The Care Quality Commission (CQC) has submitted proposals to the government for legislative changes that would close regulatory gaps in online prescribing, which have been ascribed to patient deaths.
The CQC said the changes to primary and secondary legislation would improve its ability to regulate independent primary care providers that are currently “putting people’s lives at risk”.
Its comments were in response to a coroner’s report to prevent future deaths, which recommended the CQC take on the regulation of “all online prescribing services accessible by patients in England”, regardless of the prescriber’s location and the professional group undertaking the prescribing.
The report followed the death of Katie Emma Corrigan from “excess consumption of codeine” that was obtained from online pharmacies without consulting her GP.
In its response to the coroner’s report, the CQC said on 12 April 2021 that it “has identified gaps in the regulatory framework for online providers”.
“We share HM Coroner’s concerns that members of the public may be able to source medicines with the potential for harm from providers who structure their business in such a way as to be outside the scope of registration with the CQC or the GPhC [General Pharmaceutical Council],” it said.
As a result, the CQC said that, since January 2021, it has “been in discussions with, and submitted, proposals for legislative changes to the Department of Health and Social Care (DHSC), to improve CQC’s ability to take action against independent providers of online primary care services”.
It said that the changes would address “safety gaps”, including “the lack of measures and checks in place when medicines are dispensed in England, following a prescription from outside England; and [the] limited jurisdictional ability for UK regulators to take action in response to harmful prescribing by providers or registered persons based outside the UK”.
The CQC added in its response that it was also looking at addressing gaps in the regulation of overprescribing opioids, the type and quantities of medicines that can be prescribed by independent providers online, and prescribing online “without knowledge of a patient’s history or access to patient records”.
It also said it is working with the GPhC “to explore other opportunities for taking this work forward”.
In 2019, the GPhC said it had written to the chief executive of the CQC, supporting a switch for the CQC to take on the regulation of pharmacist-run online services outside of a registered pharmacy.
Currently, online prescribing services only need to register with the CQC — whose regulatory responsibilities include online primary care services — if they employ a listed healthcare professional, which does not include pharmacists or pharmacist prescribers.
Loopholes in online prescribing regulations were also raised as a concern in a coroner’s report following the death of Debbie Headspeath in 2017, who died after spending more than £10,000 on codeine from 16 different online pharmacies in the space of six months.
READ MORE: The deadly online prescribing loophole
Who’s regulating whom online?
In August 2017, eight healthcare regulators — including the CQC and GPhC — wrote to providers of NHS services, outlining the challenges online healthcare provision present “by transforming how care is delivered and blurring the geographic borders”, and committed to sharing intelligence about online providers to improve regulatory coverage.
But it is not immediately clear who is regulating whom when it comes to supplying medicines online.
Although the CQC regulates some online primary care providers, it only does so if they employ a healthcare professional listed in the CQC’s ‘scope of registration’ document, which does not include pharmacists or pharmacist prescribers.
The regulation of pharmacists working in registered pharmacies online falls under the remit of the GPhC.
However, the GPhC said in April 2019 that it would fully support the CQC taking on the regulation of pharmacist-run online services outside of a registered pharmacy, in an effort to catch online dispensers that fall through the cracks between the two regulators.
But none of the eight regulators are currently able to regulate providers that prescribe to UK patients from outside the UK.
Brexit has created the opportunity for this to change, with the GPhC no longer bound by EU law, which states that an online pharmacy’s regulator depends on the location of the healthcare professional, rather than the patient.