Ohio Admin. Code 4729:5-5-02.4 - Significant delays in the provision of pharmacy services
(A)
An outpatient pharmacy has a duty to properly dispense
lawful prescriptions for dangerous drugs or devices without significant
delay.
(1)
For
purposes of this rule, "significant delay" means a prescription that was
submitted to the pharmacy for processing by a prescriber, patient, or caregiver
and has yet to be dispensed (e.g., final verification) by a pharmacist as
follows:
(a)
For new prescriptions: within three business days of
receiving the prescription.
(b)
For refill
prescriptions not generated by a pharmacy auto-refill program: within three
business days of receiving the prescription.
(c)
For refill
prescriptions generated by a pharmacy auto-refill program: within five business
days of receiving the prescription.
(2)
Receipt of the
prescription as described in paragraph (A)(1) of this rule is said to
occur:
(a)
For
new prescriptions: receipt occurs on the day when the prescription is
transmitted or submitted to the pharmacy.
(b)
For refills on
existing prescriptions: receipt occurs on the day when a refill request is
submitted to the pharmacy by a patient, caregiver, or prescriber or when a
refill request is generated as part of a pharmacy's auto-refill
program.
(3)
For purposes of this rule, "significant delay" does not
mean any of the following:
(a)
A prescription that has been submitted to the pharmacy
but where there is a documented drug shortage, or the pharmacy documents the
drug is not available from the pharmacy's drug distributor.
(b)
A prescription
that has been submitted to the pharmacy that requires clarification or
consultation by the issuing prescriber.
(c)
A prescription
that has been submitted to the pharmacy that requires prior authorization or is
otherwise delayed because of the patient's prescription insurance
coverage.
(d)
A prescription that is for a compounded drug
product.
(e)
A prescription that the pharmacist, using their
professional judgement, determines is of questionable, doubtful, or suspicious
origin.
(f)
A prescription that, in the pharmacist's professional
judgment, if dispensed, cannot be safely provided or may negatively impact
patient care.
(g)
A prescription where the prescriber indicates a "do not
fill until" date or similar designation.
(h)
A prescription
where the patient, caregiver, or issuing prescriber has communicated to the
pharmacy that dispensing may occur beyond the period described in paragraph
(A)(1) of this rule.
(i)
A prescription where the patient, caregiver, or issuing
prescriber has requested a transfer to another pharmacy.
(j)
A prescription
where the pharmacy has experienced any of the following:
(i)
A natural
disaster (fire, flood, etc.), civil unrest, or human made
disaster;
(ii)
An outbreak of a pandemic illness or the declaration of
a state or federal public health emergency;
(iii)
A loss of
power; or
(iv)
An unplanned information technology system
outage.
(k)
Any other circumstance as determined by the
board.
(B)
Each prescription
that experiences a significant delay, as defined in paragraph (A) of this rule,
shall be considered a violation of this rule and shall subject the outpatient
pharmacy to disciplinary action in accordance with rule
4729:5-4-01 of the
Administrative Code.
(C)
Immediately upon discovery or at the request of an
agent, inspector, or employee of the board, a pharmacy experiencing a
significant delay shall implement one or more of the following remediation
measures to dispense all prescriptions that are experiencing a significant
delay:
(1)
Limiting pharmacy hours (e.g., dark hours);
(2)
Transferring
prescriptions to another pharmacy, upon patient consent;
(3)
Increasing
pharmacy staff; or
(4)
Any other strategy that is mutually agreed upon by the
outpatient pharmacy and the agent, inspector, or employee of the
board.
(D)
As part of the remediation process required in
paragraph (C) of this rule, the outpatient pharmacy shall implement a process
that triages lifesaving and life-sustaining medications that are experiencing a
significant delay.
(E)
As used in this rule, "business day" means any day,
excluding holidays, where the pharmacy is open for business.
(F)
An outpatient
pharmacy shall only provide auto-refills of a prescription upon the
authorization of the patient or the patient's caregiver.
(1)
The pharmacy
shall maintain documentation indicating the patient or the patient's caregiver
has enrolled in the pharmacy's auto-refill program.
(2)
Consent for
enrollment in the pharmacy's auto-refill program may be captured
electronically, verbally by pharmacy staff, or in writing.
(3)
The pharmacy
shall maintain a record of consent in the patient's profile, or another system
maintained by the pharmacy, in a readily retrievable manner. As part of this
record, the pharmacy shall document the date the patient or caregiver consented
to enrollment in the pharmacy's auto-refill program.
(4)
The pharmacy
shall discontinue enrollment in an auto-refill program upon the request of the
patient or the patient's caregiver.
Notes
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.54, 4729.55
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