labelling and artwork

Labelling and Artwork are still the highest causes of the recall of pharmaceutical products. Andrew Love, Vice President at Pharmaceutical Advisory Services, Be4ward Ltd, and former Director of Global Pack Management, GlaxoSmithKline, talks to Pharma IQ about his hopes to resolve these issues in the bid of patient safety .

Pharma IQ: Andrew, I’d like to begin by asking you, what are your thoughts on adapting the Falsified Medicines Directive and how do you foresee that this will affect packaging? A Love: Yes, an interesting topic. The main bit of the Falsified Medicines legislation that interests us is the whole area around authentication and serialisation and ensuring that the right product is available to the right person at the right time. I think that whilst there’s going to be a whole series of typological challenges there, I think the challenge that interests me more is around the organisational challenges it’s going to present, because it’s going to require many different parts of the supply chain to have to work together in harmony and agree on how to do things in harmony and across many different interest groups, who maybe traditionally have not been able to work together or have got different things that they’re looking to try and get out of this legislation. This means that the coalitions, the agreements and the disagreements are going to make the effectiveness of final solutions quite an interesting topic area. I wouldn’t single out the pharmaceutical industry as different from any other, but I think when you see different interest groups trying to work together, it always presents a challenge because people have their different perspectives that they’re trying to achieve. So I think it’s going to be interesting as we see these different groups move forward just how well we’ll be able to come up with solutions that meet everybody’s needs, but still keep the final goal of the right product at the right place for the right person as the final outcome that we’re trying to get. (Get this interview on podcast) Pharma IQ: Andrew, what challenges will this mean for the pharmaceutical industry? A Love: Well I think it’s going to require people to start working outside of their traditional boundaries within the organisations that they work in, so people are going to have to start thinking about what’s the total end-to-end solution there and the role their organisation plays in that total end-to-end solution, rather than necessarily just this is what’s right for me or this is what’s right for my organisation and that’s all that we want to think about. People are going to have to get used to working in alliances and coalitions and we’ve seen from the likes of the work that FP has been doing on the pilot around the authentication solution that that’s been very successful to date. The pharma companies have come together, they’ve worked together, they’ve come up with solutions, but it’s not just pharma companies that need to be involved in that. There’s a whole myriad of other groups that will need to get involved as these solutions roll out into the future. So I think that’s going to be an interesting area to watch because it tends to be relatively easy to focus on the technical problems and solve the technical problems, but the organisational and people problems are always that bit more difficult because they’re greyer, they’re fuzzier and they tend to be more political bent than just a straight technical issue resolution activity. Pharma IQ: Andrew, you are going to be giving a workshop on 25th June in Basel at the . Pharmaceutical Packaging and Labelling Summit. Can you perhaps tell our audience what that workshop will include? [inlinead] A Love: The workshop will be around ways to deliver cost effective pharmaceutical artwork. One of the products areas that Be4ward has is around pharmaceutical labelling and artwork and we will talk to the workshop participants about good practice and how to generate your labelling and artwork; we’ve gathered this information from many years of experience across the pharmaceutical industry. The key output that we want to achieve across the industry is, labelling and artwork are still the highest causes of recall in the pharmaceutical industry. We want to help resolve that issue. It’s a good and proper thing to do in terms of patient safety to get the labelling and artwork correct. We’ve gathered a lot of knowledge about how that can be done and what we want to do is help people be able to do it better. The solutions are out there; it’s just a case of helping people through the problems that they’ve got and what can they do to improve. Pharma IQ : I wonder if you could maybe give us your top tip for developing better artwork? A Love: The one that always comes to mind to me is making sure that you’ve got a clear specification for what it is that you would want. Now in our line we would call that the brief, but if it’s a clearly documented requirement of the new artwork that you want or the change to an existing artwork that you want that’s unambiguous, that’s been approved by everybody who’s involved in making that change happen, and ultimately when it’s given to the person who’s going to produce the artwork, they can produce that artwork correctly first time because they’ve got all the information they need, they know exactly what it is that they’ve got to do, they know when they’ve got to do it and all of the data that has to go into that artwork is correct, up to date, delivered on time, etc. I’ve just been doing a lot of building work on the house that I live in. We got a clear specification around the building work that we wanted to do because if we were making it up as we were going along, we would have had a lot more work, be doing a lot more re-work, we would have had a lot more problems with the builder, etc, etc. So it’s around making sure that your requirements are clear because if you’re not clear about what you want, the probability is that you’re not going to get it. If you can get those requirements clear, then it’s much easier for the artwork operator to be able to deliver exactly what you were looking for in the first place. Pharma IQ: So contribute to better planning? A Love: Yes. It’s a simple thing, but it’s one of the things that we find is overlooked. What we actually see when we go out and talk to people about how they do their artwork is the artwork evolves over time through multiple changes of the artwork as people add to it. Pharma IQ: Andrew, what do you believe to be the biggest challenges today in packaging for the global market? A Love: For me, it’s the growing levels of complexity that we’re seeing. I think with a lot of the clients that we work with had five to ten products that they’ve been selling in the top ten to 20 markets, but are looking to push those assets out around the world as much as they possibly can, so the number of markets that they’re selling in is growing dramatically. And I think if you’re trying to replicate the sales revenue that you get from an SKU or a product in the US across the rest of the world, you have to put that into somewhere between 30 and 50 different markets to generate the same amount of turnover. I think what we see is a drive on one side to try and get more international harmonisation but that’s being offset at the same time by lots of local legislation that makes it a very complex picture, first of all around what is the regulatory requirements in each of these different countries round the world and how do I, as a company, keep on top of that versus how do I avoid a huge proliferation in the product range that I’ve got, the number of SKUs that I’ve got, the number of components that I’ve got as I’m having to meet all of these local requirements. All of the companies that we deal with are finding that a significant challenge either because they’ve got too much complexity and they’ll have to get rid of some of it or they’re worried that as they grow their complexity is going to increase, so how can they put in controls to stop it happening in the first place? So things like multi language, shared market packs, late stage customisation, influence and harmonisation of legislation, all of these things are very, very hot topics around the people that we work with to try and find ways of dealing with this global level of complexity which is big challenges, particularly for the supply chain people where you’re selling very small volume SKUs to very targeted countries around the world. Pharma IQ: Patient compliance is obviously costing the industry millions of dollars every year. What considerations do organisations need to make in packaging to facilitate patient compliance? A Love: I think the first thing is, anything that improves patient compliance has got to be a good thing and I don’t think anybody would disagree with that. Anyone who’s in the healthcare industry is there to help make people better and so if there are things that we can do that can make that happen, then that’s a great thing. Lots of people look at how can you dramatically improve your revenue through packaging design for improved compliance and I’m not sure that people have necessarily been as successful there because anything that any company comes up with is pretty easily copied by another company. The next part is to put new product variance into your manufacturing facilities which can often mean that your manufacturing cost goes up. So I think where most of the debate has been for me is around how we can deliver improved packaging designs that don’t cause a penalty on the pharmaceutical company side, but provide a significant benefit to the patients, and I think there’s still a huge amount of opportunity there. If we look at the ageing population, the range of drugs that people are starting to take, and the implications in some cases of taking the wrong dosages, then there’s a lot that we can do to move that whole compliance situation forward and when you look at the percentages of compliance with some disease groups, it’s surprisingly low. So I think for the packaging professionals around the world, this is still and definitely one of the biggest challenge areas that we need to be looking at because there must be many things that we can do that’s going to drive that situation forward. Pharma IQ: Finally, Andrew, you have co-authored a book around the artwork, etc, behind this. Can you tell us a little bit about that? A Love: One of my partners and I have written a book around how to improve your pharmaceutical labelling and artwork capabilities. I mentioned earlier that labelling and artwork is still the highest cause of recall within the industry and we’re passionate about doing something about that and we know that lots of other people are passionate about doing something about that, but there’s actually very little information out there about how to do labelling and artwork really well. So with the information that we’ve gathered from all of the different clients that we work with, it felt appropriate to do something to try and give that back. So the book that we’ve written is based on the knowledge that we gained working across the industry about how to be effective in how you do your labelling and artwork. The book will be coming out shortly, which is good, and hopefully it’s there to provide a reference text to people who are involved right across the end to end process about all the different aspects, not just around the process, but around the technologies, around should you outsource, should you inhouse, etc. So hopefully it will provide a good reference and help to people who are involved in this important space. Pharma IQ: It sounds brilliant, Andrew. Where can people get that book and when can we expect it to be on the market? A Love: It should be on the market at the end of May and it will be on Amazon - I know that -or if you go onto www.be4forward.com website, there will be links there and you can pick it up from there as well. Ultimately, if you’re really stuck, come chasing after me! Written by Niamh Madigan Have Your Say Rate this feature and give us your feedback in the comments section below

IQPC Please note that we do all we can to ensure accuracy within the translation to word of audio interviews but that errors may still understandably occur in some cases. If you believe that a serious inaccuracy has been made within the text, please contact niamh.madigan@iqpc.co.uk

labelling and artwork

How to Deliver Cost Effective Pharmaceutical Global Artwork

FIND CONTENT BY TYPE

Pharma IQ COMMUNITY

ADVERTISE WITH US

JOIN THE Pharma IQ COMMUNITY