Pharmacy liability is a major concern to many of our clients and obviously to every pharmacy owner. We all keep reading about pharmacies being sued for various incidents regarding liability of various practices and in many areas. Here are two primary examples from just last week that have been receiving national press coverage:
– In Newbern, Tennessee a pharmacy owner has pleaded guilty for manufacturing and distribution of contaminated prescription drugs. Main Street Family Pharmacy and its owner (David Newbaker) each pleaded guilty to a misdemeanor criminal act of producing and selling contaminated methylprednisolone that was linked to 26 incidents of patients suffering skin abscesses and other adverse reactions after injection of the compounded drug. It should be noted that the product (methylprednisolone acetate), was the same steroid produced by a Massachusetts compounding pharmacy that caused the 2012 outbreak of fungal meningitis, sickening 751 people across the nation with 64 deaths. Newbaker was sentenced to 12 months of probation and ordered to pay a $25,000 fine. The pharmacy will have to pay the same fine. In addition, a permanent injunction was issued against the pharmacy, prohibiting them from making, holding and distributing compounded medications until the pharmacy comes into compliance with federal regulations. Earlier this summer the FDA had inspected the pharmacy and determined the pharmacy did not adequately clean and disinfect rooms and equipment. The FDA also said the pharmacy failed to do proper testing on their products.
– In Edmond, Oklahoma, a pharmacy has paid $43,000 in civil penalties to settle claims stemming from alleged procedural violations of a federal controlled substances law. The charges stemmed from the DEA claiming that the pharmacy ignored regulations that pharmacies maintain complete and accurate records of each controlled substance manufactured, received, sold, delivered, dispensed or otherwise disposed of by pharmacy for two years. Sherry’s Drug paid the civil penalties to the federal government to settle claims stemming from alleged violations of the Controlled Substances Act. It must be noted that in reaching the settlement, Sherry’s Drug did not admit liability and the government did not make any concession regarding the legitimacy of its claims against the pharmacy. It basically allowed the pharmacy and the prosecution to avoid the delay, expense, inconvenience and uncertainty involved in litigating the case. Sherry Ross, owner of Sherry’s Drug, said her business did not admit liability in the settlement and agreed to it in order to avoid the delay and expense of litigation. The point is that in both cases the incidents could have been avoided if the pharmacies had instituted and followed proper policies and procedures in their businesses. More importantly than the fines that each had to pay, was the bad publicity each received and the stigma that will remain associated with their pharmacy in the future. In the end that will probably far outweigh the cost of the fines in business lost.
Prevent problems like these before they happen and it is too late! Does your pharmacy have written policies and procedures in place regarding its business operations? Are they being followed by your employees? Can you document this? Has an expert reviewed them to ensure that your practices are compliant and up to date? If any of the answers to these questions is NO, then contact HCC today to see how we can help. Healthcare Consulting has been a full service Pharmacy staffing and consulting firm that has been in business for over 25 years. HCC has been helping pharmacies plan, prepare and avoid dealing with such issues since 1989. Although we all hope that we will never personally deal with such situations, I strongly urge you to be prepared. Contact us on line or call us today for a Free Consultation at 800-642-1653 to discuss how we can help you.