Your browser doesn't support javascript.
Show: 20 | 50 | 100
Results 1 - 20 de 121
Filter
1.
Clin Drug Investig ; 42(12): 1065-1074, 2022 Dec.
Article in English | MEDLINE | ID: covidwho-2085621

ABSTRACT

BACKGROUND AND OBJECTIVE: Coronavirus disease 2019 (COVID-19) caused by the SARS-CoV-2 virus has caused millions of deaths worldwide. The mRNA vaccines prevented the figure from being more severe. The objective of this retrospective study is to evaluate the safety of COVID-19 vaccines by analyzing the adverse events following immunization (AEFIs). METHODS: A retrospective observational pharmacovigilance study was conducted, based on the collection of reports of suspected AEFIs reported between 1 January 2021 and 31 December 2021 at the Naples 3 local health authority. AEFIs were stratified and described according to mRNA vaccine, demographics, clinical status, description of AEFI, and degree of severity. In 2021, local health authority Asl Naples 3 South received 1164 reports of suspected adverse events that occurred following the administration of mRNA vaccines. RESULTS: During the reporting period, 746 reports were related to the Comirnaty vaccine (64.1%), 281 to the Vaxzevria vaccine (24.1%), 107 to the Spikevax vaccine (9.2%), and 30 to the Jcovden vaccine (2.6%); 89.3% of the reports were classified as not serious (N = 1039 reports), the remaining 10.7% as serious (N = 125 reports). CONCLUSIONS: This retrospective pharmacovigilance study demonstrates that COVID-19 mRNA vaccines are safe in all population groups.


Pharmacovigilance is an activity that ensures the safety of health care treatments. The COVID-19 pandemic has accelerated the administration of vaccines whose efficacy and safety is to be evaluated. In the year 2021, an analysis of all reported adverse events following immunization (AEFIs) to the vaccine was conducted on a sample of about 1 million people with the aim of understanding efficacy and safety. All adverse events were divided by age, sex, type of reaction, and severity. Serious reactions were divided into subcategories to report the most common critical issues. At the conclusion of the work, it can be seen that COVID-19 mRNA vaccines are safe but can give serious cardiovascular (12% of the total number of serious reports) and neurological (one serious case that led to the development of Guillain Barré syndrome) side effects that need to be monitored by medical personnel.


Subject(s)
COVID-19 , Vaccines , Humans , Pharmacovigilance , COVID-19 Vaccines/adverse effects , Adverse Drug Reaction Reporting Systems , Retrospective Studies , RNA, Messenger/genetics , COVID-19/prevention & control , SARS-CoV-2 , Vaccines/adverse effects , Vaccination/adverse effects
2.
Mult Scler ; 28(13): 2112-2123, 2022 11.
Article in English | MEDLINE | ID: covidwho-2079316

ABSTRACT

BACKGROUND: Limited information is available on associations between COVID-19 vaccines and central nervous system (CNS) demyelinating diseases. OBJECTIVES: We investigated potential safety signals for CNS demyelinating diseases related to COVID-19 vaccines using the World Health Organization pharmacovigilance database. METHODS: Disproportionality analyses of CNS demyelinating disease following COVID-19 vaccination were performed by calculating the information component (IC) or the reporting odds ratio (ROR) compared with those for the entire database and for all other viral vaccines. RESULTS: We identified 715 cases of optic neuritis, 515 of myelitis, 220 of acute disseminated encephalomyelitis (ADEM), and 2840 total CNS demyelinating events adverse drug reactions from July 2020 through February 2022. For mRNA-based and ChAdOx1 nCoV-19 vaccines, there were no potential safety signals of disproportionality for optic neuritis (IC025 = -0.93, ROR025 = 0.38; IC025 = -1.76, ROR025 = 0.26), myelitis (IC025 = -0.69, ROR025 = 0.50; IC025 = -0.63, ROR025 = 0.53), ADEM (IC025 = -1.05, ROR025 = 0.33; IC025 = -1.76, ROR025 = 0.20), or overall CNS demyelinating disease events (IC025 = -0.66, ROR025 = 0.52; IC025 = -1.31, ROR025 = 0.34) compared with other viral vaccines. CONCLUSION: As with other viral vaccines, our disproportionality analyses indicate that the risk of COVID-19 vaccine-associated CNS demyelinating disease was low.


Subject(s)
COVID-19 , Encephalomyelitis, Acute Disseminated , Myelitis , Optic Neuritis , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Central Nervous System , ChAdOx1 nCoV-19 , Humans , Myelitis/etiology , Optic Neuritis/etiology , Pharmacovigilance , RNA, Messenger , Vaccination/adverse effects , World Health Organization
3.
Muscle Nerve ; 66(6): 766-770, 2022 Dec.
Article in English | MEDLINE | ID: covidwho-2059561

ABSTRACT

INTRODUCTION/AIMS: There are limited studies on the association of COVID-19 vaccination with neuralgic amyotrophy (NA). Therefore, we evaluated the association between COVID-19 vaccination and the occurrence of NA. METHODS: We explored unexpected safety signals for NA related to COVID-19 vaccination through disproportionality analysis using VigiBase, the World Health Organization's pharmacovigilance database. RESULTS: On October 15, 2021, 335 cases of NA were identified in the database. The median time to onset of NA after vaccination was around 2 weeks. A significant signal of disproportionality of NA was observed for the ChAdOx1 nCoV-19 vaccine (AstraZeneca) (information component [IC]025  = 0.33, reporting odds ratio [ROR]025  = 1.30) and two mRNA-based COVID-19 vaccines (BNT162b2 [Pfizer and BioNTech] and mRNA-1273 [Moderna]) (IC025  = 1.74, ROR025  = 3.82) compared with the entire database. However, when compared with influenza vaccines, we did not detect any signal of disproportionality of NA for both the ChAdOx1 nCoV-19 vaccine (IC025  = -2.71, ROR025  = 0.05) and mRNA-based COVID-19 vaccines (IC025  = -1.38, ROR025  = 0.13). DISCUSSION: A weak association was observed between NA and COVID-19 vaccines. However, the risk did not surpass that of influenza vaccines.


Subject(s)
Brachial Plexus Neuritis , COVID-19 Vaccines , COVID-19 , Humans , BNT162 Vaccine , ChAdOx1 nCoV-19 , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Influenza Vaccines , Pharmacovigilance , RNA, Messenger , Vaccination/adverse effects , World Health Organization
5.
Drug Saf ; 45(10): 1083-1098, 2022 10.
Article in English | MEDLINE | ID: covidwho-2048656

ABSTRACT

INTRODUCTION: Involving patients in decision making adds value in the context of pharmacovigilance (PV). This added value goes beyond participation in spontaneous reporting systems for adverse drug reactions. However, there is a gap between allowing patients to report and actual patient involvement. Views regarding best practices from regulators, patient organizations and pharmaceutical companies could help increase and improve patient involvement in PV. OBJECTIVE: The aim of this study was to investigate the factors contributing to best practices for patient involvement in PV and to develop a definition of patient involvement based on a qualitative multistakeholder study across Europe. METHODS: A literature review was conducted to map the field of study and obtain insights for the elaboration of an interview guide. Subsequently, patient representatives, members of the pharmaceutical industry and regulators were invited to participate in interviews. These interviews were analyzed using NVIVO® software and employing reflective thematic analysis. RESULTS: A total of 20 interviews were conducted with representatives at both the national and European levels. The best practices identified were engagement from the start, face-to-face communication, a full circle of feedback, same-level partners, structured involvement and guidelines, establishing common goals, patient education and empowerment, and developing trust and balance. These activities can be implemented via deep collaboration among stakeholders. A definition of patient involvement was constructed in accordance with the input of all stakeholder groups, which reflects the involvement of all types of patients at all levels of the decision-making process. CONCLUSION: In this study, we developed a definition for patient involvement based on qualitative interviews. The factors contributing to best practices for patient involvement were mentioned across stakeholder groups and aimed to stimulate patient involvement in PV. Patients are eager to become equal partners and to engage effortlessly in the same manner as other stakeholders.


Subject(s)
Patient Participation , Pharmacovigilance , Europe , Humans , Pharmaceutical Preparations , Qualitative Research
6.
Farm Hosp ; 46(3): 152-156, 2022 Mar 04.
Article in English | MEDLINE | ID: covidwho-2046387

ABSTRACT

OBJECTIVE: To analyze the local and systemic reactions that appeared after the first and second dose of the BNT162b2 vaccine against COVID­19 (Pfizer- BioNTech) in a sample of workers from a tertiary hospital, and to identify the  factors related to greater vaccine reactogenicity. METHOD: A self-administered questionnaire was used to interview 291 workers  from a tertiary hospital who received the BNT162b2 vaccine against COVID-19  between January and March 2021. The questionnaire included questions about  the sociodemographic variables of the participants, previous COVID-19  infection, and local and systemic reactions after the first and second dose of  the vaccine. RESULTS: The most common adverse reaction was soreness at the injection site, which was reported more frequently after the first dose of the  vaccine. The systemic reactions evaluated were reported more frequently after the second dose of the vaccine. Women, younger adults, and  subjects with a prior COVID-19 infection reported increased reactogenicity. Furthermore, high reactogenicity after the first dose was found  to be related to a higher number of adverse reactions after the second dose of  the vaccine. CONCLUSIONS: The distribution of reactogenicity in the present study is consistent with the data reported in previous studies on the BNT162b2 vaccine, especially in terms of its association with the participants'  characteristics. These findings could facilitate the identification of people at a  higher risk of developing high reactogenicity to the vaccine, thereby making it  possible to anticipate the appearance of adverse reactions and plan for their  treatment.


OBJETIVO: Analizar las reacciones locales y sistémicas aparecidas tras la  primera y segunda dosis de la vacuna BNT162b2 (Pfizer-BioNTech) frente a  COVID-19 en una muestra de trabajadores de un hospital de tercer nivel, e  identificar los factores relacionados con una mayor reactogenicidad a la  vacuna.Método: Se empleó un cuestionario autoadministrado para entrevistar a 291  trabajadores de un hospital de tercer nivel que recibieron la vacuna BNT162b2  frente a COVID-19 entre enero y marzo de 2021. El cuestionario incluyó  preguntas acerca de las variables sociodemográficas de los participantes,  infección previa de COVID-19 y las reacciones locales y sistémicas tras la  primera y segunda dosis de la vacuna. RESULTADOS: La reacción más comúnmente informada fue el dolor en el lugar  de la inyección, siendo más frecuente tras la primera dosis de la vacuna. Las  reacciones sistémicas evaluadas se informaron con mayor frecuencia tras la  segunda dosis de la vacuna. Las mujeres, los adultos más jóvenes y las  personas con una infección previa por COVID-19 notificaron una mayor  reactogenicidad. Además, una alta reactogenicidad tras la primera dosis estuvo relacionada con un mayor número de reacciones adversas tras la segunda  dosis de la vacuna. CONCLUSIONES: La distribución de la reactogenicidad en el presente estudio es  consistente con los datos reportados en los estudios realizados  con la vacuna  BNT162b2, especialmente en términos de asociación con las características de  los participantes. Estos hallazgos pueden facilitar la identificación de personas  con mayor probabilidad de presentar una alta reactogenicidad a la vacuna,  permitiéndonos anticipar su aparición y tratamiento.


Subject(s)
BNT162 Vaccine , COVID-19 Vaccines , COVID-19 , Adult , BNT162 Vaccine/administration & dosage , BNT162 Vaccine/adverse effects , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Female , Health Personnel , Humans , Pharmacovigilance , SARS-CoV-2 , Tertiary Care Centers , Vaccines, Synthetic , mRNA Vaccines
7.
Infect Dis Now ; 52(8S): S16-S18, 2022 Nov.
Article in English | MEDLINE | ID: covidwho-2041793

ABSTRACT

As of February 2022, more than 130 million Covid vaccine doses had been distributed in France. During the first year of relevant vaccination, 128,766 adverse events (AE) were reported and analysed, as compared to an average of 40,000 per year for all drugs combined in the pre-pandemic years. A weekly monitoring committee was set up. Through enhanced pharmacovigilance, by February 2022, 49 safety signals had been identified nationwide and submitted to the EMA. For example, very few cases of myocarditis and pericarditis were reported. In children, 9 multisystem inflammatory syndromes were reported.


Subject(s)
COVID-19 Vaccines , COVID-19 , Pharmacovigilance , Humans , Adverse Drug Reaction Reporting Systems , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects
8.
J Clin Pharm Ther ; 47(11): 1789-1795, 2022 Nov.
Article in English | MEDLINE | ID: covidwho-2019417

ABSTRACT

WHAT IS KNOWN AND OBJECTIVE: Evidence on whether the coronavirus disease 2019 (COVID-19) vaccination could cause hearing-related adverse events is still conflicting. This study aims to access the association between COVID-19 vaccine and hearing disorder. METHODS: The Vaccine Adverse Event Reporting System (VAERS) was queried between January 2020 to November 2021. The disproportionality pattern for hearing impairment of COVID-19 vaccine was accessed by calculating the reporting odds ratio (ROR) and proportional reporting ratio (PRR). A further subgroup analysis based on the type of COVID-19 vaccine and the doses administered was performed. In addition, the disproportionalities for hearing dysfunction between COVID-19 and influenza vaccines were compared. RESULTS AND DISCUSSION: A total of 14,956 reports of hearing-related adverse events were identified with COVID-19 vaccination and 151 with influenza vaccine during the analytic period in VAERS. The incidence of hearing disorder following COVID-19 vaccination was 6.66 per 100,000. The results of disproportionality analysis revealed that the adverse events of hearing impairment, after administration of COVID-19 vaccine, was significantly highly reported (ROR 2.38, 95% confidence interval [CI] 2.20-2.56; PRR: 2.35, χ2 537.58), for both mRNA (ROR 2.37, 95% CI 2.20-2.55; PRR 2.34, χ2 529.75) and virus vector vaccines (ROR 2.50, 95% CI 2.28-2.73; PRR 2.56, χ2 418.57). While the disproportional level for hearing dysfunction was quite lower in influenza vaccine (ROR 0.36, 95% CI 0.30-0.42; PRR 0.36, χ2 172.24). WHAT IS NEW AND CONCLUSION: This study identified increased risk for hearing disorder following administration of both mRNA and virus vector COVID-19 vaccines compared to influenza vaccination in real-world settings.


Subject(s)
COVID-19 , Influenza Vaccines , Humans , Pharmacovigilance , COVID-19 Vaccines/adverse effects , Adverse Drug Reaction Reporting Systems , Influenza Vaccines/adverse effects , Vaccination/adverse effects , Hearing Disorders/chemically induced , RNA, Messenger
9.
BMC Public Health ; 22(1): 1568, 2022 08 17.
Article in English | MEDLINE | ID: covidwho-1993342

ABSTRACT

Pharmacovigilance (PV) systems in many countries in sub-Saharan Africa (SSA) are not fully functional. The spontaneous adverse events (AE) reporting rate in SSA is lower than in any other region of the world, and healthcare professionals (HCPs) in SSA countries have limited awareness of AE surveillance and reporting procedures. The GSK PV enhancement pilot initiative, in collaboration with PATH and national PV stakeholders, aimed to strengthen passive safety surveillance through a training and mentoring program of HCPs in healthcare facilities in three SSA countries: Malawi, Côte d'Ivoire, and Democratic Republic of Congo (DRC). Project implementation was country-driven, led by the Ministry of Health via the national PV center or department, and was adapted to each country's needs. The implementation phase for each country was scheduled to last 18 months. At project start, low AE reporting rates reflected that awareness of PV practices was very low among HCPs in all three countries, even if a national PV center already existed. Malawi did not have a functional PV system nor a national PV center prior to the start of the initiative. After 18 months of PV training and mentoring of HCPs, passive safety surveillance was enhanced significantly as shown by the increased number of AE reports: from 22 during 2000-2016 to 228 in 18 months to 511 in 30 months in Malawi, and ~ 80% of AE reports from trained healthcare facilities in Côte d'Ivoire. In DRC, project implementation ended after 7 months because of the SARS-CoV-2 pandemic. Main challenges encountered were delayed AE report transmission (1-2 months, due mainly to remoteness of healthcare facilities and complex procedures for transmitting reports to the national PV center), delayed or no causality assessment due to lack of expertise and/or funding, negative perceptions among HCPs toward AE reporting, and difficulties in engaging public health programs with the centralized AE reporting processes. This pilot project has enabled the countries to train more HCPs, increased reporting of AEs and identified KPIs that could be flexibly replicated in each country. Country ownership and empowerment is essential to sustain these improvements and build a stronger AE reporting culture.


Subject(s)
COVID-19 , Pharmacovigilance , Humans , Malawi , Pilot Projects , SARS-CoV-2
10.
J Peripher Nerv Syst ; 27(3): 206-214, 2022 Sep.
Article in English | MEDLINE | ID: covidwho-1986062

ABSTRACT

Vaccinations against the severe acute respiratory syndrome coronavirus 2 which causes COVID-19 have been administered worldwide. We aimed to investigate associations of COVID-19 vaccination with the occurrence of Guillain-Barré syndrome (GBS). We explored potential safety signals regarding the development of GBS using disproportionality analyses to compare COVID-19 vaccination with all adverse drug reaction (ADR) reports and influenza vaccines reported to VigiBase. As of October 15, 2021, a total of 2163 cases (0.13%) of GBS and its variants (including 46 cases of Miller-Fisher syndrome and 13 cases of Bickerstaff's encephalitis) were identified in entire ADR database after vaccination with the ChAdOx1 nCoV-19 (AstraZeneca, Cambridge, UK) or the two messenger RNA-based COVID-19 (BNT162b2; Pfizer and BioNTech) or mRNA-1273; Moderna) vaccines. The median time to onset of GBS after vaccination was around 2 weeks. The ChAdOx1 nCoV-19 and two messenger RNA-based COVID-19 vaccines demonstrated a higher risk for GBS against entire database (information component [IC]025  = 1.73 reporting odds ratio [ROR]025  = 3.51; IC025  = 1.07, ROR025  = 2.22, respectively). When compared with influenza vaccines, neither the ChAdOx1 nCoV-19 nor mRNA-based vaccines were found to be associated with greater risks of GBS (IC025  = -1.84, ROR025  = 0.11; IC025  = -1.86, ROR025  = 0.06, respectively). Although potential safety signals associated with GBS COVID-19 vaccines have been identified, the risk of GBS from COVID-19 vaccines were low and did not surpass those of influenza vaccines; however, because of the heterogeneity of the sources of information in the WHO pharmacovigilance database, further epidemiological studies are warranted to confirm these observations.


Subject(s)
COVID-19 , Guillain-Barre Syndrome , Influenza Vaccines , BNT162 Vaccine , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , ChAdOx1 nCoV-19 , Guillain-Barre Syndrome/chemically induced , Guillain-Barre Syndrome/epidemiology , Humans , Influenza Vaccines/adverse effects , Pharmacovigilance , RNA, Messenger , Vaccination/adverse effects , World Health Organization
11.
PLoS One ; 17(8): e0269268, 2022.
Article in English | MEDLINE | ID: covidwho-1968860

ABSTRACT

With the progression of global vaccination against coronavirus disease 2019 (COVID-19), embolic and thrombotic events (ETEs) following COVID-19 vaccination continue to be reported. To date, most reports on the type of COVID-19 vaccine and ETEs have been based on clinical trials, and other reports include a small number of cases. Further, the relationship between the type of COVID-19 vaccine and ETEs has not been clarified. It is important to elucidate trends in the development of ETEs after vaccination, which is a crucial concern for both prospective patients and healthcare providers. In this retrospective, pharmacovigilance study, we analyzed the Vaccine Adverse Event Reporting System (VAERS) reports from January 1, 2020 to June 18, 2021, and performed signal detection and time-to-onset analysis of adverse events by calculating the reported odds ratio (ROR) to understand ETE trends after COVID-19 vaccination based on the vaccine type. Using VAERS, we could collect data about several ETEs associated with COVID-19 vaccination. Nine adverse events associated with ETEs were reported following the administration of viral vector vaccines. The median time to ETE onset was 6 (interquartile range: 2-17) days for mRNA vaccines and 11 (interquartile range: 4-21) days for viral vector vaccines. This study suggests that VAERS aids in disequilibrium analysis to examine the association between vaccine type and ETEs after COVID-19 vaccination. Additionally, the tendency to develop ETEs and the number of days taken to develop ETEs varied depending on the type of the COVID-19 vaccine. Thus, vaccinators and healthcare providers should consider the primary diseases associated with ETEs while selecting vaccines for administration and carefully monitor patients following vaccination for potential ETEs based on the characteristics of vaccine type-specific onset period.


Subject(s)
COVID-19 Vaccines , COVID-19 , Embolism , Pharmacovigilance , Thrombosis , Adverse Drug Reaction Reporting Systems , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Embolism/chemically induced , Humans , Prospective Studies , Retrospective Studies , Thrombosis/chemically induced , United States , Vaccination/adverse effects
12.
Drug Saf ; 45(7): 765-780, 2022 07.
Article in English | MEDLINE | ID: covidwho-1959196

ABSTRACT

INTRODUCTION: Statistical signal detection is a crucial tool for rapidly identifying potential risks associated with pharmaceutical products. The unprecedented environment created by the coronavirus disease 2019 (COVID-19) pandemic for vaccine surveillance predisposes commonly applied signal detection methodologies to a statistical issue called the masking effect, in which signals for a vaccine of interest are hidden by the presence of other reported vaccines. This masking effect may in turn limit or delay our understanding of the risks associated with new and established vaccines. OBJECTIVE: The aim is to investigate the problem of masking in the context of COVID-19 vaccine signal detection, assessing its impact, extent, and root causes. METHODS: Based on data underlying the Vaccine Adverse Event Reporting System, three commonly applied statistical signal detection methodologies, and a more advanced regression-based methodology, we investigate the temporal evolution of signals corresponding to five largely recognized adverse events and two potentially new adverse events. RESULTS: The results demonstrate that signals of adverse events related to COVID-19 vaccines may be undetected or delayed due to masking when generated by methodologies currently utilized by pharmacovigilance organizations, and that a class of advanced methodologies can partially alleviate the problem. The results indicate that while masking is rare relative to all possible statistical associations, it is much more likely to occur in COVID-19 vaccine signaling, and that its extent, direction, impact, and roots are not static, but rather changing in accordance with the changing nature of data. CONCLUSIONS: Masking is an addressable problem that merits careful consideration, especially in situations such as COVID-19 vaccine safety surveillance and other emergency use authorization products.


Subject(s)
COVID-19 Vaccines , COVID-19 , Adverse Drug Reaction Reporting Systems , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Humans , Pharmacovigilance , Vaccines/adverse effects
13.
Clin Ther ; 44(9): 1225-1236, 2022 09.
Article in English | MEDLINE | ID: covidwho-1956104

ABSTRACT

PURPOSE: The COVID-19 pandemic poses an unprecedented threat to global business relationships and dynamics. The pharmacovigilance function of pharmaceutical companies is particularly susceptible to changing external pressures because of its highly structured compliance activities. We conducted an industry-wide survey to provide insights on how the pharmacovigilance function responded to the challenges posed by the pandemic. We compared smaller companies and larger companies regarding impact on portfolios and operational activity metrics. METHODS: We conducted a survey through the Navitas Life Science annual benchmark of pvnetTM, a network of large enterprise (LE) companies, and pvconnectTM, a network of small and medium enterprise (SME) companies, using an online surveying tool during the first quarter of 2021. We collected information on pharmacovigilance activities, including quantitative measures of workload, costs, and key performance indicators, and qualitative data on the effects of the pandemic on product portfolios and operations. FINDINGS: Survey questions were posed to LE (pvnet) network members (n = 12) and SME (pvconnect) network members (n = 18) for the period from January 1 through December 31, 2020. The date of data collection was March 26, 2021. Descriptive median values of parameter metrics included the following: revenue ($28.4 billion for LE companies and $1.6 billion for SME companies), number of products (127 for LE companies and 19 for SME companies), and volume of individual case safety reports (391,000 for LE companies and 13,000 for SME companies). SME companies reported a greater impact on 2 survey categories, remote working and employee well-being, than did LE companies. However, LE companies reported a greater impact than did SME companies on all other survey categories: effect on strategic priorities, shift in product focus, workload changes, changes in sourcing model, effect on case reporting compliance, effect on business continuity, changes in pharmacovigilance technology strategy, impact of interactions with health authorities, effect on resource capacity, and impact on recruitment. IMPLICATIONS: Four major themes emerge from this survey: (1) shift to remote working, (2) recognition of the impact on employee well-being, (3) shift in strategic priorities, and (4) newly recognized aspects of risk mitigation. The COVID-19 pandemic has had a marked effect on every aspect of pharmaceutical companies' pharmacovigilance functions, although the effects appear to be different for LE companies than for SME companies.


Subject(s)
COVID-19 , Pharmacovigilance , Humans , COVID-19/epidemiology , Drug Industry , Pandemics
14.
Clin Appl Thromb Hemost ; 28: 10760296221115112, 2022.
Article in English | MEDLINE | ID: covidwho-1950835

ABSTRACT

Pharmacovigilance plays a lifesaving role in the practice of medicine. In 2021, during the Coronavirus Infectious Disease 2019 (COVID-19) pandemic, Loyola University Chicago launched a graduate-level Pharmacovigilance Certificate Program (PV-CERT) and a pre-professional non-graduate Pharmacovigilance Certificate Course (EPEC-PV), to provide students a comprehensive and contemporary understanding of the principles and practices of pharmacovigilance. Formal training in pharmacovigilance through this course provided a structured understanding of how safety data are generated through clinical trials and from real-world evidence as well as the regulatory environment in which data are monitored and interpreted. Pharmacovigilance training is of critical importance, especially during the COVID-19 pandemic, during which several drugs were re-purposed for the management of various stages of COVID-19 without conventional safety data. Moreover, the safety of currently-used vaccines is of concern in some populations. Although anticoagulants and antithrombotic medications are crucial in the management of COVID-19, a clear pharmacovigilance program on their use in this indication is not established. As the century progresses, new diseases and infectious agents will require novel therapies for which the evaluation of benefits versus risks will be as essential as it has been for the current COVID-19 pandemic. As such, the Loyola course and accompanying programs on pharmacovigilance will play a key role in educating the next generation of professionals in pursuing careers in the development of therapies that ultimately improve patient outcomes while maintaining rigorous safety standards.


Subject(s)
COVID-19 , Communicable Diseases , Humans , Pandemics , Pharmacovigilance
15.
Int J Clin Pharm ; 44(5): 1179-1187, 2022 Oct.
Article in English | MEDLINE | ID: covidwho-1942479

ABSTRACT

BACKGROUND: Coronavirus disease 2019 (COVID-19) is a global pandemic. Hydroxychloroquine (HCQ)-associated cardiovascular adverse events (CVAEs) have been increasingly reported. AIM: This study aimed to present an observational, retrospective, and comprehensive pharmacovigilance analysis of CVAE associated with HCQ in patients with and without COVID-19 using the US Food and Drug Administration Adverse Events Reporting System (FAERS) data from January 2020 to December 2020. METHOD: We identified 3302 adverse event reports from the FAERS database in the year 2020 and divided them into COVID-19 and non-COVID-19 groups, respectively. Then we analyzed whether there were differences in CVAEs between the two groups. RESULTS: We found that CVAE was higher in cases with COVID-19 compared to those without COVID-19, odds ratio (OR) of 1.26 and a 95% confidence interval (95% CI) of 1.02-1.54. Cases with COVID-19 treated with HCQ exhibited relatively higher proportions of torsade de points (TdP) and QT prolongation (OR 3.10, 95% CI 2.24-4.30), shock-associated TdP (OR 2.93, 95% CI 2.13-4.04), cardiac arrhythmias (OR 2.07, 95% CI 1.60-2.69), cardiac arrhythmia terms (including bradyarrhythmias and tachyarrhythmias) (OR 2.15, 95% CI 1.65-2.80), bradyarrhythmias (including conduction defects and disorders of sinus node function) (OR 2.56, 95% CI 1.86-3.54), and conduction defects (OR 2.56, 95% CI 1.86-3.54). CONCLUSION: Our retrospective observational analysis suggested that the proportion of CVAE associated with HCQ, especially TdP and QT prolongation, was higher in patients with COVID-19. Understanding the effects of COVID-19 on the cardiovascular system is essential to providing comprehensive medical care to patients receiving HCQ treatment.


Subject(s)
COVID-19 , Cardiovascular System , Long QT Syndrome , Humans , Hydroxychloroquine/adverse effects , COVID-19/drug therapy , COVID-19/epidemiology , Pharmacovigilance , Retrospective Studies , Bradycardia/chemically induced , Long QT Syndrome/chemically induced , Long QT Syndrome/epidemiology , Arrhythmias, Cardiac/chemically induced , Arrhythmias, Cardiac/epidemiology , Arrhythmias, Cardiac/drug therapy , Cardiac Conduction System Disease/chemically induced , Cardiac Conduction System Disease/drug therapy , DNA-Binding Proteins
16.
Pharm Stat ; 21(4): 764-777, 2022 07.
Article in English | MEDLINE | ID: covidwho-1929591

ABSTRACT

Andy Grieve, the first pharmaceutical statistician to be President of the Royal Statistical Society, practiced in the regulated world of drug development. With reduction in drug development costs as his motivation, Grieve advanced Bayesian methods for developing predictive methods for efficacy and toxicity - to be used as early as possible in the drug development process; and his presidential address exhorted statisticians to weigh-in wherever data are used to make decisions. Diagnostic tests for infectious diseases are less regulated than drugs and vaccines unless the blood supply is at risk. Unlike in the HIV and HCV pandemics of the late 20th century, even well-designed surveys linked to a volunteered biological sample (to be tested for SARS-CoV-2 antigen or antibodies) have had modest or low consent rates. Record-linkage, statistical design and reporting standards have seen triumph and tragedy. Among the triumphs are: Liverpool's insistence on dual testing (lateral flow device; polymerase chain reaction [PCR]) of some 6000 asymptomatic citizens who attended for SARS-CoV-2-screening; two tricky randomized controlled public-policy trials on daily contact testing for close contacts of index cases of SARS-CoV-2 infection versus self-isolation (with or without initial PCR); and among already-consented participants in surveillance, over 80% secondary consent for linkage to their health records, including the Immunization Management Service. Before the next pandemic we need to entrench better regulation of diagnostic tests, better informed consent (not via weblinks), better feedback to participants, and transparency about basic safety data.


Subject(s)
COVID-19 , Pandemics , Bayes Theorem , COVID-19/epidemiology , COVID-19/prevention & control , Humans , Pandemics/prevention & control , Pharmacovigilance , SARS-CoV-2
17.
Rev Peru Med Exp Salud Publica ; 39(1): 91-97, 2022.
Article in Spanish, English | MEDLINE | ID: covidwho-1912405

ABSTRACT

The study aimed to evaluate a group of health professionals' knowledge, attitudes, and practices on pharmacovigilance in the context of COVID-19 in the Peruvian Social Health Insurance (EsSalud). A descriptive secondary analysis was carried out on a database that included responses from an online survey conducted by the Institutional Referral Center for Pharmacovigilance and Technovigilance of EsSalud. Of 144 participants, 66% showed a high level of knowledge and 81.2% had a positive attitude; however, 71.5% had an inadequate level of pharmacovigilance practice. Although EsSalud professionals demonstrated a high level of knowledge and positive attitude to implement pharmacovigilance, this is not reflected in the practice of this activity during the SARS-CoV-2 pandemic. Strategies should be implemented to integrate pharmacovigilance into healthcare activities to benefit patient safety.


El estudio tuvo como objetivo evaluar el conocimiento, las actitudes y prácticas de un grupo de profesionales de la salud sobre la farmacovigilancia en el contexto de la COVID-19 en el Seguro Social de Salud del Perú (EsSalud). Se realizó un análisis secundario descriptivo de una base de datos que incluía las respuestas de una encuesta en línea realizada por el Centro de Referencia Institucional de Farmacovigilancia y Tecnovigilancia de EsSalud. De 144 participantes, el 66% mostró alto nivel de conocimiento y el 81,2%, actitud positiva; sin embargo, el 71,5% tuvo un inadecuado nivel de práctica de farmacovigilancia. Si bien los profesionales de EsSalud demostraron tener alto conocimiento y actitud positiva para implementar farmacovigilancia, esto no se ve reflejado en la práctica de esta actividad en la época de pandemia por el SARS-CoV-2. Se deben emplear estrategias para integrar a la farmacovigilancia en las actividades asistenciales en beneficio de la seguridad del paciente.


Subject(s)
COVID-19 , Drug-Related Side Effects and Adverse Reactions , Attitude of Health Personnel , Health Knowledge, Attitudes, Practice , Humans , Peru/epidemiology , Pharmacovigilance , SARS-CoV-2 , Social Security , Surveys and Questionnaires
19.
Br J Clin Pharmacol ; 88(5): 2180-2189, 2022 05.
Article in English | MEDLINE | ID: covidwho-1895952

ABSTRACT

AIMS: To explore and describe the adverse reaction signals in the safety reporting for alpelisib. METHODS: We performed a disproportionality analysis of the World Health Organization's VigiBase pharmacovigilance database from 1 January 2019 to 30 June 2021. Disproportionality analysis by information components (ICs) were used to evaluate the potential association between adverse events (AEs) and alpelisib. RESULTS: A total of 33 327 reports were extracted, 5695 of them were chosen with alpelisib as the suspected drug. After combining the same ID, 687 cases remained. The 45-64-years group had the most cases (n = 203, 29.55%). There were 129 Preferred Terms with significant signals. Hyperglycaemia (IC025 = 6.74), breast cancer metastatic (IC025 = 5.85) and metastases to liver (IC025 = 4.70) were the AEs with the strongest signal. AEs with the most cases were hyperglycaemia (n = 595), rash (n = 535) and diarrhoea (n = 475). CONCLUSION: We established a comprehensive list of AEs potentially associated with alpelisib. AEs with the most significant signals were hyperglycaemia, breast cancer metastatic, metastases to liver. The AEs with the most cases were hyperglycaemia, rash, diarrhoea, blood glucose increase and nausea.


Subject(s)
Breast Neoplasms , Drug-Related Side Effects and Adverse Reactions , Exanthema , Hyperglycemia , Adverse Drug Reaction Reporting Systems , Breast Neoplasms/drug therapy , Databases, Factual , Diarrhea , Drug-Related Side Effects and Adverse Reactions/epidemiology , Female , Humans , Hyperglycemia/chemically induced , Hyperglycemia/epidemiology , Pharmacovigilance , Thiazoles , World Health Organization
20.
Drug Saf ; 45(5): 403-405, 2022 05.
Article in English | MEDLINE | ID: covidwho-1872803

ABSTRACT

Authors' views on the role of artificial intelligence and machine learning in pharmacovigilance. (MP4  139807 kb).


Subject(s)
Artificial Intelligence , Machine Learning , Humans , Pharmacovigilance
SELECTION OF CITATIONS
SEARCH DETAIL