Drug shortages threaten patient safety

By guest blogger Michael Cohen:

Severe drug shortages are on the rise and leading to serious patient safety issues and frustration among health care workers. The lack of availability of prefilled epinephrine (adrenaline) syringes for example has lead to patient injuries and deaths.
 
In one report we received at the Institute for Safe Medication Practices, the shortage of the so-called "epi" syringes led to the death of a 16-year-old boy in an ER. The teen was brought to an emergency department with priapism, a painful persistent erection that can lead to permanent erectile dysfunction. A doctor ordered epinephrine to treat the teen. Unfortunately, the urologist thought the 1:1,000 ratio on drug label meant that the epinephrine had been "prediluted" by the manufacturer. So, instead of the intended 0.4 mg dose the teen got 10 times the dose - 4 mg of undiluted solution.  When the epinephrine reached the teen's blood system, he suffered a cardiac arrest and died.
 
That situation is just one of the shortages among the most commonly used medications, including critically important emergency drugs, pain medications and anesthetics are either hard to come by or completely unavailable.
 
As a result pharmacists, nurses and emergency medical response teams have been forced to come up with alternatives to commonly used drugs and familiar protocols. But using unfamiliar new medications, with different dosing methods, adds to the complexity of care. That in turn increases the risk to patient safety, especially when the drugs in question are used in high risk situations.
 
On July 8 the Bucks County's Emergency Health Service notified emergency medical service (EMS) squads that the shortage of prefilled syringes of epinephrine for the EMS drug boxes carried by all ambulances in Bucks County and elsewhere. The notice provided emergency personnel with instructions to use a concentrated form of the drug after diluting it.
 
In the past, we've received reports about some health care workers misreading labels of tiny epinephrine ampuls, mixing it up with another drug, ephedrine. Or miscalculating a dose, which is often based on ratio expressions such as 1:1,000 or 1:10,000 and easily confused, leading to fatal 10-fold overdoses.
 
This situation with the epinephrine syringe shortage is so potentially dangerous that we, along with the American Society of Health System Pharmacists (ASHP) sent out a nationwide alert two weeks ago to warn practitioners about dangers.
 
Fortunately, this epinephrine shortage does not involve Epipen syringes, a different form of the drug, self injected by patients prone to severe allergic attacks. This year has seen more drug shortages than most pharmacy professionals can recall. Here are lists from the FDA and ASHP of drugs in short supply.  
 
It is not always clear what causes these shortages. One serious concern is what appears to be an ongoing trend with older sterile injectable products (like the above prefilled epinephrine syringes) that involve fewer and fewer firms making these critical products.
 
Regardless, drug shortages are a major problem and it's time for FDA to hold a public meeting and invite stakeholders to put their heads together to solve this problem. Maybe regulatory changes could be implemented so that once a company gains approval to manufacturer and distribute a drug, they aren't allowed to simply stop making it if they don't feel it is profitable enough, at least not until other manufacturers are lined up.

For information on the Institute for Safe Medication Practices' consumer website go www.consumermedsafety.org

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