1. Medicines Safety Mary R. Couper
Medical Officer Quality Assurance and Safety: Medicines, WHO
2/26/2019

2. Medicine Safety
To undergo treatment you have to be very healthy, because apart from your sickness you have to stand the medicine.
Molière
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3. Risk
No medicinal drug is entirely or absolutely safe for all people, in all places, at all times. We must always live with some measure of uncertainty.
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4. The magnitude of the problem
During last decades it has been demonstrated by a number of studies that medicine morbidity and mortality is one of the major health problems which is beginning to be recognized by health professionals and the public.
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5. Financial implications
In addition suitable services to treat ADRs have a high financial burden on health care due to the hospital care of patients with drug related problems. Some countries spend up to 15-20% of their hospital budget dealing with drug complications.
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6. Vigilance Vigilare = to watch alert watchfulness
forbearance of sleep; wakefulness
watchfulness in respect of danger; care; caution; circumspection
the process of paying close and continuous attention
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7. Pharmacovigilance
The science and activities relating to the detection, evaluation, understanding and prevention of adverse drug reactions or any other drug-related problems
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8. Task of Pharmacovigilance
The task of pharmacovigilance is to define and reduce risk and harm as far as is humanly possible.
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9. Aims of Pharmacovigilance
The ultimate aims of pharmacovigilance are:
to improve patient safety in relation to use
to improve public health and safety
to contribute to assessment of benefit and risk
to encourage safe, rational and more effective use
to promote understanding, education, training and communication
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11. WHO Programme for International Drug Monitoring
Exchange of Information
Provision of technical support to countries in all aspects of pharmacovigilance
Collection and analysis of adverse drug reactions
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12. Exchange of Information
WHO Pharmaceuticals Newsletter
WHO Drug Alerts
WHO Drug Information
WHO Restricted List
Vigimed - electronic exchange
Uppsala Reports
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13. Technical Support to countries
Technical guidelines on all aspects of pharmacovigilance
Training courses on pharmacovigilance
Strengthening active surveillance systems
Support to countries participating in the Programme
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15. Collection and Analysis of Adverse drug Reaction Reports
Input
ADR Reports from National Centres
Processing
At the WHO Collaborating Centre for International Drug Monitoring
Output
Feedback to National Centres
Signal documents
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16. 71 National Centres
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17. Input No of reports: more than 3 millon
Each year increase ~160,000 / year
Top 5 reporting countries
USA
United Kingdom
Germany
Australia
Canada

18. Essential information in report
Patient information
Adverse event or product problem
Suspected medication
Reporter
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19. Processing Reports are processed in batch
Data mining techniques are used
Technical/logical checks are made automatically
Incorrect reports are rejected by the system and corrected manually

20. Output Screening for signals Customised reports
By external review panel of experts
Customised reports
on request by National Centres or pharmaceutical companies
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21. End Result Published in “Signal” document if verified
Published in the Pharmaceutical Newsletter
Change in product information
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22. Raise awareness of the importance of monitoring all medicines*
07/16/96
Future challenges
Raise awareness of the importance of monitoring all medicines
Integrate work throughout all WHO
Improve training activities at grass root level
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23. In conclusion ….
The work of WHO in the area of safety monitoring of medicines is necessary if we are to achieve the mission of EDM:
Medicines should be Available, Affordable, Safe and Properly used.
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