Pharmacovigilance Informatics

Background On Pharmacovigilance

Adverse Drug Reactions (ADR) defined as a response to a medicinal product which is noxious and unintended (WHO) are a well-recognized public health problem worldwide, and a major cause of death and hospitalization in developed countries(Lazarou, Pomeranz, & Corey, 1998). It is estimated that about 6,5% of the hospitalizations are related to ADR(Pirmohamed et al., 2004). Besides, in the USA, about 100.000 people die each year due to ADR(Lazarou et al., 1998), and in Europe this annual mortality rate increases to 197.000(European Medicines Agency, 2014). ADR can be expressed in many ways and with different degrees of seriousness. An anaphylactic shock caused by penicillin is an example of a serious ADR (a serious ADR is any untoward medical occurrence that at any dose: results in death, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity or is life-threatening(WHO). Another type of ADR, not always recognized as such, is the drug ineffectiveness, for example, a vaccination failure. This can be (or not) related with a product quality issue and should be reported when detected in order to allow the regulatory authorities to take appropriate decisions.