A near crisis shortage of drugs, especially chemotherapy, sedation, and pain relief medications, is endangering patient safety and costs hospitals more than $200 million annually for higher priced substitutes, according to Premier Inc., a hospital purchasing alliance.
"For months, our healthcare system has experienced a 10-year high in the drug shortage arena, with 240 drugs in short supply or completely unavailable in 2010, and many remain in short supply or unavailable in 2011," says Mike Alkire, president of Premier Purchasing Partners.
That was the finding from Premier's survey of 311 pharmacy experts representing 220 hospitals or centers specializing in infusion, oncology, surgery, outpatient care, and retail pharmacies during the last six months of 2010.
Some of the cost increase and shortages have been deliberately caused, Alkire said. "During times of shortages, grey market distributors take advantage of the needs of providers. They buy up available supplies and offer to send them to end producers at significantly higher prices, creating huge profits for themselves."
In one case, the drug furosemide, which reduces swelling and fluid retention, previously contracted for $1.21 per vial, could only be purchased for $195, or 160 times the cost, he said. The same dosage of hydroxyprogesterone, used to prevent pre-term births in high-risk pregnancies, went from $15 to $1500.
The report by Premier, which represents 2,500 hospitals, says the frequency and impact of these shortages has more than tripled between 2005 and 2010; 77% involved sterile injectable products used in acute care settings, and many of those were the result of product discontinuations.
Alkire says that the shortages also occur when prescription drug manufacturers consolidate, thus reducing the number of suppliers. Safety issues may permanently or temporarily shut down manufacturing facilities. And in the case of some generic drugs, he said, "a number of manufacturers ceased production of products that generated little or no profit." A shortage of raw materials can slow the supply chain as well.
In a briefing to announce the survey results, Premier was joined by Sen. Amy Klobuchar, (D-MN), who last month introduced a bill that would require drug manufacturers to notify the FDA when supplies of a drug might be curtailed, for any reason.
"For anyone struggling with cancer, the last thing they want to hear is that they might lose access to essential medications," Klobuchar said. "These shortages are approaching crisis proportions as life-saving and medically necessary drugs are running low or even running out."
"I don't think it's that intrusive to simply ask these drug companies to give the FDA a warning when something has changed – either they project that they're going to stop making a drug or there's a shortage of raw materials that could result in a drug shortage – so the FDA can start early on looking for alternative suppliers, either in our country or in other parts of the world, and notify the doctors and pharmacists that this is coming," she said.
The shortage also has the potential to create scenarios for drug dosing errors and near misses, she added. "You can imagine when you're up to the wire, you can't find the drug, and people are calling all around the state for distributors." In a pinch, she said, pharmacists find creative ways to solve the problem, "but this is no way to run a system."
She added, "Right now pharmacists and physicians are the last to know that a shortage is coming. Sometime they find out right before a patient is treated. That's just not right."
Among the survey's findings:
• 89% of the experts said they experienced shortages that may have caused a medication safety issue or error in patient care, with 53% saying that occurred more than six times.
• 80% experienced shortages that resulted in a delay or cancellation of a patient care intervention, and 34% reported the shortage occurred more than six times.
• 98% experienced shortages that resulted in an increase in costs.
• Use of "just-in-time" inventory practices, in which providers stock leaner quantities to save money or to avoid expired waste, as well as stockpiling by end-users anticipating shortages, can exacerbate the problem.
Currently, drug manufacturers are only required to report drug discontinuances if produces are life-saving and medically necessary, and they are the sole supplier.
Under Klobuchar's "Preserving Access to Life-Saving Medications Act," SB 296, non-sole source manufacturers would have to report such discontinuances, as well as any interruption or adjustment in production resulting from changes in raw material supplies, alterations to production capabilities or business decisions that could affect supply.
Manufacturers would have to give the FDA at least six months notice, or as soon as practicable, and allows for the Secretary of Health and Human Services to issue regulations that establish monetary penalties for manufacturers who fail to report.
Martin Caponi, pharmacy director for PeaceHealth Sacred Heart Medical Center in Eugene, OR, highlighted some of the day-to-day problems created by the shortage.
"We often don't find out that day (that we need the drug) that the drug is not going to be available, so you can imagine the scrambling for the drug and the confusion, which is very counterproductive to high quality patient care," he said. "We're the ones recommending therapeutic alternatives, and we often have to do that in not-the-best circumstances, where we're approaching the physicians that day that we need to make a change in the profile."
A different size of a drug, or a different strength "can lead to a host of errors, especially with look-alike, sound-alike medications. It undermines error prevention or as we like to think about it, the reliability of our system," Caponi said.
Asked to comment on Premier's report, Maya J. Bermingham, senior assistant general counsel for Pharmaceutical Research and Manufacturers of America (PhRMA), said the organization's member companies "recognize the importance of avoiding unexpected disruptions in the supply of needed medicines to patients."
To achieve that goal, PhRMA companies work closely with the FDA, supply chain partners and providers when unexpected shortages do occur, she said.
However PhRMA would not comment on the Klobuchar's proposed bill, saying that the group is still reviewing it.
She attributed drug shortages to "natural disasters, shifts in clinical practices, wholesaler and pharmacy inventory practices, raw material shortages, changes in hospital and pharmacy contractual relationships with suppliers and wholesalers that can cause fluctuations in the availability of certain products."
She said other factors include "adherence to FDA-mandated distribution protocols, which can impact patients' timely access to medicines, individual company decisions to discontinue specific medicines and manufacturing challenges."