In its ongoing efforts to combat drug abuse and save lives, the Governor’s Cabinet Opiate Action Team (GCOAT), established in 2011, developed new prescribing guidelines for the outpatient management of acute pain.
The acute guidelines follow previous prescribing guidelines for emergency departments and the management of chronic pain. All three guidelines were developed in conjunction with clinical professional associations, healthcare providers, state licensing boards, and state agencies.
The prescribing guidelines are designed to prevent “doctor shopping” for prescription opioids, to urge prescribers to first consider non-opioid therapies and pain medications, to reduce leftover opioids that can be diverted for abuse, and to encourage prescribers to check Ohio’s Automated Rx Reporting System (OARRS) before prescribing opioids to see what other controlled medications a patient might already be taking.
These prescribing guidelines are intended to supplement, not replace, clinical judgment.
Emergency Department/Acute Care Facility Opioid Prescribing Guidelines
In April 2012, the GCOAT released Emergency and Acute Care Facility Opioid and Other Controlled Substances Prescribing Guidelines to reduce “doctor shopping” for prescription pain medications that could be abused or sold illegally, to encourage emergency department clinicians to check OARRS to see a patient’s other prescriptions for controlled medications, to urge prescribers to limit the quantity of opioids prescribed, and to refer patients to a primary care provider or specialist for evaluation, treatment and monitoring of continuing pain.
Opioid Prescribing Guidelines for Treatment of Chronic Pain
In October 2013, the GCOAT released Opioid Prescribing Guidelines for Treatment of Chronic, Non-Terminal Pain to ensure the safety of patients on high daily doses of opioids for chronic pain lasting longer than 12 weeks, and to urge prescribers to check OARRS to see a patient’s other prescriptions for controlled medications.
Chronic pain is defined as pain that has persisted after reasonable medical efforts have been made to relieve the pain or cure its cause and that has continued, either continuously or episodically, for longer that three continuous months.
- Patient Education Letter for Chronic Pain Management
- Patient Handout: What is Prescription Drug Abuse and How Do You store and Dispose of Unused Medications?
Parental Informed Consent Form for Prescribing Opioids to Minors
Under provisions of House Bill 314 signed into law by Governor John Kasich on June 17, 2014, all prescribers must obtain written informed consent from a minor’s parent, guardian, or other person responsible for the minor before issuing a controlled substance prescription to the minor. The law, sponsored by Representative Nan Baker (R – Westlake, OH), also establishes penalties for a prescriber’s failure to comply with this requirement.
Since September 17, 2014, a signed consent form, known as the “Start Talking!” consent form, is required to be completed and maintained in the medical record of a minor for which opioids are prescribed.
- The minor’s treatment is associated with or incident to a medical emergency.
- The minor’s treatment is associated with or incident to surgery, regardless of whether the surgery is performed on an inpatient or outpatient basis.
- In the prescriber’s professional judgment, fulfilling the bill’s informed consent requirement would be a detriment to the minor’s health or safety.
- The minor’s treatment is rendered in 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, when the treatment is rendered in a prescriber’s office that is located on the premises of or adjacent to any of the foregoing facilities or locations.
- The prescription is for a compound that is a controlled substance containing an opioid that the prescriber issues to a minor at the time of discharge from a facility or other location described in No. 4 above.
Opioid Prescribing Guidelines for Treatment of Acute Pain
In January 2016, GCOAT released Guidelines for the Management of Acute Pain Outside of Emergency Departments to encourage non-opioid therapies and pain medications – when appropriate – for the management of acute pain expected to resolve within 12 weeks, to urge prescribers to check OARRS to see a patient’s other prescriptions for controlled medications, to encourage clinicians to prescribe the minimum quantity of opioid pills needed, to discourage automatic refills of opioid prescriptions, to help reduce the number of leftover opioids that could be diverted or abused, and to recommend the reevaluation of patients prescribed opioids at certain checkpoints.
90-Day Opiate Supply Prescriptions
Effective April 1, 2017, there are new limits on the amount of opiate pills that can be dispensed from a single prescription to a 90-day supply. In addition, opiate prescriptions that are unused after 30 days are invalid. This change was brought about with passage of Senate Bill 319, the mid-biennium review legislation regarding opiates that was passed during the 131st General Assembly and signed into law by Gov. Kasich on January 4, 2017.
- The prescription is one of multiple prescriptions for the drug issued by a single prescriber to the patient on a single day.
- When combined, the prescriptions do not authorize the patient to receive an amount that exceeds a 90-day supply of the drug, as determined according to the prescriptions’ directions for use of the drug.
- The prescriber has provided written instructions on the prescription indicating the earliest date on which the prescription may be filled.
- Not more than 14 days have elapsed since the earliest date on which the prescription may be filled.
Acute Pain Rules
- No more than seven days of opioids can be prescribed adults.
- No more than five days of opioids can be prescribed in the initial prescription for minors, and only after the written consent of the parent or guardian is obtained.
- Physicians and other licensed health care prescribers may prescribe opioids in excess of the day supply limits only if they provide a specific reason in the patient’s medical record.
- Except as provided for in the rules, the total morphine equivalent dose (MED) of a prescription for acute pain cannot exceed an average of 30 MED per day.
- These limits do not apply to opioids prescribed for cancer, palliative care, end-of-life/hospice care, or medication-assisted treatment for addiction.
- The rules apply to the first opioid analgesic prescription for the treatment of an episode of acute pain.
- The rules do not apply to inpatient prescriptions as defined in rule 4729-17-01 of the Ohio Administrative Code.
Acute pain is defined in the rule as pain that normally fades with healing, is related to tissue damage, significantly alters a patient’s typical function and is expected to be time limited.
- Rule 4729-5-30 requires prescribers to include the first four characters (ex. M16.5) of the diagnosis code (ICD-10) or the full procedure code (Current Dental Terminology – CDT) on opioid prescriptions, which will be entered by the pharmacy into OARRS. Note, this requirement took effect for all other controlled substance prescriptions on June 1, 2018.
- Rule 4729-5-30 requires prescribers to indicate the days’ supply on all controlled substance and gabapentin prescriptions.
To assist prescribers in calculating a patient’s MED, the State of Ohio Board of Pharmacy (SOBP) has developed a conversion chart.
For additional information, please review your licensing board’s respective rules and the SOBP’s manner of issuance rule:
- 4731-11-01 – Definitions (related to controlled substances)
- 4731-11-02 – General provisions (related to controlled substances)
- 4731-11-13 – Prescribing of opioid analgesics for acute pain.
- 4729-5-30 – Manner of issuance of a prescription. (NOTE: This rule went into effect on December 29, 2017.
Regulations for Chronic and Subacute Opioid Prescriptions
Establishing safety checkpoints on prescription opioids for long-term pain will help ensure that treatment is improving patients’ quality of life without increasing the risk of opioid misuse and addiction.
Since December 23, 2018, Ohio prescribers have been following new regulations when prescribing opioids for the treatment of long-term pain (lasting 12 weeks or more) and subacute pain (lasting between six and 12 weeks). The specific requirements can be found in Ohio Administrative Code 4731-11.
Below is an overview of the regulations. These regulations are not meant to take away medication for those in need, but instead strengthen communication between physicians and patients by establishing check points for additional assessment.
Physicians are required to engage in conversations with patients before starting on a long-term medication treatment to ensure opioids are improving function and the patient is offered non-opioid treatments when appropriate:
- Prior to treating or continuing to treat subacute or chronic pain with an opioid, the physician needs to first consider and document non-medication and non-opioid treatment.
- If opioid medication is appropriate, the physician should prescribe it for the least amount of days and strength to adequately address the pain.
- Prescribers should complete and document in the patient’s record: history and appropriate physical exam, diagnostic tests if substance misuse disorder is suspected or known, check on the patient’s history in OARRS, functional pain assessment and a treatment plan.
According to the Centers for Disease Control and Prevention, a dose of 50 MED or more per day doubles the risk of opioid overdose death. At 90 MED or more, the risk of overdose increases ten times. The new rules establish the following check points to ensure appropriate prescribing:
- 50 MED: prescribers are required to re-evaluate the status of the patient’s underlying condition causing pain, assess functioning, look for signs of prescription misuse, consider consultation with a specialist, and obtain written informed consent from the patient.
- 80 MED: prescribers need to look for signs of opioid prescription misuse, consult with a specialist, obtain a written pain-management agreement, and offer a prescription for naloxone, the lifesaving overdose antidote.
- 120 MED: in order for prescribers to prescribe a dosage that exceeds 120 MED (unless the patient was already on a dosage of 120 MED or more prior to December 23, 2018), there must be a recommendation from a board certified pain medicine physician or board certified hospice and palliative care physician that is based upon a face-to-face visit and examination. There does not need to be a recommendation if the prescribing physician is himself/herself board certified in pain medicine or hospice and palliative care.
The rules do not apply to patients receiving medication for terminal conditions or those within a hospital or in-patient setting where they are closely monitored. They also take into consideration patients who are already being treated for chronic pain by not establishing a maximum dose or duration of treatment. For patients that are already being treated with opioids for chronic pain, medical standards of care still apply, however, these patients will not be required to consult with a pain management specialist unless dosages increase.
Office-Based Treatment of Opioid Addiction Using Buprenorphine Products
To prescribe or dispense buprenorphine, physicians must notify the Substance Abuse and Mental Health Services Administration’s (SAMHSA) Center for Substance Abuse Treatment (CSAT), Division of Pharmacologic Therapies (DPT) of their intent to practice this form of medication-assisted treatment (MAT). The notification of intent (NOI) must be submitted to SAMHSA before the initial dispensing or prescribing of opioid use disorder (OUD) treatment medication. Physicians are also required to complete buprenorphine training.
View the State Medical Board’s FAQ on office-based opioid treatment and the SAMHSA’s website for more information.
Ohio Automated Rx Reporting System
OARRS data is used to assess the impact of the Ohio clinical guidelines. OARRS can help physicians improve patient care, reduce prescription abuse, and prescribe safely. Are you registered for OARRS? If you are not using OARRS, you need to start today!
State Medical Board of Ohio Resources
- Chronic and Subacute Pain
- FAQ on New Limits on Prescription Opioids for Acute Pain (November 17, 2017)
- FAQ on Office-Based Opioid Treatment (February 2015)
- Red Flag Signs of Prescription Drug Abuse (September 2015)
State of Ohio Board of Pharmacy Resource
Ohio Department of Mental Health and Addiction Services Resources
- Opioid Prescribing Guidelines
- Opioid Online Learning Series
- Patient Education Letter for Acute Pain Treatment (Word) (PDF)
- Progressive Opioid Prescribing Guidelines for a Safer Ohio Summary
American Academy of Family Physicians Resources
- Chronic Pain Management Toolkit
- Chronic Pain Management and Opioid Misuse: A Public Health Concern (Position Paper)
- Opioid Prescribing for Chronic Pain Clinical Practice Guideline
- Joint Principles: Addressing the Opioid Epidemic
- Help Save Lives: Co-Prescribe Naloxone to Patients at Risk for Overdose
- Safe Storage and Disposal of Opioids and all Medications
Centers for Disease Control and Prevention Resource
- What is Prescription Drug Abuse and How Do You store and Dispose of Unused Medications?
- Safe Storage and Disposal of Opioids and all Medications
- Opioid Settlement Announced (Weekly Family Medicine Update, February 9, 2021)
- CDC Drug Overdose Death Rates Accelerating Amid Pandemic (Weekly Family Medicine Update, January 12, 2021)