scholarly journals Substandard and Falsified Medicines: Proposed Methods for Case Finding and Sentinel Surveillance (Preprint)

2021 ◽  
Author(s):  
Elizabeth Pisani ◽  
Amalia Hasnida ◽  
Mawaddati Rahmi ◽  
Maarten Olivier Kok ◽  
Steven Harsono ◽  
...  

UNSTRUCTURED The World Health Organization and others warn that substandard and falsified medicines harm health and waste money, especially in low- and middle-income countries. However, no country has measured the market-wide extent of the problem, and no standardized methods exist to estimate the prevalence of either substandard or falsified medicines. This is, in part, because the task seems overwhelming; medicine markets are huge and diverse, and testing medicines is expensive. Many countries do operate some form of postmarket surveillance of medicine, but their methods and goals differ. There is currently no clear guidance on which surveillance method is most appropriate to meet specific public health goals. In this viewpoint, we aimed to discuss the utility of both case finding and risk-based sentinel surveillance for substandard and falsified medicines, linking each to specific public health goals. We posit that choosing the system most appropriate to the goal, as well as implementing it with a clear understanding of the factors driving the production and sale of substandard and falsified medicines, will allow for surveillance resources to be concentrated most efficiently. We adapted principles used for disease outbreak responses to suggest a case-finding system that uses secondary data to flag poor-quality medicines, proposing risk-based indicators that differ for substandard and falsified medicines. This system potentially offers a cost-effective way of identifying “cases” for market withdrawal, enhanced oversight, or another immediate response. We further proposed a risk-based sentinel surveillance system that concentrates resources on measuring the prevalence of substandard and falsified medicines in the risk clusters where they are most likely to be found. The sentinel surveillance system provides base data for a transparent, spreadsheet-based model for estimating the national prevalence of substandard and falsified medicines. The methods we proposed are based on ongoing work in Indonesia, a large and diverse middle-income country currently aiming to achieve universal health coverage. Both the case finding and the sentinel surveillance system are designed to be adaptable to other resource-constrained settings.

2019 ◽  
Author(s):  
Pélagie Diambalula Babakazo ◽  
Joelle Kabamba-Tshilobo ◽  
Emile Okitolonda Wemakoy ◽  
Léopold Lubula ◽  
Léonie Kitoko Manya ◽  
...  

Abstract Background The World Health Organization recommends periodic evaluations of influenza surveillance systems to identify areas for improvement and provide evidence of data reliability for policymaking. However, data about the performance of established influenza surveillance systems are limited in Africa, including in the Democratic Republic of Congo (DRC). Methods We used the Centers for Disease Control and Prevention guidelines to evaluate the performance of the influenza sentinel surveillance system (ISSS) in DRC during 2012-2015. The performance of the system was evaluated using eight surveillance attributes: (i) data quality and completeness for key variables, (ii) timeliness, (iii) representativeness, (iv) flexibility, (v) simplicity, (vi) acceptability, (vii) stability and (viii) utility. For each attribute, specific indicators were developed and described using quantitative and qualitative methods. Scores for each indicator were as follows: <60% weak performance; 60-79% moderate performance; ≥80% good performance. Results During 2012-2015, we enrolled and tested 4,339 patients with influenza-like illness (ILI) and 2,869 patients with severe acute respiratory illness (SARI) from 11 sentinel sites situated in 5 of 11 provinces. Influenza viruses were detected in 446 (10.3%) samples from patients with ILI and in 151 (5.5%) samples from patients with SARI with higher detection during December-May. Data quality and completeness was >90% for all evaluated indicators. Other strengths of the system were timeliness, representativeness, simplicity, stability and utility that scored >70% each. Flexibility and acceptability had moderate to week performance. It was reported that the ISSS contributed to: (i) a better understanding of the epidemiology, circulating patterns and proportional contribution of influenza virus among patients with ILI or SARI; (ii) acquisition of new key competences related to influenza surveillance and diagnosis; and (iii) continuous education of surveillance staff and clinicians at sentinel sites about influenza. However, due to limited resources no actions were undertaken to mitigate the impact of seasonal influenza epidemics. Conclusions The system performed overall satisfactorily and provided reliable and timely data about influenza circulation in DRC. The simplicity of the system contributed to its stability. A better use of the available data could be made to inform and promote prevention interventions especially among the most vulnerable groups.


2019 ◽  
Author(s):  
Pelagie Diambalula Babakazo ◽  
Joelle Kabamba-Tshilobo ◽  
Emile Okitolonda Wemakoy ◽  
Léopold Lubula ◽  
Léonie Kitoko Manya ◽  
...  

Abstract Background The World Health Organization recommends periodic evaluations of influenza surveillance systems to identify areas for improvement and provide evidence of data reliability for policymaking. However, data about the performance of established influenza surveillance systems are limited in Africa, including in the Democratic Republic of Congo (DRC). Methods We used the Centers for Disease Control and Prevention guidelines to evaluate the performance of the influenza sentinel surveillance system (ISSS) in DRC during 2012-2015. The performance of the system was evaluated using eight surveillance attributes: (i) data quality and completeness for key variables, (ii) timeliness, (iii) representativeness, (iv) flexibility, (v) simplicity, (vi) acceptability, (vii) stability and (viii) utility. For each attribute, specific indicators were developed and described using quantitative and qualitative methods. Scores for each indicator were as follows: <60% weak performance; 60-79% moderate performance; ≥80% good performance. Results During 2012-2015, we enrolled and tested 4,339 patients with influenza-like illness (ILI) and 2,869 patients with severe acute respiratory illness (SARI) from 11 sentinel sites situated in 5 of 11 provinces. Influenza viruses were detected in 446 (10.3%) samples from patients with ILI and in 151 (5.5%) samples from patients with SARI with higher detection during December-May. Data quality and completeness was >90% for all evaluated indicators. Other strengths of the system were timeliness, simplicity, stability and utility that scored >70% each. Representativeness, flexibility and acceptability had moderate performance. It was reported that the ISSS contributed to: (i) a better understanding of the epidemiology, circulating patterns and proportional contribution of influenza virus among patients with ILI or SARI; (ii) acquisition of new key competences related to influenza surveillance and diagnosis; and (iii) continuous education of surveillance staff and clinicians at sentinel sites about influenza. However, due to limited resources no actions were undertaken to mitigate the impact of seasonal influenza epidemics. Conclusions The system performed overall satisfactorily and provided reliable and timely data about influenza circulation in DRC. The simplicity of the system contributed to its stability. A better use of the available data could be made to inform and promote prevention interventions especially among the most vulnerable groups.


2018 ◽  
Author(s):  
Denton Callander ◽  
Clarissa Moreira ◽  
Carol El-Hayek ◽  
Jason Asselin ◽  
Caroline van Gemert ◽  
...  

BACKGROUND New biomedical prevention interventions make the control or elimination of some blood-borne viruses (BBVs) and sexually transmissible infections (STIs) increasingly feasible. In response, the World Health Organization and governments around the world have established elimination targets and associated timelines. To monitor progress toward such targets, enhanced systems of data collection are required. This paper describes the Australian Collaboration for Coordinated Enhanced Sentinel Surveillance (ACCESS). OBJECTIVE This study aims to establish a national surveillance network designed to monitor public health outcomes and evaluate the impact of strategies aimed at controlling BBVs and STIs. METHODS ACCESS is a sentinel surveillance system comprising health services (sexual health clinics, general practice clinics, drug and alcohol services, community-led testing services, and hospital outpatient clinics) and pathology laboratories in each of Australia’s 8 states and territories. Scoping was undertaken in each jurisdiction to identify sites that provide a significant volume of testing or management of BBVs or STIs or to see populations with particular risks for these infections (“priority populations”). Nationally, we identified 115 health services and 24 pathology laboratories as relevant to BBVs or STIs; purposive sampling was undertaken. As of March 2018, we had recruited 92.0% (104/113) of health services and 71% (17/24) of laboratories among those identified as relevant to ACCESS. ACCESS is based on the regular and automated extraction of deidentified patient data using specialized software called GRHANITE, which creates an anonymous unique identifier from patient details. This identifier allows anonymous linkage between and within participating sites, creating a national cohort to facilitate epidemiological monitoring and the evaluation of clinical and public health interventions. RESULTS Between 2009 and 2017, 1,171,658 individual patients attended a health service participating in ACCESS network comprising 7,992,241 consultations. Regarding those with unique BBV and STI-related health needs, ACCESS captured data on 366,441 young heterosexuals, 96,985 gay and bisexual men, and 21,598 people living with HIV. CONCLUSIONS ACCESS is a unique system with the ability to track efforts to control STIs and BBVs—including through the calculation of powerful epidemiological indicators—by identifying response gaps and facilitating the evaluation of programs and interventions. By anonymously linking patients between and within services and over time, ACCESS has exciting potential as a research and evaluation platform. Establishing a national health surveillance system requires close partnerships across the research, government, community, health, and technology sectors. INTERNATIONAL REGISTERED REPOR DERR1-10.2196/11028


2019 ◽  
Author(s):  
Pelagie Diambalula Babakazo ◽  
Joelle Kabamba-Tshilobo ◽  
Emile Okitolonda Wemakoy ◽  
Léopold Lubula ◽  
Léonie Kitoko Manya ◽  
...  

Abstract Background The World Health Organization recommends periodic evaluations of influenza surveillance systems to identify areas for improvement and provide evidence of data reliability for policymaking. However, data about the performance of established influenza surveillance systems are limited in Africa, including in the Democratic Republic of Congo (DRC). Methods We used the Centers for Disease Control and Prevention guidelines to evaluate the performance of the influenza sentinel surveillance system (ISSS) in DRC during 2012-2015. The performance of the system was evaluated using eight surveillance attributes: (i) data quality and completeness for key variables, (ii) timeliness, (iii) representativeness, (iv) flexibility, (v) simplicity, (vi) acceptability, (vii) stability and (viii) utility. For each attribute, specific indicators were developed and described using quantitative and qualitative methods. Scores for each indicator were as follows: <60% weak performance; 60-79% moderate performance; ≥80% good performance. Results During 2012-2015, we enrolled and tested 4,339 patients with influenza-like illness (ILI) and 2,869 patients with severe acute respiratory illness (SARI) from 11 sentinel sites situated in 5 of 11 provinces. Influenza viruses were detected in 446 (10.3%) samples from patients with ILI and in 151 (5.5%) samples from patients with SARI with higher detection during December-May. Data quality and completeness was >90% for all evaluated indicators. Other strengths of the system were timeliness, representativeness, simplicity, stability and utility that scored >70% each. Flexibility and acceptability had moderate to week performance. It was reported that the ISSS contributed to: (i) a better understanding of the epidemiology, circulating patterns and proportional contribution of influenza virus among patients with ILI or SARI; (ii) acquisition of new key competences related to influenza surveillance and diagnosis; and (iii) continuous education of surveillance staff and clinicians at sentinel sites about influenza. However, due to limited resources no actions were undertaken to mitigate the impact of seasonal influenza epidemics. Conclusions The system performed overall satisfactorily and provided reliable and timely data about influenza circulation in DRC. The simplicity of the system contributed to its stability. A better use of the available data could be made to inform and promote prevention interventions especially among the most vulnerable groups.


2019 ◽  
Author(s):  
Pelagie Diambalula Babakazo ◽  
Joelle Kabamba-Tshilobo ◽  
Emile Okitolonda Wemakoy ◽  
Léopold Lubula ◽  
Léonie Kitoko Manya ◽  
...  

Abstract Background The World Health Organization recommends periodic evaluations of influenza surveillance systems to identify areas for improvement and provide evidence of data reliability for policymaking. However, data about the performance of established influenza surveillance systems are limited in Africa, including in the Democratic Republic of Congo (DRC). Methods We used the Centers for Disease Control and Prevention guidelines to evaluate the performance of the influenza sentinel surveillance system (ISSS) in DRC during 2012-2015. The performance of the system was evaluated using eight surveillance attributes: (i) data quality and completeness for key variables, (ii) timeliness, (iii) representativeness, (iv) flexibility, (v) simplicity, (vi) acceptability, (vii) stability and (viii) utility. For each attribute, specific indicators were developed and described using quantitative and qualitative methods. Scores for each indicator were as follows: <60% weak performance; 60-79% moderate performance; ≥80% good performance. Results During 2012-2015, we enrolled and tested 4,339 patients with influenza-like illness (ILI) and 2,869 patients with severe acute respiratory illness (SARI) from 11 sentinel sites situated in 5 of 11 provinces. Influenza viruses were detected in 446 (10.3%) samples from patients with ILI and in 151 (5.5%) samples from patients with SARI with higher detection during December-May. Data quality and completeness was >90% for all evaluated indicators. Other strengths of the system were timeliness, representativeness, simplicity, stability and utility that scored >70% each. Flexibility and acceptability had moderate to week performance. It was reported that the ISSS contributed to: (i) a better understanding of the epidemiology, circulating patterns and proportional contribution of influenza virus among patients with ILI or SARI; (ii) acquisition of new key competences related to influenza surveillance and diagnosis; and (iii) continuous education of surveillance staff and clinicians at sentinel sites about influenza. However, due to limited resources no actions were undertaken to mitigate the impact of seasonal influenza epidemics. Conclusions The system performed overall satisfactorily and provided reliable and timely data about influenza circulation in DRC. The simplicity of the system contributed to its stability. A better use of the available data could be made to inform and promote prevention interventions especially among the most vulnerable groups.


2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Pélagie Babakazo ◽  
Joelle Kabamba-Tshilobo ◽  
Emile Okitolonda Wemakoy ◽  
Léopold Lubula ◽  
Léonie Kitoko Manya ◽  
...  

Abstract Background The World Health Organization recommends periodic evaluations of influenza surveillance systems to identify areas for improvement and provide evidence of data reliability for policymaking. However, data about the performance of established influenza surveillance systems are limited in Africa, including in the Democratic Republic of Congo (DRC). Methods We used the Centers for Disease Control and Prevention guidelines to evaluate the performance of the influenza sentinel surveillance system (ISSS) in DRC during 2012–2015. The performance of the system was evaluated using eight surveillance attributes: (i) data quality and completeness for key variables, (ii) timeliness, (iii) representativeness, (iv) flexibility, (v) simplicity, (vi) acceptability, (vii) stability and (viii) utility. For each attribute, specific indicators were developed and described using quantitative and qualitative methods. Scores for each indicator were as follows: < 60% weak performance; 60–79% moderate performance; ≥80% good performance. Results During 2012–2015, we enrolled and tested 4339 patients with influenza-like illness (ILI) and 2869 patients with severe acute respiratory illness (SARI) from 11 sentinel sites situated in 5 of 11 provinces. Influenza viruses were detected in 446 (10.3%) samples from patients with ILI and in 151 (5.5%) samples from patients with SARI with higher detection during December–May. Data quality and completeness was > 90% for all evaluated indicators. Other strengths of the system were timeliness, simplicity, stability and utility that scored > 70% each. Representativeness, flexibility and acceptability had moderate performance. It was reported that the ISSS contributed to: (i) a better understanding of the epidemiology, circulating patterns and proportional contribution of influenza virus among patients with ILI or SARI; (ii) acquisition of new key competences related to influenza surveillance and diagnosis; and (iii) continuous education of surveillance staff and clinicians at sentinel sites about influenza. However, due to limited resources no actions were undertaken to mitigate the impact of seasonal influenza epidemics. Conclusions The system performed overall satisfactorily and provided reliable and timely data about influenza circulation in DRC. The simplicity of the system contributed to its stability. A better use of the available data could be made to inform and promote prevention interventions especially among the most vulnerable groups.


Author(s):  
Chris Bullen ◽  
Jessica McCormack ◽  
Amanda Calder ◽  
Varsha Parag ◽  
Kannan Subramaniam ◽  
...  

Abstract Background: The global COVID-19 pandemic has disrupted healthcare worldwide. In low- and middle-income countries (LMICs), where people may have limited access to affordable quality care, the COVID-19 pandemic has the potential to have a particularly adverse impact on the health and healthcare of individuals with noncommunicable diseases (NCDs). A World Health Organization survey found that disruption of delivery of healthcare for NCDs was more significant in LMICs than in high-income countries. However, the study did not elicit insights into the day-to-day impacts of COVID-19 on healthcare by front-line healthcare workers (FLHCWs). Aim: To gain insights directly from FLHCWs working in countries with a high NCD burden, and thereby identify opportunities to improve the provision of healthcare during the current pandemic and in future healthcare emergencies. Methods: We recruited selected frontline healthcare workers (general practitioners, pharmacists, and other medical specialists) from nine countries to complete an online survey (n = 1347). Survey questions focused on the impact of COVID-19 pandemic on clinical practice and NCDs; barriers to clinical care during the pandemic; and innovative responses to the many challenges presented by the pandemic. Findings: The majority of FLHCWs responding to our survey reported that their care of patients had been impacted both adversely and positively by the public health measures imposed. Most FLHCs (95%) reported a deterioration in the mental health of their patients. Conclusions: Continuity of care for NCDs as part of pandemic preparedness is needed so that chronic conditions are not exacerbated by public health measures and the direct impacts of the pandemic.


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