The day-to-day business of most community pharmacies centres around dealing with prescriptions and conventional over-the-counter medicines. But in some branches, these products share shelf space with what can loosely be described as “alternative medicines”.
The evidence base for these treatments ranges from good to practically non-existent. So if you choose to stock them, what practical, ethical and legal challenges does this create?
What are alternative medicines?
Some would argue that the distinction between conventional and alternative medicines is a false one – any product with proven efficacy to treat a medical condition is a medicine, regardless of its origin. There may be some basis for this argument, as many common modern medicines are derived from herbs. Yet no one would describe aspirin, digoxin or tamoxifen – all examples of drugs derived from herbal compounds – as alternative medicines.
Instead, the alternative products sold in pharmacies tend to fall into four groups: herbal medicines, aromatherapy oils, flower tinctures and homeopathic remedies (see box, below).
Whether these are regulated as medicinal, cosmetic or food products is largely down to the claims being made for them by their manufacturers. For example, a cream advertised as a moisturiser is a cosmetic product, but if the manufacturer claims it prevents dermatitis, it would fall under medicinal regulations. Alternative medicines sold in pharmacies for medicinal use must be licensed by the UK’s watchdog, the Medicines and Healthcare products Regulatory Agency (MHRA).
Where’s the evidence?
Patients and pharmacists alike often query the evidence base for alternative medicines. This is always a contentious area, as many of the perceived effects of these treatments are attributed to the placebo effect. Critics of alternative medicines point out that many lack the backing of randomised controlled trials (RCTs) – studies that could untangle whether these products have a beneficial effect beyond an individual’s expectation of improvement when they take anything labelled as a treatment.
The group with the strongest evidence base is herbal medicines, some of which have been well-studied. The best-known example is St John’s Wort, an extract of the plant Hypericum perforatum, which has been shown in randomised clinical trials to work better than a placebo – and as well as standard antidepressants – in people with mild to moderate depression.
In contrast, there is insufficient RCT evidence to back the use of any aromatherapy or flower remedies. The same goes for homeopathy, which is also scientifically implausible, says Professor Jayne Lawrence, chief scientist at the Royal Pharmaceutical Society (RPS). “We would have to completely rethink the whole of science if homeopathy was correct,” she adds.
Check the label
So how can pharmacists check the evidence basis for an alternative product before they decide whether to stock it? Under the MHRA’s traditional herbal registration (THR) scheme, there is a requirement to supply medicinal products with an evidence base. Professor Lawrence says: “If it has the THR label, it’s been through the MHRA, who have accepted there is a body of evidence – not RCTs, which are the gold standard – but evidence to support the use of these products in Europe, and that’s about the strongest [support] they can get.”
The MHRA introduced the registration scheme in 2011, Professor Lawrence says, to address concerns about the safety of herbal medicines.
“The THR was brought in because a lot of herbal products have been around for quite a long time, and to expect them to undergo clinical trials is going to make them incredibly expensive.” Pharmacists should only stock herbal products with a THR label, because it ensures the quality of the products, she stresses.
However Professor Edzard Ernst, emeritus professor of complementary medicine at Plymouth University’s Peninsular Medical School, says the THR scheme is “tricky” because it does not require proof of efficacy. He suggests pharmacists go even further than relying on the scheme, and verify the evidence for different alternative treatments themselves, for example by checking the NHS Choices website or the Cochrane Database of Systematic Reviews.
It’s a common misconception among patients that alternative medicines are ‘natural’ and therefore safe or without side effects. However, pharmacists will know that many not only have side effects, but can interact with conventional medicines – with potentially dangerous consequences.
For example, many pharmacists are asked about St John’s Wort, which interacts with both the contraceptive pill and antidepressants. This month, the MHRA issued new guidance, recommending that women requiring emergency contraception inform their pharmacist if they have “taken any herbal remedies that contain St John’s Wort”, as they may need a double dose of the levonorgestrel contraceptive in order for it to be effective.
Alternative medicines suppliers have to produce a summary of product characteristics and a patient information leaflet, which should include side effects and contraindications, in the same way as conventional medicines.
This is where pharmacists have an important role. As medicines specialists, they can reinforce a vital safety message to patients. “It’s important to get over this idea that just because they’re natural, they’re safe,” says Professor Lawrence. “It’s clearly not the case – strychnine is natural.”
Pharmacists need to be aware of the interactions and contraindications of any herbal medicines they choose to sell, and ensure patients also pay attention to them, she says. “Pharmacists should encourage patients to be honest with their doctors and say they are a taking herbal medicine. A lot of people either think it won’t affect them or are a bit embarrassed,” she says.
The ethical arena
Most pharmacists tend to be staunch believers in, and defenders of, evidence-based clinical decisions. Yet it’s a curious contradiction that despite this, some also offer customers the choice of alternative medicines – including controversial homeopathic treatments.
On the one hand, pharmacists are trusted healthcare professionals, and people may see the presence of alternative medicines on pharmacy shelves as an endorsement.
The common retaliation is that if they did not stock these products, people might access them through unregulated outlets or over the internet, where they will not get the same level of professional advice as they will get in a pharmacy.
So should community pharmacies sell alternative medicines, especially products such as aromatherapy, if there is no evidence base? The debate has raged across the sector – and the pages of C+D – for decades.
Reader responses to a C+D investigation last year epitomise the opposing views. Take community pharmacist Chris Maguire, who argued: “It's a disgrace that pharmacies stock homeopathy. We should only stock things that are evidence-based. I honestly can't believe a profession based in science can view this in any other way.”
In the opposing corner was superintendent pharmacist John Robinson, who maintained a more pragmatic view. “Pharmacists are well-trained to discuss [the issues and] advertising is tightly controlled,” he pointed out. “What’s the fuss about? There are probably dubious claims made for licensed medicines.”
Use your judgment
This divided opinion is reflected in the National Pharmacy Association’s (NPA) own attitude. The organisation’s chief pharmacist Leyla Hannbeck says that although it does not generally endorse alternative medicines, the decision ultimately comes down to each pharmacist’s professional judgment. “We believe pharmacists are trained to provide evidence-based medicine, so it could be considered an ethical problem because of the lack of evidence base. We ask each individual pharmacist to consider their own options,” she says.
To pharmacists who do wish to stock alternative treatments, Ms Hannbeck offers the following practical advice to help avoid patient confusion: “Have a dedicated section, so it’s clear and separate from other sections – not mixed in with non-medical stock and conventional medicines.”
When it comes to handling requests from patients, her advice is equally pragmatic. “The first thing a pharmacist should ask a customer is what they require the alternative medicine for and if they have tried any other products,” she says. “You should check which options are appropriate, including a referral, and ask, ‘What options would be useful or suitable?’”
The RPS has detailed advice on the topic, and tells C+D that pharmacists should be “competent in any area in which they offer advice on treatment or medicines”. Pharmacists that sell or supply homeopathic products “must ensure any stock is obtained from a reputable source” and “only recommend a product where they are satisfied of its safety and quality,” the society says.
“When asked, assist patients in making informed decisions about homeopathic products by providing the necessary and relevant information, particularly the lack of clinical evidence to support the efficacy of homeopathic products,” the RPS adds.
Much of a choice?
This sounds straightforward, but for most pharmacists – who don’t own their own business – the decision of whether to stock alternative medicines or not is out of their control. Boots, for example, sells herbal and homeopathic products across its more than 2,500 stores, leading to the health and beauty giant being targeted for a mass protest by anti-homeopathy campaigners in 2010.
Boots declined to provide a comment for this article, but in 2009, the multiple’s former professional standards director Paul Bennett told a committee of MPs that the decision to stock alternative medicines was “about consumer choice for us, and a large number of our customers do believe they are efficacious”.
He’s not alone – the NHS spends £4 million a year on homeopathic products, according to the British Homeopathic Association.
Professor Lawrence’s advice for those working in multiples is that, where possible, they discuss the evidence base with patients. If the individual still wants to use it, recommend that they “do not stop taking conventional medicines”.
Professor Ernst takes a harder line on the question of whether pharmacists should stock homeopathic products. “The short answer is no. It’s quite clear – they should not be actively selling these as medicines.
“It’s not as complicated as people make out,” he explains. “If the customer asks, I would say: ‘We don’t stock it because there’s no evidence that it works. I feel a responsibility to sell you things backed up by evidence.’”
An informed decision
What everyone agrees on is the need to ensure patients have access to the best information with which to make their choices.
Ms Hannbeck says: “All pharmacists need to be sure that whatever advice they give is completely unbiased and based on factual evidence. Customers should not be misled or influenced by the manner in which the information is provided. The most important aspect is having patient safety at heart when recommending or considering a product.”
She advises pharmacists to initiate a conversation when a customer asks for an alternative medicine, and while she stresses that their decision must be respected, she agrees that “the most important thing is that the patient makes an informed decision”.
Ultimately, it’s up to pharmacists to use their expertise to make sure patients get the right information about all of their medicines – whatever the alternative.
Concerned about herbal interactions? Read our St John’s Wort MUR case study.