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

Medicine Safety To undergo treatment you have to be very healthy, because apart from your sickness you have to stand the medicine. Molière 2/26/2019

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. 2/26/2019

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. 2/26/2019

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. 2/26/2019

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 2/26/2019

Pharmacovigilance The science and activities relating to the detection, evaluation, understanding and prevention of adverse drug reactions or any other drug-related problems 2/26/2019

Task of Pharmacovigilance The task of pharmacovigilance is to define and reduce risk and harm as far as is humanly possible. 2/26/2019

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 2/26/2019

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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 2/26/2019

Exchange of Information WHO Pharmaceuticals Newsletter WHO Drug Alerts WHO Drug Information WHO Restricted List Vigimed - electronic exchange Uppsala Reports 2/26/2019

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 2/26/2019

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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 2/26/2019

71 National Centres 2/26/2019

Input No of reports: more than 3 millon Each year increase ~160,000 / year Top 5 reporting countries USA United Kingdom Germany Australia Canada

Essential information in report Patient information Adverse event or product problem Suspected medication Reporter 2/26/2019

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

Output Screening for signals Customised reports By external review panel of experts Customised reports on request by National Centres or pharmaceutical companies 2/26/2019

End Result Published in “Signal” document if verified Published in the Pharmaceutical Newsletter Change in product information 2/26/2019

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 2/26/2019 *

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. 2/26/2019