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Volume 8 Issue 1

PEER REVIEWED

Contributions from Human-Whale Historiography to Ocean Sciences Salmonella Sampling: Achieving the Right Result Begins Outside the Chicken House Overcoming Problematic Production Issues in the Manufacture of Animal Nutraceuticals New IBV Strain D181 Active: Does it Resemble the Strains We Already Know? Official Supporting Associations -

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CONTENTS 04 FOREWORD WATCH PAGES 06 Needle-free Injection

MANAGING DIRECTOR Martin Wright PUBLISHER Mark A. Barker EDITORIAL MANAGER Beatriz Romao beatriz@pharmapubs.com RESEARCH AND CIRCULATION Virginia Toteva virginia@pharmapubs.com DESIGNER Jana Sukenikova www.fanahshapeless.com BUSINESS DEVELOPMENT Keith Martinez keith@pharmapubs.com ADMINISTRATOR Orla Brennan orla@pharmapubs.com FRONT COVER © istockphoto PUBLISHED BY Pharma Publications J101 Tower Bridge Business Complex London, SE16 4DG Tel: +44 0207 237 2036 Fax: +0014802475316 Email: info@pharmapubs.com www.animalhealthmedia.com International Animal Health Journal – ISSN 1758-5678 is published quarterly by PHARMAPUBS.

The opinions and views expressed by the authors in this Journal are not necessarily those of the Editor, Publisher or the Supporting Organisations which appear on the front cover. Please note that although care is taken in preparation of this publication, the Editor and the Publisher are not responsible for opinions, views and inaccuracies in the articles. Great care is taken with regards to artwork supplied, the Publisher cannot be held responsible for any loss or damage incurred. This publication is protected by copyright. Volume 8 Issue 1 Spring 2021 PHARMA PUBLICATIONS www.animalhealthmedia.com

Needle-free injection technologies can be used to administer vaccines and medications in the livestock industry. They offer a fast, safe and effective route of administration. Therefore, needle-free vaccination is moving more and more into the focus of those interested in improving animal health, while new technologies allow the development of even more efficient devices with a greater range of features and services. Marius Leyhausen at Henke-Sass informs about the advantages of modern needle-free injections. 08 New IBV Strain D181 Active: Does it Resemble the Strains we Already Know? Infectious bronchitis virus (IBV) is a Coronavirus belonging to the gammacoronaviruses. As it can spread rapidly both within and between groups of chickens, it has a high impact on poultry production worldwide. IBV is an RNA virus that mutates at a relatively high rate. This can pose challenges when making vaccination programmes for poultry flocks. Sjaak de Wit and Robert Jan Molenaar discuss ways to induce cross-protection using existing vaccines. REGULATORY & MARKETPLACE 10 The Rise in Pet Telemedicine Following the Coronavirus Pandemic During the Coronavirus pandemic, the public was unable to visit their veterinary practice as they usually would and as such, pet parents and veterinary practitioners sought out new ways of connecting, ensuring that animal wellbeing was not impacted by the lockdown. Jessica May at FirstVet explains the impact of pet telemedicine following the Coronavirus pandemic. 14 One Health: Professional Stakeholder Engagement Key to Tackling Zoonotic Disease Globally, endemic and emergent disease risks persist as significant challenges to human and animal health. Rural livestock farming communities in lowand middle-income countries are disproportionately affected by zoonoses and animal diseases due to poverty and concomitant poorly available health and veterinary services. Dr. Alison Z. Pyatt, Dr. Stephen C. Mansbridge and Dr. Vetja Haakuria explain why a One Health approach to tackling zoonosis is now broadly advocated and a successful strategy requires sector stakeholder recognition, inclusion, and engagement to ensure a holistic response to a complex problem. 18 EMA/CVMP Proposals for the Requirements for Limited Markets and Minor Species: An Update in 2021 In less than a year, on January 28, 2022, Regulation (EU) 2019/6 will become applicable. The CVMP has now issued different guidance documents on how the new Regulation impacts the registration for limited markets including minor species. CVMP reflects on the approach for classification of such products and guides efficacy and safety data requirements in the target species for both biological and non-biological products. Klaus International Animal Health Journal 1


CONTENTS Hellmann and Cornelia Hüttinger at Klifovet give you an update on the requirements for limited markets and minor species.

RESEARCH & DEVELOPMENT

22 Contributions from Human-whale Historiography to Ocean Sciences In the next decade, the world will see how the sustainability of oceanic waters and their strong connection with human lives are under threat. Society must be involved in creating this transnational invitation, expressing its global commitment through the formulation of initiatives and policies, based on scientific evidence toward the protection of oceans. Ana Lucia Camphora, author of ‘Animals and society in Brazil from the 16th to the 19th century’, focuses on the contributions from human-whale historiography to ocean sciences. 24 Know your Mission: Developing Breakthrough Innovations in a Challenging World In an increasingly harsh economic climate, it is those businesses with a clear aim and an innovative mindset that will be best equipped to succeed. By establishing a defined goal and thinking creatively about how to achieve it, companies can uncover opportunities to develop truly ground-breaking innovations. Calum Macrae at Nestlé Purina PetCare examines the value of scientific innovation in the pet food industry. 28 Of Mice and Men: Why Faith in Animal Experimentation is Misplaced In 2004, a non-steroidal anti-inflammatory drug known as Vioxx was abruptly removed from circulation five years after it had been released to the market by Merck & Co. The drug, which was marketed to treat conditions like arthritis, was one of the most widely used drugs to have ever been withdrawn. It turned out to be deadly. Katy Taylor at Cruelty-Free International and CrueltyFree Europe explains why faith in animal experimentation is misplaced.

MANUFACTURING 37 Overcoming Problematic Production Issues in the Manufacture of Animal Nutraceuticals The importance of wellness has been brought to the forefront during the Coronavirus pandemic and nutraceuticals have played an important role in this. Nutraceuticals have taken even more of a centre stage as consumers consider ways to stay healthy turning to supplements with natural health benefits. Alex Bunting at I Holland reports on the problematic production issues in the manufacture of animal nutraceuticals. COMPANION ANIMALS 40 Managing Dental Disease in Dogs and Cats: It is All About Consistency In veterinary dentistry, the concept of preventive medicine is well known but under-utilised. The prevalence of the dental disease in dogs is greater than 80%, and 24% in cats. One issue to consider is the idea of preventive dental care in dogs and cats. This paper by Jeanne R. Perrone at VT Dental Training discusses three actions needed to develop a management plan for veterinary dental patients. LIVESTOCK DISEASES 43 Successful Depopulation and Reopening of an Isolation Facility Within a Large Production Compound Without Allowing ASFV Spread to the Main Breeding Herd Dr. Jiancong Yao at PIC demonstrates an unusual progression of ASFV infection in a population of naive replacement stock in an isolation facility. Early detection by accurate diagnosis was a big challenge, as initially, no clear clinical signs were pointing to ASFV infection, and diagnostic kits and laboratories gave inconsistent results.

32 Antimicrobial Resistance Antibiotic resistance has the potential to become one of the greatest problems of our generation, given the ever-increasing rise in bacterial strains that are less and less sensitive to existing treatments. Emily Marshall at Alltech demonstrates how antimicrobial resistance arising in agriculture can negatively impact public health. FOOD & FEED 35 Salmonella Sampling: Achieving the Right Result Begins Outside the Chicken House Salmonella seems to be inextricably linked with poultry farming. Not so much due to a general belief that all salmonella comes from chickens, but because of the many measures put in place in the sector to prevent salmonella and reduce the risk to humans. One important measure within the EU is the determination of the salmonella status of each flock by collecting samples from the chicken house. Christiaan ter Veen at GD Animal Health discusses in detail the salmonella sampling process. 2 International Animal Health Journal

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May 6-7 www.klifovet.com

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18th Workshop on VICH Good Clinical Practice and efficacy studies in animals


FOREWORD In the northern hemisphere, spring is definitely on its way and so commiserations to those readers who happen to live in the southern hemisphere – depending of course on where you live. For many of us, north and south, not only have we had to contend with climatic conditions, as in all years, but we also had to live with the effects of the COVID-19 pandemic and the measures taken to combat this disease. Those of us who have endured social distancing, face masks and lockdowns are therefore looking forward to relaxations of restrictions as well as improvements in the weather. This edition of the Journal should help to alleviate the effects of these restrictions. As readers of this publication might expect, there are articles in this edition to please a wide audience. On this occasion, I have chosen to focus attention on a single article. In this issue, Dr Katy Taylor of Cruelty Free International has contributed an article entitled Of mice and men: Why faith in animal experimentation is misplaced. Animal experimentation has long been a bone of contention and undoubtedly will remain so. Critics like to point out that the results from animal tests are misleading, inconclusive or irrelevant, or any combination of these. These accusations frequently miss the point. Many critics, admittedly not all, object to animal testing. The shortcomings are used to justify why animal testing should be curtailed but the critics would still object to animal studies even if the results provided were perfectly predictable for humans. Limitations are only used to strengthen their case for the abolition of animal testing. Animals are used for testing for several reasons, but the main reasons are that there are currently no alternatives to some types of tests. Those who conduct animal tests are fully aware of the limitations of using animals as surrogates for the predictions of outcomes in humans. They fully appreciate that rats or mice or dogs are not small, furry versions of human beings and that results obtained must be treated with a degree of caution. Furthermore, scientists involved in animal testing are fully aware of the 3Rs: reduction, refinement and replacement. These three words mean exactly what they say. Reduction is the conduct of experiments using smaller numbers of animals, refinement is the design of experiments which reduce and minimise animal suffering, and replacement is the use of studies where animals are replaced by cells, tissues or isolated organs. Such efforts are promoted and supported by various organisations. In the United Kingdom, the National Centre

for Replacement, Refinement and Reduction of Animals in Research (NC3Rs; https://nc3rs.org.uk) works to promote the application of the 3Rs through the efforts of its own scientists, but also by supporting other workers, either by collaboration or through funding programmes. Even before this type of initiative, scientists have been striving to achieve progress in the 3Rs long before the term was coined. In the field of toxicology, acute toxicity was investigated using the LD50 test. This test attempted to define a dose of chemical that would be lethal to 50% (median lethal dose) of the test animals. The test was developed in the 1920s. It involved the use of several doses with up to 100 animals per dose group. The emphasis was on death and the identification of the LD50 value. It was later recognised that the numbers of animals used was excessive and that comparable results could be obtained by using much smaller numbers, usually 10 per dose group (reduction). Later, tests were developed which took different approaches. These tests go by various names (fixed dose procedure, acute toxic class and up and down procedure) which departed from the LD50 approach to estimate a lethal dose rather than determine it. There was greater emphasis on observing the animals for signs of toxicity rather than focussing on a value, and yet again, smaller numbers of animals were involved (refinement and reduction). Efforts now focus on in vitro approaches and other methodologies (replacement). In vitro and ex vivo approaches now feature in such areas as skin and eye irritancy, dermal sensitisation and genotoxicity testing, the latter also being a focus for the replacement or refinement of animal carcinogenicity testing. So, scientists do not rest on their laurels. Workers in academia and in industry are working, frequently together and with the support of organisations like to 3Rs to develop tests which not only reduce the numbers of animals used in testing, but give more informative results. Dr Taylor asks “What medical marvels have been missed or ignored because researchers are so hell-bent on using animals?” I can confidently state that the vast majority of researchers are not hell-bent on using animals. Many are active in designing new approaches and new technologies but in many cases, researchers are only doing what regulatory authorities demand of them. I will leave it up to readers to make their own minds up on the issues involved in this topic. It is interesting to note that from data available on the European Medicines Agency’s website, studies in animals were pivotal in the development of the COVID-19 vaccines currently authorised. Kevin Woodword, Managing Director, KNW Animal Health Consulting

EDITORIAL ADVISORY BOARD Germán W. Graff - Principal, Graff Global Ltd Fereshteh Barei - Health Economist & Strategy Advisor, Founder of BioNowin Santé Avenue Association Carel du Marchie Sarvaas Executive Director Health For Animals Kimberly H. Chappell - Senior Research Scientist & Companion Animal Product Development Elanco Animal Health Dr. Sam Al-Murrani - Chief Executive Officer Babylon Bioconsulting & Managing Director at Bimini LLC Sven Buckingham - Buckingham QA Consultancy Ltd. Dan Peizer - Director Animal Health at Catalent Pharma Solutions Dawn Howard - Chief Executive of the National Office of Animal Health (NOAH) Jean Szkotnicki - President of the Canadian Animal Health Institute (CAHI) Dr. Kevin Woodward - Managing Director KNW Animal Health Consulting Norbert Mencke - VP Global Communications & Public Affairs Bayer Animal Health GmbH 4 International Animal Health Journal

Volume 8 Issue 1


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Needle-free Injection

Needle-free injection technologies can be used to administer vaccines and medications in the livestock industry. They offer a fast, safe and effective route of administration. Therefore, needle-free vaccination is moving more and more into the focus of those interested in improving animal health, while new technologies allow the development of even more efficient devices with a greater range of features and services. The following article intends to inform about the advantages of modern needle-free injection, but also aims to address possible challenges and other points of interest. Safety for Workers and Animals ​Safety is a key factor to any operation. Employees must be thoroughly trained in the use and maintenance of all equipment. Needle injection can be dangerous due to inadvertent needle sticks or cuts, whereas needle-free systems reduce these risks by design. Many needle-free application technologies integrate multi-step trigger and safety systems. However, needle-free injection is not entirely safe either. Needle-free systems are designed for a high-force dose to be administered very quickly and should only be used diligently and with proper training. Operator training is the most important ingredient to the success and elimination of risk associated with a needle-free roll-out. Another key factor, especially for vaccination and drug delivery, is sterility, which is often impaired by human error, such as for example the use of one needle for many animals, or forgetting to change needles when drawing vaccine from a bottle. In contrast, needle-free injection takes the needle out of the equation, and due to the high-powered dosing mechanism, there is little to no chance of crosscontamination. The use of needles, along with human error, may also cause carcass defects. If needles are disposed of incorrectly or dropped after use, there is always the possibility of an animal ingesting the needle or being stuck in an unassuming place. Needle-free injection systems eliminate residual needles and needle fragments from carcasses. As scientific

6 International Animal Health Journal

studies* have shown, needle-free injection offers a less painful and less stressful method of vaccination for the animal, resulting in less-stressed and more productive animals. Accuracy and User-friendliness The injection site is a crucial element in making sure that the animal receives a proper dosage. A needle injection provides many unknown variables that can prevent proper dosing and in turn create havoc in your vaccination programme. Proper dosing is highly dependent on many factors as well. Among these are the size and age of the animal and the recommended route of administration. Different methods of administration such as subcutaneous (SQ) or intramuscular (IM) are very important in guaranteeing a highquality vaccination. If a vaccine or drug is not administered accordingly, the effectiveness of the drug and the withdrawal time are altered. Emerging needle-free technologies may also embed features to aid in injection quality and accuracy for increased confidence and support of users. Some needlefree injectors accomplish this via visual or audible alerts indicating injection quality. In addition, needle-free injectors may include positional sensors to ensure proper reloading of injectable solutions, further increasing dosage accuracy and consistency. Last but not least, some providers also offer smartphone applications to create easy digital documentations of vaccinations with all-important data such as animal group, barn, vaccine, dosage, etc., as well as the possibility to export consistent vaccination reports with high data quality to existing farm management software. Efficiency ​ Needle-free injection systems can potentially reduce medical costs for the producer because the chance of injury to an employee from inadvertent needle sticks is eliminated. Needle-free systems also eliminate the purchase of needles. Needle breaks, which can damage tissue and cause a decrease in overall yield and profitability, are also eliminated.** In addition, the fast immune response provided by needle-free vaccination can lead to increased weight gain and profitability from your herd.** The working speed of needle-free injectors is comparable to traditional injection by

Volume 8 Issue 1


WATCH PAGES needle and syringe.** However, the start-up costs associated with needle-free injection systems are not comparable to those of traditional needle and syringe and must be evaluated with farm size and long term ROI in mind. Producers should weigh these costs versus the long-term benefit to their overall production system. Methods Needle-free injection devices are suitable for many different methods of application. Different systems will have varying potential for application type, but in general intra-dermal, subcutaneous and intra-muscular injection are possible. The history of needle-free injection systems goes back a long time. First systems were developed as early as the 1930s and have been used in a wide variety of medical areas over the years. However, through innovation and new technology there have been modifications and variations that allow for needle-free injection systems to be more widely available and effective to consumers in both animal health and human applications. Battery-powered Jet Injector When it comes to different drive concepts, the spring-loaded, battery-powered jet injector has proven to be the most customer-friendly and intuitive option. A battery-powered jet injector uses a small rechargeable battery pack to retract the dosing device. The dosing device has an electrically-driven piston that is automatically redrawn after dosing. It is good for continuous use and minimises worker fatigue. It is released by a small trigger accompanied by a nozzle sensor to promote user safety. At first sight the injector resembles a batterypowered hand drill. There are battery-powered systems for the administration of subcutaneous, intramuscular or intradermal dosage depending on the recommended method.

Summary Needle-free injection systems have the potential to improve the future of vaccination and drug delivery in animal health. Major advantages of needle-free systems are the elimination of broken needles, a more consistent delivery of vaccines and drugs, increased worker safety and increased animal welfare and productivity. Needle-free injection systems are customisable to each operation and can be modified to optimise productivity. Once start-up efforts are invested and once staff are trained in a proper way, the use of needle-free technology can indeed be a game-changer in the farm. * Kemper et al. (2016): Stressarm unter die Haut, dlz primus Schwein, p. 40 – 42 ** T.A. Houser et al. (2004): Meat Science 68, p. 329-332

Marius Leyhausen Marius is an Industrial engineering graduate, University of Stuttgart. He is the Sales Manager of veterinary products at Henke-Sass, Wolf GmbH for the last 5 years. Marius is the Project lead for the development of EPIG® (development time approx. 2½ years). EPIG® is the most advanced piece of technology for intramuscular needle-free injection in pigs. Henke-Sass, Wolf GmbH is a leading player in veterinary products (injectors, drenchers, needles, etc.) with strategic focus on needle-free injection.

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Sophisticated – increasing vaccination quality and piglet welfare while reducing risk of cross-contamination and broken needles www.animalhealthmedia.com

International Animal Health Journal 7

For further information please contact: Henke-Sass, Wolf GmbH · Keltenstraße 1 · 78532 Tuttlingen · Germany · www.henkesasswolf.de · info@henkesasswolf.de


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New IBV Strain D181 Active: Does it Resemble the Strains we Already Know? Introduction Infectious bronchitis virus (IBV) is a coronavirus belonging to the gammacoronaviruses. Because it is able to spread rapidly both within and between groups of chickens, it has a high impact on poultry production worldwide. IBV is an RNA virus which mutates at a relatively high rate. Because of this, new mutations are constantly being introduced when an IBV infection spreads through a flock, and in some cases this ultimately might lead to the selection of successful new viral strains with modified antigenicity or enhanced pathogenicity. This can pose challenges when making vaccination programmes for poultry flocks. Developing a new vaccine for each new strain of IBV is not realistic, so ways to induce cross-protection using existing vaccines should always be evaluated. The paper ‘Characterization of infectious bronchitis virus D181, a new serotype (GII-2)’ describes the characterisation of a new IBV strain named D181. This new IBV strain managed to evolve from an incidental finding in 2017 to one of the most important field strains found in Dutch egg-laying chickens in 2018 and 2019. Despite findings of the strain in Germany, Belgium and the United Kingdom, not much is

8 International Animal Health Journal

known about the spread of this important strain. There might be considerable underdiagnosis, since many routinely used IBV PCR tests are not (or are poorly) able to detect this strain, as is shown in the paper. The fact that this strain has become so dominant in such a short period of time seems to suggest that it has an advantage compared to earlier strains. This might be due to changes in its antigenicity, as the affected layer and breeder flocks had all been primed using live vaccines of the Massachusetts, 793B and QX serotypes and boosted with an inactivated vaccine with at least an M41 antigen. To get more insights into this aspect, virus cross-neutralisation tests were performed using strains and antisera of a panel of serotypes, including the new D181 strain. This allowed the determination of the antigenic relationship of D181 with these other IBV strains. The virus neutralisation test showed that the new IBV strain (D181) is a new serotype. While the strain is genetically and serologically most related to a known strain (D1466), it deviated too much to be classified as one of the known serotypes. Clinical Signs in Experimental Conditions Further research showed that infection with the new

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strain (D181) in adult layers without co-infections led to a significant reduction in egg production and egg quality without respiratory symptoms. In young pullets, respiratory signs were present. This work showed the pathogenicity of this strain. Diagnostic Challenges A number of routinely used IBV PCR tests were analysed in silico. It was found that these tests needed primer sets for GII lineage in order to be able to detect D181. What this means is that it is possible that in many cases, routine PCR tests miss this new serotype. The virus could therefore be much more widespread than we currently know. Current Vaccine Strains May Not Be Effective Against New IBV Strain The available vaccine strains do not produce neutralising antibodies against D181. It is, therefore, uncertain whether the current vaccines or vaccine combinations offer sufficient protection against the new IBV strain. In short, the new IBV strain D181 is a new serotype, resulting in a significant decline in egg production and egg quality under experimental conditions, and the current vaccine strains may not be able to induce sufficient protection against it. That is why the poultry sector has commissioned further research into this strain in 2020, which will answer the question: can some new IBV strains including D181 cause kidney damage and false layers? Funding This work was supported by the AVINED. www.animalhealthmedia.com

Sjaak de Wit Sjaak de Wit gained his veterinary qualification at the University of Utrecht in 1989 and completed a PhD degree, concerning diagnosis and transmission of infectious bronchitis virus, in 1997 at the University of Utrecht. His job as an immunologist and senior researcher at Royal GD has included responsibility for the quality and accreditation of serological tests for poultry pathogens, test development, applied research and on-site consultancy at farms, hatcheries and integrations. In 2016 he became president of the European College of Poultry Veterinary Science.

Robert Jan Molenaar Robert Jan Molenaar gained his veterinary qualification at the University of Ghent in 2008. In 2017 he became a fellow at the Royal College of Pathologists in London, after passing the veterinary pathology exams with a focus on avian pathology. His job as a senior poultry veterinarian and poultry pathologist at Royal GD has included research for salmonella, influenza and IBV and responsibility for the mink disease monitoring in the Netherlands.

International Animal Health Journal 9


REGULATORY & MARKETPLACE

The Rise in Pet Telemedicine Following the Coronavirus Pandemic Introduction Telehealth for pet owners has existed as a formal service for a number of years now, but until recently, awareness of such services has been limited. During the coronavirus pandemic, the general public were unable to visit their veterinary practice as they usually would and as such, pet parents and veterinary practitioners sought out new ways of connecting with one another, ensuring that animal wellbeing was not impacted by the lockdown. What has followed is a sizeable shift in how both pet owners and veterinary practitioners are choosing to operate. For pets, telehealth has put a digital vet at their side for health and welfare needs as they arise. For vets, it offers flexibility and the opportunity to work remotely. It also allows the vet to see the animal – something that telephone consultations do not allow. For pet owners, teleconsultations cut out travel time, offer immediacy and enable them to learn more about how to examine their pets. Now that lockdown is easing, we have been surprised to learn that a large majority of people want to continue having the option for a remote veterinary consultation, similar to those offered by many GP practices. With veterinary care becoming more digitised, this article will look at what the future of pet telehealth may hold: the opportunities that it presents – both to vets and pet owners – what needs to be done to fully integrate pet telehealth solutions into the veterinary care chain, and what data analysis from the past six months can tell us about what the future of pet care might look like. During the Pandemic During the initial phases of the pandemic in the UK, owners were only able to leave their house to seek help for their pet in exceptional circumstances. Because they could only contact their veterinary clinic via phone, owners chose remote video consultations. This service expanded quickly, providing a more accurate and reliable preferred alternative to ‘Dr. Google’. Owners needed a natural first point of contact for trusted, professional, remote advice. This was evidenced by the fact that the UK FirstVet service saw a six-fold increase in the number of consultations from February to August 2020. Wave 4, an independent survey by CM Research, found that 92% of UK veterinary clinics used telemedicine/remote consultations during lockdown1. This collective experience will provide invaluable data for practices to inform business planning and future changes to service delivery. Similar data is being gathered independently to provide important data for the RCVS review of guidance on under care, including remote prescribing. Wave 4 also reported that telemedicine gained interest in other European countries during the pandemic. For example, France is currently running pilot studies on telehealth. However, not all vets were keen to keep using remote consultations; a similar number of UK vets indicated that they were just as likely (38%) or unlikely (35%) to continue using telemedicine after the pandemic. This is understandable as veterinary medicine is a hugely practical vocation, which uses skills that many 10 International Animal Health Journal

people would not want to forgo. Although it is quite easy to build trust and client relationships virtually, not all staff will be as comfortable interacting with clients in this way. It is also important for all stakeholders to understand the limitations of telemedicine; remote consultations cannot replace a physical hands-on examination, which is a requirement for prescriptions. The RCVS changed their prescribing guidance during lockdown to temporarily allow veterinary surgeons to prescribe prescription-only veterinary medicines (POMVs) remotely, without first having physically examined the animal. At present, this measure has been extended to 31 October 2020. On a webinar during the pandemic, Dr. Rens van Dobbenburgh, President of the Federation of Veterinarians of Europe (FVE), reported that the UK was the only European country to allow temporary remote prescribing2; in most countries, telemedicine is not allowed for diagnosing or prescribing, only for triage purposes. For pets, there have been several key advantages to the increased awareness of veterinary telemedicine. Firstly, access to virtual care has lowered the barrier for owners seeking medical advice for their pets. In addition to the common barriers to veterinary care, there have been movement restrictions due to COVID-19 as well as health risk(s) associated with public spaces. We know that some pet owners would not have seen a vet if a telemedicine service was not available. This is measured in two ways: 1) our vets record this information during the consultation and 2) our insurance partners conduct post-consultation surveys. Secondly, it has improved animal welfare by signposting owners to see a vet when needed, as well as creating greater capacity for pets that need an in-clinic or emergency appointment. This has been especially pertinent in recent months due to the marked rise in pet ownership and first-time pet parents. Thirdly, remote consultations represent reduced stress for the pet being examined outside of a consultation room, where the vet is also able to assess environmental factors. For owners, remote consultations have provided professional advice whilst not being able to leave the house, self-isolating or shielding; their need for advice did not necessarily require a hands-on physical examination. Such advice has helped owners to navigate the pathway to Volume 8 Issue 1


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International Animal Health Journal 11


REGULATORY & MARKETPLACE to virtual care can ensure that vets and vet nurses in-clinic have the time to focus on the most important skilled tasks. Telehealth needs to be integrated more fully into the veterinary care chain to be delivered safely and effectively in the long term. The outcome of the RCVS ‘under care’ and 24-hour review will provide a stronger framework around which telemedicine will develop further. Whether or not remote prescribing of POMVs in the future is appropriate remains to be seen. The fact that telemedicine has so many definitions, and remains a broad term in the UK, is one reason that veterinarians may be cautious in incorporating it into their service offering. In the UK we currently use these definitions interchangeably.

getting appropriate veterinary care when a lot of unknowns and unanswered questions remained. Some teleconsulting services have provided the additional benefit of consultation notes, written for the owner, which help to improve compliance and patient outcomes. It is interesting to observe that owner compliance with remote veterinary advice is high. When vets recommend that a pet owner visits a vet immediately (as measured by whether they made an insurance claim for a vet visit), owner compliance is incredibly high; they are a trusted source of pet-specific advice. Lastly, remote consultations improve client satisfaction with veterinary care overall. This is because access to virtual care means that owners understand the care that their pet is going to receive in-clinic, and the necessity of it, better. For vets and veterinary clinics, the silver lining to the coronavirus cloud has been the unique opportunity for the profession to test a new way to practice. Vets have needed a formal way to continue delivering pet healthcare during the pandemic whilst clinics were allowed to only provide emergency services. The RCVS survey on the economic impact of COVID-19 on veterinary clinical practices reported that clinics were using remote consulting for a variety of reasons. These included providing triage and advice (>90%), for repeat prescriptions (90%) and to prescribe medication for new conditions (70%)3. The Future The future of veterinary telemedicine is exciting. Interestingly, the demand from pet owners for remote consultations continues to grow despite lockdown restrictions being lifted. Pet owners love using telemedicine. This is most likely due to a combination of familiarity and convenience. Incorporating a dynamic post-teleconsultation feedback loop will be useful to practices in order to continually develop and adapt their service. In addition, teleconsultations, as a value-added service with pet insurance products, are very well received by pet owners. Practices view insured pets positively since it facilitates their goal of delivering pet healthcare. Growth in the number of insured pets, through such benefits, would no doubt further support vets in achieving this goal. It is also an invaluable opportunity for data analysis to inform business decisions allowing new clinics to decide whether or not to incorporate remote services into their future business model and customer care offering. Whilst telemedicine increases the availability of professional hours, of course service delivery will differ between practices; from the purpose and implementation, to the integration with existing care pathways. In Sweden, when a pet is sent to their clinic, the receiving vet in-clinic typically saves 20% of visit time. When it is well integrated into the overall animal care journey, access 12 International Animal Health Journal

In the US, the American Veterinary Medical Association (AVMA) however, has defined telehealth, telemedicine and teleconsulting; this approach may be useful in further shaping the framework for delivery of remote services in the UK. The AVMA have developed a Telehealth Resources Centre (avma. org/telehealth), which is a resource that provides practical information for veterinarians and veterinary teams to help to get ‘telehealth-ready’. When considering how to set up telehealth services in UK practices, clinical conversations, CPD and the development of similar resources will be pivotal. Telemedicine represents a significant change in our way of working. The landscape surrounding telemedicine and the ways in which it is delivered will continue to evolve in the future. It is an opportunity for vets and vet nurses to use their skills in a different way and to gain new skills. Veterinary staff are continuing to learn how telemedicine is best delivered; this will take time. Training will be essential. Practice managers will need to consider whether there is capacity and engagement within their teams to sustain a teleconsulting service. Will the service be provided by staff working from home? Does the practice have its own facilities, such as a sound booth, where staff could consult uninterrupted? Speaking about embracing innovation at the FVE General Assembly in November 2018, Dr. Denis Avignon said that “Telemedicine should be [an] integral part of the initial veterinary training and of CPD.”4. New telemedicine resources will also need to be incorporated into university courses to allow those people joining the profession to gain the appropriate knowledge and skills. The wellbeing of the whole veterinary team is paramount. Many employers and employees in veterinary practice want to work more flexibly to achieve better work-life integration, but this can be difficult to arrange. Remote consulting offers vets and vet nurses one flexible way of working that enables them to factor in other commitments, interests, and hobbies, as well as changes in routine. They have the ability to work despite being unable to work in-clinic or if they are shielding, for example. It also provides continued employment and a source of income during times of financial insecurity. Future expansion of telemedicine within the veterinary industry in future will allow more people to benefit from this increased flexibility. Anecdotal evidence suggests that caseloads are currently continuing to stretch clinic teams beyond capacity, with widespread fatigue and burnout amongst veterinary staff. Greater availability of teleconsultations will help to reduce the burden on staff of pets that do not need to be seen in a clinic. It will also allow cases to be handled in a more timely manner. For example, it could be used to support the reception team, where triage and advice calls could be diverted directly to a dedicated vet or vet nurse. Setting up a telemedicine platform in a clinical setting is straightforward. There are now many platforms to choose Volume 8 Issue 1


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from and the level of integration will vary. Each service has its own integration and support services. Where remote veterinary advice has been fragmented and somewhat informal, delivering telehealth via a formal platform will enable vets to record and store clinical information, photos and videos more comprehensively, alongside a written record of the remote consultation and advice given. With the benefit of a video, versus a phone call, vets no longer have to guess what colour of mucous membranes the owner is describing. Dr. Eve Hanks said that “it is the first time I’ve been able to take an accurate resting respiratory rate in a consultation.” As a result of delivering telemedicine consultations, another member of our vet team, Dr. Clare Sparks, said that she felt that she had “learned how to triage patients by phone in her clinic more effectively”. It is likely that there will be increasing integration of telehealth platforms with practice management systems. This would allow staff to work from home whilst being able to access a pet’s full clinical history and maintain a complete clinical record. Moreover, for health and safety reasons, this may help to reduce the number of staff required in the practice at any one time. Education and advice are an important part of veterinary medicine, which is easily delivered via telemedicine. Owners are becoming increasingly tech-savvy, having had additional necessity during lockdown, and their expectations are growing. They enjoy learning how to examine their pet and understanding when to seek veterinary advice. In general, owners are very capable of being walked through a basic physical examination to help the consulting vet to gather additional clinical information via the video call. Many factors can impede this critical part of a consultation, including internet connection and speed, camerawork, patient compliance and owner experience. However, the quality of the information that can be gained should not be underestimated and technological advances will continue to facilitate this. Reflecting on our collective experience of telemedicine in the veterinary industry during the pandemic, evidence www.animalhealthmedia.com

shows that concerns about telemedicine replacing an inperson appointment with a hands-on physical examination are not justified; whilst many problems can be addressed remotely, a simple vaccination injection cannot. Whilst not all clinics will continue to provide a remote consulting service, telemedicine will almost certainly continue to form part of an enhanced patient care pathway. It is clear that the most important factor for the future of veterinary telemedicine is to keep the pet’s welfare at the front and centre of our decision-making. REFERENCES 1. 2. 3. 4.

Report Wave 4: https://www.cm-research.com/downloadour-covid-19-survey-results-here/ Accessed 02 October 2020 Covid-19 and the veterinary profession (31st May 2020) https://www.thewebinarvet.com/webinar/covid-19-andthe-veterinary-profession-31st-may Accessed 31 May 2020 Coronavirus: economic impact on veterinary practice. Result from RCVS survey #2 1-5 May 2020 www.rcvs.org. uk/coronavirus-surveys Accessed 02 October 2020 Embracing innovation and new horizons. Rome: FVE General Assembly November 2018 https://www.fve.org/cms/wpcontent/uploads/080-FVE-GA-summary-report-2.pdf Accessed 02 October 2020

Dr. Jessica May Dr. Jessica May is UK lead vet at FirstVet (www.firstvet.com), the largest independent digital veterinary telehealth provider in Europe. FirstVet launched in the UK in April 2019. The UK FirstVet service is staffed by experienced, RCVS registered vets, offering pet owners triage and advice, simple treatment recommendations and, if necessary, a recommendation to visit their own first opinion physical veterinary clinic.

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One Health: Professional Stakeholder Engagement Key to Tackling Zoonotic Disease Introduction Globally, endemic and emergent disease risks persist as significant challenges to human and animal health. Rural livestock farming communities in low- and middle-income countries (LMICs) are disproportionately affected by zoonoses and animal diseases due to poverty and concomitant poorly-available health and veterinary services. In countries heavily reliant on animal production for socio-economic stability, the impact of zoonotic disease is devastating. A One Health approach to tackling zoonosis is now broadly advocated and a successful strategy requires sector stakeholder recognition, inclusion, and engagement to ensure a holistic response to a complex problem. Agriculture and Poverty Livestock farming is essential to the livelihoods of many rural Africans1, with lives immersed in animal production for self-sufficiency, and increasingly robust home and export markets. Pastoralist systems are prevalent in arid regions where inconsistent rainfall prohibits effective crop production, promoting animal farming as a dependable source of income2. As 66% of Africa’s land expanse is used to graze animals, pastoralism is a vital part of the African economy. Animals also fulfil a spiritual and cultural role in rural populations through ritualised practices which enhance self-knowledge and identity. Livestock production contributes to almost half of the global agricultural gross domestic product (GDP)3, yet poverty in the Sub-Saharan African farmer community is widespread and persistent.

Boar goat production on a commercial farm in the Omaheke Region (Namibia)

Livestock Sector and Production In some regions, the international meat export markets have surged, with growing demand from the EU and Norway for meat products from Botswana, Namibia, Swaziland, and South Africa. After almost twenty years of lobbying and successful introduction of strict biosecurity measures, in 2020, the Namibian state-owned Meat Corporation of Namibia (MeatCo) entered the American meat market, with an initial shipment of 25 tonnes of beef to Philadelphia. The approval will enable MeatCo to deliver 860 tonnes in the first trading year, 14 International Animal Health Journal

Poultry unit on the outskirts of Windhoek

with a target annual delivery of 5,000 tonnes. The Kenyan Meat Commission routinely exports to the Middle East and North Africa (MENA) region, confirming globalisation of the animal products export market. This sector makes an increasingly important contribution to the national economy of many SubSaharan African nations, but in districts where commercial and subsistence farming systems run in close proximity, and disease risks from wildlife persist, then securing livestock health is challenging. Low livestock productivity is attributed to weak production systems and poor animal health4,5, often linked to restricted access to comprehensive animal health services. Zoonotic Disease Millions of lives are affected on a global basis daily by zoonotic disease. The outbreak of COVID-19 brings a stark reminder of the ongoing risk to human health, and modelling of worldwide disease outbreaks indicates that around threequarters of emergent human disease is zoonotic in origin3. Endemic zoonoses have a devastating effect on human health and livelihoods; as well as animal health, welfare, and production. Rural communities in LMICs are the most vulnerable to zoonotic disease6 due to the close residence of people with animals and dependence on livestock farming, traditional food consumption practices, and limited access to human and animal health services3,7. Endemic zoonotic disease outbreaks continue to be problematic and since 2000, a number of epidemic zoonoses not previously known have been widely reported (Table 1). One Health in the Animal Health Sector The World Health Organisation (WHO) defines One Health as “an approach to designing and implementing programmes, policies, legislation and research in which multiple sectors communicate and work together to achieve better public health outcomes”. Central to the success of a One Health approach is the engagement and collaboration of sector expertise and stakeholders working together for shared objectives. For the animal health sector, this can encompass a broad range of professionals and paraprofessionals, all of whom make a valid contribution. Farmer Access to Veterinary Services Despite the recognised socio-economic importance and Volume 8 Issue 1


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Epidemic zoonoses not previously known before 2000

Anthrax

Severe Acute Respiratory Syndrome (SARS)

Brucellosis

Middle-East Respiratory Syndrome (MERS)

Echinococcosis/ hydatidosis

COVID-19

Mycobacterium tuberculosis

Avian flu (H5N1)

Rabies

Swine flu (H1N1)

health has concurrent positive effects of minimising the risk of zoonotic disease transfer. Unfortunately, training for veterinary medicine stockists in Sub-Saharan African rural farming regions has been found to be variable10,11 and employees can be under pressure to stock and sell certain products. Outreach, farmer education, and enhanced communication from animal health services are all recognised as key success factors; but without readily available access to veterinarians and services, how may this be achieved?

Rift Valley Fever Campylobacteriosis Porcine cysticercosis Q fever Salmonellosis Trypanosomiasis West Nile Fever Table 1. Current Global Endemic and Emergent Zoonotic Diseases Risks

widespread use of livestock farming in rural Sub-Saharan Africa, farmer access to veterinary services and medicines is often inadequate. The critical risks to the livestock farming sector are recognised as follows: failing animal health status; non-compliance of infrastructure; lack of preventative support and advice on matters of animal health, and the subsequent decline in animal production8. Risk factors are compounded as pastoralist farming communities are typically poor and have limited access to animal health resources including education and medicines6,8. Low numbers of veterinarians and veterinary paraprofessionals (with practitioners often required to cover a broad geographical expanse), declining animal health services (due to reduced government capacity), and limited farmer access to agri-merchant retail outlets all severely impact farmer ability to source veterinary services, veterinary advice and guidance, and safe veterinary medicinal products. In the absence of professional animal health advice, rural farmers will draw on their previous experiences, ethnoveterinary practice or tacit knowledge. Such findings are reflected in livestock farming practice in Tanzania, Ghana, Kenya, Zambia and Zimbabwe9,10. Insufficiencies in the availability of education and advice to farmers is known to be associated with poor access to veterinarians. Limitations to animal health services are known to heighten the risk from zoonotic disease7 and potentially the development of emergent zoonoses. Informed and educated farmers are better placed to recognise disease in their livestock and to understand the risk from zoonoses. Consequently, farmers who are able to access veterinary guidance and safe veterinary medicinal products are better positioned to initiate measures to enhance food security and concurrently veterinary public health. Simultaneously, they improve animal health/welfare and production to secure their own livelihoods. Farmers would be better equipped to reduce the risk of zoonosis and to safeguard public health in the broader sense, such as slowing the development of antimicrobial resistance. Linking animal health service providers to agricultural merchants can increase farmer access to animal health services, helping to reduce animal mortality, and enhance production and farming profitability. Importantly, maintenance of animal www.animalhealthmedia.com

Traditional meat market selling

One Health Approach to Tackling Zoonotic Disease The general international consensus on zoonotic disease control is that a One Health approach is often required. The interlocking nature of human, animal, and environmental factors is broadly accepted as the key to health across all three spheres. Fundamentally, a successful One Health approach to livestock farming requires all core stakeholders to be informed, engaged, and active in the quest for disease prevention, management and resolution. Core stakeholders to the rural African livestock sector include veterinarians, allied animal health practitioners such as veterinary paraprofessionals, farmers themselves, and arguably the interconnecting pharmaceutical professional the veterinary pharmacist. Stakeholder Contribution Stakeholders may be defined as any individual or group that is or should be involved in preventing or managing a health threat at the human-animal-environment interface. It should also include those who are impacted by such a health threat, in this instance the farming community. Engagement of the identified stakeholders is a crucial component of the One Health approach and working towards successful solutions to zoonotic disease risk. Many nations advocate the development of a vet-led team approach to the provision of veterinary health services; incorporating a broad range of allied animal veterinarian-led team such as veterinary nurses and technicians, nutritionists, reproductive technologists, and animal medicine advisers. This model seeks to delegate tasks to specialist professionals under veterinary direction. In LMICs where access to veterinarians is limited, vet technicians, animal health technicians or community animal health workers (CAHWs) are a veterinarian replacement, rather than an accompaniment to a broader team effort. In pastoral regions, services provided by CAHWs have developed in direct response to inadequate veterinary health services and veterinarians. CAHWs are deeply rooted in the community, and correspondingly are highly trusted by rural farmers12, aiding the successful communication of advice and guidance. Yet they continue to face challenges stemming from insufficient veterinary medicine regulation (safe usage, dosage, route of administration and disposal) and inadequate staff training. International Animal Health Journal 15


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Agri-merchant outlets are commonly the core source of veterinary medicine supply. Appropriate retail staff training is proposed as a tool to encourage rational and correct medicine dispensing process and procedures. Studies corroborate training with improved quality of advice and information provided to clients during dispensing of veterinary medicines13,14,15. Recent NGO initiatives have clearly determined the positive impact on animal health and welfare from training and education programmes for agri-merchant retail staff16. This perhaps indicates a broader role for the veterinary pharmaceutical sector in facilitating effective and accessible training platforms for veterinary medicine stockists. Interlocking Human and Animal Health Strategy Recent years have seen the comprehensive extension and 16 International Animal Health Journal

expansion of the pharmacist role into matters of broader public health incorporating the overlap between human and animal health. Indeed, the professional discipline of veterinary pharmacy is now established and generally well accepted. As public-facing and accessible professionals, pharmacists (with the appropriate training) are extremely well-placed to provide advice and guidance on veterinary medicines practice. This is not to suggest a replacement to veterinarian services but as an additional professional practitioner leveraging accessibility to support the farming community through a One Health approach. In rural regions, where a paucity of veterinarians and animal health technicians is distinctly problematic, the veterinary pharmacy role could include veterinary public health, ensuring safe supply of veterinary medicines, as well as providing advice on correct use, storage and disposal, Volume 8 Issue 1


REGULATORY & MARKETPLACE pharmacovigilance, and information on zoonoses prevention and control. In LMICs, the community-based cadre is wellpositioned to extend veterinary pharmaceutical services to rural communities. Trained in pharmaceutics, community pharmacists are embedded within rural communities, and are recognised as established healthcare practitioners within the community. As the only health professional able to bridge both human and veterinary medicine, the veterinary pharmacist could serve to be the interlocking professional to secure interdisciplinary health. In summary, the risks to human and animal health from endemic and emergent zoonoses will persist in the absence of accessible veterinary services, advice and guidance, and a secure supply chain for veterinary medicinal products. Risk to human health is both localised and international, as we have experienced in the recent outbreaks of SARS, MERS, and COVID-19. In regions where the demand for veterinarians outstrips supply, contributions from allied veterinary paraprofessionals and others, such as a veterinary pharmacy cadre, animal health technicians, and well-trained retail staff, may serve well to ameliorate insufficiencies. REFERENCES 1.

McDermott, J., Staal, S., Freeman, A., Herrero,M., Van de Steeg, J. Sustaining intensification of smallholder livestock systems in the tropics. Livestock Sci. 2012; (130): 95–109. 2. Rota, A., Sperandini, S. Livestock and pastoralists. Livestock Thematic Papers: Tools for Project Design. International Fund for Agricultural Development, Rome, Italy. 2009; [Online] www. ifad. org/lrkm/factsheet/pastoralists. pdf. Visited 10.12.2020. 3. Grace D, Mutua F, Ochungo P, Kruska R, Jones K, Brierley L, Lapar L, Said M, Herrero M, Phuc PM, Thao NB, Akuku I and Ogutu F. 2012. Mapping of poverty and likely zoonoses hotspots. Zoonoses Project 4. Report to the UK Department for International Development. Nairobi, Kenya: ILRI 4. Oladele, O., Antwi, M., Kolawole, A. Incidence and Prevalence of Livestock Diseases along Border Villages of South Africa and Namibia. Journal of Animal and Veterinary Advances. 2013; 12 (2): pp.177-180. 5. Meat Board of Namibia. Meat Board of Namibia, Business Plan 2018-19. [On-line]. http://www.nammic.com.na/index.php/ library/send/23-annual-reports/244-ar2019 Visited 01.02.2021 6. Grace, D., Lindahl, J., Wanyoike, F., Bett, B., Randolph, T., Rich, K. Poor livestock keepers: ecosystem–poverty–health interactions. Philosophical Transactions of the Royal Society B: Biological Sciences. 2017; Jul 19;372(1725):20160166. 7. Cleaveland, S., Sharp, J., Abela-Ridder, B., Allan, K.J., Buza, J., Crump, J., Davis, A., Del Rio Vilas, V., De Glanville, W., Kazwala, R., Kibona, T. One Health contributions towards more effective and equitable approaches to health in low-and middleincome countries. Philosophical Transactions of the Royal Society B: Biological Sciences. 2017; Jul 19;372(1725):20160168. 8. Food and Agricultural Organization of the United Nations (FAO). Farming Systems and Poverty. [On-line]; .http:// www.fao.org/3/Y1860E/y1860e00.htm#TopOfPage. Visited 07.02.2020. 9. Caudell, M., Dorado-Garcia, A., Eckford, S., Creese, C., Byarugaba, D., Afakye, K., Chansa-Kabali, T., Fasina, F., Kabali, E., Kiambi, S., Kimani, T. Towards a bottom-up understanding of antimicrobial use and resistance on the farm: A knowledge, attitudes, and practices survey across livestock systems in five African countries. PLOS one. 2020; Jan 24; (1) 15. 10. Keyyu, J., Kyvsgaard, N., Kassuku, A., Willingham, A. Worm control practices and anthelmintic usage in traditional and dairy cattle farms in the southern highlands of Tanzania. Veterinary Parasitology. 2003; May 15;114(1):51-61. 11. Bett, B., Machila, N., Gathura, P., McDermott, J., Eisler, M. Characterisation of shops selling veterinary medicines in a www.animalhealthmedia.com

12.

13.

14.

15. 16.

tsetse-infested area of Kenya. Preventive Veterinary Medicine. 2004. (63), 29–38. Grasswitz, T., Leyland, T.J., Musiime, J., Owens, S., Sones, K. The veterinary pharmaceutical industry in Africa: a study of Kenya, Uganda and South Africa. African Union/Inter-African Bureau for Animal Resources (AU/IBAR), Nairobi, Kenya. 2004. Higham, L.E., Ongeri, W., Asena, K., Thrusfield, M.V. Characterising and comparing animal-health services in the Rift Valley, Kenya: an exploratory analysis (part I). Tropical animal health and production. 2016; 48 (8):1621-1632. Higham, L.E., Ongeri, W., Asena, K., Thrusfield, M.V. Characterising and comparing drug-dispensing practices at animal health outlets in the Rift Valley, Kenya. Tropical animal health and production. 2016; 48(8):1633-1643. Haakuria, V.M., Pyatt, A.Z., Mansbridge, S.C., 2020. Exploration of veterinary service supply to rural farmers in Namibia: a One Health perspective. PAMJ-One Health, 2(17). Brooke. https://www.thebrooke.org/our-work/one-healthbrooke Visited 10.01.2021

Dr. Alison Z. Pyatt Dr. Pyatt works in the International Development and Training Office (Sub-Saharan Africa/ Asia) at the UK Veterinary Medicines Directorate. She holds a PhD in veterinary services at Hartpury University and Harper Adams University. Research interests are founded in stakeholder-centric and co-production of services in the global animal health and veterinary sectors. Dr. Pyatt is an international veterinary pharmacy consultant. Email: azp@alisonpyatt.co.uk

Dr.Stephen C. Mansbridge Dr. Mansbridge is an accredited animal scientist and Senior Lecturer in Animal Science and Bioinformatics at Harper Adams University, UK. He holds a PhD in animal health and nutrition, working both in academia and industry to improve knowledge and applications for the animal and veterinary sectors. Email: smansbridge@harper-adams.ac.uk

Dr.Vetja Haakuria Dr. Haakuria is an academic and research consultant. He served as the Deputy Associate Dean in the School of Pharmacy, University of Namibia, where he lectured in the Pharmaceutics Department. A trained Veterinary Pharmacy specialist, his interests are in tackling global health challenges such as zoonoses and antimicrobial resistance across the One Health platform. He is currently leading projects to mainstream veterinary pharmacy as a profession to interface animal health and welfare, promoting sustainable animal production while safeguarding public health. Email: haakuria@gmail.com

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EMA/CVMP proposals for the requirements for limited markets and minor species: an update in 2021 In less than a year, on January 28, 2022, Regulation (EU) 2019/6 will become applicable. The CVMP has now issued different guidance documents how the new Regulation impacts the registration for limited markets including minor species. While article 23 provides an abbreviated pathway for such products to obtain a marketing authorisation with a reduced dataset on safety and efficacy, resulting in a 5 years period for marketing authorisation, an unlimited authorisation is achieved with an adapted amount of data for such limited market products according to Article 8. CVMP reflects on the approach for classification of such products, and provides guidance for efficacy and safety data requirements in the target species for both, biological and non-biological products. Further guidance is given for safety and residue data requirements to establish an MRL.

Although for guidance only, the following thresholds for potential market size are proposed: • •

To evaluate the eligibility for such an application, applicants need to address two questions as outlined in Article 23. 1. Is the product intended for a limited market as defined in Article 4 (29) and Art. 23 (1) b of the Regulation ()? As compared to the current definition of Directive 2004/28/EC for MUMS, regulation 2019/6 defines ‘limited markets’ slightly different, being either intended for use in a non-major species (major species are cattle, non-lactating sheep, pigs, chicken, dogs and cats) or for the treatment of diseases that occur infrequently or in limited geographical areas. While the categorisation by species is straight forward, a limited market in a major species targets ‘diseases that occur infrequently’ or in limited geographical areas. In the future, the decision is based primarily on the estimated potential size of the market applying the following formula:

=

Whether the product is intended for prevention or treatment. The frequency of the disease/condition in the EU relevant to the indication sought. Diseases with low prevalence, occurring infrequently or sporadically and in only a small number of animals will be considered for classification as a limited market. Estimates of disease prevalence should be supported by up-to-date data in the published

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The potential number of animal treatments in a standard treatment course (ranging from one-off, single administration to daily administration over the remaining life of the animal) or the need for repeated treatments during the course of one year. Time to return on investment. This parameter will be influenced by multiple factors including the nature of the product and associated development costs, cost of manufacture, potential market size, unit price, etc. The approach to estimating the time to return on investment should be clearly outlined in the request for classification and justified based on reference to appropriate data.

All these criteria meant to address the first question, are mentioned to be taken into account, which indicates that any such classification as a limited market in a major species will be a case-by-case decision and difficult to predict by an applicant when considering developing such product. 2. Does the benefit of the availability on the market outweigh the risk that certain documentation has not been provided in a dossier (Art. 23 (1) a)? The said benefit in this case is proposed to be accepted if the medicinal product (intended for the treatment or prevention of disease) is intended to treat a serious or life-

total annual number of animals potentially treated

The calculated potential market size can be influenced by various factors. •

less than 0.5% of the EU target species population for veterinary medicinal products or less than 5.0% of the EU target species population for vaccines.

On top, other factors may be taken into account:

The reflection paper on classification of a product as intended for limited market and eligibility for authorisation according to Article 23 published by EMA for consultation, first time outlines the understanding of CVMP of Article 23, here to obtain marketing authorisations for products defined as ‘limited market products’.

Estimated potential size of the market %

literature and/or from appropriate and reliable sources. The geographical area in which the disease/condition is present. Diseases that occur in limited geographical areas or regions that are distinguished by physical, chemical, or biological factors that limit the distribution of a disease or condition will be considered for classification as limited market.

EU (EEA) target species population

x 100

threatening disease/condition or addresses an ‘unmet medical need’. For the definition of these terms, guidance from human medicine as well as from US FDA served as a basis. ‘Serious or life-threatening disease or condition’ is defined to be associated with morbidity that has substantial impact or is associated with mortality, is zoonotic or has the potential to cause significant economic impact for individual producers. However, the proposal is made that products intended to treat diseases that have zoonotic potential including antimicrobials and parasiticides are not deemed to be eligible for authorisation under Article 23; they typically Volume 8 Issue 1


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a product for a limited market can also be done according to Art. 8.

These proposals limit the political objective to improve the availability of veterinary medicinal products for limited markets. In the context of promoting the availability of veterinary medicinal products for limited markets including minor species, it is surprising to see antiparasitics and antibiotics excluded right away. Any products “preventing such diseases” should be included here.

The marketing authorisation (MA) for a limited market under Article 23 will be valid for five years and either, based on a re-examination, be prolonged for further periods of five years, or can be upgraded to an unlimited full MA under Article 8 when providing the missing information on safety and efficacy. However, it is unclear for the moment, to which degree further data must be provided.

The term of an ‘unmet medical need’ is taken from human medicine and means a condition for which no satisfactory method of diagnosis, prevention or treatment in the Union exists or if such methods exist, they will be of major therapeutic advantage. This means that either no available therapy exists for the same intended use (if such therapy exists at all); the new product is reasonably expected to be safer, more effective, or clinically superior. In this context, it is noted that ‘available therapy’ means an authorised veterinary medicinal product, independent of the authorisation procedure but not including off-label use of an approved veterinary or human medicinal product.

Furthermore, it remains unclear now, which are the specific data requirements for a limited market product authorised under Article 8, either being eligible or not for an authorisation under Article 23. This guidance will be much appreciated to be issued by EMA/CVMP; it is expected that such recommendations will be taken on a case-by-case basis, in many cases making consultation with the competent authorities highly recommendable. Certainly, any further guidance will be welcome.

The authors consider that the definition of “unmet medical need” should be broader in animal health as compared to human health: due to the variety of animal species and diseases, different mode of actions, technologies, route of administrations, safety profile, and assurance of availability should be considered as unmet medical need depending on the animal species and number of products available. To apply for a marketing authorisation according to Article 23, the applicant has to provide evidence that the product falls under the definition of ‘limited markets’ to benefit from reduced data requirements for safety and efficacy. A complete quality part must be provided in any case. EMA/CVMP request that there must be a ‘real’ consideration of the ‘benefit of availability’ versus the risk of absence of data on safety and/or efficacy. However, an application for

As EMA/CVMP proposes that all currently authorised MUMS products are considered Annex II compliant, these will get a full marketing authorisation according to Article 8, without re-evaluation. Considering this, it will be interesting to see if products for limited markets to be registered according to Article 8 still need the same data requirements for safety and efficacy as required for a major species. The authors consider that there will also be room for negotiation that reduced data requirements may also be possible for limited market products authorised under Article 8. The guidelines on safety and residue data requirements and on efficacy and target animal safety data requirements for non-immunologicals continue to outline data gaps that may be accepted for applications under Article 23. A more specific guidance is provided for immunologicals (guideline on data requirements for immunologicals). In

Thus, the following approach for limited market products can be taken:

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REGULATORY & MARKETPLACE line with the current approach under Directive 2001/82/EC as amended, the draft guideline proposes that specific requirements, like GLP and GCP compliance, may be lifted, but also some safety and efficacy studies may be possible to omit (e.g. safety of first re-vaccination or field efficacy studies). In summary, the guidance issued by EMA/CVMP give hope to a pragmatic approach for obtaining marketing authorisations for limited markets in the future under Regulation 2019/6. While the minor species are clearly defined in legislation, the guidance on the definition of limited markets in major species is welcome, although still quite vague. It will be interesting to see how this will be implemented in a case-by-case manner. The safety and residue guideline provides evidence that the safety for the consumer is paramount, even in the absence of products to treat diseases. The requirements for immunological VMPs appear to be reduced slightly more than those for non-immunological products; however, this will all depend on the final version of these guidance documents and its practical implementation. Meetings with the ITF and/or ADVENT group of CVMP and furthermore approaching CVMP for scientific advice in a well-organised manner will be even more important for any applicant for a successful registration of a VMP in the future. REFERENCE 1.

https://www.ema.europa.eu/en/veterinary-regulatory/ research-development/minor-use-minor-species-limitedmarkets

Dr. Klaus Hellmann Dr. Klaus Hellmann is a veterinarian with 30 years’ experience in the animal health industry. Prior to founding Klifovet in 1997 as a CRO and extending it to a CDMO, he worked in veterinary practice, science and the animal health industry. He is a Board-certified veterinary pharmacologist, Diplomat of the European College of Veterinary Pharmacology and Toxicology, and a trained Quality Manager and Auditor (European Organisation of Quality). As CEO of Klifovet, he acts as consultant on international animal health product development. He has specific interest in the availability of medicines for minor species and limited markets to assure safe and effective products for such animals as well. Email: klaus.hellmann@klifovet.com

Dr. Cornelia Hüttinger Dr. Cornelia Hüttinger is a veterinarian with nearly 10 years’ experience in the animal health industry. Before joining KLIFOVET in 2012, she completed her thesis in small animal oncology, participated in a rotating internship programme at the University of Vienna and worked in veterinary practice. She is now heading the regulatory affairs unit and is consulting companies on the regulatory strategy to obtain marketing authorisations for animal health and nutrition products. Email: cornelia.huettinger@klifovet.com

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18th Workshop on VICH Good Clinical Practice and efficacy studies in animals

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Contributions from Human-whale Historiography to Ocean Sciences In the next decade, the world will see how the sustainability of oceanic waters and its strong connection with human lives is under threat. The United Nations Decade of Ocean Science for Sustainable Development (2021–2030) is being designed as a participative and transformative process of reinforcing dialogues from integrative multidisciplinary approaches in the science-policy interface. Society as a whole must be involved in creating this transnational invitation, expressing its global commitment through the formulation of initiatives and policies, based on scientific evidence toward the protection of oceans. In this sense, narratives built from forecasted exchanges and connections may encourage dialogues between different parts of the world, in order to promote effective actions and capacities to save the oceans. The preparatory arrangements for the Decade of Ocean Science were abruptly affected by the social and economic damages spread by the global COVID-19 pandemic. The increasing perception of national vulnerabilities associated with geographical and social inequalities and exclusion may severely affect expectancies concerning the capability of some governments and multilateral organisations to solve old and basic issues. For many countries, the exercise of prospection for future trends has been suddenly blurred by cumulative impacts of pandemy on their development policies. Now, more than ever, new angles to face contemporary challenges will be required in order to enhance integrative actions which aim to qualify forms of interaction between human societies and oceans, as envisioned by the UN Decade. Integrative perspectives embrancing marine sciences and intercultural approaches open up large spaces that rethink the critical effects of inbalance in the relationship between societal and natural systems. To clarify this argument, I propose a review of worthy developments in human-whale historiography, the subject of intense dialogues between ocean history, history of science and marine sciences. The UNESCO’s Global Ocean Science Report, published in 2017, defines ocean science as the integrative, interdisciplinary and strategic research areas covering the marine ecosystems functions and process, oceans and climate, ocean health, human health and wellbeing, blue growth, ocean crust and marine geohazards, and ocean technology. The category ‘human health and wellbeing’ covers physical and social studies on the access to marine ecosystem services such as food security, recreation, harmful algae blooms, and social, educational and aesthetic values. This broad panorama is permeated by the multiple interconnections between environmental sciences and the humanities which are indicative of novel interpretative categories to amplify our understanding of the entangled trajectories crossing terrestrial and maritime spaces. This is further accentuated by the intersections of past and present marine ecosystems and societal practices, in both material and symbolic schemes. As Virginia Richter emphasised (referring to the complexity of diverse existing littoral spaces), there are various movements, acts and discursive exchanges on, through and beyond its topographies.1 22 International Animal Health Journal

Bearing in mind that a common language may support discussions of a common legacy – the sea waters – shared by diverse national states, some strategic pathways seeking common responses to scientific and societal concerns would inspire essential answers in the frontier between science and politics. Launched in 2016, the UNESCO Chair’s 'The Ocean’s Cultural Heritage' held by NOVA University of Lisbon, express the commitment with the dissemination of ocean heritages in the Atlantic, which are been investigated from collaborative initiatives of research and education. Alongside this initative, multiple societal challenges involving critical conditions of marine ecosystems in the open ocean, underwater realm and coastlines have been the subject of intercultural studies developed by a international network of researchers. Tangible and intangible memories of cultural and natural heritages encompassing the early modern history of the ocean are integrated in an agenda of studies on underwater archaeology, maritime cultural landscapes, marine environmental history, environments and resources management.2 Concerning to transnational policies structured to guarantee the protection of large cetacean species, the proposal of the creation of the South Atlantic Whale Sanctuary must be highlighted as a substantial strategy to promote biodiversity conservation and the non-extractive and non-lethal utilisation of whale resources in the South Atlantic. The proposal, elaborated by a group of countries – Argentina, Brazil, Gabon, South Africa and Uruguay – with the support of International Whaling Commission (IWC), was firstly presented in its 50th Meeting, in 1998, and has been evaluated since 2001. Until now, the South Atlantic Sanctuary did not achieve the necessary three-quarters of IWC’s Member States’ votes, but its objectives of promoting the long-term conservation of large cetaceans is conceived as a coordinated cooperation involving developed and developing countries, in a same pathway inspired by conservation strategies aiming the protection of marine life.3 Outlining Human-whale Interactions by Different Voices and Disciplines In the ocean realm, the history of human-whale interplay compounds a dense component of human cultures all over the world. Many remarkable narratives are built by singular voices and collective experiences from specific spacetemporal frameworks. Over centuries of whaling activity and until the second half of the 20th century, available databases concerning large cetacean species were mainly obtained from registers of land-based and offshore whalers. Regular fishing statistics, bulletins of archives of fisheries, number of trips, capture numbers and cetaceans’ biological parameters such as length and gender, were the unique source of knowledge regarding their presence in different oceanic regions, strandings events and sightings.4 Since the 15th and 16th centuries, popular iconographical representations and literacy about such marine monsters were disseminated in the European societies as potent symbols of adventures, mysteries and myths surrounding the long journeys and trades across remote high seas.5 From 1946, the transnational debate promoted by the International Whaling Commission, to find international response to the collapse of the large cetaceans population Volume 8 Issue 1


RESEARCH AND DEVELOPMENT inaugured (and publicized) a novel science-based scheme of decision. Nonetheless, applied research focusing on the conservation of large cetaceans became to increase in the 70s, and from the first Biennial Conference on Biology of Marine Mammals held in 1975. The contemporary science of large cetaceans has been built in a context marked by conflicted interests. In 1981, the Society for Marine Mammalogy6 was instituted and, in 1999, first issue of the IWC’s Journal of Cetacean Research and Management was published. The global whaling moratorium implemented by the IWC from 1986, evidences, until now, how deep are the entanglements between marine sciences and an institutional environment of uncertainties, polarization and tensions which have pushed the decisions carried by the IWC. This panorama suggests that, in fact, science and politics were always interlinked and that multicultural approaches on the past and present are equally essential in the production of knowledge on human-whale relationships and its subsequent effect on marine environments and societies. The manifold studies are characterised by integrative framework of specific space-temporal scales, amplification of connectiveness between a diverse database generated in different sources, and by the focus on local and regional circumstances of the interaction between marine ecosystems and societal practices. An illustrative overview has indicated its relevant links to marine historiography. An assessment of the presence of whales and dolphins in the sea of Portugal in the 12th and 20th centuries were obtained from sources related to whaling, strandings, and sightings at sea, which permited the number of accounts in each period for each species in specific regions. Until the 1970s, its sources would be the only effective data available about cetaceans in Portugal.7 Another study is based on registers of whaling activity in the Pacific islands of O‘ahu, Maui, Kaho‘olawe, and Hawaii, which was published in local sources as newspaper and public archives over the period of the late 1840s to the early 1870s. These invaluable records of shore-based small whaling enterprises strategically located on these four islands described migration routes and breeding areas of cetaceans from sightings which occurred primarily from January to April, and sometimes between October and December.8 Reports of colonial and province authorities, the Royal Treasury documents, newspapers, travellers' stories and other literary sources were compiled in a comparative investigation of whaling on the Atlantic coast of the United States and Brazil, in the period 1750–1850. The investigation examined the aspects of processing and marketing of oil, and circumstances of labour relations involving native groups of North American and African slaves in Brazil.9 The reconstruction of whaling activity and walrus hunting took place between the 17th and 19th centuries, in the Spitsbergen island in the North Atlantic. This was until the Bowhead whale (Baleana mysticetus) and the Atlantic walruses (Odobaenus rosmarus) went completely extinct, which was conducted by multidisciplinary investigation. Archaeological excavations, historical sources, biological and zoological inventories and podological sources structured a repertoire of information to reconstitute the ecology of these species in that period, as well as the current ecological traces derived from past activities.10 Other studies could also illustrate the potential linkages of intercultural studies and ocean sciences as a contribution to hybrid trajectories around different societies and ocean waters. Many sources of relevant academic and scientific expertise have enhanced dialogues and focused their attention on regional initiatives, taking into consideration www.animalhealthmedia.com

legitimate needs and cultural legacies. The intrinsic benefits from shared contributions of human-whale historiography and ocean sciences can play many different parts in the evolution of the UN Decade of Ocean Science. Such possibilities and compatibilities are huge, as well as the extent to which marine heritage can be potentially understood and shared by all. REFERENCES 1.

Richter, Virginia (2015). Where things meet in the world between sea and land: Human-whale encounters in littoral space. In: KLUWICK, U. & RICHTER, V. (ed.) The beach in Anglophone literatures and cultures: reading littoral space. Ashgate Publishing. 2. Brito, Cristina, Patrícia Carvalho et al. (2018). ‘The UNESCO Chair of the Ocean’s cultural heritage: a brief note on ocean history, science and literacy.’ In: Mares e Litorais: Perspetivas transdisciplinares - Tomo VII da Rede BRASPOR. 33-43. 3. IWC/67/10. The South Atlantic: a Sanctuary for Whales. 67th Annual Meeting of the IWC, Florianópolis, Brazil, 2018. 4. Brito, Cristina & Nina Vieira (2009). Past and recent sperm whales sightings in the Azores based on catches and whale watching information. In: Journal of the Marine Biological Association of the United Kingdom, 2009, 89(5), 1067 – 1070. 5. Brito, Cristina (2016) New Science from old news. Escola del Mar, Lisboa, Portugal. 6. Marega-Imamura et al (2020) Scientific collaboration networks in research on human threats to cetaceans in Brazil. Marine Policy 112, 103738. 7. Brito, Cristina & Andreia Souza (2011). ‘The Environmental History of Cetaceans in Portugal: Ten Centuries of Whale and Dolphin Records.’ In PLOS one, September 2011, Vol 6 / 9. 8. Lebo, Susan A. (2019). ‘Newspaper stories promoting local nineteenth-century shore-based whaling in Hawaiian waters’. In: Jones, Ryan T. & Angela Wanhalla. New Histories of Pacific Whaling. RCC Perspectives / Transformations in Environments and Societies. 9. Castellutti, Jr., Wellington (2015). ‘Histórias conectadas por mares revoltos: uma história da caça de baleias nos Estados Unidos e no Brasil (1750-1850).’ In: Revista de História Comparada, Rio de Janeiro, v. 9, n. 1, p. 88-118, 2015. 10. Hacquebord, Louwrens (2014). ‘Three centuries of whaling and walrus hunting in Svalbard and its impacts on the Artic ecosystem.’ In: SarahAnimals. Themes in Environmental History. Cambridge: White Horse Press.

Ana Lucia Camphora Ana is Brazilian post-doctoral independent scholar and her investigations have overpassed the boundaries between nature and society, by interdisciplinary paths. This trajectory and an extensive working experience as an environmental consultant in the fields of environmental policy instruments, economic sustainability and governance of protected areas, and rural sustainability, brought a substantial backgrounds to examine innovative approaches on the hybrid intersubjectivities highlighted in the recent animal turn. The English edition of her book, ‘Animals and Society in Brazil from the 16th to 19th century’, (launched in 2017 and endorsed by the Brazilian Academy of Veterinary Medicine), has been launched by the British publisher, the White Horse Press. Email: alcamphora@gmail.com

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Know Your Mission: Developing Breakthrough Innovations in a Challenging World In an increasingly harsh economic climate, it is those businesses with a clear aim and an innovative mindset that will be best-equipped to succeed. By establishing a defined goal and thinking creatively about how to achieve it, companies can uncover opportunities to develop truly ground-breaking innovations. Why Businesses Today Need a Clear Focus In the last memorable year, countless people across the globe have had their lives thrown into disarray by a virus that has turned our established routines and expectations upside down. In the months we have spent unable to engage in our normal habits, many of us have found ourselves reevaluating our outlook and questioning many things we had previously taken for granted. The same upheaval has shaken the world of business. Not only has the COVID-19 pandemic caused many company leaders to challenge their assumptions about commercial risk, it has also forced them to see their work in a fresh light and re-examine some of the most fundamental questions of all. “Why am I doing this? What is the point? What is our purpose?” Now more than ever, it is important for business leaders to recognise these central questions and develop clear answers. As the great American statesman and founding father Alexander Hamilton once reputedly said: “Those who stand for nothing fall for anything.” A catchy one-liner, perhaps, but it contains a sizeable grain of truth. For if businesses are sure of their purpose – if they know what they stand for – they can make clear-sighted decisions to reach towards this goal. Of course, this principle is not new, but the challenges of a global pandemic have thrown it into sharp relief. In the midst of a global crisis, it is the businesses that are set on and guided by their ultimate goal that will be best able to navigate the minefield of unfolding challenges. What’s more, they will also be better equipped to uncover and capitalise on a range of emerging opportunities. Indeed, by re-focusing on their fundamental aims and considering all potential ways of exploring them, companies can discover new directions in unexpected fields. This could involve developing new concepts – not just novel products or technologies, but innovative ideas. One of the best recent examples of this approach is in the sphere of pet food, where scientists were making great strides in innovation well before the spectre of COVID-19 began to infiltrate the way we think about everything. Scientific Innovation in the Pet Food Industry In the public imagination, some industries are intimately linked with scientific advancement and innovation – space exploration, computer technology, and surgical techniques are a few examples that readily spring to mind. In contrast, the epithet of innovation is rarely used in the context of pet food. Quite understandably, hundreds of years of scientific progress does not tend to be top of mind when portioning out the dog’s breakfast. There is, however, a strong scientific background to this sector. 24 International Animal Health Journal

Scientific advances in the context of diet are of course more well-established in the field of human health. Across the globe, expert nutritionists and dietitians dedicate their lives to the optimisation of health specifically through the medium of food. Their work is supported by a growing body of research that highlights the key role of diet in human functionality. As well as the obvious impact of nutrition on body weight and physical appearance, there is mounting evidence to show that diet plays an important role in diverse areas such as sleep quality, mental wellbeing, inflammation, hormone levels, and allergies. In light of this, there is growing interest within the arena of healthcare in functional medicine, an approach based on considering the role of dietary and lifestyle factors in health and then modifying these factors to help manage various chronic conditions. A wealth of new advances and innovations have been developed in this area, from novel dietary strategies and supplements, to health-focused apps that can be used to monitor and improve daily routines. Diet is equally important for pets, and scientific progress in pet nutrition is aiding our understanding of how to optimise various aspects of animal health. A pet body condition scoring system that we developed at PURINA® over two decades ago, for example, now helps us better understand, diagnose and manage obesity in companion animals.1 More recently, we have begun to see how diet can be used to help manage issues that are not so intuitively linked directly with nutrition. A fascinating example of this is that certain dog foods can provide support when owners are faced with their dog’s age-related cognitive decline, considered to be similar to the decline we see in humans.2 Through such scientific advances, researchers, nutritionists, and veterinary surgeons are unleashing the power of nutrition to help pets live healthier and longer lives. Simply by selecting the most appropriate diet for our pets, we are now able to reap the rewards of years of scientific progress. That, until recently, has been the picture of innovation in the area of nutrition. In a nutshell, we have seen huge advances in using human diet to improve human health, and considerable progress in using pet food to benefit pet health. However, scientists have now begun to think more broadly and explore the uncharted territory between these separate spheres. In particular, at PURINA® we have – over the course of the last decade and more – developed a pet food which helps people reduce their exposure to cat allergens. As well as catering for the cat’s complete nutritional requirements, this new diet can also be a powerful tool to help strengthen and protect the bond between the animal and their owner. This is not only a new innovation, but the first in a new field. Using Nutrition to Strengthen the Human-animal Bond The power of the human-animal bond has been recognised for many years. Recently, the benefit of this bond has also been demonstrated empirically, with one research study finding that people who owned pets reported greater Volume 8 Issue 1


RESEARCH AND DEVELOPMENT

Results from Purina®’s survey of 5000 cat owners across the UK, France, Germany, Italy and Russia

satisfaction with their lives than those who did not.3 Pet companionship has also been associated with a reduction in depression and anxiety, as well as with encouragement of physical activity.4 For elderly people, it is increasingly well-accepted that interactions with pets can enhance quality of life, with various studies showing that animalassisted therapy can improve some of the symptoms of dementia.5   It is not only humans that derive benefit from close companionship with their pets – this bond is mutually beneficial and enhances the wellbeing of the animals in question too. In the tumultuous times of the last year, when many pets and their owners will have spent more time together than ever before, they will have constantly found each other to be a source of comfort and support. But for anyone living with a sensitivity to cat allergens, who also owns a cat, the extra time at home may also have actually increased the issues around managing their allergens. We also know a lot of people have adopted new pets during the pandemic, and while in most cases this will hopefully offer a wonderful chance for pets to find their forever homes – for www.animalhealthmedia.com

some it may have been the start of having to manage a cat allergen sensitivity that they didn’t even know they had. This was the driving force behind the work of PURINA® scientists when developing a pet food which aims to help humans manage their cat allergen exposure. The concept was developed by Dr. Ebenezer Satyaraj, an immunologist and molecular nutritionist, whose daughter is a cat lover but suffers from sensitivities to cat allergens. As such, Dr. Satyaraj had first-hand experience of the distress that placing a strain on the pet-human bond can cause. He wanted his daughter to enjoy the benefits of a loving relationship with cats – and so he used his scientific background to work towards that goal. Dr. Satyaraj and his team devoted more than a decade of research to the problem, eventually developing a cat food (Pro Plan® LiveClear®) that successfully reduces the level of active allergens on cat hair and dander.6 This breakthrough innovation is based on a particular egg product that contains a specific antibody to Fel d 1, which is the major cat allergen. International Animal Health Journal 25


RESEARCH AND DEVELOPMENT with many owners devoting significant chunks of their time to mitigate the problem. Of the cat owners with allergies surveyed, one in four reported cleaning their homes and furniture on a daily basis to help manage the issue. For many owners in this situation, Pro Plan® LiveClear® can be a real game-changer. Ultimately, this breakthrough came from creative scientific thinking around the company’s purpose – developing a new way to work towards an established goal. Purpose really matters. At PURINA® the entire global organisation is focused on enriching the lives of pets and those who love them. This simple purpose, combined with a belief that people and pets are better together, has inspired much of the pioneering science we see today. Successful Innovation to Transform our Future Within the continually evolving arena of science and technology, true innovation often comes in the form of a product that functions in a way that we would not naturally expect. In today’s uncertain times, it is now more important than ever before to develop these game-changing solutions to drive progress. Indeed, in an environment of heightened risk, it is the most creative, inventive and goal-focused businesses that will survive. In virtual c-suite board rooms across all of Europe, we have a responsibility to challenge each other and re-focus on our fundamental aims in order to make sure we are innovating to achieve the goals we stand for. REFERENCES 1. 2.

3. 4.

5.

6. The Pro Plan® LiveClear® diet that reduces the level of allergens on cat hair and dander

Fel d 1 is normally produced in the cat’s saliva, and is transferred onto the cat’s coat during grooming, and consequently spread all around the house when the cat sheds its fur. For cats eating Pro Plan® LiveClear®, however, the active allergen is neutralised in the cat’s saliva as soon as the cat chews the kibble. This diet has the potential to transform the lives of cat owners around the world, helping them enjoy more time with their pets. Indeed, the impact on owner-cat interactions could be considerable – a research study we conducted at PURINA® found that more than two-thirds of owners sensitive to cat allergens currently remove their cat from their surroundings when their symptoms become problematic. Not only that, there are indirect impacts on wellbeing too, 26 International Animal Health Journal

Laflamme DP (1997). Development and validation of a body condition score system for dogs. Canine Practice 22:10-15. Pan Y, Landsberg G, Mougeot I, Kelly S, Xu H, Bhatnagar S, Gardner CL, Milgram NW (2018). Efficacy of a Therapeutic Diet on Dogs with Signs of Cognitive Dysfunction Syndrome (CDS): A Prospective Double Blinded Placebo Controlled Clinical Study. Frontiers in Nutrition 5:127. doi: 10.3389/ fnut.2018.00127 Bao KJ, Schreer G (2016). Pets and Happiness: Examining the Association between Pet Ownership and Wellbeing. Anthrozoös 29.2:283-296. doi: 10.1080/08927936.2016.1152721. Schreiner PJ (2016). Emerging Cardiovascular Risk Research: Impact of Pets on Cardiovascular Risk Prevention.  Current Cardiovascular Risk Reports 10.2:1-8. doi:  10.1007/s12170-0160489-2. Cherniack EP, Cherniack AR (2014). The Benefit of Pets and Animal-Assisted Therapy to the Health of Older Individuals. Current Gerontology and Geriatrics Research 2014:623203. doi: 10.1155/2014/623203 Satyaraj E, Gardner C, Filipi I, Cramer K, Sherrill S (2019). Reduction of active Fel d1 from cats using an antiFel d1 egg IgY antibody. Immunity, inflammation and disease 7(2):68– 73. doi: 10.1002/iid3.244

Calum Macrae Calum Macrae is Nestlé Purina PetCare’s Regional Managing Director for the UK, Ireland, the Netherlands and the Nordic countries. He leads a team of over 400 pet care professionals and sits on the NPP EMENA and Nestlé UK operating boards. Calum is a board director of tails. com, a tailored pet food company, and Lily’s Kitchen, a natural pet food business.

Volume 8 Issue 1


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To find out how Orego-Stim can help your business, visit www.anpario.com/orego-stim or email orego-stim@anpario.com www.animalhealthmedia.com

International Animal Health Journal 27


RESEARCH AND DEVELOPMENT

Of Mice and Men: Why Faith in Animal Experimentation is Misplaced In 2004, a non-steroidal anti-inflammatory drug known as Vioxx was abruptly removed from circulation five years after it had been released to market by Merck & Co. The drug, which was marketed to treat conditions like arthritis, was one of the most widely used drugs to have ever been withdrawn. It turned out to be deadly. By the time Vioxx was discovered to cause serious heart disease, at least 20 million Americans had taken it, and up to 140,000 people had suffered heart attacks that were linked to it.1 As you would expect, the case was widely reported and caused a great deal of damage to the reputation of and trust in the pharmaceutical industry. What was less reported was why a drug, that had been tested so extensively, turned out to be so dangerous. In tests, not only had the drug been proven to be safe, but the results showed it was also extremely effective. The problem with these results was that Merck had been carrying them out using African Green Monkeys. In fact, even when test results from 8000 humans revealed it was killing people, they still justified selling the drug by referring to the animal studies.2 More recently, in 2016, a French drug trial left one man dead and five others hospitalised after a Phase I trial for a new pain medicine produced surprising toxic effects in the brain. Despite the fact that rats, mice, dogs and monkeys were all used in testing, no ill-effects had been noted in the animals despite doses 400 times stronger than those given to the human volunteers.3 A similar problem arose in 2018 when one of the many attempts to repurpose Sildenafil, marketed as Viagra, resulted in a test to see if it could increase the growth of unborn children. After promising animal data was produced from rats, trials were greenlighted to proceed to humans, where they were immediately halted after 11 babies died in the Netherlands. Sildenafil has repeatedly been force-fed or injected in huge doses into dogs, rats, mice, rabbits and sheep in the past. Yet, when it was used successfully in rats to create foetal growth, it had the opposite effect in humans.4 This should not necessarily be that surprising. Humans are, after all, not giant rats. And as any dog owner who has accidentally left the chocolate out will testify, things that are safe to us can often be toxic to our pets. The reverse is sadly often true. The discordance between human and animal physiology, particularly when it comes to diseases, means symptoms often have to be artificially induced in the animals used in testing. This presents formidable challenges in itself, not least because even with the most successfully standardised trials, scientists will never be able to account for the huge disparity between animal and human subjects. This inability to successfully model from animals means that over 90% of drugs fail to reach the market even after they have been successfully tested in animals.5 Given that science, particularly medical science, is expected to be grounded in an evidence-based approach, it 28 International Animal Health Journal

is concerning that the repeated failures that animal methods produce are clearly not being held to this standard. In fact, they are hardly being scrutinised at all. Public Acceptance of Animal Experiments Should Be Conditional on it Producing Benefits While there is widespread acceptance in the medical community that animal experimentation is often unreliable and occasionally dangerous, there remains a persistent confidence that many of these limitations can still be overcome. This year, more than 192 million animals will be subjected to invasive experiments2 – some to help medicines pass regulatory tests, others to investigate ‘interesting questions’ relating to human health and medicine, and many to test the batch quality of cosmetics and aesthetic injectables. This number also includes animals used to maintain breeding colonies, bred and killed for tissue supply, bred and killed as they are ‘surplus’ to researchers’ needs, and animals held indefinitely for future use. Many of these animals – including dogs, monkeys and rabbits – will suffer extensively as a result of testing. Recent statistics from the European Union put moderate to severe testing at 40% of animals subject to testing,7 a figure which must be interpreted with caution due to the fact that researchers are asked for their subjective opinion of the extent of suffering. In “Too stressed to work”,8 an article published in New Scientist, it was reported that in one experiment mice had been genetically altered to develop defects in their hearts. When studying the changes in the mice, scientists were surprised to discover that after they were moved to larger cages, the defects almost completely disappeared. The scientists had merely been studying the stress of living in laboratory conditions. The article concluded that unless animals are kept in decent conditions, researchers must accept their results could be useless. If smaller cages can cause such extreme stress, the extent to which the contagious anxiety that is said to be rife in laboratories as animals watch each other routinely face experimentation must render results almost meaningless. In a paper titled “Sources of stress in captivity”,9 the authors found huge stress indicators in monkeys who saw other monkeys being restrained for blood collection, and blood pressure and heart rate elevation in rats who witness other rats being decapitated. It is usual at the end of experiments for the majority of animals to be simply ‘disposed of’ – a euphemism that lacks even politeness. Unfortunately, the alternative is for the animals to be used for experiments repeatedly for the length of their natural life. Despite greater awareness within the scientific community of the alternatives, the number of animals used for testing is still barely dropping. There has been an estimated 1% reduction in the number of animals used on average per year.10 And, contrary to popular belief, animal testing is still common practice in the United Kingdom and in Europe. More than 10 million experiments took place across Europe in 2017, Volume 8 Issue 1


RESEARCH AND DEVELOPMENT with the UK responsible for almost a quarter of that number.10 In fact, the UK is the highest annual user of animals in testing in Europe and is in the top three users of monkeys – usually macaques – and dogs.10 Nor are animal tests exclusively used in the medical field. Despite the huge growth of cruelty-free cosmetics and aesthetic products, the chemicals used in these products are still tested on animals. Animals are also used in experiments for agricultural items such as weedkiller, which are in some cases tested in beagles, and household products. Beagles are considered particularly useful for experimentation as they are small and amenable. These facts should shock even those who consider animal testing to be a necessary evil that produces benefits for human health. Yet, it is also the case that most animal testing is rarely scientifically necessary and, in many cases, has not been for a great many years. In the UK, only 13% of tests that are carried out are even required by regulators.7 In fact, non-animal methods are often quicker, cheaper and more effective – they simply lack the century of tradition and acceptance which animal testing has. Resources would be Better Invested in Developing Humanbased Testing Methods Compounding this issue is that every single pound spent on animal testing is siphoning resources away from more effective experimentation that could lead to cures or treatments. HIV/AIDS vaccine research is one of the most notable failures in animal experimentation. Enormous resources and decades of time have been spent researching HIV using primates, most notably chimpanzees, yet of the 90 HIV vaccines that succeeded in animals, all failed in humans.11 Not only did the research not produce any meaningful results, but key differences between primates and humans were actually misleading researchers into taking expensive and time-consuming detours. Despite the repeated failures, primates remain widely used in HIV research. Clearly, it is not the case that researchers continue to rely on outdated animal testing simply because they do not care. Factors which have driven decades of scientific reliance on the animal testing model are as complex as the questions that researchers are trying to solve. In many cases, researchers likely lack knowledge of the alternatives. For science students in the UK, education is heavily focused on the established and traditional methods of investigating a hypothesis – including animal testing. Researchers need to be published, and it is therefore understandable that so many rely on animals for that purpose. It is interesting that, while this approach is so important for researchers to be published or to be considered to be published, so little scrutiny is ever given to the method itself. Normalising the Unthinkable: Animal-based Research “Breakthroughs” in the UK National Press If what is left of the public acceptance towards animal experimentation is based on the benefits that humans derive from it, the next question is to wonder, if there are now so few benefits, why is there still any public acceptance? Reading published articles in the scientific press may give some indication. One study found that just 5% of high impact medical discoveries based on animal tests actually lead to a treatment or drug discovery within 20 years.12 More recent research by Cruelty Free International into so-called animal research ‘breakthroughs’,13 published in BMJ Open, had similar findings. Their analysis of 27 animal based “breakthroughs” reported in the UK found that overspeculation and www.animalhealthmedia.com

exaggeration of human relevance was evident in all the articles examined. Of the “breakthroughs” studied, only one had clearly resulted in human benefit. Twenty were classified as failures, three were deemed inconclusive and three were partially successful. Yet, as we have seen in the news recently at Neuralink Corporation, animals are often not even being used to test medical or domestic products. More than half (57%) of experiments in the UK are now in the area of basic research, much of it driven by the “curiosity” of university researchers.14 There are sadly still too many examples of animal experiments being used, even when non-animal-based alternatives are available that are cheaper, quicker and in many cases, more accurate. Cruelty Free International’s Replace Animals Tests (RAT) list highlights some examples of tests that are still being done when there are already valid alternatives.15 Stopping these ten tests could happen right now without any detriment to human health, and could save the lives of three-quarters of a million animals every year in Europe alone. It is time we put the onus of proof on animal experimenters to justify the means, not only the desired ends. What studies there have been into the methods have repeatedly highlighted the poor quality of research, the poor conditions that render results almost meaningless and the lack of tangible benefits for humans. Merck & Co knew there were superior alternatives to animal tests. The legal complaint made against them highlighted the animal tests they used are "often proven misleading to the point of being dangerous.”16 Yet, lessons from insurmountable evidence continue to be ignored. Nobody wants to see animals used for testing, especially when there are alternatives. Ethical concerns should not be ignored, but increasingly, the economic and biological arguments are too. It is hugely costly, both financially and in other resources. What medical marvels have been missed or ignored because researchers are so hell-bent on using animals? Sadly, we may never know. REFERENCES 1.

2. 3.

4.

5.

6. 7.

Bhattacharya, S. 2005. Up to 140,000 heart attacks linked to Vioxx. New Scientist online. Available at: https://www. newscientist.com/article/dn6918-up-to-140000-heartattacks-linked-to-vioxx/ Last accessed: 9 February 2021. Gartner, J. 2005. Vioxx suit faults animal tests. Wired. Available at:https://www.wired.com/2005/07/vioxx-suit-faults-animaltests/ Last accessed: 9 February 2021. 2016. Man who died in French drug trial. The Guardian. Available at https://www.theguardian.com/science/2016/mar/07/frenchdrug-trial-man-dead-expert-report-unprecidented-reaction Last accessed: 9 February 2021. Metro.co.uk. 2018. Available at: https://metro.co.uk/2018/07/ 24/eleven-babies-die-pregnant-women-given-viagradrug-trial-7754782/?ito=article.desktop.share.bottom.link Last accessed: 9 February 2021 Clinical Development Success Rates 2006-2015. Biotechnology Innovation Organization: https://www.bio.org/ sites/default/files/Clinical%20Development%20Success%20 Rates%202006-2015%20-%20BIO,%20Biomedtracker,%20 Amplion%202016.pdf Taylor, K., Rego Alvarez, L. 2020. An estimate of the number of animals used for scientific purpose worldwide in 2015. ATLA 47(5-6) 196-213 REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL 2019 report on the statistics on the use of International Animal Health Journal 29


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8.

9.

10.

11. 12. 13.

14.

animals for scientific purposes in the Member States of the European Union in 2015-2017. COM/2020/16 final. See https://ec.europa.eu/environment/chemicals/lab_animals/ reports_en.htm Baldwin, A., Bekoff, M. 2007. Too stressed to work. The New Scientist 194(2606):24-2. Available at: https://www.researchgate.net/deref/http%3A%2F%2Fdx.doi.org%2F10.1016%2FS02624079(07)61358-X Last accessed: 9 February 2021 Morgan, K., Tromberg, C. 2006. Sources of stress in captivity. Applied Animal Behaviour Science. 102(3-4):262-3 Available at: https://www.sciencedirect.com/science/article/abs/pii/ S0168159106001997 Last accessed: 9 February 2021. European Commission. 2017. EU figures adjudged between 1996-2017. Available at: https://ec.europa.eu/environment/ chemicals/lab_animals/reports_en.htm Last accessed: 9 February 2021. Bailey, J. An assessment of the role of chimpanzees in AIDS vaccine research. Alternatives to Laboratory Animals 2008;36:381–428 Translation of highly promising basic research into clinical applications. (2003). American Journal of Medicine, 114: 477-484. Bailey,  J.,  Balls,  M. 2020. Clinical impact of high-profile animal-based research reported in the UK national press. BMJ Open Science  2020;4:e100039.  Available at: http:// dx.doi.org/10.1136/bmjos-2019-100039 Last accessed: 9 February 2021. Use Annual Statistics of Scientific Procedures on Living Animals, Great Britain 2019. https://www.gov.uk/government/ statistics/statistics-of-scientific-procedures-on-livinganimals-great-britain-2019

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15. Cruelty Free Europe. 2020. RAT List. Available at: https://www. crueltyfreeeurope.org/RATlist Last accessed: 9 February 2021. 16. Gartner, J. 2005. Vioxx suit faults animal tests. Wired. Available at: https://www.wired.com/2005/07/vioxx-suit-faults-animaltests/ Last accessed: 9 February 2021.

Dr. Katy Taylor Katy is Director of Science and Regulatory Affairs at Cruelty Free International – the leading organisation working to end animal testing worldwide. Katy is Director of Science and Regulatory Affairs at Cruelty Free International and Cruelty Free Europe. Katy manages the scientific output of the organisations, ensuring their call to end animal testing is supported by strong scientific argument. She represents the organisations at international regulatory meetings including the OECD in Paris, the European Medicines Agency in London and the European Chemicals Agency in Helsinki. Katy holds a BSc in Zoology and a PhD in veterinary behavioural epidemiology. An animal welfare scientist by training and personally dedicated to animal protection, Katy is now one of Europe’s foremost experts on the scientific, legal and ethical issues regarding the use of animals in testing and on non-animal alternative methods.

Volume 8 Issue 1


INSIGHT / KNOWLEDGE / FORESIGHT

SUPER PUBLICATIONS FOR SUPER PHARMACEUTICALS IPI

Peer Reviewed, IPI looks into the best practice in outsourcing management for the Pharmaceutical and Bio Pharmaceutical industry.

www.ipimediaworld.com

JCS

Peer Reviewed, JCS provides you with the best practice guidelines for conducting global Clinical Trials. JCS is the specialist journal providing you with relevant articles which will help you to navigate emerging markets.

PHARMA’S DNA

www.jforcs.com

Listen to industry experts on the latest in drug discovery, development, research, industry regulations and much more at Pharma,s DNA, the podcast channel by Pharma Publications, available on Sound Cloud, Spotify, iTunes and YouTube.

IAHJ

IBI

Peer Reviewed, IAHJ looks into the entire outsourcing management of the Veterinary Drug, Veterinary Devices & Animal Food Development Industry.

www.animalhealthmedia.com

Peer reviewed, IBI provides the biopharmaceutical industry with practical advice on managing bioprocessing and technology, upstream and downstream processing, manufacturing, regulations, formulation, scale-up/technology transfer, drug delivery, analytical testing and more.

www.biopharmaceuticalmedia.com www.animalhealthmedia.com

International Animal Health Journal 31


RESEARCH AND DEVELOPMENT

Antimicrobial Resistance

Antibiotic resistance has the potential to become one of the greatest problems of our generation, given the everincreasing rise in bacterial strains that are less and less sensitive to existing treatments. Now, more than ever, alternative strategies are required to further reduce antibiotic use on-farm and to restrict antibiotic use to therapeutic uses only, following the 2006 European Union ban on the use of antibiotics for all non-therapeutic use, such as antibiotic growth promoters (AGPs). The public is also aware of the increasing problem of antibiotic resistance, and this has led to heightened awareness of the prevalence of bacteria in meat products; retailers are also putting more pressure on their suppliers to change their management practices to find ways to limit the use of antibiotics on-farm, with many retailers including antibiotic usage data as a key metric on audits. The statistics behind the rise in resistance are startling, with almost 23,000 people dying in the US each year due to infections caused by antibiotic-resistant bacteria. Even more alarming is that, since 1998, the US Food and Drug Administration (FDA) has only approved two new classes of antibiotics, meaning that the vast majority of today’s antibiotics were developed before the 1970s. The story continues in the EU, with estimates showing that close to one in five infections are due to antibiotic-resistant bacteria, and direct treatment costs and the problems associated with these bacteria cost the healthcare systems of these countries 1.1 billion Euros annually. Antimicrobial resistance arising in agriculture can negatively impact public health. Treating animals with antimicrobials that are important in human medicine or drugs of the same family or class can select for drug resistance in zoonotic pathogens (e.g., Salmonella, Campy-lobacter), which can be transmitted to humans through direct contact or indirectly through food or water. Resistant bacteria from animals or plants are part of a larger antimicrobial-resistant ecosystem, and these resistant genes could find their way through a variety of poorly understood, indirect pathways to huma n pathogens. Bacteria from animals can be spread to food products during slaughter and processing, and this spread has been extensively documented for conventional foodborne pathogens, such as Salmonella, Campylobacter and E. coli. More recent studies have indicated the emergence of enterococci that are resistant to antimicrobials, with the direct transmission of resistant enterococci between animals and farm workers also being identified. More importantly, these studies have found identical or closely related subtypes of enterococci in animals, food and humans, supporting the hypothesis that the foodborne route of antibiotic resistance transmission is significant. An increase in food safety concerns resulting from extensive antibiotic use has been a challenge for the poultry and livestock industries in recent years, as meat being free from antibiotics and disease has become a requirement within the European Union. Consumer demand for antibiotic-free meat 32 International Animal Health Journal

has also increased within the US and other antibiotic-using countries as a result of concerns about the rise in antibiotic resistance, making it necessary for producers to find suitable replacements for antibiotic growth promoters. Globally, it is recognised that there is no so-called “silver bullet” to replace antibiotic use in animal production, and producers will also have to focus on incremental improvements in hygiene and husbandry to address this issue. Since the European ban on the use of prophylactic antimicrobial growth promoters in animal feed, the use of MOS has become more prominent. With its ability to bind and limit the colonisation of gut pathogens, MOS has proven to be an effective solution for antibiotic-free diets, as well as providing support for immunity and digestion. Further refinements of yeast MOS have led to the isolation of a mannose-rich fraction (MRF) with enhanced benefits for intestinal health. One drawback to the use of antibiotics is their non-specific effects on the gut microbiome and the reduction in overall gut microfloral diversity that they can cause (Vrieze et al., 2014). Without intervention, the use of antibiotics can lead to a vicious cycle in which their use reduces the overall microfloral diversity and selects for the expansion of resistant species to the detriment of non-resistant commensal strains. This reduced diversity allows for the continued proliferation of resistant species and, without intervention, can have a negative impact on health and performance. One strategy to combatting the negative consequences of antibiotic use is to repair and rehabilitate the microfloral diversity after their administration. Multiple studies looking at the means of promoting microbiota diversity showed that MRF can alter the composition of the bacterial community. Corrigan et al. (2015) found that with MRF supplementation, the microbiota shifted, with Bacteroidetes replacing Firmicutes, although Firmicutes, Bacteroidetes, Proteobacteria, Actinobacteria and Tenericutes remained the predominant phyla. The bacterial species and the overall interaction with the internal GI (gastrointestinal) structure play an important role in the physiological capabilities of the GI tract. In poultry, the fermentation of undigested feed occurs in the caeca, with the microbial population contributing to the functionality of the fermentation process. As such, alterations of the microbiota through supplementation with MRF are also likely to alter the functional capability of the caeca and have been shown to improve performance. Given the ability of MRF to enhance the overall gut microfloral diversity, it was believed to be an ideal solution to combat the negative consequences of diversity reduction and to break the cycle of resistant strain expansion whilst helping producers move toward antibiotic-free production systems. Further investigation into the alteration of microbial populations in the gut identified that MRF could not only alter the bacterial profiles but could also reduce the growth rate of antibiotic-resistant strains. Smith et al. (2017) looked at the influence of MRF on E. coli and Salmonella carrying plasmids that conferred antibiotic resistance. Enterobacteria, when grown in the presence of MRF, showed a reduction in the growth of antibiotic-resistant strains – but another interesting observation was that when enterobacteria were grown in the presence of both MRF and antibiotics, a greater reduction in Volume 8 Issue 1


RESEARCH AND DEVELOPMENT the bacterial growth rate was observed than with antibiotics alone (Figure 1). This finding demonstrated that resistant organisms became more susceptible to antibiotics when in the presence of MRF. The possible field applications for this finding are significant. If antibiotics can be administered alongside an MRF programme, then bacterial sensitivity should increase, and this could provide a means of looking at lower doses. Furthermore, as discussed above, one of the major issues with antibiotic usage is that it promotes a reduction of the diversity of the GI tract and allows resistant strains to expand at the expense of commensals. However, due to MRF’s ability to promote diversity and improve the sensitivity of bacterial organisms to antibiotics, it will also help prevent the vicious cycle of usage. Figure 2

to be impacting cellular energetics while enhancing the susceptibility of bacteria to antibiotics.

Figure 1

The kind of work described above is a solid starting point for further research, but understanding the underlying mechanisms of antibiotic resistance is crucial if this work is to be applied in a commercial setting. To fully utilise alternative approaches, we must first understand how we can impact the phenotypic antibiotic outcome. Antibiotics, both bactericidal and bacteriostatic, are known to impact cellular energetics, which affect metabolism and energy output, resulting in cell growth reduction or the induction of apoptosis (Smith et al., 2020). It had long been suspected that MRF was likely

www.animalhealthmedia.com

Work that was recently published in Nature’s Scientific Reports (Smith et al., 2020) shows that MRF from Saccharomyces cerevisiae modulates the growth of antibiotic-susceptible and -resistant E. coli and potentiates the bactericidal antibiotic efficiency through the modulation of bacterial cellular respiration. Figure 2 shows the impact of MRF on both resistant and sensitive organisms. Effectively, MRF is having a classical prebiotic effect in stimulating the metabolism of cells. This is because they are driven to a higher state of metabolic activity, so the bacterial cells are metabolising faster. As cells respire, however, they are producing a larger number of internal by-products, including toxic ones, and these toxins stress the bacterial cells, leading to an increased sensitivity to antibiotics. Initially, this work has been done on E. coli, but as MRF has also been shown to increase the sensitivity of Salmonella to antibiotics, it is likely that its mode of action is similar. New research such as this has exciting implications for antibiotic usage in commercial settings. The historic work completed by the same group mentioned earlier showed that, through interacting with the microbial community in the gut, dietary MRF can help alter the profile of organisms

International Animal Health Journal 33


RESEARCH AND DEVELOPMENT

and, in doing so, can reduce the prevalence of potentially pathogenic species. When looking at microbial populations in vivo taken from poultry caeca, it is shown again that when changing the way that bacteria metabolise or grow through the supplementation of MRF, the diversity of the bacteria alters, too. In commercial settings, this showed as a decrease in resistant enterococci. In addition to this, altering the bacterial metabolism to increase sensitivity to antibiotics is thought to impact their prevalence as well, and research that is soon to be published is expected to show that an increase in sensitivity to antibiotics can decrease the bacterial prevalence. Information such as this is critical when devising new programmes for producers looking to reduce both their antibiotic usage and the level of antimicrobial resistance on their farms. New classes of antibiotics are notoriously hard to find, with no new drugs being brought to market in recent decades. If new antibiotics are not being found and direct alternatives are also slow to be introduced, then alternative approaches to improve the use of what we already have available become extremely important. If we can change the way we need to use antibiotics as a result of the antibiotics that we do use becoming more effective, then overall, the industry levels of utilisation will drop. This, in turn, will prevent a contribution to the rise in antimicrobial resistance at a bacterial population level and should, therefore, reduce our requirements for usage. The traditional overuse of antibiotics has led to the widespread evolution of antimicrobial resistance. Antibiotics are crucial for promoting animal welfare when used therapeutically, and consequently, alternative strategies are needed to reduce the antibiotic load on-farm. Antibiotic 34 International Animal Health Journal

usage has a non-specific impact on the modulation of cellular proliferation and the metabolism of the gut microbiota, often leading to a significant reduction in both commensal and pathogenic strains. Understanding the molecular epidemiology associated with resistant organisms allows for the modulation of said mechanisms to enhance the susceptibility of all organisms, especially resistant ones, to antimicrobials — without providing any selection pressure that could contribute to the emergence of resistance. Reducing antibiotic use through dosages and by reducing the necessity for treatment may be possible by gaining a better understanding of the mechanisms behind the interaction between MRF and antibiotics. This, in addition to the improvements in animal performance and natural immunity seen as a result of MRF supplementation, provides producers an excellent means of improving both their production targets and their profitability in an easily applicable manner, all whilst reducing their antibiotic usage.

Emily Marshall Emily graduated from the University of Nottingham with a degree in Biology. Since graduating she has held a number of roles in retail, both commercial and technical, and now works at Alltech as Technical Coordinator for Poultry. Emily works on Alltech’s Gut Health Platform and acts as technical support for Alltech’s European poultry team.

Volume 8 Issue 1


FOOD & FEED

Salmonella Sampling: Achieving the Right Result Begins Outside the Chicken House Salmonella seems to be inextricably linked with poultry farming. Not so much due to a general belief that all salmonella comes from chickens, but because of the many measures put in place in the sector to prevent salmonella and reduce the risk to humans. One important measure within the EU is the determination of the salmonella status of each flock by collecting samples from the chicken house. But what is the correct way to take a sample and how can you reduce the chances of a false positive result? If the salmonella status of a flock is determined, products (such as eggs) from flocks infected with salmonella can be processed separately and undergo additional processing where necessary. This prevents vertical transmission and ensures that the food delivered to consumers is safe. As (part of) the costs for this processing are borne by the poultry farmer, a positive salmonella sampling will have a significant impact on business operations and the financial results. For layers, in the case of a positive result, it is sometimes possible to request a confirmation sampling by the government. For broilers and breeders, this option is not available. It is therefore important to minimise the chance of cross-contamination or sample mix-ups during sample collection and at the laboratory. Usually, you cannot see if an animal is infected with salmonella, so it is entirely possible that one of the houses or the farm is infected.

Hygienic Sample Collection is Particularly Important when Verification is Not an Option: Prevent an Incorrect Result

Figure 1. What you will need to take a salmonella sample.

How to Get Started A hygienic sample collection always starts with clean and aseptic or sterile sampling equipment, so this should not be stored on a dusty shelf but in a clean cupboard. You should also wash your hands before you start the sample collection. Label the sample pot or sample bag with the farm number, house number and the sample collection date, so that the sample can always be traced back to the house it was taken from. Then go to the house and put on a pair of clean, house-specific boots or overshoes as you step over the threshold (i.e. as you step into the house). Disinfect your hands or put on gloves. Then put on the boot swabs and walk around the house. While still in the house, place the boot swabs in the sample pot or sample bag and then seal it. Put the pot(s) or bag(s) down outside the house. Disinfect your hands again, then repeat the process in the next house. Make sure that the sampling equipment used in the next house is not contaminated by material from the previous house. I’ve Finished Taking the Samples; What’s Next? Once you’ve finished taking the samples, gather them together and clean the outside of each pot or bag if necessary. If there is faecal matter or dust on the sample pot or sample bag, this can cause cross-contamination or even infection of the laboratory worker during handling of the samples. You will want to avoid this, for yourself and for others. Then package the samples in a second, leakproof bag to keep them together, possibly grouping them by house and by farm, and send them to the laboratory along with a completed submission form (not in the bag with the samples). Avoiding Cross-contamination at the Laboratory The way work is carried out at the laboratory is also determined www.animalhealthmedia.com

Figure 2. What you should not do. Ensure hygienic sample collection. International Animal Health Journal 35


FOOD & FEED

to a large extent by the need to prevent cross-contamination. GD has a strong preference for sample pots, but this may vary from laboratory to laboratory. The large, sturdy opening at the top of a pot allows work to be carried out more cleanly. They are less likely to leak as they can be sealed tightly and they are less likely to fall over. In addition, separate areas are used for the different steps in the testing process in the lab. Of course, all pots and dishes are individually labelled and separate sterile equipment is used for each sample. Two control samples are used to ensure that work in the laboratory is carried out hygienically. The positive control consists of a separate strain of salmonella that is distinguishable if it ends up in other samples. The negative control is a blank sample, so if salmonella grows here, crosscontamination has clearly taken place. And last but not least, the entry of the eventual result is double-checked to prevent input errors. GD does everything it can to ensure a correct result. But achieving the right result starts in the chicken house. Because the system for the control of salmonella is successful in the Netherlands and most results are negative, mistakes often go unnoticed. So it is easy to simply walk from house to house. That does not usually cause problems, but if the first house is in fact infected, cross-contamination can occur in the other samples. Hygienic sample collection is particularly 36 International Animal Health Journal

important when verification is not an option, to prevent an incorrect result.

Christiaan ter Veen Christiaan ter Veen started studying veterinary medicine at the University of Utrecht in The Netherlands. The flockbased approach of animal health and the possibilities of disease control on integration or higher levels took his interest. After graduating in 2010, Christiaan started working at the Royal GD as a poultry veterinarian and researcher. His work includes giving general advice to veterinarians, poultry professionals, farmers and legislators regarding monitoring, diagnosis and disease control for a wide array of diseases. He has worked on a number of research projects with varying subjects including viral enteritis, coccidiosis, salmonella (both typhoid and non-typhoid), avian mycoplasmas and histomonosis. In 2015, Christiaan graduated as a Master of Avian Health and Medicine at the University of Melbourne, Australia and the University of Georgia, USA.

Volume 8 Issue 1


MANUFACTURING

Overcoming Problematic Production Issues in the Manufacture of Animal Nutraceuticals The importance of wellness has been brought to the forefront during the coronavirus pandemic and nutraceuticals have played an important role in this. Nutraceuticals have taken even more of a centre stage as consumers consider ways to stay healthy turning to supplements with natural health benefits. Animal supplements are also seeing ongoing growth as owners look to treat pets as part of the family. This mindset has not wavered during the onslaught of COVID-19 with reports showing that animal nutraceutical supplements are as important as ever. According to the research study by Facts and Factors, the global pet supplements market was estimated at USD 637.6 million in 2019 and is expected to reach USD 1023.8 million by 2026. The global pet supplements market is expected to grow at a compound annual growth rate of 7% from 2020 to 20271. To meet this demand, developing solid-dose veterinary nutraceuticals and pet supplements into a formulation that can be successfully compressed in a modern tablet press at high speed can be challenging, time-consuming and expensive. It differs from producing veterinary pharmaceutical tablets simply because of the formulas used in vitamin, mineral and food supplement (VMS) production. In the pharmaceutical industry, one of the main difficulties most tablet producers experience is sticking of granule to the punch tip face. The ingredients in these formulations are very often synthetic and are formulated to aid compression, containing ingredients that help bind the tablet, having little impact on the tooling. VMS, however, in their natural state, can be difficult to compress as they can contain many high percentages of active ingredients which make production problematic. Multivitamin formulas can contain up to 50 active ingredients and two to eight excipients including coating ingredients. Pharmaceutical formulations usually contain one to four active ingredients and five to six excipients. Due to the high number of active ingredients in nutraceutical formulations, more consideration is required because of the characteristics of the formula. Problems related to particle size, flow, compressibility, moisture sensitivity, ingredient interaction, content uniformity and quality control testing can occur. Some active ingredients may be available in granular form, and others only in fine powder form. Some may be hydrophilic and others hydrophobic. Because of this, the ingredient blend may have many different particle sizes with a variety of features, including being extremely abrasive and corrosive, resulting in damage to the tooling used during manufacture. Ingredient blends can also have separation and flow issues. Tablet production from these blends can result in capping, sticking and different patterns on the faces of tablets during compression, as well as basic content uniformity problems. www.animalhealthmedia.com

Tablet punches and dies are the main components that interface with the powders and granules, so have to be robust both metallurgically and in terms of design to withstand the rigours of compacting nutraceuticals. VMS tablets for animals tend to be quite large and bulky when compared with pharmaceutical tablets. They often require high compaction forces to bond the ingredients into a robust tablet, and the tabletting equipment is usually run at high speeds for long periods of time to satisfy the industry's requirement for high output and low cost.  Choosing the Correct Tool Steel to Withstand the Demand Nutraceutical formulations are well known for their coarse granule. This brings with it wear and degradation of the tooling, which leads to other tabletting problems; for example, adherence of the granules due to pitted and worn surfaces of the punches, and also capping or lamination of the tablets, all of which will prove costly for the manufacturer. The answer is to ensure the correct tool selection is made. This means the appropriate tool steel and the right coating for the aggressive formulation which requires compression. Choosing the correct tool material will help to reduce the probability of damage to the punches and dies. Because of the aggressive nature of the ingredients, the properties of materials are extremely important, and must be balanced to give optimum tooling performance and durability. Tooling needs to be anti-abrasive and wear- and corrosionresistant, and include compressive strength and resistance to chipping and cracking.  There are many tool steels available, some of which have been specifically designed for nutraceutical compression, and include high carbon, high chrome, cold work tool steels. A common choice when it comes to nutraceutical production is tungsten carbide. This material has high hardness values and specific structures which abrade at a much lower rate, making it extremely wear-resistant. This helps to reduce die bore wear and ringing, and extend the life of tablet compression tooling. Another option is to use specialised powder metallurgy grade steels. These offer uniform carbide distribution and small carbide size, making them particularly resistant to high wear. Although wear-resistance has to be the number one consideration due to the characteristics of natural formulations, it is also important that steel can withstand an applied stress without failure. Also think about its hardness; does it have enough resistance to impregnation from hard, sharp granules? Is it corrosion-resistant to lessen the chance of oxidising, staining and discoloration, common effects of nutraceutical formulations? Is it tough enough to stop chipping, cracking and punch tip breakage? These are all questions that need to be answered. The best way to find the solution is with the help of an experienced tablet tooling manufacturer who understands the issues and has a comprehensive offering of materials to eliminate common problems. Improve Wear with Tool Coatings If the selection of a more wear-resistant steel alone is not sufficient for the rigours of nutraceutical tablet production, then International Animal Health Journal 37


MANUFACTURING an enhanced wear-resistant coating should be applied to the tooling. Coating that will improve the hardness of the tooling is extremely important in nutraceutical manufacture. The ingredients used have such high quantities of hard, abrasive, sharp-edged minerals that when repeatedly compressed can scrape away or penetrate the surface of the tool. The abrasion can lead to the erosion of punch tip detail such as logo embossing and other identification specifications. Eventually this wear can lead to weight variation, sticking and other issues, resulting in the scrapping of the punch. Traditionally, electro-plated hard chromium was the most popular coating used within the tablet tooling industry, but it has many disadvantages. When hard chromium is applied to tooling, a certain amount of hydrogen penetrates the substrate, which can decrease the steel’s working load by up to 20%. To counter this effect, the plated tools undergo a baking process known as de-embrittlement that reduces, but does not totally eliminate, the unwanted characteristic. It is also subject to micro-cracks which can develop during the plating process when the internal stress exceeds the tensile strength of the chromium. These micro-cracks are problematic because they provide a porous route to the substrate that will allow tablet formulas or cleaning solutions to attack the steel beneath. Specialised coatings have been developed which are chromium-rich and applied via an advanced physical vapour deposition (PVD) process. This advanced PVD process creates a very smooth dense anti-stick coating. This process incurs none of the drawbacks associated with applying hard chrome. Another benefit of using an enhanced coating is its corrosion-resistance. Some formulations can contain a high number of corrosive elements, for example, salts and acids, which react with the steel and eventually result in oxidation and other forms of decay. Corrosion can also present through wash treatments. Some modern tablet presses are fitted with wash in place systems, exposing tooling to water and cleaning solutions, causing corrosion. In these instances, an appropriate coating should be selected; for example, those containing chromium or titanium nitride, both of which contain corrosion-resistant properties. Finding a coating that will enhance a tablet tool’s ability to be highly wear-resistant and strong, and withstand corrosive elements, is crucial. The tool coating should match the characteristics of the formulation to ensure the correct treatment is used for tool longevity and to lessen production problems. Design Your Tablet to Meet Requirements Design is another extremely important consideration in the manufacture of nutraceuticals, just as it is in pharmaceutical production. Correctly designed tablets can impact upon anticounterfeiting, tooling strength, coating of tablets, durability and functionality. It also helps avoid tablet sticking, picking, lamination, capping or premature tooling failures. Ensuring design is correct early in the production process will help in producing a quality problem-free end product. The tablet design can help in minimising the susceptibility to tablet tooling wear. Tablet designs where the tool profile requires a deep concave can often cause wear around the steepest areas of the concave when compressing abrasive formulations. During the compression stage, the granule has to travel laterally across this area to form the tablet. This will cause friction, which abrades the punch tip face, removing material over time. This can often lead to tabletting issues such as capping and delamination, as the tip design’s integrity 38 International Animal Health Journal

in this area is compromised and ‘crowning’ can occur. To reduce this effect, a flatter tablet profile, or one that has been specially designed to reduce the effects of abrasive wear, should be used. The process is something that should not be rushed; it needs to be well thought out and considered, as good tablet design is essential to prevent downstream problems, produce high quality tablets and maximise the efficiency of the tabletting process, a necessity when looking to massproduce animal nutraceuticals. Put a Plan in Place A big obstacle when it comes to insufficient production, and one that should be overcome early, is poor planning. It is all very well having production goals but how do you manage your tooling to ensure it is available when required and they work seamlessly? The answer is through the implementation of a planned and professional maintenance process to manage tablet punches and dies. A maintenance process will help to extract the maximum life from tablet tooling through a consistent and accurate approach. Using a clear, comprehensive and effective strategy helps to reduce many of the common tablet and tooling problems that can occur when manufacturing nutraceuticals. This results in better quality tabletting, and reduced tablet press downtime, improving profitability through planned professional maintenance processes. Modern tablet production requires increased capacity, flexibility, speed of response and robust traceability, with the core objective of maximised press uptime. What was once monitored through simple manual methods is not enough in the current culture of ‘high volume’ tightly controlled and audited tablet production. Many nutraceutical tablet manufacturers have the philosophy that tooling should be treated as a consumable item to be written off and thrown away. However, through the development of computer-based monitoring systems, this way of thinking is changing and productivity per punch can be maximised far more effectively to meet high-capacity manufacturing requirements. Knowing where tools are, and what condition they are in, should be a priority. Without this information, either unnecessary tooling replacements are made, reducing productivity, or punches are deployed when they should be in maintenance or replaced. The latter scenario produces problems with the end tablet when it is found that the tooling being used does not meet the highly demanding process of nutraceutical tablet manufacture. Rejected tablets, wasted formulation, very expensive press damage and press downtime are the usual results. In addition to this, not having a clear picture of tooling availability may lead to the loss of opportunities in a fast-moving and competitive nutraceutical environment. Any problems within tool inventory management can have serious implications on the bottom line and manufacturers should have a complete audit trail covering tooling usage and maintenance. Without a robust management system that controls the procedure efficiently, the consequences will be costly. Make the Right Choice The development of animal nutraceutical products into a formulation that can be compressed in a modern tablet Volume 8 Issue 1


MANUFACTURING

Abraded punch tip

Supplements

Tip wear

Punch tip face showing high level of abrasion

to ensure it can successfully produce the challenging formulation found within nutraceuticals. Don’t let it be an afterthought. It is important to consult with an expert tablet designer as early on in the process as possible, who can ensure that tablet designs are not only unique and visually appealing, but are also robust and producible in a rigorous tablet manufacturing environment. Specialist advice on tool materials and coating that match with the nutraceutical formulations being compressed is also extremely important and will save not just time, but also money, as production efficiency is increased and failures are reduced. Coatings

press to a tablet form, with both speed and quantity, can be a complex and problematic procedure. With certain considerations and measures in place, however, it can be achieved successfully. As nutraceutical formulations nearly always have more actives present in a higher weight than pharmaceutical formulas, the room for excipients is restricted, making it harder to formulate. The formulations used within nutraceuticals are also usually coarse and corrosive in nature, another challenge to conquer. By choosing the right quality punches and dies using the correct metallurgy and coating, problems during manufacture can be prevented. Detailed design of nutraceutical tablets is essential in order to produce robust tablets with tailor-made properties. Manufacturers of animal nutraceuticals should not overlook tablet design, because it is key to the quality of the end product. Let’s also not forget to plan your tooling and ensure it is all present and correct and in the best possible shape www.animalhealthmedia.com

REFERENCES 1.

https://www.fnfresearch.com/pet-supplements-markettype-pills-chewable-tablets-powders-880

Alex Bunting Alex manages the marketing team at I Holland, is a graduate of English and member of the Institute of Digital Marketing. He joined I Holland in April 2008 having spent the previous years working in Environmental Science. Alex was instrumental in the design of the 2010 edition of the widely adopted Eurostandard, educational animations and hosts I Holland’s extensive webinar program. Email: alex.bunting@iholland.co.uk

International Animal Health Journal 39


COMPANION ANIMALS

Managing Dental Disease in Dogs and Cats: It is All About Consistency Abstract In veterinary dentistry, the concept of preventive medicine is well known but under-utilised. The prevalence of dental disease in dogs is greater than 80%, and 24% in cats. One issue to consider is the idea of preventive dental care in dogs and cats. Is it genuinely preventable, or is it more accurate that we manage dental disease in our patients? Management of dental disease requires a team approach between the pet owner, the pet, and the veterinary staff. This paper discusses three actions needed to develop a management plan for veterinary dental patients. Introduction In veterinary dentistry, the concept of preventive medicine is well known but under-utilised. The prevalence of dental disease in dogs is greater than 80%, and 24% in cats.1,2 The goal of preventive medicine in human medicine is to help people stay healthy. In her article on the need for coverage for preventive care, Amadeo3 proposes that dealing with a disease before it becomes severe can help keep medical costs low. More importantly, preventive care keeps people productive, which leads to improved quality of life. In the United States, dental cleanings fall under the umbrella of preventive care, but for many, it is a luxury due to the expense and lack of comprehensive coverage. In veterinary medicine, while the concept of preventive medicine is well known, there are areas where it is underutilised. In 2006, the United Kingdom passed the Animal Welfare Act 4. The Act lists five welfare needs for animals. The five requirements are 1) for a suitable environment, 2) for a suitable diet, 3) to exhibit normal behaviour patterns, 4) to be housed with, or apart from other animals, and 5) to be protected from pain, injury, suffering, and disease. Preventive medicine protects these needs to improve the quality of life for pets. Veterinary dentistry is one service where prevention can make an impact. One issue to consider is the idea of preventive dental care – is it genuinely preventable or is it more accurate that we manage dental disease. Management of dental disease requires consistent contact with the patient and the pet owner. Constant contact provides the pet owner and patient with education and support. This paper will discuss three actions needed to develop a management plan for veterinary dental patients. Increase Your Knowledge of Dental Disease With dental disease being one of the most common conditions encountered in veterinary practice, having a solid understanding of oral anatomy and disease is paramount to provide successful patient treatment. The World Small Animal Veterinary Association (WSAVA) published the WSAVA Global Dental Guidelines. Niemiec et al. 5 noted that in many veterinary schools, dental education was incomplete, and many graduates enter practice with minimal dental knowledge. Continuing education beyond veterinary school is required to provide professional dental treatment to our patients. Greenfield et al.6 ranked knowledge and skills veterinarians needed for new graduates entering practice. Of the 35 skills and knowledge surveyed, dentistry was number 28. While 40 International Animal Health Journal

dentistry was low on the list, it does show its importance to the services provide by the practice. If there are gaps in dentistry knowledge and skills, it is recommended that veterinarians and staff members participate in lectures and hands-on training which are available globally and digitally. The baseline training needed to provide high-quality dentistry is the Comprehensive Oral Health Assessment and Treatment (COHAT). The COHAT is an eleven-step process that takes the patient from the awake oral exam, the anaesthetised oral exam with charting and dental radiographs to treatment and recovery7. It is essential that veterinarians and staff are honest with their level of comfort with dental procedures and seek help through training or referring patients to a dental specialist. Building Communication with the Pet Owner The Owner-Animal-Environment Triad One crucial component of designing a successful dental prevention programme is to build a supportive relationship with the pet owner. The Owner-Animal-Environment Triad was developed by Dr. Fraser Hale.8 The three elements of the triad interact and can affect the outcome of the treatment and management. In terms of the owner – while we as patient care providers have opinions on how the case should turn out, we must not lose sight of the owner's role in the long-term success of the plan. Pet owners must be directly consulted and make decisions that align with the reality of their situation. The pet/animal in the triad is the recipient of the treatment. The staff must familiarise themselves with the pet's behaviour and relationship with the owner. In what conditions is the pet most cooperative? Can they be directly handled? What is the patient's medical or anatomical considerations? Lastly, the environment should be considered in its impact on recovery and follow-up care. If medications or special diets need to be introduced, other pets that are in the household need to be considered. Dental Care Strategies Each patient needs to have their dental care programme individualised based on their previous dental treatments, age, and systemic conditions. According to the American Animal Hospital Association (AAHA) Dental Guidelines,9 dental care strategies need to begin with the first visit and continue throughout the patient's life. Recording the oral exam and treatment using a dental chart provides a history of disease conditions for that patient. Follow-up visits and procedures are based on the disease trends of that patient. For older patients, regular health screenings, including lab work, are necessary to rule out systemic disease which may affect anaesthesia protocols for that patient. In contrast, patients with systemic disease can be affected by the concurrent presence of dental disease. Minimally, an awake oral exam with a prevention strategy should be performed during the yearly exam. The AAHA Dental Guidelines also note that when a patient is examined on every visit, dental disease can be identified at an earlier stage with treatment causing minimal discomfort to the pet. Using the pet owner's dental health can provide a bridge when educating on oral health and treatment. Volume 8 Issue 1


COMPANION ANIMALS Obstacles to Dental Care The two top reasons a patient is reluctant to allow their pet to be treated for dental disease is cost and fear of anaesthesia.10 Performing regular oral exams can lower the cost since the veterinarian is not returning a mouth with severe disease back to normal. These situations cause the patient to be under anaesthesia for an extended period, and even more so if the veterinarian does not have the skills to perform the needed procedures. It is frustrating for all involved. Of course, many times, the disease can be hidden until you perform an oral exam under anaesthesia and take full-mouth radiographs. Communication is the key to overcoming pet owner resistance. Cost concerns should be addressed at the time of the exam with the presentation of the estimate. What needs to be made clear as an estimate at the time of the exam is an informed possibility of costs for the treatment. The full examination will take place with the patient under anaesthesia, and the pet owner needs to be told that more problems could be found with the addition of the tooth-bytooth inspection and full-mouth radiographs. Many clinics present the costs in a range of low to high. Getting a phone number where the owner can be reached to review the revised estimate is recommended. In the pet owners' experience, anaesthesia for a teeth cleaning does not make sense since humans do not require anaesthesia for a teeth cleaning. Dental procedures without anaesthesia are not well tolerated by dogs and cats and are at best a limited procedure because it does not provide a thorough examination, cleaning, and treatment of dental disease. 5,9 Concerns about anaesthesia are best allayed if the veterinarian explains the need for preoperative lab work, diagnostics, and anaesthesia protocols involved with the dental procedure. Defining what each component of the procedure is and the purpose of each component while patiently fielding questions from the pet owner will help the pet owner feel that the treatment planning is in the best interest of their pet. Follow-up and Home Care Managing dental disease using consistent preventive strategies will maintain the quality of life for the patient. Following-up with the pet owners and the patient is another opportunity to provide support and educate the pet owner. Follow-up should be delivered any time a treatment has been performed, an awake oral exam with treatment planning has been completed, or preventive home care has been prescribed. After the Awake Oral Exam If the oral exam has shown that dental treatment is required and an estimate has been sent home, the pet owner may have further questions. The timeframe for contacting the pet owner can be flexible. If the pet owner was not able to schedule a surgery appointment, contact should be made 24 hours after the examination to schedule, review the estimate, and inquire if there are any questions. If the surgery has been scheduled, a phone call can be made just before surgery date to review the estimate, give drop-off instructions, and field any questions. A member of the surgery team who will be involved with the case would be the best person to handle this. Post-treatment Provide oral and written homecare instructions individualised to the patient. Speak with the pet owner and present the findings and treatments before the pet is returned to the owner. Adding visuals such as dental radiographs, pre and post photographs, and the dental chart adds clarity to the presentation. According to the AAHA-AVMA Canine www.animalhealthmedia.com

and Feline Preventive Healthcare Guidelines, a follow-up plan should be individualised to the treatment performed.11 Alert the client to possible side-effects, such as bleeding, coughing, nasal discharge, neurological signs, vomiting diarrhoea, anorexia, or signs of pain. Soft food should be fed either in the form of moistened hard food or canned food. A good rule of thumb is to set up at discharge a recheck appointment 10–14 days after surgery. Call the pet owner the day after surgery to inquire about the patient's condition. Inquire about their ability to give the medication and the patient's tolerance to the medication, and answer any questions or concerns. At the dental treatment recheck appointment, check the sutured areas for signs of dehiscence or further infection. If the suture sites look healthy, and healing is taking place, resume the patient's regular diet. Go over home care instructions again and revise if necessary. Schedule more recheck appointments until the disease or wound is controlled – monthly to every three months. Home Oral Hygiene Products Home oral hygiene products, sometimes known as homecare products, are an essential part of managing a healthy mouth between professional cleanings. The owner must use the product consistently for the pet to benefit from it. Consistency will bring about the best outcome as both the pet and the owner will acclimate to a routine. What makes for successful owner compliance is implementing the Owner-AnimalEnvironment Triad to help choose the right products that cater to the needs of the pet in a form the owner can give, and the pet will tolerate. Oral hygiene products are best started when the mouth is the cleanest, which is after a professional cleaning. The goal of therapy is to maintain a healthy mouth by preventing gingivitis, which can turn into periodontal disease. Maintaining a healthy mouth is a daily process as plaque bacteria build up soon after a professional dental cleaning. For patients that have had extractions, oral rinses can be used before more aggressive products are introduced. Products are categorised as active or passive. Active products are products that are applied to the tooth surface by the pet owner – toothbrushing, antiseptics, anti-plaque rinses, and fatty acid supplements. Passive products require little to no pet to owner interaction. Passive products usually have ingredients that retard plaque and calculus – dental diets, textural foods, food additives, or water additives. Choosing the right products for each patient can be daunting, as there are many to choose from. A place to start is the products recommended by the Veterinary Oral Health Council (VOHC). The VOHC is run by the American Veterinary Dental College (AVDC). Manufacturers voluntarily test their products to prove they retard dental plaque and calculus. Approved products are given the registered seal of the VOHC, which can be used in the labelling of their product. The best place to start is to interview the pet owner to gain a better perspective of the commitment to maintain their pet's oral health, the pet's behaviour, and the pet's daily routine and environment. The results from this interview will help the pet owner and the veterinarian choose products that will provide long-term success. An interview form can be designed in hard copy or digital format and can take place either during the examination or over the phone. Keep the interview short to not infringe on the owner's time. An example interview form can be found here: https://docs.google.com/forms/d/12fs42VaW-zu08IT2jM2 gbiwy2g2wc4bZ6yHjzUA37Xw/edit?usp=sharing International Animal Health Journal 41


MANUFACTURING When dispensing oral hygiene products, providing a demonstration or reviewing product instructions can ensure the pet owner is comfortable using the product. A phone call 24 hours and 14 days after the product has been dispensed will provide another level of support and confirm the product is being used continuously. Client education and support are the best way to get pet owners on board with providing preventative dental care to their pets. Showing that you care for their pet's wellbeing increases the chance the pet owner will be compliant with the instructions. Conclusion Prevention and treatment of periodontal disease is a common issue in veterinary practice. According to Belshaw et al.,12 preventive healthcare consultations are involved, which causes time pressures to the schedule. While it may seem that there are many steps to managing dental patients, these techniques previously mentioned can be used for other veterinary services. To maintain good long-term oral hygiene or treat existing periodontal disease takes input from the veterinary staff, the owner, and the pet. Choosing staff that are excited about dentistry ensures that the patient's needs are met professionally. The combination of practising highquality dentistry, updating your knowledge and treatment protocols, knowing when to refer, and reliable client support brings about a successful outcome for the patient. REFERENCES 1.

Stella JL, Bauer AE, Croney CC. A cross-sectional study to estimate prevalence of periodontal disease in a population of dogs (Canis familiaris) in commercial breeding facilities in Indiana and Illinois. PLoS ONE. 2018;13(1). doi:10.1371/journal.pone.0191395 2. Lund EM, Armstrong PJ, Kirk CA, Kolar LM, Klausner JS. Health status and population characteristics of dogs and cats examined at private veterinary practices in the United States. J Am Vet Med Assoc. 1999;214(9):1336-1341. 3. Amadeo K. Preventive Care: How It Lowers Healthcare Costs in America. The Balance. Accessed August 17, 2020. https://www.thebalance.com/preventive-care-how-itlowers-aca-costs-3306074 4. Animal welfare act 2006. legislation.gov.uk. Published 2006. https://www.legislation.gov.uk/ukpga/2006/45/contents 5. Niemiec B, Gawor J, Nemec A, et al. World Small Animal Veterinary Association Global Dental Guidelines. J Small Anim Pract. 2020;61(7):395-403. doi:10.1111/jsap.13113 6. Greenfield CL, Johnson AL, Schaeffer DJ. Frequency of use of various procedures, skills, and areas of knowledge among veterinarians in private small animal exclusive or predominant practice and proficiency expected of new veterinary school graduates. J Am Vet Med Assoc. 2004;224(11):1780-1787. doi:10.2460/javma.2004.224.1780 7. Ringen D. What is a COHAT? Why We Don't Just Call it a "Pet Dental Cleaning." Animal Dental Care & Oral Surgery. Published February 17, 2019. Accessed August 20, 2020. https://www.wellpets.com/blog/59-what-is-a-cohatwhy-we-don-t-just-call-it-a-pet-dental-cleaning 8. Hale FA. The owner-animal-environment triad in the treatment of canine periodontal disease. J Vet Dent. 20(2):118-122. doi:10.1177/089875640302000206 9. Bellows J, Berg M, Dennis S, et al. 2019 AAHA Dental Care Guidelines for Dogs and Cats. J Am Anim Hosp Assoc. 55(2). doi:10.5326/JAAHA-MS-6933 10. Mills A. Anesthesia and the dental patient. In: Small Animal Dental Procedures for Veterinary Technicians and Nurses. Wiley-Blackwell; 2013:45-57. 11. Development of new canine and feline preventive healthcare guidelines designed to improve pet health. J Am Anim Hosp Assoc. 2011;47(5):306-311. 12. Belshaw Z, Robinson NJ, Brennan ML, Dean RS. Developing 42 International Animal Health Journal

practical recommendations for preventative healthcare consultations involving dogs and cats using a Delphi technique. Vet Rec. 2019;184(11):348-348. doi:10.1136/vr.104970

Jeanne R. Perrone Credentialed as a Veterinary Technician Specialist in Dentistry in 2006. Owner and facilitator of VT Dental Training which provides consulting and dentistry skills training for veterinary staff. Parttime dentistry technician at Veterinary Medical Clinic in Tampa, FL Adjunct instructor for the BAS VT program in dentistry at St Petersburg College. Career online instructor at Ashworth College for the Veterinary Assisting program. Online instructor of dentistry courses at Vetmedteam.com. Edited and published the book Small Animal Dental Procedures for Veterinary Technicians and Nurses, published in 2012 by Wiley-Blackwell with a second edition being published in 2020-2021. Contributor, Healthcare for Pets at www. healthcareforpets.com. Dentistry editor – Veterinary Nurse. From 2006–2015 dentistry technician at Tampa Bay Veterinary Specialists in Largo, FL and The Pet Dentist of Tampa Bay in Wesley Chapel, FL. Founding member and former president of the Academy of Veterinary Dental Technicians – A NAVTA Specialty Group which certifies, trains and mentors credentialed technicians to be specialists in dentist. MS Instructional Design and Technology Ashford University, San Diego, CA. A.A.S. Veterinary Technology Parkland College, Champaign, IL BA Drew University, Madison, NJ.

Volume 8 Issue 1


LIVESTOCK DISEASES Successful Depopulation and Reopening of an Isolation Facility within a Large Production Compound without Allowing ASFV Spread to the Main Breeding Herd

starting on December 20th, 2019 with the C source shipment, and the X shipment arrived on Dec 21st.

Onset of ASFV, Diagnosis and Disease Progression The isolation room as described in this paper was inside the same production compound, 54 metres away from the B/G area of the main herd, separated by a road. This facility was installed with air filtration (HEPA) and was fenced to create a separation from the main herd and constructed to receive replacement pigs. The details of biosecurity had been planned and implemented for the isolation assuring a biosecure transfer of genetics after isolation monitoring procedures were performed.

On Dec 23rd, a single pig from X started to show watery diarrhoea.

Millions of years ago when life began on earth, numerous species emerged and co-evolved sharing earth's resources and habitat. Homo sapiens, which evolved as the most intelligent species, dominated and exploited the major share of resources pushing the other species towards extinction or (at the very least) struggling to thrive. Humans expanded their habitat, croplands and livestock into the forests, which disrupted the natural ecosystem and thus ruined the harmonious coexistence with other wild species. Meanwhile, broken barriers by close human-animal interfaces enabled the interspecies transmission of pathogens to distant and diverse species. Incidences of novel pathogen emergence by animal to human transmissions and the extermination of millions of humans from Earth have been witnessed on various occasions. Outbreaks from emerging infectious diseases have been reported to increase every decade since the 1980s and most of them have been linked to wildlife.

Watery diarrhoea on Dec 26th, 2019

On Dec 26th, most of the pigs in the isolation began showing watery diarrhoea. Rapid tests indicated positive for PEDV. Population exposure was practised with watery faeces spread to all pens to ensure simultaneous exposure/infection. A PEDV elimination programme was instituted and additional biosecurity measures were put in place to avoid leakage and/ or people tracking from the isolation barn to the resident pigs in the main herd. On Dec 25th, the first pig died, and on 27th, the second. Both pigs were sudden deaths without any clinical signs. Nasal swabs were collected from dead pigs for lab ASFV diagnosis. On Dec 27th, all the roads in the farm and surroundings of the isolation room were covered with dry lime, to avoid potential spread of the diseases by the fomites. Dry hydrated lime is frequently used in China as a disinfectant to curb contamination because of movements of pigs, trucks and materials in the farm environment. Oral swabs from the pigs in the pens, and 300 serum samples and 60 rectal swabs were collected for diagnosis of PEDV (faecal samples) and ASFV and PRRSV (serum samples).

Pens inside the isolation room

The delivery of 176 boars from source X and 352 replacements from source C were moved into the isolation

On Dec 29th, a third death occurred. By Dec 30th, all isolation pigs had shown diarrhoea signs.

Pen No.

Boars C

Boars C

18 C

17 C

16 C

15 C

14 C

13 X

12 X

11 X

Pen No.

1C

2C

3C

4C

5C

6C

7X

8X

9X

10 X

Note:

C: C source

X: X source Layout of the pens inside the isolation barn

www.animalhealthmedia.com

International Animal Health Journal 43


LIVESTOCK DISEASES On Jan 9th, most of the pigs in the 9th pen started to show signs of inappetence, lethargy, red skin, and high temperature (41°C–41.5°C). Five whole blood samples from affected pigs were collected and sent to a private lab. These pigs from pen 9 came from X farm. The sick pigs in this pen were treated with ceftiofur and flunixin meglumine with no clinical improvement.

Dead pig seen on Dec 29th

On Dec 31st, the fourth pig died without clinical signs, and by then most pigs had stopped scouring and were recovering, raising suspicion that another agent may be present. The PEDV sequencing on Jan 6th indicated a different genetic strain compared with previous sequencing at source farm C and another farm having a pig source linkage to C, pointing to a likely contamination during transport or at the isolation facility. On Jan 1st, 2020, the fifth pig died from apparent stress, without clear clinical signs. On Jan 3rd, the test results (collected on December 27th and 28th, sent on 29th) came back, indicating PEDV positive, and TGE and porcine delta coronavirus negative. Testing of 300 serum samples via RT-PCR PRRSV indicated the pigs were PRRSV negative. However, eight of 107 pooled oral fluids swabs were positive for ASFV with the IDEXX kit RT-PCR, but the positive samples are negative when tested on a local Chinese manufacturer ASFV RT-PCR test. CT values were close to the critical CT value of 37, possibly indicating the samples were negative. On Jan 4th, it was decided to collect serum samples from all pigs in the pens that were tested ASFV positive using a different test kit by Thermo Fisher on each individual pig from the positive pool samples. On Jan 12th, the results came back from a different laboratory indicating negative results for ASFV (Thermo Fisher RT-PCR test kits). On Jan 5th, another pig died, and rectal body temperatures of 10 pigs in the same pen were randomly taken to see if there were any fevers, but no feverish pigs were found. On this same day, a boar was observed with black faeces and paleness, and on Jan 7th, it died. On Jan 8th, a gilt died from flatulence.

Pigs showing reduced feed intake, red skin and lethargy

On Jan 10th, pigs in the neighbouring pen 10 began to show fever. One pig had a body temperature measured at 41.3°C. On Jan 11th, four pigs in pen 9 died. On Jan 12th, six pigs in pen 9 died, and two were seen vomiting with blood. Some pigs in pen 8 started to show skin discoloration and off-feed with high body temperature. On Jan 12th, the private lab results showed that the five whole blood samples collected from pen 9 were positive for ASFV (Thermo Fisher: CT 22; IDEXX: CT 18). On Jan 13th, the team decided that this was an ASFV infection and an outbreak, and determined to depopulate the isolation herd. A plan was developed to prepare for depopulation. Details were discussed to ensure biosecure logistics and supplies needed to humanely euthanise the pigs, and disposal could be performed in a manner preventing contamination of the adjacent breeding herd. On Jan 13th, the pigs from pens 7 and 8, and more pigs in 9 and 10, began to show clinical signs. Five from pen 9 died, and five from pen 8 died. On Jan 14th, one from pen 10 died, and 10 from pen 9 died.

A boar died with black faeces 44 International Animal Health Journal

By this time the disease was progressing quickly and escalating after an inapparent period of transmission in the isolation. Volume 8 Issue 1


LIVESTOCK DISEASES Depopulation of the Isolation Herd Since Jan 13th, the team worked to find a burial place to dispose these pigs, and one site was found. On Jan 15th, all the pigs in the isolation barn were euthanised. On Jan 16th in the evening, the pigs were moved out of the facility in a biosecure way to avoid leakage. • • • • •

Trucks entering the farm grounds were washed and disinfected before getting close to the loading gate of the isolation room; Interior of carriage of trucks were covered with impermeable plastic film; The roads inside the facility grounds were paved with dry lime; A burying site at a different location 4 km away from the farm was selected; A minimum of 2 metres of soil on top of the disposed carcasses was required.

Cleaning and Decontamination (C&D) of the Isolation Facility Post Removal of the Pigs After the depopulation was completed on Jan 17th, biosecurity work was initiated to thoroughly clean and disinfect the facility

Trucks hauling the euthanised pigs

and the environment, and final inspection of the isolation occurred on May 24th. At this time the isolation was determined to be ready to place sentinel pigs as a final step before reopening the isolation. Site cleanup standards and priorities: • • • • • • •

No organic matter inside and outside the isolation barn; Ensured that the isolation barn was strictly separated from the main compound; Covered all the roads linked to the isolation facility and all the roads inside/outside the main compound with dry hydrated lime to minimise contamination; Ensured that the pits were soaked with caustic soda to get the pH higher than 13.5, and kept it for a minimum of two weeks before cleaning and disinfection of the pits; All the disposables supplies were being disposed, and equipment being dismantled and thoroughly washed and disinfected; Filters dismantled and replaced with new; Adopted a multiple-step cleaning, washing and disinfection approach; use multiple methods such as drying, flaming, pit treatments, and fumigation at different points of time to ensure effectiveness.

Emergency Response Plan and Communication An action plan was formulated for the decontamination and repopulation of the isolation facility, targeting complete cleaning and decontamination (C&D, several rounds). Details of biosecurity were discussed for actions, and work progress were reported and communicated daily. An action plan to monitor the health status of the pigs in the main herd was formulated and implemented. This response plan had five main pillars: • Define who should be in the communication and the decision-making loop; • Complete cleaning and decontamination of the isolation room and surrounding area; to eliminate/minimise residual ASFV virus in the environment;

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International Animal Health Journal 45


LIVESTOCK DISEASES • • •

Avoid leakage and spread of virus to the main herd beyond the separation road/fence; Measure the effectiveness of all procedures as best as the team could, to demonstrate measurable results and assure confidence in re-stocking the isolation facility; Ensure the virus would not be re-introduced to the isolation after it is thoroughly decontaminated, and after environmental testing assured the facility was ASFV negative before introducing sentinels. Monitor sentinels as the last step of assurance that the facility was no longer contaminated with ASFV.

Investigation of Source of Contamination: The investigation pointed to these potential sources of contamination: Potential contamination of a hauling truck from source X either because of non-effective decontamination or while routing to the destination farm. As suspicious clinical signs first appeared in pen 9, 10, 8, 7 etc., all sourced from farm X, the team had a legitimate reason to speculate that the farm X delivery truck was the source of infection. Source X had no clinical or diagnostic indication that the pigs were infected at the source farm before shipment and remained unaffected at the time of this investigation and later, so the source farm was ruled out as a potential source of the virus. Prior to this shipment, this truck had hauled pigs from X to another herd owned by clients on Dec 4th, then washed in an outside washing site. A second wash and disinfection were done after returning to the X washing facility (or truck wash facility) on Dec 5th. It was very cold in the north China winter, and in X truck wash facility, freezing and icing was an obstacle for thorough washing and cleaning, and the site was not equipped with a heated drying facility. On Dec 18th, prior to shipping pigs to the isolation facility, the truck carriage was covered with a tarpaulin and heated by blowing/ flowing hot air under the tarpaulin at 20°C with a forced air heater. In retrospect, the team had good reason to believe that effectiveness of the truck wash procedures against ASFV was doubtful.

On May 26th, 20 sentinel pigs were introduced into the isolation barn and allowed complete access to all parts/ surfaces of the facility. Oral swab samples were collected at seven days post arrival to test for ASFV, and whole blood and rectal swabs were collected at 14 days, 21 and 28 days post arrival to test for the presence of ASFV, PEDV and PRRSV. No positives were found, and sentinel pigs were released for slaughter sales on June 26th. 46 International Animal Health Journal

In addition, for this long-distance haul, the contamination could have occurred during the trip because it had to park in resting areas five or six times, and at toll gates where the cashiers had to check and take photos, which added biosecurity risks. In the investigation, it was found that some potential tracking mistakes were also made during the loading process. However, the slowness of the development of disease prompted some questions. The breeding herd feedback exposure to the isolation was done on Dec 26th soon after arrival, due to containment of PEDV added complexity as this approach might spread the virus, if there was contamination, from some single infected individuals to others. Likelihood of other contamination sources exist, such as inadequate decontamination of the barn itself, or because of contamination from people or supplies, such as contaminated cell phones owned and brought in by farm staff, or from people not properly showered in to the isolation room. Surveillance, Sentinels and Re-introduction into the Isolation Facility As the cleaning and decontamination were underway, on March 20th, April 11th, May 25th, sets of environmental samples from various surfaces, including corners, equipment, cooling cells, filters, and pits were collected and tested for the presence of ASFV nucleic acids. Some samples collected on March 20th were found PCR ASFV positive but subsequent samplings all indicated negative for ASFV. Introduction of Sentinel Pigs The isolation barn was prepared, thoroughly foamed, washed, disinfected and flamed, then closed to people traffic for three days, before receiving the sentinel pigs.

The surveillance of environmental samples for presence of ASFV nucleic acids

Repopulation It was decided that the barn was safe to repopulate after sentinel pigs were not showing clinical signs and were tested free of diseases of concern, and thus it was prepared to restock. On July 2nd, one day prior to re-stock, the barn was thoroughly flamed as a final biosecurity assurance step. On July 3rd, 500 gilts were introduced into this isolation facility, and monitored for ASFV before releasing them into Volume 8 Issue 1


LIVESTOCK DISEASES

The surveillance of ASFV for sentinels

the main herd in mid-August. At the time of completion of this paper, six months after introducing the pigs into the main herd, there has been no evidence of ASFV infections in the farm.

Flaming the barn

Repopulation

Conclusions This case has demonstrated an unusual progression of ASFV infection in a population of naive replacement stock in an isolation facility. Early detection by accurate diagnosis was a big challenge, as initially there were no clear clinical signs pointing to ASFV infection, and diagnostic kits and laboratories gave inconsistent results. Via considerable efforts on biosecurity, the team was able to prevent the spread of the virus to the main herd, which was only 54 metres away, and was able to decontaminate then successfully reintroduce replacement pigs in the isolation barn and into the breeding herd six months after a diagnosis of ASFV was first established. Acknowledgement to Co-authors: PIC colleagues Tian Xia, Qi Chen, Zhi Li, Jer Geiger, Angel Manabat, Dr Rodney Butch Baker from Swine Health Consulting and Dr Dan Tucker from the University of Cambridge have coauthored this paper. Their efforts are appreciated.

Dr. Jiancong Yao Dr. Jiancong Yao currently works with PIC as its Health Assurance Director for Asia region. He had studied virology and holds a Master Degree in Preventive Veterinary Medicine from China Agricultural University; he also holds Master degrees in Agricultural Economics and in General Management, each from University of Purdue and the University of Indiana. Dr. Yao have authored numerous articles on swine health management subjects. Email: miles.yao@genusplc.com

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