRNP. This section does not restrict or limit the application of The Controlled Substance, Drug, Device and Cosmetic Act or of another statute or regulation, and does not relieve a CRNP from complying with more stringent standards that may be imposed by another statute or regulation, or policy of the CRNP’s employer or facility in which the CRNP is employed.

(d) Compliance with this section will not be treated as compliance with the standards of acceptable and prevailing practice as a CRNP when medical circumstances require that the CRNP exceed the requirements of this section.

The provisions of this § 21.284b adopted December 11, 2009, effective December 12, 2009, 39 Pa.B. 6994.

Notation

Cross References

This section cited in 49 Pa. Code § 21.284a (relating to prescribing and dispensing drugs).