Look beyond drug makers to avoid tragedies like meningitis outbreak, expert says

October 17, 2012 by Elizabeth K. Gardner

(Medical Xpress)—A Purdue University medication safety expert said it is important to look at the larger system surrounding medication use, as well as the facilities where drugs are made to avoid tragedies like the meningitis outbreak that has claimed 15 lives.

"No one condones making a bad product, but we also need to examine the quality assurance process of the larger medication-use system that doesn't catch it," said John B. Hertig, project manager for the Purdue College of Pharmacy's Center for Medication Safety Advancement. "It is a failure of the larger system and practices that allow a harmful product to make it through numerous hands and be administered to a patient. A system-wide view is the most effective in improving overall ."

The broader pharmaceutical system can be thought of as a stack of slices of Swiss cheese, Hertig said. Each step in the system, from manufacture to shipping and receiving to treatment, has holes where a mistake could go undetected. It is only when the holes in each piece line up that a mistake can make it all the way through to a patient, he said.

The recently linked a meningitis outbreak that spans 15 states to possibly tainted that were made in a Massachusetts facility. The on Monday (Oct. 15) reported 212 people have been infected and 14,000 may have received the injections.

The outbreak raises questions about the oversight of such facilities, called compounding pharmacies, which create customized medication solutions for patients for whom manufactured drugs won't work or are not available, Hertig said.

"In the midst of tragedy our emotions run high and we can get caught up in putting all of the blame on an individual," he said. "We certainly shouldn't tolerate gross negligence, but we also need to take a step back and look at the bigger picture. Even after the individuals responsible for a particular incident have been held accountable, unaddressed flaws in the system will continue to produce negative consequences."

Hertig also is concerned that over-regulation of compounding pharmacies could have the unintended consequence of adding significant costs to the facilities, raising the prices of such treatments and shrinking a critical source of pharmaceuticals.

There have been 200 instances of harmful side effects or illnesses caused by treatments involving 71 compounded products reported to the Food and Drug Administration since 1990, Hertig said.

"It is important to note that these cases represent a very small fraction of the total number of compounded medications dispensed, and without these pharmacies many patients would not have access to much-needed therapies," he said. "Greater regulation may be part of the solution, but enacting increasingly complicated legislation could inhibit compounding pharmacies to the detriment of patient care."

Explore further: Official: pharmacy tied to meningitis outbreak may have broken state law

Related Stories

Official: pharmacy tied to meningitis outbreak may have broken state law

October 12, 2012
(HealthDay)—The company at the center of the ongoing meningitis outbreak appears to have violated Massachusetts law by producing and distributing large quantities of a contaminated steroid compound, a state health official ...

Experts list many ways funguses can taint drugs

October 16, 2012
(AP)—Experts say there are many ways funguses could have gotten inside the Massachusetts pharmacy at the center of the deadly U.S. outbreak of fungal meningitis.

US clinics rush to warn of tainted steroid; 5 dead

October 5, 2012
(AP)—Health providers scrambled to notify patients in nearly two dozen U.S. states that the steroid injections they received for back pain may have been contaminated with a deadly fungal meningitis. Five people have died.

Tainted drug death toll rises to 14 in US

October 11, 2012
The death toll from a deadly meningitis outbreak in the United States blamed on a tainted drug rose to 14 Thursday as the number of cases jumped to 172 in 11 states, health officials said.

US: Avoid drugs from company tied to meningitis (Update)

October 4, 2012
U.S. health officials ramped up warnings Thursday about a specialty pharmacy linked to a widening outbreak of a rare kind of meningitis, urging doctors and hospitals not to use any products from the company.

Calls for more US oversight after tainted drug outbreak

October 11, 2012
A deadly meningitis outbreak in the United States blamed on a tainted drug has triggered outrage and calls for tighter regulation of the loosely controlled pharmaceutical compounding industry.

Recommended for you

Sensor-equipped pill raises technological, ethical questions

November 17, 2017
The first drug with a sensor embedded in a pill that alerts doctors when patients have taken their medications was approved by the Food and Drug Administration, raiding issues involving privacy, cost, and whether patients ...

New painkillers reduce overdose risk

November 16, 2017
Scientists on the Florida campus of The Scripps Research Institute (TSRI) have developed new opioid pain relievers that reduce pain on par with morphine but do not slow or stop breathing—the cause of opiate overdose.

Separating side effects could hold key for safer opioids

November 16, 2017
Opioid pain relievers can be extremely effective in relieving pain, but can carry a high risk of addiction and ultimately overdose when breathing is suppressed and stops. Scientists have discovered a way to separate these ...

US regulators approve first digital pill to track patients

November 14, 2017
U.S. regulators have approved the first drug with a sensor that alerts doctors when the medication has been taken, offering a new way of monitoring patients but also raising privacy concerns.

Introduction is different, but top medications for opioid addiction equally effective

November 14, 2017
With opioid addiction officially declared a public health emergency in the U.S., medical intervention to treat the illness is increasingly important in responding to the epidemic. Now, a new study concludes that two of the ...

Drugstore pain pills as effective as opioids in ER patients

November 7, 2017
Emergency rooms are where many patients are first introduced to powerful opioid painkillers, but what if doctors offered over-the-counter pills instead? A new study tested that approach on patients with broken bones and sprains ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.