Guidelines for submitting adverse event reports for publication

Publication of case reports describing suspected adverse effects of drugs and medical products that include herbal and complementary medicines, vaccines, and other biologicals and devices is important for postmarketing surveillance. Publication lends credence to important signals raised in these adverse event reports. Unfortunately, deficiencies in vital information in published cases can often limit the value of such reports by failing to provide sufficient details for either (i) a differential diagnosis or provisional assessment of cause-effect association, or (ii) a reasonable pharmacological or biological explanation. Properly described, a published report of one or more adverse events can provide a useful signal of possible risks associated with the use of a drug or medical product which might warrant further exploration. A review conducted by the Task Force authors found that many major journals have minimal requirements for publishing adverse event reports, and some have none at all. Based on a literature review and our collective experience in reviewing adverse event case reports in regulatory, academic, and industry settings, we have identified information that we propose should always be considered for inclusion in a report submitted for publication. These guidelines have been endorsed by the International Society for Pharmacoepidemiology (ISPE) and the International Society of Pharmacovigilance (ISoP) and are freely available on the societies' web sites. Their widespread distribution is encouraged. ISPE and ISoP urge biomedical journals to adopt these guidelines and apply them to case reports submitted for publication. They also encourage schools of medicine, pharmacy, and nursing to incorporate them into the relevant curricula that address the detection, evaluation, and reporting of suspected drug or other medical product adverse events.     

324例可疑医疗器械不良事件报告分析

目的 对324例可疑医疗器械不良事件报告进行分析，评价报告可利用性，探索安全使用医疗器械监测手段及医疗器械不良事件监测模式。方法 采用描述性分析的方法进行分析。结果 医疗器械不良事件监测工作为安全有效使用医疗器械提供了有意义的启示，医疗器械不良事件监测模式初步形成。结论 加强医疗器械不良事件监测工作是确保安全使用医疗器械的有力手段。     

286例可疑医疗器械不良事件报告分析

目的通过对辽宁省286例可疑医疗器械不良事件报告进行分析，为临床安全用械提供警示。方法采用描述性分析的方法进行分析。结果引起不良事件的可疑医疗器械共涉及47种（类），占前3位的分别是宫内节育器、骨科植入器械以及一次性导尿包。结论加强医疗器械科学使用，保障用械安全。     

415例可疑医疗器械不良事件报告分析

目的通过对收集到的医疗器械不良事件信息的汇总分析,发挥医疗器械不良事件监测工作的指导作用,以保障公众用械安全。方法采用描述性分析的方法进行综合分析。结果医疗器械不良事件监测工作为安全有效使用医疗器械起到了预警作用。结论加强医疗器械不良事件监测工作是确保安全使用医疗器械的有效措施。     

31例盐酸头孢替安药品不良事件分析

目的:分析院内盐酸头孢替安致不良事件的(ADE)发生原因和特点,为临床安全应用提供药师建议.方法:对我院2010～2016年报告的31例盐酸头孢替安ADE报告进行回顾性归纳分析.结果:31例报告中女性患者明显多于男性,发生年龄段51～60岁最多,不良事件损害表现以皮肤黏膜损害、循环系统、消化系统损害为主,严重不良事件为过敏性休克、呼吸困难、多型性红斑.结论:盐酸头孢替安临床应用不良事件的发生并不单纯是由于药物本身特性以及患者个体的差异导致,药物的选择、给药剂量、给药频次的不当等也是导致不良事件发生的因素,提示临床合理选择抗菌药物并严格按照药品说明书的给药剂量和给药频次,加强给药后的观察以及发生不良事件的及时干预,可以减少或避免不良事件的发生,提高临床安全用药水平.     

香丹注射液致不良反应/事件报告分析

香丹注射液为临床常用的中药注射液,是由丹参、降香经过提取,加辅料聚山梨酯80制成的棕色澄明液体。临床主要用于心绞痛、心肌梗塞等。随着临床的广泛应用,其药品不良反应报道也日益增多。     

阿奇霉素药物不良反应/事件报告相关因素的分析

目的通过对我院阿奇霉素药物不良反应/事件(ADR/ADE)报告相关因素分析,了解阿奇霉素药物ADR/ADE发生特点及规律,为促进临床安全、有效、合理用药提供参考。方法对我院2004年1月1日至2011年3月20日收集到的198例阿奇霉素药物ADR/ADE报告,从患者情况、不良反应的临床表现、给药途径、原患疾病及因果关系的评价等方面进行回顾性统计分析。结果 198例阿奇霉素药品ADR/ADE报告中,女性多于男性;0~15岁的儿童57例占28.79%,50~81岁的患者109例占55.05%;给药途径主要是静脉点滴192例占96.97%;累及的系统-器官主要是皮肤及其附件69例34.85%,消化系统56例28.29%和呼吸系统42例21.22%等;主要发生在用药后10~35min。结论不合理使用阿奇霉素是ADR/ADE发生的主要因素之一,临床应重视阿奇霉素引起的ADR/ADE,减少或者避免严重的ADR/ADE的发生,确保用药安全。     

抗感染药物不良反应/事件报告相关因素分析及预防

目的通过对我院抗感染药物不良反应/事件(ADR/ADE)报告相关因素分析,了解抗感染药物ADR/ADE发生特点及规律,为促进临床安全、有效、合理用药提供参考。方法对我医院2005年1月1日至2010年12月31日收集到的522例抗感染药物ADR/ADE报告,从患者情况、不良反应的临床表现、给药途径、抗感染药物的种类及因果关系的评价等方面进行回顾性统计分析。结果 522例抗菌药品ADR/ADE报告中,女性多于男性;0～14岁的儿童106例,占20.31%;50-86岁的患者282例,占54.03%;头孢菌素类居首位239例,占45.79%;其次为喹诺酮类121例,占23.18%;给药途径以静脉点滴所占比例最大468例,占89.66%。抗菌药物ADR/ADE累及的系统-器官主要是皮肤及其附件129例,占24.72%;消化系统108例,占20.69%;呼吸系统97例,占18.59%等。结论加强抗菌药物使用管理,做好ADR/ADE监测工作,减少或者避免ADR/ADE的发生。     

Pediatric medication error reports in Korea adverse event reporting system database, 1989-2012: Comparing with adult reports

在江西省儿童医疗联盟内构建区域药学服务综合平台,实现儿科分级诊疗用药管理,提高药学服务质量。

在江西省儿童医疗联盟各医疗机构间建立统一诊疗信息标准及儿童合理用药规则知识库,在此基础上结合区块链技术将患者在区域内各医疗机构就诊的医疗记录、用药信息通过结构化方式实时上传至链上,构建区域药学服务综合平台。

基于区块链技术构建的药学服务综合平台,可使各医疗机构间医疗资源与信息得以共享,实现合理用药管理、远程审方、个体化用药指导、科普宣教、政府监管等,提高药学服务质量。

通过构建儿童医疗联盟内的药学服务综合平台,可实现优质医疗资源(用药安全知识库、儿科药师)下沉,保障儿童用药安全的同时,为政府监管奠定了基础,具有较大的现实意义。

     

An appraisal of spontaneous adverse event monitoring.

Awareness of the need to continue the safety assessment of new drugs into the post-marketing period has continued to increase over the past few years. The stage has been reached where there is, for all practical purposes, unanimous agreement that all new drugs, particularly those intended for widespread use and/or long-term administration, be subjected to some form of post-marketing monitoring. In many cases nationally sponsored spontaneous reporting systems are claimed to be sufficient to meet the needs without any critical appraisal being made of the suitability or reliability of this method. The adoption of 'pharmacovigilance' (spontaneous reporting) as the system for the whole European Community (EC) emphasizes the faith that has been placed in the system. At a recent symposium (Management Forum, 9-10 March, 1992) on post-marketing safety evaluation, more than half of the 16 papers presented were entirely or predominantly concerned with spontaneous reporting systems, which is a pattern common to other meetings on this topic. The Committee on Safety of Medicines (CSM) has referred to spontaneous reporting as the cornerstone of post-marketing surveillance which has further endorsed a general feeling of confidence that the system will meet our societal needs even though its scientific capability may be deficient. It is the purpose of this paper to challenge these assumptions and to make an objective appraisal of the various methods available.     

Tracking vaccine lot lifecycles using reports to the vaccine adverse event reporting system (VAERS)

PURPOSE: There is currently no systematically available information available on how rapidly a specific lot of vaccine is used once distributed. We used data from reports to the Vaccine Adverse Event Reporting System (VAERS) to develop a proxy means of surveillance for the lifecycle of selected vaccine lots. METHODS: A convenience sample, consisting of selected lots of: diphtheria, tetanus, and acellular pertussis (DTaP), Haemophilus influenzae type b (Hib), Hepatitis B, and varicella vaccines, was selected for lifecycle analysis. Assuming that circulation of a vaccine lot is proportional to vaccine-specific adverse event (AE) reporting for that vaccine type, we constructed Gamma distributed usage models and compared them with lot-specific VAERS reports to estimate the actual lifecycle of lots in the system. RESULTS: Evidence of lot circulation was detected within 1-2 months, and a peak was observed 3-4 months after the vaccine release date for most of the study vaccines. Ninety percent of the vaccine doses in each lot were estimated to be used within 5-9 months of distribution. The length of time a vaccine lot was in use ranged from 5 to 17 months from earliest vaccination date. CONCLUSIONS: Our modeled and inferred administration of the selected lots of different vaccines were concordant. This method may be useful for spatial and temporal tracking of vaccine lot utilization.