DEA Regulations for Pre-populated Controlled Substance Prescription Requests

It has come to the attention of VPhA that significant concern exists in the industry regarding pre-printed forms that both retail and long-term care pharmacies use to "remind" prescribers that a patient is out of refills on certain controlled substance prescriptions. There has been a lot of messaging and general confusion in the marketplace since the letter from the Drug Enforcement Administration headquarters to Omnicare's general counsel regarding this topic surfaced. Click here for the letter.

NCPA spoke with the DEA regarding this issue in order to gain clarity. The DEA told NCPA that the pharmacist can't send a reminder letter that "provides a partially or fully pre-populated form" for the prescriber or prepare a prescription for signature because the pharmacist is NOT an agent of the prescriber. Any "reminder letters" can't look like a prescription.  DEA stated that it is aware of software that makes these forms look like prescriptions and this is not allowed. In other words, if a pharmacy faxes a refill request for a controlled substance to the prescriber that includes all of the previous prescription information pre-populated on the request form the prescriber cannot simply sign and return the reminder letter to the pharmacy and that serve as the original prescription. If a form has a reminder on the top portion and the bottom is blank whereby the prescriber has to write the prescription and sign, that is permitted.

VPhA encourages pharmacists to work with technology vendors to ensure that these forms are in full compliance with DEA rules. This may require a significant change in current practice that will be new to many prescribers.

VPhA would like to remind members that you should be aware of all requirements by the Virginia Board of Pharmacy for both written and faxed prescriptions.  These can be easily found on Guidance Document 110-35 by clicking here.