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Pharmacy law practitioner Richard Hough considers a consultation on draft GPhC guidance for pharmacies providing internet and distance sales

On September 17, 2014, the General Pharmaceutical Council (GPhC) launched a consultation on its draft guidance for registered pharmacies providing
internet and distance sales, supply or service provision, which is designed to help pharmacy owners ensure that current and future pharmacy services continue to safeguard the health, safety and wellbeing of patients and the public.

We act for an increasing number of providers of internet pharmacies and have had increased interest from pharmacists wanting to know about the legal constraints of alternative models of service delivery undertaken on a 'distance selling' basis, such as 'click and collect', mail order services and 'hub and spoke'. In this respect, the guidance is timely. The GPhC has recognised the increasing popularity of these types of service, which also include collection and delivery services and electronic transfer of prescriptions, and has highlighted the need for pharmacy owners to manage the additional risks associated with those types of services which are not undertaken wholly on a face-to-face basis between their staff and the service recipient at a registered pharmacy.

Unfortunately the guidance contains limited detail, but the GPhC has chosen to highlight a number of areas for pharmacy owners where it expects service-specific risks to be managed and evidence to be produced to demonstrate that such types of service are legally compliant and properly managed.

The guidance applies in all cases where one or more parts of the sale or supply of medicines or pharmacy services are provided over the internet or in other forms of distance selling. In particular, it applies in all cases where pharmacy staff and the service recipient are not together in the registered pharmacy at the same time. Responsibility for compliance with the guidance, which is grouped under the following five principles, lies with the pharmacy owner or the superintendent pharmacist.

Principle 1

The governance arrangements safeguard the health, safety and wellbeing of patients and the public.

Owners will be expected to undertake tailored risk assessments for each part of the service that is provided on a distance-selling basis and will need to produce evidence to demonstrate that such assessments have been undertaken. Where applicable, risk assessments should reflect the risks associated with any separation of service provision. Owners should ensure that IT systems which exchange information between different locations do so securely and in compliance with data protection and data security requirements.

Risk assessments should reflect the risks associated with any separation of service provision

Procedures for handing over medicines to patients other than those who are physically present at the pharmacy premises carry an increased risk. Owners must demonstrate that they understand the lines of responsibility and accountability for staff who provide parts of the service where no pharmacist may be present or able to direct that element of the service. It is especially important where pharmaceutical services are provided on a distance-selling basis that records are kept to demonstrate the safety of the service provided and that evidence is obtained to support clinical judgements made.

Principle 2

Staff are empowered and competent to safeguard the health, safety and wellbeing of patients and the public. Owners must ensure that staff are competent and have undertaken the relevant training before being involved in any element of distance-selling services. This may include training on information security management, the Data Protection Act and cyber security.

Principle 3

The environment and condition of the premises from which the pharmacy services are provided and any associated premises safeguard the health, safety and wellbeing of patients and the public.

All pharmacy premises must comply with relevant medicines legislation. Websites that promote the sale of pharmacy medicines must be operated by a registered pharmacy. Website owners will be required to demonstrate that their websites are secure and comply with information security management guidelines. Relevant information, including the pharmacy's GPhC registration number, should also be included on the website. New legislation is expected to come into force in July 2015, further to which all organisations that sell medicines over the internet will have to display an EU-approved internet pharmacy logo in a prominent position on their website.

Principle 4

The way in which pharmacy services, including the management of medicines and medical devices, are delivered safeguards the health, safety and wellbeing of patients and the public.

Internet pharmacies pose further risks in respect to the identity of the patient. Owners will need to ensure that systems are implemented to ensure that medicines are delivered safely to the correct person when needed. How information is provided to the patient should be carefully considered so that patients can use medicines safely without having had face-to-face contact with the pharmacist at the pharmacy premises. Owners should obtain fully informed patient consent where elements of the services take place at different locations.

Principle 5

The equipment and facilities used in the provision of pharmacy services safeguard the health, safety and wellbeing of patients and the public.

Owners should ensure that any specialist equipment and facilities are of sufficiently high specification, accurate and secure for their intended purpose.
The deadline for responding to the consultation was December 10, 2014.

Richard Hough is senior associate, pharmacist and head of healthcare at Brabners LLP.
Contact him on 0151 600 3302, or at richard.hough@brabners.com.