Transcript December 2002

Best Practice Guidelines From
MCA
R T Calvert
Consultant in Medicines Management
NEYNL HA
Key aspects of packaging design
Good packaging should
•Maintain product integrity
•Ensure no damage during transport
•Aid identification of medicine
•Be user friendly (can you open it!)
•Be attractive on display
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Labelling
Good label design should
Assist users to select correct medication pack
Minimise selection errors
Be user friendly
Design must not be led by marketing issues
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Background to Formation of
Working Party
“An organisation with a memory- A report of an expert
group on learning from adverse effects in the NHS”
DH 2000
“Building a safer NHS for patients - Implementing
“An organisation with a memory”
DH April 2001
“External inquiry into the adverse incident that occurred at
QMC, Nottingham” Jan 2001
“Prevention of intrathecal medication errors” A report
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to the CMO by Professor
Kent Woods
Medication Errors
•Methotrexate taken daily not weekly
•Vincristine given intrathecally not intravenously
•Bupivacaine given intravenously not epidurally
•Nitrous oxide given when oxygen intended
•Potassium given as a high strength injection
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Root Causes of Medication Errors
Distraction
Labelling
Supervision
Comptency
Information accesss
Storage/access
Communication
Orientation/Training
0
10
20
30
40
% of events
Taken from “Building a safer NHS”
50
60
70
Purpose of Working Party
The WGLPM agreed that the prime function of a label is to
identify the medicine, what it is for and how to use it safely.
There is no substitute for reading the label.
However within the regulatory framework there is the possibility of
improving the layout of key labelling items to aid clarity.
This would assist health professionals and patients to select the
correct product and use it safely thereby minimising medication
errors.
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Summary of Literature Review
Certain items of information are vital for the safe
use of a drug
Such information must be presented in a legible
manner which is easily understood by all those
involved in the supply and use of the medicine
There is the potential for confusion between
similarity in drug names and similarity in drug
packaging.
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Key Findings (I)
1. A common approach is recommended for all medicines based on
key principles – a“number
plate”.
2. There is tension between commercial information being present
on labelling and available space. This should not impinge on the
critical information or weaken its clarity.
3. Case-specific strategies should be employed to support labelling
improvements:e.g. judicious use of colour to enhance clarity;
provision of drugs in kit form to assist correct administration.
4. All labelling should be subject to user testing by companies.
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Key Findings (II)
5. Further research is required on the use of warning
statements and symbols on medicines labelling and the
clarity of standard additional labels.
6. The use of IT systems could help reduce confusion
caused by look-alike and soundalike similarities of
new drug names.
7. CSM should receive feedback on implementation of
OWAM from the Office of the Chief Pharmacist and others.
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Labelling Principles to Be
Applied
Labelling must comply with the requirements set out in
Article 54 of Directive 2001/83/EC
Five items of critical information to be located together, in
same field of view
•Name of medicine
•Strength
•Route of administration
•Dose (medicines intended for self administration)
•Warnings as required by SPC
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Presentation of Critical
Information (1)
•Maximum font size possible on at least one of
face of the carton
•Name on at least three non opposing faces
•When required the common name should be given due
prominence
•Judicious use of colour and pack design to aid
accurate identification
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Presentation of Critical
Information (2)
•Space for dispensing label with no text or printing of any
•kind where possible
•Positive statements to avoid ambiguity
•User testing to give feedback to designers
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Blister Packs
•Statutory information should be presented using as large
a font as possible
•Colour and text should be chosen carefully bearing in mind
the reflective nature of the packaging
•Where possible the critical information should appear
over each blister or across the centre of the pack
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Example of a Layout for a Small
Container
Brand X injection
5mg per ml
common name tartrate
50mg in 10ml
Solution for injection.
For intravenous infusion only
PL xxxxx/xxxx
MA holder: A Pharmaceutical Co
Based on “Labelling of drugs ampoules and vials”
A National Standard of Canada CAN/CSA-Z264.2-99
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Style of Labels
•The largest type size possible should be used for the
critical information on medicine labels
Fonts used should be sans serif
•Bold should be used for emphasis.
•Capitals (upper case alone) and italics are less easy to read.
•Black text on a white background should be used for
critical information.
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Use of Colour
Colour Coding not supported:
A limited number of colours are available for use
The incidence of colour-blindness
Individual perception of colour
Difference in appearance of the same colour in different lighting
conditions
No colour coding system could positively differentiate between all
12,000 medicines authorised in the UK
 In the absence of a nationally or internationally agreed colour
code any UK system could be perceived as a barrier to trade.
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
Old design

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New design
Other Issues 1
1. Design solutions in respect of medication errors with
vinca alkaloids
Interchangeability of spinal needles and intravenous needles
are a further risk to patient safety
The benefits of provision of vinca alkaloids in large volume
solutions (>10ml) should be investigated and balanced against the
risk of extravasation problems.
Further work on the production of a “vinca kit” including
the drug and all the necessary administration kit
(which could not be used spinally) should continue.
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Other Issues 2
2. Statutory Warnings and Cautionary and Advisory
Labelling
Members acknowledged that there was a body of evidence suggesting the statutory
warnings and other warnings applied by pharmacists were not well understood by
patients
3. Dispensing Labels
4. Use of colour on dispensed medicines in operating theatres
5.Use of IT in the Approval Process of Drug Names
6. Use of Warning Symbols on Drugs with a low Therapeutic
Index
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Response From ABPI
1. Must have Pan European agreement
2. Predominance of generic name.Strongly disagree
3.Number plate redundant since required information already
clearly presented on pack.
4.Company logos ensure traceability and is an aid to
identification
5.User testing should not be compulsory
6.Anecdotal evidence re sans serif fonts not acceptable
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Outcome of Consultation:
MAIL 130 March/April 2002
Having considered all the views expressed,
which came from a wide range of interests,
the CSM has agreed a set of principles to be applied when
preparing and designing labelling and packaging of all
Components of medicines.
The MCA will now work with a small group ….. To develop
a best practice guideline…
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Best Practice Guidelines
Will be published in New Year
Agreed by Industry/MCA/User working group
•Improve clarity of advice
•Define scope
•Stress “where practical”
•Reinforce need for user testing
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Common Factors
Information: Certain items are vital for safe use
Format:
Style:
Legible and easily understood by users of
medicines
Potential for confusion between
similarity in drug names
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Key Message
The primary purpose of labelling and packaging should be
for the clear, unambiguous identification of medicines
and not for promotional or marketing purposes.
The pharmaceutical industry needs to treat labelling and
packaging safety in the same manner in which it treats
the safety of the medicine itself and must develop expertise
to enable it to do so
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