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