title: Web-based intensive monitoring: from passive to active drug surveillance.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors: Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237MH 's-Hertogenbosch, 's-Hertogenbosch, The Netherlands. l.harmark@lareb.nl
authors: Linda
authors: L
authors: Härmark
authors: Kees
authors: K
authors: van Grootheest
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D016903:Drug Monitoring / Q000379:methods*; D064420:Drug-Related Side Effects and Adverse Reactions; D005062:European Union; D006801:Humans; D020407:Internet; D007880:Legislation, Drug; D060735:Pharmacovigilance; D011795:Surveys and Questionnaires