Controlled Substances Prescription Regulation
Clinicians must review the state Prescription Drug Monitoring Program (PDMP) when starting controlled substance therapy and periodically during continuation—ideally before every prescription, or at minimum every 3 months—to identify dangerous combinations and high-risk dosing patterns. 1
Core Regulatory Requirements
PDMP Consultation Mandates
- Check PDMP data before each controlled substance prescription to determine if patients are receiving dangerous combinations (e.g., opioids with benzodiazepines) or high total dosages from multiple prescribers that increase overdose risk 1
- Calculate total morphine milligram equivalents (MME) per day when multiple opioid prescriptions are identified to assess cumulative exposure 1
- Review for benzodiazepine co-prescriptions specifically, as this combination increases mortality risk 3- to 10-fold due to synergistic respiratory depression 2, 3
- Document PDMP review results in the medical record, including discussions with patients about additional prescriptions discovered 4
Urine Drug Testing Requirements
- Perform urine drug testing before initiating opioid therapy for chronic pain (Category B recommendation) 1
- Conduct annual urine drug testing at minimum during ongoing opioid therapy to assess for prescribed medications, other controlled substances, and illicit drugs 1, 4
- Use immunoassay panels initially for cost-effectiveness, reserving confirmatory testing (gas/liquid chromatography-mass spectrometry) for unexpected results or less common opioids 1
- Test for substances that affect clinical management, including nonprescribed opioids, benzodiazepines, and heroin that increase overdose risk when combined with prescribed opioids 1
Specific Controlled Substance Classes
Opioid Prescribing Standards
- Avoid dosages ≥90 MME/day or carefully justify any decision to titrate to this level 1
- Exercise increased caution at ≥50 MME/day, carefully reassessing individual benefits versus risks 1
- Limit acute pain prescriptions to 3 days or less when sufficient; rarely prescribe more than 7 days 1
- Prescribe immediate-release formulations at the lowest effective dose for acute pain 1
Benzodiazepine Management
- Verify absence of concomitant opioid prescriptions before each benzodiazepine renewal, as this combination increases respiratory depression and death risk 4, 3
- Screen for other CNS depressants (muscle relaxants, hypnotics, sedating antihistamines) that potentiate central nervous system depression 4
- Assess for tolerance and dependence signs (need for dose increase, decreased efficacy), which indicate need for discontinuation rather than renewal 4
- Implement monthly follow-up during continued use or tapering, with more frequent contact during difficult phases 4
Stimulant Prescribing (e.g., Methylphenidate)
- Recognize Schedule II controlled substance status requiring DEA registration and specific prescribing practices 5
- Monitor for abuse, misuse, and addiction potential as highlighted in FDA black box warnings 5
- Check PDMP for concurrent controlled substances before prescribing stimulants 5
High-Risk Combinations to Avoid
Opioid-Benzodiazepine Co-Prescribing
- Avoid prescribing opioids and benzodiazepines concurrently whenever possible (Category A recommendation) 1
- Communicate with other prescribers managing the patient to discuss needs, prioritize goals, and coordinate care when concurrent prescribing is unavoidable 1
- Offer naloxone when concurrent benzodiazepine and opioid use is present, as this represents increased overdose risk 1
- Provide education on overdose prevention and naloxone use to patients and household members 1
Special Populations Requiring Enhanced Monitoring
- Elderly patients (≥65 years): Use additional caution due to decreased drug clearance, increased CNS depressant sensitivity, and higher fall risk 1, 3
- Patients with substance use disorder history: Discuss increased risks, carefully weigh benefits versus harms, and increase monitoring frequency 1
- Patients with prior overdose: Consider offering naloxone and implement more frequent follow-up 1
- Recently incarcerated patients: Recognize risk of returning to previously tolerated high doses after loss of tolerance 1
Actions When PDMP Reveals Concerning Patterns
Patient Communication Protocol
- Discuss PDMP findings with the patient and confirm awareness of additional prescriptions 1
- Explain safety concerns including increased respiratory depression and overdose risk with multiple prescribers or dangerous combinations 1
- Discuss concerns with other prescribers who are writing controlled substance prescriptions for the patient 1
Clinical Decision-Making
- Consider substance use disorder when patterns suggest misuse and discuss concerns directly with the patient 1
- Consider tapering to safer dosages when high total daily opioid doses are identified 1
- Use urine drug testing to determine if patients are actually taking prescribed opioids versus diverting them 1
Critical Pitfalls to Avoid
- Never dismiss patients from practice based on PDMP information alone, as this eliminates opportunities to provide potentially lifesaving interventions 1, 4
- Never dismiss patients based on urine drug test results, as this has adverse consequences for patient safety including missed opportunities for substance use disorder treatment 1
- Never implement rapid tapers for long-term benzodiazepine users; reduce by 10% per month for use exceeding 1 year, or over several months for use exceeding 6 years 4
- Never prescribe benzodiazepines to manage anxiety in elderly patients already on opioids without first attempting safer alternatives like buspirone 3
Documentation Requirements
- Record PDMP consultation dates and findings in the medical record 4
- Document discussions about safety risks particularly with multiple prescriptions or dangerous combinations 4
- Maintain records of doses, frequency, and perceived efficacy for all controlled substances 4
- Record urine drug screening results and any follow-up actions taken 4
- Document clear rationale when prescribing high-risk combinations like opioids with benzodiazepines 2