Impact of educational interventions on adverse drug events reporting

Spontaneous adverse drug events (ADE) reporting is the main source of data for assessing the risk/benefit of drugs available in the pharmaceutical market. However, its major limitation is underreporting, which hinders and delays the signal detection by Pharmacovigilance (PhV). To identify the techniques of educational intervention (EI) for promotion of PhV by health professionals and to assess their impact. A systematic review was performed in the PUBMED, PAHO, LILACS and EMBASE databases, from November/2011 to January/2012, updated in March/2013. The strategy search included the use of health descriptors and a manual search in the references cited by selected papers. 101 articles were identified, of which 16 met the inclusion criteria. Most of these studies (10) were conducted in European hospitals and physicians were the health professionals subjected to most EI (12), these studies lasted from one month to two years. EI with multifaceted techniques raised the absolute number, the rate of reporting related to adverse drug reactions (ADR), technical defects of health technologies, and also promoted an improvement in the quality of reports, since there was increased reporting of ADR classified as serious, unexpected, related to new drugs and with high degree of causality. Multifaceted educational interventions for multidisciplinary health teams working at all healthcare levels, with sufficient duration to reach all professionals who act in the institution, including issues related to medication errors and therapeutic ineffectiveness, must be validated, with the aim of standardizing the Good Practice of PhV and improve drug safety indicators.

Possible adverse drug events leading to hospital admission in a Brazilian teaching hospital

OBJECTIVES: Drug safety problems can lead to hospital admission. In Brazil, the prevalence of hospitalization due to adverse drug events is unknown. This study aims to estimate the prevalence of hospitalization due to adverse drug events and to identify the drugs, the adverse drug events, and the risk factors associated with hospital admissions. METHOD: A cross-sectional study was performed in the internal medicine ward of a teaching hospital in São Paulo State, Brazil, from August to December 2008. All patients aged ≥18 years with a length of stay ≥24 hours were interviewed about the drugs used prior to hospital admission and their symptoms/complaints/causes of hospitalization. RESULTS: In total, 248 patients were considered eligible. The prevalence of hospitalization due to potential adverse drug events in the ward was 46.4%. Overprescribed drugs and those indicated for prophylactic treatments were frequently associated with possible adverse drug events. Frequently reported symptoms were breathlessness (15.2%), fatigue (12.3%), and chest pain (9.0%). Polypharmacy was a risk factor for the occurrence of possible adverse drug events. CONCLUSION: Possible adverse drug events led to hospitalization in a high-complexity hospital, mainly in polymedicated patients. The clinical outcomes of adverse drug events are nonspecific, which delays treatment, hinders causality analysis, and contributes to the underreporting of cases.

Causes for the underreporting of adverse drug events by health professionals: a systematic review

Objective: Identifying the main causes for underreporting of Adverse Drug Reaction (ADR) by health professionals. Method: A systematic review carried out in the following databases: LILACS, PAHO, SciELO, EMBASE and PubMed in the period between 1992 and 2012. Descriptors were used in the search for articles, and the identified causes of underreporting were analyzed according to the classification of Inman. Results: In total, were identified 149 articles, among which 29 were selected. Most studies were carried out in hospitals (24/29) for physicians (22/29), and pharmacists (10/29). The main causes related to underreporting were ignorance (24/29), insecurity (24/29) and indifference (23/29). Conclusion: The data show the eighth sin in underreporting, which is the lack of training in pharmacovigilance. Therefore, continuing education can increase adherence of professionals to the service and improve knowledge and communication of risks due to drug use.

Causes for the underreporting of adverse drug events by health professionals: a systematic review

Objective: Identifying the main causes for underreporting of Adverse Drug Reaction (ADR) by health professionals. Method: A systematic review carried out in the following databases: LILACS, PAHO, SciELO, EMBASE and PubMed in the period between 1992 and 2012. Descriptors were used in the search for articles, and the identified causes of underreporting were analyzed according to the classification of Inman. Results: In total, were identified 149 articles, among which 29 were selected. Most studies were carried out in hospitals (24/29) for physicians (22/29), and pharmacists (10/29). The main causes related to underreporting were ignorance (24/29), insecurity (24/29) and indifference (23/29). Conclusion: The data show the eighth sin in underreporting, which is the lack of training in pharmacovigilance. Therefore, continuing education can increase adherence of professionals to the service and improve knowledge and communication of risks due to drug use.

Adverse drug reaction as cause of hospital admission of elderly people: a pilot study

The objective of this study was to estimate the prevalence of adverse drug reactions (ADR) related to hospital admission of elderly people, identifying the use of potentially inappropriate medication (PIM), the ADR and the risk factors associated with the hospitalization. A cross-sectional study was conducted in a private hospital of São Paulo State, Brazil. All patients aged ≥ 60 years, admitted in the general practice ward in May 2006 were interviewed about the drugs used and the symptoms/complaints that resulted in hospitalization. More than a half (54.5 %) of elderly hospitalizations were related with ADR. The therapeutic classes involved with ADR were: cardiovascular (37.7 %), central nervous (34.6 %) and respiratory (5.7 %). The ADR observed were disorders in circulatory (28.4 %), digestive (20.0 %) and respiratory (18.9 %) tracts. 27 elderly had made PIM and in 20 of them this was the cause of hospitalization. Polypharmacy was an ADR risk factor (p = 0.021).These data allows the healthcare professionals upgrade, qualifying them in pharmcovigilance.

Notificações espontâneas de eventos adversos a medicamentos hospitalares: estudo piloto

Introduction: Post-marketing surveillance of drugs aims to detect problems related to safety, effectiveness and quality. The identification of adverse drug events (ADE) is made, mainly, by health professionals´ spontaneous reporting. This method allows risk communication in pharmacovigilance and contributes for market regulation. Objective: To estimate the prevalence of adverse drug reaction (ADR) and the suspicions of therapeutic failure (TF) reported by health professionals; to verify the active principle and type of drugs related to ADE, seriousness, causality, production mechanism and clinical manifestation of the events identified. METHODS: A cross-sectional study was performed in a teaching and public hospital which integrates the Sentinel Hospital Network, in 2008. ADR seriousness was classified according to intensity (mild, moderate, serious and lethal); drugs associated with ADE were categorized according to type (brand name drugs and non-brand name drugs); causality was imputed with Naranjo algorithm and the mechanism of occurrence was analyzed according to Rawlins e Thompson definitions (A or B). Results: There were 103 ADE reports in the period, of which 39 comprised TF and 64 ADR. Nurses reported the most ADE (53.4%). The majority of ADR were classified as type A (82.8%), mild (81.3%), possible (57.8%), according to causality assessment, and related to brand name drugs (20/35). Human immunoglobulin, docetaxel and paclitaxel were the drugs frequently associated with ADR. TF arising from no-brand name drugs (26/29), regarding, mainly, midazolam and ganciclovir. Conclusion: The results of the ADE report contribute for proposition of trigger tools for intensive monitoring of drug safety, as well as for the supplier qualification and for the improvement of quality products.

Avaliações farmacoeconômicas em vigilância de medicamentos

The study aimed to identify pharmacoeconomic studies in pharmacovigilance and to observe the economic outcomes in post-marketing surveillance. Therefore, a bibliographic survey was performed in databases Lilacs, PubMed/ Bireme. The search strategy was done by using scientific health descriptors [ "adverse drug reaction reporting systems " OR " medication errors " OR "product surveillance, postmarketing" OR " sentinel surveillance" ] AND [ " cost-benefit analysis" OR "cost efficiency analysis " OR " costs and cost analysis " OR " hospital costs " OR " cost-effectiveness " OR " cost-effectiveness evaluation " OR " drug costs " ]. Manuscripts published in the last 10 years were selected. We chose 13 articles, of which 12 corresponded to cost-benefit analysis and only one to cost-effectiveness assessment. In only one study there was no economy, all the other ones generated savings, ranging from 13.7 to 30% in spending valued service. Surveillance actions were: continuing education; active search through tracking devices and / or implementation of round; teamwork and multidisciplinary deployment; computerized security services management, enabling traceability of information and alerts. The results of the proposed actions have led to the prevention of adverse drug reactions, to decline of risks to the patient, to the reduction of inappropriate prescriptions, as well as the length of hospital stay spending valued service. Surveillance actions were: continuing education; active search through tracking devices and / or implementation of round; teamwork and multidisciplinary deployment; computerized security services management, enabling traceability of information and alerts. The results of the proposed actions have led to the prevention of adverse drug reactions, to decline of risks to the patient, to the reduction of inappropriate prescriptions, as well as the length of hospital stay

Queixas técnicas e eventos adversos a medicamentos notificados em um hospital sentinela do interior de São Paulo, 2009-2010

Objective: to describe technical complaints and adverse drug events reported in a sentinel hospital in São Paulo state in 2009 and 2010. Methods: This is a descriptive study. Information was obtained from the sentinel hospital Risk Management database. Results: we found 199 reports related to drugs: 70.0% were technical complaints, 21.0% ineffective therapy and 9.0% adverse reaction to medication. The pharmacological groups with highest number of reports were: drugs that act on alimentary tract and metabolism (25.1%), the nervous system (25.1%) and anti-infective drugs for systemic use (22.1%). Conclusion: technical complaints and adverse drug events were frequent, despite recognized underreporting. The characterization of these events could inform the adoption of control measures and permanent educational actions in health services in order to prevent their occurrence.

Role of the clinical pharmacist in detection of drug therapy problemas in critically impatients: experience report

This is an experience report on clinical pharmacy in New York, United States of America, in a teaching hospital, describing the results of drug therapy monitoring in critically ill patients, as well as interventions to solve or prevent identified drug therapy problems. The cross-sectional study was conducted by the clinical staff at the Surgical Intensive Care Unit during August 20th to 24th, 2012. Blood counts, serum levels of certain antibiotics, microbiological cultures and their antibiotic susceptibility, possible drug interactions, dosage of each drug prescribed and the compatibility between the route of administration and pharmaceutical form were assessed daily through review of electronic medical records. Twenty seven patients were followed up and 16 drug therapy problems were identified: Unnecessary drug therapy (seven), adverse drug reaction (four), needs additional drug therapy (two), noncompliance (two) and dosage too low (one). After evaluation, the drug therapy problems and their pharmaceutical interventions were reported to clinical pharmaceutical responsible for the Surgical ICU, as well as the multidisciplinary team. Further, the clinical outcomes were monitored and interventions were classified as to its acceptance. Data demonstrate that clinical pharmacists can contribute to the security and proper use of medications, as the trigger tools for intensive monitoring helps in early detection of drug therapy problems and patient safety.

Safety Assessment of Potentially Inappropriate Medications (PIM) use in Older People and the Factors Associated with Hospital Admission

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

Terminologia de incidentes com medicamentos no contexto hospitalar

Incidentes com medicamentos geram problemas aos pacientes e custos adicionais ao sistema de saúde. A variedade de termos utilizada para comunicá-los propicia divergências nos resultados de pesquisas e confundem notificadores. Objetivou-se revisar os termos utilizados para descrever estes incidentes confrontando-os com as conceituações/definições oficiais disponíveis. Pesquisaram-se as bases PubMed, MEDLINE, IPA e LILACS para selecionar estudos publicados entre janeiro de 1990 e dezembro de 2005. Selecionaram-se 33 publicações. Verificou-se que a terminologia supranacional recomendada para descrever incidentes com medicamentos é insuficiente, mas que há consenso de uso das expressões em função do gênero do incidente. O termo Reação Adversa a Medicamento é mais utilizado quando não se verifica intencionalidade. A expressão Evento Adverso a Medicamento foi mais usada quando se descreviam incidentes durante a hospitalização; e Problema Relacionado a Medicamento foi mais utilizada em estudos que avaliaram atenção/cuidados farmacêuticos (uso/falta do medicamento). Ainda assim, a linha divisória entre essas três categorias não é clara e simples. Futuros estudos das relações entre as categorias e investigações multidisciplinares sobre erro humano podem subsidiar a proposição de novas conceituações.