introduction to pharmacovigilance
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TRANSCRIPT
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Introduction to Pharmacovigilance
Done By CID PV Team
QPPV :- Dr. Rania Kamel
Deputy :- Dr. Nahla Raafat
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Outlines of the presentation
Smooth orientation
to pharmacovi
gilance
Why do we need
pharmacovigilance?
WHO programme
for drug monitoring
Pharmacovigilance in
Egypt
Important terminologie
s in pharmacovi
gilance
Yellow Card &
Blue CardWorkshop
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Smooth orientation to Pharmacovigilance concept.
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Medicine 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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Risk/Benefit Balance of medications
Medicines are safe! (X)
Approved medicines are safe! (X)
No medicine is safe! (X)
No medicine is without risk (√)
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Risk/Benefit Balance of medications
Acceptable
Unacceptable
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What is Pharmacovigilance?
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WHO definition ofpharmacovigilance
Pharmacovigilance is
the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem
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Pharmacovigilance
prevention of adverse
effects
Assessment &Understand
ing
Detection
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Learning from History
Thalidomide Disaster: •Tranquilizer launched - 1957
• First reports of birth defects - 1959
• 13 reports of birth defects - 1961
•Withdrawn shortly afterward
•10000 infants affected by Phocomelia.
• No teratogenicity detected in testis during clinical trials and prior to launch.
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Why do we need Pharmacovigilance?
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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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Limitations of clinical trials
•Small number of patients studied
•Restricted populations (age, sex, ethnicity)
•Narrow indications
•Short duration of drug exposure
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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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• ADRs were 4th-6th commonest cause of death in the US in 1994 Lazarou et al, 1998
USA
• It has been suggested that ADRs may cause 5700 deaths per year in UK. Pirmohamed et al, 2004
UK
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Reason 3:
ADRs are expensive !!• 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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Reason 4: Promoting rational use of medicines and adherence
Reason 5: Ensuring public confidence
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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Pharmacovigilance is needed in every country
because of differences in:• Drug production • Distribution and use ( e.g.
indications, dose, availability)• Genetics, diet, traditions of the
people (e.g. use of herbal remedies, etc.)
• Pharmaceutical quality and composition (active/inactive ingredients )
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Who program for international drug monitoring
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Who program for international drug monitoring
• Started 1968
• Located in Uppsala, Sweden
• Collaborating centre for maintaining global ADR database - Vigibase
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Roles of WHO Collaborating Centre
• Identify early warning signals of serious adverse reactions to medicines
• Evaluate the hazard
• Undertake research into the mechanisms of action to aid the development of safer and more effective medicines
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Pharmacovigilance in Egypt
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What is EPVC (Egyptian Pharmacovigilance centre )
In accordance with the legislation, EPVC has established a pharmacovigilance system for the collection and evaluation of information relevant to the risk-benefit balance of medicinal products, Medical devices & Biocides.
(cosmetics, Vet. Products & Herbal products )
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Implemented levels of regulatory actions in Egypt based on EPVC decisions
• Asking for specific data from MAH• Modify the package insert• Black box warning in the insert • Boxed warning on the outer pack • Contraindication • Distribute “Dear Dr Letter”• Preventing importation of specific batches • Recall of certain batches from the market• Suspension of the marketing authorization• Withdrawal of the marketing authorization
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Important Terminologies in Pharmacovigilance
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Side Effect (SE) Vs Adverse Drug Reaction (ADR) Vs Adverse Event (AE)
SEResponse to a drug which is unintended and which occurs at
doses normally used in man for prophylaxis, diagnosis or therapy of disease.
AEAny untoward medical occurrence in a patient or clinical
investigation subject administered a medicinal product and which does not necessarily have to have a causal relationship with this
treatment.
ADRResponse to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of disease A causal relationship between the drug and the occurrence is suspect.
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Adverse Drug Reaction (ADR) Vs Adverse Event (AE)
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Medication Errors (ME)
They could occur during prescribing, transcribing, dispensing, administering a drug. Examples of medication errors include, misreading or miswriting a prescription.
Medication errors are more common than adverse events, but result in harm less than 1% of the time. About 25% of adverse events are due to medication errors.
Not all medication errors lead to adverse outcomes.
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Adverse Drug Reactions (ADR) vs Adverse Events (AE) vs Medication Errors (ME)
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Seriousness of Adverse drug reactions
Serious ADR• Life-Threatening• Hospitalization (initial or prolonged)• Disability• Death• Congenital Anomaly• Medically important event or reaction• Cause Cancer
OTHER WISE ADR IS NON-SERIOUS
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Serious reports should be submitted in expedited manner i.e. as soon as
possible & no later than 15 calendar
daysThus they best submitted
Online Email or Fax
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We are almost there
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A VALID REPORT CONSISTS OF:-
• Identifiable patient
• Identifiable drug (pharmaceutical product)
• Identifiable reaction
• Identifiable reporter
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Who should report? • Healthcare Professionals
• Marketing authorization holder (MAH)
• Patients & their relatives
• Nurses
• Pharmacists
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Reports Journey
Reporter QPPV Data entry RA
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Workshop
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Q1:- Define Pharmacovigilance:
Pharmacovigilance is
the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem
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Q2:-Why do we need Pharmacovigilance ?
• Humanitarian concern
• Medicines are supposed to save lives
• ADRs are expensive !!
• Promoting rational use of medicines and adherence
• Ensuring public confidence
• Ethics To know of something that is harmful to another person who does not know, and not telling, is unethical
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Q3:- What are limitations to Clinical trials:
1. Small number of patients studied
2. Restricted populations (age, sex, ethnicity)
3. Narrow indications
4. Short duration of drug exposure
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Q4:- Define ADRs :
Response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of disease A causal relationship between the drug and the occurrence is suspect
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Q5:- Mention four examples for serious ADR:
1. Life-Threatening
2. Death
3. Congenital Anomaly
4. Disability
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Q6:- Mention four criteria for a valid report:
1.Identfiable patient
2.Identfiable Drug
3.Identfiable reaction
4.Identfiable reporter
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Q7:- Who should report ?
1. Healthcare professional
2. Marketing Authorization Holder
3. Nurses
4. Pharmacist
5. Patient
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Contact informationDr. Rania Kamel
Dr. Nahla Raafat
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