Section IThe United States is experiencing a rapidly cumulative incidence of drug shortages. This has caused numerous complications for healthcare facilities, doctors, their patients, and federal regulators. Drug shortages are believed to be caused by multiple factors such as business decisions, regulatory issues, disruptions within the supply chain, difficulties in acquiring raw materials, and manufacturing issues. These problems negatively impact patient care because they cause effective and safe therapies to be replaced with substitute treatments. This can delay or compromise medical procedures. This can lead to medication errors. To manage such drug shortages effectively, it is necessary to establish a management approach that includes clear policies and procedures for information gathering, decision making, collaborative efforts, and timely communication (Ventola, 2011). Drug shortages have been the most challenging challenges 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 problem is the merger of the pharmaceutical industry which results in a reduction in suppliers. Quality problems are created due to shortages of certain underlying raw materials, which will slow drug production, as well as due to delays in FDA approval of new manufacturing facilities, particular processes, and drugs. Furthermore, in 2011, demand for more than 200 drugs exceeded supply (Chanet.org, 2014). Many manufacturers routinely give no warning of impending drug shortages or provide little advance notice and provide no estimate of expected drug shortages. duration (Ventola, 2011). Causes of drug shortages may include: shortage of ... middle of paper ......ve. To improve oversight of shortages, especially as the agency refines how it collects data on shortages and changes from its database to a more vigorous system, it is recommended that the FDA Commissioner take the following actions: Establish policies and procedures for using the current drug shortage database and possibly the new shortage information system to ensure that staff enter data into the database on a regular basis and to confirm the accuracy of the information in the database and conduct episodic analyzes using the current Drug Shortage Database and, finally, the new Drug Shortage Information System to regularly and methodically measure drug shortage information and use this information to practically help the FDA identify trends, explain causes, and resolve problems before drugs decrease in supply (GOA.gov, 2014).