Current through Register Vol. 54, No. 12, March 23, 2024
(a) For purposes of
this section, "drug" includes the following:
(1) Controlled substances under The
Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. §§
780-101-780-144) or substances that are
controlled substances under Federal law.
(2) Carisoprodol or agents in which
carisoprodol is an active ingredient.
(3) Butalbital or agents in which butalbital
is an active ingredient.
(4)
Tramadol hydrochloride or agents in which tramadol hydrochloride is an active
ingredient.
(b) When
prescribing, administering or dispensing drugs regulated under this section, a
person licensed to practice medicine and surgery in this Commonwealth or
otherwise licensed or regulated by the Board shall carry out, or cause to be
carried out, the following minimum standards:
(1)
Initial medical history and
physical examination. An initial medical history shall be taken and an
initial physical examination shall be conducted unless emergency circumstances
justify otherwise. Medical history and physical examination information
recorded by another licensed 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 shall include an
objective evaluation of the heart, lungs, blood pressure and body functions
that relate to the patient's specific complaint.
(2)
Reevaluations.
Reevaluations of the patient's condition and efficacy of the drug therapy shall
be made consistent with the condition diagnosed, the drug or drugs involved,
expected results and possible side effects.
(3)
Patient counseling. The
patient shall be counseled regarding the condition diagnosed and the drug
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. Accurate and complete medical records must document the
evaluation and care received by patients.
(i)
On the initial occasion when a drug is prescribed, administered or dispensed to
a patient, the medical record must include the following:
(A) A specification of the symptoms observed
by the licensed health care provider and reported by the patient.
(B) The diagnosis of the condition for which
the drug is being given.
(C) The
directions given to the patient for the use of the drug.
(D) The name, strength and quantity of the
drug and the date on which the drug was prescribed, administered or
dispensed.
(ii) After the
initial occasion when a drug is prescribed, administered or dispensed, the
medical record must include the information required in subsection (b)(4)(i)(D)
and changes or additions to the information recorded under subsection
(b)(4)(i)(A)-(C).
(5)
Emergency prescriptions. In the case of an emergency contact
from a known patient, a prudent, short-term prescription for a drug 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 is first conducted by a licensed health care provider. The results of
this examination and evaluation shall be recorded in the patient's medical
record together with the diagnosis of the condition for which the drug 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.
(6)
Compliance with other laws.
(i) This section may not be construed as
restricting or limiting the application of The Controlled Substance, Drug,
Device and Cosmetic Act or statutes or regulations of the Department of Health
and the Department of Public Welfare that govern the prescription,
administration and dispensation of drugs and medical recordkeeping in certain
health care facilities.
(ii) This
section may not be construed as restricting or limiting the application of
Federal laws or regulations that govern the prescription, administration and
dispensation of drugs and medical recordkeeping in certain health care
facilities.
(iii) This section does
not relieve a person from complying with more stringent standards that may be
imposed by another statute or regulation.
(7)
Compliance with facility
policy. This section does not relieve a person from complying with
more stringent standards that may be imposed by the health care facility in
which the person practices or by the person's employer.
(8)
Adherence to standards of
practice. Compliance with this section will not be treated as
compliance with the standards of acceptable and prevailing medical practice
when medical circumstances require that the licensed health care provider
exceed the requirements of this section.
The provisions of this §
16.92 amended under section 8 of
the Medical Practice Act of 1985 (63 P. S. §
422.8).
This section cited in 49 Pa. Code §
18.6a (relating to prescribing,
dispensing and administering drugs); 49 Pa. Code §
18.157 (relating to administration
of controlled substances and whole blood and blood components); and 49 Pa. Code
§
18.158 (relating to prescribing
and dispensing drugs, pharmaceutical aids and
devices).