scholarly journals Development of a pharmacovigilance system in a resource-limited country: the experience of the Democratic Republic of Congo

2019 ◽  
Vol 10 ◽  
pp. 204209861986485 ◽  
Author(s):  
Didier Nzolo ◽  
Andrea Kuemmerle ◽  
Yves Lula ◽  
Nsengi Ntamabyaliro ◽  
Aline Engo ◽  
...  
Keyword(s):  
Public Health ◽  
Democratic Republic ◽  
Health Programs ◽  
African Countries ◽  
Pv System ◽  
Public Health Programs ◽  
Pv Systems ◽  
Resource Limited ◽  
Sub Saharan ◽  
Set Up

Implementation of pharmacovigilance (PV) systems in resource-limited countries is a real endeavor. Despite country- and continent-specific challenges, the Democratic Republic of the Congo (DRC) has been able to develop one of the most active PV systems in the sub-Saharan Africa. The World Health Organization (WHO) regional Office identified the DRC experience to set up a PV system for antimalarial drugs safety monitoring as a ‘best practice’ that needed to be documented in order to help DRC improve its PV system and to be scaled up in other African countries. In response to the WHO request, a best practices and bottlenecks analysis was conducted in 2015. This analysis was updated in 2018 in the light of the minimum requirements of the WHO to set up a PV system taking into account other guidance for PV systems. The following themes were retained for analysis: (1) creation of the national PV center; (2) implementation of PV in the health system; (3) data collection and analysis; (4) collaboration with public health programs; (5) collaboration with the National Regulatory Authority. Lessons learnt from the DRC experience show that it is possible to implement PV systems in order to promote patients’ safety in resource limited sub-Saharan African countries with no guaranteed funding. The ability of national PV centers to collaborate with Public health stakeholders, including public health authorities at all levels as well as public health programs, and to use existing health information systems are considered the main key to success and may substantially reduce the cost of PV activities.

scholarly journals Baseline assessment of Pharmacovigilance activities in four sub-Saharan African countries: a perspective on tuberculosis

2021 ◽  
Author(s):  
Everdina W. Tiemersma ◽  
Ali Ibrahim ◽  
Asnakech Alemu ◽  
Yohanna Kambai Avong ◽  
Alemayehu Duga ◽  
...  
Keyword(s):  
Public Health ◽  
Interpersonal Relationships ◽  
Healthcare Providers ◽  
Sub Saharan Africa ◽  
Health Programs ◽  
African Countries ◽  
Public Health Programs ◽  
Roles And Responsibilities ◽  
Adr Reporting ◽  
Sub Saharan

Abstract Background: New medicines have become available for the treatment of drug-resistant tuberculosis (DR-TB) and are introduced in sub-Saharan Africa (SSA) by the national TB programs (NTPs) through special access schemes. Pharmacovigilance is typically the task of national medicines regulatory agencies (NMRAs), but the active drug safety monitoring and management (aDSM) recommended for the new TB medicines and regimens was introduced through the NTPs.We assessed the strengths and challenges of pharmacovigilance systems in Eswatini, Ethiopia, Nigeria and Tanzania, focusing on their capacity to monitor safety of medicines registered and not registered by the NMRAs for the treatment of DR-TB. Methods: Assessment visits were conducted to all four countries by a multidisciplinary team. We used a pharmacovigilance indicator tool derived from existing tools, interviewed key stakeholders, and visited health facilities where DR-TB patients were treated with new medicines. Assessment results were verified with the local NMRAs and NTPs.Results: Most countries have enabling laws, regulations and guidelines for the conduct of pharmacovigilance by the NMRAs. The relative success of NTP-NMRA collaboration iss much influenced by interpersonal relationships between staff. Division of roles and responsibilities is not always clear and leads to duplication and unfulfilled tasks (e.g. causality assessment). The introduction of aDSM has increased awareness and adverse drug reaction (ADR) reporting to the NMRAs among DR-TB healthcare providers.Conclusion: aDSM has created awareness about the importance of pharmacovigilance among NTPs and has increased ADR reporting rates from the NTPs and/or TB healthcare providers to the NMRAs. In the future, a push for conducting pharmacovigilance through public health programs seems useful, but this needs to coincide with increased collaboration with between public health programs and NMRAs with clear formulation of roles and responsibilities.

scholarly journals Baseline assessment of pharmacovigilance activities in four sub-Saharan African countries: a perspective on tuberculosis

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Everdina W. Tiemersma ◽  
Ibrahim Ali ◽  
Asnakech Alemu ◽  
Yohanna Kambai Avong ◽  
Alemayehu Duga ◽  
...  
Keyword(s):  
Public Health ◽  
Interpersonal Relationships ◽  
Healthcare Providers ◽  
Sub Saharan Africa ◽  
Health Programs ◽  
African Countries ◽  
Public Health Programs ◽  
Roles And Responsibilities ◽  
Drug Safety Monitoring ◽  
Sub Saharan

Abstract Background New medicines have become available for the treatment of drug-resistant tuberculosis (DR-TB) and are introduced in sub-Saharan Africa (SSA) by the national TB programs (NTPs) through special access schemes. Pharmacovigilance is typically the task of national medicines regulatory agencies (NMRAs), but the active drug safety monitoring and management (aDSM) recommended for the new TB medicines and regimens was introduced through the NTPs. We assessed the strengths and challenges of pharmacovigilance systems in Eswatini, Ethiopia, Nigeria and Tanzania, focusing on their capacity to monitor safety of medicines registered and not registered by the NMRAs for the treatment of DR-TB. Methods Assessment visits were conducted to all four countries by a multidisciplinary team. We used a pharmacovigilance indicator tool derived from existing tools, interviewed key stakeholders, and visited health facilities where DR-TB patients were treated with new medicines. Assessment results were verified with the local NMRAs and NTPs. Results Most countries have enabling laws, regulations and guidelines for the conduct of pharmacovigilance by the NMRAs. The relative success of NTP-NMRA collaboration is much influenced by interpersonal relationships between staff. Division of roles and responsibilities is not always clear and leads to duplication and unfulfilled tasks (e.g. causality assessment). The introduction of aDSM has increased awareness among DR-TB healthcare providers. Conclusion aDSM has created awareness about the importance of pharmacovigilance among NTPs. In the future, a push for conducting pharmacovigilance through public health programs seems useful, but this needs to coincide with increased collaboration with between public health programs and NMRAs with clear formulation of roles and responsibilities.

scholarly journals Assessment of the Current State of Pharmacovigilance System in Pakistan Using Indicator-Based Assessment Tool

2022 ◽  
Vol 12 ◽  
Author(s):  
Muhammad Akhtar Abbas Khan ◽  
Saima Hamid ◽  
Tofeeq Ur-Rehman ◽  
Zaheer-Ud-Din Babar
Keyword(s):  
Public Health ◽  
Regulatory Authority ◽  
Assessment Tool ◽  
Health Programs ◽  
Expert Committee ◽  
Pv System ◽  
Private Hospitals ◽  
Public Health Programs ◽  
Drug Regulatory Authority ◽  
National Public Health

Objectives: Pakistan felt the need for an effective and robust pharmacovigilance (PV) system after one of the deadliest drug-related tragedies causing more than 300 deaths in 2012. The country set up its national PV center in 2015 and joined WHO’s Program for International Drug Monitoring (PIDM) in 2018 as a full member. The current study was aimed to evaluate the PV system’s functionality, identify the gaps, areas of improvement, and a strategy to lead a functional PV system in Pakistan.Methods: The descriptive cross-sectional study was conducted by providing an interviewer-administered questionnaire of the PV system across Pakistan by utilizing the Indicator based Pharmacovigilance assessment tool (IPAT). By a convenience sampling method 36 study participants were selected from the Drug Regulatory Authority of Pakistan (DRAP), drug administration of provincial health departments of 4 provinces and federally affiliated areas, 5 national public health programs, and 23 public and private hospitals. The assessment includes document review, interviews of the key informants by structured open-ended questions, and a review of websites of relevant organizations.Results: Drug Regulatory Authority of Pakistan (DRAP) with a national PV center received a 75% overall performance score on IPAT. To be regarded as “minimally functioning,” a country’s PV and drug safety system must meet all core indicators. DRAP scored 80.76% on the core indicators so cannot be deemed functional at this time. The only province with a regional PV center, Punjab, had scored 72.13% on relevant parameters. Despite receiving funding from the Global Fund, none of the National Public Health Programs (PHPs) have PV centers or associated activities. All hospitals except two private hospitals could not qualify the minimum requirements for functional PV. The absence of a legal framework for mandatory ADR reporting, lack of drug information center, budgetary constraints, no active surveillance activities, the nonexistence of pharmacovigilance risk assessment expert committee, and insufficient coordination among stakeholders were identified as major gaps.Conclusion: The results of the study reveal that Pakistan’s PV system is not fully functional at all levels. A two-phased strategy encompassing the non-financial and financial interventions is proposed to improve the PV systems at the national, provincial, PHPs, and hospitals levels.

Risk Attitudes and Behavior Among Norwegian Adolescents

2005 ◽  
Vol 10 (1) ◽  
pp. 25-38 ◽  
Author(s):  
Hilde Iversen ◽  
Torbjørn Rundmo ◽  
Hroar Klempe
Keyword(s):  
Public Health ◽  
Traffic Safety ◽  
Behavior Modification ◽  
Health Programs ◽  
Risk Attitudes ◽  
Community Based ◽  
Public Health Programs ◽  
The Core ◽  
And Behavior ◽  
Attitudes And Behavior

Abstract. The core aim of the present study is to compare the effects of a safety campaign and a behavior modification program on traffic safety. As is the case in community-based health promotion, the present study's approach of the attitude campaign was based on active participation of the group of recipients. One of the reasons why many attitude campaigns conducted previously have failed may be that they have been society-based public health programs. Both the interventions were carried out simultaneously among students aged 18-19 years in two Norwegian high schools (n = 342). At the first high school the intervention was behavior modification, at the second school a community-based attitude campaign was carried out. Baseline and posttest data on attitudes toward traffic safety and self-reported risk behavior were collected. The results showed that there was a significant total effect of the interventions although the effect depended on the type of intervention. There were significant differences in attitude and behavior only in the sample where the attitude campaign was carried out and no significant changes were found in the group of recipients of behavior modification.

Crowdsourcing Covid-19 signals in sub-Saharan Africa: Leveraging digital contributor networks for participatory surveillance of Covid-19 symptoms and deaths (Preprint)

2020 ◽  
Author(s):  
Ngozi A Erondu ◽  
Sagal A Ali ◽  
Mohamed Ali ◽  
Schadrac C Agbla
Keyword(s):  
Public Health ◽  
Sub Saharan Africa ◽  
Specific Information ◽  
Surveillance Systems ◽  
Health Seeking ◽  
African Countries ◽  
Cross Sectional Survey ◽  
Local Networks ◽  
The World ◽  
Sub Saharan

BACKGROUND In sub-Saharan Africa, underreporting of cases and deaths has been attributed to various factors including, weak disease surveillance, low health-seeking behaviour of flu like symptoms, and stigma of Covid-19. There is evidence that SARS-CoV-2 spread mimics transmission patterns of other countries across the world. Since the Covid-19 pandemic has changed the way research can be conducted and in light of restrictions on travel and risks to in-person data collection, innovative approaches to collecting data must be considered. Nearly 50% of Africa’s population is a unique mobile subscriber and it is one of the fastest growing smart-phone marketplaces in the world; hence, mobile phone platforms should be considered to monitor Covid-19 trends in the community. OBJECTIVE We demonstrate the use of digital contributor platforms to survey individuals about cases of flu-like symptoms and instances of unexplained deaths in Ethiopia, Kenya, Nigeria, Somalia, and Zimbabwe. METHODS Rapid cross-sectional survey of individuals with severe flu and pneumonia symptoms and unexplained deaths in Ethiopia, Kenya, Nigeria, Somalia and Zimbabwe RESULTS Using a non-health specific information platform, we found COVID-19 signals in five African countries, specifically: •Across countries, nearly half of the respondents (n=739) knew someone who had severe flu or pneumonia symptoms in recent months. •One in three respondents from Somalia and one in five from Zimbabwe respondents said they knew more than five people recently displaying flu and/or pneumonia symptoms. •In Somalia there were signals that a large number of people might be dying outside of health facilities, specifically in their homes or in IDP or refugee camps. CONCLUSIONS Existing digital contributor platforms with local networks are a non-traditional data source that can provide information from the community to supplement traditional government surveillance systems and academic surveys. We demonstrate that using these distributor networks to for community surveys can provide periodic information on rumours but could also be used to capture local sentiment to inform public health decision-making; for example, these insights could be useful to inform strategies to increase confidence in Covid19 vaccine. As Covid-19 continues to spread somewhat silently across sub-Saharan Africa, regional and national public health entities should consider expanding event-based surveillance sources to include these systems.

scholarly journals Evaluation of Typhoid Conjugate Vaccine Effectiveness in Ghana (TyVEGHA) Using a Cluster-Randomized Controlled Phase IV Trial: Trial Design and Population Baseline Characteristics

Vaccines ◽  
2021 ◽  
Vol 9 (3) ◽  
pp. 281
Author(s):  
Andrea Haekyung Haselbeck ◽  
Birkneh Tilahun Tadesse ◽  
Juyeon Park ◽  
Malick M. Gibani ◽  
Ligia María Cruz Espinoza ◽  
...  
Keyword(s):  
Public Health ◽  
Blood Culture ◽  
Typhoid Fever ◽  
Conjugate Vaccine ◽  
Incidence Rates ◽  
Health Programs ◽  
Public Health Programs ◽  
High Burden ◽  
Pan African ◽  
Cluster Randomized

Typhoid fever remains a significant health problem in sub-Saharan Africa, with incidence rates of >100 cases per 100,000 person-years of observation. Despite the prequalification of safe and effective typhoid conjugate vaccines (TCV), some uncertainties remain around future demand. Real-life effectiveness data, which inform public health programs on the impact of TCVs in reducing typhoid-related mortality and morbidity, from an African setting may help encourage the introduction of TCVs in high-burden settings. Here, we describe a cluster-randomized trial to investigate population-level protection of TYPBAR-TCV®, a Vi-polysaccharide conjugated to a tetanus-toxoid protein carrier (Vi-TT) against blood-culture-confirmed typhoid fever, and the synthesis of health economic evidence to inform policy decisions. A total of 80 geographically distinct clusters are delineated within the Agogo district of the Asante Akim region in Ghana. Clusters are randomized to the intervention arm receiving Vi-TT or a control arm receiving the meningococcal A conjugate vaccine. The primary study endpoint is the total protection of Vi-TT against blood-culture-confirmed typhoid fever. Total, direct, and indirect protection are measured as secondary outcomes. Blood-culture-based enhanced surveillance enables the estimation of incidence rates in the intervention and control clusters. Evaluation of the real-world impact of TCVs and evidence synthesis improve the uptake of prequalified/licensed safe and effective typhoid vaccines in public health programs of high burden settings. This trial is registered at the Pan African Clinical Trial Registry, accessible at Pan African Clinical Trials Registry (ID: PACTR202011804563392).

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