THE GENERAL ASSEMBLY OF PENNSYLVANIA

HOUSE BILL

INTRODUCED BY BOYD, BEAR, BEYER, CALTAGIRONE, CREIGHTON, DeLUCA, DENLINGER, EVERETT, GEIST, GILLESPIE, GINGRICH, GROVE, HALUSKA, HELM, HICKERNELL, JOSEPHS, M. KELLER, KILLION, LONGIETTI, MANDERINO, MARSHALL, McILVAINE SMITH, MELIO, MILNE, MURT, O'NEILL, PALLONE, PYLE, RAPP, REICHLEY, ROHRER, SANTONI, SCAVELLO, SIPTROTH, SONNEY, SWANGER, TALLMAN, TRUE, WATSON AND YOUNGBLOOD, JUNE 24, 2009

REFERRED TO COMMITTEE ON HEALTH AND HUMAN SERVICES, JUNE 24, 2009  

AN ACT

Amending the act of October 9, 2008 (P.L.1413, No.114), entitled

"An act providing for long-term care patient access to

pharmaceuticals; and conferring powers and duties on the

State Board of Pharmacy," further providing for legislative

intent, for definitions, for third-party drugs in long-term

care facilities and for civil liability and unprofessional

conduct.

The General Assembly of the Commonwealth of Pennsylvania

hereby enacts as follows:

Section 1.  Section 2 of the act of October 9, 2008

(P.L.1413, No.114), known as the Long-Term Care Patient Access

to Pharmaceuticals Act, is amended to read:

Section 2.  Legislative intent.

The General Assembly finds and declares as follows:

(1)  A mechanism is to be provided whereby patients who

have the ability to acquire lower cost drugs through the

Veterans' Administration, a Federal or State program, any

insurance benefit program or provider or other entity have

access to those drugs if they reside in a long-term care

facility.

(2)  The mechanism is to be provided by permitting the

pharmacy within the long-term care facility or which has a

contract with the long-term care facility to:

(i)  receive the lower cost drugs directly from the

Veterans' Administration drug benefit program, a Federal

or State program, any insurance benefit program or a

program through a provider or other entity in the

patient's name; and

(ii)  repackage and relabel those drugs so they may

be dispensed in unit doses in compliance with the Food

and Drug Administration, the United States Pharmacopeia

and the long-term care facility's policies and procedures

to patients in a long-term care facility.

(3)  This act shall be interpreted and construed to

effectuate the following purposes:

(i)  To provide for the care, protection and

treatment of patients in long-term care facilities by

allowing them to utilize the drug benefit provided by the

Veterans' Administration, a Federal or State program, any

insurance benefit program or program through a provider

or other entity.

(ii)  Consistent with the care, protection and

treatment of patients in long-term care facilities, to

provide a means by which a pharmacy in a long-term care

facility or a pharmacy which has a contract with a long-

term care facility may:

(A)  accept, on behalf of the patient, drugs

received directly from the Veterans' Administration,

a Federal or State program, any insurance benefit

program or a program through a provider or other

entity; and

(B)  repackage and relabel those drugs so that

the patient may receive them in a unit dose in

compliance with the Food and Drug Administration, the

United States Pharmacopeia and the long-term care

facility's policies and procedures.

(iii)  To provide a means through which the

provisions of this act are executed and enforced and in

which long-term care facilities, pharmacists, drug source

facilities and pharmaceutical providers may implement the

provisions of this act.

[(4)  Only individuals eligible for benefits provided by

the Veterans' Administration are eligible for the program

under this act.]

Section 2.  The definition of "drug source facility" in

section 3 of the act is amended and the section is amended by

adding definitions to read:

Section 3.  Definitions.

The following words and phrases when used in this act shall

have the meanings given to them in this section unless the

context clearly indicates otherwise:

"Board."  The State Board of Pharmacy.

["Drug source facility."  A facility:

(1)  where drugs are lawfully manufactured, dispensed or

distributed; and

(2)  which is:

(i)  operated by or under contract with the Veterans'

Administration; or

(ii)  approved by the Veterans' Administration.]

"Dispense."  As related to a drug, to prepare the drug for

subsequent administration to a patient. The term includes:

(1)  The act of screening the drug for potential drug

therapy problems, including reviewing possible drug

interactions, reviewing the dosage and duration of drug

therapy, reviewing contraindications of the drug, reviewing

information regarding the patient and pharmaceutical coverage

and compounding and mixing the drug.

(2)  Any other activity associated with review of the

drug which is designed to ensure the safety of the drug.

"Drug."  Medication which has been approved by the Food and

Drug Administration. The term does not include medication which

is provided under Title XVIII Pt. D of the Social Security Act

(49 Stat. 620, 42 U.S.C. § 1395W-101 et. seq.).

"Drug source."  A facility where or a program under which

drugs are lawfully manufactured, dispensed or distributed. The

term includes a pharmacy, an entity and a Federal or State

agency or instrumentality. The term does not include a long-term

care pharmacy.

"Long-term care facility."  A long-term care nursing facility

as defined in section 802.1 of the act of July 19, 1979

(P.L.130, No.48), known as the Health Care Facilities Act.

"Long-term care pharmacy."  Any of the following:

(1)  A pharmacy within a long-term care facility.

(2)  A pharmacist employed by a long-term care facility

who fills prescriptions for patients of a long-term care

facility.

(3)  A pharmacist who contracts with a long-term care

facility to fill prescriptions for patients of a long-term

care facility.

(4)  A pharmaceutical provider that contracts with a

long-term care facility to fill prescriptions for patients of

a long-term care facility.

"Pharmaceutical provider."  An entity that employs a

pharmacist.

Section 3.  Sections 5 and 8 of the act are amended to read:

Section 5.  Third-party drugs in long-term care facilities.

(a)  Authority.--Notwithstanding any other provision of law,

all of the following may dispense a drug acquired from a drug

source [facility] outside the long-term care facility to a

patient of a long-term care facility:

(1)  A pharmacist employed by a long-term care facility.

(2)  A pharmacy who contracts with a long-term care

facility to fill prescriptions for patients of the long-term

care facility.

(b)  Unit dose.--A person authorized under subsection (a) to

dispense a drug shall repackage, relabel and dispense the drug

in a unit dose if all of the following conditions are met:

(1)  The drug is obtained from a drug source [facility].

(2)  There is a prescription for the drug.

(3)  The prescriber has signed a form authorizing the

long-term care facility to administer a drug from a drug

source [facility] outside the long-term care facility.

(4)  The patient has signed a form authorizing the long-

term care facility to administer a drug from a drug source

[facility] outside the long-term care facility and provided

payment information for payment of the related fees to the

pharmacy. In the case of a minor or a patient who is unable

to sign the form, a parent, a guardian, an agent acting under

a power of attorney or a family member is authorized to sign

the form. The form must explain that a person authorized

under subsection (a) to dispense a drug from a drug source

[facility] outside the long-term care facility:

(i)  is required to go through the process of

repackaging and relabeling the drug;

(ii)  may charge a fee for repackaging and relabeling

the drug, including the amount of the fee and the

frequency of its assessment; and

(iii)  has immunity from civil liability arising from

dispensation of the drug if the person properly

repackages and relabels the drug as set forth in section

8.

(5)  The nursing facility attending physician has issued

an order continuing the patient's medical regime.

(6)  The repackaging is in compliance with the Food and

Drug Administration, the United States Pharmacopeia and the

long-term care facility's policies and procedures.

(7)  The Veterans' Administration, Federal or State

program, insurance program or other provider or other entity 

provides the drug directly to the long-term care pharmacy in

the patient's name and with the following information in

preparation for the repackaging and relabeling:

(i)  The name and address of the dispensing pharmacy.

(ii)  The name of the dispensing pharmacist.

(iii)  The lot number of the drug.

(iv)  A copy of the original prescription.

(v)  The date the drug was dispensed.

(vi)  Directions for use, contraindications and other

materials required by law to be provided to the patient.

Section 8.  Civil liability and unprofessional conduct.

(a)  Repackaging and relabeling.--A person authorized under

section 5(a) to dispense a drug shall be immune from civil

liability arising out of dispensation of the drug if the person

properly repackages and relabels a drug based on the information

received from the original drug source [facility].

(b)  Administration of drug.--A long-term care facility or an

employee or agent of a long-term care facility that properly

administers a drug from a person authorized under section 5(a)

to dispense the drug shall be immune from civil liability

arising out of administration of the drug.

(c)  Unprofessional conduct.--A pharmacist authorized under

section 5(a) to dispense a drug who properly relabels and

repackages the drug shall not be deemed to have engaged in

unprofessional conduct under section 5 of the act of September

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

Section 4.  This act shall take effect in 60 days.