Härmark Linda V D, Huls Harmen J, de Gier J J Han, van Grootheest A C Kees
Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, the Netherlands; Division of Pharmacotherapy and Pharmaceutical Care, Department of Pharmacy, University of Groningen, Groningen, the Netherlands.
Int J Pharm Pract. 2014 Apr;22(2):159-62. doi: 10.1111/ijpp.12038. Epub 2013 May 20.
Worldwide pharmacists play an increasingly important role in pharmacovigilance. Lareb Intensive Monitoring (LIM) in the Netherlands is a new form of active pharmacovigilance where pharmacists play a key role. Patients using drugs which are monitored are identified in the pharmacy and invited to participate in the active monitoring. Not all invited patients participate. This study aimed to investigate non-response bias in LIM, as well as reasons for non-response in order to identify barriers to participation.
The study population consisted of patients who received a first dispensation of an antidiabetic drug monitored with LIM between 1 July 2010 and 28 February 2011. Possible non-response bias was investigated by comparing age, gender and the number of drugs used as co-medication. Reasons for non-response were investigated using a postal questionnaire.
Respondents were on average 4.5 years younger than non-respondents and used less co-medication. There were no differences regarding gender. The main reason for non-response was that information in the pharmacy was lacking.
Differences between respondents and non-respondents should be taken into account when analysing and generalising data collected through LIM, as this might contribute to non-response bias. The relatively high response to the postal questionnaire, together with the answers about reasons for non-response, show that patients are willing to participate in a web-based intensive monitoring system, when they are informed and invited in the pharmacy.
在全球范围内，药剂师在药物警戒中发挥着越来越重要的作用。荷兰的拉雷布强化监测（LIM）是一种新的主动药物警戒形式，药剂师在其中发挥关键作用。在药房中识别出使用受监测药物的患者，并邀请他们参与主动监测。并非所有受邀患者都会参与。本研究旨在调查LIM中的无应答偏倚以及无应答原因，以确定参与的障碍。
研究人群包括在2010年7月1日至2011年2月28日期间首次配用受LIM监测的抗糖尿病药物的患者。通过比较年龄、性别和作为联合用药使用的药物数量来调查可能的无应答偏倚。使用邮政问卷调查无应答原因。
应答者的平均年龄比无应答者小4.5岁，联合用药较少。在性别方面没有差异。无应答的主要原因是药房缺乏信息。
在分析和归纳通过LIM收集的数据时，应考虑应答者和无应答者之间的差异，因为这可能导致无应答偏倚。对邮政问卷的相对较高的应答率，以及关于无应答原因的答案表明，当患者在药房得到通知和邀请时，他们愿意参与基于网络的强化监测系统。
