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 the physician assistant.
(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) "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 a reported drug, a physician
assistant 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
a reported drug is appropriate for the patient, the physician assistant shall
use sound clinical judgment and obtain and review an OARRS report consistent
with the provisions of this rule.
(C) A physician assistant shall obtain and
review an OARRS report to help determine if it is appropriate to prescribe an
opioid analgesic, benzodiazepine, or other reported drug to a patient as
provided in this paragraph and paragraph (F) of this rule:
(1) A physician assistant shall obtain and
review an OARRS report before prescribing an opioid analgesic or benzodiazepine
to a patient, unless an exception listed in paragraph (H) of this rule is
applicable.
(2) A physician
assistant 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 (H)
of this rule is applicable.
(3) A
physician assistant shall obtain and review and 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 care of the physician assistant or the physician
assistant's supervising physician;
(h) Receiving reported drugs from multiple
prescribers, without clinical basis;
(i) Traveling with a group of other patients
to the physician assistant'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 assistant'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 assistant 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 the opioid analgesic,
benzodiazepine, or other reported drug:
(1)
Review and document in the patient record the reasons why the physician
assistant 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 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
assistant shall obtain and review an 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 assistant shall obtain and review
an 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 (H) of this rule is applicable.
(F) When a physician assistant or
their delegate requests an OARRS report in compliance with this rule, a
physician assistant 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 assistant practices
primarily in a county of this state that adjoins another state, the physician
assistant 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 assistant 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) Review of the physician assistant's
compliance with this rule shall be included as an activity in the quality
assurance plan required by division (F) of section
4730.21 of the Revised Code and
rule
4730-1-05
of the Administrative Code.
(H) A
physician assistant shall not be required to review and assess an OARRS report
when prescribing an opioid analgesic, benzodiazepine, or other reported drug
under the following circumstances, unless a physician assistant believes or has
reason to believe that a patient may be abusing or diverting reported drugs:
(1) The reported drug is prescribed 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 in an amount indicated for a period not to exceed seven
days;
(4) The reported drug is
prescribed for the treatment of cancer or another condition associated with
cancer.