Pharmacy Audit Checklist

• Site

• Registered Address
  Address

• Pharmacy Manager

• Conducted on

  Date

Prescribing Practices

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

  Yes

  No

• Check to see if the prescriber appears on the Office of Inspector General (OIG) List of Excluded Individuals/Entities (LEIE) database.

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

  Yes

  No

• Fill only prescriptions written for a legitimate medical purpose and within the prescriber’s State-defined scope of practice limitations.

• 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

  Yes

  No

• Consult State-approved compendial sources, which vary by State and consider prescriptions written for drug classes often associated with inappropriate prescribing practices.

• 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?

  Yes

  No

• Counsel the patient to verify the patient understands the medication prescribed and if the patient does not have a diagnosis of cancer, contact the prescriber to advise this medication is covered only for FDA-labeled indications. Discuss alternative options.

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

  Yes

  No

• Ask the ff. questions: What did your prescriber tell you the medication is for? How did your prescriber tell you to take the medication? What did your prescriber tell you to expect? Verify the prescription has been written by a prescriber who is in compliance with the Drug Addiction Treatment Act (DATA) requirements. Contact the prescriber if the drug is used to treat pain or any indication other than opioid dependence maintenance.

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

  Yes

  No

• Verify the patient understands the medication prescribed. Contact the prescriber if the drug is being used for sedation to advise this medication is covered only for FDA-labeled indications. Suggest an alternative, including a benzodiazepine or another FDA-labeled sedative hypnotic, such as zolpidem, zaleplon, or ramelteon.

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

  Yes

  No

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

  Yes

  No

• Explain the medication’s use, actions, and anticipated benefit. Advise the caregiver of potential risks for common or severe side effects. Explain the importance of close monitoring and prescriber follow-up.

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

  Yes

  No

• If the drug is being used for erectile dysfunction (ER), explain the exclusion to the patient and offer a self-pay cash option for the prescription.

• 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?

  Yes

  No

• If the drug is being used for cosmetic purposes, explain the exclusion to the patient and offer a self-pay cash option for the prescription.

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

  Yes

  No

• If the drug is being used for weight loss, explain the exclusion to the patient and offer a self-pay cash option for the prescription.

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

  Yes

  No

• If the drug is being used for an off-label use, such as to enhance academic performance, treat depression, or enhance weight loss, explain the exclusion to the patient and offer a self-pay cash option for the prescription.

Controlled Substances

• Do hiring procedures include adequate background checks?

  Yes

  No

• Conduct a financial and criminal background check after consulting with your State police agency or pharmacy association. Consult your State pharmacy board to determine whether any prior disciplinary action has been taken against the potential employee.

• Are there no vulnerabilities for internal diversion?

  Yes

  No

• Consider a policy on checking employees’ personal bags. Require boxes be broken down inside the pharmacy. Dispose of all regular pharmacy trash in clear bags and store all waste in secured trash bins. Account for outdated drugs removed from the pharmacy shelf. Use a tamper-evident or resistant receptacle for drugs awaiting transport.

• Has the controlled substance inventory management been carefully examined?

  Yes

  No

• Maintain perpetual inventory for all Controlled Substances Act (CSA) Schedule II controlled substances. Perform random inventory counts on CSA Schedule III through V controlled substances. Document and witness all controlled substance inventory counts.

• Has the documentation of a physical inventory that has taken place within the last 2 years been carefully examined?

  Yes

  No

• Verify the following inventory components:
  1. Date of the inventory
  2. Name of each controlled substance inventoried;
  3. Finished form of each of the substances inventoried (for example: 10 milligram tablet)
  4. Number of dose units of each finished form in the commercial container (for example: three 100 tablet bottles);
  5. Exact count for CSA Schedule II drugs (and Schedule III, IV, and V drugs if the container holds more than 1,000 dosage units)
  6. Count on effective date of rule for previously non-controlled drugs that are reclassified as controlled substances and for controlled substances that have a change in scheduling
  7. eparate CSA Schedule II inventories and records and CSA Schedule III, IV, and V inventories and records (if not, controlled substance information must be readily retrievable from non-controlled substance pharmacy records).

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

  Yes

  No

• Complete and submit the DEA Form 106 within 1 business day after discovery of the theft or loss and keep a copy of the submitted report for 2 years.

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

  Yes

  No

• Perform a complete controlled substance inventory and complete State-specific requirements, there is an incoming or outgoing PIC.

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

  Yes

  No

• Submit all State PDMP required reporting elements. Report to the State PDMP in a timely manner if a process for real-time data collection is not implemented and perform periodic quality assurance to ensure data submission is accurate and complete.

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

  Yes

  No

• Restrict pharmacy access to authorized pharmacy personnel by key or key code. Examine, periodically, security logs to ensure personnel access the pharmacy only at appropriate times. Use a key log to document each time the spare key is accessed. Re-key the pharmacy in the event of a security breach.

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

  Yes

  No

• Document and disseminate information received from prescribers, between pharmacies in and around your local area, by State and local law enforcement, and by State licensing boards. Create a notebook to store external communications received so pharmacy personnel can readily review the communications.

Invoice Management

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

  Yes

  No

• Compare the number of units of medication purchased from wholesale distributors and other applicable companies to the corresponding number of claims for that drug and upon receipt of delivery, confirm the stock bottle of medication is sealed and has not been tampered with. Pay particular attention to National Drug Codes (NDCs).

• Is there no invoice shortage?

  Yes

  No

• In an invoice shortage, payers may suspect you have billed them for: drugs obtained from illegal sources, prescription drug samples, drugs returned to stock, on drugs returned from institutions or patients.

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

  Yes

  No

• Check wholesale distributors and other applicable company Verified-Accredited Wholesale Distributor (VAWD) status and ensure they are registered with the DEA and the appropriate State controlled substance agency if no VAWD accreditation is found.

• Do pharmacy staff members know about appropriate procedures with regard to medication samples?

  Yes

  No

• Talk to pharmacy staff members. Store sample medications in a separate location to prevent inadvertent claims for sample medications if drug samples are maintained in the pharmacy for distribution by an on-site health care provider.

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

  Yes

  No

• Talk to pharmacy staff members. Reverse any third-party insurance claims before returning a medication to stock.

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

  Yes

  No

• Talk to pharmacy staff members. Modify the pharmacy’s DEA registration to become an authorized collector if the pharmacy elects to accept medication returns and review and implement the DEA requirements to operate a secure collection receptacle.

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

  Yes

  No

• Talk to pharmacy staff members. Require the pharmacist who fills any controlled substance or high-dollar prescription and one other person to double count the medication whether manually or robotically and initial the quantity filled and be proactive and alert staff that you monitor inventory.

• Are pharmacy practices related to pharmacy sales examined?

  Yes

  No

• Scrutinize gift cards given to customers. Require pharmacy staff to document and initial any prescription alterations and question unusually high quantities of prescriptions processed for controlled substances or high-dollar medications.

• Do pharmacy staff members know about POS billing parameter manipulation?

  Yes

  No

• Talk to pharmacy staff members. Do not dispense a generic drug while submitting a claim to a third-party payer for the brand name drug. Do not submit a claim for a contracted NDC product while dispensing a non-contracted NDC product. Do not split prescriptions into multiple fills within 1 month unless the patient requests to fill only a partial quantity of the amount of drug prescribed.

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

  Yes

  No

• Talk to pharmacy staff members. Do not submit claims to multiple insurance providers without coordination of benefits. Do not list more than one health plan as the primary provider for coordination of benefit claims. Do not submit a claim to a manufacturer’s assistance program as if a patient is uninsured and also submit a claim to a primary insurance provider.

• Do pharmacy staff members know about phantom claims?

  Yes

  No

• Talk to pharmacy staff members. Establish a procedure to reconcile prescription sales, claims, and inventory receipts for prescription drugs. Verify documentation for prescription claims most commonly associated with fraud. Confirm each prescription claim is supported by corresponding documented verbal prescription order, electronically generated prescription, or prescription hard copy

Billing Practices

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

  Yes

  No

• Provide staff members with job aids associated with common types of quantity and/or days’ supply miscalculations. Oral products such as anti-migraine agents, bowel preparations, multi-drug/multi-month packs, and osteoporosi agents. Other dosage forms such as inhalers, ophthalmic products, topical products, and vaginal products. Injections and Kits.

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

  Yes

  No

• Look for the date of issuance, prescriber’s signature, prescriber’s authority to prescribe, drug name, drug strength, drug dosage form, quantity of drug prescribed, directions for use, number of refills authorized by the prescriber (if any),“brand name medically necessary” if no generic substitution is allowed; if hand written, controlled substance prescriptions must be written in ink or pencil that cannot be erased, and prescribers must manually sign controlled substance prescriptions on the date issued.

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

  Yes

  No

• Multiply the number of doses per day by the number of days of therapy to determine the correct quantity to dispense. Reverse-verify by dividing the quantity dispensed by the number of doses per day to determine the number of days’ supply.

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

  Yes

  No

• Talk to pharmacy staff members. Reduce the quantity dispensed to correspond to a number of days equal to or less than the plan-imposed maximum if the days’ supply calculated by dividing the quantity dispensed by the number of doses per day exceeds the plan-imposed maximum allowable days’ supply.

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

  Yes

  No

• Talk to pharmacy staff members. Examine high doses with scrutiny and consult the FDA label. Contact the prescriber to verify the dose if it exceeds FDA recommendations and document all communication on the hard copy.

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

  Yes

  No

• Talk to pharmacy staff members. Document frequency of use and size of area to be treated for shampoos, creams, and ointments. Document number of headaches treated per month for migraine medications. Document exact regular dosage and maximum daily dosage for any sliding scale directions for insulin. Document maximum use per day for diabetic syringes, test strips, or lancets.

• Do pharmacy staff members know about refill practices?

  Yes

  No

• Talk to pharmacy staff members. Do not push-bill or auto-refill without patient consent or request or when prohibited by State law. Do not refill and mail to patients without request or patient consent, and only perform patient outreach to initiate refills in attempts to improve medication adherence and clinical outcomes. Do not use financial incentives to influence beneficiary decisions about when or where to fill prescriptions paid by a federally funded program.

• Are possible patient-driven inappropriate refill practices?

  Yes

  No

• Counsel patients if stockpiling is suspected. Be aware of red flags that may indicate diversion and require further scrutiny and if diversion is suspected, report concerns to the proper authorities.

• Do pharmacy staff members know about overrides at the POS?

  Yes

  No

• Talk to pharmacy staff members. Submit claims with vacation supply override codes only if the patient is on vacation and with known prior authorization (PA) override codes only if the patient meets the PA criteria

• Do pharmacy staff members know about prescription origin codes?

  Yes

  No

• Talk to pharmacy staff members. Do not alter prescription origin codes and verify the prescriber DEA number and office telephone number for all controlled substances prescriptions received by telephone. If the caller or prescriber is unknown, confirm the contact information with a secondary source.

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

  Yes

  No

• Talk to pharmacy staff members. Only use the DAW 1 product selection code when the prescriber has indicated product substitution is not allowed on the prescription and only use the DAW 2 product selection code when the patient has requested to receive the brand name drug rather than the generic equivalent.

• Do pharmacy staff members know about partial fill procedures?

  Yes

  No

• Talk to pharmacy staff members. Adjudicate partial fills appropriately. Do not “owe” patients any drug quantity if the full quantity to be dispensed has already been billed. Only use the partial fill functionality of the billing system when unable to fill the full quantity to be dispensed. Do not bill the payer for the full amount of a partial refill. Do not bill the payer for a second dispensing fee when completing a partial refill.

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

  Yes

  No

• Talk to pharmacy staff members. Select the smallest commercially available package size to address the prescription requirements. Ensure the NDC dispensed matches the NDC billed, particularly for generic and compounded medications. Bill accurate quantities of medications used in compounded medications. Confirm that commercially available equivalents do not exist and that the compounded medications are treating a medically necessary indication.

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

  Yes

  No

• Talk to pharmacy staff members. Always obtain signatures from patients or their agents at the time of prescription pickup.

Completion

• Additional Observations

• Pharmacy Manager Name & Signature

  Sign