The UK’s General Pharmaceutical Council (GPhC) has published new guidance for registered pharmacies providing pharmacy services at a distance, including on the internet. The GPhC is the pharmacy regulator for Great Britain. Pharmacies and pharmacists, including those operating online, are required to be registered with GPhC and follow the standards it sets.

The prevalence of online pharmacies, “telemedicine” or “telehealth”, has rocketed in recent years and they provide a valuable service. However, cases have been identified where medicines were supplied inappropriately, and people were put at risk. As such, the guidance introduces enhanced safety measures whereby prescribers must take additional steps to ensure the information that a person provides in order to obtain medicines from an online pharmacy is accurate. Notably, medicines categorised as “high-risk” should not be prescribed based on an online questionnaire alone. Pharmacies are required to ensure that their own prescribers meet the requirements and, where they are dispensing product prescribed online by a third-party prescriber, ensure that those prescribers operate in accordance with the guidance.

The guidance covers risk assessments, record keeping and audits, the empowerment of staff and suitable facilities and equipment. However, this blog focuses on the requirements of the digital platform, compliance with laws, the online consultation process, enhanced requirements for “high risk” medicines and working with third-party providers.

The digital platform

Transparency is a key theme of the guidance. Pharmacy-only (P) medicines (medicines that can only be sold in a registered pharmacy, by a pharmacist or someone acting under the supervision of a pharmacist) sold or supplied on a digital platform like a website or an app, may only be displayed for sale on the digital platform that is associated with the registered pharmacy. The public may be able to access the digital platform directly or through a third-party site, but it must be made clear which pharmacy is supplying the medicine.

The digital platform must be clear, accurate and updated regularly. The design and layout of the site must work effectively and look professional. The digital platform must be structured so that it cannot mislead the public in any way. It can include information about medicines, health advice and links to other information sources. However, the user must be clear what pharmacies are involved in providing the services and where they are located.

The guidance sets out details that must be prominently displayed on the digital platform including, the pharmacy’s GPhC registration number, the name of the owner and the name and physical address of the registered pharmacy(ies) that supply the medicines with relevant phone numbers and email addresses. If a person is prescribed medicines following an online consultation, the digital platform must prominently display:

• The name of the prescriber, the address of the prescribing service and their contact details;
• The prescriber’s registration number and the country they are registered in;
• Whether the prescriber is a doctor or a non-medical independent prescriber (e.g. pharmacist, nurse or physiotherapist);
• Information on how to check the registration status of the prescriber and the service, if the service is regulated.

The digital platform must have secure facilities for collecting, using and storing pharmacy users’ details and have a secure link for processing card details. It must follow data protection laws and include a privacy notice. Any business linked to on the platform must be legitimate and registered with the relevant regulator.

Compliance with the law

Online services supplying medicinal products to the public must, of course, comply with the law on advertising and promotion set out in the Human Medicines Regulations 2012 (as amended) and guidance published by the Medicines and Healthcare products Regulatory Agency (MHRA) and Advertising Standards Authority (ASA). This is emphasised in the guidance on account of frequent compliance issues that have been identified by MHRA and ASA in relation to online pharmacies promoting prescription-only medicines (POMs).  Although it is permissible for a service which provides POMs to be advertised, the promotion of a POM to the public is a criminal offence in the UK.  

In addition, pharmacies should not apply incentives or targets to the prescribers they employ. Prescribers must be free to use their own professional judgment on the most suitable treatment for any particular patient. The application of incentives or targets could be considered illegal inducements to prescribe.

Consultation

There is an emphasis on the importance of “timely two-way communication” throughout the guidance.

POMs may only be supplied after a person has had an appropriate consultation with a prescriber.  It is permissible for the digital platform to allow a person to give their preferred choice of medicine, by brand or formulation, before the consultation, if it is made clear that the decision about treatment is for the prescriber and person to consider together during the consultation. The prescriber must carefully consider the safety and suitability of the treatment for the person and be sure they have all necessary information to take the best decision. As such, the digital platform should provide a means for timely two-way communication between the prescriber and the person.

The guidance notes that selling and supplying medicines over the internet brings different risks to those of the “traditional” community pharmacies, and obliges the pharmacy owner to decide which method of consultation is best suited to obtain the information needed to deliver safe and effective care. This may be the need for a diagnostic test or physical examination. Frequently, it will require a two-way dialogue, i.e. the prescriber should be able to ask questions to obtain all relevant information and the person receiving the medication should be able to ask questions before a decision about prescription is made. The implication here appears to be that some form of “live chat”, which facilitates real time back and forth between the individual and the prescriber, may be sufficient. Where two-way communication is appropriate but not available, a method should be considered to direct the person to a care provider to be appropriately assessed, e.g. their regular prescriber, a walk-in centre or an urgent care centre.

The method of consultation chosen should allow the pharmacy professional to get the information they need to make an informed decision on the person’s capacity to make decisions about their own treatment. If permission is not given to share information with the person’s usual prescriber, or GP, the professional needs to get as much information as possible from the person to determine the method of consultation used, before deciding whether it is safe and appropriate to prescribe.

High risk medicines

The guidance has carved out certain medicines as “high risk”, which are not suitable to be prescribed by a questionnaire model alone and, should not be supplied unless further safeguards have been put in place. These include:

• antimicrobials
• medicines likely to be misused (such as opioids, sedatives, laxatives)
• medicines with a higher risk of fatality or serious harm if taken in overdose
• medicines to treat long-term conditions that require ongoing monitoring or management (such as medicines used for diabetes, asthma, epilepsy, heart conditions and mental health conditions)
• medicines where there needs to be a physical examination to support a safe prescribing decision
• medicines for weight management
• medicines labelled with a black triangle (that require additional monitoring)

For these medicines, additional safeguards include:

1. the prescriber must have a robust process to check the identity of the person to make sure the medicines prescribed go to the right person. For example, use of the Identity Verification and Authentication Standard for Digital Health and Care Services, which provides a consistent approach to identity.
2. an online questionnaire alone is not suitable. The prescriber must independently verify the information provided. This could be through timely two-way communication, assessing the person’s clinical records, or contacting the person’s GP, their regular prescriber, or a third-party provider. If the prescriber chooses not to use two-way communication with the person they should make a record, specific to the individual’s circumstances, justifying their reasons. If none of the independent verification options are available to the prescriber, the person should be directed to an appropriate care provider so that they can be appropriately assessed.
3. the person should provide the contact details of their regular prescriber or GP, and their consent to contact them, and the prescriber should share all relevant information. If this information is not provided, the prescriber should decide whether it is safe to prescribe, carrying out an individual risk-based assessment and making a record to justify their decision. The prescriber should consider the risk of death or serious harm if the person was also getting the medicines from other sources.
4. the prescriber must be working within national prescribing guidelines for the UK and good practice guidance. This would include following national patient safety alerts and the relevant guidance on prescribing, including prescribing “off-label”.   

When assessing persons for weight loss medicines, prescribers will be required to “independently verify” the person’s weight, height and/or body mass index. The guidance states that “independently” means “that the prescriber uses a different way to verify the information provided to them by the person”.  This could be via video consultation, in person, based on the person’s clinical records or contact with the person’s healthcare provider, e.g. a GP. It is noted that a telephone conversation would not be considered adequate. In addition, separate FAQs published by GPhC state that it would not be appropriate to use a photograph or pre-recorded video because it can be difficult to assess a person’s weight from these sources and they could be digitally edited by the person. Heightened controls were deemed necessary due to reports of underweight young persons obtaining weight loss products not clinically appropriate for them. Some commentators have raised concerns that increased difficulty obtaining legitimate product may fuel the counterfeit market, which is prevalent for certain weight-loss products. However, MHRA is alive to the issue of the counterfeit market, and this is being tackled separately.

On the supply side, a pharmacist supplying medicines online that are liable to misuse, or a higher risk of fatality or serious harm if taken in overdose, must take appropriate steps to confirm that the medicine is appropriate before making the supply, e.g. by contacting the person’s GP, their regular prescriber or a third party provider or checking the person’s medical records, with their consent.

Third-party providers

Where third-party providers are used, GPhC expects clear, written, service-level agreements to be in place. These must make sure that the roles and responsibilities of each organisation are clear, the pharmacy team are able to contact relevant team members of the third-party service if they need to, and patients and members of the public know who they can contact, if needed. Where a third-party is used, or where responsibilities are split between different pharmacies, the pharmacy must consider, amongst other things:

1. how the systems will work together, including information flow and the systems used for exchanging information between different locations;
2. making sure the provider of the systems is assured and has risk assessments in place to cover all aspects of their service, including the medicines and treatments they provide, how consent is obtained, and how any follow-up and monitoring will take place;
3. whether the provider has appropriate indemnity arrangements in place for the business, the services they provide and the staff they employ;
4. making sure the provider and their staff are registered with the appropriate regulator.

The guidance issues a warning “do not work with online providers who avoid, or try to avoid, keeping to the regulatory system put in place within the UK to ensure patient safety throughout the healthcare system.”

The full guidance is available here and is immediately applicable. While some of the requirements may be implemented fairly quickly and cost-effectively, others may require a complete overhaul of established operating practices, or contractual arrangements. Arnold & Porter can provide expert assistance in regulatory, contractual and risk management matters.