Dr' Fatima Ali Abdullah Deputy Director, Drug Control Department

1
Pharmacovigilance in the United Arab Emirates
(UAE)
a short presentation UMC Training Course, May
2003
2
Pharmacovigilance is not well developed in the
UAEI will present

• Background to the UAE
• Current activities
• Challenges
• Vision

3
UAE - Less than 40 years old
4
The UAE

• Population 3 million
• 20 UAE Nationals
• Less than 2 over 60 years
• Approx 3000 medicines (over 7000 products)
• Pharma market estimated to be US200 million per
  year
• Over half of this in the private sector
• 3 Pharma factories, but over 95 of medicine is
  imported
• Medical negligence etc not yet well described in
  law
• Spontaneous reporting very low outside of
  specialist government hospitals

5
Current medicine safety activitiesThe following
activities are coordinated by the Drug Control
Department at the UAE Ministry of Health

• Medicines Information Bulletin
• Issued 2-3 times per year to all doctors
  pharmacists
• ADR form and list of drugs of concern issued to
  all hospitals and on web-page
• www.moh.gov.ae
• Some voluntary reporting, mainly from externally
  accredited specialist hospitals
• Some companies submit Periodic Safety Update
  Reports (PSURs) to drug control
• Post-marketing surveillance via market and ports
  inspections poor quality and counterfeit
• 120 inspection samples analyzed by UAE drug
  control laboratory in 2002

6
Challenges

• With respect to medicines safety, roles and
  responsibilities of healthcare members not well
  described in law
• Role of Marketing Authorization Holder not well
  understood
• Rapidly expanding private healthcare
  sectorEnsure that medicines safety is seen as a
  multi-disciplinary priority for private and
  government
• Change the culture and thinking away from blame
  when studying medical events such as ADRs
• Need a great increase the number of voluntary /
  spontaneous reports (less than 30 per year at
  moment)
• Make better use of email and the internet to
  gather and distribute information
• Improve the cooperation with industry to benefit
  from the industry Periodic Safety Update Reports
• Harmonize the collection and exchange of safety
  data within the region (especially GCC)

7
Ongoing improvements

• CommunicationsUAE is now the 19th most Internet
  connected country!
• Bulletin now distributed mainly via internet.
  Surveying effect of this.
• LegislationLaw on medical negligence, pharmacy
  and medicines all under review
• GCCRecent WHO activities in Riyadh for GCC
  states
• My attendance here today ?!

8
Vision for medicine safety in the UAE

• Establish an independent, federal medicines
  monitoring centre in the UAE
• UAE (and all GCC neighbors) to become partner of
  the WHO-UMC
• MOH to work closely with medical districts,
  private sector and other government sectors to
  raise the profile of Medicines Safety
• Patients and healthcare workers to be as well
  informed as their peers in the medicines country
  of origin