strategies for increasing spontaneous adverse drug reaction reporting rates among portuguese...
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ARTICLE IN PRESSAbstracts / European Journal of Integrative Medicine 1 (2009) 223–260250
outcome of the requirements of the DRG (diagnosis-relatedgroups) system.
Conclusion: The interests of the patients, the hospital ownersand the insurance companies are represented. Given thepositive response from patients, no obstacles exist – contraryto initial expectations – at the general practitioner level and interms of external care services; rather, they exist primarilywith respect to hospital care structures.
10.1016/j.eujim.2009.08.051
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Stiff-Man-Syndrome: Association of an autoimmune-ence-
phalomyelitis with endocrinopathies and organ-specific anti-
bodies
N. Keilbar
Department of Neurology, University of Heidelberg, Heidel-
berg, Germany
Stiff-Man-Syndrome (SMS) is a complex neuroimmunologicaldisease of the Central Nervous System (CNS) with endocri-nological, motoric, vegetative symptoms and is associated withautoantibodies to glutamate decarboxylase (GAD). SMS andits variants, stiff limb syndrome (SLS) and progressiveencephalomyelitis with rigidity and myoclonus (PERM),appear to occur more frequently than hitherto thought. Thecause of SMS is unknown.In a retrospective assessment of 92 patients (1989–2005)
we investigated the correlation between SMS/SLS/PERM,associated autoimmune disorders, organ-specific antibo-dies and immungenetic HLA-association to find out theimmunological differences between SMS, its variants andGAD-Ab positive- and negative patients. In total 54 of 92patients with SMS and its variants were associated with 96autoimmune diseases included autoimmune-endocrinopa-thies, e.g. Diabetes mellitus Typ I n ¼ 40, HashimotoThyroiditis n ¼ 13, Vitamine B12 Hypovitaminosis n ¼ 11,Pernicious anemia n ¼ 4 and Atrophic gastritis n ¼ 4.Associated immunopathies are most presented in patientswith GAD-Ab: in 65 patients with GAD-Ab appeared 83immunopathies, 26 patients without GAD-Ab only 13.In total 70% of autoimmune-endocrinopathies werediagnosed after the manifestation of this neurologicaldisorder.Organ-specific antibodies are more frequent in patients
with GAD-Ab than in patients without GAD-Ab, e.g.beta cell antibodies were found in 23 of 40 patients withGAD-Ab, but no antibodies were found in 13 patientswithout GAD-Ab. Two different groups can be distin-guished pathogenetic. GAD-Ab as a Master-Ab is leadingthe way in the diagnostics of SMS.We have observed anoticeable association of this autoimmune-encephalomye-litis between GAD-Ab and HLA-haplotypes DQB1*03,DRB1*04, DQB1*02 and DQA1*0102. This show a
similarity with diabetes mellitus Type I and mayrepresent a genetic disposition.These results show interac-tions between neuroimmunology, endocrinology, immun-genetics. Diagnostic, therapy and treatment of thesepatients indicate integrative and complementary proceed-ings. We hope that, e.g. natural medicine, ayurveda,TCM will help to find the cause of this disease and extendthe therapeutical options in the treatment of Stiff-Man-Syndrome and many other neuroimmunologicaldiseases.
10.1016/j.eujim.2009.08.052
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Strategies for increasing spontaneous Adverse Drug
Reaction reporting rates among Portuguese pharmacists
I. Ribeiro Vaza, T. Herdeirob, A. Figueirasc, J. Poloniaa
aFaculdade de Medicina na Universidade do Porto, Unidade
de Farmacovigilancia do Norte, Porto, PortugalbIPSN-CESPU, Centro de Investigac- ao em Tecnologias da
Saude, Vila Nova de Famalicao, PortugalcUniversidade de Santiago de Compostela, Departamento de
Medicina Preventiva e Saude Publica, Santiago de Compostela,
Spain
Background: It is well known worldwide, that AdverseDrug Reactions (ADRs) are an important cause ofmorbidity and mortality in developed countries. InPortugal, as in many other countries, ADR reporting rateis rather low [1–3], and as a consequence there is a lack ofinformation being transmitted to the Medicines RegulatoryAuthority, which does not effectively represent the realnumber of adverse events.
Objective: Our aim was to increase the number andrelevance of ADR reporting among pharmacists, withworkshops and telephone interviews.
Method: We conducted a cluster-randomized controlledtrial, among pharmacists working in the Northern regionof Portugal.
Results: The ADR reporting rate increased 3-fold as aresult of this action (RR=3.22; 95% CI 95%: 1.33–7.80)compared with the control group, during the studiedperiod. Besides, the relevance of ADR reported was alsoincreased. In fact, serious ADR reports increased 4-fold(RR=3.87; 95% CI: 1.29–11.61) and unexpected ADRreports increased 5-fold (RR=5.02; 95% CI: 1.33–18.93),compared with the control group.
Conclusions: Educational interventions are efficient inincreasing the ADR spontaneous reporting rate, amongPortuguese pharmacists. Among this professional group,workshops are as efficient as telephone interview to improveADR spontaneous reporting.
ARTICLE IN PRESSAbstracts / European Journal of Integrative Medicine 1 (2009) 223–260 251
References
[1] McGettigan P, et al. Reporting of adverse drug reactions by hospital
doctors and the response to intervention. Br J Clin Pharmacol
1997;44(1):98–100.
[2] Smith CC, et al. Adverse drug reactions in a hospital general medical
unit meriting notification to the Committee on Safety of Medicines. Br
J Clin Pharmacol 1996;42(4):423–9.
[3] Begaud B, et al. Rates of spontaneous reporting of adverse drug
reactions in France. JAMA 2002;288(13):1588.
10.1016/j.eujim.2009.08.053
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Effectiveness and tolerability of Lymphomyosot N solution
for injection in treating oedemas and swellings of thrombotic
or inflammatory aetiology in general clinical practice
V. Moyseyenkoa, V. Corgiolub
aNational Bogomolets Medical University, Department of
Propedeutics of Internal Diseases, Kyiv, UkrainebBiologische Heilmittel Heel GmbH, Baden-Baden,
Germany
Background: Complementary and alternative medicat-ions are often used for mild inflammatory disorders.The effectiveness and tolerability of the homeopathicpreparation Lymphomyosot N for the treatment ofoedemas and swellings of thrombotic or inflammatoryaetiology was studied under conditions of everyday clinicalpractice.
Methods: Prospective observational study conducted in 13general and specialist clinics in the Ukraine between January2009 and June 2009. Subjects were X18 years old, diagnosedwith oedemas and swellings of thrombotic or inflammatoryaetiology with different localisation, mainly in lymphaticvessels and nodes, and allergic diseases. Lymphomyosot Ninjection solution was administered according to localprescribing information and practices (ranging from oncedaily to once weekly) with changes in regimens at thediscretion of the treating physicians. Other therapies forconcomitant diseases were documented during the course ofthe study. The total observation period was 8 weeks.Effectiveness was evaluated 1 week after the initiation oftherapy and at the end of the observation period, withvoluntary weekly interim evaluations recommended. Theeffectiveness variables were severity of oedema, severity ofoedema symptoms, global severity of disease (pathologicalprocess), time to first global symptomatic improvementand an overall evaluation of the therapeutic effectiveness.Effectiveness was assessed on a 5-point Likert scale by thephysicians together with the patients. All analyses wereconducted on the effectiveness population, defined as allsubjects who received treatment with Lymphomyosot Nsolution for injection. Tolerability was evaluated both locally
at the injection site 30min after injections and globally, bothon a 4-point Likert scale from ‘no issues’ to ‘severe intolerancesymptoms’. Quality of life was evaluated with the EQ-5Dquestionnaire. Safety data were collected on all serious andnon-serious adverse reactions considered related to theadministration of Lymphomyosot N solution.
Results: Data will be presented for �150 subjects. Theanalysis is ongoing at the time of abstract submission and allfinal results will be available at the time of the congress.
Conclusions: The results will show whether LymphomyosotN can be considered an effective and well-toleratedtreatment of oedemas and swellings of thrombotic orinflammatory aetiology under conditions of everydayclinical practice.
10.1016/j.eujim.2009.08.054
PO-052
Attitudes towards remedies of Complementary Medicine of
pharmacy customers and pharmacists
T. Ostermann, E. Seydak-Doht, P.F. Matthiessen
Universitat Witten/Herdecke, Lehrstuhl fur Medizintheorie
und Komplementarmedizin, Herdecke, Germany
Background: Remedies of Complementary Medicine (CAM)constitute a significant part of the German pharmaceuticalmarket. This cross-sectional study intended to give a firstoverview on knowledge and appraisal of complementaryremedies in a sample of pharmacy customers and pharmacistsin Germany.
Material and methods: Based on expert hearings in the run-upto the study two questionnaires for customers and pharmacistswere developed. Customers and pharmacists all over Germanywere asked randomly to take part in this study. From Octoberto December 2005 a total of 1300 questionnaires then weredistributed in Nordrhine-Westfalia (70%), Bavaria (10%),Saxonia (5%), Mecklenburg-Western Pomerania (5%), Schles-wig-Holstein (5%) and Hesse (5%).
Results: More than 75% of the customers stated to have usedCAM-remedies more than once in the past. Efficacy of CAM-remedies was rated high in more than 70%, whereas 25%believed, that this kind of treatment takes longer comparedwith conventional medicine. The pharmacist was ranked at thefirst place as consultant for CAM (50%) followed by thegeneral physician and the healing practitioner. Customersshowed significant shifts in attitudes with respect to gender,age, level of education and social status. More than 80% offemale, but only 50% of male customers tended to be positiveabout remedies of complementary medicine. Particularlyparticipants aged between 40 and 65 years were open mindedfor this topic. For the pharmacists herbal remedies ranged firstbefore vitamins and minerals and homeopathic remedies. Intotal 80% of the pharmacists affirmed a correlation between