Best Practice Guidelines From MCA

R T Calvert

Consultant in Medicines Management

NEYNL HA

R Calvert Dec 2002

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

R Calvert Dec 2002

LabellingGood label design should

Assist users to select correct medication pack

Minimise selection errors

Design must not be led by marketing issues

Be user friendly

R Calvert Dec 2002

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 atQMC, Nottingham” Jan 2001

“Prevention of intrathecal medication errors” A reportto the CMO by Professor Kent Woods

R Calvert Dec 2002

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

Root Causes of Medication Errors

0 10 20 30 40 50 60 70

Orientation/Training

Communication

Storage/access

Information accesss

Comptency

Supervision

Labelling

Distraction

% of events

Taken from “Building a safer NHS”

R Calvert Dec 2002

Purpose of Working PartyThe 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 medicationerrors.

R Calvert Dec 2002

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.

Summary of Literature Review

R Calvert Dec 2002

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.

Key Findings (I)

R Calvert Dec 2002

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.

R Calvert Dec 2002

Labelling Principles to Be Applied

Labelling must comply with the requirements set out in Article 54 of Directive 2001/83/ECFive 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

R Calvert Dec 2002

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

R Calvert Dec 2002

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

R Calvert Dec 2002

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

R Calvert Dec 2002

Brand X injection5mg per mlcommon name tartrate50mg in 10mlSolution for injection.For intravenous infusion onlyPL xxxxx/xxxxMA holder: A Pharmaceutical Co

Based on “Labelling of drugs ampoules and vials”A National Standard of Canada CAN/CSA-Z264.2-99

Example of a Layout for a Small Container

R Calvert Dec 2002

•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.

•The largest type size possible should be used for the critical information on medicine labelsFonts used should be sans serif

Style of Labels

R Calvert Dec 2002

Colour Coding not supported:A limited number of colours are available for useThe incidence of colour-blindnessIndividual perception of colourDifference in appearance of the same colour in different lighting conditionsNo 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.

Use of Colour

R Calvert Dec 2002

Old design

New design

R Calvert Dec 2002

1. Design solutions in respect of medication errors with vinca alkaloids

Interchangeability of spinal needles and intravenous needles are a further risk to patient safetyThe 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.

Other Issues 1

R Calvert Dec 2002

2. Statutory Warnings and Cautionary and Advisory LabellingMembers acknowledged that there was a body of evidence suggesting the statutorywarnings and other warnings applied by pharmacists were not well understood by patients

3. Dispensing Labels4. Use of colour on dispensed medicines in operating theatres 5.Use of IT in the Approval Process of Drug Names6. Use of Warning Symbols on Drugs with a low Therapeutic Index

Other Issues 2

R Calvert Dec 2002

Response From ABPI

1. Must have Pan European agreement2. Predominance of generic name.Strongly disagree3.Number plate redundant since required information alreadyclearly presented on pack.4.Company logos ensure traceability and is an aid to identification5.User testing should not be compulsory6.Anecdotal evidence re sans serif fonts not acceptable

R Calvert Dec 2002

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 whenpreparing and designing labelling and packaging of allComponents of medicines.The MCA will now work with a small group ….. To developa best practice guideline…

R Calvert Dec 2002

R Calvert Dec 2002

Best Practice Guidelines

Will be published in New YearAgreed by Industry/MCA/User working group

•Improve clarity of advice

•Define scope

•Stress “where practical”•Reinforce need for user testing

R Calvert Dec 2002

Common Factors

Information: Certain items are vital for safe use

Format: Legible and easily understood by users of medicines

Style: Potential for confusion between similarity in drug names

R Calvert Dec 2002

Key MessageThe 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