Pharmacists are all too familiar with the delicate balance between ensuring patient access to necessary medications and preventing controlled substance diversion in their communities. The Controlled Substance Monitoring Program (CSMP), a set of stringent requirements imposed by the Big 3 distributors (Cencora (formerly AmerisourceBergen), Cardinal Health, and McKesson) on their customers, plays a vital role in managing controlled substance compliance efforts. A huge part of this controlled substance policy revolves specifically around CSMP thresholds.

Understanding the CSMP is essential for all retail pharmacists and their staff. However, the challenging part is that CSMP personnel are prohibited from providing pharmacies specific information about their thresholds or how they are calculated. This blog aims to give pharmacists a run-down of all the information known about CSMP thresholds, the pharmacy customer data the Big 3 distributors collect, and how this all relates to the previously discussed CSMP red flags.  

CSMP Thresholds: What They Are and Their Role in Controlled Substance Compliance

Think of CSMP thresholds as carefully calculated limits on the quantity of controlled substances a pharmacy can order within a given period. These limits, established for individual Drug Enforcement Administration (DEA) base codes, help maintain controlled substance compliance by acting as early warning systems, flagging potentially suspicious orders before they even leave the distributor’s warehouse.

Threshold Establishment Methods

When it comes to establishing and maintaining customer thresholds for controlled substance compliance, distributors will use one of two methods:

1. Model-Based Thresholds: 

The primary approach used by distributors, this method relies heavily on sophisticated statistical models. A model-based approach considers a range of factors, including:

• Pharmacy Size: Larger pharmacies with a higher volume of prescriptions typically have higher thresholds.
• Ordering and Dispensing History: A pharmacy’s past ordering and dispensing patterns, particularly for controlled substances, are crucial data points. This Pharmacy Customer Data provides valuable insights into a pharmacy’s typical needs.
• Geographic Location: Regional variations in prescribing and dispensing trends influence threshold calculations.
• Business Model: Pharmacies serving specialized patient populations may have their thresholds adjusted accordingly.

2. Non-Model Thresholds: 

In certain situations, distributors may deviate from model-based thresholds, opting for a more individualized approach based on documented due diligence and analysis. These non-model thresholds are used when specific circumstances warrant a more tailored approach.

Threshold Management and Oversight

The CSMP mandates strict procedures when it comes to managing and overseeing the setting, auditing, and modification processes of all CSMP thresholds.

Threshold Setting:

• Each of the big 3 distributors has a CSMP department responsible for overseeing the establishment and modification of all thresholds.
• Sales departments within the big 3 are strictly prohibited from influencing threshold decisions.
• Distributors must consider the diversion risk of each drug base code, reassessing it annually.
• Thresholds must be established for new customers before any controlled substances are supplied.

Threshold Auditing:

• Distributors must review customer thresholds annually and make necessary adjustments.
• The CSMP department also conducts annual evaluations of its threshold-setting methodology, processes, and personnel performance.

Threshold Modifications:

• Based on CSMP policies and procedures, distributors may increase or decrease a customer’s threshold.
• Pharmacies can also request a threshold increase, which triggers a due diligence process conducted by the distributor’s CSMP personnel. This includes:
  • Obtaining a written justification for the request.
  • Reviewing three months of dispensing data for both controlled and non-controlled substances.
  • Potentially conducting an on-site visit.

• However, distributors cannot proactively contact a customer to suggest that the customer request an increase to any of its thresholds 
• The Chief Diversion Control Officer may approve criteria for threshold adjustments in specific circumstances, such as seasonal ordering, national emergencies, IT errors, or data anomalies.
• All threshold changes must be documented, clearly stating the reason for the change and ensuring alignment with the distributor’s controlled substance policy.

CSMP Red Flags: Beyond Thresholds

CSMP thresholds and red flags are distinct but interconnected components of the CSMP. In essence, red flags can oftentimes serve as the basis for a customer’s threshold, while a threshold can be the trigger point of a red flag investigation. Together, they work to evaluate the effectiveness of each customer’s controlled substance compliance efforts.

• Setting the threshold: If a pharmacy consistently exhibits red flags like high cash payments for controlled substances, their threshold might be set lower than a comparable pharmacy without such red flags.
• Triggering an investigation: If a pharmacy’s order surpasses its threshold, distributors are more likely to scrutinize that order for other red flags, such as unusual formulations or out-of-area patients, before fulfilling it.

Conclusion

CSMP thresholds, combined with red flags, serve as a proactive framework for overseeing controlled substance compliance initiatives. Pharmacists are central to this system, ensuring compliance by adhering to controlled substance policies, understanding threshold limits, and maintaining open communication with distributors to sustain seamless operations. When controlled substances go missing, pharmacists must act swiftly to resolve the issue and implement measures to prevent future occurrences. For guidance on reconciling missing pills, click here, or explore best practices for maintaining compliant records here.