Archive for the ‘Main’ Category
Posted by James
It is now well known that pain is both highly prevalent and undertreated in the elderly. Pain management is a particular problem in nursing-home patients, a vulnerable population that poses significant and unique challenges to caregivers in terms of their ability to provide adequate treatment. Some of these challenges include the misconceptions and unfounded fears about patients becoming addicted to prescription opioids.
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Posted by James
Many states have enacted legislation to mandate the reporting of medical errors and to require a form of public disclosure. It is thought that via public transparency, we can compare process-improvement strategies, thereby lowering the rate of medication errors and improving the quality and safety of health care. Among these state agencies, one has been hailed as a bellwether for the rest of the nation, namely the Patient Safety Authority (PSA) in the Commonwealth of Pennsylvania. I would like to review the early history and progress of this agency, with an emphasis on its efforts to reduce medication errors.
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Posted by James
Manufacturer: Omrix Biopharmaceuticals Ltd., Oak
Island, NC
Indications: Used topically, Evithrom is a blood-clotting protein that aids hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and when control of bleeding by standard surgical techniques is ineffective or impractical. It may be used in conjunction with an absorbable gelatin sponge.
Drug Class: Human thrombin is derived from human plasma obtained from carefully screened and tested U.S. donors. The product has undergone steps to reduce the risk for transfusion-transmitted diseases.
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Posted by James
Manufacturer: TopoTarget A/S, Copenhagen, Denmark
Indication: Totect is used to treat extravasation resulting from IV anthracycline agents used in chemotherapy. Anthra-cyclines (e.g., daunorubicin, doxorubicin, and epirubicin) constitute one of the cornerstones in the treatment of breast cancer and leukemia. Extravasation occurs when injected drugs leak out of the vein and into the skin.
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Posted by James
Amlodipine/Olmesartan Medoxomil (Azor)
Manufacturer: Daiichi Sankyo, Parsippany, NJ
Indication: Amlodipine medication besylate plus olmesartan medoxomil is indicated for the treatment of hypertension, alone or with other antihypertensive agents. It is not indicated for the initial therapy of hypertension.
Drug Class: This product combines the complementary actions of the calcium-channel blocker generic amlodipine, which inhibits the entrance of calcium into the blood vessel walls, and of those of olmesartan, which blocks angiotensin II receptors. Angiotensin II is a hormone that causes blood vessels to constrict.
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Posted by James
Given the failure of Congress to appropriate adequate funds for drug safety, no one expects future FDA appropriations to add congressional money to the user fees that will be available for the database. That is why the agency hopes to also supplement user fees with funding provided by the Reagan-Udall Foundation, also being established by the FDAAA. The fund has a much broader purpose, however. It is a private foundation, modeled on the ones already used by the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH). The fund will raise its own operating budget. That money will be spent on collaborative research in which drug companies, academic centers, and others join together for research that would be dispersed broadly and whose results generally would not be patented. The kinds of research projects to be undertaken would be those on the FDA’s Critical Path Initiative (CPI) list.
The FDA established the CPI in March 2004. The CPI list includes 76 projects, but the FDA has funded only half a dozen or so. These projects cover biomarkers, animal models, inter-individual variability in drug response, data analysis technology and methodology in drug development, and improvements in designing and conducting clinical trials.
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Posted by James
Dolly A. Judge, Pfizer Vice President of Federal Government Relations, says:
I think more interactions are better for drug safety management purposes. But I know the optics of the industry and agency meeting more frequently is not necessarily better politically. Senator Grassley and others have been critical of the relationship between industry and FDA, so more meetings could further enhance a false perception that the relationship is too close or somehow it is unholy, so to speak.
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