Topic: Veterinary Medicines Directorate

The Veterinary Medicines Directorate has ruled that it will likely censor any individual or journalist who talks about a veterinary prescription medicine on social media.

The VMD's ruling sets a chilling precedent for the curtailment of free speech by a Government body.

The ruling came to light after VetNurse.co.uk published an independent video news report relating to the launch of Bravecto Injectable, a new yearly flea treatment for dogs.

The film was neither paid for nor commissioned by the manufacturer, and nor did the maker exercise editorial control over its content.

The film was clearly labelled for and aimed at veterinary professionals, and its intent was not to promote the sale or supply of a prescription medicine, but rather to inform vets and nurses about the new product, albeit in an enthusiastic manner.

It was therefore not an advertisement, but journalism.

The Dictatorship nevertheless argued that it defines any social media content that mentions the brand name of a prescription veterinary medicine and which does not give a balanced overview of all the other treatment options for a given condition, as an advertisement.

This, it said, is regardless of whether content is created by the manufacturer or supplier of drug to promote sales of their product, or any member of the public or journalist who just wants to talk about or report on a prescription medicine publicly without any intent to promote sales.

The Dictatorship's position is that any such content can only appear in spaces dedicated to the appropriate audiences.

Notwithstanding the fact that all of VetSurgeon.org's social media channels are dedicated to the appropriate audiences, it leaves us in the almost laughable position where, according to the VMD, the BBC is allowed to report about powerful prescription medicines for humans in a way that inevitably promotes their supply, but VetSurgeon.org cannot report the launch of ... wait for it ... a flea treatment. 

However the VMD then shared its incontinent interpretation of the law in a series of emails in which it was unable to provide a consistent definition of where it would allow content about prescription veterinary medicines to be published. 

It first claimed (without any supporting evidence of any law to this effect), that:

The National Office of Animal Health and the Veterinary Medicines Directorate have issued a joint statement concerning the supply of veterinary medicines when the UK leaves the EU, deal or no deal.

"The majority of veterinary medicines used in the UK (and ingredients and components to make them) are either produced in or enter via the EU. The government is working with animal health companies who have been carrying out extensive contingency planning for all EU Exit scenarios, including no deal. These plans cover all aspects of their supply chains, from regulatory compliance and stocking levels to logistics and customs. They also include, as appropriate, increasing stocks of products in the UK, changing supply routes, transferring marketing authorisations and other regulatory processes. 

"To reduce any risk to medicines availability in the UK, detailed planning is ongoing to ensure that supply chain measures are appropriate to address the sector’s complex needs and priorities.

"Much work has been done by companies with the objective of ensuring fair and appropriate distribution of this inventory to avoid disruption.

"Supply is expected to cope with a normal ordering pattern with adequate forward planning and communication with suppliers.

"With this planning in place, we are confident that we have made every effort to ensure continuity of supply of veterinary medicines in the UK."

Well that makes a nice change from the incessantly and determinedly gloomy picture painted elsewhere.

The Veterinary Medicines Directorate has suspended ten drugs for food-producing animals which contain the excipient diethanolamine (DEA), after advice from the Committee for Medicinal Products for Veterinary Use (the scientific advisory committee to the European Medicines Agency) about its carcinogenic risk to humans.

All bar one of the suspended drugs contain the NSAID flunixin. The other affected drug is the antibiotic, Tribrissen:

• Allevinix 50 mg/ml Solution for Injection for Cattle, Pigs and Horses (Ceva Animal Health)

• Cronyxin Injection, 5% w/v Solution for Injection, for cattle and horses (Cross Vetpharm Group Ltd)

• Dugnixon 50 mg/ml Solution for Injection for Cattle, Pigs and Horses (Global Vet Health S.L.)

• Finadyne 50 mg/ml Solution for Injection for cattle, pigs and horses (Intervet UK Ltd)

• Flunixin 50 mg/ml Solution for Injection for Cattle, Horses and Pigs (Norbrook Laboratories Limited)

• Meflosyl 5% Solution for Injection for horses and cattle (Zoetis UK Limited)

• Norixin 5% Solution for Injection for cattle and horses (Norbrook Laboratories Limited)

• Pyroflam 50 mg/ml Solution for Injection for Cattle, Horses and Pigs (Norbrook Laboratories Limited)

• Tribrissen 48% Suspension for Injection for horses, pigs and cattle (Intervet UK Ltd)

The British Equine Veterinary Association says that the decision to suspend the drugs was taken without consultation with the veterinary profession, and is urging the VMD to overturn the suspension in horses not destined for the human food chain, to reduce the potential impact on equine welfare.

The Veterinary Medicines Directorate (VMD) has published its Pharmacovigilance Annual Review 2015, which reviews 5674 reports of adverse events in animals, humans and the environment following the use of veterinary medicines over the course of the year.

5638 events were reported spontaneously, mainly by the marketing authorisation holder (61%), with the remainder largely reported by veterinary surgeons. 

Of these, 5512 were reports of adverse reactions in animals: 829 concerning suspected lack of efficacy, 4638 concerning safety. The majority of reports concerned dogs (2927), cats (1426) and cattle (386).

In dogs, medicines for the control of epilepsy were most often suspected of not having performed as expected (80 reports) whilst vaccines were most commonly reported as having failed to work (71).  However, the VMD points out that in many cases, vaccination failure was attributable to other causes (such as incomplete vaccination schedule).

In cats, flea spot-on products were most likely to be reported as not having worked (21). However, there are many reasons why owners may continue to see live fleas on their animal which are unrelated to product efficacy (such as reinfestation from the environment). 

Notably, the majority of efficacy reports in horses (12/19) related to euthanasia products, which the report says should serve as a reminder that alternative means of euthanasia should always be available in case the chosen method does not proceed as planned.

Of the safety reports, 59.6% involved dogs, 31% cats, 4.9% horses and 3.9% rabbits. The majority concerned vaccines (1360 reports, most commonly general signs or symptoms, such as lethargy or pyrexia), parasiticides (472 reports, most commonly lethargy, emesis, inflammation/pruritus, depending on method of administration) and inflammation control (412 cases, most commonly emesis, renal insufficiency and diarrhoea, depending on the drug type).

There were 124 reports of adverse events in humans. Of those involving veterinary professionals (about a quarter):

• There were two cases where owners were injured by a vet with a needle. In one case, despite the owner washing and disinfecting their hands immediately, the hand became too swollen to move and required anti-histamines and anti-inflammatories.
• A veterinary nurse developed a sore eye when vaccine was squirted into it as the needle came off the syringe. The symptoms resolved the following day.
• A veterinary surgeon reported brief periods of numbness around an injury sustained from a needle used for a rabies vaccination.
• A veterinary surgeon reported injection site pain after inadvertently injecting a small volume of a macrolide antimicrobial into his thumb. 
• A veterinary surgeon scratched his finger with a needle he had used to administer tilmicosin, and he thought a drop may have entered the wound. Nevertheless he did not seek medical attention until more than 3 hours later. Fortunately no treatment was required. 
• A veterinary surgeon pricked her finger with a needle on a syringe full of alfaxalone. No product was injected and she experienced no other symptoms than bleeding and pain from the puncture wound. 
• A veterinary surgeon was administering pentobarbital to a cat when the needle came off the syringe and between 1 and 20 ml of product squirted back into her eyes and mouth. She rinsed her eyes and mouth, drank some water and ate a banana. 45 minutes later she felt tired and ‘fuzzy’. She spoke to her GP by phone, but did not attend the surgery or receive treatment. She recovered within 3 hours. 
• A locum veterinary nurse developed swelling around an injury on her hand from a needle on a syringe of medetomidine. She had punctured a blood vessel, but thought only a small amount of product was injected. She felt light-headed and was monitored in hospital for a couple of hours, after which she returned to work with no lasting effects. 
• Two veterinary surgeons and a pet owner suffered needle stick injuries whilst an anti-emetic was administered to an animal that was being restrained by the owner. 

The VMD says that reports of needle stick injuries involving vaccines with a mineral oil adjuvant are of particular concern, because they often fail to show that the injured party has received prompt and correct treatment, either because they are themselves unaware of the necessity for swift intervention, or because they do not take the product package information leaflet with them when seeking medical treatment. 

Similarly, the VMD says that incidents involving injectable tilmicosin seem to be often dismissed as just a scratch, and that if you use these products, you should make sure you are fully aware of the warnings contained in the product leaflets.

To read the full report, visit: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/608968/PhV_Annual_Review_2015_v7.pdf 

Following ongoing lobbying by the British Veterinary Association and others, the Veterinary Medicines Directorate has dropped controversial plans for a new veterinary medicines category - POM EA (prescription-only medicine extended administration).

The proposed category has been discussed at the Veterinary Products Committee (VPC) since 2009. The original purpose was to provide a new category under which a veterinary surgeon would make a clinical assessment and, if appropriate, issue a Veterinary Permission of Extended Administration (VPEA) allowing the animal holder to obtain the prescribed POM EA medicine (from a veterinarian, pharmacist or SQP) for up to 36 months from the date of authorisation.  

The BVA, along with its specialist divisions, says it opposed POM EA from the outset and failed to see that there was any justification for a new category. Veterinary surgeons are already able to write prescriptions for extended use and, as most health plans are reviewed annually, anything beyond a yearly assessment would be unacceptable on health and welfare grounds. An additional category would have also taken the UK even further out of step with the rest of the EU.

The BVA submitted written comments and attended a stakeholder meeting with the VMD to discuss concerns. Despite the VMD suggesting revisions to the original proposal the BVA and other stakeholders maintained that the new category was unnecessary.

Following these consultations, the VPC decided, at a meeting in March, not to progress the proposal any further.

Harvey Locke, President of the BVA, said: "We are extremely pleased that the Veterinary Products Committee has listened to our concerns and decided to drop its plans for POM EA.

"The BVA felt strongly that the proposed new category was unnecessary at best and potentially harmful to animal health and welfare at worst.

"In all fields of practice veterinary surgeons would not feel comfortable prescribing for such long periods without regular contact with the animals they care for."

Alternative remedies which could be dangerous to pets are being targeted by the Government in a major drive to improve animal health and welfare.
 
Some herbal and homeopathic products are claiming medicinal benefits without scientific proof, meaning they may not properly treat or prevent serious diseases, leaving pets at risk.

The Veterinary Medicines Directorate’s (VMD) Director of Operations, John FitzGerald, said: "Some of these products are claiming to be effective and safe when no scientific evidence has been presented to us to show they are.

"Animal owners have a right to know if a product does what it claims. The products claim to treat diseases which can cause serious welfare problems and in some circumstances kill animals if not properly treated. So in some cases owners are giving remedies to their pets which don’t treat the problem."

A number of unauthorised products are being targeted, including:

• Homeopathic ‘nosodes’ - which are derived from diseased animal tissues, in the belief they act as a vaccination to prevent infection.
• Animal food supplements - known as neutraceuticals, which claim to treat diseases or bring extra health benefits such as improved mental ability in pet animals.
• Herbal liquids, powders and pellets - sold as herbal wormers - claiming to irritate and repel parasitic worms from the guts of horses, livestock, and pets.

From now on, the VMD will be contacting manufacturers to ensure that they demonstrate the products are safe and provide the benefits which they claim to. If this is not the case the manufacturers will be required to re-brand the products to make it clear they are not medicinal.

Supporting the action, British Veterinary Association President Harvey Locke said: "As veterinary surgeons we rely on the use of safe, effective and quality medicines for the health and welfare of animals under our care – and there must always be sound scientific evidence to back up medicinal claims made by the manufacturer of any product.

"Some of these unauthorised products may at the least be ineffective and at worst could cause harm because serious life-threatening diseases may go undiagnosed. We would urge animal owners always to check with their veterinary surgeon before giving any remedy or supplement to their pet."