Current through all regulations passed and filed through September 16, 2024
(A) For purposes of this rule:
(1)
"Delegate" means an authorized representative who
is registered with the Ohio board of pharmacy to obtain an OARRS report on
behalf of a physician;
(2) "OARRS"
means the "Ohio Automated Rx Reporting System" drug database established and
maintained pursuant to section
4729.75
of the Revised Code.
(3) "OARRS
report" means a report of information related to a specified patient generated
by the drug database established and maintained pursuant to section
4729.75
of the Revised Code.
(4)
"Personally furnish" means the distribution of drugs by a prescriber to the
prescriber's patients for use outside the prescriber's practice
setting.
(5) "Reported drugs" means
all the drugs listed in rule 4729:8-2-01 of the Administrative Code that are
required to be reported to the drug database established and maintained
pursuant to section
4729.75
of the Revised Code, including controlled substances in schedules II, III, IV,
and V.
(B) Standards of
care:
(1) The accepted and prevailing minimal
standards of care require that when prescribing or personally furnishing a
reported drug, a physician shall take into account all of the following:
(a) The potential for abuse of the reported
drug;
(b) The possibility that use
of the reported drug may lead to dependence;
(c) The possibility the patient will obtain
the reported drug for a nontherapeutic use or distribute it to other persons;
and
(d) The potential existence of
an illicit market for the reported drug.
(2) In considering whether a prescription for
or the personally furnishing of a reported drug is appropriate for the patient,
the physician shall use sound clinical judgment and obtain and review an OARRS
report consistent with the provisions of this rule.
(C) A physician shall obtain and review an
OARRS report to help determine if it is appropriate to prescribe or personally
furnish an opioid analgesic, benzodiazepine, or reported drug to a patient as
provided in this paragraph and paragraph (F) of this rule:
(1) A physician shall obtain and review an
OARRS report before prescribing or personally furnishing an opiate analgesic or
benzodiazepine to a patient, unless an exception listed in paragraph (G) of
this rule is applicable.
(2) A
physician shall obtain and review an OARRS report when a patient's course of
treatment with a reported drug other than an opioid analgesic or benzodiazepine
has lasted more than ninety days, unless an exception listed in paragraph (G)
of this rule is applicable.
(3) A
physician shall obtain and review an OARRS report when any of the following red
flags pertain to the patient:
(a) Selling
prescription drugs;
(b) Forging or
altering a prescription;
(c)
Stealing or borrowing reported drugs;
(d) Increasing the dosage of reported drugs
in amounts that exceed the prescribed amount;
(e) Suffering an overdose, intentional or
unintentional;
(f) Having a drug
screen result that is inconsistent with the treatment plan or refusing to
participate in a drug screen;
(g)
Having been arrested, convicted, or received diversion or intervention in lieu
of conviction for a drug related offense while under the physician's
care;
(h) Receiving reported drugs
from multiple prescribers, without clinical basis;
(i) Traveling with a group of other patients
to the physician's office where all or most of the patients request controlled
substance prescriptions;
(j)
Traveling an extended distance or from out of state to the physician's
office;
(k) Having a family member,
friend, law enforcement officer, or health care professional express concern
related to the patient's use of illegal or reported drugs;
(l) A known history of chemical abuse or
dependency;
(m) Appearing impaired
or overly sedated during an office visit or exam;
(n) Requesting reported drugs by street name,
color, or identifying marks;
(o)
Frequently requesting early refills of reported drugs;
(p) Frequently losing prescriptions for
reported drugs;
(q) A history of
illegal drug use;
(r) Sharing
reported drugs with another person; or
(s) Recurring visits to non-coordinated sites
of care, such as emergency departments, urgent care facilities, or walk-in
clinics to obtain reported drugs.
(D) A physician who decides to utilize an
opioid analgesic, benzodiazepine, or other reported drug in any of the
circumstances within paragraphs (C)(2) and (C)(3) of this rule, shall take the
following steps prior to issuing a prescription for or personally furnishing
the opioid analgesic, benzodiazepine, or other reported drug:
(1) Review and document in the patient record
the reasons why the physician believes or has reason to believe that the
patient may be abusing or diverting drugs;
(2) Review and document in the patient's
record the patient's progress toward treatment objectives over the course of
treatment;
(3) Review and document
in the patient record the functional status of the patient, including
activities for daily living, adverse effects, analgesia, and aberrant behavior
over the course of treatment;
(4)
Consider using a patient treatment agreement including more frequent and
periodic reviews of OARRS reports and that may also include more frequent
office visits, different treatment options, drug screens, use of one pharmacy,
use of one provider for the prescription or personally furnishing of reported
drugs, and consequences for non-compliance with the terms of the agreement. The
patient treatment agreement shall be maintained as part of the patient record;
and
(5) Consider consulting with or
referring the patient to a substance abuse specialist.
(E) Frequency for follow-up OARRS reports:
(1) For a patient whose treatment with an
opioid analgesic or benzodiazepine lasts more than ninety days, a physician
shall obtain and review and OARRS report for the patient at least every ninety
days during the course of treatment, unless an exception listed in paragraph
(G) of this rule is applicable.
(2)
For a patient who is treated with a reported drug other than an opioid
analgesic or benzodiazepine for a period lasting more than ninety days, the
physician shall obtain and review and OARRS report for the patient at least
annually following the initial OARRS report obtained and reviewed pursuant to
paragraph (C)(2) of this rule until the course of treatment utilizing the
reported drug has ended, unless an exception in paragraph (G) of this rule is
applicable.
(F) When a
physician or their delegate requests an OARRS report in compliance with this
rule, a physician shall document receipt and review of the OARRS report in the
patient record, as follows:
(1) Initial
reports requested shall cover at least the twelve months immediately preceding
the date of the request:
(2)
Subsequent reports requested shall, at a minimum, cover the period from the
date of the last report to present;
(3) If the physician practices primarily in a
county of this state that adjoins another state, the physician or their
delegate shall also request a report of any information available in the drug
database that pertains to prescriptions issued or drugs furnished to the
patient in the state adjoining that county; and
(4) If an OARRS report regarding the patient
is not available, the physician shall document in the patient's record the
reason that the report is not available and any efforts made in follow-up to
obtain the requested information.
(G) A physician shall not be required to
review and assess an OARRS report when prescribing or personally furnishing an
opioid analgesic, benzodiazepine, or other reported drug under the following
circumstances, unless a physician believes or has reason to believe that a
patient may be abusing or diverting reported drugs:
(1) The reported drug is prescribed or
personally furnished to a hospice patient in a hospice care program as those
terms are defined in section
3712.01
of the Revised Code, or any other patient diagnosed as terminally
ill;
(2) The reported drug is
prescribed for administration in a hospital, nursing home, or residential care
facility;
(3) The reported drug is
prescribed or personally furnished in an amount indicated for a period not to
exceed seven days;
(4) The reported
drug is prescribed or personally furnished for the treatment of cancer or
another condition associated with cancer; and
(5) The reported drug is prescribed or
personally furnished to treat acute pain resulting from a surgical or other
invasive procedure or a delivery.