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We will conclude this series on pharmaceutical compounding errors with this issue.
A medication error is "any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer."
There is no question that pharmacies that compound specific drugs for individual patients are an important part of health care today. Compounding pharmacies formulate therapeutic and diagnostic products for physicians in practice and those engaged in research. These pharmacies include hospital pharmacies, neighborhood pharmacies, chain pharmacies, nuclear pharmacies, specialty pharmacies, and others. These pharmacies are essential if the healthcare system is to serve populations with particular and specific needs. Strict compliance with all the laws, regulations, and standards is vital to the provision of compounded preparations that are safe and effective.
However, the system is not perfect and problems can occur in the compounding of prescriptions. One problem that sometimes occurs involves errors that may arise. Some errors are minimal with no adverse effects; however, some are serious and lead to patient harm and even death, as has been covered by the media.
The New England Compounding Center (NECC) case is only briefly mentioned here because it has been a driving force for significant changes in the laws, regulations, and standards related to pharmaceutical compounding. NECC was breaking the law by manufacturing drug products under the guise of compounding and was involved in errors of commission and omission.
In 2012, an outbreak of fungal meningitis was traced to fungal contamination in three lots of methylprednisolone suspension for epidural steroid injections compounded by NECC. Doses from these three lots were administered to 14,000 patients. The NECC case is a tragedy for the 64 individuals who died, the hundreds who were sickened, and their families and loved ones.
In December 2014, the federal government issued an indictment against 14 NECC personnel, including the owners, supervising pharmacists, staff pharmacists, technicians, and the director of sales. The seriousness of the charges in the indictment is commensurate with the deaths and injuries allegedly caused by the lapses in compliance with law, quality assurance, and quality control at NECC. These charges include the following:
- Twenty-six charges of second-degree murder
- Mail fraud: Contaminated and mislabeled vials were sent by interstate courier
- Criminal contempt
- Structuring
- Racketeering
The indictment states in part, "All compounding personnel were responsible for understanding the fundamental practices and procedures outlined in USP 797 for developing and implementing appropriate procedures, and for continually evaluating the procedures and quality of sterile drugs." This is a critical point in the indictment. The owners, pharmacist-in-charge, supervising pharmacists, pharmacists, and technicians were all indicted and cited regarding lapses in compliance with applicable law and USP standards. The indictment clearly states that in the interest of public safety, all personnel in the pharmacy are responsible for complying with quality and safety standards.
The tragic events associated with NECC are a stark lesson in the results of a failure to adhere to quality assurance, quality control, and legal requirements. Since the compounding processes were not performed properly or their results were ignored, as is alleged in the NECC case, serious injury and death occurred.
Pharmacists Education in Compounding*
As an example, compounding errors have been observed in pharmacy student training. Kadi and colleagues, in 2005, examined the accuracy of the compounding of two simple solutions by pharmacy students. For one of the solutions, only 54% of the students prepared the medications within 10% of the desired concentration. Errors for the remaining mixtures ranged from less than 75% to greater than 200% of the desired concentration. Although results for the second solution showed 78% of the students within +/- 10% of the desired concentration, the range of concentration errors was greater (-89% to 269%). Another study in 2014 by Pignato and Birnie showed an error range of 0.6% to 140% with an average error of 23.7%.
Dennis, Owora, and Kirkpatrick published a study in 2015 on the topic of "Comparison of Aseptic Compounding Errors Before and After Modified Laboratory and Introductory Pharmacy Practice Experiences". They concluded that the addition of second-year aseptic compounding laboratory experiences and third-year institutional introductory pharmacy practice experience content reduced instructor-assessed errors at the end of the third year. Two years later, Mudit and Alfonso published "Analytical Evaluation of the Accuracy and Retention of Compounding Skills Among PharmD Students". Their conclusion was that "While most students readily develop compounding skills during regular laboratory coursework, long-term competency depends on constant exposure to compounding activities and the retention of calculation skills."
Clearly, insufficient time is spent studying both the sciences and the technology involved in pharmaceutical compounding and dispensing. The pharmaceutical sciences are the basis for pharmacy, especially pharmaceutical compounding. Student pharmacists need to devote more studies to this critical area of pharmacy. In turn, pharmacists need access to more quality continuing-education programs related to compounding-both the basics and advanced topics. Quality-control and quality-assurance topics need to be covered in detail, as do the advantages of certification and advanced education. Pharmacists are taught to be extremely focused and careful, especially when preparing the actual medication-sterile or nonsterile-to be administered to a patient.
Conclusion
Medication errors are a worldwide concern and are routinely reported in the literature. Fortunately, those related to compounding pharmacy are relatively few but can be very serious, and need to be minimized and/or eliminated.
In summary, pharmacy compounding, preparing patient-specific medications, is a high-risk activity resulting in a final product where the final ingredients and their concentrations are not verified. Errors can occur and must be prevented through careful attention and compliance with the facility's standard operating procedures and thorough checking at each step of the compounding procedure. These processes must begin with the education at the colleges of pharmacy and progress through the practice years by participation in continuing education programs, study of current literature, and sharing of experiences with colleagues. The process can, and must, be followed because patients put their trust in the pharmacists who serve them.
*Allen LV, Jr. The Art, Science, and Technology of Pharmaceutical Compounding. 6th ed. Washington, DC: American Pharmacists Association: 2020.
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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