What is the schedule system for controlled substances?

Schedule System for Controlled Substances

The United States Controlled Substances Act (CSA) classifies drugs into five schedules (I through V) based on their abuse potential, accepted medical use, and safety profile, with Schedule I representing substances with the highest abuse potential and no accepted medical use, and Schedule V representing the lowest potential for abuse. 1

Legal Framework and Administration

• Schedules II and III are classifications established by the Comprehensive Drug Abuse Prevention and Control Act of 1970 and determined by the Drug Enforcement Administration (DEA). 2
• Classification decisions for specific drugs are based on judgments about the potential for their abuse, accepted medical use, and safety under medical supervision. 2
• The Department of Health and Human Services (HHS) and DEA jointly determine scheduling through an Eight-Factor Analysis (8FA) that evaluates scientific and medical data. 1, 3

Schedule I Controlled Substances

• Schedule I substances have high abuse potential AND no currently accepted medical use in the United States. 1
• Heroin is the prototypical Schedule I opioid, distinguished from Schedule II opioids like morphine and oxycodone specifically because it lacks accepted medical use despite similar abuse potential. 1
• Cannabis has historically been classified as Schedule I, though recent recommendations suggest rescheduling to Schedule III based on findings that its abuse potential is less than Schedule I and II substances, it has currently accepted medical use, and may lead to moderate or low physical dependence. 2

Schedule II Controlled Substances

• Schedule II opioids include morphine (e.g., MS Contin), oxymorphone (e.g., Opana), oxycodone (e.g., Roxicodone) and oxycodone combination products (e.g., Percocet, Percodan), as well as hydromorphone (e.g., Dilaudid) and fentanyl (e.g., Duragesic patch, Actiq). 2
• Morphine sulfate contains morphine, a Schedule II controlled substance with high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, oxycodone, oxymorphone, and tapentadol. 4
• Codeine (without combination products) is classified as Schedule II. 2
• Schedule II prescriptions require the most stringent documentation including specification of total quantity, number of days, strength, dose, and frequency. 1

Schedule III Controlled Substances

• Schedule III opioids include combination products, such as hydrocodone (15 mg or less) combined with acetaminophen (e.g., Vicodin, Lortab) or ibuprofen (e.g., Vicoprofen), as well as some codeine combination products. 2
• Codeine combined with acetaminophen (APAP) is classified as Schedule III. 2
• Schedule classifications for opioids may change over time in response to factors including their perceived risk of abuse—calls to reclassify hydrocodone combination products from Schedule III to Schedule II have increased in recent years due to increasing levels of abuse. 2

Schedule IV Controlled Substances

• Benzodiazepine receptor agonists are uniformly classified as Schedule IV, including non-benzodiazepines: eszopiclone, zolpidem, zaleplon, and benzodiazepines: estazolam, temazepam, triazolam, flurazepam. 1

Prescription Monitoring and Control Measures

• Prescription drug monitoring programs (PDMPs) track Schedule II through IV (or II through V) controlled substances to identify diversion and doctor shopping, with forty-one states having operational programs. 1, 2
• Doctor shopping is defined variably as obtaining prescriptions from 2 or more prescribers within 30 days, greater than 4 during one year, or greater than 5 during one year. 1, 2
• Most states allow healthcare providers and pharmacists to access PDMPs for patients under their care, while law enforcement and regulatory boards may also have access. 2

Clinical Implications for Prescribing

• In general, equianalgesic doses of opioids are equally efficacious in relieving pain regardless of their DEA classification—there is no reason to consider an equianalgesic dose of a short-acting Schedule II opioid more effective in providing pain relief than a short-acting Schedule III opioid. 2
• Long-acting or extended-release Schedule II products such as oxycodone ER (OxyContin), methadone, fentanyl patches, or morphine extended-release (MS Contin) are indicated for chronic pain and should not be used for acute pain. 2
• Long-acting and extended-release opioids are for use in opioid-tolerant patients only and are not intended for use as an "as-needed" analgesic. 2

Rescheduling Process

• The process of scheduling an abusable drug involves both HHS (through FDA and NIDA) and the Department of Justice (through DEA), with HHS performing an Eight-Factor Analysis that is evaluated and signed by the Assistant Secretary for Health before transmission to DEA. 3
• DEA permanently places substances into schedules after public notices are published in the Federal Register. 3
• If a Schedule I substance receives FDA approval as a medicine, it must be removed from Schedule I and rescheduled, as Schedule I by definition means no currently accepted medical use. 5