Adverse reaction of any drug is a major concerning issue in many countries. A medicine may act as poison without proper dosing as well as management. Sometimes, adverse drug reaction is life threatening. About 10% of diseased people are dying due to adverse reaction of drug. They even don't know why medicine is not being effective them well. So, to get proper medication, knowledge about adverse drug reaction is a must.

1. WELCOME TO
MY PRESENTATION

2. FIROZ ROSID
B. Pharm. Professional
Department of Pharmacy
Pabna University of Science and Technology

3. Adverse Drug Reaction (ADR)

4. Adverse drug reaction (ADR, or adverse drug effect) is a broad term referring to
unwanted, uncomfortable, or dangerous effects that drugs (including medications ) may
have.
Adverse drug reactions can be considered a form of toxicity which is suspected to be
due to a drug.
Adverse Event (AE): Adverse
event is any untoward medical
occurrence which may occur
during treatment with
pharmaceutical product, which
does not necessarily have a
causal relationship with the
treatment.
ADEs
ADRs
No need to have
causal relationship
Causal relationship
is suspected
Definition

5. When medications
have a narrow
therapeutic index.
Dose-
related
ADRs
Require prior
exposure. After
sensitized,
subsequent
exposure may
produce allergic
reaction.
Allergic
ADRs
Idiosyncrasy is an
imprecise term
defined as a
genetically
determined abnormal
response to a drug.
Idiosyncratic
ADRs
Etiology of Adverse Drug Reactions

6. Classification
Depending on onset of event-
֍ Acute
֍ Sub acute
֍ Latent
Depending on severity-
֍Minor
֍Moderate
֍Severe
֍Lethal
Extended Rawlins-Thompson classification
Type A
(Augmented)
Type B
(Bizarre)
Type C
(Chemical or
Dose related)
Type D (Time
related)
Type E
(Withdrawal)
Type F
(Unexpected
failure)

7. Type A: Augmented pharmacological effects
Features-
۞Have predictable effect
۞Dose dependent
۞Common
۞Low mortality and morbidity
۞Can be alleviated by dose
reduction
Examples
Bradycardia due to beta blocker
Bleeding due to anticoagulants
Headache due to Nitrates

8. Type B: Bizarre effects not related to Pharmacological effect
Features-
۞Unpredictable effect
۞Not dose-depended
۞Uncommon
۞High morbidity and mortality
Example-
Anaphylaxis due to penicillin
Hypersensitivity due convulsant

9. Type C: Chemical or Dose related
Features-
۞Uncommon
۞Related to the cumulative dose
۞Biological characteristics can
be predicted
Example-
Hypothalamic suppression due to
Corticosteroids
Hepatotoxicity due to Paracetamol
Type D: Time related
Features-
۞Uncommon
۞Usually dose related
۞Due to accumulation of drug
Example-
Carcinogenesis
Teratogenicity due to Phenytoin
Nephropathy due to Analgesics

10. Type E: Withdrawal
Features-
۞Uncommon
۞Occurs on withdrawal a drug
abruptly
Example-
Opiates withdrawal syndrome
Seizures due to Phenytoin
Type F: Unexpected therapy failure
Features-
۞Uncommon
۞Dose related
۞Caused by drug interaction
Example-
Failure of oral contraceptive due
to enzyme inducer

11. Minor- There is no need of therapy, antidote or prolongation of
hospitalization in this case.
Major- In this case, there is required of changing in drug therapy,
specific treatment or prolongation of hospitalization by at least a day.
Severe- It is potentially life threatening and may cause permanent
damage or requires intensive medical treatment.
Lethal- In this situation, directly or indirectly contributes to death of
the patient.
Depending on severity-

12. ֍ Overdosing
֍ Allergies to components of drug
֍ Alcohols
֍ Incorrect dosages of medicine
֍ Drug-drug interaction
֍ Wrong/incorrect prescription
֍ Patho-physiologic condition of patient
Common causes of ADRs

13. Factors affecting ADRs
Patients related
֍ Age
֍ Gender
֍ Ethnicity
֍ Genetic influence
֍ Concomitants medicines
֍ Pharmacogenetics
֍ Concurrent diseases
֍ Environmental exposure
֍ Diet, Smoking
֍ Compliance of dosing regiments
֍ Porphyrias
Drug related
֍ Dose
֍ Duration
֍ Pharmacodynamic properties
֍ Pharmacokinetic properties
֍ Inherent toxicity of the agent

14. Subtle ADRs-
 Functional deterioration
 Changes in mental status
 Failure to thrive
 Loss of appetite
 Confusion
 Depression
 Cough
 Headache
Common signs and symptoms ADRs
Allergic ADRs
 Itching
 Rash
 Fixed-drug eruption
 Hypotension.
 Ototoxicity
 Bronchial Asthma
 Upper or lower airway edema with
difficulty breathing

15. 1. Side effects: Dry mouth, Supress cough, Travellers diarrhoea, Baldness
2. Secondary effects: Super-infection, Latent T.B
3. Toxic effects: Bleeding, Ototoxicity
4. Allergy/Hypersensitivity
5. Idiosyncrasy: Excitement, Mental confusion, Aplastic anaemia, Cramps,
Purpura, Asthma, Diarrhoea
6. Drug Intolerance: Muscular dystonia, Sensitivity
7. Photosensitivity: Phototoxicity, Photoallergicity
8. Drug withdrawal reaction: Myalgia, Depression, Angina, Precipitate MI
9. Teratogenicity: Cleft lip, Microcephaly, Vaginal adenocarcinoma, Phocomelia,
Neural tube defects
10.Carcinogenicity and mutagenicity
11. Iatrogenic: Peptic ulcers, Parkinsonism, Hepatitis
12. Drug Dependence: Physical, Physiological.
Adverse drug reaction may be categorized by-

16. The immune system is able to recognize drugs as foreign particles, leading to
allergic reaction.
Large molecules can trigger an immune response directly where smaller molecules
can bind with proteins to trigger immune response.
The immune response is not related to the pharmacological action of the drug and
prior exposure is required.
Allergic reaction range from rash, serum sickness and angioedema to life
threatening bronchospasm and hypotension associated with anaphylaxis.
The four types of hypersensitivity are:
 Type I: Reaction mediated by IgE antibodies
 Type II: Cytotoxic reaction mediated by IgG or IgM antibodies
Type III: Reaction mediated by immune complexes
Type IV: Delayed reaction mediated by cellular response
Immunological Reaction

17. Treatment of Adverse Drug Reactions
֍Modification of dosage: For dose-related adverse drug reactions to
medications, modifying the dose or eliminating or reducing precipitating
factors may suffice. Increasing the rate of drug elimination is rarely
necessary.
֍Discontinuation of drug or medication if necessary: For allergic and
idiosyncratic ADRs, the drug usually should be discontinued and not tried
again.
֍Switching to a different medication: Switching to a different drug class is
often required for allergic ADRs and sometimes required for dose-related
ADRs. For example, opioid-induced constipation may be improved with
the use of an opioid receptor antagonist such as lubiprostone.

18.  Avoid inappropriate use of drug.
 Use appropriate dose, route and frequency of drug
administration
 Rule out possibility of drug interaction.
 Consider previous history of drug reaction.
 Elicit allergic diseases & cautions.
 Free from taking alcohol.
 Be aware of interaction with certain foods.
 Imply correct drug administration.
 Carry out appropriate laboratory investigation.
Prevention of ADRs

19. Conclusion
All drugs have the potential for adverse drug reactions,
conducting a risk-benefit analysis (the likelihood of benefit
vs risk of ADRs) is necessary whenever a medication is
prescribed. For rational use of any drug it is very necessary
to remember its adverse effects with its clinical significance.
Without correct dose, a medicine may act as a poison. So,
correct dosing and proper handling of medicine is very
much needed to overcome adverse effect of the drugs.
Again, early detection of any adverse effect and proper
management may be life saving in many cases.

20. THANK YOU