labeling Flashcards
requirements for main label
- name of preparation
- name and strength of active ingredient
- dosage form of preparation
- total quantity
- precise instructions for use (in active/ passive)
- patient’s name
- ref no
- date
- exp date
- name and address of pharmacy
what are the auxillary labels to ensure proper preparation, storage and disposal
- shake the bottle
- store in a cool place
- refrigerate, do not freeze
- discard after xx
what are the auxillary labels used to ensure proper route of administration
for topical use on skin
- IN RED: for external use only
for eye, nasal, otic, vaginal or rectal use
- IN RED: not to be taken
for mouthwashes and gargles
- IN RED: not to be taken in large quantities
for linctus
- IN BLACK: sip and swallow slowly
what are the auxillary labels to ensure proper administration
- take on empty stomach
- take with a full glass of water
- finish all this medication
what are the auxillary labels that serve as warning labels about potential ADRs
- warning. may cause drowsiness. if affected, fo not drive or operate machinery.
- avoid sun exposure
- may cause discoloration of urine or feces
what are the auxillary labels serving as warning labels for potential drug-drug or drug-food interactions
- avoid alcohol while on this medication
roman numbers
ss = 1/2
L = 50
C = 100
D = 500
M = 1000
if bar above letter = increase value by 1000x
explain various percentage concentrations
%w/v = number of grams (g) of constituent in 100mL of solution
%v/v = number of millilitres (mL) of constituent in 100mL of solution
%w/w = number of grams (g) of constituent in 100g of preparation
equation for specific gravity
sp g = density of substance/ density of water
density of water = 1g/mL
concert concentration to mg/mL: what is 4%(w/v) to mg/mL
40mg/mL
1% is 1g/100mL
thus 4% is 4g/100mL
= 4000mg/100mL
convert product ratio to mg/mL: what is 1:10000 (w/v) to mg/mL
1 refers to the mass of solute in g
10000 refers to volume of solution in mL
thus this ratio is 1g:10000mL
1000mg:10000mL = 1mg:10mL
conc = mass of solute/ volume of solution = 1/10 = 0.1mg/mL
what are the legal requirements for a valid Rx
- prescriber’s name, address and signature
- prescribing date
- patient’s name, ID and contact details
- info of prescribed therapeutic product (name and total amount to be supplied, dose to be taken)
- prescriber’s intent for prescription to be repeated (number of times to be repeated, time period between dispensing)
- “for dental treatment only” if dentist
what are the requirements for a repeated Rx
- if balance left, photocopy Rx for record and return original to patient
- if zero balance left, retain original Rx and permanent records of past collections for filling for ≥2yrs
what are the requirements for dispensing records
each record must have
- date of supply
- name, ID, contact details of patient
- name of therapeutic product and total amount supplied
- name and address of prescriber who signed the Rx
records must be
- made on day of dispensing (within 24hrs)
- kept at dispensary for ≥2yrs
- made available for inspection by HSA at all reasonable time
what are the requirements for records of direct retail sales of therapeutics, without Rx (P only, or POM with exemption)
- to be entered by the pharmacist who made the supply
- to be kept at the retail pharmacist where the supply was made
- to be done for every supply on the day of the supply
- to be retained for ≥2yrs after date of supply
- to be made available for HSA
records should contain
- date of supply
- name, strength of therapeutic product supplied and total amount supplied
- dosing of therapeutic product
- name, ID and contact details of the patient
- purpose of treatment for which supply is made
- identification number
