In US a new rule came into action when the deaths due to medical errors are on the rise. Medical errors occur due to loads of confusing information given on the drug labels. Food and Drug Administration (FDA) come up with a solution of the highlight section //thereby making it easy for the doctors. Doctors face a huge amount of information before they could assess a drug as completely safe for the patient.
The new rule would bring about a change in the drug advertisements offered by the companies but would protect the drug makers.
Statistics shows that the number of people injured were 300,000 and those who lost their lives were nearly 100,000. Studies show that all this is a result of medical error.
The reason behind medical errors is due to the lack of knowledge of the physicians about the drug labels. In response to this Dr. Charles Gerson, a Gastroenterologist in Manhattan said that the information given on the label is not easy to locate.
The FDA announced that the drug labels should contain a highlight section, which gives the gist of the information regarding drug safety. It will list safety warnings and then summarize any recent changes for that particular drug. Also information about the dose, the information that the doctor should tell the patients and usage of the drugs are to be mentioned in the label.
Dr. Andrew C. von Eschenbach, the drug agency's acting commissioner, said that this rule is an important step in reducing the percentage of medical errors in the future. But the rule does not address the information sheets hat do not include drug warnings.
Dr. Sidney M. Wolfe, director of the health research group at Public Citizen, said that similar rules should be incorporated in the patient information. This would enable better knowledge of the drugs among the patients.
Statistics sow that around $4 billion to $4.8 billion are spent on medical errors, which could be avoided. Drug
advertising and television commercials will change after the new rule and will result in clear crisp note about the drug risks.
But the lawyers feel that the new rule would protect the drug makers, as it will make it impossible to file liability claims against the drug maker.
Chris Mather, a spokeswoman for the Association of Trial Lawyers of America, said that the rule has proved the power of drug makers over the political process.
Dr. Woodcock said that the three important reasons for the Drug labels to become very confusing these days are due to the liability and marketing concerns faced by the drug maker. In this confusion he has forgotten to cater the needs of the physician. Secondly a lot of information is known about the drug and all of it has to be included in the label, which again becomes very difficult. And thirdly the numbers of drugs are on the rise.
The rule is applicable to all the new drugs; all the drugs approved in the past five years and to any drug for which a major label revision is requested.
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