Difference between revisions of "Drug Legislation"
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==Introduction== | ==Introduction== | ||
| − | The information | + | The Veterinary Medicines Regulations, which are revised and updated on an annual basis govern the supply and prescribing of veterinary drugs. The Veterinary Medicines Regulations replaced the Medicines Act 1968 in 2005. The Veterinary Medicines Directorate (VMD), which is a department of the Department for Environment, Food and Rural Affairs (DEFRA) check the safety and efficacy of veterinary drugs for owners, animals and the environment prior to a drug reaching the sales market. Once a drug is authorised, the VMD collect information from veterinary surgeons about suspected adverse reactions to medications. The VMD also inspect premises where veterinary drugs are manufactured, stocked or supplied to the general public and enforce the regulations where necessary. |
| − | + | In 2003 the Competition Commission investigated the supply of veterinary medicines, and an Order was drawn up by the Department of Trade and Industry to alter the way in which prescription only medicines (POMs) were supplied to the public in the UK. The aim of the order was to increase public awareness of the price of POMs, to encourage the use of prescriptions to give the public more choice of suppliers, and to increase the manufacturer’s supply of POMs to other outlets such as pharmacies. The Competition Commission’s involvement with veterinary medicines was to investigate trading conditions – in this case monopolies; it has no interest in drug safety or efficacy. | |
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| − | In 2003 the Competition Commission investigated the supply of veterinary medicines, and an Order was drawn up by the Department of Trade and Industry to alter the way in which prescription only medicines (POMs) were supplied to the public in the UK. The aim of the order was to increase public awareness of the price of POMs, to encourage the use of prescriptions to give the public more choice of suppliers, and to increase the manufacturer’s supply of POMs to other outlets such as pharmacies. The Competition Commission’s involvement with veterinary medicines was to investigate | ||
==Drug Classifications== | ==Drug Classifications== | ||
| − | + | There are four different categories of medication which should be displayed clearly on the label of any veterinary medication. | |
| − | *'''POM-V''' or prescription only medicine – veterinarian. Drugs in this class require a clinical assessment of the animal by a qualified vet; the animal must be under his or her care, and only the minimum amount of medication required for treatment should be dispensed. A prescription is always required but it need not be in writing if the vet who prescribed the medication also supplies it. Vets can delegate the handing over of a POM-V medicine to a ‘competent’ person proving that each transaction is individually authorised. The regulations do not define what competent means, but some evidence must be available for the vet to be able to justify delegating to the person concerned | + | *'''POM-V''' or prescription only medicine – veterinarian. Drugs in this class require a clinical assessment of the animal by a qualified vet; the animal must be under his or her care, and only the minimum amount of medication required for treatment should be dispensed. A prescription is always required but it need not be in writing if the vet who prescribed the medication also supplies it. Vets can delegate the handing over of a POM-V medicine to a ‘competent’ person proving that each transaction is individually authorised. The regulations do not define what competent means, but some evidence must be available for the vet to be able to justify delegating to the person concerned (such as attendance at a relevant Continued Professional Development (CPD) event), and a standard operating procedure for use by members of staff who give out POM-V drugs to clients is considered good practice under the regulations. Information must be given to the client on the safe use of the product, and the client must be evaluated as intending to use the product in the authorised manner. |
| − | *'''POM-VPS''' or prescription only medicine – veterinarian, pharmacist or | + | *'''POM-VPS''' or prescription only medicine – veterinarian, pharmacist or suitably qualified person (SQP). Medicines in this category also require a prescription, but the animal does not have to be clinically assessed or be under the care of a vet. Prescriptions must consider the health and wellbeing of the animal concerned, and can also be written by a pharmacist or a SQP operating from premises registered with the VMD. The vet can delegate the handing over of these medicines to a competent person (see above)and prices of POM-V and POM-VPS medications can be advertised to the public, but not the medications themselves. |
| − | *'''NFA-VPS''' or non food producing animal – veterinarian, pharmacist, | + | *'''NFA-VPS''' or non food producing animal – veterinarian, pharmacist, SQP. Medicines in this category do not require a prescription, but must be supplied by a vet, pharmacist or SQP and the supplier must ascertain if the owner is likely to use the drug in the authorised manner. Information must be given on the safe use of the medication. NFA-VPS medication can be advertised to the general public. |
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| − | ==RCVS Guidance on | + | ==RCVS Guidance on 'Animals under the care of a vet'== |
| − | The RCVS have outlined their interpretation of the requirement for an animal to be ‘under the care of the veterinarian’ | + | The RCVS have outlined their interpretation of the requirement for an animal to be ‘under the care of the veterinarian’; |
#The vet must have been given the responsibility for animal’s care by the owner or the owner’s representatives. | #The vet must have been given the responsibility for animal’s care by the owner or the owner’s representatives. | ||
#The animal must have been seen immediately prior to prescribing a POM-V drug, or recently enough for the vet to have personal knowledge of the animal’s condition and current health status. | #The animal must have been seen immediately prior to prescribing a POM-V drug, or recently enough for the vet to have personal knowledge of the animal’s condition and current health status. | ||
#The vet must maintain clinical records for that individual animal (or herd). | #The vet must maintain clinical records for that individual animal (or herd). | ||
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Revision as of 20:23, 31 August 2010
Introduction
The Veterinary Medicines Regulations, which are revised and updated on an annual basis govern the supply and prescribing of veterinary drugs. The Veterinary Medicines Regulations replaced the Medicines Act 1968 in 2005. The Veterinary Medicines Directorate (VMD), which is a department of the Department for Environment, Food and Rural Affairs (DEFRA) check the safety and efficacy of veterinary drugs for owners, animals and the environment prior to a drug reaching the sales market. Once a drug is authorised, the VMD collect information from veterinary surgeons about suspected adverse reactions to medications. The VMD also inspect premises where veterinary drugs are manufactured, stocked or supplied to the general public and enforce the regulations where necessary.
In 2003 the Competition Commission investigated the supply of veterinary medicines, and an Order was drawn up by the Department of Trade and Industry to alter the way in which prescription only medicines (POMs) were supplied to the public in the UK. The aim of the order was to increase public awareness of the price of POMs, to encourage the use of prescriptions to give the public more choice of suppliers, and to increase the manufacturer’s supply of POMs to other outlets such as pharmacies. The Competition Commission’s involvement with veterinary medicines was to investigate trading conditions – in this case monopolies; it has no interest in drug safety or efficacy.
Drug Classifications
There are four different categories of medication which should be displayed clearly on the label of any veterinary medication.
- POM-V or prescription only medicine – veterinarian. Drugs in this class require a clinical assessment of the animal by a qualified vet; the animal must be under his or her care, and only the minimum amount of medication required for treatment should be dispensed. A prescription is always required but it need not be in writing if the vet who prescribed the medication also supplies it. Vets can delegate the handing over of a POM-V medicine to a ‘competent’ person proving that each transaction is individually authorised. The regulations do not define what competent means, but some evidence must be available for the vet to be able to justify delegating to the person concerned (such as attendance at a relevant Continued Professional Development (CPD) event), and a standard operating procedure for use by members of staff who give out POM-V drugs to clients is considered good practice under the regulations. Information must be given to the client on the safe use of the product, and the client must be evaluated as intending to use the product in the authorised manner.
- POM-VPS or prescription only medicine – veterinarian, pharmacist or suitably qualified person (SQP). Medicines in this category also require a prescription, but the animal does not have to be clinically assessed or be under the care of a vet. Prescriptions must consider the health and wellbeing of the animal concerned, and can also be written by a pharmacist or a SQP operating from premises registered with the VMD. The vet can delegate the handing over of these medicines to a competent person (see above)and prices of POM-V and POM-VPS medications can be advertised to the public, but not the medications themselves.
- NFA-VPS or non food producing animal – veterinarian, pharmacist, SQP. Medicines in this category do not require a prescription, but must be supplied by a vet, pharmacist or SQP and the supplier must ascertain if the owner is likely to use the drug in the authorised manner. Information must be given on the safe use of the medication. NFA-VPS medication can be advertised to the general public.
RCVS Guidance on 'Animals under the care of a vet'
The RCVS have outlined their interpretation of the requirement for an animal to be ‘under the care of the veterinarian’;
- The vet must have been given the responsibility for animal’s care by the owner or the owner’s representatives.
- The animal must have been seen immediately prior to prescribing a POM-V drug, or recently enough for the vet to have personal knowledge of the animal’s condition and current health status.
- The vet must maintain clinical records for that individual animal (or herd).