Hearing Held to DetermineElectronic Submissions
The FDA recently held a public hearingto determine whether to require electronicsubmissions of all data related tothe approval of drugs, medical devices,and other treatments. The agency alsowanted answers to 35 specific questionareas, such as current electronic submissionsand the obstacles to more, theircosts, the timing of a transition, and theuse of third-party entities to operate acore electronic submission platform.
For the past several years, the FDA hasslowly been increasing the types of informationit can receive electronically,either voluntarily or by mandate. Theinformation includes electronic records,electronic signatures, labeling content,and certain premarket applications. Theagency has also worked with the industryto create data standards and to builddatabases for sharing information onclinical trials.
Epocrates Unveils New On-lineFeatures
Epocrates has enhanced its free Web-baseddrug and formulary referenceguide with patient education materialsand additional clinical tools. The newresources include:
The Epocrates Online application alsoincludes information on >3300 drugs;MultiCheck; and formulary coverageinformation for >130 health plans and allMedicare Part D plans.
New CPOE System ImprovesPatient Safety
Partners HealthCare recently licensedFirst DataBank's new computerized physicianorder entry (CPOE)-ready drug database,OrderView Med Knowledge Base.
"Building the medication orderingcontent that supports CPOE applicationsis a significant task for CPOE implementers,whether or not they build ahomegrown system or purchase onefrom a vendor," said Virginia Halsey, FirstDataBank's product management director."Without a whole infrastructure andcontent collection process in place, it'sreally hard to research and rigorouslytest the data efficiently in a clinical environment.With OrderView, a dedicatedteam of clinical pharmacists and [qualityassurance] professionals do the researchand testing for you."
The database content promotes accuracyby providing validated dose and frequencyselections for a specific drug. Italso optimizes the concept of prebuilt"orderable medications" that enable cliniciansto arrive at their order in the fewestpossible steps. This need was identifiedearly and reflected in the way thatPartners built its content. The contentsupports features such as dose adjustmentsfor organ impairment, mg/kg calculationsand rounding for final doses,and pediatric and discharge orders.
OrderView Med Knowledge Base alsoprovides translations for discharge prescriptionsand patient instructions. Thistactic contrasts favorably with a generalizeddose or warning message—after thefact—that a dose may not be correct. Italso helps diminish alert fatigue, a problemtoo often connected with clinicaldecision support.
"We've determined that as long as wehave a reliable, professional contentsource, it's easier and more cost efficientto customize the content where necessary,rather than building our entire databasefrom scratch and maintaining it," explained Carol Broverman, PhD, corporatemanager of Medication Informaticsand Clinical Informatics Research andDevelopment.
Agreement Provides Accessto Medication History
PharmaCare, a wholly owned subsidiaryof CVS Corp, will now allow physiciansusing SureScripts certified technologyto access data regarding a patient'sdrug formulary and eligibility—in realtime, during the patient's office visit.
With this information readily accessibleto the physician, it eliminates many ofthe questions that often require pharmacistsand prescription benefit managersto make multiple phone calls to a physician'soffice. SureScripts' ability to connectto medication history data from thenation's community pharmacies andpresent data to physicians will also beimproved by the addition of medicationhistory data from PharmaCare. Theenhancement will give physicians a morethorough, timely, and clinically soundview of a patient's medication history.
The agreement with SureScripts helpsPharmaCare take a major step towardcomplying with the Medicare ModernizationAct. After the SureScripts certificationprocess is complete, PharmaCare willbe able to send this critical information toa patient's physician via the SureScriptsElectronic Prescribing Network.
"The nation's pharmacies are leadingthe country toward a more interoperablesystem of health care," commentedKevin Hutchinson, president and chiefexecutive officer of SureScripts. Theagreement with "PharmaCare is a primeexample of how community pharmacy isactively forming new relationships—withprescription benefit managers as well aspayers and health systems—that opendoors and allow for the sharing of criticalinformation that will cut costs, save lives,and dramatically improve health care inthe United States."