FDA, GHS collaborate on safety monitoring of drugs

The Head of Safety Monitoring Department of the Food and Drugs Authority (FDA), Mr. George Sabblah, has highlighted the need for a stronger Pharmacovigilance system in the country.

He explained that an effective post approval safety monitoring of drugs would help reduce adverse drug reaction and also achieve the best clinical outcome for patients.

This, he said, was needed especially when new vaccines and antibiotics were being introduced coupled with infiltration of counterfeits and substandard drugs.

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problem.

Mr. Sabblah was delivering a presentation on “Pharmacovigilance and the need for Safety Monitoring of Medicines” at a Pharmacovigilance Assessment Tool (PAT) Training of Trainees Workshop in Cape Coast on Tuesday.

PAT is a set of monitoring guidelines on adverse drug reaction that was jointly formulated by the FDA and GHS and had already been piloted in Accra, later to be replicated across the country.

The two-day workshop, organised by the FDA in collaboration with the Ghana Health Service (GHS) is being attended by participants, made up of health managers from the Central, Western, Volta, Greater Accra and Eastern Regional Health Directorates.

It aims at introducing participants to the PAT, discuss the general pharmacovigilance and importance of adverse drug reaction reporting, challenges of Pharmacovigilance at the regional levels and the way forward.

Explaining the importance of Pharmacovigilance further, Mr. Sabblah stated that pre-clinical and clinical studies on drugs lacked sufficient evidence for safety since size, duration, and population, among others for such studies were limited.

He pointed out that effective Pharmacovigilance would help prevent unnecessary harm, reduce healthcare cost such as hospital admission due to adverse effect and ensure public confidence in medicines.

“Drugs are good weapons of fighting diseases but can destroy humanity”, he cautioned, and urged all health professionals to report adverse drug reaction they encounter to help build a better pharmacovigilance.

Explaining the PAT, Mrs. Ruby Awittor, a Pharmacist with the GHS, said it had features such as peer review and monitoring and evaluation, and reiterated the need for all health professionals to strengthen the pharmacovigilance system in the country to help improve healthcare delivery.

Mr. Kingsley Nsiah-Poku, Central Regional Director of FDA, urged the public to be extra-vigilant when purchasing drugs since there were some counterfeits in the system and stressed the need for the public to seek the assistance of the Authority in the safe disposal of expired drugs.