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74 Cards in this Set
- Front
- Back
Generic Name: rosiglitazone (row zi GLI ta zone)
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Brand Names: Avandia
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Acetaminophen/Hydrocodone (
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Vicodin,Lortab)
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Top drugs associated with increased death
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1) Rosiglitazone 2)Acetaminophen/Hydrocodone (Vicodin,Lortab)
3)Digoxin 4) Oxycodone 5)Fentanyl 6)Ibandronate 7)Acetaminophen |
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Generic Name: venlafaxine (VEN la fax een)
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Brand Names: Effexor, Effexor XR
Venlafaxine is an antidepressant in a group of drugs called selective serotonin and norepinephrine reuptake inhibitors (SSNRIs). |
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Generic Name: mirtazapine (mir TAZ a peen)
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Brand Names: Remeron, Remeron SolTab
an antidepressant |
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Generic Name: tramadol (TRAM a dol)
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Brand names: Rybix ODT, Ryzolt, Ultram, Ultram ER
Tramadol is a narcotic-like pain reliever |
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What is an adverse drug effect (ADE)
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Any unfavorable event associated with the use of a medication
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What are the two types of ADEs
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Medication Errors and ADRs
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What are the types of medication errors
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Prescribing, Dispensing, Administering, Monitoring
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What is an Adverse Drug Reaction (ADR)
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“Injury†resulting from the medical use of a drug where no error is involved; adverse event with a causal link to a drug
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What are the 5 catefories of ADEs
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1) Adverse drug reactions2) Medication errors3) Therapeutic failures4) Adverse drug withdrawal events5) Overdoses
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Patients who experience adverse drug events are hospitalized ______ days longer and incur _______ more in hospital costs than patients who do not suffer an event
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8-12, $16,000-$24,000
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Over _________ Americans are injured or die from adverse drug events each year
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770,000
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Nearly ____% of adverse drug events caused permanent disability. Adverse drug events _____ the risk of patient death.
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10%; doubles
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Pneumonic for identifying ARDs
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SOAPIII
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What is SOAPIII
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Side effectOverdoseAllergyPseudoallergy (Sim to allergic rxn but no immuno specificityInteraction Intolerance (low threshold to normal action)Idiosyncrasy (abnormal rxn due to enzyme deficiency)
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What are the 4 questions of the NARANJO ALGORITHM
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1. Are there previous conclusive reports on this reaction?2. Did the adverse event appear when the suspected drug was administered? 3. Did the adverse reaction improve when the drug was discontinued or a specific antagonist was administered? 4. Did the adverse reaction reappear when the drug was readministered?5. Are there alternative causes (other than the drug) that could on their own have caused the reaction?
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How is the NARANJO ALGORITHM scored
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Point scale for the questions; Definite (Certain) >9; Probable 5-8; Possible 1-4; Doubtful (Unlikely) 0
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What is the difference between side effect and AREs
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Both: Unplanned symptoms that a person may experience or feel when taking a medication, Symptoms are somewhat predictable. Side Effect:Some symptoms are manageable with minor intervention such as taking the medication with foodADE: Symptoms cause problems for the patient and requires treatment
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What are the Top drugs associated with increased death
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Rosiglitazone, Acetaminophen/Hydrocodone (Vicodin,Lortab), Digoxin, Oxycodone, Fentanyl, Ibandronate, Acetaminophen
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What are the RISK FACTORS FOR ADRS
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Advanced age, Female gender, Nature and degree of illness requiring drug therapy, Type of medication administered
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What types of medication are risk factors for ADRs
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Antibiotics, Cardiovascular Drugs, Analgesics, Psychotherapeutic Drugs, Anticonvulsants, Anticoagulants, Sedatives
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What is a Type A ARD
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“Aâ€ugmentation of a drug’s primary or secondary pharmacologic effect: Reactions that are common, predictable, and that may occur in any individual
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___% of all adverse drug events are Type A events
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80
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What are some examples of Type A ADRs
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Toxicity or overdose (Hepatic failure with excessive use of acetaminophen), Side effect (Sedation with antihistamines), Secondary Effect (Development of diarrhea with antibiotic use), Drug interaction (Theophylline toxicity when co administered with erythromycin)
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What is a Type B ARD
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“Bâ€izarre or idiosyncratic in nature; Reactions are not related to a drug’s primary or even secondary pharmacologic effect; Reactions which are unpredictable, uncommon, and usually not related to the pharmacological actions of the drug
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What are some examples of Type B ADRs
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Intolerance (Tinnitus with aspirin use), Hypersensitivity reaction/immunological reaction (Anaphylaxis with penicillin administration), Pseudoallergic reaction/non-immunological reaction (Radiocontrast dye reaction)
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When are Type B ARDs usually discovered
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after the drug has been marketed
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For Type B ARDs, Reactions ARE/AREN'T usually dose dependent, ARE/AREN'T they related to the mechanism of action
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aren't; aren't
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What are Type C ARDs
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Chronic Effects: Benzodiazepine dependence
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What are Type D ARDs
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Delayed Effects: carcinogenic and teratogenic
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What are Type E ARDs
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End of Treatment Effects: Narcotic withdrawal, Beta Blocker withdrawal
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What are Type F ARDs
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Failure of Therapy: Could be caused by drug interactions, failure of oral contraceptives due to induction of enzymes by a second drug such as anticonvulsants
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Describe Ranking the severity of the ADR
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Minor: No treatment requiredModerate: Change in therapy, increased hospital staySevere: Potentially life threatening, causes permanent damage, requiring intensive careLethal: directly or indirectly causes the death of the patient
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What are the 4 classes of ADRs
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Predictable/Unpreventable, Unpreventable, Unpredictable, Preventable
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Explain the Predictable/Unpreventable class of ADRs
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Reactions are common and we should warn patients: Example: GI upset with NSAIDs; diarrhea with Augmentin
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Explain the Unpredictable class of ADRs
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Reaction is fairly rare and occurrence can not be predicted: Example: Angioedema with ACE Inhibitors
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Explain the Preventable class of ADRs
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Most important ADR: example: Administering normal dose of aminoglycoside in a patient with renal impairment
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What questions should be asked to deterimine ARD
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At what stage of therapy did the current reaction occur?At the time of the reaction, what drugs was the patient taking? When were they started, and what were the doses of each? Had the patient taken these medications previously? What other medical problems does the patient have?What was the reaction? When the drug was discontinued, did the reaction cease?
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Whuy is it important to classify ADRs
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Aids in developing a monitoring programAids in determining where to place health care resources in preventing ADRsJust one report of a severe ADR could lead to further investigation and subsequent withdrawal of a dangerous medication from the market, Example: Terfenadine (Seldane)
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What is Medwatch
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FDA Medical Products Reporting Program
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What are the 4 goasl of Medwatch
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Increase awareness of medical product/drug induced disease Clarify what should be reported and increase awareness of importance of reportingFacilitate the ease of reportingProvide feedback to HCP about new safety issues
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How does the Medwatch program provide feedback
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Dear Healthcare professionals correspondence/newslettersSafety alertsFDA public health advisorieswww.fda.gov/medwatch
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Explain the medwatch report for: Hydrocodone Bitartrate And Acetaminophen Tablets, Phenobarbital Tablets by Qualitest
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Recall - Incorrect Package Labeling; Patients may unintentionally take Hydrocodone and acetaminophen tablets, instead of the intended dose of Phenobarbital, which can lead to serious adverse events
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Explain the medwatch report for: Avandia (rosiglitazone)
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REMS - Risk of Cardiovascular Events; UPDATED 02/04/2011. Information on the cardiovascular risks (including heart attack) of rosiglitazone has been added to the physician labeling and patient Medication Guide
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_________ requires and ADR surveillance program
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JCAHO
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What are the components of an ADR surveillance program
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Surveillance system which will identify ADRs and allow tracking and trending and classify the ADR, Assess the causality of ADR, Categorize the ADR by severity, Reported ADR should be reviewed and evaluated by P&T Committee, Feedback to health care professionals should occur ASAP
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How can a pharmacist reduce the risk of ADRs
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Always take a complete medication history; Evaluate your patient to determine the risk of ADRs; Remember the common medications associated with ADRs
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What are the 6 BASIC STEPS IN MEDICATION USE PROCESS
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Prescribing, Transcribing, Dispensing, Administration, Monitoring, Patient Education
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What is the definition of medicaiton errors
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Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer
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What is a Prescribing error
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The inappropriate selection of a drug or drug therapy by the prescriber, or incorrect or inadequate instructions for use
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What is a Transcribing error
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The failure to transcribe information or the improper entry of an order into an information system
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What is a Dispensing error
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The failure to dispense medication as prescribed, or to provide appropriate labeling
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What is an Administration error
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A discrepancy between the drug therapy received and the drug therapy intended
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What is a Monitoring error
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The failure to review a prescribed regimen for appropriate treatment or to assess patient response to therapy
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What is a Patient Adherecne error
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Failure by a patient to take medications as prescribed
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What are some examples of perscribing errors
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Inappropriately selecting a drug: Indication, Contraindication, Known allergies, Existing drug therapy, Dose, Dosage form, Quantity, Route of administration, Concentration, Rate of Administration
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_________ should not be prescribed to any patient who has a SCr>1.4 in women (1.5 in men)
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Metformin
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________ is not effective in CrCl<30ml/min
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HCTZ
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Ramipril and Lisinopril: _______ of therapy
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duplication
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What are some common transcribing errors
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Oral prescription orders, Prescription Data Entry, Confirmation Bias
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How can a pharmasist prevent transcribing errors
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Call for clarification: write down order and read back, Never assume anything, counseling properly
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What are some examples of dispensing errors
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Can happen during any of stage of the dispensing process: Failure to dispense a medication, Dispensing of an incorrect drug, dose, or dosage form, Failure to dispense the correct amount of medication, Incorrect or inappropriate preparation, packaging, or storage of medication prior to dispensing, Dispensing of expired, improperly stored or physically or chemically compromised medications
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What are some examples of drug administration errors
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Timing Errors, Omissions, Incorrect drug administration technique, Wrong route of drug administration, Administration of an improper dose
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What are some examples of monitoring errors
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Failure to review a prescribed regimen for appropriate treatment, Failure to use appropriate clinical or laboratory data for adequate assessment of patient response to the prescribed therapy
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What FACTORS THAT MAY CAUSE OR CONTRIBUTE TO MED ERRORS
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Miscommunication of drug orders, Poor technology, Poor procedures or techniquesInappropriate labeling when drug is repackaged, Poor knowledge of drug therapy, Environmental factors and job stress
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What strategies can be developed to avoid med errors
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Verify if patients have any allergies and/or reactions to medications, Ask patients about all medications they are taking including OTC and Herbal Medications, Compile a list of high alert medications and a list of Look Alike Sound Alike (LASA) drugs, Make sure LASA drugs are not shelved close together, Develop a systematic counseling process to ensure patients are informed about all medications, Continue to educate yourself on common medication errors and new strategies to decrease these type of errors, Verify drug information databases are up to date
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STAFF EDUCATION: FDA Medication errors website
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Basic info on medication errors, Specific drug products associated with med errors, Medication safety videos, Information on how to report medication errors
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STAFF EDUCATION: Institute for Safe Medication Practices (ISMP)
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List of high alert medications, Improvement strategies to decrease medical errors, Auxiliary labels, Standardizing ordering, storage, and preparation of products
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STAFF EDUCATION: US Pharmacopeia (USP)
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Patient information on patient safety including comprehensive handouts
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What are the ways to report med errors
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Voluntary reporting system: confidential, Medication Errors, Near Misses; USP-ISMP Medication Error Reporting Program (MERP); FDA MedWatch Program
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What is a root cause analysis
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Systematic approach to identify the various factors leading to an error or event, Attempting to understand the true problem before something is fixed, Important process for improving quality and safety
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What is a root cause analysis (RCA)
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A retrospective approach to error analysis, A process developed to look at systems errors and avoiding individual blame, Attempts to undercover a collection of system errors if they exist allowing for opportunity to change to prevent future incidents, View this as a tool of continuous improvement
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What are the steps of a RCA
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1. Define the problem2. Gather data/evidence of what happened3. Ask questions and attempt to identify the causal relationships associated with the defined problem4. Identify any causes that could prevent a recurrence of the incidence5. List possible solutions6. Implement recommendations7. Continue to assess changes as part of continual quality improvement
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