Effect of an educational intervention to improve adverse drug reaction reporting in physicians: a cluster randomized controlled trial.

Transcrição

1 Drug Safety Effect of an educational intervention to improve adverse drug reaction reporting in physicians: a cluster randomized controlled trial. Elena Lopez-Gonzalez, 1 Maria T. Herdeiro, 2,3 María Piñeiro-Lamas, 4 Adolfo Figueiras 1,4 on behalf of the GREPHEPI group 1. Department of Preventive Medicine and Public Health, University of Santiago de Compostela, Spain. 2. CESPU, Instituto de Investigação e Formação Avançada em Ciências e Tecnologias da Saúde, Rua Central de Gandra, 1317, Gandra PRD, Portugal. 3. Northern Pharmacovigilance Unit, Faculty of Medicine, University of Porto, Porto, Portugal. 4. Consortium for Biomedical Research in Epidemiology & Public Health (CIBER en Epidemiología y Salud Pública- CIBERESP), Santiago de Compostela, Spain. GREPHEPI Group consists of Adolfo Figueiras, Francisco Caamaño, Juan J. Gestal-Otero, Teresa Herdeiro, Margarita Taracido, Elena Lopez-Gonzalez, Montserrat Domínguez, Sandra Comendador; Carlos Díaz, Ana Clavería, Isabel Sastre, María Piñeiro-Lamas, Ana Estany, Paula López-Vázquez, Maruxa Zapata-Cachafeiro, Cristian González-González, Juan M. Váquez-Lago, Angel Salgado, Ana López-Durán.

2 Electronic supplementary material I: Hospital departments classified by probability of observing ADRs. Hospital department Priority 1 Priority 2 Priority 3 * Emergency Gynaecology/Obstetrics Nuclear medicine Internal medicine Pneumology Rehabilitation Nephrology Neurology Surgery Gastroenterology Rheumatology Radiodiagnosis Paediatrics Intensive care Ophthalmology Oncology Anaesthetics Ear, nose and throat Dermatology Psychiatry Traumatology Haematology Allergology Urology Cardiology Endocrinology Clinical analysis Geriatrics Neurophysiology * Hospital departments not intervened. Electronic supplementary material II

3 Pharmavigilance Public health activity focused on the identification, cuantification, evaluation and prevention of risks associated to marketed drugs. Spanish Regulation 1344/2007 Maria Teresa 12/09/14 Herdeiro II Jornadas de Farm 3 Adverse drug reaction Morbidity and mortality associated with drug consumption Harmful or undesirable response to the drug Occurring at standard doses used for prophylaxis, diagnosis and treatment Causal link between drug and ensuing adverse event Maria Teresa 12/09/14 Herdeiro II Jornadas de Farm 2 Maria Teresa 12/09/14 Herdeiro II Jornadas de Farm 4

4 ADR constitute the 4 th -6 th leading causes of death in the USA 15%-20% of hospital budgets are spent on solving drug-related complications Maria Teresa 12/09/14 Herdeiro II Jornadas de Farm 5 Maria Teresa 12/09/14 Herdeiro II Jornadas de Farm 7 Methods Epidemiologic (cohort, case-control) studies Voluntary reporting Prescription-event monitoring Patient database studies Maria Teresa 12/09/14 Herdeiro II Jornadas de Farm 8

5 Voluntary reporting Whole population All drugs on the market Throughout drug s life cycle No interference with prescribing habits Enables very rare ADR to be identified Underreporting Maria Teresa 12/09/14 Herdeiro II Jornadas de Farm 9 Are all serious adverse drug reactions known? Maria Teresa 12/09/14 Herdeiro II Jornadas de Farm 11 12/09/14 II Jornadas de Farm 10 Voluntary report BUT... why don t we Whole population All drugs on the market Throughout drug s life cycle No interference with report? prescribing habits Enables very rare ADR to be identified Underreporting 12/09/14 II Jornadas de Farmacovigilância 12 do Centro Yes, pharmaceutical companies conduct pre-clinical and clinical trials before drugs are launched onto the market.

6 But...some drugs register a small incidence of adverse drug reactions that are not detectable during such premarketing clinical trials. Selected populations!! Maria Teresa 12/09/14 Herdeiro II Jornadas de Farm 13 12/09/14 II Jornadas de Farmacovigilância 15 do Centro For example Chloranphenicol, (aplastic anemia: incidence 1/6,000) or Halothane (jaundice: incidence 1/10,000). Short-term trials!! 12/09/14 II Jornadas de Farmacovigilância 14 do Centro 12/09/14 II Jornadas de Farmacovigilância 16 do Centro

7 Healthy people!! When do I report? Maria Teresa 12/09/14 Herdeiro II Jornadas de Farm 17 12/09/14 II Jornadas de Farmacovigilância 19 do Centro Limited size of sample!!! I report, when I ascertain that a given drug is responsible for a particular adverse reaction 12/09/14 II Jornadas de Farmacovigilância 18 do Centro 12/09/14 II Jornadas de Farmacovigilância 20 do Centro

8 ! I would only report an adverse drug reaction if I were sure that it was related to the use of a particular drug. But...does the risk of a false alarm exist? Maria Teresa 12/09/14 Herdeiro II Jornadas de Farm 21 12/09/14 II Jornadas de Farmacovigilância 23 do Centro I think that one should always report when there is a suspicion. No, because a committee of experts evaluates all ADR. 12/09/14 II Jornadas de Farmacovigilância 22 do Centro 12/09/14 II Jornadas de Farmacovigilância 24 do Centro

9 Is my A minha notificação report será importante? A minha notificação? será importante? Yes!! A minha notificação será importante? Maria Teresa 12/09/14 Herdeiro II Jornadas de Farm 25 12/09/14 II Jornadas de Farmacovigilância 27 do Centro Is my report A Is minha my notificação report será importante? All suspected ADR Serious and not serious ADR What ADR should I report? Unexpected and expected ADR 12/09/14 II Jornadas de Farmacovigilância 26 do Centro 12/09/14 II Jornadas de Farmacovigilância 28 do Centro

10 All suspected ADR All!! How does it work? Receipt of data Check to test validity of data Request for more data Coding and entry onto database Serious and not serious ADR Unexpected and expected ADR Validation (attribution of causality) Forwarding to Pharmacovigilance Department Analysis and assessment Decision-making Maria Teresa 12/09/14 Herdeiro II Jornadas de Farm 29 12/09/14 II Jornadas de Farmacovigilância 31 do Centro

11 Well...sometimes I don t have time to fill out the yellow card... But, it only takes 5 minutes. Maria Teresa 12/09/14 Herdeiro II Jornadas de Farm 33 12/09/14 II Jornadas de Farmacovigilância 35 do Centro But, it only takes 5 minutes. Minimum information Patients (initials, age, sex) Report (name, address, specialty) Adverse reaction Suspected drug 12/09/14 II Jornadas de Farmacovigilância 34 do Centro 12/09/14 II Jornadas de Farmacovigilância 36 do Centro

12 Pharmacovigilance Centre in Galicia x 12/09/14 II Jornadas de Farm 37 x 31 Farmaprod 3 cp/día; VO 18/09/07 21/09/07 Infección ORL x Vómitos 20/09/07 21/09/07 Recuperado Diarrea intensa 20/09/07 Aun no recuperado X X M. Pérez Centro de Salud do Val Miñor La Ramallosa /09/07 x Tel.: / Fax: farmacovixilancia@sergas.es Dirección: Subdirección Xeral de Farmacia e Productos Sanitarios Servicio Galego de Saúde Edificio Administrativo-San Lázaro SANTIAGO DE COMPOSTELA Maria Teresa 12/09/14 Herdeiro II Jornadas de Farm 39 Summary... ADR are a major public health problem Voluntary yellow-card reporting of ADR is an easy method There is one disadvantage, i.e., UNDERREPORTING Thank you for your attention But with your help, it is possible to remedy this, namely, by REPORTING. Maria Teresa 12/09/14 Herdeiro II Jornadas de Farm 38 Maria Teresa 12/09/14 Herdeiro II Jornadas de Farm 40

13 Electronic supplementary material III Sensibility analysis: OR of reporting total, serious, expected, unexpected and highcausality adverse drug reactions, obtained by fitting a conditional logistic regression models with physician as a stratum. Independent variables OR (95% CI)* P value Effect of intervention on total of ADR reports Period 0.95 ( ) Group 0.83 ( ) Intervention 1.87 ( ) Effect of intervention on reports of serious ADRs Period 1.02 ( ) Group 0.64 ( ) Intervention 2.59 ( ) Effect of intervention on reports of unexpected ADRs Period 0.94 ( ) Group 0.76 ( ) Intervention 1.68 ( ) Effect of intervention on reports of high-causality (defined and probable) ADRs Period 0.81 ( ) Group 0.73 ( ) Intervention 1.85 ( ) Abbreviations: ADR, adverse drug reaction; CI, confidence interval. *OR for period is the adjusted OR of ADR reporting between the pre and postintervention period in the control group. It assesses secular trends and possible contamination of the control group by the intervention group. OR for the group category is the adjusted OR of baseline ADR reporting between the intervention group and the control group. OR for intervention measures the adjusted OR of ADR reporting for the intervention itself, as an interaction between the group variable and the period variable.