The General Pharmaceutical Council (GPhC) has recently issued updated guidance for those providing pharmacy services at a distance, including on the internet. The guidance was issued shortly after the GPhC wrote an open letter to the chief executive of the Care Quality Commission (CQC) in support of their current aim to bring online pharmacies within their regulation in an attempt to close current loopholes for these types of services. It is clear that there is a heavy focus on the regulation of this type of service at present and the regulatory landscape is likely to continue to change moving forwards.
A BBC Panorama expose highlighted concerns relating to the online pharmacy sector in 2018. Since then, tightening the regulation around these services has been high on the agenda for many regulators, particularly the GPhC and the CQC.
The GPhC set out that they considered online research they had commissioned through YouGov which found that 25% of people say they are likely to use online pharmacies in the future, but 50% of those unlikely to do so stated they had concerns about the safety of online pharmacies. After considering feedback from the sector, patients and the public to proposals published in 2018, the GPhC has introduced ‘strengthened’ guidance and introduced further safeguards to be implemented by those operating online pharmacies.
The updated guidance focuses on strengthening the processes in place to carry out identity checks on those purchasing medicines online and ensuring there are processes in place to identify requests for medicines that are inappropriate and identifying multiple orders to the same address or using the same payment details. Online pharmacies must also change the set-up of their websites, so that it does not allow a patient to choose a prescription-only medicine and its quantity before there has been a consultation with a prescriber. In addition, further safeguards have been implemented relating to certain categories of prescription only medicines, to ensure that they are clinically appropriate. Unsurprisingly, this relates to antibiotics, medicines liable to abuse, overuse or misuse, medicines that require ongoing monitoring or management and non-surgical cosmetic medicinal products, such as botox.
There is also a focus on transparency and patient choice, meaning that pharmacy owners will be required to supply more details about where the service and health professions involved in prescribing and supplying the medicine are based and how they are regulated. Pharmacy owners working with prescribers or prescribing services operating outside the UK will also be expected to take steps to manage any additional risks this may create, such as ensuring that the prescriber is working within national prescribing guidelines for the UK.
In reality, those operating online pharmacies will already have these safeguards and measures in place to some degree and will simply need to strengthen their safety measures so that they can evidence compliance with the more detailed guidance that has been issued. The biggest change is likely to be the manner in which the websites operate, in that most are currently set-up on the basis that users will go onto the website and select both the medicine and quantity they require, before then proceeding to a consultation. Those operating online pharmacies will need to ensure that their processes are updated as soon as possible to ensure compliance with the new guidelines.
As well as the GPhC, the CQC are also looking closely at this sector to ensure that services are not operating unlawfully. If a service is carrying out activities that could be deemed to fall within the legal definition of ‘treatment of disease, disorder, or injury’ and they are not registered with the CQC, they could potentially be committing a criminal offence. The CQC are currently in discussions with the government about taking on the regulation of these services, which would require them to be registered and therefore inspected by the CQC.
The CQC’s recommendation that they have regulatory oversight of these services is one that is supported by the GPhC and will likely involve an all-round approach from both regulators, plus the MHRA. This is also likely to be seen to be in the public interest by the government when considering the CQC’s recommendation. The number of online pharmacies is likely to increase, in an age where the majority of purchases are now made online for various different aspects of day-to-day life. The ease of obtaining prescription medicines online is likely to suit much of the general public in years to come and therefore an increase in regulatory oversight is a natural consequence of a growing sector, especially one that relates to health and wellbeing.
At Stephensons, we have specialist lawyers with experience of advising on both issues relating to registration and criminal investigations by the CQC. If you require any advice and assistance in relation to registration with, or an investigation by the CQC, please contact our specialist CQC lawyers now on 0175 321 6399.