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FDA Deputy Chief Cautions Staff about Leaks
The FDA Deputy Commissioner has outlined prohibitions on disclosure of commercial information that may result in disciplinary sanctions and/or individual criminal liability.
The President's call for open government and transparency is all fine and good, but the FDA delivered this warning shot to anyone thinking of disclosing information the agency doesn't want leaked.
The Deputy Commissioner continued to say that the release of intra- and interagency documents with protected information was covered, including "internal memoranda, letters, and e-mail to and from employees within FDA" and between government agencies. Documents that might contain this kind of information include drafts of policymaking documents, draft notices of proposed and final rules, drafts of other Federal Register documents, recommendations to take (or not to take) some regulatory or enforcement action, requests for legal opinions and the opinions themselves, etc.
http://blogs.wsj.com/health/2009/03/17/memo-to-fda-staff-dont-leak-this/
Serious Parenteral Medication Errors Common in Intensive Care Units
Errors involving parenteral medications at the administration stage are common in intensive care units and may result in permanent harm or death, according to a multinational study published online March 12 in the British Medical Journal. (Online March 12, 2009)
"The combination of complexity and the potential for great harm makes medicine, especially intensive care, even more fraught with risk than other high complexity areas such as aviation," explain Andreas Valentin, MD, from the Department of Emergency Medicine, Medical University of Vienna and the Rudolfstiftung Hospital, Medical Department II in Vienna, Austria, and colleagues.
There were, at the administration stage in intensive care units, 74.5 errors per 100 patient days. In addition, while 71% of errors resulted in no change in the patient's health status, 0.9% of the total study population experienced permanent harm or death as a result of errors in the administration of parenteral drugs in intensive care units.
Errors were most frequently associated with the wrong time of administration, followed by missed medication, wrong dose, wrong drug, and wrong route. Furthermore, the administration of antimicrobial drugs and those in the class of sedation or analgesia were most frequently associated with errors.
Workload, stress, and fatigue were reported as the most frequent contributing factors to medication errors (32%). Other contributing factors included changes in drug names; written or oral miscommunication; lack of experience, knowledge, or supervision; violation of protocol; shift change; and equipment failure. More than half of the errors (53%) that resulted in permanent harm or death occurred in situations in which trainees were involved.
http://www.589596.htm
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