The Department of Agriculture, Food and the Marine (DAFM) has provided some clarity on the recently signed Veterinary Medicinal Products Regulations 2024 and how they will affect farmers.
The regulations provide for the upregulation of all antiparasitics to prescription-only medicine (POM) status. This means that antiparasitics will now be available only on foot of a veterinary prescription issued by a vet.
The regulations, which are introduced under the Veterinary Medicinal Products, Mediated Feed and Fertiliser Regulation Act, were signed into law by Minister for Agriculture, Food and the Marine, Charlie McConalogue.
Veterinary Medicinal Products Regulations 2024
What is the purpose of these regulations?
These regulations provide for a range of matters including: the retail, handling and storage and supply of veterinary medicinal products, as well as the prescribing and dispensing of these products.
The regulations aim to protect animal health and welfare, and public health by addressing antimicrobial and antiparasitic resistance and promoting prudent use of veterinary medicinal products.
How do the regulations address antimicrobial resistance (AMR)?
The regulations aim to address AMR by promoting prudent use of antimicrobials, and provide for the introduction of a mandatory electronic National Veterinary Prescription System (NVPS).
The NVPS will provide greater oversight of veterinary medicinal products and in particular antimicrobials. This will allow better assessment of current actions to curb the development and spread of AMR detailed in the One Health action plan 2021-2025.
When will use of the NVPS be mandatory?
A commencement order for the NVPS will be drafted in due course. It is intended that use of the NVPS will be mandatory from mid-January 2025.
From this date, all veterinary medicinal products (with the exception of antiparasitics) will be required to be prescribed and dispensed using the NVPS.
The requirement for a prescription for antiparasitics will be introduced in June 2025 and after that all must be prescribed using the NVPS.
How do the regulations address antiparasitic resistance?
The regulations aim to address antiparasitic resistance by ensuring prudent use of veterinary medicinal products. This includes:
- The up-regulation of all antiparasitics to prescription-only medicine (POM) status, whereby they can only be purchased or supplied on foot of a veterinary prescription;
- The reduction in the prescription validity period for antiparasitics to six months.
Why do antiparasitics need a prescription when they were available over the counter until now?
Until now, Ireland availed of a derogation to allow the vast majority of antiparasitics to be supplied over the counter without a prescription.
The up-regulation of antiparasitics to POM for food-producing animals is a result of a determination in 2019 by the Health Products Regulatory Authority (HPRA) that Ireland no longer met the criteria to avail of the derogation based on a growing problem with antiparasitic resistance and the risk of environmental contamination.
Antiparasitic resistance threatens the sustainability of the grass-based pasture production model in Ireland as parasitic disease is a major challenge to the health and welfare of animals and impacts farm productivity, farm profitability and food security.
This change brings Ireland into line with the rest of the EU in relation to the supply of antiparasitics for food-producing animals.
Why are POM(e) vaccines not available in retailers including co-ops?
There has been no change to the route of supply for prescription-only medicine (exempt) (POM(e)) vaccines. These vaccines can only be supplied by vets or pharmacists and were never permitted for supply by any retailers.
The HPRA has determined that these vaccines are used in relation to complex diseases, and therefore there is a need for professional point-of-sale advice regarding effective use, safety risk associated with use, and disposal of unused vaccine or vaccine containers.
Impact on vets, farmers, retailers and pharmacists
How will the regulations impact veterinary practitioners?
From mid-January 2025, all veterinary practitioners will be required to use the NVPS when issuing a prescription. From June 2025, all antiparasitics will require a veterinary prescription.
When prescribing antiparasitics, a veterinary practitioner is required to complete a proper assessment protocol if he or she is not providing ongoing veterinary services to the farmer, including clinical contact with the animals.
In terms of record keeping, vets are required to keep a statement justifying the prescribing of an antimicrobial, in particular for preventive use or group treatment.
How will the regulations impact farmers?
From mid-January, farmers will be receiving electronic prescriptions from their vet in place of paper prescriptions.
The introduction of the NVPS will offer greater choice to the farmer as to where they purchase their medicines as prescription is issued via email and text message to the farmer.
Farmers will be able to access veterinary medicines through the same supply channels as before now. When the requirement for a prescription for antiparasitics is introduced in June 2025, the proper assessment protocol will facilitate access to antiparasitics through licensed retailers and co-ops.
The requirement for a prescription for antiparasitics will ensure prudent prescribing and use, thus improving animal health and efficiencies at farm level.
How will the regulations impact retailers?
From mid January 2025, retailers will be required to use the NVPS when dispensing prescription-only medicines. From June 2025, retailers will require a veterinary prescription in order to supply antiparasitics.
How will the regulations impact pharmacists?
From mid-January 2025, pharmacists will be required to use the NVPS when dispensing prescription-only veterinary medicines. From June 2025, pharmacists will require a veterinary prescription in order to supply antiparasitics.