NOAH Statement on the Prescribing Cascade for Veterinary Medicines
11th December 2024
NOAH is committed to supporting robust veterinary practices and safeguarding the welfare of animals in the UK. Recent discussions stemming from the Competition and Markets Authority’s (CMA) inquiry into the veterinary services market underscore the need for clarity around the UK’s veterinary prescribing Cascade and its importance in ensuring optimal animal health outcomes.
The veterinary Cascade is a critical regulatory requirement that empowers veterinarians to prescribe medicines responsibly and legally when no licensed product is available for a specific condition or species, e.g. certain infectious disease in snakes. For example, there are very few licensed products for exotic pets and the prescribing cascade allows vets to use unlicensed products to treat these pets. Similarly, there are few authorised chemotherapy products for use in pets and the prescribing cascade provides a legal framework to allow vets to use human medicines. This system allows for veterinary professionals to prioritise the health and wellbeing of animals, while maintaining high safety, quality and efficacy standards. Authorised veterinary medicines have been specifically formulated and assessed for safety, quality and efficacy for use in the species and condition in question. The Cascade reduces reliance on human medicines, which are not specifically developed, authorised, tested or optimised for animal use, lowering the risk of adverse effects and treatment failures. Instead, the Cascade is a mechanism that ensures access to appropriate treatment options while protecting the incentive for development of licensed veterinary medicines.
The animal medicines industry also provides extensive technical support and educational training to veterinary practices, investigates reports of suspected adverse events and is committed to supporting veterinary practices in maintaining high standards of animal health and welfare. The human medicines industry will not provide any support of this nature to vets who may use their products in animals, as this is not the purpose of human medicinal products.
Compared to the human medicines industry, the veterinary medicines sector is a comparatively small industry; Europe wide, the veterinary medicines sector has only 2-3% of the market value of its human counterpart. This means that the business case for developing and registering authorised veterinary medicines is dependent on them being used ahead of human medicines or unauthorised products (known as extemporaneous preparation products, sometimes referred to as veterinary specials). The UK’s Cascade is consistent with the approach taken in the EU and in other parts of the world such as Australia, reflecting a commitment to animal welfare and veterinary independence and a viable market to encourage innovation.
We are concerned that any reform targeting the Cascade as part of broader market changes may inadvertently undermine animal health and welfare by encouraging the use of products that have not been assessed for their safety and efficacy in species-specific animals, as well as the long-term development of licensed veterinary medicines. Simplistic adjustments risk creating inappropriate “one-size-fits-all” prescribing practices, potentially compromising animal health and veterinary independence.
While NOAH acknowledges the CMA’s commitment to address valid consumer concerns, such as transparency and affordability of veterinary care, we urge all stakeholders to avoid undermining the tools that support nuanced, high-quality animal care. NOAH remains committed to collaborating with regulators, veterinary professionals, and industry partners to uphold the highest standards of animal health and ensure a balanced approach to market improvements.
For further dialogue, NOAH invites stakeholders to engage with us to discuss the vital role of the Cascade in supporting effective veterinary care across the UK.
The Benefits of Licensed Veterinary Medicines
There are sound scientific reasons that mean it is preferable for animals to be treated with licensed veterinary medicines rather than unauthorised products or human medicines.
Species-Specific Safety and Dosage
Veterinary medicines are specifically formulated and tested for use in animals, accounting for differences in metabolism, physiology, and sensitivity across species. Human medicines may contain excipients or active ingredients that are safe for humans but toxic to animals (e.g. paracetamol is highly toxic to cats). Extemporaneous preparations also may not always account for these species-specific requirements. Using licensed veterinary products reduces the risk of adverse effects caused by species-specific sensitivities.
Tailored Administration Forms
Licensed veterinary medicines are designed for ease of administration in animals, including palatable oral formulations, injections, or topicals. These forms consider the challenges of medicating animals and help improve compliance. Human medicines often lack such species-specific considerations It cannot be assumed that such human medicines will be suitable for use in animals as they have not been assessed by the independent regulators for safety and efficacy in the relevant target species. Furthermore, authorised medicines are required to be in an appropriate form and dose size for the animal being treated. It is not advantageous or safe for an animal owner to be told that they must treat a pet cat, with 1/16th of a tablet (designed and formulated for a 70 kg person), as the human medicine dose form will contain far more active ingredient than would be appropriate to use in a 3kg cat.
Evidence-Based Efficacy for Animals
Licensed veterinary medicines undergo rigorous testing to ensure they are effective for the target species and condition. This testing is absent when human medicines are used off-label, potentially leading to suboptimal treatment outcomes. Extemporaneous preparations also lack standardised testing, and their effectiveness and safety are often not scientifically validated
Minimisation of Adverse Reactions
Licensed veterinary medicines are specifically dosed for animals, reducing the likelihood of overdosing or underdosing, which can be a significant issue when extrapolating doses from human medicines. Extemporaneous preparations may inadvertently include inappropriate excipients or incorrect dosages, posing greater risks. Extemporaneous medications may also suffer from variability in active ingredient concentration, increasing the risk of underdosing or overdosing.
Responsible Antimicrobial Use
Licensed veterinary antimicrobials are specifically approved for certain animal infections, helping combat antimicrobial resistance (AMR). Using human antibiotics in animals could inadvertently contribute to AMR due to inappropriate spectrum coverage or dosing.
Compliance with Regulatory Standards
The use of licensed veterinary medicines supports adherence to national and international regulatory frameworks, ensuring responsible medication practices. Off-label use of human medicines may not meet these standards, raising ethical and legal concerns. Extemporaneous preparations, being bespoke and unlicensed, often fall outside these systems, making it harder to monitor safety.
Support for Animal-Specific Conditions
Veterinary medicines are developed for animal-specific diseases and conditions that human medicines do not address. For instance, certain parasitic diseases or behavioural issues are unique to animals and require targeted treatment.
Traceability and Safety Monitoring
Licensed veterinary medicines are monitored under legally required pharmacovigilance systems that ensure ongoing safety and efficacy. Human medicines used off-label in animals may not provide this level of post-market surveillance.
Challenges of Using Human Medicines in Animals
While the veterinary Cascade allows human medicine use when no alternative is available, this approach is a fallback rather than a first choice. The lack of animal-specific testing and data increases the risk of unpredictable outcomes. Extemporaneous preparations are valuable in specific situations, such as when no licensed medicine is available for a rare condition or an unusual species. Their use, however, should always be a secondary option, applied only when licensed alternatives are unavailable or unsuitable.
Cost-Effectiveness in the Long Term
While extemporaneous preparations and/or human medicines might seem cost-effective in certain cases, the lack of consistent quality and potential for treatment failures or adverse reactions can increase long-term costs for pet owners and animal caretakers.
Quality Control
Licensed medicines are manufactured in facilities that adhere to strict Good Manufacturing Practice (GMP) standards, ensuring consistency, stability, and purity. Extemporaneous preparations, which are often made on a case-by-case basis in pharmacies or veterinary clinics, may not consistently meet these high standards.
Removing the Cascade Does Not Address CMA Investigation Concerns
The CMA inquiry primarily addresses issues such as transparency in pricing, competition among veterinary practices, and the costs incurred by pet owners. The prescribing Cascade, however, governs how veterinarians can prescribe medicines, particularly when no licensed product is available. These are separate issues, and altering the Cascade would not directly affect market competition or pricing transparency.
The Cascade is a framework for ensuring animal welfare and clinical flexibility, not a pricing mechanism. The cost concerns highlighted by the CMA are more likely related to broader market dynamics and limited consumer understanding of veterinary fees, rather than the prescribing framework itself.
One of the CMA’s main concerns is the lack of transparency in veterinary costs and treatment options. Changes to the Cascade would not enhance consumer understanding of treatment plans, pricing structures, or available alternatives, instead, addressing these issues requires better communication and clearer pricing from veterinary practices.
If the Cascade were removed or restricted, there would be damage to innovation and research in the animal health industry, resulting in fewer new products coming to the UK market, with a longer-term deleterious effect on animal health and welfare. This could drive up costs for pet owners rather than reduce them. Additionally, by treating pets with medicines that have not been licensed for use in animals with unknown consequences for animal health, this could have the opposite effect of the CMA’s objective to improve the consumer experience of veterinary care.