A pharmacy audit checklist can serve as a guideline to help you prepare for a DEA audit and avoid costly mistakes. CompleteRx provides all clients with a defined process and checklist, which is reviewed and updated by the CompleteRx operations team. In addition, our compliance department conducts independent onsite audits to ensure adherence.
What is a DEA Audit?
The DEA performs periodic audits to ensure that pharmacies, practitioners, distributors, and manufacturers remain compliant with the Controlled Substance Act. Using a vast array of resources, they work to identify entities that are careless or reckless with drugs that can be abused or lead to addiction.
But even when pharmacies strive to follow the CSA, they can find themselves in trouble if they do not have a thorough process in place to track and implement practices around controlled substances, sterile-compounding, accreditation and record keeping.
As a law enforcement agency, the DEA can deliver administrative, civil, and criminal consequences. Depending on the severity, a violation could result in penalties like a letter of admonition, heavy fines for each violation, loss of accreditation or prison time.
What Triggers a DEA Audit
There is no set schedule for when an audit may occur. The DEA is constantly going into the field to evaluate all systems that interact with controlled substances, such as retail pharmacies, hospital pharmacies, doctor’s offices, distributors and manufacturers.
Reasons for a visit may include improper paperwork or tips regarding potential violations of the CSA. These tips may come from the Board of Pharmacy, wholesalers, prescribers or even patients.
If a state investigation finds something, the DEA is likely to follow up with its own pharmacy inspection.
Alerts from Automation of Reports and Consolidated Orders System (ARCOS) can also trigger a DEA Audit. This may come from an imbalance of numbers, inconsistencies with area practices or the pharmacy is flagged as an outlier compared to similarly situated pharmacies.
Regular audits related to the opioid crisis as well as random audits to ensure compliance with CSA can occur. These visits may be investigative, or they may simply be a routine visit, double-checking that everything is compliant.
How to Prepare for a DEA Pharmacy Inspection and Audit
Prepare for a potential DEA inspection with the following pharmacy audit checklist:
Pharmacy Audit Checklist:
- Evaluate any issues with things like technology, training, personnel, etc.
- Review overrides with ADCs. (You shouldn’t typically have any.)
- Look at waste. For example: Are you pulling an excess of milligrams? Where did the extra go? Was it documented appropriately?
- Look at 3rd party software results each month to see if there are any discrepancies.
- Look at procedural areas that have high narcotic use, where there are a lot of hand-offs and exchanges.
- Perform monthly audits and reconciliations of purchases, receipts, dispensing, storage, documentation, transactions and automated dispensing cabinets (ADCs)
- Look at places that have manual documentation and drug storage areas where things can be hidden or paperwork can be fudged.
- Reviewing each of these processes at a basic level with your entire pharmacy team allows you to know which processes are working and which ones aren’t.
Avoid DEA Penalties by Keeping Excellent Records
In general, the DEA focuses on over-dispensing and diversion. However, most fines from a DEA audit are due to simple and innocuous record-keeping errors. Typical errors that result in large monetary penalties are:
Inventory omissions: This includes missing info like dates and times or finished form of the substances.
Receiving and dispensing records: Receiving records must include the quantity and date received. Dispensing records must include the number of units, name and address of the person to whom it was dispensed, date of dispensing, and name or initials of the individual who dispensed or administered the drug. The correct DEA number of the prescriber must be included as well.
Power of attorney: All ordering personnel must properly execute a power of attorney with the registrant, and the power of attorney must be dated.
Employee screening: State, county, and federal background checks should be run on all employees with access to controlled substances. Pharmacies can not employ anyone who has access to controlled substances who has been convicted of a felony relating to controlled substances or whose application with the DEA has been denied, revoked, or surrendered for cause.
Corresponding Responsibility: Pharmacists must run prescription drug monitoring program (PDMP) reports on new and existing patients. Corresponding responsibility can also occur when pharmacies fill scripts that come from problematic prescribers who are on the DEA’s radar. Training all staff on proper record keeping is an important way to comply with federal regulations and avoid violations and monetary penalties.
Maintain Up-To-Date Required Records on Location
All records must be available for inspection by the DEA:
- Current DEA registration certificate
- State narcotics license (if applicable)
- State medical license
- Executed official order forms or the electronic equivalent
- Power of Attorney authorization to sign order forms
- Receipts and/or invoices for schedules III, IV, and V controlled substances
- All inventory records of controlled substances
- Records of controlled substances distributed (i.e., sales, returns, distributions)
- Records of controlled substances dispensed, including prescriptions or a logbook of controlled substances which may be lawfully dispensed without a prescription
- Reports of Theft or Significant Loss, if applicable
- Registrant Record of Controlled Substances Destroyed, if applicable
- Self-certification certificate and logbook or electronic equivalent
What to Expect During a DEA Audit – When the DEA Diversion Investigator Arrives:
- Review their credentials and photo ID.
- Gather their contact information.
- Ask about the reason for the inspection.
- Notify the necessary individuals about the inspection (Registrant, etc.).
- The Registrant will sign the Notice of Inspection form to grant informed consent.
- Upon request, provide access to all required records, storage areas, and substance inventory, including all areas where narcotics are stored.
- Copy any records required and obtain a receipt for any original records or controlled substances that are taken off site.
- Keep meticulous notes on all recommendations and observations made by the investigators.
- Ask questions about the findings so that any necessary corrective actions can be put in place.
What Happens if There is a Violation
The penalty depends on the severity of the violation. If administrative violations are found, you will receive a “Letter of Admonition” outlining the problems found in the audit. For example: There were issues with proper documentation, documentation storage, or numbers that didn’t match. It’s not a systemic issue, but it still needs to be corrected.
If more severe, there could be major fines up to $15,000 per violation. For example: Systemic issues are found where there is lack of control, or the process isn’t properly overseen.
The most severe violations could lead to suspension or revocation of a controlled substance practitioner registration, and criminal action can be taken that may lead to prison time. For example: Falsified information or deceitful practices were found.
After a violation has been found, you have 30 days to respond to the DEA with information about how the problem was corrected.
ASHP Drug Diversion Guidelines
According to Protenus, diversion is up and dependency is rising. 60 – 100 people die every day from Fentanyl. Patients are at risk, which leads to issues around safety and trust within the community.
Pharmacists have general guidelines they must follow. The American Society of Health-System Pharmacists (ASHP) provides guidance for pharmacists on handling narcotics. And the DEA recently (July 2022) updated the Code of Federal Regulations. However, data around diversion is always changing, and pharmacists must constantly keep an eye on it so that they can evolve, adapt, and take quick action when necessary.
Action steps to stay on top of diversion:
- Facilities are timid or resistant to report it or even dig deeper, but full transparency is key.
- Implement proper systems and processes to continuously evaluate diversion.
- Form a committee to oversee diversion that includes a representative from every group that comes in contact with narcotics.
- Collect metrics and data for everyone to review.
- Ensure proper communication, and document everything because the Registrant will be on the hook for any issues.
- When an issue is identified, address it and make sure it is solved.
Let us help you ensure compliance with our onsite audits and pharmacy audit checklist.
About the Author
Dana Fox, Pharm. D., Director of Quality and Compliance
Dr. Dana Fox joined CompleteRx in 2003 and is the Director of Quality and Compliance. In his role, Dana oversees the compliance assessments and solutions and the quality improvement solutions – such as pharmacy implementations and processes changes – to meet the needs of hospitals and pharmacists across the country.
Dana previously served as Director of Pharmacy for a health system in Atlanta, Georgia and has over 22 years of experience in hospital pharmacy management and operations including operational and process improvements, implementation of automation, 340B, pharmaceutical purchasing and medication safety.
Dana received his Pharm.D. from University of Illinois at Chicago and completed a two-year health system pharmacy administration degree at University of Wisconsin Health. He has completed Six Sigma Green Belt training with Purdue University.
