Conquering Pharmacy Audits: Evaluating CS Recordkeeping Methods

According to the Pharmacist’s Manual, the DEA’s closed system of distribution requires pharmacies to account for controlled substances from receipt through dispensing, transfer, and disposal, making effective CS recordkeeping a critical component of compliance and audit preparedness. A common challenge pharmacies face with this work is figuring out how to maintain accurate, complete, and readily retrievable records while keeping up with the demands of daily operations.

To meet these requirements, pharmacies typically rely on one of three approaches. Some choose to manage everything through their pharmacy management system (PMS). Others supplement their PMS with a paper logbook or spreadsheet to improve accountability and strengthen their readiness for pharmacy audits. Increasingly, pharmacies are adopting integrated compliance platforms such as C2 Keep to automate documentation and improve visibility across their controlled substance workflows. In the rest of this blog, we’ll examine the pros and cons of each approach to help you determine which solution best supports your organization and prepares you for future pharmacy audits.

Most modern pharmacy management systems include features for dispensing controlled substances, maintaining perpetual inventory records, and generating reports. As a result, some pharmacies choose to rely solely on their PMS for CS recordkeeping.

This approach is appealing because the system is already part of the daily workflow, eliminating the need to invest in additional compliance tools and training resources relating to CS recordkeeping.

• Simplicity: The biggest advantage of relying solely on a PMS is convenience. Staff are already using the system to fill prescriptions and manage inventory, allowing CS recordkeeping activities to remain within a familiar workflow.
• Lower Cost: Since pharmacies already pay for their PMS, no additional software or documentation system is required.

• No Backup Records: A PMS may serve as the primary source of information, but many pharmacies prefer having an additional layer of accountability. Without a secondary system, pharmacies may have limited options if records are altered, corrupted, or difficult to reconcile.
• Lack of Organization: Relying predominantly on a pharmacy management system oftentimes requires significant manual effort to reconcile discrepancies and review inventory usage. Auditors frequently request to see specific information and locating that can be time-consuming.
• Increased Risk as Operations Grow: As controlled substance volume increases, inventory management becomes more complex. Multi-store pharmacies, LTC pharmacies, and organizations with extensive controlled substance activity may find it more difficult to maintain complete visibility using a PMS alone.

This is a traditional method of CS recordkeeping in which pharmacies manually record controlled substance activities and store associated records in logbooks, binders, or Excel spreadsheets. Typically, this method is used in tandem with a PMS and acts as a safety check to ensure accurate counts. This creates a second accounting record that can be used to verify inventory and support compliance activities. Many DEA and Board of Pharmacy investigators encourage pharmacies to maintain a multi-check workflow that provides an additional layer of accountability and supports pharmacy audit preparedness.

• Additional Security and Accountability: Maintaining a secondary log helps pharmacies verify inventory counts and identify discrepancies that may not be apparent when relying exclusively on a PMS.
• Cost Effective: Compared to software platforms, logbooks and spreadsheets require minimal financial investment.
• Improved Audit Readiness: When maintained properly, manual logs can organize controlled substance activity in a manner that supports inspections and inventory reconciliation.
• Proven and Familiar: Many pharmacists and technicians have used paper logs and spreadsheets for CS recordkeeping for years and are comfortable incorporating them into existing workflows.

• Time-Consuming Data Entry: Every transaction must be documented manually. Over time, this can consume a significant amount of staff time.
• Increased Human Error: Documentation errors remain one of the most common findings during pharmacy audits and inspections. Manual CS recordkeeping introduces risks such as:
  • Mathematical errors
  • Illegible handwriting
  • Missed entries
  • Duplicate entries
  • Incorrect quantities
• Susceptible to Disorganization: Records and files begin to pile up, making it difficult to pull necessary data to complete audits and reconcile inventory discrepancies.
• Delayed Documentation: Paper-based systems can make real-time documentation difficult, increasing the risk of forgotten entries and reconciliation issues.

C2 Keep is a cloud-based controlled substance compliance, audit preparedness, and inventory management platform designed to work alongside a pharmacy’s existing PMS.

Unlike manual logbooks, C2 Keep integrates directly with pharmacy management systems and wholesalers to create a unified compliance workflow. Orders received from wholesalers can automatically populate within the platform, while controlled substance transactions from the PMS generate activity cards that can be reviewed, confirmed, and organized into a readily retrievable audit trail for CS recordkeeping and pharmacy audits.

Supporting documentation such as DEA Form 222 records, CSOS documentation, invoices, and other compliance-related files can also be attached directly to transactions for quick and easy retrieval in the middle of an audit.

• Improved Accuracy: By automating many documentation processes, C2 Keep reduces the manual data entry associated with traditional CS recordkeeping.
• Enhanced Organization and Retrieval: Records, supporting documents, inventory activity, and reporting tools are centralized in a single location.
• Stronger Audit Preparedness: C2 Keep was built specifically with pharmacy audits and controlled substance accountability in mind. Users can quickly locate records, generate reports, and provide supporting documentation when requested.
• Greater Visibility: C2 Keep creates a clearer, more reliable point of reference for controlled substance activity and inventory reconciliation.
• Peace of Mind: For Power Pharmacy, a recent Board of Pharmacy inspection became an opportunity to demonstrate transparency and accountability rather than a stressful search for records.
• Integrated Workflows: Because C2 Keep works alongside both PMS platforms and wholesalers, pharmacies can eliminate much of the duplicate work associated with manual recordkeeping while maintaining the accountability benefits of a secondary compliance system.

• Additional Cost: Compared to using a PMS alone or maintaining paper records, implementing a dedicated compliance solution represents an additional investment. This investment is quickly realized with the time-savings offered and the peace of mind gained with the platform’s audit-preparedness options.
• Learning Curve: Like any software platform, staff must learn new processes and workflows during implementation, simplified by the company’s robust help guides and support staff.

One thing is certain: regulatory scrutiny is not decreasing. As DEA inspections and Board of Pharmacy audits continue to place greater emphasis on inventory reconciliation, documentation accuracy, and readily retrievable records, pharmacies should regularly evaluate whether their current processes are still meeting their needs.

If you’re looking for a better way to streamline CS recordkeeping, improve audit preparedness, and gain greater confidence during pharmacy audits, now may be the perfect time to explore a more integrated approach.

To learn more about how C2 Keep supports controlled substance compliance, watch an interactive demo and explore the platform for yourself.