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ADVERSE DRUG EVENTS Géza T. Terézhalmy, D.D.S., M.A. Professor and Dean Emeritus School of Dental Medicine Case Western Reserve University Cleveland, Ohio
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7/21/2021 Terezhalmy 2 Adverse Drug Events Clinicians and patients both acknowledge the major role played by drugs in modern health care
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7/21/2021 Terezhalmy 3 Adverse Drug Events
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7/21/2021 Terezhalmy 4 Adverse Drug Events There are no “absolutely” safe biologically active therapeutic agents
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7/21/2021 Terezhalmy 5 Adverse Drug Events Therapeutic agents seldom exert their beneficial effects without also causing adverse drug events
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7/21/2021 Terezhalmy 6 Adverse Drug Events OHCP should be aware of the spectrum of drug-induced events and should be actively involved both in monitoring for and reporting such events
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7/21/2021 Terezhalmy 7 Adverse Drug Events Etiology and epidemiology 75 % of office visits to general medical practitioners and internists are associated with the initiation or continuation of pharmacotherapy 3 to 11 % of hospital admissions are attributed to adverse drug events 0.3 to 44 % of hospitalizations are complicated by adverse drug events
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7/21/2021 Terezhalmy 8 Adverse Drug Events Etiology and epidemiology The FDA has the most rigorous approval requirements in the world Clinical trials cannot and are not expected to uncover every potential adverse drug event Pre-marketing study populations generally include 3,000 to 4,000 subjects Only adverse events, which occur more frequently than 1 in 1,000 will be observed Detecting an adverse event with a incidence of 1 in 10,000 would require a study population of 30,000
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7/21/2021 Terezhalmy 9 Adverse Drug Events Etiology and epidemiology Classification of adverse drug events Type A reactions Associated with the administration of therapeutic dosages of a drug (exception: drug overdose) Usually predictable and avoidable Responsible for most adverse drug events Overdose Cytotoxic reactions Drug-drug interactions Drug-food interactions Drug-disease interactions
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7/21/2021 Terezhalmy 10 Adverse Drug Events Etiology and epidemiology Classification of adverse drug events Type B reactions Generally independent of dose Rarely predictable or avoidable While they are uncommon, they are often among the most serious and potentially life threatening Idiosyncratic reactions Immunologic/allergic reactions Pseudo-allergic reactions Teratogenic effects Oncogenic effects
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7/21/2021 Terezhalmy 11 Adverse Drug EventsType A Reactions Etiology and epidemiology Cytotoxic effects Formation of unstable or reactive metabolites related to some abnormality that interferes with normal metabolism and/or excretion of a drug Two mechanisms Oxidative pathway: the formation of electrophilic compounds, which bind covalently with cellular macromolecules Reductive pathway: gives rise to intermediate compounds with an excess of electrons, which interact with O2 to produce free radicals
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7/21/2021 Terezhalmy 12 Adverse Drug EventsType A Reactions Etiology and epidemiology Drug-drug interactions Two or more drugs administered at the same time or in close sequence May act independently May interact to  or  the magnitude or duration of action of one or more of the drugs May interact to cause an unintended reaction Drug-drug interactions all seem to have either a pharmacodynamic or a pharmacokinetic basis
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7/21/2021 Terezhalmy 13 Adverse Drug EventsType A Reactions Etiology and epidemiology Drug-drug interactions Pharmacodynamic mechanisms The intended or expected effect produced by a given plasma level of drug A is altered in the presence of drug B Pharmacological drug-drug interactions Physiological drug-drug interactions Chemical drug-drug interactions Drug-related receptor alterations
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7/21/2021 Terezhalmy 14 Adverse Drug EventsType A Reactions Etiology and epidemiology Drug-drug interactions Pharmacodynamic mechanisms Pharmacological drug-drug interactions Drug A and drug B compete for the same receptor site and as a function of their respective concentrations either produce (an agonist) or prevent (an antagonist) an effect respectively opioids vs. naloxone acetylcholine vs. atropine epinephrine vs. adrenergic receptor blocking agents
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7/21/2021 Terezhalmy 15 Adverse Drug EventsType A Reactions Etiology and epidemiology Drug-drug interactions Pharmacodynamic mechanisms Physiological interactions Drug A and drug B interact with different receptor sites and either enhance each other’s action or produce an opposing effect via different cellular mechanisms cholinergic agents vs diazepam epinephrine vs. lidocaine epinephrine vs. histamine
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7/21/2021 Terezhalmy 16 Adverse Drug EventsType A Reactions Etiology and epidemiology Drug-drug interactions Pharmacodynamic mechanisms Chemical interactions Drug A interacts with drug B and prevents drug B from interacting with its intended receptor protamine sulfate vs. heparin
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7/21/2021 Terezhalmy 17 Adverse Drug EventsType A Reactions Etiology and epidemiology Drug-drug interactions Pharmacodynamic mechanisms Drug-related receptor alterations Drug A, when administered chronically, may either  or  the number of its own receptors or alter the adaptability of its receptors to physiological events alpha1-adrenergic receptor agonists down-regulate their own receptors beta1-adrenergic receptor antagonists up-regulate their own receptors
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7/21/2021 Terezhalmy 18 Adverse Drug EventsType A Reactions Etiology and epidemiology Drug-drug interactions Pharmacokinetic mechanisms Following concomitant administration, drug A may  or  the plasma level of drug B Interactions affecting absorption Interactions affecting distribution Interactions affecting metabolism Interactions affecting renal excretion Interactions affecting biliary excretion
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7/21/2021 Terezhalmy 19 Adverse Drug EventsType A Reactions Etiology and epidemiology Drug-drug interactions Pharmacokinetic mechanisms Interactions affecting absorption Drug A, by causing vasoconstriction, interferes with the systemic absorption of drug B epinephrine  the systemic absorption of lidocaine Drug A, by forming a complex with drug B, interferes with the systemic absorption of drug B calcium  the systemic absorption of tetracycline
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7/21/2021 Terezhalmy 20 Adverse Drug EventsType A Reactions Etiology and epidemiology Drug-drug interactions Pharmacokinetic mechanisms Interactions affecting absorption Drug A, by delaying gastric emptying, delays the systemic absorption of drug B, which is absorbed primarily in the small intestine opioids delay the absorption of acetaminophen Drug A, by elevating gastric pH, prevents the absorption of drug B (weak acids) antacids  absorption of acetylsalicylic acid
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7/21/2021 Terezhalmy 21 Adverse Drug EventsType A Reactions Etiology and epidemiology Drug-drug interactions Pharmacokinetic mechanisms Interactions affecting distribution Drug A ( a weak acid), by competing for plasma protein binding with drug B,  the plasma level of drug B acetylsalicylic acid  the plasma level of many drugs
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7/21/2021 Terezhalmy 22 Adverse Drug EventsType A Reactions Etiology and epidemiology Drug-drug interactions Pharmacokinetic mechanisms Interactions affecting metabolism Drug A, by  or  hepatic microsomal enzyme activity responsible for the metabolism of drug B,  or  plasma level of drug B respectively H2-receptor antagonists  the plasma level of many drugs macrolides, azole antifungal agents, ethanol (chronic use)  plasma level of many drugs
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7/21/2021 Terezhalmy 23 Adverse Drug EventsType A Reactions Etiology and epidemiology Drug-drug interactions Pharmacokinetic mechanisms Interactions affecting metabolism Drug A, by  hepatic non-microsomal enzyme activity responsible for the metabolism of drug B,  the plasma level of drug B MAO-inhibitors  the plasma level of benzodiazepines
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7/21/2021 Terezhalmy 24 Adverse Drug EventsType A Reactions Etiology and epidemiology Drug-drug interactions Pharmacokinetic mechanisms Interactions affecting metabolism Drug A, by inhibiting the enzyme acetaldehyde dehydrogenize, interferes with the further metabolism of intermediate metabolites (oxidation products) of drug B disulfuram and metronidazole interfere with the metabolism of ethanol
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7/21/2021 Terezhalmy 25 Adverse Drug EventsType A Reactions Etiology and epidemiology Drug-drug interactions Pharmacokinetic mechanisms Interactions affecting renal excretion Drug A, which competes with drug B for the same excretory transport mechanisms in the proximal tubules,  the plasma level of drug B acetylsalicylic acid and probenecid  the plasma level of penicillin and other weak acids
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7/21/2021 Terezhalmy 26 Adverse Drug EventsType A Reactions Etiology and epidemiology Drug-drug interactions Pharmacokinetic mechanisms Interactions affecting renal excretion Drug A, by alkalizing the urine,  the plasma level of drug B sodium bicarbonate  the plasma level of weak acids Drug A, by acidifying the urine,  the plasma level of drug B ammonium chloride  the plasma level of weak bases
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7/21/2021 Terezhalmy 27 Adverse Drug EventsType A Reactions Etiology and epidemiology Drug-drug interactions Pharmacokinetic mechanisms Interactions affecting biliary excretion Drug A, by increasing bile flow and the synthesis of proteins, which function in biliary conjugation mechanisms,  the plasma level of drug B Phenobarbital  the plasma level of many drugs Drug A binds drug B, which undergoes extensive hepatic recirculation,  the plasma level of drug B activated charcoal and cholestyramine  the plasma level of many drugs
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7/21/2021 Terezhalmy 28 Adverse Drug EventsType A Reactions Etiology and epidemiology Drug-food interactions Most known drug-food interactions appear to be associated with pharmacokinetic mechanisms Interactions affecting absorption Nutrients may act as a mechanical barrier that prevents drug access to mucosal surfaces and  the rate of absorption of some drugs Nutrients with high fatty acid content may actually  the rate of absorption of drugs with high lipid solubility
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7/21/2021 Terezhalmy 29 Adverse Drug EventsType A Reactions Etiology and epidemiology Drug-food interactions Interactions affecting absorption Chemical interactions between a drug and food component can result in the formation of inactive complexes and  the absorption of the drug calcium  the absorption of tetracyclines ferrous or ferric salts  the absorption of tetracyclines and fluoroquinolones zinc  the absorption of fluoroquinolones
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7/21/2021 Terezhalmy 30 Adverse Drug EventsType A Reactions Etiology and epidemiology Drug-food interactions Interactions affecting metabolism Components of some nutrients can inhibit CYP450 isoenzymes and  the metabolism of some drugs grapefruit juice  the metabolism of warfarin, benzodiazepines, and calcium-channel blocking agents
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7/21/2021 Terezhalmy 31 Adverse Drug EventsType A Reactions Etiology and epidemiology Drug-disease interactions A drug prescribed for the treatment of one disease can adversely affect a different condition that has been generally well controlled Pharmacodynamic mechanisms Pharmacokinetic mechanisms
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7/21/2021 Terezhalmy 32 Adverse Drug EventsType A Reactions Etiology and epidemiology Drug-disease interactions Pharmacodynamic mechanisms Non-selective beta1-adrenergic receptor antagonists, prescribed for the treatment of chronic stable angina, hypertension, or cardiac arrhythmia can increase airway resistance by interacting with beta2-adrenergic receptors induce asthma in susceptible patients
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7/21/2021 Terezhalmy 33 Adverse Drug EventsType A Reactions Etiology and epidemiology Drug-disease interactions Pharmacodynamic mechanisms Beta1-adrenergic receptor antagonists and calcium-channel blocking agents prescribed for the treatment of chronic stable angina, hypertension, or cardiac arrhythmia interacting with their own receptors precipitate cardiac complications secondary to negative inotropism (decreased contractility), decreased nodal conductance, and peripheral vasodilatation (cardiac steal syndrome) in susceptible patients
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7/21/2021 Terezhalmy 34 Adverse Drug EventsType A Reactions Etiology and epidemiology Drug-disease interactions Pharmacodynamic mechanisms Beta1-adrenergic receptor antagonists can adversely affect carbohydrate metabolism and inhibit epinephrine-mediated hyperglycemic response to insulin Increase the risk of hypoglycemia and mask some of its clinical manifestations in diabetic patients
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7/21/2021 Terezhalmy 35 Adverse Drug EventsType A Reactions Etiology and epidemiology Drug-disease interactions Pharmacodynamic mechanisms COX-1 inhibitors block cyclooxygenase-dependent prostaglandin and thrombaxane A2 synthesis Exacerbate peptic ulcer disease and gastroesophageal reflux disease in susceptible patients
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7/21/2021 Terezhalmy 36 Adverse Drug EventsType A Reactions Etiology and epidemiology Drug-disease interactions Pharmacodynamic mechanisms Hypothyroidism  sensitivity to CNS depressants in susceptible patients Hyperthyroidism  susceptibility to epinephrine-induced hypertension and cardiac arrhythmia
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7/21/2021 Terezhalmy 37 Adverse Drug EventsType A Reactions Etiology and epidemiology Drug-disease interactions Pharmacokinetic mechanisms Cardiac dysfunction  metabolism and excretion of drugs Hepatic dysfunction  metabolism and biliary and renal excretion of drugs Renal dysfunction  hepatic metabolism and renal excretion of drugs
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7/21/2021 Terezhalmy 38 Adverse Drug EventsType B Reactions Etiology and epidemiology Idiosyncratic reactions Drug metabolism is largely dominated by oxidation reactions catalyzed by the cytochrome P450 enzyme system Genetic polymorphism is the primary factor responsible for inter-individual variability in response to drugs Therapeutic consequences intrinsic characteristics of the drug importance of the deficient metabolic pathway existence of alternative pathways
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7/21/2021 Terezhalmy 39 Adverse Drug EventsType B Reactions Etiology and epidemiology Allergic/immune reactions In susceptible patients alkylation and/or oxidation of cellular macromolecules by drug metabolites can lead to the production of immunogens Not related to the dose administered Specificity to a given agent Transferability by antibodies or lymphocytes Recurrence when re-exposure to the offending drug occurs Most reactions occur in young or middle aged adults Drug allergy is twice a frequent in women than in man
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7/21/2021 Terezhalmy 40 Adverse Drug EventsType B Reactions Etiology and epidemiology Allergic/immune reactions Type I (immediate) hypersensitivity
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7/21/2021 Terezhalmy 41 Adverse Drug EventsType B Reactions Etiology and epidemiology Allergic/immune reactions Type II (cytotoxic) hypersensitivity
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7/21/2021 Terezhalmy 42 Adverse Drug EventsType B Reactions Etiology and epidemiology Allergic/immune reactions Type III (immune-complex) hypersensitivity
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7/21/2021 Terezhalmy 43 Adverse Drug EventsType B Reactions Etiology and epidemiology Allergic/immune reactions Type IV (delayed) hypersensitivity
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7/21/2021 Terezhalmy 44 Adverse Drug EventsType B Reactions Etiology and epidemiology Pseudoallergic reactions Cannot be explained on an immunologic basis Occur in patients who had no prior exposure to the drug Certain medications directly activate mast cells through non-IgE-receptor pathways and initiate the release of bioactive substances Other medications block the degradation of bioactive substances Still other medications, by inhibiting the action of cyclooxygenase activity,  synthesis of lipoxygenase-dependent leukotrienes
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7/21/2021 Terezhalmy 45 Adverse Drug EventsType B Reactions Etiology and epidemiology Teratogenic/developmental effects Teratogens are substances capable of causing physical or functional defects in the fetus in the absence of toxic effects in the mother Teratogenic effects depend on the accumulation of a drug or its metabolite in the fetus at critical time periods 3rd to 12th week of gestation
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7/21/2021 Terezhalmy 46 Adverse Drug EventsType B Reactions Etiology and epidemiology Oncogenic effects Primary oncogenic effects Produced by certain procarcinogenic drugs, which have been converted into carcinogens by polymorphic oxidative reactions Reactive metabolites bind covalently to DNA Secondary oncogenic effects Therapeutic immunosuppression in the presence of infection with oncogenic viruses HBV, HCV, CMV, HSV, HPV, and EMV Pattern of cancer is different than in the general population
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7/21/2021 Terezhalmy 47 Adverse Drug Events
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7/21/2021 Terezhalmy 48 Adverse Drug Events Clinical manifestations Type A reactions Primary (direct effects) or secondary (indirect effects) Dose dependent Exaggerations of direct effects Multiple concurrent “side “ effects Type B reactions Primary (direct effects) or secondary (indirect effects) Generally independent of the dose
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7/21/2021 Terezhalmy 49 Adverse Drug EventsType A Reactions Clinical manifestations Cytotoxic reactions
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7/21/2021 Terezhalmy 50 Adverse Drug EventsType A: Cytotoxic Reactions
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7/21/2021 Terezhalmy 51 Adverse Drug EventsType A: Cytotoxic Reactions
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7/21/2021 Terezhalmy 52 Adverse Drug EventsType A Reactions Clinical manifestations Gastrointestinal disturbances Nausea and vomiting Vomiting center Chemoreceptor trigger zone Pharynx Gastrointestinal tract Cerebral cortex (emotion, olfaction, visual stimuli) Stimulation of the vestibular apparatus opioid-, dopaminergic (D2)-, histaminic (H1)-, muscarinic-, and serotonengic (5-HT3)-receptor agonists
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7/21/2021 Terezhalmy 53 Adverse Drug EventsType A Reactions Clinical manifestations Gastrointestinal disturbances Constipation Diet, functional abnormalities, colonic disease, rectal problems, neurological disease, metabolic disorders, drugs anticholinergic agents, antihistamines, antidepressants, anticonvulsants, antiparkinsonian drugs, opioid analgesics, antacids
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7/21/2021 Terezhalmy 54 Adverse Drug EventsType A Reactions Clinical manifestations Gastrointestinal disturbances Diarrhea Chronic Functional abnormalities, colonic disease, neurological disease, and metabolic disorders Acute Osmotic changes when poorly absorbable solutes are present in the intestine Inhibition of ion transport or stimulation of ion secretion Toxins, infection (viral, bacterial), drugs cholinergic agents, antibacterial agents
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7/21/2021 Terezhalmy 55 Adverse Drug EventsType A Reactions Clinical manifestations Urinary incontinence Increased urinary flow diuretics, cholinergic agents Overflow secondary to urinary retention anticholinergic agents, adrenergic agonists Increased ADH release Painful stimuli, fear, anger, drugs opioid analgesics Decrease ADH release alcohol
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7/21/2021 Terezhalmy 56 Adverse Drug EventsType A Reactions Clinical manifestations Mood alterations Depression beta1-adrenergic blocking agents, cardiac glycosides, benzodiazepines, phenothiazines, corticosteroids, Delirium (acute confusional states) drugs with anticholinergic properties, cardiac glycosides, opioid analgesics, benzodiazepines, other CNS depressants
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7/21/2021 Terezhalmy 57 Adverse Drug EventsType A Reactions Clinical manifestations Cardiac dysfunction Orthostatic hypotension antihypertensive agents (reduce BP), psychotropic drugs (impair autonomic reflexes) Arrhythmia cardiac glycosides, macrolides, calcium-channel blocking agents, azoles (antifungal agents), protease inhibitors
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7/21/2021 Terezhalmy 58 Adverse Drug EventsType A Reactions Clinical manifestations Equilibrium problems Increased risk of falls (patients with decreased vision, impaired mobility and cognition, postural hypotension, peripheral neuropathy) drugs that impair autonomic reflexes (benzodiazepines, alcohol)
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7/21/2021 Terezhalmy 59 Adverse Drug EventsType A Reactions Clinical manifestations Xerostomia Diuretics Drugs with anticholinergic activity antihistamines, psychotropic drugs, CNS stimulants, antineoplastic agents
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7/21/2021 Terezhalmy 60 Adverse Drug EventsType A Reactions: Xerostomia
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7/21/2021 Terezhalmy 61 Adverse Drug EventsType A Reactions Clinical manifestations Mucositis Drugs that arrest the growth and maturation of normal cells antineoplastic agents
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7/21/2021 Terezhalmy 62 Adverse Drug EventsType A Reactions Clinical manifestations Bleeding diatheses Drugs that interfere with platelet function and the coagulation phase of hemostasis COX-1 inhibitors clopedigrol, warfarin, heparin
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7/21/2021 Terezhalmy 63 Adverse Drug EventsType A Reactions: Bleeding Diatheses
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7/21/2021 Terezhalmy 64 Adverse Drug EventsType A Reactions Clinical manifestations Bacterial infections Drugs that alter the normal flora antibacterial agents Drugs that cause immuno-suppression immuno-suppressants
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7/21/2021 Terezhalmy 65 Adverse Drug EventsType A Reactions Clinical manifestations Fungal infections Drugs that alter the normal flora antibacterial agents Drugs that cause immuno-suppression immuno-suppressants
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7/21/2021 Terezhalmy 66 Adverse Drug EventsType A Reactions Clinical manifestations Viral infections Drugs that cause immuno-suppression immuno-suppressants
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7/21/2021 Terezhalmy 67 Adverse Drug EventsType A Reactions: Viral Infections
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7/21/2021 Terezhalmy 68 Adverse Drug EventsType A Reactions Clinical manifestations Gingival hyperplasia phenytoin, calcium-channel blocking agents, cyclosporine
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7/21/2021 Terezhalmy 69 Adverse Drug EventsType A Reactions Clinical manifestations Neurological complications Oral pain drugs that cause mucositis and/or immuno-suppression certain antineoplastic agents (vincristine) Tardive dyskinesia neuroleptic agents, which alter striatal dopaminergic receptor activity Taste alterations drugs that affect trace metal homeostasis
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7/21/2021 Terezhalmy 70 Adverse Drug EventsType A Reactions Clinical manifestations Inadequate nutrition drugs that produce nausea, vomiting, diarrhea drugs that produce mucositis, xerostomia, drugs that are hepatotoxic
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7/21/2021 Terezhalmy 71 Adverse Drug EventsType B Reactions Clinical manifestations Idiosyncratic reactions An unusual reaction of any intensity observed in a small number of patients Hypo-reactive patient The drug produces its usual effect at an unexpectedly high dose Hyper-reactive patient The drug produces its usual effect at an unexpectedly low dose
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7/21/2021 Terezhalmy 72 Adverse Drug EventsType B Reactions Clinical manifestations Allergic/ immunologic reactions Type I (immediate) hypersensitivity reaction
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7/21/2021 Terezhalmy 73 Adverse Drug EventsType B Reactions Clinical manifestations Allergic/ immunologic reactions Type II (cytotoxic) hypersensitivity reaction
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7/21/2021 Terezhalmy 74 Adverse Drug EventsType B Reactions Clinical manifestations Allergic/ immunologic reactions Type III (immune-complex) hypersensitivity reaction
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7/21/2021 Terezhalmy 75 Adverse Drug EventsType B Reactions Clinical manifestations Allergic/ immunologic reactions Type IV (delayed) hypersensitivity reaction
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7/21/2021 Terezhalmy 76 Adverse Drug EventsType B Reactions Clinical manifestations Lichenoid mucositis diuretics beta1-adrenergic antagonists ACE-inhibitors COX-1 inhibitors
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7/21/2021 Terezhalmy 77 Adverse Drug EventsType B Reactions Clinical manifestations Erythema multiforme Stevens-Johnson syndrome sulfonamides anticonvulsive agents COX-1 inhibitors
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7/21/2021 Terezhalmy 78 Adverse Drug EventsType B Reactions: SJS
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7/21/2021 Terezhalmy 79 Adverse Drug EventsType B Reactions Clinical manifestations Teratogenic effect Drugs given during pregnancy can affect the fetus by producing lethal, toxic, or teratogenic effect Constricting placental vessels Impairing gas and nutrient exchange between fetus and mother Producing hypertonia resulting in anoxic injury Indirectly, changing the biochemical dynamics of the mother
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7/21/2021 Terezhalmy 80 Adverse Drug EventsType B Reactions Clinical manifestations Teratogenic effect Fetal age, drug potency, and dosage < 20 days after fertilization An all-or-nothing effect 2nd to 3rd trimesters Unlikely to be teratogenic Alter growth and function of normally formed fetal organs and tissues
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7/21/2021 Terezhalmy 81 Adverse Drug EventsType B Reactions Clinical manifestations Teratogenic effect 3rd to 8th week No measurable effect Spontaneous abortion Sublethal True teratogenic effect
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7/21/2021 Terezhalmy 82 Adverse Drug EventsType B Reactions: Teratogenic Effects
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7/21/2021 Terezhalmy 83 Adverse Drug EventsType B Reactions Clinical manifestations Oncogenic effects SCC of the skin SCC of the lips 7 to 8.1 % vs. 0.3 % Average age 42 years vs. 60 years Latency 5.3 years
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7/21/2021 Terezhalmy 84 Adverse Drug EventsType B Reactions Clinical manifestations Oncogenic effects Kaposi sarcoma 5.6 % vs. 0.03-0.07 % 60 % non-visceral Skin Oral ( 2 %) Visceral Skin (24 %) Oral 3 %
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7/21/2021 Terezhalmy 85 Adverse Drug EventsType B Reactions Clinical manifestations Oncogenic effects Lympho-proliferative disease Lymphomas Leiomyoma Leiomyosarcoma Spindle-cell sarcoma
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7/21/2021 Terezhalmy 86 Adverse Drug Events Preventing adverse drug events Rational approach to the pharmacological management of oral/odontogenic disease Accurate diagnosis Critical assessment of the need for pharmacotherapy Benefits versus risks of drug therapy Individualization of drug therapy Patient education Continuous reassessment of drug therapy
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7/21/2021 Terezhalmy 87 Adverse Drug Events Diagnosing adverse drug events Step 1 Identify the drug(s) taken by the patient Step 2 Verify that the onset of signs and symptoms was after the initiation of pharmacological intervention Step 3 Determine the time interval between the initiation of drug therapy and the onset of the adverse drug event
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7/21/2021 Terezhalmy 88 Adverse Drug Events Diagnosing adverse drug events Step 4 Stop drug therapy and monitor the patient’s status Step 5 If appropriate, restart drug therapy and monitor for recurrence of adverse drug event
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7/21/2021 Terezhalmy 89 Adverse Drug Events Reporting adverse drug events An event is serious and should be reported when the patient outcome is Death Life-threatening Hospitalization Disability Congenital anomaly Requires intervention to prevent permanent impairment or damage
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7/21/2021 Terezhalmy 90 Adverse Drug Events Reporting adverse drug events FDA Form 3500 http://www.fda.gov/medwatch/report/hcp.htm Complete the voluntary form 3500 online Download a copy of the form Fax it to 1-800-FDA-0178 OR Mail it back using the postage-paid addressed form Call 1-800-FDA-1088 to report by telephone
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7/21/2021 Terezhalmy 91 Adverse Drug Events Conclusion ADEs evolve through the same physiological and pathological pathways as normal disease Prerequisites to consider ADEs in the differential diagnosis An awareness that an ever increasing number of patients are taking more and more medications (polypharmacy) Recognition that many drugs will remain in the body for weeks after therapy is discontinued Clinical experience Familiarity with relevant literature about ADEs
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7/21/2021 Terezhalmy 92 Adverse Drug Events Conclusion Recognize that some ADEs occur rarely and detection based on clinical experience or reports in the medical literature at time is difficult if not impossible
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7/21/2021 Terezhalmy 93 Adverse Drug Events Conclusion Timely reporting of ADEs Saves lives Reduces morbidity Decrease the cost of health care
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7/21/2021 Terezhalmy 94 Adverse Drug Events
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7/21/2021 Terezhalmy 95 Adverse Drug Events
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7/21/2021 Terezhalmy 96 Adverse Drug Events