According to a recent report of the Canadian Patient Safety Institute, the management of adverse drug events (ADEs) in primary medical care is a public health priority [
1]. The proportion of patients presenting an ADE within the first three months following an ambulatory drug prescription was estimated to reach 25% in Gandhi et al. [
2]. Cardiovascular drugs have been found responsible for 20% to 30% of hospitalisations for ADEs; meanwhile, 20% to 40% of ADEs could be prevented [
2,
3]. A lack of information and communication between patients and health care professionals has been identified as an underlying factor favouring the occurrence of ADEs [
4,
5]. A significant proportion of ADEs and associated complications could be prevented if risk situations were detected earlier and if patients were better informed about participating in their own medical care and about reporting ADEs [
6]. In the InPAct (Information for Participating Actively) study, we focused on the reporting of ADEs by patients. Because clear differences have been shown between reports emanating from patients and those emanating from health professionals, it is essential that patients be able to report ADEs in order to supplement the reporting of ADEs by health professionals [
7,
8]. It has been found that patients report ADEs four times less often than do health professionals [
7,
9]. Considerable variations have been observed from one country to another in terms of the proportion of total ADE reports submitted by patients as opposed to the proportion submitted by health professionals [
10]. In France, according to data from the ANSM (French National Agency for the Safety of Medicines and Health Products), only 1% of official ADE reports are made by a patient. We decided to focus on ADE reports made by antihypertensive-treated patients in primary care for three reasons. First of all, hypertension is common, with two-thirds of people older than 65 affected by this condition in developed countries [
11]. Also, drug prescriptions for this sector of the population are often composed of at least four different drugs, which increases the risk of ADEs [
12‐
14]. Finally, the proportion of patients experiencing at least one ADE within the first three months following the prescription of an antihypertensive has been estimated at 12.6% [
2].
The InPAct intervention is an interactive program. It consists of educating patients about taking a more active role in their own care, so that they are more likely to report antihypertensive-related ADEs to their general practitioner (GP). Another important goal of the InPAct program is to improve patient safety in primary care.
Our purpose is to present the methodology and expected results of the InPAct trial. The primary outcome aims to evaluate the effectiveness of the InPAct program in promoting patient reports of ADEs. The secondary outcomes include the measurement of the InPAct program’s effectiveness in limiting ADE risk situations and in reducing the occurrence and severity of ADEs. The other secondary outcomes are the evaluation of the health knowledge and the level of satisfaction of antihypertensive patients with respect to the medical care provided by their GP.