In the opening part to my new blog series examining how to create and apply excellent artwork capabilities, I look at why packaging artwork matters so much and what happens when you get it wrong. What are the far-reaching impacts of artwork error on the various stakeholders involved?
Packaging artwork is an often-forgotten back room process in most pharmaceutical companies, but the changing business environment has brought issues from this capability to the fore. Pharmaceutical and other healthcare companies are facing one of the most difficult periods in their history. Current products are rapidly going off patent leaving significant revenue challenges. At the same time, weak product pipelines are failing to fill the gap. Furthermore, global markets are changing rapidly. Traditional markets are stagnating and new markets are evolving at a rapid pace. Everywhere, key healthcare purchasers are putting increasing pressure on drug prices. In response to these significant challenges, pharmaceutical companies are looking to make the most out of their current assets. This often manifests itself in a drive to launch as many product variants in as many markets as possible. For the traditional molecule-based global pharmaceutical companies, this represents a significant change in strategy.
The rapid growth in the number of drugs coming off patent, together with the increasing pressure on price from the major purchasers, has led to a huge opportunity and growth for generic pharmaceutical companies. For them the challenges are very similar to the pharmaceutical companies, namely to market as many product variants in as many markets, as quickly as possible.
In today’s world, all drug companies have an increasing need to develop and maintain an excellent reputation with a diverse group of stakeholders. Pharmaceutical companies are looking to develop and maintain trust with governments and purchasing groups in order to help maintain the product prices necessary to support their significant drug development spending. The increasing competition amongst generic companies means that they each need to develop and sustain their reputation in order to win business and maintain their production licences.
Maintaining this reputation whilst rapidly growing the number of products is particularly challenging when one considers that one of the largest single causes of product recall is packaging errors. In recognition of this, regulators around the world are focusing on driving improvement in all business capabilities associated with the management of packaging design and manufacture.
When launching product variants in new markets much, if not all, of the physical packaging design is already established. The text and graphics, or ‘artwork’ as it is known, that is placed on these physical components is what changes every time. It is this artwork design and maintenance capability that becomes critical to achieving and maintaining the objectives of both pharmaceutical and generic drug companies.
For a large global pharmaceutical company, developing artwork for tens of thousands of products is typically a process involving thousands of people, in over a hundred countries, from tens of different organisations. To orchestrate all this activity, the right combination of business processes, organisation design, information technology, facilities and suppliers must be managed. For smaller organisations, whilst the scale of the problem may be reduced, all of the same challenges have to be met.
So, what are the types of packaging labelling and artwork errors (which we refer to as “artwork errors”) that often occur and what are their significant and far reaching impacts? This will provide some context for later posts discussing the capabilities that need to be put in place to prevent them.
Whilst written from the perspective of a typical pharmaceutical company, we believe the points made apply equally well to other supply chain partners and other regulated industries.
What is an artwork error?
We categorise artwork errors into four groups for the purposes of discussion:
Gross errors – Where significant information is omitted from an artwork. An example would be completely missing the need to change a piece of artwork in response to a new regulatory requirement.
Context and meaning errors – Where information is presented in an ambiguous or incorrect way on the artwork. An example of this might be the inappropriate use of hyphenation causing ambiguous or incorrect meaning.
Content errors – Where there are errors and omissions in the detailed content of the artwork. An example of this would be incorrect symbols being used in the artwork.
Technical errors – Where there are errors or omissions in the technical aspects of the artwork. An example of this would be the wrong specification of barcode being used in an artwork.
The implications of an artwork error
The implications of an artwork error can be as far-reaching and serious as any other error with the supplied product. Artwork text and graphics describe the product and provide information and instruction for its safe and effective use.
Impact on patients – The bond between the patient and their medicine is deep-rooted. Patients trust that the product will make them better and expect that it has been developed, manufactured and supplied to the highest quality and ethical standards. Errors in the information provided with the product are significant and can be life-threatening. We are sure that you will agree that any risk to the patient’s well-being is not acceptable and their confidence in the treatments they are taking must be maintained. Trust is easily lost and almost impossible to recover.
Impact on prescribers – All prescribers (whether doctors, pharmacists, nurses or other healthcare professionals) are busy people with a clear mission – to make the patients they treat better. They expect that the products and information they are provided with are fit for purpose, error-free and safe to use. They don’t want to administer products that will make their patients more unwell. Rectifying the patient issues created by artwork errors is a burden they neither want nor welcome. Furthermore, the remedial action following an incident diverts their limited resources away from their core purpose
These healthcare professionals are often the final decision-makers when it comes to selecting the product that is prescribed or used in the future. Hence, any lack of confidence that they may have in a particular product, brand or company can have a direct impact on the products that get used. Also, it must not be forgotten that there is also a serious personal impact for some prescribers involved in incidents leading to patient harm. Indeed, some prescribers involved in such incidents subsequently go on to leave their chosen profession altogether.
Impact on regulators – The remit of the pharmaceutical regulators, amongst other things, is to set and enforce the standards by which the industry must operate to ensure patient safety. They have the authority to allow or block product use and the power to take punitive action against companies who they see fail to meet expected standards. The regulatory environment is becoming ever more complex and stringent and there is less and less tolerance for artwork error. Moreover, as we have already observed, the information age means that an incident in any country has visibility to all regulators worldwide. It is therefore understandable that regulators expect companies to be continually striving to eliminate artwork errors and take appropriate actions to reinforce that view.
Impact on pharmaceutical company staff – Two groups of pharmaceutical company staff are typically impacted by an artwork error: the team managing the recall and the operations teams who support the artwork process in which the error occurred.
The team managing the recall need to focus on the immediate and urgent tasks related to identifying the impacted product, withdrawing it from the supply-chain and reinstating adequate supply as quickly as possible. Whilst challenging, this work is often very motivating for those involved as a great deal of satisfaction can be derived from solving the immediate and significant recall problem.
The impact on the staff involved in the operation of the artwork process is somewhat different. Not only are they likely to be involved in the rectification activity, they will be heavily involved in the incident enquiry and corrective and preventative actions. Furthermore, there are the undoubted performance and morale issues that will likely need to be addressed.
Impact on the company – The impact on the company can be significant. The patient safety implications are counter to any pharmaceutical company’s core values. This is compounded by the sales, reputation and sanction impacts, through unfavourable publicity, loss of customer confidence, possible loss of licence and increased regulator scrutiny and action. As we discussed earlier, in today’s business environment, these impacts are potentially significant to the success of the company.
The cost impacts of these errors are also substantial. There are the immediate tangible costs of recall, product write-off, repacking and market re-supply. However, these can be overshadowed by the less tangible follow-on costs occurring through loss of sales and market share, customer reimbursement and litigation. In the extreme these not only impact the bottom line but can directly influence the company’s share price.
The benefits of getting it right
There are of course very tangible benefits to getting your artwork right. Achieving excellence in this area can help deliver many significant strategic benefits including:
• Increased patient safety
• Improved regulatory compliance
• Increased sales
• Improved profit margin
• Improved reputation
• Reduced cost and valuable resource absorption
In part two of this blog series I will take a closer look at some of the main causes of artwork error, how to prevent them and how to create right-first-time packaging artwork. I’ll also discuss developing a common service culture, internally and externally across an organisation.
To help you with your artwork improvement programme, you can also find useful information in our book Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities
Should you have any questions about this or any other of my blogs, or would simply like to request a copy of any of our publications, please don’t hesitate to contact me directly on my email: firstname.lastname@example.org
For more information on artwork, go to our free download section.