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Collaboration with a patient organization for insight into patients’ experiences with drug use and ADRs


3 April 2019

  • Lareb was approached by the patient organization for patients with attention-deficit/hyperactivity disorder (AD(H)D) dyslexia and dyscalculia called Impuls & Woortblind. The aim of this study was to investigate if a collaboration between Lareb and the patient organization could give more insight in patients’ experiences with drug use and ADRs.

    A web-based questionnaire was developed with six domains. The domains of interest were: patient characteristics and disease diagnosis, medication use and the extent of satisfaction with the information provided by the doctor and pharmacist about their medicines, experiences with efficacy of the drug, reasons for discontinuation of medical treatment, experiences with ADRs, and experiences with generic drug substitution for AD(H)D treatment. If patients had experienced an ADR, they were encouraged to report this through the official reporting form to Lareb. Patients were approached in several different ways to fill in the questionnaire.

    A total of 1160 patients completed the questionnaire. More than 70% experienced positive effects of their drugs. However 75.2% of the respondents also experienced ADRs. The most frequently mentioned ADRs of methylphenidate and dexamphetamine are mentioned in the SmPC. Of the respondents 60.7% discontinued treatment because of one or more ADR(s). Additionally, 5.0% of the respondents reported their ADRs to Lareb. These reports contributed to raising two signals. One about ‘Lack of effect after substitution of methylphenidate prolonged-release’. The other signal concerned problems with cracked tablets of methylphenidate.

    This study demonstrates how collaboration between a pharmacovigilance center and a patient organization can be used to gather information about patients’ experiences with drug use and ADRs. More intensive collaboration between PV centers and patient organizations can be a way to obtain more information about patients’ experiences in drug use and ADRs in a selective cohort. It is however, important to make clear rules of engagement prior to starting the collaboration.

    Reference: Weits G, Härmark L, Hartman J, and Kant A. Collaboration between patient and pharmacovigilance organizations to gain insight into adults’ experiences with drug use and ADRs for the treatment of ADHD Expert Opinion On Drug Safety Epub ahead of print.