Coming full circle in pharmacovigilance: communicating safety information to patients through patient package inserts
✍ Scribed by Willem K. Amery
- Book ID
- 101290337
- Publisher
- John Wiley and Sons
- Year
- 1999
- Tongue
- English
- Weight
- 104 KB
- Volume
- 8
- Category
- Article
- ISSN
- 1053-8569
No coin nor oath required. For personal study only.
✦ Synopsis
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' con®dence in the bene®t of a drug treatment and their fear of its side eects are strong determinants of their adherence to that treatment. Yet, the European PPI format does not allow a discussion of the treatment's bene®ts, which results in an unbalanced focus on side eects. This serious shortcoming may signi®cantly interfere with a patient's compliance. In addition, prescribers are often unaware of the content of the PPI of the products thay are prescribing. To rectify this situation, the development is proposed of annotated PPIs providing the scienti®c background to the PPI message. In conclusion, European PPIs need to be improved. The patient should be informed of the expected bene®t of a drug treatment, its likelihood and the expected time course of the eect, and not only of side eects and interactions, which constitutes the present focus. Moreover, prescribers need to be informed about the content of the PPIs for the medicines they prescribe.