Specialist nurse reporting of adverse drug reactions

Up to 36% of inpatients experience an adverse drug reaction (ADR) while in hospital. Nurses are well-placed to monitor patients' responses to drugs. Spontaneous reporting of ADRs is the cornerstone of drug safety monitoring and should be the shared responsibility of all health-care staff.     

Recognizing, reporting, and reducing adverse drug reactions

Adverse drug reactions (ADRs) are underreported and consequently are an underestimated cause of morbidity and mortality. Recent epidemiologic evidence estimates that ADRs represent the fourth to the sixth leading cause of death. Public awareness is increasing as reports of ADRs and medication errors become more prevalent in the lay press. Reducing the number of ADRs can be accomplished by systems changes made at an individual and national level. At the individual level, increased diligence should be used with regard to reporting and documenting ADRs. At the national level, ADRs can be reduced by expanding the role of the arm of the Food and Drug Administration (FDA) responsible for postmarketing surveillance.     

Reduction of adverse drug events and medication errors in a community hospital setting

Keys to success in reducing ADEs have included the support of administrative leaders through their visibility and emphasis on safety as an organizational priority, and financial support for safety projects. Administrative participation was also helpful in promoting safety efforts through the reinforcement of expectations when progress was sluggish. The use of rapid cycle change provided enough early success to serve in motivating staff to push ahead. It allowed staff the opportunity to analyze changes, make adjustments, and retest on a slightly larger scale. Other key success factors included the motivation of teams through continual sharing of progress and success stories; celebrations for achievements are held routinely. As an organization, SJMC has shared its success strategies with other organizations and promoted networking with other organizations to determine what strategies have worked elsewhere. This is helpful as it prevents time from being wasted on solutions that have been tried without success.Within the OSF Healthcare System, the following phrase has been adopted in regard to patient safety, "Safety is like peeling an onion; the more you look, the more you find, and each layer makes you cry."     

Ophthalmic adverse drug reactions: A nationwide detection using hospital databases

AIM: To detect ophthalmic adverse drug reactions (ADRs), that occurred in Portugal from 2000 to 2009, through the utilization of administrative hospital databases. We also intended to compare the results of this methodology with spontaneous reporting. METHODS: We conducted a retrospective nationwide study using hospital administrative databases, which included all inpatients and outpatients in all public hospitals in Portugal, from 2000 to 2009. We used International Classification of Diseases - 9^th Revision - Clinical Modification (ICD-9-CM) coding data that allowed the detection of ADRs. We used WHO’s definition for ADR. We searched all of ICD-9-CM terms in Ophthalmology for codes that included “drug-induced”, “iatrogenic”, “toxic” and all other that could signal an ADR, such as “362.55 - toxic maculopathy” or “365.03 - steroid responders”, and also “E” codes (codes from E930 to E949.9, that exclude intoxications and errors). RESULTS: From 11944725 hospitalizations or ambulatory episodes within that period of time, we identified 1524 probable ophthalmic ADRs (corresponding to a frequency of 1.28 per 10000 episodes) and an additional 100 possible ophthalmic ADRs. We used only 4 person-hours in the application of this methodology. A total of 113 spontaneous reports arose from ophthalmic ADRs from 2000 to 2009 in Portugal (frequency of 0.095 per 10000 episodes).To our knowledge, this was the first estimate of the frequency of ophthalmic ADRs through the use of databases, and the first nationwide estimate of ophthalmic ADRs, in Portugal. We identified 1524 probable ADRs and 100 possible ADRs. CONCLUSION: This database methodology adapted for Ophthalmology may represent a new approach for the detection of ophthalmic ADRs, since these codes exist in the ICD-9-CM classification. Its performance was clearly superior to spontaneous reporting.     

Survey to assess public awareness of patient reporting of adverse drug reactions in Great Britain

What is known and Objective: Patient reporting to the Yellow Card Scheme (YCS) for reporting adverse drug reactions (ADR) has been available in the UK since 2005. By the end of 2009, 18% of the ADRs reported were submitted by patients. Thus, some patients are aware of the scheme, but we do not know how much awareness exists in the general population and hence the true impact of patient reporting. Methods: We added eight questions to a telephone omnibus survey of the adult population of the UK, administered over two weekends in January 2009. Results and Discussion: Results are based on 2028 completed interviews. Of respondents, 8·5% (n = 172) had heard of the YCS, but only three individuals had self‐reported to the scheme. People of a higher social grade and those with further education were significantly more likely to be aware of the YCS. Those who reported a preference for online reporting were more likely to be men, younger, of middle social grade with further education and in full‐time employment. Those suggesting a preference for telephone reporting tended to be women, of working class and with a lower level of education, as did those who expressed a preference for postal reporting, but in addition they were more likely to be older and retired. Each of the three current methods of reporting was preferred by some respondents and could be continued. This is supported by reports that each of the three methods is currently used. What is new and Conclusion: This first survey of awareness of the YCS in the general population of the UK indicates awareness is low and could be improved.     

护理人员药物不良反应监测知识态度及行为现状调查

目的了解护理人员对药物不良反应监测知识、态度和行为情况,以加强用药安全。方法采用方便抽样法,于2013年11—12月选取复旦大学附属上海市第五人民医院护理人员,采用自行设计的问卷进行调查,内容包括一般资料、药物不良反应相关知识、药物不良反应监测态度及行为3部分。共发放问卷198份,收回有效问卷164份,有效回收率82.8%。结果护理人员对药物不良反应监测知识平均得分为(6.95±1.82)分;93.9%护理人员认为要积极上报药物不良反应;78.0%护理人员认为上报药物不良反应是自身的职责;45.7%护理人员不赞同将其作为临床工作的考核指标;67.7%的护理人员曾遇到药物不良反应,其中只有56.8%护理人员上报至有关部门。结论护理人员对监测药物不良反应的态度总体较为积极,但实际监测情况仍存在一定问题,尚需通过多种途径加强相关培训,激励护理人员主动监测和上报药物不良反应,促进临床安全用药。     

护理人员药物不良反应监测知识、态度和行为现状调查

目的 了解护理人员对药物不良反应监测知识、态度和行为情况,为促进和加强我院护理人员对药物不良反应监测提供基础资料。方法 采用方便抽样法对198例护理人员进行问卷调查。结果 本研究共回收问卷164份,有效回收率为90.1%,护理人员对药物不良反应监测知识得分为6.95±1.82;154 (93.9%) 名护理人员认为要积极上报药物不良反应,128 (78.0%) 名护理人员认为上报药物不良反应是自身的职责,45.7%的护理人员不赞同将其作为临床工作的考核指标;67.7%的护理人员曾遇到药物不良反应,其中56.8%的护理人员将发现的药物不良反应上报至有关部门。结论 我院护理人员对监测药物不良反应的态度较为积极,但实际监测情况仍存在一定问题,尚需通过多种途径加强对护理人员药物不良反应监测相关知识的培训,激励护理人员主动监测和上报,促进临床安全用药。     

Improving the quality of drug error reporting

Background Drug errors are a common and persistent problem in health care and are also associated with serious adverse events. Reporting has become the cornerstone of learning from errors, but is not without its imperfections. Aim The aim of this study is to improve reporting and learning from drug errors through investigating the contributory factors in drug errors and quality of reporting in an acute hospital. Methods A retrospective, random sample of 991 drug error reports from 1999 to 2003 were subjected to quantitative and qualitative analysis. This was followed by 40 qualitative interviews with a volunteer, multi‐disciplinary sample of health professionals. The combined analysis has been used to develop a knowledge base for improved drug error reporting. Results The quality of reports varied considerably, and 27% of reports lacked any contributory factors. Documentary analysis revealed a focus on individuals, sometimes culminating in blame without obvious justification. Doctors submitted few reports, and there were notable differences in reporting according to clinical location. Communication difficulties commonly featured in causation, and high workload and interruptions were predominant contributory factors in the interview data. Interviewees viewed causation as multifactorial, including cognitive and psychosocial factors. Organizational orientation to error was predominantly perceived by interviewees as individual rather than systems‐based. Staff felt obliged to report but rarely received feedback. Implications and conclusion Drug errors are multifactorial in causation. Current reporting schemes lack a theoretical basis, and are unlikely to capture the information required to ensure learning about causation. Health professionals have reporting fatigue and some remain concerned that reporting promotes individual blame rather than an examination of systems factors. Reporting can be strengthened by human error theory, redesigned to capture a range of contributory factors, facilitate learning and foster supportive actions. It can also be feasible in routine practice. Such an approach should be examined through multi‐centred evaluation.     

Factors that influence spontaneous reporting of adverse drug reactions: a model centralized in the medical professional

RATIONALE, AIMS AND OBJECTIVES: The spontaneous reporting of adverse drug reactions (ADRs) through the yellow card and made concrete by the knowledge and attitudes of doctors, has been rousing a great deal of bibliographical interest in recent years. However, there does not seem to be any actual revision in the theme on which the theoretical models that explain the process of decision in reporting are proposed. In this work an explanatory model of the factors that condition reporting is proposed and a revision of the literature on the subject has also been carried out. METHODS: The proposed model is centralized in the medical professional and it considers the habit of reporting as the result of the doctor's formation and his interaction with the environment. The combination of knowledge-attitudes-practices and the theory of the satisfaction of needs seemed very adequate for ADR systematization. RESULTS AND CONCLUSIONS: The results also indicate that, to improve the participation of health professionals in surveillance systems through spontaneous reporting, it might be necessary to design combined strategies that modify both intrinsic (knowledge, attitudes) and extrinsic (relationship between health professionals and their patients, the national health system and pharmaceutical companies) factors.     

Pharmacoeconomics of adverse drug reactions

Abstract Adverse drug reactions (ADRs) are common causes of hospitalization and lead to large costs to society. The cost of hospitalization is, however, only a part of the total costs as most adverse reactions never come to clinical attention. There are two main costs associated with ADRs, cost of treating illnesses due to ADRs and cost of avoiding them. The main objective of this study was to discuss the social costs of ADRs from an economic point of view. We also reviewed the literature and summarized studies investigating cost and occurrence of adverse reactions. Three different approaches to assess the costs of ADR are distinguished. The first is cost studies, where the following three steps must be done to estimate the costs: define ADR, estimated the incidence of ADRs and measure the costs of ADRs. Most cost studies have focused on hospitalizations due to ADRs and the literature shows that about 3-7% of all hospitalizations are caused by ADRs. The second approach concerns costs and benefits of safety: the decision to prescribe, use, distribute or produce a drug involves both costs and benefits, and decisions makers must weigh costs of ADRs against costs of avoiding them. The third approach discusses regulations and mechanisms for achieving an optimal balance between costs and benefits of drug therapies. The problem with ADRs is, from an economic point of view, not a problem of minimization but of optimization, to find the right balance between costs and benefits.     

Incidence of hospital admissions due to adverse drug reactions in France: the EMIR study

To assess the incidence of hospital admissions related to adverse drug reactions (ADRs) in France and the frequency of preventable ADRs in France, a prospective study was conducted among a representative randomly selected sample of medical wards in public hospitals between December 2006 and June 2007; all patients admitted during a 2‐week period were included. An ADR‐related hospitalization case was defined as a hospital admission because of an ADR, and an independent committee reviewed and validated all potential cases. Preventability was assessed using the French ADR preventability scale. Data were extrapolated to the population of France. Among 2692 admissions, 97 were related to an ADR (incidence 3.6%, 95% confidence interval, CI [2.8–4.4]). Patients admitted for an ADR were significantly older than those admitted for other reasons (P < 0.001). A third (32.0%) of ADR‐related hospitalizations were ‘preventable’, 16.5% ‘potentially preventable’. Drug interactions accounted for 29.9% of ADR‐related hospitalizations. The most frequent causes of ADR‐related hospitalizations were vascular disorders (20.6%), mainly bleeding complications, central nervous system disorders (11.3%), gastrointestinal disorders, and general disorders (9.3%). Antithrombotic and antineoplastic agents were the most frequently involved (12.6% each), followed by diuretics and analgesics (9.0% each). Vitamin‐K‐antagonists (VKAs) were the most common drugs associated with admission. The estimated annual number of ADR‐related hospitalizations in France was 143 915 (95% CI [112 063–175 766]). ADRs were a significant cause of hospital admission in 2006–2007, in particular those due to VKAs. As new oral anticoagulants (NOACs) have been marketed, more attention needs to be paid to ensure a safe use of antithrombotic agents.     

以医院药师为中心的药学服务降低药物不良反应发生率的效果

目的观察以医院药师为中心的药学服务降低药物不良反应发生率的效果。方法选取2017年5月至2019年5月在我院门诊药房用药治疗的120例患者为研究对象,随机将其分为对照组和观察组,每组60例。对照组采用常规用药指导,观察组在对照组基础上开展以医院药师为中心的药学服务。比较两组的应用效果。结果观察组的不良反应总发生率低于对照组(P<0.05)。观察组患者的满意度高于对照组(P<0.05)。观察组的用药依从率高于对照组(P<0.05)。结论以医院药师为中心的药学服务可以有效降低药物不良反应发生率,同时能够提高患者满意度和用药依从性,有助于促进患者康复。