‘Patient-centric’ is an oft-heard term in pharma packaging. The goal of this approach is to create labels that are easy for patients to follow, thereby minimising the likelihood of lawsuits following misuse. Human factors and ergonomics, as well as patient comfort, are the guides by which products should be designed, marketed and packaged, but the range of elements that must be considered for drugs makes it difficult to balance these priorities.
All packaging and labelling must be regulation-compliant, and these rules are constantly evolving alongside patients’ expectations. Products must not only be efficient and cost- effective, but also secure to guarantee user confidence.
Using global target labels to achieve a more cohesive offering, from the supply chain all the way through to patients, makes products as streamlined and efficient as possible, but how is this achieved?
Go global
Labelling conveys agency-approved information on product use. Gerrit-Jan Nijveldt, senior director global regulatory affairs (labelling) at Sanofi, regards labels as the appropriate measure taken to warn patients of drugs’ effects “based on the results of scientific research that demonstrate safety and efficacy in humans”. He also says that the labelling serves as a basis for prescription, advertising and promotion.
The information required by law on pharmaceutical products varies from region to region, which means that labels that are fine in one country may have to be rewritten or redesigned to comply with the laws of another.
The most common information on pharmaceutical labels covers approved indications, dosing requirements, methods of administration, information for concerns of special patient populations, packaging and storage requirements and limitations of the pharmaceutical, incompatibilities and pharmacological properties, and of course, basic safety.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) specifies explicitly that all labels must be clear, and that “healthcare professionals and patients must easily be able to identify the medicine by the label”.
There are also a host of non-compulsory recommendations that MHRA and its international equivalents publicise as being desirable, but not legally enforceable, for manufacturers to include on labelling. The advice offered by MHRA continues with the rule that “All information on packaging for licensed medicines must be printed directly on to the packaging. Over-labelling must not be used.”
This feeds in to one of the most important aspects of labelling, which is the information expressed and how it is organised. Ideally, labelling should represent a company’s position based on the data it uses, and be developed for the marketing authorities worldwide. It should not simply restate the relevant regulatory agency’s position on the product, or regurgitate the laws to which it adheres.
Once the requisite background information is in place, the idea of ‘core’ labelling becomes involved. This includes data, legal advice and corporate strategy information, as well as regulatory information on best practice and ways that’ll help the product receive easier approval.
These, according to Nijveldt, ought to communicate a company’s opinions of its product to affiliates, disclosing its view of safety profiles to regulators, and are essential for a global label target.
What to include
Labelling systems must adhere to company core data sheets (CCDSs). These documents are prepared by marketing authorisers and contain material that relates to indications, dosing, pharmacology and other areas that are not necessarily viewed as safety related.
These act as central information indexes and contain the comparative analysis of local label content, the preparation of a label comparison chart showing similarities and differences for the relevant market, the preliminary evaluation of similarities and differences for inclusion in a CCDS for all other products on the market – including other labelling strategies, regulatory adherence and the provision of guidance on any requisite additional elements.
Many other ideas must also be taken into consideration, such as product naming services, summaries of product characteristics (SmPC), patient leaflets, inner and outer package labels, mock-ups covering blue-box requirements, barcoding and product information files (PIFs).
There are many types of CCDS, but they are essential to achieving a systematic global labelling target and ensuring that companies remain regulatory compliant.
A CCDS should achieve global company consistency in labelling. Pharmaceutical companies should define their business rules as ways to address common questions and provide guidance for consumers as well as regulatory bodies. Many of these rules are in the form of standard operating procedures and more detailed work instructions, so should be easy to fill in for most operations, though individual procedures and global strategies may provide headaches, as even the most streamlined corporations sometimes vary their approach across regions. Business rules must address:
- structure
- content/terminology
- what is mandatory to implement
- what is the desired level of similarity between CCDS and local labelling
- when affiliates need to obtain HQ approval before acting locally.
These strategies will benefit the drug development process when used early on and will save companies money; a rigorous, well-researched CCDS guarantees compliance with local legislation.
International labelling strategies should be focused primarily on seeking out problems before they arise and investigating local markets (attitudes, legal requirements and regulatory agency codes of conduct, for example).
The MHRA and the UK’s National Patient Safety Agency have worked together to provide better safety standards. These provide pharmaceutical producers with a set list of things they must include in order to cover themselves in the event any problems. No corners should ever be cut on labels; the surfeit of regulations exists for a reason.
Label properly, save money
A global labelling strategy should do two things: provide easy, clear information for the consumer so that they can use the product as easily as possible. It should be streamlined, easy to understand, using wording that does not require a high level of literacy (some users may not fluently speak the language in which the label is written, or be sufficiently well educated to grasp its finer points). As Nijveldt says, “The methods and concepts for labelling development vary across the industry, and there is a need to ensure the importance of this role is maintained.”
Labelling should also be cost-effective, without cutting corners. A global strategy can help with this; forward-planning and a full investigation of the regulatory requirements of the relevant markets are among the first things that should be undertaken in order to avoid unforeseen financial hiccups. Too often an afterthought, labelling strategies are a key way of keeping costs down.
Laws on labelling around the world
MHRA
The UK’s medicine authority has a wide-ranging take on guidance, much of which focuses on ensuring that EU guidelines are upheld and that patient information leaflets (PILs) are up to date and full of vital information.
FDA
The US Food and Drug Administration has a plethora of information available on different labelling requirements, depending on which certain category a product fits into. Much of the data may not be obviously relevant to non-US firms, and there may be information that could be easily misconstrued, or appear contradictory. If your company wants to break into the US market, or is about to unveil a new product, it is advisable to hire a local expert to identify which areas are likely to be important.
CFDA
The Chinese Food and Drug Administration is unable to draw upon years of practical experience of working together with the pharmaceutical industry and with customer/patient groups, so its guidelines often tend either to be lifted from other, more established rulebooks, or written up as needed.
TGA
Labelling is part of a national medical regulation system in Australia. Most products must be included in the Australian Register of Therapeutic Goods (ARTG), with a small number of exemptions. All pharma products fall in two categories: AUST R (prescription-only medicines and many over-the-counter products, such as those for pain relief, coughs and colds and antiseptic creams) and AUST L (vitamins, supplements and other ‘low-risk’ medicines).
