Open Letter to DEA

Last week a pharmacist called to apologize to me for mistakenly dispensing Suboxone 8mg/2mg when I had ordered the 2mg/0.5 mg dose. She said they caught the error when the patient brought it to their attention. As with all my other non-Schedule 2 controlled substance prescriptions I ordered this one by telephone, so I have no written record (other than my prescription log) to prove what I ordered, and thus I particularly appreciate the pharmacist for admitting the mistake. No harm or diversion resulted.

Faxing the prescription to the pharmacy would likely have prevented this error while affording me and the pharmacy a written document proving the order. In fact, until your agents audited my buprenorphine practice a few years ago I ordered all such prescriptions via fax. But when I told the auditing agents that I used a stylus to sign prescriptions on my tablet computer they told me to stop, insisting that DEA policy requires “wet” signatures on all prescriptions and that my stylus signature constituted a digital or electronic signature. Since then I have ordered all buprenorphine prescriptions by telephone.

21CFR1311 lays out the requirements for e-prescribing and digital signatures, making it clear that a manual signature with a stylus in no way conforms to the statutory definition of a digital signature. The recipient of my faxed prescription cannot distinguish between prescriptions signed manually with a stylus and those signed manually with an ink pen.

Please advise me whether you have changed DEA policy in a way that might allow me to return to my earlier practice using manual stylus signature and fax. I believe this method of ordering prescriptions will reduce risk of diversion and errors.

If you have not changed this policy, until e-prescribing of controlled substances becomes more widely available I urge you to do so.

Please explain your decision.

Thank you.

moviedoc

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