Course
Tennessee Controlled Substance Prescribing
Course Highlights
- In this Tennessee Controlled Substance Prescribing course, we will learn about the federal categories of controlled substances.
- You’ll also learn the steps for obtaining APRN prescriptive authority in Tennessee.
- You’ll leave this course with a broader understanding of the State of Tennessee’s clinical practice guidelines for the management of chronic pain.
About
Pharmacology Contact Hours Awarded: 2
Course By:
Joanna Grayson
BSN, RN
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The following course content
Introduction
Advanced practice registered nurses (APRNs) can prescribe medications, including controlled substances, in states that allow prescriptive authority. APRNs have full practice authority in more than 30 states that allows them to administer, dispense, prescribe, and procure medications (2). However, in Tennessee, APRNs work under restricted practice authority, where physician involvement, medical supervision, and mutually approved formularies are required for APRNs who prescribe schedule II-V controlled substances (1, 3). The AMA tracks the number of APRNs with prescriptive authority in Tennessee, but it does not track the number of APRNs with DEA numbers (1).
According to Tennessee law, an APRN is a licensed registered nurse who has a master’s degree or higher in a nursing specialty and has national specialty certification as a nurse practitioner, nurse anesthetist, nurse midwife, or clinical nurse specialist. There are four recognized delineations for advanced practice nurses: Clinical Nurse Specialist (CNS), Nurse Anesthetist (CRNA), Nurse Midwife (CNM), and Nurse Practitioner (NP) (8).
These APRNs prescribe medications to specific populations in six specialized areas: individual and family across the lifespan, adult-gerontology, neonatal, pediatrics, women’s health/gender-related, and psychiatric-mental health (7). Controlled substances are prescribed to all these populations, including neonates who are born with neonatal opioid withdrawal syndrome (NOWS) and treated with morphine and methadone (5).
APRNs in Tennessee are challenged to distinguish between the legitimate prescription of controlled substances versus the prescription being used by patients for illegitimate purposes. Therefore, these nurses need to be able to recognize the signs, symptoms, and treatment of acute and chronic pain versus the signs and symptoms of patients who are seeking controlled substances, especially opioids, for non-legitimate reasons.
Patients with acute, end-of-life, neurologic, and cancer-related pain are often prescribed opioid analgesics as an accepted standard of care, but the increased cases of opioid use disorder that have led to the opioid crisis have made it difficult for prescribers to feel like they are issuing prescriptions appropriately. Patients have different cultural, emotional, psychological, and behavioral responses to pain, as well as varying tolerance levels, which make it difficult for prescribers to tell the difference between those patients who legitimately require the medication and those with substance use disorder (6).
Following are recent statistics regarding the prescription and abuse of opioids in Tennessee (9):
- 2022: Tennessee ranked number six in the United States for its per capita prescription dispensing rate of opioids.
- 2021: Approximately 4,000 Tennesseans died of a drug overdose. This was a 26% increase from 2020.
- 2020: Almost 900 babies were born with neonatal abstinence syndrome (NAS) in Tennessee.
Prescribing opioids for chronic conditions is extremely controversial and thus adds to the confusion surrounding whether the patient is seeking medication for legitimate non-use disorder purposes or because the patient is addicted to opioids (6). Almost 120 million U.S. adults suffer from chronic pain conditions, which is more than the number affected by heart disease, diabetes, and cancer combined (9).
Self Quiz
Ask yourself...
- In how many states do APRNs have full prescriptive authority?
- In which six populations do APRNs prescribe medications, including controlled substances?
- Which situations make it challenging for APRNs to prescribe opioids?
- What are the recent statistics regarding the prescription and abuse of opioids in Tennessee?
Controlled Substances and Prescriptive Authority
APRNs must be knowledgeable of the categories of controlled substances as mandated by the FDA.
Federal law categorizes controlled substances in this manner (2, 6):
- Schedule II: These are substances that have a high capacity for both use disorder and misuse, such as amphetamine, codeine, fentanyl, morphine, and hydrocodone. These drugs put the patient at high risk for both physical and psychological dependence. They are prescribed for acute pain, anxiety, insomnia, and attention deficit hyperactivity disorder (ADHD). These drugs have the tightest regulations when compared to other prescription drugs and refills of these medications are not allowed.
- Schedule III: This includes substances that have less abuse potential than Schedule I and II drugs. They can lead to physical dependence but are more commonly associated with psychological dependence. These medications are used for pain control, anesthesia, or appetite suppression, and may include compounds that contain limited Schedule II drugs, such as Tylenol with codeine. These drugs must not contain more than 90 milligrams of codeine per dosage unit and buprenorphine. Medications in this class include benzphetamine, ketamine, phendimetrazine, and anabolic steroids. Within a six-month timeframe, the patient can refill the drug only five times.
- Schedule IV: These drugs have a limited risk of physical or psychological dependence than Schedule I, II, and III drugs. Examples of these medications are alprazolam, carisoprodol, clorazepate, and tramadol. The patient may refill the drug five times within a six-month timeframe.
- Schedule V: These medications have the lowest abuse potential and contain limited amounts of narcotics and stimulants, such as analgesics. Other examples of these drugs are cough medicines with codeine, antidiarrheals that contain atropine/diphenoxylate, pregabalin, and ezogabine. When these drugs contain codeine, the codeine amount must be less than 200 mg per 100 mL.
Schedule I drugs are illicit “street” drugs that have no medical use and include heroin, lysergic acid diethylamide (LSD), mescaline, methylenedioxymethamphetamine (MDMA), and methaqualone (6).
Each state has laws regarding which type of healthcare providers can prescribe medications to patients. The American Association of Nurse Practitioners divides prescriptive authority into three categories (2, 3):
- Full practice: This means that APRNs can prescribe independently without physician oversight. They can also diagnose a patient, order diagnostic tests, and operate their independent practices.
- Reduced practice: This requires a collaborative practice agreement with a physician or limits on the prescribed medications. APRNs in reduced practice states typically work in a medical practice that is supervised by a physician rather than operating their independent practice where they can operate with relative autonomy. The APRN can diagnose patients and order diagnostic tests under physician supervision.
- Restricted practice: This delineation requires physician supervision or delegation when prescribing controlled substances. APRNs must work under the supervision of a physician for all their scope of practice, and they are not permitted to act as an independent practitioner.
Tennessee abides by restricted practice regulations where APRNs must work under a collaborative practice agreement with physicians to provide patient care (3).
Self Quiz
Ask yourself...
- What are the differences among Schedule I, II, III, IV, and V drugs?
- What are the refill stipulations surrounding Schedule III and IV drugs?
- What are the medical uses of Schedule I drugs?
- What are the differences among the three categories of prescriptive authority?
Collaborative Practice Agreements
Collaborative relationships between physicians and APRNs foster better communication and thus improve patient outcomes (2). APRNs are becoming more specialized and independent, which encourages states to permit them to practice and prescribe more autonomously. However, America has several states that do not permit full prescribing authority by APRNs, which necessitates reduced and restricted practice and restricted prescribing authority. This in turn causes several states, including Tennessee, to rely upon collaborative practice agreements, physician oversight, and additional restrictions (2).
Many APRNs in the state routinely advocate for these restrictions to be removed because they feel that these barriers impede patient access to care instead of protecting citizens (4). They also feel that the restrictions benefit physicians versus patients and APRNs because APRNs have to pay physicians monthly to maintain a collaborative practice agreement. These nurses also stipulate that states that have removed APRN practice barriers have witnessed an improvement in patient outcomes whereas states that maintain APRN practice restrictions do not experience higher-quality patient care.
APRNs in Tennessee cite unnecessary physician signature requirements, medication prescribing bureaucracy, and mandatory physician chart reviews as some of the practice barriers (4).
Self Quiz
Ask yourself...
- What are the advantages of collaborative practice agreements?
- Why are states encouraged to permit more autonomy to APRNs?
- Do APRNs in Tennessee have to adhere to a collaborative agreement?
- Why do APRNs in Tennessee feel that collaborative agreements benefit physicians more than other parties?
Obtaining Prescriptive Authority
Obtaining prescriptive authority by APRNs is influenced by state laws, licensing processes, and other requirements. The bureaucratic differences depend on whether the state allows APRNs full, reduced, or restricted practice authority (2).
To be issued and maintain a certificate of fitness as an advanced practice nurse with privileges to write and sign prescriptions and/or issue legend drugs in Tennessee, the APRN must (8):
- Hold a current, unencumbered license as a registered nurse
- Possess a master’s, post-master, doctoral, or post-doctoral level, including, but not limited to, at least three one-quarter hours of pharmacology instruction or its equivalent
- Have a current national certification in the appropriate nursing specialty area
- Graduate from a program conferring a master’s or doctoral degree in nursing
- Maintain their DEA Certificate to Prescribe Controlled Substances at their practice location to be inspected by the Board or its authorized representative
- File a notice with the Boarding of Nursing that contains the nurse’s full name, a copy of the formulary describing the categories of legend drugs to be prescribed and/or issued by the nurse, and the name of the licensed physician having supervision, control, and responsibility for prescriptive services rendered by the nurse. This information must be updated within 30 days of any changes by APRN.
- Complete a minimum of two contact hours of continuing education that specifically addresses controlled substance prescribing practices. The continuing education must include instruction in the Tennessee Department of Health’s treatment guidelines on opioids, benzodiazepines, barbiturates, and carisoprodol, as well as information about medication addiction and risk management tools.
The Tennessee Board of Nursing stipulates that any nurse who prescribes or issues drugs without proper certification is subject to disciplinary action by the Board (8).
APRNs must apply to the Drug Enforcement Agency (DEA), which includes Form 224, which is specific to mid-level practitioners. Additionally, APRNs must adhere to all state licensing requirements and provide proof of continuing education and training (2).
If an APRN takes a leave of absence or changes employer, they must provide evidence of a new position and a supervising agreement to obtain DEA renewal (2). Additionally, the address the APRN uses on the DEA application and license must be the nurse’s practice address. This prevents APRNs in restricted practice states from trying to obtain full prescribing rights by listing an address that is in a full rights state (2).
Self Quiz
Ask yourself...
- What steps are required to achieve a certificate of fitness as an advanced practice nurse with privileges to write and sign prescriptions and/or issue legend drugs in Tennessee?
- How many hours of pharmacology instruction are required for APRNs in Tennessee?
- How many contact hours of continuing education that specifically addresses controlled substance prescribing practices are required of APRNs in Tennessee?
- In which timeframe should the APRN notify the Board of Nursing of any changes to their prescriptive practices?
Treating Chronic Pain with Controlled Substances
Chronic pain is pain that lasts longer than 90 days, and the goal of treating patients with this type of pain is to improve the ability to function and quality of life (9). The State of Tennessee formulates clinical practice guidelines for the outpatient management of chronic non-malignant pain, which are summarized in this section.
Initial Evaluation
Before prescribing opioids, APRNs should ascertain the patient’s previous experience with these medications; if the patient is, or intends to become, pregnant; and the patient’s comprehensive medical history. Any examination findings and diagnostic test results should be documented in the patient’s medical record before initiating opioid therapy, including screenings for mental health disorders (9). Included in the mental health screening is the patient’s risk for misuse, abuse, diversion, and addiction of medications. The Controlled Substance Monitoring Database (CSMD) should be consulted to review the patient’s records of controlled substance prescriptions. A urine drug test (UDT), or test on oral fluids, should be obtained before starting therapy. The nurse must compare the CSMD, UDT, and initial assessment findings to ascertain the patient’s risk of misuse, abuse, or diversion of medications. Finally, the nurse should ensure that the patient has a current diagnosis that justifies the need for opioid therapy (9).
Treatment Goals
The nurse’s primary treatment goal is the patient’s clinically significant improvement in function, and the treatment plan should reflect this goal. The treatment plan should also include non-pharmacological and non-opioid pharmacological modalities, a proposed timeline for treatment, and realistic goals for pain and function. The nurse should teach the patient that the goal of chronic opioid therapy is not to eliminate pain, but rather to reduce it and increase physical function. The nurse must document this teaching in the patient’s medical record (9).
Prescribing Principles
- The APRN in Tennessee must adhere to these principles when prescribing opioids for the management of chronic pain (9):
- Telemedicine is not an appropriate mode for prescribing opioids for the treatment of chronic non-malignant pain. The patient must be assessed, diagnosed, and treated in person.
- The risk of overdose death starts at 40 morphine equivalent daily dose (MEDD) in opioid-naïve patients with the greatest risk posed within the first two weeks of treatment. The risk for overdose of all patients increases tenfold at 100 MEDD, but Tennessee data suggests the tenfold risk may start closer to 81 MEDD.
- Immediate-release opioids instead of extended-release or long-acting opioids should be prescribed.
- Products containing buprenorphine, with or without naloxone, can only be prescribed for medical use as endorsed by the FDA.
- Benzodiazepines should not be used in chronic opioid therapy. If benzodiazepines are considered, the patient should be referred to a mental health practitioner to assess necessity.
- If Methadone is considered, the patient should be referred to a pain specialist.
- If treatment deviates from the recommended guidelines, the details should be documented in the patient’s record.
- No prescriber is obligated to continue opioid therapy that has been initiated by another provider. If the current prescriber does not feel that the opioid therapy prescribed by the previous clinician is warranted, the current prescriber should discuss the risks of continuation, discontinuation, weaning, and potential withdrawal symptoms with the patient.
Initiating Therapy
The APRN should follow these guidelines when initiating opioid therapy (9):
- The patient should be told that opioid therapy is a therapeutic trial where the medications and dosages may be changed based on the patient’s reaction to the medication.
- In opioid-naive patients, the lowest dose should be prescribed and monitored and then titrated.
- The patient’s informed consent must be obtained before initiating therapy. The consent should include potential risks and benefits of therapy; potential side effects; and potential risks of physical dependence, over-sedation, pregnancy, impaired motor skills, addiction, and death.
- The clinician-patient agreement should include the reasons for treatment and the circumstances under which opioids may be discontinued. The practice policy regarding refills, lost prescriptions, safe storage of medications, drug testing, and use of one pharmacy must be shared. Female patients must agree to notify the prescriber if she becomes, or intends to become, pregnant.
Maintaining Therapy
- The APRN should follow these guidelines when maintaining opioid therapy (9):
- All chronic opioid therapy should be managed by a single provider or medical practice and all prescriptions filled at a single pharmacy.
- Opioids should continue to be prescribed at the lowest effective dose.
- The concurrent use of more than one short-acting opioid should not be used. If the prescriber determines that this is necessary, the medical reasons should be clearly documented in the patient’s medical record.
- The five A’s must be documented at all patient visits: analgesia, activities of daily living, adverse side effects, aberrant drug-taking behaviors, and affect.
- Patients receiving opioid doses of 120 mg MEDD or greater should be referred to a pain specialist for consultation or management. If the prescriber is unable to refer the patient, the reason must be documented in the patient’s medical record.
- A urine drug test should be performed at least every six months to monitor the patient for signs of opioid abuse, misuse, or diversion.
- In addition to regular UDTs, monitoring patient behavior, CSMD results, and ongoing risk for opioid abuse, misuse, or diversion should be initiated. Changes to the patient’s treatment plan based on these results of patient monitoring should occur promptly. Inconsistent results should be addressed and documented immediately.
- When the risks outweigh the benefits, opioids should be discontinued. The medication should be weaned, if indicated and as appropriate, to prevent opiate withdrawal.
- Clinicians should coordinate evidence-based treatment for patients with substance use disorder. This may include a referral to an addiction specialist.
- Methods for preventing unintended pregnancy with every woman of childbearing age who can reproduce should be discussed. If the woman does become pregnant, she should be referred to an obstetrician.
Self Quiz
Ask yourself...
- Why should the APRN consult the Controlled Substance Monitoring Database before prescribing opioids to a patient?
- What step must the APRN take instead of collaborating with a patient via telemedicine who requires opioid therapy?
- Which physiologic change must female patients who are receiving opioid therapy report to the APRN?
- Which step should the APRN take for any patient with a substance use disorder?
Conclusion
APRNs in Tennessee prescribe opioids to patients with pain to assist these patients in improving their symptoms, function and mobility, and overall quality of life while mitigating adverse effects, substance use disorders, overdoses, and neonatal abstinence syndrome. APRNs are responsible for meeting Tennessee’s requirements for nursing education and licensure, as well as the DEA’s requirements for prescriptive privileges. These nurses must also adhere to the State’s guidelines for prescribing opioids to chronically ill patients while helping to maintain their safety while receiving opioid therapy.
Self Quiz
Ask yourself...
- For which types of pain conditions are opioids most prescribed?
- Which patient factors make it difficult for prescribers to feel like they are issuing prescriptions appropriately?
- How many Americans suffer from chronic pain conditions and how do these compare to other chronic conditions?
- Which drugs fall into Schedule II, III, IV, and V categories?
- What are the guidelines regarding codeine for Schedule III and Schedule V drugs?
- Which DEA form is required of APRNs who wish to seek prescriptive privileges?
- Why should the APRN test a patient’s urine before prescribing controlled substances?
- Which components should the APRN include in the patient’s opioid treatment plan?
- What is the goal of chronic opioid therapy?
- Which teaching is important for the APRN to document in the patient’s medical record?
- What is the morphine equivalent daily dose (MEDD) amount that poses a risk of overdose death in opioid-naïve patients?
- What is the morphine equivalent daily dose (MEDD) amount that poses a tenfold risk of overdose death in all patients, as determined by Tennessee data?
- What step must the APRN take if prescribing benzodiazepines to a patient receiving chronic opioid therapy?
- To which specialist should the APRN refer the patient receiving chronic opioid therapy if Methadone is considered?
- Which steps should the APRN take if they do not agree with continuing a patient’s opioid therapy that was originally prescribed by another provider?
- Which opioid dose should be prescribed to opioid-naïve patients?
- Which details should be included in the patient’s informed consent document?
- Which information is included in the clinician-patient agreement regarding opioid therapy?
- How many providers should manage the patient’s chronic opioid therapy?
- What are the five As of chronic opioid therapy documentation?
References + Disclaimer
- American Medical Association. 2017. State law chart: nurse practitioner prescriptive authority. Retrieved from: https://www.ama-assn.org/sites/ama-assn.org/files/corp/media-browser/specialty%20group/arc/ama-chart-APRN-prescriptive-authority.pdf.
- Deering, M. 2023. Nurse practitioner prescriptive authority by state. Retrieved from: https://nursejournal.org/articles/nurse-practitioner-prescriptive-authority-by-state/.
- Feeney, A. 2024. Nurse practitioner practice authority: a state-by-state guide. Retrieved from: https://nursejournal.org/nurse-practitioner/APRN-practice-authority-by-state/.
- Kleinpell, R., Myers, C.R. 2022. Remove outdated Tennessee laws restricting advanced practice registered nurses | Opinion. Retrieved from: https://www.tennessean.com/story/opinion/2022/03/22/remove-outdated-tennessee-laws-restricting-advanced-practice-rns/9458863002/.
- National Institutes of Health. 2024. Help for babies born dependent on opioids. Retrieved from: https://heal.nih.gov/news/stories/neonatal-opioid-withdrawal-syndrome.
- Preuss, C.V., Kalava, A., King, K.C. 2023. Prescription of controlled substances: benefits and risks. Retrieved from: https://www.ncbi.nlm.nih.gov/books/NBK537318/.
- RegisteredNursing.org. 2023. Advanced practice registered nurse (APRN). Retrieved from: https://www.registerednursing.org/aprn/.
- Tennessee Board of Nursing. 2019. Rules of the Tennessee Board of nursing: advanced practice nurses and certificates of fitness to prescribe. Retrieved from: https://publications.tnsosfiles.com/rules/1000/1000-04.20190812.pdf.
- TN Department of Health. 2024. Tennessee chronic pain guidelines. Retrieved from: https://www.tn.gov/content/dam/tn/health/healthprofboards/pain-management-clinic/ChronicPainGuidelines.pdf.
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