Foods and Drugs Authority

The National Pharmacovigilance Centre of the Food and Drugs Authority (FDA) has expressed concern about the reluctance of the nation’s health facilities to report outcomes of adverse drug reaction (ADR), experienced by their patients.

Mr. George Sabblah, Head of Safety and Monitoring Department of the FDA, said this was not only unethical but dangerous – putting the lives of patients at risk. For the entire 2015, a total of 600 such reports were submitted by the hospitals and the figure rose to 1,006, last year.

This, fell far short of the annual threshold of 5,000 recommended by the World Health Organization (WHO). Mr. Sabblah said the situation could not continue as it was undermining the effort of the FDA to ensure that only wholesome and authorized drugs were sold on the market.

He indicated that out of the 1,006 ADR reports received by the Centre in year 2016, 0.8 per cent of the patients did not survive. He was speaking at a workshop on pharmacovigilance held in Kumasi for pharmacists from across the Ashanti Region.

The goal was to sensitize them on the SafeWatch System – an online database developed by the FDA to encourage and facilitate the submission of ADR reports by the hospitals. It provided the platform to update them on interventions by the Authority to improve patient safety through the usage of authorized and wholesome drugs.

Similar workshops had already been held in the Upper-West, Upper-East, Northern and Brong-Ahafo Regions.  Mr. Sabblah said the nation since joining the WHO Pharmacovigilance Programme in 2001, had worked hard to educate the public on the safe use of drugs.

At the same time it had upped its game to tackle the proliferation of fake drugs on the market. He underlined the determination of the FDA to do everything to discourage the use of products outside the terms of the marketing authorization to protect the public from drug misuse.

He spoke of plans to incorporate pharmacovigilance courses into the curricular of the health training institutions.  This, he noted, was necessary to train health personnel on safety and effective monitoring of medicines to promote consumer protection.