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Fungal Diseases Caused by Serious Contamination of Pharmaceuticals and Medical Devices, and Rapid Fungal Detection
Mohamed Abd El-Gawad El-Sayed Ahmed1, Heba S Abbas2,3, Muddukrishnaiah Kotakonda4
1Department of Microbiology and Immunology, Faculty of Pharmaceutical Science and Drug Manufacturing, Misr University for Science and Technology, Cairo, 6th of October City, Egypt.
Abstract:
Fungal-contaminated compounded pharmaceuticals and medical devices pose a public health problem. This review aimed to provide an organized overview of the literature on that critical issue. Firstly, it was found that compounding pharmacies can produce drugs that are contaminated with fungi, leading to outbreaks of severe fungal diseases. Secondly, inadequate sterile compounding techniques or storage conditions, or exceeding the limit of a fungal count, can result in fungal contamination. Lastly, nanotools can be used to rapidly detect fungi, thus improving fungal diagnostic procedures. To achieve this goal, we have reviewed the published data on PubMed, the CDC, and FDA Web sites, and a literature search was undertaken to identify severe fungal infections associated with compounding pharmacies outside of hospitals, limited by the dates 2003 to 2021. The "Preferred Reporting Items for Critical Reviews" were followed in searching, including, and excluding papers. Fungal outbreaks have been documented due to contaminated pharmaceuticals and medical devices. In 2013, 55 people died from fungal meningitis caused by contaminated steroid injections containing methylprednisolone acetate. Additionally, in 2021, Aspergillus penicillioides contamination was reported in ChloraPrep drugs, which was attributed to the storage conditions that were conducive to the growth of this fungus. These incidents have resulted in severe infectious diseases, such as invasive mycoses, cornea infections, Endophthalmitis, and intestinal and gastric mycosis. By implementing preventive measures and policies, it is possible to avoid these outbreaks. Creating Nano-diagnostics presents a major challenge, where promptly diagnosing fungal infections is required to determine the proper corrective and preventive measures.
Insights
Fungal contamination in compounded drugs and medical devices causes severe infections and outbreaks. Implementing preventive measures and advanced nano-diagnostics is crucial for public health safety.
Area of Science:
- Pharmaceutical Microbiology
- Public Health
- Medical Mycology
Background:
- Fungal contamination in compounded pharmaceuticals and medical devices presents a significant public health risk.
- Compounding pharmacies have been identified as sources of fungal contamination, leading to severe fungal disease outbreaks.
- Inadequate sterile techniques, improper storage, and exceeding fungal count limits contribute to contamination events.
Purpose of the Study:
- To provide an organized overview of the literature concerning fungal contamination in compounded pharmaceuticals and medical devices.
- To identify severe fungal infections linked to compounding pharmacies outside of hospital settings.
- To explore the role of nanotechnology in improving fungal diagnostic procedures.
Main Methods:
- A literature search was conducted on PubMed, CDC, and FDA websites for severe fungal infections associated with compounding pharmacies (2003-2021).
- The Preferred Reporting Items for Critical Reviews (PRISMA) guidelines were followed for study selection.
- Data on fungal outbreaks, causative agents, and contributing factors were systematically reviewed.
Main Results:
- Documented fungal outbreaks linked to contaminated pharmaceuticals and medical devices, including fatal meningitis from contaminated steroid injections (2013).
- Reported contamination of ChloraPrep drugs with Aspergillus penicillioides due to improper storage conditions (2021).
- Resulting severe infections include invasive mycoses, cornea infections, endophthalmitis, and gastrointestinal mycosis.
Conclusions:
- Implementing preventive measures and policies can effectively mitigate the risk of fungal outbreaks from compounded products.
- Advanced nano-diagnostics offer potential for rapid detection of fungal infections, improving timely intervention.
- Prompt diagnosis is essential for implementing appropriate corrective and preventive actions against fungal contamination.
