Adverse Drug Reactions: Detection, Prevention and Reporting
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Questions and Answers

What is the primary difference between an adverse drug reaction and a side effect?

  • The causal relationship with the medicinal product (correct)
  • The severity of the reaction
  • The novelty of the reaction
  • The intentionality of the reaction

    • What is the primary purpose of the 'Yellow card' scheme?

  • To track patient compliance with medication regimens
  • To educate patients about medication side effects
  • To report suspected adverse drug reactions (correct)
  • To monitor medication errors

    • What is the minimum requirement for a causal relationship between a medicinal product and an adverse event?

  • The product is the probable cause of the event
  • The product is a likely cause of the event
  • The product is the only possible cause of the event
  • There is at least a reasonable possibility of a causal relationship (correct)

    • What type of adverse drug reaction is an allergic reaction an example of?

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

    What is the primary objective of identifying patient groups most at risk from adverse drug reactions?

    <p>To reduce the risk of adverse drug reactions</p> Signup and view all the answers

    In the scenario described, what is the potential medication error that could occur with Fred's treatment?

    <p>Overdose due to miscommunication</p> Signup and view all the answers

    What is the primary purpose of pharmacovigilance?

    <p>To detect and prevent adverse effects of medicines</p> Signup and view all the answers

    What is the average number of people who would have taken a medicine by the time it receives marketing authorisation?

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

    What type of adverse drug reactions are unlikely to be detected in clinical trials?

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

    Who is responsible for pharmacovigilance in the UK?

    <p>Medicines and Healthcare Regulatory Agency (MHRA)</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

    Who can report suspected ADRs?

    <p>All healthcare professionals, including pharmacists, people taking medicines, parents, and carers</p> Signup and view all the answers

    What is the most likely reason for Fred's prescribed dose of clobazam being increased to 40mg at night?

    <p>To help with his 'behaviours'</p> Signup and view all the answers

    What information should be clearly stated in an ADR report?

    <p>Brand name and batch number of the medicine</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 is the role of pharmacists in the Yellow Card Scheme?

    <p>To advise patients on the reporting of suspected ADRs</p> Signup and view all the answers

    What type of reactions must be reported to the Yellow Card Scheme?

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

    What is the primary mechanism of Type B ADRs?

    <p>Immune system-mediated</p> Signup and view all the answers

    What is the purpose of the MHRA?

    <p>To grant marketing authorisations, approve clinical trials, inspect manufacturing facilities, and classify medicines</p> Signup and view all the answers

    Which of the following is a risk factor for ADRs?

    <p>Age (very old and very young)</p> Signup and view all the answers

    What is the primary goal of assessing a person with a suspected ADR?

    <p>To assess the nature and severity of the reaction</p> Signup and view all the answers

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

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

    What is the term for the study of how genetic variations affect the metabolism of medications?

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

    What is the primary concern in managing a person with a suspected ADR?

    <p>Urgent action may be required to manage the reaction</p> Signup and view all the answers

    What is the term for the review of ADR information, including the BNF and SmPC?

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

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

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

    What is the primary purpose of the Black Triangle Scheme?

    <p>To encourage extra monitoring of certain medicines</p> Signup and view all the answers

    What type of reactions should be reported in older people (>65)?

    <p>All suspected reactions, including minor side-effects</p> Signup and view all the answers

    What is the purpose of the Drug Safety Update?

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

    What information should be included in a Yellow Card report?

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

    What is the main benefit of considering the benefit-risk ratio when prescribing?

    <p>To minimize the risk of ADRs</p> Signup and view all the answers

    What is the correct sequence of steps to decide whether to report an ADR using the Yellow Card system?

    <p>Step 1: Decide if the reaction is in a child, Step 2: Decide if the reaction is serious, Step 3: Check if it's a black triangle drug</p> Signup and view all the answers

    What type of medicines should be reported on a batch-to-batch basis?

    <p>Biological medicines and vaccines</p> Signup and view all the answers

    Why is it important to consider the patient's medical history when reporting an ADR?

    <p>To determine if the patient has had a previous ADR</p> Signup and view all the answers

    What is the purpose of the Yellow Card Scheme?

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

    What should a prescriber consider when trying to prevent ADRs?

    <p>The benefit-risk ratio, 'at risk' groups, and potential interactions</p> Signup and view all the answers

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