Preparing for a Wholesaler CSMP Visit

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Full Article: 

Overview 

A wholesaler CSMP (Controlled Substance Monitoring Program) audit is designed to ensure that pharmacies are actively monitoring, evaluating, and responsibly dispensing controlled substances. The goal is to confirm that pharmacy staff understand prescribing trends, identify potential red flags, and consistently apply due diligence when dispensing. 

Not all questions will be asked during an audit, but preparation is essential. Staff should answer all questions honestly and concisely, providing only the information requested. 

Common Onsite Questions 

Inspectors may ask about pharmacy practices, policies, and observations related to controlled substances. Be prepared to address topics such as: 

• Employee background checks  
• Awareness of concerning prescribers in the area  
• Use of the state Prescription Drug Monitoring Program (PDMP)  
• Procedures for handling out-of-state or out-of-area prescriptions  
• History of theft or loss of controlled substances, including reporting and corrective actions  
• Recent visits from regulatory agencies  
• Communication processes with prescribers when concerns arise  
• Pharmacist authority to refuse prescriptions and examples of when this has occurred  
• Policies on patient transfers and prescription transfers  
• Observations of drug-seeking behavior (e.g., gabapentin or promethazine with codeine)  
• Identification and handling of high-risk prescribing combinations (e.g., opioid + benzodiazepine + muscle relaxant, also known as the “holy trinity”)  
• Risks associated with combinations such as amphetamines, opioids, and benzodiazepines  
• Mailing prescriptions, especially controlled substances, across state lines  
• Knowledge of commonly abused controlled substances  
• Identification of top prescribers and their specialties  
• Recognition of prescribers with disproportionate controlled substance prescribing  

Due Diligence and Corresponding Responsibility 

Pharmacies must demonstrate compliance with due diligence and corresponding responsibility requirements under the Controlled Substances Act (CSA). Key processes include: 

• Routine PDMP checks  
• Clear refill policies for controlled substances  
• Verification procedures for geographically distant prescriptions  
• Monitoring and documentation of cash-pay prescriptions  
• Documentation of diagnosis where appropriate  
• Evaluation of prescriber scope of practice  
• Review of dosage, strength, and Morphine Milligram Equivalents (MME)  
• Evaluation of total stimulant doses 
• Assessment of therapeutic appropriateness and step therapy  
• Monitoring for doctor or pharmacy shopping  
• Identifying patterns such as identical prescriptions across multiple patients  
• Use of controlled substance dispensing checklists  

Implementing a standardized dispensing checklist helps ensure consistent application of these safeguards. 

Expectations for Pharmacists-in-Charge (PIC) and Owners 

Leadership should be prepared to discuss: 

• Controlled substance policies, procedures, and documentation of compliance  
• Local and internal prescribing and dispensing trends  
• Highly diverted controlled substances within the pharmacy  
• Top prescribers of controlled substances  
• Identified red flags and corresponding explanations, including:  
  • High ratios of controlled vs. non-controlled prescriptions  
  • High volumes of highly diverted drugs  
  • Frequent dispensing of high-dose medications (e.g., oxycodone 30 mg)  
  • Disproportionate prescribing patterns  
  • High percentage of cash-paid controlled substance prescriptions  
  • Significant increases in ordering volumes  

If previous audits identified deficiencies, leadership must clearly explain corrective actions taken. 

Additionally, pharmacies should be prepared to disclose and discuss any past disciplinary actions, including resolutions and safeguards implemented. 

Inspection Logistics and Considerations 

• The PIC and/or pharmacy owner should dedicate uninterrupted time for the audit  
• Audits do not require granting access to the dispensing area and may be conducted in a separate space  
• Inspectors may request documentation such as employee background checks  
• Auditors may review dispensing and purchasing data  
• The national benchmark for controlled vs. non-controlled prescriptions is approximately 20%  

Consequences of Noncompliance 

Failure to meet CSMP expectations can result in significant consequences. Wholesalers may revoke a pharmacy’s ability to order controlled substances—typically for up to one year. 

While these audits are not conducted by government agencies, their impact can be severe, potentially disrupting pharmacy operations and patient care. 

Key Takeaway 

Preparation, consistency, and documentation are critical. All pharmacy staff should be knowledgeable about controlled substance policies and actively engaged in compliance efforts to ensure a successful CSMP audit outcome. 

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.