L5 + L8 – Rational drug selection and usage, and legislation – Flashcards
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What is empirical therapy?
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Drug selection base on prior (historical) experience.
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What is rational therapy?
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Drug selection based on detailed *risk/cost/benefit* considerations.
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What are the two approaches to drug therapy?
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Empirical and rational.
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What is the rational behind therapeutic decision making?
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1. Accurate *diagnosis* 2. Decide that drug treatment is *required*. 3. Choose *correct drug*. 4. Choose correct *formulation* and *route of administration*. 5. Choose correct *dosage regime* and *duration of therapy*. 6. *Supply/prescribe* drug.
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What affects drug formulation?
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- *Physiochemical* properties of drug. - The *barriers* that the drug is capable of passing. - The *setting* in which the drug will be used. - *Urgency* of the medical situation. - *Stability* of drug. - *First pass effect*.
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What aspects of the patient profile must be considered when choosing which drug to use?
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Age, physical state, health, genetic/breed/species difference, diet, mobility, circadian rhythms, drug interactions, client compliance.
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How does age affect the pharmacokinetics of a drug?
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Drug metabolising enzymes often *under-developed in paediatric* and *depressed in elderly*.
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What physical states are important when choosing drug therapy?
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Pregnancy, obesity, lean-ness
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What aspects of health affect drug therapy?
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E.g. reduced liver or kidney function --> reduced dose required. Particular problems in geriatric patients.
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What genetic/breed/species differences are important in the patient profile?
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Genetic differences may influence pharmacokinetics in cats. E.g. NSAIDs in cats, halothane in pigs, ivermectin in collies.
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Why is diet important and what about diet is important when choosing drug therapy?
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Influence on drug absorption, affected by changes in gastric motility, blood flow, barrier effect of food, type of meal, time between feeding.
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Why is mobility important in the patient profile?
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Sedentary vs mobile patients may have different absorption rates.
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Why is circadian rhythm important in the patient profile?
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*Time of day* may influence effects e.g. *adrenocorticoids*.
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What influences client compliance?
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Client commitment, vet-client communication, complexity of drug regime, improper administration, medication preparation, patient compliance (ease of administration).
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Example of a pharmacokinetic difference between species?
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Alterations in metabolism - *cats* have *slow* rates of *hepatic glucuronidation* so prolonged half-life of aspirin, morphine.
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Example of a pharmacodynamic difference between species?
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Morphine in cats and horses causing CNS excitability, xylazine between cattle, dogs, cats and horses.
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Example of a behavioural difference between species that may alter drug choice?
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Excessive licking in cats
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When is the rate of termination of therapy important?
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When *side effects* arise from *sudden ceasing* of treatment. E.g. cortisosteroids, drugs must be withdrawn to *prevent suppression of the HPA* and an *Addisonian crisis*.
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What are society's concerns with drug usage in animals?
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Efficacy in animal populations Safety in animal populations Safety of the food supply Susceptibility of human vs animal pathogens.
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What does the VMD do?
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Approves drug products, oversees distribution channels and manufacturing processes, records adverse reactions and inefficacy complaints, funds and conducts drug research related to regulatory concerns.
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What is the cascade system as it applies to food animals?
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Option 1: Product licensed for species and condition under treatment. Option 2: Product licensed for another condition in same species. Option 3: Product licensed for use in another species. Option 4: Product licensed for use in humans. Option 5: Special product made up by authorised person.
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If using options 3-5 in the cascade for food animals, what rules must you stick to?
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Only a small no. of animals at a holding may be treated. The product administered should only contain substances licensed in food animals. The product should be administered by a vet. Records kept.
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What information must be kept on the records when giving option 3-5 drugs from the cascade?
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Date of exam, owner details, diagnosis, product and dosags, no. animals treated, duration of treatment, withdrawal period (lack of...)
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How long must records of purchase, administration and supply be kept for drugs supplied to food animals? What information should they contain?
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3 years ID no. of product, batch no. of product, quantity prescribed, name and address of recipient.
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What is the cascade system as it applies to non-food animals?
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Option 1: Product licensed in that species for that condition. Option 2: Product licensed in that species for a different condition OR for use in another species. Option 3: Product licensed for humans Option 4: Special product made up by authorised person.
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Non-food animals: What is the ruling around giving animals options 2-4 drugs?
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Must be given in accordance with the instructions from the vet surgeon in whose case the animal is, and restricted to a small number of animals.
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What is the law around using cheaper human counterparts of drugs?
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Technically illegal! But unlikely to prosecute if alternative is animal receives no treatment at all.
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What are some factors considered by the drug industry during drug development?
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1. Number of doses used by the animal industry. 2. Cost to produce each dose. 3. Likely acceptance of dose regime. 4. Product performance. 5. Withdrawal period. 6. Need for product. Therapeutic equivalents?
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What are the different drugs according to the legislation of who can provide them?
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POM-V - supplied by vet or pharmacist with vet prescription. POM-VPS - Vet, pharmacist or suitably qualified person. NFA-VPS - Non-food animal medicine, vet, pharmacist or SQP. AVM-GSL - Authorised veterinary medicine, general sales list.
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What is POM-V?
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Prescription-only-medicine-Veterinarian.
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What is POM-VPS?
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Prescription-only-medicine-vet, pharmacist, SQP
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What is SQP?
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Suitably qualified person
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What is NFA-VPS?
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Non-food animal - vet, pharmacist, SQP
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What is AVM-GSL?
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Authorised veterinary medicine - general sales list.
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Which drugs must be prescribed with prior vet examination?
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*POM-V* (and also POM-VPS where possible)
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What information should be on the prescription document?
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Should state: *WHAT* is to be given and *TO WHOM* and *BY WHOM* prescribed. Should give instructions on: *HOW MUCH* should be taken and *HOW OFTEN*, by *WHAT ROUTE* and for *HOW LONG or TOTAL QUANTITY*. *WITHDRAWAL PERIOD* - if food producing animal. *SIGN and DATE*.
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What are the controls on drugs according to the 5 schedules of drugs under the misuse of drug regulations 2001?
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Schedule 1: Vet surgeons cannot possess them (cannabis, LSD). Possession required *home office license*. Schedule 2: Record each purchase and supply, keep *record for 2 years*, keep *locked up*, *destroy* drugs in presence of licensed person (Opioids, *ketamine*, fentanyl). Schedule 3: Keep *invoices for 2 years*, advised to keep locked up (buprenorhine, barbiturates, tramadol). Schedule 4: Fewer controls (anabolic substances, benzodiazapines - diazepam) Schedule 5: V. low strength preparations. Fewer controls. Exempt from full control when used in small amounts. Keep invoices for 2 years (Cocaine, codeine, morphine).
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How was ketamine's schedule recently changed?
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Previously schedule 4, now schedule 2 and Class B.
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What is required for schedule 2 and 3 drugs?
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A mandatory requisition form.
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The purchase and supply of which schedule drugs must be recorded in a CD register?
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Schedule 2
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How long is prescription for schedule 2 and 3 drugs valid?
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28 days
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For what schedule of drug must destruction be witnessed?
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Schedule 2
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What are the minimum statutory withdrawal periods?
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Milk = 7 days Meat from poultry and mammals = 28 days Meat from fish = 500 degree days
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What is the withdrawal period for drugs listed in the essential substances list?
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6 months
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If you are going to give an animal a medicine not authorised for the condition in the species being treated, where one is available, what should be obtained? What animals is this esp. important for?
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Consent from the owner in writing. Exotics, most medicines are unlikely to be authorised for use in the UK.
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Is it acceptable to use a one-off life long consent form for use of any and all off-label/off-license drugs?
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No.
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When is it acceptable to use a single life-long consent form for off-label drugs?
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But, where there is a *specific ongoing condition* requiring off-label drugs lifelong consent form may be used. AND, for *exotics* where there are no licensed medicines.
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Do NFA-VPS drugs have to be prescribed?
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No
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For what type of drug is must the animal be under your care and the vet have carried out a clinical assessment?
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POM-V
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What does 'under care' mean?
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Vet must have responsibility for health of animal or herd. Animal or herd must have been seen immediately before prescription recently enough that vet has knowledge of condition and status to diagnose and prescribe. Maintain records.
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For POM-VPS medicines, do the animals have to be under your care of have a clinical assessment?
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No
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How long is a prescription valid for?
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6 months
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What form can prescriptions be in?
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Oral or writing
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How many times may a prescription be used for?
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Only once, unless says its repeatable and must indicate no. repeats.
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What should be on a written prescription?
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Name, address and telephone of prescriber. Qualifications of prescriber. Name and address of owner. Identification of animal/herd. Premises animal kept at. Date. Signature of prescriber. Name and amount of product prescribed, dose instructions, warnings. Withdrawal period if present. If cascade.
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Is there a minimum age requirement on the VMR regarding handling of veterinary medicines?
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No minimum age.
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For which drugs must a dispensing label be attached?
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Drugs under the cascade
