On 16 April 2019 the General Pharmaceutical Council (GPhC), the regulator for all pharmacies and pharmacists in Great Britain, published new guidance for pharmacies providing medication from a distance, such as online pharmacies and medication delivery services. The guidance includes for the first time the additional controls the GPhC expects distance pharmacies to have in place, and provides specific advice for providing pharmaceutical services across international borders.
Distance pharmaceutical services is a rapidly growing area with many different services entering the market. The GPhC guidance states that it is keen to support innovation as long as patients are protected, although some providers may be critical of the apparent extra requirements placed upon distance services as opposed to their traditional counterparts. The updated guidance provides useful insights for services expected to comply with GPhC principles.
Key priorities that can be seen in the guidance include a far greater focus on robust identity checks; an expectation that providers will ask for GP details and will then proactively share details of prescriptions with GPs; a push to ensure distance provisions is not able to become simply online "shopping" for prescription medicines; and a far higher burden on providers who may be working with for example overseas prescribers to risk assess compliance.
The guidance specifies certain groups of medicines that it considers may not be suitable for online or distance dispensing unless there are further safeguards in place. These are:
- Antibiotics
- Medicines liable to abuse, overuse or misuse, particularly those with a risk of addiction, such as opiates
- Medicines that require ongoing monitoring or management, such as sodium valproate
- Non-surgical cosmetic medicinal products, such as Botox.
In particular, it warns against websites allowing patients to select a specific prescription-only medicine and quantity before discussing this with a professional, emphasising that patients and prescribers should make joint decisions in relation to treatment. These recommendations are in place to ensure that patients are not able to use online or distance services as a route to obtaining medicines that would not normally be prescribed, or would not be prescribed without careful monitoring.
The guidance also emphasises the importance of checking patient identity and ensuring that those receiving pharmacy services (and, crucially, medicines) are who they claim to be. It recommends keeping to standards such as the NHS' DCB3051 Identity Verification and Authentication Standard for Digital Health and Care Services. This standard is not yet fully supported with technological solutions but businesses should consider carefully how they can comply. This is intended to prevent misuse of medicines, for example an individual attempting to obtain more medication through prescriptions made out in multiple names.
To reinforce these structural safeguards, the guidance also recommends specific areas for risk assessment and audits to ensure that the particular risks of distance pharmaceutical services are addressed. Perhaps controversially, it suggests that distance services may also want to keep records beyond those required in the Human Medicines Regulations for "normal" pharmacies, such as decisions on whether to provide over the counter (P) medicines as evidence of good clinical decision-making.
Finally, the guidance addresses the risks and requirements of providing services across borders. This has become a particular consideration in recent years as more services are provided direct to patients without face-to-face contact, allowing for (for example) a UK based pharmacy to serve patients in continental Europe or further afield. However, the guidance is clear that it is the responsibility of pharmacies providing such services to ensure that they have checked the legal requirements in both the country where they are based and where the patient is based. They are also expected not to work with providers who are seeking to circumvent UK regulation and to risk assess and have adequate insurance cover when working with prescribing services not based in the UK.
Fieldfisher's healthcare and life sciences team have been working with a number of innovative businesses providing healthcare and prescribed medicines remotely. We would be happy to discuss with you any issues that arise in relation to this Guidance.