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B N W: Biafra Nigeria World News |
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NAFDAC launches drug reaction monitoring project
OSTENSIBLY to ensure greater consumer participation in monitoring the effect of drugs on the body, the National Agency for Food and Drug Administration and Control (NAFDAC) yesterday in Abuja launched the Adverse Drug Reactions (ADR) project.
The project, known as the National Pharmacovigilance Project is designed to consumers a medium that will collate and ensure prompt reporting of the effects of pharmaceutical products on their system to NAFDAC for prompt action.
Director-General of NAFDAC, Dr. Dora Akunyili said the programme is long overdue and following the loss of lives due to absence of channel to report adverse drug reactions to the agency. This, she said, was a very important because most drugs being consumed by humans are just coming out of animal trials.
According to her, "In the cause of developing drugs, a lot of activities are carried out to ensure that they offer more benefits than harm. Before a drug receives approval for use in humans, it first undergoes testing in animals. Thereafter, it is subjected to clinical trials in a selected number of people. The safety implications of using a drug in the entire population can therefore not be fully established during clinical trial and before the drug is granted marketing authorisation. It is only when the drug is actually in use that the full safety implications begin to unravel".
She, therefore, opined that, "The most rational approach in ensuring the safety of pharmaceutical products, which includes drugs, medical devices, biologicals, vaccines, or herbal preparations in any country is through sustained monitoring for early detection and prevention of Adverse Drug Reactions (ADR) and other harmful effects".
Akunyili said that from the findings of earlier efforts to establish such a scheme, it was identified that the initial ones did not carry consumers along, hence their failure and the need to rehabilitate the programme with greater involvement of the consumers.
"There was also dearth of expertise and management. These, among other factors, informed our decision to establish a new revived Pharmacovigilance centre in Nigeria", Akunyili said.
The NAFDAC chief citing the National Drug Policy as the source of her power in establishing the centre, said the new Pharmacovigilance Centre will not limit reporting to responses that occur at doses normally used in human since the nation at the moment lacks a system for effective monitoring of over dosage, misuse and abuses of drugs.
He added that efforts would be made to ensure that the costly mistake of applying results obtained from other nations in Nigeria is not permitted since there are many differences in body make up, diet and culture that will normally produce different reactions for different people.
Akunyili commended Dr. Ambrose Isah of the University of Benin Teaching Hospital, who pioneered and has sustained drug safety monitoring against all odds in the teaching hospitals.
"University of Benin Teaching Hospital has generated 40 Adverse Drug Reaction reports this year, which clearly proves that there are ADRs in Nigeria", she said.
The Minister of Health, Prof. Eyitayo Lambo, commending the NAFDAC director-general for the "bold step recalled with sorrow the past futile attempts to establish the centre and showered encomium on Akunyili for realising the dream which eluded many.
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