Manuela Tabali

Educational intervention to improve physician reporting of adverse drug reactions (ADRs) in a primary care setting in complementary and alternative medicine

BackgroundRecent studies have shown that adverse drug reactions (ADRs) are underreported. This may be particularly true of ADRs associated with complementary and alternative medicine (CAM). Data on CAM-related ADRs, however, are sparse.Objective was to evaluate the impact of an educational intervention and monitoring programme designed to improve physician reporting of ADRs in a primary care setting.MethodsA prospective multicentre study with 38 primary care practitioners specialized in CAM was conducted from January 2004 through June 2007. After 21 month all physicians received an educational intervention in terms of face-to-face training to assist them in classifying and reporting ADRs. The study centre monitored the quantity and quality of ADR reports and analysed the results.To measure changes in the ADR reporting rate, the median number of ADR reports and interquartile range (IQR) were calculated before and after the educational intervention. The pre-intervention and post-intervention quality of the reports was assessed in terms of changes in the completeness of data provided for obligatory items. Interrater reliability between the physicians and the study centre was calculated using Cohens kappa with a 95% confidence interval (CI). We used Mann Whitney U-test for testing continuous data and chi-square test was used for categorical data. The level of statistical significance was set at P < 0.05.ResultsA total of 404 ADRs were reported during the complete study period. An initial 148% increase (P = 0.001) in the number of ADR reports was observed after the educational intervention. Compared to baseline the postinterventional number of ADR reportings was statistically significant higher (P < 0.005) through the first 16 months after the intervention but not significant in the last 4-month period (median: 8.00 (IQR [2.75; 8.75]; P = 0.605). The completeness of the ADR reports increased from 80.3% before to 90.7% after the intervention. The completeness of the item for classifying ADRs as serious or non-serious increased significantly (P < 0.001) after the educational intervention. The quality of ADR reports increased from kappa 0.15 (95% CI: 0.08; 0.29) before to 0.43 (95% CI: 0.23; 0.63) after the intervention.ConclusionThe results of the present study demonstrate that an educational intervention can increase physician awareness of ADRs. Participating physicians were able to incorporate the knowledge they had gained from face-to-face training into their daily clinical practice. However, the effects of the intervention were temporary.

Remedies Containing Asteraceae Extracts: A Prospective Observational Study of Prescribing Patterns and Adverse Drug Reactions in German Primary Care

AbstractBackground: The use of complementary therapies by patients has increased over the past 20 years, both in terms of self-medication and physician prescriptions. Among herbal medicines, those containing extracts of Asteraceae (Compositae), such as Echinacea spp., Arnica montana, Matricaria recutita and Calendula officinalis, are especially popular in the primary-care setting. However, there remains a gap between the growing acceptance of these remedies and the lack of data on their safety. Objective: The aim of this study was to analyse prescribing patterns and adverse drug reactions (ADRs) for Asteraceae-containing remedies in Germany. Methods: Primary-care physicians, all of whom were members of the German National Association of Anthroposophic Physicians were invited to participate in this prospective, multicentre, observational study. During the study period (September 2004 to September 2006), all prescriptions and suspected ADRs for both conventional and complementary therapies were documented using a web-based system. The study centre monitored all ADR reports and conducted a causality assessment according to Uppsala Monitoring Centre guidelines. Relative risks (RRs) and proportional reporting ratios (PRRs) were calculated. Results: Thirty-eight physicians, 55% of whom were general practitioners and 45% were specialists, fulfilled the technical requirements and were included in the investigation. Because documenting all ADRs (i.e. serious and non-serious) was time consuming, only a subgroup consisting of seven physicians agreed to report nonserious in addition to serious ADRs. During the study period, a total of 50 115 patients were evaluated and 344 ADRs for conventional and complementary remedies were reported. Altogether, 18 830 patients (58.0% female, 60.3% children) received 42 378 Asteraceae-containing remedies. The most frequently prescribed Asteraceae was Matricaria recutita (23%), followed by Calendula officinalis (20%) and Arnica montana (20%). No serious ADRs for Asteraceae-containing remedies were reported. In the analysis of the subgroup of seven physicians who also documented nonserious ADRs, 11 nonserious ADRs for Asteraceae-containing remedies occurred in 6961 patients, resulting in an RR of 0.13 (95% CI 0.07, 0.23). The majority of reported ADRs for Asteraceae-containing remedies were classified as uncommon. A subgroup analysis comparing phytotherapeutic and homoeopathic preparations did not reveal any relevant differences. The PRR for Asteraceae-containing remedies with respect to all other prescriptions was 1.7 (95% CI 1.0, 2.0) for the system organ class ‘skin and subcutaneous tissue disorders’ (six ADRs) and 1.0 (95% CI 0.3, 3.6) for ‘gastrointestinal disorders’ (three ADRs). Neither result was significant according to the PRR criteria developed by Evans et al. Conclusion: This is the first study to provide a systematic overview of prescribing patterns and ADRs for Asteraceae-containing remedies in the German primary-care sector. Asteraceae-containing remedies were used frequently in this context, especially among children. Our results indicate that treatment with Asteraceae-containing remedies is not associated with a high risk of ADRs.

Prescribing patterns in dementia: a multicentre observational study in a German network of CAM physicians

BackgroundDementia is a major and increasing health problem worldwide. This study aims to investigate dementia treatment strategies among physicians specialised in complementary and alternative medicine (CAM) by analysing prescribing patterns and comparing them to current treatment guidelines in Germany.MethodsTwenty-two primary care physicians in Germany participated in this prospective, multicentre observational study. Prescriptions and diagnoses were reported for each consecutive patient. Data were included if patients had at least one diagnosis of dementia according to the 10th revision of the International Classification of Diseases during the study period. Multiple logistic regression was used to determine factors associated with a prescription of any anti-dementia drug including Ginkgo biloba.ResultsDuring the 5-year study period (2004-2008), 577 patients with dementia were included (median age: 81 years (IQR: 74-87); 69% female). Dementia was classified as unspecified dementia (57.2%), vascular dementia (25.1%), dementia in Alzheimers disease (10.4%), and dementia in Parkinsons disease (7.3%). The prevalence of anti-dementia drugs was 25.6%. The phytopharmaceutical Ginkgo biloba was the most frequently prescribed anti-dementia drug overall (67.6% of all) followed by cholinesterase inhibitors (17.6%). The adjusted odds ratio (AOR) for receiving any anti-dementia drug was greater than 1 for neurologists (AOR = 2.34; CI: 1.59-3.47), the diagnosis of Alzheimers disease (AOR = 3.28; CI: 1.96-5.50), neuroleptic therapy (AOR = 1.87; CI: 1.22-2.88), co-morbidities hypertension (AOR = 2.03; CI: 1.41-2.90), and heart failure (AOR = 4.85; CI: 3.42-6.88). The chance for a prescription of any anti-dementia drug decreased with the diagnosis of vascular dementia (AOR = 0.64; CI: 0.43-0.95) and diabetes mellitus (AOR = 0.55; CI: 0.36-0.86). The prescription of Ginkgo biloba was associated with sex (female: AOR = 0.41; CI: 0.19-0.89), patient age (AOR = 1.06; CI: 1.02-1.10), treatment by a neurologist (AOR = 0.09; CI: 0.03-0.23), and the diagnosis of Alzheimers disease (AOR = 0.07; CI: 0.04-0.16).ConclusionsThis study provides a comprehensive analysis of everyday practice for treatment of dementia in primary care in physicians with a focus on CAM. The prescribing frequency for anti-dementia drugs is equivalent to those found in other German studies, while the administration of Ginkgo biloba is significantly higher.

Verordnungsverhalten anthroposophisch orientierter Ärzte bei akuten Infektionen der oberen Atemwege

Hintergrund: Akute Atemwegsinfektionen gehören zu den häufigsten Ursachen für einen Arztbesuch. Die vorliegende Arbeit untersucht die Behandlung akuter Atemwegsinfekte durch anthroposophisch orientierte Ärzte unter besonderer Berücksichtigung von Antibiotikaverordnungen, Komplikations- und Rezidivraten sowie Rezeptkosten. Material und Methoden: In einem Netzwerk von 35 Hausärzten in Deutschland wurden alle Verordnungsdaten beginnend ab Mai 2004 über den Zeitraum eines Jahres erfasst. Dazu wurden regelmäßig ärztliche Routinedaten durch speziell entwickelte Schnittstellen aus Praxissystemen ausgelesen. In standardisierten Web-Interfaces nahmen die Ärzte ergänzend eine Verknüpfung von Medikamenten und Diagnosen vor. Ergebnisse: Es wurden 21 818 Verordnungen von 12 081 Patienten (73,7% Kinder) für 19 050 akute Infekte der oberen Atemwege ausgewertet. Die häufigsten Diagnosen waren grippale Infekte (63,3%) und akute Tonsillitiden (12,9%). 63,0% der Erkrankungen wurden rein komplementärmedizinisch behandelt. Antibiotika wurden in 6,3% der Fälle verordnet (Minimum: grippale Infekte: 1,9%, Maximum: Tonsillitis: 24,3%). Prädiktive Faktoren für den Antibiotikaeinsatz waren neben den Diagnosen Tonsillitis (Odds Ratio [OR]: 6,7; 95%-Konfidenzintervall [KI]: 4,5-9,9) und Sinusitis (OR: 1,9; 95%-KI: 1,1-3,1) Begleiterkrankungen (OR: 1,2; 95%-KI: 1,0-1,4), Komplikationen (OR: 7,2; 95%-KI: 5,5-9,4) und die Facharztausrichtung Pädiatrie (OR: 2,1; 95%-KI: 1,7-2,6). Die Nachverschreibungsrate von Antibiotika für zunächst rein komplementärmedizinisch behandelte Patienten war mit 0,7% gering, ebenso die Komplikationsrate (2,9%) und die Folgekonsultationsrate (6,3%). Durchschnittlich erkrankten die Patienten 2,4-mal pro Jahr an einer akuten Atemwegsinfektion (Erwachsene: 1,7; Kinder: 2,7). Die Medikamentenkosten von komplementärmedizinischen und Antibiotikarezepten unterschieden sich nicht. Schlussfolgerung: Durch Aufbereitung und Ergänzung ärztlicher Routinedaten konnte der Verschreibungsalltag anthroposophischer Hausärzte abgebildet werden. Bezüglich des Einsatzes von Antibiotika wurde eine spezifische leitlinienkonforme Therapie durchgeführt. Die Antibiotikaverschreibungsrate lag deutlich unter dem Bundesdurchschnitt.

Diagnostic profiles and prescribing patterns in everyday anthroposophic medical practice--a prospective multi-centre study.

Background: Although anthroposophic medicine has been used for more than 80 years and global interest in complementary treatments is increasing, a comprehensive and long-term description of everyday anthroposophic care is still lacking. Our study aims to evaluate how anthroposophic medicine is practised under everyday conditions. Methods: A total of 38 primary-care physicians in Germany participated in this prospective, multi-centre observational study. Prescriptions, diagnoses, and non-pharmacological therapies were reported for each consecutive patient. Results: In 2005, 95,116 prescriptions for 32,839 patients (56.2% children, 57.3% female) were recorded. The median duration of consultation depended on physician specialization (general practitioners: 9.5 min; paediatricians: 8.1 min). The most frequent single diagnoses were acute upper respiratory tract infections (URTI), otitis media, and bronchitis in children; hypertension, breast cancer, and depressive episodes in adult females; and hypertension, URTI, and asthma in adult males. Anthroposophic remedies accounted for 41.8% of all drugs prescribed. The odds ratio (OR) for receiving an anthroposophic remedy was very high for cancer (OR = 4.5; 95% CI: 4.2–4.8) and >1 for dorsopathies (OR = 1.5; CI: 1.3–1.6), otitis media (OR = 1.3; CI: 1.2–1.3), and URTI (OR = 1.1; CI: 1.1–1.2). Of the 5,289 therapeutic procedures prescribed, 27% were anthroposophic. Conclusion: A broad range of anthroposophic remedies and non-pharmacological therapies are prescribed for a specific set of diseases in everyday anthroposophic practice. Particularly, patients <60 years received anthroposophic care. Our findings will help in the planning and implementation of further studies.

Adverse Drug Reactions in a Complementary Medicine Hospital: A Prospective, Intensified Surveillance Study

Background. Anthroposophic medicine is one of the widely used approaches of complementary and alternative medicine. However, few prospective studies have generated safety data on its use. Objectives. We aimed to assess adverse drug reactions (ADRs) caused by anthroposophical medicines (AMEDs) in the anthroposophical Community Hospital Havelhoehe, GERMANY. Study Design and Methods. Between May and November 2007, patients of six medical wards were prospectively assessed for ADRs. Suspected ADRs occurring during hospitalization were documented and classified in terms of organ manifestation (WHO SOC-code), causality (according to the Uppsala Monitoring Centre WHO criteria), and severity. Only those ADRs with a severity of grade 2 and higher according to the CTCAE classification system are described here. Results. Of the 3,813 patients hospitalized, 174 patients (4.6%) experienced 211 ADRs (CTCAE grade 2/3 n = 191, 90.5%, CTCAE grade 4/5 n = 20, 9.5%) of which 57 ADRs (27.0%) were serious. The median age of patients with ADRs (62.1% females) was 72.0 (IQR: 61.0; 80.0). Six patients (0.2%) experienced six ADRs (2.8% of ADRs) caused by eight suspected AMEDs, all of which were mild reactions (grade 2). Conclusion. Our data show that ADRs caused by AMEDs occur rarely and are limited to mild symptoms.

Pharmacotherapy of elderly patients in everyday anthroposophic medical practice: a prospective, multicenter observational study.

BackgroundPharmacotherapy in the older adult is a complex field involving several different medical professionals. The evidence base for pharmacotherapy in elderly patients in primary care relies on only a few clinical trials, thus documentation must be improved, particularly in the field of complementary and alternative medicine (CAM) like phytotherapy, homoeopathy, and anthroposophic medicine. This study describes diagnoses and therapies observed in elderly patients treated with anthroposophic medicine in usual care.MethodsTwenty-nine primary care physicians in Germany participated in this prospective, multicenter observational study on prescribing patterns. Prescriptions and diagnoses were reported for each consecutive patient. Data were included if patients were at least 60 years of age. Multiple logistic regression analysis was used to determine factors associated with anthroposophic prescriptions.ResultsIn 2005, a total of 12 314 prescriptions for 3076 patients (68.1% female) were included. The most frequent diagnoses were hypertension (11.1%), breast cancer (3.5%), and heart failure (3.0%). In total, 30.5% of the prescriptions were classified as CAM remedies alone, 54.4% as conventional pharmaceuticals alone, and 15.1% as a combination of both. CAM remedies accounted for 41.7% of all medications prescribed (35.5% anthroposophic). The adjusted odds ratio (AOR) for receiving an anthroposophic remedy was significantly higher for the first consultation (AOR = 1.65; CI: 1.52-1.79), treatment by an internist (AOR = 1.49; CI: 1.40-1.58), female patients (AOR = 1.35; CI: 1.27-1.43), cancer (AOR = 4.54; CI: 4.12-4.99), arthropathies (AOR = 1.36; CI: 1.19-1.55), or dorsopathies (AOR = 1.34; CI: 1.16-1.55) and it decreased with patient age (AOR = 0.97; CI: 0.97-0.98). The likelihood of being prescribed an anthroposophic remedy was especially low for patients with hypertensive diseases (AOR = 0.36; CI: 0.32-0.39), diabetes mellitus (AOR = 0.17; CI: 0.14-0.22), or metabolic disorders (AOR = 0.17; CI: 0.13-0.22).ConclusionThe present study is the first to provide a systematic overview of everyday anthroposophic medical practice in primary care for elderly patients. Practitioners of anthroposophic medicine prescribe both conventional and complementary treatments. Our study may facilitate further CAM-research on indications of, for example, dementia or adverse drug reactions in the elderly.

The Relationship between Health-Related Quality of Life and Care Dependency among Nursing Home Residents in Germany: A Longitudinal Study

Nursing home staff should assist residents in achieving better health-related quality of life (HRQOL). HRQOL has become an increasingly important means of assessing the individual’s needs in health care. Up to date assessment of the care dependency of the residents is a standard means of knowing the residents’ care needs in nursing homes in Germany. We aimed at evaluating changes in the HRQOL of nursing home residents and the relationship between HRQOL and care dependency. Methods: A prospective study was conducted in eleven nursing homes (72 residents). HRQOL was measured at admission and after twelve weeks using the Nottingham Health Profile (NHP) in the domains “Physical Mobility”, “Energy”, “Pain”, “Social Isolation”, “Emotional Reaction” and “Sleep”. Care dependency was evaluated using the Care Dependency Scale. Results: HRQOL in the domain “Physical Mobility” improved significantly in 55.6% of the residents (p=0.002). A significant decrease was found in the domain “Emotional Reaction” in 54.2% of the residents (p=0.047). Residents with constant or higher values in their “Emotional Reaction” (worse HRQOL in these domain) at T1 compared to T0 were less cognitively impaired than residents with an improved (better HRQOL) “Emotional Reaction”. Care dependency improved significantly in the study period. No correlation between HRQOL and care dependency was found. Conclusion: As there is no correlation between HRQOL and care dependency over the study period, the residents’ HRQOL should be evaluated in regular intervals which can be important in drawing conclusions about possible undiscovered needs from the resident’s perspective. Assessing the changes from the resident’s perspective supports the nursing home staff to assist residents in achieving better HRQOL.

Does the care dependency of nursing home residents influence their health-related quality of life?-A cross-sectional study

BackgroundStudies on health-related quality of life (HRQOL) are missing for nursing home residents independent from their health conditions or interventions after admission. Our aim was to analyse if the care dependency of nursing home residents influence their HRQOL and to describe HRQOL of nursing home residents at the time of admission.MethodEleven German nursing homes were randomly selected for a cross-sectional multicentre study from April 2008 until December 2009. HRQOL was measured with the Nottingham Health Profile (NHP) in the six domains “Physical Mobility”, ”Energy”, “Pain”, “Social Isolation”, “Emotional Reaction” and “Sleep”. Domain scores range from zero (good subjective health status) to 100 (poor subjective health status). Care dependency was evaluated using the Care Dependency Scale, age, sex, cognitive status and diseases were documented by the research assistants. Multivariate regression analysis was performed to quantify the influence of care dependency on HRQOL.Results120 residents were included in total. HRQOL was mostly reduced in the domains “Physical Mobility” and ”Energy“ (mean scores >43.0), while impairment differences in the domains “Pain”, “Social Isolation”, “Emotional Reaction” and “Sleep” were only moderate (≤25.0). HRQOL was not influenced by the age. Women (n = 85) had a significantly poorer HRQOL in the domain “Pain” than men (mean score women: 29.5 ± 31.5; males: 14.9 ± 17.2; p = 0.011). Care dependency had an influence on the domain “Sleep” (ß = −0.195, p = 0.031), while the other domains were not influenced by care dependency. Residents with a low care dependency scored significantly lower (better HRQOL) in the domain “Sleep” than residents with a high care dependency (mean score 15.3; SD ± 19.0 versus mean score 32.8 SD ± 33.2; p < 0.02).ConclusionThe level of care dependency has no influence on the HRQOL from the nursing home residents’ perspective apart from the domain “Sleep”. High care dependency residents have a lower HRQOL in the domain “Sleep” compared to moderate and low care dependency residents. We found a significantly lower HRQOL in women compared to men in the domain “Pain“.

Depression, Comorbidities, and Prescriptions of Antidepressants in a German Network of GPs and Specialists with Subspecialisation in Anthroposophic Medicine: A Longitudinal Observational Study

Background. Depression is a major reason for counselling in primary care. Our study aims at evaluating pharmacological treatment strategies among physicians specialised in anthroposophic medicine (AM). Methods. From 2004 to 2008, twenty-two German primary care AM-physicians participated in this prospective, multicentre observational study. Multiple logistic regression was used to determine factors associated with a prescription of any antidepressant medication. Results. A total of 2444 patients with depression were included (mean age: 49.1 years (SD: 15.4); 77.3% female). 2645 prescriptions of antidepressants for 833 patients were reported. Phytotherapeutic preparations from Hypericum perforatum were the most frequently prescribed antidepressants over all (44.6% of all antidepressants), followed by amitriptyline (16.1%). The likelihood of receiving an antidepressant medication did not depend on comorbidity after controlling for age, gender, physician specialisation, and type of depression (adjusted OR (AOR) = 1.01; CI: 0.81–1.26). Patients who had cancer were significantly less likely to be prescribed an antidepressant medication than those who had no cancer (AOR = 0.75; CI: 0.57–0.97). Conclusion. This study provides a comprehensive analysis of everyday practice for the treatment of depression in AM -physicians. Further analysis regarding the occurrence of critical combinations is of high interest to health services research.