Assessment of pharmacotherapeutic safety of medical prescriptions for elderly residents in a long-term care facility

The present study aimed to estimate the prevalence of elderly using potentially inappropriate medications (PIM) and with occurrence of potentially hazardous drug interactions (PHDI), to identify the risk factors for the prescription of PIM and to evaluate the impact of pharmaceutical intervention (PI) for the prescription of safer therapeutic alternatives. Therefore, a cross-sectional study was performed in a long-term care facility in São Paulo State, between December/2010 and January/2011. The medical records of the patients >= 60 years old who took any drugs were consulted to assess the pharmacotherapeutic safety of the medical prescriptions, in order to identify PIM and PHDI, according to the Beers (2003) and World Health Organization criteria, respectively. PI consisted of a guidance letter to the physician responsible for the institution, with the suggestions of safer equivalent therapeutics. Approximately 88% of the elderly took at least one drug, and for 30% of them the PIM had been prescribed. Most of the PIM identified (53.4%) act on the central nervous system. Among the 13 different DI detected, 6 are considered PHDI. Polypharmacy was detected as a risk factor for PIM prescription. After the PI there was no change in medical prescriptions of patients who had been prescribed PIM or PHDI. The data suggests that PI performed by letter, as the only interventional, method was ineffective. To contribute it a wide dissemination of PIM and PHDI among prescriber professionals is necessary for the selection of safer treatment for elderly. Additionally, a pharmacist should be part of the health care team in order to help promote rational use of medicines.

Fatores relacionados à adesão das drogarias e farmácias de Tatuí-SP no projeto Farmácias Notificadoras

Pharmacovigilance is accomplished by voluntary notification of suspected adverse reactions, medication errors, and deviations from quality, by users and health professionals, through the filling in of forms that are sent to a data bank. To broaden the sources of notifications, the National Health Surveillance Agency (ANVISA), in partnership with the Regional Pharmacy Council (CRF) and Center for Health Surveillance (CVS) of each state, introduced the scheme of Notifying Pharmacies. The present study was aimed at determining the factors influencing the decision of drugstores and private pharmacies in Tatuí/SP in 2007, to join this project A descriptive, observational survey of knowledge, attitude and practice (KAP) was applied to volunteer pharmacists in the town. The results showed that the professionals are awave of pharmacovigilance, (95.24%) and have attitude (95.24%). However, practice is limited (6.0%). Based on this information we concluded that the low support of the project was due to lack of time, interest and no information about the benefits to society of such activity and a lack of support from the pharmacists' organizations. This situation is expected to change with the current introduction of a professional profile, the fusion of professional bodies and the promotion of social awareness on pharmacovigilance.

Análise do sistema de distribuição de medicamentos em hospital oncológico do Estado de São Paulo

Pós-graduação em Ciências Farmacêuticas - FCFAR

Potenciais interações medicamentosas responsáveis por internações hospitalares

As interações medicamentosas (IM) são consideradas um problema de saúde pública, pois podem causar resultados negativos à saúde dos usuários de medicamentos. Portanto o referido trabalho teve como objetivos: estimar a prevalência de internações hospitalares relacionadas a Potenciais IM (PIM); identificar os sinais e sintomas, e os fatores de risco para a hospitalização relacionados à PIM. Metodologia: Realizou-se estudo transversal na clínica geral de um hospital privado do interior de São Paulo (Brasil), em maio de 2006, com pacientes acima de 18 anos, com tempo de hospitalização superior a 24horas, sendo os mesmos entrevistados sobre os sintomas/motivos de internação e os medicamentos que haviam utilizado previamente à hospitalização. Calculou-se Odds-ratiopara identificar fatores de risco, sendo encontrado os seguintes resultados: 168 pacientes utilizando mais de um medicamento, dos quais 57 apresentaram PIM, sendo que em 17(10,1%), os sinais e sintomas da PIM possivelmente foram a causa da hospitalização. A maioria das manifestações clínicas das PIM foram sintomas cardiovasculares (44,3%), gastrintestinais (17,2%) e musculoesqueléticos (13,8%) e 10% das PIM foram consideradas potencialmente perigosas. Não foram detectados fatores de risco relacionados ao gênero, idade, uso de medicamentos de estreita faixa terapêutica para hospitalização por PIM. A polimedicação foi fator de risco para ocorrência de PIM (p < 0,0001) opostamente ao aumento da idade que revelou ser um fator de proteção (p=0,02). Conclusão: Se faz necessário seguimento farmacoterapêutico de pacientes que utilizam fármacos de estreita faixa terapêutica, pois estas substâncias estão frequentemente envolvidas em IM perigosas. Palavras-chave: Problema relacionado ao medicamento. Resultado negativo associado ao medicamento. Erros de medicação. Interações de medicamentos.

Análise dos aspectos ambientais e organizacionais e estratégias de prevenção de riscos para erros de medicação em hospital de ensino

Pós-graduação em Bases Gerais da Cirurgia - FMB

Incidentes relacionados a medicamentos em uma instituição hospitalar: subsídios para a gestão

Pós-graduação em Enfermagem (mestrado profissional) - FMB

Eventos adversos relacionados à gravidade e carga de trabalho de enfermagem em Unidade de Terapia Intensiva

Pós-graduação em Enfermagem - FMB

Safety assessment of essential medicines for elderly people: a bibliographic survey

Certain medicines are considered potentially inappropriate (PIM) for elderly people as they increase the risk of adverse drug events (ADE) and because safer alternative therapies are available on the market. In this context, in order to identify the instruments that assess the quality of medical prescriptions for elderly and to determine which drugs are considered PIM, a bibliographic survey was conducted in PUBMED, LILACS and PAHO databases, in February and March/2010. The search strategy included the use of health descriptors and a manual search in the references cited by selected papers. During the period of data collection, 15 instruments were identified. In 2012, with the publication of the update of Beers criteria, this instrument was included in the study. We identified 163 PIM of 25 therapeutic classes, of which 125 (76.7%) are marketed in Brazil. Of these, 31 (24.8%) are essential medicines (RENAME 2012), of which 13 have safer therapeutic equivalents and 19 (15.2%) are over-the-counter drugs. Data suggest the need for inclusion of safer alternatives for the elderly in the national list of essential medicines and the pharmaceutical care for early detection of ADE in this age group, in order to contribute to the safe use of medicines.

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.

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

Adverse Drug Events Leading Children to Hospital Emergency Care

To determine the incidence of adverse drug events (ADE) that resulted in the need for children's emergency care, a total of 23,286 pediatric emergency case notes were analyzed. They were selected on the basis of the ICD code indicating a possible ADE. ADEs were found in 13 case notes (0.06%), predominantly among girls and mainly in the 1 to 5 year age group. About half of the observed events occurred as a result of accidental ingestion, 27.3% were suicide attempts, and 27.3% arose due to the discontinuation of treatment. Antiepileptic drugs were those most often involved. Three (23%) were serious. The results suggest that children have easy access to medications and are involved in the majority of accidental occurrences. Using drugs involves risks, and drawing attention to such risks while prescribing and dispensing them fosters the sharing of responsibility and the empowerment of the users, measures necessary to health promotion.

Neue Untersuchungen zum Verordnungsmonitoring sowie zur Kompatibilität und Stabilität applikationsfertiger Zytostatika-Zubereitungen

Applikationsfertige Zytostatikazubereitungen werden heute unter der Verantwortung eines Apothekers in zentralisierten Herstellungsbereichen hergestellt. Weil die Verordnung der Chemotherapie ein großes Fehlerrisiko birgt, ist konsequentes Verordnungsmonitoring ein wesentlicher Teilprozess der zentralen Zytostatikazubereitung. rnDie aktuelle Umsetzung und die Ergebnisse des Verordnungsmonitorings in den Universitätskliniken Deutschlands wurden im Rahmen dieser Arbeit in einer prospektiven Erhebung erfasst. Als häufigste Verordnungsirrtümer wurden Dosisberechnungsfehler (48%), welche als von hoher Relevanz (78%) für die Patientensicherheit angesehen wurden, genannt. Die Inzidenz der Verordnungsfehler betrug durchschnittlich 0,77% bei rund 1950 Verordnungen pro Tag. Das konsequente Verordnungsmonitoring von pharmazeutischer Seite erfolgt höchst effizient und leistet einen hohen Beitrag zur Patienten- und Arzneimitteltherapiesicherheit in der Onkologie.rnFür die Herstellung der applikationsfertiger Zytostatika-Zubereitungen sind fundierte Kenntnisse zu deren physikalisch-chemischen Stabilität erforderlich. Zu neu zugelassenen Zytostatika und insbesondere Biologicals, stehen häufig noch keine Daten zur Stabilität der applikationsfertigen Lösungen zur Verfügung. Die Bestimmung der physikalisch-chemischen Stabilität war daher Gegenstand dieser Arbeit. Die applikationsfertigen Infusionslösungen der Purin-Analoga Nelarabin und Clofarabin (RP-HPLC), sowie des monoklonalen Antiköpers Trastuzumab (SEC, UV-Spektroskopie, SDS-Page), erwiesen sich über einen Zeitraum von mindestens 28 Tagen als stabil. Die Stabilität zweier Camptothecin-Derivate (Topotecan und Irinotecan) beladen auf DC Beads™, wie auch die Ladungskapazität und Kompatibilität mit Kontrastmitteln, wurde ebenfalls bewiesen. rn

Standardization of infusion solutions to reduce the risk of incompatibility

PURPOSE: Although critically ill patients usually have various central intravenous (i.v.) lines, numerous drugs have to be infused simultaneously through the same lines. This can result in potentially harmful in-line incompatibility that can cause decreased drug effectiveness or increased microparticle load. To minimize the risk of these medication errors at an anesthesia intensive care unit (ICU), the preparation and administration of continuously infused drugs were standardized and the practicability in daily clinical routine was evaluated. SUMMARY: The concentration and diluent of continuously administered i.v. drugs were standardized. The drugs were grouped according to pH, medical indication, and chemical structure. The ICU staff decided to use multilumen central venous catheters, and each group of drugs was assigned to one lumen. Only drugs that belonged to the same group were infused simultaneously through the same lumen; therefore, intragroup incompatibilities had to be excluded before establishing the new drug administration plan at the ICU. The visual compatibility of 115 clinically reasonable intragroup drug mixtures was investigated. All drug combinations were compatible for six hours except mixtures containing thiopental, which was reassigned to a single-line use. In the following year, the practicability of this drug administration plan was evaluated. No deviations were found in the compliance of the staff prescribing and preparing only standardized concentrations and diluents. Further research to investigate the chemical compatibility of the drugs in these multiple mixtures will follow. CONCLUSION: A project intended to avoid incompatibility among i.v. drugs infused in the intensive care setting included steps to standardize solutions and determine which could be given together.

Evaluating a medical error taxonomy

Healthcare has been slow in using human factors principles to reduce medical errors. The Center for Devices and Radiological Health (CDRH) recognizes that a lack of attention to human factors during product development may lead to errors that have the potential for patient injury, or even death. In response to the need for reducing medication errors, the National Coordinating Council for Medication Errors Reporting and Prevention (NCC MERP) released the NCC MERP taxonomy that provides a standard language for reporting medication errors. This project maps the NCC MERP taxonomy of medication error to MedWatch medical errors involving infusion pumps. Of particular interest are human factors associated with medical device errors. The NCC MERP taxonomy of medication errors is limited in mapping information from MEDWATCH because of the focus on the medical device and the format of reporting.

Perceções dos enfermeiros sobre os erros de medicação no pré-hospitalar

Quase metade da totalidade de eventos adversos evitáveis é consequência de erros de medicação (EM), contudo, não sendo possível evitá-los completamente, estes podem ser minorados. Esta problemática em contexto pré-hospitalar (PH) tem sido pouco estudada a nível internacional e nunca foi abordada em Portugal. O objetivo deste estudo é relacionar as variáveis sociodemográficas, socioprofissionais, formação, conhecimentos e experiências com EM com a perceção dos enfermeiros que exercem no PH relativamente à frequência da ocorrência dos tipos e causas de EM, dos obstáculos ao relato de EM, dos fatores facilitadores do relato de EM e com o grau de concordância sobre divulgação de EM. Métodos: Trata-se de um estudo analítico, descritivo, transversal e correlacional. A amostra é composta por 107 enfermeiros do PH (método snowball), dos quais 56.1% são do sexo masculino. Foi aplicado um questionário eletrónico constituído por uma componente sociodemográfica, escala de conhecimentos, perceções e experiência com erros de medicação (Raimundo, 2011; Maurer, 2010; Bohomol & Ramos, 2006; Mayo & Duncan, 2004; Osborne, Blais & Hayes, 1999; Gladstone, 1995). Resultados: Dos inquiridos 60.7% apresentam fracos a razoáveis conhecimentos sobre EM; mais de 54% perceciona a sua formação académica/contínua sobre EM como sendo inexistente/insuficiente e 52.3% não recebe formação sobre farmacologia há pelo menos 6 anos; 45.8% diz ter experienciado no PH um ou mais EM sem dano para o doente e apenas 14.9% relatou um ou mais EM sem dano para o doente. Os tipos e as causas de EM identificadas ocorrem com uma frequência elevada para mais de 39% dos inquiridos. A maioria dos inquiridos (47.7%) considera que no PH existem grandes obstáculos ao relato de EM e os fatores facilitadores do relato de EM apresentados são considerados por 49.5% dos enfermeiros como altamente prováveis de facilitar o relato. 52,3% dos enfermeiros do PH discordam de uma forma global com a divulgação de EM. O sexo feminino apresenta uma perceção mais elevada da ocorrência das causas primárias de EM (MF=2.68, Dp= 0.60 vs MM=2.36, Dp=0.66) e uma perceção mais elevada dos fatores facilitadores ao relato dos EM (MF=4.40, Dp= 0.64 vs MM=4.12, Dp=0.74). Os enfermeiros que exercem exclusivamente no PH possuem uma melhor perceção da frequência de ocorrência das causas primárias de EM. Quanto maior o conhecimento dos enfermeiros sobre EM, maior é a perceção destes relativamente aos tipos de erros e maior o grau de concordância com a divulgação dos EM. Existe evidência estatisticamente significativa (p<0.05) de que os enfermeiros que experienciaram a ocorrência de pelo menos 1 erro com dano para o doente possuem melhor perceção dos tipos, causas primárias e obstáculos ao relato dos EM, assim como apresenta um maior grau de concordância com a divulgação de EM. Conclusão: A perceção dos enfermeiros sobre a frequência dos tipos e das causas de EM, assim como dos obstáculos e dos fatores facilitadores do relato de EM por parte dos enfermeiros no PH não tem, de uma forma geral, relação com as características sociodemográficas e socioprofissionais, o que demonstra a transversalidade desta problemática. Tão ou mais importante do que avaliar a dimensão e caracterizar a tipologia, causas, obstáculos e fatores facilitadores ao relato dos EM será, com base no conhecimento obtido, definir e implementar ações de gestão de risco que permitam a sua redução ou mesmo a sua supressão. PALAVRAS-CHAVE: Erros de Medicação, Perceção dos Enfermeiros, Pré- Hospitalar.