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Web site gives system pharmacy best practices
Advancement of 'high performance' pharmacy
A new web site developed by the Health Systems Pharmacy Executive Alliance identifies best practices for improving health system pharmacy operations and recommendations for adopting the practices.
The Health Systems Pharmacy Executive Alliance is a collaboration of well-known leaders who are dedicated to advancing hospital pharmacy's contributions to patient safety, clinical quality, and financial performance through increased effectiveness and efficiencies.
The group's vision is advancement of what it calls the High Performance Pharmacy, a concept that it says enhances and elevates the profession of health system pharmacy, as well as its practice and standing, within healthcare today and in the future.
More than 70 elements of high performance were identified across eight key dimensions —leadership, medication preparation and delivery, patient care services, medication safety, medication use policy, financial performance, human resources management, and education. The study estimated the level of effort required to implement each element and the expected impact on quality, safety, and financial performance.
[Editor's note: Learn more at http://www.highperformancepharmacy.com]
New suicide warnings on antidepressants
FDA has proposed that all makers of antidepressants update the existing black box warning on the products' labeling to include warnings about increased risks of suicidality in young adults ages 18 to 24 during initial treatment (generally the first one to two months).
The proposed labeling changes also include language stating that scientific data did not show an increased risk in adults older than age 24, and that adults ages 65 and older taking antidepressants have a decreased risk of suicidality.
The proposed labeling changes apply to the entire category of antidepressants. FDA said results of individual placebo-controlled scientific studies are reasonably consistent in showing a slight increase in suicidality for patients taking antidepressants in early treatment for most of the medications. Available data are not sufficient to exclude any single medication from the increased risk of suicidality, the agency said. FDA also emphasized that depression and certain other serious psychiatric disorders are themselves the most important causes of suicide.
All Shelhigh medical devices recalled
FDA issued a formal written request that Shelhigh, Inc., recall all of its medical devices remaining in the marketplace, including hospital inventories, because of sterility concerns. On April 17, U.S. Marshals acted on an FDA request and seized all medical devices, including components, at Shelhigh's Union, NJ; facility after finding significant deficiencies in the company's manufacturing processes. During the seizure, the company was asked for a voluntary recall of its products but it declined.
FDA said Shelhigh devices are used in infants, children, and adults, and include pediatric heart valves, conduits for blood flow, surgical patches, dural patches, annuloplasty rings, and arterial grafts.
The agency said the company's deficiencies, outlined in a complaint filed in New Jersey federal court, may compromise the devices' safety and effectiveness. The company's records indicate a number of sterility test failures and that its testing and retesting procedures were not properly performed, FDA said.
Avandia safety alert issued
FDA said it is aware of a potential safety issue related to GlaxoSmithKline's Avandia (rosiglitazone), indicated for treating type 2 diabetes. The agency said safety data from controlled clinical trials have shown a potentially significant increase in risk of heart attack and heart-related deaths in patients taking Avandia. However, the agency said, other published and unpublished data from Avandia long-term clinical trials provide contradictory evidence about the risks in patients treated with Avandia.
The agency said it has not confirmed the clinical significance of the reported increased risk in the context of other studies. Pending questions include whether the other approved treatment from the same class of drugs, piolglitazone (Takeda's Actos), has less, the same, or greater risk. Also, it said, there is inherent risk associated with switching patients with diabetes from one treatment to another, even in the absence of specific risks associated with particular treatments. For that reason, FDA said, it is not asking Glaxo to take any specific action.
FDA said patients taking Avandia, especially those known to have underlying heart disease or who are at high risk of heart attack, should talk to their doctor about this alert as they evaluate available treatment options for their type 2 diabetes.
MRI contrast agents should have warning
FDA has asked manufacturers to include a new boxed warning on product labeling of all gadolinium-based contrast agents used to enhance the quality of MRI images. The requested warning would state that patients with severe kidney insufficiency who receive gadolinium-based agents are at risk for developing nephrogenic systemic fibrosis, a debilitating and potentially fatal disease. The boxed warning would also state that patients just before or after liver transplantation, or those with chronic liver disease, are also at risk for developing nephrogenic systemic fibrosis if they are experiencing kidney insufficiency of any severity. Five gadolinium-based contrast agents have been approved for use in the U.S.—Bayer Schering Pharma's Magnevist, GE Healthcare's Omniscan, Mallinckrodt's OptiMARK, and Bracco Diagnostics' ProHance and Multihance.
FDA targets timed-release guaifenesin
FDA has given companies 90 days to stop producing and 180 days to stop distributing unapproved drug products in timed-release dosage form that contain guaifenesin , commonly used in cough and cold medications to stimulate removal of mucous from the lungs. The action does not affect products containing guaifenesin in immediate release form. Only Adams Respiratory Therapeutics has FDA approval for timed-release products containing guaifenesin (600 mg and 1,200 mg) under the trade names Mucinex and Humibid.