Growing Prescription Drug Shortages Alarm Falls Pharmacists

Last year, the number of newly reported prescription drug shortages in the United States hit a record total of 211. 

Already during the first quarter of 2011, there have been 196 reported shortages and if the trend continues,  the number of drug shortages will double those seen in 2010.

That was the alarming message presented at recently during a President’s Advisory Council meeting. Terry Audley, the hospital’s Pharmacy Clinical Supervisor and Mark Meranda, the hospital’s Outpatient Pharmacist, painted a disturbing picture of the situation for area business leaders who attended.

The list of drugs becoming harder to get include certain antibiotics, cancer, heart and high blood pressure medications such as Dyazide and Maxide. The latest high profile drug to be added to the list is the generic form of Adderall XR, used to treat attention-deficit hyperactivity disorder (ADHD) in children and adults.

“We order medications that we generally use day to day in the hospital that are unable to be supplied to us through our wholesalers because manufacturers are not supplying them to the wholesalers,” Audley said.  “So we can’t get the drugs. There have been documented cases where people have died because they could not get the antibiotic they needed to treat a particular infection. There have been delays in treatment for cancer where some patients get an alternate cancer treatment protocol that may not be as effective because you can’t get the most effective drugs.”

Why the shortages?

There are multiple reasons in play. In some cases, a product is recalled because there are issues with sterility, contamination or poor manufacturing practices. In other cases, a drug is in short supply and there is a surge to find an alternative drug which then creates a shortage with the alternate medication. Sometimes pharmaceutical companies consolidate so, instead of having two companies that produce the product, now there’s only one. That cuts the supply in half.

Another big contributing factor is the global nature of the pharmaceutical industry.

“The pharmaceutical industry is more global now so a lot of raw materials may come from other parts of the world,” Audley explained. “Things can disrupt the supply chain like a hurricane, a tsunami, or an earthquake, so you can’t get the raw materials or even the final product into the United States to prepare the meds that we need. Sometimes pharmaceutical companies aren’t making enough money on a product so they just choose to stop making it.”

The line of communication, or lack thereof, between the drug makers and the pharmacists also creates problems.

“I think communication with providers is essential and that’s something we don’t have right now,” Meranda said.  “If we could get communication like a drug company saying, ‘This is not a profitable drug for us. We’re trying to streamline our production and get rid of those products where we don’t see much market share’ – well, let us know a year or six months in advance so we can start to plan, so we can move patients over to another manufacturer or find another alternative for the patient.”

The prescription drug shortages are also causing a stir on Capitol Hill. On June 27, a bipartisan group of federal lawmakers urged the U.S. Department of Health and Human Services (HHS) to hold a public hearing on the matter. They are also urging passage of a U.S. Senate bill called the Preserving Access to Life-Saving Medicines Act which will increase the Food and Drug Administration’s authority to address the problem.

“The biggest issue that we see is that there is absolutely no authority in the FDA  over these drug shortages,” Audley said. “There is no requirement that the drug companies alert the FDA of an impending shortage or that they’re going to stop preparing a drug. They may be the only company that makes it and they can just stop making it without any advanced warning to anyone. Really, it’s kind of a free-for-all.”

In the meantime, what can consumers do to enhance their chances of getting the medications they need? 

“Be your own advocate, talk to your legislators who can give FDA more authority to require that companies that are sole providers of a drug are not be able to just decide to stop making it because it’s not profitable enough,” Audley said.

Consumers are also urged to stay in contact with their pharmacists.

“Your pharmacist should be talking to patients when you pick up your prescription and giving some form of consultation,” said Meranda.  “Don’t wait until the last minute for your medications to run out before you call in your refill because it takes time to come up with alternatives.”

For more information and to keep track of the prescription drug shortage situation, you can visit the web site of the American Society of Health-System Pharmacists.