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Pharmacy Compliance Audits – Are You Prepared?

Pharmacy Compliance Audits – Are You Prepared?

Pharmacy Compliance Audits:

Just the mention of the word “audit” makes every pharmacy owner, manager and staff member anxious. In today’s environment of media scrutiny and computerization, it is safe to assume that eventually your pharmacy will be the subject of a pharmacy compliance audit. With over 25 years of experience in Pharmacy Consulting on a national level, Healthcare Consultants can help make sure that when the time for a compliance audit does arrive, you are ready! If you are prepared, while the notice of a pending pharmacy compliance audit may not be the most welcomed news, an audit should be viewed as a fact of life that can result in recommendations for improvement.

A Pharmacy compliance audit assess a pharmacy’s level of compliance in regards to procedures stipulated by regulatory or contractual arrangements. Basically pharmacy compliance audits can be placed into two categories:

  1. Third Party Provider Audits – Every pharmacy that is a contract provider of prescription services is subject to a clause in its provider agreement that allows an audit of the pharmacy’s records, including hard-copy prescriptions, signature logs, computerized records of refills, and invoice records.
  2. Regulatory Agency Audits – Pharmacies obviously are subject to audits conducted by state or federal licensing agencies such as the DEA and State Board of Pharmacy.

To help you prepare, HCC recommends that you consider the following topics that are generally seen in typical audits and then ask yourself the following questions: Do we have policies and procedures in place AND do we have documentation of adherence to the procedures in place?

Topics that are routinely seen in a pharmacy compliance audit include:
– Purchasing and dispensing of controlled substances
– Accuracy of claims including quantity, dispensing date, dispensing intervals, and prescriber information
– Product selection criteria for generic versus brand utilization
– Assuring that special inventory controls exist for government mandated discount programs
– Proper administration of a benefit plan
– Assuring that rebates and risk-sharing provisions in a benefit plan are working properly
– Compliance with contractual requirements for Point of Dispensing programs
– Accuracy of invoice preparation
– Compliance with formulary requirements
– Suspicion of fraud and abuse

To be prepared for a pharmacy compliance audit it is critical to be aware of the types of documentation that you may need to provide to an auditor. The data typically reviewed may include:
– Hard-copy prescriptions
– Computerized dispensing records
– Physician records to support prescription records
– Patient signature logs
– Purchase records and invoices
– Policies and procedures
– Financial records
– Communications logs
– Provider payment record
– Contracts
– Quality control plans
– Clients and membership eligibility records and contracts
– Computer flowcharts and programs

With over 25 years of experience in dealing with pharmacy compliance audits, let HCC help you be prepared. Eventually your pharmacy will be the subject of a pharmacy audit. Don’t let an audit notification be a crisis situation and threat to your pharmacy business. As the old cliché says: An ounce of prevention is worth a pound of cure! Contact us on line or call us today for a Free Consultation at 800-642-1652 to discuss how we can help!

Bob Miller


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