ArticleEuropean journal of clinical pharmacology2017
From prescription-only (Rx) to over-the-counter (OTC) status in Germany 2006-2015: pharmacological perspectives on regulatory decisions.
Article in European journal of clinical pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
5 citing papers in PubMed.
- Attitudes, attributions, and usage patterns of primary care patients with regard to over-the-counter drugs-a survey in Germany.Wiener medizinische Wochenschrift (1946) · 2024Article
- The Awareness of Risks Associated with OTC Drugs Available in Non-Pharmacy Outlets among Polish Patients-A Cross-Sectional Study.Healthcare (Basel, Switzerland) · 2021Article
- Analysing the landscape for prescription to non-prescription reclassification (switch) in Germany: an interview study of committee members and stakeholders.BMC health services research · 2019Article
- Over-The-Counter (OTC) Drug Consumption among Adults Living in Germany: Results from the German Health Interview and Examination Survey for Adults 2008⁻2011 (DEGS1).Pharmacy (Basel, Switzerland) · 2018Article
- Over-the-counter medicines: Global perspective and Indian scenario.Journal of postgraduate medicineReview
Corrections and comments
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Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeLittle is known about the extent of switches from prescription-only (Rx) to over-the-counter (OTC) status in Europe and about the pharmacological properties of the switched substances. The objectives of this study were to provide an overview of the substances that were switched from Rx to OTC status in Germany between 2006 and 2015 and to assess their pharmacological properties.
methodsSession minutes of the German Expert Advisory Committee for Prescription-Only Issues, changes to the German Ordinance on Prescription-Only Medicines and the Summary of Product Characteristics of the switched substances were analysed. Pharmacological properties were studied in relation to the EU Guideline on Changing the Classification for the Supply of a Medicinal Product for Human Use (the 'EU switch guide').
resultsBetween 2006 and 2015, seven substances (almotriptan, omeprazole, benzydamine, ibuprofen/pseudoephedrine, racecadotril, ketotifen and levonorgestrel) were switched from Rx to OTC status in Germany. In all cases, the OTC status was restricted to certain indications, doses, pack sizes, or other limitations. Notwithstanding recommendations of the EU switch guide, some of the switched substances might interact with commonly used drugs potentially resulting in serious adverse drug reactions or have contraindications or warnings regarding substantial parts of the population.
conclusionsThe stipulations of the EU switch guide were fully met for only some switches, while this was not completely the case for others. Further development of guidance on balancing risks and benefits of OTC availability is recommended.
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