Assessing studies of patients spontaneously reported adverse drug reactions (ADR's): a review study

Background: Adverse drug reactions (ADRs) are an important health issue with significant impact on patient safety. Most ADRs are submitted by health professionals (HCP) however there is increasing interest in patient reporting of ADRs. Reports submitted by patients is considered limited majorly due to lack of
knowledge on the reporting process.

Objectives: To review spontaneous reporting of ADRs by patients with a focus on the methods used for reporting.

Methods: MEDLINE and EMBASE databases were searched for studies in English published any year. Main keywords used were patient self-reporting, ADR, spontaneous reporting, patient safety, and patient ADR reporting. Studies that evaluated ADRs reported by HCP were excluded. Two independent reviewers were responsible for assessing studies eligibility and data extraction. A third reviewer resolved any disagreement regarding.

Results: Thirteen studies were included in this review. The studies were mainly from Europe (53.8%) and the majority of patients who completed ADR reports were female (69.2%). The most commonly used method by patients for spontaneous reporting were paper based (n=6) and web-based forms (n=4). Studies investigated any ADRs had a slightly higher prevalence rate compared to reports of ADRs secondary to a specific pharmacological class or medical
condition. Patient ADR reporting using pre-specified forms yielded higher response rate than general reporting forms. In addition, patients tended to take
longer time to complete an ADR report compared with health professionals and in some cases there was considerable difference in content between health professional and patient reported ADRs.

Conclusions: Encouraging patients to report encountered ADRs can add to the patient safety profile, capturing different aspects of ADRs than that reported
by health professionals. Using a specific designed questionnaire for a certain drug class or medical condition may help in increasing the number of reports submitted by patients, however patient education is needed to ensure that patients are aware of and able to complete such forms.