Patient Friendly Labelling - the Way Forward

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Patient Friendly Labelling - the Way Forward

• Jane Nicholson

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Patient Friendly Labelling
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The Patient Friendly Pack -Factors Affecting
Legibility

• Font size and style
• Use of colour
• Orientation of labelling information, i.e. design
  / layout

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• THE LABELTEXT
• Use sans serif types, as it is easier to read.

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• Use sans serif types, as easier to read.
• Use upper and lower case (not all capitals).

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Use of tall letters VinBLAStine VinCRIStine S
eroquel SerZONE as recommended by the Institute
of Safe Medication Practices.
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• Use sans serif types, as easier to read.
• Use upper and lower case (not all capitals).
• Use bold type face to emphasise.

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• Use sans serif types, as easier to read.
• Use upper and lower case (not all capitals).
• Use bold type face to emphasise.
• Critical warnings should be in red.

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• Use sans serif types, as easier to read.
• Use upper and lower case (not all capitals).
• Use bold type face to emphasise.
• Critical warnings should be in red.
• Numbers should have no trailing zeros, e.g. 5
  mg, not 5.0 mg.

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• Use sans serif types, as easier to read.
• Use upper and lower case (not all capitals).
• Use bold type face to emphasise.
• Critical warnings should be in red.
• Numbers should have no trailing zeros, e.g. 5
  mg, not 5.0 mg.
• Distinguish decimal points from full stops.
  Commas should not be used in decimal numbers.

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• Use sans serif types, as easier to read.
• Use upper and lower case (not all capitals).
• Use bold type face to emphasise.
• Critical warnings should be in red.
• Numbers should have no trailing zeros, e.g. 5
  mg, not 5.0 mg.
• Distinguish decimal points from full stops.
  Commas should not be used in decimal numbers.
• Maximise contrast of text and background.

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• Use sans serif types, as easier to read.
• Use upper and lower case (not all capitals).
• Use bold type face to emphasise.
• Critical warnings should be in red.
• Numbers should have no trailing zeros, e.g. 5
  mg, not 5.0 mg.
• Distinguish decimal points from full stops.
  Commas should not be used in decimal numbers.
• Maximise contrast of text and background.
• Use appropriate spacing of text.

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• Use appropriate spacing of text.
• Lower case print size should normally not be less
  than 2 mm in height, but optimum, not minimum,
  should be used.

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• Use appropriate spacing of text.
• Lower case print size should normally not be less
  than 2 mm in height, but optimum, not minimum,
  should be used.
• Visual impairment and use by the elderly need
  consideration.

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• Use appropriate spacing of text.
• Lower case print size should normally not be less
  than 2 mm in height, but optimum, not minimum,
  should be used.
• Visual impairment and use by the elderly need
  consideration.
• Abbreviations should not be used.

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• Use appropriate spacing of text.
• Lower case print size should normally not be less
  than 2 mm in height, but optimum, not minimum,
  should be used.
• Visual impairment and use by the elderly need
  consideration.
• Abbreviations should not be used.
• Avoid names (both trade and generic) similar to
  those of other medicines on the market.

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• Use appropriate spacing of text.
• Lower case print size should normally not be less
  than 2 mm in height, but optimum, not minimum,
  should be used.
• Visual impairment and use by the elderly need
  consideration.
• Abbreviations should not be used.
• Avoid names (both trade and generic) similar to
  those of other medicines on the market.
• Machine readable coding (e.g. bar coding) will be
  used by the future pharmacist.

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Text critical for the safe use of medicines

• Registered name followed by generic name (given
  due prominence

• Strength

• Route of administration

• Dosage instructions for self-medication products

• Any special warnings
• - should appear in as large a font as
  possible on the pack, in the same field of view
  and should not be broken up by additional
  information, logos, other text or graphics.

For prescription medicines, the name of the
patient, dosage instructions and indication or
intended use should be added at the time of
dispensing.
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The full name, strength and, if appropriate,
the route of administration should appear on
three non-opposing pack faces.
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Patient Information Leaflets

• Leaflets designed to go in the manufacturers pack

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50 of medicines are not taken as directed

• Marshall Marinker (1997)

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Method of Testing ReadabilityUsability
Guidelines for Consumer Medicine
InformationWHAT TO TEST?

• Can the consumer find the information
  quickly and easily?
  
• EASE OF LOCATION
• Having found it, can they understand and act on
  it ?
• USER FRIENDLINESS
• David Sless
• Rob Wiseman, Communications Institute of
  Australia

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20 subjects each asked the same 15
questionsfirst question about product name to
establish literacy then 14 safety related
questions
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The European Guideline suggests 16 of 20 subjects
should be able to answer all questions correctly.
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Results
12 out of the 15 questions met the
targetQuestion 1 What is the name of the
medicine?Only 15 /20 got it right ( the 5 wrong
answers were mis-pronounciations)Question 4
Suppose you went red in the face whilst taking
this medicine?Only 11/20 got it right ( the
wrong answers all went for caution to consult a
doctor and stop medication- the right answer was
to continue taking the medicine)Question 9
Suppose you were prescribed the medicine before
an operation?Only 12/20 got it right ( most of
the wrong answers were because people could not
find it )
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Overall Results On 41 occasions (14) people
could not find the informationOn 42 occasions
(14) the incorrect answer was given One rogue
subject , a nervous interviewee could read and
find information well, as he correctly answered 7
questions but for the other 8, he was a complete
blank
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Remarks made by Subjects The leaflet is too
long Its hard going - there is a lot of stuff
at the beginning you dont need Most people
dont read the whole thing so put when and how
to take the medicine up front Is it really
necessary to have these contact addresses?
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Remarks made by Subjects

• Size of print is not good when you are old. This
  one is not too bad as it happens- I can read it
• Size of print is not good when you are old. This
  one is not too bad as it happens- I can read it
• Sometimes I need a magnifying glass- this is OK
• Its for high blood pressure - right ?-by the
  picture of the arm - thats how I know where to
  look
• Nice to have diastolic and systolic blood
  pressure explained - I always wanted to know that
• Its for high blood pressure- right by the picture
  of the arm-thats how I know where to look
• Nice to have diastolic and systolic blood
  pressure explained- I always wanted to know that

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Remarks made about Side-effects

• Thats the bit I dont like reading- I think oh
  dear!
• For me, the more information, the better - there
  is more fear in not knowing
• Must be quite strong these tablets!
• Same old boring rubbish
• Well if you get a swollen tongue and rash, you
  would feel a bit worried too !
• If I feel dodgy, I get down to the old Docs
  straight away!

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Remark on Storage I store all my medicines in
the fridge- then I know where to find them
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1. Patients need to be informed not overwhelmed
with information
Conclusions
2. The European legislation on leaflets should be
changed
3. Pictograms are helpful in finding and informing
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Conclusions
4. Flexibility is needed as it is important that
information on different products can have a
different emphasis
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Patient Friendly Informationand the Internet
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Zerit - Stavudine - d4T - HIV
infections

• In 1999, 4,000 sites on Internet mentioned d4T
• Proposed users for U.K. site -
• Doctors, pharmacists, nurses involved in HIV
  healthcare
• (Factual information, pharmacology, safety,
  efficacy, tolerability of product)
• Patients
• (Factual information with links to disease
  specific sites)
• Not placed on any search engines.

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Zerit - Stavudine - d4T - HIV
infections
Proposed U.K. site ruled in breach of our
Advertising Code because trade name and logo for
Zerit was mentioned and statements A foundation
of anti-HIV therapy
and B.M.S. is a leading manufacturer of HIV
related treatments - in open access on health
professionals site. This could raise unfounded
hopes in patients of successful treatment.
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Internet websites for Patients on Prescription or
non-Prescription Products should contain
1. Company identity (sponsor of website)
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Internet websites for Patients on Prescription or
non-Prescription Products should contain
1. Company identity (sponsor of website)
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Internet websites for Patients on Prescription or
non-Prescription Products should contain
1. Company identity (sponsor of website)
2.
Health education information - methods of
disease prevention, screening advice on public
health
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Internet websites for Patients on Prescription or
non-Prescription Products should contain
1. Company identity (sponsor of website)
2.
Health education information - methods of
disease prevention, screening advice on public
health
3.
Balanced and accurate patient information on
products marketed by company, to include
registered text of patient leaflet (P.I.L.)
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Internet websites for Patients on Prescription or
non-Prescription Products should contain
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Internet websites for Patients on Prescription or
non-Prescription Products should contain
5.
Links to other websites such as patient groups,
medical research or professional bodies (but not
link from general public site to company site for
health professionals)
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Internet websites for Patients on Prescription or
non-Prescription Products should contain
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Internet websites for Patients on Prescription or
non-Prescription Products should contain
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Reference to patient websites printed on patient
leaflets in product packs.
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Advertising Controls on Prescription Medicines
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Internet websites for Patients on Prescription or
non-Prescription Products should contain
7.
Reference to patient websites printed on patient
leaflets in product packs.
8.
All websites must have internal company
scientific review.
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Conclusions
In conjunction with the advice of health
professionals, patient-friendly labelling in and
on the pack and on the internet helps to inform
patients. Well informed patients are more likely
to adhere to prescribed medications, with safer,
more successful outcomes and more efficient use
of healthcare resources.