Pharmacy audit checklist
A pharmacy audit checklist is used by pharmacists who own, operate, and work in pharmacies to perform comprehensive self-audits and ensure compliance with regulations. this checklist contains best practices for instances when internal auditors identify non-compliance. use this pharmacy audit checklist to easily evaluate current prescribing practices, controlled substance management, invoice management, and billing practices.
What does this form include?
This form contains 6 sections:
Prescribing Practices
- 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 a combination of prescriber communication and patient counseling used to confirm the prescription is written for a U.S. Food and Drug Administration (FDA)-labeled or approved compendial indication?pr
- Are 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 buprenorphine-naloxone 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 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 counseling 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 the controlled substance inventory management been carefully examined?
- Has the documentation of a physical inventory that has taken place within the last 2 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 physical security of the pharmacy?
- Are 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 with regard to 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 billing procedures discussed with staff to determine if they correctly submit claims for drugs commonly submitted 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 labeling?
- 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 size is available?
- Do pharmacy staff members know about how they document beneficiary receipt of prescriptions?
Additional Observations
Pharmacy Manager Name & Signature
Use this template