medicine safety
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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. - PowerPoint PPT PresentationTRANSCRIPT
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Technical Briefing Seminar 22- 26 September 20081 |
The need for Pharmacovigilance
Mary R Couper and Shanthi PalQuality Assurance and Safety of Medicines
The need for Pharmacovigilance
Mary R Couper and Shanthi PalQuality Assurance and Safety of Medicines
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Technical Briefing Seminar 22- 26 September 20082 |
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Technical Briefing Seminar 22- 26 September 20083 |
Medicine SafetyMedicine Safety
To undergo treatment you have to be very healthy, because apart from your sickness you have to withstand the medicine.
Molière
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Technical Briefing Seminar 22- 26 September 20084 |
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.
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Technical Briefing Seminar 22- 26 September 20085 |
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.
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Technical Briefing Seminar 22- 26 September 20086 |
Pharmaco - VigilancePharmaco - Vigilance
Pharmaco = medicineVigilare = to watch
– alert watchfulness– forbearance of sleep; wakefulness– watchfulness in respect of danger; care; caution;
circumspection– the process of paying close and continuous attention
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Technical Briefing Seminar 22- 26 September 20087 |
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
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Technical Briefing Seminar 22- 26 September 20088 |
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
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Technical Briefing Seminar 22- 26 September 20089 |
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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Technical Briefing Seminar 22- 26 September 200810 |
Why do we need pharmacovigilance?
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Technical Briefing Seminar 22- 26 September 200811 |
1959 / 61– Epidemia de focomelia por Talidomida (4.000 – 10.000 casos no mundo, com 15% de mortos)
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Technical Briefing Seminar 22- 26 September 200812 |
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
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Technical Briefing Seminar 22- 26 September 200813 |
Drug DevelopmentDrug Development
Phase IVPost-approval studies to
determine specific safety issues
Clinical development of medicines
Animal experiments for acute toxicity, organ
damage, dose dependence, metabolism, kinetics,
carcinogenicity, mutagenicity/teratogenicity
PreclinicalAnimal Experiments
Phase I Phase II
Development Post Registration
Phase III Phase IVPost-approval
SpontaneousReporting
Phase I
20 – 50 healthy volunteers to gather preliminary data
Phase II150 – 350 subjects with disease - to determine
safety and dosage recommendations
Phase III250 – 4000 more varied
patient groups – to determine short-term safety
and efficacy
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Technical Briefing Seminar 22- 26 September 200814 |
Limitations of phase 1 -3 clinical trialsLimitations 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
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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
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Technical Briefing Seminar 22- 26 September 200816 |
Why do we need pharmacovigilance?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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Technical Briefing Seminar 22- 26 September 200817 |
UK:
US:
ADRs were 4th-6th commonest cause of death in the US in 1994Lazarou et al, 1998
It has been suggested that ADRs may cause 5700 deaths per year in UK.
Pirmohamed et al, 2004
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Technical Briefing Seminar 22- 26 September 200818 |
125 Patients
24 Patients experienced ADRs (19%)
(59%) were avoidable
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Why do we need pharmacovigilance?Why do we need pharmacovigilance?
Reason 3: ADRs are expensive !!
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Technical Briefing Seminar 22- 26 September 200820 |
6.5% of admissions are due to ADRs
Seven 800-bed hospitals are occupied by ADR patients
Cost £446 million per annum
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Technical Briefing Seminar 22- 26 September 200821 |
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
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Technical Briefing Seminar 22- 26 September 200822 |
Why do we need pharmacovigilance?Why do we need pharmacovigilance?
Reason 4:
Promoting rational use of medicines and adherence
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Technical Briefing Seminar 22- 26 September 200823 |
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
8) Sildenafil
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Technical Briefing Seminar 22- 26 September 200824 |
Main reasons of discontinuation of first HAART regimen within
1st year: ICONA
Main reasons of discontinuation of first HAART regimen within
1st year: ICONAI C O
N A
ItalianCohort
NaiveAntiretroviral
Monforte et al. AIDS 1999
Toxicity
Failure
Non-adherence
Other
Continued
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Technical Briefing Seminar 22- 26 September 200825 |
Why do we need pharmacovigilance?Why do we need pharmacovigilance?
Reason 5: Ensuring public confidence
If something can go wrong, it will – Murphy's law
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Guardian Weekly
March 18-24 2004
disaster!
!
ALLEGATION:
Known about SSRI prescribing at unsafe doses for a decade
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Technical Briefing Seminar 22- 26 September 200829 |Need for Pharmacovigilance
Freetown, Sierra Leone 19th Aug. 200829
PV in Emerging Countries, CPT2008 29th July 200829
Safety concerns now high on the agenda of ALL countries
Safety concerns now high on the agenda of ALL countries
Developed countries Developing countries
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Why do we need pharmacovigilance?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
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ConsequenceConsequence
Not reporting a serious unknown reaction is unethical
valid for everyone• patient• health professional• manufacturer• authorities
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Pharmacovigilance is EssentialPharmacovigilance is Essential