Adverse Rxns/Medication errors
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| Adverse events = ADE, includes (2) | *adverse drug reactions (ADR)
*medication errors (ME)
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| ADR definition-WHO | noxious, unintended and undesired effect that occurs at normal drug dosages
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| ADR definition-FDA | includes unproven association with drug, drug interactions and overdosage
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| Adverse Drug Reactions - first four | *side effect
*toxicity
*allergic reaction
*idiosyncratic effect
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| Adverse drug reactions - second 4 | *iatrogenic disease
*physical dependence
*carcinogenic effect
*teratogenic effect
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| Side effect definition | nearly unavoidable secondary effect of a drug at a therapeutic dose
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| Side effect properties -3 | *usually predictable, time frame varies
*known effects that simply accompany intended beneficial effect
*intensity is usually dose dependent (exception - allergic rxn)
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| Toxicity definition | can overlap with side effects. ADR caused by excessive dose.
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| Everyday toxicity definition | toxicity has come to mean a severe ADR regardless of dose that produced it (OD not required)
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| allergic reaction definition | immunologic reaction mediated by antibody produced by body, interacting with exposure to antigen (drug) to start immunologic cascade (cytokines, etc)
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| 3 properties of allergic reaction | *requires prior expose to drug Ag - first exposure does NOT cause rxn
*subsequent exposure may be associated with rxn
*intensity essentially independent of dosage
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| Idiosyncratic effect definition | uncommon drug response from a genetic predisposition
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| 2 examples of idiosyncratic effect | *succinylcholine
*Isoniazid (INH) metabolized by acetylation - some are fast/slow acetylators
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| Iatrogenic disease definition | disease produced by physician, therapy or tx
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| example of iatrogenic disease | admin antipsychotic --> Parkinsons symptoms. Given to a Parkinson's pt would worsen their s/s and iatrogenic seems appropriate
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| physical dependence definition | expected consequence of long term use of some drugs -->neurophysiological adaption that occurs on abrupt d/c, decreased dose, or use of antagonist
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| physical dependence drug examples | *opioids, ETOH, barbiturates, amphetamines
*TCAs, steroids, BNZs
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| Physical dependence does NOT | predict/indicate addiction, predict abuse
*warning to pt appropriate
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| addiction definition | inappropriate use of drug
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| addiction maladaptive behaviors -3 | *loss of control of use
*preoccupation with use despite relief
*continuation of use despite adverse consequences
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| abuse indication | use other than intended, use that may cause harm
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| pseudoaddiction definition | perception on part of caretaker of apparent 'drug seeking' behavior
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| pseudoaddiction - real problem | inadequate pain relief. preoccupation is really with pain relief
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| how to distinguish psuedoaddiction from true addiction | drug seeking behavior stops with pain relief
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| carcinogenic effect agents | chemicals, env pollutants, some drugs (mostly chemo drugs)
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| example of carcinogenic drug | cyclophosphamide - bladder ca, leukemia develops years later
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| example of carcinogenic drug | DES --> vag/ut ca in female & offspring
DES--> testicular ca in male & offspring
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| teratogenic effects | chemicals causing birth defects
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| organ-specific toxicity | many drugs predictably cause ADR or SE involving specific organs based upon cumulative experience
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| hepatotoxicity | based upon its metabolic roles
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| nephrotoxicity | based upon its excretory role
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| cardiac toxicity example | QT prolongation predisposition to torsade de pointes --> vent fib
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| bone marrow toxicity mechanism | effects production of formed elements of blood
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| examples of bone marrow toxicity | *anemia
*thrombocytopenia
*granulocytopenia
*pancytopenia
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| example of dermatological toxicity | rashes
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| example of nervous system toxicity | *CNS: sedation, psychiatric
*PNS: neuropathies
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| Identification of ADR factors 1-4 | *cause may not be obvious
*other drugs
*u/l disease
*preexisting organ dysfunction
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| identification of ADR factors 5-8 | *time relationship (start, stop, rechallenge)
*is ADR compatible with known patterns of suspected drug
*another more likely explnation?
*more sophisticated models for attribution of given ADR to drug
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| Prevention of ADR -3 | *know ADR assoc with every drug admin
*know pt hx - u/l disease, conditions, organ dysfunction, allergy, intolerance
*educate pt s/s of ADRs
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| ADR reporting | *esp imp in new drugs
*report severe & clusters of ADRs
*report via FDA's medwatch
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| 90% of all fatal med errors from | *human factors
*communication
*name confusion
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| other sources of med errors | packaging, labeling
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| Types of med errors 'wrong . . . ' | *pt
*drug, route, dose (hi/low/missed/extra)
*dose form
*diluent, stength/conc
*infusion rate
technique (crushing SR)
*duraton (too long/short)
*expired drug
*see table 7-3
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| Sources of human factors | 30% = performance
14% = knowledge deficits
13% = miscalculation
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| Sources of communication errors (16%) | *illegibility
*abbreviations
*incorrect decimal point
*verbally misunderstanding
*LASA
*packaging/labeling
*see table 7-4
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| RMSPH | Regional Medication Safety Program for Hospitals, table 7-6
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| NCC MERP | National Coordinating Council for Medication Error Reporting & Prevention
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| ISMP | Institute for Safe Medicaton Practices
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| FDA | medwatch program
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| Med Error reporting system originated by | USP + ISMP
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| Med error reporting system now conducted solely by | ISMP
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