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BACKGROUND: Adverse events following immunization (AEFIs), especially if serious, may impact vaccine recipients' quality of life and financial well-being and fuel vaccine hesitancy. Nigeria rolled out COVID-19 vaccination in 2021 with little known about the impact of AEFIs on an individual's quality of life. No study in Africa has explored the health and financial impact of AEFIs. We explored patient-reported outcomes (PROs) of adverse events after COVID-19 vaccination and documented the lived experiences of those with serious AEFIs to understand the effect on their health, financial well-being, and attitude to future vaccinations. METHODS: We conducted a convergent mixed-methods study using the RAND 36-item health survey and in-depth interviews to collect PROs on vaccine recipients in Nigeria. Eight health scale scores and two summary composite scores were used to measure the health-related quality of life outcomes from the survey and inductive analysis was used to identify themes from the interview scripts. The results of both studies were integrated in a joint display to highlight areas of concordance. RESULTS: In total, 785 survey responses were analyzed (53% females, 68% aged 18-30 years). Responders reporting an AEFI were 58%, of whom 62% received the first dose only. Younger age and first vaccine dose (p < .001 respectively) were associated with experiencing an AEFI. Not reporting an AEFI was associated with better quality of life, measured as higher scores on all eight SF-36 Health scales and the physical and mental component summary scores. All six interviewees with serious AEFIs experienced physical, mental, and financial distress. Some expressed a strong negative attitude toward future COVID-19 vaccinations but not toward vaccines for routine immunization. CONCLUSION: AEFIs negatively impact the health and financial well-being of affected individuals and their attitude to future vaccinations, especially if serious. Understanding the impact of AEFIs on people is important and should inform future policies and interventions. The results of our study can inform policy and planning for future mass vaccination campaigns in LMICs.
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Vacunas contra la COVID-19 , COVID-19 , Medición de Resultados Informados por el Paciente , Calidad de Vida , Vacunación , Humanos , Femenino , Masculino , Nigeria , Adulto , Vacunas contra la COVID-19/efectos adversos , Vacunas contra la COVID-19/administración & dosificación , Adolescente , Adulto Joven , COVID-19/prevención & control , Persona de Mediana Edad , Vacunación/efectos adversos , Vacunación/psicología , SARS-CoV-2/inmunología , Encuestas y Cuestionarios , Anciano , Vacilación a la Vacunación/psicología , Vacilación a la Vacunación/estadística & datos numéricosRESUMEN
INTRODUCTION: Spontaneous reporting of adverse events (AEs) is a mainstay of pharmacovigilance, and an ongoing challenge is how to ensure that more high-quality reports are collected for comprehensive information provision. The Med Safety App, a smartphone-based application, was launched in Nigeria in November 2020 to provide an electronic platform for users to seamlessly report AEs. There has been a paucity of evidence on the use of this application or other mobile applications for reporting adverse drug reactions/AEs following immunization in the Nigerian environment. OBJECTIVE: The aim of this study was to evaluate the trends in adverse event reporting before and after the introduction of the Med Safety App in Nigeria. METHODS: This was a retrospective, observational study using data from the VigiFlow database to compare adverse event reporting in Nigeria before and after the deployment of the Med Safety App. The baseline period was 1st April 2019 to 30th October 2020 and the comparison period was 1st November 2020 to 31st May 2022. We used Vigilance Hub, the back-end system for the Med Safety App, to extract data on App downloads and de-identified user statistics. Data were summarized using descriptive statistics, frequencies and proportions. Quality was assessed by assigning a completeness score to each individual case safety report. The Kruskal-Wallis test was used to test for differences in medians between groups. RESULTS: Following deployment of the App, the Nigerian National Pharmacovigilance Centre recorded an increase in the total number of adverse event reports received in VigiFlow, from 2051 in the baseline period to 18,995 following deployment of the App, with 81.7% of those reported via the Med Safety App. There was a reduction in the proportion of paper-based reporting from 98.4 to 15.7% post-deployment, and direct reporting by consumers increased from 2.7 to 17.6%. Of the 15,526 reports submitted via the App, 15,111 (97.3%) had a completeness score above 70% and 6993 (45%) had a completeness score of 100%. The median completeness score of adverse event reports on the Med Safety App was 6 out of 7. On bivariate analysis using the Kruskal-Wallis test, there was an association between means of reporting and completeness score, and this association was significant, with a p value of 0.0001, which may reflect the validation rules that are applied within the App. CONCLUSION: Deployment of the Med Safety App increased both the number and quality of adverse event reports; however, more awareness and capacity building are needed to strengthen and sustain reporting on the tool by all categories of healthcare professionals and consumers/patients.
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Sistemas de Registro de Reacción Adversa a Medicamentos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Aplicaciones Móviles , Farmacovigilancia , Humanos , Sistemas de Registro de Reacción Adversa a Medicamentos/estadística & datos numéricos , Nigeria , Estudios Retrospectivos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Teléfono Inteligente , Bases de Datos FactualesRESUMEN
BACKGROUND: Adverse Drug Reactions (ADRs) are a major clinical and public health problem world-wide. The prompt reporting of suspected ADRs to regulatory authorities to activate drug safety surveillance and regulation appears to be the most pragmatic measure for addressing the problem. This paper evaluated a pharmacovigilance (PV) training model that was designed to improve the reporting of ADRs in public health programs treating the Human Immunodeficiency Virus (HIV), Tuberculosis (TB) and Malaria. METHODS: A Structured Pharmacovigilance and Training Initiative (SPHAR-TI) model based on the World Health Organization accredited Structured Operational Research and Training Initiative (SOR-IT) model was designed and implemented over a period of 12 months. A prospective cohort design was deployed to evaluate the outcomes of the model. The primary outcomes were knowledge gained and Individual Case Safety Reports (ICSR) (completed adverse drug reactions monitoring forms) submitted, while the secondary outcomes were facility based Pharmacovigilance Committees activated and health facility healthcare workers trained by the participants. RESULTS: Fifty-five (98%) participants were trained and followed up for 12 months. More than three quarter of the participants have never received training on pharmacovigilance prior to the course. Yet, a significant gain in knowledge was observed after the participants completed a comprehensive training for six days. In only seven months, 3000 ICSRs (with 100% completeness) were submitted, 2,937 facility based healthcare workers trained and 46 Pharmacovigilance Committees activated by the participants. Overall, a 273% increase in ICSRs submission to the National Agency for Food and Drug Administration and Control (NAFDAC) was observed. CONCLUSION: Participants gained knowledge, which tended to increase the reporting of ADRs. The SPHAR-TI model could be an option for strengthening the continuous reporting of ADRs in public health programs in resource limited settings.
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Educación/métodos , Personal de Salud/educación , Salud Pública/métodos , Síndrome de Inmunodeficiencia Adquirida/clasificación , Síndrome de Inmunodeficiencia Adquirida/epidemiología , Adulto , Sistemas de Registro de Reacción Adversa a Medicamentos , Estudios de Cohortes , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/clasificación , Femenino , VIH , Humanos , Malaria/clasificación , Malaria/epidemiología , Masculino , Persona de Mediana Edad , Nigeria , Farmacovigilancia , Estudios Prospectivos , Salud Pública/educación , Práctica de Salud Pública/economía , Tuberculosis/clasificación , Tuberculosis/epidemiología , Organización Mundial de la SaludRESUMEN
Artemisinin-based combination antimalarial therapy (ACTs), is still highly effective in uncomplicated falciparum malaria, however, there remain some concerns in relation to its safety and tolerability. Comorbid disease conditions may influence susceptibility to adverse drug reactions (ADRs) as the presence of multiple disease conditions may predisposes patients to ADRs due to the use of many medicines. There is therefore need to assess the impact of comorbidities on the ADR profile of malaria patients treated with ACTs. The study was carried out in health care facilities spread across Nigeria. From the database of over 10,000 patients recruited into an initial cohort, data for 1000 patients with comorbidities was extracted and matched with a control group of 1000 randomly selected patients with no comorbidity. There were 1105 adverse drug reactions in all, of which 66.2% were recorded in patients with comorbidity, and 34% are patients without comorbidity. The mean age of patients with comorbidities was 38.3 ± 17.5 years and 23.8 ± 17.2 for those without comorbidity. Out of the 979 patients with comorbidity, 36% were hypertensive, 2.2% hypertensive-diabetes, 16.4% peptic ulcer disease, 10.4% HIV/AIDS, 4.4% diabetes and 4.3% were asthmatic. Patients with comorbidity were three times more likely to have adverse drug reaction than those without comorbidity (Odds ration = 2.96; 95% CI = 2.23-3.93). HIV/AIDS and osteoarthritis were significantly associated with development of adverse drug reactions. Probability was <0.0001. Age, weight, and height of patients were also found to be risk factor for development of adverse drug reactions.
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BACKGROUND: Adverse drug reactions (ADRs) in children recorded in national pharmacovigilance databases in high-income countries have been analysed. Nigeria has a population of 31 million children and became a member of the WHO Programme for International Drug Monitoring in 2004 since when it has been submitting reports of suspected ADRs to the WHO Global Individual Case Safety Report database, VigiBase. OBJECTIVE: To gain information on reported ADRs in Nigerian children aged 0-17 years in VigiBase from 2005 to 2012. METHODS: The data were analysed for annual reports, age and sex of patients, type of reporters, suspected drugs and adverse reactions. The most commonly reported ADRs and suspected drugs were ranked, and drugs associated with the fatalities were evaluated. RESULTS: A total of 297 reports of 473 ADRs in 297 children were received from doctors, pharmacists, other health-care professionals and consumers during the period. ADRs were most frequently reported for anti-retrovirals (74, 24%), antibiotics (71, 23%) and anti-malarials (60, 20%). The most frequently reported ADRs were rash (15.2%), fever (10.3%) and pruritus (6.8%). Anti-infective agents were responsible for more than half of the reports. Twenty-one children (7%) died, eight from acute renal failure. Seven of the cases of acute renal failure were associated with contaminated paracetamol/diphenhydramine hydrochloride and herbal medicines used for teething problems. In the majority of cases, the products were contaminated with diethylene glycol. There were 14 cases of Stevens-Johnson syndrome, three of which were fatal. CONCLUSION: Anti-infective agents (antibiotics, anti-malarials and anti-retrovirals) were associated with a majority of the ADRs. Stevens-Johnson syndrome was the most frequent severe ADR. Some of the fatalities were associated with sub-standard and herbal medications.
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Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/patología , Farmacovigilancia , Adolescente , Niño , Preescolar , Femenino , Humanos , Lactante , Recién Nacido , Masculino , Nigeria/epidemiología , Estudios RetrospectivosRESUMEN
INTRODUCTION: Cohort event monitoring (CEM) is an intensive method of post-marketing surveillance for medicines safety. The method is based on prescription event monitoring, which began in the 1970s, and has since been adapted by WHO for monitoring the safety of medicines used in Public Health Programmes. CEM aims to capture all adverse events that occur in a defined group of patients after starting treatment with a specific medicine during the course of routine clinical practice. OBJECTIVE: The aims of this study were to describe the experiences of National Pharmacovigilance Centres (NCs) that have used CEM to monitor artemisinin-based combination therapy (ACT) for uncomplicated malaria in the African setting, to raise awareness of some of the challenges encountered during implementation and to highlight aspects of the method that require further consideration. METHOD: A questionnaire-based survey was conducted to capture the experiences of NCs that have implemented CEM for active post-marketing surveillance of antimalarial medicines in sub-Saharan Africa. Six NCs were identified as having implemented CEM programmes and were invited to participate in the survey; five NCs indicated willingness to participate and were sent the questionnaire to complete. RESULTS: Four NCs responded to the survey-Ghana, Kenya, Nigeria and Zimbabwe-providing information on the implementation of a total of six CEM programmes. Their experiences indicate that CEM has helped to build pharmacovigilance capacity within the participating NCs and at the monitoring sites, and that healthcare providers (HCPs) are generally willing to participate in implementing the CEM method. All of the programmes took longer than expected to complete: contributing factors included a prolonged enrolment period and unexpectedly slow data entry. All of the programmes exceeded their budget by 11.1-63.2 %. Data management was identified as a challenge for all participating NCs. CONCLUSIONS: The reported experiences of four NCs that have undertaken CEM studies on ACTs indicate that CEM has helped to build pharmacovigilance capacity within NCs and monitoring sites and that HCPs are willing to participate in CEM programmes; however, the method was found to be labour intensive and data management was identified as a challenge. Reducing the workload associated with CEM, particularly in relation to data management, and integrating the method into the routine work of HCPs and NCs should be considered for future implementation.
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Antimaláricos/efectos adversos , Farmacovigilancia , Encuestas y Cuestionarios , Estudios de Cohortes , Ghana/epidemiología , Humanos , Kenia/epidemiología , Nigeria/epidemiología , Estudios Prospectivos , Zimbabwe/epidemiologíaRESUMEN
BACKGROUND: Adverse events (AEs) of second line anti-tuberculosis drugs (SLDs) are relatively well documented. However, the actual burden has rarely been described in detail in programmatic settings. We investigated the occurrence of these events in the national cohort of multidrug-resistant tuberculosis (MDR-TB) patients in Nigeria. METHOD: This was a retrospective, observational cohort study, using pharmacovigilance data systematically collected at all MDR-TB treatment centers in Nigeria. Characteristics of AEs during the intensive phase treatment were documented, and risk factors for development of AEs were assessed. RESULTS: Four hundred and sixty patients were included in the analysis: 62% were male; median age was 33 years [Interquartile Range (IQR):28-42] and median weight was 51 kg (IQR: 45-59). Two hundred and three (44%) patients experienced AEs; four died of conditions associated with SLD AEs. Gastro-intestinal (n = 100), neurological (n = 75), ototoxic (n = 72) and psychiatric (n = 60) AEs were the most commonly reported, whereas ototoxic and psychiatric AEs were the most debilitating. Majority of AEs developed after 1-2 months of therapy, and resolved in less than a month after treatment. Some treatment centers were twice as likely to report AEs compared with others, highlighting significant inconsistencies in reporting at different treatment centers. Patients with a higher body weight had an increased risk of experiencing AEs. No differences were observed in risk of AEs between HIV-infected and uninfected patients. Similarly, age was not significantly associated with AEs. CONCLUSION: Patients in the Nigerian MDR-TB cohort experienced a wide range of AEs, some of which were disabling and fatal. Early identification and prompt management as well as standardized reporting of AEs at all levels of healthcare, including the community is urgently needed. Safer regimens for drug-resistant TB with the shortest duration are advocated.
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Tuberculosis Resistente a Múltiples Medicamentos/epidemiología , Adulto , Femenino , Humanos , Masculino , Nigeria/epidemiología , Farmacovigilancia , Estudios RetrospectivosRESUMEN
BACKGROUND: Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug related problem.. The effectiveness of this system revolves on the active participation of the healthcare practitioners. Poor knowledge and practice of pharmacovigilance has necessitated training of healthcare professionals in different parts of Nigeria. OBJECTIVES: The objectives of this study are to determine the knowledge and practice of pharmacovigilance amongst health professionals in Nigeria and the impact of previous training in pharmacovigilance on their knowledge and practice. METHODS: In this descriptive cross sectional study, purposive and systematic random sampling method was used in selecting health facilities and health care practitioners respectively. Data were collected using a three-part peer-reviewed structured questionnaire administered through electronic mail (25) and self administration by healthcare professionals (316). RESULTS: Respondents who had received training on pharmacovigilance had better knowledge of correct definition of pharmacovigilance (P = 0.001) and better theoretical knowledge and practice scores of pharmacovigilance (P = 0.001). Receiving quarterly newsletters was not significantly associated (p = 0.220) with improved knowledge of pharmacovigilance. Overall, knowledge and practice of pharmacovigilance in Nigeria was still below average. The main challenges faced in the reporting and detecting of ADR were lack of awareness, poor communication, lack of continuity in training and poor funding. CONCLUSION: Although training was associated with improved knowledge and practice of pharmacovigilance amongst the health care providers studied, its overall impact was mild. Strengthened awareness creation and innovations in PV training methods are necessary to improve the efficiency of the program.
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Actitud del Personal de Salud , Conocimientos, Actitudes y Práctica en Salud , Personal de Salud/estadística & datos numéricos , Farmacovigilancia , Estudios Transversales , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Femenino , Humanos , Masculino , Nigeria , Médicos , Encuestas y CuestionariosRESUMEN
BACKGROUND: A pilot programme of Cohort Event Monitoring (CEM) was conducted across the six geopolitical zones of Nigeria on patients treated for uncomplicated malaria with artemisinin-based combination therapy (ACT). The emergence and spread of malaria parasites resistant to commonly available antimalarial drugs necessitated a shift in policy for malaria treatment by the Federal Government from the use of chloroquine and sulphadoxine-pyrimethamine (SP) as first-line treatments to ACTs. Initial reports following deployment of ACTs in clinical settings raised safety concerns regarding their use. Although artemisinin and its derivatives are generally thought to be safe, there are currently few or no data on their safety among populations in Nigeria. OBJECTIVES: The main objectives of the CEM programme were to proactively determine the adverse event (AE) profile of artesunate/amodiaquine (AA) and artemether/lumefantrine (AL) in real-life settings and to find out the factors predisposing to AEs. METHODS: The CEM study was observational, longitudinal, prospective, and inceptional. Patients were observed in real-life situations. It was conducted in six public health facilities in Nigeria on patients with a clinical diagnosis of uncomplicated malaria treated with ACTs. Patients were prescribed one of the ACTs on an alternate basis as they enrolled into the programme. Follow-up reviews were undertaken on days 3 and 7 following commencement of ACT treatment. At follow-up, patients were evaluated for any clinical event that they might have experienced following the use of the ACTs. We report the result of this initial pilot in which 3,010 patients treated for uncomplicated malaria with AA or AL were enrolled. RESULTS: The seven most common AEs seen were general body weakness 25.0/36.6% (AL/AA); dizziness 11.9/17.2% (AL/AA); vomiting 8.0/10.2% (AL/AA); abdominal pain 8.5/7.2% (AL/AA); insomnia 6.3/5.9% (AL/AA); body pains 3.4/5.2 (AL/AA) %; anorexia 8.5/4.6% (AL/AA). Most adverse events occurred from day 1 and peaked by day 2 and 3 of medication with the mean duration of events being 3 days. By the end of the follow-up visit on day 7, the AEs had resolved in the majority of patients. Adverse events were more common in the AA group than AL revealing a better safety profile for AL (p < 0.001). Both ACTs demonstrated good ability to resolve the clinical symptoms of uncomplicated malaria. CONCLUSION: In conclusion, this pilot CEM programme suggests that adverse events with ACTs were common. However, serious life-threatening events were not common. It appears that ACTs have a tolerable safety profile among Nigerians.