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FDA Mini-Sentinel pilot launches
The first step toward a national electronic system that will transform FDA?s ability to track the safety of drugs, biologics, and medical devices is up and running, according to a recent press release announcing the Mini-Sentinel Pilot project.
The first step toward a national electronic system that will transform FDA’s ability to track the safety of drugs, biologics, and medical devices is up and running, according to a recent press release announcing the Mini-Sentinel pilot project.
The Mini-Sentinel pilot project will facilitate the informed development and implementation of the larger fully operational Sentinel System. Through the Mini-Sentinel pilot, FDA will evaluate valid and reliable scientific methods, safety issues using existing electronic healthcare data systems, and the barriers and challenges to building a viable and accurate system of safety surveillance, according to the project’s Website.
The Mini-Sentinel system is designed to accommodate urgent FDA requests for information about medical product exposures and outcomes, and aims to post results relating exposure of a medical product to a health outcome within 30 days of completion of standard checks for accuracy.
FDA cautions that the presence of a drug, device, or biologic as a subject of Mini-Sentinel activity does not mean the agency has concluded there is a risk associated with it. The agency may have identified a potential safety issue, but not a causal relationship between the drug, device, or biologic and the named risk, according to the disclaimer on the project’s Website.
The Mini-Sentinel pilot project database took 2 years to develop, and it focuses on drugs, vaccines, other biologics, and medical devices. With 17 data partners across the United States, the database now includes data on nearly 100 million patients, 2.9 billion prescription drug dispensings, and 2.4 billion unique medical encounters, including 38 million acute inpatient hospital stays.
For more information, visit the Mini-Sentinel Website: http:/mini-sentinel.org/.
Coalition promotes important acetaminophen dosing reminders
November 18th 2014It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.
Support consumer access to specialty medications through value-based insurance design
June 30th 2014The driving force behind consumer cost-sharing provisions for specialty medications is the acquisition cost and not clinical value. This appears to be true for almost all public and private health plans, says a new report from researchers at the University of Michigan Center for Value-Based Insurance Design (V-BID Center) and the National Pharmaceutical Council (NPC).
Management of antipsychotic medication polypharmacy
June 13th 2013Within our healthcare-driven society, the increase in the identification and diagnosis of mental illnesses has led to a proportional increase in the prescribing of psychotropic medications. The prevalence of mental illnesses and subsequent treatment approaches may employ monotherapy as first-line treatment, but in many cases the use of combination of therapy can occur, leading to polypharmacy.1 Polypharmacy can be defined in several ways but it generally recognized as the use of multiple medications by one patient and the most common definition is the concurrent use of five more medications. The presence of polyharmacy has the potential to contribute to non-compliance, drug-drug interactions, medication errors, adverse events, or poor quality of life.
Medical innovation improves outcomes
June 12th 2013I have been diagnosed with stage 4 cancer of the pancreas, a disease that’s long been considered not just incurable, but almost impossible to treat-a recalcitrant disease that some practitioners feel has given oncology a bad name. I was told my life would be measured in weeks.
