78 Questions
What is a primary difference between an adverse drug reaction (ADR) and a side effect?
An ADR is an unintended response, while a side effect is an intended response.
What is a major contributor to hospital admissions in the UK?
Hazardous prescribing practices
What percentage of the UK population may have defects in the metabolism of isoniazid and sulfasalazine?
50%
What is a characteristic of a Type A ADR?
Predictable and dose-dependent
What is a risk factor for ADRs?
Multiple drug therapy
What is the estimated annual cost of preventable ADRs in the UK?
£83.7 million
What percentage of white people has inactive CYP2D6?
6%
What is the name of the enzyme that metabolizes warfarin?
CYP2C9
What is the term for a rapid or ultra-rapid metabolizer of a medication?
Ultra-rapid metabolizer
What is the term for an adverse drug reaction that occurs immediately after exposure to a medication?
Immediate reaction
What is the purpose of the Yellow Card Scheme?
To monitor the safety of medicinal products
What is the agency responsible for pharmacovigilance in the UK?
MHRA
What is the term for the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine/vaccine-related problem?
Pharmacovigilance
What percentage of people will have taken a medication by the time it receives marketing authorization?
1500
What type of adverse drug reaction is more common in people with atopic background?
Type B
What is the term for the process of stopping a medication and observing the patient's response?
Dechallenge
What type of pharmacists have a professional responsibility to advise people and/or their carers on the reporting of any suspected side effects associated with their medicines?
All pharmacists
What is the purpose of the Black Triangle Scheme?
To monitor new medicines and vaccines
What type of reactions should be reported in children?
All suspected reactions, even if the reaction is well recognized
What should be included in a Yellow Card report?
Details about the person affected, the drug(s)/vaccine(s) they were taking, and the ADR they experienced
What is the purpose of the Yellow Card Scheme?
To report all suspected ADRs
What type of medicines should be reported, even if the reaction is well recognized?
All established drugs (OTC and Rxed/ vaccines/ herbal)
What should prescribers consider when trying to minimize ADRs?
The benefit: risk for this patient, 'at risk' groups, and safer alternatives
What is the purpose of the Drug Safety Update?
To provide latest information and advice to ensure the safe use of medicines
What type of information can be found on the Government website?
Details on how to report a problem with a medical device in Wales, Scotland, or Northern Ireland
What is the three-step approach to reporting ADRs?
Decide if the reaction is in a child, decide if the reaction is serious, decide if it's a black triangle drug
What is the main difference between an adverse drug reaction (ADR) and a side effect?
An ADR is an unintended response, while a side effect is an intended response.
What is the estimated annual cost of preventable ADRs in the UK?
£83.7 million
What is the characteristic of a Type A ADR?
It is predictable from pharmacology and has high morbidity.
What is the percentage of prescription items that contain errors in the UK?
5%
What is the role of genetic polymorphisms in pharmacovigilance?
They can alter the metabolism of a medication.
What is the contribution of hazardous prescribing to hospital admissions in the UK?
1 in 25
What is the term for the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine/vaccine-related problem?
Pharmacovigilance
Which of the following is NOT a criteria for identifying ADRs?
Age of patient
What percentage of white people are approximated to have inactive CYP2D6?
6%
What is the term for a rapid or ultra-rapid metabolizer of a medication?
Ultra-rapid metabolizer
What is the term for the process of stopping a medication and observing the patient's response?
Dechallenge
What type of adverse drug reaction is more common in people with atopic background?
Type B
What is the purpose of the Yellow Card Scheme?
To monitor the safety of medicines and medical devices post-marketing
What type of products are covered by the Yellow Card Scheme?
Medicines, vaccines, blood factors, and medical devices
What should be included in a Yellow Card report?
Brand name, batch number, and patient symptoms
What is the agency responsible for pharmacovigilance in the UK?
MHRA
Who can report suspected adverse drug reactions?
All healthcare professionals, patients, parents, and carers
What is the purpose of the Black Triangle Scheme?
To encourage monitoring of new medicines and vaccines
What should be reported in children?
All suspected reactions, even if it is not certain that the drug has caused it
What is the purpose of the Drug Safety Update?
To provide the latest information and advice on the safe use of medicines
What should be included in a Yellow Card report?
Details about the person affected, the medicine, and the suspected adverse drug reaction
What is the three-step approach to reporting suspected adverse drug reactions?
Decide if the reaction is in a child, then if it is serious, then if it is a black triangle drug
Why should pharmacists report suspected adverse drug reactions?
Because they have a professional responsibility to advise people on the reporting of suspected adverse drug reactions
What should prescribers consider when trying to minimize adverse drug reactions?
The benefit and risk of the medicine for the individual patient
What type of information can be found on the Government website?
Information on how to report a problem with a medical device in Wales, Scotland, or Northern Ireland
What is the purpose of the Yellow Card Scheme?
To encourage the safe use of medicines
What is the estimated cost of preventable ADRs in the UK?
£83.7 million
What percentage of prescription items contain potentially life-threatening errors?
1 in 550
What is the characteristic of Type B ADRs?
Not predictable from pharmacology
What is the percentage of the UK population that may have defects in the metabolism of isoniazid and sulfasalazine?
50%
What is the contribution of hazardous prescribing to hospital admissions in the UK?
1 in 25
What is a risk factor for ADRs?
All of the above
What is the main consequence of polymorphisms in CYP450 enzymes?
Poor metabolisers of certain medications
What is the characteristic of CYP2D6 substrates?
They include antidepressants, antipsychotics, and cardiac drugs
What is a key factor in identifying an allergic reaction to a medication?
The timing of the reaction
What is the purpose of reviewing ADR information in the BNF/SmPC/iDAP?
To assess whether the signs and symptoms are in keeping with the medication
What is the role of the MHRA in pharmacovigilance?
All of the above
What type of products are covered by the Yellow Card Scheme?
Medicines, vaccines, and medical devices
What is the purpose of the Yellow Card Scheme?
To monitor the safety of medications
What should be included in a Yellow Card report?
The brand name and batch number of the medication
What is the term for the process of stopping a medication and observing the patient's response?
Dechallenge
What is a risk factor for allergic reactions to medications?
Atopic background
Who can report suspected adverse drug reactions?
Healthcare professionals, patients, parents, and carers
How can suspected adverse drug reactions be reported?
All of the above, plus via the app or by downloading a form
What is the purpose of the Yellow Card Scheme?
To monitor the safety of medicines
What types of reactions should be reported in children?
All suspected reactions, regardless of severity
What is the Black Triangle Scheme?
A scheme to monitor the safety of new medicines and vaccines
What should be included in a Yellow Card report?
Details about the person affected, the drug(s) taken, the reaction experienced, and the person reporting
What is the purpose of the Drug Safety Update?
To provide the latest information and advice on the safe use of medicines
Who has a professional responsibility to advise people on the reporting of suspected adverse drug reactions?
All healthcare professionals
What type of reactions should be reported, even if the reaction is well recognized?
All suspected reactions to established drugs
What is the three-step approach to reporting suspected adverse drug reactions?
Decide if the reaction is in a child, if not decide if it's serious, if not decide if it's a black triangle drug
Learn about adverse drug reactions, their causes, and differences from side effects. Understand how ADEs arise from medicinal product use and the importance of pharmacovigilance.
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