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PROF jAZANUL aNWAR 1 ADVERSE DRUG REACTION (ADR) Prof Dr dr Jazanul Anwar SpFK Fakultas Kedokteran USU Dept Farmakologi dan Terapi BIOMEDIK.

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Presentasi berjudul: "PROF jAZANUL aNWAR 1 ADVERSE DRUG REACTION (ADR) Prof Dr dr Jazanul Anwar SpFK Fakultas Kedokteran USU Dept Farmakologi dan Terapi BIOMEDIK."— Transcript presentasi:

1 pROF jAZANUL aNWAR 1 ADVERSE DRUG REACTION (ADR) Prof Dr dr Jazanul Anwar SpFK Fakultas Kedokteran USU Dept Farmakologi dan Terapi BIOMEDIK

2 pROF jAZANUL aNWAR2 Kebanyakan obat membangkiitkanbanyak efek, biasanya hanya satu efek dimanfaatkan untuk efek terapi, efek yag dimanfaatkan untuk mengobati suatu gangguan kesehatan. Efek-efek lainnya bisa dianggap tak diinginkan baik yang meusak atau tidak. Umpamanya antihistaminika tertentu menyebabkan ngantuk atau hoyong Obat (O) + reseptor obat (R)  OR  stimulus  Efek Ox + R1  OR1  Efek1 Ox + R2  OR2  Efek2 Ox + R3  OR3  Efek 3 Efek utama : efek yang paling menonjol Efek samping

3 pROF jAZANUL aNWAR3 EFEK OBAT YANG TAK DIINGINKAN DAPAT DIPRAKIRAKAN Keracunan Teratogenik Karsinogenik TAK DAPAT DIPRAKIRAKAN Adverse drug reaction, Alergi

4 pROF jAZANUL aNWAR4 PENYEBAB KERACUNAN Overdosis

5 pROF jAZANUL aNWAR5 Kehebatan dan keparahan ADR Kematian Ancaman kehidupan Dirawat rumah sakit ( pemulaan atnau perpanjagan) Gangguan fungsi (permanan, sementara, Kelainana bawa lahir Bentuk ADR Efek farmakologi yang meningkat Alergi Efek khronik Efek tertunda Kegagalan pengobatanegagalan pengobatan

6 pROF jAZANUL aNWAR6 TAK DAPAT DIPRAKIRAKAN Rekasi alergi:hipersentivitas Antibodi Antigen Hapten: Obat + protein  alergen

7 pROF jAZANUL aNWAR7 Protein Antibodi Hapten + An-tigen + An Kompleks antigen-antibodi Merangsang sel dan jaringan Membebaskan mediator: histamin Manifestasi alergik

8 pROF jAZANUL aNWAR8 Mediator: Autakoid: Histamin Bradikinin Serotonin Prostaglandine

9 pROF jAZANUL aNWAR9 Idiosyncrasy Akut Subakut Khronis Serum sickness Bentuk alergi

10 pROF jAZANUL aNWAR10 GEJALA –GEJALA REAKSI ALERGI Kulit : Pruritus, urtikaria Dermatitis exfoliativa Selaput mukosa : Terut. Mata & hidung Keradangan hiperekskresi Saluran nafas : Susah bernafas Sistem vaskuler : Tekanan darah Darah & RES : Pengurangan jumlah sel darah

11 pROF jAZANUL aNWAR11 TERATOGENIK Pertumbuhan alat tubuh janin abnormal Mekanisme kerja ??? KARSINOGENIK Periode laten Karsinogen: radiasi, viruses, senyawa kimia

12 pROF jAZANUL aNWAR12 What is an Adverse Drug Reaction (ADR)? “an unwanted or harmful reaction experienced following the administration of a drug or combination of drugs under normal conditions of use and suspected to be related to the drug” Ref. MCA/CSM Suspected adverse drug reaction (ADR) reporting and the Yellow Card Scheme, Guidance notes

13 pROF jAZANUL aNWAR13  WHO –response to a drug that is noxious and unintended and that occurs at doses used in humans for prophylaxis, diagnosis, or therapy of disease, or for the modification of physiologic function Definition –excludes therapeutic failures, overdose, drug abuse, noncompliance, and medication errors

14 pROF jAZANUL aNWAR14 Examples of ADRs Common ADRs –Constipation with opioids –Sedation with antihistamines –Nausea when starting fluoxetine –Gastrointestinal upset with non steroidal anti-inflammatory drugs

15 pROF jAZANUL aNWAR15 Who is most at risk from ADRs? Patients who; are young, or old or female are taking multiple therapies –50% of patients on 5 drugs or more have more than one medical problem have a history of allergy or a previous reaction to drugs

16 pROF jAZANUL aNWAR16 Why are ADRs a problem?

17 pROF jAZANUL aNWAR17 Because…. they account for around 5% of hospital admissions they cause death in 1 in 1000 medical inpatients they complicate drug therapy they decrease compliance and delay cure

18 pROF jAZANUL aNWAR18 Are ADRs avoidable? 30-50% are preventable Obvious interactions –many drugs interact with warfarin Use of contra-indicated drugs –use of a non-selective beta-blocker in an asthmatic  bronchospasm Drug use in an inappropriate clinical indication or medically unnecessary –antibiotics for a viral infection –antibiotics for viral infections

19 pROF jAZANUL aNWAR19 How do I recognise ADRs?

20 pROF jAZANUL aNWAR20 What should raise my suspicion of an ADR? A symptom that appears soon after a new drug is started appears after a dosage increase disappears when the drug is stopped reappears when a drug is restarted (do not deliberately rechallenge!)

21 pROF jAZANUL aNWAR21 Who might get an ADR? Anyone who takes a medicine –Differential diagnosis should include the possibility of an ADR if the patient is taking any form of medication

22 pROF jAZANUL aNWAR22 What you might see if an ADR has occurred Lab results –liver function tests,  by statins and methotrexte –full blood count, deranged by carbimazole –biopsies, important for assessing liver dysfunction –chest X-rays, pulmonary fibrosis with pergolide

23 pROF jAZANUL aNWAR23 What you might see if an ADR has occurred Clinical measurements –BP,  by opiates –weight,  by carbamzepine, increased appetite –blood glucose,  by corticosteroids

24 pROF jAZANUL aNWAR24 How common are ADRs? Up to 40% patients in the community experience ADRs In the UK Non Steroidal Anti-Inflammatory Drug (NSAID) use alone accounts for 1 –65,000 emergency admissions/year –12,000 ulcer bleeding episodes/year –2,000 deaths/year 1 Blower et al. Emergency admissions for upper gastrointestinal disease and their relation to NSAID use. Aliment Pharmacol Ther 1997; 11:

25 pROF jAZANUL aNWAR25  Severity of reaction: Mild bothersome but requires no change in therapy Moderate requires change in therapy, additional treatment, hospitalization Severe disabling or life-threatening Classification - Severity

26 pROF jAZANUL aNWAR26  Types of allergic reactions Type I - immediate, anaphylactic (IgE) e.g., anaphylaxis with penicillins Type II - cytotoxic antibody (IgG, IgM) e.g., methyldopa and hemolytic anemia Type III - serum sickness (IgG, IgM) antigen-antibody complex e.g., procainamide-induced lupus Type IV - delayed hypersensitivity (T cell) e.g., contact dermatitis Classification

27 pROF jAZANUL aNWAR27 Classification - Type lHypersensitivity Life-threatening Cause disability Idiosyncratic Secondary to Drug interactions Unexpected detrimental effect Drug intolerance Any ADR with investigational drug Reportable

28 pROF jAZANUL aNWAR28 Antibiotics Antineoplastics* Anticoagulants Cardiovascular drugs* Hypoglycemics Antihypertensives NSAID/Analgesics Diagnostic agents CNS drugs* *account for 69% of fatal ADRs Common Causes of ADRs

29 pROF jAZANUL aNWAR29 Hematologic CNS Dermatologic/Allergic Metabolic Cardiovascular Gastrointestinal Renal/Genitourinary Respiratory Sensory Body Systems Commonly Involved

30 pROF jAZANUL aNWAR30 Interactions Before Administration Phenytoin precipitates in dextrose solutions (e.g. D5W) Amphotericin precipitates in saline Gentamicin is physically/chemically incompatible with most beta-lactams, resulting in loss of antibiotic effect

31 pROF jAZANUL aNWAR31 Interactions Before Administration Phenytoin precipitates in dextrose solutions (e.g. D5W) Amphotericin precipitates in saline Gentamicin is physically/chemically incompatible with most beta-lactams, resulting in loss of antibiotic effect

32 pROF jAZANUL aNWAR32 In the GI Tract Sucralfate, some milk products, antacids, and oral iron preparations Omeprazole, lansoprazole, H2-antagonists Pharmacodynamic interactions –Target organ Didanosine (given as a buffered tablet) Cholestyramine Block absorption of quinolones, tetracycline, and azithromycin Reduce absorption of ketoconazole, delavirdine Reduces ketoconazole absorption Binds raloxifene, thyroid hormone, and digoxin

33 pROF jAZANUL aNWAR33 Interactions in the Serum Protein “bumping” interactions in the serum are a test-tube phenomenon without clinical relevance

34 pROF jAZANUL aNWAR34 Spectrum of Consequences of Drug Metabolism Inactive products Active metabolites Similar to parent drug More active than parent New action Toxic metabolites

35 pROF jAZANUL aNWAR35 Microsomal Enzymes Cytochrome P450 Flavin mono-oxygenase (FMO3)

36 pROF jAZANUL aNWAR36 Liver disease Renal disease Cardiac disease ( hepatic blood flow) Acute myocardial infarction? Acute viral infection? Hypothyroidism or hyperthyroidism? Drug-Disease Interactions

37 pROF jAZANUL aNWAR37 Drug-Food Interactions Tetracycline and milk products Warfarin and vitamin K-containing foods Grapefruit juice

38 pROF jAZANUL aNWAR38 Some Serious Adverse Drug Reactions Nonsteroidal antiinflammatory AspirinAspirin drugs Ibuprofen Ketoprofen NaproxenIbuprofenKetoprofenNaproxen Anticoagulants Heparin WarfarinWarfarin Adverse Drug Reaction Types of Drugs Examples Peptic ulcers or bleeding Corticosteroids taken by Hydrocortisone stomach mouth from the or by injection (not those applied to the skin or lotions in creams) PrednisoneHydrocortisonePrednisone

39 pROF jAZANUL aNWAR39 Anemia (resulting from Certain antibiotics Chlorampheni a decreased production or increased destruction of red blood cells)Chlorampheni Some nonsteroidal anti- Phenylbutazone inflammatory drugs Antimalarial and Chloroquine antituberculous drugs Isoniazid in people with Primaquine enzyme deficiency ChloroquineIsoniazid Adverse Drug Reaction Types of Drugs Examples

40 pROF jAZANUL aNWAR40 Liver damage Some analgesics Acetaminophen (use of excessive doses)Acetaminophen Kidney damage Nonsteroidal anti-Ibuprofen inflammatory drug Ketoprofen (repeated use of Naproxen excessive doses)IbuprofenKetoprofenNaproxen Aminoglycoside Kanamycin antibioticsGentamicin CisplatinKanamycinGentamicin Cisplatin Confusion and Sedatives, Diphenhydramine drowsiness many antihistaminesDiphenhydramine Antidepressants Amitriptyline (especially in older people) Imipramine AmitriptylineImipramine Adverse Drug Reaction Types of Drugs Examples


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