Ohio Law Governing Drugs and Prescriptive Therapy

Advanced Practice Registered Nurses (APRNs) include certified registered nurse anesthetists (CRNA), clinical nurse specialists (CNS), certified nurse-midwives (CNMs), and certified nurse practitioners (CNP). The required Ohio licensure is assumed when any APRN is mentioned in this course. The CNS, CNM, or CNP prescriptive authority must not prescribe drugs or devices that exceed the prescriptive authority of the collaborating providers or are in violation of Federal or Ohio law or rules (OAC 4723-9-10, 2022). They can prescribe schedule II controlled substances if:

• The patient has a terminal condition
• A physician initially prescribed the substance
• The prescription is for an amount not more than a seventy-two-hour period (ORC 4723.481, 2017)

These limits do not apply if the CNS, CNM, or CNP prescribes to a patient in:

• A hospital
• An entity owned or controlled, in whole or in part, by a hospital
• A healthcare facility operated by the Department of Mental Health and Addiction Services or the Department of Developmental Disabilities
• A nursing home licensed
• A county home or district home certified under the Medicare or Medicaid program
• A hospice care program
• A community mental health services provider
• An ambulatory surgical facility
• A freestanding birthing center
• A federally qualified health center
• A federally qualified health center look-alike, as defined in section 3701.047
• A health care office or facility operated by the board of health of a city or general health district or the authority having the duties of a board of health
• A site where medical practice is operated, if the practice has physician ownership, provides direct patient care
• A residential care facility (ORC 4723.481, 2017)

The exclusion is a CNS, CNM, or CNP cannot prescribe schedule II controlled substances from a convenience care clinic regardless of the owners (ORC 4723.481, 2017). A CNS, CNM, or CNP cannot delegate the administration of controlled substances or listed in the formulary to a person not otherwise authorized to administer medication (ORC 4723.489, 2017). ORC 4723.489 has a revision effective in 2024. That revision does not change any prescriptive regulations in this discussion (ORC 4723.481, 2024).

Acute pain fades with healing, is related to tissue damage, interferes with normal function, and is not expected to persist for more than six weeks. Sub-acute pain persists for more than six weeks but less than twelve weeks. Chronic pain persists after treatment and occurs periodically or continually. Terminal conditions are not considered chronic pain (OAC 4723-9-10, 2022).

Extended-release or long-acting opioids cannot be prescribed for acute pain. Non-opioid treatment options must be considered before prescribing an opioid. The prescription must be for a minimum quantity and potency needed for the expected pain duration. Three days or less is usually enough. Adults can have a seven-day supply with no refills, and minors can have a five-day supply with no refills. An explanation must be documented if the prescription is extended (OAC 4723-9-10, 2022).

The total morphine equivalent dose (MED) for treating acute pain cannot be more than an average of 30 MED per day, except when done with consultation with a provider before prescribing. The rationale has to be documented (OAC 4723-9-10, 2022).

For subacute or chronic pain, non-opioid treatment must be considered and documented if not chosen. The prescription must be for a minimum quantity and potency needed for the expected pain duration. Before prescribing, the APRN must complete an OARRS check. A prescription for naloxone should be offered if the patient:

• Has a history of overdose
• Is also taking benzodiazepine, sedative hypnotic drug, carisprodal, tramadol, or gabapentin
• Has a concurrent substance use disorder
• The dosage exceeds 80 MED (OAC 4723-9-10, 2022)

Consider offering a prescription for naloxone if the dosage exceeds 50 MED. The MED equivalences are available at CDC Opioid prescribing guidelines.

When treating a patient with opioid analgesics above the dose average of 50 MED daily, periodically follow up and document the patient's functionality, progress toward treatment objectives, adverse drug reactions, and indicators of addiction, drug abuse, or diversion. Before increasing an opioid dose above an average of 50 MED, review and update the assessment. If the patient already exceeds an average of 50 MED, consider a consultation with a specialist, getting a medication therapy management review by a pharmacist, or consulting with an addiction specialist (OAC 4723-9-10, 2022).

Before increasing the opioid dosage above an average of 80 MED, a written pain management agreement must be agreed upon with the patient. The APRN cannot prescribe an opioid at the dose of an average of 120 MED or above. An exception is if the APRN is nationally certified in pain management, hospice, and palliative care, oncology, hematology, or coursework in hematology, leading to oncology certification. An exception is if the prescription is based on a written recommendation from a physician certified in hospice and palliative care, oncology, or hematology. The APRN must get a written recommendation before prescribing if the patient is already using this high dose (OAC 4723-9-10, 2022).

The sub-acute and chronic pain MED requirements do not apply when an opioid analgesic is prescribed to a hospice patient or patient with a terminal condition (OAC 4723-9-10, 2022). The Ohio Board of Nursing provides a Prescribing Process Flow chart at this link. The Ohio Board of Nursing provides other prescribing resources at nursing.ohio.gov.

An adult has to give written consent for the treatment of minors. A minor is anyone under 18 who is not emancipated. The consent should be recorded on a form known as the "Start Talking!" consent form. The form must contain:

• The name, quantity, and amount of the opioid analgesic being prescribed
• 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 medical treatment with the minor and the consenting adult
• The number of refills, if any, authorized
• The signature of the consenting adult (ORC 3719.061, 2020)

Before issuing a prescription of opioids to a minor, the prescriber will assess the history or current mental health problem, substance abuse disorder, or is under treatment for these conditions. Discussions with the minor and the consenting adult must include:

• The risks of addiction and overdose
• The increased risk of addiction of minors with both mental health and substance abuse disorders
• The dangers of taking opioid analgesics with benzodiazepines, alcohol, or other central nervous system depressants
• Information on the patient counseling information on the labeling (ORC 3719.061, 2020)

These restrictions do not apply when an opioid analgesic meets any of the following:

• The treatment is associated with or incident to a medical emergency
• The 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, waiting to meet requirements may
• be a detriment to the minor's health or safety
• The treatment is rendered in a hospital, emergency facility, ambulatory surgical facility, nursing home, pediatric respite care program, residential care facility, freestanding rehabilitation facility, or similar institutional facility
• The prescription is issued at the time of discharge from a facility, excluding a prescriber's office (ORC 3719.061, 2020)

A CNS, CNM, or CNP can personally furnish or prescribe overdose reversal drugs or naloxone without examining the patient if:

• The overdose reversal drug or naloxone is given to an individual who can assist a patient who may be at risk for opioid overdose
• The CNS, CNM, or CNP educates the person receiving the overdose reversal drug or naloxone  to call emergency services as soon as possible before or after giving the overdose reversal drug or naloxone  (ORC 4723.484, 2020)

A CNS, CNM, or CNP can authorize others to furnish overdose reversal drugs or naloxone  if there is an established protocol and if:

• The person believes a patient is experiencing or at risk of experiencing an opioid overdose
• Family, friends, or others who assist the patient believes the patient is experiencing or at risk for an opioid overdose
• Educates the person receiving the overdose reversal drug or naloxone  to call emergency services as soon as possible before or after giving the Overdose reversal drug or naloxone (ORC 4723.485, 2020)

The authorized person who can furnish overdose reversal drugs or naloxone must be trained and comply with an established protocol (ORC 4723.485, 2022). They can do so without examining the patient before administration (ORC 4723.485, 2020). The drug must be obtained from the entity where the person works, and they must call emergency services as soon as possible before or after giving the overdose reversal drug or naloxone (ORC 4723.486, 2020).

When overdose reversal drugs or naloxone are furnished or prescribed in good faith, the person is not liable for damages in any civil action, prosecution in any criminal proceeding, or professional disciplinary action (ORC 4723.485, 2020). An updated version of ORC 4723.485 is effective 9/23/22, but these discussions comply with that new version (ORC 4723.485, 2022).

When prescribing or personally furnishing a controlled substance schedules II, III, IV, and V, an APRN shall consider:

• Potential for abuse
• Possibility that the drug may lead to dependence
• Possibility the patient will obtain the drug for nontherapeutic use or distribute it to other persons
• Potential existence of an illicit market for the drug (OAC 4723-9-12, 2020)

When considering these possibilities, the APRN uses sound clinical judgment and considers obtaining and reviewing an OARRS report. The APRN must obtain and review an OARRS report when a patient shows any of the following red flags 

• Selling prescription drugs
• Forging or altering a prescription
• Stealing or borrowing reported drugs
• Increasing the dosage of reported drugs in amounts that exceed the prescribed amount
• Suffering an overdose, intentional or nonintentional
• Having a drug screen result that is inconsistent with the treatment plan or refusing to participate in a drug screen
• Having been arrested, convicted, or received diversion or intervention instead of conviction for a drug-related offense while under the APRN's care
• Receiving reported drugs from multiple prescribers without a clinical basis
• Traveling with a group of other patients to the APRN's office, where all or most of the patients' request controlled substances prescriptions
• Traveling an extended distance or from out of state to the APRN's office
• Having a family member, friend, law enforcement officer, or healthcare professional express concern related to the patient's use of illegal or reported drugs
• Known history of chemical abuse or dependency
• Appearing impaired or overly sedated during an office visit or examination
• Requesting reported drugs by a specific name, street name, color, or identifying marks
• Frequently requesting early refills of reported drugs
• Frequently losing prescriptions for reported drugs
• History of illegal drug use
• Sharing reported drugs with another person
• Recurring visits to non-coordinated sites of care, such as emergency departments, urgent care facilities, or walk-in clinics, to obtain reported drugs (OAC 4723-9-12, 2020)

A 12-month OARRS report must be reviewed when prescribing opioids and benzodiazepines before initially prescribing an opioid analgesic or benzodiazepine to a patient. An OARRS report is also needed when prescribing opioid analgesics to treat sub-acute and chronic pain. If the patient continues to receive opioid analgesics or benzodiazepines after the initial prescription, review an OARRS report at least every 90 days (OAC 4723-9-12, 2020). An OARRS report is not required if the patient is:

• In hospice
• Terminal
• In a hospital, nursing home, or residential care facility
• If not prescribed for more than seven days
• If prescribed for treatment of non-terminal cancer or another condition associated with non-terminal cancer, except if prescribed for sub-acute or chronic pain (OAC 4723-9-12, 2020)

Review an OARRS report after treatment for more than ninety days if the treatment includes prescribing or furnishing reported drugs that are not opioid analgesics or benzodiazepines. Review an OARRS report annually as long as the reported drug is being prescribed (OAC 4723-9-12, 2020). If an OARRS report indicates red flags, consult with a physician before prescribing or furnishing the drug (OAC 4723-9-12, 2020).

The Governor's Cabinet Opiate Action Team (GCOAT) made recommendations for managing Acute Pain Outside of Emergency Departments in 2016. A more recent version has not been published.

Treatment options are recommended by the quality of pain as follows:

• Somatic Pain
  • Acetaminophen
  • Non-steroidal anti-inflammatory drugs (NSAIDs)
  • Corticosteroids

Alternatives include the following: gabapentin/pregabalin, skeletal muscle relaxants, serotonin-norepinephrine reuptake inhibitors, selective serotonin reuptake inhibitors, and tricyclic antidepressants (Governor's Cabinet Opiate Action Team, 2016).

• Visceral Pain
  • Acetaminophen
  • Non-steroidal anti-inflammatory drugs (NSAIDs)
  • Corticosteroids

Alternatives include the following: dicyclomine, skeletal muscle relaxants, serotonin-norepinephrine reuptake inhibitors, topical anesthetics, and tricyclic antidepressants (Governor's Cabinet Opiate Action Team, 2016).

• Neuropathic Pain
  • Gabapentin/pregabalin
  • Serotonin and norepinephrine reuptake inhibitors
  • Tricyclic antidepressants

Alternatives include the following: other antiepileptics, baclofen, bupropion, low-concentration capsaicin, selective serotonin reuptake inhibitors, and topical lidocaine (Governor's Cabinet Opiate Action Team, 2016).

Short-term opioids may be first-line therapy in specific circumstances, like immediately post-operative. Opioids should usually be used as adjuncts to additional therapies rather than alone (Governor's Cabinet Opiate Action Team, 2016).

The Food and Drug Administration (FDA) is responsible for assuring the safety of the drug supply in the United States. They require the pharmacy to confirm that prescribers and organizations they work with are licensed and registered with the FDA. Under the FDA, the hospital must investigate and handle suspicious or known illegitimate prescriptions.

The Drug Enforcement Agency (DEA) regulates the distribution of controlled substances. The DEA is responsible for enforcing laws and regulations related to controlled substances. They also have the authority to bring about criminal or civil charges to individuals or organizations involved in the illicit traffic of controlled substances. The Controlled Substance Act requires a schedule of controlled substances. The list describes chemicals that may be classified as controlled substances. The Department of Justice, Drug Enforcement Administration, and Diversion Control Division maintain the current list of Controlled Substances Schedule.

The Environmental Protection Agency (EPA) helps ensure the proper disposal of pharmaceutical waste. This protection prevents pharmaceutical waste in the environment, such as in the ground and drinking water. The EPA has regulations that the pharmacy must follow. The CDC published guidelines in 2016. They are similar to Ohio law. Those recommendations are available at CDC Guideline for Prescribing Opioids for Chronic Pain.

Non-steroidal anti-inflammatory drugs (NSAIDs) have risks, and some patients cannot tolerate NSAIDs due to side effects and pre-existing co-morbid conditions. Examples of non-pharmacological therapy are :

• Ice, heat, positioning, bracing, wrapping, splints, stretching, and directed exercise are available through physical therapy
• Massage therapy, tactile stimulation, acupuncture/acupressure, chiropractic adjustment, manipulation, and osteopathic neuromuscular care
• Biofeedback and hypnotherapy

Non-opioid medications should be used with non-pharmacologic therapy. When initiating pharmacologic therapy, educate patients on the proper use of medication, the importance of maintaining other therapies, and expectations for the duration and degree of symptom improvement.

Opioids are indicated for acute pain resulting from severe injuries, medical conditions, surgical procedures, or when non-opioid options are ineffective or contraindicated. When opioids are used for chronic pain, treatment is typically started with a short-acting drug, and the drug is titrated upwards to control pain while side effects are monitored. After determining the dose of the drug required to provide adequate pain relief with minimal side effects, the drug can be converted to a sustained release form and administered once or twice a day. When a long-acting drug is used, a breakthrough drug can be given. Dosage and scheduling should be based on the most recent manufacturer's recommendations. Extended use may lead to dependence, and these drugs should be tapered. Caution should be taken with dosage for patients with renal or hepatic impairment. Opioids have the potential for abuse, addiction, and diversion. Driving, operating machinery, or performing other hazardous tasks while taking an opioid is unsafe.

All benzodiazepines are schedule IV controlled substances. Benzodiazepines are indicated for alcohol withdrawal, epileptic seizures, generalized anxiety disorder, insomnia, and panic disorder. They have the potential for abuse, addiction, and diversion. Driving, operating machinery, or performing other hazardous tasks while taking a benzodiazepine is unsafe. Alcohol may potentiate these effects. Patients who are co-prescribed benzodiazepines and opioids are at higher risk of overdose ( Ayers & Paquin, 2017). Dosage and scheduling should be based on the most recent manufacturers' recommendations.

Benzodiazepine should be prescribed for a short course of treatment, no more than two to four weeks. Expectations of clinical benefits must be clear. Do not escalate the dosage without a clear clinical benefit ( Ayers & Paquin, 2017). Side effects of benzodiazepines are:

• Drowsiness
• Sleepiness
• Dizziness
• Amnesia (forgetfulness)
• Confusion
• Constipation
• Nausea
• Sexual dysfunction
• Unsteadiness when walking or standing
• Unusually slow and shallow breathing
• Vision problems (blurred or double vision) ( Ayers & Paquin, 2017)

Stop the drug if side effects are not tolerable. Benzodiazepine should be tapered, not abruptly stopped. Withdrawal symptoms may occur with abrupt discontinuation. These symptoms may include convulsions, cramps, insomnia, sweating, tremors, and vomiting. Some people develop a paradoxical reaction to benzodiazepines. This reaction is the opposite of what would be expected, including:

• Become agitated
• Very anxious
• Develop hallucinations
• Have difficulty sleeping
• Exhibit bizarre behavior
• Taking unnecessary risks ( Ayers & Paquin, 2017)

The use of controlled substances is laced with risks for the prescriber and the patient. Abuse, misuse, drug diversion, and overdose are potential complications of opioid use.

Prescribers must be knowledgeable in pain assessment, knowledge of addiction, and the appropriate management of pain. Multiple techniques are important to implement to reduce the risks associated with opioid therapy, including informed consent, controlled substance agreements, screening for drug abuse, patient education, teaching patients about proper storage and disposal of drugs, and monitoring patients using controlled substance monitoring programs.

• Anekar, A. A., & Cascella, M. (2022). WHO Analgesic Ladder. In StatPearls. StatPearls Publishing. Visit Source.
• CDC. (2022, March 2). Addiction Medicine Primer. Centers for Disease Control and Prevention. Visit Source.
• Fuentes, A., Pineda, M., & Veenkata, K. (2018). Comprehension of Top 200 Prescribed Drugs in the US as a Resource for Pharmacy Teaching, Training, and Practice. Pharmacy, 6(2), 43.
• Governor's Cabinet Opiate Action Team. (2016). Ohio Guideline for the Management of Acute Pain Outside of Emergency Departments. Visit Source.
• OAC 4723-9-10 (2022). Formulary; standards of prescribing for advanced practice registered nurses designated as clinical nurse specialists, certified nurse-midwives, or certified nurse practitioners, 4723 Ohio Administrative Code (2022). Visit Source.
• OAC 4723-9-12 (2020). Standards and procedures for review of OARRS, 4723 Ohio Administrative Code § 4723-9-12 (2020). Visit Source.
• ORC 4723.50 (2021). Administrative rules for prescribing drugs and therapeutic devices, Chapter 4723 Nurse Practice Act Ohio Revised Code § 4723.50 (2021). Visit Source.
• ORC 4723.481 (2017). Authority of APRN designated as clinical nurse specialist, certified nurse-midwife, or certified nurse practitioner to prescribe drugs and therapeutic devices, Chapter 4723 Nurse Practice Act Ohio Revised Code § 4723.481 (2017). Visit Source.
• ORC 4723.481 (2024). Authority of APRN designated as clinical nurse specialist, certified nurse-midwife, or certified nurse practitioner to prescribe drugs and therapeutic devices, Chapter 4723 Nurse Practice Act Ohio Revised Code § 4723.481 (2024). Visit Source.
• ORC 4723.486 (2020). Authorizing others to administer naloxone, Chapter 4723 Nurse Practice Act Ohio Revised Code § 4723.486 (2020). Visit Source.
• ORC 4723.485 (2020). Authorizing others to furnish supplies of naloxone, Chapter 4723 Nurse Practice Act Ohio Revised Code § 4723.485 (2020). Visit Source.
• ORC 4723.485 (2022). Authorizing others to furnish supplies of naloxone, Chapter 4723 Nurse Practice Act Ohio Revised Code § 4723.485 (2022). Visit Source.
• ORC 4723.489 (2017).Delegated authority to administer drugs, 4723 Ohio Revised Code § 4723.489 (2017). Visit Source.
• ORC 4723.48 (2018). Delegation of authority to administer certain drugs, Chapter 4723 Nurse Practice Act Ohio Revised Code § 4723.48 (2018). Visit Source.
• ORC 4723.484 (2020). Naloxone prescribed or furnished without examination, Chapter 4723 Nurse Practice Act Ohio Revised Code § 4723.484 (2020). Visit Source.
• ORC 4723.484 (2020). Naloxone prescribed or furnished without examination, Chapter 4723 Nurse Practice Act Ohio Revised Code § 4723.484 (2022). Visit Source.
• ORC 3719.061 (2020). Prescription of opioids to minors, Chapter 3719 Controlled Substances Ohio Revised Code Title 37 Health-Safety-Morals § 3719.061 (2020). Visit Source.