Pharmacovigilance teaching and learning: a mixed cross-sectional analysis of the Portuguese public higher education system Margarida Perdigão, Anabela Afonso, Sofia de Oliveira-Martins, Manuel José Lopes, Ana Margarida Advinha BMC Medical Education, 2024 Pharmacovigilance stands out for its importance in obtaining existing knowledge about medicine and patient safety and should be recognized as a continuous line of study. It constitutes a highly relevant component in the activities of health professionals, with spontaneous notification of suspected adverse drug reactions being its main emphasis. The underreporting that persists can be overcome through continuous professional development programs, reinforcing theoretical and practical knowledge in the curricular plans of health courses. As a result, more educated professionals will also allow citizens to recognize the importance of pharmacovigilance. The main objective of this study was to describe and characterize the teaching-learning process of pharmacovigilance in Portugal, analyzing the knowledge, perceptions and attitudes of students and health professionals. In total, ninety-three curricular unit forms of the seventeen healthcare courses included were analyzed, among which only three referred to pharmacovigilance as mandatory and thirty-nine did not address any keywords. The questionnaire applied was answered by 650 participants, both students (62%) and professionals (38%). Approximately 84.4% of the students and 54.7% of the professionals affirmed that they had never spontaneously reported an adverse drug reaction. Only 24.6% of the students and 17.8% of professionals referred to the existence of specific course content dedicated to pharmacovigilance in their coursework. In view of these results, it is evident that there is a need for a wider reflection regarding the further training and constant update of practicing professionals as well as in diverse health institutions, investing in the creation of an academic curriculum that integrates pharmacovigilance in healthcare courses.
Pharmacist's role in influenza immunisation: a scoping review Edna Ribeiro Parracha, António Teixeira Rodrigues, Sofia Oliveira‐Martins, Sónia Romano, Diogo Almeida, et al. Journal of Pharmacy Practice and Research, 2024 BackgroundCommunity pharmacists have become flu vaccine immunisers in several countries to increase vaccine uptake.AimThis study aimed to perform a scoping review to evaluate the pharmacist's role and contribution to flu immunisation coverage, satisfaction and promotion as vaccine providers.DesignThe framework proposed by Arksey and O'Malley and the PRISMA Extension for Scoping Reviews (PRISMA‐ScR) were considered for this analysis. Two electronic databases (PubMed and Cochrane Library) were used to search for relevant peer‐reviewed quantitative, qualitative and mixed‐method studies published between 1990 and 2022.ResultsA total of 37 studies were included. These studies suggested that, over time, there was an increase in the rate of vaccine administration within community pharmacies across the various countries examined. Moreover, patients have consistently expressed their satisfaction with the convenience and accessibility of pharmacy‐based vaccine services, with some expressing a preference for pharmacies over traditional visits to their general practitioner′s office.ConclusionSeveral initiatives aimed at promoting flu vaccination have been rolled out in pharmacy settings, and a number of these initiatives have demonstrated positive outcomes. The flu vaccination service provided by pharmacists has proven to be an asset in public health by improving accessibility to immunisation services. Pharmacists should continue to take part in yearly flu vaccination programs as flu vaccine providers as they contribute to an increased uptake of immunisations by the population. Extending these services to other vaccines should be further considered.
Artificial intelligence integration in the drug lifecycle and in regulatory science: policy implications, challenges and opportunities Wahiba Oualikene-Gonin, Marie-Christine Jaulent, Jean-Pierre Thierry, Sofia Oliveira-Martins, Laetitia Belgodère, et al. Frontiers in Pharmacology, 2024 Artificial intelligence tools promise transformative impacts in drug development. Regulatory agencies face challenges in integrating AI while ensuring reliability and safety in clinical trial approvals, drug marketing authorizations, and post-market surveillance. Incorporating these technologies into the existing regulatory framework and agency practices poses notable challenges, particularly in evaluating the data and models employed for these purposes. Rapid adaptation of regulations and internal processes is essential for agencies to keep pace with innovation, though achieving this requires collective stakeholder collaboration. This article thus delves into the need for adaptations of regulations throughout the drug development lifecycle, as well as the utilization of AI within internal processes of medicine agencies.
Experience and Learning from the COVID-19 Pandemic in Portugal: Perceptions of Community Pharmacy Professionals Ana Margarida Advinha, Margarida C Santos, Filipa Duarte-Ramos, Margarida Perdigão, Patricia Santos, et al. Portuguese Journal of Public Health, 2023 Background: During the COVID-19 pandemic, community pharmacy (CP) professionals were among those who experienced the greatest risk of contracting SARS-CoV-2, which forced major adaptations. Objectives: The objectives of the study were to describe the changes implemented in CP professionals during the pandemic, understand the perception of professionals about their experience, and explore changes to remain. Methods: An observational and cross-sectional study was conducted via an online questionnaire (June–September 2020). The target population was CP professionals working in Portugal for >2 years and serving the public during the pandemic. Results: Of a total of 353 participants, 84% were female (mean age of 37.6 years), and 81% were pharmacists (mean professional experience of 12.9 years). In the management and organizational dimensions, the most mentioned changes were adaptation to legislative changes (90%), fluctuations in the treasury (82%), and reduction of working hours (46%). Only 2% resorted to simplified layoff. In the back office, there was a need to adapt stock management (93%) and purchase personal protective equipment (99%). In the front office, there was a change in service policies – wicket or conditional opening (92%), routes of the arrival of user requests (91%), and home delivery (82%). Physical changes occurred in 100% of pharmacies. The most frequently implemented procedures were the use of protection systems and PPE, articulation with hospital pharmacies for dispensing in proximity (75%), and training in this area (55%). Regarding interpersonal climate, improvements in the connection between team members are evident: increase in mutual help (57%), solidarity (54%), and group cohesion (50%); in the relationship with clients, the majority indicated the replacement of the usual user by third parties (71%), and changes in communication channels (increase in use of technological means 68%). Conclusions: Results illustrate the profound impact of the pandemic on CP professionals, both professionally and personally. It also highlights the importance of their roles in proximity and community support.
Mobile apps for quick adverse drug reaction report: A scoping review Edna Ribeiro Parracha, Ana Margarida Advinha, Manuel José Lopes, Sofia Oliveira‐Martins Pharmacoepidemiology and Drug Safety, 2023 Spontaneous notification systems are essential in a post‐marketing safety context. However, using this method, only about 6% of all adverse drug reactions are notified. To overcome this sub‐notification problem, new methods need to be developed to improve and facilitate reporting. In this sense, the use of digital media, mainly medical mobile apps, has been presented as a powerful tool, including in pharmacovigilance. We performed a scope review to identify the available apps used to report adverse drug reactions around the world to eventually identify which of them best fits the Portuguese pharmacovigilance system.