PRINTER'S NO. 1019
No. 808 Session of 2005
INTRODUCED BY ARMSTRONG, FERLO, BROWNE, M. WHITE, TARTAGLIONE, PIPPY, WOZNIAK, RAFFERTY AND LEMMOND, JUNE 28, 2005
REFERRED TO PUBLIC HEALTH AND WELFARE, JUNE 28, 2005
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 a 13 Federal or State program, any insurance benefit program or 14 provider or another entity, have access to those drugs if 15 they reside in a long-term care facility. 16 (2) The mechanism is to be provided by permitting the 17 pharmacy within the long-term care facility or which has a 18 contract with the long-term care facility to:
1 (i) receive the lower cost drugs from the Federal or 2 State program, insurance program or provider or other 3 entity; and 4 (ii) repackage and relabel those drugs so they may 5 be dispensed in unit doses to patients in a long-term 6 care facility. 7 (3) This act shall be interpreted and construed to 8 effectuate the following purposes: 9 (i) To provide for the care, protection and 10 treatment of patients in long-term care facilities by 11 allowing them to utilize the drug benefit provided by the 12 Federal Government or State government, any insurance 13 program or provider or any other entity. 14 (ii) Consistent with the care, protection and 15 treatment of patients in long-term care facilities, to 16 provide a means by which a pharmacy in a long-term care 17 facility or a pharmacy which has a contract with a long- 18 term care facility may: 19 (A) accept, on behalf of the patient, drugs 20 received from a Federal or State program, any 21 insurance program or provider or another entity; and 22 (B) repackage and relabel those drugs so that 23 the patient may receive them in a unit dose. 24 (iii) To provide a means through which the 25 provisions of this act are executed and enforced and in 26 which long-term care facilities, pharmacists, drug source 27 facilities and pharmaceutical providers may implement the 28 provisions of this act. 29 Section 3. Definitions. 30 The following words and phrases when used in this act shall 20050S0808B1019 - 2 -
1 have the meanings given to them in this section unless the 2 context clearly indicates otherwise: 3 "Board." The State Board of Pharmacy. 4 "Drug source facility." A facility where drugs are lawfully 5 manufactured, dispensed or distributed. The term includes a 6 pharmacy, an entity and a Federal or State agency or 7 instrumentality. 8 "Long-term care facility." A long-term care nursing facility 9 as 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 "Pharmaceutical provider." An entity that employs a 12 pharmacist. 13 Section 4. State Board of Pharmacy. 14 The board has the following powers and duties: 15 (1) Develop the form required by section 5(b)(3) and 16 (4). 17 (2) Promulgate regulations to set the fee under section 18 7. Included in this rulemaking, the board shall make a 19 statement that the forms under paragraph (1) have been 20 developed. 21 (3) Provide a written report every 90 days regarding the 22 steps taken by the board to implement paragraphs (1) and (2), 23 to all of the following: 24 (i) The Consumer Protection and Professional 25 Licensure Committee of the Senate. 26 (ii) The Professional Licensure Committee of the 27 House of Representatives. 28 (iii) The Commissioner of the Bureau of Professional 29 and Occupational Affairs. 30 (iv) The Secretary of the Commonwealth. 20050S0808B1019 - 3 -
1 Section 5. Third-party drugs in long-term care facilities. 2 (a) Authority.--Notwithstanding any other provision of law, 3 all of the following may dispense a drug acquired from a drug 4 source facility outside the long-term care facility to a patient 5 of a long-term care facility: 6 (1) A pharmacist employed by a long-term care facility. 7 (2) A pharmacist who contracts with a long-term care 8 facility to fill prescriptions for patients of the long-term 9 care facility. 10 (3) A pharmaceutical provider that contracts with a 11 long-term care facility to fill prescriptions for patients of 12 the long-term care facility. 13 (b) Unit dose.--A person authorized under subsection (a) to 14 dispense a drug shall repackage, relabel and dispense the drug 15 in a unit dose if all of the following conditions are met: 16 (1) The drug is obtained from a drug source facility. 17 (2) There is a prescription for the drug. 18 (3) The prescriber has signed a form authorizing the 19 long-term care facility to administer a drug from a drug 20 source facility outside the long-term care facility. 21 (4) The patient has signed a form authorizing the long- 22 term care facility to administer a drug from a drug source 23 facility outside the long-term care facility. In the case of 24 a minor or a patient who is unable to sign the form, a 25 parent, a guardian, an agent acting under a power of attorney 26 or a family member is authorized to sign the form. The form 27 must explain that a person authorized under subsection (a) to 28 dispense a drug from a drug source facility outside the long- 29 term care facility: 30 (i) is required to go through the process of 20050S0808B1019 - 4 -
1 repackaging and relabeling the drug; 2 (ii) may charge a fee for repackaging and relabeling 3 the drug, including the amount of the fee and the 4 frequency of its assessment; and 5 (iii) has immunity from civil liability arising from 6 dispensation of the drug if the person properly 7 repackages and relabels the drug as set forth in section 8 8. 9 Section 6. Recordkeeping. 10 For each drug dispensed in accordance with section 5(a), the 11 person authorized to dispense the drug and the long-term care 12 facility shall maintain a record for at least two years of all 13 of the following: 14 (1) The name and quantity of the drug prescribed, 15 including whether the prescription is a controlled substance 16 or if it was written PRN or ad lib refill. 17 (2) The name and address of the patient to whom it was 18 dispensed. 19 (3) The name and address or other identifier of the 20 prescriber. 21 (4) The date the prescription was issued and the date 22 the drug was dispensed. 23 (5) Directions for use, including cautions communicated 24 to the patient by auxiliary labels or other means when 25 dispensed. 26 (6) The date the prescription was compounded or 27 dispensed. 28 (7) The name and address of the dispensing pharmacist. 29 (8) The drug source facility which provided the drug. 30 Section 7. Fee. 20050S0808B1019 - 5 -
1 A person authorized under 5(a) to dispense a drug may charge 2 a reasonable fee, set by the board, to repackage and relabel the 3 drug. 4 Section 8. Civil liability and unprofessional conduct. 5 (a) Repackaging and relabeling.--A person authorized under 6 section 5(a) to dispense a drug shall be immune from civil 7 liability arising out of dispensation of the drug if the person 8 properly repackages and relabels a drug. 9 (b) Administration of drug.--A long-term care facility or an 10 employee or agent of a long-term care facility that properly 11 administers a drug from a person authorized under section 5(a) 12 to dispense the drug shall be immune from civil liability 13 arising out of administration of the drug. 14 (c) Unprofessional conduct.--A pharmacist authorized under 15 section 5(a)(3) to dispense a drug who properly relabels and 16 repackages the drug shall not be deemed to have engaged in 17 unprofessional conduct under section 5 of the act of September 18 27, 1961 (P.L.1700, No.699), known as the Pharmacy Act. 19 Section 40. Effective date. 20 This act shall take effect as follows: 21 (1) The following provisions shall take effect upon 22 publication of the rulemaking in the Pennsylvania Bulletin 23 under section 4(2): 24 (i) Section 5. 25 (ii) Section 7. 26 (2) The remainder of this act shall take effect 27 immediately. F2L35JLW/20050S0808B1019 - 6 -