Pharm Law Flashcards
What makes a prescription valid?
1) Name, address & signature of prescriber
2) Date of prescribing
3) Name, ID Number (IC/Passport), & contact details of the patient (to whom the prescription relates to)
4) Name & total amount of the prescribed therapeutic product to be supplied, as well as the dose to be taken
Extra circumstances:
5) Prescriber’s intent for the prescription to be repeated (if so, the number of times to be repeated and time period between dispensing)
6) If prescriber is a dentist, to declare “for dental treatment only”
What records should be made for retail sale of any pharmacy-only medicines?
- Date of supply
- Name, ID number (IC/Passport), & contact details of the patient (to whom the product is supplied to)
- Name of therapeutic product (proprietary name or the appropriate non-proprietary name), strength & total amount supplied
- the dosage, frequency & purpose of the treatment for which the supply is made
When should the records be made?
On the day of dispensing (within 24 hours)
How long must the records be kept?
Kept at the dispensary for at least 2 years after the date of supply.
What is required on the dispensing label?
Labelled in English:
- Name of the therapeutic product (proprietary or the appropriate non-proprietary name)
- Where the appropriate non-proprietary name is included on the label, the appropriate quantitative particulars of any active ingredient of the therapeutic product
- Directions for use
- Name of the person to whom the therapeutic product is to be administered
- Date of dispensing
- Name, address & any identification number/logo of the licensed healthcare institution or licensed retail pharmacy where the therapeutic product is supplied or dispensed
What is the compulsory cautionary labels to be included for products containing aspirin/ acetylsalicylic acid for oral administration?
Not to be given to persons below 16 years of age except under the direction of a doctor
What is the compulsory cautionary labels to be included for products containing the following for oral administration:
- Diphenoxylate
- Loperamide
- Anti-histamines
This may cause drowsiness. If affected, do not drive or operate machinery
Describe POM with exemption
Limited supply of a POM by pharmacists WITHOUT prescription, upon review that the product can be used in a safe and effective manner under the supervision of a pharmacist
With specified conditions for the following:
- Indication
- Strength
- Max daily dose
- Max supply
- Age restriction
Describe POM
- Drug can only be obtained from a doctor/dentist, or from a pharmacist with a prescription from a doctor/dentist
- Condition to be treated needs to be diagnosed and treated by a doctor
-Can also have serious side effects which require a doctor’s monitoring or follow up
Describe Pharmacy only medicines (P)
- Can be obtained from a pharmacist at a retail pharmacy
- Condition is self-limiting and can be assessed and treated by pharmacists
Describe GSL
- Can be freely obtained from any retailer
- Can be used safely by the public without medical supervision & intended for short term self treatment only
Regulations on codeine containing cough preparations - health product regulation 2016
- Limited to 240mL (ie two 120mL bottles) per customer
- Must not supply to the same individual more than once within a period of 4 days
- Number of purchases per day must be recorded
- No public display of products
- Compulsory patient counselling by pharmacist
- where codeine cough preparations are supplied to the individual in solid form only or in both liquid and solid forms — an aggregate amount of 355 mg of codeine (calculated as codeine base) contained in the codeine cough preparations supplied.
What are the legal requirements for supply of CDs in S2 or S3?
- Must be in ink/ indelible
- Prescriber’s name & address
- Date & signature of prescriber
- Declaration for dental or veterinary use if any
- Additional requirements to be written in the prescriber’s own handwriting (see another flashcard)
- NO repeats for CD prescriptions
- CD prescriptions cannot be dispensed:
- unless prescribers
address is in Singapore - before date stated on
prescription OR later than
30 days after date stated
on the prescription
- unless prescribers
What are the additional requirements that needs to be handwritten by the prescriber?
- Name and address of patient
- Dose to be taken
- If CD is a preparation, the form (and strength) of the preparation to be supplied
- If CD is a preparation, quantity (words and figures) of preparation or number (words and figures) of dosage units to be supplied
- If CD is not a preparation, quantity (words and figures) of CD to be supplied
- For prescription to be dispensed in instalments, must specify amount of instalments of total amount which may be dispensed, and intervals to be observed when dispensing
