In a veterinary practice, the responsible handling and storage of controlled drugs are crucial not only for regulatory compliance but also for the safety of both animals and staff. Controlled drugs, such as opioids and certain sedatives, have the potential for misuse and can pose serious risks if mishandled.
Understand Regulatory Requirements
Familiarizing yourself with the regulatory requirements governing controlled drugs in your region is essential. These requirements can vary by country, state, or province. Key regulatory bodies often include the Drug Enforcement Administration (DEA) in the United States or equivalent agencies in other countries. Ensure you and your staff know these regulations and regularly check for updates. It is also crucial to review which drugs are controlled in your area, as sometimes these are revised.
- Check your state and federal regulations.
- Do not be afraid to consult with regulatory boards for guidance.
- Review your processes often to make sure that your practice is compliant.
- Many practices overlook hiring and onboarding processes. Background checks are required.
Designate a Controlled Substance Manager
Appoint a designated individual within your veterinary practice as the Controlled Substance Manager. This person should have a deep understanding of the regulatory requirements and be responsible for overseeing all aspects of controlled drug management, including storage, record-keeping, and disposal.
Unpacking an inventory order that contains controlled drugs
Controlled drugs typically come packed separately from the non-controlled inventory. Amounts must be updated and entered into the drug log immediately upon receipt. Invoices must be kept for at least two years. These should be easily accessible during inspection.
Secure and Lock Storage
Controlled drugs must be stored securely in a locked cabinet or safe that meets specific security requirements outlined in regulations. The storage area should be separate from other medications to prevent confusion and unauthorized access. Invest in a sturdy, tamper-resistant locking system to ensure the highest level of security.
Access Control and Authorized Personnel
Access to the controlled drug storage area should be restricted to authorized personnel only. Maintain a list of individuals with access rights and regularly update it. Consider implementing electronic access control systems that track and log who enters the storage area and when.
Accurate record-keeping is critical for controlled drugs. Maintain detailed records of drug acquisitions, dispensing, administration, and disposal. Include information such as drug name, quantity, date, patient information, prescriber, and dispenser’s signature. Regularly review and reconcile records to identify discrepancies or missing items promptly.
Logs must be stored in a locked cabinet separate from the physical drugs. CII logs should be stored separately from your class CIII-CV logs.
Refrigerated controlled drugs should be stored in the refrigerator in a locked box.
Regular Audits and Inventory Checks
Conduct routine audits and inventory checks to ensure that the quantity of controlled drugs on hand matches what is documented in your records. These checks help detect potential theft or discrepancies in a timely manner and maintain compliance with regulatory requirements. Daily audits at both the beginning and end of each day are recommended. Practice management software can be beneficial in monitoring controlled drugs if used correctly. If using practice management software or a computerized drug log, you must be able to print the log in the event of an audit.
Temperature and Environmental Control
Some controlled drugs may require specific temperature and environmental conditions for stability. Ensure that your storage area maintains the necessary temperature and humidity levels. Use temperature monitoring devices to track and record conditions regularly.
Clearly label all containers holding controlled substances with essential information, including the drug name, concentration, expiration date, and a unique identifier for the container. This labeling helps prevent mix-ups and ensures easy identification.
Educate and Train Staff
Comprehensive staff training ensures that everyone in your veterinary practice understands the importance of controlled drug storage and handling. Train your team on the specific protocols and security measures in place, emphasizing the legal and ethical responsibilities associated with controlled substances.
Dispose of expired or unused controlled drugs following the appropriate regulations. This often involves working with a licensed waste disposal company (reverse distribution) to ensure proper disposal methods are followed.
Some reverse distributors are:
If you have drugs to waste, waste them using DEA form 41 with an approved disposal method. You must ensure your forms are complete and accurate and you have a witness present throughout the process.
Your veterinary distributors are a valuable source of information on this topic.
Properly storing controlled drugs in a veterinary practice is essential for regulatory compliance and patient safety. By designating a Controlled Substance Manager, following regulatory requirements, securing storage, maintaining accurate records, and regularly educating your staff, you can create a safe and responsible environment for handling controlled substances. Prioritize these best practices to ensure the well-being of your patients, staff, and your practice’s reputation.
Written by: Cynthia Tucker Bain