Monitoring the safety of influenza A (H1N1) vaccine using web-based intensive monitoring

BACKGROUND: When adjuvant vaccines against the pandemic influenza A (H1N1) virus became available after an accelerated registration process, safety issues dominated the public debate. As part of the immunisation campaign, the Dutch government installed an active monitoring of possible adverse events following immunisation (AEFIs). As part of the monitoring we conducted an anonymous prospective cohort study to identify and quantify the occurrence of AEFIs related to pandemic vaccination among the population immunised in general practice. METHOD: Adults aged 60 years and older or persons with a risk-elevating medical condition recommended for vaccination in general practice were eligible for participation. After receipt of the first pandemic vaccine the administrator handed over an information flyer of the web-based monitoring program. The patient could sign up for study participation online. Within one week, three weeks and three months after the first immunisation questions were asked about demographics and health, immunisations, injections site reactions and labeled reactions as well as other possible new AEFIs. RESULTS: In all, 3569 participants filled in the first questionnaire. Corresponding figures for the second and third questionnaires were 3395 (95.1%) and 3162 (88.6%). Mean age was 58 years (SD 15) and 50.1% was female. Main indication was 60 years or older followed by presence of pulmonary or cardiovascular disease. Of all participants, 1311 (37%) reported an AEFI. Unexpected serious reactions were not reported nor were there signals of possible new AEFIs. The occurrence of an AEFI was determined by gender, age and type of co-morbidity. CONCLUSION: The web-based intensive monitoring system among patient immunised in general practice revealed AEFIs due to pandemic vaccination in one-third of participants. There were no unexpected serious adverse events in this population. This advanced methodology can be further developed to monitor real-time use and AEFIs of vaccines

Web-based intensive monitoring:from passive to active drug surveillance

Introduction: Recently, the European pharmacovigilance legislative framework changed. Post-authorisation safety studies (PASS) and additional monitoring of drugs will be important tools in ensuring the safety of drugs. Methods that can facilitate gathering of the requested information are essential. In this article, web-based intensive monitoring is described and future applications of this method are discussed. Areas covered: Web-based intensive monitoring is a non-interventional observational cohort study using patients as a source of information. Eligible patients are identified in the pharmacy, and information about drug use and adverse events is collected through web-based questionnaires. An overview of the results as well as the pros and cons of this method is given. A discussion on how this methodology can be expanded to other settings and how it can be used in the future is included. Expert opinion: The main idea with web-based intensive monitoring, using a specific inclusion point, letting patients be the source of information and following the patients over time via web questionnaires, can be a useful tool in post-marketing surveillance. Aspects other than adverse drug reactions, such as information about indication for use and off-label use, dosage and compliance can also be collected

De besluitvorming over werkzaamheid en veiligheid van rosiglitazon bij de FDA en de EMA. Wat zijn de lessen?

The rosiglitazone decision process at FDA and EMA. What should we learn? In September 2010 the EMA decided to suspend the market authorisation of rosiglitazone while the FDA decided to restrict its use. These actions were taken because rosiglitazone had been associated with an increased risk of ischemic heart disease. Remarkably, in 2007, when the evidence against the combination of rosiglitazone and insulin had increased, the EMA made a decision that encouraged the use of insulin in combination with rosiglitazone, while the FDA tried to restrict this combination therapy. Despite the publication of several studies, including a large randomized controlled study, the cardiovascular risk of rosiglitazone has still not been definitively established. To prevent new cases like rosiglitazone, more attention should be given to evaluation of study protocols of safety trials prior to their start. The rosiglitazone story further underlines the critical importance of publicly available trial data