PRINTER'S NO. 835
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
AND YOUNGBLOOD, FEBRUARY 14, 2001
REFERRED TO COMMITTEE ON PROFESSIONAL LICENSURE,
FEBRUARY 14, 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 (16) "Drug administration" means the direct introduction of
18 or the application of a drug into or on the body of a patient by
19 injection, inhalation, ingestion or any other means, and where
20 required by law, shall occur only pursuant to a medical order.
21 (17) "Medical order" means a lawful order by a specifically
22 identified medical practitioner for a specifically identified
23 patient.
24 (18) "Physician" means an individual licensed under the laws
25 of this Commonwealth to engage in the practice of medicine and
26 surgery in all its branches within the scope of the act of
27 December 20, 1985 (P.L.457, No.112), known as the "Medical
28 Practice Act of 1985," or in the practice of osteopathic
29 medicine within the scope of the act of October 5, 1978
30 (P.L.1109, No.261), known as the "Osteopathic Medical Practice
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1 Act."
2 (19) "Protocol" means a written document that describes the
3 nature and scope of the drug therapy management to be carried
4 out by the pharmacist.
5 Section 2. The act is amended by adding sections to read:
6 Section 9.1. Drug Therapy Protocols.--(a) A pharmacist
7 shall be permitted to enter into a written agreement or protocol
8 with a licensed physician authorizing the delegation of the
9 management of drug therapy in an institutional setting.
10 (b) The licensed physician who is a party to a written
11 agreement or protocol authorizing the delegation of the
12 management of drug therapy shall be in active practice and the
13 delegation shall be within the scope of the licensed physician's
14 current practice.
15 (c) Participation in a written agreement or protocol
16 authorizing the delegation of the management of drug therapy
17 shall be voluntary, and no licensed physician shall be required
18 to participate.
19 (d) (1) A pharmacist who is a party to a written agreement
20 or protocol authorizing the delegation of the management of drug
21 therapy shall obtain and maintain, to the satisfaction of the
22 board, professional liability insurance coverage in the minimum
23 amount of one million dollars ($1,000,000). The professional
24 liability insurance coverage shall remain in effect as long as
25 that pharmacist is a party to a written agreement or protocol
26 authorizing the delegation of the management of drug therapy.
27 Failure to maintain insurance coverage as required under this
28 subsection shall be actionable under section 5 of this act.
29 (2) The board shall accept from pharmacists as satisfactory
30 evidence of insurance coverage under this subsection, any and
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1 all of the following: self-insurance, personally purchased
2 professional liability insurance, professional liability
3 insurance coverage provided by the pharmacist's employer or any
4 similar type of coverage.
5 (3) The board shall adopt, by regulation, standards and
6 procedures established by the Insurance Commissioner for self-
7 insurance. In the absence of these standards and procedures, the
8 board, after consultation with the Insurance Commissioner, shall
9 establish standards and procedures by regulation for self-
10 insurance under this subsection.
11 (e) Within eighteen months of the effective date of this
12 section, the board shall adopt regulations establishing the
13 parameters of written agreements or protocols authorized by this
14 section. Such parameters shall include, but not be limited to,
15 the requirement that written agreements or protocols:
16 (1) Be in writing.
17 (2) Require that drug therapy regimens be initiated by a
18 licensed physician for patients referred to a pharmacist for
19 drug therapy.
20 (3) Provide for notification of the role of the pharmacist
21 by a licensed physician to each referred patient whose drug
22 therapy management may be affected by the agreement.
23 (4) Be available as follows:
24 (i) At the practice site of any licensed physician who is a
25 party to the agreement.
26 (ii) At the practice site of any licensed pharmacist who is
27 a party to the agreement.
28 (iii) To any patient whose drug therapy management is
29 affected by the agreement.
30 (iv) Upon request, to investigators of the State Board of
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1 Medicine, the State Board of Osteopathic Medicine and the State
2 Board of Pharmacy.
3 (5) Identify, by name, each licensed physician and each
4 licensed pharmacist who are parties to the agreement.
5 (6) Be signed and dated by each licensed physician.
6 (7) Specify the functions and tasks which are the subject of
7 the delegation.
8 (8) Provide for execution of the agreement when any licensed
9 physician or licensed pharmacist may be temporarily absent from
10 a practice setting or temporarily unavailable to participate in
11 its execution.
12 (9) Establish an appropriate time frame, not to exceed
13 seventy-two hours, within which the licensed pharmacist must
14 notify the licensed physician of any changes in dose, duration
15 or frequency of medication prescribed.
16 (10) Be filed with the State Board of Pharmacy and the State
17 Board of Medicine and/or the State Board of Osteopathic
18 Medicine.
19 (11) Remain in effect for a period not to exceed two years
20 upon the conclusion of which, or sooner, the parties shall
21 review the agreement and make a determination as to its renewal,
22 necessary modifications or termination.
23 (12) Allow for termination of the agreement at the request
24 of any party to it at any time.
25 (f) Managing drug therapy within an institutional setting
26 may occur without the requirements of subsection (e) provided it
27 is pursuant to a medical order by a licensed physician for
28 managing drug therapy protocol or guideline approved by the
29 medical staff of the institution.
30 Section 9.2. Authority to Administer Injectable Medications,
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1 Biologicals and Immunizations.--(a) Within eighteen months from
2 the effective date of this section, the board shall by
3 regulation establish education and training standards and
4 practice guidelines pursuant to which pharmacists shall be
5 authorized to administer injectable medications, biologicals and
6 immunizations to persons who are more than eighteen years of
7 age. Such standards and guidelines shall include, but not be
8 limited to, the following:
9 (1) Satisfactory completion of an academic and practical
10 curriculum approved by the board that includes the current
11 guidelines and recommendations of the Centers for Disease
12 Control and Prevention in the Public Health Service of the
13 United States Department of Health and Human Services, the
14 American Council on Pharmaceutical Education or a similar health
15 authority or professional body, and includes, but is not limited
16 to, disease epidemiology, vaccine characteristics, injection
17 technique, emergency response to adverse events and related
18 topics.
19 (2) Maintenance of a current cardiopulmonary resuscitation
20 (CPR) certificate acceptable to the board.
21 (3) That the administration of injectable medications,
22 biologicals and immunizations be in accordance with a definitive
23 set of treatment guidelines established by a physician and
24 approved by the board.
25 (4) That a minimum of two hours of the thirty-hour
26 requirement for continuing education for license renewal be
27 dedicated to this area of practice.
28 (b) A pharmacist's authority to administer injectable
29 medications, biologicals and immunizations shall not be
30 delegated to any other person.
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1 Section 3. This act shall take effect in 60 days.
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