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GPhC: Regulation should not stop innovation, but online pharmacies must meet standards

The regulation of online pharmacies “should not stand in the way of innovation” but it must follow the law and “the outcomes must meet our standards”, the General Pharmaceutical Council (GPhC) has told C+D.

The regulator told C+D last night (December 6) that it had responded to a letter from Mark Koziol, the Pharmacists’ Defence Association’s (PDA) chairman, in which he urged the GPhC to address pharmacists' concerns over the impact of automation and online pharmacy provision on patient safety.

“Our position remains that regulation should not stand in the way of innovation, but it needs to be consistent with the legal framework, and the outcomes must meet our standards," GPhC chief executive Duncan Rudkin said.

“That's why we've already provided guidance to help make sure the right clinical governance and safeguards are in place to protect patient safety when using online pharmacies and have taken enforcement action in cases where such pharmacies have not met our standards.”

“We are seeing delivery models for pharmacy services changing fast, including the use of technology, automation and artificial intelligence," he added.

While providing online services “with the help of new technologies can bring real benefits to people... the right safeguards need to be in place to protect patients”, he said.


Koziol: Some pharmacists “extremely concerned”


In his letter to the GPhC, Mr Koziol warned that the “increasing use of technology and procedures” within community pharmacy “could have the effect of eroding the focus on patient safety”.

He added: “Recently, pharmacists who have experience at the heart of several technology-based operations have told us that they are extremely concerned about some of the procedures that they are required to follow. They believe that these will cause increased risk and the potential for patient harm and we concur.”


Concerns over productivity targets


The PDA had recently received a “significant increase in calls” from members concerned about “their roles” and “their legal obligations as a responsible pharmacist”, given the procedures they are required to follow with technology-based operations, Mr Koziol wrote.

This included the use of “artificial intelligence to make automated clinical checks”, as well as “productivity targets for individuals working in some of the ‘assembly’ centres” and the “inappropriate” demands placed on them to process large volumes of prescriptions in short periods of time.

While the PDA “is supportive of modern and efficient technology-led operations”, Mr Koziol said, the “use of technology must not outpace patient safety considerations and pharmacy regulation must be evolved quickly and enforced in ways that cater for this rapidly emerging reality”.


GPhC “will be looking into concerns”


Mr Rudkin told C+D that the GPhC “will be looking into the concerns [the PDA has] raised and will take the appropriate regulatory action in response to protect patient safety”.

The regulator will “also share relevant information with other regulators with a role in this”, such as the Medicines and Healthcare products Regulatory Agency, and will “continue to work closely with them on these issues”.

He added: “These concerns are of clear interest to us, not only with regards to the potential immediate operational patient safety concerns, but also by way of broader implications for our wider policy work and how we regulate going forwards.” 

The GPhC director of insight, intelligence and inspection Claire Bryce-Smith acknowledged last month that the GPhC recognises that, with “all of these changes to online service delivery, there hasn't really been the same amount of investment by anybody in educating the public”.

Meanwhile in August, Ms Bryce-Smith wrote to organisations representing pharmacies and pharmacy professionals to highlight the “serious patient safety concerns” the GPhC had identified relating to online prescribing services.


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