Adverse drug reactions in hospitalized patients: An operational procedure to improve reporting and investigate underreporting

Background — Adverse event (AE) underreporting is a serious obstacle to drug safety monitoring in hospitalized patients, and it is necessary to find new approaches for improving the situation. The aim of the present study was to try to improve reporting and to evaluate the difference between actual and expected reporting. Methods — The drug surveillance programme was implemented in a 72-bed internal medicine ward. A simple algorithm was printed on each page of the progress notes of the patients' medical record, which the physicians were asked to use in choosing the AEs to be reported to the drug surveillance system. The actual reporting was evaluated for a period of 12 months (1203 patients). Using the same algorithm, two reviewing doctors evaluated expected reporting by analysing all of the AEs deduced from the records of 120 randomly selected patients. Results — Actual reporting: over a period of 12 months, the doctors reported 89 AEs (7.4 per 100 patients), whereas no event had been reported to the national drug surveillance system in the twelve months preceding the introduction of the project. Actual versus expected reporting: in 120 randomly selected patients, 22 AEs were considered by the reviewers as constituting the expected reporting; nine were actually reported. Conclusions — The described drug surveillance programme led to a substantial improvement in adverse event reporting, although a considerable difference still remains between expected and actual reporting.     

Adverse drug reactions in elderly patients

Many studies from around the world show a correlation between increasing age and adverse drug reaction (ADR) rate, at least for some medical conditions. More than 80% of ADRs causing admission or occurring in hospital are type A (dose-related) in nature, and thus predictable from the known pharmacology of the drug and therefore potentially avoidable. Frail elderly patients appear to be particularly at risk of ADRs and this group is also likely to be receiving several medicines. The toxicity of some drug combinations may sometimes be synergistic and be greater than the sum of the risks of toxicity of either agent used alone. In order to recognize and to prevent ADRs (including drug interactions), good communication is crucial, and prescribers should develop an effective therapeutic partnership with the patient and with fellow health professionals. Undergraduate and postgraduate education in evidence-based therapeutics is also vitally important. The use of computer-based decision support systems (CDSS) and electronic prescribing should be encouraged, and when problems do occur, health professionals need to be aware of their professional responsibility to report suspected adverse drug events (ADEs) and ADRs. "Rational" or "obligatory" polypharmacy is becoming a legitimate practice as increasing numbers of individuals live longer and the range of available therapeutic options for many medical conditions increases. The clear risk of ADRs in this situation should be considered in the context that dose-related failure of existing therapy to manage the condition adequately may be one of the most important reasons for admission of the elderly to hospital. Thus, age itself should not be used as a reason for withholding adequate doses of effective therapies.     

头孢曲松钠的不良反应

目的探讨头孢曲松钠的药物不良反应类型及其相应的不良反应机制。方法检索CNKI、维普、Pubmed、OVID等数据库中头孢曲松钠不良反应、产生不良反应的机制和对应的预防处理措施的相关报道,进行回顾性分析。结果头孢曲松钠所致的不良反应涉及人体多个系统,以变态反应最多,最严重的是过敏性休克;其次为神经系统、血液系统、泌尿系统、消化系统等不良反应。部分不良反应是由给药途径不同、剂量过大、不合理配伍用药所致。结论通过对头孢曲松钠的不良反应及其不良反应机制的分析,以期合理应用头孢曲松钠。     

某院581例药品不良反应报告分析

目的：了解该院药品不良反应（ADR）的发生特点,促进临床合理用药。方法对该院2012—2013年上报的581例ADR 报告进行统计和分析。结果581例 ADR 报告中,男性290例,女性291例,基本持平;静脉给药方式引发的 ADR 最多,占总例数的72．81％,抗感染药物引起的 ADR 最多,占总例数的26．68％,其次为中药制剂,占总例数的17．21％;ADR 表现以皮肤及附件损伤最为常见,占总例数的28．92％;ADR 报告分类多为一般,占总数的91．57％。结论临床应重视药品不良反应的报告和监测工作,慎用中药制剂,合理使用抗感染药物,以减少 ADR 的发生。     

药学监护中的药品不良反应监察

药学监护（ＰｈａｒｍａｃｅｕｔｉｃａｌＣａｒｅ）这一概念是１９８８年国际药学会议上提出来的，药学监护第一个受益者是病人。而药品不良反应（ＡＤＲｓ）则是临床治疗中必须予以重视的问题，因而在药学监护涉及的众多的内容中，首先被指出的就是规定要对药物引起的不良反应进行监护。本文结合临床药学工作实践，就药学监护中有关ＡＤＲｓ监察的问题提出讨论。     

Adverse reactions to practolol in hospitalized patients

Summary Adverse reactions to practolol were studied in 198 prospectively monitored hospitalized medical patients. The mean age of the practolol recipients was 57 years; angina and cardiac arrhythmias were the most common indications for therapy. Adverse reactions were attributed to practolol in 20 patients (10%). Fifteen of these twenty reactions involved impairment of cardiac function (bradyarrhythmias, heart block, congestive heart failure, hypotension), and in three instances the reaction was considered life-threatening. Three additional patients had cutaneous reactions attributed to the drug. Adverse reactions to practolol were not dose-related, but toxicity appeared to be more frequent among patients concurrently receiving quinidine. The frequency of cardiovascular complications of propranolol in a similar series of patients was nearly identical. However, no skin reactions were attributed to propranolol. The findings suggest that practolol and propranolol produce unwanted cardiovascular effects with nearly equal frequency among hospitalized patients. Cutaneous reactions to practolol are evident even during short-term use.     

Adverse reactions to alclofenac

Summary

By far the largest proportion of adverse reactions reported with the use of alclofenac relate to skin rashes. Estimates of the incidence of rash in approximately 1,500 patients participating in clinical trials suggest that this reaction occurred principally with the tablet (10.3 %) rather than the later capsule formulation (2.1 %) and since the tablet form has been discontinued there have been fewer reports. Detailed investigation of medical records and re-examination of patients developing a rash with alclofenac therapy indicate that there may be a ‘cross-sensitivity’ between alclofenac and other drugs such as penicillin, gold salts and salicylates. Other adverse reactions to alclofenac, such as gastro-intestinal haemorrhage and blood disorders, have been reported only rarely.     

Adverse drug reactions associated with antiretroviral therapy during pregnancy

Introduction: Antiretroviral (ARV) drug use during pregnancy significantly reduces mother-to-child HIV transmission, delays disease progression in the women and reduces the risk of HIV transmission to HIV-serodiscordant partners. Pregnant women are susceptible to the same adverse reactions to ARVs as nonpregnant adults as well as to specific pregnancy-related reactions. In addition, we should consider adverse pregnancy outcomes and adverse reactions in children exposed to ARVs during intrauterine life. However, studies designed to assess the safety of ARV in pregnant women are rare, usually with few participants and short follow-up periods.

Areas covered: In this review, we discuss studies reporting adverse reactions to ARV drugs, including maternal toxicity, adverse pregnancy outcomes and the consequences of exposure to ARV in infants. We included results of observational studies, both prospective and retrospective, as well as randomized clinical trials, systematic reviews and meta-analyses.

Expert opinion: The benefits of ARV use during pregnancy outweigh the risks of adverse reactions identified to date. More studies are needed to assess the adverse effects in the medium- and long term in children exposed to ARVs during pregnancy, as well as pregnant women using lifelong antiretroviral therapy and more recently available drugs.     

消渴丸的不良反应与合理应用

消渴丸是治疗糖尿病的中西药复方制剂，具有较好的临床疗效。随着临床的广泛使用，消渴丸引起的不良反应报告也日渐增多。通过对近年来消渴丸引起的不良反应和国外相关安全性监管措施的文献检索，分析该药品引起严重不良反应的发生原因，并针对该品种的管理和临床合理使用提出了相关建议，以减少不良反应的重复发生。     

我院近期药品新的严重不良反应报告分析

回顾性分析发生在镇江市中医院的药品25例新的、严重的不良反应的症状、药物监测和治疗,以及其中3个典型病例。     

儿童中常见的药物不良反应

病人特别是儿童常发生药物不良反应,在新生儿监护室中发生的不良反应高达30％。甲氧氟普胺引起的肌张力障碍,抗惊厥药引起嗜睡,氯霉素引起灰婴综合征以及皮质类固醉造成的发育障碍都可在儿童中出现。药物有关不良反应在儿童中发生率比成人高的主要原因可能是儿童代谢功能不成熟之故。     

呼吸内科病房药物不良反应监察与评价

在呼吸内科病房进行了为期一年的药物不良反应（ＡＤＲｓ）集中监察。２３９例病人中５２例发生了７０次ＡＤＲｓ，ＡＤＲｓ的总发生率为２１．８％。ＡＤＲｓ的发生与病人的住院时间、用药种数及既往药物过敏史等因素密切相关。常见的ＡＤＲｓ为神经肌肉反应、各型皮疹、消化道反应或肝功损害。抗结核药物、抗生素、心血管药物等发生不良反应的频度较高。     

抗心律失常新药决奈达隆的不良反应与相互作用

决奈达隆是一种化学结构与胺碘酮相似的新的抗心律失常药物。2011年美国版和2010年欧洲版心房颤动指南均推荐决奈达隆用于心房颤动的治疗。决奈达隆的疗效虽然不如胺碘酮,但不良反应及耐受性明显好于胺碘酮,无甲状腺毒性、肺毒性和眼毒性,致心律失常的可能性也很低。决奈达隆的不良反应主要是消化系统反应(腹泻、恶心和呕吐等)、循环系统反应(致尖端扭转型室速、心动过缓、心血管不良事件死亡率升高等)、升高血清肌酐水平及头晕、头痛等神经系统不良反应。决奈达隆与其他药物的不良相互作用主要涉及经CYP450 3A4和CYP450 2D9代谢(诱导剂和抑制剂)的药物。决奈达隆的不良反应及药物相互作用值得心血管内科临床医生重视。     

常用药物对男性生育力影响的研究进展

为临床遴选男性患者治疗药物提供一定参考,以避免选用对男性生育力存在不利影响的药物。本文就近年已有研究可能对男性生育力存在不利影响的药物进行归纳和总结。目前有关药物对男性生殖系统影响的研究较少,但从现有研究中发现,包括外源性睾酮、5-α还原酶抑制剂、抗抑郁药、抗癫痫药及抗菌药物等在内的多种药物均可能对男性生育力产生不利影响。许多常用药物均可对男性生育力产生不同程度的损害,临床医生为男性患者遴选治疗药物时需在一定程度上考虑到该因素。但现有有关药物对男性生育力影响的研究仍较少,故仍需更多临床试验加以关注和验证。     

Adverse drug reactions in children: a ten-year review of reporting to the Portuguese Pharmacovigilance System

Objective: Adverse drug reactions (ADR) are a public health problem. They cause significant morbidity, mortality and health costs. Less is known about pediatric ADR. Our goal was to characterize a pediatric case series of ADR reported to the Portuguese Pharmacovigilance System (PPS) during the past 10 years.

Research design and methods: Retrospective analysis of ADR reports concerning patients till 17 years old received by the PPS between 2003 and 2012. We evaluated patients’ demographic data and involved drugs, as well as characteristics and seriousness of reactions, stratified by age groups.

Results: We found 1742 reports (50% females) corresponding to 9.7% of the total received. The age of the patients varied from 0 to 17 years (median: 5 years, interquartile range: 10.6), with 566 cases (32%) occurring in patients younger than 2y. Among the 1195 serious cases, 31% (370) episodes led to hospitalization. In 32 cases (2%) there was a fatal outcome. Most of the ADR reported referred to general disorders and administration site conditions, followed by skin and subcutaneous tissue reactions. Vaccines were the most represented group (42%) followed by antibacterials for systemic use (17%).

Conclusions: Pediatric ADR represents about 10% of the reports received by the PPS. Most ADR were considered serious. Major findings varied according to age groups.     

流感治疗指南中常用中成药制剂的不良反应

中成药在流感治疗中一直占有重要地位,然而普通民众、甚至一些医师往往忽视其不良反应,以致对患者造成严重后果或不必要的损害。本文介绍流感治疗指南中常用中成药制剂的不良反应,以便临床上及时发现或减少可能发生的不良反应。     

临床常用降糖药物的不良反应及防治策略

随着糖尿病(diabetes mellitus,DM)患者的日益增多,采用降糖药物治疗的同时会存在诸多的药物不良反应(ADR),对患者影响甚大,尤其是特殊人群,易造成生活质量的下滑和经济上的巨大损失。本文从介绍临床常用的各种类型降糖药物的ADR开始,提出如何使用不同类型的降糖药物对DM进行治疗,以及怎样避免ADR对患者的影响等措施,从而营造出健康、安全、和谐的生活方式。