Cloth face mask use during COVID-19 crisis: A multi-country on-line cross-sectional study among adult runners
26 August 2021
This project is part of the EDCTP2 programme supported by the European Union

Strengthening Pharmacovigilance and Regulatory Capacities in four Southern African countries (SPaRCS)


SPaRCS is a 3-year project which commenced in April 2020 funded by the European and Developing Countries Clinical Trials Partnership (EDCTP)

Project Duration:


1 April 2020 to 31 October 2023

Strengthening pharmacovigilance and regulatory capacities in four Southern African countries (SPaRCS) is a 3-year project which commenced in April 2020, funded by European and Developing Countries Clinical Trials Partnership (EDCTP2) (under grant number CSA2018ERC-2332). The project is led lead by the University of the Western Cape – Dr Hazel Bradley, School of Public Health, and Prof Michelle Viljoen and Prof Star Khoza of the School of Pharmacy, in collaboration with partners from Ministries of Health and National Regulatory Authorities from four countries – Ms Anna Shimbulu, MoHSS, Namibia; Ms Nomsa Shongwe, MOH, Eswatini; Dr Mukesh Dheda, NDOH, South Africa; and Mr Liberty Chirinda, MCAZ, Zimbabwe.

The aim of SPaRCS is to strengthen pharmacovigilance (PV) systems and clinical trials oversight of National Regulatory Authorities (NRAs) in Namibia, South Africa, Eswatini and Zimbabwe. The project uses a participatory action learning, and co-creation approach to develop personal and institutional capacities of the NRAs in the four countries. Key activities include: a mapping and review of PV systems across the four countries, learning exchanges and thematic workshops on topics including approaches to strengthen adverse drug reaction reporting, and analysis, clinical trials oversight and the development of capacity building initiatives for health workers.

During the first year the project used desktop and literature reviews, country questionnaires and virtual participatory workshops to map the PV systems in the four countries and identify areas of strength and innovation, as well as, gaps and opportunities for learning. The second year of the project commenced with a virtual public webinar in May 2021 in which Dr Helen Ndagije of the Ugandan National Drug Regulatory Authority spoke on Pharmacovigilance and Clinical Trials Oversight in the era of COVID-19. This topical webinar drew 90+ participants for across Africa and beyond, including partners of several EDCTP-funded projects, and served as the project launch, as we were not able to have a formal in-person launch at the beginning of the project. Building on the outcomes of year one, we focused mutual learning activities in the first thematic area – Strengthening pharmacovigilance systems to increase spontaneous reporting.  Three 2-hour interactive virtual workshops, with presenters drawn mainly from Africa, took place during October and November 2021. The workshop topics were: Advocacy and communication of pharmacovigilance; Patient/consumer ADR reporting plus E-reporting of ADRs; and Using country level PV data to make regulatory decisions. These workshops were attended by project partners and invited participants from neighbouring countries and other EDCTP projects who had expressed interest. These virtual workshops replaced the in-person workshop planned in Namibia. The capacity building initiative focused on community health workers (CHWs), and in collaboration with a non-profit organisation, based in Cape Town, appropriately tailored training materials on adverse drug reaction reporting were developed and piloted with a selected group of CHWs. During year 3, the training materials will be further developed into train-the-trainer materials suitable for use in four partner countries.

Despite COVID-19 restrictions, virtual communication has facilitated shared learning amongst the partners and established a community of practice at a time when travel and face-to-face engagement was limited. Thankfully, towards the end of the second year, project partners and colleagues with interest in project, met in-person in Cape Town for the first time for an extended Project Steering Committee meeting. Connections with a wider group of like-minded colleagues have grown as a result of the public webinar and attendance at the thematic workshops, as well as involvement in other EDCTP Project events, including EDCTP 10th Forum, and with professional organisations such the International Society of Pharmacovigilance (ISoP). We hope to maximise on these connections as we move into the third year of the project.

In October 2022 the project convened its first face to face thematic workshop and exchange visit in Zimbawe, focussing on Clinical Trials Oversight.

SPaRCS Project Steering Committee


hazel

Dr Hazel Bradley

Project Co-ordinator; WP 1 lead;  WP 2 co-lead

Organization: University of the Western Cape, South Africa.

Dr Hazel Bradley, is a registered pharmacist with more than 10 years’ experience in Pharmaceutical public health. She leads a new area of specialisation within the MPH in Pharmaceutical Public Health and was instrumental in the development of short courses (including in online mode) focusing on Rational Medicines Use, and Medicines Supply Management and Pharmaceutical Policy and Management. She has a number of international collaborations including with the Institute of Tropical Medicine, Antwerp and Boston University; and with the East African Regional Centre of Excellence in Health Supply Chain Management, and other partnerships in Sub-Saharan Africa which link academia and supply chain practice.

michelle

Prof Michelle Viljoen

WP 4 co-lead

Organization: University of the Western Cape, South Africa.

Prof Michelle Viljoen is a registered pharmacist with a PhD in Pharmacology.  She has more than eight years of expertise and experience in the field of medicine regulatory affairs in southern Africa as well as experience of regulatory dossiers within the European Community. She currently teaches Pharmacovigilance to 4th year pharmacy students and to postgraduate students in the Master of Science in Pharmacy Administration and Policy Regulation program; and has publications in the field of adverse drug reporting.

star

Prof Star Khoza

WP 3 co-lead

Organization: University of the Western Cape, South Africa.

Star Khoza is an associate professor of pharmacology with more than ten years of experience in the regulation of medicines. His research interests are in diabetes, respiratory disorders, and pharmacovigilance. In pharmacovigilance, his previous research has focussed on the assessment of adverse drug reaction (ADR) reporting systems, attitudes of healthcare practitioners on the reporting of ADRs, and drug safety studies.

liberty

Mr Liberty Chirinda

WP 3 co-lead

Organization: Medicines Control Authority of Zimbabwe, Zimbabwe

Mr Chirinda is a Senior Regulatory Officer with the Pharmacovigilance and Clinical Trials Division at the MCAZ, and has served for seven years with the MCAZ. He comes with hands on experience in the policy and practice of pharmacovigilance as outlined in the projects he has been involved in.

anna

Ms Anna Shimbulu

WP 3 co-lead

Organization: Ministry of Health and Social Services , Namibia

Ms Shimbulu obtained her Bachelors of Pharmacy at Rhodes University (SA) and an MSc in Clinical Pharmacology at the University of Aberdeen (UK). She is currently finalising her research for a Masters of Pharmacy at the University of Namibia.  She has over five years experience in pharmacovigilance and currently heads the Therapeutics Information and Pharmacovigilance Centre. She is involved in medicine safety surveillance training initiatives, essential medicines list committee and treatment guideline reviews.

nomsa

Ms Nomsa Shongwe

WP 2 co-lead

Organization: Ministry of Health, Kingdom of Eswatini.

Ms Shongwe has 17 years experience in the pharmaceutical services. She is a registered pharmacist in Eswatini. She is a Principal Pharmacist.

Qualifications : BSc Biochem, MSc Pharmacy, PhD Pharmacy student

mukesh

Dr Mukesh Dheda

WP 4 co-lead

Organization: National Department of Health – National Pharmacovigilance Centre, South Africa

Dr. Mukesh Dheda is the Director of the Pharmacovigilance Centre for Public Health Programmes based at the National Department of Health. He obtained a B Pharm from the University of Durban Westville, an M Pharm  from the University of Potchefstroom and a PhD from the University of KwaZulu Natal.  He has been instrumental in understanding pharmacovigilance (PV) in South Africa. He is involved in a number of policy, research and training initiatives which have grappled with the challenge of improving PV in South Africa. He has worked in the area of PV, both regulatory and public health PV, since the early 2000s. In his ongoing tenure as a registered pharmacist for almost forty years, Dr. Dheda has trained many pharmacists and interns, some directly under his supervision.

Carnita Ernest

Ms Carnita Ernest

PSC member

Organization: University of the Western Cape, South Africa.

Ms Ernest is a development practitioner with more than 20 years of experience working in the civil society and higher education sectors. She brings experience of working in governance and development projects in South Africa and the African region, including in policy development. She assists in the grant management of the SPaRCS project.

Administrative Support Staff – University of the Western Cape


Sidiqa Abbas

Ms. Sidiqa Abbas

Ms Abbas assists in the financial administration and preparation of financial reports.

7. Tamlin Petersen

Ms. Tamlin Petersen

Ms Petersen assists with project administration and management; logistics and communication.

Lead Partners


Sparcs
University of the Western Cape, School of Pharmacy

Eswatini

Namibia

Ministry of Health and Social Services, Namibia – Namibia Medicines Regulatory Council: Therapeutics Information and Pharmacovigilance Centre
Ministry of Health and Social Services, Namibia – Namibia Medicines Regulatory Council: Therapeutics Information and Pharmacovigilance Centre

South Africa

Zimbabwe