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Vaccine Xxx (2018) Xxx–Xxx Vaccine xxx (2018) xxx–xxx Contents lists available at ScienceDirect Vaccine journal homepage: www.elsevier.com/locate/vaccine Spontaneous reports of vaccination errors in the European regulatory database EudraVigilance: A descriptive study ⇑ Christina E. Hoeve a,b, , Anja van Haren a, Miriam C.J.M. Sturkenboom c, Sabine M.J.M. Straus a,b a Medicines Evaluation Board, Utrecht, the Netherlands b Erasmus University Medical Center, Rotterdam, the Netherlands c University Medical Center, Utrecht, the Netherlands article info abstract Article history: Background: Among all post-marketing medication error reports submitted to EudraVigilance, vaccines Received 4 August 2018 are the most frequently reported medicinal products. This study aims to describe the characteristics of Received in revised form 30 October 2018 vaccination errors submitted to Eudravigilance between 2001 and 2016. Accepted 1 November 2018 Methods: EudraVigilance is a spontaneous reporting database for adverse events maintained by the Available online xxxx European Medicines Agency. We extracted Individual Case Safety Reports (ICSRs) submitted to EudraVigilance between 1 January 2001 and 31 December 2016. Reports were included for analysis if Keywords: a vaccine was reported as interacting or suspect drug and at least one medication error term was listed Spontaneous reporting as an adverse reaction. ICSRs were stratified by age and gender, by year of reporting, region of origin, Medication errors Vaccination errors reporter profession, seriousness of outcome, ATC, and type of error. EudraVigilance Results: In total, 7097 ICSRs were included in the study. We observed a yearly increase in the reporting of Pharmacovigilance vaccination errors, with the proportion to all vaccine ICSRs increasing from 0.4% to 4.0% between 2001 and 2016. The majority of reports was classified as serious (4248, 59.9%), but non-serious reports were increasingly reported since 2012. The mean age of patients was 24.1 years. The most frequently reported vaccines were influenza (13.5%), bacterial and viral combined (12.3%), and hepatitis vaccines (11.8%). A total of 8167 medication error terms were reported. The most frequently reported terms were ‘‘Inappropriate schedule of drug administration” (27.2%), ‘‘Incorrect route of drug administration” (12.5%) and ‘‘Drug administered to patient of inappropriate age” (10.0%). For infants and children, the error ‘‘Drug administered to patient of inappropriate age” was reported more often than for all other age categories. Discussion: Vaccination errors are increasingly submitted to EudraVigilance. Errors related to the sched- ule are the most common errors reported with vaccines. However, consequences of vaccination errors appear to be relatively mild. Ó 2018 Elsevier Ltd. All rights reserved. 1. Introduction In the EU, all adverse event reports are collected and shared in EudraVigilance, a European wide pharmacovigilance database [1,2]. Since July 2012 the EU pharmacovigilance legislation pro- Abbreviations: VAERS, Vaccine Adverse Event Reporting System; HCP, Health- vides a legal framework to share data on medication errors, in care Professional; NCA, National Competent Authority; MAH, Marketing Application Holder; ICSR, Individual Case Safety Report; ATC, Anatomical Therapeutic Classi- which medication errors are defined as ‘‘an unintended failure in fication; MedDRA, Medical Dictionary for Regulatory Activities; SMQN, Narrow the drug treatment process that leads to, or has the potential to Standard MedDRA Query; PT, Preferred Term; ICH, International Council on lead to, harm to the patient” [1,3]. The definition of medication Harmonisation of Technical Requirements for Registration of Pharmaceuticals for errors in this legislation does not include ‘intended errors’ such Human Use; SmPC, Summary of Product Characteristics; HPV, Human Papilloma as off-label use, misuse and abuse [3]. In EudraVigilance, vaccines Virus; HiB, Haemophilus influenza B. ⇑ Corresponding author at: Erasmus University Medical Center, Rotterdam, the are the most frequently reported medicinal group among medica- Netherlands. tion errors cases in EU countries [4]. Several studies have reported E-mail address: [email protected] (C.E. Hoeve). https://doi.org/10.1016/j.vaccine.2018.11.003 0264-410X/Ó 2018 Elsevier Ltd. All rights reserved. Please cite this article in press as: Hoeve CE et al. Spontaneous reports of vaccination errors in the European regulatory database EudraVigilance: A descrip- tive study. Vaccine (2018), https://doi.org/10.1016/j.vaccine.2018.11.003 2 C.E. Hoeve et al. / Vaccine xxx (2018) xxx–xxx data on vaccination errors, although the majority of these origi- ‘Medication error’ from MedDRA version 20.0. This SMQN is a collec- nated from US reporting systems [5–14]. Although in some cases tion of MedDRA preferred terms (PTs) to identify medication error vaccination errors may leave the patient unprotected against dis- cases (e.g. administration error or product administered to wrong ease [15,16], vaccination errors do not necessarily cause injury. patient). All PT’s listed in the SMQN were categorized into 10 error Above mentioned studies in Vaccine Adverse Event Reporting Sys- groups based on the types of errors: Accidental exposure, Adminis- tem (VAERS) show that in general vaccination errors result in little tration errors, Contraindication/Warning, Dispensing/selection/pre harm. Studies have shown that the reporting of vaccination errors scription error, General error, Information error, Storage error or has increased in the past decade in the USA, which may be quality-related issue, Vaccination incomplete, Wrong dose, Wrong explained by several reasons such as changes in reporting prac- patient/drug/age (Appendix A). Reported cases in EudraVigilance tices, the increasing number of vaccines in the national immuniza- are classified as serious when categorized in at least one of the fol- tion program, and increased awareness of the importance of lowing subcategories: death, life-threatening, hospitalization, dis- reporting medical errors [12,17]. abling, congenital anomaly or other nature according to the ICH Specific pharmacovigilance guidance has been developed for definitions [19,20]. vaccines as these have a specific position in the spectrum of medic- inal products. In contrast to most regular medications, vaccines are 2.3. Analysis used to prevent rather than cure diseases and are used in relatively healthy populations. As a result, fewer risks are tolerated with the The reports extracted from EudraVigilance were classified by use of vaccines. Vaccines are often administered to large popula- age and gender, by year and month of reporting, region of origin tions as part of public health programs. Moreover, specific storage of the report (EU or non-EU), reporter profession (healthcare pro- requirements apply to vaccines, and vaccination schedules may be fessional or non-healthcare professional), seriousness of reported complex and difficult to adhere to [18]. Errors may occur at any outcome, ATC level 4, and PT. All countries associated with the stage of the treatment process and consequences of errors associ- European Medicines Agency (i.e. EU countries plus Iceland, Liecht- ated with vaccines may be different from other medications. enstein, and Norway) were classified as EU. Patients were catego- The role of spontaneous reporting systems in the context of rized in age groups as follows: infants 0 < 2 years, children medication errors has been described for medications in general, 2 < 12 years, adolescents 12 < 18 years, adults 18 < 65 years, but limited knowledge is available on vaccination errors submitted elderly 65 < 75 years, very elderly 75 years. Where applicable a to EudraVigilance. In the current study, we aim to describe vacci- two-sided binomial test was performed to compare proportions, nation errors in EudraVigilance, to gain insight into the types of with the null-hypothesis assuming that there is no difference errors and to identify potential areas where preventive measures between the proportions of the categories tested. The aim of such may be beneficial. testing was to highlight differences in reporting of vaccination errors that may need further evaluation, rather than to confirm dif- 2. Methods ferences in the occurrence of vaccination errors. Data handling and analysis were performed in SAS software version 9.3 (SAS Institute 2.1. Study design Inc., USA). Missing data were considered as ‘not reported’ and formed an extra outcome category. A descriptive case series study was performed in EudraVigilance on vaccination errors reported by a healthcare professional (HCP) or non-HCP to an EU national competent authority (NCA) or mar- 3. Results keting application holder (MAH) in the period of 1 January 2001 through 31 December 2016. We retrieved all reports and as refer- Between 1 January 2001 and 31 December 2016, there were ence date for all analyses we used the date when an NCA or MAH 233,285 vaccine reports of which 7097 (3.0%) reported a vaccina- received the initial report. If multiple versions of the same report tion error. The number of vaccination error reports received per were identified, only the latest version was used for further analy- year increased from 5 in 2001 to 1007 in 2016 (Fig. 1). Simultane- sis. For the analysis, all Individual Case Safety Reports (ICSRs) ously, the proportion of vaccination error reports among all vac- reporting a medication error term and at least one vaccine as a sus- cine reports increased from 0.4%
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