Medication and where to get more information
Dec 31, 2016 23:30:56 GMT
pthurg and randomname like this
Post by titchycatnipsandwich on Dec 31, 2016 23:30:56 GMT
The Veterinary Medicines Cascade
Most of us will be familiar with having to sign a disclaimer at the vets to say we are happy to administer or have the vet administer medication. But what are we signing?
In the UK there is a piece of legislation from DEFRA that is mainly aimed at protecting consumers from the use of medicines in food animals, but which also is applied to pets. It is called "The Cascade" and sets the guidelines for using medication in animals.
www.gov.uk/guidance/the-cascade-prescribing-unauthorised-medicines
When prescribing a medication for your pet, the vet must follow these steps:
1. Is there a medicinal product which is licensed for the specific breed of animal for the specific condition? (Baytril is licensed in the UK for "small mammals", so degus are prescribed Baytril under this step if the vet follows 5mg/kg BD as per manufacturer guidelines)
2. Is there a medicinal product which is licensed for a different breed of animal for the same condition, or licensed in the same animal for a different condition? (Metacam is licensed for cats or dogs, depending on the product - degus getting metacam come under this step, as the product is licensed for pain in a different animal. Baytril at a dose other than 5mg/kg BD is also in this step, as it is being used in a way other than the licensed dose).
3. If neither of those steps are appropriate, one of the following may be considered:
A. Use of a UK licensed human product (I'll cover this in more detail below, but metronidazole (a human antibiotic) would be prescribed under this step)
B. A veterinary medicine not licensed in the UK, but licensed in the EU (under the Special Import Scheme)
C. An extemporaneously prepared product (the vet makes it themselves - ie crushing and dispersing tablets in syrup to make a suspension). This may also include a Specials Manufacture product, where the vet has outsourced production to a company specialising in extemporaneously prepared products (these tend to be hideously expensive).
4. If all else fails, a product from outside the EU may be used.
For the most part, your vet will dispense your pet's medication themselves. In situations where a UK licensed human product is used, you may receive a prescription to take to a community pharmacy for the pharmacist (a Suitably Qualified Person under the legislation) to dispense instead. This may be cheap or expensive depending on the pharmacy's fees - chains tend to have a set fee, independent pharmacies set their own charges for dispensing these and they range from acceptably priced to extortionate. You are allowed to ask for a guideline price and to shop around. It may also take a while, as pharmacists don't often see veterinary prescriptions (mostly, veterinary surgeons dispense medication themselves now) and the pharmacist may have to familiarise themselves with the law around processing a veterinary prescription.
If your pet is prescribed a medication that you can buy **for humans** over the counter or on a shop floor, officially you are not allowed to purchase it for a pet. If the pharmacist knows that you are going to use it for your pet, they are not allowed to sell the product. I am going to say no more on this bit
The paperwork you are signing is acceptance that your vet has followed the Cascade and you are using a medication off-label or off-license - this means that the manufacturer is liable for nothing , and the prescribing is your vet's responsibility. However, as you are administering under their instruction, you are sharing some of the liability if anything goes wrong (which we always hope never will happen, but can and might - so the vet needs you to be aware of the possibility).
Where can you find more information on the medication your vet has prescribed?
There are three main resources in the UK.
If your pet has been prescribed a UK licensed medication for pets, have a look at:
www.vmd.defra.gov.uk/ProductInformationDatabase/
It's a pain in the butt to navigate, but it has a search function and lists the Summary of Product Characteristics and Patient/Product Information Leaflets where available. The PAA simply lists any changes made to this official documentation.
If your pet has been prescribed an EU licensed medication for pets, or the VMD Product Information Database does not list your pet's medication, have a look at:
www.ema.europa.eu/ema/index.jsp?curl=/pages/medicines/landing/vet_epar_search.jsp&murl=menus/medicines/medicines.jsp&mid=WC0b01ac058001fa1c
It also has a search function and is slightly clunky to use, but again has SPCs for EU licensed medication. Things like Metacam are also listed here - it's licensed in the UK, but the VMD simply points you to the EMAR anyway. If you can't find your UK licensed product on the VMD, try here.
If your pet has been prescribed a UK licensed human product, look at:
www.medicines.org.uk
It lists the manufacturer's SPCs and PILs for the medication, and is fairly easy to search. However, if your pet has been given a human medicine, there will not be information on here about use of the human medicine in pets. For some medication, your vet will be able to give you a leaflet produced in-house with information about why this has been prescribed for your pet and any expected side effects.
If there's anything else you would like to know about on this, or if you're not able to find information on the medication your pet has been prescribed, send me a message and I'll try to help. This information is UK based, as I am a pharmacist working in the UK, but the information is all out there on the Internet to find for yourself if you want to. Your country may have similar legislation. However, in terms of general information, the VMD and EMAR are valid worldwide - it's simply that the specifics of licensing may vary by country.
Most of us will be familiar with having to sign a disclaimer at the vets to say we are happy to administer or have the vet administer medication. But what are we signing?
In the UK there is a piece of legislation from DEFRA that is mainly aimed at protecting consumers from the use of medicines in food animals, but which also is applied to pets. It is called "The Cascade" and sets the guidelines for using medication in animals.
www.gov.uk/guidance/the-cascade-prescribing-unauthorised-medicines
When prescribing a medication for your pet, the vet must follow these steps:
1. Is there a medicinal product which is licensed for the specific breed of animal for the specific condition? (Baytril is licensed in the UK for "small mammals", so degus are prescribed Baytril under this step if the vet follows 5mg/kg BD as per manufacturer guidelines)
2. Is there a medicinal product which is licensed for a different breed of animal for the same condition, or licensed in the same animal for a different condition? (Metacam is licensed for cats or dogs, depending on the product - degus getting metacam come under this step, as the product is licensed for pain in a different animal. Baytril at a dose other than 5mg/kg BD is also in this step, as it is being used in a way other than the licensed dose).
3. If neither of those steps are appropriate, one of the following may be considered:
A. Use of a UK licensed human product (I'll cover this in more detail below, but metronidazole (a human antibiotic) would be prescribed under this step)
B. A veterinary medicine not licensed in the UK, but licensed in the EU (under the Special Import Scheme)
C. An extemporaneously prepared product (the vet makes it themselves - ie crushing and dispersing tablets in syrup to make a suspension). This may also include a Specials Manufacture product, where the vet has outsourced production to a company specialising in extemporaneously prepared products (these tend to be hideously expensive).
4. If all else fails, a product from outside the EU may be used.
For the most part, your vet will dispense your pet's medication themselves. In situations where a UK licensed human product is used, you may receive a prescription to take to a community pharmacy for the pharmacist (a Suitably Qualified Person under the legislation) to dispense instead. This may be cheap or expensive depending on the pharmacy's fees - chains tend to have a set fee, independent pharmacies set their own charges for dispensing these and they range from acceptably priced to extortionate. You are allowed to ask for a guideline price and to shop around. It may also take a while, as pharmacists don't often see veterinary prescriptions (mostly, veterinary surgeons dispense medication themselves now) and the pharmacist may have to familiarise themselves with the law around processing a veterinary prescription.
If your pet is prescribed a medication that you can buy **for humans** over the counter or on a shop floor, officially you are not allowed to purchase it for a pet. If the pharmacist knows that you are going to use it for your pet, they are not allowed to sell the product. I am going to say no more on this bit
The paperwork you are signing is acceptance that your vet has followed the Cascade and you are using a medication off-label or off-license - this means that the manufacturer is liable for nothing , and the prescribing is your vet's responsibility. However, as you are administering under their instruction, you are sharing some of the liability if anything goes wrong (which we always hope never will happen, but can and might - so the vet needs you to be aware of the possibility).
Where can you find more information on the medication your vet has prescribed?
There are three main resources in the UK.
If your pet has been prescribed a UK licensed medication for pets, have a look at:
www.vmd.defra.gov.uk/ProductInformationDatabase/
It's a pain in the butt to navigate, but it has a search function and lists the Summary of Product Characteristics and Patient/Product Information Leaflets where available. The PAA simply lists any changes made to this official documentation.
If your pet has been prescribed an EU licensed medication for pets, or the VMD Product Information Database does not list your pet's medication, have a look at:
www.ema.europa.eu/ema/index.jsp?curl=/pages/medicines/landing/vet_epar_search.jsp&murl=menus/medicines/medicines.jsp&mid=WC0b01ac058001fa1c
It also has a search function and is slightly clunky to use, but again has SPCs for EU licensed medication. Things like Metacam are also listed here - it's licensed in the UK, but the VMD simply points you to the EMAR anyway. If you can't find your UK licensed product on the VMD, try here.
If your pet has been prescribed a UK licensed human product, look at:
www.medicines.org.uk
It lists the manufacturer's SPCs and PILs for the medication, and is fairly easy to search. However, if your pet has been given a human medicine, there will not be information on here about use of the human medicine in pets. For some medication, your vet will be able to give you a leaflet produced in-house with information about why this has been prescribed for your pet and any expected side effects.
If there's anything else you would like to know about on this, or if you're not able to find information on the medication your pet has been prescribed, send me a message and I'll try to help. This information is UK based, as I am a pharmacist working in the UK, but the information is all out there on the Internet to find for yourself if you want to. Your country may have similar legislation. However, in terms of general information, the VMD and EMAR are valid worldwide - it's simply that the specifics of licensing may vary by country.
