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Pharmacy Controlled Substances Management Audit Checklist

A comprehensive checklist for auditing controlled substances management practices in pharmacies, covering inventory control, security measures, record-keeping, and staff training to ensure regulatory compliance and prevent drug diversion.

Pharmacy Controlled Substances Management Audit Checklist

by: audit-now
4.1

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About This Checklist

Proper management of controlled substances in pharmacies is crucial for patient safety, regulatory compliance, and prevention of drug diversion. This Pharmacy Controlled Substances Management Audit Checklist is designed to help healthcare professionals systematically evaluate and improve their practices in handling, storing, and dispensing controlled substances. By addressing key areas such as inventory control, security measures, record-keeping, and staff training, this checklist helps identify potential risks, ensure strict adherence to DEA regulations, and maintain the highest standards of controlled substance management. Regular use of this checklist can significantly reduce the risk of drug diversion, improve accountability, and ultimately contribute to safer medication practices and community health.

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Industry

Healthcare

Standard

DEA Controlled Substances Regulations

Workspaces

Pharmacies

Occupations

Pharmacists
Pharmacy Managers
Controlled Substance Coordinators
Pharmacy Technicians
Compliance Officers
1
Is the controlled substance inventory reconciled regularly?
2
Is there a procedure in place for verifying prescriptions?
3
How often are controlled substances disposed of?
Min: 1
Target: Monthly
Max: 365
4
Describe the security measures in place for controlled substances.
5
Have all staff members undergone drug diversion prevention training?
6
What is the procedure for reporting incidents related to controlled substances?
7
When was the last inspection conducted for controlled substances?
8
What is the temperature range maintained for storing controlled substances?
Min: 15
Target: 20-25°C
Max: 30
9
Is access to controlled substances restricted to authorized personnel only?
10
What record-keeping practices are in place for controlled substances?
11
How often is the inventory of controlled substances audited?
Min: 30
Target: Quarterly
Max: 365
12
Describe the emergency response plan in case of drug diversion incidents.
13
Are there systems in place to monitor the usage of controlled substances?
14
What methods are used for the disposal of controlled substances?
15
What is the average time taken to process a prescription for controlled substances?
Min: 1
Target: Under 30 minutes
Max: 120
16
When is the next scheduled compliance training for staff regarding controlled substances?
17
Are surveillance procedures in place for monitoring controlled substance dispensing?
18
What educational materials are provided to patients regarding controlled substances?
19
What is the accuracy rate of controlled substance inventory counts?
Min: 0
Target: Above 95%
Max: 100
20
What actions are taken to follow up on audit findings related to controlled substances?

FAQs

The audit should be conducted monthly, with additional spot checks performed randomly throughout the year to ensure ongoing compliance.

The audit is typically performed by the pharmacist-in-charge, designated controlled substance coordinators, or specially trained pharmacy staff members with authority to handle controlled substances.

The checklist covers areas such as inventory reconciliation, security measures, prescription verification, disposal procedures, staff access controls, and record-keeping practices.

Audit results can be used to identify areas for improvement in security protocols, enhance staff training on controlled substance handling, update policies and procedures, and implement more robust tracking systems.

Yes, the checklist is designed to cover all schedules of controlled substances (II-V) with specific considerations for each schedule as required by regulations.

Benefits of Pharmacy Controlled Substances Management Audit Checklist

Ensures compliance with DEA regulations and state laws governing controlled substances

Reduces the risk of drug diversion and improves accountability in controlled substance handling

Enhances security measures for storage and access to controlled substances

Improves accuracy in controlled substance inventory management and record-keeping

Facilitates early detection of discrepancies or suspicious activities related to controlled substances