The on-pack information conundrum facing packaging and labelling manufacturers in the prescription medicine field has been given an extra spin with new guidelines, which came into force this March reports Louise Hunt
A spate of medication errors in hospital pharmacies has led the Medicines Control Agency to believe that the way in which medicines packs are presented is behind some cases of mis-dispensing of prescription medicines.
In response, the MCA – advised by the Committee on Safety of Medicines – has published the Best Practice Guidance on Medicines Labelling and Packaging. The guidelines set out what factors should be considered when designing medicines labelling to reduce medication errors.
Key changes will involve layout, size of text and colours, along with ‘rapid access’ to five pieces of critical information: the name of the medicine, strength, route of administration, dose and warnings. All of which will have to be clearly displayed together on the front of the pack.
The Best Practice Guidance supplements the legal requirements set out in the Council Directive 2001/83/EEC and the existing European Commission guidance on labelling and patient information leaflets. Pharmaceutical manufacturers will be expected to make any necessary amendments to packs and labels and suppliers will need to respond with solutions. Non-compliance will have to be justified to the MCA.
The potential impact for suppliers could be significant if the increase in information leads to changes in pack and label formats. What’s more the basis for these corrections is debatable.
Richard Ley, spokesperson for the Association of the British Pharmaceutical Industry (ABPI) says that, while the guidance is welcome as part of a solution, it should not be seen as the whole answer.
“We believe that the guidelines are acceptable but changing the way the packaging is presented is not the answer to this particular problem. It is the way that hospital pharmacies operate that needs to be addressed.
“All sorts of practical problems could arise from what seem like small changes. Suppliers might have to modify machinery or provide alternative formats. The impact could be huge.”
Despite the possible ramifications, there appears to be a general lack of awareness from suppliers of the MCA publication. This may be due to difficulties in keeping abreast of the seemingly constant changes in pharmaceutical guidelines, along with the time taken for new requirements to filter from manufacturer to supplier.
Those suppliers who are clued-up may be able to keep possible disruption to a minimum. In the best scenario there is the opportunity to turn the guidelines to their advantage.
Manufacturers of leaflet labels are likely to be well placed to meet additional demands in information. Andrew Walker, group business development manager of Inprint Europe, talks about the possible impact of the MCA guidelines on its leaflet label business.
“Any new legislation always has some impact on our industry. This could mean additional business for some suppliers, while meaning a loss of business to others due to a necessary change in packaging styles.
“The need to increase type sizes and add more information to the front of the pack will make it even more crowded. In some cases this will cause real issues for the drug manufacturers as to how they are going to fit all this text on.”
Mr Walker speculates that this may mean that some products which have so far managed to use a label only or dry peel label will now need to go to leaflet labels or alternative styles of packaging to meet requirements. But even leaflet labels may have issues to address.
“The guidelines also talk about allowing space for the dispensing label. This is fine if it is on a carton or a large container but, if it is a small pack, the dispenser’s label is likely to cover up some of the primary label.
“If you look at a lot of the small packs that we produce leaflet labels for the label covers the majority of the available area. Any additional label normally just gets stuck on top of the pack label – will this not be allowed in the future?”
Part of the solution may lie in 2D barcodes, which have so far had limited take-up. Says Mr Walker: “The traditional pharmaceutical codes are only used by the industry to ensure that the correct label is being used. But they take up a lot of room on the front faces. 2D codes are compact and would give relief to confined text areas.”
Mr Walker outlines the influence on the MCA guidelines is likely to have on Inprint’s leaflet label developments.
“Our extended tables regularly carry 24-page books with customers now using 32-page versions or more. This means that concertina folded leaflets used on pack will become less user friendly due to the pull out length, thus driving people towards booklet formats.
“As a supplier we are going to be under pressure to maximise the printable areas on our products, putting our production tolerances to the test. If we go too tight we risk cutting off the text. Too wide a tolerance and the customer has a space issue.
“We will no doubt be needing to address our product designs and systems to meet the new guidelines. But this will have to be in harmony with our customers, as each will have different needs and interpretations.”