Monitor the benefit and risk of medicines in primary care; Building a bridge between daily practice and research

Rolfes, L., Hek, K., Verheij, R., Van Dijk, L. & Van Puijenbroek, E., 1-Nov-2018, p. 1147. 1 p.

Research output: Contribution to conferenceAbstractAcademic

Background/Introduction: Monitoring the benefits and risks of medicines in the post-marketing phase is important for a safe and effective treatment of patients. The aim of this project is to create an infrastructure in which data from the patient's electronic health records from general practitioners (GPs) can be linked to patient reported outcomes (PROs) about their perspective of the effect and adverse drug reactions (ADRs) of medicines. In this way information about (cost) effectiveness and ADRs of medicines can be acquired. The system is designed to be applied to any new medication on the market and has several advantages above more traditional monitoring instruments like larger cohorts, longer follow-up, and a real life setting. Objective/Aim: To evaluate the feasibility of acquiring real world data to monitor the (cost) effectiveness and ADRs of medicines. Methods: For this pilot study, two GP practices in the Netherlands were included. Patients with an overactive bladder (OAB) were used as a use case. OAB patients were selected from electronic health records from the two GPs as obtained in the Nivel Primary Care Database. The GP indicated whether the patient was suitable to be included in the monitor. PROs were obtained by an electronic questionnaire, using the Lareb Intensive Monitoring system. Questions were posed about patient characteristics, bladder complaints, treatment (physiotherapeutic interventions and medicines), ADRs, therapy compliance, and quality of life. Results: 109 OAB patients were selected from the electronic health records. After revision by the GPs, an invitation to contribute to the monitor was send to 82 (75%) patients. Reasons for excluding patients were: patient cannot work with a computer or questionnaire (10×), cognitive/ mental not able to fill in questionnaire (10×), patient in hospital (3×), patient died/moved (2×). GPs were enthusiastic about the method. Nineteen patients (23%) filled in the questionnaire. Average age was 63 years (38-79 years) and it concerned 14 women. Patients reported an average score of 4.0 for urogenital complaints, on a scale from 1 (none) to 10 (very much). Eleven patients received physiotherapeutic interventions and 5 received medicines to treat the OAB. Of these, 3 patients mentioned that they experience ADRs; dry mouth (3×), dry eyes (1×) and dry vagina (1×). The OAB had an average influence of 3.0 on the quality of life, on a scale from 1 (none) to 10 (very much). These data indicate that patients are willing and able to give proper information about the effect and ADRs of their OAB treatment. After analysis, the wording of some questions was revised to make the question clearer. Conclusion: GPs are enthusiastic and a sufficient number of patients per GP practice have been included, providing clear information about their perspective of the effect and ADRs of their treatment. A next step is to expand the registry to a greater number of patients and to develop an automatic feedback module. This concerns individualized feedback for patients which will give them insight in their own situation. In addition, there will be feedback for patients and GPs to get a general insight in the patient's perspectives of effects and risk of medicines. This could result in better treatment, tailored to patients' needs and experiences.
Original languageEnglish
Number of pages1
Publication statusPublished - 1-Nov-2018
Event18th ISoP Annual Meeting “Pharmacovigilance without borders” Geneva, Switzerland, 11–14 November, 2018 - Geneva, Switzerland
Duration: 14-Nov-201818-Nov-2018


Conference18th ISoP Annual Meeting “Pharmacovigilance without borders” Geneva, Switzerland, 11–14 November, 2018


18th ISoP Annual Meeting “Pharmacovigilance without borders” Geneva, Switzerland, 11–14 November, 2018


Geneva, Switzerland

Event: Conference


  • adult, adverse drug reaction, conference abstract, cost effectiveness analysis, dry eye, electronic health record, feasibility study, female, follow up, general practitioner, human, major clinical study, market, middle aged, monitoring, Netherlands, outcome assessment, overactive bladder, patient-reported outcome, pilot study, quality of life, questionnaire, side effect, vaginal dryness, xerostomia

ID: 71293474