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E-Prescriptions Leading to Uncharted Waters
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Electronic computer-to-computer transactions have impacted the way pharmacies conduct their business. The biggest impact was from the introduction of online claims adjudication 25 years ago, which replaced universal claim forms. Remember them?

Now there is the use of e-prescribing for new prescriptions, including controlled substances. The main benefit of using this technology is patient safety. However, as technology helps solve problems, it may also create new problems.

One specific example is from New York state and will likely be a model for other states in the future.

New York

In New York, legislation known as I-STOP (Internet System for Tracking Over-Prescribing) required all prescriptions, including those for controlled substances, to be transmitted electronically beginning March 27, 2015. However, the Medical Society of the State of New York asked the state legislature for a delay to allow all prescribers more time to have the required software for controlled substances installed. Two weeks before the March 27 deadline, the governor signed a bill to delay the electronic prescribing mandate for one year.

Challenges

One concern aired by New York pharmacists is how e-prescribing systems used by prescribers will allow the two parties to communicate outside of the relatively simple process of transmitting a new prescription to the pharmacy.

For example, what happens when a pharmacy receives an electronic prescription for a controlled substance and is unable to fill that prescription for any reason? The pharmacy is unlikely to print out the prescription for the patient to take to another pharmacy, and if it did, could another pharmacy accept it? The pharmacy, in this case, wants to let the prescriber know promptly about this, but does the communication back to the prescriber need to use the e-prescribing route in reverse? While it is probably not required that the return communication be electronic, the processes pharmacists and prescribers are asked to use should be consistent.

The NCPDP SCRIPT standard allows for over 20 different types of transactions between prescribers and pharmacies. Transaction types include allowing the pharmacy to send a message to the prescriber requesting additional refills for an existing prescription, or a new prescription, for a patient. Another example is a transaction that can be used when the pharmacy needs to request a change in the original prescription, such as allowing for generic substitution. However, if the systems used in the prescriber’s office or pharmacy are not set up to create and process these transaction types, then this leads to the old-fashioned method of communicating by phone.

Pharmacy Responsibilities

In my September/October 2014 column, I wrote about the requirements for electronic prescriptions for controlled substances (EPCS), which include a vendor audit showing that the software meets the Drug Enforcement Administration (DEA) requirements. This audit for compliance with EPCS should be performed by an independent organization recognized by the DEA. Once the audit validates that the software is in compliance, a letter should be provided to the software vendor, a copy of which should be given to each user upon request. It is a good idea to have a copy of this letter on file in the event a DEA agent asks to see it. Keep in mind that Surescripts certification is required for compliance with the SCRIPT standard. Surescripts does not audit the software for EPCS compliance. Surescripts, however, does require that EHR/EMR and pharmacy system vendors provide proof of the audit and successfully complete the Surescripts certification process before allowing these prescriptions to flow through to pharmacies.

Pharmacists also have the responsibility to treat electronic prescriptions for controlled substances the same way as paper prescriptions. This means pharmacies accepting electronic prescriptions for controlled substances are using the software in accordance with DEA regulations. One example would be that the pharmacy application is required to document instances in which a controlled substance is annotated, modified, or deleted; when this occurred; and who took the action. Another example would be that the prescription is digitally signed by the pharmacy or by the last intermediary and is archived. The private key used by the pharmacy for the DEA’s Controlled Substance Ordering System can be used to sign the EPCS prescriptions. Then there is the distinction made between an audit trail and the internal auditing of auditable events. An auditable event addresses security concerns, such as attempts to alter a record by someone not authorized to do so. This is why it is a good idea to Google the final rule published by the DEA and read about the pharmacy’s responsibilities.

Another thing you should be aware of is that the audit of your vendor’s software must take place every two years, or sooner if there is a new release of the software prior to the end of the two-year period. That said, you should make a note to check with your vendor every two years to verify that an updated audit has been done and request documentation for your file, or when you download a new release if prior to the end of the two-year period. Another important point is to understand the functionality in the e-prescribing software and work with your prescribers to see how you can both benefit from extended use of this software. SCRIPT provides a platform to improve the efficiency of your pharmacy, and the same for a medical practice. I recently spoke to a physician who told me he knows how to send new prescriptions, but was not aware of any other e-prescribing features. This illustrates the importance that all users receive thorough training to maximize the benefit from e-prescribing software. CT

David Schuetz, R.Ph., has been working in pharmacy for over 30 years. His areas of expertise are pharmacy practice management, electronic ordering systems operations, testing, training, documentation, and deployment. He also specializes in pharmacy database and drug file management, and serves as a subject matter expert in pharmacy data warehousing. He can be reached at dschuetz@phsirx.com.