In AnalysisIt’s time to delve deeper into health discussions. Broaden your understanding of a range of pharmacy news and topics through in-depth analysis and insight.
There doesn’t seem to be a month go by without news of another online pharmacy getting into hot water because of questionnaire-based prescribing models.
It is an issue with growing prominence given the private availability of weight loss drugs like Wegovy from pharmacies. Concerns have also been raised about internet pharmacies appearing to be advertising prescription-only medicines.
At the 2023 Sigma conference in March, the GPhC’s director of insight, intelligence and inspection, Claire Bryce-Smith, admitted that almost a third (31 per cent) of online pharmacies were failing to meet regulatory standards, a disproportionate amount compared to other pharmacy service providers.
The regulator says it has taken action against five pharmacies since August 2022 – two involving suspension of registrants, one given advice and two receiving warnings – plus one interim order linked to concerns around high risk online prescribing practices using a questionnaire-based prescribing model.
At the time of writing, there were 261 open cases linked to pharmacies that the GPhC had classed as online operators, with 102 unique pharmacies linked to the 261 cases.
While the GPhC will not comment on the specifics of cases currently under investigation, it says its investigations involving online pharmacies or online prescribing tend to be focused on the following regulatory concerns:
- Poor governance and oversight of prescribing high-risk medications open to abuse
- Prescribing transactionally using questionnaire-based models only, with little or no verification with patients’ GPs or without access to patient medical records
- Prescribing medication (as above) repeatedly with no monitoring or review
- Prescribing outside scope of practice
- Prescribing medication off licence without clear evidence of the skills or expertise to undertake this
- Prescribing transactionally with apparent financial incentive
- Dispensing against prescriptions issued using an online questionnaire-based prescribing model without due diligence of the prescribing model being used or the skills or competence of those prescribing.
Resurgence of cases
According to David Reissner, solicitor and chair of the Pharmacy Law and Ethics Association, there are two main types of case that come up most often in relation to online pharmacy practices. “The first is where pharmacists are selling codeine linctus in excessive quantities,” he says.
Its OTC status has meant there is a long history of pharmacists supplying excessive quantities of codeine linctus, although Reissner says the Royal Pharmaceutical Society, when it was the regulator, and subsequently the GPhC have both worked hard to clamp down on this.
“However, we’ve seen a resurgence of those cases online and part of that problem, I believe, is the failure of operators behind the online pharmacies to recognise that patients should be treated in the same way online as if they were in a pharmacy.”
The second type of case, says Reissner, is where “pharmacist prescribers get drawn into prescribing things online that are outside their scope of practice and clinical competence”. One recent example came before the fitness to practise committee at the GPhC, he says. “The pharmacist had prescribed medicines for children with epilepsy, which is a highly specialised area, and was also prescribing veterinary medicines for cats, dogs and, in one case, for parrots – which was way outside that pharmacist’s sphere of competence.”
Part of that problem, I believe, is the failure of operators behind the online pharmacies to recognise that patients should be treated in the same way online as if they were in a pharmacy.
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”.
Ultimately, online is here to stay 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.
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.”
POM promotion running riot?
Promoting a prescription-only medicine to the public is prohibited by UK law, yet search for many brand name drugs online – in particular some new weight loss medicines – and they appear on the pages of lots of websites.
The problem here, say sector commentators, is that while online pharmacies led by pharmacists are regulated by the GPhC, online doctor sites fall under the legal jurisdiction of the CQC. This leads to compliance around the advertising of POMs “falling through the cracks”, with the MHRA, perhaps restricting itself to only scrutinising the home pages, “failing to get a grip” on the situation.
Aside from tighter regulatory inspections, one remedy, say pharmacy insiders, is for no shopping baskets to be allowed prior to a proper and full consultation being carried out, so that patients cannot self-select their medicine and put it straight in their basket.
The GPhC has also published a guide with other UK health organisations, which includes the following tips for patients on how to keep safe when getting medicines or treatment online:
- Check if the online health service and people working there are registered with UK regulators
- Ask questions about how the service works
- Answer questions honestly about your health and medical history
- Find out your options for treatment and how to take any medicines you’re prescribed
- Expect to be asked for consent for information to be shared with other healthcare professionals involved in your care
- Check what after-care you will receive.