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
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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 Act Regulations

Workspaces

Pharmacies

Occupations

Pharmacists
Pharmacy Managers
Controlled Substance Coordinators
Pharmacy Technicians
Compliance Officers

Controlled Substances Management Practices

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1
What actions are taken to follow up on audit findings related to controlled substances?

Provide a detailed description of follow-up actions for audit findings.

Documenting follow-up actions is crucial for addressing issues and improving compliance.
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2
What is the accuracy rate of controlled substance inventory counts?

Enter the inventory accuracy rate as a percentage.

High accuracy rates are essential for ensuring compliance and preventing diversion.
Min0
TargetAbove 95%
Max100
3
What educational materials are provided to patients regarding controlled substances?

Describe the educational materials for patients.

Educating patients about controlled substances promotes safe usage and awareness of risks.
4
Are surveillance procedures in place for monitoring controlled substance dispensing?

Select the status of surveillance procedures.

Surveillance procedures help detect irregularities in dispensing practices that may indicate diversion.
5
When is the next scheduled compliance training for staff regarding controlled substances?

Select the date for the next compliance training.

Regular training is essential for keeping staff updated on compliance requirements and best practices.
6
What is the average time taken to process a prescription for controlled substances?

Enter the average processing time in minutes.

Monitoring processing times can help identify inefficiencies and improve patient care.
Min1
TargetUnder 30 minutes
Max120
7
What methods are used for the disposal of controlled substances?

Describe the disposal methods for controlled substances.

Proper disposal methods are crucial for preventing environmental contamination and misuse of controlled substances.
8
Are there systems in place to monitor the usage of controlled substances?

Select the status of monitoring systems for controlled substances.

Monitoring systems help in identifying patterns that may indicate misuse or diversion of controlled substances.
9
Describe the emergency response plan in case of drug diversion incidents.

Provide a detailed description of the emergency response plan.

Having a response plan ensures swift action to mitigate risks associated with drug diversion.
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10
How often is the inventory of controlled substances audited?

Enter the frequency of inventory audits in terms of days.

Regular audits are necessary to ensure accurate inventory records and compliance with regulations.
Min30
TargetQuarterly
Max365
11
What record-keeping practices are in place for controlled substances?

Describe the record-keeping practices for controlled substances.

Proper record-keeping is essential for compliance with DEA regulations and for tracking inventory.
12
Is access to controlled substances restricted to authorized personnel only?

Select the access control status.

Restricting access is vital for preventing unauthorized handling and potential diversion of controlled substances.
13
What is the temperature range maintained for storing controlled substances?

Enter the storage temperature in degrees Celsius.

Maintaining the proper storage temperature is crucial for the efficacy and safety of controlled substances.
Min15
Target20-25°C
Max30
14
When was the last inspection conducted for controlled substances?

Select the date of the last inspection.

Keeping track of inspection dates is essential for maintaining compliance with regulatory requirements.
15
What is the procedure for reporting incidents related to controlled substances?

Describe the incident reporting procedure for controlled substances.

Having a clear reporting procedure helps in addressing incidents swiftly and ensuring compliance.
16
Have all staff members undergone drug diversion prevention training?

Select the training compliance status.

Training ensures that staff members are aware of the risks and prevention strategies related to drug diversion.
17
Describe the security measures in place for controlled substances.

Provide a detailed description of security measures.

Documenting security measures is vital for compliance and risk management.
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18
How often are controlled substances disposed of?

Enter the frequency of disposal in terms of days.

Regular disposal of controlled substances is necessary for compliance and to prevent misuse.
Min1
TargetMonthly
Max365
19
Is there a procedure in place for verifying prescriptions?

Indicate whether a prescription verification procedure is established.

Having a verification procedure helps prevent errors and misuse of controlled substances.
20
Is the controlled substance inventory reconciled regularly?

Select the compliance status.

Regular reconciliation ensures that inventory levels match actual stock, which helps prevent drug diversion.

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

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