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What is the definition of veterinary medicine?
By presentation - either the manifacturer claims medicinal products or it is administered in the way medicine would be for example injection
By function - allows a chemical to be defined as a medicine if knowledge exists that it causes changed in the body regardless of what the manufacturer says about it
What are the roles of legislation around pharmacology?
Safety (animals, humans and environment), welfare, efficacy, honesty, control access
Who provides licences for medicines?
European medicines agency (might store some from when we were in EU)
Veterinary medicine directorate (mainly used)
What does MA stand for?
Marketing authorisation
If somthing has a marketing authorisation (MA), what does it need?
A Vm number
What is a Vm number?
Indicates to users that their safety, quality and efficacy have been fully tested for use in the UK in the species in which use is recommended (+ ongoing assessment) and indication of how to use the medication
If a product needs a MA, what directive does it apply to?
The Veterinary Medicines Directorate (VMD)
What are some voluntary manufacturers?
Veterinary medicines directorate, NOAH, health for animals global animal health association
What are the 3 groups of prescribers known as?
Veterinary surgeons, pharmacists, and suitable qualified persons (SQPs)
What are the VMD’s responsibilities?
Monitoring and acting on reports of adverse events from veterinary medicines
Testing for residues of veterinary medicines or illegal substances in animals and animal products
Assessing applications for authorising companies to sell veterinary medicines
Contolling how veterinary medicines are made and distributed
Advising government ministers on developing veterinary medicines policy and putting it in to action
Making, updating and enforcing the Veterinary Medicines Regulations
All things VM
What is the main regulations around veterinary medicines?
Veterinary Medicines Regulations 2013, which is now the Veterinary Medicines (Amendment etc..) Regulations 2024
What’s the legislation around controlled drugs?
Misuse of drugs regulations 2001
What the legislation around disposing medications?
Hazardous waste regulations 2005
What do the Veterinary Medicines (Amendment etc..) regulations 2024 set out?
Legal controls on the marketing, manufacture, distribution, possession and administration of VM and medicated feed
Who enforced the Veterinary medicines (Amendment ect) regulations 2024?
The Veterinary Medicines Directory
What is prescribing?
The act of deciding which is the most suitable medication after assessing the patient
What is dispensing?
The act of preparing and providing medication to the client/animal owner
What is supplying?
The act of selling (or handing over) the medication/making it available
What does POM-V stand for?
Prescription only medicine - veterinarian
What is POM-VPS stand for?
Prescription only medicine - veterinarian, pharmacist, SQP
What is AVM-GSL stand for?
Authorised veterinary medicines - general sales list
What does POM-V mean?
The animal must be under the care of the veterinary surgeon.
A veterinary surgeon must first conduct a clinical assessment of the animal or group of animals.
The veterinary surgeon must be satisfied that the person who will use the product will do so safely/is competent and intends to use it for the purpose for which it is authorised (for the correct species and condition)
Prescribed by a veterinary surgeon only.
Dispensed and supplied by a veterinary surgeon or pharmacist
What does POM-VPS mean?
May be prescribed by a Registered Qualified Person (RQP)
Clinical assessment of the animal is not required and does not need to be under the RQP’s care.
Sufficient information about the animal and the way it is kept must be known to the prescriber in order to prescribe, dispense and supply appropriately. (These include drugs like: antiparasitic, vaccines)
The RQP must be satisfied that the person who will use the product will do so safely/is competent and intends to use it for the purpose for which it is authorised.
POM-VPS drugs are for food-producing animals. (may be licensed in other species too)
What does NFA-VPS mean?
Similar to POM-VPS but for use in non-food animals.
A prescription is not required. - RQV still has to go through the decision of what medication to supply
Dispensing and supply requirements must be followed.
Horses are considered ‘food-producing animals’ under these regulations (POM-V or NFA-VPS)
What does AVM-GSL mean?
Licensed veterinary medicines with a Vm number - but no control over sales
Minimal restrictions on supply of these veterinary medicines as they are deemed as ‘very’ safe
Can be supplied by any retailer as an ‘over the counter’ medicine.
No legal restrictions.
A responsible approach to the supply of these medicines is still expected (anti-parasitic over the counter but might be changing as the use of it can create a resistance)
What is a veterinary prescription?
‘’Any prescription for a medicinal product issued by a professional person qualified to do so in accordance with applicable national law’’ (BSAVA, 2024)
When would a written veterinary prescription be required?
If the prescriber is not dispensing and supplying the medicine themselves
What is phase I of medicine development?
Safety in target species, dose, when gets toxic
What is phase II of medicine development?
Include animals with the disease, lab-based data collected, the apply for a certificate
What is phase III of medicine development?
Using referral hospitals, bigger numbers, clients sign up to studies, blinded studies - controlled studies, control group (positive control - drug being compared to something that is already licensed), this is so all animals are treated and not just using a placebo
What is phase IV of medicine development?
Doing clinical trials, areas on manufacturers that don't think are key to the product (impacting things on the animal, eg cows and milk production affected), gives vets more information on the drug
What does Pharmacovigilance mean?
“the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem”
Are there any legal requirements for labelling medicinal products?
No legal requirement to label a veterinary medicinal product (VMP) that is supplied in its authorised packaging. (if in original packaging it doesn't need a label as its safe)
RCVS recommends labelling of all dispensed products.
What does cascade mean? And should they be labelled?
Cascade means off-license and the products must be labelled as a legal requirement
What do the RCVS require on labels of medications?
Name and address of the animal owner
Name and address of the veterinary practice supplying the medicine
Date of supply
Name, strength and quantity of product
Dosage and directions for use
‘For animal treatment only’
For topical preparations ‘For external use only’.
What is ment by the withdrawal period for a food-producing animal?
‘’The withdrawal period is a specific set period of time, after the last dose of the veterinary medicine has been administered, that must elapse before an animal or foodstuffs from an animal can enter the food chain’’ (NOAH, 2016)
Why are withdrawal periods important and why must they be adhered to by veterinary surgeons, SQPs, farmers and professional animal keepers?
Because they are going to be consumed
Medications are safe for animals, humans, the environment, and medication residue not being consumed, they need to fall below certain levels before consumable
Medicines have to be on a list of approved food construction species
Withdrawal periods are mandatory. What is the regulation around this?
Animals, Meat and Meat Products (Examination for Residues and Maximum Residue Limits) Regulations 2015’’ (as amended) control residues of animal medicines in food producing animals
What is the definition of residues of animal medicines (except for biologically active constituents)?
These are pharmacologically active substances (wether active principles, exipients or degradation products) and their metabolites, which remain in foodstuff obtained from animals that have been administered the animal medicine in question
What is the definition of Maximum residue limit (MRL)?
Maximum concentration level of residue resulting form administration of a animal medicine which is legally permitted in the community or recognised as acceptable in or on a food (we can get down to small amounts of level of medications that is safe for human consumption. There will be different withdrawal period for different produce)
What is the definition of withdrawal period?
The time between the last dose given to the animal and the time when the level of residues in the tissues (muscle, liver, kidney, skin/fat) or products (milk, eggs, honey) is lower than or equal to the MRL
How often are food-producing animals serveillanced (medicine residue in food) by the VMD?
Annually samples are taken
What do the VMD look for when surveillance food-producing animals?
Residues of licensed medicines, prohibited substances, other contaminants that impact the safety of food
What is a controlled drug?
Controlled drugs are listed in Schedules 1 to 5 of the Misuse of Drugs Regulations 2001 (MDR) - which categorises the drugs based on therapeutic usefulness and potential harm caused by misuse
What are the 5 schedules of controlled drugs (with examples) and where might they be stored?
Schedule 1 – ecstasy, heroin, cannabis. (highest use of abused, addiction)
Schedule 2 – morphine, fentanyl, ketamine, pethidine, methadone. (control, record use)
Schedule 3 – barbiturates, buprenorphine, tramadol, gabapentin (controlled drug cabinet)
Schedule 4 – diazepam, anabolic steroids. (POM-V)
Schedule 5 – (lower level strength) codeine/paracetamol (no/low use of abuse)
What is the prescribing cascade?
A provision in the Veterinary Medicines Regulations (VMR) that allows a veterinary surgeon to prescribe medicines to animals that would not otherwise be permitted.
If a suitable medicine authorised in the UK does not exist ⇒ use the prescribing cascade (‘off-license’ / ‘off-label’).
What is the purpose of the prescribing cascade?
To avoid causing unacceptable suffering and to treat the animal (welfare vs. economics).
We can still treating animals using medications that has not gone through the licencing process
What are the exemptions for small pet animals (ESPA)
Formerly known as the Small Animal Exemption Scheme (SAES).
Aims to improve availability of veterinary products for these species.
Does not require a marketing authorisation. - quick route of getting a product out there, the establishment needs to be authorised
Restriction: Does not include antibiotics and narcotic or psychotropic substances (anaesthetics). - protects/maintains control
Restricted to topical and oral administration routes, and fish medicines administered via the water.
Animals not for intended for human consumption. - eg rabbit used for food cannot have them only pet rabbits
Similar to AVM-GSL
What are the restrictions around advertising medicine?
Restriction depends on the distribution category of the medicine
POM-V can only be advertised to veterinary professionals and professional keepers of animals (farmers and owners of livestock)
Manufactures can only advertise based on the licensed use of the medicine (Cant use studies to advertise, and has to be within the license - you have to ask the right questions - if it was only advertised in dogs, you can ask manufacture if can use in cats for example then they can give the answer)
Educational material can be produced relating to the condition the medicine treats/prevents – manufacturers and veterinary practices must tread a fine line here! EG advert about fleas with maufacture logo not product
Why is nutrition important?
Body weight, Growth and bone development, Malocclusion, Dilated cardiomyopathy
What legislation is there around nutrition?
The World Small animals veterinary associations (WSAVA)
What do the world small animals veterinary associations do about nutrition?
They provide guidelines and assessment
What vital sign is nutrition?
The 5th
What are the three steps of the nutritional assessment?
Check in
Clinical assessment
Nutritional recommendation
What is included in the check-in part of the nutrition assessment?
To gain information on what they are currently eating and can be carried out as part of a checklist
What is included in a clinical assessment part of the nutrition assessment?
A body condition scoring (5 or 9 point scale) and muscle condition scoring
What does a body condition scoring measure?
The amount of fat
What does a muscle condition scoring measure?
The amount of muscle loss
What is included in the recommendations part of the nutrition assessment?
To change something like caloric intake, diet, feeding management, and/or environmental factors
Which minerals are important for development?
Calcium and phosphorus
What ratio should minerals be in?
1:1 to 2:1 calcium:phosphors
How do we know the nutritional value of a protein?
Biological value (amount that is digested)
What essential amino acid do cats require in their diet?
Taurine
What essential fatty acid do cats require in their diet?
Arachidonic acid
When might a deficiency in carbohydrates cause a problem?
When the animal has high energy demands - pregnancy and lactations
Why might a patient be fed a prescription diet?
When they have a disease
What diseases might we need to provide a prescription diet for?
Gastrointestinal, renal, hepatic, obesity, recovery, allergy, joint, neoplasia, brain, dental, cardiac, thyroid, urinary, diabetic, skin
What makes the prescription diets better than commercial diets?
To better support the patient
What is the normal renal function?
To excrete urea and creatinine (lose function of the kidneys)
What are the symptoms of chronic renal disease?
Azotaemia and uraemia, hyperphosphatemia, dilute urine, PUPD, hypokalaemia, hypertension, uraemia
What are the features of renal diets?
Change to protein, highly palatable, energy dense, restricted phosphorus, reduce sodium, potassium supplementation
What supplements can we use to support renal disease along with a normal diet?
Phosphate binders (calcium bicarbonate), supplement potassium
What are the normal hepatic (liver) functions?
Makes enzymes and proteins,
produces bile,
metabolism of protein, carbohydrates and fats,
manufacture, breakdown and regulates hormones
Break down drugs and toxins
Breakdown
RBCs
Storage of iron and vitamins
What happens to a patient who has hepatic disease?
Protein metabolism is reduced, which increases ammonia, which leads to hepatic encephalopathy
Reduced protein production which leads to a decrease in albumin
Decreases vitamin K production leading to blood clots
May see copper accumulation in some breeds
Hepatic lipidosis
What is hepatic lipidosis?
An increase in fat metabolism means that there are fatty deposits on the liver which impacts the liver function
What is Hepatic encephalopathy?
A serious neuropsychiatric condition caused by the liver dysfunction, leading to the accumulation of toxins in the bloodstream that affect brain function
What is changed in prescribed hepatic diets?
Change to protein, added soluble fibre, reduced sodium, L-carnitine, Vitimin K supplemented, Low copper, anti-oxidents, reduced fat
What are supplements to support hepatic disease?
SAMe = S-adenosylmethionine and milk thistle
What is diabetes?
Where insulin is not produced or ineffective
What does diabetes hyperglycaemia mean?
A toxic beta cell where insulin is produced but there’s not enough of it for a response that we want so the beta cells end up being damaged and less insulin is produced
How is diabetes treated?
With insulin injections but diet is important for disease management
What are some diet aims for diabetes?
To reduce fluctuations in blood glucose, encourage weight lose or maintenance
What are included in prescribed diabetic diets?
Low calorie, Complex carbohydrates, Increased fibre and/or water
What are included in prescribed diabetic diets in cats?
Low carbohydrates, high protein with good biological value, moderately low fat
What is congestive heart failure (CHF)?
A drop in arterial BP leading to hypotension
What are some compensatory measures of cardiac disease?
Sodium and fluid retention, vasoconstriction, increased HR and stroke volume
What are the prescription diets to support patients with cardiac disease?
Reduced sodium, supplemented with taurine (cats) and L-carnitine (levels drop), reduced phosphorus, high quality protein, omega-3 fatty acids, B complex vitamins
What health problems are associated with obesity?
Impact QOL, musculoskeletal, exercise intolerance, risk of anaesthetics, skin (matted fur), neoplasia, increased risk of tracheal claps, increased risk of diabetes, urinary tract disease, asthma
How do we reduce obesity in patients?
Exercise and reduce calories. A prevention is better than a cure
What is included in a prescribed obesity diet?
Reduced calorie, increased high-quality protein, increased fibre, L-carnitine, may contain joint supplements, balanced macronutrients and still getting other nutrients within the diet to prevent further issues
When a patient is on an obesity diet, how do we calculate differences and the aim of this?
THe calculation is based of the ideal weight of the pateint.
Aim - 1-3% body weight loss per week in the first 3 months then 0.5-2% at week, we lower the amount of food until we get the ideal weight then maintain it
How do we maintain body weight in an obese patient on a diet?
Once we reached the ideal weight to maintain it we increase the daily ration until the weight is stabilised
What drugs can we use in obese patients for weight loss?
Yarvitan, Sletrol, inhibits the protein involved in absorption of fat from the diet, reducing appetite as it makes them nauseous (is this ethical?). These are used short term.
What can we do in nurse clinics to help clients with nutrition?
Nutrition assessments then advise
What client support can we provide in obesity clinics?
Vital for successful weight loss, Motivate and encourage clients, Never be judgemental, Advise on appropriate diet and food reduction, food diary, encourage exercise
Client compliance is important to help with nutrition and diets. How do they help their pets?
Transition to a new diet, weighing all food, not transitioning to a new diet when they’re ill, owner reluctance - cost