FDA launches programme to check medicine-related harm to patients
A project to encourage patients and consumers to file complaints about the effects of medicines and medical devices has been launched by the Food and Drugs Authority (FDA).
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To facilitate the success of the project, the FDA will place reporting forms at pharmacies, community chemists, health centres and hospitals to enable consumers and patients to file their complaints to the authority.
The project, on the theme: “Patient engagement in medicine safety”, embodies patient engagement, consumer empowerment, health advocacy and patient activism in an effort to effectively reduce adverse medicine reaction on patients and consumers.
It will also enable the FDA to collect data to ensure the prevention of medicine-related harm to patients, which can ultimately lead to error reduction in medicine administration to patients.
According to the Chief Executive Officer (CEO) of the FDA, Mr Hudu Mogtari, although there was a system for formal post-marketing studies by the authority on medicines, capturing information on consumer complaints continued to be a challenge.
He explained that the Technical Advisory Committee on medical devices would supervise the project, which is set to run for a four-year period, with funding from the United Kingdom (UK) Department for International Development (DFID).
Safety Monitoring
Mr Mogtari indicated that involving patients and consumers would help reduce adverse medicine reaction, prevent unnecessary harm to patients and reduce health care costs.
“Changing trends in clinical trials present further challenges to regulators in ensuring that the rights and health of patients and their communities are protected,” he said.
He said the reporting mechanism would be vetted by the committee, which would offer modalities for the withdrawal of medicines if they were found to endanger the lives of consumers.
“The role of the patient in ensuring medicine safety cannot be overlooked and we will urge healthcare organisations which are our allies in this campaign to encourage patients’ active involvement in the project,” he said.
Communication strategy
Mr Mogtari said a three-month public education was being rolled out to reach out to the public.
The campaign, he said, would be taken to lorry parks, churches and mosques, as well as educational institutions, among other places, as a means to improve adherence to safety practices.
He, however, expressed worry that in spite of the continued sensitisation of the public to desist from patronising medicines on vehicles, such practice was rather on the ascendency and expressed the hope that the project would help reduce the patronage of such medicines.
Pilot
The Head of Medicine Safety and Monitoring at the FDA, Mr George Sablah, said the project, which had been piloted over a two-year period, had recorded some 80 reports from various parts of the country.
He said the reports received were on product quality and failure which the FDA had since addressed.
He said patient behaviour, such as failure to attend scheduled appointments and administer medicines, came handy during the pilot processes.
“Low health literacy and poor provider-patient communication,” he said, were also linked to medication errors.
Mr Sablah, therefore, appealed to the public to embrace the project to enable the FDA to protect the health and safety of the public.
