The DEA’s oversight on prescription drug practices continues to be the same during the ongoing pandemic. However, there has been some easing with special guidance in specific areas of concern.
The U.S. Drug Enforcement Administration (DEA) continues to enforce its laws and regulations for prescribing, handling and dispensing controlled substance medications even in the face of the unprecedented COVID-19 pandemic. DEA compliance is expected to be a top priority for doctors, hospitals, pharmacies and other providers just like in 2019 and earlier. However, the agency has proactively assessed some of the specific areas of concern thrown up by the enormous healthcare challenges of the ongoing public health crisis and issued guidance and advise accordingly.
Dispensing Across State Lines – The DEA has temporarily eased practitioner registration with the agency when practicing in additional states. Given that many states have granted reciprocity to neighboring states and their practitioners to practice across state lines, the DEA is also making the exception of allowing registered health care providers to dispense prescription medications across state lines even if they are registered only in a single state. In normal circumstances, practitioners are required to register in each state where they dispense controlled substances. However, the providers should still be licensed to practice in each state and must comply with the laws of both states.
5% Distribution Rule – Registered health care providers are temporarily allowed to distribute more than 5% of their total dosage units to other registered providers as long as they continue to abide by all security, recordkeeping and other applicable DEA regulations.
Early Refills – The DEA is also permitting the diktat of some states allowing pharmacies to dispense early refills of controlled substances due to the COVID-19 emergency. However, the prohibitions against refills of Schedule II controlled substances continue to apply.
Telemedicine – In view of the new challenges, the DEA further permits authorized practitioners to prescribe schedule II-V controlled substances via tele-consultation evenwithout a prior in-person medical examination. However, the practitioner is required to ensure that:
Moreover, the providers are permitted to prescribe scheduled drugs via telemedicine to patients in states in which they are not DEA-registered.
Oral prescriptions – While emergency oral prescriptions for Schedule II controlled substances have to be mandatorily followed up with a paper copy within 7 days to the pharmacy, practitioners are now allowed a 15 day window for the same. Furthermore, the practitioners are also permitted to send the follow-up prescription as a facsimile, photograph or scan to the pharmacy in place of the paper prescription. However, it should have the statement, ‘Authorization for Emergency Dispensing’ while the original paper prescription should be maintained in the patient file.
Apart from this, all other regulations regarding DEA forms for controlled substances, inventory management, record-keeping, storage, disposal, diversion prevention, etc. continue to apply as earlier.
5% Distribution Rule – Registered health care providers are temporarily allowed to distribute more than 5% of their total dosage units to other registered providers as long as they continue to abide by all security, recordkeeping and other applicable DEA regulations.
Early Refills – The DEA is also permitting the diktat of some states allowing pharmacies to dispense early refills of controlled substances due to the COVID-19 emergency. However, the prohibitions against refills of Schedule II controlled substances continue to apply.
Telemedicine – In view of the new challenges, the DEA further permits authorized practitioners to prescribe schedule II-V controlled substances via tele-consultation evenwithout a prior in-person medical examination. However, the practitioner is required to ensure that:
- He/she issues the prescription for a legitimate medical purpose within the usual course of professional practice.
- The virtual consultation is conducted via ‘an audio-visual, real-time, two-way interactive communication system’.
- The controlled substance is issued in full compliance with all other pertinent state and federal laws.
Moreover, the providers are permitted to prescribe scheduled drugs via telemedicine to patients in states in which they are not DEA-registered.
Oral prescriptions – While emergency oral prescriptions for Schedule II controlled substances have to be mandatorily followed up with a paper copy within 7 days to the pharmacy, practitioners are now allowed a 15 day window for the same. Furthermore, the practitioners are also permitted to send the follow-up prescription as a facsimile, photograph or scan to the pharmacy in place of the paper prescription. However, it should have the statement, ‘Authorization for Emergency Dispensing’ while the original paper prescription should be maintained in the patient file.
Apart from this, all other regulations regarding DEA forms for controlled substances, inventory management, record-keeping, storage, disposal, diversion prevention, etc. continue to apply as earlier.
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