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The need for Pharmacovigilance Mary R Couper and Shanthi Pal Quality Assurance and Safety of Medicines PowerPoint Presentation
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The need for Pharmacovigilance Mary R Couper and Shanthi Pal Quality Assurance and Safety of Medicines. Medicine Safety. To undergo treatment you have to be very healthy, because apart from your sickness you have to withstand the medicine. Molière. Risk.

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Presentation Transcript
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The need for PharmacovigilanceMary R Couper and Shanthi PalQuality Assurance and Safety of Medicines

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

slide4
Risk
  • No medicinal product is entirely or absolutely safe for all people, in all places, at all times. We must always live with some measure of uncertainty.
what is pharmacovigilance
What is Pharmacovigilance?

WHO definition:

The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.

This applies throughout the life cycle of a medicine equally to

the pre-approval stage as to the post-approval.

pharmaco vigilance
Pharmaco - Vigilance
  • Pharmaco = medicine
  • 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
what is the scope of pharmacovigilance
What is the scope of pharmacovigilance?
  • improve patient care and safety in relation to the use of medicines, and all medical and paramedical interventions,
  • improve public health and safety in relation to the use of medicines,
  • contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective (including cost-effective) use, and
  • promote understanding, education and clinical training in pharmacovigilance and its effective communication to the public
adverse event experience who definition
Adverse event/experience – WHO definition

Any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with this treatment

adverse reaction to a medicine adr who definition
Adverse Reaction to a medicine (ADR) –WHO Definition

A reaction which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function

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1959 / 61– Epidemia de focomelia por Talidomida (4.000 – 10.000 casos no mundo, com 15% de mortos)
why do we need pharmacovigilance
Why do we need pharmacovigilance?

Reason 1:

  • Humanitarian concern –
    • Insufficient evidence of safety from clinical trials
    • Animal experiments
    • Phase 1 – 3 studies prior to marketing authorization
limitations of phase 1 3 clinical trials
Limitations of phase 1 -3 clinical trials
  • limited size: no more than 5000 and often as little as 500 volunteers
  • narrow population: age and sex specific
  • narrow indications: only the specific disease studied
  • short duration: often no longer than a few weeks
examples of product recalls due to toxicity
Examples of product recalls due to toxicity

Medicine Year

Thalidomide 1965

Practolol 1975

Clioquinol 1970

Benoxaprofen 1982

Terfenadine 1997

Rofecoxib 2004

Veralipride 2007

Examples of serious and unexpected adverse events leading to withdrawal of medicine

Phocomelia

Sclerosing peritonitis

Subacute nephropathy

Nephrotoxicity, cholestatic jaundice

Torsade de pointes

Cardiovascular effects

Anxiety, depression, movement disorders

why do we need pharmacovigilance16
Why do we need pharmacovigilance?

Reason 2

  • Medicines are supposed to save lives

Dying from a disease is sometimes unavoidable; dying from a medicine is unacceptable. Lepakhin V. Geneva 2005

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UK:
  • US:

It has been suggested that ADRs may cause 5700 deaths per year in UK.

Pirmohamed et al, 2004

ADRs were 4th-6th commonest cause of death in the US in 1994

Lazarou et al, 1998

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125 Patients
  • 24 Patients experienced ADRs (19%)

(59%) were avoidable

why do we need pharmacovigilance19
Why do we need pharmacovigilance?

Reason 3: ADRs are expensive !!

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6.5% of admissions are due to ADRs
  • Seven 800-bed hospitals are occupied by ADR patients

Cost £446 million per annum

cost of adrs in the us
Cost of ADRs in the US?
  • Cost of drug related morbidity and mortality exceeded $177.4 billion in 2000 (Ernst FR & Grizzle AJ, 2001: J American Pharm. Assoc)
  • ADR related cost to the country exceeds the cost of the medications themselves
why do we need pharmacovigilance22
Why do we need pharmacovigilance?

Reason 4:

Promoting rational use of medicines and adherence

slide23

HIV Clinic 2005

  • Prescription
  • Dr A. Who 31 December 2000
  • Re: Mr Joseph Bloggs 
  • 1)abacavir + lamivudine + zidovudine 1 BD
  • 2)atenolol 100 mg/d
  • 3)acetylsalicylic acid 150mg/d
  • 4)cerivastatin 10 mg/d
  •  5) gemfibrozil 200 mg/d
  • 6) metformin 500 mg/d
  • 7) fluoxetine 50 mg/d
  • Sildenafil
main reasons of discontinuation of first haart regimen within 1st year icona
Main reasons of discontinuation of first HAART regimen within 1st year: ICONA

Italian

Cohort

I

C

O

N

A

Naive

Antiretroviral

Monforte et al. AIDS 1999

why do we need pharmacovigilance25
Why do we need pharmacovigilance?

Reason 5: Ensuring public confidence

If something can go wrong, it will – Murphy's law

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ALLEGATION:

Known about SSRI prescribing at unsafe doses for a decade

disaster!!

Guardian Weekly

March 18-24 2004

safety concerns now high on the agenda of all countries
Safety concerns now high on the agenda of ALL countries

Developed countries

Developing countries

PV in Emerging Countries, CPT2008 29th July 2008

Need for Pharmacovigilance

Freetown, Sierra Leone 19th Aug. 2008

29

29

why do we need pharmacovigilance30
Why do we need pharmacovigilance?

Reason 6: Ethics

To know of something that is harmful to another person who does not know, and not telling, is unethical

consequence
Consequence
  • Not reporting a serious unknown reaction is unethical

valid for everyone

      • patient
      • health professional
      • manufacturer
      • authorities