Drug Shortages Past and Present

Written by: Everett Castle, MD, FACEP

The Federal Drug Administration states from 2005 to 2011 the number of drug shortages have increased from 60 to about of 250 reported at the end of 2011. In numerous emergency departments and emergency medical services across the country have had wide spread shortages of many important injectable drugs. Many of the older and newer forms of injectable medications for the use for pain control via emergency medical service (EMS) ambulances staffed by paramedics, emergency departments, and hospitals are in short supply and rationed by both hospitals and their supplies of these medications.


I have been working in Emergency Departments in since 1978 and I have not experienced this shortage of numerous essential injectable medications during the first 2 decades of my practice. There has been a steady increase of many of the injectable medications over the past 7 years. At first this was not experienced very frequently, but at present this issue presents to all inpatient and outpatient health care providers and emergency services personal on a daily basis. In hospital, shortages are experienced on the medical floors, ICUs, inpatient and outpatient surgeries. There are shortages of many generic narcotic medications used in pain control. Morphine, dilaudid, and fentanyl have generally been in short supply or unavailable. Source pharmacies for hospital have been rationing these medications. There also shortages of chemotherapy medications, antibiotics, and tranquilizing medications like Valium and Ativan.  Etomidate and Propofol used for conscious sedation with procedures have been lacking or rationed. Many of the standby medications used for deep sedation have become difficult to obtain. Many medications in unit dose form have been unavailable. Thus large multiple dose vials are being used which can lead to medication errors with administration resulting in poor patient outcomes.


At first these problems were thought to be random or based on unforeseen events in production. Floods inPakistandestroying narcotic producing factories and possible large purchases of these medications by foreign governments (ChinaandIndia) for stock piling have been alluded to by some people involved in the industry as the source of shortages. Things have become clear over time with the many shortages presently reported. What has caused the disturbing shortage of medications essential for patient care and comfort? What are causes of this present problem and what led to these shortages?


In 2003 under the Bush administration the Medicare Modernization Act was passed. Like many things concerning government regulations there are sometimes unattended consequences. How could medicines in such high demand face these present shortages? With passage of this law manufacturers are unable to adjust prices due to artificially low government price caps. The companies must produce these products at a loss or not produce them. This law has made some drugs cheaper for seniors but has made some medications scarce and unavailable to the majority of people. Before this law producers received compensation proportional to the average wholesale cost.




It was felt at the time of passage that manufactures were charging inflated prices way above real costs of some drugs like chemotherapy medications. After passage of this act Medicare began reimbursing at 106% of average sale price of medications over previous 2 quarters. This was an attempt to end abuse of system.


Most insurance companies follow Medicare rules and regulations and have adapted to these rules. In the past drug companies have had financial incentives to make the many medications that are in short supply. The many companies that manufacture these medications have much to lose and little gain to allocate recourses to produce generic injectable medications.  Many of the companies have left this market and only a few remain to produce these products. In 2010, 90% of all generic injectable oncology drugs were produced by 2-3 suppliers. When problems arise with process of manufacturing these drugs either by contamination by various inert things or by bacteria or fungus there are few manufacturers than can fill this void to meet the demand. One manufacturer of injectable narcotics overloaded unit dose syringes with medication two times the labeled strength. This large lot of medications was pulled from numerous hospitals across the county exacerbating the existing shortages of narcotics. These shortages have come about after the fall of their prices in the market. Drug manufacturers do not want to invest in expensive infrastructure to meet the demand of the fixed priced medications. Middlemen have stepped into the market to hoard high demand medications and sell these products at inflated prices.


The Obama administration and congress have addressed some of availability issues by asking the drug companies to give a warning of future shortages. This does nothing to address the issues on the production side. Only changing the law to allow for increased profits will improve the supply. With Obama Care the situation will most likely worsen. The Affordable Care Act requires the independent Payment Advisory Board to cut expenses if they exceed a predetermine amount. This fact will direct the market away from common market forces to increase the supply. Although the Medicare Modernization Act was well intentioned the end result will be increasing shortages of drugs that give patient comfort and some that are life saving .The greater good was some how shortchanged with the passing of this act. Hopefully Congress will address this issue and improve production of necessary medications; however, with the apparent gridlock inWashingtonthe likelihood of this changing is doubtful.

Written by Everett Castle, MD, FACEP

Everett Castle, MD, FACEP is the current Medical Director and Corporate Manager of High Desert Clinic Urgent and Occupational Care in Sierra Vista, Arizona. Born in Tucson and long-time Arizona resident, Dr. Castle attended the University of Arizona as an undergraduate. He graduated from the University Arizona College of Medicine and completed his postgraduate medical training at Maricopa County Hospital in Phoenix.

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