Immunisation, pharmacovigilance and public health

34 Gulf Prometric Pharmacist (DHA, DOH, MOH, SCFHS, QCHP) practice questions on Immunisation, pharmacovigilance and public health, part of Pharmacy Practice, Law and Management. The first 25 are below; the first 5 with answers and explanations (tap Show answer after you have chosen), the rest in Learn with a free account.

1. Question 1 · Medium

   Which of the following vaccines is a live attenuated vaccine that should generally be avoided in pregnancy?

   1. ATetanus toxoid
   2. BHepatitis B vaccine
   3. CInactivated seasonal influenza vaccine
   4. DMeasles, mumps and rubella (MMR)

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   Answer: D · Measles, mumps and rubella (MMR)

   Live attenuated vaccines carry a theoretical risk to the fetus because the weakened virus can replicate. MMR is therefore avoided in pregnancy and should be given before conception or after delivery. Inactivated, toxoid and recombinant vaccines can be used when indicated.

   • A: Tetanus toxoid is used in pregnancy to protect the newborn.
   • B: Hepatitis B is a recombinant vaccine and is safe when needed.
   • C: Inactivated influenza vaccine is recommended in pregnancy.

   Remember this

   Live attenuated vaccines such as MMR are avoided in pregnancy.

2. Question 2 · Medium

   According to the Ottawa Charter, health promotion is best described as:

   1. AInforming the public of the price of medicines
   2. BProviding treatment and rehabilitation to those who are already ill
   3. CScreening for early disease in older adults only
   4. DEnabling people to increase control over their health and improve it

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   Answer: D · Enabling people to increase control over their health and improve it

   The Ottawa Charter defines health promotion as enabling people to increase control over their health and its determinants. It includes building healthy public policy, supportive environments, community action and personal skills, not only treatment.

   • A: Price information is not health promotion.
   • B: Treatment of illness is curative care.
   • C: Screening is a form of secondary prevention.

   Remember this

   Health promotion enables people to increase control over and improve their health (Ottawa Charter).

3. Question 3 · Easy

   Pharmacovigilance is best defined as the science and activities relating to:

   1. ADispensing, storage and record keeping of controlled drugs
   2. BPricing, reimbursement and tendering of new medicines
   3. CTraining of pharmacy students and new pharmacy interns
   4. DDetection, assessment, understanding and prevention of adverse effects

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   Answer: D · Detection, assessment, understanding and prevention of adverse effects

   The WHO definition covers the detection, assessment, understanding and prevention of adverse effects and other medicine-related problems. Pharmacists contribute by reporting suspected adverse drug reactions to the national centre.

   • A: Controlled drug handling is a legal topic.
   • B: Pricing is part of health economics.
   • C: Education is not pharmacovigilance.

   Remember this

   Pharmacovigilance covers detection, assessment, understanding and prevention of adverse effects.

4. Question 4 · Easy

   A pharmacy has a dedicated vaccine refrigerator. Which of these must never be stored in it?

   1. AVaccines in their original cartons
   2. BWater bottles that steady the temperature
   3. CDiluents supplied with the vaccines
   4. DStaff food and drinks

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   Answer: D · Staff food and drinks

   A vaccine refrigerator is used only for vaccines and related products. Food and drinks bring frequent door opening, temperature swings and contamination, and are never kept in it. Vaccines stay in their cartons to protect them from light, diluents may be stored with them, and water bottles in unused space help keep the temperature stable.

   • A: Original cartons protect vaccines from light and are recommended.
   • B: Water bottles are advised to buffer temperature changes.
   • C: Diluents may be stored in the refrigerator with their vaccines.

   Remember this

   Keep only vaccines and related products in a vaccine refrigerator, never food or drink.

5. Question 5 · Hard

   In a trial, the attack rate of influenza was 2% in vaccinated adults and 10% in unvaccinated adults. What is the vaccine efficacy?

   1. A20%
   2. B80%
   3. C8%
   4. D98%

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   Answer: B · 80%

   Vaccine efficacy = (attack rate in unvaccinated - attack rate in vaccinated) / attack rate in unvaccinated = (10 - 2) / 10 = 0.8, which is 80%. It is the proportional reduction in risk, not the absolute difference in attack rates.

   • A: 20% is the ratio of the two attack rates (2/10), not the reduction.
   • C: 8% is the absolute difference in percentage points, not the proportional reduction.
   • D: 98% subtracts the vaccinated attack rate from 100%.

   Remember this

   Vaccine efficacy = (attack rate unvaccinated minus vaccinated) divided by the unvaccinated attack rate.

6. Question 6 · Hard

   A man stops long-term propranolol suddenly and is admitted with rebound tachycardia and chest pain. Which type of adverse reaction does this represent?

   1. AType C, a chronic reaction from long-term use
   2. BType A, an augmented reaction
   3. CType D, a delayed reaction
   4. DType E, an end-of-use or withdrawal reaction

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7. Question 7 · Hard

   A Dubai clinic's vaccine refrigerator data logger shows the temperature rose to 11 degrees Celsius for about 3 hours overnight, then returned to range. It holds several vaccine types. What is the best action?

   1. AUse the vaccines first, since the temperature returned to range afterwards
   2. BQuarantine at 2 to 8 degrees, label as not for use, and seek manufacturer stability advice
   3. CDiscard everything at once without seeking any further advice or data
   4. DMove them to the freezer for safety

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8. Question 8 · Medium

   Before packing freeze-sensitive vaccines in a cold box for an outreach clinic, the frozen ice packs should first be:

   1. AConditioned until the pack sweats and the ice moves inside
   2. BReplaced with dry ice to keep temperatures stable
   3. CWrapped in foil and left frozen hard
   4. DPlaced straight from the freezer next to the vials in the box

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9. Question 9 · Hard

   A refrigerator fault freezes the stock at minus 4 degrees Celsius for two hours. Which pair of vaccine vials must be discarded?

   1. AHepatitis B and diphtheria-tetanus-pertussis vaccines
   2. BMeasles-rubella and oral polio vaccine vials together
   3. CVaricella and oral polio vaccines
   4. DMeasles-rubella and varicella vaccines

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10. Question 10 · Hard

    A suspected adverse drug reaction is assessed with the Naranjo scale. Previous reports exist (+1), the event followed the drug (+2), the reaction improved after withdrawal (+1), no alternative cause was found (+2), and objective evidence exists (+1). Other items scored 0. What is the causality category?

    1. APossible
    2. BProbable
    3. CDefinite
    4. DDoubtful

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11. Question 11 · Medium

    Under the WHO multi-dose vial policy, which of these opened vials can usually be used for up to 28 days?

    1. AA liquid hepatitis B vial kept cold with a good VVM and no contamination
    2. BA reconstituted BCG vial stored in the refrigerator overnight between clinic sessions
    3. CAny opened vial whose label has been lost but which was kept in the refrigerator
    4. DA reconstituted measles vial kept on the counter during the whole clinic day

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12. Question 12 · Medium

    Which description fits a serious adverse drug reaction for pharmacovigilance reporting?

    1. AAny reaction listed in the product leaflet
    2. BA reaction that leads to hospital admission
    3. CAny reaction needing the dose to be lowered
    4. DA reaction that is unpleasant but settles at home

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13. Question 13 · Medium

    A pharmacist in Riyadh notices that a patient developed lip and tongue swelling a week after starting ramipril, and the doctor has stopped it. What should the pharmacist do next regarding pharmacovigilance?

    1. AReport it to the national pharmacovigilance centre
    2. BWait until causality is proven with a rechallenge before reporting
    3. CRecord it in the patient file only and not report it further
    4. DReport only if the patient is admitted to hospital

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14. Question 14 · Easy

    A vaccine vial monitor (VVM) on a vial label indicates:

    1. AWhether the vial has been frozen
    2. BThe date on which the vial was opened
    3. CThe batch's expiry date
    4. DThe cumulative heat exposure of the vial

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15. Question 15 · Medium

    A patient develops anaphylaxis minutes after the first dose of an antibiotic. Which type of adverse drug reaction is this, and what is the key feature?

    1. AType B (bizarre): unpredictable and not related to the dose
    2. BType A (augmented): predictable, dose-related and linked to the drug's action
    3. CType D: delayed carcinogenic effect
    4. DType C: related to long-term use

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16. Question 16 · Easy

    Which of the following is an example of primary prevention?

    1. ACardiac rehabilitation after infarction
    2. BMammography screening
    3. CChildhood immunisation
    4. DInsulin treatment of existing diabetes

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17. Question 17 · Easy

    Which vaccine is damaged by freezing and must never be allowed to freeze in the refrigerator?

    1. AVaricella vaccine
    2. BOral polio vaccine
    3. CLyophilised measles vaccine
    4. DHepatitis B vaccine

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18. Question 18 · Medium

    A pharmacist suspects that a vial of aluminium-adjuvanted vaccine has been frozen. The shake test is performed against a control vial. What result suggests freeze damage?

    1. AThe suspect vial stays cloudy longer than the control
    2. BThe suspect vial changes colour to yellow
    3. CThe suspect vial sediments faster than the control
    4. DBoth vials form a clear layer at the same speed

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19. Question 19 · Easy

    At what temperature range should most vaccines be stored in a refrigerator?

    1. A8 to 15 degrees Celsius
    2. B-20 to -10 degrees Celsius
    3. C15 to 25 degrees Celsius
    4. D2 to 8 degrees Celsius

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20. Question 20 · Medium

    Pilgrims travelling from India to Saudi Arabia for Umrah must show proof of vaccination against which disease?

    1. ARabies (pre-exposure prophylaxis)
    2. BTyphoid fever (oral live vaccine)
    3. CHepatitis A (inactivated vaccine)
    4. DMeningococcal disease (quadrivalent ACWY)

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21. Question 21 · Medium

    A woman at 14 weeks of pregnancy asks for a missing MMR vaccine because her rubella serology shows no immunity. What is the best advice?

    1. AGive half the usual dose now and the second half after delivery
    2. BGive it today, since the vaccine is inactivated and safe in pregnancy
    3. CDefer it; vaccinate after delivery and advise avoiding rubella contacts
    4. DGive it today and counsel about possible termination because of the fetal risk

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22. Question 22 · Easy

    The main purpose of spontaneous adverse drug reaction reporting after a medicine is marketed is to:

    1. AProve that a drug caused a reaction
    2. BReplace clinical trials before approval
    3. CDetect new or rare safety signals
    4. DMeasure the exact incidence of every reaction

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23. Question 23 · Hard

    A clinic plans to vaccinate 450 children using 10-dose vials of a liquid vaccine. Expected wastage is 20% (wastage factor 1.25). How many vials should be ordered?

    1. A45
    2. B57
    3. C63
    4. D56

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24. Question 24 · Medium

    A black inverted triangle printed next to a newly licensed medicine's name in the product information means that the medicine:

    1. ACan be dispensed only against a hospital specialist's prescription
    2. BIs unlicensed and imported
    3. CHas been withdrawn from the market because of safety concerns
    4. DIs under additional monitoring, so report all suspected reactions

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25. Question 25 · Medium

    A pharmacist who gives vaccines in a Dubai pharmacy should keep adrenaline for anaphylaxis. What is the correct adult intramuscular dose of adrenaline 1 mg/mL?

    1. A0.5 mg (5 mL) as a rapid intravenous bolus
    2. B0.5 mg (0.5 mL) into the anterolateral thigh
    3. C5 mg (5 mL) intramuscularly into the thigh
    4. D0.1 mg (0.1 mL) subcutaneously into the upper arm

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