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74 Cards in this Set

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Generic Name: rosiglitazone (row zi GLI ta zone)
Brand Names: Avandia
Acetaminophen/Hydrocodone (
Vicodin,Lortab)
Top drugs associated with increased death
1) Rosiglitazone 2)Acetaminophen/Hydrocodone (Vicodin,Lortab)
3)Digoxin
4) Oxycodone
5)Fentanyl
6)Ibandronate
7)Acetaminophen
Generic Name: venlafaxine (VEN la fax een)
Brand Names: Effexor, Effexor XR

Venlafaxine is an antidepressant in a group of drugs called selective serotonin and norepinephrine reuptake inhibitors (SSNRIs).
Generic Name: mirtazapine (mir TAZ a peen)
Brand Names: Remeron, Remeron SolTab
an antidepressant
Generic Name: tramadol (TRAM a dol)
Brand names: Rybix ODT, Ryzolt, Ultram, Ultram ER

Tramadol is a narcotic-like pain reliever
What is an adverse drug effect (ADE)
Any unfavorable event associated with the use of a medication
What are the two types of ADEs
Medication Errors and ADRs
What are the types of medication errors
Prescribing, Dispensing, Administering, Monitoring
What is an Adverse Drug Reaction (ADR)
“Injury” resulting from the medical use of a drug where no error is involved; adverse event with a causal link to a drug
What are the 5 catefories of ADEs
1) Adverse drug reactions2) Medication errors3) Therapeutic failures4) Adverse drug withdrawal events5) Overdoses
Patients who experience adverse drug events are hospitalized ______ days longer and incur _______ more in hospital costs than patients who do not suffer an event
8-12, $16,000-$24,000
Over _________ Americans are injured or die from adverse drug events each year
770,000
Nearly ____% of adverse drug events caused permanent disability. Adverse drug events _____ the risk of patient death.
10%; doubles
Pneumonic for identifying ARDs
SOAPIII
What is SOAPIII
Side effectOverdoseAllergyPseudoallergy (Sim to allergic rxn but no immuno specificityInteraction Intolerance (low threshold to normal action)Idiosyncrasy (abnormal rxn due to enzyme deficiency)
What are the 4 questions of the NARANJO ALGORITHM
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?
How is the NARANJO ALGORITHM scored
Point scale for the questions; Definite (Certain) >9; Probable 5-8; Possible 1-4; Doubtful (Unlikely) 0
What is the difference between side effect and AREs
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
What are the Top drugs associated with increased death
Rosiglitazone, Acetaminophen/Hydrocodone (Vicodin,Lortab), Digoxin, Oxycodone, Fentanyl, Ibandronate, Acetaminophen
What are the RISK FACTORS FOR ADRS
Advanced age, Female gender, Nature and degree of illness requiring drug therapy, Type of medication administered
What types of medication are risk factors for ADRs
Antibiotics, Cardiovascular Drugs, Analgesics, Psychotherapeutic Drugs, Anticonvulsants, Anticoagulants, Sedatives
What is a Type A ARD
“A”ugmentation of a drug’s primary or secondary pharmacologic effect: Reactions that are common, predictable, and that may occur in any individual
___% of all adverse drug events are Type A events
80
What are some examples of Type A ADRs
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)
What is a Type B ARD
“B”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
What are some examples of Type B ADRs
Intolerance (Tinnitus with aspirin use), Hypersensitivity reaction/immunological reaction (Anaphylaxis with penicillin administration), Pseudoallergic reaction/non-immunological reaction (Radiocontrast dye reaction)
When are Type B ARDs usually discovered
after the drug has been marketed
For Type B ARDs, Reactions ARE/AREN'T usually dose dependent, ARE/AREN'T they related to the mechanism of action
aren't; aren't
What are Type C ARDs
Chronic Effects: Benzodiazepine dependence
What are Type D ARDs
Delayed Effects: carcinogenic and teratogenic
What are Type E ARDs
End of Treatment Effects: Narcotic withdrawal, Beta Blocker withdrawal
What are Type F ARDs
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
Describe Ranking the severity of the ADR
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
What are the 4 classes of ADRs
Predictable/Unpreventable, Unpreventable, Unpredictable, Preventable
Explain the Predictable/Unpreventable class of ADRs
Reactions are common and we should warn patients: Example: GI upset with NSAIDs; diarrhea with Augmentin
Explain the Unpredictable class of ADRs
Reaction is fairly rare and occurrence can not be predicted: Example: Angioedema with ACE Inhibitors
Explain the Preventable class of ADRs
Most important ADR: example: Administering normal dose of aminoglycoside in a patient with renal impairment
What questions should be asked to deterimine ARD
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?
Whuy is it important to classify ADRs
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)
What is Medwatch
FDA Medical Products Reporting Program
What are the 4 goasl of Medwatch
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
How does the Medwatch program provide feedback
Dear Healthcare professionals correspondence/newslettersSafety alertsFDA public health advisorieswww.fda.gov/medwatch
Explain the medwatch report for: Hydrocodone Bitartrate And Acetaminophen Tablets, Phenobarbital Tablets by Qualitest
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
Explain the medwatch report for: Avandia (rosiglitazone)
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
_________ requires and ADR surveillance program
JCAHO
What are the components of an ADR surveillance program
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
How can a pharmacist reduce the risk of ADRs
Always take a complete medication history; Evaluate your patient to determine the risk of ADRs; Remember the common medications associated with ADRs
What are the 6 BASIC STEPS IN MEDICATION USE PROCESS
Prescribing, Transcribing, Dispensing, Administration, Monitoring, Patient Education
What is the definition of medicaiton errors
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
What is a Prescribing error
The inappropriate selection of a drug or drug therapy by the prescriber, or incorrect or inadequate instructions for use
What is a Transcribing error
The failure to transcribe information or the improper entry of an order into an information system
What is a Dispensing error
The failure to dispense medication as prescribed, or to provide appropriate labeling
What is an Administration error
A discrepancy between the drug therapy received and the drug therapy intended
What is a Monitoring error
The failure to review a prescribed regimen for appropriate treatment or to assess patient response to therapy
What is a Patient Adherecne error
Failure by a patient to take medications as prescribed
What are some examples of perscribing errors
Inappropriately selecting a drug: Indication, Contraindication, Known allergies, Existing drug therapy, Dose, Dosage form, Quantity, Route of administration, Concentration, Rate of Administration
_________ should not be prescribed to any patient who has a SCr>1.4 in women (1.5 in men)
Metformin
________ is not effective in CrCl<30ml/min
HCTZ
Ramipril and Lisinopril: _______ of therapy
duplication
What are some common transcribing errors
Oral prescription orders, Prescription Data Entry, Confirmation Bias
How can a pharmasist prevent transcribing errors
Call for clarification: write down order and read back, Never assume anything, counseling properly
What are some examples of dispensing errors
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
What are some examples of drug administration errors
Timing Errors, Omissions, Incorrect drug administration technique, Wrong route of drug administration, Administration of an improper dose
What are some examples of monitoring errors
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
What FACTORS THAT MAY CAUSE OR CONTRIBUTE TO MED ERRORS
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
What strategies can be developed to avoid med errors
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
STAFF EDUCATION: FDA Medication errors website
Basic info on medication errors, Specific drug products associated with med errors, Medication safety videos, Information on how to report medication errors
STAFF EDUCATION: Institute for Safe Medication Practices (ISMP)
List of high alert medications, Improvement strategies to decrease medical errors, Auxiliary labels, Standardizing ordering, storage, and preparation of products
STAFF EDUCATION: US Pharmacopeia (USP)
Patient information on patient safety including comprehensive handouts
What are the ways to report med errors
Voluntary reporting system: confidential, Medication Errors, Near Misses; USP-ISMP Medication Error Reporting Program (MERP); FDA MedWatch Program
What is a root cause analysis
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
What is a root cause analysis (RCA)
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
What are the steps of a RCA
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