Pharmaceutical industry urged to monitor drug safety

Dr June Raine, the Director of Vigilance Risk Management of Medicines Divisions, Medicines and Healthcare Regulatory Agency, has called on the Ghanaian Pharmaceutical Industry to resource qualified persons to keep an oversight of the safety systems of medicines supplied to patients.

She said “this would add up to better use of medicines for the undoubted benefit of improving health and prolonging life.”

Dr Raine made the call in an interview with the Ghana News Agency on the sidelines of a day’s Pharmacovigilance and Patient Safety Symposium for Mangers of the Local Pharmaceutical Industry in Accra.

The symposium, organized by the Food and Drugs Authority (FDA) and sponsored by the UK Department for International Development (DFID), brought together 39 Managers and CEO’s of the Local Pharmaceutical Industry.

It was to provide Managers of the Pharmaceutical Industry with up-to-date information on the need to establish pharmacovigilance systems to promote access to safe and effective medicines for local consumption and export as well as to highlight requirements for the establishment of pharmacovigilance in their respective industries.

Dr Raine commended the FDA for the symposium and called for a continuous coordination and collaboration of stakeholders in the health sector to ensure safety of drugs for the public.

She said a prolific and productive pharmaceutical industry was not only for health of the citizens of Ghana but the wealth of the economy, hence industries should ensure to report back adverse reactions or any unusual happenings in the course of the treatment to the FDA.

Mrs Delese Darko, the Chief Executive Director of the FDA said Ghana was 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 a formal training programme for Qualified Persons for Pharmacovigilance (QPPV).

She said Pharmacovigilance was involved with the identification of safety issues with marketed medicinal products.

Mrs Darko said: “Generally, generic medicines are similar to branded medicines but differences may arise based on excipients, formulation or commercial presentation and container closure systems, which could sometimes affect quality, efficacy and ultimately safety of the medicine.”

“There is therefore the need for a robust pharmacovigilance system for both branded and generic drugs irrespective of the age of the molecule.”

She said the FDA with support from DFID had continuously trained staff to be responsible for the safety monitoring of products as envisaged in Section 125 of the Public Health, Act, Act 851- the QPPV.

“The FDA believes that the goal of the requirements in Section 125 of the Public Health Act cannot be realized without dialogue, cooperation and collaboration with you, CEOs and Managers of the pharmaceutical industry hence the need for this symposium.”