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BPH > D2: OTC medicines > Flashcards

D2: OTC medicines Flashcards

1
Q

Classification of medicines

A
  • General Sales Medicines
  • Pharmacy Medicines
  • Prescription Only Medicines
  • Controlled Drugs
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2
Q

Which medicine class symbol does not need to be included on packaging

A

GSL

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3
Q

GSL (general sales list medicines)

A 
- Displayed on open shelves for self selection by
patient
- Wide range of medicines
- Food and non food
- Vitamins and supplements
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4
Q

Pharmacy medicines

A

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

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5
Q

Prescription only medicines (POM)

A 
Usually found in the Dispensary
Normally require a prescription for supply
Different forms
– Tablet
– Capsule
– Powder
– Liquid
– Cream
– Ointment
– Injection
– Infusion
– Suppository/pessary
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6
Q

Controlled drugs need to be in…

A

Safe custody

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7
Q

Where would you store schedule 2 controlled drugs

A

In a locked, secured cabinet in the dispensary

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8
Q

Controlled drugs

A

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

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9
Q

What else would you find in a pharmacy

A

Complementary + alternatives meds

  • herbal
  • anthroposophic
  • homeopathy

Diagnostic aids
Mobility aids

pharmacy team

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10
Q

Why do people visit a pharmacy

A
  • Collect a prescription
  • To get advice
  • To buy medicine
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11
Q

Mnemonics

A 
WWHAM
Who - is the patient
What - are the symptoms
How - long
Actions?
M - medication
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12
Q

Who is the patient

A 
– Person present?
– Someone else?
– Any special circumstances?
 Gender
 Pregnancy/lactation
 Elderly
 Very young
– General health status/social factors?
 Do they look ill?
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13
Q

What are the symptoms

A

Get patient to describe
– Open questions
– Give the patient time to talk
– Follow up

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14
Q

How long

A 
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
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15
Q

Actions

A

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?

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16
Q

Medication

A 
Medicines for this episode of symptoms
Concurrent medicines for other conditions
• Adverse drug reactions
• Drug interactions
• Indication of other medical conditions
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17
Q

MHRA changes for codeine + dihydrocodeine

A

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

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18
Q

Standard labelling particulars of medicinal products

A
  1. Name of medicinal product
  2. Strength and pharmaceutical form of product
  3. Where appropriate, whether product is intended for adults, children or babies
  4. Where the product contains up to three active ingredients, the common name of each active substance
  5. Product’s expiry date (month and year) in clear terms
  6. Manufacturers batch number
  7. Method of administration of
    product and if necessary, route of administration
  8. 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
  9. Pharmaceutical form and
    contents by weight, by volume or
    by number of doses of the
    product
  10. 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
  11. Where appropriate, space for the prescribed dose to be indicated
  12. A warning that the product
    should be stored out of reach
    and sight of children
  13. Any special warnings applicable to product
  14. Any special storage precautions
  15. Any special precautions relating to the disposal of unused product, part of product or waste derived and reference to appropriate collection system in place
  16. 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
  17. The number of the marketing authorisation, Article 126a authorisation or traditional herbal registration for placing the medicinal product on the market
  18. In the case of a product that is not a Prescription Only Medicine (POM), instructions for use
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19
Q

Legislation in labelling of licensed medicines

A

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

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20
Q

Where would the legislation in labelling licensed medicines appear on OTC medicines

A

Over-the-counter medicines

• it is usual for this to appear together on the back of the pack due to differences in pack design

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21
Q

Where would the legislation in labelling licensed medicines appear on medicines available on prescription

A

For medicines available on prescription

• This information will usually appear together on the front face of the labelling

22
Q

Name of medicine

A

• 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.

23
Q

Strength of medicine

A

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

24
Q

Route of administration

A
  • 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
25
Q

Posology

A
  • 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
26
Q

Warnings

A
  • 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
27
Q

How should the medicine be labelled

A

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

28
Q

Braille guidelines

A

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.”

29
Q

What should be on a Blister packaging

A
  • 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
30
Q

How to label small containers

A

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

31
Q

Layout of a PIL

A
  1. What is this medicine and what is it used for?
  2. Before you take this medicine
  3. How to take this medicine
  4. Possible side effects
  5. Storage
  6. Further information
32
Q

Active style of writing in a PIL

A

GENERAL CONSIDERATIONS

  1. TYPE SIZE AND FONT
  2. DESIGN AND LAYOUT OF THE INFORMATION
  3. HEADINGS
  4. PRINT COLOUR
  5. SYNTAX
  6. STYLE
  7. PAPER
  8. USE OF SYMBOLS AND PICTOGRAMS
  9. CLEAR LANGUAGE
33
Q

Information contained in a PIL

A

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

34
Q

Legislation defining the PIL design + content

A

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

35
Q

What are Analgesics

A

Used to alleviate aches and pains

36
Q

The OTC oral analgesics

A 
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

37
Q

NSAIDs

A

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
38
Q

What is Diclofenac Potassium classed as

A

POM

39
Q

MHRA changes to Codeine and Dihydrocodeine’s Indication

A

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

40
Q

MHRA changes to Codeine and Dihydrocodeine’s pack size

A
  • Any pack containing more than 32 dose units now requires marketing
    authorisation as a POM
  • This change includes effervescent formulations
41
Q

MHRA changes to Codeine and Dihydrocodeine’s PILs + Labels

A

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

42
Q

How many OTC meds containing codeine/dihydrocodeine can be sold

A

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.

43
Q

Combination analgesic products

A

Ibuprofen with Codeine
Paracetamol with dihydrocodeine
Paracetamol with ibuprofen

44
Q

Naproxen tablets

A

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.
45
Q

NSAID + Aspirin side effects

A

Gastric irritation + side effects + bleeding

46
Q

NSAID + Aspirin cautions

A
  • Asthma – may precipitate attacks
  • Renal and hepatic disease
  • Pregnancy, particularly 1st and 3rd trimesters
47
Q

NSAID + Aspirin contraindications

A
  • Current or history of ulcers or gastric problems

- Aspirin in children under 16

48
Q

NSAID + Aspirin interactions

A

Interactions include:
• Aspirin – Warfarin and Methotrexate
• Ibuprofen – Lithium and Diuretics

49
Q

Who can take Aspirin

A
  • Adults + children over 16 yrs

- children under 16 cannot due to Reyes Syndrome

50
Q

Topical Analgesic Preparations

A

NSAIDs and Salicylates
Ibuprofen, Diclofenac, Felbinac , Benzydamine
- Short-term use (<2 weeks)
- Can have systemic effects and side-effects

Rubefacients

  • Nicotinates
  • Capsicum

BPH (7 decks)

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