Current through Register Vol. 55, No. 13, March 29, 2025
(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.
This section cited in 49 Pa. Code §
21.284a (relating to prescribing
and dispensing drugs).