The Food and Drug Administration needs to step up inspections and enforcement actions to prevent the next New England Compounding Center from distributing a batch of infected product.
Marlton, NJ (PRWEB) February 08, 2013
Many supposed ‘sterile’ drugs are often contaminated, according to a new survey of hospital pharmacists conducted by the Institute for Safe Medication Practices (ISMP). The report, highlighted in a recent article by NBC News, says 13 percent of pharmacists and pharmacy technicians believe contamination of compounded sterile drugs occurred in their shops in 2012. These are the same class of medications that reportedly caused the deaths of 45 people across the country and led to 700 infections from fungal meningitis. In New Jersey, where more than a dozen patients died after receiving injections of tainted steroid compound, personal injury attorney Richard P. Console Jr. sees the potential for another serious outbreak.
“Compromised facilities are endangering the lives of patients everywhere,” he said. “The Food and Drug Administration needs to step up inspections and enforcement actions to prevent the next New England Compounding Center from distributing a batch of infected product. These compounds are supposed to help people, not put their lives in jeopardy.”
The majority of pharmacists surveyed had little to no confidence that contamination at their facilities were completely free of contamination during the year, according to NBC News. Almost 75 percent of all healthcare professionals participating in the ISMP study reportedly said conditions for the contamination of sterile drug compounds could exist at their sites. Compounding centers have come under increasing fire in the last year after conditions at facilities owned by the New England Compounding Center lead to a nationwide fungal meningitis outbreak. The company has since shuttered its doors.
Compounding centers take existing medications from actual pharmaceutical manufacturers and combine them to create new materials. While the Food and Drug Administration (FDA) does not regulate these centers as it does pharmaceutical manufacturers, the federal government has moved to inspect their facilities more closely in light of the widespread meningitis infections. This move overlays current inspection and regulation duties, which state authorities are supposed to handle. Console, whose firm has represented more than 5,000 clients, doesn’t believe the measures go far enough to protect consumers.
“If we were doing enough to protect patients from harm, we wouldn’t have pharmacists and doctors saying sterile medications are still being contaminated,” he said. “Aggressive pursuit of compounding centers that sell contaminated drugs and allow deplorable conditions to exist at their facilities is necessary to curtail the behavior. The victims and their families deserve compensation. Civil suits are sometimes the only way to make these industries change their ways.”
Richard P. Console Jr. managing partner of Console & Hollawell P.C., has been a personal injury lawyer in New Jersey since 1994. His firm has obtained more than $30,000,000 in compensation for injured victims, including those who have suffered due to the actions of negligence manufacturers and healthcare providers.