What Is a Controlled Substance?
Prescription drugs are those drugs that are prescribed by a provider for a specific person and bought at a pharmacy. These are regulated by FDA. Prescription drugs are classified into two categories:
- Non-controlled prescription drugs
- Controlled prescription drugs
Non-controlled drugs are prescribed to treat medical conditions such as high blood pressure, diabetes, and bacterial infections. Such prescriptions are not subject to some of the same limitations as controlled substance prescriptions.
Controlled substances are drugs or medications (whether prescription or illicit) considered to have the highest misuse and use disorder potential and therefore have the strictest regulation and prescription requirements on a federal and state levels. They are regulated by the Controlled Substance Act (CSA) which was enacted as part of the Comprehensive Drug Abuse Prevention and Control Act of 1970. To prescribe controlled substance medication, a clinician must have a DEA (Drug Enforcement Administration) license; to fill a prescription, a pharmacist must also have a controlled substance license.
Controlled Substance Act (CSA) divides all controlled substances into five categories called schedules. The schedules range from Schedule I (highest level of potential for addiction and use disorder) to Schedule V (lowest potential for addiction/use disorder).
These drugs have no recognized medical use in the United States. They are not safe to use even within a medical environment. They possess the highest potential for use disorder and misuse. Examples of Schedule I drugs include heroin, lysergic acid diethylamide, etc.
These drugs carry a high risk of potential abuse. They also may cause physical or psychological dependence when used. Schedule II drugs are now permitted to be electronically transmitted through Electronic Prescribing of Controlled Substances (or EPCS) and have the tightest regulations when compared to other prescription drugs.
There is less risk of abuse in Schedule III than in the higher tiers. These drugs carry low to moderate risks of physical dependence. Drugs in this category may cause physical dependence but more commonly lead to psychological dependence. Schedule III drugs can be prescribed verbally over the phone, with a paper prescription, or via EPCS.
Schedule IV drugs have have an even lower misuse potential than I, II, or III. They have a limited risk of physical or psychological dependence. Schedule IV drugs can be prescribed verbally over the phone, with a paper prescription, or via EPCS.
Schedule V drugs are the least likely of the controlled substances to be misused. They result in very limited physical or psychological dependence. Pharmacies are responsible for monitoring these drugs in terms of quantities accessed.
The SUPPORT Act, 2018
According to the Centers for Disease Control, in 2018 more than 67 thousand people died from prescription drug overdoses. The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act was signed into law in October of 2018 as a response to the overdose crisis. The SUPPORT Act was designed to educate healthcare workforce, standardize the delivery of addictive medications, and expand access to care while providing coordinated and comprehensive addiction treatment for patients.
What is Electronic Prescribing of Controlled Substances (EPCS)?
Electronic prescribing of controlled substances, or EPCS, is the electronic transmission of a prescription for a controlled substance to pharmacies. EPCS goes a long way towards preventing fraud and the forgery of paper prescriptions while empowering healthcare providers to reduce drug theft and misuse all while continuing to care for patients who need safe and effective pain management.
History of EPCS
The U.S. government took measures in 2010 to address the crisis with greater controls around prescription opioids and the expansion of treatment and recovery options. Electronic prescribing of controlled substances (EPCS) began as a proposal by the Drug Enforcement Agency (DEA) to curtail the diversion of controlled substances. EPCS allowed physicians to prescribe controlled substances through a secure and certified electronic system. The regulations also permitted pharmacies to receive, dispense, and archive these electronic prescriptions. They also provided pharmacies, hospitals, and practitioners with the ability to use modern technology for controlled substance prescriptions while maintaining the closed system of controls on controlled substances.
Providers Responsibilities with Controlled Substances
DEA Title 21 Electronic Code of Federal Regulations (eCFR) puts the responsibility of ensuring the safety of EPCS on the provider. To be in a position to prescribe controlled substances, the provider must register with the DEA and get a DEA number. Title 21 also requires prescribers to use an Electronic Medical Record (EMR) system or prescribing technology. Prescribers must also maintain sole possession of any two-factor authentication tokens and cannot share passwords with anyone.
EHR Vendor Responsibilities with Controlled Substances
DEA Title 21 requires that the EMR or any other technology used for prescribing controlled substances be certified by a third party auditor or certification body. Being adequately certified ensures proper creating, signing and refilling of controlled substance prescriptions. The technology must allow prescribers to access identity verification as well as two-factor authentication (2FA), more rubust audit trails and strict auditing procedures. The technology must link the provider to a minimum of one DEA registration number and ensure only they are signing prescriptions. Part 1311 of Title 21, Requirements for Electronic Orders and Prescriptions, goes into the specifics of these requirements in detail.
SUPPORT for Patients and Communities Act
In 2018, more than 67 thousand people died from prescription drug overdoses. The SUPPORT for Patients and Communities Act was signed into law in October of 2018 as a response to the overdose crisis. The SUPPORT Act was designed to educate healthcare workforce, standardize the delivery of addictive medications, and expand access to care while providing coordinated and comprehensive addiction treatment for patients.
EPCS Federal Mandate
In December 2020, the Centers for Medicare and Medicaid Services (CMS) announced a revision to the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act that mandated Electronic Prescribing for Controlled Substances (EPCS) covered under Medicare Part D. The law took effect on January 1, 2021; however, CMS has delayed enforcement of penalties until January 1, 2022.
Under this final rule, the establishment of penalties to a future proposed rule have been deferred, with a comment period. Such penalties will not be enforced until January 1, 2022.
State EPCS requirements
In addition to the federal mandate, many states have passed similar legislation. New York became the first state to mandate EPCS when its groundbreaking Internet System for Tracking Over-Prescribing (I-STOP) Act took effect in 2016. Since then, many additional states have passed similar legislation, and many other legislatures are considering proposed EPCS mandates.
How to get started with EPCS?
When getting started with EPCS, the Drug Enforcement Administration (DEA) provides two pathways to regulatory compliance for medical practices. The path that you take depends on how your EHR is setup. Practitioners who are using an EHR system registered to an individual DEA number will usually fit into the 'Small and Solo Group Practices' pathway.
Practitioners who are registered to an institutional or shared DEA number are typically part of a Health System Affiliated Practice pathway.
Smaller and solo practices where practitioners are registered to an individual DEA number must take the following four required steps to be able to transmit electronic prescriptions for controlled substances legally.
1. EHR Software Update
Find out if the EHR software version in use by your practice has already been certified and approved for EPCS.
2. ID Proofing
Proof of ID can be done in-person or online through companies that work directly with your EHR. You may need to answer a security question, and email all scanned copies of government-issued documents alongside your photo and medical license for online ID proofing. Often, a bank statement or electric bill will also be required to confirm your practice address.
3. Two Factor Authentication
This is a double-level process to ensure that only you can sign and send the pharmacy's controlled substance prescriptions. There are various options available such as mobile phone authentication, smart cards, fob tokens, USB thumb drives, and biometrics such as fingerprint scanners.
4. Setting Software Access
- In this final step, you will need two separate people to set secure access controls for your EHR EPCS software. One of these people must be a DEA registrant who has been ID-verified and has their two-factor authentication measure in place.
- The other person must be someone who can confirm your identity, such as a member of your practice, but they do not need to be an employee of your practice.
For practitioners who are registered to a shared DEA number in the Health System Affiliated Practices, there also four required steps that must be taken to allow you to transmit electronic prescriptions for controlled substances legally.
Benefits of EPCS
- Improves patient safety by reducing incidence of adverse drug events due to an array of potential errors due to lack of access to the patient’s complete record, illegible handwriting, inconsistent ordering formats, and lack of alerts for allergies and interactions.
- It institutionalizes careful monitoring and oversight of a patient’s prescription history and use of controlled substances.
- Improves workflow efficiency and ROI by integrating EPCS within already existing technology (EHR) and workflows.
- Increased security because E-prescribing integrated with EPCS provides pharmacists with the assurance that the prescription for controlled substances they receive is exactly what the provider ordered and has not been tampered with. And since electronic prescription is delivered directly to the pharmacy, the physician’s DEA number is not exposed to the patient or other parties.
- EPCS regulations mitigate opioid-related deaths by reducing errors, prescription fraud, and “doctor shopping” for medications—while increasing prescription security and drug monitoring.
- Electronic prescribing of each controlled substance reduces the time spent by more than 600%, from 3-5 minutes to 30 seconds.