PRIOR PRINTER'S NOS. 1019, 1888 PRINTER'S NO. 2045
No. 808 Session of 2005
INTRODUCED BY ARMSTRONG, FERLO, BROWNE, M. WHITE, TARTAGLIONE,
PIPPY, WOZNIAK, RAFFERTY, LEMMOND AND WASHINGTON,
JUNE 28, 2005
SENATOR WENGER, APPROPRIATIONS, RE-REPORTED AS AMENDED,
SEPTEMBER 19, 2006
AN ACT
1 Providing for long-term care patient access to pharmaceuticals;
2 and conferring powers and duties on the State Board of
3 Pharmacy.
4 The General Assembly of the Commonwealth of Pennsylvania
5 hereby enacts as follows:
6 Section 1. Short title.
7 This act shall be known and may be cited as the Long-Term
8 Care Patient Access to Pharmaceuticals Act.
9 Section 2. Legislative intent.
10 The General Assembly finds and declares as follows:
11 (1) A mechanism is to be provided whereby patients who
12 have the ability to acquire lower cost drugs through the
13 Veterans' Administration have access to those drugs if they
14 reside in a long-term care facility.
15 (2) The mechanism is to be provided by permitting the
16 pharmacy within the long-term care facility or which has a
17 contract with the long-term care facility to:
1 (i) receive the lower cost drugs directly from the
2 Veterans' Administration drug benefit program in
3 patient's name; and
4 (ii) repackage and relabel those drugs so they may
5 be dispensed in unit doses in compliance with the Food
6 and Drug Administration, the United States Pharmacopeia
7 and the long-term care facility's policies and procedures
8 to patients in a long-term care facility.
9 (3) This act shall be interpreted and construed to
10 effectuate the following purposes:
11 (i) To provide for the care, protection and
12 treatment of patients in long-term care facilities by
13 allowing them to utilize the drug benefit provided by the
14 Veterans' Administration.
15 (ii) Consistent with the care, protection and
16 treatment of patients in long-term care facilities, to
17 provide a means by which a pharmacy in a long-term care
18 facility or a pharmacy which has a contract with a long-
19 term care facility may:
20 (A) accept, on behalf of the patient, drugs
21 received directly from the Veterans' Administration;
22 and
23 (B) repackage and relabel those drugs so that
24 the patient may receive them in a unit dose in
25 compliance with the Food and Drug Administration, the
26 United States Pharmacopeia and the long-term care
27 facility's policies and procedures.
28 (iii) To provide a means through which the
29 provisions of this act are executed and enforced and in
30 which long-term care facilities, pharmacists, drug source
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1 facilities and pharmaceutical providers may implement the
2 provisions of this act.
3 Section 3. Definitions.
4 The following words and phrases when used in this act shall
5 have the meanings given to them in this section unless the
6 context clearly indicates otherwise:
7 "Board." The State Board of Pharmacy.
8 "Drug source facility." A facility where drugs are lawfully
9 manufactured, dispensed or distributed. The term includes a
10 pharmacy, an entity and a Federal or State agency or
11 instrumentality.
12 "Long-term care facility." A long-term care nursing facility
13 as defined in section 802.1 of the act of July 19, 1979
14 (P.L.130, No.48), known as the Health Care Facilities Act.
15 "Pharmaceutical provider." An entity that employs a
16 pharmacist.
17 Section 4. State Board of Pharmacy.
18 The board has the following powers and duties:
19 (1) Develop the form required by section 5(b)(3) and
20 (4).
21 (2) Publish a notice in the Pennsylvania Bulletin that
22 the form has been developed.
23 Section 5. Third-party drugs in long-term care facilities.
24 (a) Authority.--Notwithstanding any other provision of law,
25 all of the following may dispense a drug acquired from a drug
26 source facility outside the long-term care facility to a patient
27 of a long-term care facility:
28 (1) A pharmacist employed by a long-term care facility.
29 (2) A pharmacy who contracts with a long-term care
30 facility to fill prescriptions for patients of the long-term
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1 care facility.
2 (b) Unit dose.--A person authorized under subsection (a) to
3 dispense a drug shall repackage, relabel and dispense the drug
4 in 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
8 long-term care facility to administer a drug from a drug
9 source facility outside the long-term care facility.
10 (4) The patient has signed a form authorizing the long-
11 term care facility to administer a drug from a drug source
12 facility outside the long-term care facility and provided
13 payment information for payment of the related fees to the
14 pharmacy. In the case of a minor or a patient who is unable
15 to sign the form, a parent, a guardian, an agent acting under
16 a power of attorney or a family member is authorized to sign
17 the form. The form must explain that a person authorized
18 under subsection (a) to dispense a drug from a drug source
19 facility outside the long-term care facility:
20 (i) is required to go through the process of
21 repackaging and relabeling the drug;
22 (ii) may charge a fee for repackaging and relabeling
23 the drug, including the amount of the fee and the
24 frequency of its assessment not to exceed $20 for up to <--
25 90 units per drug, $10 additional for half tablets and
26 $10 for each additional 90 units; and
27 (iii) has immunity from civil liability arising from
28 dispensation of the drug if the person properly
29 repackages and relabels the drug as set forth in section
30 8.
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1 (5) The nursing facility attending physician has issued
2 an order continuing the patient's medical regime.
3 (6) The drug is not a controlled substance.
4 (7) The repackaging is in compliance with the Food and
5 Drug Administration, the United States Pharmacopeia and the
6 long-term care facility's policies and procedures.
7 (8) The Veterans' Administration provides the drug
8 directly to the long-term care pharmacy in the patient's name
9 and with the following information in preparation for the
10 repackaging and relabeling:
11 (i) The name and address of the dispensing pharmacy.
12 (ii) The name of the dispensing pharmacist.
13 (iii) The lot number of the drug.
14 (iv) A copy of the original prescription.
15 (v) The date the drug was dispensed.
16 (vi) Directions for use, contraindications and other
17 materials required by law to be provided to the patient.
18 Section 6. Recordkeeping.
19 For each drug dispensed in accordance with section 5(a), the
20 person authorized to dispense the drug and the long-term care
21 facility shall maintain a record for at least two years of all
22 of the items specified in section 5(b)(8). <--
23 (1) The name and quantity of the drug prescribed, <--
24 including whether the prescription is a controlled substance
25 or if it was written PRN or ad lib refill.
26 (2) The name and address of the patient to whom it was
27 dispensed.
28 (3) The name and address or other identifier of the
29 prescriber.
30 (4) The date the prescription was issued and the date
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1 the drug was dispensed.
2 (5) Directions for use, including cautions communicated
3 to the patient by auxiliary labels or other means when
4 dispensed.
5 (6) The date the prescription was compounded or
6 dispensed.
7 (7) The name and address of the dispensing pharmacist.
8 (8) The drug source facility which provided the drug.
9 Section 7. Fee.
10 A person authorized under 5(a) to dispense a drug may charge
11 a reasonable fee to repackage and relabel the drug. FEES SO <--
12 CHARGED SHALL NOT EXCEED:
13 (1) $20 FOR UP TO 90 UNITS PER DRUG;
14 (2) $10 ADDITIONAL FOR HALF TABLETS; AND
15 (3) $10 FOR EACH ADDITIONAL 90 UNITS.
16 Section 8. Civil liability and unprofessional conduct.
17 (a) Repackaging and relabeling.--A person authorized under
18 section 5(a) to dispense a drug shall be immune from civil
19 liability arising out of dispensation of the drug if the person
20 properly repackages and relabels a drug based on the information
21 received from the original drug source facility.
22 (b) Administration of drug.--A long-term care facility or an
23 employee or agent of a long-term care facility that properly
24 administers a drug from a person authorized under section 5(a)
25 to dispense the drug shall be immune from civil liability
26 arising out of administration of the drug.
27 (c) Unprofessional conduct.--A pharmacist authorized under
28 section 5(a)(3) 5(A) to dispense a drug who properly relabels <--
29 and repackages the drug shall not be deemed to have engaged in
30 unprofessional conduct under section 5 of the act of September
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1 27, 1961 (P.L.1700, No.699), known as the Pharmacy Act.
2 Section 40. Effective date.
3 This act shall take effect 90 days following the publication
4 of the rulemaking NOTICE in the Pennsylvania Bulletin REQUIRED <--
5 under section 4(1) 4(2). <--
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