|NEWARK – Attorney General Jeffrey S. Chiesa and the State Division of Consumer Affairs today announced they are seeking the revocation of Med Prep Consulting Inc.’s State pharmacy permit, and the revocation of the State license of Med Prep pharmacist-in-charge Stephen Kalinoski, due to multiple allegations of gross negligence and professional misconduct at the Tinton Falls compounding pharmacy.
The Division and its Enforcement Bureau discovered the alleged violations during their investigation into the cause of mold contamination found in intravenous bags that Med Prep compounded and sent to a Connecticut hospital. To date, no injuries or illnesses have been linked to the contamination.
"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.”
Immediately after the discovery of contamination, the State Board of Pharmacy on March 15 entered into a consent order with Med Prep in which the company agreed to temporarily cease operation during the State’s investigation. Meanwhile, Med Prep and the U.S. Food and Drug Administration on March 16 and 17 announced recalls of all products compounded by Med Prep.
According to the State’s complaint, Med Prep and Kalinoski engaged in the following failures and violations, among others, of New Jersey’s laws and regulations regarding pharmacy practices and compounding:
- Incorrect labeling. During the 24 months preceding April 3, 2013, Med Prep allegedly distributed approximately 20 types of sterile products – representing hundreds of units of injectable medications – that were incorrectly compounded, labeled, or packaged. In some cases there were significant discrepancies between what was printed on the label, and the product’s actual active ingredient strength or content. In other cases, light-sensitive drugs were provided without protective bags. In still others, temperature controls were not provided for frozen medications. Each of these errors was found by customers of Med Prep. However, after learning about them, Med Prep allegedly failed to undertake thorough investigations or corrective action.
- Inadequate product testing. Med Prep allegedly failed to ensure consistently sterile products. It conducted sterility testing on approximately one-half of one percent of the approximately 6,000 units of drug products it compounded daily. Sterile preparations were not visually inspected with a lighted black and white box to detect particulate or foreign matter. These failures allegedly created the risk that patients would receive non-sterile injectable drugs and be exposed to an unacceptable risk of infection.
- Threats to the sterility of Med Prep’s cleanroom. Personnel allegedly were not required to scrub hands and arms with soap before working in the facility’s cleanroom. Personnel also allegedly failed to adequately disinfect certain equipment before bringing it to the cleanroom. During the 26-month period ending April 3, Med Prep documented seven occasions in which a compounded product contained visible cloudiness or floating particles. After destroying the products, the company allegedly failed to adequately investigate or adopt a remediation plan. In addition, in connection with the recent contamination issues, multiple bags of intravenous solutions compounded by Med Prep were found to contain mold contamination.
- Improper and impermissible extension of products’ “use-by” dates. Med Prep allegedly labeled certain magnesium sulfate products with “use-by” dates of 45 days after compounding. State regulation requires that such products be given “use-by” dates of 24 hours, absent proof to justify a longer period, and in no case more than 30 days.
- Failure to adequately document its compounding practices. Med Prep allegedly failed to comply with “audit trail” requirements and to keep required records, including lists of the specific employees who were involved in compounding specific batches of drugs. Med Prep also allegedly failed to document adequate investigations or remediation plans on the seven occasions in which compounded products contained visible cloudiness or floating particles during the 26-month period ending April 3.
- False representations. In response to the State’s inquiry, Med Prep allegedly produced conflicting information about which personnel, pharmacists and pharmacy technicians were personally involved in compounding the batches of magnesium sulfate during the critical period in February 2013. Med Prep also allegedly made false claims on its website and marketing brochures, which inaccurately stated the company complies with all aspects of the United States Pharmacopeia’s USP 797 practices for sterile compounding.
- Impermissible ratio of pharmacists to pharmacy technicians. Med Prep exceeded the permissible ratio by having more than two pharmacy technicians for every one pharmacist in its compounding facility. Although Med Prep had applied to the Board for an expanded ratio, such permission was never granted and Med Prep continued to operate with an impermissible ratio.
- Breach of duty by Med Prep’s registered pharmacist-in-charge. As pharmacist-in-charge, Kalinoski was responsible for the oversight and supervision of Med Prep’s sterile compounding facility and operations. The State alleges that “Kalinoski’s failure to discharge his responsibilities … caused and/or contributed to the violations alleged above.”
- Failure to comply with New Jersey’s requirements for centralized prescription handling. Since at least 2002, Med Prep provided compounded sterile drugs to numerous in-state and out-of-state hospitals under a “central fill” model. Under this model, Med Prep performed the sterile compounding, and the hospital pharmacy dispensed the drugs to patients. However, Med Prep has allegedly operated in violation of State Board of Pharmacy regulations regarding central fill agreements that have been in place since 2004, and additional regulations adopted in 2007. For example, central fill pharmacies must file a formal application to the Board, delineating the scope of practice for each pharmacy that is party to a central fill arrangement. However, Med Prep allegedly did not seek or obtain approval for any central fill arrangements with any hospital client until 2011 – and then only with New Jersey hospital clients, not with any out-of-state clients. State regulation also requires that, if an out-of-state pharmacy engages with a central fill arrangement with a New Jersey pharmacy, the out-of-state pharmacy must be registered with the New Jersey State Board of Pharmacy. However, at least one of Med Prep’s out-of-state clients is not registered with the Board, and therefore could not be part of a valid central fill agreement. Additionally, all pharmacies that are party to a central fill arrangement must maintain an audit trail and ensure all prescriptions are properly filled. However, Med Prep allegedly compounds sterile drugs for hospitals in advance of actual patient need, and does not obtain patient-specific prescriptions or medication orders either before or after dispensing its products.
In addition to seeking the revocation of Med Prep’s pharmacy permit and of Kalinoski’s pharmacist license, the State’s Complaint also asks the Board to impose civil penalties against Med Prep and Kalinoski for each violation of State law. It also asks the Board to require the respondents to reimburse the State’s investigative costs, attorney’s fees, and related costs.
Separate from the Attorney General's Complaint which seeks to revoke the company's permit, the Board of Pharmacy on April 24 ruled on Med Prep's petition to resume operations. The Board ruled that Med Prep may resume operations on a significantly limited basis subject to certain strict controls and restrictions, and only after Med Prep provides documentation showing its employees have been extensively retrained. Med Prep agreed to abide by the restrictions ordered by the Board.
Among those restrictions, the Board ruled that Med Prep is precluded from compounding intravenous bags until the company can demonstrate its ability to do so safely, to the Board's satisfaction. In addition, Med Prep must also significantly reduce the quantity of drugs it compounds each week. It must conduct sterility testing on every batch it produces, and retain samples from each batch for ongoing testing, after the batches are distributed to customers. Med Prep must refrain from shipping to out-of-state hospital pharmacies until they have a valid central fill agreement approved by the Board. Med Prep must appoint a new pharmacist-in-charge, and prohibit Kalinoski from supervising other pharmacists. Med Prep must enact other significant changes to its practices with regard to sterile compounding, environmental testing, sterility cleansing, labeling, and beyond-use dating.
The Board additionally ruled that Med Prep must hire a compounding pharmacy consulting firm, pre-approved by the Board, to act as an independent monitor. The third-party monitor will observe all acts of compounding and all aspects of Med Prep's compliance with the Board's requirements, and provide regular reports to the Board. In the event of any significant violation of the terms of the order, Med Prep agreed to immediately cease operating and be required to show cause as to why is permit should not be revoked or suspended.
After giving Med Prep the opportunity to submit an answer to the Attorney General’s Complaint, the Board will determine whether it will hold a hearing, or refer the State’s Complaint to the Office of Administrative Law for a hearing.
Deputy Attorneys General Kim Ringler and Jodi Krugman, of the New Jersey Division of Law, are representing the State in this matter. Investigators in the Division of Consumer Affairs’ Enforcement Bureau conducted the investigation.
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