Welcome! Accelerate Your Discovery

Be a part of a committed society that is shaping the future of knowledge Search

15th January, 2023

Assessments of the quality systems of pharmaceutical distributors: a remote approach to be applied in times of COVID-19 and beyond

Anthony Bourasseau, Laurine Lavergne & Raffaella Ravinetto

Background: Adequate quality systems throughout pharmaceutical supply chains are crucial to protect individuals and communities from substandard and falsifed medical products. Thus, pharmaceutical distributors are regularly assessed by qualifed experts. Since the COVID-19 pandemic has forced a suspension of normal activities, remote assessments via videoconferencing may represent a temporary alternative to on-site audits. We exploratorily evaluated the feasibility of remote assessments of pharmaceutical distributors, located in a low- or middle-income country hard-to reach during the COVID-19 pandemic. Methods: We conducted pilot remote assessments of four conveniently selected distributors. The expert was remotely connected via videoconference, and supported by an in-country assessment facilitator (ICAF), who had received ad hoc training and was present at the assessed facility. First, the remote expert assessed the quality assurance (QA) activities and rated their compliance with the standards of the World Health Organization Good Storage & Distribution Practices (GSDP), as per routine practice. Second, s/he assessed the completeness, clarity and accuracy of data collected remotely, frst per distributor, and then in aggregated form. Results: Data completeness was assessed by the expert as excellent, while clarity and accuracy were good. Overall data quality (a combination of completeness, clarity and accuracy) was good, with no major diferences across QA activities, nor across distributors. Contextual limitations included poor internet connection, language barriers, and distributors’ lack of familiarity with QA terminology. Conclusions: Our fndings are exploratory and cannot be extrapolated to other contexts, nor to other types of audits. Nonetheless, this pilot experience suggests that a well-planned remote assessment of pharmaceutical distributors, conducted with the support of a well-trained onsite ICAF, can provide data of acceptable quality, allowing to assess GSDP-compliance and to make temporary decisions about licensing or purchasing. Purchasers and policy makers should read the results of remote assessments in light of their intrinsic limitations. At the moment, onsite assessments remain the gold standards, but this could change in the longer term, with improved information technology and in light of the need to avoid unnecessary travels. Furthermore, remote assessments could be considered for routine prescreening candidates for on-site assessments, and for targeted follow-up of on-site assessment.

Journal of Pharmaceutical Policy and Practice volume

Volume: `14
Issue: 43
Page numbers: 1-9
ISSN or DOI: 10.14716/ijtech.v7i7.4716
14 cite
Save article
Share article

Recommended Articles

Determination of Forgery Risk Indicators in Land Transaction Documents in Ghana
Samuel Boamah Asiedu, Emmanuel Offei Akrofi, Eric Kwabena Forkuo
Disputes, Documents, Land Ownership, Land Transactions

The multiplicity of land transactions takes place on the same land parcel coupled with myriad documentation efforts by both statutory and customary tenure systems. These are susceptible to fraud and... 5 months ago

Measures to Improve Participation in Physical Education among Basic Schools
Tabiri Ibrahim
Students, Learning, Physical Education (PE), Student Participation, Ghana

This research investigated strategies to enhance student involvement in Physical Education (PE) classes within Jaman South Municipality, Bono region, Ghana. Employing a descriptive cross-sectional ... 5 months ago

Evolving Strategies and Practices in Physical Education Assessment
Abubakari Alhassan, Tabiri Ibrahim
Physical Education Assessment, Inclusive Evaluation, Technological Integration, Professional Development, Student-Centered Learning

This paper explores the evolving landscape of assessment in Physical Education (PE), highlighting the shift from traditional physical performance metrics to a more comprehensive, inclusive evaluatio... 6 months ago

Empowering Nations through Education: A Curriculum Revolution in Ghana and Beyond
Abubakari Alhassan, Tabiri Ibrahim
Education, curriculum, national growth, Ghana, economic development

This research paper explores into the critical role of education in fostering national growth and prosperity. It explores the challenges and concerns surrounding curriculum development and implemen... 6 months ago

Application of the Theory of Diffusion of Innovation on the Adoption of Automated Teller Machines in the Sunyani Municipality
Williams Awuma, Isaac Danso, Paul Yeboah, Richard Akentara
Adoption, relative advantage, innovators, late majority and laggards

The ongoing debate concerning economic losses associated with human tellers and the negative impact of queuing in the banking halls have led to new technologies and innovation diffusion. This paper ... 7 months ago

Comparative Efficacy of Introducing Mood Stabilizers in Acute or Maintenance Treatment of Bipolar Disorder: An Observational Prospective Study
Eugene Oppong kyere, Ruth Owusu-Antwi, Courage Mawufemor Danku, Kwame Ohene Buab...
Mood stabilizer, insight, adherence, bipolar disorder

Bipolar disorder is a severe chronic psychiatric disorder characterized by recurrent fluctuations in mood, energy, and behavior. The study determined the comparative efficacy of introducing mood sta... 7 months ago

The Implications of Corporal Punishment on Student Discipline and Academic Performance Within the Berekum Municipality
Kyeremeh Dennis, & Augustine Owusu-Addo
Corporal Punishment, Student Discipline, Academic Achievement, Behavioral Interventions, Positive Reinforcement, Student Well-being, Educational Practices, Classroom Management

This study examines the implications of corporal punishment on student discipline and academic performance within the Berekum municipality's learning institutions. Through quantitative analysis, the... 7 months ago

Prevalence and Predictors of Occupational Stress among Senior High School Teachers in Ghana
Isaac Sardello Kodzo Agbesi, Opoku Mustapha Osman, & George Kafui Agbozo
Occupational Stress, Senior High School Teachers, Western-North Region, Ghana, Stressors in Education, Workload

This study investigates the prevalence and predictors of occupational stress among Senior High School teachers in Ghana's Western-North Region. Adopting a positivist research philosophy and a quant... 7 months ago

The Impact of Employee Training Programs on Knowledge, Attitudes, and Productivity in Occupational Health and Safety Practices at Weiply Company Limited
Bright Peter Dzah, & Atianashie Miracle A.
Occupational health and safety, Weiply Company Limited, Employee training, Knowledge, Attitude, Workers' productivity, Safety practices, Workplace safety

This study examines occupational health and safety practices within Weiply Company Limited, a manufacturing company in Sunyani, formerly known as Oti-Yeboah Complex Limited (OYCL). The company under... 7 months ago

Gender Perception of Solid Waste Management in the Sunyani Municipality in the Bono Region of Ghana
Isaac Kwasi Henyo, Daniel Buor, & Divine Odame.
Gender, Waste management, Perception, Waste, Solid waste

Sustainable Development Goal Six is about ensuring the availability and sustainable management of water and sanitation for all. The sanitation situation in the Sunyani Municipality is getting worse ... 7 months ago

The legitimation crisis of educational change
Dennis Shirley
Education, life changes, social sciences

The legitimation crisis of educational change explores the challenges and doubts surrounding the justification and acceptance of reforms in the education system. This abstract delves into the complexi... 7 months ago

Forecasting Future Volta River System Discharges: Evaluating the Influence of Climate Change and Socio-Economic Shifts
Kwasi Appeaning Addo, Salifu Ali Dayinday, Atianashie Miracle A
river flow, climate impacts, modeling, water resources, Ghana, Africa

As the scientific consensus concerning global climate change has increased in recent decades, research on potential impacts of climate change on water resources has been given high importance. ... 7 months ago

Concept and Nature of Classroom Management Practices
Kwasi Bonna
classroom management, teaching strategies, educational practices, classroom discipline, teacher-student interaction

Classroom management is an essential aspect of effective teaching and learning. This paper explores the concept and nature of classroom management practices, highlighting their significance in creat... 7 months ago

Adverse Events Following Immunization (AEFI) Surveillance System Evaluation, 2016-2020 Kumasi Metropolis
Kingsley A. Ampratwum, R Asante, Akosua Gyimah Omar-Sasu
Adverse Events, Immunization, Kumasi, Surveillance System, Evaluation

Even though the process of vaccine licensure is rigorous, vaccines meant to protect individuals and populations may result in Adverse Events Following Immunization (AEFIs). An AEFI is any untow... 7 months ago

Mobile Money Payment System: Is Ghana on the Path Toward a Cash-lite Agenda
Isaac Appiah Amankwa, Joseph Amo, Bella Sima Mofaw
Cashless economy, cash-lite agenda, mobile money, payment systems, interoperability, e-levy, cashless instruments

There has been a significant increase in mobile money accounts and transactions in recent years due to the interoperability of mobile money platforms. The literature on mobile money still needs to ... 7 months ago

Manual Brick Production: Profiling Akwansosem Bricks Company in Gomoa Akyereko in the Central Region of Ghana
Kofi Asante-Kyei, Alexander Addae, Caleb Nii Darku Doodo
Burnt bricks, Clay, Production-techniques, and Marketing

In Ghana, the role of brick production in the construction industry is significant, yet it remains somewhat overlooked. A survey revealed that manual brick production factories are relatively unkno... 7 months ago

Prospective Small Hydroelectric Power Sites along the Black Volta River
Salifu Ali Dayinday
Power, Black Volta River, Hydropower Generation, Sustainable Energy, Geospatial Analysis, Feasibility Assessment, Environmental Impact, Renewable Energy, River Morphology

This study investigates the potential sites for Small Hydroelectric Power (SHP) generation along the course of the Black Volta River. The growing demand for clean and sustainable energy sources has... 10 months ago

Assessment and Spatial Analysis of Land Use and Land Cover (LULC) Dynamics in the Black Volta Basin
Salifu Ali Dayinday
Spatial Analysis, Land Use, Land Cover Dynamics, LULC, Black Volta Basin, Multi-Sensor Remote Sensing, GIS Approach

The Black Volta Basin, a critical hydrological region, is experiencing rapid changes in Land Use and Land Cover (LULC) patterns due to diverse anthropogenic and environmental factors. This study em... 10 months ago

Perceptions of School Administrators and Students on Security and Safety at Selected Tertiary Institutions in Ghana
Desmond Oppong
Perceptions, School Administrators, Students, Security, Safety, Tertiary Institutions, Ghana, Campus Security, Safety Measures, Stakeholder Views, Security Policies, Student Well-being, Infrastructure, Crime Prevention, Emergency Response, Risk Assessment

The goal of the study is to review the perceptions of school administrators and students on security and safety at selected tertiary institutions in Bono Region, Ghana. The study was conducted at t... 10 months ago

Perceived Barriers to Service Utilization of Cervical Cancer Screening
Emma Plange, Jacob K Abebrese, Said Al-Hussien, Chukwuma Chinaza Adaobi, Patric...
Barriers, women, cervical cancer, cancer screening, Ghana

The study's main goal is to identify the Perceived Barriers to Service Utilization of Cervical Cancer Screening. To attain its goals and objectives, the study used a quantitative design approach, an... 10 months ago

Records : 20 of 2070 | Page : of 104 | Limit


Search SIS !

Articles, journal, project, hall of fame

Username or Email

Don't have an account? Register

Do you have an account already? Login

Copyright © Scholar Indexing Society All Rights Reserved.