FDA Promotes Electronic Prescription Data with Proposed Rule | EHRintelligence.com | Healthcare and Technology news | Scoop.it
The transmission of electronic prescription data would ensure that providers receive up-to-date patient safety and usage information for drugs and other products.

The transmission of electronic prescription data may be getting a big boost according to a new proposed rule from the Food and Drug Administration (FDA), which would make electronic transmission of certain prescription information a necessity for all healthcare professionals.  The rule would change previous labeling regulations for biologics, prescription drugs, and blood products by requiring all information typically included on packaging to be sent electronically to healthcare providers as a way to ensure patient safety.

The rule intends to address the possibility that printed instructions on certain products may be lacking the latest safety and usage instructions that could potentially prevent an adverse event.  Electronic information, however, can be updated and distributed in real-time, which eliminates the possibility of errors due to misinformation.  “FDA is taking this action to ensure that the most current prescribing information for prescription drugs will be available and readily accessible to health care professionals at the time of clinical decision-making and dispensing,” the rule states.  The data will

The rule would apply only to information distributed to healthcare providers, not to patient packaging inserts, patient-facing medication guides, or information related to promotional labels.  The containers and packaging of medications and products would be required to state that the latest information is available on the FDA’s centralized labeling repository website, which is available to the public.  The website will provide a “single data source that is reliable, authoritative, and comprehensive,” the rule says, and will address concerns about the impact of multiple sources of information that may not be complete.

The FDA anticipates significant industry-wide cost savings from the proposed switch.  After initial implementation costs, most of which would be borne by pharmacies and pharmaceutical companies, the ten-year returns are projected to total between $52 million and $164 million.  The savings tally does not include estimates of how much the industry would save through the avoidance of adverse reactions or other public health impacts.

“This proposed rule complements other FDA and Department of Health and Human Services initiatives that are intended to provide accessible electronic drug product information to health care professionals, consumers, and/or the public,” the rule says.  The provision will work in conjunction with existing ePrescribing programs, which are widely in use thanks to meaningful use and financial incentives offered as part of the 2008 Medicare Improvement for Patients and Providers Act (MIPPA).  Recent data from the ONC shows that 70% of providers already participate in ePrescribing, while the vast majority of pharmacies are equipped with the ability to accept electronic prescriptions.

“Given the time necessary for industry to make preparations needed to comply with this regulation, FDA is proposing an effective date of 6 months after the publication date of the final rule in the Federal Register and a compliance date of 2 years after the date of publication of the final rule,” states the FDA.  Stakeholders may submit written or electronic comments on the proposal until March 18, 2015, and may see the complete rule for details.