Pharmacy audits and inspections are a fact of life for every pharmacy and pharmacy owner. It is actually a pretty safe assumption to make these days that your pharmacy will be audited at a minimum of every two years. In this brand new world of computerization, shared databases of controlled substances, prescription data and patient information, plus the ever increasing use of social media, a negative inspection or audit outcome can be a catastrophic event and may cause irreparable damage to a pharmacy’s hard earned reputation.
Recent DEA Audit at a North Carolina Pharmacy
Just a few days ago in Elizabethtown, North Carolina, DEA agents, assisted by the Bladen County Sheriff’s Office, unexpectedly arrived at Anderson’s Drug Store. Arriving before the pharmacy actually opened for business (at about 7 AM in the morning), the Drug Enforcement Administration agents proceeded to perform an unexpected controlled inventory audit.
Why Did the DEA Audit This Pharmacy?
The Anderson’s Drug Store pharmacy has been located and doing business in Elizabethtown for over forty years now. The drugstore had never previously received any documented regulatory agency violations during those forty years of operating the independently owned retail community pharmacy. Yet the DEA agents and the County Sheriff’s Office deputies forced the store to not open up for over four hours while they performed a controlled drug inventory. They even had the store cordoned off from the public by surrounding the area with yellow police-tape. The DEA agents and inventory auditors all left shortly after noon, finally allowing the pharmacy to open its doors to their customers.
The owner of the pharmacy (Mr. Gene Anderson) would not comment to the news media. However, according to the local news station, an anonymous person tied to the drugstore stated that there was nothing to worry about because the store has always operated “above board” and would never operate in an illegal manner. The spokesperson also stated that the surprise audit was only due to the DEA’s response in fighting the opioid epidemic that the CDC (Centers for Disease Control and Prevention) had declared to be a national crisis.
Today it was announced that the audit revealed what many might consider irregularities in the volume of oxycodone tablets that the pharmacy has dispensed over the past eighteen months. According to the federal affidavit that the DEA filed, the drugstore has dispensed over three-hundred thousand oxycodone tablets (318,000) in just the first five months of 2018 (covering January of 2018 through May of 2018). Additionally, according to the federal DEA affidavit, the pharmacy dispensed over three-hundred and fifty thousand oxycodone pills in 2017 (365,000 total). With a population of approximately thirty-four thousand residents living in Bladen County (34,318 according to the 2015 U.S. Census Bureau), that equates to every county resident receiving ten pills, including men, woman and children.
Does it Matter if the Pharmacy Passes the DEA Audit?
Yet this question remains to be answered: Was the pharmacy’s reputation damaged even if they are found to be innocent of any violations? Although the number of oxycodone tablets dispensed by the pharmacy is best described as “suspicious”, what happens if the prescription audit ultimately proves that no illicit actions or practices actually took place? The story has been picked up nationally, but what would be the damage to the drugstore’s reputation and business on the local level of the Elizabethtown, North Carolina community? Although perhaps it’s difficult to put an exact monetary number on the possible financial damage that would ensue, the point is that the harm has already occurred.
What Should a Pharmacy Owner Do To Be Ready For a DEA Audit?
The answer is to be prepared! Plus be proactive in monitoring your pharmacy’s business practices. There are two steps that every pharmacy owner should consider:
1. Make absolutely certain that your Policy and Procedure Manual is current and up-to-date. The first thing that any regulatory or compliance agency will ask for during an inspection of your pharmacy is the Policy and Procedure Manual. Be proactive to make certain that yours is always kept up to date. Additionally, consider having an experienced third party consultant review it and customize any areas that your business may specialize in. These days having a generic Policy and Procedure Manual is a sure way to get a negative inspection report. Most auditors say that when they encounter a pharmacy that uses a “free templated” P & P manual, it’s a “red flag” that they will uncover areas of concern that will need to be addressed.
2. Have an experienced third-party pharmacy consulting firm perform mock DEA inspections regularly. These experts understand all of the inspection process and the audit criteria. If the owner of Anderson’s Drug Store pharmacy had a qualified and experienced pharmacy consultant perform a “mock” DEA inspection, the dispensing of that many oxycodone tablets would easily have been uncovered. In such a case the “red flag” could have been both anticipated and documentation already in place to explain the pharmacy’s practices.
About Healthcare Consultants
For over 29 years now, HCC has been a national leader in providing pharmacy consulting services in all 50 states in the USA. With our experienced in-house pharmacy regulatory experts, HCC can perform mock DEA inspections and identify those areas of your business that should be of concern to you. Our consultants will, upon completion of the inspection, also prepare a Gap Analysis with corrective recommendations and discuss these with you and your team. If significant issues are found, our consultants are available to assist in the implementation of the corrective actions and perform a re-inspection to confirm compliance. We are also the national leader in customizing Policy and Procedures Manuals that are prepared to meet each of our client’s specific needs on an “individualized” basis.
Don’t just wait until a surprise inspection knocks on your pharmacy’s doors! 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 get you prepared for any regulatory or compliance audits.