KOMAR UNIVERSITY

OF SCIENCE AND TECHNOLOGY

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 What is pharmacovigilance and its
objecyives
• The process and science of monitoring the safety of medicines and
taking action to reduce the risks and increase the benefits of
medicines.
• Objective of pharmacovigilance in accordance of EU legislation are:
Adverse drug reaction harm reduction to human arising from use of
authorized medicinal products within or outside the terms of marketing
authorization or from occupational exposure
Promotion of safe and effective medicinal products by providing timely
information about the safety of medicinal products to patient, healthcare
professionals and the public

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 Why is pharmacovigilance needed?
All things are poison, and nothing is without poison; only the dose
permits something not to be poisonous.
Paracelsus (1493-1541)

Positive balance
No medication is free of toxicities
Benefit of use must be greater than risks
Better knowledge = better decisions

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 Medication error

Adverse drug Counterfeit

Pharmacovigilance

Medicines interaction Lack of efficacy

Abuse and
misuse of
medicines

Adapted from WHO pharmacovigilance 5

Compleme
ntary Pharmacovigilance Biologics
medicines

Blood
Vaccines
Medical products
devices

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 Definitions
• Adverse Event (AE)
• Adverse Drug Reaction (ADR)
• Serious Adverse Event (SAE)
• Serious Adverse Drug Reaction (SADR)
• Reference Safety Information (RSI)
• Suspected Unexpected Serious Adverse Reaction (SUSAR)

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 Adverse event Vs Adverse drug
reaction
Adverse event Adverse drug reaction
• An unfavorable and unintended • Response to a medicinal
sign due to a medicine product which is noxious and
• Example: an abnormal unintended
laboratory finding, symptom, or
disease temporally associated
with the use of medicinal
product, whether or not
considered related to the
medicinal product
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 AE vs ADR
If the AE is considered related to Temporal correlation does not
the medicinal product, it is called imply causation
and adverse reaction • AE: temporal correlation
• AR: causality
Reaction

Relatedness

Adverse
Event

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 Classification of ADRs
Type A effects: Augmented pharmacologic effects
• Dose dependent and predictable
• Due to (exaggerated) pharmacological effects
• Effects tend to be fairly common, dose related (i.e. more frequent or
severe with higher doses)
• Avoided by using doses appropriate to the individual patient
• Effects can usually be reproduced and studied experimentally and
are often already identified before marketing

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 Classification of ADRs
Type B effects: Bizarre effects (or idiosyncratic)
• Dose independent and unpredictable (Patient reactions)
• Occurs in only a minority of patients and display little or no dose
relationship
• Rear, serious and are notoriously difficult to study
• Effects are either immunological or non-immunological and occur
only in patients, with - often unknown - predisposing conditions

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 Classification of ADRs
Type B effects:
• Immunological reactions: rashes, anaphylaxis, vasculitis,
inflammatory organ injury, to highly specific autoimmune syndromes
• Non-immunological: occur in a minority of predisposed, intolerant,
patients, e.g. because of an inborn error of metabolism or acquired
deficiency in a certain enzyme, resulting in an abnormal metabolic
pathway or accumulation of a toxic metabolite.

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 Classification of ADRs
Type C effects:
• chronic effects refer to situations where the use of a medicine, often
for unknown reasons, increases the frequency of a "spontaneous“
disease
• Effects may be both serious and common (and include malignant
tumors) and may have pronounced effects on public health
• Effects may be coincidental and often concern long term effects

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 Classification of ADRs
Type D effects: Type E and F effects
• Delayed effects (dose Type E
independent) • End-of-treatment effects
• Carcinogenicity (e.g.,
immunosuppressants)
Type F
• Teratogenicity (e.g., fetal
hydantoin syndrome; mental • Failure of therapy
and physical birth defects)

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 Serious adverse event
• Any untoward medical occurrence that at any dose:
Result in death SAE
Is life threatening (ie patient at risk of death) Seriousness
Requires inpatient hospitalization
Adverse
Result in persistent disability Event
Congenital anomaly
Medically significant event
Any suspected transmission via medicinal product of an infectious
agent

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 Serious Adverse Drug Reaction
• An AE that is considered
serious (as per defined criteria)
AND
possibly related to the medicinal product

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 Reference safety Information (RSI)
• Ie the known as safety information/adverse reactions for a product
• Investigator’s Brochure or Summary of Product Characteristics
(SmPC)

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 Suspected Unexpected Serious
Adverse Reaction
• Is the reaction known (included in the RSI)?
If no, event is known to be “unexpected”

• The event is suspected to be related Suspected Adverse Reaction

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Assessments SUSAR

Serious
SAE = ADR

+
Reaction

Seriousness Expectedness
Relatedness
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 Who should report ADR?
• All health care professionals/workers
• Marketing authorization holder (MAH), being primarily responsible
for the safety of their products, they are obligated to report serious
adverse drug reactions they receive about their Products to PvC
• Non-serious ADRs should be included in the periodic safety update
report

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 What to report
• New medicines: Report all suspected adverse reactions including
minor ones for the newly marketed medicines in Iraq for 5 years
regardless the nature and intensity of the ADRs
• Report all the serious ADRs including:
rare
unexpected
fatal or life-threatening
permanently / significantly disabling
required or prolong hospitalization
cause a congenital anomaly

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 What to report
• increased frequency of a given reaction
• ADRs associated with drug-drug, drug food or drug-food
supplements (including herbal and complementary products)
interactions
• ADRs occurring from overdose, medication error or medicine
withdrawals
• ADRs in special fields of interest such as medicine abuse and
medicine use in pregnancy (teratogenicity) and during lactation
• ADRs occurring under the age of 18 years, regardless of whether
the medicine is licensed for use in children

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 What happens to the reported ADRs
• Additional investigations into the use of the medicine
• Appropriate changes in the package insert
• Change the schedule of the medicine
• Enhancing educational initiatives to improve the safe use of that
medicine
• Other regulatory and health promotion interventions as the situation
may warrant including withdrawal / recall

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 Expectedness of the adverse drug
reaction
Reaction is defined

• Expected:
• Include in the SPC

• Unexpected:
• Not included in the SPC
• Include in SPC, but showed changes in its known frequency
• Included in SPC, but showed changes in its known severity

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 Benefit of the report
Healthcare provider and patient benefit as:
• Improvement quality of care and knowledge offered
• Better treatment outcome, through reduction of drug related issue
• Professional growth through improved patient confidence in healthcare
professionals
• Accessible feedback information on drug related problems reported
within the country and internationally
• Fulfillment of a moral and professional obligation
• Importance of ADRs in the meetings of Pharmacovigilance
• Letters of thanks dedicated to the health care professionals

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 What happen to the report
• Outcome of the report with any important or relevant information
relating to the reaction reported, will be communicated to the
reported as appropriate
• Details of the report are stored in a confidential database at the
Iraqi pharmacovigilance center and the analyzed report sent to the
Uppsala Monitoring Center (UMC)
• Names of the reporters or any other health professionals named on
the report and the patient will be removed before any details about
ADR is communicated with others
• Information only used to improve understanding and use of
medicine in Iraq
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 How to obtain reporting forms
• Pharmacy department of hospital or health center will have ADR
reporting form or ministry of health website
• Pharmacovigilance will be assigned to clinical pharmacist, drug
information centers
• Forms should be available at community pharmacies and private
clinics
• Submit to IPhvC through direct letter, e-mail or by hand, direct call

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 Basic principles of efficient reporting
• In time reporting
• Report as soon as possible to relevant center
Continue strong suspicion of the medicine-induced illness in the
same patient group and other’s
• Keep a vigil for signs and symptoms that may now enhance or
exclude the possibility of a medicine induced reaction
• Document follow - up / supplementary information and submitted to
the Iraqi Pharmacovigilance center
• Ensure that the patient names and patient code are the same in the
1st report & the Follow up report

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 Basic principles of efficient reporting
• Accuracy and completeness
• Ensure reported Suspected ADR Reporting Form is filled accurately
with all the necessary information as much as possible
• Remember the 4 basic components that make a report reliable are:
• An identifiable patient
• An identifiable health-care professional
• An identifiable Adverse reaction or product problem
• An identifiable medicine (suspected)

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 Yellow card scheme
• MHRA is the executive Agency of the Department of Health and
Social Care, acts on behalf of the Ministers to protect and promote
public health and patient safety
• The Yellow Card scheme run by the MHRA, is the UK system for
collecting and monitoring information on safety concerns such as
suspected side effects or adverse incidents involving medicines and
medical devices
• Purpose of the scheme is to provide an early warning that the
safety of a medicine or a medical device may require further
investigation
• https://yellowcard.mhra.gov.uk/the-yellow-card-scheme/
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THANK YOU
questions

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