دورية أكاديمية
Food or medicine? A European regulatory perspective on nutritional therapy products to treat inborn errors of metabolism
| العنوان: | Food or medicine? A European regulatory perspective on nutritional therapy products to treat inborn errors of metabolism |
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| المؤلفون: | Stolwijk, N. N., Bosch, A. M., Bouwhuis, N., Häberle, J., van Karnebeek, C., van Spronsen, F. J., Langeveld, M., Hollak, C. E.M. |
| المصدر: | Stolwijk , N N , Bosch , A M , Bouwhuis , N , Häberle , J , van Karnebeek , C , van Spronsen , F J , Langeveld , M & Hollak , C E M 2023 , ' Food or medicine? A European regulatory perspective on nutritional therapy products to treat inborn errors of metabolism ' , Journal of Inherited Metabolic Disease , vol. 46 , no. 6 , pp. 1017-1028 . https://doi.org/10.1002/jimd.12677Test |
| سنة النشر: | 2023 |
| المجموعة: | University of Groningen research database |
| مصطلحات موضوعية: | European Union, food supplements, foods for special medical purposes, inborn errors of metabolism, medical food, nutritional therapy |
| الوصف: | Dietary or nutritional management strategies are the cornerstone of treatment for many inborn errors of metabolism (IEMs). Though a vital part of standard of care, the products prescribed for this are often not formally registered as medication. Instead, they are regulated as food or as food supplements, impacting the level of oversight as well as reimbursed policies. This scoping literature review explores the European regulatory framework relevant to these products and its implications for current clinical practice. Searches of electronic databases (PubMed, InfoCuria) were carried out, supplemented by articles identified by experts, from reference lists, relevant guidelines and case-law by the European Court of Justice. In the European Union (EU), nutritional therapy products are regulated as food supplements, food for special medical purposes (FSMPs) or medication. The requirements and level of oversight increase for each of these categories. Relying on lesser-regulated food products to treat IEMs raises concerns regarding product quality, safety, reimbursement and patient access. In order to ascertain whether a nutritional therapy product functions as medication and thus could be classified as such, we developed a flowchart to assess treatment characteristics (benefit, pharmacological attributes, and safety) with a case-based approach. Evaluating nutritional therapy products might reveal a justifiable need for a pharmaceutical product. A flowchart can facilitate systematically distinguishing products that function medication-like in the management of IEMs. Subsequently, finding and implementing appropriate solutions for these products might help improve the quality, safety and accessibility including reimbursement of treatment for IEMs. |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf |
| اللغة: | English |
| العلاقة: | https://research.rug.nl/en/publications/d7450522-aecb-4d43-9f5f-a8b07057f4e2Test |
| DOI: | 10.1002/jimd.12677 |
| الإتاحة: | https://doi.org/10.1002/jimd.12677Test https://hdl.handle.net/11370/d7450522-aecb-4d43-9f5f-a8b07057f4e2Test https://research.rug.nl/en/publications/d7450522-aecb-4d43-9f5f-a8b07057f4e2Test https://pure.rug.nl/ws/files/876945607/Food_or_medicine_A_European_regulatory_perspective_onnutritional_therapy_products_to_treat_inborn_errors_ofmetabolism.pdfTest http://www.scopus.com/inward/record.url?scp=85170712073&partnerID=8YFLogxKTest |
| حقوق: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.DE1E843C |
| قاعدة البيانات: | BASE |
| DOI: | 10.1002/jimd.12677 |
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