SENATE AMENDED
PRIOR PRINTER'S NOS. 835, 1673, 1989 PRINTER'S NO. 4066
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 AMENDED ON THIRD CONSIDERATION, IN SENATE, JUNE 19, 2002
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 FOR THE PROVISION OF PHARMACY <--
12 SERVICES or prescription drug orders; the delivery, dispensing
13 or distribution of prescription drugs; participation in drug and
14 device selection; drug administration; drug regimen review; drug
15 or drug-related research; compounding; proper and safe storage
16 of drugs and devices; managing drug therapy in an institutional
17 setting CONSISTENT WITH THE INSTITUTION'S ASSIGNMENT OF CLINICAL <--
18 DUTIES; maintaining proper records; patient counseling; and such
19 acts, services, operations or transactions necessary or incident
20 to the provision of these health care services. [Provided,
21 however, That] The "practice of pharmacy" shall not include the
22 operations of a manufacturer or distributor as defined in "The
23 Controlled Substance, Drug, Device and Cosmetic Act."
24 * * *
25 (14) "Managing drug therapy" means any of the following
26 processes which shall be performed in an institutional setting
27 only: Adjusting a drug regimen; adjusting drug strength,
28 frequency of administration or route; administration of drugs;
29 and ordering laboratory tests and ordering and performing other
30 diagnostic tests necessary in the management of drug therapy,
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1 consistent with the testing standards of the health care <--
2 facility INSTITUTION. Managing drug therapy shall be performed <--
3 pursuant to a written agreement or protocol as set forth in
4 section 9.1 of this act., authorizing the delegation of <--
5 management of drug therapy from a licensed physician to a
6 pharmacist, in accordance with section 17 of the act of December
7 20, 1985 (P.L.457, No.112), known as the "Medical Practice Act
8 of 1985," which authorizes a medical doctor to delegate duties
9 to health care practitioners, and section 3 of the act of
10 October 5, 1978 (P.L.1109, No.261), known as the "Osteopathic
11 Medical Practice Act," which authorizes services and acts
12 rendered by allied medical persons under the supervision,
13 direction or control of a licensed 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," which offers CARE AND <--
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) (17) "Physician" means an individual licensed under the <--
27 laws of this Commonwealth to engage in the practice of medicine
28 and 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) (18) "Protocol" means a written document that describes <--
5 the nature and scope of the drug therapy management to be
6 carried 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 WRITTEN AGREEMENT OR PROTOCOL shall be within the <--
16 scope of the licensed physician's 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, PHARMACIST OR <--
20 INSTITUTION shall be required 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) PER OCCURRENCE OR <--
26 CLAIMS MADE. The professional liability insurance coverage shall
27 remain in effect as long as that pharmacist is a party to a
28 written agreement or protocol authorizing the delegation of the <--
29 management of drug therapy. Failure to maintain insurance
30 coverage as required under this subsection shall be actionable
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1 under section 5 of this act.
2 (2) The board shall accept from pharmacists as satisfactory
3 evidence of insurance coverage under this subsection, any and
4 all of the following: self-insurance, personally purchased
5 professional liability insurance, professional liability
6 insurance coverage provided by the pharmacist's employer or any
7 similar type of coverage.
8 (3) The board shall adopt, by regulation, standards and
9 procedures established by the Insurance Commissioner for self-
10 insurance. In the absence of these standards and procedures, the
11 board, after consultation with the Insurance Commissioner, shall
12 establish standards and procedures by regulation for self-
13 insurance under this subsection.
14 (e) Within eighteen months of the effective date of this
15 section, the board shall adopt regulations establishing the
16 parameters of written agreements or protocols authorized by this
17 section. Such parameters shall include, but not be limited to,
18 the requirement that written agreements or protocols:
19 (1) Be in writing.
20 (2) Require that drug therapy regimens be initiated by a
21 licensed physician for patients referred to a pharmacist for
22 drug therapy.
23 (3) Provide for notification of the role of the pharmacist
24 by a licensed physician to each referred patient whose drug
25 therapy management may be affected by the agreement.
26 (4) Be available as follows:
27 (i) At the practice site of any licensed physician who is a
28 party to the agreement.
29 (ii) At the practice site of any licensed pharmacist who is
30 a party to the agreement.
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1 (III) AT THE INSTITUTION WHERE A WRITTEN AGREEMENT OR <--
2 PROTOCOL IS IN PLACE.
3 (iii) (IV) To any patient whose drug therapy management is <--
4 affected by the agreement.
5 (iv) (V) Upon request, to investigators REPRESENTATIVES of <--
6 the State Board of Medicine, the State Board of Osteopathic
7 Medicine and, the State Board of Pharmacy AND THE DEPARTMENT OF <--
8 HEALTH.
9 (5) Identify, by name, each licensed physician and each
10 licensed pharmacist who are parties to the agreement.
11 (6) Be signed and dated by each licensed physician AND EACH <--
12 LICENSED PHARMACIST.
13 (7) Specify the functions and tasks which are the subject of
14 the delegation THE WRITTEN AGREEMENT OR PROTOCOL. <--
15 (8) Provide for execution of the agreement when any licensed
16 physician or licensed pharmacist may be temporarily absent from
17 a practice setting or temporarily unavailable to participate in
18 its execution.
19 (9) Establish an appropriate time frame, not to exceed
20 seventy-two hours, within which the licensed pharmacist must
21 notify the licensed physician of any changes in dose, duration
22 or frequency of medication prescribed.
23 (10) Be filed with the State Board of Pharmacy and the State
24 Board of Medicine and/or the State Board of Osteopathic
25 Medicine.
26 (11) Remain in effect for a period not to exceed two years
27 upon the conclusion of which, or sooner, the parties shall
28 review the agreement and make a determination as to its renewal,
29 necessary modifications or termination.
30 (12) Allow for termination of the agreement at the request
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1 of any party to it at any time.
2 (f) Managing drug therapy within an institutional setting
3 may occur without the requirements of subsection (e) provided it
4 is pursuant to a medical order by a licensed physician for
5 managing drug therapy protocol or guideline approved by the <--
6 medical staff of the institution.
7 Section 9.2. Authority to Administer Injectable Medications,
8 Biologicals and Immunizations.--(a) Within eighteen months from
9 the effective date of this section, the board shall by
10 regulation establish education and training standards and
11 practice guidelines pursuant to which pharmacists shall be
12 authorized to administer injectable medications, biologicals and
13 immunizations to persons who are more than eighteen years of
14 age. Such standards and guidelines shall include, but not be
15 limited to, the following:
16 (1) Satisfactory completion of an academic and practical
17 curriculum approved by the board that includes the current
18 guidelines and recommendations of the Centers for Disease
19 Control and Prevention in the Public Health Service of the
20 United States Department of Health and Human Services, the
21 American Council on Pharmaceutical Education or a similar health
22 authority or professional body, and includes, but is not limited
23 to, disease epidemiology, vaccine characteristics, injection
24 technique, emergency response to adverse events and related
25 topics.
26 (2) Maintenance of a current cardiopulmonary resuscitation
27 (CPR) certificate acceptable to the board.
28 (3) That the administration of injectable medications,
29 biologicals and immunizations be in accordance with a definitive
30 set of treatment guidelines established by a physician and
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1 approved by the board.
2 (4) That a minimum of two hours of the thirty-hour
3 requirement for continuing education for license renewal be
4 dedicated to this area of practice.
5 (b) A pharmacist's authority to administer injectable
6 medications, biologicals and immunizations shall not be
7 delegated to any other person.
8 Section 3. This act shall take effect in 60 days.
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