THE GENERAL ASSEMBLY OF PENNSYLVANIA

HOUSE BILL

INTRODUCED BY BEAR, BARRAR, SANTONI, BENNINGHOFF, AUMENT, BAKER, BOBACK, BOYD, CALTAGIRONE, CAUSER, COHEN, D. COSTA, COX, CREIGHTON, CUTLER, DAVIS, DELOZIER, DENLINGER, DeWEESE, DONATUCCI, EMRICK, EVERETT, FARRY, FLECK, GEIST, GEORGE, GIBBONS, GILLEN, GINGRICH, GOODMAN, GRELL, GROVE, HACKETT, HARRIS, HEFFLEY, HENNESSEY, HICKERNELL, HUTCHINSON, KILLION, KORTZ, MAJOR, MARSHALL, METCALFE, MICCARELLI, MICOZZIE, MILLARD, MILLER, MILNE, MOUL, MURT, O'NEILL, PERRY, PETRI, PICKETT, PYLE, RAPP, READSHAW, REED, ROCK, SAYLOR, SCAVELLO, STEPHENS, SWANGER, TALLMAN, TAYLOR, VULAKOVICH AND WATSON, MAY 9, 2011

REFERRED TO COMMITTEE ON VETERANS AFFAIRS AND EMERGENCY PREPAREDNESS, MAY 9, 2011  

AN ACT

Amending Title 51 (Military Affairs) of the Pennsylvania

Consolidated Statutes, consolidating the Long-Term Care

Patient Access to Pharmaceuticals Act; further providing for

declaration of policy, for definitions and for third-party

drugs in long-term care facilities; and making a related

repeal.

The General Assembly of the Commonwealth of Pennsylvania

hereby enacts as follows:

Section 1.  Title 51 of the Pennsylvania Consolidated

Statutes is amended by adding a chapter to read:

CHAPTER 95

LONG-TERM CARE PATIENT ACCESS TO PHARMACEUTICALS

Sec.

9501.  Scope of chapter.

9502.  Declaration of policy.

9503.  Definitions.

9504.  State Board of Pharmacy.

9505.  Third-party drugs in long-term care facilities.

9506.  Recordkeeping.

9507.  Fee.

9508.  Civil liability and unprofessional conduct.

§ 9501.  Scope of chapter.

This chapter relates to long-term care patient access to

pharmaceuticals.

§ 9502.  Declaration of policy.

The General Assembly finds and declares as follows:

(1)  A mechanism is to be provided through which patients

who have the ability to acquire lower cost drugs through the

Department of Veterans Affairs 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

Department of Veterans Affairs drug benefit program in

the patient's name; and

(ii)  repackage and relabel those drugs so they may

be dispensed in unit doses to patients in a long-term

care facility in compliance with the Food and Drug

Administration, the United States Pharmacopeia and the

long-term care facility's policies and procedures.

(3)  This chapter 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

Department of Veterans Affairs.

(ii)  Consistent with the care, protection and

treatment of patients in long-term care facilities, to

provide a means by which a long-term care pharmacy may:

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

received directly from the Department of Veterans

Affairs; 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 this chapter

is executed and enforced and in which long-term care

facilities, pharmacists, drug source facilities and

pharmaceutical providers may implement this chapter.

(4)  Only individuals eligible for benefits provided by

the Department of Veterans Affairs are eligible for the

program under this chapter.

§ 9503.  Definitions.

The following words and phrases when used in this chapter

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

Department of Veterans Affairs; or

(ii)  approved by the Department of Veterans Affairs.

"Lockbox."  A cabinet or safe to contain medications that

shall be securely locked, substantially constructed and

accessible only to the pharmacist or his representative as

authorized by the regulations of the State Board of 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.

"Means."  The placement of a lockbox at a secure drop-off

location at the long-term care facility.

"Pharmaceutical provider."  An entity that employs a

pharmacist.

§ 9504.  State Board of Pharmacy.

The board has the following powers and duties:

(1)  Develop the form required by section 9505(b)(3) and

(4) (relating to third-party drugs in long-term care

facilities).

(2)  Publish a notice in the Pennsylvania Bulletin that

the form has been developed.

§ 9505.  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 that 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

9508 (relating to civil liability and unprofessional

conduct).

(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 Department of Veterans Affairs provides the drug

by mailing it to a lockbox located at the long-term care

facility 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)  (Reserved).

(iii)  (Reserved).

(iv)  A copy of the original prescription upon

request.

(v)  The date the drug was dispensed.

(vi)  Directions for use, contraindications and other

materials required by law to be provided to the patient.

(8)  A pharmacist shall be held responsible for his

activity or activity performed under his supervision or

authorization.

(9)  The pharmacist manager of the long-term care

pharmacy responsible for access to the lockbox shall be

responsible for the following:

(i)  Reviewing and approving written policies and

procedures for lockbox operation, safety, security,

accuracy, access and patient confidentiality.

(ii)  Ensuring that medications received at the

lockbox are inspected for expiration date, misbranding

and physical integrity and ensuring that the lockbox is

inspected for security and accountability every month.

(iii)  Inspecting medications received at the lockbox

to determine if:

(A)  the original contents have deteriorated

significantly due to heat, cold fermentation or

prolonged agitation; or

(B)  the sensors indicate the integrity of the

drug was compromised if the drugs were shipped in a

manner that would preserve the integrity of the drug,

such as cold packs or other temperature control

devices.

(iv)  Assigning, discontinuing or changing authorized

personnel access to the lockbox.

(v)  Ensuring that an accountability record is

maintained in accordance with the written policies and

procedures of operation.

(vi)  Ensuring compliance with the applicable

provisions of Federal and State law.

§ 9506.  Recordkeeping.

For each drug dispensed in accordance with section 9505(a)

(relating to third-party drugs in long-term care facilities),

the person authorized to dispense the drug and the long-term

care facility shall maintain a record for at least two years of

all of the items specified in section 9505(b)(7).

§ 9507.  Fee.

A person authorized under section 9505(a) (relating to third-

party drugs in long-term care facilities) to dispense a drug may

charge no more than the maximum dispensing fee authorized by the

Department of Public Welfare regulations under the medical

assistance program.

§ 9508.  Civil liability and unprofessional conduct.

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

section 9505(a) (relating to third-party drugs in long-term care

facilities) 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

9505(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 9505(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(9) of the act of

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

Act.

Section 2.  Repeals are as follows:

(1)  The General Assembly declares that the repeal under

paragraph (2) is necessary to effectuate the addition of 51

Pa.C.S. Ch. 95.

(2)  The act of October 9, 2008 (P.L.1413, No.114), known

as the Long-Term Care Patient Access to Pharmaceuticals Act,

is repealed.

Section 3.  The addition of 51 Pa.C.S. Ch. 95 is a

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

known as the Long-Term Care Patient Access to Pharmaceuticals

Act. The following apply:

(1)  Except as otherwise provided in 51 Pa.C.S. Ch. 95,

all activities initiated under the Long-Term Care Patient

Access to Pharmaceuticals Act shall continue and remain in

full force and effect and may be completed under 51 Pa.C.S.

Ch. 95. Orders, regulations, rules and decisions which were

made under the Long-Term Care Patient Access to

Pharmaceuticals Act and which are in effect on the effective

date of section 2 of this act shall remain in full force and

effect until revoked, vacated or modified under 51 Pa.C.S.

Ch. 95. Contracts, obligations and collective bargaining

agreements entered into under the Long-Term Care Patient

Access to Pharmaceuticals Act are not affected nor impaired

by the repeal of the Long-Term Care Patient Access to

Pharmaceuticals Act.

(2)  Except as set forth in paragraph (3), any difference

in language between 51 Pa.C.S. Ch. 95 and the Long-Term Care

Patient Access to Pharmaceuticals Act is intended only to

conform to the style of the Pennsylvania Consolidated

Statutes and is not intended to change or affect the

legislative intent, judicial construction or administration

and implementation of the Long-Term Care Patient Access to

Pharmaceuticals Act.

(3)  Paragraph (2) does not apply to the addition of the

following provisions of Title 51:

(i)  Section 9502(3)(ii).

(ii)  The definitions of "lockbox" and "means" in

section 9503.

(iii)  Section 9505(b)(7) introductory paragraph,

(ii), (iii) and (iv), (8) and (9).

Section 4.  This act shall take effect as follows:

(1)  The following provisions shall shall take effect

immediately:

(i)  Section 3 of this act.

(ii)  This section.

(2)  The remainder of this act shall take effect in 60

days.