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No Medicine Is Safe – FDA

The Chief Executive Officer (CEO) of the Food and Drugs Authority (FDA), Mrs Delese Darko has called for the robust monitoring and continuous evaluation of medicines that are brought into the Ghanaian market.

According to her “There is no safe medicine” anywhere, explaining that though medications may be harmless from its manufacturers, issues of safety, quality and efficacy may arise during the marketing of these products.

Speaking at the Pharmacovigilance and Patient Safety Symposium for Managers of Local Pharmaceutical Industry held in Accra last Friday, Mrs Darko urged local pharmaceutical companies to be proactive in ensuring that patient’s safety is upheld.

The seminar organised by the Food and Drugs Authority (FDA) and sponsored by the UK Department for International Development (DFID), was to mark the end of the fifth training session of 39 Qualified Persons for Pharmacovigilance (QPPV).

Mrs Darko said: “these training programmes are aimed at building capacity for designated staff to be responsible for the safety monitoring of products as envisaged in Section 125 of the Public Health Act, Act 851.”


In explaining how Pharmacovigilance works, the CEO said in the same way pharmaceutical companies promote their products, it is expected that they go to all those involved in the distribution of drugs to see how the medicine is faring in the market.

She said: “…you find out how patients are doing…Are patients experiencing any adverse effects? Then you collect all that information and bring it back to the regulator and they will take it back to whoever manufactured the medicines either inn or outside the country and present the findings to them.”

Punishment for flouting guidelines

Meanwhile, the inability to comply with the Pharmacovigilance Guidelines shall attract an administrative penalty of not more than 2500 penalty units and subsequently five years imprisonment if the fine is not paid —a penalty unit is equivalent to Gh12.

It is in the light of this that the Director of Vigilance Risk Management of Medicines at the Medicines and Healthcare Regulatory Agency (MHRA), Dr June Raine has advised Ghanaian Pharmaceutical Industry to resource qualified persons to record the inaccuracy spotted in the safety systems of medicines supplied to patients.

“Prompt signal detection, early action by your QPPVs will safeguard your company from having its products withdrawn… A well supported QPPV is the key to a robust pharmacovigilance system… give them all the support, listen when they knock on your door, listen when they speak because they are telling you something very important,” she said.

Dr. Raine added that “being prepared and proactive will actually promote safe access and build confidence in the people who have access to your medicines.”

Trail Blazers

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).

Five of such training have been held since its inception in 2015 and out of it, 57 QPPVs have been trained and designated.

The FDA has also embarked on 25 good pharmacovigilance practice inspections in two years and out of this, 371 adverse reaction reports have been garnered from January 2015 till date.

Source: Grace Ablewor Sogbey/ [email protected]

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