questions (vs) Flashcards

1
Q
  1. Company ABC is a local company and manufactures medical device X and supply (transaction with) X to XYZ company. Which of the following license is required?
    a) Manufacturer’s license
    b) Importer’s license
    c) Wholesaler’s license
    d) Retailer’s license
A

a) Manufacturer’s license

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q
  1. Company AVC manufactures medical devices but does not need a manufacturer’s license. Why?
    a) Private hospitals and medical clinics when manufacturing custom-made medical devices
    b) For laboratory-developed tests
    c) Manufacturing by “secondary assembly”
    d) Manufacturing of Class A devices for charitable purposes
A

a) Private hospitals and medical clinics when manufacturing custom-made medical devices
b) For laboratory-developed tests
c) Manufacturing by “secondary assembly”
d) Manufacturing of Class A devices for charitable purposes

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q
  1. Person A brought 2 BP monitors from MY to SG. Why were the BP monitors not confiscated?
    a) Solely for re-export out of Singapore
    b) Use of specific ‘named patients’
    c) Importing limited quantities solely for personal use
    d) It is an irradiating device, thus licensed under Radiation Protection Act
A

c) Importing limited quantities solely for personal use

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q
  1. A patient comes to XYZ retail pharmacy and there is a ‘pharmacy assistant’. You asked for omeprazole (P only). Why can/can’t the ‘pharmacy assistant’ give the medication?
    a) ‘pharmacy assistant’ = in-store pharmaceutical officer; can give because he has the key to the secure dispensing area.
    b) ‘pharmacy assistant’ = in-store pharmaceutical officer; cannot give because he is not supervised by a qualified pharmacist.
    c) ‘pharmacy assistant’ = in-store pharmaceutical officer; cannot give because he is not supervised by a supervisor/ manager of XYZ.
    d) ‘pharmacy assistant’ = qualified pharmacist; can give because he has a pharmacy license
A

b) ‘pharmacy assistant’ = in-store pharmaceutical officer; cannot give because he is not supervised by a qualified pharmacist.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q
  1. Manufacturers of medical devices must (choose more than 1):
    a) Provide and maintain staff, premises, equipment and facilities for manufacture, handling, storage of devices
    b) Ensure products are of correct identity, and conform with strength, quality and purity
    c) Ensure devices are not wrongly labelled
    d) Comply with requirements of ISO13485
    e) Comply with good manufacturing practices
A

a,c,d

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q
  1. Which of the following are ‘subsets’ of health products? (more than 1)
    a) Medical devices
    b) Cosmetic products
    c) Therapeutic products
    d) Oral dental gum
    e) CTGT
A

all of the above

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q
  1. Company WHO is a wheelchair manufacturing company. WHO sells a range of wheelchairs, from non-automated to automated ones. Which of the following statements is true?
    a) Wheelchair is Class A; Requires a product license and manufacturer’s license
    b) Wheelchair is Class A; Does not require a product license and manufacturer’s license
    c) Wheelchair is Class B; Requires a product license and manufacturer’s license
    d) Wheelchair is Class B; Does not require a product license and manufacturer’s license
A

b) Wheelchair is Class A; Does not require a product license and manufacturer’s license

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q
  1. A research laboratory AST has received skin from its importers. However, the skin was later used to create gene modified cells for a named patient at RAS hospital. Which of the following is true for the lab AST?
    a) Skin is Class 1, Gene modified cells is Class 2, product license and manufacturer’s license is required for both Class 1 and 2
    b) Skin is Class 2, Gene modified cells is Class 1, product license and manufacture’s license is not required for both Class 1 and 2
    c) Skin is Class 1, Gene modified cells is Class 2, product license is not required for Skin but GM cells need product license and manufacture’s license.
    d) Skin is Class 1, Gene modified cells is Class 2, product license is not required for Skin but GM cells does not require product license and requires manufacture’s license.
A

c) Skin is Class 1, Gene modified cells is Class 2, product license is not required for Skin but GM cells

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q
  1. What is the difference between professional use only and trainer use only?
    a) Only qualified practitioners (or under their supervision) can supply by administering or applying to other persons VS Supplier can only operate the medical device
    b) Only qualified practitioners (or under their supervision) can supply by administering or applying to other persons VS Supplier must provide training on safe and efficacious use of device, and ensure every user (operator has been trained)
    c) Only qualified practitioners (i.e., doctors, pharmacists, nurses, etc.) can supply by administering or applying to other persons VS Supplier must provide training on safe and efficacious use of device, and ensure every user (operator has been trained)
    d) Only qualified practitioners (i.e., doctors, pharmacists, nurses, etc.) can supply by administering or applying to other persons VS Supplier must be trained to operate the medical device
A

b) Only qualified practitioners (or under their supervision) can supply by administering or applying to other persons VS Supplier must provide training on safe and efficacious use of device, and ensure every user (operator has been trained)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q
  1. Who can supply and administer a POM product?
    a) Practitioner
    b) Person supervised under the practitioner
    c) Master of the ship with a doctor
    d) Navy corpsman without a doctor
A

a, d

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q
  1. What are the particulars that are required in a valid prescription? (choose more than 1)
    a) Date of prescription
    b) Dosage, frequency and purpose of treatment
    c) Name of product (generic and/or proprietary)
    d) Name, ID no., contact details of patient
    e) Name and address of practitioner
    f) Name and total quantity of product to be supplies, and dose to be taken by patient
    g) Instructions on repeats, if any
    h) Declaration, if prescribed by surgeons – “for surgical treatment only”
A

a) Date of prescription
d) Name, ID no., contact details of patient
e) Name and address of practitioner
f) Name and total quantity of product to be supplies, and dose to be taken by patient
g) Instructions on repeats, if any

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q
  1. What should a ‘signed order’ state for wholesaler of (POM/P) therapeutic product? (choose more than 1)
    a) Recipient’s name and address
    b) Recipient’s name, trade business or profession
    c) Dosage, frequency and purpose of treatment
    d) Name of product (generic and/or proprietary)
    e) Name and total quantity of therapeutic product supplied
A

a) Recipient’s name and address
b) Recipient’s name, trade business or profession
e) Name and total quantity of therapeutic product supplied

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q
  1. Wholesalers must record what kind of details of movement of stocks in Form E record of the Poison Rules?
    a) Date of supply
    b) Date of transaction
    c) Date of delivery
    d) Delivery order/ sales note number
    e) Name and address of purchaser or supplier
    f) Opening stock, quantity transacted, and closing stock
A

b) Date of transaction
d) Delivery order/ sales note number
e) Name and address of purchaser or supplier
f) Opening stock, quantity transacted, and closing stock

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q
  1. Which of the following is true for records, receipts and supply relating to manufacture of therapeutic products under HPA? (Select all that applies)
    a) Name of product
    b) Date on which product is received/supplied
    c) Name and address of person from whom, or to whom, product is received/supplied
    d) Quantity of product received/supplied
    e) Batch number of product received/supplied
    f) Records maintained for 1 year after expiry date of product
    g) 5 years after date of manufacture of product
    h) At least 2 years after date of supply of products
A

all of the above

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q
  1. Which of the following are true for P-only medicines dispensing records of supply? (Select all that applies)
    a) Date of supply
    b) Name, ID no., contact details of patient
    c) Name and address of practitioner
    d) Name and total quantity of P-only product to be supplied, and dose to be taken by patient
    e) Name, strength and total amount of P-only medicine supplied
    f) Dosage, frequency and purpose of treatment
    g) Records must be kept at premises where product is supplied
    h) Records must be made on the day of supply
    i) Records cannot be made after the following day
    j) Records must be kept for at least 2 years after date of supply
    k) Records can be kept for 3 years after date of supply
A

a) Date of supply
b) Name, ID no., contact details of patient
e) Name, strength and total amount of P-only medicine supplied
f) Dosage, frequency and purpose of treatment
g) Records must be kept at premises where product is supplied
h) Records must be made on the day of supply
i) Records cannot be made after the following day
j) Records must be kept for at least 2 years after date of supply
k) Records can be kept for 3 years after date of supply

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q
  1. Pharmacist A dispensed a prescribed therapeutic product to Patient B on 24/12/2021. Which of the following statements are true? (Select all that applies)
    a) Mark the prescription with name and date of dispensing only
    b) Mark the prescription with name, address of dispenser and date of dispensing only
    c) Retain the prescription for at least 2 years after dispensing
    d) Give back the prescription to patient B as it is a repeat prescription
    e) Only records the date of dispensing on 26/12/2021 since pharmacist had to leave early and didn’t come to work because public holiday Christmas.
A

b) Mark the prescription with name, address of dispenser and date of dispensing only
c) Retain the prescription for at least 2 years after dispensing

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q
  1. A CTGT product’s expiry date is 11/2022. The date of manufacture of this CTGT product was 12/2017 (month/year). Which of the following is true? (Select all that applies)
    a) Manufacture record is maintained until 11/2022
    b) Manufacture record is maintained until 12/2022
    c) Manufacture record is maintained until 12/2023
    d) Traceability record is maintained until 11/2052
    e) Traceability record is maintained until 11/2047
    f) Records relating to receipt and supply must be retained until 11/2052
    g) Records relating to receipt and supply must be retained until 11/2047
A

b, d, f

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q
  1. What is identification number also known as? (Select all that applies)
    a) Control number
    b) Lot number
    c) Batch number
    d) Serial number
    e) Tag number
A

a,b,c,d

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q
  1. Which of the following labelling for CPM is required? (Select all that applies)
    a) Proprietary and ‘generic’ name of product
    b) Trade/brand and ‘generic’ name of product
    c) Trade/brand or ‘generic’ name of product
    d) Manufacturing batch number
    e) Registration number
    f) Name and address of distributor/importer and manufacturer
    g) Dose, indications, contraindications, side effects
A

b) Trade/brand and ‘generic’ name of product
d) Manufacturing batch number
f) Name and address of distributor/importer and manufacturer
g) Dose, indications, contraindications, side effects

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q
  1. What are the labels required for “dispensed” therapeutic products? (Select all that applies)
    a) Patient’s name
    b) Date of dispensing
    c) Proprietary or ‘generic’ name of product
    d) Trade/brand or ‘generic’ name of product
    e) Quantitative particulars of active ingredient(s), when ‘proprietary’ name is used
    f) Quantitative particulars of active ingredient(s), when ‘generic name is used
    g) Name, address and ID number and logo of healthcare institution or Pharmacy where product is dispensed
A

a) Patient’s name
b) Date of dispensing
c) Proprietary or ‘generic’ name of product
f) Quantitative particulars of active ingredient(s), when ‘generic name is used

21
Q
  1. Which of the following are required for labelling of key product information of therapeutic products? (Select all that applies)
    a) Proprietary or ‘generic’ name of product
    b) Proprietary and ‘generic’ name of product
    c) Batch number
    d) Product registration number
    e) If loperamide is present, “cause drowsiness” to be stated
    f) If aspirin is present, “not to be given to person below 12 years of age” to be stated
    g) The product should not contain false statement and not suggests the product is promoted or endorsed by HSA/ HPB.
A

b) Proprietary and ‘generic’ name of product
c) Batch number
d) Product registration number
e) If loperamide is present, “cause drowsiness” to be stated
g) The product should not contain false statement and not suggests the product is promoted or endorsed by HSA/ HPB.

22
Q
  1. Which label is not required in dispensing CTGT products but required in key product info of CTGT products?
    a) Excipients, including preservatives
    b) Warnings and precautions on disposal
    c) Name and address of registrant or manufacturer
    d) Expiry date
    e) Storage conditions
A

c) Name and address of registrant or manufacturer

23
Q
  1. When should expiry date be labelled on key product information of cosmetic product? (Select all that applies)
    a) When the number of months between expiry date and manufacture date is less than 30 months
    b) When the number of months between expiry date and manufacture date is more than 30 months
    c) When manufacture date is only specified on the label
    d) When manufacture date is not specified on the label
A

a) When the number of months between expiry date and manufacture date is less than 30 months
c) When manufacture date is only specified on the label
d) When manufacture date is not specified on the label

24
Q
  1. Which of the following definition are correct for ‘adulterated’ drug under the Sales of Drug Act? (Select all that applies)

a) If any substance is ‘undesirable’ or of lesser value has been added to it
b) If it contains any substance or ingredients (other than permitted inactive ingredients) that is not cleared as an ingredient on its label
c) If any ingredient that it should contain has been extracted or omitted from it
d) If it does not comply with any prescribed standard

A

a) If any substance is ‘undesirable’ or of lesser value has been added to it
c) If any ingredient that it should contain has been extracted or omitted from it
d) If it does not comply with any prescribed standard

25
Q
  1. Which of the following medicinal product (CPM) is prohibited?
    a) CPM product containing 0.8g of E. coli
    b) Traditional medicine containing 1 part per million of Arsenic
    c) CPM containing more than 5% of berberine
    d) CPM containing 10% of boric acid
    e) CPM oral preparation containing 4 x 10^2 per gram of yeast and mould
    f) CPM external preparation containing 10^3 of total aerobic microbial count
A

d) CPM containing 10% of boric acid

26
Q
  1. What is considered an ‘unwholesome’ product? (Select all that applies)

a) If it does not conform with its manufacturer’s specifications
b) If it is not of the standard represented on its label
c) If it is modified or interfered with, including introduction or incorporation of any substance or component that is not in its manufacturing specifications
d) If it is presented to resemble or pass off as a registered product when it is not
e) If it is past its expiry date
f) If it is manufactured/ stored in an unsanitary manner, or the product itself is unsanitary and has inappropriate packaging
g) If any of its labelled ingredients has been extracted or omitted from it
h) If it is presented with ‘false information as to its manufacturer or origin’
i) If it contains prohibited substances of substances exceeding permitted levels

A

a) If it does not conform with its manufacturer’s specifications
b) If it is not of the standard represented on its label
e) If it is past its expiry date
f) If it is manufactured/ stored in an unsanitary manner, or the product itself is unsanitary and has inappropriate packaging
g) If any of its labelled ingredients has been extracted or omitted from it
i) If it contains prohibited substances of substances exceeding permitted levels

27
Q
  1. Company HIJ received a compliant from user KLM about a medical device that KLM used. Complaint: infusion pump was malfunctioned and did stop infusion at the specified time. Because of this incident, KLM was brought to the hospital for an overdosage of the drug in the pump. This was not the first time HIJ received such complaints. After a few years, HIJ is intending to recall the infusion pump. What steps should HIJ take? (Select all that applies)
  2. Keep records of all complaints received about the infusion pump
  3. Report to HSA on progress and outcome of recall no later than the 21st day after the date of commencement of the recall
  4. Inform HSA of any intended recall
  5. Report cases of defects to HSA within 10 days
    a) 1  2  4  3
    b) 1  4  3  2
    c) 1  3  4  2
    d) 1  2  3  4
A

b) 1 –> 4 –> 3 –> 2

28
Q
  1. Which of the following dealers are not part of the post-market duties and obligation of dealers?
    a) CPM no license holders
    b) CPM licensed holders
    c) Medical device no licensed holders
    d) CTGT licensed holders
A

a) CPM no license holders

CPM not part of HPA yet, so it falls under Med Act and Med Act post-market duties only applies for licensed dealers

29
Q
  1. Which of the following disease and conditions is not part of the first schedule?
    a) Hypertension
    b) Diabetes
    c) Hyperlipidaemia
    d) Sexual function
A

c) Hyperlipidaemia

30
Q
  1. Which of the following prohibition applies to both healthcare professionals and the general public?
    a) Prohibition against the First Schedule Diseases and Conditions
    b) Claims for ‘unauthorised recommendation’
    c) Advertisement of POM products
    d) Advertisements of “professional use only”
A

b) Claims for ‘unauthorised recommendation’

31
Q
  1. What control replaces the Permit System in the Medicines (Medical Ad) Regulations?
    a) “Unauthorised recommendation” under Medicines Act
    b) “Code of advertising” under HPA (Advertisement of specified health products)
    c) “Code of advertising” under HPA (TP)
    d) Trade purposes under Medicines Act
A

b) “Code of advertising” under HPA (Advertisement of specified health products)

32
Q
  1. KKH is conducting a trial on Pfizer COVID vaccination with 5–12-year-olds. Which of the following are true? (Select all that applies)
    a) Must get written consent from legal representatives
    b) Must get written and oral consent from legal representatives
    c) The trial can only be conducted at KKH
    d) The principal investigator can be a qualified practitioner or someone experienced in the research field
    e) A sponsor takes responsibility for the initiation, management or financing of a clinical trial
A

a) Must get written consent from legal representatives
d) The principal investigator can be a qualified practitioner or someone experienced in the research field
e) A sponsor takes responsibility for the initiation, management or financing of a clinical trial

33
Q
  1. Pharmacist C who has the key to the shelf of controlled drugs is ending her shift and Pharmacist D replaces C. D was tasked to dissolve propiram into a cup of water for a patient. However, the doctor notified last minute that the patient no longer requires it. Which of the following statements are true in this scenario? (Select all that applies)

a) The key should be passed from pharmacist C to pharmacist D when shift is over
b) The mutual exchange of key should be done at the CD cupboard where stocks and balanced are checked and Pharmacist C signs off
c) Pharmacist D can just dispose the solution of propiram by herself and state in the CD register
d) The propiram solution must only be destroyed with the presence and instructions of a CD inspector
e) CD inspector will endose the documenting date of destruction and quantity of CDs destroyed that was written by Pharmacist D

A

a) The key should be passed from pharmacist C to pharmacist D when shift is over
b) The mutual exchange of key should be done at the CD cupboard where stocks and balanced are checked and Pharmacist C signs off
d) The propiram solution must only be destroyed with the presence and instructions of a CD inspector
e) CD inspector will endose the documenting date of destruction and quantity of CDs destroyed that was written by Pharmacist D

34
Q
  1. Which of the following are true for S1 to S4 controlled drugs? (select all that applies)
    a) Any person can administer CDs in S1 to another person
    b) Any person can possess S1 CDs
    c) For hospital wards, the CD register is simplified in the Fifth Schedule
    d) Requisition order and prescription orders are for CDs in S2 and/or S3
    e) A nurse in-charge of the ward can administer S2 or S3 CD drugs to the patient
A

a) Any person can administer CDs in S1 to another person
b) Any person can possess S1 CDs
d) Requisition order and prescription orders are for CDs in S2 and/or S3

Nurse in-charge can supply but only can administer under the instructions of doctor or dentist

35
Q
  1. Which of the following is required for tongue depressors (Class A medical device)
    a) Manufacturer’s license
    b) Importer’s license
    c) Wholesaler’s license
    d) Retailer license
    e) Product license
A

a) Manufacturer’s license
b) Importer’s license
c) Wholesaler’s license
d) Retailer license

36
Q
  1. Which of the following is required for skin (Class 1 CTGT)?
    a) Manufacturer’s license
    b) Importer’s license
    c) Wholesaler’s license
    d) Retailer license
    e) Product license
    f) None of the above
A

none of the above

37
Q
  1. If a product is manufactured in SG but it merely for export (not for SG public use), which of the following is required?
    a) Manufacturer’s license
    b) Importer’s license
    c) Wholesaler’s license
    d) Retailer license
    e) Product license
A

a) Manufacturer’s license

38
Q
  1. Which of the following are GSL items?
    a) CPM
    b) Homeopathic medicines
    c) Traditional medicines
    d) Quasi-medicinal products
    e) Raw materials which are used as ingredients in preparation or manufacture of any medicinal product
    f) Medicated oil and balm
    g) Oral dental gum
A

a) CPM
b) Homeopathic medicines
c) Traditional medicines
d) Quasi-medicinal products
e) Raw materials which are used as ingredients in preparation or manufacture of any medicinal product

39
Q
  1. Which of the following controlled drugs under MDR does not require a prescription?
    a) S1
    b) S2
    c) S3
    d) S4
A

S1

40
Q
  1. Which of the following controlled drugs require a prescription?
    a) S1
    b) S2
    c) S3
    d) S4
A

S2 S3

41
Q
  1. Which of the following controlled drugs require recording of the movement of stocks?
    a) S1
    b) S2
    c) S3
    d) S4
A

S2 S4

42
Q
  1. Which of the following controlled drugs require labelling and authorisation (lock and key)?
    a) S1
    b) S2
    c) S3
    d) S4
A

S2 3 4

43
Q
  1. How long should you keep a record on the manufacturing of therapeutic products?
    a) 1 year after expiry date
    b) 5 years after date of manufacture
    c) 30 years after expiry date
    d) 2 years after expiry date
A

a) 1 year after expiry date

b) 5 years after date of manufacture

44
Q
  1. How long should you keep a record of the manufacture and supply of medical devices?
    a) Projected useful life of the medical device
    b) 2 years after the date on which the medical device is supplied to another person
    c) 30 years after expiry date
    d) 2 years after expiry date
A

a) Projected useful life of the medical device

b) 2 years after the date on which the medical device is supplied to another person

45
Q
  1. How long should you keep a record of the prescribed therapeutic product (P-only and POM)/ prescribed CTGT?
    a) 30 years after expiry date
    b) 2 years after dispensing/supplying the product
    c) 1 year after expiry date
    d) 5 years after date of manufacture
A

b) 2 years after dispensing/supplying the product

46
Q
  1. A Pharmacist would like to renew her practising certificate. Should a pharmacist get registered on 1 Feb 2021. How many CPE points must she get in order for her PC to still be valid from 1/1/2023 to 31/12/2024?
    a) 39 points, and 13 points from pharmaceutical care programmes
    b) 39 points, and 12 points from pharmaceutical care programmes
    c) 40 points, and 12 points from pharmaceutical care programmes
    d) 40 points, and 14 points from pharmaceutical care programmes
A

c) 40 points, and 12 points from pharmaceutical care programmes

47
Q
  1. A Pharmacist would like to renew her practising certificate. Should a pharmacist get registered on 1 October 2025. How many CPE points must she get in order for her PC to still be valid from 1/1/2027 to 31/12/2028?
    a) 23 points, and 6 points from pharmaceutical care programmes
    b) 23 points, and 7 points from pharmaceutical care programmes
    c) 33 points, and 6 points from pharmaceutical care programmes
    d) 33 points, and 7 points from pharmaceutical care programmes
A

b) 23 points, and 7 points from pharmaceutical care programmes

48
Q
  1. Which of the following an inactive pharmacist of more than 5 years need to do in order to renew his/her practising certificate?
    a) Pass examinations prescribed by SPC (forensic exam and/or practice of pharmacy examination)
    b) Fulfil 25 CPE points
    c) Fulfil 20 CPE points
    d) Support of certificate of good standing
    e) Certification by medical practitioner of fitness-to-practice
A

c) Fulfil 20 CPE points

49
Q
  1. Which of the following are required to restore his/her name in the register for someone who has not renewed his practising certificate for 10 years?
    a) Pass examinations prescribed by SPC (forensic exam and/or practice of pharmacy examination)
    b) Fulfil 25 CPE points
    c) Fulfil 20 CPE points
    d) Support of certificate of good standing
    e) Certification by medical practitioner of fitness-to-practice
A

a) Pass examinations prescribed by SPC (forensic exam and/or practice of pharmacy examination)
b) Fulfil 25 CPE points
d) Support of certificate of good standing
e) Certification by medical practitioner of fitness-to-practice