What are the characteristics of drugs designated as Schedule II by the U.S. Drug Enforcement Administration (DEA)?

Schedule II Controlled Substances: Regulatory Characteristics

Schedule II drugs may not be refilled; a new prescription must be written each time. This is the defining regulatory characteristic that distinguishes Schedule II substances from Schedule III-V controlled substances under the Controlled Substances Act of 1970. 1

Key Regulatory Features of Schedule II Drugs

Prescription Requirements

• No refills are permitted - each dispensing requires a completely new prescription to be written by the prescriber 1
• Schedule II prescriptions require the most stringent documentation, including specification of total quantity, number of days, strength, dose, and frequency 1
• These substances require additional documentation under the Misuse of Drugs Act compared to lower schedules 1

Abuse Potential Classification

• Schedule II drugs have high potential for abuse, similar to other controlled opioids, but maintain accepted medical use under supervision 2, 1
• The Drug Enforcement Administration determines scheduling based on judgments about abuse potential, accepted medical use, and safety under medical supervision 2, 1
• Examples include morphine, oxymorphone, oxycodone, hydromorphone, fentanyl, and methadone 2

Prescription Monitoring

• All Schedule II substances are tracked by prescription drug monitoring programs (PDMPs) in 41 states to identify diversion and doctor shopping 1, 3
• The CDC recommends checking the state PDMP before prescribing any Schedule II medication to identify potential diversion or concurrent prescriptions from multiple providers 3

Common Misconceptions Addressed

Regarding the Answer Choices:

"May be dispensed without a prescription" - This is incorrect. Schedule II drugs require prescriptions and cannot be dispensed without one. 1

"Have a low abuse potential" - This is incorrect. Schedule II drugs have high abuse potential, which is why they are in this restrictive category rather than Schedule III-V. 2, 1

"Are known teratogens during pregnancy" - This is incorrect. Teratogenicity is not a criterion for DEA scheduling. Scheduling is based on abuse potential, accepted medical use, and safety profile, not pregnancy risk. 1

Clinical Implications

• The no-refill requirement for Schedule II drugs was implemented specifically to limit overprescribing and increase awareness of their abuse potential 4
• Research demonstrates that stricter Schedule II controls (compared to Schedule III) resulted in a 60.4% decrease in prescriptions at one institution, with prescribers shifting to non-Schedule II alternatives 5
• When Schedule II opioids are prescribed on discharge, use the lowest practical dose for limited duration (e.g., 1 week) and assess the patient's risk for misuse, abuse, or diversion 2