D2: OTC medicines Flashcards
Classification of medicines
- General Sales Medicines
- Pharmacy Medicines
- Prescription Only Medicines
- Controlled Drugs
Which medicine class symbol does not need to be included on packaging
GSL
GSL (general sales list medicines)
- Displayed on open shelves for self selection by patient - Wide range of medicines - Food and non food - Vitamins and supplements
Pharmacy medicines
May only be sold under the supervision of a
pharmacist
• Usually kept on shelving or in drawers behind
medicines counter
• May be kept in secure display units
• Cannot be on open display for self selection
Prescription only medicines (POM)
Usually found in the Dispensary Normally require a prescription for supply Different forms – Tablet – Capsule – Powder – Liquid – Cream – Ointment – Injection – Infusion – Suppository/pessary
Controlled drugs need to be in…
Safe custody
Where would you store schedule 2 controlled drugs
In a locked, secured cabinet in the dispensary
Controlled drugs
Schedule 2/certain schedule 3 drugs are stored in a LOCKED, controlled drug cabinet, safe, room
- Structural and technical details (design of the cabinet, safe or room must
comply) are detailed in Schedule 2 of the Safe
Custody Regulation
- Controlled drug register entries required for
Schedule 2 drugs
What else would you find in a pharmacy
Complementary + alternatives meds
- herbal
- anthroposophic
- homeopathy
Diagnostic aids
Mobility aids
pharmacy team
Why do people visit a pharmacy
- Collect a prescription
- To get advice
- To buy medicine
Mnemonics
WWHAM Who - is the patient What - are the symptoms How - long Actions? M - medication
Who is the patient
– Person present? – Someone else? – Any special circumstances? Gender Pregnancy/lactation Elderly Very young – General health status/social factors? Do they look ill?
What are the symptoms
Get patient to describe
– Open questions
– Give the patient time to talk
– Follow up
How long
How long have they had the symptoms? • When did they come on? • What was the person doing at the time? • How did they come on? • Are the symptoms always there? • Is it a recurrence of a previous occasion
Actions
What has the patient already done about it?
• Have they taken anything for it?
• What was the outcome?
• Have they seen another HCP about it previously?
Medication
Medicines for this episode of symptoms Concurrent medicines for other conditions • Adverse drug reactions • Drug interactions • Indication of other medical conditions
MHRA changes for codeine + dihydrocodeine
The warning “can cause addiction. For three days use only” must now be
positioned in a prominent clear position on the front of the pack
PIL and packaging need to state
• The indication
• The medicine can cause addiction or overuse headache if used continuously for more
than three days
PIL must also contain information about the warning signs of addiction
MEP 3.2.4 - codeine and dihydrocodeine
Standard labelling particulars of medicinal products
- Name of medicinal product
- Strength and pharmaceutical form of product
- Where appropriate, whether product is intended for adults, children or babies
- Where the product contains up to three active ingredients, the common name of each active substance
- Product’s expiry date (month and year) in clear terms
- Manufacturers batch number
- Method of administration of
product and if necessary, route of administration - Statement of active substances in product expressed qualitatively
and quantitatively per dosage unit or according to form of administration for a given
volume or weight, using their common names - Pharmaceutical form and
contents by weight, by volume or
by number of doses of the
product - A list of…
— a. Excipients when product is injectable or is a topical or eye preparation
— b. In any other case, those excipients known to have a recognised action or effect and included in guidance published pursuant to article 65 of 2001 directive - Where appropriate, space for the prescribed dose to be indicated
- A warning that the product
should be stored out of reach
and sight of children - Any special warnings applicable to product
- Any special storage precautions
- Any special precautions relating to the disposal of unused product, part of product or waste derived and reference to appropriate collection system in place
- Name and address of holder of Market Authorisation Article 126a authorisation or traditional
herbal registration relating to the product and, where applicable, the name of the holder’s representative - The number of the marketing authorisation, Article 126a authorisation or traditional herbal registration for placing the medicinal product on the market
- In the case of a product that is not a Prescription Only Medicine (POM), instructions for use
Legislation in labelling of licensed medicines
Labelling of licensed medicines must contain all elements required by article
54 of Council Directive 2001/83/EEC, HMRs Reg.257 and Schedule 24.
Nevertheless, certain items of information are deemed critical for the safe
use of the medicine, these items are:*
• Name of medicine
• Expression of strength (where relevant)
• Route of administration
• Posology
• Warnings
Where would the legislation in labelling licensed medicines appear on OTC medicines
Over-the-counter medicines
• it is usual for this to appear together on the back of the pack due to differences in pack design
Where would the legislation in labelling licensed medicines appear on medicines available on prescription
For medicines available on prescription
• This information will usually appear together on the front face of the labelling
Name of medicine
• The full name of the medicine should appear on at least three nonopposing
faces of the pack to aid accurate identification of the drug
• Where the common name(s) appears after the brand name, these should be given due prominence.
Strength of medicine
It may be necessary in some cases to express the strength as:
• quantity per unit volume and also as the total quantity per total volume
• Reference to the total quantity per total volume should be highlighted
• Do not add trailing zeros to numbers (2.5mg not 2.50mg)
• Wherever possible use whole numbers
• Express different strengths in the same way e.g. 250mg, 500mg and
1000mg
• Spell out micrograms wherever possible
• On small containers use mcg not μg
Route of administration
- This should be as registered in the Summary of Product Characteristics (SPC) only
- Positive messages should be used; for example
- “give by …”
- only standard abbreviations will be acceptable
- Non-standard routes of administration should be spelt out in full to avoid confusion
Posology
- This will be necessary only when the product is intended for self-medication
- Posology remains a legal requirement for products marketed for over-the-counter sale
- Medicines that are supplied on prescription would have the posology added at the time of dispensing
Warnings
- Only those warnings, specifically required by the terms of the marketing authorisation to be stated on the labelling, will form part of the critical labelling
- Many medicines will not need the addition of any warnings on the front of the pack
How should the medicine be labelled
Orientation
• Text should be orientated in same direction for easier reading
• Portrait may be easier to read than landscape
Use blank space to emphasise critical information
• Critical health information should not include company logos, trademarks or graphics
Give prominence to generic names
Use body text that is readable
• Use largest text possible
• Dark text on light background
• Put company details on side panel to increase space for critical health information
Use upper and lower case
• Do not use capitals or italic type where there is an alternative method of
emphasis, such as bold type
Align text to the left
Braille guidelines
The name of the medicinal product, as referred to in Article 54, point
(a) must also be expressed in Braille format on the packaging. The marketing authorisation holder shall ensure that the package
information leaflet is made available on request from patients’ organisations in formats appropriate for the blind and partially sighted.”
What should be on a Blister packaging
- Name of product and Marketing Authorisation licence holder
• Batch number and expiry date must be included at end of blister preferably on both ends
• Labelling must remain visible until final dose is taken/used
• If this is not possible, information must be repeated frequently across the pack
• Print on foils should be sufficiently large to ensure legibility
• Careful choice to colour of text and font style
• Non reflective or coloured foil may enhance readability and identification of the medicine
• Unit dose blisters should contain all relevant information required for
each dosage unit
How to label small containers
Difficult to contain all information on packaging set out in article 54 of
Directive 2001/83/EEC by MHRA therefore consider
• Information required
• Required font size vs legibility
• Use of wrap around or concertina labels
Layout of a PIL
- What is this medicine and what is it used for?
- Before you take this medicine
- How to take this medicine
- Possible side effects
- Storage
- Further information
Active style of writing in a PIL
GENERAL CONSIDERATIONS
- TYPE SIZE AND FONT
- DESIGN AND LAYOUT OF THE INFORMATION
- HEADINGS
- PRINT COLOUR
- SYNTAX
- STYLE
- PAPER
- USE OF SYMBOLS AND PICTOGRAMS
- CLEAR LANGUAGE
Information contained in a PIL
Name of medicinal product
• Strength and pharmaceutical form
• Where appropriate, whether it is intended for
babies, children or adults
• Where product contains up to three active
substances the common name of each of the
three
The pharmaco-therapeutic group or type of
activity of product in user friendly terms
• The products therapeutic indications
• A list of
– Contra-indications
– Appropriate precautions for use
– Interactions which may affect the action of the
product
– Any special warnings related to product
Special requirements for different patient groups
• Possible effects on ability to drive or operate
machinery
• List of excipients
• Instructions for use
• List and description of adverse reactions, if any
and any actions that should be taken in such
circumstances
Storage conditions
• Reference to expiry date printed on packaging
• Full qualitative composition – active
substances and excipients
• For each presentation of product
– Pharmaceutical form
– Content in weight, volume or units dosage
Name and address of holder of Marketing
Authorisation (MA)
• Name and address of manufacturer
• Signposting to Yellowcard reporting where
appropriate
• Date of revision of PIL
Signposting
• Specific information relating to product eg
– Paracetamol
– Medicines containing
• Codeine/dihydrocodeine
• Pseudoephedrine
• Complaints procedure/Clinical governance
• Availability of Braille leaflet
• Availability of leaflet in other languages
Legislation defining the PIL design + content
MHRA Changes
The warning “can cause addiction. For three days use
only” must now be positioned in a prominent clear
position on the front of the pack
PIL and packaging need to state
• The indication
• The medicine can cause addiction or overuse headache if
used continuously for more than three days
PIL must also contain information about the warning
signs of addiction
—-MEP 3.2.4 - codeine and dihydrocodeine
What are Analgesics
Used to alleviate aches and pains
The OTC oral analgesics
NSAIDS and Aspirin • Aspirin • Ibuprofen • Naproxen Paracetamol
Combinations containing one or more of the above
Combinations of one or more of the above with codeine or dihydrocodeine
Topical analgesics
NSAIDs
Non-steroidal anti-inflammatory agents
- Act by blocking prostaglandin synthesis
- Analgesic and antipyretic
- Licensed for mild to moderate pain from a wide range of causes and as antipyretic
Side-effects - Gastric irritation and bleeding Cautions - Asthma – may precipitate attacks - Renal and hepatic disease - Pregnancy, particularly 1st and 3rd trimesters Contraindications - Current or history of ulcers or gastric problems - Aspirin in children under 16 Interactions include: - Aspirin – Warfarin and Methotrexate - Ibuprofen – Lithium and Diuretics
What is Diclofenac Potassium classed as
POM
MHRA changes to Codeine and Dihydrocodeine’s Indication
Indication
• solid dose OTC codeine and dihydrocodeine products are restricted to short
term treatment of acute moderate pain that is not relieved by paracetamol,
ibuprofen or aspirin alone
• Remove all previous indications including cold, flu, cough, sore throats and
minor pain
MHRA changes to Codeine and Dihydrocodeine’s pack size
- Any pack containing more than 32 dose units now requires marketing
authorisation as a POM - This change includes effervescent formulations
MHRA changes to Codeine and Dihydrocodeine’s PILs + Labels
The warning “can cause addiction. For three days use only” must now be
positioned in a prominent clear position on the front of the pack
PIL and packaging need to state:
- The indication
- The medicine can cause addiction or overuse headache if used continuously for more
than three days
PIL must also contain information about the warning signs of addiction
How many OTC meds containing codeine/dihydrocodeine can be sold
1/one
- as sale of more than one pack would undermine the reduction pack size and POM restriction on packs containing more than 32 doses.
Combination analgesic products
Ibuprofen with Codeine
Paracetamol with dihydrocodeine
Paracetamol with ibuprofen
Naproxen tablets
Licensed for short term treatment of period pain + menstrual cramps
- take 2 250mg tablets (or a further tablet) after 4 - 6 hours.
- Not more than 3 tablets in 24 hrs
- licensed for women aged between 15-50 years old.
NSAID + Aspirin side effects
Gastric irritation + side effects + bleeding
NSAID + Aspirin cautions
- Asthma – may precipitate attacks
- Renal and hepatic disease
- Pregnancy, particularly 1st and 3rd trimesters
NSAID + Aspirin contraindications
- Current or history of ulcers or gastric problems
- Aspirin in children under 16
NSAID + Aspirin interactions
Interactions include:
• Aspirin – Warfarin and Methotrexate
• Ibuprofen – Lithium and Diuretics
Who can take Aspirin
- Adults + children over 16 yrs
- children under 16 cannot due to Reyes Syndrome
Topical Analgesic Preparations
NSAIDs and Salicylates
Ibuprofen, Diclofenac, Felbinac , Benzydamine
- Short-term use (<2 weeks)
- Can have systemic effects and side-effects
Rubefacients
- Nicotinates
- Capsicum
