Responsible Controlled Substance and Opioid Prescribing

Excerpt

According to the United States Drug Enforcement Administration (DEA), drugs, substances, and certain chemicals used in drug manufacturing are classified into 5 categories or schedules depending on the drug's acceptable medical use and potential for abuse or dependency. The Controlled Substance Act (CSA) outlines the criteria for scheduling a substance, which includes:

1. Potential for abuse (actual or relative)

2. Scientific evidence of pharmacological effects

3. Current scientific knowledge regarding the drug or other substance

4. History and patterns of abuse

5. Scope, duration, and significance of abuse

6. Risks to public health

7. Liability for psychic or physiological dependence

8. Whether the substance is an immediate precursor to a controlled substance

Controlled substances include all opioid analgesics, sedatives, hypnotics, and stimulants. In the United States, federal regulation restricts when and how these substances may be prescribed to prevent misuse and abuse.

In 2020, 91,799 drug overdose deaths were reported in the United States, with opioids involved in 68,630 deaths—approximately 75% of all drug overdose deaths involved opioids. Synthetic opioids were associated with 82.3% of opioid-related deaths.[CDC. Overdose Prevention] The age-adjusted overdose death rate increased by 31% from 2019 to 2020.[CDC. CDC Wonder]

Opioids continue to be a significant public health crisis. In 2021, 80,411 lives were lost to opioid overdose.[NIH. Drug Overdose Deaths: Facts and Figures] By 2022, out of the 107,081 reported drug overdose deaths in the United States, 68% of these deaths were caused by synthetic opioids, particularly illegally manufactured fentanyl.[CDC. Illicitly Manufactured Fentanyl–Involved Overdose Deaths with Detected Xylazine — United States, January 2019–June 2022] The prevalence of opioid misuse, addiction, and overdose has increased across the country. According to the Substance Abuse and Mental Health Services Administration (SAMHSA), in 2020, approximately 2.7 million individuals aged 12 or older had opioid use disorder in the United States, including 2.3 million individuals with a prescription opioid use disorder.[SAMHSA. The National Survey on Drug Use and Health: 2020]

In response to these staggering statistics, clinical prescribers, dispensers, and manufacturers play a crucial role in reducing opioid distribution and ensuring the proper disposal of unused medications. Prescribers are encouraged to proactively prescribe opioid reversal agents to individuals receiving prescribed opioids and those at risk for opioid use disorder. Prescribers must also adhere strictly to federally mandated clinical guidelines for responsible prescribing of controlled substances and opioids. Finally, healthcare professionals must also prevent prescription violations by adhering to best practices for opioid prescribing and monitoring. These measures are essential to combat the opioid crisis and the rising prevalence of substance use disorders in the United States.

Prescription opioids have emerged as a gateway to substance use disorders, contributing to the ongoing opioid crisis in the United States. Studies indicate that leftover or unconsumed opioid medications—originally prescribed for legitimate medical use—are often misused, particularly among vulnerable adolescents. This concerning trend exacerbates the crisis, amplifying its impact on individuals and communities nationwide.

Despite their risks, prescription opioids are essential in managing acute and chronic pain. More than one-fourth of the United States population experiences chronic pain, with annual healthcare costs exceeding 100 billion dollars due to pain management and opioid dependence. These costs surpass the combined expenses of cancer, diabetes mellitus, and heart disease.

Given the profound impact of chronic pain on a patient's quality of life, prescribers must adopt best practices to ensure responsible opioid use. The consequences of pain management decisions are far-reaching, underscoring the need for a thoughtful, evidence-based approach to opioid prescribing.

Appropriate opioid prescribing encompasses a comprehensive approach that involves regular assessment, treatment planning, and ongoing monitoring. The goal is to provide adequate pain relief while minimizing the risks of addiction, abuse, overdose, diversion, and misuse. Clinicians must understand that inappropriate opioid prescribing, including under-prescribing, overprescribing, or continuing to prescribe opioids when they are no longer effective, can have serious consequences, particularly in patients with chronic pain.

Patients with chronic pain face additional challenges, as prolonged opioid use can lead to tolerance, dependence, and significant psychological, behavioral, and emotional problems, including anxiety and depression. Inadequate or excessive prescribing can exacerbate these complications.

Healthcare Provider Knowledge Deficit

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

Healthcare providers may lack an understanding of addiction pathophysiology, at-risk populations, and the distinctions between prescription and nonprescription opioid addiction. A common misconception equates addiction with dependence, underscoring the need to clarify this distinction. The outdated belief that opioid addiction is purely psychological must be reframed. In reality, it is a complex condition involving both psychological and physiological factors, often intertwined with chronic pain disorders.

Despite efforts to incorporate education on substance use disorders in medical school curricula, a pervasive practice gap remains in appropriately managing these conditions and implementing responsible prescribing practices for controlled substances. Bridging this gap is essential for improving patient outcomes and mitigating the opioid crisis.

Definitions

Clinicians should be familiar with key terms associated with addiction and substance use disorders, as they are frequently used in medical literature. Clear definitions help establish diagnostic criteria, enabling providers to identify individuals 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] Individuals with addiction engage in behaviors that become compulsive and are continued despite adverse consequences. However, the ASAM emphasizes that prevention and treatment strategies for addiction are as successful as those for other chronic diseases. ASAM identifies 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), eliminates 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, providing greater diagnostic clarity 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, such as altering one's state of consciousness.

1. Dependence: Physiological 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.