Medscape Business of Medicine

Ronald B. Sterling, MBADisclosures

July 10, 2014

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E-prescribing has become a regular part of many physicians' daily routines. Yet, there's a problem within the e-prescribing process that can cause serious issues with physicians and their patients, and even lead to claims of malpractice by patients.

 

According to Surescripts, which runs the nation's largest e-prescribing network, 58% of prescriptions were submitted electronically in 2013.[1] Electronic prescriptions are one of the meaningful use requirements, and as a result, e-prescribing will continue to grow. E-prescribing offers compelling benefits to providers, patients, and the healthcare industry. For example, New York State requires electronic prescriptions for all prescriptions by March 27, 2015.

 

However, there is a weak link in the e-prescribing infrastructure that delays the practical availability of new drugs and prevents physician access to the latest drug information, including changes to drug/drug interactions and drug allergies.

 

Drug compendia are the catalogs of drug information that sit behind e-prescribing. The drug compendia market is dominated by four vendors: First Data, Medi-Span, Elsevier, and Cerner Multum. The drug compendia include product information about drugs, dosage forms, and packaging, and even patient education materials.

 

In addition, the drug compendia include drug interaction information, clinical references, and warnings. The US Food and Drug Administration (FDA) maintains the National Drug Code (NDC), which is assigned to all drugs for people in the United States. The NDC code is the "product ID" used in e-prescribing.

 

The weak link is a delay of up to six months between approval of new drugs by the FDA, publication of new drug information, updates to drug/drug interactions and drug allergies, and the availability of the information to several electronic health records (EHRs) for their e-prescribing features.

 

Publishers of the drug compendia post the new information as soon as they receive it. But the drug compendia have to be delivered to the EHR vendors, and then the EHR vendors have to roll out the updates to their EHR customers. The EHR vendors may get their copies on a periodic basis (eg, monthly or quarterly). The rollout to EHR users out varies from updating a cloud service (typically within 30 days of the update) to downloading the update (or even mailing CD-ROMs) to a practice. In some cases, the practice has to apply the compendia update to their local server-based EHR.

 

The Problem Reaches Patients

 

This problem is not an academic exercise. Physicians cannot use the e-prescribing feature of their EHRs to prescribe drugs that are not in the compendia. (Without an NDC code, the drug cannot be practically ordered through e-prescribing.)

 

 

In addition, the information that doctors are basing their prescribing decisions on, including interaction checking, may be up to six months old. For example, a new treatment option could not be accessed or prescribed through an EHR's e-prescribing feature without an entry in the drug compendia. This is particularly troublesome for healthcare organizations that require use of e-prescribing for all prescriptions and for any provider in New York after March 27, 2015.

 

The drug compendia weakness is compounded by the recently published notice of proposed rulemaking from the US Department of Health and Human Services. The Voluntary 2015 Edition Electronic Health Record Certification Criteria, a rule that presents a new timeline and new certification criteria for meeting meaningful use stage 3 requirements, includes a change to track user responses to e-prescribing warnings for drug/drug interaction and drug-allergy checking in certified EHRs.

 

This means an audit trail of physician responses to such interactions will now be available for quality checking, as well as for any questions on care (or medical professional liability). This is a serious patient safety issue, because the due diligence and care of physicians could be affected by information on drug/drug interactions and drug allergies that may be as much as six months old, as well as by their inability to prescribe appropriate -- and new -- treatments.

 

Patient safety is a goal for the move to EHRs driven by meaningful use and the array of quality standards through patient-centered medical homes, patient-centered specialty practices, the Physician Quality Reporting System (PQRS), and even the proposed permanent sustainable growth rate (SGR) fix. From the physician's perspective, e-prescribing quality and patient safety issues are contingent on the drug compendia in use.

 

Indeed, what passes for "good" in drug compendia maintenance (a 30-day delay) sounds completely inadequate when e-prescribing is required, and physicians believe that their EHR-based information is accurate and timely. Indeed, most physicians are not aware of the delay or the currency of the drug compendia in use.

 

What Can You Do?

 

The drug compendia issue is a serious EHR design and management flaw that demonstrates a lack of sensitivity or understanding by the government and the EHR industry to a significant and serious patient safety issue. Nonetheless, it is physicians who are responsible for maintaining the integrity of the patient medical record under the security and professional standards of the Health Insurance Portability and Accountability Act (HIPAA). Can physicians maintain the integrity of patient records when the basis for prescription information and interaction checking is not the most current drug information?

 

This is not a problem that doctors can solve, but it is a problem that physicians have to deal with and manage. To address the risk that ultimately rests with physicians, practices need to contact their EHR vendors and uncover how current their drug compendia are. In addition, doctors should discuss what a vendor is doing to decrease the lag time between drug updates. It may also be worthwhile to contact the various regulatory organizations, such as the Centers for Medicare & Medicare Services and the Office of the National Coordinator for Health Information Technology, to highlight the issue and address a flaw that could lead to a serious problem, but which is solvable with some proposals from the EHR software vendors.

 

Otherwise, healthcare providers will be susceptible to claims of liability and questions of due diligence, as well as potentially denying patients new treatment and drug options.