Pharmaceutical and medical products can be broadly divided into prescription drugs, non-prescription (or over-the-counter/OTC) drugs, and hospital equipment/consumables. While these categories are partly overlapping, their requirements for the label converter are substantially different, for legal, usage and marketing reasons. The principal regulations, which the label designer or converter needs to know about, are detailed below.
DIRECTIVES AND REGULATIONS
The two main regulatory bodies are the Food & Drug Administration (FDA), for the United States, and the European Union for Europe. Other official agencies regulate drug sales in China and other countries but generally, their rules tend to approximate to those of the FDA and EU.
Label converters are not expected to know all the very complex regulations regarding the text for pharmaceutical labels but should at least be familiar with the general requirements so as to be able to discuss with their customers and understand their constraints.
For the United States, the Federal Food, Drug and Cosmetic Act (FFDCA) defines ‘labeling’ as all labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers, or accompanying such article. The term 'accompanying' is interpreted liberally to mean more than physical association with the product.
Label converters wishing to get full details of US compliance requirements can consult the US Registrar Corp who (for a fee) will provide confirmation that a given label or package meets FDA requirements.
PRODUCT INFORMATION REQUIRED ON PHARMACEUTICAL LABELS/PACKAGING
Requirements will vary from country to country and product to product, but the following will generally be required:
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Ingredients, active and inactive
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Any specific product warnings
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Directions for taking or use
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Information about allergic or other reactions.
MARKET STRUCTURE – PRODUCTION, DISTRIBUTION AND MARKETING
The pharma business has seen increasing concentration in recent years as bigger firms bought up smaller ones to increase their market share. Globally, the biggest drug producers are those listed in Figure 5.1.
Consumables include blood pouches, serums and indeed all products administered to, or injected into, a patient. The double or triple layer self-adhesive label, with one copy going onto the patient’s record, avoids the risk of errors when copying by hand. For blood bags, the hospital sector needs very special labeling materials due to regulatory requirements and the extreme conditions associated with blood storage and processing.
Several labelstock producers have developed laminates specifically for this use. UPM Raflatac for example have designed a range of primary blood bag label materials fully compliant with ISO 3826 standards. These labeling products use an adhesive that can tolerate temperatures from +121 deg C during steam sterilization, down to -80 deg C, as well as freezing in ethanol to -50 deg C.
Other medical equipment requiring specialty labels includes syringes and all kinds of flacon. Much ingenuity has been shown by label converters whose innovations have included ‘Needletrap’ a safety label for syringes and ‘Flexicap’ a protective pack with integrated label for the protection of dangerous fluids.
A particularly ingenious syringe label has been designed for so-called ‘auto-injector’ syringes, as used for example by those suffering from acute diabetes (Figure 5.3). As well as the usual printed information, this label comes with an anti-slip varnish to prevent slipping during injection, an integrated hologram which identifies the product as an original, and a printed QR code or Near Field Communication (NFC) chip which provides a link, via smartphone, to a website with additional product information.
Consumables include blood pouches, serums and indeed all products administered to, or injected into, a patient. The double or triple layer self-adhesive label, with one copy going onto the patient’s record, avoids the risk of errors when copying by hand. For blood bags, the hospital sector needs very special labeling materials due to regulatory requirements and the extreme conditions associated with blood storage and processing.
Several labelstock producers have developed laminates specifically for this use. UPM Raflatac for example have designed a range of primary blood bag label materials fully compliant with ISO 3826 standards. These labeling products use an adhesive that can tolerate temperatures from +121 deg C during steam sterilization, down to -80 deg C, as well as freezing in ethanol to -50 deg C.
Other medical equipment requiring specialty labels includes syringes and all kinds of flacon. Much ingenuity has been shown by label converters whose innovations have included ‘Needletrap’ a safety label for syringes and ‘Flexicap’ a protective pack with integrated label for the protection of dangerous fluids.
A particularly ingenious syringe label has been designed for so-called ‘auto-injector’ syringes, as used for example by those suffering from acute diabetes (Figure 5.3). As well as the usual printed information, this label comes with an anti-slip varnish to prevent slipping during injection, an integrated hologram which identifies the product as an original, and a printed QR code or Near Field Communication (NFC) chip which provides a link, via smartphone, to a website with additional product information.
IMPACT OF NEW EUROPEAN DIRECTIVE ON SERIALIZATION: 2011/62/EU ('FALSIFIED MEDICINES DIRECTIVE')
Serialization: what is it? Serialization means giving a unique, traceable number to each individual pack of a product, along with corresponding numbers to each carton or pallet. As an anti-counterfeit system it is not limited to pharmaceutical products, but will be used worldwide for these products which are particularly subject to counterfeiting (see Figure 5.5).
For Europeans, compliance with the ‘Falsified Medicines Directive’ (2011/62/EU) will be mandatory from 2018 and will cover all sales of pharmaceutical products in the European Union, whatever their country of origin. Large markets like China have already implemented a law that requires serialization of each single product including full traceability over the entire logistics chain. Other countries like the USA will be among many others following very soon or at least starting to think about this.
While current serialization requirements are limited to marking the unit of sale with a unique data carrier, by 2023 the process will require a product to be traceable through the entirety of its journey - from the carton/pallet through to the retail pharmacist or hospital..In the United States, the Healthcare Distribution Management Association (HDMA) is suggesting that pharmaceutical companies should begin to support this level of serialization, called aggregation, now. The problem facing the pharma label converter is that no one knows how the different markets of the world will specify the rules for serialization.
A leading company in this sector is Atlantic Zeiser, whose CEO went on record as saying that we should ‘Focus on the installation of a central serialization software and database application that is characterized by a modular architecture in order to be able to grow seamlessly with any need. This way it is possible to quickly adapt workflows and coding principles to new emerging regulations without the need of reprogramming and time-consuming revalidation’.
Another international company developing software for unique product identification (UPID) and track & trace solutions is Adents.
This company, based near Paris, has worked with Microsoft to jointly develop and market a new Cloud platform. Named Adents Prodigi, it has been hailed as the only Level 4 traceability solution that can centrally manage regulatory requirements imposed on the pharmaceutical industry.
GRAY MARKET DISTRIBUTION
A particular problem of pharmaceuticals concerns the selling of genuine goods by unauthorized persons or companies. For example, an importer in a country with artificially low prices for certain medicines may try to re-sell them in a high-price country where they will compete unfairly with the same goods sold by an authorized distributor. The brand owner may need covert protection, which can be given by special inks which change color in UV light. In many cases brand owners may just need to track cross-border movements of their products to trace trading movements which while unwanted may not be illegal.
WHO MAKES WHAT?
The constraints and regulations governing pharmaceutical labels are so strict that many converters specialize only in this end-user sector. Specialized label converters with interesting new ideas for pharmaceutical labeling include:
CCL – probably the world’s largest self-adhesive label supplier, CCL has 23 plants worldwide exclusively focused on the pharmaceutical industry. All of these plants offer serialization, plus a high level of security control.
Constantia Flexibles – also a major player. Constantia’s label division makes not just labels but the full range of packaging requirements for pharmaceuticals.
PagoPharm – based in Switzerland, makes multi-layer, security and functional labels.
Reynders Pharmaceutical Labels – this division of the leading Belgian label group is particularly specialized in anti-counterfeit features, and in fully integrated camera inspection systems.
Schreiner Medipharm – with plants in Germany and USA, has developed a range of innovative products to simplify the dispensing and administration of pharmaceuticals, particular for hospital and laboratory use. Examples are the ‘Needle trap’ (photo) and the protective closure and packaging for dangerous liquids (photo).
Securikett – this Austrian label converter, as its name implied, is specialized in security labeling and track-and-trace systems, mainly for the pharmaceutical and medical sectors. Stratus – this Franco-Belgian converter makes labels for all end-user sectors, but has six production lines reserved exclusively for pharmaceutical labels.
Autajon and August Faller – market-leading label and packaging producers based in France and Germany respectively also have plants producing folding cartons, leaflets and labels for many different products, but both strong is the pharmaceutical/medical sector.
POINTS TO REMEMBER
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Strict quality compliance rules apply for pharma labels
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Although leading drug companies are big, the global market is not concentrated
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Labeling requirements are different for prescription drugs, OTCs and hospital/medical requirements
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Many pharma labels must stand up to scuffing, to chemicals and to extremes of temperature
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Serialization will, it is hoped, reduce the very widespread counterfeiting of pharmaceuticals.
