Controlled Substances and Prescription Restrictions
The specific controlled substances and prescription restrictions vary by state, but federal law under the Controlled Substances Act (CSA) establishes five schedules (I-V) that all states must follow as a baseline, with states permitted to impose additional restrictions. 1
Federal Controlled Substance Schedules
Schedule I
- Cannabis/marijuana remains federally classified as Schedule I, indicating no accepted medical use and high potential for misuse, though 38 states and Washington, DC have legalized medical use as of April 2023. 1
- Manufacturing, distribution, and possession are effectively prohibited outside limited research activity. 1
Schedule II
- Opioids: Oxycodone, hydrocodone (reclassified from Schedule III to II in October 2014), morphine, fentanyl 2, 3, 4
- These medications carry the highest risk of addiction, abuse, and misuse among medically accepted drugs. 2, 3
- Prescriptions cannot be refilled and must include specific patient information (full name, address, drug name, strength, dosage form, quantity, directions for use, date of issue, and prescriber's signature). 5
Schedule III
- Historically included hydrocodone combination products until 2014 rescheduling. 4
- Buprenorphine (for opioid use disorder treatment) 1
Schedule IV
- Benzodiazepines: Alprazolam and other benzodiazepines 6
- Non-benzodiazepine sedative-hypnotics: Zolpidem, eszopiclone, zaleplon 5, 7
- Weight loss medications: Phentermine 5
- Prescriptions may be issued orally, in writing, or by electronic transmission where permitted by state law. 5
- Records must be kept for at least 2 years and be readily retrievable for DEA inspection. 5
Schedule V
- Epidiolex (CBD for epilepsy) was initially listed in Schedule V after 2018 FDA approval, then descheduled from the CSA in 2020. 1
Universal Prescription Requirements
All prescribers must check Prescription Drug Monitoring Programs (PDMPs) in their own and neighboring states before writing prescriptions for controlled substances. 1
Key Prescribing Obligations:
- Physicians must become familiar with and follow clinical guidelines related to pain management and controlled substances. 1
- Prescribers must understand pertinent laws and regulations regarding controlled substances, recognizing that state laws may be more restrictive than federal requirements. 1, 5
- Prescribe controlled substances in the smallest appropriate quantity to reduce diversion risk. 1
- Educate patients and families about risks, benefits, safe storage, use, and disposal of controlled substances. 1
Telemedicine Restrictions
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 generally requires at least one in-person evaluation before prescribing controlled substances via telemedicine. 5
- Some states have enacted specific legislation allowing controlled substance prescribing during telemedicine practice. 5
- Prescribers must verify both federal and state-specific telemedicine regulations. 5
Risk Mitigation Strategies
Mandatory Actions:
- Assess each patient's risk for opioid addiction, abuse, or misuse prior to prescribing, with particular attention to personal or family history of substance abuse or mental illness. 2, 3
- Monitor all patients receiving controlled substances for development of addiction, abuse, or misuse behaviors. 2, 3
- Implement universal precautions approach to minimize abuse and adverse consequences. 1
- Exercise caution when coprescribing other centrally acting drugs, particularly benzodiazepines with opioids. 1
Documentation Requirements:
- Thorough documentation of prescribing decisions is essential. 8
- Assessment and follow-up of patient risk for misuse or addiction must be documented. 8
- Use urine drug screening and PDMP checks to verify patient adherence. 8
State-Specific Variations
States may impose more restrictive regulations than federal law, including:
- Prescription quantity limits 5
- Mandatory PDMP checking requirements 1
- Additional prescriber training requirements 5
- Specific documentation standards 8
Cannabis-Specific State Variations:
- 24 states and Washington, DC have legalized recreational adult use as of November 2023. 1
- 38 states and Washington, DC have legalized medical use as of April 2023. 1
- Several states have liberalized laws related to low-THC products like CBD. 1
Critical Pitfalls to Avoid
- Failing to check state-specific regulations that may be more restrictive than federal requirements. 5
- Not consulting PDMPs before prescribing, which is strongly urged by the American College of Physicians. 1
- Inadequate patient education about risks, storage, and disposal of controlled substances. 1
- Coprescribing benzodiazepines with opioids without careful consideration of increased overdose risk. 1
- Abrupt discontinuation of benzodiazepines or opioids, which can cause withdrawal seizures or abstinence syndrome. 1, 6