The Pharmaceutical Society doesn’t think pharmacists should be able to sell healthcare products with no evidence of efficacy.

Last week I wrote about the Pharmacy Council’s proposal to change their Code of Ethics, and summarised the submissions that I was aware of. One important organisation that was missing from that roundup is the Pharmaceutical Society.

The Pharmaceutical Society is a professional association representing New Zealand pharmacists. Given their important position in the pharmacy industry, I think their submission might arguably be the most important. Earlier this week I spoke with Bob Buckham, Chief Pharmacist Advisor at the Pharmaceutical Society, about their submission on the Pharmacy Council’s proposal.

The Pharmaceutical Society does not support the proposed change. Coming from the perspective of pharmacists, their submission also raised two important points around this issue:

• Pharmacists need clarity: what behaviour is consistent with the Code of Ethics, and what is not?
• The Code of Ethics is important and cannot be ignored. The Pharmacy Council must be willing to provide guidance and to enforce the code.

The reason why the Pharmaceutical Society does not support this change is similar to the reasons given by other organisations, in that it would implement a double standard:

The Society does not support the proposed supplementary wording in obligation 6.9 as the split wording in the two parts separates the therapy terms “medicine or herbal remedy” in 6.9a from “complementary therapy or other healthcare product” in 6.9b. The result is that the subsequent obligation attached to those therapies does not apply to the other.

To clarify further, “credible evidence of efficacy” is only required when supplying or promoting a “medicine or herbal remedy” (Obligation 6.9a) and “no reason to doubt… quality or safety and when sufficient information about the product can be provided” only applies to “any complementary therapy or other healthcare product.

The Society considers that the obligations of “credible evidence of efficacy” and no reason “to doubt… quality or safety” should apply to the supply or promotion of all therapies and products – ie. any medicine, herbal remedy AND any complementary therapy or other healthcare product.

Submission to the Pharmacy Council of New Zealand (Pharmaceutical Society of New Zealand)

Like other submissions, the Pharmaceutical Society does support the addition of a new clause about providing sufficient information for patients to make informed choices. However, they also made a similar suggestion to one in the Society for Science Based Healthcare’s submission in that the wording of this clause should be strengthened:

The Society also considers that “sufficient information about the product” must be provided in order for purchasers to make an informed choice with respect to efficacy of that product and the risks and benefits of that against other treatment options.

Submission to the Pharmacy Council of New Zealand (Pharmaceutical Society of New Zealand)

Aside from their comments on the new proposed wording, the Pharmaceutical Society raised concerns about the application of this section of the Code of Ethics. Part of their submission focussed on pharmacists’ responsibility to comply with the Code of Ethics:

Pharmacists must comply with the Code of Ethics
The Council have stated that it is not the purpose of the Code, or the Council, to endorse or prohibit the supply of any particularly complementary and/or alternative medicine, product, or practice. However, as the responsible authority for pharmacy under the Health Practitioners Competence Assurance Act 2003, standards of ethical conduct set by the Council must be observed by pharmacists. Indeed, in the Code of Ethics the Council requires that pharmacists must comply with “all the implied requirements of ethical practice” within the Code.

The Medicines Regulations 1984 (in Schedule 2 related to applications for a licence to operate a pharmacy) also refers to how pharmacists being employed or engaged in duties in a pharmacy are

not requested or required to act in a way that is inconsistent with the applicable professional or ethical standards of the pharmacy practice

Therefore, the obligations within the Code of Ethics must be interpreted clearly so that pharmacists have a clear understanding of what is considered ethical practice, but also so that the Council can investigate and act upon breaches of the Code.

Submission to the Pharmacy Council of New Zealand (Pharmaceutical Society of New Zealand)

This call for clarity has been a common theme among submissions. Both the NZ Skeptics’ submission and Dr Ben Albert’s submission called for guidelines on product categories that should not be sold in pharmacies due to a lack of evidence. Also, when the Society for Science Based Healthcare complained to the Pharmacy Council last year, one of the recommendations made was to for the Pharmacy Council provide guidance on this issue:

As a result of this complaint, we want pharmacists to have the opportunity to do the right thing and fulfill their ethical obligations. In order to achieve this, we suggest that the Pharmacy Council consider the following courses of action:

…

5. To assist pharmacies in evaluating whether or not a healthcare product is supported by credible evidence of efficacy, the Pharmacy Council should develop and publish guidelines regarding what constitutes credible evidence of efficacy. This need not be a strict requirement so much as a useful guide that pharmacists can use to establish a consistent minimum standard of evidence.

NaturoPharm Wartoff Complaint (Society for Science Based Healthcare)

If it’s unclear where the line is drawn with regard to “credible evidence of efficacy”, it makes it more difficult for pharmacists to practice ethically. The Pharmaceutical Society’s submission raises questions about where this line might be drawn regarding alternative healthcare products, and talks about how the Code will be applied in practice:

Definition and interpretation of obligations
The wording of the proposed obligations 6.9a and 6.9b make reference to “credible evidence of efficacy” and “quality and safety”. Therefore, if presented with a complaint against a pharmacist claimed to be in breach of the obligations within the Code of Ethics, the Council is expected to determine what is “credible evidence of efficacy” and/or “quality or safety”.

The Society recognises that the application of a principles-based Code of Ethics to individual scenarios or circumstances is open to interpretation and challenge. Such scenarios are often not “black and white”, but “shades of grey” where a group of peers may have differing opinions to the acceptability or otherwise of a particular practice. It is expected that such “shades of grey” will always exist in pharmacy practice, as indeed it does in medicine and other areas of professional practice. However where a particular practice is determined to be unethical or unacceptably, this must be made clear. This is a difficulty faced when considering the evidence and use of complementary treatments against regulated medicines.

Submission to the Pharmacy Council of New Zealand (Pharmaceutical Society of New Zealand)

The submission goes on to compare “natural” or herbal healthcare products with homeopathic products, in terms of plausibility:

Complementary/alternative medicine: natural/herbal remedies
The Society recognises the history of pharmaceuticals, and indeed of the pharmacy profession, where the first “medicines” were derived from natural products. Many of these have been purified, refined and further manipulated in the development of modern day pharmaceutics. Much of modern pharmaceutical research continues to analyse the therapeutic potential of compounds found naturally occurring substances derived from flora and fauna. We recognise how the levels of evidence of the therapeutic benefits (or otherwise) of natural products can vary markedly, but understand the science behind their potential mechanisms of action has the same pharmacological basis and pharmaceuticals.

…

Homeopathy
We note the Council’s own ‘Complementary and alternative medicines – best practice guidance for pharmacists’ document makes reference to the Natural Health and Supplementary Products Bill which states:

currently there is no accepted scientific evidence for the effectiveness of homeopathy and therefore that health benefit claims should not be made for homeopathic products

This aligns with further documents and statements issued internationally, including the Australian National Health and Medical Research Council (NHMRC)⁽¹⁾, the Cochrane Library and others have noted homeopathic products show no effects beyond placebo. A large number of government committees, professional pharmacy and medical organisations internationally have issued statements reinforcing this lack of effectiveness of homeopathy in treating health conditions. The Pharmaceutical Society of New Zealand does not at this time have a position statement on complementary medicines or homeopathy.

Homeopathy is not herbalism, and homeopathic science is not consistent with currently accepted medical and pharmacological science. Some pharmacists, and indeed other health professions, have argued for the role of homeopathy as a valid form of treatment to meed patient demand, while acknowledging any “benefit” is achieved through a placebo effect, while not necessarily agreeing with the purported science behind homeopathic practice.

The question for the Council must then be whether it is considered ethical practice for pharmacists to charge a fee for products for which there is no accepted scientific evidence for effectiveness; OR for which they acknowledge a lack of evidence yet sell for the purposes of providing a placebo effect.

⁽¹⁾ National Health and Medical Research Council of Australia (NHMRC). NHMRC Information Paper: Evidence on the effectiveness of homeopathy for treating health conditions [Internet]. Canberra: National Health and Medical Research Council; 2015. Available from: https://www.nhmrc.gov.au/guidelines-publications/cam02

Submission to the Pharmacy Council of New Zealand (Pharmaceutical Society of New Zealand)

The Pharmaceutical Society also noted something that was raised in a few other submissions; when pharmacies sell ineffective products they lend them the credibility of their profession, which can inadvertently lead to patients being misled about their efficacy.

While we again note that the Council have expressed that it’s not their purpose or the purpose of the Code of Ethics to “endorse any particular complementary or alternative medicine or practice”, in setting the requirements for pharmacists to conform with obligation 6.9 (or 6.9a and 6.9b), the Council must determine whether the practice of homeopathy is consistent with the Code. Particularly when having homeopathic products available alongside pharmaceutical medicines, or indeed herbal/complementary medicines with their varied levels of evidence, potentially implies clinical benefit by association and provision through a respected and regulated health professional.

Submission to the Pharmacy Council of New Zealand (Pharmaceutical Society of New Zealand)

I’ve not yet been made aware of any other submissions that have been made to the Pharmacy Council, but I imagine a number of individuals at least will have made submissions that have not been publicised. As it stands though, the Pharmacy Council’s proposal seems to have strong opposition from all sides, with the only significant support I have seen so far coming from the Pharmacy Guild, who represent only those pharmacists who own their own pharmacies.

It seems no group other than pharmacy owners wants to keep the status quo of pharmacies selling ineffective products without consequences.