Pharmacovigilance: Adverse Drug Reactions
78 Questions
0 Views

Choose a study mode

Play Quiz
Study Flashcards
Spaced Repetition
Chat to Lesson

Podcast

Play an AI-generated podcast conversation about this lesson

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 (C)</p> Signup and view all the answers

What is a risk factor for ADRs?

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

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

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

What percentage of white people has inactive CYP2D6?

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

What is the name of the enzyme that metabolizes warfarin?

<p>CYP2C9 (D)</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 (A)</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 (B)</p> Signup and view all the answers

What is the purpose of the Yellow Card Scheme?

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

What is the agency responsible for pharmacovigilance in the UK?

<p>MHRA (D)</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 (B)</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 (A)</p> Signup and view all the answers

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

<p>Type B (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 (A)</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 (D)</p> Signup and view all the answers

What is the purpose of the Black Triangle Scheme?

<p>To monitor new medicines and vaccines (C)</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 (A)</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 (C)</p> Signup and view all the answers

What is the purpose of the Yellow Card Scheme?

<p>To report all suspected ADRs (D)</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) (A)</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 (B)</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 (A)</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 (A)</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 (A)</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. (A)</p> Signup and view all the answers

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

<p>£83.7 million (D)</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. (C)</p> Signup and view all the answers

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

<p>5% (A)</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. (A)</p> Signup and view all the answers

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

<p>1 in 25 (B)</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 (A)</p> Signup and view all the answers

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

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

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

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

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

<p>Type B (C)</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 (D)</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 (B)</p> Signup and view all the answers

What should be included in a Yellow Card report?

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

What is the agency responsible for pharmacovigilance in the UK?

<p>MHRA (A)</p> Signup and view all the answers

Who can report suspected adverse drug reactions?

<p>All healthcare professionals, patients, parents, and carers (A)</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 (A)</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 (A)</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 (B)</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 (D)</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 (C)</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 (C)</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 (D)</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 (A)</p> Signup and view all the answers

What is the purpose of the Yellow Card Scheme?

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

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

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

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

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

What is the characteristic of Type B ADRs?

<p>Not predictable from pharmacology (A)</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% (D)</p> Signup and view all the answers

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

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

What is a risk factor for ADRs?

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

What is the main consequence of polymorphisms in CYP450 enzymes?

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

What is the characteristic of CYP2D6 substrates?

<p>They include antidepressants, antipsychotics, and cardiac drugs (B)</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 (D)</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 (A)</p> Signup and view all the answers

What is the role of the MHRA in pharmacovigilance?

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

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

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

What is the purpose of the Yellow Card Scheme?

<p>To monitor the safety of medications (B)</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 (C)</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 (B)</p> Signup and view all the answers

What is a risk factor for allergic reactions to medications?

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

Who can report suspected adverse drug reactions?

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

What is the purpose of the Yellow Card Scheme?

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

What types of reactions should be reported in children?

<p>All suspected reactions, regardless of severity (A)</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 (D)</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 (D)</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 (A)</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 (B)</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 (A)</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 (A)</p> Signup and view all the answers

More Like This

Use Quizgecko on...
Browser
Open
Browser
Browser