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Pharmacovigilance. Dr Mary Couper Quality Assurance and Safety of Medicines WHO. Procurement and Supply Management Plan. 2.6 Ensuring rational use of medicines

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pharmacovigilance

Pharmacovigilance

Dr Mary Couper

Quality Assurance and Safety of Medicines

WHO

procurement and supply management plan
Procurement and Supply Management Plan

2.6 Ensuring rational use of medicines

Is there a system for monitoring adverse drug reactions and drug resistance? If yes, describe briefly how the system works. If no, describe plans to establish a system.

learning objectives
Learning objectives
  • Participants will be aware of what pharmacovigilance is
  • Participants will learn why safety monitoring is important
  • Participants will learn what WHO is doing in pharmacovigilance
medicine safety
Medicine Safety
  • To undergo treatment you have to be very healthy, because apart from your sickness you have to withstand the medicine.

Molière

pharmacovigilance5

Pharmacovigilance

What IS this?

vigilance

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

pharmacovigilance7
Pharmacovigilance
  • The science and activities relating to the detection, evaluation, understanding and prevention of adverse drug reactions or any other drug-related problems
pharmacovigilance major aims
Pharmacovigilance Major Aims
  • early detection of unknown safety problems
  • detection of increases in frequency
  • identification of risk factors
  • quantifying risks
  • preventing patients from being affected unnecessarily

Rational and Safe use of Medicines

why pharmacovigilance
Why Pharmacovigilance?
  • Pre-marketing safety data

Animal Experiments: Relevant?

Clinical Trials: Complete?

why pharmacovigilance10
Why Pharmacovigilance?
  • Post Marketing Topics

Unexpected adverse reactions

Interactions

Risk factors

Quality of life

Long-term efficacy

Cost assessment

why pharmacovigilance factors influencing change
Why pharmacovigilance? Factors influencing change
  • Toxicity (adverse drug reactions)
  • Lack of patient adherence
slide12

HIV Clinic 2005

Prescription

Dr A. Who

31 December 2005

Re: Mr Joseph Bloggs 

R/

1)abacavir + lamivudine + zidovudine 1 BD

2)atenolol 100 mg/d

3)acetylsalicylic acid 150mg/d

4)simvastatin 10 mg/d

 5) bezafibrate 200 mg/d

6) metformin 500 mg/d

7) fluoxetine 50 mg/d

8) sildenafil

why pharmacovigilance for procurement and management supply plans
Why Pharmacovigilance for Procurement and Management Supply Plans?
  • It is not always the product that determines drug safety but how it is used
  • More than 50% of ADRs are preventable
  • there is a high risk of misuse of drugs

Disease

Population

Drug

Health care system

populations
Populations
  • Mass treatment regimens,
  • Low standard of living and education,
  • Cultural specificities,
  • not always suffering from the diseases
  • unlabelled and off labelled indications
  • (pregnant or breast feeding woman, small children, elderly people),
  • Drug and disease interactions.
urgent need for synergistic collaboration
PHP

opportunity to implement PV activities

Offer a cohort of patients under controlled conditions to be monitored for safety over a period of time

PV

detect, evaluate, and prevent adverse events

promote rational use of drugs in mass treatment programmes

Evaluate the impact of the programmes

improve acceptability of the programme

Urgent need for synergistic collaboration
slide16

INTEGRATING P.H.P AND PV

FUNCTIONAL AND STRUCTURAL RELATIONSHIP

T r a c h o m a t i s

F i l a r i a s i s

T u b e r c u l o s i s

M a l a r i a

V a c c i n e s

WHO-PV

(UMC)

WHO ADVISORY

COMMITTEE

W.H.O

PROGRAMMES

DRUG REGULATORY AUTHORITY

Expert Safety Review

Panel

T r a c h o m a t i s

F i l a r i a s i s

T u b e r c u l o s i s

M a l a r i a

PV Coordinator

National PV centre

V a c c i n e s

NATIONAL PUBLIC HEALTH PROGRAMMES

DISTRICT INVESTIGATION TEAM

PATIENTS

PATIENTS

Health workers

who programme for international drug monitoring
WHO Programme for International Drug Monitoring

WHO

HQ

WHO

Collaborating

Centre, Uppsala

National

Centres

who programme for international drug monitoring hq
WHO Programme for International Drug Monitoring (HQ)
  • Policy
  • Exchange of Information
  • Technical support to countries
  • Advisory Committee on Safety of Medicinal Products
exchange of information
Exchange of Information
  • WHO Pharmaceuticals Newsletter
  • WHO Drug Alerts
  • WHO Drug Information
  • WHO Restricted Pharmaceuticals List
  • International Conference of Drug Regulatory Authorities (ICDRA)
policies guidelines and normative activities
Policies, Guidelines and Normative Activities
  • Guidelines
    • The Importance of Pharmacovigilance (2002)
    • Safety Reporting - A guide to detecting and reporting adverse drug reactions (2002)
    • Pharmacovigilance in public health
    • Safety monitoring of herbal medicines
    • Advisory Committee on the Safety of Medicines (ACSOMP)
country support
Country Support
  • Strengthen spontaneous reporting systems
  • Establish active surveillance component in public health programmes

HIV/AIDS

Malaria

Lymphatic filariasis

  • Work with the WHO Collaborating Centre for International Drug Monitoring (the Uppsala Monitoring Centre)
technical support to countries
Technical support to countries
  • Technical guidelines on all aspects of pharmacovigilance

(Several Publications and documents)

  • Training courses on pharmacovigilance

(Regional Training Courses, biennial course by UMC and HQ)

who programme for international drug monitoring24
WHO Programme for International Drug Monitoring

WHO

HQ

WHO

Collaborating

Centre, Uppsala

National

Centres

who collaborating centre uppsala monitoring centre
WHO Collaborating Centre (Uppsala Monitoring Centre)

ADR database

  • No of reports: more than 3.5 million
  • Each year increase ~160,000 / year
who collaborating centre uppsala monitoring centre27
WHO Collaborating Centre (Uppsala Monitoring Centre)

ADR Reports

  • Analysis
  • Output
    • Feedback to National Centres
    • Signal documents
who programme for international drug monitoring28
WHO Programme for International Drug Monitoring

WHO

HQ

WHO

Collaborating

Centre, Uppsala

National

Centres

national centres
China

India

Indonesia

Philippines

Sri Lanka

Thailand

Vietnam

Associate members:

Nepal

Pakistan

National centres
procurement and supply management plan30
Procurement and Supply Management Plan

2.6 Ensuring rational use of medicines

There should be a system for monitoring adverse drug reactions and drug resistance. Describe briefly how the system works.