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Frider Chimimba is a pharmacist and lecturer at the Pharmacy Department, College of Medicine, University of Malawi. Recently, she has also played an important part in the establishment of the Malawi National Pharmacovigilance Centre. She describes her journey in Pharmacovigilance below:

After graduating with a BPharm from the University of Dar-Es-Salaam, Tanzania, I began my career working in the community pharmacy sector in Malawi. For over twenty years, I held a range of positions (including Pharmacist Manager at a pharmaceutical company which owned wholesale and retail outlets throughout the country) and also opened my own outlets. Malawi has a very small manufacturing industry and therefore depends heavily on the importation of medicines. In the early 90’s there were increasing incidences of substandard and falsified medicines entering the market through the supply chain. There were also cases of such medicines being sold by street vendors because of severe drug shortages in public health institutions. The impact of these could not easily be measured but it concerned me greatly that the public were being exposed to medicines carrying a potentially high risk of harm. The National Regulatory Authority (NRA) tried to control the importation of unregistered medicines as well as using WHO pre-qualification products to ensure quality medicines were imported. Nevertheless, drug shortages in government institutions still forced patients to buy from street vendors as many couldn’t afford to buy from private pharmacies. My interest in this situation was the beginning of my transition from a business-oriented career to patient safety. Pharmacovigilance (PV) practice was virtually nonexistent at that time, even amongst health care workers and, aside from the challenges of poor quality medicines, I saw a lot of patients prescribed multiple drugs or a drug to treat a side effect of another drug because the prescriber had identified it as a new symptom, and not a possible Adverse Drug Reaction (ADR). I decided to pursue further studies in the UK, completing an MSc in Pharmaceutical Services and Medicines Control at the University of Bradford, followed by an MSc in Clinical Research at Cranfield University, where my passion for pharmacovigilance became very clear.

A colleague of mine who knew of my interest in drug safety monitoring, and was now the head of the Pharmacy Department at the College of Medicine, University of Malawi, then asked me if I was interested in relocating back to Malawi under GIZ (German Corporation for International Cooperation) sponsorship to help establish a PV centre there. During this period, investment by global health initiatives (e.g. Global Fund, GAVI, BMGF etc.) had improved access to medicines and vaccines, but with a concurrent increase in the risk of ADRs as medicines began reaching unprecedented numbers of people in Sub Saharan Africa. In addition, some medicines were developed specifically for use in developing countries and were advancing into pre/post licensure stages (e.g. RTS,S/AS01, Malaria vaccine candidate [GSK], Dengue vaccine [Sanofi Pasteur], new ART regimens and antibiotics e.g. Bedaquiline [Janssen]). However, these were being made available to regions with suboptimal PV infrastructures on a large scale, to populations with varying co morbidities, and health workers and patients unaware of how or where to report suspected ADRs. The NRA was responsible for establishing a National PV centre but lacked the capacity, in terms of personnel and funding, to do so. There was some element of safety monitoring occurring within donor funded projects (HIV, Malaria, TB, and Immunization) but data was limited and not shared or analyzed.

Given these circumstances, I relocated to Malawi in 2015, being employed by the College of Medicine, at which the PV centre was to be housed. I also taught Pharmacy Practice and subsequently Pharmacovigilance as a standalone module.

We began the process of establishing the PV centre by having a memorandum of understanding (MOU) signed between the college, Ministry of Health and the NRA. Space was kindly provided by the College and we sought funding from different organizations to cater for fixtures and fittings, short-term training at the Uppsala Monitoring Centre (UMC) and training of health workers on basic pharmacovigilance (including for vaccines) with a focus on monitoring and reporting ADRs and Adverse Effects Following Immunization (AEFI). Malawi became an associate member of the WHO International Drug Safety Monitoring Programme (WHO PIDM) in 2016 and a full member as of March 2019 - a great achievement from our small team. Reporting rates have increased significantly as a result of our sensitization and training activities. In 2016, Malawi only had 4 ADR reports submitted to the UMC database (VigiBase), which has now risen to around 250 per year. In addition, we are planning to launch a public awareness campaign once we feel the majority of health care workers are aware of the importance of drug safety monitoring and reporting to the National PV centre. Another activity in the pipeline is the introduction of PV into curricula for all health training institutions in Malawi (e.g. nursing colleges, laboratory sciences etc.). I am also involved in collecting and collating AEFIs on the recently launched Malaria vaccine.

I am grateful to all the organisations that have assisted us in establishing the National PV Centre and helped us to achieve a lot in a very short time. Special thanks to my colleagues (a small team of four pharmacists) who worked tirelessly to have the centre meet the WHO minimum requirements to become full members of WHO-PIDM, the Principal, College of Medicine, for giving us space to set up the centre rent-free, and the NRA for their team work and regulatory oversight - including adding PV to the recent Pharmacy Medicine Regulatory Authority Act (PMRA), making it a legal requirement for companies to produce safety updates on their products in Malawi. Thanks also go to the Australian Government, GIZ, CDC, the Global fund and GSK for their generous support in funding the centre.

Ensuring the sustainability of the PV centre remains a challenge for the future, but our aim of creating a functional PV system for the whole country looks promising.