| September 02, 2022 | By
“It all comes down to the labeling. It’s all about labeling.
So says Cathleen O’Connell, architect of the RAPS online university’s new course, “Pharmaceutical Labelling: An Introduction to an Essential Function”. She is also the author of Essentials of health product labeling, a RAPS publication that dives into the subject. Cathleen has over 20 years of experience in health product labeling as a practitioner and educator.
O’Connell joined RAPS for an interview about health product labeling, RAPS’ new online college course and more. This conversation has been lightly edited for clarity.
What is health product labeling and why should regulatory professionals know it?
Just to give a general introduction to health product labeling, you need to think about it in terms of what it is, who writes it, and who reads it.
And that’s more than one thing. It’s a whole family of entities. But the fundamental purpose is—it’s the informational component of a product; it is identification; these are the words; these are the graphics; it is the brand image. It is printed as physical components or distributed electronically. It’s a family of manuscripts in various languages, various formats, various versions—for some reason. It’s flyers; they are websites; these are cartons of labels. So that’s it. And that’s the heart of the importance of it. Because a product without its information, how to use it and information on benefits-risks and help in selecting the appropriate therapeutic element, is useless.
This goes back to the whole comment of, I think it was Paracelsus: The difference between a poison and a medicine is the dose. Well, how do you know what the dose is without the information component?
Who writes it is usually the sponsor of the product – the manufacturer, sponsor or developer. And it is approved by the health authority of this region for everyone who uses the product because we are not talking about the distribution label. Dispensing etiquette is overseen, in this country at least, by pharmacy boards. And that’s for labeling; it is information for a particular patient written by a particular prescriber, if it is a prescription drug. This is therefore not the subject of this course. The objective of the course is information on a health product developed by the promoter. And who reads it depends on the purpose of the information.
This is unique in submission documents for a regulated product [because] it is accessible to the public. It is written, even if it is approved by the health authority after negotiation with the sponsor, it is written for the user. The prescribing information is written for the healthcare professional. If there is patient-oriented labeling, it is written for the patient. It comes down to the fact that there is a whole family of components.
Speaking of the new RAPS Online University course, you are the author. Why was this course necessary and what do you think regulatory professionals will gain from it?
The course focuses, as I said and as I believe, on the most important culmination of drug development. That’s a culminating function of drug development, that’s labelling. Thus, everyone involved in the regulation of health products should be aware of the function, regardless of their involvement.
What I want people to know about the course is that labeling is a dynamic field. Things are constantly changing and evolving, so the course is intended to give everyone a general appreciation of what to know and, if they work in or with labeling, where to find information.
And ideally, we’d like to spark some interest in the topic so they can explore further and dig deeper. And we provide resources for doing so, including references to the manual, which have somewhat more complete details for each of the subsections.
Why is health product labeling an important topic for regulatory professionals to know about?
It is an important part of the product; and it is submitted to the health authorities for approval. Thus, regulatory professionals need to understand how they can meet the expectations of these health authorities knowing that labeling is data-driven and that the evidence presented must support the claims.
You can’t go beyond the benefit-risk labeling and claims, proper use, and all the details unless it’s approved by the interpretation of the evidence. You can also use labeling as a guide for drug development by stating the claims you want and then considering the development you need to do. It is a concept that had some [credence] earlier in this century—targeted labeling—as it’s called, using labeling as a roadmap to development, basically. And that would then be discussed with the health authorities. Not to get language guarantees, but to help with the strategic and efficient use of resources in your product development.
What might be the toughest challenges for someone new to regulatory affairs or someone unfamiliar with labeling as they begin to learn about the subject?
The challenge is that it all comes down to labeling. That’s always been my motto: it’s all about the labeling. There are so many touchpoints. And I guess at first glance it would seem overwhelming. It’s an onion with many layers, and there are so many documents, components, versions, and activities because there are so many users and touchpoints. Internal users of the company, the company and the sponsoring company, as well as external users [users]. And so many touchpoints along the continuum of drug development, from NCE declaration to deletion and discontinuation of registration.
It’s so much and it can be done [but] on the face of it, this is just another regulated aspect of drug development and management. It involves things like version control, document management, proofreading, all sorts of boring stuff. But there’s major drama every day and it’s kind of refreshed by the fact that it’s not a harmonized element. There are regional versions; there are always problems for global products.
So I would say on the surface it looks dull. But, if you peel the onion, it can be very interesting. And one thing that is a common issue to point out is the need for careful communication. You can’t just speculate what would be appropriate wording in a language and in the label without looking at the data and really checking that out, because emails and things that are immature speculation come back to bite companies in liability actions.
What’s different for an entry-level regulatory professional learning about labeling versus a veteran who might be looking for more information about labeling?
The person who is new to regulations and labeling should learn all that labeling entails. It’s not just one document. Very often we have colleagues from other parts of the company who are, well – “just write the label and I’ll see you tomorrow afternoon and you’ll be done.” It’s much more than that.
And it involves contributions from across the enterprise and it involves a multitude of documents and components. So there is still a lot to do. But for a seasoned pro who knows the labeling game and really what it’s all about, I’d say the infinitely refreshing aspect of what’s different about every project is that every project is a product in development.
You are also the author of a book on labelling. What do you think someone takes away from the course compared to the book? What could be the differences between who could take it or what they could get out of it?
I think the course is a higher level introduction and overview. And that grounds you, as I describe it, in the function, and gives you a taste and appreciation of the scope of the function; then frees you to explore further.
And the manual, which is also at an introductory level because you just can’t get too deep into such a dynamic field, is much more comprehensive. It provides more detail on the different labeling, different regions and different audiences, and all that. And a thousand other references. So this is for people who have taken the course and say, “You know what? It’s quite interesting; and I think I would like to know more.
Pharmaceutical labelling: introduction to an essential function is available now.
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