Attitudinal survey of voluntary reporting of adverse drug reactions

AIMS: Voluntary adverse drug reaction (ADR) reporting schemes have operated since the early sixties in many Western countries. It is generally recognized, however, that only a small proportion of ADRs is actually reported. The current survey was conducted to assess attitudes towards reporting of ADRs, and to study which types of ADRs are reported. METHODS: A questionnaire seeking reasons for nonreporting was sent to a random sample of 10% of medical practitioners in The Netherlands in October 1997. After 6 weeks, a reminder was sent to those who had not responded. RESULTS: One thousand four hundred and forty-two (73%) questionnaires were returned, of which 94% were complete. The percentage of GPs (51%) which had ever reported an ADR to the national reporting centre was significantly higher than the percentage of specialists (35%), who reported more often to the pharmaceutical industry (34% vs 48%). 86% of GPs, 72% of surgical specialists and 81% of medical specialists had ever diagnosed an ADR, which they had not reported. Uncertainty as to whether the reaction was caused by a drug (72%), the ADR being trivial (75%) or too well known (93%) were the most important reasons for not reporting. 18% were not aware of the need to report ADRs, 22% did not know how to report ADRs, 38% did not have enough time, 36% thought that reporting was too bureaucratic and only 26% of Dutch physicians knew which ADRs to report. A serious ADR, an unlabelled ADR, an ADR to a new drug, history of reporting of one or more ADRs, and specialty were all independently associated with reporting of 16 hypothetical ADRs. Surgical and medical specialists tended to report less often than GPs. CONCLUSIONS: There is a considerable degree of underreporting, which might partly be explained by lack of knowledge and misconceptions about spontaneous reporting of adverse drug reactions.     

Spontaneously reported fatal suspected adverse drug reactions: a 10-year survey from Sweden

PURPOSE: One of the main methods for monitoring the safety of marketed drugs is spontaneously reporting of suspected adverse drug reactions (ADRs). The objective of this study was to describe the pattern of spontaneously reported fatal adverse drug reactions (FADRs) by analysing data from the national spontaneous reporting system in Sweden. METHODS: In Sweden it is compulsory to report all new or serious suspected ADRs to the Medical Products Agency. The information in these reports is stored in the national database SWEDIS (Swedish Drug Information System). All suspected FADRs reported to SWEDIS between 1 January 1995 and 31 December 2004 were reviewed and analysed. RESULTS: During the study period 990 reports of FADRs were found. The main distribution of suspected FADRs was: haemorrhages (n = 603; 60.9%), blood and bone marrow dysfunction (n = 71; 7.2%), sudden death (n = 38; 3.8%) and pulmonary embolism (n = 30; 3.0%). Antithrombotic agents were the drugs most frequently implicated in the FADRs (n = 605; 61.1%). Vitamin K antagonists were reported in 453 cases (45.8%) and acetylsalicylic acid in 82 cases (8.3%). Among the fatalities with blood and bone marrow dysfunction methotrexate was the most frequently reported drug. For sudden death and pulmonary embolism, antipsychotics and oestrogen containing drugs, respectively, were most commonly reported. CONCLUSIONS: Bleeding complications amounted more than half of all reports of FADRs and vitamin K antagonists were implicated in most of these reports. However, as spontaneous reporting systems are primarily set up for signalling purposes, the data must be interpreted with utmost care.     

Incretin-mimetics associated pancreatitis: evidence from the spontaneous adverse drug reactions reporting in Italy

Objective: New incretin-mimetics increased the treatment options for type 2 diabetes mellitus. Studies on the safety of incretin-based therapy showed a risk of hypersensitivity reactions, acute pancreatitis, renal failure, infection, thyroid and pancreas cancer. We contributed to safety assessment of these new drugs by evaluating the spontaneous adverse drug reactions (ADRs) reporting in Italy.

Research and methods: Reports of suspected ADRs associated with incretin-mimetics were selected from the Italian Spontaneous ADR Reporting Database. For a subgroup of cases belonging to the Hospital of Cento (Ferrara), levels of pancreatic enzymes, amylase and lipase, before and after the therapy with the incretin-mimetics were available.

Results: As of December 2012, the reports of ADR associated with hypoglycemic drugs (excluding insulin) were 2443, 1169 (47.85%) concerned the incretin-mimetics. A total of 90 reports described pancreatitis (44) and elevated pancreatic enzymes (46). Out of 90 cases, 34 were serious (37%). Data on amylase/lipase values for 10 patients were provided and an analysis of the published literature was performed.

Conclusions: Our data from the daily clinical practice add up and confirm the information available on the association between incretin-mimetics and pancreatic damage and suggest caution in the prescribing of these new drugs and a close monitoring of exposed patients.     

Assessment of adverse drug reactions in psychiatric hospitals

Summary A system for monitoring adverse drug reactions (ADR) in psychiatric inpatients was introduced in psychiatric hospitals in the FRG in May 1979. It consists of intensive drug monitoring (IDM) and a so-called organized spontaneous reporting system (OSR). ADR are rated separately according to impact on therapy and probability of causal relationship. With IDM all ADR (Grades I–III) are assessed in a randomly selected sample of inpatients. With OSR only ADR leading to discontinuation of the drugs in question (=ADR Grade III) are assessed. In 406 drug-treated inpatients monitored by IDM in the psychiatric hospitals of Berlin and Munich from May 1979 to Dec. 1981, ADR were observed in 60,4%. In 15% of IDM-patients ADR led to discontinuation of the drugs in question; with OSR the relative frequency of these Grade III ADR was 9,0% in 5096 patients monitored throughout the entire period. Life-threatening events were observed in 1,2% of patients undergoing IDM as well as 1.2% of those undergoing OSR. The most frequently observed ADR by IDM were sedation, extrapyramidal signs, disturbances of the autonomic nervous system and increase in transaminases, and by OSR Parkinsonism, akathisia, sedation, toxic delirium and increased transaminases. The relative frequency of Grade III ADR was similar for neuroleptics and antidepressants (5,4% and 5,3% in OSR); a very low relative frequency of ADR Grade III was found for tranquilizers and hypnotics (0,7% and 0,2%). Methodological aspects of this drug monitoring system are discussed in the light of current literature.     

发达国家药物不良反应监测概况

药物不良反应(ADRs)是世界医疗界的难题,本文对欧美等发达国家药物不良反应发生现状、监管现状及避免ADRs增进药物安全性的方法等几方面进行综合评述,以助于吸取有效经验。     

第二军医大学长海医院2003年度229例药品不良反应报告分析

目的:综合分析评价第二军医大学长海医院2003年药品不良反应(ADR)呈报的基本情况和填写质量。方法:将ADR报告表填写项目录入MicrosoftExcelXP电子表格,根据统计药品ADR发生的患者性别、年龄,及药品类别、ADR表现的分布情况等,分析评价ADR填写质量。结果:229份ADR报告中,涉及的药品有13大类共131个品种,其中ADR发生率较高的分别是抗微生物药、抗肿瘤和免疫调节药。皮肤及附件损害占50%以上,神经及消化系统反应次之。229份报告表中51.97%数据基本完整,27.07%缺少必需数据。结论:应加强ADR监测力度,增强ADR呈报意识,提高ADR报告表的填写质量。     

吉非替尼不良反应文献分析

目的：整理吉非替尼不良反应发生情况,包括常见的、药品说明书中未提及的罕见的药品不良反应,为临床合理用药提供参考。方法：对国内、外近5年应用吉非替尼出现的不良反应个案报道进行整理、归纳和分析。结果：吉非替尼不良反应的发生可累及多个器官和系统,其中皮肤及附件不良反应发生率最高,呼吸系统不良反应死亡率最高,循环系统和泌尿系统等也可发生严重不良反应。50～59岁年龄段不良反应发生率高,有12例（37.5%）。男性发生率高于女性。不良反应最快的可在用药后2～3 d内发生,最迟的可在持续用药2年后发生,用药后1～4周不良反应发生率最高。结论：临床应重视吉非替尼的不良反应,特别是监测和上报罕见、严重的不良反应。     

重症急性胰腺炎合并严重药物不良反应的药学服务

目的：通过分析1例重症急性胰腺炎合并严重药物不良反应病人的药学服务,探讨临床药师如何在临床实践中发挥作用。方法：在药学服务过程中,临床药师从药物不良反应评价、抗菌药物使用、营养支持等方面提出建议。结果：临床药师提出多项合理建议,优化了治疗方案。结论：临床药师是治疗团队的重要成员之一,为促进临床合理用药发挥了重要作用。     

肺癌化疗严重药品不良反应的危险因素分析

目的：调查肺癌病人住院化疗期间发生严重药品不良反应（adverse drug reactions,ADRs）的危险因素。方法：采用多因素Logistic回归分析236例肺癌病人的临床因素与化疗期间发生严重ADRs的关系。结果：年龄,性别,肝、肾功能,以及同时患有多种疾病且服用多种药物均能影响肺癌病人化疗期间严重ADRs的发生。老年病人和女性病人发生严重ADRs的风险比分别为1.048和1.033。与严重ADRs相关的临床因素按风险比由大到小依次为：肝功能损害〉肾功能损害〉同时患有多种疾病且服用多种药物。结论：对于存在上述风险因素的病人应监测血药浓度,注意化疗方案的选择以及联合用药情况,以减少严重ADRs的发生。     

我院304例药品不良反应报告分析

目的了解我院药品不良反应(ADR)发生的特点,进一步促进临床用药的安全性和合理性。方法对我院近2年收集的304例不良反应报告进行统计、分析。结果静脉给药方式导致的不良反应例数最多(占97.04%);导致不良反应的药品以抗微生物药物最多(占58.81%);临床表现以皮肤及其附件损害和全身性损害为主。皮肤及其附件损害占22.52%,全身性损害占20.54%。结论医务工作者应进一步加强不良反应监测工作,以期更大程度地减少不良反应的发生,确保患者用药安全。     

湖南省2008年987例严重药品不良反应病例情况分析

目的确定今后湖南省药品不良反应监测重点,提高药品不良反应监测报告质量。方法通过使用泛珠三角不良反应监测网络平台对2008年湖南省上报国家中心的数据进行规整,使用Mcrosoft Excel软件进行统计学分析。结果湖南省2008年严重不良反应病例的药品剂型以注射剂为主,占总数的86％;静脉给药为主要用药途径,占总数的790A;抗微生物注射液和中药注射液引起的严重不良反应分别为54．7％和11．44％。结论抗微生物注射剂和中药注射剂是今后一段时间内本省药品不良反应监测的重点。     

121例严重的药品不良反应报告分析

目的:了解2010-2013年某院报告为严重的药品不良反应的发生情况,促进临床安全合理用药。 方法:回顾性调查某院121例严重的不良反应病例报告,从患者的一般情况、药品种类、不良反应类型等方面进行统计和分析。结果:121例严重的不良反应中,男性略多于女性,以≥60岁老年患者居多;怀疑药品以抗感染药物最多,代表药物为头孢哌酮钠舒巴坦钠;涉及药品中注射剂型最多,口服给药方式最常见;累及系统或器官以消化系统居首,其次为全身损害;临床表现以过敏为多。结论:应继续加强临床药品不良反应尤其是严重的药品不良反应的监测,为临床安全合理用药提供依据。     

169例药物不良反应报告分析

目的：了解我院药物不良反应（ADR）发生特点，促进临床合理用药。方法：对我院2005年上半年收集到的169例ADR报告分别从临床具体表现、严重程度、患者年龄、药物剂型、给药途径以及涉及药物种类等方面进行统计分析。结果：涉及97个药品品种的169例ADR中，抗微生物药物引起的ADRl04例，占总数的56．22％；严重ADR8例，死亡2例。ADR引起的皮肤及附件损伤较多，共80例，占总数的43．24％。结论：医院应重视ADR监测工作，为临床合理用药提供依据。