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.
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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 for malpractice, face ethical challenges to dispensing pharmaceuticals and consultations for patients. The purpose of the paper is to find an article that or current legal case that involves a critical regulatory issue in health care.
Many drugs that Americans consume are not approved by the FDA. Some medicines are beyond the scope of the FDA regulatory authority or some are approved to be used in other ways. Often some problems occur after the product has been approved by the FDA (Hooper, 2008). A manufacturer of the popular cholesterol reducing drug recalled 40 batches after finding out that it may contain small particles of glass. The glass particles were similar to the size of a grain of sand. If ingested it could be dangerous.
There were no true adverse effects related to the recall are very low which means there are no injuries reported The pharmaceutical company Ranbaxy is recalling bottles of 10, 20, and 40 milligram tablets atorvastatin calcium, the generic version of Lipitor. The FDA granted the company approval of the manufacture of drug in New Jersey in 2011. Ranbaxy has been under the radar since 2006 for submitting false data to FDA and barred the company from manufacturing drugs in the United States until they met standards. Patients needed to find out if they pills they are taking are in the recall.
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 drug there may be shortage of the drug over the next two weeks. Pharmacies and wholesalers will be the two most impacted (Walton, 2012)
The recall comes at a bad time for the FDA due to the meningitis outbreak and another well known medicine Wellbutrin is being recalled. Also, the FDA is being criticized for approving Lipitor generic brand after already knowing how poor reputation Ranbaxy had prior. The removal of Ranbaxy’s atorvastrin was a long line of recall. People are left to doubt the federal and state because the quality of medicine is not ensured. Consumers and patients need to become more aware and attentive about what they are going to be taking and reporting any issues or concerns to physician, FDA, and pharmacist.
Hooper, C. (2013). “Pharmaceuticals: Economics and Regulation.” The Concise Encyclopedia of Economics. Liberty Fund, Retrieved from http://www.econlib.org/library/Enc/PharmaceuticalsEconomicsandRegulation.html. Walton, J. (2012). “Generic Cholesterol Medication Recalled.” Timesfreepress.com. Chattenooga Publishing Company, Retrieved from http://www.timesfreepress.com/news/2012/nov/24/generic-cholesterol-medication-recalled/.