As the nation’s opioid epidemic rages on, states across the country are continuing to mandate the use of technology to fight back. Maine’s mandate for the electronic prescribing of opioids goes into effect on July 1, 2017. To date, it is one of three states to pass legislation making written prescriptions for pharmaceutical opioids illegal.
In 2015, opioid abuse claimed the lives of 272 Maine residents, a 31 percent increase over 2014, according to data from the Office of the Attorney General for Maine. And with one-third of those deaths due to pharmaceutical opioids, much of Maine’s legislation is focused on the ways and frequency prescription painkillers and other controlled substances can be prescribed.
The mandate, “An Act To Prevent Opiate Abuse by Strengthening the Controlled Substances Prescription Monitoring Program,” was signed into law on April 19, 2016, by Governor Paul R. LePage. The bill introduces several initiatives designed to address Maine’s rising drug abuse epidemic, including the electronic prescribing of controlled substances (EPCS).
Following New York state’s I-STOP legislation that went into effect in March of 2016, Maine was the second state in the nation to mandate EPCS. Next up was Virginia, where Gov. Terry McAuliffe greenlit legislation in February of 2016 that mandates electronic prescribing of opioid medications beginning on July 1, 2020.
Now, many other states are forging ahead to make EPCS a non-negotiable requirement. Connecticut, Illinois, Massachusetts, New Jersey, North Carolina, Pennsylvania, Rhode Island and Texas have introduced EPCS legislation, with the goal of stamping out drug diversion, decreasing the fraud and dea
dly abuse associated with these medications.
EPCS delivers a number of benefits for patients and care providers, including:
- Reducing “doctor shopping” and minimizing the risk of altered, stolen or fraudulent prescriptions
- Eliminating dual prescribing workflows to improve provider efficiency and satisfaction
- Increasing e-prescribing rates to meet Meeting Meaningful Use requirements
- Minimizing prescription errors and inaccuracies
- Improving patient satisfaction by eliminating repeated doctor visits and long pharmacy wait times
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Electronic prescribing is commonplace in Maine, with about 70 percent of all prescriptions sent electronically in 2014, according to a report on e-prescribing trends from the ONC. However, opioid-based medications are classified by the DEA as controlled substances and are therefore subject to different regulations and requirements for electronic prescribing.
The DEA interim final rule (IFR), “Electronic Prescriptions for Controlled Substances” was published in 2010. The primary objective is to reduce the potential for diversion, and subsequent abuse, of controlled substances. In accordance with these objectives, the DEA ruling contains a number of requirements designed to track and audit the connection between practitioners and the signatures they use for EPCS orders.
Some of these requirements include:
- The EHR and/or e-prescribing applications used to generate and process EPCS orders need to be certified as DEA-compliant.
- Pharmacies must use software certified as DEA-compliant to accept prescriptions for controlled substances that are sent electronically.
- Prescribers must complete an identity proofing process to confirm that they are authorized to prescribe controlled substances, and have been assigned the proper credentials to sign an EPCS prescription. The DEA allows two types of identity proofing: institutional (hospitals can identity proof providers internally) or individual (using a third-party credential service provider).
- Prescribers must use two-factor authentication when signing an EPCS prescription. This includes a combination of two of the following: something the prescriber knows (such as a password), something the prescriber is (such as fingerprint biometrics) and something the prescriber has (such as an OTP token). It is important to note that the authentication methods used for EPCS must comply with FIPS-201 standards, and modalities such as proximity cards and some fingerprint biometric readers are considered out-of-band and cannot be used for EPCS.
These are just a few of the requirements for EPCS, all of which need to be met to comply with federal regulations for prescribing opioids and other controlled substances electronically. “A Quick Guide to EPCS” outlines how to implement EPCS with solutions that meet DEA requirements while giving prescribers a fast, efficient e-prescribing workflow for all medications, including what to look for from your solution vendors, how identity proofing works and the roles and processes you need to define to achieve success.
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