The following words and terms, when used in this chapter,
have the following meanings, unless the context clearly indicates
otherwise:
ACPE- The Accreditation Council for
Pharmacy Education.
Act- The Pharmacy Act (63 P. S.
§§ 390-1-390-13).
Automated medication system-
(i) A process that performs operations or
activities, other than compounding or administration, relative to the storage,
packaging, dispensing and distribution of medications, and which collects,
controls and maintains all transaction information.
(ii) The term does not include an automatic
counting device or unit-based dispensing cabinet.
Automatic counting device- A device used
in a pharmacy to automatically count medication for dispensing.
Board- The State Board of
Pharmacy.
Bureau- The Bureau of Professional and
Occupational Affairs of the Department.
CEU-Continuing education units- The unit
of measuring contact hours of continuing education provided by ACPE accredited
providers. Ten contact hours are equivalent to 1.0 CEU.
Central fill pharmacy- A pharmacy
engaging in centralized prescription processing by filling and refilling
prescriptions, which includes the preparation and packaging of the medication.
A central fill pharmacy may also be the originating or delivering
pharmacy.
Central processing center- A pharmacy
operated under the direction of a pharmacist that processes information related
to the practice of pharmacy and that engages solely in centralized prescription
processing but from which drugs are not dispensed.
Centralized prescription processing- The
processing, under the direction of a pharmacist, of a request to fill or refill
a prescription, to perform functions such as refill authorizations,
interventions or other matters related to the practice of pharmacy for
subsequent delivery to the delivering pharmacy.
Commissioner- The Commissioner of
Professional and Occupational Affairs in the Department.
Contact hours- Continuing education
units of measure equivalent to 50 to 60 minutes of participation in an approved
organized learning experience, including home study with approved educational
materials.
Continuing education- Professional
education obtained to maintain, improve or expand current skills or knowledge,
or to develop new skills or knowledge.
DEA- The Federal Drug Enforcement
Administration.
Delivering pharmacy- The pharmacy that
receives the processed prescription or the filled or refilled prescription for
delivering to the patient or the patient's authorized representative. A
delivering pharmacy may also be an originating or central fill pharmacy.
Department- The Department of State of
the Commonwealth.
Drug order-
(i) An oral or written order issued by a
medical practitioner which is either written on or entered by computer into the
medical record of a patient in an institution for the dispensing of a drug or
device for administration to the patient.
(ii) The term does not include an order for a
drug for a patient in an institution which the patient will self-administer
which will be considered a prescription.
FDA-The United States Food and Drug
Administration, a division of the United States Department of Health and Human
Services.
FDLE- Federal Drug Law
Examination.
Institution- A health care facility as
defined in section 103 of the Health Care Facilities Act (35 P. S. §
448.103) which offers care and medical
treatment to patients who require food, board and overnight sleeping
facilities.
Licensed person- A person holding a
license issued by the Board.
Long-term care facility- A nursing home,
retirement care, mental care or other institution that provides extended health
care to resident patients.
MJPE- Multistate Pharmacy Jurisprudence
Examination.
Management of drug therapy-
(i) Any of the following processes performed
under a written protocol as set forth in section
9.1 of the
act (
63 P. S. §
390-9.1) or under a collaborative agreement
as set forth in section
9.3 of the
act (
63 P. S. §
390-9.3):
(A) Adjusting a drug regimen.
(B) Adjusting drug strength, frequency of
administration or route.
(C)
Administration of drugs.
(D)
Ordering laboratory tests and ordering and performing other diagnostic tests
necessary in the management of drug therapy.
(E) Monitoring the patient's vital
signs.
(F) Providing education and
training to the patient that is related to the management of the drug
therapy.
(ii) The term
excludes medication therapy management services in the practice of
pharmacy
provided under the Medicare
Prescription Drug, Improvement, and Modernization
Act of 2003 (
Pub. L. No.
108-173, 117 Stat.
2066).
Medical practitioner- A physician,
dentist, veterinarian or other individual authorized and licensed by law to
prescribe drugs.
Non-institutional setting- A setting
other than an institution as defined in the act and this section.
Nonproprietary drug- A drug containing
any quantity of a controlled substance or a drug which is required by an
applicable Federal or state law to be dispensed only by prescription.
Order- Any directive from a medical
practitioner.
Originating pharmacy-
(i) The pharmacy that receives the patient's
or prescribing practitioner's request to fill or refill a prescription and
performs functions such as the prospective drug review.
(ii) The term includes a central processing
center or a central fill pharmacy if the prescription was transmitted by the
prescriber directly to the central processing center or central fill pharmacy
or if the patient requested the refill from that pharmacy.
PDR- Prospective drug review performed
to assure that a drug dispensed under a prescription is not likely to have an
adverse medical result by attempting to identify potential drug therapy
problems that might result from therapeutic duplication, drug-drug
interactions, incorrect dosage, incorrect duration of drug treatment,
drug-allergy interactions, and clinical abuse or misuse.
Pharmacist manager- The pharmacist named
in the permit to operate a pharmacy who is in charge of a pharmacy and
responsible for operations involving the practice of pharmacy under section 4
of the act (63 P. S. §
390-4).
Pharmacy- The place licensed by the
Board where the practice of pharmacy is conducted.
Pharmacy intern- A person registered by
the Board as a pharmacy intern under section 3(e) of the act (63 P. S. §
390-3(e)) and §
27.26 (relating to pharmacy
internship).
Pharmacy technician-
(i) An unlicensed person working in a
pharmacy to assist a pharmacist in the practice of
pharmacy in accordance with
§
27.12 (relating to practice of
pharmacy and delegation of duties).
(ii) The term does not include a pharmacy
intern, or clerical or housekeeping personnel.
Practice of pharmacy-
(i) The provision of health care services by
a pharmacist, which includes:
(A) The
interpretation, evaluation and implementation of medical orders for the
provision of pharmacy services or prescription drug orders.
(B) The delivery, dispensing or distribution
of prescription drugs.
(C)
Participation in drug and device selection.
(D) Drug administration.
(E) Drug regimen review.
(F) Drug or drug-related research.
(G) Compounding.
(H) Proper and safe storage of drugs and
devices.
(I) Management of drug
therapy under a written collaborative agreement as set forth in section
9.3 of the
act or, if in an
institutional setting, consistent with the
institution's assignment of clinical
duties under a written protocol as set forth in section
9.1 of the
act.
(J) Maintaining proper records.
(K) Patient counseling.
(L) Acts, services, operations or
transactions necessary or incident to the provision of these health care
services.
(M) Drug therapy
management, including services provided under the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003.
(ii) The term does not include the operations
of a manufacturer or distributor as defined in The Controlled Substance, Drug,
Device and Cosmetic Act (35 P. S. §§ 780-101-780.144).
Prescription- A written, electronic or
oral order issued by a licensed medical practitioner in the course of
professional practice for a controlled substance, other drug or device, or
medication which is dispensed for use by a consumer.
Prescription area-
(i) That area of the pharmacy used for
compounding, legend drug storage and other activities necessary to the practice
of pharmacy.
(ii) The term does not
include waiting counters or display space attached to the waiting
counters.
Proprietary drug- A nonprescription,
nonnarcotic medicine or drug which may be sold without a prescription and which
is prepackaged for use by the consumer and labeled in accordance with the
requirements of Federal and State statutes and regulations.
Satellite pharmacy-
(i) A pharmacy in an institution which
provides specialized services for the patients of the institution and which is
dependent upon the centrally located pharmacy for administrative control,
staffing and drug procurement.
(ii)
The term does not include a pharmacy serving the public on the premises of an
institution nor does it include a pharmacy located off premises from the
centrally located pharmacy of the institution regardless of whether the
pharmacy is owned by the same person or entity which owns the
institution.
USP-The United States Pharmacopeia-A
compendium of drug information published by the United States Pharmacopeial
Convention.