Ohio Law Governing Drugs and Prescriptive Therapy

This course discusses the standards and conditions concerning the authority of advanced practice registered nurses (APRNs) who are designated to prescribe drugs and therapeutic devices according to Ohio Laws and Administrative Rules. Definitions associated with this course include the following (Ohio Administrative Code [OAC] 4723-9-01, 2021):

Controlled substance: A substance, mixture, preparation, or compound included as a Schedule I-V.

Physician: Someone who holds a valid and current license issued by the Ohio State Medical Board to practice medicine and surgery or someone who holds a valid and current license to be able to prescribe drugs and therapeutic devices from a different jurisdiction.

Jurisdiction: States, territories, and political subdivisions within the United States where a legal authority, such as a board, regulates nursing practice and licensure while maintaining membership with the National Council of State Boards of Nursing (NCSBN).

Collaboration: A standard care arrangement between a physician and APRN where a physician is continuously available for communication in person or electronically.

APRNs include certified registered nurse anesthetists (CRNA), clinical nurse specialists (CNS), certified nurse-midwives (CNM), 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 (Ohio Revised Code [ORC] 4723.481, 2023):

• 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.

These limits do not apply if the CNS, CNM, or CNP prescribes to a patient in the following (ORC 4723.481, 2023):

• 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 that is 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 a medical practice is operated and the practice has physician ownership and provides direct patient care
• A residential care facility 

The exclusion is that a CNS, CNM, or CNP cannot prescribe Schedule II controlled substances from a convenience care clinic regardless of the owners (ORC 4723.481, 2023). A CNS, CNM, or CNP cannot delegate the administration of controlled substances 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).

An APRN, designated as a CNS, CNM, or CNP, may provide a drug/therapeutic device to a patient, whether a sample or a partial or complete supply if (OAC 4723-9-08, 2021):

• The drug/therapeutic device is not excluded in the formulary outlined in rule 4723-9-10
• If the drug is a controlled substance, the requirements of 4729.291 are met
• If the drug is a dangerous drug, other than a sample drug, the nurse affixes labeling to the container as specified in rule 4729:5-19-02
• The nurse complies with 4723-9-12 regarding procedures/standards for review of Ohio Automated RX Reporting System (OARRS) reports
• The nurse maintains a written record of drugs/therapeutic devices the nurse supplied as required by rule 4729:5-19-04
• The nurse maintains current knowledge of and complies with state/federal laws and rules for supplying drugs/therapeutic devices

An APRN, designated as a CNS, CNM, or CNP, may supply a patient with a sample drug only if, in addition to the requirements outlined in the paragraph above, the following requirements are met (OAC 4723-9-08, 2021):

• The sample drug complies with section 3719.81 of the Revised Code, including the requirement that the sample be supplied free of charge.
• The requirements of rule 4729:5-19-02 of the Administrative Code are met if the sample is a dangerous drug.

Also, an APRN, designated as a CNS, CNM, or CNP, may supply naloxone, according to 4723.488 of the Revised Code, and may provide a partial or complete drug supply to treat gonorrhea, chlamydia, or trichomoniasis as specified in 4723.4810 of the Revised Code (OAC 4723-9-08, 2021).

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 as 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 (OAC 4723-9-10, 2022):

• Has a history of overdose
• Is also taking benzodiazepine, sedative hypnotic drug, carisoprodol, tramadol, or gabapentin
• Has a concurrent substance use disorder
• The dosage exceeds 80 MED 

For example, John is a 54-year-old patient who is being prescribed morphine after a long fall off a ladder that resulted in a compound fracture of the arm. Because of a history of back pain from a serious motor vehicle accident a few years previously, John also has a prescription for tramadol that he uses. With the potential for the use of both of these medications concurrently, John should be offered a prescription for naloxone.

Providers should consider offering a prescription for naloxone if the dosage exceeds 50 MED.

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, 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 here.

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 following (ORC 3719.061, 2023):

• 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 (DEA) 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 

Before issuing a prescription of opioids to a minor, the prescriber will assess the history or current mental health problem, substance abuse disorder, or if the patient is under treatment for these conditions. Discussions with the minor and the consenting adult must include (ORC 3719.061, 2023):

• 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
• Education on the patient counseling information on the labeling 

These restrictions do not apply when an opioid analgesic meets any of the following (ORC 3719.061, 2023):

• 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.

When prescribing a controlled substance that is a Schedule II, III, IV, and V, an APRN shall consider the following (OAC 4723-9-12, 2021):

• Potential for abuse
• The possibility that the drug may lead to dependence
• The possibility the patient will obtain the drug for nontherapeutic use or distribute it to other persons
• The potential existence of an illicit market for the drug 

When considering these possibilities, the APRN should use sound clinical judgment and consider 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 (OAC 4723-9-12, 2021):

• 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 substance 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 

A 12-month OARRS report must be reviewed 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. An OARRS report is not required if the patient is (OAC 4723-9-12, 2021):

• In hospice
• Terminal
• In a hospital, nursing home, or residential care facility
• If the drug is 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 

Review an OARRS report after treatment for more than ninety days if the treatment includes prescribing reported drugs that are not opioid analgesics or benzodiazepines. Review an OARRS report annually as long as the reported drug is being prescribed. If an OARRS report indicates red flags, consult with a physician before prescribing the drug (OAC 4723-9-12, 2021).

The APRN's delegate may request OARRS reports. However, they have to be personally reviewed by the APRN. Assessment of the OARRS report, including consulting with the collaborating physician, should be documented in the patient record. Requested reports should cover at least the twelve months prior to the date of the request. If the APRN practices in an Ohioan county adjoining another state, the APRN or the delegate should request a report of any information available in the drug database pertaining to prescriptions issued to the patient in the state that adjoins the Ohioan county. If an OARRS report is unavailable, the APRN should document the reason the report is unavailable in the patient's record (OAC 4723-9-12, 2021).

If the APRN who prescribed/provided a drug to a patient determines that the patient may be diverting or abusing the drugs, the APRN should consult with a physician before prescribing more drugs at the next patient visit. Consultation with the physician should include a review of the patient's progression toward the objectives of treatment, reviewing the patient's functional status, and a review of the reasons why the APRN is concerned the patient is diverting or abusing the drugs. The consultation with the physician may result in a patient treatment program that includes more office visits and drug screens, an outline of the consequences of non-compliance, and the possibility of utilizing different treatment options. Another option is a referral to a substance abuse specialist (OAC 4723-9-12, 2021).

For example, Matthew, an APRN, suspects that Lisa, a patient he prescribes an opioid to, is abusing the drug. Matthew consults with his collaborating physician the evening before Lisa's appointment. Matthew details the red flags he believes indicate that Lisa is abusing the drug. After the consultation with the physician, it was decided that Matthew would update the treatment agreement and inform Lisa that there would be more frequent office visits and urine drug screens.

The Governor's Cabinet Opiate Action Team (GCOAT) made recommendations for the Management of Acute Pain Outside of Emergency Departments. While these recommendations were made in 2016, a more recent version has not been published.

Treatment options are recommended based on 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 (GCOAT, 2016).

• Visceral Pain
  • Acetaminophen
  • NSAIDs
  • Corticosteroids

Alternatives include the following: dicyclomine, skeletal muscle relaxants, serotonin-norepinephrine reuptake inhibitors, topical anesthetics, and tricyclic antidepressants (GCOAT, 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 (GCOAT, 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 (GCOAT, 2016).

Executive Order 2019-01D, signed by the governor on January 14, 2019, created the RecoveryOhio Initiative. This cabinet-level organization provides guidance on addiction support and mental health resources in Ohio, coordinates recovery-focused initiatives, serves as an information hub on addiction and mental health, and engages service providers in supplying information and education.

The RecoveryOhio Initiative has a 2024-2027 strategic plan that involves three phases: engage and discover, analysis, and implementation planning.

In the engage and discover phase, meetings were held with community stakeholders to identify opportunities and insights. From these meetings, guiding principles were established and included (RecoveryOhio, 2024):

• A human-centered approach.
• Creating diverse partnerships.
• Establishing a vision, mission, responsibilities, roles, structure and reporting standards.
• Embracing objectivity.
• Measuring performance with clear goals and metrics.
• Being culturally relevant.
• Standardizing processes and measures.
• Developing communication strategies.
• Accommodating unique and diverse needs.
• Being mindful of indicators of potential adverse events.

Phase two involved analysis of the insights, opportunities, and principles identified in the engage and discovery phase. From the analysis, phase three, or implementation planning was outlined.

The deliverable of this phase involves a three-year road map that outlines seven initiatives to be created and improved upon between 2024 and 2027. These seven initiatives include the following (RecoveryOhio, 2024):

• Establishing an Advisory Council governance model
• Create/promote a continuum of care information portal
• Developing predictive analytics with a toxicology data dashboard
• Developing a statewide data reporting dashboard
• Establishing collection standards for field data
• Creating/providing access to prevention education and resources
• Delivering prevention programming for youth/families

Each initiative has a problem statement, an outcome, and a scope, with the overall goal of removing barriers and enhancing care (RecoveryOhio, 2024).

The Food and Drug Administration (FDA) is responsible for assuring the safety of the drug supply in the United States. It requires pharmacies 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 (Centers for Disease Control and Prevention [CDC], 2022).

The 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, DEA, 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 that were updated in 2022. They are similar to Ohio law. Those recommendations are available in the CDC Guideline for Prescribing Opioids for Chronic Pain.

NSAIDs have risks, and some patients cannot tolerate NSAIDs due to side effects and pre-existing co-morbid conditions. Therefore, it is necessary for some patients to utilize non-pharmacologic options.Examples of non-pharmacological therapy are:

• Ice, heat, positioning, tone and strengthening, movement restriction, bracing, wrapping, splints, stretching, and directed exercise are available through physical therapy. Examples of exercise may include aquatic, aerobic, and resistance training. Occupational therapy may also be helpful.
• Relaxation therapy, massage therapy, yoga, meditation, tactile stimulation, acupuncture/acupressure, chiropractic adjustment, manipulation, transcutaneous electrical nerve stimulation (TENS), and osteopathic neuromuscular care.
• Biofeedback, cognitive behavioral therapy, counseling, talk therapy, and hypnotherapy, including imagery and distraction.
• Music and art therapy.

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

For example, Sarah, a 47-year-old patient, sprained her ankle while working in her yard. She prefers not to take NSAIDS because of the gastrointestinal side effects, such as nausea and vomiting, that she experiences. In talking with her provider, it was decided the best form of treatment for her sprained ankle includes physical therapy and TENS.

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 dosages 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 (Mcdonald et al., 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 (Mcdonald et al., 2017).

The use of controlled substances has 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 essential 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.

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