questions (vs) Flashcards
- 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) Manufacturer’s license
- 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) 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
- 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
c) Importing limited quantities solely for personal use
- 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
b) ‘pharmacy assistant’ = in-store pharmaceutical officer; cannot give because he is not supervised by a qualified pharmacist.
- 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,c,d
- 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
all of the above
- 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
b) Wheelchair is Class A; Does not require a product license and manufacturer’s license
- 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.
c) Skin is Class 1, Gene modified cells is Class 2, product license is not required for Skin but GM cells
- 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
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)
- 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, d
- 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) 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
- 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) Recipient’s name and address
b) Recipient’s name, trade business or profession
e) Name and total quantity of therapeutic product supplied
- 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
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
- 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
all of the above
- 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) 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
- 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.
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
- 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
b, d, f
- 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,b,c,d
- 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
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