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Internal Audit Checklist for Pharmacy

This pharmacy audit checklist is used by pharmacists who own, operate, and work in pharmacies to perform extensive self-audits and assure compliance with regulations. In this checklist, we show you the best practices for situations when internal auditors identify non-compliance. You can use this pharmacy audit checklist to easily evaluate current controlled substance management, prescribing practices, invoice management, and billing practices.
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Internal Audit Checklist for Pharmacy

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?

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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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