Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training

A lack of training on pharmacovigilance likely leads pharmacists to underreport adverse drug reactions (ADRs), according to a recent analysis.

To identify the main causes of ADR underreporting among health care professionals, researchers from São Paulo State University in Brazil reviewed 29 studies published over a 20-year period, most of which were conducted in hospitals (24) and involved physicians (22) or pharmacists (10).

From those studies, the investigators compiled a list of 7 factors related to the causes of ADR underreporting, which they termed the “7 deadly sins”:

1. Complacency, or believing that serious ADRs are well documented when the drug is on the market

2. Fear of a lawsuit

3. Guilt for being responsible for damage observed in the patient

4. Ambition of group and publish case series for financial benefit

5. Ignorance on how to describe the notification, supposing that only serious ADRs must be reported

6. Insecurity about reporting suspicious ADRs, believing that there should only be notification if the damage was undoubtedly caused by the use of a specific drug

7. Indifference, or lack of interest, time, or other excuses related to postponing ADR notification

Among those sins, the main causes of ADR underreporting were ignorance and insecurity, which were strongly correlated with pharmacists’ and physicians’ low knowledge about the activities involved in drug safety analysis. As a result, the researchers called for more educational interventions aimed at clarifying the concepts and processes of reporting ADRs, including information on “which ones should be recorded (any suspected adverse drug events), who can register, and the return to society (patient safety), health facilities (reduction of unnecessary costs), and the pharmaceutical market (control and regulation).”

The authors also identified indifference as a main cause of ADR underreporting, mainly due to the lack of interest and time among physicians and pharmacists. Thus, they concluded that improving access to registration forms and simplifying the documentation process would help boost ADR reporting rates, in addition to facilitating greater communication between pharmacists and pharmacovigilance centers.

Based on their overall findings, the researchers added an eighth deadly sin regarding ADR underreporting: the lack of training on drug safety for pharmacists and physicians.

“The underreporting causes often informed by health professionals are related mainly to the low knowledge of concepts and processes related to pharmacovigilance and to indifference regarding this service,” the authors concluded. “Continuing education, easy access to the registration form, and its simplification are strategies that can be developed to increase the registration rates of ADR.”