labelling and patient info leaflets Flashcards
what are the HMR 2012 regulations around packaging and labelling?
- must be suitably contained
- protected and labelled from the time of manufacture until used by patient
- most be patient friendly to promote compliance
what are the penalties for contravening labelling requirements?
up to £5000 fine and/or imprisonment for up to 2 years
what labelling compliance do all containers and packaging for medicinal products must follow in the UK?
- medicines regulation 1994
what can the labelling requirement regulations be divided under?
can be divided into those which apply to:
- labels produced by the manufacture
- dispensing labels
- special situations( chemists’ nostrums)
what must all packaging for licensed products have?
- prominent labelling with ingredients
- space for dispensing label (if POM)
- information in Braille
what happens if the marketing authorization wants to change labelling in any way?
they must seek a variation to their marketing authorisation
what is a variation to a marketing authorisation?
it is a formal process that can take 30-90 dats
it us to change the labelling in any way at all on a product
what are the 4 general labelling provisions?
all labelling must be : 1-legible 2-comprehensible 3-indilible 4-in English only or in English and one of more other languages provided all particulars are provided in all languages
what are the 15 standard labelling requirements for commercially available medicines?
1-name of product
2-followed by the recommended international non-priority name
3-state of active ingredients and stregth
4-pharmaceutical form
5- lists of excipients BUT if eye prep- all excipients
6- route of admin
7-special warning
8- any warnings particular to the product
9-expiry date in clear terms]
10- special storage conditions
11- special precautions for disposal
12- marketing authorisation holder’s name and address
13- marketing authorisation number
14- batch reference /LOT number
15- if product is for self administration any required instructions for use
where are there modifications made for other preparations?
modifications made for smaller containers and blister packs
can products be labelled promotionally?
no
what are the standard labelling req for P and POM medicinal products?
general std labelling req apply +2 more
- if a pharmacy medicine= P in a rectangle
- if a prescription only medicine- POM- in a rectangle
what are the requirements for labelling of products containing paracetamol?
- if symptoms persist consult your doctor
- contains paracetamol-unless this is in the name
- do not exceed the standard dose
- immediate medical advice should be sought in the event of an overdose, even if you feel well OR immediate medical advice should be sought in the event of an overdose even if you feel well, because of the risk of delayed, serious liver damage.
what are the labelling requirements of products containing codeine and dihydrocodeine?
- additional statutory label to be included on the front of each pack : can cause addiction. for 3 days use only.
- PIL will carry info about addiction
what are the 4 labelling requirement exceptions?
- Packaging that allows the particulars on the container label to be clearly visible (e.g. cellophane packaging)
- Packing cases and crates for delivery, but if only for single product must have batch number, expiry date and storage conditions.
- Paper/bags used when product is sold
- Any package of a dispensed medicinal product
what are the 6 legal requirements on a dispensed medicinal product?
- Name of person to whom the medicine is to be administered
- Name and address of person who sells or supplies
- Date of dispensing
- Name of the product
- Directions for use of the product
- Precautions relating to the use of the product
what are the extra 2 points the RPS recommend that should appear on a dispensed medicinal product?
‘Keep out of the sight and reach of children’
•‘Use this medicine only on your skin’ where applicable
is the BNF cautionary label a legal requirement?
no- but good practice to include them
when should non-BNF labels be included?
if applicable e.g. shake bottle, store in a refrigerator
what are the good practice labelling points?
- label using active verbs rather than passive ones ‘take rather than taken’
- avoid numbers in the dose line on the label -take ONE tablet THREE times a dat’ rather than ‘Take 1 tablet 3 times a day’
- avoid the use of two numbers together on a dose line’ take ONE tablet THREE times a day’ rather than ‘ take ONE TREE times a day’
- if the medicine is to be supplied with a 5ml spoon, label in multiples of that
- name of patients- as full as possible
- if using a syringe- take xml using the oral syringe’
- if labelling a private Rx, include the reference number of the entry in the POM register on the label
- avoid words that may not be understood by the patient/ medical terminology
what happens with pre-packed medicines? when can they be made?
- Some dispensaries break down bulk to save time in busy periods in the pharmacy
- Technically this is assembly
- Can’t be made at request of practitioner or some other organisation without an assembly licence
- All pre-packs must be re-labelled before supply to a patient may be made
what must the label of pre- packed medicines include?
- Name of product
- Appropriate quantitative particulars of ingredients
- Quantity
- Special handling or storage requirements
- Expiry date
- Batch reference preceded by BN or Lot No.
what are chemists nostrums?
Medicinal products prepared in a registered pharmacy for retail sale from that pharmacy only, which are not advertised
•Preparation and sale or supply must be carried out by or under the supervision of a pharmacist
what are the legal requirements for chemists nostrums?
. Name of product2. Pharmaceutical form3. Appropriate quantitative particulars
- Quantity
- Directions for use
- Handling and storage requirements
- Expiry date
- Keep out of the reach of children or similar
- Name and address of seller
- Where appropriate ‘Do not exceed the stated dose’ in a rectangle in which there is no other matter (where one of the ingredients is normally POM, incorporated in such a way that makes it a P e.g. low strength)
- The letter P in a rectangle (since Chemist’s nostrums are pharmacy medicines)
can you supply a product without a PIL?
no it is a criminal offence
where can sample PILs be viewed?
on the MHRA website - good practice
what are the advantages of PILs?
- Provides information to patients/carers
- Encourages patients to be informed about their medicines and this may help to encourage adherence
- Useful to help pharmacists with patient counselling
what are some of the disadvantages of PILs?
- May worry patients with list of side effects or cautions
- May not relate to the indication the patient is taking it for
- Leaflets from different generic manufacturers may contain slightly different information
when do child safety regulations apply?
apply to the sale or supply of medicinal products for human use
what is a CRC?
child resistant container (CRC)
what products must have a CRC?
All products containing aspirin, paracetamol and elemental iron more than 24mg, in tablet, capsule, lozenge, pastille, suppositories or oral liquid form sold or supplied must legally be in a CRC
All cough and cold oral liquid products for children containing certain antihistamines, antitussives, expectorants and decongestants must legally be in a CRC
what are the exceptions for CRCs?
Exceptions include effervescent and single dose units of the above drugs (e.g. sachets)
when do you not have to supply all solid dose, oral liquid and external liquid medicinal products in a CRC?
- Medicine is in a patient pack/original container
- Patient can’t open CRC
- Patient requests not to have CRC
- No suitable CRC exists
- Patient requests a 7-day compliance aid
can CRCs be reused?
no- single use
are CRCs child proof?
no
