Sale And Supply Of Medicines Flashcards
What is a container?
In law, the inner receptacle which actually contains the medicinal
products is a container.
What is a package?
Every outer receptacle is a package (this is sometimes referred to as
the outer container)
What are the packaging requirements?
- Name of the medicine
- Expression of strength
- Route of administration
- Dosage
- Warnings
What is the name of the medicine defined by?
The name is defined as comprising the name, strength and
pharmaceutical form of the medicine
-Where the medicine contains up to three active ingredients, the
names of these should immediately follow the name of the medicine
on the pack
On the packaging, is abbreviation allowed?
NO
*For safety reasons it is important that ’micrograms’ is spelled out in
full and not abbreviated.
Route of administration: positive
Positive messages should be used; for example ”give by …”
Route of administration:nonpos
Non-standard routes of administration should be spelt out in full to
avoid confusion.
other routes of administration
Some routes of administration will be unfamiliar to patients and may
need careful explanation.
When Is a told dosage necessary?
- This will be necessary only when the product is intended for self-
medication. - Medicines that are supplied on prescription would have the dose
added at the time of dispensing.
warnings and medicine?
Only warnings, specifically required by the terms of the marketing
authorisation to be stated on the packaging
What medicines require indications?
Only over—the—counter medicines (P or GSL) need to make
reference to the approved indications
What is on blister packs?
- Name
- Strength and form
- Babies, children or adults?
- Common names (if up to three active substances)
- Expiry date
- Batch number
- Holder of the marketing authorisation
Other medicine pack type?
*small packs
*radionucleotides
When is child safety packaging ignored/ removed?
- Specific request if difficulty opening
- Original pack may not be child resistant
- No child-resistant packaging exists for a particular liquid medicine
What is the legal requirement on dispensing labels?
- Name of the patient
- Name and address of the supplying pharmacy
- Date of dispensing
- Name of the medicine
- Directions for use
- Precautions/warnings relating to the use of the medicine
How to word directions for medicines?
Active rather than passive verbs for directions.
* ‘Take TWO’ (not ‘TWO to be taken’)
* ‘Use ONE’ (not ‘ONE to be used’)
* ‘Insert ONE’ (not ‘ONE to be inserted’)
* Adjacent numbers should be separated by the formulation name.
* ‘Take TWO tablets THREE times a day’ NOT ‘Take TWO THREE times a day
What are some useful phrases to remember in pharmacy administration?
- Never use the word ‘Take’ on a preparation that is not intended for the oral
route of administration. - Use ‘Give’ as a dosage instruction on products for children as a responsible
adult should administer them. - Only use numerals when quoting the number of millilitres to be given or
taken. All other dosage instructions should use words in preference to
numerals. - Always be prepared to give the patient a verbal explanation
RpharmS recommendations for labels?
The following should also appear on the dispensing label:
* ’Keep out of the reach and sight of children’
* ’Use this medicine only on your skin’ where applicable.
What are some example warnings?
- Co-ordination, performance of skilled tasks (e.g. driving or work)
- Foods or medicines to be avoided
- What to do if a dose is missed
- Possibility of staining of the clothes or skin,
- Discolouration of urine or stools
- Unusual method or time of administration
- Potential interaction with a common food or domestic remedy
rules and advice to do with outer containers?
- The law states to label the outer container
- National Patient Safety Agency guidelines raise the issue that the
outer container may be discarded - Labelling information could be lost
- The actual container (e.g. inhaler or tube of cream) should be labelled
rather than the outer container.
when did PIL/ patient info leaflets become a legal requirement in the uk?
1999
What are PILs based on?
PILs are based on the Summaries of Product Characteristics (SPCs)
which are a description of a medicinal product’s properties and the
conditions attached to its use
When will PILs not be provided in a medicine packaging?
- a medicinal product is manufactured or assembled in a pharmacy
- all the required information is conveyed on the outer packaging or the
immediate packaging of the product
What Is included in the PIL?
- Identification of the medicine
- Therapeutic indications
- Information necessary before taking the medicine
- Dosage
- Description of side effects
- Additional information
What is required to identify a medicine?
- The name, the active substance(s), the pharmaceutical form, and the
strength of the product should be stated. - Therapeutic indications
- The conditions for which the medicine is authorised must be listed. This
section should include any benefit information considered appropriate
What information is necessary before taking a medicine?
- Situations where the medicine should not be used
- Precautions
- Warnings
- Interactions with other medicines or foods
- Information for special groups of patients (pregnant or nursing
mothers) - Any effects the medicine may have on the patient’s ability to drive
What additional information should you have on all medicines?
- Excipient details
- Description of the product
- Registered pack sizes
- Storage conditions
- Name and address of the MAH and manufacturer
How is medicine made more accessible?
- The name must also be expressed in Braille format on the outer
packaging of the product - A holder of a marketing authorisation must ensure the package leaflet
is available on request in formats suitable for blind and partially-
sighted persons
