Following on from our piece on safety in remote consultations the General Pharmaceutical Council is seeking views (by 21 August) on its proposals that online pharmacies will have to put in place new safeguards to protect people who want to obtain certain medicines online including opiates, antibiotics, asthma inhalers and Botox.
The online pharmacy market is rapidly expanding and the regulators, including the GPhC, CQC and MHRA, have to constantly review the regulatory frameworks intended to keep patients safe. Many of the providers in the sector are every bit as passionate about patient safety and are investing in technology and data analysis tools to assist them with safe and effective prescribing.
The GPhC regulates all registered pharmacies and of course that includes those providing services on the internet. Some of these pharmacies are linked with online doctor or clinic provision, usually regulated by the CQC. All online sellers of medicine are also required to register with the MHRA and to display the EU-wide common online selling logo required under EU Directive 2001/83/EU on every page of the website.
The MHRA and EU Directive are primarily focussed on the medicines being sold, whether prescription or general sales medicines, being lawful genuine medicines and not fake or counterfeit. The CQC (or Health Improvement Scotland or the Healthcare Inspectorate in Wales) and GPhC are more focussed on ensuring that the services being delivered are safe. Some in healthcare are highly resistant to the emergent non-traditional and disruptive services but, as the new Health and Social Care Secretary of State has recognised, the provision of healthcare must modernise and the new technologies are to be embraced.
The regulator's task is to ensure trust and safety in the systems, whilst supporting and encouraging responsible innovation. The current GPhC proposals suggest new guidance might cover:
- Transparency around the precise identity and location of the pharmacy and the prescriber;
- Possible limitations on patients being able to choose a prescription-only medicine for purchase before having had any form of consultation with a prescriber;
- Additional requirements associated with the provision of antibiotics, opiates and medication for certain chronic conditions, in particular contact with the patient's GP;
- Regulatory oversight of providers involving services not based within the UK
The CQC reported on 23 March 2018 on its inspection of 55 online digital providers. It found that 97% of the providers were meeting the regulations around being ‘caring’ and 90% of the providers were meeting the regulations around being ‘responsive’ to people’s needs. There was also recognition that online consultations have the potential to improve access and convenience for some patients.
However, and clearly informing the GPhC proposals, the CQC reported concerns around the inappropriate prescribing of antibiotics, the prescribing of high volumes of opioid-based medicines without talking to the patient’s registered GP and inappropriate prescribing of medicines for long-term conditions, including failures to monitor the volume of asthma inhalers being prescribed to individuals when their condition should be regularly checked.
Additional areas of concern, and undoubted focus in future inspections, included approaches to safeguarding children and those who may not have the mental capacity to understand or consent to a consultation and the failure to collect or share information with a patient’s NHS GP, who should have an accurate and up to date record of their previous and current treatments and health problems.