Over the past few years, prescription drug shortages have been on the rise, and in 2011 have hit an all-time high with shortages of more than 175 drugs.
Tim Riley, owner of Riley Drug in Geneva, says there are many causes of the shortages, which range "from manufacturing issues to shortages of raw materials.”
The FDA defines a drug shortage as “a situation in which the total supply of all a drug, and all of its approved alternatives, is inadequate to meet demand.”
But the FDA's strict guidelines could be at least part of the problem.
“The FDA has very stringent policies regarding the manufacturing of medications, so some of the holdups in drugs are actually caused by the FDA,” Riley said. “When the FDA does its inspections, they often will discover problems or unacceptable practices and are liable to shut a line or an entire plant down.”
And when this happens, production slows and different drug companies have to take over and play catch-up while consumer demand for the drugs increases.
“If several companies are forced to shut down or have to alter their production practices, then there is a great burden left on the few remaining companies in operation,” Riley said.
It is unfeasible for fewer companies to meet consumer needs, and combined with little to no access to the raw materials to manufacture the drugs, shortages in drugs is an inevitable problem that is challenging to reverse.
“My understanding is that even if a drug company so much as changes a small brush in their operating line, even that brush has to meet certain requirements,” Riley said. “The FDA’s rules are in place to keep drugs safe, but certain protocols make it very difficult for companies to stay in business, let alone remain competitive in the market.”
Recently, over-the-counter drugs such as Tylenol and Motrin have been recalled in large quantities, making them difficult to find.
“The primary reason for this recall and the shortage of the medications is that when the FDA inspected the plant producing these drugs, they found that it was not clean, and proceeded to shut the plant down,” Riley said. "So, if you are trying to find Tylenol or Motrin, FDA’s closing of the plant is the primary reason why it is so challenging. The FDA may be partially responsible for this particular shortage, but the FDA is only trying to do its job by ensuring certain standards are met in efforts meet consumers' demands for safe, quality medications."
Over-the-counter drugs are not the only ones at risk of shortage, though. There has been a steady decline in the availability of prescription drugs over the past six years, as well.
“Right now, there are several medications that are out of market,” Riley said. “For example, Adderall, a medication for ADHD, quickly became unavailable as the generic one took over. Patients generally have to pay more for brand-name medications because when generics come out, there is more competition on the market, forcing brand name drugs to increase in price due to loss of revenue.”
This pricing gap, however, has nothing to do with the interference of insurance companies. “Some people are insistent on having a brand name drug, and if that’s the case, there’s no way around paying the higher price,” Riley said.
Some chemotherapy drugs, vitamin B-12 injections, Toprol and Maxide have experienced shortages within the last year, as well.
“Even though drug shortages have inconvenienced patients, there is no serious health hazard at this point,” Riley said.