Adverse drug reaction cases on the rise in the UAE
dubai — Cases of adverse drug reactions (ADR) reported to the Ministry of Health by healthcare professionals and pharmaceutical firms increased from 59 in 2013 to 825 in 2016, said a senior health official on Wednesday.
During the 6th National Conference of Continuum of Pharmacovigilance and Drug Safety in the UAE, Dr Amin Hussein Al Amiri, Assistant Undersecretary for Public Health Policy and Licenses and Chairman of the Higher Committee for Pharmacovigilance at the Ministry of Health and Prevention (MoHP), the increase was due to the rising global awareness of pharmacovigilance in light of the growing safety concerns affecting the health sector.
During the same period, pharmacovigilance officers reporting to the international Uppasala Monitoring Centre (UMC) database, which is a global reporting centre, reported 24 cases in 2013, 107 in 2014, 123 in 2015 and 281 in 2016. Total number of ADR cases reported to UMC since 1967 are 14.9 million.
Based on UMC recommendations, the UAE health ministry then decides to withdraw or replace a drug within the country.
Dr Amiri said that medication vigilance was important due to safety concerns such as self-medication practices, globalisation, consumerism and the expansion in free trade and communication across borders.
Other issues include illegal medicine sale over the internet, drug abuse, widespread manufacture and sale of counterfeit and substandard medicines globally, increasing use of traditional and herbal medicines with potential adverse effect.
Dr Amiri said that adverse drug reactions (ADRs) are among the top 10 causes of death around the world with an approximately five per cent of patients are hospitalised due to ADRs.
“Six to 10 per cent of in-patients will experience a serious case of ADRs during hospitalisation, even from common drugs such as paracetamol,” he said.
Globally, ADR-related costs may go up to $136 billion annually as per a report titled ‘FDA: Preventable Adverse Drug Reactions: A Focus on Drug Interactions 2016.’ The increasing costs are attributed to prolonged hospital stay, additional clinical investigations. “The good news is that about 50 per cent of ADRS can be prevented,” he added.
Dr Amiri cited ministerial decrees allowing local manufacturers of pharmaceutical products and generic medicine companies to file for patents for innovative medicines within 24 months, or ‘Narcotics, Controlled and Semi-Controlled Medicines Classification, Prescribing, and Dispense.’
He said that main objectives of pharmacovigilance are early detection of unknown safety problems; determination of frequency of use; identification of risk factors; quantifying risks; risk prevention among patients; and rational and safe use of medicines. The ministry enhances pharmacovigilance through drug department.
“The department promotes pharmacovigilance by regulating and licensing medicines and pharmaceutical products in the UAE in coordination with health authorities and local universities; overseeing the importation and distribution of all pharmaceutical products; analysing and conducting quality
Six to 10 per cent of in-patients will experience a serious case of ADRs during hospitalisation, even from common drugs such as paracetamol.” Dr Amin Hussein Al Amiri, Chairman of the Higher Committee for Pharmacovigilance at MoHP
assessment of pharmaceutical products; and evaluating and monitoring of pharmaceutical products,” he explained.
Currently, the ministry has 21 pharmacovigilance officers while in pharmaceutical companies, licences of 129 have been approved, 98 are undergoing assessment while 20 have been rejected.