THE GENERAL ASSEMBLY OF PENNSYLVANIA

HOUSE BILL

INTRODUCED BY KULA, McILVAINE SMITH, MANN, SOLOBAY, BARRAR, BRENNAN, CARROLL, DeLUCA, EVERETT, GEIST, GROVE, HALUSKA, HARHAI, JOSEPHS, KORTZ, LONGIETTI, MUNDY, PASHINSKI, REICHLEY, SIPTROTH, J. TAYLOR, K. SMITH, VULAKOVICH, MAHONEY, HORNAMAN AND GIBBONS, MARCH 23, 2009

REFERRED TO COMMITTEE ON PROFESSIONAL LICENSURE, MARCH 23, 2009  

AN ACT

Amending the act of September 27, 1961 (P.L.1700, No.699),

entitled "An act relating to the regulation of the practice

of pharmacy, including the sales, use and distribution of

drugs and devices at retail; and amending, revising,

consolidating and repealing certain laws relating thereto,"

further providing for definitions, for refusal to grant

revocation and suspension and for drug therapy protocols; and

providing for collaborative drug therapy management and for

construction of act.

The General Assembly of the Commonwealth of Pennsylvania

hereby enacts as follows:

Section 1.  Section 2(11) and (14) of the act of September

27, 1961 (P.L.1700, No.699), known as the Pharmacy Act, amended

or added June 29, 2002 (P.L.673, No.102), are amended to read:

Section 2.  Definitions.--As used in this act:

* * *

(11)  "Practice of pharmacy" means the provision of health

care services by a pharmacist, which includes the

interpretation, evaluation and implementation of medical orders

for the provision of pharmacy services or prescription drug

orders; the delivery, dispensing or distribution of prescription

drugs; participation in drug and device selection; drug

administration; drug regimen review; medication therapy

management, including such services provided under the Medicare

Prescription Drug, Improvements, and Modernization Act of 2003

(Public Law 108-172, 117 Stat. 2066); drug or drug-related

research; compounding; proper and safe storage of drugs and

devices; managing drug therapy pursuant to section 9.3 or, if in

an institutional setting, consistent with the institution's

assignment of clinical duties pursuant to a written agreement or 

protocol as set forth in section 9.1; maintaining proper

records; patient counseling; and such acts, services, operations

or transactions necessary or incident to the provision of these

health care services. The "practice of pharmacy" shall not

include the operations of a manufacturer or distributor as

defined in "The Controlled Substance, Drug, Device and Cosmetic

Act."

* * *

(14)  "Managing drug therapy" means any of the following

processes which shall be performed [in an institutional setting

only] pursuant to a written agreement or protocol as set forth

in section 9.1 or pursuant to section 9.3: adjusting a drug

regimen; adjusting drug strength, frequency of administration or

route; administration of drugs; [and] ordering laboratory tests

and ordering and performing other diagnostic tests necessary in

the management of drug therapy[, consistent with the testing

standards of the institution. Managing drug therapy shall be

performed pursuant to a written agreement or protocol as set

forth in section 9.1 of this act.]; monitoring the patient's

vital signs; and providing education and training to the patient

which is related to the management of drug therapy. Managing

drug therapy under section 9.1 shall be performed consistent

with the institution's assignment of clinical duties, and

ordering of laboratory tests and ordering or performing other

diagnostic tests necessary in the management of drug therapy

shall be consistent with the testing standards of the

institution.

* * *

Section 2.  Section 5(a)(9) of the act, amended December 20,

1985 (P.L.433, No.111), is amended to read:

Section 5.  Refusal to Grant, Revocation and Suspension.--(a)

The board shall have the power to refuse, revoke or suspend the

license of any pharmacist upon proof satisfactory to it that the

pharmacist:

* * *

(9)  Is guilty of grossly unprofessional conduct. The

following acts on the part of a pharmacist are hereby declared

to constitute grossly unprofessional conduct of a pharmacist:

(i)  Willfully deceiving or attempting to deceive the State

Board of Pharmacy or its agents with respect to any material

matter under investigation by the board;

(ii)  Advertising of prices for drugs and pharmaceutical

services to the public which does not conform to Federal laws or

regulations;

(iii)  The public assertion or implication of professional

superiority in the practice of pharmacy;

(iv)  The engaging by any means in untrue, false, misleading

or deceptive advertising of drugs or devices;

(v)  Paying rebates to physicians or any other persons, or

the entering into any agreement with a medical practitioner or

any other person for the payment or acceptance of compensation

in any form for the recommending of the professional services of

either party;

(vi)  The entering into of any agreement with a licensed

medical practitioner for the compounding or dispensing of secret

formula (coded), prescriptions;

(vii)  The misbranding or adulteration of any drug or device

and the sale, distribution or dispensing of any misbranded or

adulterated drug or device as defined in the act of April 14,

1972 (P.L.233, No.64), known as "The Controlled Substance, Drug,

Device and Cosmetic Act";

(viii)  Engaging in the sale or purchase of drugs or devices

whose package bears the inscription "sample" or "not for

resale";

(ix)  Displaying or permitting the display of his certificate

of licensure and biennial registration document in a pharmacy of

which he is not the proprietor or in which he is not employed;

(x)  Any holder of a biennial pocket registration card who

fails to have the card available for inspection by an authorized

agent when he is practicing;

(xi)  The acceptance back and redistribution of any unused

drug, or a part thereof, after it has left the premises of any

pharmacy, whether issued by mistake or otherwise, unless it is

in the original sealed container with the name, lot number and

expiration date on the original intact manufacturer's label. The

pharmacy shall maintain records of all such returns, and a full

refund shall be given to the original purchaser, including a

third-party payor;

[(xii)  To accept employment as a pharmacist, or share or

receive compensation in any form arising out of, or incidental

to, his professional activities from any medical practitioner or

any other person or corporation in which one or more medical

practitioners have a proprietary or beneficial interest

sufficient to permit them to exercise supervision or control

over the pharmacist in his professional responsibilities and

duties;

(xiii)  To accept employment as a pharmacist, or share or

receive compensation in any form arising out of, or incidental

to, his professional activities from any person who orders said

pharmacist, directly or indirectly, to engage in any aspect of

the practice of pharmacy in contravention of any provision of

this act.]

(xii)  To accept employment as a pharmacist from any health

care practitioner, other person or entity, whereby the

pharmacist engages in any aspect of the practice of pharmacy in

contravention of any provision of this act or Federal law.

(xiii)  To share or receive compensation in any form arising

out of, or incidental to, his professional activities whereby

the pharmacist engaged in any aspect of the practice of pharmacy

in contravention of any provision of this act or Federal law.

(xiv)  It shall be unlawful for a pharmacist or pharmacy

permit holder to enter into an arrangement with a health care

practitioner who is licensed to issue prescriptions for the

purpose of directing or diverting patients to or from a

specified pharmacy or restraining in any way a patient's freedom

of choice to select a pharmacy.

* * *

Section 3.  Section 9.1(e) introductory paragraph, added June

29, 2002 (P.L.673, No.102), is amended and the subsection is

amended by adding a clause to read:

Section 9.1.  Drug Therapy Protocols.--* * *

(e)  [Within eighteen months of the effective date of this

section, the] The board shall adopt regulations establishing the

parameters of written agreements or protocols authorized by this

section. Such parameters shall include, but not be limited to,

the requirement that written agreements or protocols:

* * *

(13)  Require a licensed pharmacist to provide to the board

satisfactory evidence of completion of all necessary training

required in the management of drug therapy for a disease , or

for a condition or symptom of a disease, which is the subject of

the written agreement or protocol. A licensed pharmacist

practicing the management of drug therapy in an institutional

setting on the effective date of this clause shall not be

required to comply with the training requirement specified in

this clause.

* * *

Section 4.  The act is amended by adding sections to read:

Section 9.3.  Collaborative Drug Therapy Management.--(a)  A

licensed pharmacist shall be permitted to enter into a

collaborative agreement with a licensed physician authorizing

the management of drug therapy for a disease, or for a condition

or symptom of a disease, in a setting other than an

institutional setting.

(b)  A licensed pharmacist who is a party to a collaborative

agreement authorizing the management of drug therapy must comply

with the following:

(1)  Be able to provide to the board satisfactory evidence of

training in the management of drug therapy for a disease, or for

a condition or symptom of a disease, which is the subject of the

collaborative agreement. A licensed pharmacist practicing the

management of drug therapy in an institutional setting on the

effective date of this section shall not be required to comply

with this clause.

(2)  Complies with registration by the board. A list of

registrants shall be accessible by the public.

(3)  Of the continuing education credits completed as a

condition of biennial renewal, has two continuing education

credits that focus on the management of drug therapy or focus on

a disease, or on a condition or symptom of a disease, being

treated through drug therapy.

(4)  Must utilize an area for consultation relating to the

management of drug therapy that ensures the confidentiality of

the patient information being discussed.

(c)  (1)  (i)  A pharmacist who is a party to a collaborative

agreement authorizing the management of drug therapy shall

obtain and maintain, to the satisfaction of the board,

professional liability insurance coverage in the minimum amount

of one million dollars ($1,000,000) per occurrence or claims

made. The professional liability insurance coverage shall remain

in effect as long as that pharmacist is a party to a written

agreement or protocol authorizing the management of drug

therapy.

(ii)  Failure to maintain insurance coverage as required

under this subsection shall be actionable under section 5.

(2)  The board shall accept from a pharmacist as satisfactory

evidence of insurance coverage under this subsection any and all

of the following: self-insurance, personally purchased

professional liability insurance, professional liability

insurance coverage provided by the pharmacist's employer or any

similar type of coverage.

(3)  The board shall adopt, by regulation, standards and

procedures established by the Insurance Commissioner for self-

insurance. In the absence of these standards and procedures, the

board, after consultation with the insurance commissioner, shall

establish standards and procedures by regulation for self-

insurance under this subsection.

(d)  A licensed pharmacist may not provide economic

incentives to a licensed physician for the purpose of entering

into a collaborative agreement for the management of drug

therapy.

(e)  The management of drug therapy pursuant to a

collaborative agreement shall be initiated by a written referral

from the physician to the pharmacist. The written referral shall

include the frequency in which the pharmacist must conduct the

management of drug therapy in person.

(f)  The licensed physician who is a party to the

collaborative agreement authorizing the management of drug

therapy shall be in active practice and in good standing, and

the collaborative agreement shall be within the scope of the

licensed physician's current practice.

(g)  Participation in a collaborative agreement authorizing

the management of drug therapy shall be voluntary, and no

licensed physician or pharmacist shall be required to

participate.

(h)  A patient's records related to the management of drug

therapy may be maintained in an automated system.

(i)  A licensed pharmacist who is a party to the

collaborative agreement authorizing the management of drug

therapy shall have access to the records of a patient who is the

recipient of the management of drug therapy.

(j)  All patient records in the possession of a licensed

pharmacist providing the management of drug therapy must comply

with the Health Insurance Portability and Accountability Act of

1996 (Public Law 104-191, 110 Stat. 1936).

(k)  The collaborative agreement must:

(1)  Be between a licensed physician and a licensed

pharmacist.

(2)  Comply with the requirements specified in section

9.1(e).

(3)  Specify the terms under which a licensed pharmacist

providing drug therapy services is permitted to adjust drug

regimen or to adjust drug strength, frequency of administration

or route without prior written or oral consent by the

collaborating physician.

Section 9.4.  Construction.--Nothing in this act shall be

construed to provide prescriptive authority to a licensed

pharmacist.

Section 5.  The State Board of Pharmacy shall promulgate

regulations to implement the addition of section 9.3 of the act

within 18 months of the effective date of this section. The

addition of section 9.3 of the act shall not be enforceable by

the State Board of Pharmacy until the publication of final

regulations.

Section 6.  This act shall take effect in 60 days.