Citations Affected: IC 12-8; IC 16-28; IC 25-26; IC 34-30.
Synopsis: Distribution of unused drugs. Allows a pharmacy or
pharmacist to donate medications to certain health clinics. Establishes
the regional drug repository program to distribute donated drugs.
Requires a health facility to return unused medication that meets
specified requirements to the pharmacy that dispensed the medication.
Allows a pharmacy or pharmacist to accept returned medications from
a hospice program. Requires the office of Medicaid policy and
planning to review the process of returning unused medication.
Effective: July 1, 2003.
January 23, 2003, read first time and referred to Committee on Health and Provider
Services.
February 13, 2003, amended, reported favorably _ Do Pass.
February 25, 2003, read second time, amended, ordered engrossed.
A BILL FOR AN ACT to amend the Indiana Code concerning
professions and occupations.
SECTION 1. IC 12-8-6-6.5 IS ADDED TO THE INDIANA CODE
AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY
1, 2003]: Sec. 6.5. (a) Before December 31, 2003, the office shall
review the process of returning unused medication under
IC 25-26-13-25 and the process of reimbursing the office for
unused medication of a Medicaid recipient. The office may
consider in the office's review information provided by long term
care pharmacies. Beginning December 31, 2003, the office may
review the process of returning unused medication when the office
determines that a review is necessary.
(c) After the office conducts a review under subsection (a), the
office may adopt rules under IC 4-22-2 to require a pharmacist to
accept medication for return under IC 25-26-13-25. The rules
adopted by the office may include compensation to the pharmacist
for the return of medication under IC 25-13-25.
SECTION 2. IC 16-28-11-4 IS ADDED TO THE INDIANA CODE
AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY
1, 2003]: Sec. 4. A health facility that possesses unused medication
that meets the requirements of IC 25-26-14-25(i)(1) through
IC 25-26-14-25(i)(6):
(1) shall return medication that belonged to a Medicaid
recipient; and
(2) may return other unused medication;
to the pharmacy that dispensed the medication.
SECTION 3. IC 25-26-13-25, AS AMENDED BY P.L.1-2002,
SECTION 98, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
JULY 1, 2003]: Sec. 25. (a) All original prescriptions, whether in
written or electronic format, shall be numbered and maintained in
numerical and chronological order, or in a manner approved by the
board and accessible for at least two (2) years in the pharmacy. A
prescription transmitted from a practitioner by means of
communication other than writing must immediately be reduced to
writing or recorded in an electronic format by the pharmacist. The files
shall be open for inspection to any member of the board or its duly
authorized agent or representative.
(b) Except as provided in subsection (c) before the expiration of
subsection (c) on June 30, 2003, a prescription for any drug, the label
of which bears either the legend, "Caution: Federal law prohibits
dispensing without prescription" or "Rx Only", may not be refilled
without written or oral authorization of a licensed practitioner.
(c) A prescription for any drug, the label of which bears either the
legend, "Caution: Federal law prohibits dispensing without
prescription" or "Rx Only", may be refilled by a pharmacist one (1)
time without the written or oral authorization of a licensed practitioner
if all of the following conditions are met:
(1) The pharmacist has made every reasonable effort to contact
the original prescribing practitioner or the practitioner's designee
for consultation and authorization of the prescription refill.
(2) The pharmacist believes that, under the circumstances, failure
to provide a refill would be seriously detrimental to the patient's
health.
(3) The original prescription authorized a refill but a refill would
otherwise be invalid for either of the following reasons:
(A) All of the authorized refills have been dispensed.
(B) The prescription has expired under subsection (f).
(4) The prescription for which the patient requests the refill was:
(A) originally filled at the pharmacy where the request for a
refill is received and the prescription has not been transferred
for refills to another pharmacy at any time; or
Emergency Refill". This subsection expires June 30, 2003.
(d) When refilling a prescription, the refill record shall include:
(1) the date of the refill;
(2) the quantity dispensed if other than the original quantity; and
(3) the dispenser's identity on:
(A) the original prescription form; or
(B) another board approved, uniformly maintained, readily
retrievable record.
(e) The original prescription form or the other board approved
record described in subsection (d) must indicate by the number of the
original prescription the following information:
(1) The name and dosage form of the drug.
(2) The date of each refill.
(3) The quantity dispensed.
(4) The identity of the pharmacist who dispensed the refill.
(5) The total number of refills for that prescription.
(f) A prescription is valid for not more than one (1) year after the
original date of issue.
(g) A pharmacist may not knowingly dispense a prescription after
the demise of the practitioner, unless in the pharmacist's professional
judgment it is in the best interest of the patient's health.
(h) A pharmacist may not knowingly dispense a prescription after
the demise of the patient.
(i) A pharmacist or a pharmacy shall not resell, reuse, or redistribute
a medication that is returned to the pharmacy after being dispensed
unless the medication:
(1) was dispensed to a patient:
(A) residing in an institutional facility (as defined in 856
IAC 1-28-1(a)); or
(B) in a hospice program under IC 16-25;
(2) was properly stored and securely maintained according to
sound pharmacy practices;
(3) is returned unopened and:
(A) was dispensed in the manufacturer's original:
(i) bulk, multiple dose container with an unbroken tamper
resistant seal; or
(ii) unit dose package; or
(B) was packaged by the dispensing pharmacy in a:
(i) multiple dose blister container; or
(ii) unit dose package;
(4) was dispensed by the same pharmacy as the pharmacy
accepting the return;
program by the following:
(1) A pharmacist or pharmacy.
(2) A drug manufacturer.
(3) A wholesale drug distributor.
(4) A hospital.
(5) A health care facility.
(6) A hospice.
(7) A practitioner.
Sec. 5. A drug that is given by a regional drug repository to a
nonprofit health clinic may not be:
(1) sold; or
(2) given to a patient except upon a practitioner's prescription
or drug order.
Sec. 6. (a) Except in cases of bad faith or willful misconduct, any
person, including a drug manufacturer, that donates a drug to the
regional drug repository program and any nonprofit health clinic
or practitioner who accepts or dispenses drugs under the program
is not:
(1) subject to disciplinary actions; or
(2) liable for civil or criminal actions for the injury, death, or
loss to a patient;
for matters related to the donation, acceptance, or dispensing of a
drug under the program.
(b) Except in cases of bad faith or willful misconduct, a drug
manufacturer is not liable for civil or criminal actions for any drug
that was made by the drug manufacturer concerning the failure to
transfer or communicate product or consumer information or the
expiration date of the drug donated under the program.
(c) Except in cases of bad faith or willful misconduct, a regional
drug repository is not liable for civil or criminal actions for the
injury, death, or loss to a patient related to the donation,
acceptance, or dispensing of a drug under the program.
Sec. 7. The board may adopt rules under IC 4-22-2 to:
(1) establish standards and procedures for accepting, storing,
and dispensing drugs donated under this chapter;
(2) establish the types of drugs that may be donated; and
(3) administer this chapter.
SECTION 5. IC 34-30-2-101.5 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JULY 1, 2003]: Sec. 101.5. IC 25-26-19-6 (Concerning
drugs donated to a regional drug repository program).