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(OTC) Antibiotics in the European Union and Norway, 2012

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(OTC) Antibiotics in the European Union and Norway, 2012 Perspective Analysis of licensed over-the-counter (OTC) antibiotics in the European Union and Norway, 2012 L Both 1 , R Botgros 2 , M Cavaleri 2 1. Public Health England (PHE), London, United Kingdom 2. Anti-infectives and Vaccines Office, European Medicines Agency (EMA), London, United Kingdom Correspondence: Marco Cavaleri ([email protected]) Citation style for this article: Both L, Botgros R, Cavaleri M. Analysis of licensed over-the-counter (OTC) antibiotics in the European Union and Norway, 2012. Euro Surveill. 2015;20(34):pii=30002. DOI: http://dx.doi.org/10.2807/1560-7917.ES.2015.20.34.30002 Article submitted on 16 September 2014 / accepted on 09 February 2015 / published on 27 August 2015 Antimicrobial resistance is recognised as a growing throughout the EU; however, there are still consider- problem that seriously threatens public health and able differences in Europe due to the different health- requires prompt action. Concerns have therefore been care structures and policies (including the extent of raised about the potential harmful effects of making pharmacist supervision for OTC medicines), reimburse- antibiotics available without prescription. Because of ment policies, and cultural differences of each Member the very serious concerns regarding further spread of State. Therefore, the availability of OTC medicines var- resistance, the over-the-counter (OTC) availability of ies in the EU and products sold as POM in certain coun- antibiotics was analysed here. Topical and systemic tries can be obtained as OTC medicines in others. OTC antibiotics and their indications were determined across 26 European Union (EU) countries and Norway As risk minimisation is an important criterion for some by means of a European survey. We identified a total of OTC products such as antibiotics, they are usually 48 OTC products containing 20 different single antibi- dispensed under the supervision of a pharmacist, as otics and three antibiotic combinations as active sub- opposed to buying them ‘off the shelf’ [4]. Switching stances, used mainly as topical preparations in short to OTC status generally makes a medicine more read- treatment courses. Given the relevance of these medi- ily available and is also often associated with a shift cines and the increasing risk of antimicrobial resist- of costs from the public purse to the private [1,2]. ance, it is important to limit the availability of OTC For pharmaceutical companies, there are potentially antibiotics and to monitor their use. attractive aspects to apply for POM to OTC switches, e.g. some advertising restrictions for pharmaceuticals Introduction are removed (as European law allows companies to The large majority of medicines are restricted to pre- advertise OTC products directly to consumers). scription-only-medicines (POM) status across the European Union (EU) Member States, but several medi- Bacterial infections often present acutely and patients cines are being reassigned to over-the-counter (OTC) may therefore benefit from easier and quicker access status post approval. The latter is done in response to certain antibacterials. This could potentially shorten to perceived public demand for easier access to medi- the period of illness and reduce both the length of cines and to government policies in some Member symptoms and infectivity, as opposed to delaying the States which aim to increase the access of patients to treatment while waiting to see a physician [5]. However, medicines when it is safe to do so. If the safety profile in light of the current spread of antimicrobial resist- is good and the risk of misuse is low, a previous POM ance, making antibiotics available as OTC medicines is medicine may be reclassified for sale or supply as an of concern and might potentially lead to their mis- and OTC medicine, usually under the supervision of a phar- overuse [6]. Indeed, the continuous rise of antimicro- macist [1,2]. The regulatory climate in some European bial resistance and the concomitant lack of new thera- countries appears moderately positive towards down- peutic options to fill the gap represent major threats regulation, but before a medicine can be reclassi- to public health that call for a variety of urgent actions fied from POM to OTC it should meet certain criteria, in order to preserve as much as possible the currently as listed in the European Commission’s guideline on available armamentarium. Incorrect use or overuse of changing the classification for the supply of a medici- antibiotics may not only reduce their benefits for the nal product for human use [3]. This guidance facilitates individual patients but may also lead to treatment fail- the harmonisation of POM and OTC status of medicines ures in the community due to emerging resistance [7,8]. www.eurosurveillance.org 1 Table 1 Resistance, the European Parliament ‘calls on the Active substances of single (A) and combination (B) OTC Member States to raise awareness against over-the- antibiotics and number of EU/EEA countries where OTC antibiotics are available, 2012 counter and illegal sales of antimicrobials in both the human health and the veterinary sector’ [13]. Based A on the above concerns around antibacterials’ use, a survey across the EU Member States to determine the Single antibiotics EU/EEA countries (n) amount of available OTC antibiotics has been con- Tyrothricin 10 ducted. The main objective of this analysis was to get Fusafungine 8 an accurate picture about which antibiotics are avail- Neomycin 3 able as OTC medicines in the EU and to characterise Chloramphenicol 3 them in terms of their antibiotics classes, presentation Gentamicin 2 as single/combination products, dosage, pharmaceuti- Oxytetracycline 2 cal form, and systemic/topical administration. In devel- Nifuroxazidea 2 oping this report, it was decided to concentrate solely Bacitracin 1 on antibiotics while it was recognised at the same time that OTC medicines against fungal, viral and parasitical Chlortetracycline 1 infections are also available. Sulfamethizole 1 Sulfanilamide 1 Methods Nitrofural 1 A questionnaire was prepared by the European Metronidazole 1 Medicines Agency (EMA) to investigate the avail- Sulfadimidine 1 ability of OTC antibiotics across the EU and Norway. Primycin 1 The questionnaire was sent by email to the National Ciprofloxacin 1 Competent Authorities (NCAs), i.e. the national regu- Fusidic acid 1 latory authorities for medicinal products, of the then Azithromycina 1 27 EU Member States and of Norway, a member of Methenaminea 1 the European Economic Area (EEA). The questionnaire Framycetin 1 asked for details of the active substance, of the main B indication(s), and – if available – of increases in sales/ Combination products EU/EEA countries (n) usage and antimicrobial resistance. The replies were Bacitracin/neomycin combination 3 edited for length and clarity and antifungals/antivirals/ antiseptics were removed from the list where neces- Oxytetracycline/polymyxin 1 combination sary, e.g. products containing (di-)propamidine isetion- Neomycin/sulfathiazole ate were not included. The tables hereafter include 1 combination topical and systemic antibiotic products (with brand names where available) and main indications for OTC EU/EEA: European Union/European Economic Area; OTC: use. Of note, certain antibiotics, including sulfaguani- over-the-counter. dine (Enteropathyl, Sulfadiar, Litoxol) in France or cer- a Systemic antibiotics. tain framycetin, ofloxacin and rifamycin formulations in Cyprus, are authorised as OTC but are not marketed and were therefore excluded from this analysis. A list of antibiotics was generated and – where possible – Thus, it is no surprise that concerns have been raised preparations were combined to account for different about the potential harmful effects of making antibi- brand names and different presentations (e.g. oint- otics available without prescription [9]. The greatest ment or cream), resulting in a total of 48 antibiotic concern is that the possible risk of societal harm may pharmaceutical forms. An analysis of the number of outweigh the potential benefits to individual patients active substances, used either alone or in combination, due to the emergence of antimicrobial resistance. was undertaken. To analyse regional differences in OTC availability across Europe, the countries were grouped Importantly, OTC availability generally appears to lead into northern/eastern/southern/western European to increases in use: in a Swedish study assessing 16 countries according to their classification by the EU (non-antibiotic) drugs, OTC availability was associated Publications Office [14]. with a 36% sales increase [10]. Moreover, in a British study, the OTC availability of antibiotic eye drops con- Results taining chloramphenicol was associated with a 48% In October 2012, a questionnaire was circulated to the sales increase [11,12]. Further investigation is needed EU Member States and Norway. Twenty-six of 28 tar- to determine if these increases in consumption will geted countries responded and Excel tables listing OTC have any effects on antimicrobial resistance. antibiotics and indications were received by EMA in January 2013. The 48 identified antibiotic pharmaceu- In the resolution of 11 December 2012 on the Microbial tical forms (averaging ~1-2 OTC pharmaceutical forms Challenge – Rising threats from Antimicrobial per country) contained 20 different active substances 2 www.eurosurveillance.org Table 2A Topical OTC antibiotics and indications in the EU Member States
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