Mistakes on medical leaflets

The packaging of pharmaceutical products is a crucial aspect of the industry. It serves not only as a protective barrier for the product, but also as a means of communication between the releaser and the consumer. The releaser, a pharmaceutical laboratory, must ensure the existence of an appropriate pharmacovigilance system that allows him to assume his responsibilities and obligations in relation to the pharmaceutical specialties he markets and ensure the adoption of appropriate measures when necessary.

Risks and consequences

One of the most important components of pharmaceutical packaging is the leaflet, also known as the patient information leaflet (PIL), which provides information about the product, including its intended use, side effects, and usage instructions.

To check the content of a leaflet thoroughly is critical, as even a small typo, missing text, or added text can have significant consequences for the patient and the releaser.

Why?

Midjourney image

It is important to avoid errors in the leaflet because they can result in medication errors. For example, if a typo results in the incorrect dosage instructions being printed on the leaflet, the patient may take too much or too little of the medication, which can have serious consequences for their health. Similarly, if important information about side effects is missing or incorrect, the patient may not be fully aware of the risks associated with taking the medication. Believe me, there are side effects which patient and relatives should be fully aware from small possible irritations to a tendency to gambling, side effect that is only revealed after clinical trials for obvious reasons.

Deviation in the leaflet can also result in recalls and legal issues for the releaser. A recall is a costly and time-consuming process, as it requires to retrieve all the affected products from the market and replace them with new, corrected versions. In some cases, the recall may result in significant financial losses, as well as a damaged reputation and loss of trust from consumers.

As a designer and knowing the sensitivity of this situation, the corresponding procedure, quality documents and relevant tools are essential. Just thinking about the lack of an appropriate software 15 years ago makes me dizzy.

How to avoid mistakes

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In order to avoid errors in the leaflet, it is important to have a robust quality control process in place. This may involve multiple rounds of review and testing by different employees within the company, we call it four eyes principle. The process should also include a thorough review of the final product before it is released to the market, in order to catch any last-minute changes or mistakes.

In conclusion, checking the content of a leaflet in the packaging of pharmaceutical products is a crucial step in ensuring patient safety and avoiding costly recalls and damage to brand image. By having a robust quality control process in place, releasers can avoid errors and ensure that the information provided in the leaflet is accurate and up-to-date. Patients can also play a role reporting any discrepancies to their healthcare provider. By working together, the industry and consumers can ensure that the information provided in the leaflet is accurate and that patients receive the best possible care.

Artwork Coordination: an often undervalued, complex role

Photo by Matt Bero on Unsplash
Photo of a business person with headset on, a backpack, wearing a shirt, crossing a zebra pad juggling some balls
Photo by Matt Bero on Unsplash

The role of an artwork coordinator in industries such as food, pharmaceutical or retail is crucial for ensuring that the packaging design of products is consistent, accurate, and meets all legal and regulatory requirements. However, this position does not always get the appreciation it deserves.

Being an artwork coordinator for the packaging design of products comes with its own set of difficulties and challenges, which can range from managing a large volume of designs, to ensuring the accuracy of information and meeting tight deadlines, amongst others:

  1. Managing a large volume of designs: Artwork coordinators are responsible for simultaneously managing a large number of designs, both for large product launches and small packaging changes, which can be a time-consuming and complex process.
  2. Maintaining design consistency: Maintaining consistency in design across multiple products and packaging, as well as keeping up to date with customer input and market inspiration (not for Pharma products, where all is more regulated) is crucial for creating a strong brand identity.
  3. Accuracy of information: The accuracy of information on packaging is crucial for ensuring product safety and compliance with legal and regulatory requirements. This is specially critical in the FMCG and pharmaceutical industries, where errors can lead to severe consequences on the consumer side. Products that are sold across multiple countries, with multi-lingual labels, represent an extra complexity on this front, to make sure that all information is accurate and meets the local standards.
  4. Meeting tight deadlines: Coordinators often have to work with very tight deadlines to ensure that products are available for sale in a timely manner.
  5. Collaboration and communication: Effective collaboration and communication between different departments and stakeholders is essential for ensuring the success of a packaging design project.
  6. Approval management: this communication and collaboration amongst departments and external parties such as external clients, regulatory bodies, or printers, takes an extra step when it comes to managing the approvals on the artworks. Dealing with both internal and external feedback rounds adds an extra layer of risk in making sure that the correct files are used when it comes to creating the final product that goes in the shelves.
  7. Control of document versions and files in general: don’t you hate it when you receive a final version and then it turns out it is no the final one, amendments are made and you lose track of which file is the one that should be used? With so many projects ongoing and multiple approvals needed, it is one artwork’s coordinator nightmare to make sure the files are correctly stored and identified.

These challenges show how important and complex the role of artwork coordinator can be. Luckily, nowadays, there are tools that can assist an artwork coordinator in their daily tasks to make them more successful and efficient.

An artwork management system (AMS) can help automate and streamline the design process, through custom workflows that will take some of the repetitive tasks out of their plate, and giving visibility to other stakeholders when they need to provide input or approve. Such technology would also make sure that designs used are the correct ones, by providing a central repository for storing and sharing artworks, keeping version control on all files. Through an audit trail on changes, it becomes much more simple to track where a design is at any given time, and who may have performed a change, taking action from there.

Artwork Management System – Twona

Reaching deadlines becomes easier, as the approval process can be automated and they only need to make sure to check feedback when completed. Because the tool would provide real-time updates on the status of designs, they can focus on more valuable activities other than chasing and reminding people. As a central platform for sharing designs and communicating with stakeholders, and AMS would improve collaboration and communication, as everyone is involved and has visibility over the process. Furthermore, additional tools such as artwork comparison/proofing systems can help coordinators verify that the information on packaging is accurate and up-to-date, reducing the risk of errors and mistakes.

The role definition does not need to change. Its beauty is that it interlocks so many areas of the packaging design process. However, it can be more appreciated when the right technology is used to support their multiple tasks, as it will help professionalize and standardize the artwork coordinator function.

Improve your quality (of your work and your Artworks)

Photo by Twona
Depicts a the design of a wrapper of a chocolate tablet, turned 90 degrees clockwise, with red markings when there are changes from two versions of the artwork.
Photo by Twona

One of the areas where we have achieved more speed, and a reduction in the number of errors, is the quality area.

Does this sound familiar?

  • Three people are reviewing the content of a new leaflet.
  • One of them reads the text from the Medicines Agency mentioning the format (e.g bold, italics, indent…).
  • The two others visually review a printed Artwork.
  • The whole process takes at least 45 minutes.

Imagine the amount of deviations that a isual check can have, without mentioning the waste of personnel time!

This (real) experience happened a while ago, and nowadays, there are tools in the market that help with this review. Do you think the one you use is quick and efficient enough?

Here is where technology makes our life much easier, as we have comparison tools at all levels, the graphical and the content side, to check Artworks. We always use them internally, before our clients do their own checks, both by the designer who is producing the Artwork and by a colleague in the QA team. This is what we call the 4-eye principle.

Photo by alessio-lin–6LYjG0H32E

Twona X-RAY

Our experience? With the content comparison we are able to review a new text in 5 minutes. Similarly, reviewing changes that we received on an Artwork graphically becomes a much simpler task.

Twona X-RAY’s graphical comparison can visually recognize documents, automatically adjust them to overlap and make the revision process much more efficient Some critical examples for us have been comparing an Artwork with a press-proof that has a different orientation, in which some technical details, such as a Laetus code, has been inserted.

I would like to invite you to try our comparison tool, and calculate how much time and resources you could be saving on your daily Artwork control and review process.

If you still have paper piling up on your desk , going to the office is mandatory to be able to do your work or have the feeling that there are things that can be improved, do not hesitate to share with us your needs, and we can help you make that leap to succeed in a changing and more demanding future.

Rafael Cruz Núñez
Artwork Manager