scholarly journals Establishment of the African Medicines Agency: progress, challenges and regulatory readiness

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Bakani Mark Ncube ◽  
Admire Dube ◽  
Kim Ward
Keyword(s):  
Public Health ◽  
Future Research ◽  
Market Authorisation ◽  
Medical Products ◽  
Significant Challenge ◽  
Regulatory Authorities ◽  
Regulatory Systems ◽  
Medicines Regulation ◽  
Model Law ◽  
Regulatory Challenges

AbstractInsufficient access to quality, safe, efficacious and affordable medical products in Africa has posed a significant challenge to public health for decades. In part, this is attributed to weak or absent policies and regulatory systems, a lack of competent regulatory professionals in National Medicines Regulatory Authorities (NMRAs) and ineffective regional collaborations among NMRAs. In response to national regulatory challenges in Africa, a number of regional harmonisation efforts were introduced through the African Medicines Regulatory Harmonisation (AMRH) initiative to, among others, expedite market authorisation of medical products and to facilitate the alignment of national legislative frameworks with the AU Model Law on Medical Products Regulation. The goals of the model law include to increase collaboration across countries and to facilitate the overall regional harmonisation process. The AMRH initiative is proposed to serve as the foundation for the establishment of the African Medicines Agency (AMA). The AMA will, as one of its mandates, coordinate the regional harmonisation systems that are enabled by AU Model Law domestication and implementation. In this paper, we review the key entities involved in regional and continental harmonisation of medicines regulation, the milestones achieved in establishing the AMA as well as the implementation targets and anticipated challenges related to the AU Model Law domestication and the AMA’s establishment. This review shows that implementation targets for the AU Model Law have not been fully met, and the AMA treaty has not been ratified by the minimum required number of countries for its establishment. In spite of the challenges, the AU Model Law and the AMA hold promise to address gaps and inconsistencies in national regulatory legislation as well as to ensure effective medicines regulation by galvanising technical support, regulatory expertise and resources at a continental level. Furthermore, this review provides recommendations for future research.

scholarly journals Privacy-Preserving Pandemic Monitoring

2021 ◽  
pp. 194-206
Author(s):  
Thu Yein Win ◽  
Hugo Tianfield
Keyword(s):  
Public Health ◽  
Data Sharing ◽  
Data Privacy ◽  
Privacy Preserving ◽  
Patient Data ◽  
Future Research ◽  
Health Safety ◽  
Patient Data Privacy ◽  
Significant Challenge ◽  
The World

The recent COVID-19 pandemic has presented a significant challenge for health organisations around the world in providing treatment and ensuring public health safety. While this has highlighted the importance of data sharing amongst them, it has also highlighted the importance of ensuring patient data privacy in doing so. This chapter explores the different techniques which facilitate this, along with their overall implementations. It first provides an overview of pandemic monitoring and the privacy implications associated with it. It then explores the different privacy-preserving approaches that have been used in existing research. It also explores the strengths as well as their limitations, along with possible areas for future research.

scholarly journals OC 8715 GOING FURTHER TOGETHER: THE ROLE OF THE EU IN SUPPORTING REGULATORY HARMONISATION OF HEALTH TOOLS IN AFRICA

2019 ◽  
Vol 4 (Suppl 3) ◽  
pp. A16.2-A16
Author(s):  
Agustin Martin Lasanta
Keyword(s):  
The European Union ◽  
African Countries ◽  
Medical Products ◽  
Research And Innovation ◽  
Regulatory Systems ◽  
National Implementation ◽  
Health Products ◽  
Union Model ◽  
Trade Partner ◽  
Model Law

BackgroundOn May 20, 2018, African governments adopted the Treaty for the establishment of the African Medicines Agency (AMA) as a stepping stone in the strengthening and harmonising of medical products regulation on the continent. Many countries in Africa lack robust and comprehensive regulatory systems supporting the research and registration of health products, hampering the translation of health research and innovation into public health impacts. The AMA could substantially improve the access to quality-assured, safe and’effective health solutions and technologies in Africa and around the world. As the main trade partner and donor to Africa, the European Union (EU) has a key role to play in supporting this effort.MethodDesk research and case-study analyses of key initiatives to strengthen medicinesregulation in Africa were conducted. Specifically, the EDCTP, the African Vaccine Regulatory Forum (AVAREF), the African Medicines Regulatory Harmonisation Programme (AMRH) and the Zazibona Process; to assess the gaps, needs and opportunities for EU collaboration using actual and reconfigured EU-Africa funding and policy cooperation mechanisms.Results and conclusionsThis presentation will explore initiatives aimed at regulatory strengthening and harmonisation in Africa and propose policy recommendations on how to improve EU efforts in order to support these initiatives in a more systematic and synergetic manner. The recommendations fall into four categories: EU-Africa priority-setting, coordination, funding and capacity-building actions. Recommendations explore, for instance, advancing the national implementation of the African Union Model Law on Medical Products Regulation by all African countries, enlarging the scope of EDCTP regulatory strengthening actions to include Africa’s Regional Centres of Regulatory Excellence (RCOREs) or improving the attractiveness and incentive system of the EMA’s article 58 procedure for African governments, researchers and manufacturers.

scholarly journals Making the investment case for national regulatory authorities

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Gloria Twesigye ◽  
Tamara Hafner ◽  
Javier Guzman
Keyword(s):  
Critical Role ◽  
Health Coverage ◽  
Middle Income ◽  
Medical Products ◽  
Middle Income Countries ◽  
Regulatory Authorities ◽  
Regulatory Systems ◽  
Robust Regulation ◽  
Pharmaceutical Trade ◽  
To Receive

AbstractWell-functioning national regulatory authorities (NRAs) ensure access to safe, effective, quality-assured, and affordable medical products. However, the benefits of their work are often unseen and difficult to attribute, thereby making NRAs undervalued and under-resourced, particularly in low- and middle-income countries. This paper offers three key arguments NRAs and other stakeholders can use to advocate for greater investment in regulatory systems strengthening—medical products regulation effectively safeguards public health; effective regulation improves health system’s efficiency by increasing access to affordable medical products, contributing to universal health coverage; and robust regulation strengthens local pharmaceutical manufacturing and bolsters pharmaceutical trade. NRAs’ critical role in health systems is indisputable, yet they need to better promote their value to receive the requisite resources to function effectively.

scholarly journals The use of Qualitative Comparative Analysis (QCA) to address causality in complex systems: a systematic review of research on public health interventions

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Benjamin Hanckel ◽  
Mark Petticrew ◽  
James Thomas ◽  
Judith Green
Keyword(s):  
Public Health ◽  
Comparative Analysis ◽  
Complex Systems ◽  
Qualitative Comparative Analysis ◽  
Complex Interventions ◽  
Health Interventions ◽  
Data Availability ◽  
Future Research ◽  
Public Health Interventions ◽  
Minimum Criteria

Abstract Background Qualitative Comparative Analysis (QCA) is a method for identifying the configurations of conditions that lead to specific outcomes. Given its potential for providing evidence of causality in complex systems, QCA is increasingly used in evaluative research to examine the uptake or impacts of public health interventions. We map this emerging field, assessing the strengths and weaknesses of QCA approaches identified in published studies, and identify implications for future research and reporting. Methods PubMed, Scopus and Web of Science were systematically searched for peer-reviewed studies published in English up to December 2019 that had used QCA methods to identify the conditions associated with the uptake and/or effectiveness of interventions for public health. Data relating to the interventions studied (settings/level of intervention/populations), methods (type of QCA, case level, source of data, other methods used) and reported strengths and weaknesses of QCA were extracted and synthesised narratively. Results The search identified 1384 papers, of which 27 (describing 26 studies) met the inclusion criteria. Interventions evaluated ranged across: nutrition/obesity (n = 8); physical activity (n = 4); health inequalities (n = 3); mental health (n = 2); community engagement (n = 3); chronic condition management (n = 3); vaccine adoption or implementation (n = 2); programme implementation (n = 3); breastfeeding (n = 2), and general population health (n = 1). The majority of studies (n = 24) were of interventions solely or predominantly in high income countries. Key strengths reported were that QCA provides a method for addressing causal complexity; and that it provides a systematic approach for understanding the mechanisms at work in implementation across contexts. Weaknesses reported related to data availability limitations, especially on ineffective interventions. The majority of papers demonstrated good knowledge of cases, and justification of case selection, but other criteria of methodological quality were less comprehensively met. Conclusion QCA is a promising approach for addressing the role of context in complex interventions, and for identifying causal configurations of conditions that predict implementation and/or outcomes when there is sufficiently detailed understanding of a series of comparable cases. As the use of QCA in evaluative health research increases, there may be a need to develop advice for public health researchers and journals on minimum criteria for quality and reporting.

Engaging Undergraduate Public Health Students Through a Textbook Creation Project

2020 ◽  
pp. 237337992096241
Author(s):  
Jessica Sloan Kruger ◽  
Christopher Hollister
Keyword(s):  
Public Health ◽  
Future Research ◽  
Open Educational Resource ◽  
Educational Resource ◽  
Final Version ◽  
Primary Motivation ◽  
Course Content ◽  
Health Course ◽  
Research Questions ◽  
Undergraduate Public Health

This study examines students’ perceptions of an open pedagogy experiment in which they created their own textbook for an undergraduate public health course. The lead author’s primary motivation for developing this assignment was the high cost associated with the traditional textbooks that were otherwise needed to cover the breadth of subject matter in the course. The resulting open textbook included 19 chapters, covering all the required components of the course, and the final version was published in a statewide open educational resource repository. Students provided feedback about this undertaking by way of an end-of-term survey. The results showed high percentages of students who associated the textbook creation project with greater engagement and satisfaction than the passive use of traditional textbooks. Students also reported their perception of a learning benefit related to the creation of course content. Pedagogical implications of this study are discussed, and future research questions are proposed.

scholarly journals Advancing precision public health using human genomics: examples from the field and future research opportunities

2021 ◽  
Vol 13 (1) ◽  
Author(s):  
Megan C. Roberts ◽  
Alison E. Fohner ◽  
Latrice Landry ◽  
Dana Lee Olstad ◽  
Amelia K. Smit ◽  
...  
Keyword(s):  
Public Health ◽  
Precision Medicine ◽  
Behavioral Science ◽  
Public Health Research ◽  
Future Research ◽  
Human Genomics ◽  
Precision Public Health ◽  
Genomics Research ◽  
Health Initiatives ◽  
Public Health Initiatives

AbstractPrecision public health is a relatively new field that integrates components of precision medicine, such as human genomics research, with public health concepts to help improve population health. Despite interest in advancing precision public health initiatives using human genomics research, current and future opportunities in this emerging field remain largely undescribed. To that end, we provide examples of promising opportunities and current applications of genomics research within precision public health and outline future directions within five major domains of public health: biostatistics, environmental health, epidemiology, health policy and health services, and social and behavioral science. To further extend applications of genomics within precision public health research, three key cross-cutting challenges will need to be addressed: developing policies that implement precision public health initiatives at multiple levels, improving data integration and developing more rigorous methodologies, and incorporating initiatives that address health equity. Realizing the potential to better integrate human genomics within precision public health will require transdisciplinary efforts that leverage the strengths of both precision medicine and public health.

scholarly journals Face Covered and Six Feet Apart: Behavioral Awareness Predicts Greater Adherence to Public Health Guidelines during the COVID-19 Pandemic

2021 ◽  
Vol 18 (16) ◽  
pp. 8247
Author(s):  
Alyssa Schneider ◽  
Emily B. Kroska
Keyword(s):  
Public Health ◽  
Psychological Flexibility ◽  
The United States ◽  
Future Research ◽  
Physical And Mental Health ◽  
Logistic Regression Models ◽  
Demographic Correlates ◽  
Amazon's Mechanical Turk ◽  
Predictors Of Adherence ◽  
Close Contacts

The COVID-19 pandemic has deleteriously impacted physical and mental health. Guidelines to limit the spread of COVID-19 include wearing a face covering in public, limiting close contacts, and physical distancing. In combatting this and future pandemics, it is essential to understand predictors of adherence, such as psychological flexibility. We hypothesized higher psychological flexibility would relate to greater adherence to public health guidelines. Participants (n = 265) were English-reading/speaking adults in the United States and were recruited through Amazon’s Mechanical Turk. Included in the present analyses are data from June (n = 360) and July 2020 (n = 265). Measures included the Comprehensive Assessment of ACT Processes (CompACT), which measured psychological flexibility. Outcome measures included mask-wearing and number of close contacts, which were operationalized categorically (100% mask-wearing in public, ≤10 close contacts in past week). Two logistic regression models examined psychological flexibility and distress as predictors of adherence to mask-wearing and limiting close contacts, while controlling for demographic correlates. Results indicated that greater behavioral awareness predicted greater odds of mask-wearing and limiting close contacts. Psychological flexibility, and behavioral awareness specifically, should be investigated in future research as targets for intervention amidst global disasters.

scholarly journals Evolving Patterns of Cryptosporidiosis: Issues and Implications in the Context of Public Health in India

2021 ◽  
Author(s):  
Bijay Ranjan Mirdha
Keyword(s):  
Public Health ◽  
Genetic Diversity ◽  
Genetic Recombination ◽  
Acute Infection ◽  
Transmission Intensity ◽  
Future Research ◽  
Cryptosporidium Hominis ◽  
Host Preferences ◽  
Childhood Growth ◽  
Life Years

AbstractCryptosporidiosis is one of the major causes of diarrhea in immune-compromised individuals and children besides causing sporadic water-borne, food-borne, and zoonotic outbreaks. In 2016, Cryptosporidium species infection was the fifth leading cause of diarrhea and acute infection causing more than 4.2 million disability-adjusted life years lost besides a decrease in childhood growth. Human cryptosporidiosis is primarily caused by two species/genotype: Cryptosporidium hominis (anthroponotic) and Cryptosporidium parvum (zoonotic) besides other six rare species/genotypes. Transmission intensity, genetic diversity, and occurrence of genetic recombination have shaped the genus Cryptosporidium population structures into palmitic, clonal, and epidemic. Genetic recombination is more in C. parvum compared with C. hominis. Furthermore, parasite–host co-evolution, host adaptation, and geographic segregation have led to the formation of “subtype- families.” Host-adapted subtype-families have distinct geographical distribution and host preferences. Genetic exchanges between subtypes played an important role throughout the evolution of the genus leading to “adaptation introgression” that led to emergence of virulent and hyper-transmissible subtypes. The population structure of C. hominis in India appears to be more complex where both transmission intensity and genetic diversity are much higher. Further, study based on “molecular strain surveillance” has resulted newer insights into the epidemiology and transmission of cryptosporidiosis in India. The identification at the species and genotype levels is essential for the assessment of infection sources in humans and the public health potential of the parasite at large. The results of the study over three decades on cryptosporidiosis in India, in the absence of a national surveillance data, were analyzed highlighting current situation on epidemiology, genetic diversity, and distribution particularly among vulnerable population. Despite creditable efforts, there are still many areas need to be explored; therefore, the intent of this article is to facilitate future research approaches for mitigating the burden associated with this disease.

scholarly journals Exploring the use of workplaces to recruit “hard-to-reach” male drinkers to a survey on alcohol use and awareness of health messages

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Sarah Dance ◽  
Charlotte Dack ◽  
Celia Lasheras ◽  
Cathy McMahon ◽  
Paul Scott ◽  
...  
Keyword(s):  
Public Health ◽  
Alcohol Use ◽  
Financial Incentive ◽  
Health Messages ◽  
Heavy Episodic Drinking ◽  
Future Research ◽  
Recruitment Strategies ◽  
Public Health Messages ◽  
Alcohol Related Harm ◽  
Related Harm

Abstract Background Lower socioeconomic status (SES) groups, particularly lower SES males, are at greater risk of alcohol-related harm than higher SES groups, despite drinking at the same level or less. However, they are rarely recruited for research through typical recruitment strategies. Consequently, limited evidence exists on patterns of alcohol use and effectiveness of public health messages for these groups. Using workplaces to recruit male drinkers from lower SES backgrounds may provide a feasible and accessible approach to research participation and enable improved understanding of alcohol use, drinking motives and acceptance of alcohol-related public health messages in this underrepresented and high-risk group. We investigated workplace-based strategies to recruit male drinkers from lower SES backgrounds. We also investigated their experiences and motivations for alcohol use, and acceptance of alcohol-related public health messages. Methods A feasibility element investigated the effectiveness of workplace-based strategies to recruit male drinkers from lower SES backgrounds in the south west of England. A pilot element investigated this population’s experiences and motivations for alcohol use, and acceptance of alcohol-related public health messages, through a mixed-methods survey. Results Feasibility results indicated that workplace-based recruitment strategies, including recruiting participants in person at their workplace and providing a financial incentive, effectively led to the recruitment of 84 male drinkers (70% recruitment rate), predominately from lower SES backgrounds, to a survey. Pilot results indicated that more than half of participants were at increasing risk of alcohol-related harm, and approximately one fifth engaged in weekly heavy episodic drinking. Participation in campaigns aimed at reducing alcohol use, and knowledge of government alcohol consumption guidelines, were low. Participants reported negative beliefs about alcohol including health effects, dependency and excess use, and financial and occupational effects. Positive beliefs about alcohol included relaxation, socialising, and enjoyment. Conclusions Workplace-based recruitment, using in-person recruitment and a financial incentive, may be a feasible strategy to recruit male drinkers from lower SES backgrounds. Pilot results may direct larger scale research aiming to understand alcohol use in this population and inform targeted public health messages. Workplace-based recruitment may represent a promising avenue for future research aiming to tackle inequalities in participation in alcohol research.

scholarly journals Investigating Community Pharmacy Take Home Naloxone Dispensing during COVID-19: The Impact of One Public Health Crisis on Another

Pharmacy ◽  
2021 ◽  
Vol 9 (3) ◽  
pp. 129
Author(s):  
George Daskalakis ◽  
Ashley Cid ◽  
Kelly Grindrod ◽  
Michael A. Beazely
Keyword(s):  
Public Health ◽  
Community Pharmacy ◽  
Online Survey ◽  
Comfort Level ◽  
Future Research ◽  
Health Crisis ◽  
Public Health Crisis ◽  
Pharmacy Technicians ◽  
The Impact ◽  
Overdose Deaths

A recent report found that the number of opioid-related deaths in Ontario in the first 15 weeks of the COVID-19 pandemic was 38.2% higher than in the 15 weeks before the pandemic. Our study sought to determine if pharmacy professionals self-reported an increase or decrease in naloxone provision due to the pandemic and to identify adjustments made by pharmacy professionals to dispense naloxone during the pandemic. A total of 231 Ontario community pharmacy professionals completed an online survey. Pharmacy professionals’ barriers, facilitators, and comfort level with dispensing naloxone before and during the pandemic were identified. The sample consisted of mostly pharmacists (99.1%). Over half (51.1%) reported no change in naloxone dispensing, while 22.9% of respondents reported an increase and 24.7% a decrease. The most common adjustments made during the pandemic were training patients how to administer naloxone over video or phone, delivering naloxone kits, and pharmacy technicians offering naloxone at prescription intake. Over half (55%) of participants said the top barrier for dispensing was that patients did not request naloxone. Naloxone distribution through pharmacies could be further optimized to address the increased incidence of overdose deaths during the pandemic. Future research should investigate the reasons for changes in naloxone dispensing.

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