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Early Introductions to Pharmacovigilance
I never set out to work in pharmacovigilance (PV). In fact, until a few years ago, pharmacovigilance, ‘adverse drug reaction (ADR)’, and ‘signal detection’ meant very little to me. My earliest memory of something PV-related is when I took an antihistamine for itching after chloroquine. I did not understand why this was the case as I knew several people who could take chloroquine without experiencing itching. Over time I came to know of several other people who experienced negative side effects after taking certain drugs.
However, I do remember reading an excerpt from Dr Martin Luther King’s ‘Letter from Birmingham jail’ in school: ‘It has been a tranquilizing thalidomide, relieving the emotional stress for a moment, only to give birth to an ill-formed infant of frustration’. There was a footnote saying thalidomide was initially used to relieve morning sickness in pregnancy but was found to result in babies being born with severe deformities. That was the first time I came across thalidomide and the realization that drugs can have lasting consequences. Subsequently I read biochemistry at Kwame Nkrumah University of Science and Technology and among the many courses I took were metabolism, drug metabolism and enzymes where I came to see how drugs affect the body and I was formally introduced to the concept of ADRs.
Preparing for a Career in PV
After almost two years working as an internal auditor for a pharmacy chain, in 2017 I received an invitation to interview for a qualified person for pharmacovigilance (QPPV) position at Salom Pharmacy Limited. In order to prepare for the role, I attended a training course organized by the Ghana Food and Drugs Authority (FDA) in collaboration with the World Health Organization Collaborating Center (WHO-CC) for Advocacy and Training in Pharmacovigilance and the UK Medicines and Health Regulatory Agency (MHRA), led by world renowned experts such as Prof Alexander Dodoo, Dr Sarah Daniels, Dr June Raine amongst others. This training provides the essential skills and knowledge needed for someone entering a PV career for the first time, and enabled me to truly understand the importance of effective safety monitoring throughout a drug’s life cycle.
My Role as a QPPV
I currently serve as a backup QPPV for Salom Pharmacy Limited here in Ghana, ensuring the effective maintenance and operability of our PV system, overseeing the safety profiles of our products and addressing any emerging safety concerns. I also screen global scientific literature and respond to queries from the FDA, contribute to the Pharmacovigilance System Master File (PSMF) and raise Corrective and Preventive Actions (CAPA). Together with the main QPPV, we push forward the PV roadmap of our company, collaborating with the FDA regularly, especially when there are emerging safety concerns relating to any of our products. Suitable qualifications to work in a similar role might include a healthcare-related degree recognized by the FDA, or a relevant scientific-discipline degree with at least two years’ experience in the field of PV and formal PV training recognized by the FDA. In addition, one must have an understanding of applicable Ghanaian and international safety monitoring legislation, guidelines, and standards for PV.
Current Challenges Facing PV in Ghana – How Does Ghana Move Forward?
One of the biggest challenges currently facing PV in Ghana is the underreporting of ADRs. In 2017, 2715 spontaneous reports were received by the National PV center. Whilst an increase on previous years, this still leaves much to be desired with several factors contributing to this challenge. In addition, PV awareness is low. I regularly interact with our customers (distributors and patients), many of whom have never heard the term and do not know what to do if someone reports an ADR to them. Others feel it not worth their time to report ADRs. This apathy contributes to the low reports. Meanwhile, some feel that reporting an ADR will reveal their ‘incompetence’ or errors and as such do not want to do so.
Because of these challenges, the National PV Center is making efforts to rouse PV awareness. Radio and televisions adverts concerning PV have been made. There are also increasing methods for ADR reporting, including a dedicated phone line, an SMS shortcode, email and consumer reporting forms available on the FDA website. Recently, the Med Safety App has been launched which allows for a much easier reporting experience. These are great tools to encourage spontaneous reporting.
Most importantly, PV education must be intensified. Healthcare workers and the public must be made aware of existing PV tools and that reporting an ADR will not result in them being penalized. The radio and television adverts should be translated into more local languages and screened frequently, and PV must be included in the education curriculum. The Uppsala Monitoring Center has produced the Annie and Mac comics in which fake medicines and the rise of antimicrobial resistance have been treated in such a way that children can easily understand. We can use such comics to teach our children and PV clubs can be created in schools to drive home the message.
PV should not be seen as a job for a select few; all healthcare workers must be involved. Moreover, when the public is made to see their role as a stakeholder, I believe this this can lead to improvements in the reporting rates. I came across an article by Moreno-Mattar et al., detailing the three key strategies employed in Colombia to increase the population-based reporting ratio to within international standards. We can study such success stories and adapt them locally to suit our own context.
The Future of PV – What Next?
It has been said that big data and artificial intelligence (AI) are the future of PV. There is also the proliferation of secondary data sources, such as from social media, routine clinical data / electronic health records, medical literature and regulatory reports. Signal detection and management activities can be quicker, with AI anonymising health records and speeding up case processing. These are exciting times and I am glad to be around!
We have come a long way in PV, we have accomplished more as a nation yet more needs to be done.
DrugLens Issue 6, April 2018. Available at: https://fdaghana.gov.gh/images/stories/pdfs/DrugLens/DrugsLens%20issue%206%20April%202018.pdf. Accessed 17/07/19.
Ghana FDA, “FDA Launches Mobile App to Monitor Side Effects of Medicines”. June 2019. Available at: https://fdaghana.gov.gh/images/stories/pdfs/News%20&%20Events/2019/FDA%20launches%20Mobile%20App%20to%20monitor%20side%20effect%20of%20medicines.pdf. Accessed 17/07/19.
Moreno-Mattar, O., Ramírez, R., Alvarado, A., Sierra, F., Guzmán, J., “Report of Adverse Events in Colombia: A Successful Case”, Current Drug Safety (2019) 14: 53. https://doi.org/10.2174/157488631366618110915064