≥92% of participants will know how to apply best practices and Ohio law in prescribing controlled substances.
CEUFast, Inc. is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center's Commission on Accreditation. ANCC Provider number #P0274.
≥92% of participants will know how to apply best practices and Ohio law in prescribing controlled substances.
After completing this course, the participant will be able to:
Advanced Practice Registered Nurses (APRNs) include certified registered nurse anesthetist (CRNA), clinical nurse specialist (CNS), certified nurse-midwife (CNM), and certified nurse practitioner (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:
These limits do not apply if the CNS, CNM, or CNP prescribes to a patient in:
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 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:
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:
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:
These restrictions do not apply when an opioid analgesic meets any of the following:
A CNS, CNM, or CNP can personally furnish or prescribe overdose reversal drugs or naloxone without examining the patient if:
A CNS, CNM, or CNP can authorize others to furnish overdose reversal drugs or naloxone if there is an established protocol and if:
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:
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
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:
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 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 by the quality of pain as follows:
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).
Alternatives include the following: dicyclomine, skeletal muscle relaxants, serotonin-norepinephrine reuptake inhibitors, topical anesthetics, and tricyclic antidepressants (Governor's Cabinet Opiate Action Team, 2016).
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 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, Diversion Control Division maintains the current list at 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 :
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.
Opioid drugs are associated with multiple side effects, including constipation, nausea, vomiting, pruritus, abdominal cramping, sedation, and mental status changes. Multiple interventions are available to reduce side effects.
Constipation is a frequent issue in those who use opioids. Risk factors for constipation include those with intra-abdominal pathology and those who eat a low-fiber diet. Those on opiates should be encouraged to increase fiber intake, drink plenty of fluids, and be encouraged to exercise. Stool softeners (e.g., docusate sodium) and stimulants (e.g., bisacodyl) may be needed to manage constipation. An osmotic laxative such as polyethylene glycol or lactulose may also be considered, which may be added to stool softeners/stimulants for resistant constipation. An antiemetic drug can help treat nausea. Antihistamines can treat pruritus.
Opioids are associated with somnolence and other mental status changes. Patients do develop tolerance to these symptoms over weeks. Reducing the dose may lessen the mental status changes. An adjunctive drug may be added to allow a lower dose of opioids to manage the pain. Rarely the use of a stimulant can be used to manage sedation due to opioid use.
Respiratory depression may occur, but it is uncommon if used carefully. Starting low and slowly titrating the dose will reduce the risk of respiratory depression. Problems arise with rapid titration, the addition of another drug that may suppress the respiratory drive (benzodiazepine, alcohol, or a barbiturate), or the patient overdoses. Sedation precedes respiratory depression, so when starting a patient on opioid therapy, encourage them to take the first dose in the office to be monitored or in the presence of a responsible adult who can help monitor the patient.
Morphine can be given orally, rectally, intravenously, subcutaneously, or intramuscularly. It comes in tablet, suppository, and parenteral solution. Morphine also comes in a controlled release form, a sustained-release form, and an extended-release form. Morphine should not be used in those with a hypersensitivity to morphine, those with toxin-mediated diarrheal disease, and those with severe/acute asthma, paralytic ileus, or severe respiratory depression. The extended-release form should not be used in those with GI obstruction. The extended-release forms of morphine are not interchangeable. Changing from one drug to another should be done only by those with experience.
Fentanyl can be given as an injection, transdermal patch (Duragesic®), an oral transmucosal lozenge (Actiq®), a sublingual tablet (Abstral®), a sublingual spray (Subsys®), a buccal tablet (Fentora®), a buccal film (Onsolis®) and a nasal spray (Lazanda®). The transdermal patch is used in opioid-tolerant patients with moderate to severe pain and is changed every 72 hours. Fentanyl transmucosal and intranasal is indicated for cancer pain. The transdermal patch is for around-the-clock pain management in those with severe chronic pain.
Contraindications include hypersensitivity, toxin-mediated diarrheal disease, and paralytic ileus. It should not be used for short-term pain or post-operative pain and should not be used for those who have severe respiratory disease. The transmucosal and nasal forms of fentanyl are typically only used by specialists for opioid-tolerant cancer patients.
The patch form should not be exposed to external heat, as this may increase the absorption of the drug. Also, patients with a fever may notice an increase in the absorption of the drug. The patch should only be applied to intact skin, contains aluminum and must be removed before an MRI. Caution should be taken to remove a previous patch before applying a new patch to avoid overdose. Cutting patches can sometimes be done, depending on patch type, but may adversely affect their adhesiveness. In the case of reservoir patches, such as fentanyl, it can potentially lead to harmful immediate drug release.
Oxycodone is a schedule II-controlled substance available in controlled and Immediate release tablets. It also comes as an oral concentrate and oral solution. Oxycodone is often combined with NSAIDs. Oxycodone is contraindicated in those with paralytic ileus, significant respiratory depression, hypercarbia, acute or severe bronchial asthma, and GI obstruction. Caution should be used in those with biliary tract impairment, such as acute pancreatitis, as it may lead to constriction of the sphincter of Oddi. It may lead to an elevation of intracranial pressure (ICP) and should be used carefully for those with intracranial lesions, elevated ICP, or a head injury.
Hydrocodone is a Schedule II Controlled Substance. It is available as a combination pill with a non-narcotic analgesic and by itself in an extended-release form. The combination pill has a short-acting version of hydrocodone. Contraindications to hydrocodone include paralytic ileus, severe asthma, severe respiratory depression, and hypercarbia.
Tramadol is a schedule IV substance. It is indicated for those who do not need a rapid onset of pain relief. When prescribing tramadol to older adults, use the lower end of the dosage range and titrate slowly. Those over 75 years old utilize extreme caution with the extended-release form. Patients may experience withdrawal symptoms from tramadol, including nausea, diarrhea, anxiety, pain, sweating, tremor, and rigors. Decrease the dosage slowly to reduce the risk of withdrawal symptoms. Tramadol has been shown to increase the risk of seizures. This risk is increased in those who take serotonin reuptake inhibitors, tricyclic antidepressants, neuroleptics, other opioids, or drugs that lower the seizure threshold. The risk may also be increased in those with seizures or who are at risk for seizures, such as those with a CNS infection, cancer, history of head trauma, or while patients are going through drug or alcohol withdrawal.
Oxymorphone is a schedule II substance. It can be given intravenously, subcutaneously, intramuscularly, or orally. Hydromorphone can be given orally, rectally, subcutaneously, intramuscularly, or intravenously. The oral drug comes in standard and extended-release forms. Parental and oral doses are not equivalent. The parenteral dose is five times more potent than the oral dose. The long-acting form (Exalgo) is used for opioid-tolerant patients with chronic severe pain.
Methadone can be given intravenously, subcutaneously, intramuscularly, or orally. Methadone is at a high risk of overdose. It has a half-life of up to five days and may accumulate in the body. Methadone may also prolong the QT interval leading to cardiac arrhythmias, especially at doses higher than 120 mg daily. Methadone should be used for severe pain that has not been responsive to other agents and only by clinicians with specific training in using methadone. Methadone is also used in detoxification.
Tapentadol (Nucynta®, Nucynta® ER) is available in immediate-release and extended-release. It is indicated for diabetic peripheral neuropathy. Propoxyphene has been taken off the US market as it has been linked with fatal cardiac arrhythmias. Meperidine (Demerol) is not recommended as a first-line agent for chronic pain as it is associated with high central nervous system toxicity rates.
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:
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:
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.
CEUFast, Inc. is committed to furthering diversity, equity, and inclusion (DEI). While reflecting on this course content, CEUFast, Inc. would like you to consider your individual perspective and question your own biases. Remember, implicit bias is a form of bias that impacts our practice as healthcare professionals. Implicit bias occurs when we have automatic prejudices, judgments, and/or a general attitude towards a person or a group of people based on associated stereotypes we have formed over time. These automatic thoughts occur without our conscious knowledge and without our intentional desire to discriminate. The concern with implicit bias is that this can impact our actions and decisions with our workplace leadership, colleagues, and even our patients. While it is our universal goal to treat everyone equally, our implicit biases can influence our interactions, assessments, communication, prioritization, and decision-making concerning patients, which can ultimately adversely impact health outcomes. It is important to keep this in mind in order to intentionally work to self-identify our own risk areas where our implicit biases might influence our behaviors. Together, we can cease perpetuating stereotypes and remind each other to remain mindful to help avoid reacting according to biases that are contrary to our conscious beliefs and values.