Responsible Controlled Substance and Opioid Prescribing

In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan.


According to the United States Drug Enforcement Administration (DEA), drugs, substances, and certain chemicals used to make drugs are classified into 5 categories or schedules depending on the drug’s acceptable medical use and abuse or dependency potential. The Controlled Substance Act (CSA) lists factors considered when determining which schedule a drug or other substance should be placed. These factors are as follows:

  1. Its actual or relative potential for abuse

  2. Scientific evidence of its pharmacological effect, if known

  3. State of current scientific knowledge regarding the drug or other substance

  4. Its history and current pattern of abuse

  5. Scope, duration, and significance of abuse

  6. What, if any, risk to the public health

  7. Its psychic or physiological dependence liability

  8. Whether the substance is an immediate precursor of a substance already controlled

Therefore, controlled substances include all opioid analgesics, sedatives, hypnotics, and stimulants. Federal regulation in the United States of America (US) restricts when and how they may be prescribed to curb these substances' potential misuse and abuse.

In 2020, 91,799 drug overdose deaths were reported in the US; opioids were involved in 68,630 deaths—approximately 75% of all drug overdose deaths involved opioids. Synthetic opioids are involved in 82.3% of opioid-involved deaths.[CDC. Drug Overdose. June 2022] The age-adjusted rate of overdose deaths increased by 31% from 2019 to 2020.[CDC Wonder. 2021] Among controlled substances, opioids have become a significant problem, resulting in rampant abuse in the community. In 2021, 80,411 deaths were due to opioid overdose.[NCHS. Drug Overdose Death Rates, 2023] In 2022, of the 107,081 reported drug overdose deaths in the USA, provisional data indicated that 68% were due to synthetic opioids, primarily illegally manufactured fentanyl.[MMWR. Mbabazi et al. 2023] The prevalence of opioid misuse, addiction, and overdose has increased in the US.

According to the Substance Abuse and Mental Health Services Administration (SAMHSA), in 2020, approximately 2.7 million people aged 12 or older in the US had an opioid use disorder (OUD), including 2.3 million people with a prescription opioid use disorder.[SAMSHA, 2020 National Survey on Drug Use and Health]

In light of these staggering statistics, all clinical prescribers, dispensers, and manufacturers are charged with reducing the number of opioids dispensed and effectively disposing of unused medications. Moreover, prescribers must proactively prescribe opioid reversal agents to those who are prescribed opioids and those who are at risk for opioid use disorder. Prescribers must also strictly follow the federally mandated clinical guidelines for responsible prescribing controlled substances and opioids to prevent violations. These actions are required to help curb the opioid crisis and the rising tide of substance use disorders in the US.

Prescription opioids have emerged as a gateway to substance use disorders, contributing to the ongoing opioid crisis in the US. According to one review, leftover or unconsumed opioid medications that were appropriately prescribed, when left unused or unattended, become susceptible to misuse and abuse, particularly among vulnerable adolescents. This concerning trend further exacerbates the severity of the crisis, amplifying its impact on individuals and communities nationwide.

Prescription opioid medications are essential to manage acute and chronic pain effectively. In the US, over a quarter of the population experiences chronic pain. As a country, the US surpasses 100 billion dollars annually in healthcare costs related to pain management and opioid dependence. Pain-related expenses exceed the combined costs of cancer, diabetes, and heart disease.

Chronic pain management is pivotal in shaping a patient's quality of life, emphasizing the critical need to use best practices when prescribing opioids. The impact of pain management decisions can have far-reaching and enduring consequences, underscoring the importance of a thoughtful and responsible approach to opioid prescribing.

Appropriate opioid prescribing encompasses a comprehensive approach that involves regular assessment, treatment planning, and monitoring. The aim is to ensure clinicians prescribe sufficient opioid medication for adequate pain control while minimizing the potential for addiction, abuse, overdose, diversion, and misuse. Clinicians must understand that inappropriate opioid prescribing includes under-prescribing, overprescribing, or continuing to prescribe opioids when they are no longer effective. These concerns are particularly prominent in patients with chronic pain. Compounding the existing challenges, individuals with chronic pain often develop opioid tolerance and significant psychological, behavioral, and emotional problems, including anxiety and depression, related to under or overprescribed opioids.

Provider Knowledge Deficit

Current evidence shows substantial knowledge gaps regarding appropriate and inappropriate prescribing of controlled substances, highlighting deficits in understanding recent research, legislation, and best prescribing practices. A practice gap persists between the recommended best practices for preventing prescription drug abuse and current clinical practice.

Providers may lack understanding of the pathophysiology of addiction, populations at risk for opioid addiction, and the differences in prescription versus nonprescription opioid addiction. The fallacious belief that addiction and dependence on opioids are synonymous needs to be addressed. The idea that opioid addiction is solely a psychological problem needs to be changed; in reality, it is likely a complex psychological and physiological issue that may be related to a chronic painful disease.

Despite efforts to incorporate education on substance use disorders (SUDs) in medical school curricula, a pervasive practice gap remains in appropriately managing these conditions and implementing responsible prescribing practices for controlled substances.


Clinicians should be familiar with commonly used terms associated with addiction and substance use disorders as they are frequently used in the literature. The definition of addiction and substance use disorders helps outline diagnostic criteria, which can be used to identify those needing treatment.

  1. Addiction: According to the American Society of Addiction Medicine (ASAM), addiction is "a treatable, chronic medical disease involving complex interactions among brain circuits, genetics, the environment, and an individual's life experiences."[ASAM Glossary of Addiction] People with addiction engage in behaviors that become compulsive and are continued despite adverse consequences. However, the ASAM states that addiction prevention strategies and treatment regimens are "as successful as those for other chronic diseases." They identify these 5 characteristics of addiction:

    1. Craving for drug or positive reward

    2. Dysfunctional emotional response

    3. Failure to recognize significant problems affecting behavior and relationships

    4. Inability to consistently abstain

    5. Impairment in control of behavior

  1. Substance use disorder: The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR), abolishes the previous categorization of substance-related addictions into "abuse" and "dependence." The DSM-5-TR combines these terms into substance use disorders, categorized as mild, moderate, or severe based on severity. This helps clarify diagnoses and prevents confusion for clinicians and patients.

  1. Abuse: Use of an illegal substance or maladaptive pattern of substance use for a nonmedical purpose other than pain relief, ie, to alter one's state of consciousness.

  1. Dependence: Physiologic reliance on a drug resulting in a withdrawal syndrome with cessation or reduction in the amount of drug administered.

  1. Diversion: Transferring a controlled substance from an authorized person's use to an unauthorized person's use for distribution or possession.

  1. Misuse: Use of a medication in a manner different than how it was prescribed.

  1. Pseudoaddiction: Pursuit of additional medication due to poor pain control, with the cessation of drug-seeking behavior upon achievement of appropriate pain control.

  1. Tolerance: The lessened effect of a substance after being exposed to that substance or the need to escalate doses to achieve the same result.

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