Patient Friendly Labelling
- the Way Forward
Jane Nicholson
Patient Friendly Labelling
1. Text and Design of Labels and Cartons
2. Patient Information Leaflet
3. Patient Friendly Information and the
Internet
The Patient Friendly Pack Factors Affecting Legibility
Font size and style
Use of colour
Orientation of labelling information,
i.e. design / layout
• THE LABELTEXT
• Use “sans serif” types, as it is easier to read.
• Use “sans serif” types, as easier to read.
• Use upper and lower case (not all capitals).
Use of “tall” letters
VinBLAStine
VinCRIStine
Seroquel
SerZONE
as recommended by the
Institute of Safe Medication Practices.
• Use “sans serif” types, as easier to read.
• Use upper and lower case (not all capitals).
• Use “bold” type face to emphasise.
• 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.
• 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.
• 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.
• 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 “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.
• 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.
• 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.
• 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.
• 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.
• 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.
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.
The full name, strength and,
if appropriate, the route of
administration should
appear on three nonopposing pack faces.
Patient Information Leaflets
Leaflets designed to go in the
manufacturer’s pack
50% of medicines are not taken
as directed
Marshall Marinker (1997)
Method of Testing Readability
Usability Guidelines for Consumer Medicine
Information
WHAT 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
20 subjects each asked the same 15 questions
first question about product name to establish
literacy then 14 safety related questions
Age Range
18-64
Men
3
Women
4
64-74
5
4
75-84
2
2
Total
10
10
Half the subjects were already being treated
for high blood pressure
The European Guideline
suggests 16 of 20
subjects should be able
to answer all questions
correctly.
Results
12 out of the 15 questions met the target
Question 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 )
Overall Results
On 41 occasions (14%) people could
not find the information
On 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
Remarks made by Subjects
* The leaflet is too long
* Its hard going - there is a lot of stuff at
the beginning you don’t need
* Most people don’t read the whole thing
so put “when and how to take” the
medicine up front
* Is it really necessary to have these
contact addresses?
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 - that’s how I know where
to look
Nice to have diastolic and systolic blood
Remarks made about Side-effects
• That’s the bit I don’t 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 Doc’s
straight away!
Remark on Storage
I store all my medicines in the
fridge- then I know where to find
them
Conclusions
1. Patients need to be “informed”
not overwhelmed with
information
2. The European legislation on
leaflets should be changed
3. Pictograms are helpful in finding
and informing
Conclusions
4. Flexibility is needed as it is
important that information on
different products can have a
different emphasis
Patient Friendly
Information
and the Internet
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.
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.
Internet websites for Patients on Prescription
or non-Prescription Products should contain:
1. Company identity (sponsor of website)
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
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.)
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.)
4. Summary of product characteristics (S.P.C.) and
public assessment report (E.P.A.R.)
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
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)
6. Suggest recommended reading and invite
electronic mail from patients wanting further
data from company Information Departments
(but not on personal matters)
- must have advisory statement to “consult a
doctor or pharmacist for further information”.
Internet websites for Patients on Prescription
or non-Prescription Products should contain:
7.
Reference to patient websites printed on patient
leaflets in product packs.
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.
Advertising Controls on Prescription Medicines
Who must approve (certify) copy?
Pre-approval of copy by health
authorities?
Germany
Italy
No
Legally
In practice
Any graduate with >2
years' industrial experience
Medical Department
Yes
Not defined.
(if nothing heard after 45
days, company can publish)
Marketing, Medical
Information,
Regulatory
Great
Britain
No
Two persons, one a medical Medical Director,
practitioner and the other a Medical Information,
pharmacist or appropriately Marketing
qualified person
Netherlands
No
Head of Scientific
Information
Marketing, Medical,
Regulatory
Portugal
No
Commercial Director
Marketing, Medical,
Regulatory
France
No
Responsible pharmacist
Marketing,
Regulatory, Medical
Ireland
No
Not specified
Medical
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.
9.
Pre-approval by regulatory authorities not
necessary but national authorities should
monitor
- treat websites like paper copy.
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.