WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000...
Transcript of WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000...
![Page 1: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/1.jpg)
1
WHO Collaborating Centre for International Drug Monitoring
the Uppsala Monitoring Centrewww.who-umc.org
![Page 2: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/2.jpg)
2
WHO Drug Monitoring ProgrammeFounding Members 1968
![Page 3: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/3.jpg)
3
Aims of International Pharmacovigilance
• An early warning system through world-wide pooling of data
• Comparison of experiences between countries
• Expansion of pharmacovigilancearound the world– Know how– Tools
• Clearinghouse function
![Page 4: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/4.jpg)
4
![Page 5: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/5.jpg)
5
0
50000
100000
150000
200000
250000
Num
ber o
f Rep
orts
1968 1972 1976 1980 1984 1988 1992 1996 2000Year (Based on Onset Date)
WHO Database 2002.07.27Number of Reports by Year
![Page 6: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/6.jpg)
6
WHO Collaborating Centrethe Uppsala Monitoring Centre
• Established as a foundation 1978• Based on agreement Sweden - WHO• International administrative board• WHO Headquarters responsible for
policy
![Page 7: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/7.jpg)
7
Flow of information
WHO CollaboratingCentre (UMC)WHO Headquarters
National Centres
Medical practice
Manufacturers
![Page 8: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/8.jpg)
8
Submitting ADR Reports to UMC
• ICH - E2b format• WHO agreed format
![Page 9: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/9.jpg)
9
Functions 1
• Signal detection–Identification of previously unknown adverse reactions
![Page 10: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/10.jpg)
10
Signal detection at the UMC
A combination of • Automated quantitative data mining • Human assessment
–National Pharmacovigiolance Centres–Review Panel–UMC staff
![Page 11: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/11.jpg)
11
Why computerized quantitative data assessment?
• Enables management of very large amounts of data
• Automatic, no manpower/time• Unexpected connections• No ”investigator’s bias”
![Page 12: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/12.jpg)
12
Automated selection for further assessment of combinations that stand out quantitatively against the back-ground, using a Bayesian confidence propagation neural network (BCPNN)
Eur J Clin Pharmacol 1998;54:315-321
![Page 13: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/13.jpg)
13
The BCPNN network is used to count:
• All reports in the database• All occurrences of variable x (e.g. ADR)• All occurrences of variable y (e.g. drug)• All occurrences of x and y together
Easily adapted to count occurrences of other variables
![Page 14: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/14.jpg)
14
BCPNN Statistical Disproportionality
• IC Information Component: strength of the association between a drug and an ADR. Positive IC values indicate that the combination has been reported more often than expected from the generality of the database. The higher the IC, the more the combination stands out from the background (logarithmic scale).
• IC-2std: IC minus two standard deviations. This is the lower value of the 95% confidence interval.
![Page 15: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/15.jpg)
15
-2
-1
0
1
2
3
4
5
6
79:1 81:1 83:1 85:1 87:1 89:1 91:1 93:1 95:1
Time(year)
Captopril - Coughing
IC
![Page 16: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/16.jpg)
16
-6
-4
-2
0
2
4
6
8
71 74 77 80 83 86 89 92 95 98year
Practolol, ATC C07AB - Peritonitis
PractololATC C07AB
![Page 17: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/17.jpg)
17
Combinations Database - combinations reported in the present quarter
• Drug name (WHO Drug Dictionary; ATC code)• Adverse reaction term (WHOART; System
Organ Class)• Total no of reports of combination in
database• Total no of reports of drug (all ADRs)• Total no of ADR (all drugs)• No of reports of combination, present quarter
only• No of reports of drug (all ADRs), present
quarter only• No of ADR (all drugs), present quarter only
![Page 18: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/18.jpg)
18
Combinations Database • IC• IC-2std• Old IC (previous quarter)• Old IC-2std (previous quarter)• Year and quarter of first introduction• Single / multiple ingredient drug• Critical WHOART term?• Dependence indicator?• Documentation quality grading• Positive rechallenge?• Fatal outcome?• Described in ADIS Reactions?
![Page 19: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/19.jpg)
19
Associations Database
• Selection from the Combinations Database of all combinations with a positive IC-2std (having passed the threshold of the lower confidence interval value)
![Page 20: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/20.jpg)
20
UMC Signal Review Panel
• 35 expert reviewers in 21 countries• Evaluation of System Organ Classes,
ATC groups and special interests• Clinical and pharmacological assessment• Case evaluations• Findings presented in SIGNAL document
![Page 21: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/21.jpg)
21
Procedure for signal analysis
Signals
Clinical evaluation
AssociationsQuantitative
threshold
Combinations
Drug safety data
Quantitative informationStatistical measurements Signal
document
![Page 22: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/22.jpg)
22
New Signalling ProcedureWhat should be achieved?
• Signals should not be missed• Signals should be found early• ‘False’ signals should be kept to a
minimum
![Page 23: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/23.jpg)
23
Functions 2
• Signal strengthening– Annual ‘Type-A’ document– Search requests– Web-based search programme– Collaboration (e.g. Drug Surveillance
Research Unit, Southampton)
![Page 24: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/24.jpg)
24
Functions 3
• Adverse reaction profilesIBUPROFEN - ADR profile
0 1000 2000 3000 4000 5000 6000 7000 8000
Appl site
Cardiovasc
Foetal
Liver-bil
Neoplasms
Repro
Skin
Vision
Syst
em O
rgan
Cla
ss
No of reports
![Page 25: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/25.jpg)
25
Functions 4Comparing national experiences
• A suspicion may be strengthened if similar observations are made in many countries
• If an association is reported in only one country there may be a country-specific problem
![Page 26: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/26.jpg)
26
International DifferencesReal or Apparent?
• Clioquinol SMON• metamizole agranulocytosis• mianserin agranulocytosis• nitrofurantoin pulmonary;
neurological• oestrogens jaundice• triazolam psychosis• acetylsalicylic acid Reye’s syndrom• flucloxacillin hepatitis
![Page 27: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/27.jpg)
27
International Differences(Quantitative and Qualitative)
• Disease prevalence• Genetic, social, cultural, traditional• Foods, herbals, alcohol, other drugs• Healthcare systems• Health professional practices• Indication for, and use of medicines• Pharmaceutical formulations• Drug monitoring practices
![Page 28: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/28.jpg)
28
Functions 5
• Identification of risk factors
![Page 29: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/29.jpg)
29
Possible Risk Factors
• Users population, indication• Other medicines• Genetic constitution• Dosage• Duration of treatment• Route of administration• Availability (’over the counter’)• Warnings and instructions for use• ..........
![Page 30: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/30.jpg)
30
Functions 6
• Combining ADR figures with other data – drug utilization statistics (IMS)– population statistics
![Page 31: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/31.jpg)
31
UMC - a communication centre
• WHO Pharmaceuticals Newsletter• Uppsala Reports• Internet home page
–http://www.who-umc.org• Vigimed e-mail discussion group
![Page 32: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/32.jpg)
32
12
![Page 33: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/33.jpg)
33
![Page 34: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/34.jpg)
34
Training and technical support
• Training courses • Regional and local activities• Internet-based training• Documentation of established
systems
![Page 35: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/35.jpg)
35
![Page 36: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/36.jpg)
36
UMC involvement in local activities, 1998 - 2002• 1998 - Norway, China, Portugal,
Malaysia, Morocco, India• 1999 - Philippines, Venezuela,
Mexico, South Africa• 2000 - India, China, Kuwait, Romania,
Uruguay• 2001 - Oman, Russia, Ghana, Fiji,
Singapore, Vietnam• 2002 - Cuba, Chile, Morocco
![Page 37: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/37.jpg)
37
Technical support
• Guidelines• Terminologies• Software development• Literature coverage
![Page 38: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/38.jpg)
38
![Page 39: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/39.jpg)
39
![Page 40: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/40.jpg)
40
![Page 41: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/41.jpg)
41
UMC Functions
• Harmonisation
![Page 42: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/42.jpg)
42
Terminologies
• WHO Adverse Reaction Terminology• WHO Drug Dictionary• ATC Classification• ICD Classification
![Page 43: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/43.jpg)
43
Definitions established within the WHO Programme
– Adverse reaction– Adverse event– Side effect– Signal– Serious reaction– Causality categories
![Page 44: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/44.jpg)
44
Worldwide network of knowledge and competence• Bilateral contacts facilitated• Annual meeting of representatives
of National Centres• Collaboration with academia (e.g.
Utrecht University)• Working relations with relevant
organizations - CIOMS, ISoP, ISPE, DIA, IPCS, HAI, IFPMA, etc
![Page 45: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/45.jpg)
45
![Page 46: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/46.jpg)
46
![Page 47: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/47.jpg)
47
![Page 48: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/48.jpg)
48
Research and development• Methods for signal identification and
analysis; complex connections• Improved monitoring of herbal or
traditional medicines– collaboration with Royal Botanical Gardens,
Kew, UK
• Good communications practice in pharmacovigilance; collaboration with: – University of Verona– CIOMS
![Page 49: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/49.jpg)
49
![Page 50: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/50.jpg)
50
![Page 51: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/51.jpg)
51
![Page 52: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/52.jpg)
52
Drugs & problems of current interest
• Herbals monitoring programme• Biopharmaceuticals• Counterfeit products • Vaccine vigilance• Haemovigilance• Safety of self-medication
![Page 53: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/53.jpg)
53
Herbal-specific classification issues
• Heterogenous group• ”Substance” nomenclature
• Genus + species + author• Parts and Extracts
• Botanical and vernacular synonyms• Anatomical, therapeutical,
pharmacognostic classification
![Page 54: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/54.jpg)
54
Herbal ATC classification
Eg. Herbal remedies for treatment of peptic ulcer A02W A02WA (containing saponins)
A02WB (containing mucilage)
![Page 55: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/55.jpg)
55
Improved herbals vigilance
• Structured herbal substance register• Retrieval of related reports• BCPNN calculations
• Herbal ATC classification• Selective herbal searches• Retrieval of summary data • Group comparison searches
• Synonym check list
![Page 56: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/56.jpg)
56
Herbal info in Drug Dictionary
Herbal substances
Full nam ePreferred namePartExtractSourceSource version
Synonyms
Synonym full nameSourceSource versionLanguage
Preferred namesPreferred nameAuthor
Therapeutic classHerbal ATC code
Medicinal product
Pharmaceutical form
Ingredients
Pharmaceuticalsubstances
![Page 57: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/57.jpg)
57
WHO Data Base on Counterfeit Pharma-ceuticals (K. Kimura, Geneva, 1998)
• 751 Cases of counterfeiting (1982-1997)- 25% developed countries- 65% developing countries
• Majority discovered by visual detection• All classes of drugs - predomination of
antibiotics
WHO Guidelines for the development of measures to combat counterfeit drugs
![Page 58: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/58.jpg)
58
WHO Guidelines for the development of measures to combat counterfeit drugs
• http://www.who.int/medicines/organization/qsm/activities/qualityassurance/counterfeit/counterfeit_info.shtml
![Page 59: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/59.jpg)
59
Data available to non-members
• On request to WHO Uppsala Monitoring Centre
• Consent from participating countries (automatic from 49 countries)
• Quantitative listings• Caveat Document
![Page 60: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/60.jpg)
60
Ideas in Planning Phase
• Single international database for industry reports
• Phenotype/genotype testing of patients experiencing adverse events
• Chemical structure/clinical safety relationship
![Page 61: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/61.jpg)
61
Thank you for your attention
![Page 62: WHO Collaborating Centre for International Drug … UMC.pdf5 0 50000 100000 150000 200000 250000 Number of Reports 1968 1972 1976 1980 1984 1988 1992 1996 2000 Year (Based on Onset](https://reader035.fdocuments.in/reader035/viewer/2022070712/5ecc91e41ebf70741050a484/html5/thumbnails/62.jpg)
62
Definitions WHOEdwards IR, Biriell C. Drug Safety 1994;10:93-102
• Side Effect: Any unintended effect of a drugoccurring at normal doses, which is related to thepharmacological properties of the drug.
• Adverse Event: Any untoward medical occurrence that may present during treament with a drug butdoes not necessarily has a causal relationship.
• Adverse Reaction: Any response to a drug that isnoxious and unintended and occurs at normaldoses