Sector specific legislation and the nature of the products can make pharmaceutical labelling problematical, but suppliers have responded to the challenges as Gerry Duggin reports
Specific challenges face the pharmaceutical packaging sector. Accuracy is an absolute pre-requisite and the amount of information that must accompany the products is vast compared to other industries. The unique format and diminutive size of some of the products, especially since the implementation of unit dose packaging, can also be problematical.
Child resistance is a perennial topic, while in some countries there is specific legislation requiring vignette labelling for health scheme reimbursements for pharmacists.
Meanwhile, the requirement for clinical trials creates an inherent demand for short-run batches, rarely a cost-effective or simple task. Add to that the threat of theft and counterfeiting because of the commonly high unit value and it makes the problems faced in other sectors pale into insignificance.
These considerations require a sophisticated and innovative approach and fortunately packaging professionals have responded – none more so, perhaps, than in the labelling industry which has addressed all of these problems, and more.
First introduced in the early 70s, leaflet labels have become a widely accepted solution to solving the “information overload” that must now accompany pharma products and fulfil the obligation that this information must stay with the pack.
Two new developments in this product area have recently been introduced by Inprint. The first is the Blister Inseal which is designed to be attached directly onto a blister pack to reduce packaging and provide added child security.
The Blister Inseal is applied to the flat, foil surface of the blister pack and its self-adhesive base attaches to the pack, “creating a more secure barrier that is significantly harder for children to break through”. This base is micro-perforated or crosscut to allow the tablets to be pushed through when the laminated label ‘cover’ is opened.
As with all leaflet labels, the multiple pages can be printed with a large volume of product information in a variety of languages, removing the need for further, loose leaflets. In some circumstances, too, Blister Inseal removes the need for a carton, thus reducing costs, which is particularly pertinent to small batch runs for clinical trials.
Moreover, because of its added security, Blister Inseal is also said to provide an ideal vehicle for over the counter medications such as paracetamol to be dispensed from vending machines in a “safe, cost-effective way”. The company says this method of OTC drug dispensation already exists in the USA and is gaining popularity in Europe.
Inprint is currently working on the next stage of its leaflet labels for blister packs incorporating a specifically designed base label tested to the new blister child-proof standards.
The company has also recently introduced Reverse-cut, a development of its traditional Extended Text leaflet label that has been designed for the accurate documentation of pharmaceutical records.
Reverse-cut includes a sub-label within the base of the parent label that can be overprinted with product details. This is, as the name suggests, reverse-cut so that it can be detached and transferred to supplementary documentation, providing a carbon copy of the product details.
In particular, Reverse-cut has been designed to meet “two key market demands”.
Firstly, in the clinical trials arena, it allows essential information to be taken from the pack and placed easily on the case report form without any transcription errors. It also allows the leaflet label to include multiple languages, obviating the requirement for re-labelling or separate production runs for each country involved in a study.
Secondly, Reverse-Cut provides a solution to the specific problem encountered in continental Europe which was mentioned earlier, where a reimbursement system is employed for prescription pharmaceuticals.
The system demands that the label is removed from the packaging and used as a record of the medicine purchased for the purposes of reimbursement. With Reverse-cut, the detachable vignette can already be overprinted with the necessary information, “eliminating errors and providing an easier route to reimbursement”.
Denny Bros, also a long-established compact media specialist, offers a variety of solutions to the pharma sector, including the original Fix-a-Form and the more recently introduced PackXtra and Informaxx formats.
One of its most recent applications for G R Lane Health Products of Gloucester highlights just how much information can be reproduced on a leaflet label. The company selected a 10-page resealable Fix-a-Form for its latest health product Detoxplan, as packaging buyer Zo Johnson explains: “When designing the food supplement tablet pack, we wanted to ensure that the packaging would be transportable, preferably the right size for a handbag or toiletries case. We also had a great deal of text to print on pack which is why we needed the help of a Fix-a-Form.
“We printed a 10-page Fix-a-Form in the same colours as the main pack to explain the detox system. Additionally, we were required by law to list the full ingredients and nutritional information relevant to the tablets. It’s important that the usage information stays with the product for its life. The Fix-a-Form makes sure that this is the case as it is stuck fast to the pack. The concertina pages can be neatly folded away and resealed, which makes it ideal for repeat reference.
“The artwork for the leaflet-label was supplied by our design company to the pre-press team at Denny Bros and so there was very little extra work for us to do.”
Meanwhile Clinical Print Finishers has launched what it claims is a unique range of miniature folded and glued ‘outsert’ leaflets – as the Americans named them – for pharmaceutical applications.
The multi-folded leaflets measure 50x30mm and each one contains some 160 folded ‘pages’ – 80 each side – on a sheet size 505x200mm. The leaflets are then prevented from springing open by the application of peelable glue spots.
Managing director, Alvin Brown says: “For Clinical, anything miniature is the key phrase. We have used our latest H&H machines and then made a quantum leap forward by attaching two special glue guns, which place two glue spots.
“Over the past 18 months, several of our existing pharmaceutical clients enquired whether it was feasible. We carefully researched current applications in the USA and we are confident that this is the first time that this combination of miniature folding and gluing has been achieved by a specialist trade-finisher.”
According to Clinical Print the outserts offer “the significant advantages of a larger flat sheet size, folded into one of the smallest finished leaflets available on the market”, which “enables faster packaging of medical and cosmetic products to meet their short deadlines”.
Turning to the problem of available space, PrisyMedica, the labelling software from MAP80 Systems for FDA 21 CFR Part 11 compliance, now includes reduced space symbology barcodes. This symbology, part of the UCC/EAN family, has been recommended by the FDA in its recent guidance for encoding critical information on unit-dose drugs, biologicals and blood products.
The use of RSS barcodes allows manufacturers and distributors to encode information such as unit of dose, lot and expiration date and even National Drug Codes on all levels of packaging even where space is limited.
MAP80 says it also enables speedier and more accurate product recalls as the product can be scanned rather than having to be visually checked.
Counterfeit drugs are a particular problem in the developing world and now US-based CCL Label and Orbid Corporation – a developer of secure track and trace systems used in the identification and protection of products – have formed a partnership which will see the incorporation of Orbid’s patented 2DMI coding system into CCL’s newly developed security packaging.
“With this innovative labelling and packaging it will be possible to validate the authenticity of pharmaceutical products throughout the supply chain, from manufacturer, to distributor, to pharmacy, to consumer,” says Kevin T. Simmons, managing director, sales, Orbid.
The companies claim the labels will provide manufacturers and pharmacies with a means of verifying that drug shipments down to the smallest unit level are authentic and authorised. They say the previous inability to track and validate authenticity beneath the level of large batches left room for counterfeiting and theft.
The 2DMI system utilises security marks that can be unobtrusively incorporated into any of CCL Label’s packaging and label designs. Each 2DMI mark is unique and can apparently be printed in virtually any colour and size on any surface while remaining easily scanned by standard commercial equipment.
Boxes, labels, and individual tablets or capsules printed or etched with 2DMI marks can be cross-checked for authenticity against a database kept only by the manufacturer. 2DMI is a closed system and the marks themselves appear as unintelligible graphical representations of encrypted data. Only the manufacturer of the pharmaceutical holds the unique algorithm that unlocks the data represented by the marks, making mass reproduction of marks by counterfeiters impossible.