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Published on: August 30, 2018
High global consumption of potentially inappropriate fixed dose combination antibiotics: Analysis of data from 75
Barbara Bortone1, Charlotte Jackson2, Yingfen Hsia2,3
1Paediatric Infectious Diseases Division, Meyer Children's University Hospital, Florence, Italy.
Abstract:
Antibiotic fixed dose combinations (FDCs) can have clinical advantages such as improving effectiveness and adherence to therapy. However, high use of potentially inappropriate FDCs has been reported, with implications for antimicrobial resistance (AMR) and toxicity. We used a pharmaceutical database, IQVIA-Multinational Integrated Data Analysis System (IQVIA-MIDAS®), to estimate sales of antibiotic FDCs from 75 countries in 2015. Antibiotic consumption was estimated using standard units (SU), defined by IQVIA as a single tablet, capsule, ampoule, vial or 5ml oral suspension. For each FDC antibiotic, the approval status was assessed by either registration with the United States Food and Drug Administration (US FDA) or inclusion on the World Health Organization (WHO) Essential Medicines List (EML). A total of 119 antibiotic FDCs were identified, contributing 16.7 x 109 SU, equalling 22% of total antibiotic consumption in 2015. The most sold antibiotic FDCs were amoxicillin-clavulanic acid followed by trimethoprim/sulfamethoxazole and ampicillin/cloxacillin. The category with the highest consumption volume was aminopenicillin/β-lactamase inhibitor +/- other agents. The majority of antibiotic FDCs (92%; 110/119) were not approved by the US FDA. Of these, the most sold were ampicillin/cloxacillin, cefixime/ofloxacin and metronidazole/spiramycin. More than 80% (98/119) of FDC antibiotics were not compatible with the 2017 WHO EML. The countries with the highest numbers of FDC antibiotics were India (80/119), China (25/119) and Vietnam (19/119). There is high consumption of FDC antibiotics globally, particularly in middle-income countries. The majority of FDC antibiotic were not approved by either US FDA or WHO EML. International initiatives such as clear guidance from the WHO EML on which FDCs are not appropriate may help to regulate the manufacturing and sales of these antibiotics.
Insights
Globally, 22% of antibiotic consumption in 2015 involved fixed-dose combinations (FDCs). Most of these FDCs were not approved by the US FDA or WHO Essential Medicines List, raising concerns about antimicrobial resistance.
Area of Science:
- Pharmacology and Pharmaceutics
- Global Health and Infectious Diseases
- Antimicrobial Stewardship
Background:
- Antibiotic fixed-dose combinations (FDCs) offer potential clinical benefits, including improved treatment effectiveness and patient adherence.
- However, the widespread use of potentially inappropriate FDCs is a growing concern, contributing to antimicrobial resistance (AMR) and increased toxicity risks.
Purpose of the Study:
- To estimate the global sales and consumption volume of antibiotic FDCs in 2015.
- To assess the regulatory approval status of identified antibiotic FDCs against US FDA and WHO Essential Medicines List (EML) criteria.
- To identify trends in FDC antibiotic consumption by drug category and geographical region.
Main Methods:
- Utilized the IQVIA-Multinational Integrated Data Analysis System (IQVIA-MIDAS®) pharmaceutical database to analyze antibiotic FDC sales data from 75 countries in 2015.
- Estimated antibiotic consumption using standard units (SU), defined as a single dosage form (tablet, capsule, etc.).
- Assessed FDC approval status based on US FDA registration or inclusion in the WHO EML.
Main Results:
- A total of 119 antibiotic FDCs accounted for 16.7 billion SU, representing 22% of total antibiotic consumption in 2015.
- Amoxicillin-clavulanic acid, trimethoprim/sulfamethoxazole, and ampicillin/cloxacillin were the most sold FDCs.
- The majority of FDCs (92%) lacked US FDA approval, and over 80% were not compliant with the 2017 WHO EML. India, China, and Vietnam showed the highest numbers of FDC products.
Conclusions:
- Significant global consumption of antibiotic FDCs exists, with a high proportion lacking regulatory approval from major health authorities.
- This widespread use of unapproved FDCs, particularly in middle-income countries, poses risks for AMR and patient safety.
- International guidance, such as clear recommendations from the WHO EML, is needed to regulate the manufacturing and sales of inappropriate antibiotic FDCs.
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