Chapter 4725-16 Additional Therapeutic Pharmaceutical Agents
Rescinded eff 7-28-08
Rescinded eff 7-28-08
A licensed optometrist, who holds a therapeutic pharmaceutical agents certificate and a valid DEA license number is authorized to employ, apply, administer and prescribe controlled substances that are determined to be appropriate for use in the practice of optometry pursuant to the following:
(A) A licensed optometrist who holds a therapeutic pharmaceutical agents certificate and a valid DEA license number may prescribe the following drug product that is used for the treatment of pain and meets one of the following conditions :
(1) A preparation used for the treatment of pain that contains not more than sixty mg of codeine per dosage unit and also contains other active nonnarcotic ingredients (e.g. acetaminophen or aspirin) in a recognized therapeutic amount.
(2) A preparation used for the treatment of pain that contains not more than 7.5 mg of hydrocodone per dosage unit and also contains other active nonnarcotic ingredients (e.g. acetaminophen, aspirin, ibuprofen) in a recognized therapeutic amount.
(B) The total quantity prescribed shall not exceed a single four-day supply of controlled substances per episode of illness, injury and/or treatment.
(C) The product contains or consists of a drug or dangerous drug that was an analgesic included in the practice of optometry under a therapeutic pharmaceutical agents certificate immediately prior to the effective date of this amendment, was not a controlled substance at that time, and subsequently becomes a schedule II, III, IV, or V controlled substance. Controlled substances may only be prescribed by an optometrist if the product's FDA approved labeling contains an indication for pain.
The failure to comply with all or part of this rule constitutes a violation of divisions (B)(3), (B)(9), and/or (B)(13) of section 4725.19 of the Revised Code.
(A) For purposes of this rule:
(1) "OARRS" means the "Ohio Automated Rx Reporting System" drug database established and maintained pursuant to section 4729.75 of the Revised Code.
(2) "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.
(3) "Personally furnish" means the distribution of drugs by a prescriber to the prescriber's patients for use outside the prescriber's practice setting.
(4) "Protracted basis" means a period in excess of twelve continuous weeks.
(5) "Reported drugs" means all the drugs listed in rule 4729-37-02 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:
(a) Controlled substances in schedules II, III, IV, and V, and
(b) All dangerous drug products containing carisoprodol or tramadol.
(c) Other non-controlled dangerous drug products as listed in rule 4729-37-02 of the Administrative Code in the definitions as paragraph (A)(5)(b) of this rule.
(B) If an optometrist believes or has reason to believe that a patient may be abusing or diverting drugs, the optometrist shall use sound clinical judgment in determining whether or not the reported drug should be prescribed or personally furnished to the patient under the circumstances.
(1) To assist in this determination, the optometrist shall access OARRS and document receipt and assessment of the information received if the patient exhibits the following signs of drug abuse or diversion:
(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) Having a drug screen result that is inconsistent with the treatment plan or refusing to participate in a drug screen;
(f) Having been arrested, convicted or received diversion, or intervention in lieu of conviction for a drug related offense while under the physician's care;
(g) Receiving reported drugs from multiple prescribers, without clinical basis; or
(h) 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.
(2) Other signs of possible abuse or diversion which may necessitate accessing OARRS include, but are not limited to the following:
(a) A known history of chemical abuse or dependency;
(b) Appearing impaired or overly sedated during an office visit or exam;
(c) Requesting reported drugs by specific name, street name, color, or identifying marks;
(d) Frequently requesting early refills of reported drugs;
(e) Frequently losing prescriptions for reported drugs;
(f) A history of illegal drug use;
(g) Sharing reported drugs with another person; or
(h) Recurring emergency department visits to obtain reported drugs.
(C) An optometrist prescribing or personally furnishing reported drugs to treat a patient on a protracted basis shall, at a minimum, document receipt and assessment of an OARRS report in the following circumstances:
(1) Once the optometrist has reason to believe that the treatment will be required on a protracted basis; and
(2) At least once annually, thereafter.
(D) An optometrist shall document receipt and assessment of all OARRS reports in the patient record.
(1) Initial reports requested in compliance with this rule shall cover a time period of at least one year;
(2) Subsequent reports requested in compliance with this rule shall, at a minimum, cover the period from the date of the last report to present.
(E) In the event an OARRS report is not available prior to writing a prescription for a reported drug or personally furnishing the reported drug, an optometrist shall document in the patient record why the OARRS report was not available.
(F) Paragraph (C) of this rule does not apply to a hospice patient in a hospice care program as those terms are defined in section 3712.01 of the Revised Code.