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      Enhancing self-medication practices in the era of infodemic: the role of pharmacovigilance

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          Abstract

          Background The COVID-19 pandemic has represented one of the most important public health events of the last century, with more than 6.9 million deaths attributable to the disease. 1 Fortunately, the advent of vaccines for this disease, almost a year after the appearance of the pandemic, drastically changed the global panorama, preventing at least 14 million additional deaths just in the first year of vaccination. 2 The combination of knowledge from many areas of expertise has allowed humanity to overcome the pandemic in an incredibly short period of time. Apart from the fundamental problem of finding preventive and therapeutic strategies to control the disease – something practically solved thanks to the vaccines – the pandemic has been characterized by an avalanche of information, often incorrect and lacking in scientific evidence, about potential new therapies that did not provide any benefit, but did have an associated risk of adverse effects, sometimes serious or even fatal. 3 Likewise, the appearance of vaccines in record time compared to the usual times of clinical research generated mistrust in some sectors of the population, who viewed with concern the appearance of some serious but at the same time very infrequent adverse events (e.g. cavernous sinus thrombosis). 4 This excessive concern was largely due to not having a clear idea of the risk-benefit ratio of vaccines for COVID-19, based on ignorance of the extreme rarity of this type of event, as well as a lack of awareness of the high effectiveness of these vaccines in preventing serious or fatal forms of the disease – even though it doesn’t have a significant effect to diminish the contagion risk. This clearly favorable risk-benefit ratio has made it possible to offer the vaccination (and application of booster doses) to practically all population groups, from 6 months onwards. 5 A special collection with 10 brilliant articles Based on this problem, I have proposed this special collection in Therapeutic Advances in Drug Safety entitled ‘Self-Medication and Pharmacovigilance in the Era of Infodemic’, which finally sees the light with 10 published articles from 3 different continents. The World Health Organization (WHO) defines self-medication as: ‘the selection and use of medicines by individuals to treat self-recognized illnesses or symptoms’ 6 ; and pharmacovigilance as ‘the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem’. 7 Hence, it is evident that these two concepts are closely intertwined, emphasizing that pharmacovigilance plays a crucial role in enhancing self-medication practices, promoting responsible and safe self-medication. On the topic of characterizing the problem, three original studies that identify the potential risks associated with self-medication for COVID-19 stand out. One of them was a Colombian study using a mystery shopping methodology, which found that pharmaceutical establishments played a critical role in contributing to inappropriate self-medication for COVID-19. 8 Two additional studies, one of them conducted in the United States, and the other in Colombia, found that self-medication for COVID-19 was a relatively frequent behavior during the pandemic, which included potentially dangerous drugs (e.g. chloroquine), and that to a large extent it was determined by the influence of social networks. 9,10 Regarding risk characterization, I wish to highlight the contribution of Baracaldo-Santamaría et al. 11 on the adverse effects of frequently self-medicated drugs for COVID-19, while the article on how the WHO Uppsala Monitoring Centre rose to the challenge of the global vaccination campaign for COVID-19 is an excellent contribution by Rudolph et al. 12 In line with these publications, Eslait-Olaciregui et al. 13 present an interesting review on neurological adverse reactions associated with COVID-19 vaccines. Risk communication in pharmacovigilance is one of the most critical and delicate aspects of this important discipline, and in particular the communication to the general public of the risk associated with COVID-19 vaccines for the aforementioned reasons. This topic was clearly addressed by Colombian, Moroccan and Middle Eastern colleagues in a brilliant review, 14 as well as by Fermont et al., 15 who share the successful experience of Israel in this special collection. In this order of ideas, Quintero-Hernández synthesizes in a magnificent editorial the importance of assertive communication not only in, but also arising from pharmacovigilance, to promote mass vaccination for COVID-19. 16 Finally, and keeping in mind that self-medication is a central theme of this special issue, my colleagues and I at the Universidad del Rosario in Bogotá, Colombia carried out a scoping review on the concept of self-medication, and we took it upon ourselves to propose a new definition of self-medication, which we submit for discussion by the global scientific community. 17 Conclusion As editor, I hope that the special issue will be of great interest to the readers, and especially to all those who played a part in overcoming this global emergency from different areas of knowledge, and that, it will leave valuable insights in terms of the appropriate use of medicines, risk communication and pharmacovigilance, which may be applicable to future global health emergencies.

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          Global impact of the first year of COVID-19 vaccination: a mathematical modelling study

          Background The first COVID-19 vaccine outside a clinical trial setting was administered on Dec 8, 2020. To ensure global vaccine equity, vaccine targets were set by the COVID-19 Vaccines Global Access (COVAX) Facility and WHO. However, due to vaccine shortfalls, these targets were not achieved by the end of 2021. We aimed to quantify the global impact of the first year of COVID-19 vaccination programmes. Methods A mathematical model of COVID-19 transmission and vaccination was separately fit to reported COVID-19 mortality and all-cause excess mortality in 185 countries and territories. The impact of COVID-19 vaccination programmes was determined by estimating the additional lives lost if no vaccines had been distributed. We also estimated the additional deaths that would have been averted had the vaccination coverage targets of 20% set by COVAX and 40% set by WHO been achieved by the end of 2021. Findings Based on official reported COVID-19 deaths, we estimated that vaccinations prevented 14·4 million (95% credible interval [Crl] 13·7–15·9) deaths from COVID-19 in 185 countries and territories between Dec 8, 2020, and Dec 8, 2021. This estimate rose to 19·8 million (95% Crl 19·1–20·4) deaths from COVID-19 averted when we used excess deaths as an estimate of the true extent of the pandemic, representing a global reduction of 63% in total deaths (19·8 million of 31·4 million) during the first year of COVID-19 vaccination. In COVAX Advance Market Commitment countries, we estimated that 41% of excess mortality (7·4 million [95% Crl 6·8–7·7] of 17·9 million deaths) was averted. In low-income countries, we estimated that an additional 45% (95% CrI 42–49) of deaths could have been averted had the 20% vaccination coverage target set by COVAX been met by each country, and that an additional 111% (105–118) of deaths could have been averted had the 40% target set by WHO been met by each country by the end of 2021. Interpretation COVID-19 vaccination has substantially altered the course of the pandemic, saving tens of millions of lives globally. However, inadequate access to vaccines in low-income countries has limited the impact in these settings, reinforcing the need for global vaccine equity and coverage. Funding Schmidt Science Fellowship in partnership with the Rhodes Trust; WHO; UK Medical Research Council; Gavi, the Vaccine Alliance; Bill & Melinda Gates Foundation; National Institute for Health Research; and Community Jameel.
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            Definition of self-medication: a scoping review

            Self-medication (SM) is a global and growing phenomenon. It represents a public health problem due to antibiotic resistance, risk of adverse drug reactions, drug–drug interactions, disease masking, and increased morbidity. There is not a consensus on the definition of SM. The definitions found in different studies make it difficult to address this problem from a theoretical perspective and therefore find an adequate solution to this public health problem. The aim of this article is to search the medical literature to characterize the current understanding of SM in the medical community. We conducted a scoping review of definitions of SM by searching on PubMed – Medline, Embase, and LILACS using the following combination of keywords: ‘self-prescription’ or ‘self prescription’, ‘self-medication’ or ‘self medication’, or ‘automedication’ and ‘definition’ or ‘explanation’. The search was limited to articles containing the definition of SM, with no limit on language or year. Duplicate studies and those that did not mention the definition of SM were excluded from the final review. A total of 65 studies were included in the final selection. We found a vast heterogeneity in the definition of SM. Most articles based their definition of SM on the process of obtaining the drug, the nonparticipation of a specific health professional, the source of the medication, and the reason for SM. Other interesting concepts such as self-care, nonadherence to a prescription, reuse of stored drugs, and sharing and lending medicines were also considered forms of SM by other authors, however. This study highlights the need to reach a consensus regarding the definition of SM to adequately propose strategies to address this global health problem. This study shows the diverse concepts that need to be included in a future definition of SM. Plain Language Summary Definition of self-medication: a review with systematic methodology Self-medication (SM) is a global and growing phenomenon that represents a public health problem due to antibiotic resistance, risk of dangerous side effects, interactions between drugs, and disease masking. Currently, there is not a consensus on the definition of SM, which makes it difficult to address this problem and therefore find an adequate solution. Making a standard definition would allow the development of programs focused on addressing drug-related problems associated with self-medication behavior. The purpose of this article is to search the medical literature to define the current understanding of SM in the medical community. We included a total of 65 studies and found a great variance in the definition of SM. Most articles based their definition of SM on the process of obtaining the drug, the nonparticipation of a specific health professional, the source of the medication, and the reason for SM. Other interesting concepts such as self-care, not following a prescription, reuse of stored drugs, and sharing and lending medicines were also considered forms of SM by other authors, however. Furthermore, this study highlights that SM is a wider concept that goes beyond aiming to promote and restore health, as aesthetic and recreational purposes are also reasons for SM that can put individuals at risk and compromise the correct and safe use of medications.
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              Global safety monitoring of COVID-19 vaccines: how pharmacovigilance rose to the challenge

              Pharmacovigilance (PV) came suddenly into the spotlight when several new vaccines, developed as a response to the COVID-19 pandemic, received emergency authorisation and were rolled out on a large scale in late 2020. The vaccines underwent stringent clinical trials and evaluation from regulatory authorities, but with the use of novel technology and an anticipated rapid and vast deployment of the vaccines, the importance of a well-functioning international post marketing safety surveillance system was stressed. International PV stakeholders were faced with several challenges due to the extent of the global vaccination campaign. The unprecedented volume of reports of suspected adverse events following immunization has led to the development and use of new tools. Furthermore, the collaboration between various PV stakeholders was encouraged and strengthened. PV rose to the challenges posed by the currently ongoing global COVID-19 vaccination campaign and successful adaptations were made in a short period of time. However, the pandemic has not ended yet, the vaccination campaign is far from being completed, and further challenges are anticipated. Advances made during the pandemic will be important to strengthen PV in future and ensure to advance medicines’ safety together. Plain Language Summary Global safety monitoring of the COVID-19 vaccines: challenges, preparations, and outlooks Pharmacovigilance (PV) is the umbrella term for all sciences and activities relating to the detection, assessment, understanding, and prevention of adverse effects relating to medicines or vaccines. PV came into the spotlight when several new vaccines were authorised and rolled out as a response to the COVID-19 pandemic. The anticipated extent of the global vaccine rollout stressed the importance of a well-functioning safety surveillance system and international collaborations between patients, health care workers, vaccine producers, regulatory authorities, and PV centres. The identification and communication of potential safety concerns showed that adaptations to PV processes made in a short period of time as well as international collaborations were successful. However, it is important to learn from experiences made so far and to make sure the positive advances are maintained in the future to advance medicines’ safety together.
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                Author and article information

                Contributors
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: Project administrationRole: ResourcesRole: SoftwareRole: SupervisionRole: ValidationRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Journal
                Ther Adv Drug Saf
                Ther Adv Drug Saf
                TAW
                sptaw
                Therapeutic Advances in Drug Safety
                SAGE Publications (Sage UK: London, England )
                2042-0986
                2042-0994
                23 August 2023
                2023
                : 14
                : 20420986231194754
                Affiliations
                [1-20420986231194754]Research Group in Applied Biomedical Sciences (UR Biomed), School of Medicine and Health Sciences, Universidad del Rosario, Carrera 24 # 63C–69, Bogotá 111221, Colombia
                Author notes
                Author information
                https://orcid.org/0000-0002-7305-8727
                Article
                10.1177_20420986231194754
                10.1177/20420986231194754
                10457137
                4a6d8834-c0ef-4c45-9206-6a3fd7fe4d17
                © The Author(s), 2023

                This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License ( https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages ( https://us.sagepub.com/en-us/nam/open-access-at-sage).

                History
                : 24 April 2023
                : 16 July 2023
                Categories
                Self-Medication and Pharmacovigilance in the Era of Infodemic
                Editorial
                Custom metadata
                January-December 2023
                ts1

                covid-19,covid-19 vaccines,editorial,pharmacovigilance,infodemic,self-medication

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