Conducting regular controlled substance audits is one of the most effective ways to protect a pharmacy’s operations and maintain regulatory compliance. Yet, for many busy pharmacists and staff, finding the time to perform these audits consistently can be a challenge, especially when relying on a manual recordkeeping system. At C2 Keep, we’ve seen firsthand how manual processes are not only time-consuming but also increase the risk of human error, inventory discrepancies, and compliance gaps.
For pharmacies looking to streamline this process, the key is maintaining a perpetual inventory that’s accurate, accessible, and audit-ready at any moment. That’s where C2 Keep comes in. Designed with pharmacy efficiency in mind, C2 Keep simplifies controlled substance audits with a customizable digital platform that makes tracking and reporting effortless. With C2 Keep, staying compliant doesn’t have to be complicated, it becomes part of your workflow.
This blog will explore why regular controlled substance audits are crucial for your pharmacy, best practices for maintaining consistent audits, and how a solution like C2 Keep can make the process seamless.
Why Regular Controlled Substance Audits Are Crucial for Your Pharmacy
Implementing regular controlled substance audits is not just a regulatory requirement, it’s a fundamental practice that supports patient safety and strengthens your business. Here’s why consistent auditing is vital:
- Ensuring Compliance with Regulations: Regulatory agencies like the Drug Enforcement Administration (DEA) and state pharmacy boards require strict adherence regarding controlled substance audits. Some states, such as California, Massachusetts, and Minnesota, impose additional requirements beyond the federal baseline. Controlled substance audits serve as proactive checks for compliance, helping identify vulnerabilities that could lead to drug diversion. Noncompliance can result in hefty fines, license suspension or revocation, and lasting damage to your pharmacy’s reputation.
- Maintaining Accurate Records: Accurate recordkeeping is a cornerstone of DEA compliance. Pharmacies are required to document every controlled substance transaction, including dispensing, destruction, and inventory tracking. Regular audits verify the accuracy and completeness of these records, ensuring nothing slips through the cracks.
- Effective Risk Management: Audits help mitigate the risk of theft, loss, or misuse—particularly with high-risk medications. Amid the ongoing opioid crisis, this level of vigilance is more important than ever. Regular auditing ensures medications are tracked properly and dispensed by authorized personnel for appropriate use.
Clearly, developing a habit of consistent auditing provides lasting benefits. The next section covers how to incorporate auditing into your pharmacy’s workflow effectively.
Best Practices for Implementing Regular Auditing Into Your Workflow
To ensure effective auditing and compliance with the Controlled Substances Act (CSA), consider the following best practices:
- Run Audits Regularly: While federal regulations require inventory records to be retained for at least two years, conducting controlled substance audits more frequently is strongly recommended. DEA inspections can occur at any time, so staying audit-ready is essential. At a minimum, consider monthly audits, especially for Schedule II substances, to stay ahead of compliance requirements.
- Maintain Clear, Perpetual Records: Records should be complete, accurate, and easy to retrieve. A perpetual inventory system provides a real-time view of your stock levels, improving accuracy and audit readiness. Ensure that your records are stored securely in a format that cannot be altered or forged.
- Separate CII Records: DEA regulations mandate that Schedule II inventory records be stored separately from other records. These should be legible, securely stored, and easily accessible during an audit.
- Use Integrated Solutions: Manual logs and spreadsheets are not only inefficient but also prone to error. Switching to an integrated digital system streamlines recordkeeping, minimizes risk, and boosts productivity. Integrated solutions also prevent silos by keeping your data in one central place.
While these practices are straightforward, time and staffing limitations often make regular audits feel out of reach. Thankfully, tools like C2 Keep make implementing them simple and stress-free.
How C2 Keep Makes Auditing a Breeze
C2 Keep is a controlled substance inventory management and compliance platform that simplifies auditing from start to finish. It helps pharmacies save up to 25 hours each month by automating tasks and streamlining workflows, freeing up time to focus on patient care. Here’s how C2 Keep makes audits easier:
- Structured Organization: C2 Keep centralizes all your controlled substance data, making it easy to access during an audit. Every inventory change is tracked to a specific time and user, providing a complete, traceable history.
- Custom Report Generation: Our platform automatically generates DEA- and state-mandated reports in seconds. You can also create customized reports, including “all drug” audits, active/inactive drug lists, ad-hoc audits, 90-day audits, and back-count audits.
- Inventory Transparency: With real-time insights from perpetual inventory tracking, C2 Keep makes it easier to investigate and resolve discrepancies. The system helps pinpoint the exact source of errors, reducing time spent on manual investigations.
- Corrective Action Plan Generation: If your pharmacy is under a Corrective Action Plan (CAP), C2 Keep provides the reporting tools you need to meet your specific compliance obligations.
- Significant Time Savings: By replacing outdated manual systems with automated workflows, C2 Keep reduces time spent on audits and lowers the risk of costly compliance issues.
Take Control of Your Audits Today
Regular controlled substance audits aren’t just a regulatory box to check, they’re critical to safeguarding your pharmacy, protecting your patients, and ensuring long-term operational success. While time and staffing challenges can make audits difficult, C2 Keep is designed to simplify the process and help you stay confidently compliant.
Stop spending unnecessary time and money on avoidable inventory issues. Schedule a free C2 Keep demo today and see how it can transform controlled substance audits to be more efficient, accurate, and audit-ready at all times.