CHILEAN PHARMACOVIGILANCE PROGRAM

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CHILEAN PHARMACOVIGILANCE PROGRAMME Centro
Nacional de Información de Medicamentos y
Farmacovigilancia CENIMEF Gonzalez-Frugone X.,
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• CHILE LOCATION
• Chile is a very long and narrow country, located
  in South America.
• It has an area of about 750.000 km2 of
  continental land and 1.250.000 km2 of Antartic
  territory. The total estimated population of
  Chile is about 15 million inhabitants.

Santiago
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• INTRODUCTION
• National Drug Information and Pharmacovigilance
  Centre (CENIMEF) is part of the Public Health
  Institute, the official regulatory agency on
  medicines.
• CENIMEF has the responsibility for the Chilean
  Pharmacovigilance Programme since 1993.

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• ORGANIZATION
• Chilean Pharmacovigilance Programme was
  established in April 1995 and was accepted in the
  WHO Drug Monitoring Centre in March 1996.
• STAFF 2 full-time pharmacists and one assistant.
  
• This programme has and Advisory
  Pharmacovigilance Committee.

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Atacamas Desert
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• PHARMACOVIGILANCE COMMITTEE FUNCTIONS
• Create and establish the Pharmacovigilance
  Programme.
•  Process and evaluate the ADR reports to be
  sended to the WHO Collaborating Centre for
  International Drug Monitoring four times a year.
•  Propose measures to Health Authority about
  safety on medicines.

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• REPORTING METHODOLOGY
• Reporters are all health professionals, i.e.
  Physicians, pharmacists, nurses, dentists.
• WHO ART terminology is used for coding.
• WHO causality terms and definitions are used for
  evaluation.
• Is on a voluntary basis by a reporting
  form/card.
• Patient and reporters identities are kept
  confidential.

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• PHARMACOVIGILANCE PROMOTIONAL
• ACTIVITIES
• 1998 CENIMEF-ISP organized and held the first
  Latin-American Training Course on ADR Monitoring.
• 2002 CENIMEF-ISP organized and held the second
  Latin-American Training Course on ADR Monitoring.
• 1998-2002 CENIMEF has organized and dictated
  workshops on pharmacovigilance for hospitals
  health professionals all over the country.
• Between 2000 and 2002, number of ADR reports
  increased from 424 to 771.

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Araucarias
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ADR reported 1995-2001 by system affected
SYSTEM Nº
Dermatological 610
31,8 Haematological 527
27,5 CNS 161
8,4 Gastrointestinal
115 6,0 Hepatic 44
2,3 Respiratory 83
4,3 Cardiovascular 98
5,1 Endocrine 19
1,0 Body as a whole 205
10,7 Others
54 2,8
TOTAL 1916
100
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ADR by Age 1995-2002

• RANGE Nº
  
• 0 -5 a 344
  13,6
• 6-10 a 128
  5,1
• 11-20 a 277
  11,0
• 21-30 a 472
  18,7
• 31-40 a 458
  18,2
• 41-50 a 284
  11,3
• 51-60 a 233
  9,2
• 61-70 a 174
  6,9
• 71-89 a 149
  5,9
• TOTAL 2519
  100

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ADR reported 1995-2001 by Pharmacological or
Therapeutic group

• DRUGS
  Nº
• Antipsychotics 496
  35,5
• Antineoplastics 131
  9,4
• NSAIDs
  115 8,2
• Anticonvulsants 102
  7,3
• Vaccines 77 5,5
• Antidepressants 34
  2,4
• Antibiotics
  369 26,4
• Others
  73 5,2
• TOTAL 1397
  100

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ADR by SEVERITY 2000-2001
SEVERITY Nº
MILD
151 12,6
MODERATE
713 59,7 SEVERE
331
27,7
TOTAL
1195 100

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ADR by CAUSALITY 1995-2002
CAUSALITY Nº
CERTAIN
64 3,6
PROBABLE
1000 55,8 POSSIBLE
549 30,6 UNLIKELY
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1,1 CONDITIONAL 95
5,3 UNCLASSIFIABLE 66
3,7
TOTAL 1793
100

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ADR reported by physicians, pharmacists and
nurses 1995-2002
1995 1996 1997 1998 1999 2000
2001 2002
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• CENIMEF FUTURE CHALLENGES
• Establish soon two Regional Pharmacovigilance
  Centres, one in the north and the other in the
  south of the country. In the near future we
  should have four Regional Pharmacovigilance
  Centres.
• Propose regulation on Pharmacovigilance.
• Increase the professional staff of CENIMEF.
• Continue improving the promotion of ADR reporting
  from health professionals.

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