Drug Allergies and Adverse Drug Reactions Flashcards
Adverse drug reaction definition
All unintended pharmacologic effects of a drug when it is administered correctly and used at recommended doses
How do ADR and med errors differ?
ADR: medication is administered correctly but there is an adverse outcome
Med error: someone did something wrong
What are the 2 types of ADR?
Predictable (Type A) - dose dependent (related to known pharmacologic actions most common type)
Unpredictable (Type B) - idiosyncratic (allergies, pseudoallergic reactions, drug intolerance)
What are the types of drug allergies?
Type I: immediate (15-30 mins) after drug exposure
Type II: minutes to hours after drug exposure
Type III: 3-10 hours after drug exposure
Type IV: delayed (48 hrs-weeks) after drug exposure
What is a BBW?
Indicates risk of death or permanent disability from a drug
What is a CI?
Situation where drug cannot be used in that patient
Risk outweighs benefit
What are warnings and precautions
reactions that can result in death, hospitalization, medical intervention, disability, or teratogenicity
What is an adverse reaction?
undesirable or uncomfortable or dangerous effects
What does REMS stand for? Who makes them? Who approves them?
Risk Evaluation and Mitigation Strategies
Made by manufacturer
Approved by FDA
When should a med guide be given to the patient?
Each time the medication is dispensed
What is the Naranjo Scale? What does it determine?
A validated causality assessment scale
Helps determine the likelihood that a drug caused an adverse reaction
Where should you report side effects, adverse events and allergies?
FDA’s MedWatch program called FDA Adverse Event Reporting System (FAERS)
What is phase IV of a drug trial?
Post-marketing safety surveillance program
Can be required by FDA to better understand the safety profile of a medication
What medications can cause photosensitivity?
Amiodarone Diuretics Methotrexate Oral and topical retinoids Quinolones St. John's wort Sulfa antibiotics Tacrolimus Tetracyclines Voriconazole
What is thrombotic thrombocytopenic purpura (TTP)
Blood disorder in which clots form throughout the body
