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New State Mandates for Opiates Create the Next Wave of Requirements for EHRs
By Connie Sinclair, RPh
New York’s I-STOP mandates have dominated health information technology news for the last three years. I-STOP requires electronic prescribing for all prescriptions, which has driven most EHR and e-prescribing vendors to come fully up to speed on e-prescribing for controlled substances (EPCS). Now many of these same vendors are moving on to the huge task of rolling out their EPCS-compliant versions to prescribers in other states.
More states are expected to follow suit with their own legislative mandates, especially now that New York’s deadline has passed without earth-shattering problems. Indeed, Massachusetts and Maine have recently passed sweeping changes to address the opiate crisis, but in true federalist style, each state is addressing the problem in unique ways and are calling upon the EHRs and e-prescribing systems to fall into line in new and different ways.
Very recently, Massachusetts and Maine passed new laws that will limit the quantities of opiate prescriptions prescribed; require the prescribers to view the prescription drug monitoring program (PDMP) under specific circumstances; and require the pharmacy to notify the prescriber via the EHR if lesser amounts of opiates are dispensed than what was prescribed. Most pharmacies do not have the ability to send messages of this type to the prescriber’s EHR, and EHRs are not equipped to receive them.
This notification requirement is similar to the biosimilar substitution notice required by several states and will require a different type of interoperability between pharmacy and EHR than what exists in practice today. Maine’s new law will also require EPCS for opiates and also impacts prescriptions for benzodiazepines. Massachusetts patients will have the ability to complete a non-opiate directive form which indicates that the patient does not want to be prescribed opiates. The prescriber must retain this form and rules have not yet been promulgated to describe how this information can be recorded in the “interoperable electronic health record.”
With all of these legislative mandates, it is clear that states and the federal government are reacting to the national epidemic of drug overdoses. According to the Centers for Disease Control and Prevention, nearly half a million people died from drug overdoses from 2010 to 2014, the vast majority of which were from prescription pain medications and heroin. Put another way, 78 Americans die every day from an opioid overdose. Officials fear the death toll will continue to escalate, which is creating urgency for new laws and programs to address the situation.
One method that seems to be successful in addressing the opiate problem is the popular mandate to require PDMP viewing by prescribers. PDMPs are databases maintained by each state (except Missouri) of prescriptions for controlled substances. This information can help prescribers be more savvy about their patients who may be inappropriately seeking pain medications. This one feature alone goes a long way toward inhibiting the doctor shopping (patients who go from one practitioner to the next requesting new prescriptions).
Some states have the technology and laws to support PDMP data sharing with neighboring states to better address this problem. A few states have enacted laws to require or encourage the integration of state PDMPs into EHR systems and workflows. The federal government also is working to make PDMPs more interoperable with EHRs and each other.
Addressing opioid abuse is one of our nation’s top priorities. States will continue to introduce bills for new mandates to address the opiate crisis. The challenge for EHRs and practitioners is that each state seems to put its own twist on their laws, so that they impact a different subset of drugs or require different quantity limits or PDMP viewing time frames. Vendors will be challenged to keep up with this developing patchwork of regulation and determine how to facilitate workflows that will help their prescriber clients with compliance.
Connie Sinclair, RPh is director of the Regulatory Resource Center of Point-of-Care Partners of Coral Springs, FL.