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Investigation of Events Related to Laboratory-Confirmed Contamination of Pharmaceutical Products: Summary of CDC Consultation
- Lina Elbadawi, Nadine Shehab, Jennifer N. Lind, Alexander Kallen, Melissa K. Schaefer, Kiran Perkins
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- Journal:
- Infection Control & Hospital Epidemiology / Volume 41 / Issue S1 / October 2020
- Published online by Cambridge University Press:
- 02 November 2020, pp. s10-s11
- Print publication:
- October 2020
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- Article
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Background: Contaminated pharmaceutical products pose serious infection risks to patients and can lead to significant morbidity and mortality. Contamination at the point of manufacturing or compounding (intrinsic contamination) has the potential to affect large numbers of patients. Public health plays a critical role in detecting and investigating such events. We identified investigations involving intrinsically contaminated pharmaceuticals to characterize the burden and scope of harm associated with these events. Methods: We reviewed Centers for Disease Control and Prevention records to identify US investigations between January 1, 2009, and December 31, 2018, involving laboratory-confirmed contamination of manufactured medications and pharmacy-compounded preparations (P-CPs), using relevant search terms (eg, “medication contamination”). Laboratory confirmation was defined as identification of a pathogen from a manufactured medication or P-CP. We determined the number and type of patient infections associated with these investigations, the number of states involved, pathogens identified, type of medication (sterile or nonsterile), route of administration, and how the contamination event was first identified. We excluded investigations when the mode of production was unknown. Results: We identified 20 investigations in at least 20 states involving laboratory-confirmed contamination of manufactured medications (n = 12) and P-CPs (n = 8). Patient infections were identified in 16 (80%) investigations (9 involving manufactured medications and 7 involving P-CPs) resulting in at least 1,183 infections and at least 73 deaths. Bloodstream infections were the most common infection type (n = 7, 44%). Waterborne pathogens (eg, Serratia marcescens, Burkholderia cepacia) were cultured from medications in 83% (n = 10) of investigations involving manufactured medications and 75% (n = 6) of investigations involving P-CPs. Contamination of sterile pharmaceutical products occurred in 14 (70%) investigations; 11 (79%) of these involved injectables. Information regarding how contaminated pharmaceuticals were first identified was documented for 18 investigations; most cases (n = 14, 78%) started with investigation of patient infections by facilities, public health, or both, which led to laboratory testing of pharmaceuticals and confirmation of contamination. Conclusions: The events summarized here likely underestimate the frequency of intrinsic contamination of pharmaceutical products in the United States. These events can have devastating consequences that impact patients across the country. Waterborne pathogens appear to be the most frequently identified source of contamination in both manufactured medications and P-CPs.
Detection, investigation, control, and prevention of pharmaceutical contamination events benefit from collaboration between state and federal public health authorities; without public health intervention. Such contamination may have gone undetected and could have harmed additional patients.
Funding: None
Disclosures: None
Development of a Skills-Based IPC Supervisor Course During the 2018-19 DRC Ebola Virus Disease Outbreak
- Katie Wilson, Danica Gomes, Samuel Mangala, Hanako Osuka, Erica Tindall Umeakunne, Carmen Hazim, Molly Patrick, Cori Dennison, Carolyn Herzig, April Baller, Landry Cihambanya, Maria Clara Padoveze, Charles Basilubo, Rodrigue Bobwa, Jonathan Lotemo, Lina Elbadawi, Patrick Mirindi, Jude Tatabod, Kevin Ousman, Deye Niang, Steve Ahuka
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- Journal:
- Infection Control & Hospital Epidemiology / Volume 41 / Issue S1 / October 2020
- Published online by Cambridge University Press:
- 02 November 2020, p. s188
- Print publication:
- October 2020
-
- Article
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- You have access Access
- Export citation
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Background: With >3,000 cases and 2,000 deaths, the current outbreak of Ebola virus disease (EVD) in the Democratic Republic of the Congo (DRC) is the second-largest reported EVD outbreak in history. Healthcare-associated transmission of EVD has been a persistent amplifier of transmission due, in part, to fragility of the healthcare system, lack of basic infection prevention and control (IPC) infrastructure, and large number of healthcare facilities (HCFs). A central component of the strategy to rapidly strengthen IPC in HCFs is the provision of IPC supervisors to oversee standardized risk assessments and improvements and provide mentorship to HCF staff. To support these activities, we designed skills based training for IPC supervisors. Methods: Staff recruited by the Ministry of Health (MoH) to strengthen IPC are part of an outbreak-specific cadre known as IPC supervisors. IPC supervisors, who originally lacked technical knowledge and mentoring experience, were trained to provide technical support and mentorship to staff at HCFs, with the objective of improving IPC-related processes and behaviors. A competency-based training course was designed by conducting informal assessments of IPC supervisors during daily tasks to identify areas for performance improvement. We developed competencies based on activities designated for IPC supervisors according to MoH guidelines. We planned an iterative training rollout to allow for continuous, real-time modifications based on lessons learned throughout the implementation phase. Results: Although IPC supervisors displayed technical knowledge of IPC recommendations, we observed large gaps in implementation. IPC supervisors frequently failed to recognize behaviors that are high-risk for infection transmission. In addition, IPC supervisors lacked the ability to develop prioritized action plans and to implement interventions aimed at rapidly improving IPC practices. The course, designed as an interactive, skills-based training, is rooted in instructional design principles and addresses 4 key competencies: risk recognition and prioritization, IPC assessment completion, action plan development, and effective leadership and communication. The course will be pilot tested in the DRC to an audience of 25 IPC supervisors. Conclusions: In an outbreak setting, strong mentorship and problem-solving skills are needed to support effective implementation of IPC quality improvement. Trainings that are informed by field experiences and teach problem-solving, coaching, and communication skills are critical and can be developed rapidly. The strategy employed by the Ministry of Health to rapidly achieve IPC capacitation at HCFs might be adapted for use in future outbreaks.
Funding: None
Disclosures: None
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