ADR

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ADVERSE DRUG REACTION:

ADVERSE DRUG REACTION Adverse drug reaction Adverse drug events Classification of ADR Severity of ADR Pharmacovigilance 1

ADVERSE DRUG REACTION:

ADVERSE DRUG REACTION It is a response to a drug which is noxious & unintended & which occurs at dose normally used in man for prophylaxis , diagnosis or therapy of disease or modification of physiological functions. 2

ADVERSE DRUG EVENTS:

ADVERSE DRUG EVENTS Any untoward medical occurance that may present during treatment with a medicine,but which does not necesssrily have a causal relationship with the treatment. 3

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What is the difference between ADR and ADE ? 4

CLASSIFICATION:

CLASSIFICATION TYPE A (AUGMENTED OR PREDICTABLE REACTION) These are based on the pharmacological properties of drug and are dose related. These are mostly preventable and reversible It includes :- a) side effects b) toxic effects c) intolerance DOSE 5

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TYPE B (BIZARRE OR Unpredictable REACTIONS) These are based on peculiarities ( genotype ) of the patient and not on the drug dose. These are less common , generally more serious & require withdrawal of the drug. It includes :- a) allergy b) idiosyncrasy GENOTYPE 6

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TYPE C These reactions occurs due to chronic effect of drug. TYPE D These are delayed adverse effect of drug. TYPE E These adverse effect appear at the end of treatment . TYPE F These adverse effects are associated with failure of treatment. 7

SEVERITY OF ADVERSE DRUG REACTION:

SEVERITY OF ADVERSE DRUG REACTION MINOR No therapy , antidote or prolongation of hospitalization is required. MODERATE It requires change in drug therapy, specific treatment or prolongs hospital stay by at least one day. SEVERE It is life threatening, cause permanent damage or requires intensive medical treatment. LETHAL/Serious It directly or indirectly contributes to death of the patient. MODERATE SEVERE LETHAL 8

PHARMACOVIGILANCE:

PHARMACOVIGILANCE Parmacovigilance has been defined by the WHO as “the science & activities relating to the detection , assessment , understanding & prevention of adverse effects or any other drug related problems.” The information generated is useful in educating doctors about ADRs & in the official regulation of drug use. WHO 9

CATEGORISE OF ADVERSE DRUG EFFECT:

CATEGORISE OF ADVERSE DRUG EFFECT Side effects Secondary effects Intolerance Idiosyncrasy Drug allergy Photosensitivity Drug dependence Drug withdrawal reactions Mutagenicity & Carcinogenicity Drug induced diseases Teratogenicity 10

SIDE EFFECTS:

SIDE EFFECTS These are unwanted but often unavoidable pharmacodynamic effects that occur at therapeutic doses. A side effect may be based on the same action as the therapeutic effect. e.g. Atropine is used in preanaesthetic medication for its antisecretory action , the same action produces dryness of mouth as a side effect. DRYNESS OF MOUTH 11

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Secondary Effects An effect may be therapeutic in one context but side effect in another context. E.g. Codeine used for cough produces constipation as a side effect but the latter is its therapeutic effect in travellers diarrhoea . 12

INTOLERANCE:

INTOLERANCE It is the appearance of characteristic toxic effects of a drug in an individual at therapeutic doses. It indicates a low threshold of the individual to the action of a drug. 13

EXAMPLES OF INTOLERANCE:

EXAMPLES OF INTOLERANCE A single dose of triflupromazine induces muscular dystonias in some individuals specially children. One tablet of chloroquine may cause vomiting & abdominal pain . MUSCULAR DYSTONIAS ABDOMINAL PAIN 14

IDIOSYNCRASY:

IDIOSYNCRASY It is a genetically determined abnormal reactivity to a chemical. As such, the type of reaction is restricted to individuals with a particular genotype . 15

Examples:

Examples Quinine/quinidine cause cramps , diarrhoea , purpura , asthma & vascular collapse in some patient. Chloramphenicol produces non dose related serious aplastic anaemia in rare individual. PURPURA ASTHMA VASCULAR COLLAPSE 16

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DRUG ALLERGY AND PHOTOSENSITIVITY 17

DRUG ALLERGY:

DRUG ALLERGY It is an immunologically mediated reaction producing serotype symptoms which are unrelated to the pharmacodynamics profile of the drug, this is also called Drug hypersensitivity. Generally occurs even with much smaller doses and have a different time course of onset and duration. 18

MECHANISM & TYPE OF ALLERGIC REACTIONS:

MECHANISM & TYPE OF ALLERGIC REACTIONS ON BASIS OF HUMORAL RESPONCE- there are three types of reactions a) type-I anaphylatic reactions b) type-II cytolytic reaction c) type-III retarded arthus reaction ON BASIS OF CELL MEDIATED RESPONCE- d) type-IV delayed hypersensitivity . 19

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Cephalosporin Penicillin Salicylates DRUGS FRQUENTLY CAUSING ALLERGIC REACTION 20

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It is a cutaneous reaction resulting from drug induced senstization of skin to uv radiation . The reaction are of two type- A) phototoxic B) photoallergic PHOTOSENSTIVITY 21

DRUG DEPENDENCE DRUG WITHDRAWAL DRUG INDUCED DISEASES MUTAGENICITY & CARCINOGENICITY:

DRUG DEPENDENCE DRUG WITHDRAWAL DRUG INDUCED DISEASES MUTAGENICITY & CARCINOGENICITY 22

DRUG DEPENDENCE:

DRUG DEPENDENCE It is a state in which use of drugs for personal satisfaction is accorded a higher priority than other basic needs. Drug dependence has following aspects: Psychological dependence Physical dependence Drug abuse Drug addiction Drug habituation 23

PSYCHOLOGICAL DEPENDENCE:

PSYCHOLOGICAL DEPENDENCE In Psychological dependence an individual has personal belives that optimal stage of well being only through the action off drug. Psychological dependence accompaines all patterns of self medication . 24

PHYSICAL DEPENDENCE :

PHYSICAL DEPENDENCE It is an altered physiological state produced by repeated administration of drug to maintain physiological equilibrium . Drugs which produce physical dependence are Alcohol Benzodiazipines Barbiturates etc. 25

DRUG ABUSE:

DRUG ABUSE Dr ug abuse refers to use of a drug by self medication in a manner and amount that deviates from the approved medical & social pattern in a given culture at a given time. It also refers to any use of an ilicit drug. 26

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Some of the drugs most often associated with this term include alcohol , amphetamines , barbiturates , benzodiazepines (particularly temazepam , nimetazepam and flunitrazepam ) cocaine and opioids . 27

DRUG ADDICTION:

DRUG ADDICTION It is a pattern of compulsive use of drug characterized by overwhelming involvement with use of drug. Is defined as a drug user's compulsive need to use drug in order to function normally . When such drugs are unobtainable, the user suffers from drug withdrawal . Examples: cannabis , LSD , amphetamine e.t.c. 28

DRUG HABITUATION:

DRUG HABITUATION It denotes less intensive involvement with the drug so that its withdrawal produces only mild discomfort. Consumption of tea coffee tobacco social drinking are regarded habituating. 29

DRUG WITHDRAWAL REACTION:

DRUG WITHDRAWAL REACTION Stopping or discontinuing any drug that was taken from long time can leads to appearance of many adverse symptoms ,which are called drug withdrawal reaction of drug. 30

EXAMPLES:

EXAMPLES Acute adrenal insufficiency may be precipitated by abrupt cessation of corticoid therapy. 31

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Severe hypertension , restlessness , sympathetic over activity may occur shortly after discontinuing Clonidine 32

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Worsening of angina pectoris , precipitation of M.I may result from stoppage of beta blockers . 33

DRUG INDUCED DISEASES:

DRUG INDUCED DISEASES These are also called iatrogenic (physician induced) diseases . These are functional disturbances (disease) caused by drugs which persist even after the offending drug has been withdrawn and largely eliminated. 34

EXAMPLES:

EXAMPLES Peptic ulcer is caused by salicylates and corticosteroids . 35

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Hepatitis is caused by isoniazid. 36

MUTAGENICTY & CARCINOGENICITY:

MUTAGENICTY & CARCINOGENICITY It refers to capacity of a drug to cause genetic defects & cancer respectively. Usually oxidation of drug results in the production of reactive intermediates , which effects genes & may cause structural changes in the chromosome. Drugs implicated in these adverse effects are -Anticancer drug , radio isotopes , tobacco. 37

TERATOGENICITY :

TERATOGENICITY 38

TERATOGENICITY:

TERATOGENICITY It refers to capacity of a drug to cause foetal abnormalities when administered to the pregnant mother . The placenta does not strictly constitute a barrier and any drug can cross it to a greater or lesser extent. The embryo is one of the most dynamic biological systems and in contrast to adults, drug effects are often irreversible . 39

EFFECT OF DRUG ON FOETUS:

EFFECT OF DRUG ON FOETUS DRUGS CAN EFFECT THE FOETUS AT THREE STAGES 1) Fertilization & implantation: Conception to 17 days : failure of pregnancy which often get unnoticed. 2) Organogenesis: 18 to 55 days of gestation: most vulnerable period, deformities are produced. 40

3) GROWTH & DEVELOPMENT:

3) GROWTH & DEVELOPMENT 56 days onwards: development & functional abnormalities can occur Examples : ACE inhibitors- can cause hypoplasia of organs , specially lungs & kidneys. NSAIDs- may induce premature closure of ductus arteriosus . 41

HUMAN TERATOGENIC DRUGS:

HUMAN TERATOGENIC DRUGS THALIDOMIDE Causes phocomelia (seal like limbs) It was an effective tranquilizer and painkiller, and was proclaimed a "wonder drug" for insomnia, coughs, colds and headaches. It was also found to be an effective antiemetic that has an inhibitory effect on morning sickness , so thousands of pregnant women took the drug to relieve their symptoms. 42

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THALIDOMIDE DISASTER In the late 1950s and early 1960s, more than 10,000 children in 46 countries were born with deformities , known as phocomelia , as a consequence of thalidomide use. 43

Aspirin:

Aspirin It acts by inhibiting cox 1 & cox 2 enzyme and thus prevent production of prostaglandins . Chronic high exposure of pregnant women to aspirin has been associated with premature closure of ductus arteriosus 44

LITHIUM CARBONATE :

LITHIUM CARBONATE It was first associated with congenital malformations , heart and large vessel anomalies, Ebstein's anomaly , neural tube defects, talipes , microtia , and thyroid anomalies. 45

WARFARIN :

WARFARIN In-utero exposure is known to cause risk of nasal hypoplasia , calcific stiffing of secondary epiphysis , and central nervous system abnormalities in 10 to 25% of exposed infants. 46

TETRACYCLINE :

TETRACYCLINE Tetracyclines can readily cross the placenta and they have been shown to cause teeth discolouration , depression of skeletal bone growth and extremely high doses may result in hypoplasia of tooth enamel. 47

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ALCOHOL 48

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Alcohol drinking during pregnancy is associated with birth defects such as intrauterine growth retardation, microcephaly, cardiac abnormalities and maxillary hypoplasia Studies show that approximately one third of the children born to alcoholic mothers suffer from foetal alcohol syndrome and all affected children exhibit developmental delay . 49

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THANK YOU 50

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