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PMP-103 > Packaging and labelling of medicines > Flashcards

Packaging and labelling of medicines Flashcards

1
Q

Name of medicine should be..

A

Displayed clearly even on brands

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2
Q

Expression of strength

A

um - ALWAYS as micrograms (avoid confusion - easily read by patients)

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3
Q

Dosage

A
  1. ONLY necessary when product is intended for self-medication
  2. Supplied on prescription = dose added at the time of dispensing
  3. WARNINGS - marketing authorisation
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4
Q

ONLY over-the-counter medicines

A
  • indications are required on packaging fro GSL and P medicines
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5
Q

Packaging appearance

A
  1. Space of the placement of the dispensing label
  2. Use of colour is to be encouraged
  3. different font

(AVOID different drug being picked up and prescribed)

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6
Q

Blister packs (packs within the cardboard box)

A
  1. Name
  2. Strength and form
  3. Babies, children or adults
  4. Common names (if up to thee active substances)
  5. Expiry date
  6. Batch number
  7. Holder of the pharmacy authorisation
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7
Q

Other medicines / special packaging instructions

A

Radio-nucleotides (showing images)

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8
Q

Child safety

A
  • suitable, resistant packaging should be used supplying all solid, all oral and external liquid dose preparations
  • UNLESS there is a good reason not to:
    1. request of difficulty opening
    2. official pack may not be child resistant
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9
Q

Dispensing labels

A
  1. name of patient
  2. Name and address of pharmacy
  3. date of dispensing
  4. name of medicine
  5. Directions of the medicine
  6. precautions
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10
Q

The patient

A
  • Full Name
  • Title of patient (if possible)/ helps distinguish between family members
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11
Q

The medicine - directions..

A

Active NOT passive
- ‘Take two’ NOT ‘Two to be taken’

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12
Q

Liquid medicines - dosage

A

‘10ml tds’

comes with 5ml spoons
-pharmacist has to TRANSLATE
‘5ml spoonfuls to be taken 3 times a day’

=15ml

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13
Q

Simple language

A
  • give
  • numbers = a hundred NOT 100
    (confusion between 10 + 100)
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14
Q

RPharms S recommendations for labels

A

By law - messages (mostly are reiterated and written again)

-‘keep out of the reach and sight of children’
- ‘use this medicine only on your skin, not for consumption’

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15
Q

warning labels

A
  • pharmacists recommended to add (as well as the other message)
    -e.g ‘take medicine when stomach is empty’ explanation of what an empty stomach is
  • cause drowsiness
  • other food or medicines that should be avoided
  • what to do if they MISS dosage
  • discolouration of urine
  • some meds taken weekly NOT daily
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16
Q

Outer containers (likely to be thrown away)

A
  • law states to label outer container
  • lot of pharmacist labels inner as well to avoid any confusion how to take drug, expiry date and strength of drug
17
Q

Optimisation of labelling

A

-remove info that is not necessary
-only important info: directions of use, name or common name, precautions

18
Q

By law, all dispensing labels must have “keep out of sight and reach of children” TRUE or FALSE?

A
  • FALSE = only a recommendation
  • this is displayed on outer packaging anyway
19
Q

Patient info leaflets (PILs)

A
  • legal requirement in UK since 1999
20
Q

SPC

A

Summaries of product Characteristics
= description of medicinal products properties and conditions attached to its use

UNLESS
- Medicinal product is manufactured or assembled in pharmacy
- all the required info is conveyed on the outer packaging or the immediate packaging

21
Q

Identification of the medicine

A
  • name, active substance (s), the pharmaceutical form, and strength of product should be stated
22
Q

Therapeutic indications

A

conditions should be authorised

23
Q

Info necessary before talking medicines

A
  1. situations where medicine should NOT be used
  2. precautions/ warning
  3. Pregnant women/ nursing mothers
24
Q

Dosage

A
  1. side effects
  2. how to take medicine/ directions/ route
  3. way side effects are listed - most common to least common
25
Q

Additional info

A
  1. excipient details
  2. description of the product
  3. registered pack size
  4. storage conditions
  5. name and address of the MAH and manufacturer
26
Q

MAH

A

Marketing authorisation holder

27
Q

Accessibility

A
  • name expressed in Braille format (for the blind)
  • packaging of the product

PMP-103 (33 decks)

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