Demystifying Controlled Substances: Prescribing Practices and Legal Considerations 

Starting in June of 2023, practitioners of controlled substances are required to complete 8 hours of training on the treatment and management of patients with opioid or other substance use disorders to comply with the Medication Access and Training Expansion (MATE) Act.  In this article, we’ll go over some specific legal requirements for prescribing controlled substances, how to prescribe responsibly amid the ongoing opioid crisis, and how to meet your continuing education requirements to maintain prescribing privileges.  

Recommended course: Controlled Substance Prescribing for DEA Initial Registration and Renewal 

What are controlled substances? 

Under the Controlled Substances Act, all drugs that pose a risk to public health or have a potential for dependence are categorized into one of five scheduling categories according to certain criteria. Certain substances may also be scheduled if they are the immediate precursor of another substance already controlled. Each category has different requirements, and drugs can be recategorized anytime. 

What are the criteria for controlled substances? 

Controlled substances are put into one of five categories based on three main considerations: 

  • Potential for abuse  
  • Psychic or physiological dependence liability 
  • Accepted medical usage 

As you know, all drugs have risks and side effects associated with them. As clinicians, part of the job of prescribing includes determining if the potential benefits outweigh the risks. In the case of scheduled substances, the accepted medical usage is considered alongside the potential for abuse and dependence to help clinicians weigh whether and when to prescribe a certain substance.  

What are the five “schedule” categories of controlled substances? 

Controlled substances are categorized into “schedules” with Schedule I being the most dangerous, most highly regulated substances and Schedule V being the safest of the controlled substances. 

Schedule I Controlled Substances 

Schedule I substances are those which have no accepted medical use in treatment in the United States. This is the only category that clinicians do not prescribe from. Drugs in this categorization are only used for research purposes.  

Schedule I substances are categorized according to the following classification requirements: 

  • High potential for abuse 
  • No accepted medical use in treatment in the U.S. 
  • Lack of accepted safety for use of drugs under medical supervision 
  • No clinical utility 

Examples of Schedule I substances include the following: 

  • Opiates including heroin 
  • Psychedelics including LSD, mescaline, psilocin 

Schedule II Controlled Substances 

Schedule II substances are categorized according to the following classification requirements: 

  • High potential for abuse 
  • May cause severe dependence, psychic or physiological 
  • Has currently accepted medical use 

There are four therapeutic categories of Schedule II substances. Examples of Schedule II substances include the following: 

  • Opiates including fentanyl, methadone, morphine, and oxycodone 
  • Stimulants including cocaine, and amphetamine 
  • Depressants, all of which are severe sedatives, including barbiturates 
  • There is one hallucinogen, nabilone (brand name: Cesamet), which is used for chemo-induced nausea and vomiting 

Schedule III Controlled Substances 

Schedule III substances are categorized according to the following classification requirements: 

  • Has less potential for abuse than Schedule II substances 
  • May cause low or moderate physical dependence but high psychological dependence 
  • Has currently accepted medical use 

The five therapeutic categories of Schedule III substances are stimulants, opioids, depressants, hallucinogens, and corticosteroids. 

Schedule IV Controlled Substances 

Schedule IV substances are categorized according to the following classification requirements: 

  • Has a low potential for abuse 
  • May cause limited dependence, psychic or physiological  
  • Has currently accepted medical use 

There are three therapeutic categories of Schedule IV substances. Examples of Schedule IV substances include the following: 

  • Opiates, which may be the same as those in higher categories, just at much lower concentrations 
  • Depressants, including benzodiazepines and sleep-aid drugs such as zolpidem (brand name: Ambien) 
  • Stimulants, including weight loss drugs like phentermine 

Schedule V Controlled Substances 

This is the lowest categorization. Schedule V controlled substances have the same categorization criteria as Schedule IV, with low potential for abuse and limited dependence liability. 

Examples of Schedule V substances include the following: 

  • Cough medicines 
  • Pyrovalerone for chronic fatigue syndrome 
  • Antiepileptic drugs pregabalin and lacosamide 

How is the ability to prescribe controlled substances regulated? 

Even though the schedules of controlled substances are regulated at the federal level and the schedules themselves come from federal law, the ability to prescribe these substances is licensed by states. Prescribing privilege is awarded at the state level, meaning prescribers must take additional steps to prescribe across state lines. Every state has different legal requirements for prescribing, documenting, and more, and it is the prescriber’s responsibility to be aware of these regulations. 

How has the ongoing opioid crisis affected prescribers of controlled substances?  

In the past couple of decades, opioid dependence and abuse have increased dramatically. And with the influx of synthetic opioids like fentanyl, deaths from opioid overdose have, too. This has led the U.S. Centers for Disease Control and Prevention (CDC) to declare opioid use an epidemic.  

As a result, the CDC published a set of twelve guidelines for managing chronic pain, which contains specific guidance for prescribing opioids. In 2022, the CDC published a revision. Being aware of these guidelines and the revised edition is critical for practitioners to stay compliant with the law and ensure they are prescribing responsibly.  

What are the four actions for prescribing opioids? 

The CDC guidelines assist practitioners in the four steps of prescribing opioids. These are:   

  • Determining whether to initiate opioids for pain 
  • Selecting opioids and determining dosages 
  • Deciding the duration of the initial opioid prescription and conducting follow-up 
  • Assessing risks and addressing potential harms of opioid use 

How do you determine whether to initiate opioids for pain? 

There are many ways to treat pain, and knowing the physiology of pain will help you better serve your patients without prescribing opioids unnecessarily. Nurse practitioners need to understand the difference between treating pain reception versus pain perception and use this knowledge in coordination with an understanding of the mechanisms of opiate and non-opiate pain agents.  

It is also important to keep in mind the many side effects of opioid treatment. Opioids can affect the respiratory and gastrointestinal systems, so much to an extent that opioid-induced constipation is a specific area of pharmacological study. Opioids also have a risk of dependence that many other pain management solutions do not. When deciding between an NSAID or opioid treatment for pain management, practitioners must weigh these concerns against the benefits to decide what is in the patient’s best interest. 

What are some of the types of legal requirements for prescribing controlled substances? 

All states have some restrictions on prescribing opioids. These restrictions include types and dosages, so understanding your state’s restrictions will help you determine the proper prescription for a patient. Restrictions on prescribing opioids appear in the following three forms: 

  • Duration: For example, for acute pain, many states have a 7-day max for opioid-naive patients before re-evaluation. 
  • Condition: For example, many states have a 4-day limit for post-dental procedures and ophthalmic pain. 
  • Total daily dose (measured in morphine milligram equivalents or MME): For example, many states limit prescribers to 90 MME, although for acute pain, the guideline is usually 50 MME. 
  • As an additional restriction, note the increased regulations around prescribing opioids to minors.  

When prescribing opioids, you will come across other regulations in terms of documentation and process. For example, many states mandate a prescription monitoring program (PMP) query prior to prescribing and during treatment. It is also common for states to require informed consent and documentation from previous providers.  

What are the opiate risk assessment elements? 

Assessing the potential harms of opioid use is one of the major keystones of responsible prescribing.  

Risk factors for opioid abuse include: 

  • History of opioid abuse, misuse, or addiction 
  • Current or past substance abuse 
  • Untreated psychiatric disorders 
  • Social or family environments that encourage misuse 

Additionally, it is helpful to note the prevalence of opioid abuse in different subpopulations to identify risks in a certain patient.  

Prevalence is higher in: 

  • People of middle age 
  • Comorbid non-opioid substance abuse 
  • Psychiatric comorbidity 

When do the CDC’s opioid guidelines not apply? 

In the 2022 update, the CDC published a list of exclusions to their guidelines. Under these exclusions, opioids are not prescribed according to the same level of scrutiny.  

The circumstances in which these guidelines do not apply are: 

  • Pain management related to sickle cell disease 
  • Cancer-related pain treatment 
  • Palliative care 
  • End-of-life care 

What continued education is required for prescribing controlled substances? 

Prescribers must be registered with the DEA and their state board and must keep up with continuing education to renew registration. The categorizations of controlled substances can change. Governing agencies update regulations for controlled substances frequently. Every nurse practitioner and advanced practice clinician must be aware of their state’s specific regulations to stay in compliance with these laws.  

Earn CE hours with our online course on Clinical Pharmacology for Nurse Practitioners and Advanced Practice Clinicians (free with Passport Membership)! 

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