Overview of Injunctive Relief and Wholesaler CSMP Process

Injunctive Relief 

AmerisourceBergen (ABDC), Cardinal Health (CAH), and McKesson Corporation (McKesson) finalized a national settlement with multiple states and local governments in response to the wholesalers’ activities related to the distribution of opioids. 

As part of that settlement, injunctive relief establishes criteria for wholesalers’ controlled substance monitoring programs (CSMPs) which monitor distribution of controlled substances to pharmacies. The injunctive relief standardizes requirements for wholesalers’ due diligence responsibilities including customer diligence reviews, customer data analysis, establishing ordering thresholds, and reporting suspicious orders. 

Wholesaler CSMPs may request pharmacies to complete pharmacy questionnaires, submit dispensing data for analysis, and participate in on-site audit or virtual audits. 

Pharmacy questionnaires-used to gather pharmacy and personnel-specific data, such as licenses, registrations, and general controlled substances ordering and dispensing information.  

NOTE: Pharmacy and licensee data will be used to research instances of disciplinary actions such as fraud, diversion, or criminal or civil penalties. Pharmacies, owners and /or PICs should be prepared to disclose any disciplinary actions on the pharmacy questionnaires and discuss the situation during the PIC interview, including any and all corrective actions taken.    

Dispensing data-Pharmacy Customer Data (PCD) is aggregate dispensing data for the previous 3 full calendar months. PCD must only be submitted if requested by CSMP teams.   

On site or virtual audits-CSMP staff conduct in-person visits to review PCD data, interview staff regarding pharmacy controlled substances policies and procedures, and address potential red flags.  

Wholesalers utilize this process to identify pharmacies that are not complying with controlled substances due diligence procedures and other red flags.  

However, wholesaler CSMP audits can be random for any pharmacy, not just those with identified red flags therefore, every pharmacy must be familiar with and prepared for a wholesaler CSMP audit. Pharmacies are typically audited every one to two years.   

Situations that Initiate a Wholesaler CSMP Audit: 

Injunctive relief terms require wholesalers to initiate a CSMP audit in the following circumstances:  

1. Before onboarding a new pharmacy.  

1. When a pharmacy requests a purchasing threshold increase.  

1. Address red flags of diversion.  

1. Other due diligence procedures (i.e. random pharmacy audits).   

Typical Highly Diverted Controlled Substances:  

Red Flags 

• Ratios of highly diverted controlled substances to noncontrolled substances.  

• Ordering ratio of highly diverted controlled substances to noncontrolled substances.  

• Excessive ordering growth of controlled substances.  

• Continued ordering of controlled substances that have hit a threshold limit. 

• Unusual formulation ordering.  

• Out-of-area patients.  

• Cash prescriptions.  

• Prescriber activity, specifically:  

• Top controlled substance prescribers where the prescriber’s office is located 50 miles away or more from the pharmacies.  

• Top prescribers participating in pattern prescribing (same dosages, quantities, etc.) of highly diverted controlled substances.  

• Top prescribers contributing more than 50% of total prescriptions for highly diverted controlled substances.  

• Public regulatory actions against pharmacies.  

• Customer termination data.   

Pharmacy Expectations  

• Promptly respond to any requests from wholesaler CSMP personnel.  

• Promptly provide any requested data and correct any data exception requests. 

• Respond to any requests (written or in-person) respectfully and professionally.  

• Pharmacy staff should be acutely aware of overall trends in controlled substance prescription prescribing and dispensing, especially for highly diverted controlled substances.  

Consequences for Noncompliance or Unsatisfactory Audits 

Wholesalers can and will revoke a pharmacy’s controlled substances ordering privileges. Typically, they revoke those privileges for one year. That means a pharmacy will not be able to order any controlled substances for an entire year.  

Although these audits are not from a state or federal regulatory agency, they can significantly impact your pharmacy business by eliminating your ability to order controlled substances. All pharmacy staff must be knowledgeable of and actively engaged in due diligence/corresponding responsibility pharmacy procedures and wholesaler CSMP audits.