Though it is faring better than most other states, Connecticut has not escaped the nationwide drug shortage.
Connecticut hospitals are not experiencing severe shortages that risk patients’ immediate treatments, according to pharmacy directors from Hartford Hospital and Saint Raphael’s Hospital in New Haven. But those two hospitals have been forced to ration certain drugs because of the shortage, they said, adding that the government needs to rectify the shortage by restructuring incentive mechanisms for pharmaceutical companies and by legislating regulations that enforce improved communications between hospitals and drug manufacturers.
“Drug shortages are inherent in the drug delivery system,” said Janet Kozakiewicz, pharmacy director at Saint Raphael’s. “But unfortunately, the numbers per year have increased to unprecedented levels.”
That drug shortages persist across the state does not necessarily mean that patients are not receiving the medications they need, because of hospitals’ rationing strategies. According to Kozakiewicz, Saint Raphael’s holds weekly meetings to review stock levels and evaluate reports from various health organizations, including the FDA. The hospital also sends out weekly updates to alert patients if a medication is in short supply and notify them of possible alternatives.
“Selecting the right alternatives is the most common way of managing drug shortage,” said Mike Rubino, pharmacy director at Hartford Hospital. “Of course it’s not ideal, but it will be much better than giving nothing to the patients who can do just fine with the alternatives.”
Rubino added that economics is the leading cause of the drug shortage. Since pharmaceutical companies can reap bigger profit margins with non-generic drugs, he said, there are few incentives for the companies to keep producing generic drugs. Because of this, many companies have discontinued the production of generic drugs, even though demand remains high, Rubino said. At the same time, he added, there has been an unanticipated surge in demand for drugs, which caused the gap between supply and demand to widen dramatically in 2006-’07.
Recent raw material shortages have also resulted in lower production rates, Kozakiewicz said. Although sudden disruptions in raw material supplies would not be a problem if pharmaceutical companies reported to the FDA about the quantity they will be able to produce, there are frequent miscommunications between companies and the FDA.
“The law states that if a company is the only supplier of a drug, it legally must notify the FDA six months before it anticipates a shortage of the medication,” Kozakiewicz said. “Since there are no consequences, this oftentimes does not happen in a timely manner, if at all.”
Additionally, concerns regarding the quality of drugs produced has prompted the FDA to toughen its regulatory practices, delaying or stopping pharmaceutical companies’ production if they fall short of the FDA’s standards. According to the FDA’s website, sterile injectable drugs — which are particularly dangerous if not properly manufactured — make up roughly 80 percent of the drugs affected by the shortage.
“There have been a lot of criticisms of FDA that they are not doing their job thoroughly over the past five, six years,” Rubino said. “So the FDA hired more people, checked more companies and found errors, contaminations and frauds. Then the FDA told the companies to stop producing and they’re now really enforcing it.”
Rubino added that the government must incentivize production of low-profit generic drugs by giving out subsidies to pharmaceutical companies. He added that he supports bills currently in the U.S. House of Representatives and Senate that would penalize companies that do not notify the FDA of upcoming drug shortages.
“Drug shortage is actually costing us quite a sum of money,” Rubino said. “An estimate of the cost of shortage is roughly 1 percent of our [drug] budget, which is $25 million. Drug prices keep rising, and we need to put more work into rationing our stockpiles and finding the right substitutes for our patients.”
Currently, there are more than 200 drugs on the Food and Drug Administration’s list of drug shortages. In 2010, there were 178 drug shortages reported to the FDA, 132 of which involved sterile injectable drugs.