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                                                      PRINTER'S NO. 1168

THE GENERAL ASSEMBLY OF PENNSYLVANIA


HOUSE BILL

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.
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     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
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     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.


















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