Our healthcare system is good but has some shortcomings. Recently, drug shortages have become an all but permanent part of the American medical landscape. The Obama administration has tried to ease shortages of critical drugs but shortfalls have persisted. This has forced doctors to resort to rationing in some cases or to scramble for alternatives. The number of annual drug shortages — both new and continuing ones — nearly tripled from 2007 to 2012.
The most common ones are for generic versions of sterile injectable drugs, partly because factories that make them are aging and prone to quality problems, causing temporary closings of production lines or even entire factories.
Function of the FDA
The FDA has another function which it is to prevent drug shortages. They have done a pretty good job of preventing many more shortages now than in the past but that the total number of shortages has continued to grow. Such drugs now include the heart medicine nitroglycerin, and cisatracurium, which is used to paralyze muscles during surgery and for patients on ventilators.
Manufacturers are now required to alert the agency of potential shortages before they happen. In return the FDA has been careful when using their regulatory muscle. For example, in some cases where particles were found to be contaminating a drug that was in short supply, the agency allowed the company to filter the drug to avoid disrupting supplies instead of shutting down the production line altogether. It is a fine line to walk between ensuring quality and availability.
Why Are There Shortages?
No one knows for sure what drives shortages. The drug industry rarely spells out the precise reason for a shortage, citing its need to protect competitive trade information. Keep in mind that two-thirds of the production disruptions that led to shortages were caused by quality problems and efforts to fix them.
Economic factors are also a contributing factor. Narrow profit margins are making some drug companies reluctant to invest in fixing old production facilities. Now add changes in Medicare reimbursement and the role of group purchasing organizations, which buy drugs on behalf of hospitals which further reduce prices that producers get for the drugs. The incentive is no longer there for prescription drug production.
Then there is the odd fact about the generic drug industry. A drug is often made by only a few producers, making it difficult to mitigate the effects of a shortage when it happens. Three manufacturers produced 71 percent of the country’s sterile injectable cancer drugs in 2008. In addition, generic drug producers have significantly ramped up the number of drugs they are producing, pumping out many different drugs on a single production line. The production lines are stretched already and limited factory capacity creates a situation ripe for quality problems.
Manufacturers, motivated by profit, will often choose to increase production of higher profit drugs on their busy factory floors, even if that means risking a shortage of less profitable drugs. At times they overlap different products in production that might conflict with the patient’s health.
Are you taking any medication that is in short supply?