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Drug Shortages affecting Patient-Care in the U.S. and the FDAs Role in it - Research Paper Example

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Most Americans sincerely believe that if they were to suddenly fall ill, they would be able to have access to the necessary medicine to treat their condition…
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Drug Shortages affecting Patient-Care in the U.S. and the FDAs Role in it
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Download file to see previous pages Moreover, it has not been discussed comprehensively by the press; causing many citizens to presume that only a small section of medical facilities in low income areas are experiencing this situation. Drug shortages are caused by different factors that are based on the different stages of the life-cycle of a drug. Reasons for Drug Shortages Different trends can result in drug shortages. Some of these include: 1. The Unavailability of Raw Materials Shortages can be caused by the suboptimal quality of the substances needed to manufacture drugs. Ineffective alternatives tend to flood the market when the original manufacturer of a drug, particularly when it is a single pharmaceutical company, shuts down. In such cases, the suboptimal drugs that flood the market may have chemical instabilities, and other impurities. In has been established that in America, more than 70% of the raw materials for drugs are imported from foreign nations by pharmaceutical companies. Drug shortages will therefore occur if the raw materials are affected by any type of infection while still in their nation as the orders for them then have to be cancelled and the exporting nation given an extended period to get more raw materials. Such shortages can be particularly difficult to tackle when the manufacturing company that processes the raw materials stops all operations as this will affect all its partner companies in different nations. In America, the healthcare sector deals with such challenges by assigning personnel to track and solve such problems before they have the chance to adversely affect it. Most American pharmacy managers go to great lengths to know the cost of alternative forms of therapy and treatment, and how they can use these different types of treatment on their patients. In the past, drug manufacturers have been particularly reluctant to provide such information. This is not just because they see this as being a method of sabotaging their own success. The fact is that there is a lot of uncertainty about the production process as well as distribution process drugs. The supply chain in the production and distribution of pharmaceutical drugs has many participants, any of who can cause delays or shortages if their role is somehow affected. There are the raw material suppliers, the wholesalers, the regulators, the buying groups, the prime vendors, and lastly, the end-user organizations affiliated with the healthcare sector. Most of these groups will acquire the needed goods just in time to avoid a lapse that can result in a shortage. This negatively affects the capacity of the supply chain to sustain the availability of drug products when the health care sector experiences interruptions in one or ore of the drug making processes. Most end-user organizations affiliated with the healthcare sector do not even make use of their own inventories any more. They have to rely on their suppliers for daily replacements. With the non-existence of such inventories which can act as a buffer, even a momentary back order will turn into a serious drug product deficiency for the end-user organization. Another cause of the shortage of raw materials used to manufacture drugs is hostilities in the country with the raw products. When the raw materials of drugs grow naturally in developing countries where there are wars or periodic tropical diseases that affect the plants that produce the raw materials, the prime raw materials will be hard to acquire, resulting in shortages of the ...Download file to see next pagesRead More
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