(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.