Are pharmacists putting themselves at professional risk by selling non-evidence-based preparations like homeopathy? Jarrod McMaugh investigates

Non-evidence-based medicine is a contentious area of healthcare, and pharmacists need to be aware of the pitfalls associated with recommending products or services that do not have an evidence base.

Non-Evidence-Based Medicine (Non-EBM) is a broad term that covers all medications, therapies, modalities, and interventions that do not have an evidence base to support their proposed mechanism of action or outcomes. This includes modalities that have been proven ineffective, such as homeopathy, as well as those for which evidence has been unable to show a viable mechanism of action or benefit, such as hyper-dosing vitamins to “boost” immunity.

Complementary medicines are those products or services that have a limited range of evidence for specific applications, that are utilised in a manner that positively impacts on the presenting symptom/condition. For completeness, the term Allopathic Medicine is used to describe medicines and therapies that have a strong level of evidence for their application in specific circumstances.

The underlying concept of evidence is based in the scientific method – by definition, the scientific method requires a person to utilise their critical thinking skills to evaluate information at hand (evidence) to support or refute a proposed theory… In the case of health, whether this product/service can deliver the outcome that it claims to be able to deliver.

Importantly, the scientific method requires flexibility. Over time, evidence changes by virtue of new work being done. For example, oseltamivir has undergone numerous meta-analyses, and the evidence now suggests that it is ineffective for the treatment of acute influenza infection. This would make the use of oseltamivir in this situation Non-EBM.

Similarly, products that may have had little evidence showing a benefit for a modality may be strengthened over time. This may be due to large studies being undertaken, meta-analyses being formulated, or a breakthrough in the manner in which data is gathered.

Evaluating evidence

Pharmacists need to have access to evidence for medicines that they are supplying (whether over-the-counter or prescribed), and the capacity to critically evaluate this evidence. It is incumbent on pharmacists to satisfy themselves about a product, rather than relying on product information, a representative’s sales pitch, or group think within the wider health professions.

Evidence hierarchy

Evidence has a hierarchy – as demonstrated in figure 1, the volume of evidence is inversely proportional to the quality of evidence. That is, the types of evidence at the top of the pyramid are the hardest to acquire, but have the least amount of bias; while those at the bottom have very little evidentiary value, but tend to be abundant.

Image from https://www.researchgate.net/figure/The-pyramid-of-evidence-represents-a-general-hierarchy-of-preferred-clinical-study_fig1_24028875

This creates a problem for the availability of products and services, in that the ability to gain high-level evidence is very expensive, and regulators do not tend to require high levels of evidence before a product can be marketed. This creates a level of risk for health professionals, who may recommend a product based on familiarity rather than evidence.

This also creates a natural tension between consumers and health professionals when a consumer requests a product that is legally available, yet the health professional feels that the product is not appropriate due to lack of evidence or safety concerns

Accessing evidence

Accessing evidence is a relatively simple process, although it can become complex if you let it. Pharmacists in Australia have access to specific references that provide a certain level of evidence for therapeutic products, such as AMH.

For complementary products, the Australian Pharmaceutical Formulary (APF) has a relatively large resource of evidence for complementary products – this edition of the APF is helpfully available online and is searchable – https://www.psa.org.au/apf24

For assessing and collating evidence, there are some databases that are particularly useful. My personal favourites are PubMed and PlosOne. Google Scholar is another resource that has significant value.

PubMed (https://www.ncbi.nlm.nih.gov/pubmed/advanced) and PlosOne (http://journals.plos.org/plosone/) are both searchable databases that have access to large numbers of primary and secondary studies in the health field. Search terms can be as specific or generalised as you would like, meaning that the results you receive may be broader or more voluminous than you can practically handle. Learning how to operate these databases is a useful skill to learn.

While using these databases, it is important to look out for some important meta-data, such as citation strength and publish date. Citation strength is a measure of how many times an article has been referred to in other works; this has been expanded by a concept known as “Altmetric” score.

The Altmetric score shows not only the number of times an article has been cited, but also how often it has been added to an individual’s online bibliography account, how often it has been disseminated via social media accounts, and other measures of attention.

Importantly, citation scores and the date of publication do not objectively measure the value of any piece of work – there is always the potential for a controversial piece of work to gain high metric scores simply because it is being discussed heavily, rather than the validity of the data the work may have generated. Pharmacists need to be able to critically judge the research they read about a product just as much as they need to judge the claims for that product.

When accessing and assessing evidence, it is important to keep in mind that a lack of evidence does not equate to evidence for the lack of benefit of a therapy. It is also important to resist criticisms of a modality that has good evidence when performed by practitioner that has not traditionally delivered that modality.

Risk versus benefit

Assessing risk versus benefit is an important step in the process of evaluating a product’s evidence. If the evidence for a product is weak, but the benefits are high, while the risks are low, does this mean that the product can be recommended?

Evidence is important because gathering and assessing it can reveal unexpected aspects that may never be fully understood without a good evidence base. There are many examples of recommendations being made when the evidence is not yet fully formed.

A famous example is the development of the “food pyramid,” which is still used broadly as a guide to healthy eating today, despite the poor levels of evidence utilised in balancing fat and simple carbohydrates within this model. It could be argued that the impact of simple carbohydrates on current health of westerners could have been prevented if the focus on “unhealthy” nutrients had been balanced between fats and carbohydrates, instead of focused on fats only.

Implications for practice

So how does evidence impact on the practice of the pharmacist? This is such a broad question, and clearly evidence should be intrinsic to the practice of pharmacy in all settings.

Pharmacists must therefore be mindful of the role of evidence, and understand that the availability of a product should not be seen as proof enough that evidence exists for that product.

Ranging products that have no evidence

One of the greatest criticisms pharmacists face is the ranging of homeopathic products in pharmacies. It is difficult to deny that ranging homeopathic products provides a level of legitimacy to these products that they do not deserve.

Conclusive evidence now exists[1] that homeopathy does not work. This is different from a lack of evidence for an effect; this is specific evidence that shows that this modality cannot and does not provide any of the purported benefits or mechanisms of action.

This evidence for lack of effect is important, due to the ethical responsibilities of pharmacists to provide evidence-based medicine. Specifically, from the Pharmaceutical Society of Australia’s Code of Ethics[2]:

Care Principle 1 g)

Before recommending a therapeutic product, considers available evidence and supports the patient to make an informed choice and only supplies a product when satisfied that it is appropriate and the person understands how to use it correctly.

It is not possible to adhere to this principle while also selling homeopathic and other non-EBM products – it is incumbent on pharmacists to always notify a patient that homeopathic medicines cannot work. Ranging homeopathic products therefore opens a pharmacist up to conflict of interest, where their professional judgement tells them that there is no benefit to a product, yet a patient wishes to purchase it anyway, even when advised not to. Not ranging a product is the only method of preventing this conflict.

Pharmacists may also find themselves in position where the pharmacy they work in ranges homeopathic or other non-EBM products, yet they do not want to be involved in the sale or recommendation of these products. In this situation, it is important to remember that the code of ethics requires that a pharmacist does not undertake any action or role if their judgement determines that this is not the correct course of action.

Integrity Principle 2

A pharmacist only practises under conditions which uphold the professional independence, judgement and integrity of themselves and others.

 

Professional misconduct

This leads to the professional risk a pharmacist puts themselves in when recommending or selling a product that lacks evidence – the Code of Ethics, as developed by the Pharmaceutical Society of Australia, has been adopted by the Pharmacy Board of Australia.

As such, any breach of the code of ethics can be the basis of a report to the Pharmacy Board for professional misconduct. If a pharmacist were to be referred to the Pharmacy Board for recommending a non-EBM product, pharmacists will be put in the position of having to justify their decision to supply a product that has no evidence, especially if this supply harms a patient or delays them from accessing effective treatment. In addition, it will not be possible to make a case defending the decision to supply non-EBM products based on pressures from employers wishes, due to Integrity Principle 2.

Clearly, the use of Non-EBM products, including homeopathy, puts consumers at risk due to delayed treatment and the risk of unexpected outcomes. It also puts pharmacists at risk of professional and ethical reprimand. Relying on evidence, and having a working knowledge of how to access and assess this evidence, remains a critical part of the role of pharmacists in all areas of practice.

[1] https://www.nhmrc.gov.au/guidelines-publications/cam02

[2] https://www.psa.org.au/downloads/codes/PSA-Code-of-Ethics-2017.pdf

Jarrod McMaugh is a community pharmacy practitioner with Capital Chemist in the northern suburbs of Melbourne. He has extensive experience in developing and delivering professional services in the community pharmacy setting.