PRINTER'S NO. 1708
No. 1376 Session of 2007
INTRODUCED BY LENTZ, BOYD, BRENNAN, CALTAGIRONE, CAPPELLI,
CARROLL, CASORIO, CREIGHTON, CUTLER, DePASQUALE, EVERETT,
FREEMAN, GEORGE, GERGELY, GOODMAN, GRUCELA, JOSEPHS, KENNEY,
KOTIK, KULA, LEACH, MOUL, M. O'BRIEN, O'NEILL, PALLONE,
RAMALEY, RAYMOND, READSHAW, SCAVELLO, SHIMKUS, SIPTROTH,
SOLOBAY, SURRA, TANGRETTI, J. TAYLOR, WANSACZ, YOUNGBLOOD,
BELFANTI AND BEYER, MAY 25, 2007
REFERRED TO COMMITTEE ON PROFESSIONAL LICENSURE, MAY 25, 2007
AN ACT
1 Providing for long-term care access for veterans to
2 pharmaceuticals; and conferring powers and duties on the
3 State Board of Pharmacy and the Legislative Budget and
4 Finance Committee.
5 The General Assembly of the Commonwealth of Pennsylvania
6 hereby enacts as follows:
7 Section 1. Short title.
8 This act shall be known and may be cited as the Long-Term
9 Care Veteran Access to Pharmaceuticals Act.
10 Section 2. Legislative intent.
11 The General Assembly finds and declares as follows:
12 (1) A mechanism is to be provided whereby patients who
13 have the ability to acquire lower-cost drugs through a
14 Federal or State program, any insurance benefit program or
15 provider or another entity, have access to those drugs if
16 they reside in a long-term care facility.
1 (2) The mechanism is to be provided by permitting the
2 pharmacy within the long-term care facility or which has a
3 contract with the long-term care facility to:
4 (i) receive the lower-cost drugs from the Federal or
5 State program, insurance program or provider or other
6 entity; and
7 (ii) repackage and relabel those drugs so they may
8 be dispensed in unit doses to patients in a long-term
9 care facility.
10 (3) This act shall be interpreted and construed to
11 effectuate the following purposes:
12 (i) To provide for the care, protection and
13 treatment of patients in long-term care facilities by
14 allowing them to utilize the drug benefit provided by the
15 Federal Government or State government, any insurance
16 program or provider or any other entity.
17 (ii) Consistent with the care, protection and
18 treatment of patients in long-term care facilities, to
19 provide a means by which a pharmacy in a long-term care
20 facility or a pharmacy which has a contract with a long-
21 term care facility may:
22 (A) accept, on behalf of the patient, drugs
23 received from a Federal or State program, any
24 insurance program or provider or another entity; and
25 (B) repackage and relabel those drugs so that
26 the patient may receive them in a unit dose.
27 (iii) To provide a means through which the
28 provisions of this act are executed and enforced and in
29 which long-term care facilities, pharmacists, drug
30 sources and pharmaceutical providers may implement the
20070H1376B1708 - 2 -
1 provisions of this act.
2 Section 3. Definitions.
3 The following words and phrases when used in this act shall
4 have the meanings given to them in this section unless the
5 context clearly indicates otherwise:
6 "Board." The State Board of Pharmacy.
7 "Commissioner." The Commissioner of Professional and
8 Occupational Affairs.
9 "Dispense." As related to a drug, to prepare the drug for
10 subsequent administration to a patient. The term includes:
11 (1) the act of screening the drug for potential drug
12 therapy problems, including reviewing possible drug
13 interactions, reviewing the dosage and duration of drug
14 therapy, reviewing contraindications of the drug, reviewing
15 information regarding the patient and pharmaceutical coverage
16 and compounding and mixing the drug; and
17 (2) any other activity associated with review of the
18 drug which is designed to ensure the safety of the drug.
19 "Drug." Medication which has been approved by the Food and
20 Drug Administration. The term does not include medication which
21 is provided under Title XVIII Pt. D of the Social Security Act
22 (49 Stat. 620, 42 U.S.C. § 1395w-101 et seq.).
23 "Drug source." A facility where or a program under which
24 drugs are lawfully manufactured, dispensed or distributed. The
25 term includes a pharmacy, an entity and a Federal or State
26 agency or instrumentality. The term does not include a long-term
27 care pharmacy.
28 "Long-term care facility." A long-term care nursing facility
29 as defined in section 802.1 of the act of July 19, 1979
30 (P.L.130, No.48), known as the Health Care Facilities Act.
20070H1376B1708 - 3 -
1 "Long-term care pharmacy." Any of the following:
2 (1) A pharmacy within a long-term care facility.
3 (2) A pharmacist employed by a long-term care facility
4 who fills prescriptions for patients of a long-term care
5 facility.
6 (3) A pharmacist who contracts with a long-term care
7 facility to fill prescriptions for patients of a long-term
8 care facility.
9 (4) A pharmaceutical provider that contracts with a
10 long-term care facility to fill prescriptions for patients of
11 a long-term care facility.
12 "Patient." A veteran who resides in a long-term care
13 facility.
14 "Pharmaceutical provider." An entity that employs a
15 pharmacist.
16 "Secretary." The Secretary of the Commonwealth.
17 "Veteran." An individual who meets the conditions in
18 paragraphs (1) and (2):
19 (1) Served in the active military, naval or air service,
20 including:
21 (i) active duty;
22 (ii) a period of active duty for training during
23 which the individual concerned was disabled from a
24 disease or injury incurred or aggravated in the line of
25 duty; and
26 (iii) a period of inactive duty training during
27 which the individual concerned was disabled from:
28 (A) an injury incurred or aggravated in the line
29 of duty; or
30 (B) an acute myocardial infarction, a cardiac
20070H1376B1708 - 4 -
1 arrest, or a cerebrovascular accident, which occurred
2 during such training.
3 (2) Was discharged or released from service described in
4 paragraph (1) under conditions other than dishonorable.
5 Section 4. State Board of Pharmacy.
6 The board has the following powers and duties:
7 (1) Within 90 days of the effective date of this
8 paragraph, develop the form required by section 5(c)(1)(iii)
9 and (2)(iii) and (e).
10 (2) Distribute the form, upon request, to long-term care
11 facilities, physicians, long-term care pharmacies,
12 pharmacists and the public.
13 (3) Make the form available electronically via the
14 Internet.
15 (4) Provide a written report every 30 days regarding the
16 steps taken by the board to implement paragraphs (1) and (3),
17 to all of the following:
18 (i) The Consumer Protection and Professional
19 Licensure Committee of the Senate.
20 (ii) The Professional Licensure Committee of the
21 House of Representatives.
22 (iii) The commissioner.
23 (iv) The secretary.
24 Section 5. Authorization to administer and dispense drugs
25 obtained outside of long-term care pharmacy.
26 (a) Long-term care facilities.--Notwithstanding any other
27 provision of law to the contrary, a long-term care facility may
28 administer a drug acquired from a drug source to a patient of a
29 long-term care facility.
30 (b) Long-term care pharmacies.--Notwithstanding any other
20070H1376B1708 - 5 -
1 provision of law to the contrary, a long-term care pharmacy may
2 dispense a drug acquired from a drug source for administration
3 to a patient of a long-term care facility.
4 (c) Provision of drug to patient.--
5 (1) A long-term care facility shall administer a drug
6 acquired from a drug source to a patient of a long-term care
7 facility if all of the following conditions are met:
8 (i) The drug is acquired from a drug source.
9 (ii) There is a prescription for the drug.
10 (iii) The patient has signed a form under subsection
11 (e) authorizing the long-term care facility to administer
12 a drug acquired from a drug source. In the case of a
13 minor or patient who is unable to sign the form, a
14 parent, a guardian, an agent acting under a power of
15 attorney or a family member is authorized to sign the
16 form.
17 (2) A long-term care pharmacy shall dispense a drug
18 acquired from a drug source to a patient of a long-term care
19 facility if all of the following conditions are met:
20 (i) The drug is acquired from a drug source.
21 (ii) There is a prescription for the drug.
22 (iii) The patient has signed a form under subsection
23 (e) authorizing the long-term care pharmacy to dispense a
24 drug acquired from a drug source. In the case of a minor
25 or patient who is unable to sign the form, a parent, a
26 guardian, an agent acting under a power of attorney or a
27 family member is authorized to sign the form.
28 (d) Unit dose.--A long-term care pharmacy shall repackage,
29 relabel and dispense a drug acquired from a drug source in unit
30 doses or such other forms as to enable a long-term care facility
20070H1376B1708 - 6 -
1 to administer the drug to a patient safely and in a manner and
2 form which conform with the long-term care facility's drug
3 administration procedures and quality assurance standards.
4 (e) Contents of form.--An authorization under subsection
5 (c)(1)(iii) and (2)(iii) must explain all of the following:
6 (1) A long-term care pharmacy:
7 (i) is required to go through the process of
8 dispensing, repackaging and relabeling the drug so that
9 the drug may be administered safely and in a manner and
10 form that conform to the long-term care facility's drug
11 administration procedures and quality assurance
12 standards;
13 (ii) may charge a reasonable fee which may not
14 exceed the limit set forth in section 7(c) which may be
15 charged to the patient for costs associated with
16 dispensing, repackaging and relabeling the drug;
17 (iii) is required to disclose the amount of the fee,
18 and that the fee may be charged for each drug dispensed;
19 and
20 (iv) is immune from civil liability arising from
21 harm caused by the drug due to acts or omissions of other
22 persons outside of the long-term care pharmacy if the
23 long-term care pharmacy properly dispenses, repackages
24 and relabels the drug.
25 (2) A long-term care facility:
26 (i) is required to administer a drug which has been
27 dispensed, repackaged and relabeled by the long-term care
28 pharmacy in a unit dose or such other form as to enable a
29 long-term care facility to administer the drug to the
30 patient safely and in a manner and form which conform
20070H1376B1708 - 7 -
1 with the long-term care facility's drug administration
2 procedures and quality assurance standards;
3 (ii) is required to maintain records;
4 (iii) may charge a reasonable fee which may not
5 exceed the limit set forth in section 7(d);
6 (iv) is required to disclose the amount of the fee
7 and that the fee may be charged for each drug dispensed;
8 and
9 (v) is immune from civil liability arising from harm
10 caused by the drug due to acts or omissions of other
11 persons outside the long-term care facility if the long-
12 term care facility properly administers the drug.
13 (f) Temporary form.--A long-term care facility may develop
14 the form required under subsections (c)(1)(iii) and (2)(iii) and
15 (e) and use the form until the board develops a form under
16 section 4.
17 Section 6. Recordkeeping.
18 (a) Maintenance of records.--For each drug dispensed by a
19 long-term care pharmacy under section 5(b) and (c)(2), the long-
20 term care pharmacy and the long-term care facility shall
21 maintain a record for at least two years of all of the
22 following:
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 on an as needed basis (PRN) or "ad lib"
26 refill.
27 (2) The name and address of the patient to whom it was
28 dispensed.
29 (3) The name and address or other identifier of the
30 prescriber.
20070H1376B1708 - 8 -
1 (4) The date the prescription was issued and the date
2 the drug was dispensed.
3 (5) Directions for use, including cautions communicated
4 to the patient by auxiliary labels or other means when
5 dispensed.
6 (6) The date the prescription was compounded or
7 dispensed.
8 (7) The name and business address of the dispensing
9 pharmacist.
10 (8) The drug source which provided the drug.
11 (b) Duty of drug source.--For each drug acquired from a drug
12 source and dispensed by a long-term care pharmacy under section
13 5, the drug source shall provide to the long-term care pharmacy:
14 (1) A copy of the original prescription. For purposes of
15 complying with this paragraph, the duty of the drug source is
16 met if the drug source provides any of the following:
17 (i) The copy of the original prescription
18 electronically, via facsimile or in some other format
19 which the long-term care pharmacy deems acceptable.
20 (ii) The information contained in the original
21 prescription. The requirement of this subparagraph is met
22 if the information is provided in writing. The writing
23 may be provided electronically, via facsimile or in some
24 other format which the long-term care pharmacy deems
25 acceptable.
26 (iii) The information contained in the original
27 prescription or a copy of the original prescription if
28 the copy or information has been provided in a manner
29 which conforms with regulations of the board.
30 (2) The name of the manufacturer of the drug, the lot
20070H1376B1708 - 9 -
1 number and the expiration date of the drug. For purposes of
2 complying with this paragraph, the duty of the drug source is
3 met if the information appears on the label of the drug.
4 Section 7. Fee.
5 (a) Fee authorized.--A long-term care pharmacy authorized
6 under section 5 to dispense a drug acquired from a drug source
7 may charge a reasonable fee for each drug as set forth in
8 subsection (c) to the patient of a long-term care facility.
9 (b) Report to the board.--The long-term care pharmacy shall
10 report the amount of the fee to the board. A change in the fee
11 shall be reported to the board within ten business days.
12 (c) Determination of fee.--A fee is reasonable if the fee
13 does not exceed an amount which is four times the specific
14 dollar amount of the program payment under section 509(6)(iii)
15 of the act of August 26, 1971 (P.L.351, No.91), known as the
16 State Lottery Law.
17 (d) Fee authorized for long-term care facilities.--A long-
18 term care facility administering a drug which has been
19 dispensed, repackaged and relabeled by a long-term care pharmacy
20 under section 5 may charge a reasonable fee for each drug which
21 has been dispensed, repackaged and relabeled by the long-term
22 care pharmacy. The fee is reasonable if it does not exceed the
23 specific dollar amount of the program payment under section
24 509(6)(iii) of the State Lottery Law.
25 Section 8. Immunity and unprofessional conduct.
26 (a) Long-term care pharmacies.--A long-term care pharmacy
27 authorized under section 5 to dispense a drug acquired from a
28 drug source shall be immune from civil liability arising from
29 harm caused by the drug due to acts or omissions of other
30 persons outside of the long-term care pharmacy if the long-term
20070H1376B1708 - 10 -
1 care pharmacy properly dispenses, repackages and relabels the
2 drug.
3 (b) Long-term care facilities.--
4 (1) A long-term care facility that properly administers
5 a drug provided by a long-term care pharmacy under section 5
6 shall be immune from civil liability arising from harm caused
7 by the drug due to acts or omissions of other persons outside
8 the long-term care facility.
9 (2) An employee or agent of a long-term care facility
10 who properly administers a drug provided by a long-term care
11 pharmacy under section 5 shall be immune from civil liability
12 arising from harm caused by the drug due to acts or omissions
13 of other persons outside the long-term care facility.
14 (c) Unprofessional conduct.--A pharmacist who properly
15 dispenses, repackages and relabels a drug acquired from a drug
16 source under section 5 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 9. Relation to Pharmacy Act.
20 (a) Prevention or prohibition.--Nothing in the act of
21 September 27, 1961 (P.L.1700, No.699), known as the Pharmacy
22 Act, shall be construed to prevent or prohibit any of the
23 following from complying with the provisions of this act:
24 (1) A pharmacist.
25 (2) A pharmacy, as defined in section 2(12) of the
26 Pharmacy Act.
27 (b) Conflict.--If there is a conflict between a provision of
28 the Pharmacy Act and a provision of this act, the provision of
29 this act shall prevail.
30 Section 10. Study by Legislative Budget and Finance Committee.
20070H1376B1708 - 11 -
1 (a) Study commissioned.--One year after the effective date
2 of this section, the Legislative Budget and Finance Committee
3 shall commence a study of the following:
4 (1) The effectiveness of this act with respect to
5 patients in long-term care facilities receiving lower-cost
6 pharmaceuticals.
7 (2) The experience of patients, long-term care
8 facilities and long-term care pharmacies authorized under
9 section 5 to dispense a drug acquired from a drug source,
10 with respect to complying with this act.
11 (3) The sufficiency of the recordkeeping requirements
12 set forth in section 6 with respect to assuring patient
13 safety, preventing diversion of drugs and assuring the
14 quality of drugs.
15 (b) Report and recommendations.--The committee shall make a
16 report of its findings and recommendations within two years of
17 the effective date of this section to the President pro tempore
18 of the Senate, the Speaker of the House of Representatives, the
19 Consumer Protection and Professional Licensure Committee of the
20 Senate and the Professional Licensure Committee of the House of
21 Representatives.
22 Section 40. Effective date.
23 This act shall take effect in 90 days.
D5L35VDL/20070H1376B1708 - 12 -