An ambulatory surgery center (ASC) in Iowa recently agreed to pay $125,000 to settle allegations that it violated the Controlled Substances Act.

How is your facility managing controlled substances? Do you have systems in place to ensure proper ordering, receiving, storage, administration and disposal? How sure are you that your policies are compliant? How sure are you that your staff is following the policies…are you $125,000 sure?!

There are so many moving parts when it comes to handling controlled substances properly and although this is a large settlement, it could always be worse, as we’ve seen in other DEA fines. Have you evaluated your controlled substances processes to ensure you are meeting all the DEA requirements from before the medications enter the building to what happens after they have been administered or otherwise disposed of?

It can be a bit overwhelming when you consider all the ducks you must line up to avoid trouble with surveyors, inspectors and auditors. The key to avoiding trouble is due diligence. If you’re familiar with the requirements of the Controlled Substance Act, you can use your expertise to set up a compliant process and then monitor to avoid discrepancies. If the thought of the Controlled Substances Act makes your eyes glaze over, you should enlist help. Maybe it’s a member of your team, or more likely, it’s someone with specific training and knowledge in this area. That “someone”, should be your consultant pharmacist.

If you look at the details of the allegations in the Iowa ASC case, you notice that it involved various violations. The ASC allegedly “failed to maintain complete and accurate records concerning the controlled substances it purchased and dispensed and failed to provide effective controls and procedures to guard against theft and diversion of controlled substances”. What questions do you need to ask yourself about your systems and how can your pharmacy consultant help?

Here is a partial list of things to consider:

How do we order controlled substances?
Who can order controlled substances?
Are we using DEA-222 forms?
What is the proper way to complete a DEA-222 form?
How is the process different with the new DEA-222 forms?
Are these different steps that must be taken when ordering via the CSOS system?
Who can sign the DEA-222 form?
When we receive controlled substances, how do we document receipt?
What is the proper way to document the receipt of controlled substances in DEA Schedule 2?
What is the proper way to document the receipt of controlled substances in DEA schedules 3-5?
Does your state have additional medications that are not “scheduled” by the DEA, but considered controlled substances in your state?
How do we document “state specific” controlled substances?
How do we document controlled substances in storage?
How do we document controlled substances in a separate safe?
How do we document removals and returns to the controlled substances cabinet?
How do providers track, and document use and “waste” of controlled substances?
How do we handle medication security?
How do providers handle medication security?
How do we witness and document waste?
How do we handle the disposal of controlled substances?
Although this is only a partial list of questions your facility should be able to answer, they are all important and a good start to ensuring compliance with DEA requirements and also keeping patients and staff safe. Your pharmacy consultant should be an expert in this space and be able to answer these questions along with providing specific guidance and policy review. The opioid crisis has increased our need to further scrutinize our processes and your pharmacy consultant is perfectly positioned to help you achieve your goals. As healthcare providers, we must take every possible step to ensure our patients are safe by maintaining accurate controlled substance records and safeguarding the controlled substances in our possession.

The Consultant Pharmacists at OctariusRx provide guidance on safe medication management, survey readiness and cost savings to ambulatory healthcare facilities/surgery centers, senior care facilities and pharmacies. We also help individual patients optimize their medications to improve their quality of life and save money. Contact us for assistance.