Adr
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ADVERSE DRUG REACTIONS Dr. Manjunath.G.N SSMC Tumkur
Definition • Any response to a drug that is noxious and unintended and that occurs at doses used in man.
Types • Dose related (Predictable – type A) • Non dose related (Unpredictable – type B) • Long term effects • Delayed effects
Severity • • • •
Mild Moderate Severe Lethal
Incidence • Hospital in-patients – 10-20% • Deaths in hospital in-patients - 0.242.9% • Hospital admissions – 0.3-5%
Classification of ADR
• Dose related 1.Pharmaceutical variation 2.Pharmacokinetic variation a) Pharmacogenetic variation b) Hepatic disease c) Renal disease d) Cardiac disease
3.Pharmacodynamic variation
a) Hepatic disease b) Altered fluid and electrolyte imbalance
Contd. •
Non dose related a) Immunological reaction b) Pharmacogenetic variation
•
Long term effects a) Adaptive changes b) Rebound phenomena c) Other long term effects
Contd. •
Delayed effects a) Carcinogenesis b) Effects connected with reproduction a) Impaired infertility b) Teratogenesis c) Drugs in breast milk
Various ADR • • • •
Side effects Secondary effects Toxic effects Intolerance – quantitative
- qualitative 1. Idiosyncracy 2. Hypersensitivity Photosensitization •
Contd. • • • • •
Drug withdrawal reaction Drug dependence Teratogenecity Carcinogenecity/mutagenecity Iatrogenecity
Manifestations of ADR • Haemopoietic toxicity • Hepatotoxicty- direct immunological • Nephrotoxicity • Ocular toxicity • Ototoxicity
Contd. Behavioural toxicity Electrolyte imbalance Endocrine disturbance Skin toxicity Unmasking and exacerbation of disease • Acute withdrawal reaction • • • • •
Contd. • • • •
Carcinogenesis Teratogenesis Alteration of taste Drug dependance
Pharmacovigilance widening horizons • Illegal sale of medicines and drugs of abuse on internet • Increasing self medication practices • Widespread manufacture and sale of counterfeit and substandard medicines • Increasing use of traditional medicines outside the confines of traditional culture • Increasing use of traditional medicines and herbal medicines with other medicines
Pharmacovigilance • French term- detection, assessment, understanding and prevention of adverse drug event
Partners in pharmacovigilance • WHO quality assurance and safety;medicines team • Uppasala monitoring center • National pharmacovigilance centers • Pharmaceutical industry • Hospitals • Health professional • Patients • Other partners
What is ADR monitoring ? • Systemically collecting information about adverse drug experiences with the aim of, through feed back to the parties involved, contribute to continuously improving drug therapy.
Aim : To detect • Serious unexpected ADRs • Increased or unexpectedly high frequency of known significant ADRs • To prepare list of ADRs not previously reported • To disseminate the information through regular bulletins, reports, and articles in the press
Surveillance methods • • • • • • • •
Anecdotal reporting Voluntary reporting Intensive event reporting Cohort studies Case control studies Population statistics Record linkage Meta analysis
Need for monitoring • Short coming of premarketing studies-which reveal most common and acute untoward effect • Increase cost of patient care • Medication : 10-57% is self medication • Our country has vast population, poverty and rich research ground • Accelerated approval and rapid introduction of new drugs • Paucity of ADR data
Who reports ? • Doctors-hospital level, Medical officer from PHC’s, GP’s • Dentists • Drug manufacturers • Pharmacists and nurses
Types of ADR Type
Type of effect
Features
examples
A
Augmented
Common, predictable, low mortality
Bradycardia–β-blockers
B
Bizarre
Uncommon, unpredictable, high morbidity & high mortality
Anaphylaxis - Penicillin
C
Chronic
Dose related & time related
Dyskinesia - Levodopa
D
Delayed
Time Related
Teratogenesis
E
End of use
Withdrawal of chronic therapy abruptly
Corticosteroids
F
Failure
Unexpected failure of therapy
Oral contraceptive failure - Rifampin
What to report ? • New drugs – all suspected adverse reaction • Established drugs - All serious reactions-well recognized - All reactions to vaccines - Unexpected high frequency of a known adverse reaction - All reactions to pregnant & lactating women including new born
Where to report ? • Nearest ADR monitoring centers • Peripheral centers • Regional centers national center at new Delhi • Directly on internet www.fda.gov/MedWatch
Importance of ADR reporting • Early detection of unknown safety problems • Detection of increases in frequency • Provides early detection of warning signals • Evaluates pattern of adverse effect • Measures incidence of adverse effects • Improves therapy
Reasons not to report • • • • • • • • • •
Uncertain association Too trivial to report Too well known to report Unaware- existence of national center Unaware- of the need of to report of ADR’s Not enough time Non availability of ADR forms Too bureaucratic Legal issues Lack of feed back
Definition • Any response to a drug that is noxious and unintended and that occurs at doses used in man.
Types • Dose related (Predictable – type A) • Non dose related (Unpredictable – type B) • Long term effects • Delayed effects
Severity • • • •
Mild Moderate Severe Lethal
Incidence • Hospital in-patients – 10-20% • Deaths in hospital in-patients - 0.242.9% • Hospital admissions – 0.3-5%
Classification of ADR
• Dose related 1.Pharmaceutical variation 2.Pharmacokinetic variation a) Pharmacogenetic variation b) Hepatic disease c) Renal disease d) Cardiac disease
3.Pharmacodynamic variation
a) Hepatic disease b) Altered fluid and electrolyte imbalance
Contd. •
Non dose related a) Immunological reaction b) Pharmacogenetic variation
•
Long term effects a) Adaptive changes b) Rebound phenomena c) Other long term effects
Contd. •
Delayed effects a) Carcinogenesis b) Effects connected with reproduction a) Impaired infertility b) Teratogenesis c) Drugs in breast milk
Various ADR • • • •
Side effects Secondary effects Toxic effects Intolerance – quantitative
- qualitative 1. Idiosyncracy 2. Hypersensitivity Photosensitization •
Contd. • • • • •
Drug withdrawal reaction Drug dependence Teratogenecity Carcinogenecity/mutagenecity Iatrogenecity
Manifestations of ADR • Haemopoietic toxicity • Hepatotoxicty- direct immunological • Nephrotoxicity • Ocular toxicity • Ototoxicity
Contd. Behavioural toxicity Electrolyte imbalance Endocrine disturbance Skin toxicity Unmasking and exacerbation of disease • Acute withdrawal reaction • • • • •
Contd. • • • •
Carcinogenesis Teratogenesis Alteration of taste Drug dependance
Pharmacovigilance widening horizons • Illegal sale of medicines and drugs of abuse on internet • Increasing self medication practices • Widespread manufacture and sale of counterfeit and substandard medicines • Increasing use of traditional medicines outside the confines of traditional culture • Increasing use of traditional medicines and herbal medicines with other medicines
Pharmacovigilance • French term- detection, assessment, understanding and prevention of adverse drug event
Partners in pharmacovigilance • WHO quality assurance and safety;medicines team • Uppasala monitoring center • National pharmacovigilance centers • Pharmaceutical industry • Hospitals • Health professional • Patients • Other partners
What is ADR monitoring ? • Systemically collecting information about adverse drug experiences with the aim of, through feed back to the parties involved, contribute to continuously improving drug therapy.
Aim : To detect • Serious unexpected ADRs • Increased or unexpectedly high frequency of known significant ADRs • To prepare list of ADRs not previously reported • To disseminate the information through regular bulletins, reports, and articles in the press
Surveillance methods • • • • • • • •
Anecdotal reporting Voluntary reporting Intensive event reporting Cohort studies Case control studies Population statistics Record linkage Meta analysis
Need for monitoring • Short coming of premarketing studies-which reveal most common and acute untoward effect • Increase cost of patient care • Medication : 10-57% is self medication • Our country has vast population, poverty and rich research ground • Accelerated approval and rapid introduction of new drugs • Paucity of ADR data
Who reports ? • Doctors-hospital level, Medical officer from PHC’s, GP’s • Dentists • Drug manufacturers • Pharmacists and nurses
Types of ADR Type
Type of effect
Features
examples
A
Augmented
Common, predictable, low mortality
Bradycardia–β-blockers
B
Bizarre
Uncommon, unpredictable, high morbidity & high mortality
Anaphylaxis - Penicillin
C
Chronic
Dose related & time related
Dyskinesia - Levodopa
D
Delayed
Time Related
Teratogenesis
E
End of use
Withdrawal of chronic therapy abruptly
Corticosteroids
F
Failure
Unexpected failure of therapy
Oral contraceptive failure - Rifampin
What to report ? • New drugs – all suspected adverse reaction • Established drugs - All serious reactions-well recognized - All reactions to vaccines - Unexpected high frequency of a known adverse reaction - All reactions to pregnant & lactating women including new born
Where to report ? • Nearest ADR monitoring centers • Peripheral centers • Regional centers national center at new Delhi • Directly on internet www.fda.gov/MedWatch
Importance of ADR reporting • Early detection of unknown safety problems • Detection of increases in frequency • Provides early detection of warning signals • Evaluates pattern of adverse effect • Measures incidence of adverse effects • Improves therapy
Reasons not to report • • • • • • • • • •
Uncertain association Too trivial to report Too well known to report Unaware- existence of national center Unaware- of the need of to report of ADR’s Not enough time Non availability of ADR forms Too bureaucratic Legal issues Lack of feed back
