Western Regional Blog – BC, YK, AB, NWT and Nunavut
By SABRINA TAVERNISE
Despite efforts by the Obama administration to ease shortages of critical drugs, shortfalls have persisted, forcing doctors to resort to rationing in some cases or to scramble for alternatives, a government watchdog agency said on Monday. The number of annual drug shortages — both new and continuing ones — nearly tripled from 2007 to 2012.
In recent years, drug shortages have become an all but permanent part of the American medical landscape. 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.
The analysis by the United States Government Accountability Office, released Monday, was required by a 2012 law that gave the Food and Drug Administration more power to manage shortages.The watchdog agency was designated to evaluate whether the F.D.A. had improved its response to the problem, among other things.
The accountability office concluded that the F.D.A. was preventing many more shortages now than in the past — 154 potential shortages in 2012 compared with just 35 in 2010 — but that the total number of shortages has continued to grow. In 2012, the number of drugs in short supply, both new and long-term, was 456, the report said, up from 154 in 2007. Such drugs now include the heart medicine nitroglycerin, and cisatracurium, which is used to paralyze muscles during surgery and for patients on ventilators.
“We are at a public health crisis when we don’t have the medicines to treat acutely ill patients and we don’t have the basics like intravenous fluids,” said Erin Fox, a drug expert at the University of Utah whose data was used in the analysis. The most acute shortage now is that of basic IV fluids, she said.
Dr. Douglas C. Throckmorton, a senior F.D.A. official who deals with shortages, pointed out in testimony on Monday at a Congressional hearing on the matter that the number of new shortages declined in 2012 for the first time in a number of years, and that 2013 data indicated a similar downward trend. He said the agency, endowed with new powers under the 2012 law, has been able to manage shortages more aggressively.
Manufacturers are now required to alert the agency of potential shortages before they happen. And agency officials have 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.
What drives shortages is often a mystery. The drug industry rarely spells out the precise reason for a shortage, citing its need to protect competitive trade information.
The 2012 law required that companies provide the F.D.A. with a general reason, but Ms. Fox said that it was often not specific enough to understand the particular causes of a shortage. Dr. Throckmorton said 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. Changes in Medicare reimbursement and the role of group purchasing organizations, which buy drugs on behalf of hospitals, could also be contributing, by further reducing prices that producers get for the drugs.
And in a peculiarity of 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. The accountability agency’s report cited a study that found just three manufacturers produced 71 percent of the country’s sterile injectable cancer drugs in 2008.
What is more, generic drug producers have significantly ramped up the number of drugs they are producing, pumping out many different drugs on a single production line, which stretches already limited factory capacity and creates a situation ripe for quality problems, the report said.
One study it cited found that production in the sterile injectable market had increased by half between 2006 and 2010, without a similar rise in manufacturing capability. 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.
The accountability office praised the F.D.A. for increased nimbleness, and acknowledged that it could not ultimately force drug companies to produce. But it said the agency needs to use its drug databases, not just to track which drugs are running low, but also to identify patterns that can help prevent shortages.