OTC medicines

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  • Created by: Louise
  • Created on: 23-12-14 15:51

GSL Medicines

General Sale List Medicines 

  • Can be sold or supplied without the supervision of a pharmacist, with resonable safety
  • Displayed on open shelves for self selection by patients
  • Wide range of medicines
  • Food, non food, vitamins, supplements
  • GSL medicines must have been made up in a container elsewhere and not opened up since
  • A GSL medicine does not need anything on the box to identify it as a GSL medicine
  • Marketing Authorisation terms may inhibit the licence holder from distributing to non-pharmacy outlets

There are regulations which impose restrictive conditions - pack sizes:

  1. Aspirin, paracetamol - maximum of 16 tablets
  2. Ibuprofen - 200mg tablets maximum of 16 tablets
  3. Paracetamol liquid preps for children maximum 20 doses

Outiside these limits the GSL medicine becomes a P medicine

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P Medicines

Pharmacy medicines:

  • May only be sold under the supervisions of a pharmacist
  • Usually kept on sheliving or in drawers behind the medicines counter
  • May be kept in secure display units
  • Cannot be on open display for self selection
  • A P medicines MUST have a P in a box somewhere on the manufacturers original packaging
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OTC medicines

OTC medicines = GSL medicines + P medicines

Includes,

  • Cough, cold, sore throat, hayfever
  • Antacids, gastrointestinal, constipation
  • Analgesics
  • Skin
  • Hair and scalp
  • Eyes and ears
  • Footcare
  • Oral health
  • Smoking cessation
  • Male and Female health
  • Vitamins and supplements
  • Sleep and travel 
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POM medicines

Prescription Only Medicines:

  • Found in the dispensary.
  • Require a prescription for supply. 
  • Are normally sold or supplied in accordance with a prescription given by an appropriate practitioner (doctor, dentist, nurse prescriber, supplementary prescriber, independant prescriber)
  •  A POM must have the letters POM in a box somewhere on the manufacturers original packaging

Some exemptions from POM status

  1. Specifically licensed products sold within the terms of that license eg Ketoconazole, Cimetidine
  2. Pack sizes of certain products
  3. High dilution products
  4. Certain controlled drugs at low doses
  5. Pseudoephedrine and ephedrine - can be sold without responsible pharmacist to one person, up to 720mg pseudoephedrine, up to 180mg ephedrine, may not supply both drugs even with limits (MEP pg 23) 
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CD

Controlled Drugs 

  • Misue of drugs acct 1971
  • Concerns drugs which are being, or appear to be likely to be misused
  • Controlled drugs are listed in legislation to the act
  • Restricts the production, supply, offer to supply, possession and cultivation of CD

3 classes based on decreasing order of harmfulness (A,B,C)

Schedules determine the controls of drugs

  1. no medicinal use
  2. CD register entries required, stored in controlled drug cabinet, POM
  3. stored in controlled drug cabinet, POM
  4. POM
  5. POM or P
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Patient Information Leaflets

PIL - Patient Information Leaflets  (In the box, on the box, part of the label)

Consider, type, size, font, design, layout, headings, colour, syntax (avoid long sentances/paragraphs) style, clear text, language, paper, symbols 

What do they tell us?

  • Drug name and active ingredient
  • Respective strengths
  • Licensed use - age, condition, gender
  • Dose/ route of administration
  • Frequency
  • Side effects and possible ADRs
  • Missed doses and overdoses

Also - signposting, manufacture name and address, product liscensing, marketing authorisation, complaints procedure, clincial governence, availability of braille leaflet, availability of leaflet in other languages

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Patient Information Leaflets

PIL - Patient Information Leaflets  (In the box, on the box, part of the label)

Consider, type, size, font, design, layout, headings, colour, syntax (avoid long sentances/paragraphs) style, clear text, language, paper, symbols 

What do they tell us?

  • Drug name and active ingredient
  • Respective strengths
  • Licensed use - age, condition, gender
  • Dose/ route of administration
  • Frequency
  • Side effects and possible ADRs
  • Missed doses and overdoses

Also - signposting, manufacture name and address, product liscensing, marketing authorisation, complaints procedure, clincial governence, availability of braille leaflet, availability of leaflet in other languages

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Packaging - On the box

  • Lot number, expiry date
  • Specific dosage instructions
  • Age restrictions
  • Mandatory, advisory and cautionary labels
  • Ingredients and excipients
  • Pack size
  • Legal status
  • Brand
  • Indication
  • MA holder details and licence number
  • manufacturers name and address
  • EU patent number
  • barcode
  • Braille information - name 
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Packaging

Blister Packaging - for tablets

  • Batch number and expiry date must be included at end of blister preferably on both end
  • Labelling must reman visible until final dose is taken/used
  • Print on foils large enough to ensure legibility, careful choice of colour of text and font
  • Non reflective or coloured foil may enhance readability
  • Unit dose blisters should contain all relevant information required for each dosage unit

Small containers -Difficult to contain all information on packaging, therefore consider:

  • Information required
  • Required font size vs legibility
  • Use of wrap around or concertina labels
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OTC analgesics

  • Used to alleviate aches and pains
  • OTC oral analgesics
  • NSAIDS (ibuprofen, diclofenacm naproxen) and Aspirin 
  • Paracetamol
  • Combinations
  • Topical analgesics
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NSAIDS and Aspirin

NSAIDS - Non- steroidal anti-inflammatory drugs

  • Act by blocking prostaglandin synthesis
  • Analgesic and antipyretic
  • Licensed for mild to moderate pain from a wide range of causes
  • Side effects - gastro irritation and bleeding
  • Cautions - Asthma, renal and hepatic disease, pregnancy
  • Contraindications - history of ulcers or gastric problems
  • Interactions vary 
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Aspirin

Should be taken with food

  • Adults and Children over 16 years
  • 300-900 mg every 4-6 hours
  • Max 4g daily
  • Interactions - Warfarin and Methotrexate
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Ibuprofen

Should be taken with food

  • Adults and Children over 12 years
  • 200-400mg every 4-6 hours
  • max 1200mg daily 

For children

  • OTC supply and prescription differs with age - see BNF
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Diclofenac Potassium

Voltarol Joint Pain tablets - 12.5mg tablets

  • Licensed to treat Rheumatic pain, Muscular pain, Backache
  • Take two for first dose then one ever 4-6 hours, max daily dose, 6 tablets
  • Do not take for longer than 3 days, do not take under 14years of age

Voltarol pain-eze tablets - 12.5mg tablets

  • Licensed to treat Headaches, dental pain, period pain, rheumatic pain, muscular pain, backache, symtoms of cold and flu
  • pack size 18
  • Same dose as Voltarol Joint Pain Tablets
  • do not take under 14 years of age

Voltarol pain-eze extra strenth tablets 25mg tablets

  • Same indications as normal strength, same dose, max is 3 tablets
  • pack size 9 tablets
  • do not take under 14 years of age
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Naproxen

Naproxen 250mg tablets

  • Licensed for short term treatment of period pain and menstural cramps
  • Take 2 tablets if needed then a further tablet after 4-6 hours
  • Not more than 3 in 24 hours
  • Not licensed for use under 15 years of age
  • Available as gastro resistant tablets, feminax ultra, first resort period pain reliever
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Paracetamol

Not an NSAID

  • mechanism of action is poorly understoof
  • analgesic and antipyretic
  • few side effects and interactions
  • BUT very dangerous in overdose - toic levels not much higher than therapeutic
  • can be taken by children, look in BNF for doses
  • tablets, capsules, soluble tablets, liquid formulation
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Combination products

Paracetamol with codeine (Co-codamol)

Ibuprofen with codeine 

Paracetamol with dihydrocodeine (Co-dydramol)

Paracetamol with Ibuprofen

Codeine/ Dihydrocodeine - mild opeiates not thought to increase the efficacy significantly. Side effects include constipation, dizziness. 

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