Increased regulation of high risk and weight loss medication – will new GPhC guidance strengthen safeguards and prevent unsafe online supply?

As access to medication becomes more convenient with the increased use of online pharmacies, concerns have emerged about the safety and appropriateness of prescribing certain drugs at a distance, particularly high-risk drugs such as weight loss medication. As demand for medication supply online increases, with popularity surging as a result of social media for high-risk drugs such as weight loss medication, questions around proper patient screening and potential misuse have been raised. The General Pharmaceutical Council (GPhC) have addressed this issue and supplying at a distance generally, in its updated guidance for pharmacies providing services at a distance^[1] published last week. The guidance is aimed at strengthening safeguards, outlining responsible prescribing practices, and highlighting the importance of managing the additional risks that come with online supply to ensure patient safety.  The updated guidance seeks to respond to concerns raised during a targeted consultation that draft proposals did not go far enough to ensure clinically appropriate online supply.

Patient safety concerns

In September 2024, the GPhC released draft guidance for providing pharmacy services at a distance and ran a targeted consultation seeking views from the public and sector stakeholder groups. Proposals included conducting a risk assessment, robust identification of the patient, an “appropriate consultation” with the patient, and ongoing monitoring of drug suitability. Some of these issues were already featured in the GPhC’s Frequently Asked Questions and Case Study sections of their website in respect of weight loss medication.

In response to the measures in the draft guidance, the National Pharmacy Association (NPA) was vocal in its concern that proposed measures did not properly address risks to patient safety, particularly in respect of weight loss medications. The NPA warned that “greater consultation with patients” is needed than measures proposed, as well as the examination of medical records, to avoid unsafe supply of “high risk” medication.

Similarly, a key theme arising in consultation responses was concern that proposals did not go far enough to protect the public. Many were concerned that there were not enough safeguards in place to protect patients against clinically inappropriate prescriptions and the misuse of medication, with 92% of patient and public responses asking for stricter safeguards specifically for weight loss medication^[2]. Rather than simply relying on online questionnaires, some suggested that face-to-face consultations should be mandatory, while others emphasised the need for two-way communication. An overwhelming 94% of patient and public respondents asked for the option to contact the prescriber directly for questions and further information about the medication^[3]. Many also felt that regulatory requirements would hold more weight than guidelines, and that the wording of certain provisions in the draft guidelines should be changed from “should” to “must” to ensure the guidelines are followed.

Key changes

Following the consultation, the GPhC published updated guidance on 4 February 2025, acknowledging the concerns raised about the adequacy of the proposed safeguards in the draft guidelines.  The guidance has been broadly welcomed by the sector, in particular measures to prevent reliance on standalone online questionnaires to prescribe weight loss and other high-risk medication.  The Health Secretary, Wes Streeting, is due to respond in March to a Prevention of Future Deaths Report published on 31 January 2025 where a “tick box” online questionnaire was deemed to have contributed to a patient’s death by enabling access to a fatal quantity of prescription medication without reference to the patient’s medical records.^[4] The new guidance is therefore timely, and much needed. 

High risk medicines

The new guidance heeds warnings about reliance on a questionnaire only model in respect of supplying medications carrying greater risk to the public. High-risk medicines, which include but are not limited to, weight loss medication, medicines liable to misuse, and medicines which have a higher risk of fatality or serious harm if taken in overdose, carry additional safeguards under the new guidance. Information provided in questionnaires must be independently verified either by medical records, two-way communication, or contacting the patient’s GP.

Prior to prescribing weight loss medication, measures include that the prescriber independently verifies the person’s weight, height and/or body mass index. This could be through a video consultation, in person, by accessing the person’s clinical records or by contacting another healthcare provider such as the person’s GP.

Further, if timely two-way communication is not available to both the prescriber and the person seeking high-risk medication, that there is a method to make sure the person is directed to an appropriate care provider for assessment.

Broader accountability

Other key changes include additional safeguards where a patient does not have a regular prescriber, and importantly making Superintendent Pharmacists jointly responsible with pharmacy owners for ensuring online pharmacies meet regulatory standards.

Where a patient does not have a regular prescriber, or they do not give consent to share information with them, there are further safeguards in place. The prescriber has a duty to record a decision with the patient’s best interests in mind. If for example, the prescriber considers it appropriate to prescribe the weight loss medication, they must make a record setting out their justification. Where a prescriber decides not to prescribe, the patient should be directed to an appropriate care provider for appropriate assessment.

In terms of joint accountability, many pharmacies operate under service level agreements, which set out expectations for patient care, the responsibilities of each party, and compliance with national standards. By ensuring both pharmacy owners and the Superintendent Pharmacist are accountable, it is hoped that the risk of any conflict of interest that could undermine compliance with regulatory standards is reduced. The guidance also stresses the duty on pharmacy owners and Superintendent Pharmacists to follow the law and guidance on the advertising and promotion of medicines. This is a key area under scrutiny particularly for weight loss medication in the era of social media and ‘influencer’ culture. 

Will the guidance be effective?

The GPhC has said that its guidance aims to protect patients and safeguard against inappropriate prescriptions. Whilst the additional safeguards have been welcomed, concerns remain. The Pharmacists’ Defence Association (PDA) has warned that there is still “significant risk” of unsafe prescriptions where the prescriber is unable to access medical records. The PDA has said the GPhC needs to go further to mandate certain provisions in the guidance, rather than simply suggest practices. It remains to be seen whether the new strengthened GPhC guidance will have the desired effect in the sector. With the spotlight firmly on the risks of failing to ensure appropriate remote supply of medications, we will be monitoring developments and our team is available to assist with your regulatory queries.

Article co-authored by Areesha Qureshi, Solicitor Apprentice at CMS.
 

^[1] Guidance for registered pharmacies providing pharmacy services at a distance, including on the internet

^[2] Survey on guidance for registered pharmacies providing pharmacy services at a distance, including on the internet: analysis report page 4-5

^[3] Ibid.

^[4] Kim Robinson: Prevention of Future Deaths Report - Courts and Tribunals Judiciary