Corresponding Responsibility & Red Flag Identification in Controlled Substance Dispensing

RELATED LINKS 

For additional resources to support pharmacy controlled substance prescription compliance click HERE. 

 

FULL ARTICLE 

Overview 

Pharmacies play a critical role in preventing the abuse and diversion of controlled substances. Every member of the pharmacy team contributes to maintaining compliance and protecting patient safety. 

A core component of this responsibility is corresponding responsibility—the obligation of pharmacists to ensure that controlled substance prescriptions are issued for a legitimate medical purpose before dispensing. 

Failure to properly evaluate prescriptions increases the risk of diversion and exposes both prescribers and pharmacists to regulatory action. 

 
 

What is Corresponding Responsibility? 

Corresponding responsibility means that a pharmacist must verify that every controlled substance prescription: 

• Is issued for a legitimate medical purpose  
• Is written by a prescriber acting within their professional scope  

This responsibility is shared between the prescriber and the pharmacist. 

 
 

Training Requirements 

To maintain compliance: 

• All pharmacy staff should complete controlled substance and red flag training at onboarding  
• Ongoing (at least annual) training should reinforce identification and response procedures  
• Training records should be maintained and accessible  

 
 

Pharmacist Responsibilities 

Pharmacists must apply professional judgment when evaluating prescriptions and: 

• Actively assess prescriptions for legitimacy  
• Identify and evaluate red flags  
• Take steps to resolve concerns before dispensing  
• Protect the pharmacy from becoming a target for diversion  

 
 

Identifying Red Flags 

Red flags are warning signs that may indicate a prescription is fraudulent, altered, or not issued for a legitimate medical purpose. 

Prescriber-Related Red Flags 

• Prescribing unusually high volumes of controlled substances  
• Prescribing excessive quantities or strengths  
• Prescribing conflicting or antagonistic medications  
• Repetitive prescribing patterns across patients  
• Prescribing high-risk drug combinations (e.g., opioid + benzodiazepine + muscle relaxer)  
• Practicing far from the patient or pharmacy without clear justification  
• Prescribing despite suspended or restricted authority  

 
 

Patient-Related Red Flags 

• Traveling long distances without reasonable explanation  
• Presenting prescriptions for multiple patients (outside caregiver scenarios)  
• Arriving in groups with similar prescriptions  
• Requesting large quantities or multiple controlled substances  
• Displaying suspicious behavior (e.g., pressure, urgency, unusual politeness)  
• Showing signs of misuse (sedation, confusion, withdrawal symptoms)  
• Preferring cash payments for controlled substances  
• Requesting drugs by street names or specific markings  
• Visiting multiple prescribers or pharmacies  
• Frequent early refill requests  
• Repeated claims of lost prescriptions  
• Requesting only controlled medications when multiple are prescribed  

 
 

Prescription-Related Red Flags 

• Stolen or suspicious prescription pads  
• Alterations to quantities, strengths, or refills  
• Unusually “perfect” or inconsistent formatting  
• Spelling errors (especially drug names)  
• Appearing copied or forged  
• Use of private or unverifiable callback numbers  
• Electronic prescriptions transmitted outside normal office hours  

 
 

Resolving Red Flags 

All red flags must be fully addressed before dispensing. 

Steps may include: 

• Contacting the prescriber to verify legitimacy  
• Confirming prescriber credentials and DEA registration  
• Clarifying prescription details (drug, dose, quantity, directions)  
• Reviewing diagnosis, treatment plan, and clinical appropriateness  
• Checking the Prescription Drug Monitoring Program (PDMP)  
• Discussing concerns directly with the patient  

 
 

Documentation Requirements 

All actions taken to resolve red flags must be clearly documented. 

Best Practices 

• Document each red flag identified  
• Record all steps taken to investigate concerns  
• Include names, titles, dates, and times of communications  
• Ensure documentation is linked to the prescription record  
• Avoid vague or generic notes  

Documentation Methods 

• Handwritten prescriptions: document directly on the prescription  
• Electronic prescriptions: maintain and link documentation electronically to the original prescription  

 
 

When to Refuse to Dispense 

A pharmacist may decline to dispense if: 

• The prescription is determined to be fraudulent  
• Legitimacy cannot be verified  
• The therapy is not medically appropriate  

In these cases: 

• Follow applicable state laws  
• Document all findings and communications  
• Communicate appropriately with the patient  

Common refusal scenarios may include: 

• Excessive MMEs without valid justification  
• High-risk drug combinations without clinical rationale  
• Multiple prescribers and pharmacies indicating potential diversion  

NOTE: In some instances, the pharmacist validates the prescription but determines the prescription is not medically indicated or appropriate, the pharmacist reserves the right to refuse to dispense the medication.  

 
 

Handling Fraudulent Prescriptions 

If a prescription is suspected or confirmed to be fraudulent: 

• Verify and document patient identification  
• Decline to dispense  
• Contact appropriate authorities as required (e.g., law enforcement, regulatory agencies) 
• Follow all applicable state regulations  

 
 

Escalation of Concerns 

If a prescriber is suspected of issuing fraudulent or inappropriate prescriptions: 

• Notify the appropriate regulatory authority (e.g., State Board of Pharmacy)  
• Contact the appropriate DEA office if necessary  

 
 

Use of Dispensing Checklists 

Implementing a controlled substance dispensing checklist helps ensure consistency and compliance. 

High-risk medications that may require enhanced review include: 

• Opioids (e.g., oxycodone, hydrocodone, morphine, fentanyl)  
• Methadone  
• Tramadol  
• Benzodiazepines (e.g., alprazolam)  
• Muscle relaxants (e.g., carisoprodol)  

Completed checklists should be stored and linked to the prescription record. 

 
 

Final Considerations 

Pharmacists are the final safeguard in preventing controlled substance misuse and diversion. Consistent application of corresponding responsibility principles, combined with strong documentation and training practices, is essential for compliance and patient safety. 

 
 

KEY TAKEAWAYS 

• Corresponding responsibility requires pharmacists to verify prescription legitimacy  
• Red flags must be identified, investigated, and resolved prior to dispensing  
• Documentation is essential—if it’s not documented, it didn’t happen  
• Pharmacists have the authority to refuse prescriptions when concerns remain  
• Training, consistency, and monitoring are critical to compliance  
• Dispensing checklists improve accuracy and audit readiness  

 

Disclaimer: These tools and templates are intended for general informational purposes and are provided by Montana Family Pharmacies as a service to pharmacies. While we try to keep the information timely and accurate, we make no guarantees. These tools and templates are not a substitute for legal, regulatory, or professional advice. 

Policies and procedure, templates, checklists, and other tools should be customized to fit the specific needs and regulatory requirements of your pharmacy. 

Montana Family Pharmacies disclaims any liability for any damages, losses, or other consequences arising from the use or reliance on the tools or policy templates.