49 Pa. Code § 27.405 - Recordkeeping
(a) A pharmacist
who administers an injectable medication, biological or immunization or who
supervises the administration by a pharmacy intern shall maintain the following
records regarding each administration for a minimum of 2 years:
(1) The name, address and date of birth of
the patient.
(2) The date of the
administration and site of the injection.
(3) The name, dose, manufacturer, lot number
and expiration date of the medication, biological or immunization.
(4) The name and address of the patient's
primary health care provider, as identified by the patient.
(5) The name or identifiable initials of the
administering pharmacist. If the administration was performed by a pharmacy
intern, the name or identifiable initials of the pharmacy intern and the
supervising pharmacist.
(6)
Documentation of informed consent for administration of injectable medications,
biologicals and immunizations, and in the case of influenza immunizations
administered to patients under 18 years of age, documentation of written
parental consent.
(7) The nature of
an adverse reaction and who was notified.
(b) A pharmacist who administers an
immunization or supervises the administration by a pharmacy intern shall also
maintain the following records regarding each administration for a minimum of 2
years:
(1) An identification of the Vaccine
Information Statement (VIS) that was provided.
(2) The date of publication of the
VIS.
(3) The date and to whom the
VIS was provided.
(c) In
an institution, the information required to be maintained in subsections (a)
and (b) may be maintained in the patients' medical records.
Notes
The provisions of this § 27.405 amended under sections 4(j), 6(k)(1) and (9) and 9.2(a) of the Pharmacy Act (63 P.S. §§ 390-4(j), 390-6(k)(1) and (9) and 390-9.2(a)).
This section cited in 49 Pa. Code § 27.12 (relating to practice of pharmacy and delegation of duties).
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