Mandated electronic prescribing finally came to pass as the final compliance date of January 1, 2023, has come and gone. Procrastinators need not be distressed—it's not too late to arrange the necessary protocols for your office.
This article will provide an overview of electronic prescribing for optometrists, offer best practices for compliance, and contains a list of requirements for each state.
Double-check with the infographic below to ensure all mandated electronic prescribing criteria are met.
Definition of electronic prescribing
E-prescribing, also known as electronic prescribing, refers to the electronic transfer of prescriptions directly from healthcare providers to pharmacies using technology systems. Electronic prescribing of controlled substances (ECPS) is a specific form of e-prescribing that focuses on scheduled medications.
The SUPPORT Act
In response to the opioid crisis, the Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) of 2018 was enacted.
Of significance is Section 2003 of the SUPPORT Act, which mandates EPCS under Medicare Part D prescription drug plans and Medicare Advantage prescription drug plans.1
The Centers for Medicare & Medicaid Systems (CMS) published the final rule, CMS-1751-F, which extended the ECPS deadline to January 1, 2023. The rule also specified that a 70% threshold must be met for compliance.1
EPCS and prescription drug monitoring programs
It should be noted that the CMS EPCS Program is separate from any state EPCS program requirements.1 A majority of states have their own EPCS mandates, but a handful do not. States without EPCS mandates usually have laws that allow EPCS so that prescribers can comply with the federal order.
Similar to EPCS programs, government-supported prescription drug monitoring programs (PDMPs) are electronic databases that track controlled substance prescriptions at the state level. PDMPs provide real-time information to healthcare providers so that patient care can be aligned with behaviors and risks.2
PDMP and EPCS mandates are used in combination to regulate controlled substances. Most states have PDMP mandates where providers are required to consult the database prior to prescribing scheduled drugs, regardless of whether state EPCS mandates are in place. Finally, several states have PDMP requirements comprising all prescription medications, encompassing both controlled and non-controlled pharmaceuticals.
Benefits/drawbacks of electronic prescriptions
- Patient care: Electronic prescriptions can improve patient care by reducing written errors and increasing the speed and accuracy of transmission. Combined with electronic health records (EHRs), providers can be alerted of allergies and contraindications before transmitting prescriptions, which enhances patient safety. With access to drug formularies, prescriptions can be filled at lower costs. E-prescribing can encourage patient compliance by boosting convenience.3
- Improved efficiency and management: The process of e-prescribing, especially with integrated patient and insurance data and state PDMP access, can allow healthcare providers better workflow efficiency and patient management.3
- Overdoses/over-prescribing: Direct prescription communications to pharmacies can reduce fraud and duplication errors. Pharmacy reporting to PDMP databases can uncover multiple prescribers and suspicious drug utilization, which can limit provider prescriptions and prevent patient overdoses.3
- New types of errors: While e-prescribing eliminates legibility or written errors, it introduces a new world of errors, such as formulation mistakes, prescriptions not being deleted properly, and compounding formulation lapses.2
- Increased cost/reduced compliance: The cost of the technology necessary to comply with e-prescriptions may be a drawback for some providers and a possible reason for non-compliance. The learning curve of the software may also cause resistance to usage and increased computer errors.2
Infographic of state EPCS/PDMP requirements
Studies on electronic prescribing of controlled substances
E-prescriptions and prescribing errors
An investigation by Franklin et al. concluded that the introduction of e-prescriptions did not reduce prescribing errors at their teaching hospital. While e-prescribing reduced written errors overall, such as legibility and incorrect dosages, the procedure introduced new types of mistakes, for instance, duplication and formulation errors.4
EPCS and over-prescribing
To determine if EPCS prevented the number of Schedule II prescriptions written, Shimoga et al. examined the quantity of Schedule II and III prescriptions written in emergency departments (EDs) nationwide. They concluded that EPCS did not deter Schedule II prescriptions and, in fact, may have facilitated more Schedule III prescriptions when the pain was involved during the ED visit.5
In contrast, Shoji et al. noted that EPCS was associated with a decreased number of opioids prescribed after upper extremity surgeries. The reduction was both in total morphine milligram equivalents (MME) and the total number of tablets.6
E-prescribing and patient compliance
A review of studies by Aluga et al. explored outpatient compliance with written versus electronic prescriptions. Defining patient adherence to medication as the fill rate of newly prescribed medications, the analysis found mixed and inconclusive results.
Out of 10 studies, four found increased fill rates, while four others suggested the opposite. No significant difference in fulfillment rates was found in the two other studies.7
EPCS mandates and opioid-related overdoses
EPCS policies aim to reduce opioid supply and prevent opioid-related overdoses. A 2021 study scrutinized New York EPCS mandates and their effect on these opioid indicators.
Researchers from William Paterson University estimated that EPCS mandates resulted in a 22% decline in opioid-related overdoses involving natural and semi-synthetic opioids. There was also a relative decline in the statewide opioid supply.8
Overview of e-prescribing software
In compliance with EPCS, providers will be obligated to use software when prescribing controlled substances. There are many EPCS software choices on the market. There are some free simple software solutions that can work independently, and there are high-end complex systems that can be integrated into any current EHR set-up.
Mobile e-prescription is available on some platforms with cloud-based EHR and authentications available. Some platforms offer direct access to state PDMP sites, so that logging in to a separate website for PDMP data would be unnecessary.
Operating under the US Department of Health and Human Services (DHHS), the Office of the National Coordinator for Health Information Technology (ONC) is part of the government's health IT initiatives, supporting the use of technology to improve the electronic exchange of health information.9
The ONC compiles the Certified Health IT Product List (CHPL), which is a complete and trusted list of all health information technology products that have passed the testing and certification process of the ONC Health IT Certification program.9,10
Drug Enforcement Agency requirements
With so many choices, it is important to make sure that the EPCS software meets the Federal Drug Enforcement Agency (DEA) requirements.
Depending on the provider and practice setting, complying with DEA specifications involve:11
- EPCS-certification: The easiest way to confirm that your EPCS software is certified is to check the CHPL or just ask the software vendor to verify its certification status.11
- ID proofing: Identity proofing is employed to access secure systems, register, and perform transactions. Connect with an approved credentialing service provider of the certification authority that works with the software vendor to prove your identity. They will request documents such as a state board license and government-issued forms or photos.11
- Two-factor authentication: Creating two-factor authentication (2FA) ensures an extra layer of protection for online accounts and sensitive data. This 2FA guarantees that the signing and transmission of scheduled controlled substance prescriptions to a pharmacy is limited to authorized individuals.11
- Secure access: Establish secure access controls for EPCS.11
HIPAA concerns
As EPCS and PDMPs involve sharing patient health information (PHI), all HIPAA rules apply to these prescription transactions. Regarding patient consent, HIPAA regulations state that healthcare providers can disclose PHI without patient permission if the disclosure is required by law.
As EPCS and PDMPs are mandated by law and not voluntary, disclosure would be exempt from the HIPAA requirements.12
Relevant drugs/medications
The DEA categorizes controlled substances by schedule, numbered I to V, in descending order of potential for abuse. EPCS pertains to all the medications in Schedule II through V.13
Schedule I medications
Schedule I drugs are considered to have the highest potential for abuse. They are deemed to have no accepted medical use.
Drugs or substances listed in DEA Schedule I may include:14
- Heroin (diacetylmorphine)
- LSD (lysergic acid diethylamide)
- Marijuana (cannabis, THC)
- Mescaline (peyote)
- MDMA (methylenedioxymethamphetamine): Street name ecstasy
- GHB (gamma-hydroxybutyric acid): Exceptions are formulations in an FDA-approved drug product sodium oxybate (Xyrem), which are considered Schedule III
- Psilocybin: Street name "magic mushrooms"
- Synthetic marijuana and analogs: Street names spice and K2
- Methaqualone: Street name quaalude
- Khat (cathinone and cathine)
- Bath salts (methylenedioxypyrovalerone [MDPV])
A full list of Schedule I drugs is available at DEA.com.
Schedule II/IIN drugs
Schedule II substances have a high potential for abuse that can lead to psychological/physical dependence. Examples of Schedule II narcotics include hydromorphone (Dilaudid), methadone (Dolophine), meperidine (Demerol), oxycodone (OxyContin, Percocet), and fentanyl (Sublimaze, Duragesic), morphine, codeine, and hydrocodone.
Within the Schedule II drugs are IIN stimulants, such as amphetamine (Dexedrine, Adderall), methamphetamine (Desoxyn), and methylphenidate (Ritalin).13
Click here for a full list of Schedule II controlled substances.15
Schedule III/IIIN drugs
Schedule III drugs have a lower potential for abuse than schedules I and II, with low to moderate potential for physical dependence, but a high psychological dependence potential.
Medications with 90 milligrams of codeine (Tylenol with Codeine) and buprenorphine (Suboxone) are Schedule III narcotics. Schedule IIIN non-narcotics include ketamine and anabolic steroids such as Depo-Testosterone.13
Click here for a full list of Schedule III controlled substances.16
Schedule IV
Schedule IV substances are considered to have a low potential for abuse and a low risk of dependence compared to the Schedule III drugs. Some examples of Schedule IV drugs include: alprazolam (Xanax), carisoprodol (Soma), clonazepam (Klonopin), clorazepate (Tranxene), diazepam (Valium), lorazepam (Ativan), midazolam (Versed) temazepam (Restoril), tramadol (Conzip, Ultram), triazolam (Halcion), pentazocine, and zolpidem (Ambien).13
Click here for a full list of Schedule IV drugs.17
Schedule V
Schedule V substances have the lowest potential for abuse out of all the controlled substances. They are usually used for antidiarrheal, antitussive cough preparations containing not more than 200 milligrams of codeine per 100 milliliters or per 100 grams (Robitussin AC, Phenergan with Codeine), analgesic purposes atropine/diphenoxylate (Lomotil), pregabalin (Lyrica), and ezogabine.13
Click here for a full list of Schedule V controlled substances.18
Final thoughts
Approximately 70% of all states have adopted their own EPCS mandates, with seven of them requiring e-prescribing for all medications, both controlled and non-controlled. As for the remaining 16 states without local EPCS directives, compliance with the federal SUPPORT Act regulations is essential.
Although this article has focused on mandated e-prescribing, it is worth noting that utilizing PDMPs is just as important, as EPCS and PDMPs work synergistically. With two exceptions, all states have implemented their own PDMP directives, making it vital to employ these databases, even in states without EPCS statutes.
The following compilation presents the status of each state and highlights any regional peculiarities. To quickly check specific state criteria, a nifty infographic has been included for your convenience. Happy e-prescribing!
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