Skip to main content

How DEA Compliance is Adapting to the Pandemic!

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:


  • 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.
Labels:

Comments

Post a Comment

Popular posts from this blog

Mere Lock and Key Will Not Suffice for Controlled Substances

 All entities that are registered to handle controlled substances have to abide by a set of strict security requirements to ensure that they are not mishandled or misused in any manner whatsoever. The Controlled Substances Act requires that all DEA registered healthcare providers and other organizations – be it DEA veterinary or others – should institute effective controls and procedures to safeguard against theft and diversion of controlled substances. The standards for the mandated physical security controls and operating procedures are clearly laid out in the Code of Federal Regulations. There are slight variations in the requirements for practitioners and non-practitioners with certain distinctions in what is expected in case of manufacturing and compounding areas, narcotic treatment programs, freight forwarding facilities, etc. The security prerequisites are more stringent for Schedule I and II drugs. For instance, these must be stored in a safe or steel cabinet that is equivalen
Post a Comment
Read more

Reporting Loss/Theft of Controlled Substances

 The DEA is mindful that any kind of shortage in controlled substances can mean that undesirable elements are at play. It requires that registrants should report such cases using the requisite form. Healthcare practitioners, pharmacies, hospitals and other entities that handle controlled substances are required to register themselves with the Drug Enforcement Administration (DEA). The law requires them to abide by various rules regarding the storage, security, recordkeeping, inventory and other parameters related to the controlled substances. Indeed, the regulations are there for good reason as these scheduled drugs have high scope for misuse and abuse. The DEA registrants do follow the protocols to the letter and ensure utmost safety of such drugs. However, discrepancies are still likely to crop up given the potential for misuse. So what is a healthcare professional or entity to do when they notice a variance in the physical stock vis-à-vis the records? The regulations require that re
Post a Comment
Read more

Know About the Correct Application of the DEA Form 106

A DEA Form 106 must be completed by pharmacies, and clinics in the United States, either manually or digitally, within one business day of any diversion, once identified. Then for the next two months, the medical institute has to update DEA with extra information to make the approach easier. Controlled substances are highly restricted drugs or medicines strictly regulated by the DEA (Drug Enforcement Agency). Violation of any of the DEA compliance for controlled substances may lead to harsh prosecution by the agency itself. Although sometimes, a license holder tangles up in a situation unintentionally, this leads to a greater consequence involving the DEA in the matter. So, to come up clear, DEA has forms to report those unfavorable issues. The most commonly reported crime associated with controlled drugs is loss or theft or drug diversion. Now, let’s delve deeper into the issue and the form one can use to report it. Report a diversion crime with DEA Form 106 Theft and loss was never
Post a Comment
Read more