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My DEA Buprenorphine Audit: My "Violations"
I fully expected retaliation from DEA for my open criticism of their disruptive practices and policies in auditing buprenorphine addiction treatment practices. Here's how they nailed me. You can judge for yourself whether DEA should penalize me.
To recap briefly, last fall two DEA agents appeared in my office without an appointment, despite my written requests to schedule their "routine" obligatory audit of my buprenorphine opiate addiction treatment practice. When I told them they would need to obtain a warrant they left. The following week five DEA agents invaded my office, copied some files from one of my computers, asked some questions, and left with a copy of my prescribing record. Days later two agents appeared in the office with no appointment or warning to discuss their determination. After I made it clear that I was not interested in chatting with them they left my waiting room, and I wrote a letter demanding a written enumeration of their findings.
Inexplicably it took DEA approximately 2 1/2 months, but finally, a couple weeks ago, I received a letter (return receipt requested) citing me for two "recordkeeping [sic] violations." (In fact both related to transmission of prescription orders rather than record keeping.)
- "Failure to include your "X" DEA Registration number on prescriptions for Schedule III narcotic drugs approved for detoxification and/or maintenance treatment.
- "Failure to use an application that meets the requirements to electronically sign and transmit controlled substance prescriptions.
"The purpose of this letter is to afford you the opportunity to come into compliance with the requirements of the Controlled Substances Act. Please ensure that these are corrected. This is a serious matter which, if continued, can lead to sanctions, finds, or the possibility of the suspension of your DEA registration."
You might consider item number one to be technically correct but for the fact that the statutes permit me to order such prescriptions by telephone with no written communication whatever. In order to minimize the risk that my DEA number might fall into the wrong hands I always communicated it to the pharmacy by telephone.
Item number two reveals the ineptness of those who draft and interpret these statutes. Literally it cites me for failure to use an "application" that does not exist. But we apparently cannot expect DEA to compose a sentence that reads as intended (even with 2.5 months to prepare!). I believe they meant to cite me for, "use of an application that fails to meet the requirements..." referring to statutes regulating eprescribing. As of yet no eprescribing "application" (service) meets DEA requirements. In fact I used a service that allows me to fax a prescription that exists as a word processing document file to the pharmacy. I did not use a digital or "electronic" signature. I used a stylus to produce a manual signature with digital "ink" on a tablet computer. Like any other fax device now in use this sends a copy of the signed document to the pharmacy. When the pharmacy views or prints this transmitted document the pharmacist cannot distinguish it from a paper document signed with a pen or pencil except that the signatures on successive transmission do not differ.
Our federal government must find this kind of efficiency threatening. Perhaps I am naive, but it seems to me that DEA should concern itself with preventing diversion and fraudulent prescribing. I contend that my procedures minimize the risk of both. Furthermore, the statutes failed to anticipate the technology I use, and DEA, rather than assessing the risk it poses, chose to trump up a charge based on technicalities. In other words, they didn't think. Today I believe all faxes are electronic, if not digital, and in all case in which the image of a manual signature arrives via fax the pharmacist sees only a copy of that signature. I also wonder why DEA has not cited the pharmacies for dispensing based on inadequate prescriptions since none of these was a "paper" prescription. After all no harm is done in transmitting the prescription. The harm occurs only when the pharmacist dispenses the drug to the wrong person. Of course the pharmacist cannot differentiate between a facsimile transmission of a computer file and of a scanned paper document except perhaps by the inferior quality of the latter.
Here is an applicable federal statute:
"Sec. 1306.21 Requirement of prescription.
(a) A pharmacist may dispense directly a controlled substance listed
in Schedule III, IV, or V that is a prescription drug as determined
under section 503(b) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 353(b)) only pursuant to either a paper prescription signed by a
practitioner, a facsimile of a signed paper prescription transmitted by
the practitioner or the practitioner's agent to the pharmacy, an
electronic prescription that meets the requirements of this part and
part 1311 of this chapter, or an oral prescription made by an individual
practitioner and promptly reduced to writing by the pharmacist..."
My plan, which I have already communicated to DEA and which I implemented on receiving the letter, consists of providing signed paper prescriptions displaying my DEA numbers when the patient appears in the office or, when the patient does not appear, authorizing refills or ordering new prescriptions by telephone. Incidentally -- and not surprisingly -- only one pharmacist has asked me to provide my DEA number.
So what is your verdict, reader? Should DEA revoke my registration? fine me? send me to Club Fed (where I will be entitled to free health care)?