Scheduled II Controlled Substances
Schedule II controlled substances are medications with high potential for abuse and dependence but with accepted medical uses, requiring strict regulatory controls due to their significant risk of addiction and diversion.
Definition and Classification
Schedule II medications are classified under the Comprehensive Drug Abuse Prevention and Control Act of 1970 and regulated by the Drug Enforcement Administration (DEA) 1. These substances are characterized by:
- High potential for abuse
- Currently accepted medical uses with severe restrictions
- Potential for severe psychological or physical dependence
Common Schedule II Medications
Schedule II medications include several important classes of drugs:
Opioid Analgesics:
- Morphine (15-30 mg PO Q4-6h PRN)
- Oxycodone (5-15 mg PO Q4-6h PRN)
- Oxycodone/APAP combinations
- Hydromorphone (2-4 mg PO Q4-6h PRN)
- Fentanyl
- Codeine (when not in combination with other medications)
- Oxymorphone (10-20 mg PO Q4-6h PRN)
Stimulants:
- Amphetamines
- Methylphenidate
- Cocaine (limited medical use)
Regulatory Requirements
Schedule II medications are subject to strict controls:
- Written prescriptions required (electronic in some jurisdictions)
- No refills allowed on prescriptions
- Prescriptions must be filled within a limited time period
- Prescribers must have valid DEA registration
- Special prescription forms often required
- Detailed record-keeping mandated for pharmacies
Clinical Considerations
When prescribing Schedule II medications, clinicians should:
- Assess each patient's risk for addiction, abuse, or misuse prior to prescribing 2
- Monitor patients for signs of addiction, abuse, and misuse throughout treatment
- Be aware that patients with personal or family history of substance abuse are at higher risk
- Prescribe the smallest appropriate quantity to minimize diversion risk
- Consider using prescription drug monitoring programs (PDMPs) to identify potential misuse patterns 3
Contrast with Other Schedules
Schedule II medications have higher abuse potential than Schedule III medications. For example:
- Schedule II: Oxycodone, morphine, hydromorphone
- Schedule III: Hydrocodone/APAP combinations (formerly; now Schedule II), codeine/APAP combinations 1
Safety Considerations
When prescribing Schedule II medications:
- Long-acting or extended-release Schedule II products (OxyContin, methadone, fentanyl patches) are indicated for chronic pain and should not be used for acute pain 1
- Extended-release opioids should only be used in opioid-tolerant patients
- Immediate-release oral transmucosal formulations of fentanyl are only indicated for breakthrough pain in cancer patients already taking sustained-release medications 1
- Strategies to reduce risks include prescribing the smallest appropriate quantity and advising patients on proper disposal of unused medications 2
Risk Evaluation and Mitigation Strategy (REMS)
The FDA requires a REMS for opioid analgesics to ensure benefits outweigh risks of addiction, abuse, and misuse 2. Healthcare providers are encouraged to:
- Complete REMS-compliant education programs
- Counsel patients about proper use, storage, and disposal
- Monitor for signs of misuse or diversion
Clinical Pitfalls to Avoid
Failing to recognize drug-seeking behavior: Be alert to emergency calls near the end of office hours, refusal to undergo appropriate examination, repeated "loss" of prescriptions, and "doctor shopping" 2
Inadequate monitoring: Regular follow-up is essential to assess for appropriate use and potential misuse
Inappropriate prescribing: Schedule II medications should only be prescribed when clinically indicated and after considering non-controlled alternatives
Neglecting to check PDMPs: These databases can help identify patterns of misuse or multiple prescribers 3
Inadequate documentation: Thorough documentation of medical necessity is essential for Schedule II prescriptions