PRIOR PRINTER'S NO. 835 PRINTER'S NO. 1673
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 REPORTED FROM COMMITTEE ON PROFESSIONAL LICENSURE, HOUSE OF
REPRESENTATIVES, AS AMENDED, APRIL 24, 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 other diagnostic
29 tests necessary in the management of drug therapy. Managing drug
30 therapy shall be performed pursuant to a written agreement or
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1 protocol as set forth in section 9.1 of this act, authorizing
2 the delegation of management of drug therapy from a licensed
3 physician to a pharmacist, in accordance with section 17 of the
4 act of December 20, 1985 (P.L.457, No.112), known as the
5 "Medical Practice Act of 1985," which authorizes a medical
6 doctor to delegate duties to health care practitioners, and
7 section 3 of the act of October 5, 1978 (P.L.1109, No.261),
8 known as the "Osteopathic Medical Practice Act," which
9 authorizes services and acts rendered by allied medical persons
10 under the supervision, direction or control of a licensed
11 physician.
12 (15) "Institution" means an extended care facility, nursing <--
13 home, nursing care facility, convalescent home, resident care
14 facility, hospital or any other place which offers medical
15 treatment to patients who require food, board and overnight
16 sleeping facilities and care.
17 (15) "INSTITUTION" MEANS A HEALTH CARE FACILITY AS DEFINED <--
18 IN SECTION 103 OF THE ACT OF JULY 19, 1979 (P.L.130, NO.48),
19 KNOWN AS THE "HEALTH CARE FACILITIES ACT."
20 (16) "Drug administration" means the direct introduction of
21 or the application of a drug into or on the body of a patient by
22 injection, inhalation, ingestion or any other means, and where
23 required by law, shall occur only pursuant to a medical order.
24 (17) "Medical order" means a lawful order by a specifically
25 identified medical practitioner for a specifically identified
26 patient.
27 (18) "Physician" means an individual licensed under the laws
28 of this Commonwealth to engage in the practice of medicine and
29 surgery in all its branches within the scope of the act of
30 December 20, 1985 (P.L.457, No.112), known as the "Medical
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1 Practice Act of 1985," or in the practice of osteopathic
2 medicine within the scope of the act of October 5, 1978
3 (P.L.1109, No.261), known as the "Osteopathic Medical Practice
4 Act."
5 (19) "Protocol" means a written document that describes the
6 nature and scope of the drug therapy management to be carried
7 out by the pharmacist.
8 Section 2. The act is amended by adding sections to read:
9 Section 9.1. Drug Therapy Protocols.--(a) A pharmacist
10 shall be permitted to enter into a written agreement or protocol
11 with a licensed physician authorizing the delegation of the
12 management of drug therapy in an institutional setting.
13 (b) The licensed physician who is a party to a written
14 agreement or protocol authorizing the delegation of the
15 management of drug therapy shall be in active practice and the
16 delegation shall be within the scope of the licensed physician's
17 current practice.
18 (c) Participation in a written agreement or protocol
19 authorizing the delegation of the management of drug therapy
20 shall be voluntary, and no licensed physician shall be required
21 to participate.
22 (d) (1) A pharmacist who is a party to a written agreement
23 or protocol authorizing the delegation of the management of drug
24 therapy shall obtain and maintain, to the satisfaction of the
25 board, professional liability insurance coverage in the minimum
26 amount of one million dollars ($1,000,000). The professional
27 liability insurance coverage shall remain in effect as long as
28 that pharmacist is a party to a written agreement or protocol
29 authorizing the delegation of the management of drug therapy.
30 Failure to maintain insurance coverage as required under this
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1 subsection shall be actionable 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) To any patient whose drug therapy management is
2 affected by the agreement.
3 (iv) Upon request, to investigators of the State Board of
4 Medicine, the State Board of Osteopathic Medicine and the State
5 Board of Pharmacy.
6 (5) Identify, by name, each licensed physician and each
7 licensed pharmacist who are parties to the agreement.
8 (6) Be signed and dated by each licensed physician.
9 (7) Specify the functions and tasks which are the subject of
10 the delegation.
11 (8) Provide for execution of the agreement when any licensed
12 physician or licensed pharmacist may be temporarily absent from
13 a practice setting or temporarily unavailable to participate in
14 its execution.
15 (9) Establish an appropriate time frame, not to exceed
16 seventy-two hours, within which the licensed pharmacist must
17 notify the licensed physician of any changes in dose, duration
18 or frequency of medication prescribed.
19 (10) Be filed with the State Board of Pharmacy and the State
20 Board of Medicine and/or the State Board of Osteopathic
21 Medicine.
22 (11) Remain in effect for a period not to exceed two years
23 upon the conclusion of which, or sooner, the parties shall
24 review the agreement and make a determination as to its renewal,
25 necessary modifications or termination.
26 (12) Allow for termination of the agreement at the request
27 of any party to it at any time.
28 (f) Managing drug therapy within an institutional setting
29 may occur without the requirements of subsection (e) provided it
30 is pursuant to a medical order by a licensed physician for
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1 managing drug therapy protocol or guideline approved by the
2 medical staff of the institution.
3 Section 9.2. Authority to Administer Injectable Medications,
4 Biologicals and Immunizations.--(a) Within eighteen months from
5 the effective date of this section, the board shall by
6 regulation establish education and training standards and
7 practice guidelines pursuant to which pharmacists shall be
8 authorized to administer injectable medications, biologicals and
9 immunizations to persons who are more than eighteen years of
10 age. Such standards and guidelines shall include, but not be
11 limited to, the following:
12 (1) Satisfactory completion of an academic and practical
13 curriculum approved by the board that includes the current
14 guidelines and recommendations of the Centers for Disease
15 Control and Prevention in the Public Health Service of the
16 United States Department of Health and Human Services, the
17 American Council on Pharmaceutical Education or a similar health
18 authority or professional body, and includes, but is not limited
19 to, disease epidemiology, vaccine characteristics, injection
20 technique, emergency response to adverse events and related
21 topics.
22 (2) Maintenance of a current cardiopulmonary resuscitation
23 (CPR) certificate acceptable to the board.
24 (3) That the administration of injectable medications,
25 biologicals and immunizations be in accordance with a definitive
26 set of treatment guidelines established by a physician and
27 approved by the board.
28 (4) That a minimum of two hours of the thirty-hour
29 requirement for continuing education for license renewal be
30 dedicated to this area of practice.
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1 (b) A pharmacist's authority to administer injectable
2 medications, biologicals and immunizations shall not be
3 delegated to any other person.
4 Section 3. This act shall take effect in 60 days.
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