Use and Safety of Anthroposophic Medicinal Products: An Analysis of 44,662 Patients from the EvaMed Pharmacovigilance Network
| العنوان: | Use and Safety of Anthroposophic Medicinal Products: An Analysis of 44,662 Patients from the EvaMed Pharmacovigilance Network |
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| المؤلفون: | Harald J. Hamre, Kirsten Heckenbach, Anja Glockmann, Harald Matthes |
| المصدر: | Drugs-Real World Outcomes |
| بيانات النشر: | Springer International Publishing, 2017. |
| سنة النشر: | 2017 |
| مصطلحات موضوعية: | medicine.medical_specialty, Traditional medicine, business.industry, medicine.medical_treatment, Medical record, 030226 pharmacology & pharmacy, Physician visit, 03 medical and health sciences, 0302 clinical medicine, Pharmacotherapy, Ambulatory care, Anthroposophic medicine, Internal medicine, Pharmacovigilance, medicine, Pharmacology (medical), 030212 general & internal medicine, Drug reaction, Original Research Article, Medical prescription, business |
| الوصف: | Background There is a need for data on the clinical safety of anthroposophic medicinal products (AMPs). Objectives The main objective of this analysis was to determine the frequency of adverse drug reactions (ADRs) to AMPs, relative to the number of AMP prescriptions. Methods EvaMed (Evaluation of Anthroposophic Medicine) was a prospective pharmacovigilance study with the patients of 38 physicians in outpatient care in Germany. Diagnoses and prescriptions were extracted from the electronic medical records. All physicians documented ADRs of Grades III–IV and serious ADRs, seven ‘prescriber physicians’ also documented non-serious ADRs of any intensity. Patients were eligible for this analysis if they had one or more AMP prescription in the years 2001–2010, followed by one or more physician visit. Results A total of 44,662 patients with 311,731 AMP prescriptions, comprising 1722 different AMPs, were included. One hundred ADRs to AMPs occurred, caused by 83 different AMPs. ADR intensity was mild, moderate, and severe in 50% (n = 50/100), 43%, and 7% of cases, respectively; one ADR was serious. Among patients of prescriber physicians, ADRs of any intensity occurred in 0.071% (n = 67/94,734) of AMP prescriptions and in 0.502% (n = 65/12,956) of patients prescribed AMPs. In subgroup analyses according to age, specific AMPs or AMP groups, dosage forms, and concentrations (altogether 11 groups), the highest ADR frequency was 0.290% of prescriptions (for one specific AMP). Among all patients, serious ADRs occurred in 0.0003% (n = 1/311,731) of prescriptions and 0.0022% (n = 1/44,662) of patients. Conclusion In this analysis from a large sample, ADRs to AMP therapy in outpatient care were rare; ADRs of high intensity as well as serious ADRs were very rare. Electronic supplementary material The online version of this article (doi:10.1007/s40801-017-0118-5) contains supplementary material, which is available to authorized users. |
| اللغة: | English |
| تدمد: | 2198-9788 2199-1154 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::87b288ef1830d1a43694f5de332d5e38Test http://europepmc.org/articles/PMC5684047Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....87b288ef1830d1a43694f5de332d5e38 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 21989788 21991154 |
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