Online pharmacies are eight times more likely to fail regulatory standards, data show

Pharmacies supplying drugs online are far more likely than their high street counterparts to fail on regulatory standards, data gathered by The Pharmaceutical Journal have revealed.

Analysis of General Pharmaceutical Council (GPhC) inspection reports shows that 28 (21.7%) of the 129 ‘distance-selling’ pharmacies that had been inspected between April 2019 and March 2022 failed to meet at least one of the five regulatory standards following their most recent inspection. Of these 28 distance-selling pharmacies, 23 failed to meet two or more standards.

This compares with just 2.6% (75 pharmacies) of the 2,808 ‘bricks and mortar’ pharmacies that were inspected over the same period, which were found to have failed to meet at least one standard following their most recent inspection.

Online pharmacy sales have boomed over recent years, with dispensing increasing fourfold in five years, from 13.2 million items in 2016 to 52.9 million items in 2021.

Meanwhile, between March 2020 and March 2022 — during the COVID-19 pandemic — the number of patients who nominated online pharmacies as their preferred option for receiving medicines through the electronic prescription service (EPS) nearly doubled, from 999,498 to 1,950,497.

Healthcare regulators told The Pharmaceutical Journal that some online pharmacies are working “with little to no oversight” as they are based abroad, and that there continue to be serious patient safety concerns over the way online pharmacies operate.

The analysis also uncovered the following about the 28 online pharmacies that failed their most-recent inspection:

• Most (23) were found to have failed to meet standards relating to governance arrangements that safeguard the health, safety and wellbeing of patients. For example, one online pharmacy used “an accountant with no pharmacy training” to approve some medicine orders;
• A similar number (22) did not meet standards on the safe management of medicines. For example, one online prescribing service based in Romania, was found to have supplied a patient with 100 codeine phosphate 30mg tablets “on six separate occasions within a five-month period”.
• Some 17 failed to meet standards relating to their premises, three did not meet standards that ensure safe staffing and one failed to meet standards relating to the equipment it uses.
• A third provide prescribing services using prescribers based outside the UK, enabling them to avoid regulation by the Care Quality Commission (CQC).

Since January 2021, healthcare regulators have been calling for the government to close a regulatory loophole that allows UK patients to access prescription medicines online from prescribers who are based overseas.

In April 2021, the CQC warned in evidence submitted to the Health and Social Care Select Committee that it had “current examples of death and severe harm caused by digital services delivered from outside England”.

In response to The Pharmaceutical Journal‘s data, Mani Hussain, deputy chief inspector of primary medical services and integrated care at the CQC, said that the regulatory body shares “concerns about the ability for some providers to work with little or no regulatory oversight because of the way in which they have established their business model”.

“If people are being exposed to risk because services are set up in a way that avoids or minimises the scrutiny designed to protect them, something needs to change,” he said.

“This is why we have been working with our regulatory partners and the DHSC to address the current regulatory gaps and the risks that they present to people.”

Meanwhile, Duncan Rudkin, chief executive of the GPhC, said that the regulator conducted a programme of online pharmacy inspections “directed at those where concerns had been raised as well as those that were selling/prescribing higher risk medicines or working with overseas prescribers”.

“Our inspectors are continuing to identify serious patient safety concerns in some pharmacies providing online prescribing services,” he says, adding that between April 2019 and December 2021, “we have taken enforcement action against 48 online pharmacies to protect patient safety”.

Following this targeted inspection programme, the GPhC’s director of insight, intelligence and inspection Claire Bryce-Smith wrote to pharmacy trade bodies in August 2021 warning of “patient safety concerns relating to pharmacies dispensing medicines prescribed by EEA prescribers working alone or for online prescribing services”.

When asked about progress on the legislative proposals put forward by the CQC, a spokesperson for the Department of Health and Social Care said it would consider them “in due course”.

“Patient safety is our top priority, and we expect doctors and pharmacists to apply the same high standards for remote prescriptions and advice as they do for face-to-face appointments,” they added.