Coronavirus: Prescribing & authorisation of supply
AMTRA has welcomed an important change in enforcement policy from VMD in the light of the Covid-19 epidemic.
As you will be aware, the normal obligations on you as a RAMA (SQP) under the Veterinary Medicines Regulations and the associated Code of Practice are that when a POM-VPS or NFA-VPS product is supplied, you must:
a. hand over or despatch the product personally; or
b. ensure that, when the product is handed over or despatched, you are in a position to intervene if necessary – in practice this means physically present, able to observe what is happening, and being able to intervene; or
c. check the product after it has been allocated for supply to a customer, and be satisfied that the person handing over or dispatching it is competent to do so.
In the current circumstances, if the only available RAMA/SQP is self-isolating, those requirements would prevent in-person supervision. Enforcing those rules would also limit the possibility for the RAMA to be working from home in an effort to limit the number of people on the business premises.
Change during the COVID-19 pandemic
In view of the unique challenges caused by the COVID-19 pandemic, the VMD is adopting the approach set out below to the enforcement of the above requirements until at least 30 June 2020 – and given the current uncertainties, this date may be amended by further notice from time to time.
In practice, this means that during the current period RAMAs will be allowed to prescribe and authorise supply remotely, provided the following procedures are observed. The RAMA is still responsible for the prescription and supply and therefore must:
• be the person that has the conversation/consultation with the animal owner;
• be the person that makes the prescribing decision;
• be satisfied that the person handing over or dispatching the prescribed product is competent to do so.
The RAMA must then instruct (in writing or orally) the person at the premises from which the physical supply is to be made (normally authorised premises) to hand over or dispatch the specific medicine that the RAMA has prescribed.
RAMAs must record details of their conversations with clients, including the information gathered on which their prescribing decisions are based, so they can ensure consistency with their own records and the records of the supplies at the relevant approved premises.
If they’re orally instructing a person at those premises to hand over/dispatch the product, the RAMA must also record that person’s name, the date and time, and their prescribing instructions.
The documentation and records must be kept for at least 5 years.
Please see VMD’s full statement for full details.
This changed approach to enforcement by VMD will be mirrored by AMTRA in respect of any complaints AMTRA receives.