ABSTRACT
The pandemic had a very negative and penalizing impact on service activity sectors, including tourism and transport, to which Portugal was not immune. TAP Air Portugal, like Ryanair and easyJet, felt these adverse effects in their operations, forcing them to readjust their operating network. The present investigation aims to assess the effects of the pandemic on these airlines at Lisbon and Porto airports between 2019 (pre-pandemic) and 2022. In methodological terms, the analysis will be exploratory, descriptive, and mostly qualitative, based on the collection of information on the departure flights operated from these airports by the selected airlines in selecting dates. The results obtained show that TAP was the airline company most penalized given its international operation with many countries and their borders closed. In Porto, the results of this company were even more severe, reducing more than 50% of the airports served. © 2023, IGI Global. All rights reserved.
ABSTRACT
Of all the Portuguese private airlines that for many years competed with TAP Air Portugal (the Portuguese owned state airline) only Portugália Airlines (PGA) resisted the hegemony of the Portuguese flag carrier until it was bought by TAP itself. Portugália Airlines, a private airline, managed to maintain its operation, even against the power of the state company. This case study shows how PGA operated certain routes (here the Turin example, in Italy) as a survival strategy. The approach is exploratory and based on an observational description of facts. In view of the recent events caused by COVID 19, the pandemic has brought about a change in business models, also providing the warning that anyone who does not have a clear strategy, dies at birth. The case study leaves some interesting clues to explore. © 2023, IGI Global. All rights reserved.
ABSTRACT
This study aims to advance the understanding of sustainable behaviour by exploring the perceptions, knowledge, and opinions about the sustainability of nearly graduated students in Portugal. A three-wave exploratory and longitudinal study was conducted with Management and Marketing students in 2020, 2021, and 2022. The findings come from both quantitative and qualitative approaches. First, the results reveal low levels of knowledge about sustainability, Sustainable Development Goals, and other related concepts. Then, by a qualitative analysis, this study highlights the terms related to sustainability and perceived sustainable practices. It also examines changes perceived since the COVID-19 pandemic and what their threats and opportunities in the coming years are. The main conclusion of this study is the critical need for education on sustainability and related concepts beyond simple recycling practices. The use of sustainability as a marketing tool is insufficient to create a viable future. Higher education must develop a new shared and sustainable vision for sustainability education. © 2023 by the authors.
ABSTRACT
Introduction: The Portuguese government put into practice a vaccination plan soon after the approval of the first COVID-19 vaccine, prioritizing healthcare professionals (HCPs) and other population groups at risk. Objective(s): To characterize the case reports of adverse drug reactions (ADRs) associated with the administration of Comirnaty to HCPs in a Portuguese oncology hospital (IPO Coimbra). Method(s): This study was a nine-month prospective, observational study following a cohort event monitoring approach focused on signalling ADRs associated with the administration of Comirnaty to HCP in IPO Coimbra. The case reports of ADRs were sent to the Pharmacovigilance Unit of Coimbra (UFC) between 14/01/2021 and 13/10/2021. The population of HCP was characterized according to gender and age distribution. The seriousness of ADRs was assessed for each individual case in accordance with WHO criteria [1]. ADRs were coded with MedDRA version 24.0 (System Organ Classification [SOC] and Preferred Term [PT]). ADRs were classified as ''expected'' or ''unexpected'' according to their description in the Summary of Product Characteristics (SmPC) of Comirnaty [2]. Result(s): A total of 816 HCPs were inoculated with at least one dose of Comirnaty-. The case reports of ADRs concerned 469 (57.5%) HCPs: 386 (82.3%) females;642 (78.7%) aged 30-59 years old. Of the 469 case reports, 24 (5%) were assessed as serious, 44 (9.4%) as unexpected, and 11 (2.3%) as both serious and unexpected. The 469 case reports contained a total of 1,955 ADRs. ''General disorders and administration site condition'' (n = 1,075;54,9%), such as vaccination site pain, chills and vaccination site swelling;''Musculoskeletal and connective tissue disorders'' (n = 373;19.1%), including myalgia and arthralgia;and ''Nervous system disorders'' (n = 250;12.8%), including headache, were the most frequently reported ADRs, which is in line with the SmPC of Comirnaty-. The 11 case reports classified as both serious and unexpected contained a total of 17 ADRs, including hyperhidrosis and paraesthesia. Conclusion(s): The results of this study bring value to the characterization of the safety profile of Comirnaty since the use of a cohort of individuals allows to estimate frequencies of ADRs in the real-world. Further, serious, and unexpected ADRs were identified. Importantly, this type of safety data was further included in the SmPC of the vaccine. In conclusion, the results are in favour of the positive benefitrisk ratio of Comirnaty-, and reinforce the importance of post-marketing pharmacovigilance to increase knowledge on drug safety.
ABSTRACT
Introduction: The COVID-19 pandemic has had an impact on several sectors of the society. Whether it has disrupted drug safety monitoring is yet to be determined. Objective(s): To investigate whether the COVID-19 pandemic has had an impact on the proportions of spontaneous reports (SRs) of serious and unexpected adverse drug reactions (ADRs). Method(s): SRs received by the Coimbra Pharmacovigilance Unit (UFC) between January 2017 and December 2021 were included, except for those containing COVID-19 vaccines as suspected medicines. The SRs were categorized into two groups: pre-pandemic (2017-2019);and post-pandemic (2020-2021). The SRs were classified as serious or non-serious, and expected or unexpected, depending on the seriousness and expectedness of the suspected ADRs, according to the WHO criteria and the Summary of Product Characteristics [SmPC] of each suspected medicine, respectively [1,2]. To study the impact of the COVID-19 pandemic on the patterns of spontaneous reporting of suspected ADRs, two null hypotheses were proposed to test whether (i) the seriousness, and (ii) the expectedness were independent of the pandemic (i.e., if the pandemic has had no impact, then the proportions of SRs containing (i) serious and (ii) unexpected ADRs were expected to be the same in both periods). The qui-square test was used to test the hypotheses;p-values <0.001 were considered statistically significant. Microsoft Excel was used for the statistical analyses. Result(s): A total of 1,311 and 657 SRs were received in the prepandemic and post-pandemic periods, respectively. Of the 1,311 SRs received in the three pre-pandemic years, 1,012 (77%) were serious and 657 (13%) contained unexpected ADRs;of the 657 SR received during the two post-pandemic years, 434 (66%) were serious and 133 (20%) contained unexpected ADRs. The changes from pre- to postpandemic on both proportions of SRs containing serious (an absolute decrease of 11%;p = 0.01) or unexpected ADRs (an absolute increase of 7%;p = 0.01) were not statistically significant. Conclusion(s): The COVID-19 pandemic has had not a significant impact on the proportions of SRs of serious or unexpected ADRs in the Central Region of Portugal. Further research should be carried out in other pharmacovigilance databases to understand if the present conclusions are applicable to other geographic regions.
ABSTRACT
Introduction: The Portuguese government put into practice a vaccination plan soon after the approval of the first COVID-19 vaccine, prioritizing healthcare professionals (HCPs) and other population groups at risk. Objective: To characterize the case reports of adverse drug reactions (ADRs) associated with the administration of Comirnaty to HCPs in a Portuguese oncology hospital (IPO Coimbra). Methods: This study was a nine-month prospective, observational study following a cohort event monitoring approach focused on signalling ADRs associated with the administration of Comirnaty to HCP in IPO Coimbra. The case reports of ADRs were sent to the Pharmacovigilance Unit of Coimbra (UFC) between 14/01/2021 and 13/10/2021. The population of HCP was characterized according to gender and age distribution. The seriousness of ADRs was assessed for each individual case in accordance with WHO criteria [1]. ADRs were coded with MedDRA version 24.0 (System Organ Classification [SOC] and Preferred Term [PT]). ADRs were classified as expected or unexpected according to their description in the Summary of Product Characteristics (SmPC) of Comirnaty [2]. Results: A total of 816 HCPs were inoculated with at least one dose of Comirnaty. The case reports of ADRs concerned 469 (57.5%) HCPs: 386 (82.3%) females;642 (78.7%) aged 30-59 years old. Of the 469 case reports, 24 (5%) were assessed as serious, 44 (9.4%) as unexpected, and 11 (2.3%) as both serious and unexpected. The 469 case reports contained a total of 1,955 ADRs. "General disorders and administration site condition" (n = 1,075;54,9%), such as vaccination site pain, chills and vaccination site swelling;"Musculoskeletal and connective tissue disorders" (n = 373;19.1%), including myalgia and arthralgia;and "Nervous system disorders" (n = 250;12.8%), including headache, were the most frequently reported ADRs, which is in line with the SmPC of Comirnaty®. The 11 case reports classified as both serious and unexpected contained a total of 17 ADRs, including hyperhidrosis and paraesthesia. Conclusion: The results of this study bring value to the characterization of the safety profile of Comirnaty® since the use of a cohort of individuals allows to estimate frequencies of ADRs in the real-world. Further, serious, and unexpected ADRs were identified. Importantly, this type of safety data was further included in the SmPC of the vaccine. In conclusion, the results are in favour of the positive benefitrisk ratio of Comirnaty®, and reinforce the importance of post-marketing pharmacovigilance to increase knowledge on drug safety.
ABSTRACT
Introduction: The COVID-19 pandemic has had an impact on several sectors of the society. Whether it has disrupted drug safety monitoring is yet to be determined. Objective: To investigate whether the COVID-19 pandemic has had an impact on the proportions of spontaneous reports (SRs) of serious and unexpected adverse drug reactions (ADRs). Methods: SRs received by the Coimbra Pharmacovigilance Unit (UFC) between January 2017 and December 2021 were included, except for those containing COVID-19 vaccines as suspected medicines. The SRs were categorized into two groups: pre-pandemic (2017-2019);and post-pandemic (2020-2021). The SRs were classified as serious or non-serious, and expected or unexpected, depending on the seriousness and expectedness of the suspected ADRs, according to the WHO criteria and the Summary of Product Characteristics [SmPC] of each suspected medicine, respectively [1,2]. To study the impact of the COVID-19 pandemic on the patterns of spontaneous reporting of suspected ADRs, two null hypotheses were proposed to test whether (i) the seriousness, and (ii) the expectedness were independent of the pandemic (i.e., if the pandemic has had no impact, then the proportions of SRs containing (i) serious and (ii) unexpected ADRs were expected to be the same in both periods). The qui-square test was used to test the hypotheses;p-values < 0.001 were considered statistically significant. Microsoft Excel® was used for the statistical analyses. Results: A total of 1,311 and 657 SRs were received in the prepandemic and post-pandemic periods, respectively. Of the 1,311 SRs received in the three pre-pandemic years, 1,012 (77%) were serious and 657 (13%) contained unexpected ADRs;of the 657 SR received during the two post-pandemic years, 434 (66%) were serious and 133 (20%) contained unexpected ADRs. The changes from pre- to postpandemic on both proportions of SRs containing serious (an absolute decrease of 11%;p = 0.01) or unexpected ADRs (an absolute increase of 7%;p = 0.01) were not statistically significant. Conclusion: The COVID-19 pandemic has had not a significant impact on the proportions of SRs of serious or unexpected ADRs in the Central Region of Portugal. Further research should be carried out in other pharmacovigilance databases to understand if the present conclusions are applicable to other geographic regions.
ABSTRACT
Background/Introduction: The approval of COVID-19 vaccines has been based on fast clinical development programs leading to limited knowledge on safety data [1]. Unexpected adverse drug reactions (ADRs), including rare ADRs or delayed ADRs from long-term exposure, may occur [2]. Moreover pre-marketing clinical trials do not have power to detect all ADRs, thereby highlighting the need to analyse post-marketing spontaneous reports (SRs). Objective/Aim: To identify unexpected ADRs associated with COVID-19 vaccines spontaneously reported to the Regional Pharmacovigilance Unit of Coimbra in Portugal (UFC). Methods: SRs of ADRs associated with COVID-19 vaccines received by UFC between 30/12/2020 and 30/04/2021 were included. ADRs were coded with MedDRA®, v.24 (System Organ Classification [SOC] and Preferred Term [PT]). ADRs were classified as "expected" or "unexpected" according to their description on the vaccines Summary of Product Characteristics (SmPC). Further, each unexpected ADR was classified as an important medical event (IME) according to the list from the European Medicines Agency (EMA). Results: A total of 771 SRs, of which 262 SRs (34%) contained a total of 420 unexpected ADRs were received. For Comirnaty®, out of 287 unexpected ADRs, 26 (9.1%) were IME. The most frequently reported IMEs were angioedema (n = 2;7.7%), bradycardia (n = 2;7.7%), death (n = 2;7.7%), deep vein thrombosis (n = 2;7.7%), ischaemic stroke (n = 2;7.7%), and seizure (n = 2;7.7%). The remaining ADRs (acute kidney injury, cardio-respiratory arrest, cerebrovascular accident, corneal opacity, haemorrhagic stroke, hypertensive crisis, laryngeal oedema, loss of consciousness, pneumonia, pulmonary oedema, sepsis, status epilepticus, tongue paralysis and upper gastrointestinal haemorrhage), had one report each (n=14;53.8%). Of the 121 unexpected ADRs reported for Vaxzevria®, 20 were IME (16.5%). The most frequently reported IMEs were ischaemic stroke (n = 5;25.0%), and conjunctival haemorrhage (n = 3;15.0%). The remaining ADRs (acute myocardial infarction, altered state of consciousness, angina pectoris, arrhythmia, death, guillain-Barre syndrome, hypothermia, mesenteric vein thrombosis, monoplegia, pericarditis, syncope and truncus coeliacus thrombosis), had one report each (n = 12;60.0%). Twelve unexpected ADRs were reported for the Moderna COVID-19 vaccine®, of which 4 IMEs (33.3%), corresponding to cerebrovascular accident (n = 1;25.0%), conjunctival haemorrhage (n = 1;25.0%), death (n = 1;25.0%) and retinal artery occlusion (n = 1;25.0%). Conclusion: A considerable proportion of SRs received by UFC contained unexpected ADRs, among which 11.9% were IMEs. These results highlight the value of post-marketing spontaneous reporting to identify unknown ADrs and to better characterize the safety profiles of newly approved COVID-19 vaccines, as well as their benefit/risk ratios.