A Sex- and Gender-Based Analysis of Adverse Drug Reactions: A Scoping Review of Pharmacovigilance Databases

Abstract

Drug-related adverse events or adverse drug reactions (ADRs) are currently partially or substantially under-reported. ADR reporting systems need to expand their focus to include sex- and gender-related factors in order to understand, prevent, or reduce the occurrence of ADRs in all people, particularly women. This scoping review describes adverse drug reactions reported to international pharmacovigilance databases. It identifies the drug classes most commonly associated with ADRs and synthesizes the evidence on ADRs utilizing a sex- and gender-based analysis plus (SGBA+) to assess the differential outcomes reported in the individual studies. We developed a systematic search strategy and applied it to six electronic databases, ultimately including 35 papers. Overall, the evidence shows that women are involved in more ADR reports than men across different countries, although in some cases, men experience more serious ADRs. Most studies were conducted in higher-income countries; the terms adverse drug reactions and adverse drug events are used interchangeably, and there is a lack of standardization between systems. Additional research is needed to identify the relationships between sex- and gender-related factors in the occurrence and reporting of ADRs to adequately detect and prevent ADRs, as well as to tailor and prepare effective reporting for the lifecycle management of drugs.

An Analysis of the Pattern and the Risk Factors of Adverse Drug Reactions at a Tertiary Care Hospital

“…Similar findings were shown in a study by Oliver Pascale et al and could be due to the fact that this population is attending hospital more frequently and is a major population receiving drug therapy [21]. A positive association between incidence of ADR and increasing age was as well found which was consistent with the findings of Barbate et al [9].…”

“…Surprisingly, there are instances where, ADR-related costs, such as hospitalization, surgery and lost productivity, far exceed the cost of the medications [3,7]. The recent epidemiological studies have reported that ADR are the fourth to sixth leading causes of death [1,8,9]. The WHO defined "Pharmacovigilance" as "The science and activities related to the detection, assessment, understanding and prevention of adverse drug effects or any other possible drug-related problems [3,10]."…”

“…Despite the various shortcomings of the spontaneous ADR reporting systems, they still remain as the most prevalent method within Pharmacovigilance centers across the world, which permits, ongoing evaluation, and continues to be one of the best ways for early detection and prevention of unexpected and uncommon ADRs [3,10,11]. In the absence of excellent ADR reporting systems, multiple preventable causes of ADRs may remain undetected for significant period of time, which amplifies the unexpected negative outcomes encountered in patient care [9,[12][13][14].…”

COVID-19 Vaccines Adverse Reactions Reported to the Pharmacovigilance Unit of Beira Interior in Portugal

“…Generally, the female gender is the one that most notified to any drug, due to the greater susceptibility to develop ADRs, compared to the male gender, probably due to the physiological differences between both sexes. Additionally, it may be related to women’s greater attention to their health and signals developed by their body [ 29 , 32 , 33 ]. International studies also confirm the aforementioned data regarding the age groups and gender with the highest notification rates of vaccine-associated ADRs [ 34 , 35 ].…”

Underreporting and Triggering Factors for Ophthalmic Drugs’ ADR Notification; a Comparison between Spontaneous Reporting and Active Pharmacovigilance Databases

“…Similar to what was found in this research, an increase of ADRs in females have already been reported. The literature divides this event into two main aspects, those related to gender (more informed on health issues, concern about your health, a propensity to report symptoms, increased interest in reporting) [25,26], and those related to sex (metabolic, pharmacokinetic, pharmacodynamic, and hormonal factors) [27,28]. It is possible that factors related to sex could be influencing the increase in ADRs in the active surveillance database.…”