Definition/Introduction

The United States Government developed the Federal Comprehensive Drug Abuse Prevention and Control Act (the Controlled Substances Act) in 1970. One of the primary purposes of the act was to improve the development, distribution, and allocation of controlled medications. The Controlled Substances Act categorizes certain medications into 5 different schedules based on misuse potential. Schedule I medications have the highest misuse potential, and Schedule V medications have the lowest misuse potential.[1]

Issues of Concern

Many states in the United States have passed laws decriminalizing marijuana; however, this does not change the federal decision to classify marijuana as a Schedule I drug. The United States Attorney General and the Department of Health and Human Services collaborate to determine the hierarchy of medication schedules.[1][2]

Given the current opioid epidemic in the United States, a recent focus has been on controlled substance policy. As part of these efforts, the Centers for Medicare and Medicaid Services (CMS) created the Medicare Part D Overutilization Monitoring System (OMS) to identify patients who may be at risk for substance use disorder. Additionally, national registries track controlled substance prescriptions; providers query the database for their patients' prescription histories.[3][4]

Clinical Significance

Schedule I medications have a significantly high misuse potential and are regarded as having no approved medical use by the US Food and Drug Administration (FDA). Schedule I medications are prohibited from being prescribed or distributed. Schedule I drugs include heroin, ecstasy (MDMA), lysergic acid diethylamide (LSD), and marijuana.[1] 

Schedule II drugs have a high misuse potential with or without known dependence to develop, yet these medications have an accepted clinical use. Schedule II drugs include cocaine, morphine, codeine, hydromorphone, methadone, and fentanyl.[1]

Schedule III pharmaceuticals have an intermediate level of misuse potential. Drugs in this classification include anabolic steroids and ketamine.[1]

Schedule IV medications have some misuse potential but are less of a risk than Schedule III drugs. Examples of such are clonazepam, diazepam, midazolam, phenobarbital, and tramadol.[1]

Schedule V drugs have the lowest potential for misuse and development of use disorder. Schedule V drugs include pregabalin, diphenoxylate/atropine, and promethazine.[1]

Only Drug Enforcement Administration (DEA) registered practitioners can prescribe controlled substances. All prescriptions for Schedule II medications must be provided to the pharmacist in written form or transmitted by an approved computer system for electronic prescribing of controlled substances (EPCS). Several states now require EPCS systems to be used for controlled substance prescribing. A prescription for a Schedule II medication may be called in by a registered practitioner in an emergency; however, a written prescription must be provided within 7 days.[5]

Nursing, Allied Health, and Interprofessional Team Interventions

The interprofessional healthcare team must collaborate to ensure effective and safe pain control for their patients, specifically in monitoring the use of opioid analgesics. The healthcare team should schedule their patients for routine follow-up visits, including a history and physical exam, to monitor for adverse drug effects and misuse.

The healthcare team bears a substantial responsibility in monitoring for indications of drug misuse due to the global epidemic of opioid misuse, especially in the USA, as it can result in fatal respiratory depression. The FDA scheduling of controlled substances is intended to establish a framework for prescribing, dispensing, and monitoring these drugs, ensuring their safe and effective use at the lowest possible dose and for the shortest necessary duration.

Methods utilized for monitoring drug abuse and drug diversion encompass various approaches, including but not limited to assessment surveys, state prescription drug monitoring programs, urine screening, adherence checklists, motivational counseling, dosage form evaluation, and tablet counting.[Level 5]