Packaging and labelling of medicines Flashcards
Name of medicine should be..
Displayed clearly even on brands
Expression of strength
um - ALWAYS as micrograms (avoid confusion - easily read by patients)
Dosage
- ONLY necessary when product is intended for self-medication
- Supplied on prescription = dose added at the time of dispensing
- WARNINGS - marketing authorisation
ONLY over-the-counter medicines
- indications are required on packaging fro GSL and P medicines
Packaging appearance
- Space of the placement of the dispensing label
- Use of colour is to be encouraged
- different font
(AVOID different drug being picked up and prescribed)
Blister packs (packs within the cardboard box)
- Name
- Strength and form
- Babies, children or adults
- Common names (if up to thee active substances)
- Expiry date
- Batch number
- Holder of the pharmacy authorisation
Other medicines / special packaging instructions
Radio-nucleotides (showing images)
Child safety
- suitable, resistant packaging should be used supplying all solid, all oral and external liquid dose preparations
- UNLESS there is a good reason not to:
1. request of difficulty opening
2. official pack may not be child resistant
Dispensing labels
- name of patient
- Name and address of pharmacy
- date of dispensing
- name of medicine
- Directions of the medicine
- precautions
The patient
- Full Name
- Title of patient (if possible)/ helps distinguish between family members
The medicine - directions..
Active NOT passive
- ‘Take two’ NOT ‘Two to be taken’
Liquid medicines - dosage
‘10ml tds’
comes with 5ml spoons
-pharmacist has to TRANSLATE
‘5ml spoonfuls to be taken 3 times a day’
=15ml
Simple language
- give
- numbers = a hundred NOT 100
(confusion between 10 + 100)
RPharms S recommendations for labels
By law - messages (mostly are reiterated and written again)
-‘keep out of the reach and sight of children’
- ‘use this medicine only on your skin, not for consumption’
warning labels
- pharmacists recommended to add (as well as the other message)
-e.g ‘take medicine when stomach is empty’ explanation of what an empty stomach is - cause drowsiness
- other food or medicines that should be avoided
- what to do if they MISS dosage
- discolouration of urine
- some meds taken weekly NOT daily
Outer containers (likely to be thrown away)
- law states to label outer container
- lot of pharmacist labels inner as well to avoid any confusion how to take drug, expiry date and strength of drug
Optimisation of labelling
-remove info that is not necessary
-only important info: directions of use, name or common name, precautions
By law, all dispensing labels must have “keep out of sight and reach of children” TRUE or FALSE?
- FALSE = only a recommendation
- this is displayed on outer packaging anyway
Patient info leaflets (PILs)
- legal requirement in UK since 1999
SPC
Summaries of product Characteristics
= description of medicinal products properties and conditions attached to its use
UNLESS
- Medicinal product is manufactured or assembled in pharmacy
- all the required info is conveyed on the outer packaging or the immediate packaging
Identification of the medicine
- name, active substance (s), the pharmaceutical form, and strength of product should be stated
Therapeutic indications
conditions should be authorised
Info necessary before talking medicines
- situations where medicine should NOT be used
- precautions/ warning
- Pregnant women/ nursing mothers
Dosage
- side effects
- how to take medicine/ directions/ route
- way side effects are listed - most common to least common
Additional info
- excipient details
- description of the product
- registered pack size
- storage conditions
- name and address of the MAH and manufacturer
MAH
Marketing authorisation holder
Accessibility
- name expressed in Braille format (for the blind)
- packaging of the product
