Patient preferences and expectation for feedback on adverse drug reaction reports submitted in Ghana

Background: Personalized feedback received for spontaneous adverse drug reaction (ADR) reports serves as motivation for future reporting and the effectiveness of the feedback is dependent on the medium used in delivering the information. Objective: Explore expectation for feedback from patients on ADR reports submitted to the National Pharmacovigilance Centre (NPvC) in Ghana and the preferred medium for receiving the feedback information.Methods: Cross-sectional study using structured questionnaire administered through face-to-face interview from August to September 2016 to patients selected by convenience sampling. Pearson chi-square (Χ2) or Fisher's exact test was used to determine associations between background variables such as age, gender and level of education. Results: The response rate was 86.7% (n=442). Of the participants interviewed, 96.5% expected to receive feedback for ADR reports submitted. Age and level of education were the two variables significantly associated with patients' expectation for feedback. The preferred medium for receiving feedback in decreasing order of preference were, telephone call (60.4%), mobile phone short messaging services (23.0%), email (8.3%), face-to-face meeting (3.4%), personalized letter (3.4%) and publication in a newsletter (1.4%). Conclusion: Patients' expectation for receiving feedback for ADR reports submitted to the NPvC is in line with modern trends in communication. NPvC should explore these alternatives for providing feedback to patients. Thisstudy is limited to what patients' expectations and preferences were for receiving feedback on ADR reports submitted, additional study to further explore the type of information patients expect to be contained in the feedback will be useful to National Pharmacovigilance Centres

Pharmacovigilance Programme of India.

Adverse drug reactions from medicinal products are one of the important public health issues. The Pharmacovigilance system is used to monitor the safety of authorized medicinal products and detect any change to their risk-benefit balance. It is characterized by its structures, processes and outcomes. To run an effective Pharmacovigilance system a protocol is required for reporting adverse reactions associated with drug use.

Farmacovigilancia activa en pacientes afiliados al sistema general de seguridad social en salud / Active pharmacosurveillance of patients affiliated to the Colombian general social security/health system

Objetivos Determinar los posibles resultados negativos asociados a la medicación mediante la metodología de búsqueda activa de posibles interacciones medicamentosas en bases de datos de pacientes afiliados al Sistema General de Seguridad Social en Salud. Métodos A partir de las bases de datos de dispensación de medicamentos de Audifarma S.A a unos 4 millones de usuarios del país, se hizo una revisión sistemática de estadísticas de una serie de medicamentos identificados por presentar interacciones de riesgo, dosis diferentes a las recomendadas o dispensación irregular. Los casos son socializados con las EPS responsables. Resultados Se encontró un caso de nefrotoxicidad por ácido zoledrónico; el 37,0 por ciento de los usuarios de clopidogrel recibían concomitantemente omeprazol, que reduce la efectividad del primero; el 29,9 por ciento de los pacientes que toman losartan están recibiendo dosis superiores a las recomendadas para su indicación; el 2,0 por ciento de los pacientes que toman metoprolol o verapamilo, los recibe simultáneamente, con riesgo de generar bradicardia sinusal, bloqueos auriculoventriculares o disfunción sistólica. Todos los casos fueron notificados a los responsables en la EPS que atienden estos pacientes. Discusión La farmacovigilancia activa permite optimizar recursos, prevenir eventos adversos que puedan potencialmente causar morbilidad importante o incluso letalidad o determinar problemas que podrían ser responsables del fracaso terapéutico. Este tipo de estrategia se anticipa a la aparición de posibles riesgos para el paciente por lo que se recomienda considerarla para reforzar los programas de vigilancia de uso de medicamentos en el país.

Objectives Determining negative results associated with medication through an active search of possible drug interactions in databases for patients affiliated to the Colombian general social security/health system. Methods Statistics related to Audifarma S.A. dispensation drug databases for about 4 million Colombian users were systematically reviewed for identifying drugs having known interactions involving risk, doses different from recommended ones or irregular dispensation. The pertinent health-care providing services were made aware of the above. Results There was one case of nephrotoxicity being caused by zoledronic acid. 37 percent of clopidogrel users concomitantly received omeprazole which reduces the former's effectiveness. 29.9 percent of patients who were taking losartan were receiving doses higher than the recommended ones. 2.0 percent of patients who were taking metoprolol or verapamil were simultaneously receiving them, at the risk of generating first-degree heart block, bradycardia, or systolic dysfunction. All these cases were notified to the pertinent health-care services. Conclusions Active pharmacosurveillance leads to resources being optimised, adverse events which can potentially cause morbidity or lethality being prevented or even determining problems which could be responsible for therapeutic failure. This type of strategy anticipates the appearance of possible risks for patients, meaning that drug use monitoring programmes in Colombia should be reinforced.

Protocolo de farmacovigilancia a reacciones de hipersensibilidad a medicamentos: resultados de su aplicación en 5 centros de Santiago / Pharmacovigilance protocol for cutaneous drug hypersentivity reactions in Santiago, Chile

Introducción: Las Reacciones de Hipersensibilidad Medicomentosa (RHM) son un motivo de consulta muy común en Dermatología. Con el objetivo de implementar la farmacovigilancia dentro de la Sociedad Chilena de Dermatología (SOCHIDERM) se creó un Protocolo paro la notificación de RHM de tipo muco-cutáneo. Objetivo: Validar una propuesta de Protocolo de Farmacovigilancia de RHM de tipo mucocutáneo de la SOCHIDERM paro el uso de dermatólogos y médicos de nuestro país. Resultados: En nuestro estudio, la frecuencia de RHM fue 0,3% -0,5% del total de consultas ambulatorias y 5,2% 17,2% de las interconsultas a Dermatología. Los patrones más frecuentes fueron el urticarial, morbiliforme y la reacción medicamentosa fija. Los fármacos imputados con mayor frecuencia fueron los analgésicos/antiinflamatorios, los fármacos con acción en el sistema nervioso central, los antibióticos y los antihipertensivos. Discusión: Es importante tener un Protocolo de Farmacovigilancia. Esto nos permitirá obtener datos a nivel nacional. El desafío a corto plazo paro farmacovigilancia en SOCHIDERM es lograr notificar las RHM de tipo muco-cutáneo graves o con compromiso vital, que sean atendidas por dermatólogos en nuestro país, a través del Protocolo de Farmacovigilancia SOCHIDERM.

Introduction: Drug Hypersensitivity Reactions (DHR) are a common cause of consultation in dermatology. In order to implement fharmacovigilance in the Chilean Society of Dermatology (SOCHIDERM), we created a protocol for the notification of mucocutaneous DHR. Objective: To validate a SOCHIDERM mucocutaneous DHR pharmacovigilance protocol for dermatologists and physicians in our country. Results: In our study. DHR accounted for 0.3-0.5 % of all outpatient consultations, and 5,2-17,2% of interconsultations in dermatology. The most frequent patterns were urticarial, morbilliform and fixed drug reaction. The drugs most frequently involved were analgesics/anti-inflammatory drugs with action in the central nervous system, antibiotics and antihypertensives. Discussion: It is important to have a Pharmacovigilance Protocol since it will allow to obtain nationwide data. The short-term challenge for the SOCHIDERM pharmacovigilance is to notify serious or life-threatening mucocutaneous DHR that have been seen by dermatologists in our country, through this Protocol.

Adverse Drug Reaction Surveillance System in Korea / 예방의학회지

Despite extensive researches and pre-market clinical trials, only limited information on the adverse drug reactions (ADRs) of a drug can be collected at the time of market approval from regulatory agency. ADRs constitute a major public health problem. Post-marketing surveillance of drugs is important to detect signals for ADR. In Korea, one of the main methods for monitoring the safety of marketed drugs is spontaneous reporting system of suspected ADRs. Re-examination and re-evaluation system are in force for monitoring safety of new market approval drugs and currently under marketing drugs, respectively. Recently, regional pharmacovigilance centers were designated from Korean Food and Drug Administration for facilitating ADR surveillance. Over recent years, with the development of information technology, there has been an increased interest in establishing data mining system for detecting signals from Health Insurance Review Agency database. The purpose of this paper is to review the current status of Korean ADR surveillance system and suggest the possible solutions for developing active pharmacovigilance system in Korea.

Reação adversa a medicamentos em pediatria: casos relatados ao programa de farmacovigilância do Hospital de Clínicas de Porto Alegre / Adverse drug reaction in children: cases reported to the pharmacovigilance program at Hospital de Clínicas de Porto Alegre

Objetivo: Apresentar os resultados das avaliações das notificações de reações adversas a medicamentos ocorridas em pacientes internados em unidades pediátricas do Hospital de Clínicas de Porto Alegre, no período de abril de 2002 a outubro de 2003. Métodos: Por meio de um estudo retrospectivo, analisou-se o arquivo de notificações de reações adversas a medicamentos da Unidade de Assistência Farmacêutica, que contém os registros de casos suspeitos provenientes da busca ativa e notificação espontânea quanto aos dados relevantes dos pacientes, medicamentos envolvidos e sintomas. Foi utilizada análise descritiva com medidas de freqüência e tendência central. Resultados: No período, ocorreram 4.709 internações em unidades pediátricas e 113 registros de reações adversas a medicamentos: 59,3 por cento em pacientes masculinos, 63,7 por cento em pacientes da Unidade de Oncologia. A maioria das notificações foi feita por profissionais de farmácia por busca ativa (56,6 por cento). A classe de medicamentos mais comumente envolvida foi a de antiinfecciosos (47,8 por cento), e o órgão mais freqüentemente afetado foi a pele e anexos (27,4 por cento). As reações foram classificadas como definidas em 9,7 por cento dos registros (Algoritmo de Naranjo). Conclusão: A maioria dos relatos foi proveniente da busca ativa. As classes de medicamentos mais envolvidas com reações adversas a medicamentos foram as mais prescritas para pacientes pediátricos. Os resultados em relação aos órgãos/sistemas mais afetados estão de acordo com os relatos da literatura

Farmacovigilancia: detección de reacciones adversas a medicamentos tipo B, factores de riesgo asociados / Pharmacovigilance: detection of adverse reactions to medications type B, associated risks factors

Las reacciones adversas a medicamentos (R.A.M.) se clasifican en de tipo A, relacionadas con la toxicidad del medicamento, y de tipo B, debido a un incremento de la susceptibilidad del paciente. El objetivo del presente trabajo consiste en detectar y evaluar las R.A.M. tipo B, y determinar sus factores de riesgo asociados. Se efectuó un estudio retrospectivo, utilizando estrategias