Essay On Drug Shortage

2826 Words6 Pages

Section I
The United States is encountering a speedily accumulative incidence of drug shortages. This has caused abundant complications for health care facilities, clinicians, their patients, and federal regulators. Drug shortages are determined to be caused by multiple factors such as, business decisions, regulatory issues, disturbances within the supply chain, difficulties in acquiring raw materials, and manufacturing issues. These problems adversely affect patient care because it causes substitutions of effective and safe therapies with substitute treatments. This can delay or compromise medical procedures. This can cause medication errors. A management approach that includes clear policies as well as procedures for gathering information, making a decision, collaborative efforts and timely communication need to be established to handle such drug shortages in an effective manner (Ventola, 2011).
Drug shortages have been the most challenging for sterile injectable drugs. This is because they are more complex to produce and are more likely to have problems with the manufacturing process. Another issue is merging in the pharmaceutical industry which results in reduced suppliers. Quality issues are created due to scarcity of some underlying raw materials, which will slow down drug manufacturing, as well as, delays in FDA approval of new facilities for manufacturing, particular processes and drugs. Also, in 2011, the demand for over 200 drugs exceeded the supply (Chanet.org, 2014).
Many manufacturers either regularly do not deliver any notice for an approaching drug shortage or they provide diminished advance notice and they give no estimate of the expected duration (Ventola, 2011). Causes of drug shortages can include: shortages of ...

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To improve its oversight of shortages, mainly as the agency perfects the manner in which it gathers data on shortages and changes from its database to a more vigorous system, it is recommended that the Commissioner of the FDA take the following actions:
Establish policies and procedures for the use of the current drug shortages database and eventually the new shortages information system to guarantee staff enter data into the database in a regular manner and to confirm the exactness of the information in the database and conduct episodic analyses using the current shortages database and ultimately the new drug shortages information system to regularly and methodically measure drug shortage information and use this information practically helping the FDA to identify trends, explain causes and resolve issues before drugs go into decreased supply (GOA.gov, 2014).

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