The General Pharmaceutical Council (GPhC), the pharmacy regulator for Great Britain, has published updated guidance that all online pharmacies are expected to follow, in response to concerns identified relating to unsafe prescribing and supply of medicines online.
The updated guidance emphasises that for high-risk medicines, the prescriber cannot base prescribing decisions on the information provided in an online questionnaire alone. Instead, the prescriber has to independently verify the information the person provides, either through timely two-way communication with the person, accessing the person’s clinical records, or contacting the person’s GP, their regular prescriber, or a third-party provider. This will help prevent people providing false information to obtain medicines that are not clinically appropriate for them.
Medicines used for weight-management and medicines requiring physical examination before a prescribing decision is made have been added to the list of high-risk medicines requiring extra safeguards before being prescribed. Before providing medicines for weight-management, the prescriber now has to independently verify the person’s weight, height and/or body mass index, to support safer decision making and ensure that the supply is appropriate for the person.
Further safeguards have also been included in the guidance for medicines liable to misuse, and those for long-term conditions or that require ongoing monitoring or management.
The updated guidance also says there should always be a means of having two-way communication between the person and the prescriber for all online prescribing, so both the person and the prescriber can discuss the possible treatments, ask questions and get further information, and make informed decisions.
Duncan Rudkin, Chief Executive at the GPhC, said:
“The message of this updated guidance is clear; online pharmacies should only supply a medicine if the prescriber has had an appropriate consultation with the person, and has made sure they have all the necessary information to check if that medicine is safe and suitable for them. For high-risk medicines, online pharmacies need to put even more safeguards in place, including always independently verifying the information provided by the person before supplying that medicine.
“We have listened carefully to feedback we had from organisations representing pharmacy and patients, and have further strengthened the guidance, including in relation to the steps a prescriber has to take before prescribing a high-risk medicine.
“We know online pharmacy services can provide a very valuable service, but through our inspections and investigations, we’ve seen too many cases of medicines being supplied inappropriately online and putting people at risk. This updated guidance will support online pharmacies to protect their patients, and we expect them to act now to make sure these safeguards are in place.”
“Our inspectors will continue to inspect online pharmacies and will be looking for evidence that pharmacies are meeting our standards. We will also continue to work closely with other regulators in response to concerns and issues, and take action when needed to protect the public.”
Other key changes to the guidance include:
- Emphasising that online pharmacies need to follow the law, rules and guidance on the advertising and promotion of medicines: This includes guidance provided by the Medicines and Healthcare Products Regulatory Agency (MHRA) and the rules and guidance provided by the Advertising Standards Authority (ASA). The GPhC is working closely with both the MHRA and the ASA to jointly tackle inappropriate advertising and promotion of medicines by some online pharmacies.
- Further safeguards when prescribing for patients without a regular prescriber such as a GP: Providing further guidance for prescribers to follow in circumstances where the person requesting a medicine does not have a regular prescriber such as a GP, or if the person has not given consent to the prescriber to share information with the person’s GP.
- Clarifying the responsibilities of an online pharmacy when it is working with a third-party prescribing service: This includes having assurances in place to make sure that the third-party prescribing service has the necessary safeguards set out in this guidance
- Making sure arrangements with prescribers are transparent and do not cause conflicts of interest: This includes making clear that pharmacy owners and Superintendent Pharmacists cannot give incentives to prescribers to issue prescriptions.
- Making Superintendent Pharmacists jointly responsible with pharmacy owners for meeting the guidance: Previously this was the sole responsibility of the pharmacy owner.
Notes to editors
Feedback on the updated guidance
- The GPhC asked patients and the public, pharmacy owners, pharmacy professionals and their representative organisations, and other regulators, to give their views on the proposed changes between September and October 2024.
- The GPhC received 85 responses to the main survey and 97 responses to the survey of patients and the public. We heard from respondents that many people really value the benefits of using online pharmacy services to get medicines and treatment, but we also heard some significant concerns about the potential risks of people being able to obtain medicines that are not safe or appropriate for them.
- There was support overall for the key changes we proposed to the guidance, with 69% of respondents to our main survey agreeing that the proposed changes would help improve patient safety. 94% of people responding to our survey for patients and the public saying they would expect to have the option to contact the prescriber directly, to discuss any questions they might have, before they were prescribed a medicine. We also received useful feedback and suggestions which has helped us to further strengthen the guidance.
Next steps
- The GPhC is writing to pharmacy owners, Superintendent Pharmacists, pharmacists and pharmacy technicians to ask them to review the updated guidance and make sure they are following it if they are providing any pharmacy services at a distance, including from an online pharmacy. A webinar is being held by the GPhC in the coming weeks where all key stakeholders can hear more about the updated guidance and ask questions.
- Online pharmacy owners and Superintendent Pharmacists are expected to review the updated guidance and make any changes needed to their online pharmacy’s operations, processes and digital platforms at the earliest opportunity. The guidance also applies to everyone in the pharmacy team, including managers with delegated responsibility, the Responsible Pharmacist and any pharmacists prescribing at a distance.
- GPhC inspectors will continue to inspect online pharmacies and will be looking for evidence that pharmacies are meeting our standards. Not taking the appropriate steps to meet our standards could result in the GPhC taking enforcement action. This could be against the pharmacy, the pharmacy owner, or the Superintendent Pharmacist (or all three). The GPhC could also investigate the fitness to practise of any pharmacy professionals involved.