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Competency > Others > Flashcards

Others Flashcards

CD, prescription validity, ADR reporting, Drug Recall

1
Q

What are the requirements for a valid prescription?

A
  • 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
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2
Q

How long can a normal prescription be valid for?

A

1 year (good practice)

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3
Q

How long should a normal prescription be kept for?

A

2 years

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4
Q

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

A
  • Date of supply
  • Name, identification, contact details of recipient
  • Name, strength & total amt of product supplied
  • Dosage, frequency & purpose of tx of supply
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5
Q

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

A
  • 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
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6
Q

When should records of prescription meds be made?

A

on the day or within 24h after supplying to patient

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7
Q

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

A

CPM, within 7 days

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8
Q

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

A

Immediately & within 15 days

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9
Q

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

A
  • serious threat: within 48h
  • others: 15 days
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10
Q

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

A
  • 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
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11
Q

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

A

≥2y

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12
Q

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

A
  • 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
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13
Q

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

A

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

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14
Q

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

A
  • 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
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15
Q

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

A
  • 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
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16
Q

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

A

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

17
Q

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

A

No
(codeine and dextro cannot if exceed max quantities)

18
Q

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

A

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

19
Q

What are the different schedules for CD?

A
  • 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
20
Q

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

A

No

21
Q

Prescription validity for CD (for S2 & S3)?

A
  • 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

22
Q

CD cannot be dispensed when?

A
  • before date stated on prescription
  • ≥30D after date stated on prescription
  • prescriber’s address not in SG
23
Q

Which schedules should CD register be kept for?

A

S2 and S4

24
Q

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

A
  • 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
25
Q

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

A

≥3 years

26
Q

When should you report adverse effects?

A
  • 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.
27
Q

What adverse effects need not be reported?

A

Adverse events caused by accidental or deliberate overdoses and medication errors

Competency (30 decks)

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