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Market prices for blood products and statistical data on hospitalisation were evaluated by literature and desktop research. Results: Treatment of 741 patients (16.7%) requiring blood products resulted in total consumption of 2,726 (mean 3.76 per patient) erythrocyte concentrates (ECs) and 267 (mean 3.38 per patient) fresh frozen plasma units (FFPs). The mean age of treated patients was 72.9 (SD=12.4) years, 412 (55.6%) were female and 567 (76.5%) were ≥65 years old. Drugs most frequently associated with ADRs were acetylsalicylic acid (281), phenprocoumon (274), and diclofenac (118). In most cases, gastrointestinal tract was affected (SOC ‘gastrointestinal disorder’, n=623). Matching statistical data of hospitalisation in Germany with our findings a total demand of 100,934 ECs and 9,882 FFPs units can be estimated resulting in total cost of approx. EUR 9.1 m per year for all German hospitals. According to a literature review on average 51% of ADRs are preventable.[1] Prevention of these ADRs could lead to a decreasing annual demand of blood products (ECs -51.981, FFPs -5.089 units) resulting in a saving potential of approx. EUR 4.68 m per year for German hospitals. Conclusion: Blood products are given in one sixth (mainly gastrointestinal bleeding) of all ADRs leading to hospital admissions in departments of internal medicine resulting in serious cost and provision burden for the respective hospitals. Both blood demand and hospital procurement costs can be reduced by half by preventing ADRs. Therefore, improving medication safety is not only essential for the health of the individual patient but should also be one of the essential concerns for medical and public health decision makers in terms of cost reduction. Supported by BfArM, V-5329-68502-68605/2007. Conflicts of interest: None declared. Reference 1. Grandt D. Friebel H. Mueller-Oerlinghausen B. Arzneitherapie(un)sicherheit. Dtsch Aerztebl 2005; 102:A 509-15 [Heft 8]
86 “Pharmacovigilance from the University: Experience in the Report of Adverse Events and Lack of Efficiency” Lipszyc PS,(1) Setton SJ,(1) Cerisola MV,(1) Vales JE,(1) Scublinsky D(1) (1)First Chair of Pharmacology, School of Medicine, University of Buenos Aires, Argentina Introduction: The First Chair of Pharmacology at the University of Buenos Aires (PhUBA) acts like peripheral effector of the National Service of Pharmacovigilance receiving reports of efficiency diminished, lack of efficiency, fail of quality and known or unknown adverse events of medicines during the stage of commercialization or extended use. We evaluated the period from June 2007 to June 2008. Objective: Analyse the reports of Pharmacovigilance during the last year in the peripheral node of the First Chair of Pharmacology at the UBA. Methods: We analysed the reports of the period from June/2007 to June/ 2008. Recollection of reports was realized in personal or telephonic form by doctors, patients or people of the community. The information was poured simultaneously in an electronic register and internal control writing register. In case of the existence of any sample of the drug, it was sent to the ANMAT, who, if necessary, sent an answer about its analysis. A descriptive analysis of the data obtained was performed. Results: Of the 35 reports obtained in the period June 2007 to June of the 2008, 4 of the same correspond to lack of efficiency. The area that present most reports was Rheumatology (17), the adverse effect reported with main frequency has been the Gastrointestinal Intolerance (9), followed by the elevation of hepatic enzymes (5) and Rash (3). Discussion: The report of adverse events and lack of efficiency showed an upturn in the period in question. From the study we can observe that most of the reports of adverse events correspond to the specialty Rheumatology, not because it is the speciality that more adverse effects has, but that the professionals of the speciality adopted a major commitment with the Pharmacovigilance System. Conclusion: The peripheral node of PhUBA experienced a marked upturn in the period analysed as regards previous similar periods. One of the causes that impulse this was the educative labour of the integrants of the © 2008 Adis Data Information BV. All rights reserved.
service that approached this tool to the doctors of the chair and of distinct hospitals. Conflicts of interest: None declared. Reference Tilson HH, Madre LK, Califf RM. Role of the centers for education and research on therapeutics (CERTs) in pharmacovigilance and proper use of therapeutics. Clin Pharmacol Ther. 2007 Aug;82(2):118-21. And others
87 Pharmacovigilance and Patient Safety – Results of the German Net of Regional Pharmacovigilance Centers Hasford J,(1) Rottenkolber M,(1) Szymanski J,(2) Mueller S,(3) Haase G,(3) May K,(4) Guenther IR,(5) Hippius M,(5) Thuermann PA(2) (1)Institute of Medical Informatics, Biometry and Epidemiology, Ludwig-Maximilians-Universitaet Muenchen, Munich, Germany (2)Institute of Clinical Pharmacology, University of Witten/Herdecke, HELIOS Klinikum Wuppertal, Germany (3)Institute of Clinical Pharmacology, University of Rostock, Germany (4)Institute of Clinical Pharmacology, University of Greifswald, Germany (5)Institute of Clinical Pharmacology, University of Jena, Germany Background: Since 1996, a net of regional Pharmacovigilance Centers has been developed in Germany. Among the major objectives is the identification of serious ADRs in outpatient care leading to hospital admission. Methods: In four hospitals all non-elective hospital admissions are screened for the presence of ADRs as cause of admission. The causality is assessed using B´egaud’s algorithm and the incidence of ADR-related hospital admission is estimated using the prescription data of the hospital service areas. We have analysed all ‘possible’, ‘likely’ and ‘very likely’ (I2 - I4) rated ADRs between 2000 and 2007. Results: There were 6168 serious ADRs with at least a severity level of 4 according to Hartwig in 5686 patients. The mean age of patients was 70.06 (SD=15.72) years and 3440 (60.50 %) were female. The most common ADRs were gastrointestinal ulcers and bleedings (22.76 %), hypoglycemia (14.96 %) and bradycardia (6.71 %). The proportion of fatal ADRs was 1.32 % and the most frequently type of ADR was Type A (88.31 %). The five drugs most commonly imputed were ASA (1208), phenprocoumon (715), digitoxin (529), diclofenac (406) and human insulin fast-acting (378). Ten drugs accounted for 39.30 % of all ADR-related hospital admissions. The incidences of ADR related hospital admissions for certain drug groups and drugs based on ATC code will be presented, too. Conclusions: It is highly relevant to learn that the majority of serious ADRs leading to hospital admission are well known and that the imputed drugs are marketed since very many years. It is widely accepted that many of these ADRs are preventable. The results of this study emphasize the value of this type of pharmacovigilance for the promotion of the safe use of drugs and patient safety. Routine pharmacovigilance monitoring of hospital admissions allows identifying the risks that agencies for patient safety need to know to act properly and in time. Supported by BfArM, V-5329-68502-68605/2007 Conflicts of interest: None declared.
88 Hospital Admissions due to Adverse Drug Reactions: EMIR, a Nationwide Study ´ ` A,(2) PeraultMiremont-Salame´ G,(1,2,3) Benard-Laribi ere Pochat M,(4) Imbs J,(5) Haramburu F,(1,2,3) French Pharmacovigilance Centres N6 ´ (1)Inserm U 675; (2)Centre Regional de Pharmacovigilance; ´ Bordeaux2; France (4)Centre CHU Bordeaux (3)Universite ´ Regional de Pharmacovigilance; CHU Poitiers; France ´ (5)Centre Regional de Pharmacovigilance; CHU Strasbourg; France Background: An assessment of the consequences of adverse drug reactions (ADRs) is important to conduct public health programmes for minimizing risk. Drug Safety 2008; 31 (10)
Abstracts
Objective: To assess the incidence of hospitalizations due to ADRs and the proportion of preventable ADRs. Methods: Cross-sectional study in a randomly selected sample of medical departments in public hospitals, including all patients admitted during a 2-week period. Patients were followed until a diagnosis was retained. All potential ADR cases were centrally reviewed by an evaluation committee. Incidence rate was calculated, taking into account the sample effect. Data were extrapolated for France. Results: A total of 2,692 patients were included: 51.4% were men and 48.6% women. Mean age was 52.3 years (median: 60; range: 0-103). Ninety seven ADR cases were considered as the cause of hospital admissions. Mean age was 62 years (median: 69 years). Patients admitted for an ADR were significantly older than those admitted for another cause (p< 0.001). Vascular disorders represented 20.6% of cases, followed by nervous system disorders (11.3%), gastrointestinal disorders and general disorders (9.3%). It was estimated that 32.0% of ADR cases were preventable and 16.5% potentially preventable. Incidence rate: 3.60% of hospitalisations were ADR-induced [95%CI: 2.77-4.43]. The incidence rate increased with age (p < 0.001): 1.35% [95%CI: 0.54-2.78] in patients less than 16 years, 3.29% between 16-64 years [95%CI: 2.40 - 4.18] and 4.91% [95%CI: 3.78 - 6.03] in patients aged 65 years and over. Oral anticoagulants (0.45% [95%CI: 0.23-0.78]), analgesics (same incidence rate), diuretics (0.40% [95%CI: 0.20-0.73]), antineoplastics (0.33% [95%CI: 0.15-0.63]) were the medicines mostly involved in hospital admission. Inference: the estimated annual number of hospital admissions due to an ADR in France was 143,915 [95%CI: 112,063 - 175,766]. Comments: These results are very close to those of the previous study conducted in 1998 (1). Different actions are necessary to reduce the incidence of ADRs. Reinforcing teaching and continuing medical education, focusing on the proper use of medicines, on interactions, particularly in the elderly and therapeutic education of patients is needed. Conflicts of interest: None declared. Reference Pouyanne P, et al. Admissions to hospital caused by adverse drug reactions: cross sectional incidence study. French Pharmacovigilance Centres. BMJ 2000; 320: 1036
89 A Tool for Preventing Medication Errors Due to Similar Labeling and Packaging of Drugs in a Brazilian Teaching Hospital Sakai MC,(1) Luppi Jr. P,(1) Takahashi PSK,(1) Sousa AB,(1) Ribeiro E(1) ˜ Paulo, Brazil (1)University Hospital of the University of Sao Introduction: Labels represent the main ‘drug/user’ interface, and numer[1,2] suggest that their characteristics, such as the drug ous case reports name, type-face, color coding or expression of drug strength greatly contribute to the incidence of medication errors. However, the impact of drug label design on human performance has received little attention. Studies have shown that print characteristics affect the readability of labels,[3,4] and that orthographic and phonetic similarity between drug names increases the probability of a false recognition error.[5] Printing a section of a drug name in capital letters has been shown to reduce errors in drug name recognition.[6] Aim: To create a tool to prevent medication error due to similar labeling or packaging of drugs and other characteristics that could cause confusion and wrong administration. Methods: Two types of identification labels were set: self-stick labels printed by computer with a warning or an information about the administration of the drug, and self-stick color labels. Also a folder was created with detailed information of the drug (generic name, strength and trademark or producer), example of label to be fixed on the product, reason for labeling and a picture showing the product fixed with the label. Results: It was identified 27 drugs which could cause confusion and wrong administration. From that, the majority were injectable drugs (21), 4 were for rectal use, 1 for topical use and 1 for inhalation. According to the © 2008 Adis Data Information BV. All rights reserved.
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type of identification label used, 3 were identified with the drug generic name and strength to differentiate from the same drug but with another strength, 5 were labeled with dilution information, 3 indicated the restricted administration via, 4 with the warning of neuromuscular blockage drug, 5 with the identification of the product and 7 were identified with color labels to differentiate from others products with similar labeling and packaging. Conclusion: In order to prevent medication errors, the Pharmacy Service of the University Hospital of the University of S˜ao Paulo developed an approach of visual identification of drug packages as a way to call the attention of the hospital staff about the similarities and information of administration. The reasons for identification were: similarities between labeling and/or packaging, restricted via for administration, potentially dangerous drugs (neuromuscular blockage drugs), directions for dilution previous to administration and lack of identification on the product package. Conflicts of interest: None declared. References 1. Edgar TA, Lee DS, Cousins DD. Experience with a national medication error reporting program. American Journal of Hospital Pharmacy 1994; 51: 1335-8 2. Cohen M. Medication Errors: Causes, Prevention, and Risk Management. Sudbury, MA: John and Bartlett, 1999 3. Watanabe R, Gilbreath K, Sakamoto C. The ability of the geriatric population to read labels on over-the-counter medication containers. Journal of the American Optometric Association 1994; 65: 32-7 4. Wogalter MS, Vigilante WJ Jr. Effects of label format on knowledge acquisition and perceived readability by younger and older adults. Ergonomics 2003; 46: 327-44 5. Lambert B, Chang K, Lin S. Effect of orthographic and phonological similarity on false recognition of drug names. Social Science and Medicine 2001; 52: 1843-57 6. Filik R, Purdy K, Gale A, et al. Drug name confusion: evaluating the effectiveness of capital (“Tall Man”) letters using eye movement data. Social Science and Medicine 2004; 59: 2597-601
90 Non-Drug Adverse Symptoms are Influenced by the Personality Trait Anxiety Almeida L,(1,2) Gama H,(1) Vaz-da-Silva M,(1,3) Nunes T,(1) Coelho R,(4) Albino-Teixeira A,(2,3) Soares-da-Silva P(1,2) (1)Department of Research and Development, BIAL - Portela & Cª, SA, Portugal (2)Institute of Pharmacology and Therapeutics, Faculty of Medicine, Porto, Portugal (3)Institute for Molecular and Cell Biology (IBMC), University of Oporto, Portugal (4)Service of Psychiatry and Mental Health, Faculty of Medicine, Porto, Portugal Background: Some adverse events commonly reported by participants in phase I studies are common complaints in individuals from normal population. Objective: The objective of this study was to investigate the relation between the trait anxiety and the adverse non-drug complaints in a group of 117 subjects from normal population who matched the socio-demographic characteristics of our historical database of phase I participants. Methods: Trait anxiety was assessed by the trait scale of the State-Trait Anxiety Inventory (STAI-T). Complaints were assessed by a questionnaire derived from the Spitzer’s Patient Health Questionnaire (PHQ). Spearman’s rho correlations between the STAI-T score and the complaints were performed. Results: Significant positive linear correlations were found between the STAI-T score and the following adverse symptoms: stomach pain (R=0.189; p<0.05), back pain (R=0.221; p<0.05), limbs or joints pain (R=0.207; p<0.05), headaches (R=0.397; p<0.001), chest pain (R=0.222; p<0.05), dizziness (R=0.269; p<0.01), fainting spells (R=0.365; p<0.001), palpitations (R=0.259; p<0.01), shortness of breath (R=0.205; p<0.05), constipation, loose stools, or diarrhea (R=0.213; p<0.05), nausea, gas or indigestion (R=0.353; p<0.001), feeling nervous or anxious (R=0.477; p<0.001), feeling restless (R=0.400; p<0.001), getting tired very easily (R=0.413; p<0.001), muscle tension, aches, or soreness (R=0.439; p<0.001), trouble falling asleep of staying asleep (R=0.493; p<0.001), concentration difficulties (R=0.481; p<0.001), becoming easily annoyed or irritable (R=0.465; p<0.001). Drug Safety 2008; 31 (10)