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ADR
BY
ASAWE TEJASWINI L
DEPARTMENT OF PHARMACOLOGY
ASSIASTANT PROFESSOR
SIDHHIS INSTITUTE OF PHARMACY
THANE
ADVERSE DRUG REACTIONS
CONTENTS
Definition of ADR
 Classification of ADR
 Detection of ADR
 Reporting of ADR
 Prevention of ADRs
Definition Of Adverse Drug Reactions
• According to WHO (1972)
 “Adverse Drug Reaction is
harmful or undesirable effect of
drug ”.
 All drug are poison until used
legally.
 Ex. Aspirin used for headache also
act on GIT and producing side
effect
 Preventing and detecting adverse
effect from medicine it termed as
pharmacovigilance.
 Adverse effect includes
 Nausea and vomiting
 Deafness (hearing loss)with
gentamycin
 Death with penicillin
Classification of ADRs
 Depending upon……..
 Type of reaction:
• Type A
• Type B
• Type C
• Type D
• Type E
• Type F
 Onset of event: Acute (<60 minutes)
 Sub-acute (1-24 hrs)
 Latent (>2 days)
 Severity: Minor, Moderate, Severe, Lethal ADRs.
Types of Adverse Drug Reactions
• A (Dose Related)
• Bizzare (Non-Dose Related)
• Chronic (Dose Related and Time
Related)
• Delayed (Time Related)
• End of Use (Withdrawal)
• Failure (Unexpected Failure of
Therapy)
Aug Augmented (Dose Related)
 Features
Commonly Related to the pharmacologic action of the
drug –
pharmacologic response is
• Predictable
• Low mortality ( number of death in one period
• of time)
 Example
• Dry mouth with Tricyclic Antidepressants
• Respiratory Depression with Opioids
• Bleeding with Warfarin
 Management
• Reduce Dose
Bleeding with Warfarin
Bizzare (Non-Dose Related
Features
• Uncommon
• Not related to the pharmacologic action of the
drug
• Unpredictable
• High mortality
 Example
• Immunologic reactions: anaphylaxis to penicillin.
• Idiosyncratic reactions: malignant hyperthermia
with general anesthetics.
Chronic
(Dose Related and Time Related)
 Features
• Uncommon
• Related to the cumulative dose
 Example
• Osteonecrosis of the jaw with bisphosphonates
 Management
• Reduce dose or use an alternate day therapy
• withdrawal may have to be prolonged
Osteonecrosis
of Jaw with
Bisphospho
nates
Delayed (Time Related)
 Features
• Uncommon
• Usually dose related
• Occurs or becomes apparent sometime after use of the drug
 Example
• Carcinogenesis
• Tardive dyskinesia
• Leucopenia with lomustine
 Management
• Often intractable
Tardive dyskinesia
tardive dyskinesia is
involuntary repetitive
movements. For example:
Eye blinking
End of use (Withdrawal)
 Features
• Uncommon
• Occurs soon after withdrawal of the drug
 Example
• Withdrawal syndrome with benzodiazepines
(e.g., insomnia, anxiety)
 Management
• Reintroduce drug and withdraw slowly
aInsomnia
Failure (Unexpected Failure of Therapy)
 Features
• Common
• Dose related
• Often caused by drug interactions
 Example
• Inadequate dosage of an oral contraceptive when used
with an enzyme inducer.
• Resistance to antimicrobial agents
 Management
• Increase dosage
Classification of ADRs….
Depending on Severity
1. Minor ADRs: No therapy, antidote or
prolongation of hospitalization is required.
2. Moderate ADRs: Requires change in drug
therapy, specific treatment or prolongs
hospital stay by at least 1 day.
3. Severe ADRs: Potentially life threatening,
causes permanent damage or requires
intensive medical treatment.
4. Lethal ADRs: (causing death)
Directly or indirectly contributes to death
of the patient.
Monitoring ADRs
(Detecting adverse drug reaction(ADR).
Documentation of ADR
Reporting serious ADRs to pharmacovigilance
centers
Assessing causality (relationship between a
drug and a drug reaction)
Reporting an ADR
 Detecting adverse drug reaction(ADR).
What may happen when
you don’t report?
A) Who can Report?
All healthcare professionals (clinicians, dentists, pharmacists, nurses etc)
and
Non-healthcare professionals including consumers can report suspected
adverse drug reaction.
B) Where to report ?
 Duly filled Suspected Adverse Drug Reaction Reporting Form
can be send to the nearest Adverse Drug Reaction Monitoring
Centre (AMC) or directly to the National Coordination Centre
(NCC).
 Call on Helpline (Toll Free) 1800 180 3024 to report ADRs.
 Or can directly mail this filled form to pvpi@ipcindia.net or
pvpi.ipcindia@gmail.com
 A list of nationwide AMCs is available at:
http://www.ipc.gov.in, http://www.ipc.gov.in/PvPI/pv_home.html
C) What to report ?
 Report serious adverse drug reactions. A reaction is
serious when the patient outcome is:
• Life-threatening
• Hospitalization (initial or prolonged)
• Disability (significant, persistent or permanent)
• Required intervention to prevent permanent
impairment or damage
 Report non-serious, known or unknown, frequent or
rare adverse drug reactions due to Medicines, Vaccines
and Herbal products.
D) Mandatory field
for suspected ADR
reporting form
 Patient initials,
 Age at onset of reaction,
 Reaction term(s),
 Date of onset of reaction,
 Suspected medication(s)
 reporter information.
What happens to the submitted information?
ADR reported
by HCP, Patient
or Others
Causality
assessment at
AMCs
Forwaded to NCC-
PvPI through ADR
database
Data is
Analyse
d &
forwarde
d
Reports are
periodically reviewed
by the NCC-PvPI
Global
Pharmacovigilance
Database
(Managed by WHO-
UMC)
Information is
submitted to the
Steering
committee of PvPI
Suggests
required
interventions
Health care
provider
Adverse Drug Reaction
Monitoring Centre (AMC) National Coordinating
Centre (NCC),
PHARMACOVIGILAN
CE PROGRAMME
OF INDIA (PVPI)
70% ADRs are
potentially
avoidable
More
rational
Prescribing
Patient
counselling
Consider
risk factors
for ADRs
Better
monitoring
of treatment
Better
communication
Preventing ADR
THANKYOU

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ADR.pptx

  • 1. ADR BY ASAWE TEJASWINI L DEPARTMENT OF PHARMACOLOGY ASSIASTANT PROFESSOR SIDHHIS INSTITUTE OF PHARMACY THANE
  • 3. CONTENTS Definition of ADR  Classification of ADR  Detection of ADR  Reporting of ADR  Prevention of ADRs
  • 4. Definition Of Adverse Drug Reactions • According to WHO (1972)  “Adverse Drug Reaction is harmful or undesirable effect of drug ”.  All drug are poison until used legally.  Ex. Aspirin used for headache also act on GIT and producing side effect  Preventing and detecting adverse effect from medicine it termed as pharmacovigilance.  Adverse effect includes  Nausea and vomiting  Deafness (hearing loss)with gentamycin  Death with penicillin
  • 5. Classification of ADRs  Depending upon……..  Type of reaction: • Type A • Type B • Type C • Type D • Type E • Type F  Onset of event: Acute (<60 minutes)  Sub-acute (1-24 hrs)  Latent (>2 days)  Severity: Minor, Moderate, Severe, Lethal ADRs.
  • 6. Types of Adverse Drug Reactions • A (Dose Related) • Bizzare (Non-Dose Related) • Chronic (Dose Related and Time Related) • Delayed (Time Related) • End of Use (Withdrawal) • Failure (Unexpected Failure of Therapy)
  • 7. Aug Augmented (Dose Related)  Features Commonly Related to the pharmacologic action of the drug – pharmacologic response is • Predictable • Low mortality ( number of death in one period • of time)  Example • Dry mouth with Tricyclic Antidepressants • Respiratory Depression with Opioids • Bleeding with Warfarin  Management • Reduce Dose Bleeding with Warfarin
  • 8. Bizzare (Non-Dose Related Features • Uncommon • Not related to the pharmacologic action of the drug • Unpredictable • High mortality  Example • Immunologic reactions: anaphylaxis to penicillin. • Idiosyncratic reactions: malignant hyperthermia with general anesthetics.
  • 9. Chronic (Dose Related and Time Related)  Features • Uncommon • Related to the cumulative dose  Example • Osteonecrosis of the jaw with bisphosphonates  Management • Reduce dose or use an alternate day therapy • withdrawal may have to be prolonged Osteonecrosis of Jaw with Bisphospho nates
  • 10. Delayed (Time Related)  Features • Uncommon • Usually dose related • Occurs or becomes apparent sometime after use of the drug  Example • Carcinogenesis • Tardive dyskinesia • Leucopenia with lomustine  Management • Often intractable Tardive dyskinesia tardive dyskinesia is involuntary repetitive movements. For example: Eye blinking
  • 11. End of use (Withdrawal)  Features • Uncommon • Occurs soon after withdrawal of the drug  Example • Withdrawal syndrome with benzodiazepines (e.g., insomnia, anxiety)  Management • Reintroduce drug and withdraw slowly aInsomnia
  • 12. Failure (Unexpected Failure of Therapy)  Features • Common • Dose related • Often caused by drug interactions  Example • Inadequate dosage of an oral contraceptive when used with an enzyme inducer. • Resistance to antimicrobial agents  Management • Increase dosage
  • 13. Classification of ADRs…. Depending on Severity 1. Minor ADRs: No therapy, antidote or prolongation of hospitalization is required. 2. Moderate ADRs: Requires change in drug therapy, specific treatment or prolongs hospital stay by at least 1 day. 3. Severe ADRs: Potentially life threatening, causes permanent damage or requires intensive medical treatment. 4. Lethal ADRs: (causing death) Directly or indirectly contributes to death of the patient.
  • 14. Monitoring ADRs (Detecting adverse drug reaction(ADR). Documentation of ADR Reporting serious ADRs to pharmacovigilance centers Assessing causality (relationship between a drug and a drug reaction)
  • 15. Reporting an ADR  Detecting adverse drug reaction(ADR). What may happen when you don’t report? A) Who can Report? All healthcare professionals (clinicians, dentists, pharmacists, nurses etc) and Non-healthcare professionals including consumers can report suspected adverse drug reaction.
  • 16. B) Where to report ?  Duly filled Suspected Adverse Drug Reaction Reporting Form can be send to the nearest Adverse Drug Reaction Monitoring Centre (AMC) or directly to the National Coordination Centre (NCC).  Call on Helpline (Toll Free) 1800 180 3024 to report ADRs.  Or can directly mail this filled form to pvpi@ipcindia.net or pvpi.ipcindia@gmail.com  A list of nationwide AMCs is available at: http://www.ipc.gov.in, http://www.ipc.gov.in/PvPI/pv_home.html
  • 17. C) What to report ?  Report serious adverse drug reactions. A reaction is serious when the patient outcome is: • Life-threatening • Hospitalization (initial or prolonged) • Disability (significant, persistent or permanent) • Required intervention to prevent permanent impairment or damage  Report non-serious, known or unknown, frequent or rare adverse drug reactions due to Medicines, Vaccines and Herbal products.
  • 18. D) Mandatory field for suspected ADR reporting form  Patient initials,  Age at onset of reaction,  Reaction term(s),  Date of onset of reaction,  Suspected medication(s)  reporter information.
  • 19. What happens to the submitted information? ADR reported by HCP, Patient or Others Causality assessment at AMCs Forwaded to NCC- PvPI through ADR database Data is Analyse d & forwarde d Reports are periodically reviewed by the NCC-PvPI Global Pharmacovigilance Database (Managed by WHO- UMC) Information is submitted to the Steering committee of PvPI Suggests required interventions Health care provider Adverse Drug Reaction Monitoring Centre (AMC) National Coordinating Centre (NCC), PHARMACOVIGILAN CE PROGRAMME OF INDIA (PVPI)
  • 20. 70% ADRs are potentially avoidable More rational Prescribing Patient counselling Consider risk factors for ADRs Better monitoring of treatment Better communication Preventing ADR