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1.
Therapie ; 2022 Oct 31.
Article in English | MEDLINE | ID: covidwho-2086767

ABSTRACT

INTRODUCTION: When the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic began, there were no effective treatments assessed by clinical trials. In this context, in France, the French Public Health Council issued, from 5 March, 2020, several proposed recommendations for the therapeutic management of this new disease. This included the use of combination lopinavir/ritonavir, which is usually indicated as HIV treatment. Thanks to the reporting of adverse drug reactions (ADRs) to the French Regional Pharmacovigilance Centers, several safety signals including hepatobiliary and cardiovascular were quickly identified. OBJECTIVE: This study aimed to compare the ADRs reported with lopinavir/ritonavir used in its usual indication prior to the pandemic with the ADRs reported with the coronavirus disease 2019 (COVID-19) indication. METHODS: Cases of ADRs were extracted from the French Pharmacovigilance Database. ADRs were compared between the two periods: pre-COVID (1985 to 31 December 2019) and COVID (1 January 2020 to 21 July 2020). RESULTS: Patients with COVID-19 were found to have a different safety profile, with significantly more damage to the liver (43% of ADRs), heart (10.6%) and kidneys (7.1%). The ADRs reported before the pandemic were mainly gastrointestinal and cutaneous. CONCLUSIONS: This different safety profile may be related to the effect of the virus on the organs, the patient profile (age, medical history…) and the drugs associated with lopinavir/ritonavir. Our study should serve as a reminder that the safety profile of a drug can depend on its use. Spontaneous reporting and pharmacovigilance have a critical role in alerting health professionals to "new" ADRs reported with well-known drugs.

2.
Rev Panam Salud Publica ; 46: e178, 2022.
Article in Spanish | MEDLINE | ID: covidwho-2083020

ABSTRACT

Objective: Characterize and describe reports of suspected adverse reactions to a group of drugs used in Colombia, Costa Rica, Cuba, Chile, El Salvador, Mexico, and Peru to treat or prevent coronavirus disease (COVID-19) between 1 March and 31 August 2020. Methods: A list of the 13 drugs used to treat or prevent COVID-19 was prepared, based on official and unofficial sources. Drawing on the databases of the national pharmacovigilance programs of the participating countries, reports of suspected adverse reactions to these drugs were collected for the period from 1 March and 31 August 2020. Results: A total of 3 490 reports of suspected adverse reactions were received from the pharmacovigilance programs of Peru (n = 3 037), Cuba (n = 270), Colombia (n = 108), Chile (n = 72), and El Salvador (n = 3). The drugs with the highest number of reported adverse reactions were azithromycin, ivermectin, and hydroxychloroquine. Diarrhea was the most frequent event (15.0%). Of the total suspected adverse reactions, 11.9% were reported as serious. The most frequent was QT prolongation following use of hydroxychloroquine. Of these suspected serious adverse reactions, 54.5% occurred in people over 65 years of age. Conclusions: While it is not possible to establish a causal relationship from the evaluation of spontaneous reports, the present study confirms the presence of adverse reactions-some of them serious-involving drugs used to treat or prevent COVID-19.


Objetivo: Caracterizar e descrever as notificações de suspeitas de reações adversas a um grupo de medicamentos utilizados na Colômbia, Costa Rica, Cuba, Chile, El Salvador, México e Peru, para tratar ou prevenir a doença do coronavírus (COVID-19), entre 1º de março e 31 de agosto de 2020. Métodos: Foi elaborada uma lista dos 13 medicamentos usados para tratar ou prevenir a COVID-19, segundo fontes oficiais e não oficiais. A partir das bases de dados dos programas nacionais de farmacovigilância dos países participantes, foram coletadas notificações de suspeitas de reações adversas a esses medicamentos, recebidas no período entre 1º de março e 31 de agosto de 2020. Resultados: Foram recebidas 3.490 notificações de suspeitas de reações adversas dos programas de farmacovigilância do Peru (n = 3.037), Cuba (n = 270), Colômbia (n = 108), Chile (n = 72) e El Salvador (n = 3). Os medicamentos com maior número de notificações de reações adversas foram azitromicina, ivermectina e hidroxicloroquina. A diarreia foi o evento mais frequente (15,0%). Do total de suspeitas de reações adversas, 11,9% foram notificadas como graves. A mais frequente foi o prolongamento do intervalo QT após o uso de hidroxicloroquina. Dessas suspeitas de reações adversas graves, 54,5% ocorreram em pessoas com mais de 65 anos. Conclusão: Embora não seja possível estabelecer uma relação causal com base na avaliação de relatos espontâneos, o presente estudo confirma a presença de reações adversas ­ algumas graves ­ a medicamentos que foram usados para tratar ou prevenir a COVID-19.

3.
Front Immunol ; 13: 965171, 2022.
Article in English | MEDLINE | ID: covidwho-2080143

ABSTRACT

Introduction: Although the European Medicines Agency (EMA) encourage coronavirus disease 2019 (COVID-19) vaccination in pregnant women, the scientific evidence supporting the use of COVID-19 vaccines during pregnancy is still limited. Aim: We aimed to investigate adverse events following immunization (AEFI) with COVID-19 vaccines during pregnancy. Methods: We retrieved Individual Case Safety Reports (ICSRs) related to the use of COVID-19 vaccines during pregnancy from the EudraVigilance database for the year 2021. We analyzed AEFI related to the mother and fetus/newborn. The reporting odds ratio (ROR) was computed to compare the reporting probability of spontaneous abortion between COVID-19 vaccines. Results: During the study period, among 1,315,315 ICSRs related to COVID-19 vaccines, we retrieved 3,252 (0.25%) reports related to the use in pregnancy. More than half (58.24%) of ICSRs were submitted by non-healthcare professionals. Although the majority (87.82%) of ICSRs concerned serious AEFI, their outcomes were mostly favorable. In this study, 85.0% of total ICSRs referred to pregnant women (n = 2,764), while 7.9% referred to fetuses/newborns (n = 258). We identified 16,569 AEFI. Moreover, 55.16% were AEFI not related to pregnancy (mostly headache, pyrexia, and fatigue), while 17.92% were pregnancy-, newborn-, or fetus-related AEFI. Among pregnancy-related AEFI, the most reported was spontaneous abortion. Messenger RNA (mRNA) vaccines had a lower reporting probability of spontaneous abortion than viral vector-based vaccines (ROR 0.80, 95% CI 0.69-0.93). Moderna and Oxford-AstraZeneca vaccines had a higher reporting probability of spontaneous abortion (ROR 1.2, 95% CI 1.05-1.38 and ROR 1.26, 95% CI 1.08-1.47, respectively), while a lower reporting probability was found for Pfizer-BioNTech vaccine compared with all other COVID-19 vaccines (ROR 0.73, 95% CI 0.64-0.84). In addition, 5.8% of ICSRs reported a fatal outcome. Conclusions: No strong insight of unknown AEFI associated with COVID-19 vaccination in pregnant women was observed. Considering the high risk associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, our analysis suggests that the benefits of COVID-19 vaccines during pregnancy outweigh the possible risks. However, it is important to continue monitoring the safety profile of COVID-19 vaccines in this subpopulation.


Subject(s)
Abortion, Spontaneous , COVID-19 Vaccines , COVID-19 , Female , Humans , Infant, Newborn , Pregnancy , Abortion, Spontaneous/epidemiology , Abortion, Spontaneous/etiology , Adverse Drug Reaction Reporting Systems , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Pregnant Women , SARS-CoV-2 , Vaccination/adverse effects , mRNA Vaccines
4.
Pharmaceutical Journal ; 308(7961), 2022.
Article in English | EMBASE | ID: covidwho-2065042
5.
Pharmaceutical Journal ; 305(7943), 2022.
Article in English | EMBASE | ID: covidwho-2064912

ABSTRACT

There have been increasing reports of misuse of a range of prescription and over-the-counter (OTC) drugs for recreational purposes. The use of psychoactive pharmaceuticals and 'pharming' are new, widespread phenomena involving the non-medical use of prescription and OTC drugs, which are recreationally used to achieve psychoactive effects either on their own or in combination with other substances. This article provides an overview of the topic, focusing on a range of medicines (e.g. prescription medicines such as quetiapine, gabapentinoids, Z-drugs, bupropion, venlafaxine and over-the-counter medicines such as loperamide, dextromethorphan, benzydamine, promethazine, chlorphenamine, diphenhydramine and hyoscine butylbromide) that have emerged as misused and diverted, or are already described through the literature, as well as recorded by drug users' online websites reporting new trends and experimentations of drug abuse. This rapidly changing drug scenario represents a challenge for pharmacy, psychiatry, public health and drug control policies. Moreover, possibly resulting from the COVID-19 pandemic, drug use habits and availability have changed, causing a shift in behaviours relating to both prescription and OTC medicines. Healthcare professionals should be aware of potential prescription drugs diversion, recognise misuse cases, consider the possibility of polydrug misuse, and prevent it where possible. Pharmacists can prevent and reduce drug abuse, and should be involved in evidence-based actions to detect, understand and prevent drug diversion activities and the adverse effects of drug misuse. Copyright © 2020 Pharmaceutical Press. All rights reserved.

6.
Otolaryngology - Head and Neck Surgery ; 167(1 Supplement):P145-P146, 2022.
Article in English | EMBASE | ID: covidwho-2064485

ABSTRACT

Introduction: Paxlovid (nirmatrelvir/ritonavir) is a novel, orally administered COVID-19 therapeutic with a reported dysgeusia incidence of 5.6%, based on the initial clinical trial. The purpose of this study is to report the incidence and associated factors of this adverse event following the emergency use authorization of Paxlovid in December 2021, compared with other COVID-19 therapeutics (OCTs), using the US Food and Drug Administration Adverse Event Reporting System (FAERS) database. Method(s): This retrospective study investigated Paxlovidassociated adverse events (PAE) and OCT adverse events queried from the FAERS database between December 1, 2021, to June 10, 2022. Descriptive statistics were performed on PAE demographic data as well as all causes of dysgeusia. Comparisons of dysgeusia incidence between Paxlovid and OCT were reported using odds ratio, Fischer exact test, and multivariate analyses. Result(s): A total of 6735 PAE and 4251 OCT adverse events were included. Paxlovid accounted for 39.4% of all medication- associated dysgeusia (n=675) between January and March 2022. Paxlovid-associated dysgeusia (PAG) was the most common PAE, with an incidence of 24.84%. PAG was associated with nonserious COVID-19 outcomes (odds ratio [OR]=4.449) and female gender (OR= 1.6), both P<.0001. Compared with OCT, Paxlovid was 12 times more likely to be associated with dysgeusia (OR=12.03;P<.0001). Conclusion(s): Our findings support a strong association between Paxlovid and dysgeusia using a real-world pharmacovigilance database. Specifically, PAG is a highly prevalent occurrence that may be particularly unique to this COVID-19 therapeutic, as compared with others. Gender may also be associated with this event. Additional studies are needed to elucidate the precise mechanism of this common adverse effect.

7.
Ther Adv Neurol Disord ; 15: 17562864221129383, 2022.
Article in English | MEDLINE | ID: covidwho-2064681

ABSTRACT

Background: Evidence on mortality risks associated with MS-immunotherapies during the SARS-CoV2 pandemic derived thus far mainly from single country experiences. Objective: In this analysis, we aim to determine the frequency of COVID-19 associated fatality reports of patients receiving an MS-immunotherapy as reported to the international Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) from February 2020 to March 2021. Methods: In all, 1071 cases for this cross-sectional analysis were retrieved from FAERS and a multivariable logistic regression was performed. We adjusted for sex, age, region, month of report to FDA, immunotherapy-class and additionally for healthcare-system and pandemic-related metrics. Result: Anti-CD20 therapies (60%) followed by sphingosine-1 phosphate modulators (12%) and dimethylfumarat (10%) were reported most frequently. In 50% of the cases, MS-phenotype is not reported, relapsing MS in 35% and progressive MS in 15%. Besides older age (odds ratio [OR]: 1.1; 95% confidence interval [CI]: 1.07-1.13; p < 0.01), anti-CD20 therapies were significantly associated with a higher risk of death (OR: 4.1; 95% CI: 1.17-14.46; p = 0.03), whereas female sex was associated with a reduced mortality risk (OR: 0.4, 95% CI: 0.22-0.72; p < 0.01). Conclusion: Using international open access data and a multidisciplinary approach for risk prediction, we identified an increased mortality risk associated with anti-CD20 therapies, which is in line with national and multi-national cohort studies.

8.
Therapie ; 2022 Oct 07.
Article in English | MEDLINE | ID: covidwho-2061919

ABSTRACT

Pharmacovigilance and pharmacoepidemiology studies regarding the sex difference in adverse drug reactions are numerous, and it is now a challenge to take them into account in order to increase drug safety. Here, we present an overview of this topic through data on epidemiology, mechanisms, and methods used for assessing sex differences in drug safety. Because the literature is extensive, we choose to expose a few examples of studies for cardiovascular drugs, anti-infectious, psychotropics, antidiabetics, anticancer drugs and some specific drugs to illustrate our purpose. Many studies show a higher risk in women for most of drugs involving in sex differences. However, physiological, methodological and subjective points have to be taken into account to interpret these results. Clinical trials must also enroll more women to better evaluate sex differences both in efficacy and pharmacovigilance. Nevertheless, when there is a pharmacological rationale underlying the observed association between sex and drug safety profile, it is now unavoidable to think about its consideration for a personalized prescription.

9.
Chest ; 162(4):A2030-A2031, 2022.
Article in English | EMBASE | ID: covidwho-2060887

ABSTRACT

SESSION TITLE: Drug-Induced and Associated Critical Care Cases Posters 1 SESSION TYPE: Case Report Posters PRESENTED ON: 10/19/2022 12:45 pm - 01:45 pm INTRODUCTION: The use of remdesivir in critical care setting has been utilized treatment of covid, but not without risk. Many cases have reported severe cardiac effects with bradycardia being the most common. CASE PRESENTATION: The patient was a 15-year-old female with a history of asthma, hyperinsulinemia who required hospitalization for acute hypoxic respiratory failure secondary to COVID-19 pneumonia. She received ceftriaxone, azithromycin, and a 10-day course of remdesivir (RDV). On her third day of admission, the patient developed significant sinus bradycardic with heart rate nadir of 30-40 bpm but denied any symptoms. She completed her remdesivir course on day five of hospitalization and was discharged on day nine with a heart rate of 47 bpm. She later presented to ED the night of discharge following acute onset of lightheadedness and blurry vision at home secondary to orthostatic hypotension and bradycardia. Her pulse was 48 bpm, temperature 36.1 C, respirations 24/min, blood pressure 119/50 mmHg and SpO2 99% on room air. Her physical exam was unremarkable. EKG showed sinus bradycardia with a PR interval of 124 ms and QTc of 406 ms. Echocardiogram showed normal cardiac anatomy and function. Patient was diagnosed with persistent RDV-associated bradycardia and discharged home with a Holter monitor and cardiology follow-up. Bradycardia resolved by her follow-up visit two weeks later. DISCUSSION: According to the WHO pharmacovigilance database, bradycardia is a relatively new adverse effect and 3.6% of the 2,603 adverse effects reported since the onset of the pandemic, with 2 million RDV doses administered during this time [1]. The mechanism of RDV-associated bradycardia is proposed to be an effect of adenosine triphosphate, an active metabolite, which reduces SA node automaticity via stimulation of vagal nerve, as well as RDV cross-reactivity with mRNA polymerase, leading to cardiotoxicity that usually resolves within 24 hours of medication discontinuation. In our patient's case bradycardia did not resolve until eight days after discontinuation of medication [2]. Review of previously case reports does not identify any association with patient age but could be related to timing of when medication reaches therapeutic window, as many patients had onset of bradycardia on day 3 of treatment [3]. We report a pediatric case of severe acute COVID-19 who developed sinus bradycardia on day 3 of RDV treatment as previously described, but the bradycardia persisted long after the discontinuation of RDV. CONCLUSIONS: With over 50 thousand pediatric COVID-19 hospitalizations to date, this case serves as a timely reminder that medication side effects should be monitored closely, and that more research needs to be done into the effects of RDV on cardiac function in pediatric patients. Reference #1: Jung SY, Kim MS, Li H, Lee KH, Koyanagi A, Solmi M, Kronbichler A, Dragioti E, Tizaoui K, Cargnin S, Terrazzino S, Hong SH, Abou Ghayda R, Kim NK, Chung SK, Jacob L, Salem JE, Yon DK, Lee SW, Kostev K, Kim AY, Jung JW, Choi JY, Shin JS, Park SJ, Choi SW, Ban K, Moon SH, Go YY, Shin JI, Smith L. Cardiovascular events and safety outcomes associated with remdesivir using a World Health Organization international pharmacovigilance database. Clin Transl Sci. 2022 Feb;15(2):501-513. doi: 10.1111/cts.13168. Epub 2021 Oct 31. PMID: 34719115;PMCID: PMC8841455. Reference #2: Touafchia A, Bagheri H, Carrié D, Durrieu G, Sommet A, Chouchana L, Montastruc F. Serious bradycardia and remdesivir for coronavirus 2019 (COVID-19): a new safety concerns. Clin Microbiol Infect. 2021 Feb 27;27(5):791.e5–8. doi: 10.1016/j.cmi.2021.02.013. Epub ahead of print. PMID: 33647441;PMCID: PMC7910147. Reference #3: Rau, Cornelius MPhil;Apostolidou, Sofia MD;Singer, Dominique MD, PhD;Avataneo, Valeria PhD;Kobbe, Robin MD Remdesivir, Sinus Bradycardia and Therapeutic Drug Monitoring in Children With Severe CO

10.
Drug Safety ; 45(10):1175-1176, 2022.
Article in English | ProQuest Central | ID: covidwho-2047170

ABSTRACT

Introduction: Pharmacovigilance (PV) activities were affected by COVID-19. Therefore, several health authorities around the world have issued guidelines and practices to ensure that PV activities are maintained and continued during the pandemic [1]. Objective: This study aimed to assess the impact of COVID-19 on the preparedness and performance of national PV systems in 14 Arab Countries in the Middle East. Methods: This was a cross-sectional study that was conducted between July and October 2020. National PV centres in 18 in the Middle East were invited to participate in this study. Descriptive analysis was used to summarize and present the results of this study. Results: Responses were obtained from 14 (77.8%) countries. Adverse events reporting was the main PV activity that was covered by PV guidelines and practices. National guidelines and practices covered other PV activities in 8 (57.14%) of the participating countries. Performance and practices of national PV centres vary considerably among participating countries during the pandemic. Conclusion: The findings highlight the differences in preparedness and performance of different national PV centres in participating Middle Eastern countries. Improving digital infrastructure among participating countries could serve as a useful tool to minimize the impact of the pandemic on PV activities.

11.
Drug Safety ; 45(10):1176-1177, 2022.
Article in English | ProQuest Central | ID: covidwho-2047123

ABSTRACT

Introduction: The SARS-CoV-2 public health emergency is leading to challenges for healthcare professionals, students, patients with COVID-19 and vulnerable persons, blocking the economic development and mental wellbeing. The pandemic containment measures and the fear of infection have caused psychological distress and inflamed underlying diseases Objective: To analyse the impact of the SARS-CoV-2 on the Mental Health in Friuli-Venezia Giulia Region, Italy, focusing on depression disorder and Antidepressants consumption. Furthermore, to assess the state of adverse event reports, from spontaneous signalling method, in patients taking Antidepressants Methods: For consumption data extraction I utilized the Regional Social and Health Information System. About reports of ADRs based on the National Pharmacovigilance Network I used the VigiSegn app. I accessed on INTERCheck System to balancing the risks and benefits of therapies. I compared two periods from 11.03.2019 to 10.03.2020 and from 11.03.2020 to 11.03.2021 separated by 11 March 2020, when the Director General of the WHO described the situation as a pandemic [1]. Antidepressants were classified using the ATC code system. Anonymous drug utilization was expressed in DDDs Results: Since 11 March 2020 I observed a marginal increase in consumption of sertraline, trazodone and vortioxetine. Regarding pharmaceutical spending there has been an increase of sertraline, trazodone, vortioxetine, bupropion, mirtazapine and venlafaxine. In the feminine gender, I observed an increase in AD consumption in the age ranges < 15 yrs, 16-19, 30-34, 55-59, 60-64, 70-74, 80-84, over 85;in the male gender in the ranges < 15 yrs, 20-24, 30-34, 55-59, 70-74, 80-84, over 85 (Picture 1). Concerning ADRs I analysed one tab about AD out of a total of 2146 medicines and vaccines reports in which the "hyponatremia" is reported on the warning label and caused by significant drug interactions Conclusion: Although the SARS-CoV-2 public health emergency is a rapidly evolving situation, the knowledge about the impact on the Mental Health is still limited. It is likely that the psychosocial demand will increase in the coming months. In the regional context, the thesis has highlighted a very slight rise in AD consumptions and a cant decrease spontaneous signalling method compared to the previous year. These scenarios also depend on the new balance of health services and the lack of access to care (10% of citizens has given up on care) [13, 14]. The healthcare systems will have to face important challenges and the success of the creation of high-quality healthcare reality will depend on the alliance between healthcare specialists

12.
Drug Safety ; 45(10):1225, 2022.
Article in English | ProQuest Central | ID: covidwho-2047094

ABSTRACT

Introduction: During the COVID-19 vaccines deployment into health institutions (hospitals, primary public health centers (PPHCs));there was a great need to establish a robust pharmacovigilance system to follow the COVID-19 vaccines safety. Integrating both EPI and Iraqi pharmacovigilance center (IPC) systems at different levels to enforce the documentation, share COVID-19 adverse events following immunization (AEFIs), and effectively communicate safety information was crucial. Objective: Describe the steps taken to introduce a third level of the VigiFlow network at the level of hospitals and public health districts (PHDs). Methods: The VigiFlow network was expanded to include not only the 18 regional centers, but also the hospitals where the COVID-19 vaccines were deployed and the PHDs that are connected to the PPHCs. In order to integrate the proposed system for monitoring AEFIs of COVID-19 vaccines;the EPI manager at each Directorate of Health, granted access to the regional center database (VigiFlow). Likewise, national EPI representatives would also have access to the national database at the ministry level (IPC). At the IPC level, the pool of data from all over the country will be available for analysis, signal detection, and decision-making. Induction training program was performed in collaboration with the WHO and EPI. An Arabic manual for using VigiFlow for AEFIs was distributed to users. UMC educational videos on how to use the VigiFlow were translated into Arabic and shared with all participants to facilitate the use of the VigiFlow. A special guideline document was created with simple and comprehensive explanations of the AEFI reporting form(s) and how to transfer the information from the paper form to the VigiFlow system. pharmacovigilance officer at the national center was assigned the mission of supporting all the VigiFlow users across the country. Results: The results showed that 56% of the total COVID-19 vaccine VigiFlow AEFI reports were received through 3rd level VigiFlow organization users. Around 30% were active and sent more than 10 reports per year, representing 33.3% of hospitals and 29% of PHDs. Only 12% of these organizations shared more than 100 reports. The highest number of reports shared in one month was 905 AEFIs reports during August 2021. During December 2021, the highest number of 3rd level VigiFlow organizations sharing AEFIs reports in a single month was 35. Conclusion: The VigiFlow system was successfully used as a national COVID-19 vaccine AEFIs database, with hospitals and public health districts serving as third level.

13.
Drug Safety ; 45(10):1139-1140, 2022.
Article in English | ProQuest Central | ID: covidwho-2047035

ABSTRACT

Introduction: High interest in the last two years was globally put by Health Authorities on the recording, coding, and reporting of medication errors to ensure the safety and effectiveness of the use of medicines and to provide reliable information to healthcare professionals and patients. Medical coding is a prerequisite for efficient, effective, and reproducible data outputs. Objective: Not applicable. Methods: A sample of medication error coding results was assessed for accuracy and consistency of MedDRA coding and identification of main types of coding errors. It included 1500 coded reported terms for COVID-19 vaccines medication errors, assigned to MedDRA codes by national regulatory authorities or pharmacovigilance centers and drawn from the Uppsala Monitoring Centre (UMC) VigiBase through August 25, 2021. Results: One-third of the records could not be assessed due to incomplete or unclear verbatims. In one-third, code assignments were correct, but another third of the sample was not adequately coded. Most frequent coding errors corresponded to vague PT assignments, while more detailed information was available for a more precise coding. This observation is similar to the EudraVigilance database, where some of the most assigned MedDRA terms for medication errors also represent vague concepts. Conclusion: These findings indicate that understanding of medication error documentation and assessment and of MedDRA content and coding guidelines need to be reinforced. The MedDRA Maintenance and Support Services Organization (MSSO) offers several MedDRA coding trainings, including coding of medication errors. The authors provide valuable references to the latter, to the applicable ICHEndorsed Guides for MedDRA Users, and to relevant EMA guidance.

14.
Drug Safety ; 45(10):1307, 2022.
Article in English | ProQuest Central | ID: covidwho-2047017

ABSTRACT

Introduction: The rapid development and deployment of SARSCoV-2 vaccines elevated reliance on pharmacovigilance to inform benefit-risk assessments and national vaccine policy recommendations. During the mass vaccination program against pandemic coronavirus, the VAERS received an unprecedented number of adverse event reports. The VAERS database doubled in size in 2021 and accumulated 856,340 SARS-CoV-2 vaccine reports (54.3% of all VAERS reports) as of May 6, 2022 (HHS 2022). This publicly available resource has been heavily relied upon to inform US vaccine policy. Objective: To understand how VAERS has been used to study the safety of the SARS-CoV-2 vaccines. Methods: Publications containing the terms "Vaccine Adverse Event Reporting System" or VAERS and COVID-19 or SARS-CoV-2 were identified from PubMed. Non-research articles, publications that did not use VAERS or did not study SARS-CoV-2 vaccines, and withdrawn publications were excluded. Key data fields were ed from the remaining articles and summarized through descriptive statistics. Results: 88 publications were identified with 27 excluded upon review;1 was withdrawn, 9 were commentaries/editorials, and the remainder did not study SARS-CoV-2 vaccines in VAERS. Approximately one-half of the 61 included publications focused on one or more Adverse Events of Special Interest (e.g., anaphylaxis, facial nerve palsy, Guillain-Barre syndrome, myocarditis/pericarditis, etc.) or death rather than all events or signal detection. Several special populations were studied including children, adolescents, and "pregnant persons." Methods ranged from constructing a case series for clinical review to modeling. Adverse event reporting rates were calculated in 36 studies (58%). Denominators were derived from state or national vaccine administration data (CDC 2022), and included estimates of doses administered, number of persons vaccinated, and person-years. In more than one-third of the publications that calculated adverse event reporting rates, these values were misreported or misinterpreted by the study authors as estimates of incidence rates or cumulative incidence (risk). Conclusion: The rapid nationwide SARS-CoV-2 vaccine rollout resulted in an unprecedented volume of VAERS reports, which have been relied upon to investigate rare adverse events and inform vaccination policy. The methods and scientific rigor of vaccine adverse event studies varied considerably. Despite the inability to calculate incidence or risk using voluntary adverse event reports, these terms were frequently used instead of, or interchangeably with, reporting rate. Where a causal relationship exists, relying on reporting rates as a proxy for incidence may substantially distort estimates of harms (Weiss 2022).

15.
Drug Safety ; 45(10):1191, 2022.
Article in English | ProQuest Central | ID: covidwho-2046981

ABSTRACT

Introduction: Undertaking effective drug safety monitoring can be particularly challenging in low-resource settings due to a lack of infrastructure, weak regulatory systems and poor access to training and education [1]. Given the continued impact the COVID-19 pandemic is having upon health systems globally, it is essential to ensure that pharmacovigilance systems in these vulnerable settings have the capacity to address both the exacerbated pre-existing and novel challenges that they now face [2]. This project seeks to harness the membership of an online pharmacovigilance platform, globalpharmacovigilance.org (GPV) to work together in a 'community of practice' (CoP) on specific challenges facing pharmacovigilance during the pandemic [3, 4]. Objective: To gather consensus on pharmacovigilance priorities in low-resource settings during the COVID-19 pandemic and provide resources to address them using a CoP model. Methods: This project has built on a consensus-gathering methodology developed by The Global Health Network that has been implemented successfully during the pandemic to address wider COVID-19 research priorities. An online survey of GPV members was used to identify highly-ranked areas for pharmacovigilance improvement in low-resource settings during the pandemic. A virtual workshop was then hosted to invite further discussion on the survey results and reach consensus on the highest priorities. Members of the CoP were next invited to form virtual working groups, each focussing on one of the top 3 priorities identified. These groups are being supported by GPV to work together and facilitate the development (or provision, if pre-existing) of pharmacovigilance resources to address the priorities identified. Results: Of the 43 pharmacovigilance 'themes' that were presented to the CoP membership in the initial survey, 3 topics were identified as the highest priorities at that point in the COVID-19 pandemic, where support, training and guidance are needed;'The safety of COVID-19 vaccination in pregnancy', 'The safety of COVID-19 vaccination in children/adolescents' and 'Analysis of COVID-19 vaccine safety data'. As of May 2022, the number of GPV members interested in involvement in working groups addressing these themes are 207, 206, and 284 respectively. Initial group meetings took place in April 2022 and discussions are ongoing as to how to take group activities forward and address the priorities identified. Conclusion: A CoP model represents an effective method of consensus gathering amongst pharmacovigilance stakeholders at a global level, and allows rapid identification of healthcare priorities during public health emergencies. It is anticipated that working groups outputs will include the provision of resources designed to address the priorities identified.

16.
Drug Safety ; 45(10):1186, 2022.
Article in English | ProQuest Central | ID: covidwho-2046964

ABSTRACT

Introduction: Remdesivir, has been evaluated in the treatment of SARS-CoV-2 pneumonia in several clinical trials, then it has been used in routine care since the European approval in this indication. Objective: The main objective of the RESPIR'Nantes study was to describe the clinical outcome and safety of patients treated with remdesivir in real life. We chose here to focus on safety outcomes. Methods: To describe the safety, we considered adverse events (AEs), based on those reported to date in the Summary of Product Characteristics and potential post-marketing signals from the inter- national pharmacovigilance database Vigilyze®. AEs were classified according to the System Organ Class (SOC) of the Medical Dic- tionary of Adverse Events terminology. The AEs of SOC "hepatobiliary disorders" and "renal and urinary disorders" being the most reported to date, a detailed analysis was performed Results: A total of 76 patients were included in the study from March 13 to December 31, 2020. The most common AEs were metabolism and nutrition disorders, hepatobiliary disorders, gastrointestinal dis- orders and renal and urinary disorders. Patients with hepatobiliary disorders had mainly include transami- nases increases and 60% had pre-existing hepatobiliary disease that worsened during treatment. The median time to onset or worsening of hepatobiliary disease was one day [1-2]. It led to discontinuation of treatment in one case. Among patients with renal and urinary disor- ders, 50% had increased blood creatinine levels prior therapy initiation. The median time to onset or worsening of renal and urinary disorders was one day [0-16]. It led to discontinuation of treatment in two cases. Conclusion: A potential signal of pharmacovigilance has been identified for liver and renal disorders in Vigilyze® and we have reported the expected remdesivir Aes. However, it is difficult to suspect remdesivir only without considering the pathology itself, but remdesevir appears to have favorable safety profile in patients who require minimal supplemental oxygen.

17.
Drug Safety ; 45(10):1197-1198, 2022.
Article in English | ProQuest Central | ID: covidwho-2046859

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.

18.
Drug Safety ; 45(10):1182-1183, 2022.
Article in English | ProQuest Central | ID: covidwho-2046844

ABSTRACT

Introduction: During the strengthened Covid-19 vaccine safety surveillance, the Moroccan pharmacovigilance center has collected a higher number of adverse events following immunization (AEFI) reports. More than half of the Individual Case Safety Reports (ICSRs) collected in the National pharmacovigilance database since its cre-ation are linked to Covid-19 vaccines [1]. Objective: To assess the impact of the inclusion of the AEFI related to Covid-19 vaccines on the measures of disproportionality in the National pharmacovigilance database. Methods: Measurement of disproportionality by the calculation of the Reporting odds ratio (ROR) [2] for the "Drug-Effect" pairs collected at the National pharmacovigilance database (data from March 16, 2022) with and without inclusion of Covid-19 vaccines. Using "VigiLyze" (Uppsala Monitoring Center) we calculated the RORs and exported to "Excel" the list of "Drug-Effect" pairs for which the lower limit of the 95% confidence interval of the ROR is greater than 1. Then, on the list obtained, we recalculated by Excel the RORs after excluding the Covid-19 vaccines from the database. Results: Among the 69,814 cases of adverse effects recorded in the National pharmacovigilance database from March 16, 2022, 36,541 cases (52.6%) concerned Covid-19 vaccines (Table 1). The measurement of the disproportionality showed that 88% of the RORs increased and 5% decreased after inclusion of Covid-19 vaccines in database. The median of the ROR change factor following this inclusion (RORCovid vaccines included/RORCovid vaccines excluded) was 2.1 (1.8-2.1);this can be explained by the higher proportion of Covid-19 vaccines cases (half of the database). Also, the degree of this influence depends on the frequency of AEFI to Covid-19 vaccines. Thus, the ROR had decreased with inclusion of cases of covid-19 vaccines for most common reactions and had been multiplied by a factor more than 2 for the low-reported reactions with Covid-19 vaccines. Conclusion: The inclusion of Covid-19 vaccines in the National pharmacovigilance database has influenced the measures of disproportionality, which would influence signal detection. This bias must be taken into account when a type of drug or vaccine is very represented in a database. The proposed solution is to specify database for these types of products or to improve VigiLyze to be able to perform disproportionality measurements from parts of the national database.

19.
Drug Safety ; 45(10):1272, 2022.
Article in English | ProQuest Central | ID: covidwho-2046802

ABSTRACT

Introduction: European legislation on pharmacovigilance was amended with the adoption of EU Regulation 2010/1235 [1], which introduced significant changes in the active participation of patients and healthcare professionals to the Adverse Drug Reaction (ADR) reporting process. In recent years a new trend has established worldwide, allowing patients to directly report ADRs to national pharmacovigilance authorities [2]. A consumer, defined as a nonhealthcare professional, is now also considered as a source of information on the safety of a medicinal product [3]. Objective: To identify numerosity and level of the involvement of citizens in ADR reporting in Sardinia. Methods: We extracted data using Vigisegn platform from the Sardinian Region, from 2013 to 2021, for ADRs, stratified by year and qualification of the signaler. ADRs were also analyzed by severity, outcome, SOC (System Organ Classification) and ATC2 (Anatomical Therapeutic Chemical Classification System, level 2). Results: In Sardinia, from 2013 to 2021, 6.591 ADR reports were recorded, 1093 (17%) of which were by citizens. Among those reports, 75% were classified as "not serious" and 37% had resolved completely. From 2013 to 2021, citizen participation in ADR reporting changed significantly, from 1 to 26% (Table). In this period, most SOCs reported by citizens were "General pathologies and conditions related to site of administration" (596), "Pathologies of nervous system" (421), "Pathologies of musculoskeletal system and connective tissue" (328). As for SOC "Pathologies of reproductive system and breast", a significant increase in reporting was recorded: from 0% in 2013 to 73% in 2021. In this period, citizen reporting of pathologies of reproductive system and breast constituted 49% of the total reports. In absolute terms, the ATC J07 Vaccine was the most reported by citizens with 799 reports (2737 in 2021). Reports by citizens for homeostatic calcium drugs (H05) account for 81% (48 ADRs) of the total reports for this ATC. Conclusion: Increase in citizen reporting in 2017 and 2021 can be traced back to the information activities of the Regional Center following the introduction of mandatory vaccination and the awareness campaign for Covid-19 vaccines. Such increase reflects the growing importance of pharmacovigilance among citizens, meaning that an increasing number of citizens have now acquired the necessary tools to ADR reporting, thus becoming a significant source of information on the safety of drugs and vaccines.

20.
Drug Safety ; 45(10):1193-1194, 2022.
Article in English | ProQuest Central | ID: covidwho-2046801

ABSTRACT

Introduction: The anti-Covid vaccines approved in Italy are: Comirnaty, Spikevax, Vaxzevria, Janssen, Nuvaxovid. As of March 26th, 2022, 134,361 adverse events following immunization have been collected in the National Pharmacovigilance Database, 69% of them concern women [1]. Regarding the Sardinian region, as of May 12th, 2022, there are 3043 total reports, 63.4% involve women. In July 2021, the French Drug Agency issued an alert about reports concerning menstrual alterations [2]. PRAC, since new studies have been published, recently decided to further investigate [3]. A cohort study conducted in the US comparing cycle length in a vaccinated cohort vs. an unvaccinated cohort, showed a statistically significant difference [4]. A British case-control study found that 20% of the population included reported menstrual changes, with a higher incidence in individuals with a history of Covid infection [5]. A Norwegian study showed similar results [6]. Objective: To describe the adverse events regarding menstrual disorders in the Sardinian population vaccinated against Covid-19. Methods: We analyzed reports of suspected adverse reactions in the National Pharmacovigilance Database regarding the region of Sardinia, from December 27th, 2020 to April 30th, 2022, we extracted those concerning menstrual cycle alterations after Covid-19 vaccine administration. Results: A total of 78 reports referring to all three scheduled administrations were collected. The majority concerned Comirnaty, with 56 reports: 51 were non-serious, concerning abnormal menstrual cycles in lenght and flow, amenorrhea, dysmenorrhea;five cases were considered serious, but there were other adverse events associated (hypersensitivity reactions, autoimmune disorders, myocarditis in one case). Six reports were related to Vaxevria, with similar manifestations as for Comirnaty;in one case the patient was treated with Tamoxifen. Sixteen cases were reported for Spikevax, with one reporting an episode of bleeding in a three-year menopausal patient. In one case, the patient (IUD carrier) reported menstrual disturbances following all three vaccine administrations (two Comirnaty, one Spikevax). Conclusion: The different distribution of reports among the vaccines can be explained by the increased administration of Comirnaty in the general population and the phasing out of Vaxzevria. Menstrual disorders are common and can be related to several conditions, although a link with Covid vaccines is plausible, as highlighted by recent studies [4-6] and as already observed for other vaccines. In particular, the strong immune system response created by mRNA vaccines may affect the hypothalamic-pituitary-ovarian axis, which regulate the menstrual cycle.

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