Reports on Adverse Drug Reaction not fault finding mechanism – FDA
The Food and Drugs Authority (FDA) has stressed that insisting on health facilities and medical practitioners to report Adverse Drug Reaction (ADR) experienced by their patients was not to find faults with their work.
Rather, it was a way of detecting any system errors and challenge and instituting measures to correct these in order to ensure patient and consumer safety to build public confidence in the healthcare delivery system in Ghana.
Mr George Sabblah of the Head of the Safety Monitoring Department of the FDA who made the remarks noted that many healthcare workers failed to report ADRs with the fear of being blamed or victimised.
He was speaking at a professional development training workshop for medical doctors and physician assistants in the Central Region.
The training, sponsored by the United Kingdom’s (UK) Department for International Development, aimed at introducing the medical doctors to pharmacovigilance and patient safety and equip them with the skills and tools available for reporting ADRs to the FDA.
It formed part of the FDA’s collaborative efforts to effectively engage healthcare professionals to achieve higher reporting rates on ADRs to promote patient safety.
Participants were taken through pharmacovigilance and patient safety in Ghana, Management and Adverse Events and Causality Assessment, Reporting and Processing of ADRs and provided hands on practical exercise on the use of Safety Watch system.
Mr Sabblah said repots on ADRs would also help detect products that were substandard and others that did not meet the specifications in order to recall the products from the market.
He encouraged medical doctors and physician assistants to take active part in the reporting safety issues of medicines and other health products because they played a critical role in providing quality report to the FDA.
In this regard, he advised them not to take things for granted, but report all suspected reactions to the FDA and ensure that their patients did same for the necessary measures to be taken.
He said less than 10 per cent of medical doctors and physician assistants in Ghana reported on ADRs which was far below what was reported in other countries.
He said though Ghana recorded an improvement in its adverse report for 2017, more needed to be done to achieve a higher ADR report in order to identify safety issue with marketed products.
Professor Francis Ofei, Dean School of Medicine, University of Cape Coast (UCC) said ADR report in Ghana was low because it was not mandatory and that there were problems in recognising scenario as an ADR coupled with fear of blame from medical practitioners.
He said medical practitioners held a duty to patients and the medical World to report ADRs adding that, increased number of new and old drugs for ADRs called for increased reporting on them.
Mr John Odai-Tettey, Central Regional Head of the FDA said it was important that healthcare providers ensured that their patients did not suffer secondary ailment as a result of the medicines that they prescribed.
He said in the event that it happened, the feedback must be picked immediately in order to prevent further and excessive damage.