Podcast
Questions and Answers
What defines a severe adverse drug reaction (ADR)?
What defines a severe adverse drug reaction (ADR)?
All mild adverse drug reactions require hospitalization to manage.
All mild adverse drug reactions require hospitalization to manage.
False
What percentage of adverse drug reactions (ADRs) are considered preventable?
What percentage of adverse drug reactions (ADRs) are considered preventable?
70%
A moderate ADR requires treatment and prolongs hospitalization by at least __________ day(s).
A moderate ADR requires treatment and prolongs hospitalization by at least __________ day(s).
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Which of the following is NOT a high-risk patient group for adverse drug reactions?
Which of the following is NOT a high-risk patient group for adverse drug reactions?
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Match the type of ADR with its definition:
Match the type of ADR with its definition:
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Improvement when the drug is stopped is NOT a factor in assessing the causality of an ADR.
Improvement when the drug is stopped is NOT a factor in assessing the causality of an ADR.
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Name one common cause of preventable adverse drug reactions.
Name one common cause of preventable adverse drug reactions.
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Which type of adverse drug reaction (ADR) is predictable and dose dependent?
Which type of adverse drug reaction (ADR) is predictable and dose dependent?
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Type B (Bizarre) reactions are commonly occurring and usually not severe.
Type B (Bizarre) reactions are commonly occurring and usually not severe.
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What is the primary mechanism of Type A (Augmented) reactions?
What is the primary mechanism of Type A (Augmented) reactions?
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What is an example of a Type A (Augmented) reaction?
What is an example of a Type A (Augmented) reaction?
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Type C (Chronic) reactions are dose-dependent and predictable.
Type C (Chronic) reactions are dose-dependent and predictable.
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Name one patient factor that can influence adverse drug reactions.
Name one patient factor that can influence adverse drug reactions.
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What type of adverse drug reactions (ADRs) are related to prolonged treatment duration and cumulative dosage?
What type of adverse drug reactions (ADRs) are related to prolonged treatment duration and cumulative dosage?
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Anaphylaxis is classified under Type B reactions.
Anaphylaxis is classified under Type B reactions.
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What condition does Stevens-Johnson syndrome relate to?
What condition does Stevens-Johnson syndrome relate to?
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Type D ADRs are associated with _____ effects.
Type D ADRs are associated with _____ effects.
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Which of the following is an example of a Type E ADR?
Which of the following is an example of a Type E ADR?
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Carcinogenic effects from drugs fall under Type C ADRs.
Carcinogenic effects from drugs fall under Type C ADRs.
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Match the following types of ADRs with their descriptions:
Match the following types of ADRs with their descriptions:
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What was thalidomide originally marketed for?
What was thalidomide originally marketed for?
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Study Notes
Adverse Drug Reactions (ADRs)
- Adverse drug reaction (ADR): An unwanted or harmful reaction following medication administration, suspected to be related to the drug.
- Pharmacovigilance: The science and activities related to detecting, assessing, understanding, and preventing ADRs.
- Adverse drug event (ADE): An unwanted medical occurrence during treatment with a medication, but not necessarily caused by the medicine.
- Toxic effect: Adverse effects at high dosages, usually an exaggeration of the desired therapeutic effects.
- Side effect: Dose-related or not, includes both desirable and undesirable effects with different mechanisms from the primary pharmacological action.
- Adverse reaction/effect: All undesired effects, regardless of their mechanism or dosage.
Importance of ADRs
- Reduced adherence to medication regimens.
- Reduced drug efficacy (preventing the use of a fully effective dosage).
- Reduced quality of life.
- Increased morbidity and mortality.
- Reduced drug choices.
- Diagnostic confusion.
- Reduced patient confidence.
Factors Influencing ADRs
- Drug factors: Non-selective, narrow therapeutic window, teratogenic, etc.
- Patient factors: Age, sex, genetics, etc.
- Clinical factors: Duration of treatment, dose adjustments (up- and down-titration), drug interactions, drug choices (especially during pregnancy), and comorbidities.
Classification of ADRs
- Type A (Augmented): Related to the drug's pharmacological action, common, usually not severe, and predictable. Dose-dependent (can be alleviated by dose reduction). Examples: Sedation with barbiturates, bleeding with anticoagulants, bronchoconstriction with propranolol, sedation with diphenhydramine. Can have beneficial side effects (e.g., weight loss in some cases).
- Type B (Bizarre): Not related to the drug's pharmacological action; related to patient susceptibility (e.g., genetic), rare, unpredictable, and may be severe or fatal. Examples: Idiosyncratic reactions (Stevens-Johnson syndrome following lamotrigine or carbamazepine), immunologic reactions (anaphylaxis with penicillin), allergic reactions (mild erythema/rash with penicillin, sulfonamides, and some antiepileptic drugs). Immediately stop the medication and avoid similar medications.
Type C (Chronic Treatment Effects)
- Related to prolonged treatment duration and cumulative dosage.
- Examples: Dyskinesia with levodopa, weight gain and osteoporosis with steroids.
Type D (Delayed Effects)
- Irreversible.
- Examples: Teratogenic (thalidomide) or carcinogenic (azathioprine).
Type E (End of Treatment Effects)
- Withdrawal syndrome, especially when treatment is abruptly stopped.
- Examples: Headache, anxiety, dizziness, sleep disturbances, gastrointestinal disturbances, benzodiazepine withdrawal syndrome, adrenocortical insufficiency after steroid treatment.
Type F (Failure of Therapy)
- Unexpected treatment failure due to drug interactions (pharmacokinetic or pharmacodynamic).
- Examples: Enzyme inducer drugs decrease warfarin effect.
High-Risk Patient Groups
- Elderly
- Neonates
- Renal or hepatic impairment
- Polypharmacy
- Multiple disease states
- Asian origin
- Female
- Atopic
Types of ADRs (Severity)
- Mild: Does not require treatment or hospitalization.
- Moderate: Requires treatment and prolongs hospitalization for at least one day.
- Severe: Potentially life-threatening, permanently disabling, requiring intensive medical care, or results in cancer.
Frequency of ADRs
- Categorization of ADR frequency. (Table presented)
Assessing Causality
- Nature of the reaction
- Timing of the reaction
- Relationship to drug dose
- Other possible causes of the symptoms
- Improvement when the drug(s) is stopped
- Whether the reaction has been reported before
ADR Avoidance
- Up to 70% of ADRs are avoidable.
- Incorrect dosing or administration.
- Obvious interactions
- Use of contraindicated drugs.
- Use in inappropriate clinical indications.
Minimizing ADRs
- Avoid unnecessary drug use.
- Check drug history before prescribing.
- Identify patients with co-existing diseases.
- Avoid drug interactions with drugs and foods.
- Provide patient counseling.
- Identify drugs known to cause dose-related side effects.
Case Study Example (Page 24)
- A 67-year-old woman with a widespread rash (erythema multiforme) resulting from gliclazide.
- The treatment for such reactions is to stop the problematic drug (gliclazide).
- Other medication causes are also considered for the subsequent occurrence of pancreatitis.
Case Study Example (Page 32)
- A patient was administered sitagliptin.
- The possibility of pancreatitis due to sitagliptin.
- The frequency of pancreatitis with sitagliptin is presently unknown.
Case Study Example (Page 30-33)
- The patient developed acute pancreatitis. This is followed by resolution of this reaction when gliclazide was stopped.
- Another drug (sitagliptin) was introduced, leading to readmission for developing pancreatitis.
- The drug most likely causing the acute pancreatitis is sitagliptin.
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