Medicines News October 2020
Medicines news
Regulatory changes during the COVID-19 pandemic
VMD medicine inspections
On-site VMD inspections resumed on 24 August.
RCVS Practice Standards Scheme (PSS) assessments (which incorporate the VMD inspection for PSS member practices) will resume from 19 October, but will be conducted remotely. Click here for more details.
Temporary relaxation of enforcement of regulations ended
On 31 August the VMD ended the temporary relaxation of enforcement of regulations related to the prescribing and supply of veterinary medicines. In view of the continuing and unique challenges posed by the COVID-19 pandemic, the relaxations concerning the temporary change of veterinary practice and SQP retailer premises and the arrangements for SQP remote prescribing and authorisation of supply may be re-applied in exceptional circumstances, where:
the veterinary practice premises/SQP retailer is located in an area where the Government has deployed local lockdown measures; and/or
a veterinary surgeon/SQP needs to self-isolate as they have tested positive for the virus or due to contact tracing.
Click here for more details.
For current RCVS guidance on remote prescribing click here
Newly marketed medicines
There is usually a delay between a product receiving a marketing authorisation from the VMD or EMA and being available for use. Manufacturers have announced that the following new products are now available:
prednisolone tablets 50mg (Equipred – Virbac) for horses (first authorised November 2019). POM-V. This is the first equine prednisolone in tablet form. There is an exisiting oral podwer formulation for horses (Equisolon).
cefalexin suspension for injection (Ceporex – MSD) for cats, dogs and cattle. Not a new medicine, but this formulation (the only veterinary authorised injectable cefalexin) is now available after being out of stock in the UK for a long period. POM-V.
New veterinary medicine authorisations
The following medicines have been authorised by the VMD in the past month. Newly authorised medicines usually do not appear on the market for several months.
Newly authorised medicines for small animals and horses
suxizubone granules (Danilon Equidos Gold – Elanco) for horses and ponies. POM-V.
procaine benzylpenicillin solution for injection (Primopen – DUGV (UK) Ltd) for horses, cattle, pigs.
Newly authorised medicines for food-production animals
Marek’s disease virus vaccine (Cevac MD Rispens – Ceva) for chickens. POM-V
cloprostenol solution for injection (Cevaprost – Ceva) for cattle. POM-V
ketoprofen + tulathromycin solution for injection (Draxxin Plus – Zoetis) for cattle. Treatment of bovine respiratory disease (BRD) associated with pyrexia due to Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis susceptible to tulathromycin. This is the first tulathromycin product to incorporate ketoprofen. POM-V
procaine benzylpenicillin solution for injection (Primopen – DUGV (UK) Ltd) for horses, cattle, pigs.
Changes to product information – small animals and horses
Caniphedrin tablets for dogs (ephedrine hydrochloride). Addition to the adverse effects section: “Due to the pharmacological properties of ephedrine the following effects can occur at the recommended therapeutic dose: cardiovascular effects (like tachycardia, atrial fibrillation, stimulation of the heart activity and vasoconstriction); stimulation of the central nervous system (leading to sleeplessness, excitation, anxiety and muscle tremors); mydriasis; bronchodilatation and decrease of mucus release in the respiratory mucosal membranes; reduction of the motility and tone of the intestinal wall.”
Cestem flavoured tablets for dogs (febantel + praziquantel + pyrantel) Addition to the adverse effects section: “Gastro-intestinal signs (vomiting, diarrhoea), possibly associated with lethargy, have been observed very rarely in spontaneous reports.”
Changes to product information – food-production animals
Coxevac suspension for injection for cattle and goats (Coxiella burnetii) Addition to adverse effects section for cattle: “Systemic signs as lethargy, hyperthermia and/or anorexia have been observed rarely in post marketing safety experience.
Nobilis ND Clone 30 Live for chickens and turkeys (Newcastle disease virus). Addition of new claim for associated non-mixed use of Nobilis ND Clone 30 Live with Innovax-ILT or Innovax-ND-IBD.
You can view the up-to-date SPCs for all the products on the VMD product information database.
Our purpose...
......is to provide busy veterinary professionals with impartial information on veterinary medicines with which to make treatment decisions in the best interests of animals, their owners and the environment. We mainly do this through the Virtual Veterinary Medicines Academy where our evidence-based peer-reviewed appraisals are the result of a rigorous research and editorial process and are presented succinctly in our multi-media CPD modules. We’re independent: we don’t sell ads, or receive commercial support. We’re funded by subscribers so you can be sure the information we provide is completely objective. Subscribers get unlimited access to the Virtual Veterinary Medicines Academy.