Best Practice Guidelines From MCA

1. Best Practice Guidelines From MCA R T Calvert Consultant in Medicines Management NEYNL HA

2. 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

3. 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 R Calvert Dec 2002

4. 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 to the CMO by Professor Kent Woods R Calvert Dec 2002

5. 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 R Calvert Dec 2002

6. Taken from “Building a safer NHS”

7. 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. R Calvert Dec 2002

8. 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. R Calvert Dec 2002

9. 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. R Calvert Dec 2002

13. 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

14. 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 R Calvert Dec 2002

15. 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

16. 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

17. 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

18. 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 R Calvert Dec 2002

19. 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. R Calvert Dec 2002

20. 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. R Calvert Dec 2002

21. Old design • New design R Calvert Dec 2002

23. 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. R Calvert Dec 2002

24. 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 R Calvert Dec 2002

25. 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 R Calvert Dec 2002

26. 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… R Calvert Dec 2002

27. R Calvert Dec 2002

28. 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 R Calvert Dec 2002

29. 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

30. 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 R Calvert Dec 2002