Internal Audit Checklist for Pharmacy - FREE PDF | Lumiform

Internal audit checklist for pharmacy

About the Internal audit checklist for pharmacy

Using an internal audit checklist for pharmacy is crucial for maintaining compliance and optimizing your pharmacy operations. This template provides a structured approach to evaluating processes, inventory, and regulatory adherence. By using an internal audit checklist, you can streamline your audit process, ensuring all critical areas are covered and documented thoroughly.

The primary purpose of this template is to help you identify areas for improvement and ensure that all pharmacy operations meet industry standards. It aids in maintaining accurate records, verifying inventory levels, and ensuring that staff follow proper procedures.

Implementing this tool not only enhances compliance efforts but also improves the overall quality of service provided to customers. By using this internal audit checklist , you can safeguard your pharmacy’s reputation and ensure patient safety, setting your operations apart from others in the industry.

Key elements of an internal audit checklist for pharmacy

An internal audit checklist for pharmacy is essential for ensuring compliance and optimizing operations. Here are the crucial components that make this template effective:

Regulatory compliance review: This section ensures that your pharmacy adheres to industry regulations and standards. By verifying compliance, you can avoid potential fines and maintain a reputation for reliability and safety.
Inventory management: Track and verify stock levels, ensuring medications are stored correctly and discrepancies are addressed promptly. Effective inventory management is crucial for maintaining supply chain integrity and patient safety.
Process assessment: Evaluate the efficiency and effectiveness of your pharmacy’s processes, from prescription handling to customer service. Identifying areas for improvement helps you streamline operations and enhance service quality.
Staff training and competency: Check that all personnel are adequately trained and follow standard operating procedures. Ensuring that staff are competent and knowledgeable is vital for maintaining high-quality service and patient care.

How to customize an internal audit checklist for pharmacy

To make the most of an internal audit checklist for pharmacy, you can tailor it to fit your specific needs and organizational structure. Start by aligning the template with your unique processes and regulatory requirements. Modify sections to reflect the specific documentation and procedures relevant to your operations, ensuring comprehensive coverage.

Incorporate industry-specific standards to ensure the checklist remains relevant and thorough. This customization helps capture all essential compliance elements and facilitates a smooth audit process. Additionally, consider adding sections for feedback and continuous improvement, allowing your team to suggest enhancements based on their experiences.

You can also scale the checklist by adding or removing components based on the size and complexity of your pharmacy. This flexibility ensures the checklist is neither overwhelming nor lacking in detail. By adapting the checklist to your specific context, you enhance its effectiveness, ensuring that compliance efforts are efficient and tailored to your organizational structure.

Essential Items for an Internal Audit Checklist for a Pharmacy

An internal audit checklist for a pharmacy helps ensure that the business is operating efficiently, safely, and in compliance with regulatory requirements. The checklist should include items such as checking inventory levels, reviewing prescription orders and records, and verifying compliance with storage and disposal guidelines for medications. Other items to include on the checklist may be verifying staff qualifications and training, ensuring patient privacy and confidentiality measures are in place, and reviewing financial records and transactions. Additionally, the internal audit checklist should include procedures for identifying and addressing any issues that arise during the audit. This can include correcting errors, documenting findings, and developing plans for ongoing improvement.

Related categories

Preview of the template

Pharmacy Audit Checklist

Prescribing Practices

Is a combination of prescriber communication and patient counselling used to confirm the prescription is written for a U.S. Food and Drug Administration (FDA)-labeled or approved compendial indication?

Does the prescription presented for fill appear trustworthy or is the prescriber familiar?

Is the prescription written for a legitimate medical purpose within the prescriber’s scope of practice?

Is Transmucosal immediate-release fentanyl (TIRF) prescriptions carefully examined to determine if the patient will use the product for an FDA-labeled or compendial indication?

Are atypical antipsychotic prescriptions carefully examined to determine if the patient will use the product for an FDA-labeled or compendial indication?

Are buprenorphine-naloxone prescriptions carefully examined to determine if the patient will use the product for an FDA-labeled or compendial indication?

Are pediatric antipsychotic prescriptions carefully examined to determine if the patient will use the product for an FDA-labeled, compendial, or off-label indication?

Are caregiver counselling procedures examined for pediatric second-generation antipsychotic prescriptions?

Are Phosphodiesterase inhibitors (PDEI) prescriptions carefully to determine if the patient will use the product for an FDA-labeled or compendial indication?

Are topical retinoid and injectable botulinum toxin prescriptions carefully examined to determine if the patient will use the product for an FDA-labeled or compendial indication?

Are incretin mimetic prescriptions carefully examined to determine if the patient will use the product for an FDA-labeled or compendial indication?

Are amphetamine and cannabinoid prescriptions carefully examined to determine if the patient will use the product for an FDA-labeled or compendial indication.

Controlled Substances

Do hiring procedures include adequate background checks?

Are there no vulnerabilities for internal diversion?

Has controlled substance inventory management been carefully examined?

Has the documentation of a physical inventory that has taken place within the last two years been carefully examined?

Do all staff members know what to do when a controlled substance loss takes place?

Has the pharmacist-in-charge (PIC) met all legal and regulatory requirements and responsibilities?

Is the pharmacy complying with State Prescription Drug Monitoring Program (PDMP) regulations to address vulnerabilities for external diversion by patients?

Are there no vulnerabilities regarding the physical security of the pharmacy?

Are the current procedures communicated with other professionals—prescribers, other pharmacies, law enforcement, and State licensing boards?

Invoice Management

Are amounts of medications that appear on purchased products from wholesale distributors and other applicable company invoices or receipts reviewed?

Is there no invoice shortage?

Are all wholesale distributors and other applicable companies with whom the pharmacy does business reputable?

Do pharmacy staff members know about appropriate procedures concerning medication samples?

Do pharmacy staff members know about appropriate procedures to return medications to stock?

Do pharmacy staff members know about appropriate procedures when accepting medications returned from institutions or patients?

Do pharmacy staff members know about prescription “shorting” (providing the patient with a quantity less than the prescriber ordered)?

Are pharmacy practices related to pharmacy sales examined?

Do pharmacy staff members know about POS billing parameter manipulation?

Do pharmacy staff members know about coordination of benefits billing procedure manipulation?

Do pharmacy staff members know about phantom claims?

Billing Practices

Are the billing procedures discussed with staff to determine if they correctly submit claims for drugs commonly offered with improper billing units?

Are prescription requirements for non-controlled and controlled substances reviewed?

Are staff members able to correctly calculate a day’s supply for prescriptions?

Do pharmacy staff members know about prescriptions written for odd quantities?

Do pharmacy staff members know about prescriptions written for doses that exceed FDA labelling?

Do pharmacy staff members about prescriptions that include the use-as-directed sig code for dispensed quantities more than one billing unit per month?

Do pharmacy staff members know about refill practices?

Are possible patient-driven inappropriate refill practices?

Do pharmacy staff members know about overrides at the POS?

Do pharmacy staff members know about prescription origin codes?

Do pharmacy staff members know about product selection (dispense as written—DAW) codes?

Do pharmacy staff members know about partial fill procedures?

Do pharmacy staff members know about how they select package sizes when more than one quantity is available?

Do pharmacy staff members know about how they document beneficiary receipt of prescriptions?

Completion

Additional Observations

Pharmacy Manager Name & Signature

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Frequently asked questions

What is the purpose of an internal audit checklist for pharmacy?

An internal audit checklist for pharmacy helps ensure compliance with industry regulations and optimize operations. It provides a structured approach to evaluating processes, inventory, and staff training, helping you maintain high standards and improve service quality.

How can an internal audit improve pharmacy operations?

Conducting internal audit improves pharmacy operations by identifying areas for improvement, ensuring regulatory compliance, and streamlining processes. It helps maintain accurate records, manage inventory effectively, and enhance staff performance, ultimately leading to better patient care and service.

Who should use an internal audit checklist in a pharmacy?

Pharmacy managers, compliance officers, and quality assurance teams should use an internal audit checklist. It assists them in ensuring that all aspects of pharmacy operations meet industry standards, supporting consistent quality and regulatory compliance.

When is the best time to conduct an internal audit in a pharmacy?

The best time to conduct an internal audit in a pharmacy is during routine compliance checks, before regulatory inspections, or when implementing new processes. Regular audits help ensure ongoing adherence to industry standards, maintaining operational efficiency and patient safety.

This template, developed by Lumiform employees, serves as a starting point for businesses using the Lumiform platform and is intended as a hypothetical example only. It does not replace professional advice. Companies should consult qualified professionals to assess the suitability and legality of using this template in their specific workplace or jurisdiction. Lumiform is not liable for any errors or omissions in this template or for any actions taken based on its content.