Hearing Held to Determine Electronic Submissions
The FDA recently held a public hearing to determine whether to require electronic submissions of all data related to the approval of drugs, medical devices, and other treatments. The agency also wanted answers to 35 specific question areas, such as current electronic submissions and the obstacles to more, their costs, the timing of a transition, and the use of third-party entities to operate a core electronic submission platform.
For the past several years, the FDA has slowly been increasing the types of information it can receive electronically, either voluntarily or by mandate. The information includes electronic records, electronic signatures, labeling content, and certain premarket applications. The agency has also worked with the industry to create data standards and to build databases for sharing information on clinical trials.
Epocrates Unveils New On-line Features
Epocrates has enhanced its free Web-based drug and formulary reference guide with patient education materials and additional clinical tools. The new resources include:
The Epocrates Online application also includes information on >3300 drugs; MultiCheck; and formulary coverage information for >130 health plans and all Medicare Part D plans.
New CPOE System Improves Patient Safety
Partners HealthCare recently licensed First DataBank's new computerized physician order entry (CPOE)-ready drug database, OrderView Med Knowledge Base.
"Building the medication ordering content that supports CPOE applications is a significant task for CPOE implementers, whether or not they build a homegrown system or purchase one from a vendor," said Virginia Halsey, First DataBank's product management director. "Without a whole infrastructure and content collection process in place, it's really hard to research and rigorously test the data efficiently in a clinical environment. With OrderView, a dedicated team of clinical pharmacists and [quality assurance] professionals do the research and testing for you."
The database content promotes accuracy by providing validated dose and frequency selections for a specific drug. It also optimizes the concept of prebuilt "orderable medications" that enable clinicians to arrive at their order in the fewest possible steps. This need was identified early and reflected in the way that Partners built its content. The content supports features such as dose adjustments for organ impairment, mg/kg calculations and rounding for final doses, and pediatric and discharge orders.
OrderView Med Knowledge Base also provides translations for discharge prescriptions and patient instructions. This tactic contrasts favorably with a generalized dose or warning messageafter the factthat a dose may not be correct. It also helps diminish alert fatigue, a problem too often connected with clinical decision support.
"We've determined that as long as we have a reliable, professional content source, it's easier and more cost efficient to customize the content where necessary, rather than building our entire database from scratch and maintaining it," explained Carol Broverman, PhD, corporate manager of Medication Informatics and Clinical Informatics Research and Development.
Agreement Provides Access to Medication History
PharmaCare, a wholly owned subsidiary of CVS Corp, will now allow physicians using SureScripts certified technology to access data regarding a patient's drug formulary and eligibilityin real time, during the patient's office visit.
With this information readily accessible to the physician, it eliminates many of the questions that often require pharmacists and prescription benefit managers to make multiple phone calls to a physician's office. SureScripts' ability to connect to medication history data from the nation's community pharmacies and present data to physicians will also be improved by the addition of medication history data from PharmaCare. The enhancement will give physicians a more thorough, timely, and clinically sound view of a patient's medication history.
The agreement with SureScripts helps PharmaCare take a major step toward complying with the Medicare Modernization Act. After the SureScripts certification process is complete, PharmaCare will be able to send this critical information to a patient's physician via the SureScripts Electronic Prescribing Network.
"The nation's pharmacies are leading the country toward a more interoperable system of health care," commented Kevin Hutchinson, president and chief executive officer of SureScripts. The agreement with "PharmaCare is a prime example of how community pharmacy is actively forming new relationshipswith prescription benefit managers as well as payers and health systemsthat open doors and allow for the sharing of critical information that will cut costs, save lives, and dramatically improve health care in the United States."