During the last few years there has been an ever increasing shortage of critically needed medications, from 2005 to 2010 the number of shortages has tripled (Obama, 2011). The fundamental problem can be identified as an inability in the market to find and reward quality sterile injectable medications. This inability bolsters price competition and incentivize poor quality. The lack of focus on quality frequently leads to needed medication not reaching customers due to quality concerns. In 2011 drug shortages rose to 251 separate medications in short supply (Woodcock, Wosinska. 2012)
Commonly these shortages are significantly pronounced, as there is no adequate substitute for these medically necessary medications. The Food and Drug Administration …show more content…
Drug shortages are almost always initiated by a failure in quality management. In 2011 56% of the sterile injectable drug shortages were directly caused by quality concerns (Woodcock, Wosinska, 2012). Some sterile injectable drug shortages are caused when production issues cause a decrease in supply for precursor materials resulting in a final product shortage. Product discontinuation accounted for 9% of sterile injectable shortages in 2011. These shortages are commonly caused by production capacity constraints. Generic sterile injectable drugs generally have a low profit margin and for a company to continue to produce the medication the products revenue should exceed the cost of production. If the cost of production will exceed its revenue either cost cutting to reach profitability or product discontinuation may occur. By cutting cost to return to potential profitability quality may lapse in return for profitability and quality related shortages might …show more content…
It is costly to begin production of sterile injectable generic drugs and FDA approval for manufacturing can last 2.5 years (Alspach, 2012). In 2011 President Obama signed Executive Order 13,588 that encouraged drug manufacturers to report to The Food and Drug Administration the possibility for a medication shortage. The FDA cannot act with manufacturers unless it knows there is a potential problem. Prompt disclosure of potential supply issues can help consumers make arrangement before a shortage becomes a troubling crisis. Still drug manufacturers have not reliably given the FDA notice about looming drug shortages. This reporting is entirely voluntary and is no mandated by law. When a drug is reported to the FDA that is or has the potential to be in short supply the FDA will verify that the shortage is not transient and that the drug is medically necessary. A drug that is medically necessary is on that is used to treat or prevent serious disease or condition that has no available substitute. If the drug is in shortage and is deemed medically necessary the FDA will work with the manufacturer to resolve the medication
Commonly these shortages are significantly pronounced, as there is no adequate substitute for these medically necessary medications. The Food and Drug Administration …show more content…
Drug shortages are almost always initiated by a failure in quality management. In 2011 56% of the sterile injectable drug shortages were directly caused by quality concerns (Woodcock, Wosinska, 2012). Some sterile injectable drug shortages are caused when production issues cause a decrease in supply for precursor materials resulting in a final product shortage. Product discontinuation accounted for 9% of sterile injectable shortages in 2011. These shortages are commonly caused by production capacity constraints. Generic sterile injectable drugs generally have a low profit margin and for a company to continue to produce the medication the products revenue should exceed the cost of production. If the cost of production will exceed its revenue either cost cutting to reach profitability or product discontinuation may occur. By cutting cost to return to potential profitability quality may lapse in return for profitability and quality related shortages might …show more content…
It is costly to begin production of sterile injectable generic drugs and FDA approval for manufacturing can last 2.5 years (Alspach, 2012). In 2011 President Obama signed Executive Order 13,588 that encouraged drug manufacturers to report to The Food and Drug Administration the possibility for a medication shortage. The FDA cannot act with manufacturers unless it knows there is a potential problem. Prompt disclosure of potential supply issues can help consumers make arrangement before a shortage becomes a troubling crisis. Still drug manufacturers have not reliably given the FDA notice about looming drug shortages. This reporting is entirely voluntary and is no mandated by law. When a drug is reported to the FDA that is or has the potential to be in short supply the FDA will verify that the shortage is not transient and that the drug is medically necessary. A drug that is medically necessary is on that is used to treat or prevent serious disease or condition that has no available substitute. If the drug is in shortage and is deemed medically necessary the FDA will work with the manufacturer to resolve the medication