Others

Question 1

What are the requirements for a valid prescription?

Answer 1

• name, IC, contact details of patient
• Dr’s name, signature, address of place of practice
• date of prescription
• name & total amt of product to be supplied, & dose to be taken by pt
• for dental use
• number of repeats

Question 2

How long can a normal prescription be valid for?

Answer 2

1 year (good practice)

Question 3

How long should a normal prescription be kept for?

Answer 3

2 years

Question 4

What are the records to be kept for sale of P-only drugs?

Answer 4

• Date of supply
• Name, identification, contact details of recipient
• Name, strength & total amt of product supplied
• Dosage, frequency & purpose of tx of supply

Question 5

What are the records to be kept for supplying POM drugs?

Answer 5

• Date of supply
• Name, identification, contact details of recipient
• Name, strength & total amt of product supplied
• Name & address of qualified practitioner / collaborative prescribing practitioner who signed the prescription
• for codeine: record purpose

Question 6

When should records of prescription meds be made?

Answer 6

on the day or within 24h after supplying to patient

Question 7

Under Medicines Act, what product needs to be reported for adverse effects? and by when?

Answer 7

CPM, within 7 days

Question 8

When should adverse effects be reported for TP under HP(TP)R and CTGTP under HP(CTGTP)R?

Answer 8

Immediately & within 15 days

Question 9

When should defects be reported for TP under HP(TP)R and CTGTP under HP(CTGTP)R?

Answer 9

• serious threat: within 48h
• others: 15 days

Question 10

What is a ‘serious adverse reaction’ for TPs in HP(TP)R?

Answer 10

• May result in death / threaten a person’s life
• Results in person hospitalised / prolongs a hospital stay
• Results in persistent / significant disability / incapacity
• Results in a congenital anomaly / birth defect
• Is judged to be medically impt even tho the effect might not be immediately life-threatening or result in death or hospitalisation, but may jeopardise the person’s health / may require intervention to prevent person’s death or one of the other outcomes above

Question 11

How long should records of adverse effects be kept for TP and CTGTP under their respective regulations?

Answer 11

≥2y

Question 12

When should defects AND adverse effects be reported for medical devices under HP(MD)R?

Answer 12

• Defect representing a serious threat to persons / public health → within 48h after dealer becomes aware of defect
• Led to the death / serious deterioration in state of health → within 10 days after dealer becomes aware of defect
• Recurrence might lead to death / serious deterioration in state of health → within 30 days after dealer becomes aware of defect

Question 13

How long should complaints of adverse effects be kept for medical devices under its respective regulations?

Answer 13

≥5y after expiry of projected useful life of medical device

Question 14

When should defects AND adverse effects be reported for cosmetic products?

Answer 14

• Death / may be life-threatening → within 7 days, & detailed report within 8 days after initial report
• May result in person hospitalised / may cause persistent / significant disability / incapacity → within 15 days

Question 15

What are the different levels of recall and who are the target audience of the recall?

Answer 15

• consumer: unacceptable risk; all wholesale & retail supply of affected batches recalled from all wholesale, retail distributors & pts
• retail: moderate-high risk; all wholesale & retail supply from all wholesale & retail distributors
• wholesale: low risk; all wholesale supply from all wholesalers & distributors

Question 16

What are the two types of recall and how do they differ in terms of:
- defect
- when to notify HSA
- issue dear purchaser letter
- issue DHPL
- complete recall process

Answer 16

Class 1
- defect: critical (serious adverse health consequences or death)
- when to notify HSA: at least 24h before start of recall
- issue dear purchaser letter: within 1 day of recall commencement
- issue DHPL: within 1 day of recall commencement
- complete recall process: within 1 week

Class 2
- defect: non-critical (temporary / medically reversible adverse health consequences OR probability of serious adverse health consequences is remote)
- when to notify HSA: at least 24h before start of recall
- issue dear purchaser letter: within 3 days of recall commencement
- issue DHPL: within 3 days of recall commencement
- complete recall process: within 3 weeks

Question 17

For personal use, can people without license import psychotropic substances and codeine / dextromethorphan?

Answer 17

No
(codeine and dextro cannot if exceed max quantities)

Question 18

What is the max supply of codeine (amount and duration)?

Answer 18

240ml (liquid form), 355mg (codeine base)
for 7 days

Question 19

What are the different schedules for CD?

Answer 19

• First schedule: Preps containing CD in small quantities or formulated in such manner as to have relatively low risk of being abused
• Second schedule: CD with high risk of abuse but also have uses as medicines
• Third schedule: CD with uses as medicines but relatively less risk of abuse cf CD in S2
• Fourth schedule: CD with high potential for abuse & little therapeutic value

Question 20

Are CD licenses required for manufacture, import or export of S1?

Answer 20

No

Question 21

Prescription validity for CD (for S2 & S3)?

Answer 21

• name & address of pt
• dr name, address, signature, date
• drug name, dosing regimen, dosage form, strength, total quantity (words & figures) of the prep / number of dosage units (words & figures) to be supplied
• instalments: amt of instalments of the total amt which may be dispensed & intervals to be observed when dispensing
• for dental / vet use

no need handwrite

Question 22

CD cannot be dispensed when?

Answer 22

• before date stated on prescription
• ≥30D after date stated on prescription
• prescriber’s address not in SG

Question 23

Which schedules should CD register be kept for?

Answer 23

S2 and S4

Question 24

What are the requirements for registers for CDs? (6)

Answer 24

• bound book
• each premise has their own
• separate book for each strength / prep
• make entries on the same day (or latest next day)
• no cancelling, use footnote to make correction
• must be in ink

Question 25

How long should CD records for receipt and supply be kept for?

Answer 25

≥3 years

Question 26

When should you report adverse effects?

Answer 26

- All adverse events occurring with the use of new health products i.e. those marketed in Singapore for less than 5 years. - All serious adverse events, even if the events are well known - Unexpected adverse events such as those not consistent with the product package insert or labelling.

Question 27

What adverse effects need not be reported?

Answer 27

Adverse events caused by accidental or deliberate overdoses and medication errors