L16 Prescribing and dispensing The prescribing cascade.pptx

Prescribing & Dispensing in Veterinary Practice: The Prescribing Cascade CP3.14 L7 Supporting The Patient Pat Pawson 2 Intended learning objectives Year ILO  CP3036 Explain the current guidelines and legislative requirements that apply when stocking, prescribing, dispensing and disposing of d...

Prescribing & Dispensing in Veterinary Practice: The Prescribing Cascade CP3.14 L7 Supporting The Patient Pat Pawson 2 Intended learning objectives Year ILO  CP3036 Explain the current guidelines and legislative requirements that apply when stocking, prescribing, dispensing and disposing of drugs used in veterinary medicine, including cytotoxic & controlled drugs.  CP3039 Judge courses of action against current guidelines and legislative frameworks to ensure safe working practices and protect personnel. Lecture content ILOs  Demonstrate ability to access information regarding use of the Cascade, Annexes, Essential List, Controlled Substances & Banned Substances.  List steps of the Cascade for both non-food & food-producing animals  Describe differences between prescribing for a food-producing horse & non-equine foodproducing animals, including use of Annexes & Essential List for horses.  Explain importance of following the Cascade & observing rules for competition horses, including consequences of irresponsible use of medicines in competitive equine sport. 3 Authorised veterinary medicines What does authorisation entail?     Assessment of quality, safety and efficacy Consider potential risks to environment, to animals, to operators and consumers Results in Summary of Product Characteristics (SPC) But a costly process … – – Many drugs have been developed for use in humans Only a fraction of drugs developed reach vet market 4 Unauthorised medicines  Problems with unauthorised medicines: – – –  May not be of consistent quality May not be safe and effective May pose a risk to consumers Where possible, an authorised product should be used – And used according to its SPC 5 Exemptions   Products administered for research (ASPA) Exceptional circumstances –   Disease outbreak Immunological products for imported or exported animals The Cascade.... 6 What is the cascade?  A mechanism to allow us to prescribe unauthorized medicines to our patients  – – – “Where there is no suitable veterinary medicine authorized in your territory for the specific condition in the animal being treated, to avoid unacceptable suffering, you are permitted to use your clinical judgement to treat animals under your care in accordance with the cascade.” Need to balance benefits and risks Ensure decisions are evidence-based Comply with routine veterinary practice (RVP) 7 Informed Consent  Seek informed consent – –  Recommended by RCVS Not a legal requirement RCVS Guide to Professional Conduct – 4.17 A decision to use a medicine which is not authorised for the condition in the species being treated where one is available should not be taken lightly or without justification. In such cases clients should be made aware of the intended use of unauthorised medicines and given a clear indication of potential side effects. Their consent should be obtained in writing. 8 Who can prescribe/dispense?    Only a veterinary surgeon may prescribe a medicine for an animal using the Cascade A pharmacist may dispense an authorised VMP for use under the Cascade, human medicines or extemporaneously prepared medicines against a prescription from a vet An SQP may dispense an authorised VMP for use under the Cascade against a prescription from a vet, provided they have the relevant qualification for that species 9 What about food animals? Extra regulations to protect consumer   Treatment restricted to single holding Active substance must have an MRL in a food producing (FP) species – –    GB MRL register NI Table 1: Allowed Substances Imported products must be authorised in a FP species in country of origin Vet must specify withdrawal period Vet must keep additional records 1 0 Maximum residue limit (MRL)  Maximum safe concentration of residue in a food following use of a veterinary medicine –     Drug or a metabolite Expressed in mg k g-1 (fresh weight) Legally permitted and recognized as acceptable in a food Not needed for active principles of biological origin intended to produce active or passive immunity Can be established or provisional (or “not necessary”) 1 1 Withdrawal period  Period of time, following treatment of an animal with a veterinary medicine, in which the meat, milk , eggs or honey from the treated animal must not enter the food chain due to the possible presence of residues. 1 2 Setting a withdrawal period  Responsibility to set an appropriate withdrawal period (WP) lies with vet –  Aim to ensure that the residue level is less than the MRL when animal product enters food chain How should you decide? – – – – Check the authorised WP in the SPC Was the medicine used in accordance with SPC? If not should set at least the “minimum statutory withdrawal period” Consider pharmacokinetics 1 3 Minimum statutory withdrawal period Withdrawal period must not be less than ...  7 days for eggs & milk  28 days for meat from poultry & mammals  500 degree days for fish meat  Zero withdrawal for homeopathic remedies, containing an active ingredient from Annex II 1 4 Setting a withdrawal period – – – Used at SPC dose in a dairy cow WP 12 hours Used at a higher dose in a dairy cow WP at least 7 days Used at SPC dose in a dairy goat WP at least 7 days 1 5 Withdrawal periods for imported products  If you import a drug & use it in accordance with the SPC in the country of origin, then apply the specified WP  If you use the product in a different way (species, route, dose etc) then apply the minimum statutory WP or the product WP, whichever is longer 1 6 Record keeping: unauthorised medicines in food animals Vet must keep records of the following: • • • • • • • • • • Date of examination Name and address of owner Animal ID and number treated Result of clinical assessment Trade name of product Batch Number Name and quantity of active substance Dose administered and/or supplied Duration of treatment Withdrawal Period Records must be kept for a minimum of 5 years 1 7 Consequences of … • UK will diverge from EU over time • Information: – – – GB = England, Scotland & Wales NI = Northern Ireland UK = England, Northern Ireland, Scotland & Wales 1 8 Step 1  A vet medicine authorised in GB or UK wide for use in the indicated species and condition 1 9 Step 2  A vet medicine authorised in NI for indicated species and condition  NB: Special Import Certificate (SIC) from the VMD is required 2 0 Step 3    A vet medicine authorised in GB, NI or UK wide for use in a different species (if a food-producing animal must be another food-producing species) OR A product authorised for another condition in the same species NB: If not authorised in GB or UK a SIC from the VMD is required 2 1 Step 4  A human medicinal product authorised in GB, NI or UK OR  An authorised vet medicinal product from outside the UK (need SIC) 2 2 Step 5  An extemporaneous preparation prepared by a vet, pharmacist or person holding a Manufacturer’s authorisation in the UK  Exceptional circumstances: – A human medicinal product imported from outwith the UK (SIC) 2 3 For vets in Northern Ireland 2 4 GB MRL Register  ALLOWED SUBSTANCES – Lists substances in which an MRL …  Has been established  Is being established  Does not need to be established 2 5 GB MRL Register  PROHIBITED SUBSTANCES – Lists substances in which an MRL …  Cannot be established  Any residue, at any level, is hazardous to human health 2 6 Northern Ireland   Allowed substances listed in Table 1 Prohibited substances listed in Table 2 2 7 Summary    Use a licensed drug FIR ST If there is no suitable authorised drug follow the Cascade You can use any drug listed in the GB MRL Register (Table 1: Allowed Substances) providing … – – – You can JUSTIFY why you are using it You apply an appropriate withdrawal period You preferably gain informed consent 2 8 Use of the cascade & prescribing for food animals  Veterinary medicines guidance on the cascade available via VMD website –  GB MRL Register –  https://www.gov.uk/guidance/the-cascade-prescribing-unauthorised-medici nes https://assets.publishing.service.gov.uk/government/uploads/system/upload s/attachment_data/file/1100404/MB_2__2097921-v1-MRLs_in_GB_edi table_version.pdf Tables 1 & 2 can be accessed via VMD or directly – https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32010 R0037 2 9 Horses as food animals    EU legislation Horse classified as a food animal Use of the cascade is different 3 0 Equine passports   Legal requirement for all horses in UK since 2009 Applicable to all equidae (horses, ponies, donkeys, zebras, exotic breeds) –  Contains identifying information for the horse – –   Except wild horses (e.g. Exmoor, New Forest) Microchip details Silhouette Section IX: Intention regarding human consumption Passport must remain with the horse at all times – except short hacks etc. 3 1 Before prescribing for a horse …  Check passport, if you do not have prior knowledge –  Check Section IX –  Make sure the passport relates to the horse Note whether or not the horse is intended for human consumption Seek informed consent where applicable 3 2 Horse declared “not for human consumption” …   Treat as for any companion, non-food animal Follow the normal cascade – – Always use a licensed product first Justify unlicensed or off-label use 3 3 Horse declared “for human consumption” … OR No declaration made …  Follow the food-animal cascade – – Use allowed drug from GB MRL Register Can also use drugs on the “Essential List” 3 4 Essential Substances List  Additional substances that can be used in horses intended for consumption – – BUT a minimum 6 month withdrawal period must be applied Only applies to horses 3 5 Horse declared “for human consumption” …  Medicines which cannot be administered   Anything in GB MRL register: Prohibited substances Medicines which can be administered – Anything listed in either  GB MRL register: Allowed substances OR  Essentials list 3 6 List of substances essential for the treatment of equidae                Acepromazine Atipamezole Diazepam Midazolam Flumazenil Sarmazenil Naloxone Propofol Tiletamine Zolazepam Dobutamine Dopamine Phenylephrine Dantrolene Hydroxyethylstarch • • • • • • • • • • • • • Ephedrine Glycopyrrolate Noradrenaline Buprenorphine Fentanyl Morphine Pethidine Atracurium Edrophonium Sevoflurane Guaiafenesin Bupivacaine Prilocaine 3 7 What if there is no passport …    Do not treat the horse if it is not immediately necessary to do so Treat the horse as ‘intended for human consumption’ in the first instance In an emergency, if health/welfare of horse is at risk treatment with a substance not allowed in food animals is permitted – Need to issue owner with detailed document of medicines administered and instruction to exclude horse from food chain 3 8 Record-keeping   If the horse is intended for human consumption or if no declaration has been made, the vet should make the entry into the passport if it is available It is not necessary for records to be kept for horses which have been declared as NOT intended for human consumption 3 9 Phenylbutazone  Cannot be used in a horse intended for human consumption –    Poses risks to human health No MRL set Not on the Allowed list in GB MRL register Not on the Essential List 4 0 Competition horses   Substances may be prohibited from use in horses entering affiliated competition Seek guidance from the affiliation website – Federation Equestre Internationale (FEI)  https://inside.fei.org/fei/cleansport 4 1 Competition horses   Veterinary surgeons involved, knowingly or unknowingly, with horses receiving prohibited substances may be subject to serious consequence Prohibited substances   Banned Controlled 4 2 Prescribing for horses  Veterinary medicines guidance on the equine prescribing available at VMD website –  GB MRL Register can be accessed via VMD or directly –  https://assets.publishing.service.gov.uk/government/uploads/system/upload s/attachment_data/file/1100404/MB_2__2097921-v1-MRLs_in_GB_edi table_version.pdf Essential Substances accessed via VMD or directly –  https://www.gov.uk/guidance/horse-medicines-and-recording-keeping-requir ements https://www.legislation.gov.uk/cy/eur/2013/122 Federation Equestre Internationale (FEI) – https://inside.fei.org/fei/cleansport