sale and suplly of medicines

Question 1

What is a container?

Answer 1

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

Question 2

What is a package?

Answer 2

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

Question 3

What are the packaging requirements?

Answer 3

• Name of the medicine
• Expression of strength
• Route of administration
• Dosage
• Warnings

Question 4

What is the name of the medicine defined by?

Answer 4

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

Question 5

On the packaging, is abbreviation allowed?

Answer 5

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

Question 6

Route of administration: positive

Answer 6

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

Question 7

Route of administration:nonpos

Answer 7

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

Question 8

other routes of administration

Answer 8

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

Question 9

When Is a told dosage necessary?

Answer 9

• 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.

Question 10

warnings and medicine?

Answer 10

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

Question 11

What medicines require indications?

Answer 11

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

Question 12

What is on blister packs?

Answer 12

• 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

Question 13

Other medicine pack type?

Answer 13

*small packs
*radionucleotides

Question 14

When is child safety packaging ignored/ removed?

Answer 14

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

Question 15

What is the legal requirement on dispensing labels?

Answer 15

• 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

Question 16

How to word directions for medicines?

Answer 16

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

Question 17

What are some useful phrases to remember in pharmacy administration?

Answer 17

• 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

Question 18

RpharmS recommendations for labels?

Answer 18

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.

Question 19

What are some example warnings?

Answer 19

• 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

Question 20

rules and advice to do with outer containers?

Answer 20

• 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.

Question 21

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

Answer 21

1999

Question 22

What are PILs based on?

Answer 22

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

Question 23

When will PILs not be provided in a medicine packaging?

Answer 23

• 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

Question 24

What Is included in the PIL?

Answer 24

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

Question 25

What is required to identify a medicine?

Answer 25

• 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

Question 26

What information is necessary before taking a medicine?

Answer 26

• 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

Question 27

What additional information should you have on all medicines?

Answer 27

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

Question 28

How is medicine made more accessible?

Answer 28

• 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