- October 3, 2014
- Declarations of Conflicts of Interest:
- Keith St. John is currently employed by Wolters Klower Health.
- Patricia Kienle is currently employed by Cardinal Health.
Since the 1970s, there have been multiple instances of quality problems (e.g., microbial contamination, concentration errors, or pyogenic responses due to endotoxins) associated with compounded sterile and nonsterile pharmacy preparations, many of which resulted in recalls, patient injuries, and deaths.Between January 2000 and before the 2012 nationwide fungal meningitis outbreak, at least 11 outbreaks were identified, involving 207 infected patients and 17 deaths after exposure to contaminated compounded drugs.Ref 112-1 Meyer C. History of sterile compounding in US hospitals: learning from the tragic lessons of the past. Am J Health Syst Pharm 2013 Aug 15... - You do not have permission to view this object. ,Ref 112-2 States C, Jacobs J, Mayer J, et al. Description of outbreaks of health-care-associated infections related to compounding pharmacies, 2000... - You do not have permission to view this object. Pharmacists and pharmacy technicians are the professionals primarily responsible for the preparation and storage of compounded sterile and nonsterile preparations. Compounding is the process of combining drug ingredients to prepare medications that are not commercially available (i.e., neonate, pediatric, and geriatric dosage forms or ongoing manufacturer-related drug shortages) or to alter commercially available medications to meet specific patient needs, such as dye-free or liquid formulations.Ref 112-3 Pharmaceutical Compounding—Sterile Preparations (general information chapter 797). In: The United States Pharmacopeia, 36th rev., a... - You do not have permission to view this object. Failure to follow sterile compounding standardsRef 112-3 Pharmaceutical Compounding—Sterile Preparations (general information chapter 797). In: The United States Pharmacopeia, 36th rev., a... - You do not have permission to view this object. and proper aseptic technique has lead to intrinsic (i.e., contamination during the manufacturing process or transport to the healthcare facility) or extrinsic (i.e., contamination during preparation, storage, or administration within the healthcare facility or practitioner's office) contamination, which may result in microbial colonization or infection in the patient.
Pharmacy management personnel should participate in identifying staff who would benefit from education and proficiency evaluation of their aseptic technique and compounding procedures and calculations and, when necessary, to coordinate any medication recalls and traceability to the patients who have received specific products associated with medication errors, endemics, and epidemics. This should include both pharmacy personnel and other clinicians who may compound sterile preparations (including those intended for immediate use), such as anesthesia practitioners, nurses in oncology and other clinics, personnel in allergist offices, dialysis nurses and technicians, etc. A contaminated infusate administered through a central venous catheter is a rare cause of catheter-associated sepsis but one of the most readily identifiable causes of epidemic healthcare-associated bacteremia associated typically with one organism. Because it is not routine to culture infusate specimens in a diagnostic evaluation for a central venous catheter–associated infection unless there is strong evidence, many episodes of infusate-contaminated infections may go undetected unless they are part of a cluster of infections in a discrete patient population (e.g., hospital) or in the early stages of an epidemic.Ref 112-4 Macias AE, Huertas M, Ponce de Leon S, et al. Contamination of intravenous fluids: A continuing cause of hospital bacteremia. Am J Infect... - You do not have permission to view this object.
Pharmacy personnel are responsible for coordinating recalls of pharmaceutical preparations, such as occurs in cases of intrinsic contamination or due to other quality deficiencies (e.g., unacceptable particulate matter or potency). Pharmacists and technicians can be instrumental when they participate in multidisciplinary activities, such as quality assurance and quality improvement teams, infection prevention committees, and antimicrobial stewardship programs, to ensure appropriate preparation and use of pharmaceuticals.