data collection and accessibility for scientific research of outpatient data. Three studies (Barbosa et al. 2022, Frent et al. 2022, Okuyama et al. 2022) used data from pharmacovigilance databases to generate safety data. Okuyama, Galvao et al. 2022 analyzed cross-referenced information from three different health care administrative databases: official death records between 1996 and 2019 from the Mortality Information System in Brazil, hospitalizations between 2008 and 2020 from the Hospital Information System, and cases of poisonings between 2017 and 2020 in health services that have been notified to the National System for Vigilance of Notifiable Diseases. The analysis shows that the reports were more frequent among adults, particularly women, and due to accidents, with exposure to paracetamol identified as a concern for preventable intoxications, hospitalizations and deaths. Barbosa et al. (Barbosa, Silva et al. 2022) identified early safety signals of antibacterial agents to support pharmacovigilance systems using data from a Brazilian database (Vigimed/VigiFlow) from December 2018 to December 2021. Vancomycin was the most reported antibiotic, followed by ceftriaxone and piperacillin and tazobactam. Three serious events were associated with ceftazidime and avibactam, a new drug in the Brazilian market. Frent et al. (Frent, Leucuta, Bucsa, Farcas, Casoinic and Mogosan 2022) performed a descriptive analysis of cases of acute renal failure and nephrolithiasis reported from Sodium-Glucose Co-Transporter 2 (SGLT2) inhibitors in VigiBase to September 2021. The vast majority of acute renal failure and nephrolithiasis reports were considered serious. Canagliflozin was the gliflozin most involved in cases of acute renal failure and nephrolithiasis.Healthcare records are another important source of real-world data. Healthcare records play a crucial role in generating RWD in the field of healthcare and medical research. One way that healthcare records contribute to generating real-world evidence is through observational studies using de-identified patient data from healthcare records. A cross-sectional database study in Switzerland (Rachamin et al. 2022) used medical records to determine patient age-and sex-specific prevalence rates of polypharmacy, and rates of prescribing of the most frequently used medication classes; they also explored practitioner variability in prescribing practices in Swiss general practitioners. The prevalence of polypharmacy in the adult Swiss general practice population was determined to be 24%, increasing with age: from 6% in patients aged 18-40 years to 65% in patients aged 81-92 years. Women had higher rates of polypharmacy than men.The difference was more pronounced at younger ages, and interestingly, hormonal contraceptives did not relevantly contribute to the difference. The most clear drivers of the differing rates of polypharmacy in the younger population were higher prescription rates of vitamins, mineral supplements, and antianemic preparations in female patients. Men were more often prescribed agents targeting the cardiovascular system (such as antihypertensive agents, antithrombotic agents, and lipid modifying agents), whereas most other medications were more often prescribed to women. A cohort study (Gorgui et al. 2022) undertaken in Canada involving the linkage of three Quebec databases was undertaken to quantify the risk of babies being born small for gestational age (SGA) and very small for gestational age (VSGA) with the use of medically assisted reproduction. While no association was observed between medically assisted reproduction and SGA or VSGA in the study population; medically assisted reproduction was associated with an increased risk for SGA among preterm pregnancies; no increased risk of SGA was observed in term pregnancies. Another cohort study (Oh et al. 2022) examined the association between gabapentin use and neurocognitive changes in older adults using the National Alzheimer's Coordinating Center Uniform Data Set (NACC UDS). The NACC UDS has rich data and is an example of how building a database with real-world data focused on answering research questions can contribute to decision making in health. This data set provided a greater sample size compared with previous studies in this population and was able to measure the association between gabapentin initiation and neurocognition with various clinically relevant outcomes. The results provided evidence that gabapentin was associated with increased odds of global cognitive decline, functional status decline, and motor function change in the two years following gabapentin initiation. Considering that gabapentin may block calcium channels in the brain, it was hypothesized that it would have a neuroprotective effect, but these findings did not support this assumption. The authors concluded that further experimental studies are needed to examine the mediators of gabapentin use and neurocognitive changes.On the other hand, systematic reviews with meta-analyses (SR-MA) also play a crucial role in informing healthcare decisions, policy-making, and advancing scientific knowledge. Two systematic reviews and meta-analyses published in this Research Topic were designed to complement the knowledge obtained from randomized control trials and observational studies of primary data to evaluate the real-world effectiveness of medications. These reviews (Castro et al. 2022, Queiroz et al. 2022) summarized the evidence produced from observational studies involving administrative databases of different drug classes of disease-modifying drugs (DMARDs) in patients with rheumatoid arthritis (RA). The meta-analysis by Queiroz et al.(Queiroz, Castro, Albuquerque, Brandão, Gerlack, Pereira, Barros, Andrade, Bastos, Azevedo, Carreiro, Barreto and Santos 2022) did not suggest there is an increased risk of adverse events associated with the use of biologics for the treatment of RA, indicating a lower risk of cardiovascular events with abatacept than tumor necrosis factor inhibitors (TNFi) (low to very low certainty of the evidence). The meta-analysis by Castro et al. (Castro, Queiroz, Albuquerque, Brandão, Gerlack, Pereira, Barros, Andrade, Bastos, Azevedo, Carreiro, Barreto and Santos 2022) synthesized data on 182,098 RA patients across 21 studies included. They concluded that biologics effectively treat patients with RA, with higher effectiveness for non-TNFi and Janus kinase inhibitors (JAKi) than with TNFi. A policy brief is another type of evidence synthesis combining research evidence specific to stakeholders' contextual knowledge. The policy brief from Fulone et al. (Fulone et al. 2022) identified evidence-based strategies to improve adherence to preventive measures against COVID-19 at the community level. Three evidencebased strategies were identified: i. Risk communication; ii. Health education to the general public, and iii. Financial support and access to essential supplies and services. The evidence showed that an increase in knowledge, transparent communication, and public awareness about the risks of COVID-19 and the benefits of adopting preventive measures result in changes in people's attitudes and behavior, which can increase adherence. These strategies can guide future actions and the formulation of public policies to improve adherence to preventive measures in the community in future epidemics. Finally, this Research Topic also includes a protocol on a scoping review (Leal et al. 2022) describing the methodology for assessing the available literature on emulation target trials to study outcomes in women exposed to medications in the preconception, perinatal, or postpartum periods.To conclude, this first Research Topic on Women in Pharmacoepidemiology highlights the range of robust research that is being performed by women in science, and pharmacoepidemiology in particular, across the globe today. Research is varied, and complementary, and is being undertaken across the life course, from conception to adulthood. However, the lack of true global representation of women in science is a significant issue that has persisted for many years and requires a multi-faceted approach to address the issue. Efforts to increase the representation of women in science should be a priority for governments, educational institutions, scientific organizations, and society as a whole. By breaking down barriers and creating more inclusive environments, we can unlock the full potential of women in advancing scientific discovery and innovation. We need to do better in the future to promote the work of women scientists all over the world. It is with great pleasure that we are presenting Women in Pharmacoepidemiology 2021.
6 Authors
- IF
Ioana Frent
Department of Pharmacology, Romania
- DL
Daniel Leucuta
Department of Medical Informatics and Biostatistics, Romania
- CB
Camelia Bucsa
Pharmacovigilance Research Center, Romania
- AF
Andreea Farcas
Pharmacovigilance Research Center, Romania
- FC
Florin Casoinic
Department of Internal Medicine, Romania
- CM
Cristina Mogosan
Department of Pharmacology, Romania
4,180 views
4 citations
6 Authors
- LF
Lisiane Freitas Leal
Faculty of Medicine and Health Sciences, Canada
- SM
Sonia Marzia Grandi
Child Health Evaluative Sciences, Canada
- DM
Daniel Marques Mota
Brazilian Health Regulatory Agency (Anvisa), Brazil
- PJ
Paulo José Gonçalves Ferreira
Brazilian Health Regulatory Agency (Anvisa), Brazil
- GG
Genevieve Gore
Schulich Library of Physical Sciences, Canada
- RW
Robert William Platt
Faculty of Medicine and Health Sciences, Canada
4,583 views
2 citations

