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PMP103 - Practice Of Pharmacy > sale and suplly of medicines > Flashcards

sale and suplly of medicines Flashcards

1
Q

What is a container?

A

In law, the inner receptacle which actually contains the medicinal
products is a container.

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2
Q

What is a package?

A

Every outer receptacle is a package (this is sometimes referred to as
the outer container)

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3
Q

What are the packaging requirements?

A
  • Name of the medicine
  • Expression of strength
  • Route of administration
  • Dosage
  • Warnings
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4
Q

What is the name of the medicine defined by?

A

The name is defined as comprising the name, strength and
pharmaceutical form of the medicine

-Where the medicine contains up to three active ingredients, the
names of these should immediately follow the name of the medicine
on the pack

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5
Q

On the packaging, is abbreviation allowed?

A

NO
*For safety reasons it is important that ’micrograms’ is spelled out in
full and not abbreviated.

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6
Q

Route of administration: positive

A

Positive messages should be used; for example ”give by …”

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7
Q

Route of administration:nonpos

A

Non-standard routes of administration should be spelt out in full to
avoid confusion.

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8
Q

other routes of administration

A

Some routes of administration will be unfamiliar to patients and may
need careful explanation.

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9
Q

When Is a told dosage necessary?

A
  • This will be necessary only when the product is intended for self-
    medication.
  • Medicines that are supplied on prescription would have the dose
    added at the time of dispensing.
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10
Q

warnings and medicine?

A

Only warnings, specifically required by the terms of the marketing
authorisation to be stated on the packaging

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11
Q

What medicines require indications?

A

Only over—the—counter medicines (P or GSL) need to make
reference to the approved indications

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12
Q

What is on blister packs?

A
  • Name
  • Strength and form
  • Babies, children or adults?
  • Common names (if up to three active substances)
  • Expiry date
  • Batch number
  • Holder of the marketing authorisation
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13
Q

Other medicine pack type?

A

*small packs
*radionucleotides

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14
Q

When is child safety packaging ignored/ removed?

A
  • Specific request if difficulty opening
  • Original pack may not be child resistant
  • No child-resistant packaging exists for a particular liquid medicine
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15
Q

What is the legal requirement on dispensing labels?

A
  • Name of the patient
  • Name and address of the supplying pharmacy
  • Date of dispensing
  • Name of the medicine
  • Directions for use
  • Precautions/warnings relating to the use of the medicine
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16
Q

How to word directions for medicines?

A

Active rather than passive verbs for directions.
* ‘Take TWO’ (not ‘TWO to be taken’)
* ‘Use ONE’ (not ‘ONE to be used’)
* ‘Insert ONE’ (not ‘ONE to be inserted’)
* Adjacent numbers should be separated by the formulation name.
* ‘Take TWO tablets THREE times a day’ NOT ‘Take TWO THREE times a day

17
Q

What are some useful phrases to remember in pharmacy administration?

A
  • Never use the word ‘Take’ on a preparation that is not intended for the oral
    route of administration.
  • Use ‘Give’ as a dosage instruction on products for children as a responsible
    adult should administer them.
  • Only use numerals when quoting the number of millilitres to be given or
    taken. All other dosage instructions should use words in preference to
    numerals.
  • Always be prepared to give the patient a verbal explanation
18
Q

RpharmS recommendations for labels?

A

The following should also appear on the dispensing label:
* ’Keep out of the reach and sight of children’
* ’Use this medicine only on your skin’ where applicable.

19
Q

What are some example warnings?

A
  • Co-ordination, performance of skilled tasks (e.g. driving or work)
  • Foods or medicines to be avoided
  • What to do if a dose is missed
  • Possibility of staining of the clothes or skin,
  • Discolouration of urine or stools
  • Unusual method or time of administration
  • Potential interaction with a common food or domestic remedy
20
Q

rules and advice to do with outer containers?

A
  • The law states to label the outer container
  • National Patient Safety Agency guidelines raise the issue that the
    outer container may be discarded
  • Labelling information could be lost
  • The actual container (e.g. inhaler or tube of cream) should be labelled
    rather than the outer container.
21
Q

when did PIL/ patient info leaflets become a legal requirement in the uk?

A

1999

22
Q

What are PILs based on?

A

PILs are based on the Summaries of Product Characteristics (SPCs)
which are a description of a medicinal product’s properties and the
conditions attached to its use

23
Q

When will PILs not be provided in a medicine packaging?

A
  • a medicinal product is manufactured or assembled in a pharmacy
  • all the required information is conveyed on the outer packaging or the
    immediate packaging of the product
24
Q

What Is included in the PIL?

A
  • Identification of the medicine
  • Therapeutic indications
  • Information necessary before taking the medicine
  • Dosage
  • Description of side effects
  • Additional information
25
Q

What is required to identify a medicine?

A
  • The name, the active substance(s), the pharmaceutical form, and the
    strength of the product should be stated.
  • Therapeutic indications
  • The conditions for which the medicine is authorised must be listed. This
    section should include any benefit information considered appropriate
26
Q

What information is necessary before taking a medicine?

A
  • Situations where the medicine should not be used
  • Precautions
  • Warnings
  • Interactions with other medicines or foods
  • Information for special groups of patients (pregnant or nursing
    mothers)
  • Any effects the medicine may have on the patient’s ability to drive
27
Q

What additional information should you have on all medicines?

A
  • Excipient details
  • Description of the product
  • Registered pack sizes
  • Storage conditions
  • Name and address of the MAH and manufacturer
28
Q

How is medicine made more accessible?

A
  • The name must also be expressed in Braille format on the outer
    packaging of the product
  • A holder of a marketing authorisation must ensure the package leaflet
    is available on request in formats suitable for blind and partially-
    sighted persons

PMP103 - Practice Of Pharmacy (14 decks)

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