NEWARK - A Tinton Falls pharmacist could lose his license, and a facility he supervised could lose its permit to operate in New Jersey after shipping mold-contaminated intravenous fluids to a Connecticut hospital.
State Attorney General Jeffrey Chiesa has filed a complaint seeking the revocation of Tinton Falls compounding pharmacy Med Prep Consulting and the revocation of the license of pharmacist-in-charge Stephen Kalinoski over allegations of gross negligence and professional misconduct.
"Our investigation uncovered a disturbing pattern of alleged failures and violations with potentially grave ramifications for public health and safety,” Attorney General Chiesa said. “The State entrusts pharmacies and pharmacists with the ability to safely dispense medications that can be very harmful if contaminated or prepared incorrectly. Pharmacies and pharmacists who have demonstrably failed to live up to that trust, in violation of our laws and statutes, must be held accountable.”
Med Prep Consulting Inc. halted operation in mid-March after recalling its entire line of drugs when contaminated bags of magnesium sulfate it had compounded and dispensed to Yale-New Haven Hospital were found.
No injuries were reported but state and federal regulators, and the company, launched an investigation.
The State Division of Consumer Affairs found a number of violations committed under Kalinoski's supervision, including:
- Incorrectly labeled, packaged and compounded products, with "significant discrepancies" between product and labels in some cases.
- Products inadequately tested for sterility, which "allegedly created the risk that patients would receive non-sterile injectable drugs and be exposed to an unacceptable risk of infection."
- Alleged failure to require the sterilization of equipment and disinfecting of employees.
- Improper use and extension of 'use-by' dates, in some cases, allegedly printing dates more than two weeks later than permitted by state regulation.
- Allegedly failing to properly document its practices and procedures.
- Allegedly falsely representing its practices and and personnel to customers and investigators.
A compounding pharmacy prepares fluids and medications in bulk for hospitals in advance of their use on patients. The 20-year-old company compounds and dispenses more than 80 drugs in infusion bags, plastic syringes and glass vials. The supply is sent to hospital pharmacies throughout New Jersey, Pennsylvania, Connecticut and Delaware.
After giving Med Prep the opportunity to submit an answer to the Attorney General’s Complaint, the Board of Pharmacy will determine whether it will hold a hearing, or refer the State’s Complaint to the Office of Administrative Law for a hearing.
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