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Report on sales of veterinary antibiotics in Ireland during 2021
In this report the headings are as follows: penicillins, amphenicols, tetracyclines, fluoroquinolones, aminoglycosides, macrolides, lincosamides, sulfonamides & trimethoprim, cephalosporins and other classes., Tetracyclines 40.1% Fluoroquinolones 0.9% Aminoglycosides 5.9% Amphenicols 3.1% Penicillins 22.4% Cephalosporins 1.8% Sulfonamides & trimethoprim 18.1% Macrolides & lincosamides 6.0% Others 1.6% 3/5 Figure 2., The European Medicines Agency’s Antimicrobial Advice Ad Hoc Expert Group (AMEG) review in 2019 of the categorisation of antibiotics 1 included the WHO’s highest priority critically important antibiotics; the 3 rd and 4 th generation cephalosporins, quinolones (fluoroquinolones, other quinolones) and polymyxins in Category B (“Restrict”)., Sales (tonnes sold) of 3 rd & 4 th generation cephalosporins, fluoroquinolones and macrolides for the years 2013 - 2021 2013 2014 2015 2016 2017 2018 2019 2020 2021 3 rd & 4 th gen., cephalosporins 0.17 0.24 0.22 0.25 0.30 0.33 0.28 0.36 0.35 Fluoroquinolones 0.89 0.69 0.79 0.94 0.85 0.84 0.74 0.80 0.85 Macrolides 6.25 6.26 5.58 6.58 7.17 7.07 5.60 5.15 5.37 No sales of polymyxins (colistin) were recorded in 2021 for the first time.
https://assets.hpra.ie/data/docs/default-source/regulatory-report/veterinary-medicines/sales-of-veterinary-antibiotics-in-ireland/report-on-sales-of-veterinary-antibiotics-in-ireland-during-2021.pdf?sfvrsn=55d691fd_1Drug Safety Newsletter Issue 112 June 2023
T: +353 1 676 4971 E: medsafety@hpra.ie www.hpra.ie E DITION 112 Fluoroquinolone antibiotics: Reminder about restrictions of use and risk of rare but serious long-lasting adverse reactions Fluoroquinolones are a class of broad-spectrum antibiotics, which include the active substances ciprofloxacin, levofloxacin, and moxifloxacin*., A recent EMA-funded study (“Impact of European Union Label Changes for Fluoroquinolone Containing Medicinal Products for Systemic and Inhalation Use” (EUPA S 3 7 8 5 6 ) ) s u g g e s t s t h a t d e s p i t e t h e n e w restrictions introduced in 2019, fluoroquinolones are still potentially being used outside the authorised indications., The study involved an analysis of prescribing rates for fluoroquinolones in six European healthcare databases (Belgium, France, Germany, t h e Netherlands, Spain, and the United Kingdom)., The HPRA published a special edition Drug Safety Newsletter (Edition 91) highlighting all the primary outcomes from the 2018 EU-wide review, including recommendations for HCPs concerning fluoroquinolones and restrictions around their use., T: +353 1 676 4971 E: medsafety@hpra.ie www.hpra.ie K e y M e s s a g e • F i n d i n g s o f a s t u d y c o m m i s s i o n e d b y E M A ( E U PA S 3 7 8 5 6 ) suggest that fluoroquinolones are still potentially being used outside of their authorised indications
https://assets.hpra.ie/data/docs/default-source/product-updates/hpra-safety-notices/drug-safety-newsletter/drug-safety-newsletter-issue-112-june-2023.pdf?sfvrsn=a145e91d_1HPRA IMF article - Fluoroquinolone antibiotics - Reminder about restrictions for use - September 2023
Fluoroquinolones are a class of broad-spectrum antibiotics, which include the active substances ciprofloxacin, levofloxacin, and moxifloxacin*., The European Medicines Agency (EMA) made strong recommendations to restrict the use of systemic and inhaled fluoroquinolones following an EU-wide review conducted in 2018 1 ., • Systemic and inhaled fluoroquinolones are associated with very rare, serious, disabling, long-lasting and potentially irreversible adverse reactions., Key Message • Findings of a study commissioned by EMA (EUPAS37856) 2 suggest that fluoroquinolones are still potentially being used outside of their authorised indications, EU Review of Fluoroquinolones available at: https://www.ema.europa.eu/en/medicines/human/referrals/quinolone-fluoroquinolone- containing-medicinal-products 2.
https://assets.hpra.ie/data/docs/default-source/product-updates/mims_imf/hpra-mims-article---fluoroquinolone-antibiotics---reminder-about-restrictions-for-use---september-2023.pdf?sfvrsn=8a6f7a18_0Report on sales of veterinary antimicrobials in Ireland during 2023
In this report the headings are as follows: penicillins, amphenicols, tetracyclines, fluoroquinolones, aminoglycosides, macrolides, lincosamides, sulfonamides & trimethoprim, cephalosporins and other classes., Tetracyclines 36.1% Fluoroquinolones 0.7% Aminoglycosides 7.0% Amphenicols 5.7% Penicillins 22.0% Cephalosporins 1.5% Sulfonamides & trimethoprim 18.7% Macrolides & lincosamides 7.0% Others 1.3% 3/5 Figure 2., The European Medicines Agency’s Antimicrobial Advice Ad Hoc Expert Group (AMEG) review in 2019 of the categorisation of antibiotics 1 included the WHO’s highest priority critically important antibiotics [the 3 rd and 4 th generation cephalosporins, quinolones (fluoroquinolones, other quinolones) and polymyxins] in Category B (“Restrict”)., Sales (tonnes sold of active substance) of 3 rd & 4 th generation cephalosporins, fluoroquinolones and macrolides for the years 2017 - 2023 2017 2018 2019 2020 2021 2022 2023 3 rd & 4 th gen., cephalosporins 0.30 0.33 0.28 0.36 0.35 0.16 0.14 Fluoroquinolones 0.85 0.84 0.74 0.80 0.85 0.54 0.50 Macrolides 7.17 7.07 5.60 5.15 5.37 4.28 3.42 No sales of polymyxins (colistin) were recorded in 2023. 1 Categorisation of antibiotics in the European Union.
https://assets.hpra.ie/data/docs/default-source/regulatory-report/veterinary-medicines/sales-of-veterinary-antibiotics-in-ireland/report-on-sales-of-veterinary-antimicrobials-in-ireland-during-2023.pdf?sfvrsn=f971c3e4_1Report on sales of veterinary antibiotics in Ireland during 2020
In this report the headings are as follows: penicillins, amphenicols, tetracyclines, fluoroquinolones, aminoglycosides, macrolides, lincosamides, sulphonamides & trimethoprim (TMP), cephalosporins and other classes., The sales of the highest priority critically important antibiotics, 3 rd and 4 th generation cephalosporins, fluoroquinolones and macrolides are provided in detail below., Due to the low Tetracyclines 41.2% Fluoroquinolones 0.8% Aminoglycosides 6.8% Amphenicols 3.6% Penicillins 26.6% Cephalosporins 1.7% Sulphas & trimethoprim 11.0% Macrolides & lincosamides 6.8% Others 1.4% Injectable, 28.6% Tablet, 0.9% Premix, 35.8% Oral remedy, 31.4% Intramammary milking, 0.5% Intramammary dry, 2.7% Other,
https://assets.hpra.ie/data/docs/default-source/regulatory-report/veterinary-medicines/sales-of-veterinary-antibiotics-in-ireland/report-on-sales-of-veterinary-antibiotics-in-ireland-during-2020.pdf?sfvrsn=9902817f_1Report on sales of veterinary antibiotics in Ireland during 2022
In this report the headings are as follows: penicillins, amphenicols, tetracyclines, fluoroquinolones, aminoglycosides, macrolides, lincosamides, sulfonamides & trimethoprim, cephalosporins and other classes., The European Medicines Agency’s Antimicrobial Advice Ad Hoc Expert Group (AMEG) review in 2019 of the categorisation of antibiotics 1 included the WHO’s highest priority critically important antibiotics [the 3 rd and 4 th generation cephalosporins, quinolones (fluoroquinolones, other quinolones) and polymyxins] in Category B (“Restrict”)., Sales (tonnes sold) of 3 rd & 4 th generation cephalosporins, fluoroquinolones and macrolides for the years 2014 - 2022 2014 2015 2016 2017 2018 2019 2020 2021 2022 3 rd & 4 th gen., cephalosporins 0.24 0.22 0.25 0.30 0.33 0.28 0.36 0.35 0.16 Fluoroquinolones 0.69 0.79 0.94 0.85 0.84 0.74 0.80 0.85 0.54 Macrolides 6.26 5.58 6.58 7.17 7.07 5.60 5.15 5.37 4.28 No sales of polymyxins (colistin) were recorded in 2022. 1 Categorisation of antibiotics in the European Union.
https://assets.hpra.ie/data/docs/default-source/regulatory-report/veterinary-medicines/sales-of-veterinary-antibiotics-in-ireland/report-on-sales-of-veterinary-antibiotics-in-ireland-during-2022.pdf?sfvrsn=e776258f_1Report on sales of veterinary antibiotics in Ireland during 2019
In this report the headings are as follows: penicillins, amphenicols, tetracyclines, fluoroquinolones, aminoglycosides, macrolides, lincosamides, sulphonamides & trimethoprim (TMP), cephalosporins and other classes., The sales of the highest priority critically important antibiotics, 3 rd and 4 th generation cephalosporins, fluoroquinolones and macrolides are provided in detail below., Due to the low Tetracyclines 42.3% Fluoroquinolones 0.8% Aminoglycosides 6.1% Amphenicols 4.0% Penicillins 22.2% Cephalosporins 1.2% Sulphas & trimethoprim 15.5% Macrolides & lincosamides 6.6% Others 1.3% Injectable, 25.5% Tablet, 1.0% Premix, 37.4% Oral remedy, 34.1% Intramammary milking, 0.5% Intramammary dry, 1.6% Other,
https://assets.hpra.ie/data/docs/default-source/regulatory-report/veterinary-medicines/sales-of-veterinary-antibiotics-in-ireland/report-on-sales-of-veterinary-antibiotics-in-ireland-during-2019.pdf?sfvrsn=65d116bb_1Systemic and inhaled fluoroquinolone antibiotics Direct healthcare professional communication (DHPC) June 2023
P1 | 4 Direct Healthcare Professional Communication 8 th June 2023 Systemic and inhaled fluoroquinolone antibiotics – reminder on restrictions of use Ciprofloxacin; Delafloxacin; Levofloxacin; Moxifloxacin Dear Healthcare Professional, Marketing authorisation holders of fluoroquinolone antibiotics in agreement with the European Medicines Agency (EMA) and the Health Products Regulatory Authority, would like to remind you of the following: Summary • Recent study data suggest that fluoroquinolones continue to be prescribed outside of the recommended uses, P2 | 4 • Systemic and inhaled fluoroquinolones are associated with very rare, serious, disabling, long-lasting and potentially irreversible adverse reactions., Background to safety concern The EMA made strong recommendations to restrict the use of systemic and inhaled fluoroquinolones following an EU-wide review conducted in 2018 to evaluate the risk of serious and long-lasting (lasting months or years), disabling and potentially irreversible adverse reactions mainly affecting the musculoskeletal and nervous system., An EMA-funded study was carried out (“Impact of European Union Label Changes for Fluoroquinolone Containing Medicinal Products for Systemic and Inhalation Use” (EUPAS37856)) which was based on an analysis of prescribing rates for fluoroquinolones in six European healthcare databases (from Belgium, France, Germany, the Netherlands, Spain and the United Kingdom)., The study suggests that fluoroquinolones may still be used outside the authorised indications.
https://assets.hpra.ie/data/docs/default-source/product-updates/dhpc/human-medicines/systemic-and-inhaled-fluoroquinolone-antibiotics-direct-healthcare-professional-communication-(dhpc)-june-2023.pdf?sfvrsn=c99bc578_1Antibiotic resistance
Addressing the issue nationally and globally In recent years the European Medicines Agency (EMA) has reviewed the indications and conditions under which a number of the more modern antibiotic classes (fluoroquinolones, macrolides and cephalosporins) are used in veterinary medicine.
https://www.hpra.ie/regulation/veterinary-medicines/care-in-use-of-veterinary-medicines/antibiotic-resistance