In mid-June, Governor Kasich signed into law two bills that impose new requirements on prescribers of opioids in Ohio. Ohio House Bill 314 (“HB 314”), which will become effective on Sept. 17, 2014, requires prescribers to follow specific informed consent procedures before prescribing opioids to minors. Ohio House Bill 341 (“HB 341”) imposes new requirements on prescribers of opioids to have access to and use the Ohio Automated Rx Reporting System (“OARRS”) beginning in 2015.
This bill authorizes the enactment of Ohio Revised Code (“O.R.C.”) Section 3719.061, which requires that before “issuing for a minor the first prescription in a single course of treatment for a particular compound that is a controlled substance containing an opioid” a prescriber must:
- Assess whether the minor has suffered or is currently suffering from mental health or substance abuse disorders and has taken or is currently taking prescription drugs for treatment of those disorders.
- Discuss with the minor and the minor's parent or guardian (or another adult authorized in writing to consent to the minor's medical treatment) all of the following:
- The risks of addiction and overdose associated with the compound.
- The increased risk of addiction to controlled substances of individuals suffering from both mental and substance abuse disorders.
- The dangers of taking controlled substances containing opioids with benzodiazepines, alcohol or other central nervous system depressants.
- Any other patient counseling information set forth in the FDA labeling requirements.
- Obtain written consent for the prescription from the minor's parent, guardian or other authorized adult. (If the consent is granted by someone other than the minor’s parent or guardian, there are further restrictions on the dosage that may be prescribed.) The written consent has to be on a form known as the "Start Talking!" consent form that must be separate from any other document, must be kept in the minor’s medical record and must contain all of the following:
- The name and quantity of the compound being prescribed and the amount of the initial dose.
- A statement indicating that a controlled substance is a drug or other substance that the United States drug enforcement administration has identified as having a potential for abuse.
- A statement certifying that the prescriber discussed with the minor and the minor's parent, guardian or other authorized adult all the required topics listed above.
- The number of refills, if any, authorized by the prescription.
- The signature of the minor's parent, guardian or other authorized adult and the date of signing.
The requirements above do not apply, however, when:
- The treatment is associated with or incident to a medical emergency.
- The treatment is associated with or incident to surgery.
- “In the prescriber’s professional judgment, fulfilling the requirements … would be a detriment to the minor’s health or safety.”
- The treatment is rendered in, or upon discharge from, a hospital, ambulatory surgical facility, nursing home, pediatric respite care program, residential care facility, freestanding rehabilitation facility or similar institutional facility. This exemption does not apply, however, to treatment “rendered in a prescriber’s office that is located on the premises of or adjacent to” such a facility.
This bill amends several O.R.C. provisions, requiring various types of providers to check the OARRS database before prescribing either an opioid analgesic or a benzodiazepine.
Specifically, HB 341 requires that physicians, advanced practice nurses (“APNs”), physician assistants (“PAs”), dentists and optometrists obtain and document in the patient record his or her assessment of an OARRS report:
- That covers at least the previous 12 months, before initially prescribing such a drug.
- At least every 90 days thereafter if the drug is prescribed for more than 90 days.
Moreover, if the prescriber “practices primarily in a county of this state that adjoins another state,” the prescriber must 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” if such a drug database is available.
The requirements above do not apply if:
- A drug database report regarding the patient is not available, in which case the prescriber shall document in the patient's record the reason that the report is not available.
- The drug is prescribed for a period not to exceed seven days.
- The drug is prescribed for the treatment of cancer or another condition associated with cancer (and the prescriber is a physician, APN or PA).
- The drug is prescribed to a hospice patient in a hospice care program or any other patient diagnosed as terminally ill (and the prescriber is a physician, APN or PA).
- The drug is prescribed for administration in a hospital, nursing home or residential care facility (and the prescriber is a physician, APN or PA).
- The drug is prescribed or personally furnished to treat acute pain resulting from a surgical or other invasive procedure or a delivery and the prescriber is a physician.
In addition, an amendment to O.R.C. 4723.486 provides that, beginning Jan. 1, 2015, a clinical nurse specialist, certified nurse-midwife or certified nurse practitioner seeking to renew a certificate to prescribe opioid analgesics or benzodiazepines must certify to the nursing board that the prescriber has been granted access to OARRS.
Prescribers should familiarize themselves with the new requirements for prescribing opioids established by HB 341 and HB 314, as the bills authorize regulatory boards to impose sanctions on prescribers who fail to comply.