Board of Pharmacy Response to DEA Guidance for Oral Schedule II Emergency Prescriptions
On March 27, 2020, the United States Department of Justice Drug Enforcement Administration (DEA) published Guidance regarding the issuance of oral schedule II prescriptions in light of the nationwide public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020 resulting from the coronavirus (COVID-19) pandemic. In this Guidance, DEA is issuing two temporary exemptions to the criteria “to enable greater flexibility in oral prescribing.”
Section 21 CFR 1306.11(d)(4) of federal regulation requires that, following the issuance of an oral emergency schedule II prescription from a prescriber to a pharmacist, the prescriber is required to follow up with an original prescription (hardcopy or electronic) to the pharmacy within 7 days. EXEMPTION: During the emergency period, DEA is allowing prescribers 15 days to provide the follow-up prescription to the pharmacy.
The federal regulation also requires the follow up prescription be in hard copy format or electronically transmitted. EXEMPTION: During the emergency period, DEA is allowing prescribers to send the follow-up prescription to the pharmacy via facsimile, or to take a photograph or scan of the follow-up prescription and send the photograph or scan to the pharmacy in place of the paper prescription.
In response to the March 27 DEA Guidance temporarily exempting these two regulatory components of an oral emergency schedule II prescription, the Board will enforce 657 Iowa Administrative Code subrule 10.26(2), paragraph “e,” in accordance with the DEA’s temporary exemptions and regulations which are not exempted.
The Board would like to provide these reminders and information as it relates to oral emergency schedule II prescriptions:
Per DEA regulations, an oral emergency prescription is still required to be communicated directly from the prescriber to a pharmacist.
As noted in the DEA Guidance, “Whether an emergency situation exists is a determination made by a practitioner based on the individual facts of a particular medical situation.” During this public health emergency, prescribers may indeed encounter unavoidable barriers to issuing a schedule II prescription for a patient within the normal regulatory boundaries, such as but not limited to, when the prescriber cannot access the prescriber’s electronic prescribing software or fax machine or the prescriber is not able to ensure a written prescription will arrive via mail to a patient or pharmacy before a patient runs out of their existing supply. In such cases, the prescriber may determine an oral emergency prescription is warranted.
When a prescriber issues an oral emergency schedule II prescription, the quantity is generally limited to the quantity sufficient to meet the needs of the patient during the emergency period. During this public health emergency, “sufficient quantity” may be that which provides an adequate supply of medication to the patient until the prescriber can again access prescribing capabilities under the normal regulatory structure.
A prescription for a schedule II controlled substance is not required to be on an official prescription blank of the prescriber, so long as the prescription contains all the required elements. Prescriptions issued as follow-up to an oral emergency schedule II prescription must still include the notation “Authorization for Emergency Dispensing.”
As noted from the DEA Guidance, “Regardless of any exceptions that DEA has made in responses to COVID-19, pharmacists continue to have a corresponding responsibility to ensure that any controlled substance prescription they fill was issued for a legitimate medical purpose by a practitioner acting in the usual course of his/her professional practice.” Pharmacists are encouraged to solicit the intended method of submission for the follow-up prescription from the prescriber during the initial phone call and document the relevant information for subsequent verification (e.g., ask the prescriber to identify how the follow-up prescription will be submitted and document the fax number or email address from which the prescription will be provided for subsequent verification).
Prescribers and pharmacists should read the entirety of the DEA Guidance for a complete explanation of the DEA’s position regarding emergency schedule II prescriptions for controlled substances during the COVID-19 pandemic. Pharmacists may contact their Compliance Officer if they have additional questions.