The Consequences of Artwork Errors
If packaging and labeling recalls are frequent and often attributable to artwork error, how do these errors occur and how do the affect the various stakeholders impacted?
In my last article, I discussed how 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. In this article, I will discuss the types of packaging labeling and artwork errors (which I will refer to as “artwork errors”) that occur and their significant impacts upon the various stakeholders involved.
What is an artwork error?
Artwork errors can be categorized into four groups for the purposes of discussion:
1. 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.
2. 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.
3. 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.
4. 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 this 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 sicker. Rectifying the patient issues cre¬ated 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.
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, with¬drawing it from the supply-chain and reinstating adequate supply as quickly as possible. Whilst challenging, this work is more often than not 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 unfavorable publicity, loss of customer con-fidence, possible loss of license and increased regulatory scrutiny and action. As we discussed earlier, in today’s business environ¬ment, 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
Achieving excellence in this area can help deliver many significant strategic benefits:
• Increased patient safety.
• Improved regulatory compliance.
• Increased sales.
• Improved profit margin.
• Improved reputation.
• Reduced cost and valuable resource absorption
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Packaging and Labelling: Organisation and Governance
Packaging & Labelling: The Technology Side
Making it Happen: Change Management Issues in Artwork Improvement Programmes
The Consequences of Artwork Errors
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