ADR Theory and Practical
ADR Theory and Practical
ADR Theory and Practical
Molière
No medicinal product is entirely or absolutely safe for all people, in all places, at all times.
Type D :
• Delayed
• Teratogenesis and Carcinogenesis
• Eg. Phenytoin – cleft lip/cleft palate
Type E :
• End of use
• Withdrawal effect
• Eg. Corticosteroid withdrawal - Adrenal crisis
Severity of ADRs
Minor:
No therapy/ antidote/ prolongation of hospitalization
Moderate:
Requires change in drug therapy/ specific treatment/ prolongation of hospitalization
Severe:
Potentially life threatening/ permanent damage/ intensive medical treatment
Lethal:
Directly or indirectly contributes to death
Preventing ADRs:
Rational Use of Medicines (RUM)
Side effects
Toxic effects
Intolerance
related to ADRs
Some aspects
Idiosyncracy
Drug Allergy
Photosensitivity
Drug Dependence
Drug withdrawal
Teratogenicity
Carcinogenecity
Drug induced
diseases
Secondary effects
Indirect consequences of a primary drug action
Hastening
Resuscitation, Termination elimination -
maintenance of exposure inducing
of vitals - (decontamination) Prevention of “forced”
airway, ventilation, - fresh air, absorption - diuresis, altering
oxygen support, washing, emesis
(not in
activated charcoal urinary pH,
BP & HR, body
temperature, comatosed), haemodialysis
blood sugar. lavage and
haemoperfusion
Intolerance
Appearance of characteristic toxic effects @ Normal doses
Indicates a low threshold of the individual to drug action
Definition:
Drug use for personal satisfaction is accorded a higher priority
than other basic needs
Psychological dependence
Physical dependence
Drug Abuse
Drug Addiction
Drug Habituation
Drug dependence
Psychological dependence
• Individual believes that optimal state of wellbeing is
achieved only through the actions of the drug. (desire to
craving)
• Reward & Reinforcement- Strong - opioids, cocaine
• Faster drug more reinforcing: Inhaled, injected i.v. are highly
reinforcing.
Drug dependence
Physical dependence
• Necessitates the continued presence of the drug to
maintain physiological equilibrium.
• Intensity: Discontinuation - characteristic withdrawal
(abstinence) syndrome.
• Neuroadaptation- adaptation of the nervous system to
function normally in the presence of the drug
• Opioids, barbiturates, alcohol
Drug dependence
Drug Abuse
Self-medication in a manner and amount that deviates from
the approved medical and social patterns in a given culture at
a given time.
Drug Habituation
Less intensive involvement, withdrawal produces only mild
discomfort. tea, coffee, tobacco, social (alcohol) drinking
Drug-induced diseases
• Iatrogenic (physician induced) diseases
Peptic ulcer by NSAIDs and corticosteroids
Parkinsonism by Antipsychotics
Hepatitis by Isoniazid
DLE by hydralazine
Pharmacovigilance
Pharmacovigilance
Pharmaco = medicine
Vigilare = to watch
Drugs
Herbals
Traditional & Complementary medicine
Blood products
Biologicals
Medical devices
Vaccines
ADR Reporting : Misconceptions
Goal
• Date- 04/02/2023