Drug Shortages

Drug Shortages

Introduction

The shortage of drugs in the United States of America is defined as a state in which the total supply of the entire clinically interchangeable versions of an FDA regulated drug is insufficient to meet the projected or current demand at the user level (Birt, 2009). A term not often came across decades ago; it was not until recent years that the impact and magnitude of drug shortage stepped forward to serious levels. While the list of annual new drug shortages remained fairly even prior to 2005, a speedy, stable increase has been scrutinized over the second half of the past decade. In the year 2010, there were 211 lately reported drug shortages, tripling the quantity in 2006 with approximately 75% being sterilized injectable. The shortage is at hand in all healthcare practice settings and affects almost all drug classes, with serious therapeutic areas like antimicrobials and oncology being affected the most. Since October 2011, around 232 shortages have been reported from a number of resources, surpassing the records in 2010, and it is anticipated that 360 products will be in shortage by the end of the year 2011 (Barlas, 2011). In October 2011, U.S. President Obama passed an executive order guiding the FDA or the Food and Drug Administration to put up efforts to lessen shortages (Barlas, 2011). The White House proposal that does not demand congressional approval, the order directs the FDA to put into effect reporting compulsions for manufacturers on impending drug withdrawals, speeds up review progress of latest prescription drugs and forges alliance with the Justice Department to put on trial price gouging from the gray market. On the other hand, these approaches do not directly deal with the primary causes of drug shortages, and the proposal is unlikely to have an instantaneous impact on the situation.

Discussion

Causes of Drug Shortages

The causes of drug shortages are complex and derived from every phase of the life cycle of a drug. Yet to be methodically studied, a number of trends add to the shortage, including the shortage of raw materials, concerns related to manufacturers (pharmaceutical acquisitions and mergers, decisions founded on projected profit), legislative and regulatory factors, and labor trouble (Jensen, 2002). It is worth noting that just about 28% of the shortages are unexplained.

The sub-optimal quality of raw materials may have an insightful impact on drug shortages. The shortage of raw material can result from a variety of factors, comprising a sole source manufacturer that stops operation, sub-optimal quality of the raw material, and conflicts that disturbs importation. In 2010, almost half of drug shortages occurred due to quality concerns of raw materials, including microbial contamination, impurities, and chemical volatility. At present, 80 percent of the raw materials derive from foreign markets, which enforce challenges to quality control of the raw materials. For instance, the market for Chinese active pharmaceutical ingredients (APIs) was abridged by nearly fifty percent in 2010, fairly attributable to issues over quality concerns with Chinese APIs, demonstrated by heparin contamination in ...