DEA Documentation Requirements

from R.J. Hedges Podcast · host RJ Hedges

In early 2017, we saw DEA changing its focus on pharmacy compliance. DEA increased its enforcement from the verification of the Combat Methamphetamine Certificate to a more formal on-site inspection. Now with the emphasis on the opioid epidemic, DEA is under increasing pressure to look for abuses of the system. Naturally, the first place any inspector will start is the pharmacy. We have been spending more time updating our clients on this trend and providing as much information as we can find. Then I attended a conference last September and one of the presentations was on “Maintaining Your Pharmacy in DEA Compliance”. Carlos Aquino is the President of PharmaDiversion and he is based out of Philadelphia. Carlos is a retired DEA diversion investigator and a great supporter of independent pharmacies. If you ever have an issue with the DEA, Carlos is the first person you should call. CSOS user names and passwords Power of Attorneys for DEA forms 222 and Electronic Orders Receiving C-II orders from the wholesaler and completing the DEA documentation First, every person who uses the CSOS system must have their own user name and password. No person may share another person’s user name. Having a single user name for a pharmacy only works if the user never takes a day off, ever; and we know that won’t happen to occur so you are opening yourself for criticism with the DEA as soon as they start asking questions. Setting up additional user names is not hard, you work with your wholesaler software system to establish a new user name. Each system has its own variation and perimeters, so if you have questions, go to their IT department. When the drug order is received: a. CSOS is accessed by an authorized individual with a Power of Attorney for DEA Forms 222 and Electronic Orders with an individual user name and password that is not shared with another person b. The order of Controlled Substances is checked against the packing slip/invoice c. DEA 222 is completed through CSOS d. Print the DEA 222. Most systems will state on the document, “This is not a DEA issued Form 222. This form is available for convenience.”  If this document does not print, check your Pop-up Blocker  The Pop-up Blocker may also prevent a completed DEA 222 from being printed (Carlos picks up) • This document acts as the DEA 222 for DEA on-site inspection purposes • In most cases, this document prints with the fields empty. Manually complete this document by entering the following information: o Packages Received o Date Received o DEA requires the persons' initials:  Remember this person must have a Power of Attorney  Recommend a signature over an initial e. Attach the packing slip/invoice to the acting DEA 222 f. Keep on file for two (2) years: • DEA requires the pharmacy to produce the completed DEA 222 and invoice upon demand o DEA regulations require you to have this record to be “readily retrievable” and separate from other records o Reference: DEA Pharmacist’s Manual, Section VI – Record-Keeping o You cannot print and complete the document when a DEA inspector is on-site. Carlos, I have been working with other organizations on the opioid crisis, this process is straight forward, but as Jeff stated at the beginning, DEA is enforcing the documentation requirements. Can you give us specific examples of pharmacy who have recently received DEA fines or you are aware of the DEA fines? Example 1: CSOS user names and passwords Example 2: Power of Attorneys for DEA forms 222 and Electronic Orders Example 3: Receiving C-II orders from the wholesaler and completing the DEA documentation If time permits, one more example

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