Supply and Demand:
U-M pharmacists, doctors collaborate to ensure patients get drugs they need, despite shortages, Con't.
Doctors also work with the pharmacy to ensure that no amount of drug is wasted, said Harry Erba, M.D., Ph.D., a Cancer Center
oncologist who helped plan for the cytarabine shortage. If a vial is opened for one patient but the entire quantity is not needed, the
team works together to figure out who else can use it so the excess does not go to waste.
In the case of the cytarabine shortage, Erba and his colleagues went a step further than typical conservation efforts. They reviewed
the results of many studies to determine whether lower doses were equally effective. Lowering doses would allow more people access
to the short supply of the drug. Given what they had found in recent medical publications, they found that they could cut doses
in half in certain cases without any risk to patients.
"This was an opportunity to have a candid discussion about what is an adequate dose," Erba said. "We unanimously agreed that
based on the most recent data, we could give patients the therapy they needed by limiting the doses by 50% of what we
commonly give."
And as a result, no patients went without.
Why Are Drug Shortages Occuring?
A number of problems cause shortages, said Allen Vaida, executive vice
president for the Institute for Safe Medication Practices. Consolidation
among pharmaceutical companies has had a major impact. If only three
companies manufacture a drug, and two of them merge, often the third
company can't keep up with the resulting demand. Even if a company has
additional production lines available to produce a drug in demand, they
cannot be used unless those specific production lines have federal approval
to manufacture that specific drug.
In addition, Vaida said, the U.S. Food and Drug Administration recently
stepped up inspections to ensure drug quality. Some manufacturers had to
halt manufacturing temporarily to improve processes; others decided
it wasn't worth the cost, so they stopped manufacturing certain drugs
altogether. And since pharmaceutical companies have no obligation to
notify anyone that they plan to stop manufacturing a drug, shortages often
occur unexpectedly.
To help prevent this, Sen. Amy Kobuchar (D-Minn.) recently introduced
a bill that would require companies to provide six months' notice to the U.S.
secretary of health and human services of any manufacturing interruptions
that would likely lead to a drug shortage.
"We are trying to advocate for more transparency because then at least
practitioners could plan for shortages," Vaida said.
