Cause Mapping is a Root Cause Analysis method that captures basic cause-and-effect relationships supported with evidence.
Cause Map
Increased risk of heart attacks, stroke death Two thirds of diabetics die of heart problems; Masked test results increase risk of heart disease
Problem Solving • Incident Investigation • Root Cause Analysis Drug originally licensed with warning about risks for patients with heart failure Making medical decisions is difficult - even with all the information. When information about health risks determined during clinical trials is kept from the public, Rosiglitazone (found in Avandia, Avandamet Second-line treatment for Type 2 Diabetes "Patients trust drug companies with their health and their lives."
-Senator Max Baucus
Impact to the Goals
Patient Safety
Increased occurrence of heart attack, stroke, Since rosiglitazone was approved for use in controlling blood sugar in Type 2 diabetics who did not have success with front line treatments in 1999, studies have shown that users of this drug Employee Impact
(included in trade name drugs Avandia, Avandamet and Avaglim) increases the risk of heart Compliance
disease in users. This is of particular concern because most Type 2 diabetics die from heart Organization
Reduced sales ($2.5 billion in 2006, <$408 disease. It is estimated that 60,000 to 200,000 people have suffered from heart disease due to Patient Services
A black box warning was placed on these drugs, but not until November 2007. The European Property, Equip, Mtls
Medicines Agency recommended that the drug be suspended from European markets in 2010, Labor, Time
and the drug was withdrawn from New Zealand markets in 2011. What took so long? Timeline
The patient safety goal is impacted because of the increased occurrence of stroke, Heart problems in 66,000 to 200,000 people (One person suffers heart problems for every heart attack, and death. The compliance goal is impacted because - according the Description
Senate Finance Committee - trial results that would have indicated the increased FDA approves Avandia for controlling diabetes risk for cardiovascular disease were not publicly released in a timely manner. Manufacturer study reveals heart problems Analysis
Reduced sales as a result of the risk are estimated to be more than $2 billion (an impact to the organizational goal) and lawsuits (an impact to the patient services Manufacturer releases meta-analysis to the FDA Cause Map - Add detail as information becomes available.
goal) are projected to cost more than $1 billion.
Lancet study shoes Avandia can prevent diabetesNew England Journal of Medicine publishes analysis Although the actual mechanism that is causing the increased risk of cardiovascular showing drug increases risk of heart attacks by 43% disease is unknown, the cause of the increased occurrence of heart attack, stroke and death is due to the prescribing of the drug rosiglitazone. Although rosiglitazone NEJM publishes study by manufacturer showing drug does has been found to be an effective second-line treatment for Type 2 diabetes, it is unlikely that doctors would have prescribed it as readily had they known about the increased risk of heart disease. Instead, they were likely swayed by a multi-million House of Representatives meets to consider whether the dollar advertising campaign, while test results that showed increased cardiovascular FDA should continue to allow Avandia to be sold FDA advisory committee concludes increased risk of heart disease but that drug should remain on market Black box warning placed on drug at request of FDA Patient Safety
British Medical Journal study released discussing adverse Impacted
Senate Finance Committee accuses manufacturer of holding Studies in Journal of the American Medical Association and Archives of Internal Medicine show that drug increases risk Services
FDA convenes another advisory committee meeting vote Impacted
Senate Finance Committee releases findings that manufacturer failed to publish studies that found serious health risks in a timely manner Organization
European Medicines Agency recommended that the drug be Impacted
Drug withdrawn from New Zealand market after Medsafe concluded that the risks outweigh the benefits Avandia may only be sold with a prescription from a certified doctor through mail order to specified pharmacies in U.S.
Action Item
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