Pharmacovigilance Flashcards
What are the main distinctions between predictable (Type A) and unpredictable (Type B) adverse drug reactions?
Type A reactions are predictable
○ Often from the pharmacology of the drug
Type A reactions have a higher morbidity whereas type B have a higher mortality
○ Morbidity = illness/disease
○ Mortality = death
Type A reactions are often dose related vs Type B which are not
○ Can often be managed by a reduction in dose of the drug
Type A reactions are common whereas type B are not
How do ADRs contribute to hospital admissions
High hospital admissions
Most reactions are either definitely or possibly avoidable (Type A ADRs)
What drugs most commonly cause adverse reactions and what is the most common reaction
low dose aspirin
Diuretics
Warfarin
NSAIDs
gastrointestinal bleeding
what strategies can mitigate the occurrences of ADRs
enhance patient assessment and monitoring
Optimise medication prescribing
Utilise technology and decision support
Educate patients and healthcare providers
Implement pharmacovigilance programs
Use pharmacogenomics
Engage in medication reconciliation
Focus on high-risk drugs and populations
promote lifestyle modifications
Foster interdisciplinary collaboration
How can enhancing patient assessment and monitoring mitigate the occurrences of ADRs
Detailed Medical History and Regular Monitoring
How can optimising medication prescribing mitigate the occurrences of ADRs
individualised therapy
- tailor drug choice and dosage based on age, weight, renal and liver function, and genetic factors
avoid poly pharmacy
- minimise the number of medications prescribed, especially for older adults, to reduce drug-drug interactions
start low, go slow
- begin with the lowest effective dose and gradually adjust based on patient response
how can utilising technology and decision support mitigate the occurrences of ADRs
electronic health records (EHR)
- incorporate alerts for potential drug interactions and contraindications
clinical decision support systems (CDSS)
- provide evidence-based recommendations to guide prescribing practices
Barcoding systems
- ensure correct medication administration
how can educating patients and healthcare providers mitigate the occurrences of ADRs
patient education and provider training
how can implementing pharmacovigilance programs mitigate the occurrences of ADRs
adverse event reporting systems
- encourage the reporting of suspected ADRs to regulatory bodies (e.g. yellow card scheme)
Post-marketing surveillance
- monitor drugs after approval to identify rare or delayed ADRs
how can using pharmacogenomics mitigate the occurrences of ADRs
genetic testing
- identify genetic predispositions that may increase the risk of ADRs, such as variations affecting drug metabolism (e.g. CYP450 enzymes)
personalised medicine
- adapt drug choices based on genetic profiles to improve safety and efficacy
how can engaging in medication reconciliation mitigate the occurrences of ADRs
transition of care
- ensure accurate medication lists during hospital admissions, discharges, and other transitions
review changes
- cross-check medications for potential duplication or omissions
how can focussing on high-risk drugs and populations mitigate the occurrences of ADRs
high alert medications
- exercise extra caution with drugs like anticoagulants, opioids, and chemotherapeutic agents
vulnerable groups
- pay attention to children, the elderly and pregnant individuals who may have unique susceptibilities
how can promoting lifestyle modifications mitigate the occurrences of ADRs
non-pharmacologic interventions
- where appropriate, recommend lifestyle changes to manage conditions (e.g. diet for hypertension) to minimise the need for medications
Drug-free intervals
- avoid long term use of certain drugs unless absolutely necessary
how can fostering interdisciplinary collaboration mitigate the occurrences of ADRs
pharmacist involvement
- include pharmacists in healthcare teams to review prescriptions and provide drug related expertise
team communication
- ensure all healthcare providers involved in a patients care are aware of the medication regimen
At what stages of drug development are Type A and Type B ADRs most likely to be detected, and why?
Type A reactions: in phase 1, 2, 3 clinical trials (premarketing surveillance)
Type B reactions: phase 4 (after the drug has been marketed)
How does the Yellow Card Scheme contribute to pharmacovigilance
The Yellow Card scheme is a voluntary reporting system that collects and monitors information about suspected safety concerns with healthcare products in the UK
It allows patients and other medical professionals to report potential side effects and as a result this can make medicines safer, prevent future harm to patients, safer prescribing and use of medicines, improve patient safety and protect public health, improve medicines information and education
Using the causality assessment criteria, how would you determine if a suspected reaction is linked to a specific drug?
The timing between starting a drug and the reaction occuring?
* Occasionally a reaction will occur after a medication is stopped
Nature of the reaction
* Is there an alternative explanation
Relationship to dose
Improvement when drug(s) stopped
Dechallenge/re- challenge
* Does the reaction occur on re-challenge
Has reaction been reported before
Why might an ADR be difficult to identify in a patient with multiple conditions or medications?
The ADRs can manifest in many ways and could potentially be misinterpreted as symptoms of other conditions
Can be difficult to distinguish which medication can be causing the ADR
The drugs themselves could be interacting with eachother and causing the symptoms
How does a robust reporting culture, such as that encouraged by the Yellow Card Scheme, enhance patient safety?
Identifies emerging risks - by patients and medical professionals being able to report and flag new reactions they can be detected earlier
Improves medication safety - by the reactions being able to be reported this can facilitate new regulatory updates such as label changes, dose adjustments or product recalls
Promotes awareness - encouraging patients and medical professionals to recognise and report ADRs can increase vigilance
Data collections for research - faciltates analysis of patterns and trends
Fostering transparency - builds trust by demonstrating commitment to monitoring and improving drug safety
