AN ACT

 

1Amending Title 51 (Military Affairs) of the Pennsylvania
2Consolidated Statutes, in long-term care patient access to
3pharmaceuticals, further providing for assisted living
4residence and personal care home.

5The General Assembly of the Commonwealth of Pennsylvania
6hereby enacts as follows:

7Section 1. Sections 9502, 9503, 9505, 9506, 9507 and 9508 of
8Title 51 of the Pennsylvania Consolidated Statutes are amended
9to read:

10§ 9502. Declaration of policy.

11The General Assembly finds and declares as follows:

12(1) A mechanism is to be provided through which patients
13who have the ability to acquire lower cost drugs through the
14United States Department of Veterans Affairs have access to
15those drugs if they reside in a long-term care facility, 
16assisted living residence or personal care home.

1(2) The mechanism is to be provided by permitting the
2pharmacy within the long-term care facility, assisted living 
3residence or personal care home, or which has a contract with
4the [long-term care facility] entity to:

5(i) receive the lower cost drugs directly from the
6United States Department of Veterans Affairs drug benefit
7program in the patient's name; and

8(ii) repackage and relabel those drugs so they may
9be dispensed in unit doses to patients in a long-term
10care facility, assisted living residence or personal care 
11home in compliance with the Food and Drug Administration,
12the United States Pharmacopeia and the [long-term care
13facility's] policies and procedures of the long-term care 
14facility, assisted living residence or personal care 
15home.

16(3) This chapter shall be interpreted and construed to
17effectuate the following purposes:

18(i) To provide for the care, protection and
19treatment of patients in long-term care facilities, 
20assisted living residences and personal care homes by
21allowing them to utilize the drug benefit provided by the
22United States Department of Veterans Affairs.

23(ii) Consistent with the care, protection and
24treatment of patients in long-term care facilities, 
25assisted living residences and personal care homes, to
26provide a means by which a pharmacy, within [the long-
27term care facility] these settings or that has a contract
28with the [long-term care facility] entities listed, may:

29(A) accept, on behalf of the patient, drugs
30received directly from the United States Department

1of Veterans Affairs; and

2(B) repackage and relabel those drugs so that
3the patient may receive them in a unit dose in
4compliance with the Food and Drug Administration, the
5United States Pharmacopeia and the [long-term care
6facility's] policies and procedures of the long-term 
7care facility, assisted living residence or personal 
8care home.

9(iii) To provide a means through which this chapter
10is executed and enforced and in which long-term care
11facilities, assisted living residences, personal care 
12homes, pharmacists, drug source facilities and
13pharmaceutical providers may implement this chapter.

14(4) Only individuals eligible for benefits provided by
15the United States Department of Veterans Affairs are eligible
16for the program under this chapter.

17§ 9503. Definitions.

18The following words and phrases when used in this chapter
19shall have the meanings given to them in this section unless the
20context clearly indicates otherwise:

21"Assisted living residence." As defined in section 1001 of
22the act of June 13, 1967 (P.L.31, No.21), known as the Public
23Welfare Code.

24"Board." The State Board of Pharmacy.

25"Drug source facility." A facility:

26(1) where drugs are lawfully manufactured, dispensed or
27distributed; and

28(2) which is:

29(i) operated by or under contract with the United
30States Department of Veterans Affairs; or

1(ii) approved by the United States Department of
2Veterans Affairs.

3"Lockbox." A cabinet, safe, container or other structure to
4contain medications that shall be securely locked, substantially
5constructed and accessible only to the pharmacist or his
6representative as authorized by the regulations of the State
7Board of Pharmacy.

8"Long-term care facility." A long-term care nursing facility
9as defined in section 802.1 of the act of July 19, 1979
10(P.L.130, No.48), known as the Health Care Facilities Act.

11"Means." The placement of a lockbox at a location at [the] a
12long-term care facility, assisted living residence or personal 
13care home.

14"Personal care home." As defined in section 1001 of the act
15of June 13, 1967 (P.L.31, No.21), known as the Public Welfare
16Code.

17"Pharmaceutical provider." An entity that employs a
18pharmacist.

19§ 9505. Third-party drugs in long-term care facilities, 
20assisted living residences and personal care homes.

21(a) Authority.--Notwithstanding any other provision of law,
22all of the following may dispense a drug acquired from a drug
23source facility outside the long-term care facility, assisted 
24living residence or personal care home to a patient of a long-
25term care facility, assisted living residence or personal care 
26home:

27(1) A pharmacist employed by a long-term care facility, 
28assisted living residence or personal care home.

29(2) A pharmacy that contracts with a long-term care
30facility, assisted living residence or personal care home to

1fill prescriptions for patients [of the long-term care
2facility] residing in these settings.

3(b) Unit dose.--A person authorized under subsection (a) to
4dispense a drug shall repackage, relabel and dispense the drug
5in a unit dose if all of the following conditions are met:

6(1) The drug is obtained from a drug source facility.

7(2) There is a prescription for the drug.

8(3) The prescriber has signed a form authorizing the
9long-term care facility, assisted living residence or 
10personal care home to administer a drug from a drug source
11facility outside the long-term care facility, assisted living 
12residence or personal care home.

13(4) The patient has signed a form authorizing the long-
14term care facility, assisted living residence or personal 
15care home to administer a drug from a drug source facility
16outside the [long-term care facility] location and provided
17payment information for payment of the related fees to the
18pharmacy. In the case of a minor or a patient who is unable
19to sign the form, a parent, a guardian, an agent acting under
20a power of attorney or a family member is authorized to sign
21the form. The form must explain that a person authorized
22under subsection (a) to dispense a drug from a drug source
23facility outside the long-term care facility, assisted living 
24residence or personal care home:

25(i) is required to go through the process of
26repackaging and relabeling the drug;

27(ii) may charge a fee for repackaging and relabeling
28the drug, including the amount of the fee and the
29frequency of its assessment; and

30(iii) has immunity from civil liability arising from

1dispensation of the drug if the person properly
2repackages and relabels the drug as set forth in section
39508 (relating to civil liability and unprofessional
4conduct).

5(5) The [nursing facility] attending physician or other 
6provider prescribing medications for the patient within their 
7scope of practice has issued an order continuing the
8patient's medical regime.

9(6) The repackaging is in compliance with the Food and
10Drug Administration, the United States Pharmacopeia and the
11[long-term care facility's] policies and procedures of the 
12long-term care facility, assisted living residence or 
13personal care home.

14(7) The United States Department of Veterans Affairs
15provides the drug directly to the pharmacy in the long-term
16care facility, assisted living residence or personal care 
17home in the patient's name or by mailing it to a lockbox
18located at the long-term care facility, assisted living 
19residence or personal care home in the patient's name and
20with the following information in preparation for the
21repackaging and relabeling:

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

23(ii) (Reserved).

24(iii) (Reserved).

25(iv) A copy of the original prescription upon
26request.

27(v) The date the drug was dispensed.

28(vi) Directions for use, contraindications and other
29materials required by law to be provided to the patient.

30(7.1) A pharmacist must be held responsible for his

1activity or activity performed under his supervision or
2authorization.

3(8) The pharmacist manager of the pharmacy, within the 
4long-term care facility, assisted living residence or 
5personal care home or that has a contract with the long-term 
6care facility, assisted living residence or personal care 
7home responsible for access to the lockbox shall be 
8responsible for the following:

9(i) Reviewing and approving written policies and
10procedures for lockbox operation, safety, security,
11accuracy, access and patient confidentiality.

12(ii) Ensuring that medications received at the
13lockbox are inspected for expiration date, misbranding
14and physical integrity and ensuring that the lockbox is
15inspected for security and accountability every month.

16(iii) Inspecting medications received at the lockbox
17to determine if:

18(A) the original contents have deteriorated
19significantly due to heat, cold fermentation or
20prolonged agitation; or

21(B) the sensors indicate the integrity of the
22drug was compromised if the drugs were shipped in a
23manner that would preserve the integrity of the drug,
24such as cold packs or other temperature control
25devices.

26(iv) Assigning, discontinuing or changing authorized
27personnel access to the lockbox.

28(v) Ensuring that an accountability record is
29maintained in accordance with the written policies and
30procedures of operation.

1(vi) Ensuring compliance with the applicable
2provisions of Federal and State law.

3§ 9506. Recordkeeping.

4For each drug dispensed in accordance with section 9505(a)
5(relating to third-party drugs in long-term care facilities, 
6assisted living residences and personal care homes), the person
7authorized to dispense the drug and the long-term care facility, 
8assisted living residence or personal care home shall maintain a
9record for at least two years of all of the items specified in
10section 9505(b)(7).

11§ 9507. Fee.

12A person authorized under section 9505(a) (relating to third-
13party drugs in long-term care facilities, assisted living 
14residences and personal care homes) to dispense a drug may
15charge no more than the maximum dispensing fee authorized by the
16Department of Public Welfare regulations under the medical
17assistance program.

18§ 9508. Civil liability and unprofessional conduct.

19(a) Repackaging and relabeling.--A person authorized under
20section 9505(a) (relating to third-party drugs in long-term care
21facilities, assisted living residences and personal care homes)
22to dispense a drug shall be immune from civil liability arising
23out of dispensation of the drug if the person properly
24repackages and relabels a drug based on the information received
25from the original drug source facility.

26(b) Administration of drug.--A long-term care facility, 
27assisted living residence or personal care home or an employee
28or agent of a long-term care facility, assisted living residence 
29or personal care home that properly administers a drug from a
30person authorized under section 9505(a) to dispense the drug

1shall be immune from civil liability arising out of
2administration of the drug.

3(c) Unprofessional conduct.--A pharmacist authorized under
4section 9505(a) to dispense a drug who properly relabels and
5repackages the drug shall not be deemed to have engaged in
6unprofessional conduct under section 5(9) of the act of
7September 27, 1961 (P.L.1700, No.699), known as the Pharmacy
8Act.

9Section 2. This act shall take effect in 60 days.