BackgroundThere is a need for data on the clinical safety of anthroposophic medicinal products (AMPs).ObjectivesThe main objective of this analysis was to determine the frequency of adverse drug reactions (ADRs) to AMPs, relative to the number of AMP prescriptions.MethodsEvaMed (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.ResultsA 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.ConclusionIn 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 materialThe online version of this article (doi:10.1007/s40801-017-0118-5) contains supplementary material, which is available to authorized users.

The aim of this study was to investigate the relationship between fall risk increasing drugs (FRIDS) and the risk of falls in regard to fall-related chronic diseases. In total, 39 primary care physicians in Germany participated in the EvaMed Pharmacovigilance Network. Antihypertensives, non-steroidal anti-inflammatory drugs, hypnotics and sedatives, antidepressants and psycholeptics were labelled as FRIDS. A fall was defined according to a diagnosis in the chapter Injury or poisoning (S00-T14 in International Statistical Classification of Diseases 10th Revision (ICD-10)). Patients older than or equal to 65 years with at least two doctor’s visits were included. FRIDS were prescribed for 1768 patients from a total of 5124 patients included in the analysis. FRIDS and seven chronic diseases were statistically significant associated with a higher risk of experiencing a fall. The risk was highest for patients with a diagnosis abnormalities of gait and mobility, vertigo, visual -impairment and weight loss, and increased by 50-90% with arthritis, diseases of arteries, arterioles and capillaries and heart failure. From patients (N = 425) with at least one diagnosis of fall, 219 patients were prescribed FRIDS. In 100 (45.7%) of cases the diagnoses for fall were made before and in 105 (47.9%) of cases at least a month after the prescription of FRIDS. 14 (6.4%) patients had a prescription of FRIDS and a diagnosis of fall within one month. Perceptual disorders, low walking speed and pain are prominent predictors for falls in the elderly. A prescription of FRIDS selects more vulnerable patients having a higher risk of falls. However, experiencing a fall is mainly due to the disease followed by treatment. Thus, not prescribing FRIDS will avoid only a small number of falls.

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