Introduction: Underreporting of adverse drug reactions (ADRs) usually reaches 90%.
Objective: To explore the gap in the frequency of ADRs to antiparkinsonian drugs (APDs) in Parkinson’s disease (PD) and non-PD patients when explored by means of a full extensive questionnaire or by patients\' spontaneous disclosure.
Methods: Ambulatory cognitively-intact PD or stroke outpatients were initially asked to disclose any unpleasant effect in connection with their medication. Afterwards, they were systematically questioned about the presence of a predefined list of common ADRs to all APDs. ADRs’ causality assessment was performed according to chronological and semiological criteria. A complete medical and medication history was conducted. PD severity was evaluated by the UPDRS scale.
Results: 203 PD and 52 non-PD patients of comparable age and sex were recruited. Every PD patient vs 93% non-PD reported ≥ 1 ADR using the structured questionnaire (p<0.01). Eighty-seven percent of PD patients had ≥ 1 ADR plausibly related to an APD. Spontaneous ADRs reports frequency ranked between 57% for nausea/vomiting and 0% for some events. Spontaneous disclosure of any ADR was associated to experiencing > 2 ADRs (OR=1.2,1.1-3.2, logistic regression). Disclosure of neuropsychiatric ADRs was related to their severity (2.1,1.1-4.3) while disclosure of gastrointestinal ones was related to them being plausibly related to APDs (2.6, 1.2-5.6).
Conclusions: All PD patients reported at least one ADR using a structured questionnaire. The gap between ADRs identified using the questionnaire or by spontaneous patients\' report was >43%, thus suggesting that a pro-active attitude towards the search of ADRs should be adopted.
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