PRIOR PRINTER'S NOS. 835, 1673 PRINTER'S NO. 1989
No. 751 Session of 2001
INTRODUCED BY ALLEN, HARHART, DeWEESE, ARGALL, ARMSTRONG,
M. BAKER, BARRAR, CALTAGIRONE, CLARK, CORRIGAN, COY, CRUZ,
DALLY, EACHUS, FEESE, FLEAGLE, FORCIER, FRANKEL, GANNON,
HALUSKA, HORSEY, KAISER, LEH, McCALL, McILHATTAN, PRESTON,
SATHER, STERN, THOMAS, TIGUE, J. WILLIAMS, WILT, WOJNAROSKI,
YOUNGBLOOD, SAYLOR AND LAUGHLIN, FEBRUARY 14, 2001
AS RE-REPORTED FROM COMMITTEE ON APPROPRIATIONS, HOUSE OF
REPRESENTATIVES, AS AMENDED, MAY 21, 2001
AN ACT
1 Amending the act of September 27, 1961 (P.L.1700, No.699),
2 entitled "An act relating to the regulation of the practice
3 of pharmacy, including the sales, use and distribution of
4 drugs and devices at retail; and amending, revising,
5 consolidating and repealing certain laws relating thereto,"
6 further providing for definitions; and providing for drug
7 therapy protocol.
8 The General Assembly of the Commonwealth of Pennsylvania
9 hereby enacts as follows:
10 Section 1. Section 2(11) of the act of September 27, 1961
11 (P.L.1700, No.699), known as the Pharmacy Act, amended December
12 20, 1985 (P.L.433, No.111), is amended and the section is
13 amended by adding clauses to read:
14 Section 2. Definitions.--As used in this act:
15 * * *
16 (11) "Practice of pharmacy" means the [practice of that
17 profession concerned with the art and science of the evaluation
18 of prescription orders and the preparing, compounding and
1 dispensing of drugs and devices, whether dispensed on the
2 prescription of a medical practitioner or legally dispensed or
3 provided to a consumer, and shall include the proper and safe
4 storage and distribution of drugs, the maintenance of proper
5 records, the participation in drug selection and drug
6 utilization reviews, and the responsibility of relating
7 information as required concerning such drugs and medicines and
8 their therapeutic values and uses in the treatment and
9 prevention of disease:] provision of health care services by a
10 pharmacist, which includes the interpretation, evaluation and
11 implementation of medical orders or prescription drug orders;
12 the delivery, dispensing or distribution of prescription drugs;
13 participation in drug and device selection; drug administration;
14 drug regimen review; drug or drug-related research; compounding;
15 proper and safe storage of drugs and devices; managing drug
16 therapy in an institutional setting; maintaining proper records;
17 patient counseling; and such acts, services, operations or
18 transactions necessary or incident to the provision of these
19 health care services. [Provided, however, That] The "practice of
20 pharmacy" shall not include the operations of a manufacturer or
21 distributor as defined in "The Controlled Substance, Drug,
22 Device and Cosmetic Act."
23 * * *
24 (14) "Managing drug therapy" means any of the following
25 processes which shall be performed in an institutional setting
26 only: Adjusting a drug regimen; adjusting drug strength,
27 frequency of administration or route; administration of drugs;
28 and ordering and performing of laboratory or LABORATORY TESTS <--
29 AND ORDERING AND PERFORMING other diagnostic tests necessary in
30 the management of drug therapy, CONSISTENT WITH THE TESTING <--
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1 STANDARDS OF THE HEALTH CARE FACILITY. Managing drug therapy
2 shall be performed pursuant to a written agreement or protocol
3 as set forth in section 9.1 of this act, authorizing the
4 delegation of management of drug therapy from a licensed
5 physician to a pharmacist, in accordance with section 17 of the
6 act of December 20, 1985 (P.L.457, No.112), known as the
7 "Medical Practice Act of 1985," which authorizes a medical
8 doctor to delegate duties to health care practitioners, and
9 section 3 of the act of October 5, 1978 (P.L.1109, No.261),
10 known as the "Osteopathic Medical Practice Act," which
11 authorizes services and acts rendered by allied medical persons
12 under the supervision, direction or control of a licensed
13 physician.
14 (15) "Institution" means a health care facility as defined
15 in section 103 of the act of July 19, 1979 (P.L.130, No.48),
16 known as the "Health Care Facilities Act." ACT," WHICH OFFERS <--
17 MEDICAL TREATMENT TO PATIENTS WHO REQUIRE FOOD, BOARD AND
18 OVERNIGHT SLEEPING FACILITIES AND CARE.
19 (16) "Drug administration" means the direct introduction of
20 or the application of a drug into or on the body of a patient by
21 injection, inhalation, ingestion or any other means, and where
22 required by law, shall occur only pursuant to a medical order.
23 (17) "Medical order" means a lawful order by a specifically
24 identified medical practitioner for a specifically identified
25 patient.
26 (18) "Physician" means an individual licensed under the laws
27 of this Commonwealth to engage in the practice of medicine and
28 surgery in all its branches within the scope of the act of
29 December 20, 1985 (P.L.457, No.112), known as the "Medical
30 Practice Act of 1985," or in the practice of osteopathic
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1 medicine within the scope of the act of October 5, 1978
2 (P.L.1109, No.261), known as the "Osteopathic Medical Practice
3 Act."
4 (19) "Protocol" means a written document that describes the
5 nature and scope of the drug therapy management to be carried
6 out by the pharmacist.
7 Section 2. The act is amended by adding sections to read:
8 Section 9.1. Drug Therapy Protocols.--(a) A pharmacist
9 shall be permitted to enter into a written agreement or protocol
10 with a licensed physician authorizing the delegation of the
11 management of drug therapy in an institutional setting.
12 (b) The licensed physician who is a party to a written
13 agreement or protocol authorizing the delegation of the
14 management of drug therapy shall be in active practice and the
15 delegation shall be within the scope of the licensed physician's
16 current practice.
17 (c) Participation in a written agreement or protocol
18 authorizing the delegation of the management of drug therapy
19 shall be voluntary, and no licensed physician shall be required
20 to participate.
21 (d) (1) A pharmacist who is a party to a written agreement
22 or protocol authorizing the delegation of the management of drug
23 therapy shall obtain and maintain, to the satisfaction of the
24 board, professional liability insurance coverage in the minimum
25 amount of one million dollars ($1,000,000). The professional
26 liability insurance coverage shall remain in effect as long as
27 that pharmacist is a party to a written agreement or protocol
28 authorizing the delegation of the management of drug therapy.
29 Failure to maintain insurance coverage as required under this
30 subsection shall be actionable under section 5 of this act.
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1 (2) The board shall accept from pharmacists as satisfactory
2 evidence of insurance coverage under this subsection, any and
3 all of the following: self-insurance, personally purchased
4 professional liability insurance, professional liability
5 insurance coverage provided by the pharmacist's employer or any
6 similar type of coverage.
7 (3) The board shall adopt, by regulation, standards and
8 procedures established by the Insurance Commissioner for self-
9 insurance. In the absence of these standards and procedures, the
10 board, after consultation with the Insurance Commissioner, shall
11 establish standards and procedures by regulation for self-
12 insurance under this subsection.
13 (e) Within eighteen months of the effective date of this
14 section, the board shall adopt regulations establishing the
15 parameters of written agreements or protocols authorized by this
16 section. Such parameters shall include, but not be limited to,
17 the requirement that written agreements or protocols:
18 (1) Be in writing.
19 (2) Require that drug therapy regimens be initiated by a
20 licensed physician for patients referred to a pharmacist for
21 drug therapy.
22 (3) Provide for notification of the role of the pharmacist
23 by a licensed physician to each referred patient whose drug
24 therapy management may be affected by the agreement.
25 (4) Be available as follows:
26 (i) At the practice site of any licensed physician who is a
27 party to the agreement.
28 (ii) At the practice site of any licensed pharmacist who is
29 a party to the agreement.
30 (iii) To any patient whose drug therapy management is
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1 affected by the agreement.
2 (iv) Upon request, to investigators of the State Board of
3 Medicine, the State Board of Osteopathic Medicine and the State
4 Board of Pharmacy.
5 (5) Identify, by name, each licensed physician and each
6 licensed pharmacist who are parties to the agreement.
7 (6) Be signed and dated by each licensed physician.
8 (7) Specify the functions and tasks which are the subject of
9 the delegation.
10 (8) Provide for execution of the agreement when any licensed
11 physician or licensed pharmacist may be temporarily absent from
12 a practice setting or temporarily unavailable to participate in
13 its execution.
14 (9) Establish an appropriate time frame, not to exceed
15 seventy-two hours, within which the licensed pharmacist must
16 notify the licensed physician of any changes in dose, duration
17 or frequency of medication prescribed.
18 (10) Be filed with the State Board of Pharmacy and the State
19 Board of Medicine and/or the State Board of Osteopathic
20 Medicine.
21 (11) Remain in effect for a period not to exceed two years
22 upon the conclusion of which, or sooner, the parties shall
23 review the agreement and make a determination as to its renewal,
24 necessary modifications or termination.
25 (12) Allow for termination of the agreement at the request
26 of any party to it at any time.
27 (f) Managing drug therapy within an institutional setting
28 may occur without the requirements of subsection (e) provided it
29 is pursuant to a medical order by a licensed physician for
30 managing drug therapy protocol or guideline approved by the
20010H0751B1989 - 6 -
1 medical staff of the institution.
2 Section 9.2. Authority to Administer Injectable Medications,
3 Biologicals and Immunizations.--(a) Within eighteen months from
4 the effective date of this section, the board shall by
5 regulation establish education and training standards and
6 practice guidelines pursuant to which pharmacists shall be
7 authorized to administer injectable medications, biologicals and
8 immunizations to persons who are more than eighteen years of
9 age. Such standards and guidelines shall include, but not be
10 limited to, the following:
11 (1) Satisfactory completion of an academic and practical
12 curriculum approved by the board that includes the current
13 guidelines and recommendations of the Centers for Disease
14 Control and Prevention in the Public Health Service of the
15 United States Department of Health and Human Services, the
16 American Council on Pharmaceutical Education or a similar health
17 authority or professional body, and includes, but is not limited
18 to, disease epidemiology, vaccine characteristics, injection
19 technique, emergency response to adverse events and related
20 topics.
21 (2) Maintenance of a current cardiopulmonary resuscitation
22 (CPR) certificate acceptable to the board.
23 (3) That the administration of injectable medications,
24 biologicals and immunizations be in accordance with a definitive
25 set of treatment guidelines established by a physician and
26 approved by the board.
27 (4) That a minimum of two hours of the thirty-hour
28 requirement for continuing education for license renewal be
29 dedicated to this area of practice.
30 (b) A pharmacist's authority to administer injectable
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1 medications, biologicals and immunizations shall not be
2 delegated to any other person.
3 Section 3. This act shall take effect in 60 days.
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