Dealers unknowingly selling illegal antibiotics

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A number of aquatic retailers and wholesalers may be unknowingly selling illegal fish disease treatments based on antibiotics, Practical Fishkeeping can exclusively reveal.

Several fish disease medications and medicated fish foods currently offered for sale by wholesalers and aquatic retailers contain an antibiotic constituent called nifurpirinol.

Nifurpirinol is a nitrofuran antibiotic and has been illegal to sell in the UK without a veterinary prescription for many years.

At least seven products based on the active ingredient are currently on sale in the UK.

Companies selling the products risk a hefty fine or prison sentence if they are found guilty of selling the medicines illegally.

Risking prosecutionVeterinary medicines sold in the UK must be authorised for sale by the Veterinary Medicines Directorate, but a wide range of products sold for treating diseases in aquarium fishes have been made exempt under the Small Animal Exemption Scheme in Schedule 6 of the Veterinary Medicines Regulations 2006.

Antibiotics, such as nifurpirinol, are not among them and the medicines have been illegal to sell in the UK without a veterinary prescription for a considerable length of time.

The introduction of the Small Animal Exemption Scheme may have led some suppliers to believe that they could now sell the antibiotics legally.

Simon Hack, Head of the Enforcement Team at the Veterinary Medicines Directorate (VMD), an executive agency of the Department for Environment, Food and Rural Affairs (Defra), told Practical Fishkeeping:

"Antibiotics are not included under the Schedule 6 Small Animal Exemption Scheme. The sale of such products under this Scheme is illegal."

The VMD considers antibiotics to be veterinary medicines that require veterinary control, so they are not legal to sell without a prescription.

Hack explained: "Seizure Notices issued in accordance with the Veterinary Medicines Regulations 2006 allow us to remove these products from the market, with a view to destroying them. Our aim is get these products off the market. There is an appeals procedure with regards the issue of these Notices.

"In the case of antibiotics sold under the Schedule 6 banner, there is no recourse to appeal. Such products require a marketing authorization, and do not fall within the Scheme. We actively pursue cases of illegal marketing, sale and use of veterinary medicines, and have had a number of successful prosecutions resulting in thousands of pounds worth of fines."

Trade confusionPractical Fishkeeping magazine contacted one online retailer in October who was selling two of the illegal antibiotics, who said:

"I have spoken at length to my supplier and he was assured by the manufacturer that this product is licenced for the UK. As the sole importer of all this manufacturer's range, I have to assume he did his checks properly."

The UK importer who supplied the product, and was offering three nitrofuran-based medications, told Practical Fishkeeping that he had checked the legality of it with the manufacturer before taking on the range:

"When we took on the distribution of this product, we spoke to the supplier regarding this and I have two emails from him saying there are no problems whatsoever regarding the product."

The importer has subsequently withdrawn the products from the UK and returned the affected stock to the manufacturer.

While two of the manufacturers of the antibiotics volunteered to withdraw their products from the UK market when contacted by Practical Fishkeeping, one remained adamant that it was not breaking the law by supplying the product in the UK.

It told Practical Fishkeeping that the product was legal to sell elsewhere in the EU without prescription and since "EU law was superior to UK law", the product were therefore legal to sell here.

The Veterinary Medicines Directorate said that the EU Directive did allow member states to permit exemptions on their territory for certain veterinary medicines, however, this does not apply to those that require veterinary control, such as antibiotics.

Hack said: "In the UK, antibiotics are classified as POM-V - medicines requiring a prescription, and therefore veterinary control. So no, it is not legal to sell antibiotics under Schedule 6 in the UK. Antibiotics are not included within this exemption. In this case, EU law is not superior to UK law."

Schedule 6The Small Animal Exemption Scheme falls under Schedule 6 of the Veterinary Medicines Regulations 2006.

The Scheme applies to medicinal products intended solely for the following non-food producing animals, aquarium fish, cage birds, ferrets, homing pigeons, rabbits, small rodents and terrarium animals.

Medicines marketed under the Scheme are exempt from the rigorous procedures required for those products requiring a marketing authorization.

Manufacturers' sites must conform to GMP (Good Manufacturing Practise) standards and must be inspected by the VMD in order to comply.

Sites based in other member states in the EU can be inspected by their own country's officials, but those outside the UK, excluding Australia, Canada, New Zealand and Switzerland, will need to be inspected by the VMD, and the manufacturers must foot the bill for the expenses incurred.

All aquarium medications on sale need to be repackaged and must include a declaration that they are being marketed under Schedule 6 of the Veterinary Medicines Regulations.

Manufacturers have until November 2007 to comply with the regulations if they are to avoid the possibility of prosecution.

Indiscriminate useThe indiscriminate use by fishkeepers of antibiotics, such as nitrofurans, has been implicated in the emergence of a number of multi-resistant strains of bacteria, including some that affect humans.

Nifurpirinol, or 6-hydroxymethyl-2-pyridine to give it its full name, is a synthetic antimicrobial nitrofuran and has been widely used to treat a number of fish diseases.

The drug is a member of the nitrofuran family of compounds and has been shown to have mutagenic and carcinogenic effects. As a result it has been banned from use on food animals for several years.

Fish health consultant Dr Peter Burgess told Practical Fishkeeping: "The indiscriminate use of antibiotics increases the chances of antibiotic resistance, which is a huge problem.

"I think this underlines the fact that if people start self-prescribing antibiotics, without receiving veterinary advice, that there is a risk that they will prescribe the wrong one and they could cause themselves harm, or cause their fish harm through their ignorance."

Retailers and wholesalers are advised to check the active ingredients lists on product packaging for references to nifurpirinol.

Further informationThe Veterinary Medicines Directorate is in the process of contacting all UK aquatic retailers to inform them of the changes in the legislation regarding the sale of medications.

Simon Hack is speaking at the forthcoming Ornamental Aquatic Trade Association Conference today on the introduction of the Small Animal Exemption Scheme under Schedule 6 of the Veterinary Medicines Regulations 2006 and how it affects the ornamental fish industry.

For details on veterinary medicines and the Small Animal Exemption Scheme, please contact the Veterinary Medicines Directorate at www.vmd.gov.uk.