Pharmacovigilance: Adverse Drug Reactions
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Questions and Answers

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. (correct)
  • An ADR is a noxious response, while a side effect is a beneficial response.
  • An ADR is a predictable response, while a side effect is unpredictable.
  • An ADR is a type of medication error, while a side effect is a type of overdose.

    • What is a major contributor to hospital admissions in the UK?

  • Hazardous prescribing practices (correct)
  • Medication errors
  • Polypharmacy
  • Lack of pharmacovigilance

    • What percentage of the UK population may have defects in the metabolism of isoniazid and sulfasalazine?

  • 30%
  • 20%
  • 50% (correct)
  • 40%

    • What is a characteristic of a Type A ADR?

    <p>Predictable and dose-dependent</p> Signup and view all the answers

    What is a risk factor for ADRs?

    <p>Multiple drug therapy</p> Signup and view all the answers

    What is the estimated annual cost of preventable ADRs in the UK?

    <p>£83.7 million</p> Signup and view all the answers

    What percentage of white people has inactive CYP2D6?

    <p>6%</p> Signup and view all the answers

    What is the name of the enzyme that metabolizes warfarin?

    <p>CYP2C9</p> Signup and view all the answers

    What is the term for a rapid or ultra-rapid metabolizer of a medication?

    <p>Ultra-rapid metabolizer</p> Signup and view all the answers

    What is the term for an adverse drug reaction that occurs immediately after exposure to a medication?

    <p>Immediate reaction</p> Signup and view all the answers

    What is the purpose of the Yellow Card Scheme?

    <p>To monitor the safety of medicinal products</p> Signup and view all the answers

    What is the agency responsible for pharmacovigilance in the UK?

    <p>MHRA</p> Signup and view all the answers

    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?

    <p>Pharmacovigilance</p> Signup and view all the answers

    What percentage of people will have taken a medication by the time it receives marketing authorization?

    <p>1500</p> Signup and view all the answers

    What type of adverse drug reaction is more common in people with atopic background?

    <p>Type B</p> Signup and view all the answers

    What is the term for the process of stopping a medication and observing the patient's response?

    <p>Dechallenge</p> Signup and view all the answers

    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?

    <p>All pharmacists</p> Signup and view all the answers

    What is the purpose of the Black Triangle Scheme?

    <p>To monitor new medicines and vaccines</p> Signup and view all the answers

    What type of reactions should be reported in children?

    <p>All suspected reactions, even if the reaction is well recognized</p> Signup and view all the answers

    What should be included in a Yellow Card report?

    <p>Details about the person affected, the drug(s)/vaccine(s) they were taking, and the ADR they experienced</p> Signup and view all the answers

    What is the purpose of the Yellow Card Scheme?

    <p>To report all suspected ADRs</p> Signup and view all the answers

    What type of medicines should be reported, even if the reaction is well recognized?

    <p>All established drugs (OTC and Rxed/ vaccines/ herbal)</p> Signup and view all the answers

    What should prescribers consider when trying to minimize ADRs?

    <p>The benefit: risk for this patient, 'at risk' groups, and safer alternatives</p> Signup and view all the answers

    What is the purpose of the Drug Safety Update?

    <p>To provide latest information and advice to ensure the safe use of medicines</p> Signup and view all the answers

    What type of information can be found on the Government website?

    <p>Details on how to report a problem with a medical device in Wales, Scotland, or Northern Ireland</p> Signup and view all the answers

    What is the three-step approach to reporting ADRs?

    <p>Decide if the reaction is in a child, decide if the reaction is serious, decide if it's a black triangle drug</p> Signup and view all the answers

    What is the main difference between an adverse drug reaction (ADR) and a side effect?

    <p>An ADR is an unintended response, while a side effect is an intended response.</p> Signup and view all the answers

    What is the estimated annual cost of preventable ADRs in the UK?

    <p>£83.7 million</p> Signup and view all the answers

    What is the characteristic of a Type A ADR?

    <p>It is predictable from pharmacology and has high morbidity.</p> Signup and view all the answers

    What is the percentage of prescription items that contain errors in the UK?

    <p>5%</p> Signup and view all the answers

    What is the role of genetic polymorphisms in pharmacovigilance?

    <p>They can alter the metabolism of a medication.</p> Signup and view all the answers

    What is the contribution of hazardous prescribing to hospital admissions in the UK?

    <p>1 in 25</p> Signup and view all the answers

    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?

    <p>Pharmacovigilance</p> Signup and view all the answers

    Which of the following is NOT a criteria for identifying ADRs?

    <p>Age of patient</p> Signup and view all the answers

    What percentage of white people are approximated to have inactive CYP2D6?

    <p>6%</p> Signup and view all the answers

    What is the term for a rapid or ultra-rapid metabolizer of a medication?

    <p>Ultra-rapid metabolizer</p> Signup and view all the answers

    What is the term for the process of stopping a medication and observing the patient's response?

    <p>Dechallenge</p> Signup and view all the answers

    What type of adverse drug reaction is more common in people with atopic background?

    <p>Type B</p> Signup and view all the answers

    What is the purpose of the Yellow Card Scheme?

    <p>To monitor the safety of medicines and medical devices post-marketing</p> Signup and view all the answers

    What type of products are covered by the Yellow Card Scheme?

    <p>Medicines, vaccines, blood factors, and medical devices</p> Signup and view all the answers

    What should be included in a Yellow Card report?

    <p>Brand name, batch number, and patient symptoms</p> Signup and view all the answers

    What is the agency responsible for pharmacovigilance in the UK?

    <p>MHRA</p> Signup and view all the answers

    Who can report suspected adverse drug reactions?

    <p>All healthcare professionals, patients, parents, and carers</p> Signup and view all the answers

    What is the purpose of the Black Triangle Scheme?

    <p>To encourage monitoring of new medicines and vaccines</p> Signup and view all the answers

    What should be reported in children?

    <p>All suspected reactions, even if it is not certain that the drug has caused it</p> Signup and view all the answers

    What is the purpose of the Drug Safety Update?

    <p>To provide the latest information and advice on the safe use of medicines</p> Signup and view all the answers

    What should be included in a Yellow Card report?

    <p>Details about the person affected, the medicine, and the suspected adverse drug reaction</p> Signup and view all the answers

    What is the three-step approach to reporting suspected adverse drug reactions?

    <p>Decide if the reaction is in a child, then if it is serious, then if it is a black triangle drug</p> Signup and view all the answers

    Why should pharmacists report suspected adverse drug reactions?

    <p>Because they have a professional responsibility to advise people on the reporting of suspected adverse drug reactions</p> Signup and view all the answers

    What should prescribers consider when trying to minimize adverse drug reactions?

    <p>The benefit and risk of the medicine for the individual patient</p> Signup and view all the answers

    What type of information can be found on the Government website?

    <p>Information on how to report a problem with a medical device in Wales, Scotland, or Northern Ireland</p> Signup and view all the answers

    What is the purpose of the Yellow Card Scheme?

    <p>To encourage the safe use of medicines</p> Signup and view all the answers

    What is the estimated cost of preventable ADRs in the UK?

    <p>£83.7 million</p> Signup and view all the answers

    What percentage of prescription items contain potentially life-threatening errors?

    <p>1 in 550</p> Signup and view all the answers

    What is the characteristic of Type B ADRs?

    <p>Not predictable from pharmacology</p> Signup and view all the answers

    What is the percentage of the UK population that may have defects in the metabolism of isoniazid and sulfasalazine?

    <p>50%</p> Signup and view all the answers

    What is the contribution of hazardous prescribing to hospital admissions in the UK?

    <p>1 in 25</p> Signup and view all the answers

    What is a risk factor for ADRs?

    <p>All of the above</p> Signup and view all the answers

    What is the main consequence of polymorphisms in CYP450 enzymes?

    <p>Poor metabolisers of certain medications</p> Signup and view all the answers

    What is the characteristic of CYP2D6 substrates?

    <p>They include antidepressants, antipsychotics, and cardiac drugs</p> Signup and view all the answers

    What is a key factor in identifying an allergic reaction to a medication?

    <p>The timing of the reaction</p> Signup and view all the answers

    What is the purpose of reviewing ADR information in the BNF/SmPC/iDAP?

    <p>To assess whether the signs and symptoms are in keeping with the medication</p> Signup and view all the answers

    What is the role of the MHRA in pharmacovigilance?

    <p>All of the above</p> Signup and view all the answers

    What type of products are covered by the Yellow Card Scheme?

    <p>Medicines, vaccines, and medical devices</p> Signup and view all the answers

    What is the purpose of the Yellow Card Scheme?

    <p>To monitor the safety of medications</p> Signup and view all the answers

    What should be included in a Yellow Card report?

    <p>The brand name and batch number of the medication</p> Signup and view all the answers

    What is the term for the process of stopping a medication and observing the patient's response?

    <p>Dechallenge</p> Signup and view all the answers

    What is a risk factor for allergic reactions to medications?

    <p>Atopic background</p> Signup and view all the answers

    Who can report suspected adverse drug reactions?

    <p>Healthcare professionals, patients, parents, and carers</p> Signup and view all the answers

    How can suspected adverse drug reactions be reported?

    <p>All of the above, plus via the app or by downloading a form</p> Signup and view all the answers

    What is the purpose of the Yellow Card Scheme?

    <p>To monitor the safety of medicines</p> Signup and view all the answers

    What types of reactions should be reported in children?

    <p>All suspected reactions, regardless of severity</p> Signup and view all the answers

    What is the Black Triangle Scheme?

    <p>A scheme to monitor the safety of new medicines and vaccines</p> Signup and view all the answers

    What should be included in a Yellow Card report?

    <p>Details about the person affected, the drug(s) taken, the reaction experienced, and the person reporting</p> Signup and view all the answers

    What is the purpose of the Drug Safety Update?

    <p>To provide the latest information and advice on the safe use of medicines</p> Signup and view all the answers

    Who has a professional responsibility to advise people on the reporting of suspected adverse drug reactions?

    <p>All healthcare professionals</p> Signup and view all the answers

    What type of reactions should be reported, even if the reaction is well recognized?

    <p>All suspected reactions to established drugs</p> Signup and view all the answers

    What is the three-step approach to reporting suspected adverse drug reactions?

    <p>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</p> Signup and view all the answers

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