Others Flashcards
CD, prescription validity, ADR reporting, Drug Recall
What are the requirements for a valid prescription?
- 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
How long can a normal prescription be valid for?
1 year (good practice)
How long should a normal prescription be kept for?
2 years
What are the records to be kept for sale of P-only drugs?
- Date of supply
- Name, identification, contact details of recipient
- Name, strength & total amt of product supplied
- Dosage, frequency & purpose of tx of supply
What are the records to be kept for supplying POM drugs?
- 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
When should records of prescription meds be made?
on the day or within 24h after supplying to patient
Under Medicines Act, what product needs to be reported for adverse effects? and by when?
CPM, within 7 days
When should adverse effects be reported for TP under HP(TP)R and CTGTP under HP(CTGTP)R?
Immediately & within 15 days
When should defects be reported for TP under HP(TP)R and CTGTP under HP(CTGTP)R?
- serious threat: within 48h
- others: 15 days
What is a ‘serious adverse reaction’ for TPs in HP(TP)R?
- 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
How long should records of adverse effects be kept for TP and CTGTP under their respective regulations?
≥2y
When should defects AND adverse effects be reported for medical devices under HP(MD)R?
- 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
How long should complaints of adverse effects be kept for medical devices under its respective regulations?
≥5y after expiry of projected useful life of medical device
When should defects AND adverse effects be reported for cosmetic products?
- 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
What are the different levels of recall and who are the target audience of the recall?
- 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
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
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
For personal use, can people without license import psychotropic substances and codeine / dextromethorphan?
No
(codeine and dextro cannot if exceed max quantities)
What is the max supply of codeine (amount and duration)?
240ml (liquid form), 355mg (codeine base)
for 7 days
What are the different schedules for CD?
- 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
Are CD licenses required for manufacture, import or export of S1?
No
Prescription validity for CD (for S2 & S3)?
- 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
CD cannot be dispensed when?
- before date stated on prescription
- ≥30D after date stated on prescription
- prescriber’s address not in SG
Which schedules should CD register be kept for?
S2 and S4
What are the requirements for registers for CDs? (6)
- 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
How long should CD records for receipt and supply be kept for?
≥3 years
When should you report adverse effects?
- 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.
What adverse effects need not be reported?
Adverse events caused by accidental or deliberate overdoses and medication errors
