5. Pharmacovigilance
• Science & activities related to
1. Detection
2. Assessment
3. Understanding
4. Prevention
Of ADR or any drug related problems
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9. 4. Intolerance
• @ therapeutic doses
• Appearance of characteristic toxic effects
of a drug in an individual
• Low threshold for drug
• E.g. carbamazepine -> ataxia
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10. 5. Idiosyncrasy
• Genetically determined abnormal
reactivity to a chemical
• E.g. barbiturates -> excitation & confusion
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11. 6. Drug allergy
• Immunologically mediated reactions
• Body considers drug as allergen
• Seen in small proportion of population
• Types : I , II, III, IV
• Rx :
O2,
Inj. Adrenaline 0.5mg (1:1000) im / 1:10,000 iv
Antihistamines
Glucocorticoids
• Prevention
– Skin tests (type I)
• Eg . Penicillins
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12. 7. Photosensitivity
• Cutaneous reactions resulting from drug
induced sensitization of skin to UV rays
• Phototoxic
• Photo allergic
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15. 8. Drug dependence
• Psychological dependence
– E.g. Opioids, cocaine
• Physical dependence
– E.g. Opioids, barbiturates, alcohol
• Drug abuse
• Drug addiction
• Drug habituation
– E.g. Tea, coffee, smoking
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16. 9. Drug withdrawal
• Adverse consequences in sudden
interruption of therapy
• E.g. Angina worsens when β-blockers
stopped suddenly
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17. 10. Teratogenicity
• Capacity of a drug to cause foetal
abnormalities when given to pregnant
mother
• 3 Stages:
– Fertilization & Implantation (0-17)-Failure of
pregnancy
– Organogenesis† (18-55)- deformities
– Growth & development (56-) : Developmental
& functional abnormalities
• Avoided in pregnancy
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18. Risk category
• A – Human studies – No risk
• B - Animal Studies – No risk
• C – Potential benefit, no proper evidence
• D- Evidence of human foetal risk but
potential benefits outweigh
• X – potential risk
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21. 11. Mutagenicity & Carinogenicity
• Capacity of a drug to cause genetic defects
• Capacity of a drug to cause cancer
• Eg:
–Anticancer drugs
–Radioisotopes
–Tobaco
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