Steve Kelly, ceo of DataLase, looks at the trend for direct-to-consumer marketing and new techniques available to increase brand awareness and combat counterfeiting
With the increase in over-the-counter (otc) medicine, competition between pharmaceutical companies is heating up and a strong brand is more important than ever, causing companies to look at more consumer-led marketing strategies to further drive sales. At the same time, regulatory guidance on the marking of pharmaceutical tablets and packaging aims to combat anti-counterfeiting. It is essential that new technologies reflect the manufacturer's marketing needs while providing anti-counterfeiting capabilities.
For pharmaceutical companies, direct-to-consumer (DTC) marketing via television, the internet and packaging is becoming more important. Pharmaceutical companies are now focusing more time and money on developing individual brands in order to directly reach consumers. Instead of using medical representatives, pharmaceutical companies can use DTC marketing strategies for otc drugs that treat conditions that consumers can understand, such as common cold remedies.
Research shows that DTC advertising has a significant positive impact on pharmaceutical sales. A report by the National Institute for Healthcare Management (NIHCM) entitled "Prescription Drugs and Mass Media Advertising, 2000" 1 describes how the number of prescriptions for the 50 most heavily advertised drugs rose by 24.6% from 1999 to 2000, compared with an increase of 4.3% for all other drugs combined.
Pharmaceutical packaging plays an essential role in building brand awareness and trust. Companies can use branded packaging to build up a consistent product message.
There is also the option of marking tablets and capsules with company and brand names so that consumers can associate medication with one brand. This means pharmaceutical companies can complement brand names and advertising campaigns, building an overall image of their product. This is important when drugs become better known by brand rather than generic name in the consumer domain.
This particular effect can be seen with the antidepressant Diazepam, more commonly known by one of its brand names, Valium. Valium tablets are branded with the company name, an image that is synonymous with the packaging of the medicine as well as the corporate branding. This has led to consumers building up a relationship with not only the Valium brand, but also the company that manufactures the tablets.
Previously this effect was achieved by engraving onto tablets and capsules, but new technology means any type of information can be applied - for example the brand name, dosage, day of the week or patient name, using color-change technology. Not only does this technique help consumers to build knowledge of otc and prescribed medication, it can also be used in the tracking and tracing of drugs and to reduce the number of medication errors in hospitals. By marking drugs with patient names, dosage and day of the week, hospitals can easily avoid mistakenly mixing medications.
In February 2004, the FDA introduced rule 21 CFR Parts 201, 606 and 610, aimed at forcing stricter control of pharmaceutical packaging and labelling. This rule was in response to the growing number of medication errors in hospitals and healthcare environments.
The rule requires that human drug and biological product labels include linear barcodes containing the National Drug Code (NDC) number. Additionally hospitals will be required to use Medication Administrations Recording (MAR) systems (patient drug regimen in a computerised database). This will allow healthcare professionals to verify that the right drug, in the right dose and right route of administration is being given to the right patient at the right time. The NDC number will also enable the industry to keep track of the drug throughout the manufacturing process.
Packaging marking methods can vary depending on what type of data will be included (i.e. numeric symbols, alpha-numeric or special characters), as well as the amount of available space on which to print and the required location of the barcode. Traditional methods of marking packaging include laser, inkjet, thermal or dot-matrix printers. The FDA has commented that although inkjet and thermal printers may be appropriate for production line printing, they can cause difficulties in print speed, resolution and media compatibility.
These traditional methods of branding pharmaceutical packaging with information are all open to counterfeiting. This is because they are applied to the surface of the packaging, producing a risk that they can be tampered with, for example removing the information with solvents. It is therefore essential to develop a technology that can provide an anti-counterfeiting solution while being in keeping with other requirements of product and packaging branding.
According to the World Health Organization, a counterfeit medicine is 'one which is deliberately and fraudulently mislabelled with respect to identity or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient ingredients or with fake packaging.' 2
To address the rise in counterfeit medicines, a variety of anti-counterfeiting measures have been put into place by pharmaceutical manufacturers, from applying holograms to the packaging to using RFID solutions. However, these tend to be applied to the packaging rather than the product itself.
While the tamper-proof labelling of pharmaceutical packaging is of significant importance, it is generally recognised that the only truly effective method of ensuring that a medicine is what it purports to be is marking the tablets themselves. This would reduce medication errors and prevent the development of counterfeit drugs since it would mean that even if the packaging was removed the medication purposes would still be identifiable. This realisation has led to significant developments in tablet marking technologies.
By marking both the pharmaceutical packaging and the tablets with the brand information, companies can provide consumers with an association with their product. If tablets are marked with the brand name they can be identified even without the packaging, for example if the medication is prescribed. This can contribute to inciting the consumer to choose a particular brand of medication.
Traditional methods for tablet marking include embossing and post coating print processes such as offset gravure and inkjet spray. However, these technologies can present major downfalls. For one, the embossing method can lead to needless waste and disposal of products because it causes disintegration and cracking of tablets. Secondly, offset gravure requires the use of a pre-engraved cylinder, meaning that it is not suitable for variable data or customisation. Finally, inkjet spray can often mist, leading to spots of ink outside the required image area and slow drying of the ink.
There are also a wide range of associated problems, such as maintenance and production line down-time, in addition to issues associated with maintaining printing apparatus and replacing consumables. When dealing with sensitive products such as pharmaceuticals, these problems are particularly undesirable.
In the light of these important limitations of conventional tablet marking methods, there emerges a need for an innovative technology that will ensure reliable tablet marking, thereby providing a viable solution to medication errors, brand identification and anti-counterfeiting. Color change technology provides a practical alternative to traditional branding methods by providing a means of printing without ablation and without the use of transfer ribbons or fluids, therefore overcoming previous technological difficulties with tablet marking.
Color change technology uses a patented edible pigment, which undergoes a colour change to form a positive image once exposed to a computer controlled low power CO2 laser. The process requires no inks, ribbons or other costly consumables, making it much simpler, cheaper and more environmentally friendly than traditional printing techniques.
The laser based print engine is highly efficient with extremely high production uptime. The laser has a very long lifetime and compared to thermal printers it requires little maintenance and no replacing of print heads due to wear and tear. Unlike printing inks or inkjet fluids, images produced by colur change technology are not prone to 'bleeding' on absorbent substrates.
Color change technology provides a perfect solution for producing tamper-proof and tamper-evident images. Imaging can be formed through polypropylene and polyethylene films, allowing an indelible laser marked image to be permanently embedded or 'sandwiched' in laminates (contrasting with conventional surface printing which can be removed or damaged).
The laser responsive additive can be applied to the substrate by a variety of methods, although the most common in the pharmaceutical sector would be to use the existing label or package printing method to apply a patch of the ink. The laser responsive patch is subsequently activated using a low power 'steared beam' CO2 laser which forms the image even through an overlaminated film as detailed above. The patch changes color from neutral to black where exposed to the laser beam, thereby producing an indelible, permanent mark that does not smear, peel or fade away.
Color change technology can be used to code and mark directly onto the tablets. The laser responsive additive is also available in the form of a dry powder or water-based solution which is made up of 100% edible components. The material can be applied by the same tumble coating technique used to apply cosmetic or enteric coatings to the tablets. Companies are currently working to develop this technology into a consumable product.
Marking tablets in this way can be used for a variety of applications, and can be particularly effective to apply brand names or images onto the tablets. With color change technology it is possible to increase awareness of pharmaceutical brands while complying with FDA regulations.
Color change technology results in cost savings when compared with conventional in-line imaging processes. Furthermore, this groundbreaking technique presents a higher fidelity while the additive concentration used can be adapted to the specific coating process. Additionally, color change technology allows the image to be far more precise and it is more readily altered to apply variations of marking design.
Methods of pharmaceutical branding are constantly evolving in response to both public and regulatory requirements. As consumers build up more knowledge about pharmaceutical products, informative advertising becomes an effective tool for boosting sales. At the same time, it is necessary for pharmaceutical companies to adapt their marketing strategies while complying with regulatory guidelines.
With the increase of FDA regulations on product marking, pharmaceutical companies face the challenge of finding technologies that aid regulatory compliance while allowing them to be flexible with their product messages.
By using color change technology to mark packaging and tablets, companies can combat counterfeiting without any detriment to their packaging branding.
Color Change Technology
Colorcon is a leading provider of pharmaceutical technologies and a manufacturer of speciality chemicals for related industries has licensed to DataLase patented additives for incorporation onto pharmaceutical or nutritional supplement tablets via its film coatings. The patented additives induce a colour change in the film coating precisely at locations on the tablet surface exposed to a low-power, DataLase-approved CO2 laser.
The DataLase PHARMAMARK additives are excipients that meet all appropriate compendial and regulatory requirements for use in these countries and have been used in approved pharmaceuticals for many years