Beginning on September 17, 2014, most Ohio prescribers will be required to obtain informed consent in order to prescribe any drug containing opioids to minors. All prescribers and entities employing subscribers should be aware of the informed consent requirements and exceptions.
When the informed consent requirement applies, prescribers must complete the following three tasks:
- Assess the minor's mental health and substance abuse history;
- Discuss with the minor and the minor's parent or guardian certain risks and dangers associated with taking controlled substances containing opioids; and
- Obtain the signature of the parent or guardian on a consent form.
The law requires prescribers to use the “Start Talking!” consent form, which draws its name from the governor’s initiative to reduce drug abuse in the state of Ohio. The form may not be combined with any other document and must contain certain elements set forth in the law. The Ohio State Medical Board has developed a form that meets these requirements, and is available on the Medical Board's website.
The law includes a number of significant exceptions. The informed consent requirement does not apply:
- When the treatment is associated with or incident to a medical emergency;
- When the treatment is associated with or incident to surgery, whether inpatient or outpatient;
- When, in the prescriber’s professional judgment, obtaining the consent would be a detriment to the minor’s health/safety;
- When the treatment is rendered in a hospital or ambulatory surgical facility, nursing home, pediatric respite care program, residential care facility, freestanding rehabilitation facility or similar institutional facility (however, see next paragraph); or
- When a prescription is issued at the time of discharge from any of the facilities listed above.
While the law contains an exception for treatment rendered in certain institutional facilities, the exception does not apply to treatment rendered in a prescriber’s office that is located on the premises of or adjacent to an institutional facility. This means, for example, that informed consent must be obtained before opioids are prescribed in a physician's office located on hospital premises or adjacent to a hospital (unless one of the other exceptions would apply).
Finally, the statute limits the quantity of a controlled substance containing an opioid that a prescriber may prescribe to a minor when another adult authorized by the minor's parent or guardian gives the required consent to not more than a 72-hour supply . This limitation does not apply if the parent or guardian consents.
Prescribers must be in compliance with the new law beginning on September 17, 2014. The law authorizes regulatory boards, such as the Medical Board, to impose sanctions on prescribers who fail to comply with the law’s informed consent requirement.