PRINTER'S NO. 1168
No. 1022 Session of 2005
INTRODUCED BY BOYD, DeWEESE, STERN, KOTIK, RUBLEY, TRUE, DALLY, TIGUE, HERSHEY, CALTAGIRONE, SHANER, PICKETT, LEH, R. MILLER, ROSS, HENNESSEY, FREEMAN, WALKO, GEIST, REICHLEY, DENLINGER, CAWLEY, BALDWIN, LEACH, E. Z. TAYLOR, MANDERINO, JAMES, SOLOBAY, GINGRICH, HICKERNELL, HARPER, GOODMAN, WILT, O'NEILL AND NICKOL, MARCH 16, 2005
REFERRED TO COMMITTEE ON HEALTH AND HUMAN SERVICES, MARCH 16, 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
1 pharmacy within the long-term care facility or which has a 2 contract with the long-term care facility to: 3 (i) receive the lower cost drugs from the Federal or 4 State program, insurance program or provider or other 5 entity; and 6 (ii) repackage and relabel those drugs so they may 7 be dispensed in unit doses to patients in a long-term 8 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 Federal Government or State government, any insurance 15 program or provider or any other entity. 16 (ii) Consistent with the care, protection and 17 treatment of patients in long-term care facilities, to 18 provide a means by which a pharmacy in a long-term care 19 facility or a pharmacy which has a contract with a long- 20 term care facility may: 21 (A) accept, on behalf of the patient, drugs 22 received from a Federal or State program, any 23 insurance program or provider or another entity; and 24 (B) repackage and relabel those drugs so that 25 the patient may receive them in a unit dose. 26 (iii) To provide a means through which the 27 provisions of this act are executed and enforced and in 28 which long-term care facilities, pharmacists, drug source 29 facilities and pharmaceutical providers may implement the 30 provisions of this act. 20050H1022B1168 - 2 -
1 Section 3. Definitions. 2 The following words and phrases when used in this act shall 3 have the meanings given to them in this section unless the 4 context clearly indicates otherwise: 5 "Board." The State Board of Pharmacy. 6 "Drug source facility." A facility where drugs are lawfully 7 manufactured, dispensed or distributed. The term includes a 8 pharmacy, an entity and a Federal or State agency or 9 instrumentality. 10 "Long-term care facility." A long-term care nursing facility 11 as defined in section 802.1 of the act of July 19, 1979 12 (P.L.130, No.48), known as the Health Care Facilities Act. 13 "Pharmaceutical provider." An entity that employs a 14 pharmacist. 15 Section 4. State Board of Pharmacy. 16 The board has the following powers and duties: 17 (1) Develop the form required by section 5(b)(3) and (4) 18 (relating to third-party drugs in long-term care facilities). 19 (2) Promulgate regulations to set the fee under section 20 7 (relating to fee). Included in this rulemaking, the board 21 shall make a statement that the forms under paragraph (1) 22 have been developed. 23 (3) Provide a written report every 90 days regarding the 24 steps taken by the board to implement paragraphs (1) and (2), 25 to all of the following: 26 (i) The Consumer Protection and Professional 27 Licensure Committee of the Senate. 28 (ii) The Professional Licensure Committee of the 29 House of Representatives. 30 (iii) The Commissioner of the Bureau of Professional 20050H1022B1168 - 3 -
1 and Occupational Affairs. 2 (iv) The Secretary of the Commonwealth. 3 Section 5. Third-party drugs in long-term care facilities. 4 (a) Authority.--Notwithstanding any other provision of law, 5 all of the following may dispense a drug acquired from a drug 6 source facility outside the long-term care facility to a patient 7 of a long-term care facility: 8 (1) A pharmacist employed by a long-term care facility. 9 (2) A pharmacist who contracts with a long-term care 10 facility to fill prescriptions for patients of the long-term 11 care facility. 12 (3) A pharmaceutical provider that contracts with a 13 long-term care facility to fill prescriptions for patients of 14 the long-term care facility. 15 (b) Unit dose.--A person authorized under subsection (a) to 16 dispense a drug shall repackage, relabel and dispense the drug 17 in a unit dose if all of the following conditions are met: 18 (1) The drug is obtained from a drug source facility. 19 (2) There is a prescription for the drug. 20 (3) The prescriber has signed a form authorizing the 21 long-term care facility to administer a drug from a drug 22 source facility outside the long-term care facility. 23 (4) The patient has signed a form authorizing the long- 24 term care facility to administer a drug from a drug source 25 facility outside the long-term care facility. In the case of 26 a minor or a patient who is unable to sign the form, a 27 parent, a guardian, an agent acting under a power of attorney 28 or a family member is authorized to sign the form. The form 29 must explain that a person authorized under subsection (a) to 30 dispense a drug from a drug source facility outside the long- 20050H1022B1168 - 4 -
1 term care facility: 2 (i) is required to go through the process of 3 repackaging and relabeling the drug; 4 (ii) may charge a fee for repackaging and relabeling 5 the drug, including the amount of the fee and the 6 frequency of its assessment; and 7 (iii) has immunity from civil liability arising from 8 dispensation of the drug if the person properly 9 repackages and relabels the drug as set forth in section 10 8 (relating to civil liability and unprofessional 11 conduct). 12 Section 6. Recordkeeping. 13 For each drug dispensed in accordance with section 5(a) 14 (relating to third-party drugs in long-term care facilities), 15 the person authorized to dispense the drug and the long-term 16 care facility shall maintain a record for at least two years of 17 all of the following: 18 (1) The name and quantity of the drug prescribed, 19 including whether the prescription is a controlled substance 20 or if it was written PRN or ad lib refill. 21 (2) The name and address of the patient to whom it was 22 dispensed. 23 (3) The name and address or other identifier of the 24 prescriber. 25 (4) The date the prescription was issued and the date 26 the drug was dispensed. 27 (5) Directions for use, including cautions communicated 28 to the patient by auxiliary labels or other means when 29 dispensed. 30 (6) The date the prescription was compounded or 20050H1022B1168 - 5 -
1 dispensed. 2 (7) The name and address of the dispensing pharmacist. 3 (8) The drug source facility which provided the drug. 4 Section 7. Fee. 5 A person authorized under 5(a) (relating to third-party drugs 6 in long-term care facilities) to dispense a drug may charge a 7 reasonable fee, set by the board, to repackage and relabel the 8 drug. 9 Section 8. Civil liability and unprofessional conduct. 10 (a) Repackaging and relabeling.--A person authorized under 11 section 5(a) (relating to third-party drugs in long-term care 12 facilities) to dispense a drug shall be immune from civil 13 liability arising out of dispensation of the drug if the person 14 properly repackages and relabels a drug. 15 (b) Administration of drug.--A long-term care facility or an 16 employee or agent of a long-term care facility that properly 17 administers a drug from a person authorized under section 5(a) 18 to dispense the drug shall be immune from civil liability 19 arising out of administration of the drug. 20 (c) Unprofessional conduct.--A pharmacist authorized under 21 section 5(a)(3) to dispense a drug who properly relabels and 22 repackages the drug shall not be deemed to have engaged in 23 unprofessional conduct under section 5 of the act of September 24 27, 1961 (P.L.1700, No.699), known as the Pharmacy Act. 25 Section 40. Effective date. 26 This act shall take effect as follows: 27 (1) The following provisions shall take effect upon 28 publication of the rulemaking in the Pennsylvania Bulletin 29 under section 4(2): 30 (i) Section 5. 20050H1022B1168 - 6 -
1 (ii) Section 7. 2 (2) The remainder of this act shall take effect 3 immediately. B22L35VDL/20050H1022B1168 - 7 -