Critical Regulatory Issue in Health Care Paper

733 Words Dec 11th, 2013 3 Pages
Critical Regulatory Issue in Health Care
Febuary 19, 2013
HCS/430
Ann Nevers Critical Regulatory Issue in Health Care Pharmacists are vital to the health care industry because it provides medicine. Over time the responsibilities and duties of pharmacists have shifted drastically. The Food and Drug Administration is an agency that monitors and ensures safety of medicines Americans will use. Pharmaceuticals are the most regulated products in the country. The laws pertaining to the shifting roles and increased responsibilities in pharmaceuticals have emerged. The two legislative acts the fuel the power of the FDA is followed significant tragedies. Pharmacists provide care in case of emergencies and now are held responsible
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All pharmacies recommend patients to check and see if their medicine is included in the recall before they take another dosage of their medicine. The patients do not have to do much as far as insurance purposes because they are automatically notified. If patient receives their medicine from the pharmacy they can swap out their pills there and mail order patients will be mailed new medications (Walton, 2012). Lipitor was considered the best selling drug in the world. In 2011, the patent for Lipitor expired and many companies have begun to make generic versions. Ranbaxy has been making a generic brand of the medicine since late last year. Ranbaxy recalled the medicine out of caution with the knowledge of the FDA. The FDA has been carefully watching Ranbaxy since the investigation and sanctions back in 2006. Federal investigators found that Ranbaxy did not test the shelf life and safety factors of drugs and lied about results. Ranbaxy signed a decree that stated that they would improve manufacturing procedures, ensure product data and make sure for five years a third party would be used to review the company. Ranbaxy had $500 million set aside to cover potential criminal and civil liability. The company conducted a two week investigation of how the glass particle was found in the medication. There were no injuries caused by the tainted medicine and the problem of how the glass particles were found. Given its high volume of need for the

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