FDA ENDS SYMPOSIUM FOR REPRESENTATIVES OF LOCAL PHARMACEUTICAL INDUSTRIES
The Food and Drugs Authority, Ghana (FDA) has organized a one day symposium on Pharmacovigilance and patient safety for representatives of the Local Pharmaceutical Industries in Ghana. The Symposium was held at the Fiesta Royale Hotel in Accra on the 6th of October, 2017
The symposium was sponsored by the United Kingdom (UK) Department for International Development (DFID), an indication and confirmation of the continual support of the Government of the United Kingdom to promote medicine safety in Ghana. The symposium on Pharmacovigilance is the first ever to be held in the World.
The objective of the Symposium was to provide managers of the Pharmaceutical Industry with adequate information on the need to establish Pharmacovigilance systems to promote access to safe and effective medicines for local consumption and export and to highlight requirements for the establishment of Pharmacovigilance systems in their respective local industries.
Opening the Symposium, the Acting Chief Executive Officer (CEO) of the FDA, Mrs. Delese Darko explained that Pharmacovigilance involved the identification of safety issues with marketed medicinal products. She further explained that, although Generic medicines are similar to branded medicines, differences may arise due to excipients, formulations or commercial presentation and even container closure systems which could sometimes affect the quality, efficacy and ultimately, safety of the medicine. Therefore, there was the need for a robust Pharmacovigilance system for both branded and generic drugs irrespective of the age of the molecule.
Mrs. Darko therefore called on Pharmaceutical Industries to adequately resource the Managers and or Qualified Persons of Pharmacovigilance (QPPV) to be able to put safety systems in place to monitor their medicines on the market.
The CEO revealed that Ghana is the first country in sub Saharan Africa to become a full member of the WHO programme for International Drug Monitoring in November 2001 and also the first Country in the World to start formal training programmes for Qualified Persons for Pharmacovigilance (QPPV). She also said the FDA has organized five (5) of such programmes already with the Fifth (5) being completed on the 5th of October, 2017. The Acting CEO emphasized that the FDA was able to achieve these laudable feats through the strong collaboration with the WHO Collaborating Centre for Advocacy and Training in Pharmacovigilance (WHO-CC).
The Guest Speaker for the Occasion was Dr. June Raine, a much-sought after Consultant in Pharmacovigilance and the Director for Vigilance Risk Management of Medicines Division of the Medicines and Healthcare Regulatory Agency (MHRA) in the United Kingdom and also a member of the WHO Advisory Committee on Safety of Medicinal Products. Dr. June Raine, in her speech said she was honoured by the invitation to take part in the first ever symposium for Pharmacovigilance to be held in the World and was proud of the FDA and the hard work they have put into organizing the symposium as well as the continuous laurels the FDA continues to achieve.
She also congratulated the Local Pharmaceutical industry for their active participation in the programme and encouraged them to continue collaborating with the FDA to help form a robust Pharmacovigilance system in the Country to contribute to better use of medicines and ultimately improve health and prolong life.
Dr. Raine also reiterated that a prolific and productive pharmaceutical industry was not only for the health of the citizens of Ghana but the wealth of the economy and therefore encouraged Industry to report adverse medicine reactions or any unusual effects of their medicines in the course of patient treatments to the FDA.
She also emphasized the need for managers of the Local Manufacturing Companies to understand the importance of Pharmacovigilance and the need to resource the QPPV’s to effectively carry out safety monitoring of their products on the market.
The FDA is of the belief that when Industry manufactures anything, in this case medicines, they are obliged to monitor the safety of the medicines as they are being used although FDA as the Regulator, would continue carrying out its own monitoring as always.