ABSTRACT
Introduction: European pharmacovigilance legislation requires healthcare professionals and citizens to report any suspected adverse drug reaction (SADR). SADRs are uploaded into the National Pharmacovigilance Network (RNF) database by the local responsible of pharmacovigilance. This information feeds Eudravigilance, the European database appointed to collect spontaneous reports of adverse reactions [1]. In the Veneto Region the quality of data entered in the RNF database by the Local Health Authority (LHA) is monitored by the Regional Centre of Pharmacovigilance [2]. Given the central role of vaccines in tackling the pandemic, we focused our attention on SADRs reported for the Covid-19 vaccines. Objective(s): This analysis aims to evaluate the SADRs related to Covid-19 vaccines entered by the LHA of Verona into the RNF database. Number and type of SADRs for the different vaccines administered to people assisted in the LHA were analyzed. Method(s): The doses of Comirnaty-Pfizer/BioNTech, Vaxzevria- AstraZeneca, Spikevax-Moderna and Janssen-Janssen Cilag vaccines administered in the period 01.01.2021-31.12.2021 were considered suitable for the analysis and the SADRs were classified using Med- DRA terminology. Data related to the vaccines were analyzed using Microsoft Excel and were expressed in number and percentage. Result(s): The LHA recorded 3,595 signaling forms corresponding to 10,657 SADRs. 74.8% of the SADRs referred to females, mostly aged 40-59. 53.4% of the cases showed a complete symptom resolution;22.4% experienced an improvement or resolution of the symptoms with persisting side effects. 19.4% of the SADRs were not completely resolved at the reporting time. Death was reported in 0.3% of the cases, while in 4.5% the outcome was not available. Table 1 shows the number of administered doses for each vaccine and the related reporting rates (RRs) for all the SADRs. RR for Spikevax was the highest, regardless of the SADR seriousness. Regarding the SADRs specifically investigated by the regulatory agencies, our analysis highlighted the following figures: risk of pericarditis/myocarditis (5 vs. 2 vs. 1 reports with Spikevax, Comirnaty and Vaxzevria, respectively), vaccine-induced immune thrombotic thrombocytopenia (one report with Vaxzevria) and menstrual disorders (six reports with Comirnaty vs. one with Vaxzevria). Conclusion(s): The number of signaling forms received by the LHA of Verona highlights an increasing awareness on the importance of reporting to provide useful data for public safety. Our analysis confirms current available data regarding the most frequently SADRs experienced with Covid-19 vaccines [3-6]. However, our data are important to underline that SADRs of clinical interest related to each type of vaccine have a low incidence. (Table Presented).
ABSTRACT
Introduction: European pharmacovigilance legislation requires healthcare professionals and citizens to report any suspected adverse drug reaction (SADR). SADRs are uploaded into the National Pharmacovigilance Network (RNF) database by the local responsible of pharmacovigilance. This information feeds Eudravigilance, the European database appointed to collect spontaneous reports of adverse reactions [1]. In the Veneto Region the quality of data entered in the RNF database by the Local Health Authority (LHA) is monitored by the Regional Centre of Pharmacovigilance [2]. Given the central role of vaccines in tackling the pandemic, we focused our attention on SADRs reported for the Covid-19 vaccines. Objective: This analysis aims to evaluate the SADRs related to Covid-19 vaccines entered by the LHA of Verona into the RNF database. Number and type of SADRs for the different vaccines administered to people assisted in the LHA were analyzed. Methods: The doses of Comirnaty-Pfizer/BioNTech, VaxzevriaAstraZeneca, Spikevax-Moderna and Janssen-Janssen Cilag vaccines administered in the period 01.01.2021-31.12.2021 were considered suitable for the analysis and the SADRs were classified using MedDRA terminology. Data related to the vaccines were analyzed using Microsoft Excel® and were expressed in number and percentage. Results: The LHA recorded 3,595 signaling forms corresponding to 10,657 SADRs. 74.8% of the SADRs referred to females, mostly aged 40-59. 53.4% of the cases showed a complete symptom resolution;22.4% experienced an improvement or resolution of the symptoms with persisting side effects. 19.4% of the SADRs were not completely resolved at the reporting time. Death was reported in 0.3% of the cases, while in 4.5% the outcome was not available. Table 1 shows the number of administered doses for each vaccine and the related reporting rates (RRs) for all the SADRs. RR for Spikevax was the highest, regardless of the SADR seriousness. Regarding the SADRs specifically investigated by the regulatory agencies, our analysis highlighted the following figures: risk of pericarditis/myocarditis (5 vs. 2 vs. 1 reports with Spikevax, Comirnaty and Vaxzevria, respectively), vaccine-induced immune thrombotic thrombocytopenia (one report with Vaxzevria) and menstrual disorders (six reports with Comirnaty vs. one with Vaxzevria). Conclusion: The number of signaling forms received by the LHA of Verona highlights an increasing awareness on the importance of reporting to provide useful data for public safety. Our analysis confirms current available data regarding the most frequently SADRs experienced with Covid-19 vaccines [3-6]. However, our data are important to underline that SADRs of clinical interest related to each type of vaccine have a low incidence.
ABSTRACT
Background: For patients with cancer, the COVID-19 pandemic has increased morbidity and mortality due to their bigger susceptibility to infection and to the discontinuity of treatment. In this context, telemedicine has become an invaluable tool for cancer care. The purpose of this study is to describe the impact of telemedicine in the care of cancer patients from a Latin American public institution. Methods: Retrospective, descriptive and cross-sectional study of cancer patients who received medical care through telemedicine from the Department of Medical Oncology of the Instituto Nacional de Enfermedades Neoplasicas (INEN) during the COVID-19 pandemic, from March 2020 to February 2021. Data collection was performed in real time by medical oncologists. Impact was mesuared with a comparison between the amount of cancer care during the COVID 19 pandemic vs the previous year. A modified version of the University of Kansas Cancer Center telephone satisfaction survey was conducted. Variables included the process of requesting an appointment by telemedicine, satisfaction with telemedicine service and distribution of drugs. Results: 16 456 telemedicine visits were carried out in one year time, 96.1% were conducted by telephone and only 3.9% used a video communication platform. 73% of patients were female and 62% were in the age group from 31 to 60 years old. 43% corresponded to solid tumors where breast cancer was the most frequent diagnosis. Patients in active treatment represented 70% (n = 11587), with 64% of patients being treated with curative intent and 36% within the palliative setting. Regarding the result of telemedicine visits, 62% (n = 10,281) had a medical prescription (40% corresponded to hormonal therapy;and 19%, to intravenous or subcutaneous systemic treatment). Overall, 8% (n = 56) of cases required an in-person visit. In the annual comparative analysis (against in-person visits during the previous year), the gap was 23% (60%, 20%, 8% and 13% during the first, second, third and fourth quarters, respectively). According to the type of medical care, telemedicine accounted for the 27.6% of the total medical care employed during in the year. The maximum level of usage was in May 2020 with 52% and in February 2021 with 48%, coinciding with the first and second waves of COVID in Peru. The satisfaction survey was applied to 5765 randomly chosen patients from July to October 2020. The mean scores for the 3 variables studied were: 4.6 / 5 points for the process of requesting an appointment, 4.58 / 5 points for telemedicine service and 4.33 / 5 points for the distribution of medicines and orders. Conclusions: Telemedicine is key to guarantee the continuity of care for cancer patients with an adequate level of satisfaction. If the Telemedicine service had not been implemented, the number of medical consultations would have dropped to 40% in comparison to the previous year.