title: Coming full circle in pharmacovigilance: communicating safety information to patients through patient package inserts.
abstract: Optimal drug therapy requires that the patient should be informed adequately, unequivocally and in timely fashion. Patient package inserts (PPIs) have an important facilitating role to play in this respect. Patients' confidence in the benefit of a drug treatment and their fear of its side effects are strong determinants of their adherence to that treatment. Yet, the European PPI format does not allow a discussion of the treatment's benefits, which results in an unbalanced focus on side effects. This serious shortcoming may significantly interfere with a patient's compliance. In addition, prescribers are often unaware of the content of the PPI of the products they are prescribing. To rectify this situation, the development is proposed of annotated PPIs providing the scientific background to the PPI message. In conclusion, European PPIs need to be improved. The patient should be informed of the expected benefit of a drug treatment, its likelihood and the expected time course of the effect, and not only of side effects and interactions, which constitutes the present focus. Moreover, prescribers need to be informed about the content of the PPIs for the medicines they prescribe.
authors.affiliation: Pharmaco-epidemiology and Medical Evaluation, Janssen Research Foundation, Turnhoutseweg 30, B-2340 Beerse, Belgium.
authors.forename: W K
authors.initials: WK
authors.lastname: Amery