Despite the severe prescription drug shortage that’s been sweeping the nation over the last year, the results of a national survey released last week by my group, the Institute for Safe Medication Practices (ISMP), show that government regulations are forcing pharmacists to discard some injectable drugs unnecessarily, even those that are expensive or in short supply.
The Centers for Medicare & Medicaid Services (CMS) currently require that hospital pharmacists follow the pharmaceutical manufacturer’s directions when determining how long a drug is good once the container is opened or the drug is reconstituted for IV use. This information appears in product labeling that accompanies each drug, but provides much shorter time frames than more up-to-date scientific evidence provided in peer-reviewed literature and national drug compendia.
In communications with the Food and Drug Administration (FDA), we’ve learned that the agency does not routinely require manufacturers to update stability and compatibility data because they consider it a practice-related issue. So, in many cases, pharmacists are being forced to act on information that is no longer current. Then, if pharmacists don’t follow the out-of-date information, they risk a citation from state surveyors or accreditors like the Joint Commission.
ISMP’s survey had 715 respondents, mostly pharmacists and pharmacy managers. The vast majority (97 percent) feel that the CMS regulation requiring strict adherence to the manufacturer’s storage directions increases waste and contributes to the nation’s drug shortage crisis. Sixty-one percent said they feel compelled to discard injectable medications according to the package insert.
Some respondents to our survey raised the possibility that a conflict of interest may exist for the drug company regarding additional drug testing or acknowledgment of external testing related to a drug’s stability. Once a drug has been approved, the company may have little incentive to conduct additional testing on its products because the results may lead to required, costly labeling changes and a reduction in sales if the expiration date is extended.
Respondents collectively reported more than 100 different medications they felt they must discard despite newer evidence extending the stability and beyond use dating or altering the storage, dilution, or compatibility directions. Examples include mainstay cancer drugs like cytarabine and doxorubicin – drugs that have been in such short supply that in some cases oncologists have had to use alternatives instead. More than 80 percent of all medications that respondents reported discarding have been or are currently in short supply.
Pharmacists also indicated that the unnecessary waste of very expensive drugs can drive the cost of treatment higher than necessary. A cancer drug called Velcade is one example. Once reconstituted, the manufacturer recommends use within eight hours. Yet newer evidence suggests that may be stored at room temperature for three days or under refrigeration for five days. A single vial, which costs as much as $2,500, contains more than is needed for just one dose. But, as of now, to meet labeling requirements, leftover drug must be discarded unnecessarily if it isn’t used right away.
A serious medication safety issue related to the CMS requirements also was raised by survey respondents. If the manufacturer’s directions call for short stability dating once the drug has been diluted for infusion, nurses in clinical areas are often being called upon to create the mixture rather than the pharmacy. That increases the risk of a sterility breach, and accuracy may be compromised since an important nurse-pharmacist independent check is lost.
CMS has acknowledged the concern and has agreed to review this matter further. We are hoping the results of our survey will provide them with some baseline information to support its review process.
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