Managing Controlled Substances

1. What controlled substance is being reviewed (specific drug, dose, quantity, days' supply)? (Default: specify)
2. What DEA schedule is the substance? (Default: verify against current CSA scheduling)
3. What is the clinical indication? (Default: request diagnosis from prescriber)
4. Has the PDMP been queried? (Default: mandatory before first dispense of Schedule II-III)
5. What is the patient's opioid risk assessment (ORT, SOAPP-R, or institutional tool)? (Default: administer if not on file)
6. Is there a controlled substance agreement/treatment plan on file? (Default: required for chronic opioid therapy)
7. What is the morphine milligram equivalent (MME) daily dose? (Default: calculate)
8. Are there concurrent high-risk prescriptions (benzodiazepines, gabapentinoids, muscle relaxants)? (Default: screen active profile)

Documents to Request

• Current prescription with prescriber DEA number and state license
• PDMP report for the patient (current state + bordering states if applicable)
• Opioid risk assessment tool score
• Controlled substance agreement if chronic therapy
• Photo identification for dispensing (per state law requirements)
• Urine drug screen results (if chronic opioid management)
• Prior authorization documentation if required by payer
• Pain management treatment plan from prescriber

Step 1: Prescription Validity Verification

Every controlled substance prescription must contain:

• Patient full name and address
• Prescriber name, address, DEA number, and state license number
• Drug name, strength, dosage form, quantity (written and numeric for Schedule II in some states)
• Directions for use
• Date written (Schedule II: cannot be filled >90 days after date written in most states)
• Number of refills (Schedule II: no refills permitted; Schedule III-IV: up to 5 refills in 6 months)
• Prescriber signature (wet ink for paper Schedule II; EPCS-compliant for electronic)

Red flag indicators (corresponding responsibility):

• Excessive quantities or early refill requests
• Multiple prescribers for same drug class (doctor shopping pattern on PDMP)
• Long-distance prescriber (patient traveling far from prescriber's office)
• Cash payment when patient has insurance (insurance avoidance)
• Prescriptions from multiple pharmacies for the same class
• Non-standard combinations (opioid + benzodiazepine + muscle relaxant "holy trinity")

Step 2: PDMP Review and Risk Assessment

Query the state PDMP for every new controlled substance prescription (most states mandate this):

PDMP review elements:

• Number of controlled substance prescribers in last 12 months
• Number of pharmacies dispensing controlled substances in last 12 months
• Total MME/day across all opioid prescriptions
• Concurrent benzodiazepine prescriptions
• Early refill patterns (fill dates vs. days' supply)
• Naloxone dispensing history

MME Calculation for Common Opioids:

CDC MME thresholds:

• ≥50 MME/day: Increased overdose risk; reassess need and consider risk mitigation
• ≥90 MME/day: Substantial overdose risk; co-prescribe naloxone, intensify monitoring
• Concurrent opioid + benzodiazepine: Avoid whenever possible (FDA black box warning)

Step 3: Dispensing Controls and Documentation

Schedule II requirements:

• New prescription required each fill (no refills)
• Partial fills allowed if remaining is dispensed within 72 hours (acute care) or 30 days (CARA Act for terminally ill/LTCF)
• Emergency dispensing: up to 72-hour supply with prescriber follow-up prescription within 7 days

Inventory and accountability:

• Perpetual inventory required for Schedule II (count matches record at all times)
• Physical inventory biennial minimum (DEA Form 222 or CSOS for Schedule II ordering)
• Discrepancy investigation within 24 hours of discovery
• DEA Form 106 for theft/loss reporting
• DEA Form 41 or reverse distributor for destruction

Documentation in patient profile:

• PDMP query date and findings
• Risk assessment score
• Clinical rationale for dispensing (especially if red flags addressed)
• Naloxone counseling offered (≥50 MME/day or concurrent benzodiazepine)
• Prescriber communication notes

Step 4: Ongoing Monitoring and Compliance

For patients on chronic controlled substance therapy:

Checkpoint B: Post-Draft Alignment (Mandatory)

1. Has PDMP been queried and documented for this prescription?
2. Is the MME/day calculated and within acceptable risk thresholds?
3. Are concurrent high-risk medications (benzodiazepines) identified and addressed?
4. Has corresponding responsibility been exercised (no red flags unresolved)?
5. Is naloxone co-prescribing offered per CDC guidelines?

Quality Audit

• Prescription contains all legally required elements for its DEA schedule
• Prescriber DEA number verified as active and authorized for the schedule
• PDMP queried and results documented before dispensing
• MME/day calculated across all opioid prescriptions
• CDC MME thresholds applied (50 MME trigger, 90 MME escalation)
• Concurrent benzodiazepine use identified and prescriber notified
• Red flag indicators assessed and resolved or documented
• Corresponding responsibility exercised with clinical rationale
• Naloxone co-dispensing offered when indicated
• Controlled substance inventory reconciles with dispensing records
• Patient identification verified per state requirements
• Refill history is consistent with prescribed days' supply
• Urine drug screen results reviewed for chronic therapy patients
• All controlled substance communication with prescribers is documented

Guidelines

• Corresponding responsibility is a legal obligation: pharmacists MUST refuse prescriptions that do not meet the standard, regardless of prescriber insistence
• Always calculate total MME/day across all opioid prescriptions—a single prescription may be safe but total exposure may not be
• Naloxone co-prescribing is standard of care at ≥50 MME/day, with concurrent benzodiazepines, or with history of overdose/substance use disorder
• PDMP review is not optional in most states; document the query even when findings are unremarkable
• Methadone MME conversion is non-linear and increases disproportionately at higher doses—use extreme caution
• Never store Schedule II controlled substances in unsecured locations; perpetual inventory and access controls are DEA requirements
• Early refill requests require clinical evaluation; "lost" or "stolen" medication claims require prescriber verification and documentation
• Report suspected diversion to the DEA, state board of pharmacy, and institutional compliance immediately