What to Know About the New DEA Rules for Prescribing Controlled Substances

Ensuring your practice remains current with the ever-changing DEA regulations is not just about avoiding fines and penalties. It's about staying ahead of the curve and having an effective strategy to prevent the severe backlash of falling into noncompliance. 

While working alongside an experienced DEA compliance consultant prepares businesses to make decisions necessary to avoid hitting regulatory roadblocks or dealing with untimely damage control, making the independent decision to stay up-to-date on industry news can help you determine when to bring compliance experts in. 

In an age of rapid technological advancement, the healthcare industry continues to improve traditional methods of pharmaceutical oversight. In an effort to adapt to modern trends, the DEA has recently introduced new regulations that impact how controlled substances are prescribed and recorded electronically. Substantial changes to legislation may seem daunting, but understanding their impact on daily prescription management can set a practice up for success, providing time to adjust workflows and ensuring DEA regulations are followed correctly. 

In this blog, we’ll provide a foundational understanding of these new rules, what they mean for healthcare providers and patients, and how communication between practitioners will be affected going forward.

An Overview of the New DEA Rules

A change to prescription transfers may seem insignificant initially, but considering the rapid shifts in substances previously classified as high-risk and a field-wide push to digitize records, this decision will impact most routine administration tasks.

This ruling primarily stems from increased electronic prescribing, initially driven by the sharp increase in ongoing telehealth services following the COVID-19 pandemic. As more controlled substance prescriptions took place through a screen than ever before, the necessity to enact clear procedures for transferring electronic prescriptions became apparent. 

From preventing duplicate prescriptions to reducing patient burden, this change aims to get essential medication in the hands of those who need it, ensuring accountability on a practice’s behalf at the same time.

Key Changes in the DEA Regulations 

Minute adjustments to government documentation happen often, but what actual changes in DEA compliance come from major shifts like these? Discrepancies in communication can be prevalent in the healthcare industry, whether between small private practices, local pharmacies, or entire hospitals. 

As visits with clinicians have switched from in-person consultations to digital meetings, the need to keep track of pertinent information has only become more glaring. To strike a balance between making vital medicine more easily accessible while preventing instances of substance abuse, several stipulations—that are not to be overlooked—will be added to each facet of a prescription’s journey, from script records to handing off medication to recipients.

Electronic Prescriptions

In 2010, the DEA published an Interim Final Rule (IFR) concerning the availability of perceptions via digital means. This adjustment to DEA regulations, focused specifically on Electronic Prescriptions for a Controlled Substance (EPCS), ushered in a new era for medical practitioners. This has enabled pharmacies to receive, dispense, and archive these electronic prescriptions efficiently. It also opened the door to countless upsides that have become commonplace today, including:

• • Easier integration with electronic health record systems (EHRs) that reduced administrative burden on healthcare staff and the time-consuming organization required for tracking paper prescriptions.
  • Streamlined access to patient history and medical details thanks to digitized records, helping practices make informed decisions on treatment.
  • Tangible cost savings from a decreased reliance and demand for paper alongside lower operational costs associated with archiving physical records.

Most importantly, remote prescribing became possible, making medical care more accessible to patients who couldn’t meet with a provider in person. But as the benefits of EPCS became more widespread, so did the drawbacks. 

Patients prescribed schedules II-V controlled substances could receive the prescription they needed, but would be barred from transferring it to another pharmacy if needed. This decision, originally added to the 2010 IFR, was in place due to the supposed risk of substance abuse and dependency these drugs posed. Unfortunately, if the pharmacy that received patient prescriptions could not fill the order, patients would face the inconvenience of waiting for the medicine to be restocked.

As the final rule of 2023 takes effect, patients will now have the opportunity to transfer their Schedules II-V prescriptions. If the pharmacy that initially received the electronic prescription cannot fill it, the patient can request that the prescription be sent to another pharmacy that can. 

Telemedicine Prescriptions

Even if in-person medical care is available, more people are electing to use telemedicine services, given their ease of access and the convenience of attending an appointment from home. However, the downsides of online healthcare could become more apparent when attempting to transfer Schedules II-V drugs between pharmacies. 

Having to go through the process of scheduling a secondary appointment via an online portal or repeated back-and-forth conversations over email could lead to even longer waiting times than the pharmacy’s efforts to restock the missing prescription. 

Contacting a brick-and-mortar practice for an updated script wastes time just as much as repeatedly reaching out to a telehealth service. The most recent change to controlled substance prescriptions has put patients back in control of their wellness and avoids excess delays.  

The Impact on Pharmacies and Patients

The benefits of this change are clear; by no longer requiring to return to their prescriber for a new prescription, patients can quickly receive the medication they need from a pharmacy that already holds it, saving time for both themselves and their practitioner while avoiding the health risks of extended delays in care. But what steps should be followed to align with DEA regulations?

• First, the patient’s consent is vital; transfers must be requested by patients before proceeding with any next steps. 
• To ensure DEA compliance, the prescription must remain in its original digital state during the transfer process, and a transition to paper or another form of record is prohibited.
• Transferring and receiving pharmacists must record specific information about the transfer, including the names and addresses of both pharmacies, their DEA registration numbers, the pharmacists' names, and the transfer date itself. 
• Both pharmacies must maintain these records for at least two years, starting when the transfer occurs.

Additional steps to implement the systems necessary for handling and recording transfers may require additional resources, but taking steps to enact each of these requirements can help avoid a potential DEA investigation. That said, the improved workflow that digital records have provided was considered. To save time and use existing online records, pharmacy software can automatically populate the required fields for transfer documentation if available. 

With a proper system in place, the new DEA rules for prescribing controlled substances will minimize bottlenecks in providing prompt medical care, decrease the risk of duplicate prescriptions, and keep sensitive information secure. 

Staying Updated with DEA Regulations

Implementing the new DEA regulations at your practice requires a proactive approach. Speaking with a controlled substance compliance expert provides a streamlined path to regulatory success, but having a broad overview of how controlled substance prescriptions will help mitigate risks in the meantime and keep staff informed on what actions are required.

Implementing Secure Prescription Systems

Electronic prescriptions directly rely on safe and well-maintained systems for transfer and storage. Letting digital infrastructure fall to the wayside is an effective way to break compliance and find yourself in a mess of civil penalties or even a loss of DEA registration. 

To comply with new DEA rules for prescribing controlled substances, staff should prioritize the implementation of secure prescription systems before taking part in any transfers. This involves upgrading existing EHR systems to support the transfer of electronic prescriptions for Schedules II-V controlled substances. 

If the EHR system in place cannot meet the demands of these new regulations, finding a reliable software vendor is essential to providing secure, real-time prescription transfers while maintaining the integrity of sensitive patient data. Pharmacies must also establish stringent internal controls to monitor and verify each step of the prescription transfer process, ensuring that all DEA requirements are meticulously followed.

Conducting Regular Internal Audits

Before external parties get involved, take a holistic approach to compliance by reviewing your own processes. Are changes in regulatory laws being announced? Is your internal documentation organized and easily accessible? Asking your staff the same questions that would come up during an external audit can identify any discrepancies or areas where procedures may not fully comply with DEA regulations. 

By pinpointing these issues early, corrective actions can be taken before larger compliance problems arise. Regular audits also provide an opportunity to assess the effectiveness of staff training programs and ensure that all team members are up-to-date on current best practices.

The Benefits of Compliance

Conquering DEA compliance comes with a wealth of legal and reputational advantages. Most importantly, it significantly reduces the risk of legal penalties and fines arising from non-compliance, protecting a practice's financial health. Staying within DEA regulations also offers social perks, instilling confidence in current and potential patients who see a dedication to proper management as a reason to depend on practices. Maintaining professional and ethical daily operations that stay within the bounds of the law helps support the continued wellness of the healthcare provider and the community they serve.

Planning a Future of Controlled Compliance

Adapting to the new DEA rules for prescribing controlled substances may seem overwhelming at first, but staying compliant is vital to the continued success of any practice. Following the details above can help protect your business from potential fines, improve patient satisfaction, and prevent prescription fraud or misuse. By staying informed on new rulings, implementing secure prescription systems, conducting regular internal audits, and ensuring your staff is well-trained, adapting to new requirements doesn’t need to be complicated.

For those seeking expert guidance, TITAN Group offers comprehensive DEA compliance consulting services to help navigate these regulatory changes. 

Contact TITAN Group today to safeguard your practice and enhance your compliance strategy.