Online...but under the radar?

More guidance needed

Richard Hough, partner and head of healthcare at Brabners, says an important distinction to make when it comes to these cases is between distance selling pharmacies that undertake NHS dispensing and repeat prescriptions, and what he calls “mass market online portals”, which predominantly supply medicines like Viagra and lifestyle medicines.

“In that second category the model has at its centre a tech business that engages with prescribers to review the prescriptions and a pharmacy to dispense them,” he says. “The latter model generally attracts greater regulatory scrutiny and criticism – either because of inappropriate products that they make available to their service users or because of insufficiency of personal or clinical checks before the supply of those medicines is made.”

However, Hough believes that while the figures may well appear to show that a disproportionately high number of online pharmacies are not meeting the GPhC standards, “it simply can’t follow that the vast majority of people who enter online pharmacy are either incompetent or corrupt”.

“I would argue that it is actually the fact that the GPhC has not yet got a handle on how to regulate this space properly and is not giving registrants sufficient guidance to assist their online businesses to operate in regulatory compliance,” he says. “It wasn’t until April 2019 that the first significant piece of GPhC guidance for online pharmacies came out, which has made things less vague for operators. But we still have a model, maligned by many, that is akin to the ‘Amazonification’ of the online supply of medicines via private distance selling providers, which falls outside of the realms of the NHS.” 

The biggest challenge, Hough believes, is that such non-NHS businesses are currently unable
to access summary care records which, he says, means “they are hindered in their ability to make safe and effective clinical checks – which makes medicines supply inherently more risky – often combined with a choice of inappropriate products being made available through health portals”.

Although “the market has certainly cleaned itself up since April 2019”, Hough considers that “the GPhC has subsequently taken a disproportionate amount of regulatory action against online providers, which has generally been reactionary in nature rather than proactive, because in my view they felt pressurised to catch up and finally tackle the issue through regulation”. 

“A lot of the time the questions that online providers ask of patients are in many cases more in-depth and extensive than you would get from a locum doctor who might be squeezing you into a six-minute slot when they’re already half an hour behind schedule...”

Solutions and responses

What the GPhC needs to do now, according to Hough, is “to respond proportionately to the specific risk that each individual distance selling provider is currently exposing itself to”.

There are also potential solutions that could be implemented earlier in the online patient journey, according to PLEA’s David Reissner. “Pharmacies following the GPhC’s standards and guidance are expected to encourage patients to agree that their information can be shared with their regular doctor,” he says, “but patients are free to opt out of that, and some do. 

“One possible solution is that reputable online pharmacies decline to supply people who don’t agree that their information can be shared with their doctor – although you risk driving patients to less reputable sites or even sites that are not genuine and will not supply genuine product.” 

Reissner’s other suggestion is that “reputable pharmacists are encouraged to create some kind of database to which they have uploaded data on at least the certain types of products that are liable to abuse or misuse so that when they do get an online request for medication, they would have an opportunity to see other recent supplies or prescriptions for the same patient”. 

Obviously there are security and confidentiality issues here, he says, “but if you make patients who use the site sign up to give permission to make that information available online only to other registered pharmacists, there is a possibility that you will reduce the scope for problems.”

Hough also has technological interventions in mind. “A few years ago, one of my clients approached the regulator to discuss the possible industry-wide adoption of a blockchain solution, which all online providers would sign up to.” This would assist with concerns around verification and traceability of online medicine supply transactions, he says, adding that “robust identity checking in online interactions is really important to ensure the safe and effective supply of medicines. 

“If you have a more robust identity checking model combined with an unalterable method of traceability, then ultimately you are narrowing down the scope for abuse since patients can’t as easily go from online portal to online portal requesting the same or similar medicines. Of course, to do this, you also need to have access to their medical records to establish their previous clinical history.” 

Another way to make online medical interactions safer is by adding in video consultations. “If video consultations were used and the pharmacist could see the patient’s summary care record, they can use their clinical judgement to decide what is appropriate to dispense,” says Hough. 

“That way, the pharmacist can, for example, also check whether the patient is a chronic drug abuser, or who has never had sleeping tablets before but has a clinical justification for a short course of Z drugs, if the clinical records support that decision. 

“It shouldn’t be the case that they can’t get that medicine online purely because the person who is prescribing for them doesn’t have the technical access to relevant clinical data – like the summary care record – that would enable them to make that decision, supported through good clinical practice, if they could see that data.”

Reissner says the solution is education. “It is about making sure that pharmacists are aware of the particular risks,” he says. “I’m currently editing a new edition of Dale and Appelbe’s Pharmacy and Medicines Law which will, for the first time, include a chapter on the legal and professional issues related to online pharmacy. The law is the same as for a bricks-and-mortar pharmacy, but the risks are different – so it is important for everyone to be aware of that.”

The GPhC view

For its part, the GPhC says online pharmacy is an area it is focusing on with targeted inspections, and by reminding “all” online pharmacies that they need to follow its standards, guidance and prescribing guidelines for medicines “at all times”.

The regulator says it also “works closely with other regulators such as the MHRA and Care Quality Commission on issues relating to online health services, including those operating overseas”, adding that while each has different responsibilities and jurisdictions, they have “a shared objective and that is the safety of members of the public”.

The genie is out of the bottle as far as online service provision goes, says Hough. “Ultimately, online is here to stay,” he says, “and we are going to have to find a way of making online healthcare work safely and effectively, with the regulators on board rather than running scared of it and not knowing how to effectively and proportionately regulate it.”