Patient perspective in the benefit/risk evaluation of drugs

This project contributes to a more systematic approach to assess symptomatic adverse drug reactions (ADRs) as perceived by patients. We evaluated methods currently used to assess symptomatic ADRs, and developed and tested a questionnaire to measure ADRs reported by patients. In pre- and post-marketing studies of drugs little attention has been paid to validly and reliably measure symptomatic ADRs. Symptomatic ADRs, however, negatively influence the benefit-risk evaluation of a drug by lowering patients’ quality of life and adherence to treatment. The methods currently used to assess ADRs are inadequate for identifying all possible ADRs in a structured way. Patient-oriented methods result in rates of symptomatic ADRs that are closer to the rates in the Summary of Product Characteristics of a drug than provider-oriented methods. The validation of a newly developed generic questionnaire demonstrated critical aspects and pitfalls for measuring ADRs through patient reporting. The use of patient-oriented methods has added value in the evaluation of the benefit-risk evaluation of a drug. The project is a first step in the development of a reliable and valid instrument to assess symptomatic ADRs using patient reporting.

Results

• Hakobyan L, Haaijer-Ruskamp FM, De Zeeuw D, Dobre D, Denig P. A review of methods used in assessing non-serious adverse medicine events in observational studies among type 2 diabetes mellitus patients. In: Health Qual Life Outcomes, 2011; 9: 83. (journal publication)
• Hakobyan L, Haaijer-Ruskamp FM, De Zeeuw D, Dobre D, Denig P. Comparing adverse event rates of oral blood glucose-lowering medicines reported by patients and healthcare providers: a post-hoc analysis of observational studies published between 1999 and 2011. In: Medicine Saf, 2011; 34(12): 1191-202. (journal publication)
• De Vries ST, Mol PG, De Zeeuw D, Haaijer-Ruskamp FM, Denig P. Development and initial validation of a patient-reported adverse drug event questionnaire. In: Drug Safety, 2013. (journal publication)