UAE, April 19, 2017- The Ministry of Health and Prevention, represented by the Public Health Policy and Licensing Sector and the Drug Department, organized at the Raffles Hotel in Dubai the 6th National Conference of Continuum of Pharmacovigilance and Drug Safety in the UAE being held under the patronage of H.E. Abdulrahman bin Mohammed Al Owais, Minister of Health and Prevention and in cooperation with the Pharmaceutical Research and Manufacturers Association.

H.E. Dr. Amin Hussein Al Amiri, Assistant Undersecretary for Public Health Policy and Licenses and Chairman of the Higher Committee for Pharmacovigilance, noted the rising global awareness of pharmacovigilance in light of the growing safety concerns affecting the health sector such as self-medication practices, globalization, 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. 

Global facts about adverse drug reactions (ADRs)

H.E. said that adverse drug reactions (ADRs) are among the top 10 causes of death around the world, with an approximately 5 per cent of patients are hospitalized due to ADRs and 6 to 10 per cent of in-patients will experience a serious case of ADRs during hospitalization.
 
ADR-related costs may go up to USD 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. .

Ministry: Continuous enactment of regulations and legislations 

H.E. Dr. Al Amiri reaffirmed the UAE’s keenness to develop regulations and pass legislations according to international best practices. He cited Ministerial Decree 60-2013 regulating medical stores; Decree No. 71 for 2013 allowing local manufacturers of pharmaceutical products and generic medicine companies to file for patents for innovative medicines within 24 months; Ministerial Decree No. 1122 of 2014 or the ‘Narcotics, Controlled- and Semi-Controlled Medicines- Classification, Prescribing, and Dispense’ which was later modified by Ministerial Decree No. 888 of 2016; Cabinet Decision No 44-2016 regulating the UAE Ministry of Health and Prevention’s services fee; Ministerial Decree 1110-2016 regarding scientific offices; and Circular No. 298  for 2016 regarding  On scientific offices. 

Pharmacovigilance: Major Goals

H.E. Dr. Al Amiri said that the 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. 
Ministry’s role enhancing pharmacovigilance through Drug Department

H.E. Dr. Al Amiri said that the Drug 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; analyzing and conducting quality assessment of pharmaceutical products; and evaluating and monitoring of pharmaceutical products. The Department also recalls medicines and issues alerts regarding safety, effectiveness, and quality of medicines in the UAE, as well as monitors reports on ADRs and advisories from international drug regulatory authorities and GCC health bodies. It also conducts post-marketing surveillance to ensure compliance and screen any sub-standard, adulterated or counterfeit materials in the UAE market.

Role of National Committee for Pharmacovigilance

The duties of the National Committee for Pharmacovigilance include providing technical support and related scientific activities; extending counseling and drug safety information; assessing drugs and their side effects in cooperation with the Drug Control Department and local health authorities; disseminating information regarding side effects in local communities. 

The adoption of a standard form of documentation on drug side effects at the country level, awareness raising and promotion of the importance of drug vigilance, and the continued need to support activities targeted at health-care workers and community members. Standardization of procedures governing drug vigilance, coordination with the National Center for Drugs and Toxics, and strengthening cooperation and coordination between local and international drug authorities.