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.

17(2) The mechanism is to be provided by permitting the

1pharmacy within the long-term care facility, assisted living 
2residence or personal care home, or which has a contract with
3the [long-term care facility] entity to:

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

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

15(3) This chapter shall be interpreted and construed to
16effectuate the following purposes:

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

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

28(A) accept, on behalf of the patient, drugs
29received directly from the United States Department
30of Veterans Affairs; and

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

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

13(4) Only individuals eligible for benefits provided by
14the United States Department of Veterans Affairs are eligible
15for the program under this chapter.

16§ 9503. Definitions.

17The following words and phrases when used in this chapter
18shall have the meanings given to them in this section unless the
19context clearly indicates otherwise:

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

23"Board." The State Board of Pharmacy.

24"Drug source facility." A facility:

25(1) where drugs are lawfully manufactured, dispensed or
26distributed; and

27(2) which is:

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

30(ii) approved by the United States Department of

1Veterans Affairs.

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

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

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

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

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

18§ 9505. Third-party drugs in long-term care facilities, 
19assisted living residences and personal care homes.

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

26(1) A pharmacist employed by a long-term care facility, 
27assisted living residence or personal care home.

28(2) A pharmacy that contracts with a long-term care
29facility, assisted living residence or personal care home to
30fill prescriptions for patients [of the long-term care

1facility] residing in these settings.

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

5(1) The drug is obtained from a drug source facility.

6(2) There is a prescription for the drug.

7(3) The prescriber has signed a form authorizing the
8long-term care facility, assisted living residence or 
9personal care home to administer a drug from a drug source
10facility outside the long-term care facility, assisted living 
11residence or personal care home.

12(4) The patient has signed a form authorizing the long-
13term care facility, assisted living residence or personal 
14care home to administer a drug from a drug source facility
15outside the [long-term care facility] location and provided
16payment information for payment of the related fees to the
17pharmacy. In the case of a minor or a patient who is unable
18to sign the form, a parent, a guardian, an agent acting under
19a power of attorney or a family member is authorized to sign
20the form. The form must explain that a person authorized
21under subsection (a) to dispense a drug from a drug source
22facility outside the long-term care facility, assisted living 
23residence or personal care home:

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

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

29(iii) has immunity from civil liability arising from
30dispensation of the drug if the person properly

1repackages and relabels the drug as set forth in section
29508 (relating to civil liability and unprofessional
3conduct).

4(5) The [nursing facility] attending physician or other 
5provider prescribing medications for the patient within their 
6scope of practice has issued an order continuing the
7patient's medical regime.

8(6) The repackaging is in compliance with the Food and
9Drug Administration, the United States Pharmacopeia and the
10[long-term care facility's] policies and procedures of the 
11long-term care facility, assisted living residence or 
12personal care home.

13(7) The United States Department of Veterans Affairs
14provides the drug directly to the pharmacy in the long-term
15care facility, assisted living residence or personal care 
16home in the patient's name or by mailing it to a lockbox
17located at the long-term care facility, assisted living 
18residence or personal care home in the patient's name and
19with the following information in preparation for the
20repackaging and relabeling:

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

22(ii) (Reserved).

23(iii) (Reserved).

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

26(v) The date the drug was dispensed.

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

29(7.1) A pharmacist must be held responsible for his
30activity or activity performed under his supervision or

1authorization.

2(8) The pharmacist manager of the pharmacy, within the 
3long-term care facility, assisted living residence or 
4personal care home or that has a contract with the long-term 
5care facility, assisted living residence or personal care 
6home responsible for access to the lockbox shall be 
7responsible for the following:

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

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

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

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

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

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

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

30(vi) Ensuring compliance with the applicable

1provisions of Federal and State law.

2§ 9506. Recordkeeping.

3For each drug dispensed in accordance with section 9505(a)
4(relating to third-party drugs in long-term care facilities, 
5assisted living residences and personal care homes), the person
6authorized to dispense the drug and the long-term care facility, 
7assisted living residence or personal care home shall maintain a
8record for at least two years of all of the items specified in
9section 9505(b)(7).

10§ 9507. Fee.

11A person authorized under section 9505(a) (relating to third-
12party drugs in long-term care facilities, assisted living 
13residences and personal care homes) to dispense a drug may
14charge no more than the maximum dispensing fee authorized by the
15Department of Public Welfare regulations under the medical
16assistance program.

17§ 9508. Civil liability and unprofessional conduct.

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

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

1administration of the drug.

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

8Section 2. This act shall take effect in 60 days.