| Summary: | The aim of this thesis is to develop methodologies to engage parents in the ADR reporting process and to assess the validity of such parental reporting on behalf of their children. The first approach evaluated a community pharmacy based monitoring system to identify ADRs associated with the use of three groups of medicines, selective serotonin reuptake inhibitors (SSRIs), anti-epileptics, and treatments for attention deficit hyperactivity disorder (ADHD) including melatonin. All community pharmacies (n=827) in five Scottish Health Board Areas were approached, and were invited to participate and 72 (8.7%) agreed to take part in the study. 229 questionnaires were distributed and 55 (24%) returned. Thirty-one of the returned questionnaires reported 44 possible ADRs using free-text, and 103 possible ADRs using a symptom tick list. The second approach identified parents of children attending specialist paediatric/psychiatric clinics for the treatment of ADHD. Parents (578) received an invitation letter from their child’s specialist medical consultant together with a participant information leaflet and ADR questionnaire. Within a 2-mont period, 207 questionnaires were returned, giving a response rate of 35.9%. Of the 200 evaluable questionnaires, 61.5% reported free text ADRs. 123 questionnaires reported 213 free text and 467 tick list ADRs where perceived by the parents to be due to the medications under study. Parent reporting of ADRs via community pharmacies and specialist medical clinics is a valid pharmacovigilence approach. However, further research is necessary to improve the efficacy of this approach.
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