Tag: Pharmaceutical Society

Pharmacists Don’t Want to Sell Unproven Products

Pharmacists Don’t Want to Sell Unproven Products

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:

…

  1. 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.

Pharmacy Council’s Code of Ethics Proposal: Submissions Roundup

Pharmacy Council’s Code of Ethics Proposal: Submissions Roundup

The Pharmacy Council has proposed a change to their code of ethics, here’s everything you need to know.

EDIT 22/10/2015: When this article was published it didn’t include details of the Pharmaceutical Society’s submission. Since then, I have spoken with their Chief Pharmacist Advisor, Bob Buckham, about their submission. For more details, see my article summarising it: Pharmacists Don’t Want to Sell Unproven Products

The Pharmacy Council is the statutory body responsible for setting standards of conduct and competence of pharmacists in New Zealand. They have a code of ethics, the Safe Effective Pharmacy Practice Code of Ethics 2011, which currently includes a section that requires pharmacists must:

6.9
Only purchase, supply or promote any medicine, complementary therapy, herbal remedy or other healthcare product where there is no reason to doubt its quality or safety and when there is credible evidence of efficacy.

Safe Effective Pharmacy Practice Code of Ethics 2011 (Pharmacy Council)

In August, the Pharmacy Council proposed to change this section of the code of ethics. The first part of the proposed change is to remove the requirement for complementary therapies and other healthcare products to be supported by credible evidence of efficacy before they can be promoted or supplied in a pharmacy. The other part is to add a requirement that purchasers must be given enough information about these products to make an informed choice:

6.9a
Only supply or promote any medicine or herbal remedy where there is no reason to doubt its quality or safety and when there is credible evidence of efficacy.
6.9b
Only supply any complementary therapy or other healthcare product where there is no reason to doubt its quality or safety and when sufficient information about the product can be provided in order for the purchaser to make an informed choice with regard to the risks and benefits of all the available treatment options.

Proposed supplementary wording to clause 6.9 of the Code of Ethics 2011 (Pharmacy Council)

As part of this proposal, the Pharmacy Council called for submissions from stakeholders. In my last article on this topic, I discussed the submission from the Society for Science Based Healthcare, of which I am a co-founder. Although the extended deadline for submissions passed last Friday, various other groups have made their views on this proposal clear and made their own submissions.

The Society for Science Based Healthcare

The Society for Science Based Healthcare is a group of consumer advocates, scientists, and medical professionals. I am one of its co-founders. The submission from the Society for Science Based Healthcare proposed a modified version of the new wording:

6.9a
Only supply any medicine or herbal remedy where there is credible evidence of efficacy.
6.9b
Only promote any complementary therapy or other healthcare product where there is credible evidence of efficacy.
6.9c
Only supply or promote any medicine, herbal remedy, complementary therapy or other healthcare product where there is no reason to doubt its quality or safety, when there is not credible evidence to suggest that the product lacks efficacy.
6.9d
Provide sufficient information about any medicine, herbal remedy, complementary therapy or other healthcare product product in order for the purchaser to make an informed choice with regard to the risks and benefits of all the available treatment options.

Pharmacy Council Code of Ethics Proposal (Society for Science Based Healthcare)

After lodging a complaint last year with the Pharmacy Council regarding an incident in which a patient was misled by an Auckland pharmacy that recommended and sold them a homeopathic product, both the Pharmacy Council and the Health and Disability Commissioner refused to enforce the code by telling the pharmacy not to promote or sell the homeopathic product, despite the fact that it was not supported by any credible evidence of efficacy.

In principle, the society would oppose the change. However, having have found that the existing section of the code is disregarded rather than enforced, the society decided it was best to try to turn the code into something the Pharmacy Council might be willing to enforce that could still offer protection to patients.

It is currently widespread practice for New Zealand pharmacies to supply and promote healthcare products which are not supported by credible evidence of efficacy, such as homeopathic products.

Pharmacy Council Code of Ethics Proposal (Society for Science Based Healthcare)

This view that the current code of ethics is commonly disregarded has been shared among many of the other submissions that have been made public, and appears to be supported by a statement made by the Pharmacy Council chairman Dr Andrew Bary in a recent article on Stuff.co.nz:

But Pharmacy Council chairman Dr Andrew Bary said the rules as they stood were “unworkable” and many pharmacists, including himself, were already selling complementary medicines, even if they didn’t believe their claims.

Doctors and pharmacists clash over complimentary medicines (Stuff.co.nz)

The Society for Science Based Healthcare’s submission also argued that there are both potential risks and potential benefits to these products being sold in pharmacies. The proposed new wording is intended to provide the best risk/benefit profile for patients.

On the one hand, if these products are available in a pharmacy consumers will be more likely to visit a pharmacy to purchase them. This can put them in a position where a pharmacist is able to provide them with evidence-based advice, so they can make an informed decision on purchasing the best product for whatever problem they are experiencing. If the product were not available in a pharmacy, they may instead seek it from a source which would not provide them with this information, or which may misinform them.

…

On the other hand, when a product is available in pharmacies it is likely to lead consumers to believe that it is an effective, evidence-based product. This is often used as a selling point by products which are not supported by evidence. For example, the homeopathic product No-Jet-Lag advertises itself as being available at “Most chemists nationwide“. In this way, pharmacists stocking products without credible evidence of efficacy can also contribute to an increase in consumer demand for them. For all intents and purposes, supplying a product in a pharmacy is also a form of promotion.

Pharmacy Council Code of Ethics Proposal (Society for Science Based Healthcare)

When it was submitted this submission had a list of 36 supporters, 24 of whom are healthcare professionals or PhD scientists

The NZ Skeptics

The NZ Skeptics’ submission opposed the change. It also proposed that the Pharmacy Council maintain a list of products or product categories that are not supported by credible evidence of efficacy, to make it easier for pharmacists to determine which products could or could not be sold in pharmacies. The motivation for this recommendation is similar to one made in the Society for Science Based Healthcare’s complaint last year:

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:

…

  1. 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)

To inform their submission, the NZ Skeptics conducted a “secret shopper” exercise with their members to discover what actually happens when consumers talked to pharmacy staff about homeopathy.

We found that around half of the pharmacies visited had staff that were willing to promote or supply homeopathic products without adequately explaining the current lack of evidence.

…

It seems that some pharmacies did not stock homeopathy, but a significant number of others did have homeopathic products on their shelves and in most of these pharmacies staff were willing to offer homeopathy as a viable treatment, with no information offered about a lack of efficacy.

…

With the code being an important patient protection mechanism, we’re disappointed to see it so readily disregarded.

Submission to the Pharmacy Council’s 2015 Code of Ethics Consultation (NZ Skeptics)

The NZ Skeptics have made these reports available on their website: Pharmacy Homeopathy Reports. As well as this, they conducted a non-exhaustive search for New Zealand pharmacies promoting homeopathic products online, and made the results of this available too: Pharmacies Promoting Homeopathy.

One argument that is used to support pharmacies selling products with no credible evidence of efficacy is that, if pharmacists were prevented from selling these products, then patients’ freedom of choice would be infringed. This argument has been made, for example, by Pharmacy Council chairman Dr Andrew Bary when he was interviewed on Radio New Zealand about this proposed change:

You know, I think we need to respect the wish of the consumer from time to time, so you know, individuals have their own cultural and traditional beliefs around certain alternative and complementary therapies… So I think that the key thing is that we are setting out that we think pharmacists should be informed about the efficacy of the evidence for each individual product when they are promoting and making recommendations to people. But at the same time, we need to put the person at the centre, the consumer, and respect their wishes and desires.

Pharmacy Council moves to change code of ethics over homeopathy (Radio New Zealand)

The argument has also been put forth by pharmacists that sell these products in their pharmacies:

“Many patients believe homeopathy has been of benefit and they should be given the freedom to choose it if they want, [Lincoln Mall Pharmacy owner pharmacist Caleb Townsend] says.”

Pharmacists support patient choice with homeopathy (Pharmacy Today)

It may be worth noting that Lincoln Mall Pharmacy is one of the ones on the NZ Skeptics’ list of pharmacies promoting homeopathy online, and the Pharmacy Today article notes they have “qualified homeopaths onsite”. An Advertising Standards Authority complaint laid by Society for Science Based Healthcare member Simon Clark was settled in June when the pharmacy opted to remove claims that homeopathic products can “treat a wide range of illnesses and concerns” from an online listing.

Ben Albert et al.

Dr Ben Albert is a paediatric endocrinologist who researched fish oil for his PhD, which made headlines earlier this year after his research was published in the Nature journal Scientific Reports. Along with five other doctors, he has written a submission to the Pharmacy Council opposing the change.

Despite coming from a group of individuals rather than a professional society, the submission boasts the impressive support of 180 medical doctors, predominantly senior consultants, representing all medical specialties. It also has the support of the NZ Society of Paediatric Surgeons and the NZ Resident Doctors Association, which represents over 90% of the resident medical officer workforce in New Zealand. Its authors are:

  1. Dr Benjamin B. Albert FRACP, Paediatric Endocrinologist and Clinical Research Fellow. Liggins Institute, University of Auckland.
  2. Professor Wayne S. Cutfield MD FRACP. Professor of Paediatric Endocrinology, and Director of A Better Start National Science Challenge, Liggins Institute, University of Auckland. Past president, Australasian Paediatric Endocrinology Group. Past president, Asia Pacific Paediatric Endocrine Society.
  3. Professor Paul L. Hofman FRACP. Professor of Paediatric Endocrinology, Director of the Maurice and Nessie Paykel Clinical Research Unit, Liggins Institute, University of Auckland. President Asia Pacific Endocrine Society. Past president Australasian Paediatric Endocrinology Group.
  4. Professor Alistair J. Gunn PhD FRACP. Professor of Physiology and Paediatrics, and Head of Department of Physiology, University of Auckland. Paediatric Endocrinologist.
  5. Associate Professor Timothy Kenealy PhD FRANZCGP, Professor of Integrated Care, University of Auckland. General Practitioner.
  6. Dr Olivia J. Albert FANZCA. Anaesthetist, Royal Hospital for Women, Sydney, Australia.

The specific recommendations made in their submission are:

  • Reject the proposed change, or reinsert the requirement for “credible evidence of efficacy” in to clause 6.9b. We suggest this wording.

    • where there is no credible evidence to suggest a specific complementary and/or alternative medicine/product is effective, or the proposed effect of the product is scientifically implausible pharmacists should not promote or recommend its use
  • Current ethical standards should be enforced
  • Treatments and products that do not have “credible evidence of efficacy” such as homeopathic remedies, ear candles and magnet based therapies should be listed by the PCNZ, with the intention that they are not sold in pharmacies.

Submission to the Pharmacy Council of New Zealand (Ben Albert et al.)

The last recommendation echoes that of the NZ Skeptics, aiming to simplify things for pharmacists by providing a list of products or product categories which clearly are not supported by credible evidence of efficacy.

The rationale for their opposition to the change is laid out clearly and concisely in the submission:

The suggested change is in opposition to the general principles of the code, and the expectations of the public and other members of the multidisciplinary science based healthcare team.

…

This change would make it permissible within the ethical code for pharmacists to promote and sell products that are unproven and even scientifically implausible. We believe that this is harmful and wrong.

…

the current code should be enforced, not amended.

Submission to the Pharmacy Council of New Zealand (Ben Albert et al.)

They raise another counterargument to the “freedom of choice” argument, noting that pharmacists should be wary of their conflict of interest between advising against patients purchasing products that aren’t supported by evidence and selling more products to generate more profit for the pharmacy:

pharmacists (like many health providers) have a conflict of interest when they sell and give advice about health products from which they make profit. There is evidence that financial pressures do impact the clinical decisions of pharmacists1. One of the reasons that a code of ethics is important is because it provides guidance where the interests of pharmacists and patients differ.

1 Chaar B, Brien Ja, Krass I. Professional ethics in pharmacy: the Australian experience. International Journal of Pharmacy Practice. 2005;13(3):195-204

Submission to the Pharmacy Council of New Zealand (Ben Albert et al.)

They also raise the issue that products sold in pharmacies are likely to be seen as effective by the public, which can lead to harm when they are sold in pharmacies:

Many patients will assume that the pharmacist endorses the health products sold in the pharmacy as scientifically supported. But many pharmacists sell products that are known to be ineffective, such as homeopathic remedies3 or potentially harmful, such as ear candles4. Selling such products conflicts with the principles of the current code5 as it reduces patient autonomy. The patient that wrongly assumes that a health product is scientifically supported is ill-prepared to make an informed decision.

3 Ernst E. A systematic review of systematic reviews of homeopathy. Br J Clin Pharmacol. 2002;54(6):577-82.
4 Seely DR, Quigley SM, Langman AW. Ear Candles-Efficacy and Safety. The Laryngoscope. 1996;106(10):1226-9.
5 Zealand PCoN. Code of ethics 2011: Pharmacy Council of New Zealand; 2011 [cited 1015 17 September]. Available from: http://www.pharmacycouncil.org.nz/cms_show_download.php?id=200.

Submission to the Pharmacy Council of New Zealand (Ben Albert et al.)

Although this submission has not been made public, it shares much in common with a letter to the editor from the same authors that was published today in the New Zealand Medical Journal.

I spoke with Dr Albert to ask what motivated him to take action on the Pharmacy Council’s proposal, here’s what he had to say:

For years it has bothered and surprised me that products that are entirely implausible such as magnets and homeopathic remedies, and harmful products such as ear candles are sold in pharmacies. When scientifically trained and trusted health professionals promote and sell such treatments they betray the trust of the public who will quite reasonably assume such products are endorsed by the pharmacist and supported by scientific evidence. The current PCNZ code of ethics indicates that it is unethical and unprofessional for pharmacists to sell these products. The right course of action is to stop selling them. To instead change the code to redefine ethical behaviour appears cynical and makes the sale of unsupported or harmful treatments no less wrong.

Dr Ben Albert

The New Zealand Medical Association

The New Zealand Medical Association is New Zealand’s largest medical organisation, representing over 5,500 medical professionals. The New Zealand Medical Association’s submission strongly opposes the change. They echo the views of other submissions that in the face of widespread behaviour at odds with the current code, the way forward should be change behaviour to match the code rather than to relax the code to permit existing behaviour:

The NZMA is strongly opposed to the above proposed change

…

We do not believe that pharmacists should be selling ‘treatments’ that are known to be ineffective or lack evidence of effectiveness. We contend that doing so is unethical. While this practice may be happening under the present Code, we believe that the PCNZ should be seeking ways to enforce the Code rather than amend it to accommodate this practice.

Submission to the Pharmacy Council of New Zealand (New Zealand Medical Association)

The NZMA acknowledged the trust placed in pharmacists by the public, and how this affects the way in which products sold in pharmacies are perceived:

It is our view that allowing pharmacists to sell ineffective therapies or products is contrary to the profession’s own aspirations, including of trustworthiness and professionalism. More broadly, it undermines the social contract between the public and the profession. The pharmacist is trusted by patients and other members of the health care team precisely because of their scientific training. The sale of products by pharmacists that knowingly do not work is inconsistent with the high trust health care professional the public expects and the profession requests.

Submission to the Pharmacy Council of New Zealand (New Zealand Medical Association)

The NZMA also deals with the “freedom of choice” argument in a similar way to the other submissions:

We understand that patient autonomy and freedom of choice are being advanced as the rationale for the proposed rewording to the Code. We believe these are spurious arguments on which to remove the requirement for “credible evidence of efficacy” for pharmacists to sell complementary therapies or other healthcare products. Freedom of choice should not transcend the health and well-being of the patient. Furthermore, such products are already available to people to purchase at other outlets, such as health food shops and supermarkets.

Submission to the Pharmacy Council of New Zealand (New Zealand Medical Association)

The NZMA raised some new concerns, regarding the potential impacts of the proposed change:

The proposal is of all the more concern given the current lack of regulation of complementary therapies in New Zealand.

…

We are also concerned at the impact of the proposal on equity. Patients that are least likely to consult a doctor could end up being even more likely to purchase costly ‘healthcare’ products from their pharmacy that do not work.

…

The proposal also undermines the wider health sector’s efforts to improve health literacy.

Submission to the Pharmacy Council of New Zealand (New Zealand Medical Association)

The NZMA’s final recommendation is for the requirement for credible evidence of efficacy to be kept and enforced, and until it is enforced for the newly proposed requirement for supplying sufficient information to make an informed choice to bridge the gap:

Ideally, we would like to see pharmacists end the sale of complementary therapies or other healthcare products for which there is no credible evidence of efficacy (ie, meet their obligations under the existing Code). Until such time, we would suggest the addition of a subclause to 6.9 which addresses the need to provide sufficient information for herbal remedy, complementary therapy or other healthcare product. Accordingly, we proposed the following wording:

6.9
Only purchase, supply or promote any medicine, complementary therapy, herbal remedy or other healthcare product where there is no reason to doubt its quality or safety and when there is credible evidence of efficacy.
6.9a
When supplying a herbal remedy, complementary therapy or other healthcare product, sufficient information about the product must be provided in order for the purchaser to make an informed choice with regard to efficacy of the product and the risks and benefits of all available treatment options.

Submission to the Pharmacy Council of New Zealand (New Zealand Medical Association)

The Pharmacy Guild

The Pharmacy Guild represents pharmacy owners in New Zealand. The Pharmacy Guild’s submission supports the Pharmacy Council’s proposed change:

We support the Council’s intentions of the proposed changes to clause 6.9 of the Code of Ethics 2011 (the Code).

Consultation on the proposed wording to clause 6.9 of the Code of Ethics 2011 (Pharmacy Guild)

The primary motivation for this support seems to be a combination of the “freedom of choice” argument I described above, and the potential for benefit described in the Society for Science Based Healthcare’s submission:

We believe that if pharmacists were prevented from selling natural products then patients wanting these products would continue to source them from somewhere. We consider that it is far safer for consumers to approach pharmacists for advice and that they purchase supplies of complementary medicines from a pharmacy rather than over the internet for instance, where the quality and safety of a product cannot always be guaranteed.

Consultation on the proposed wording to clause 6.9 of the Code of Ethics 2011 (Pharmacy Guild)

As well as these submissions, I have been made aware of a few more, mainly submitted by individuals. Of those I am aware of, such as Edward Linney’s submission, they are predominantly opposed to the change for many of the reasons described in these submissions. I am aware of one instance of an ex-pharmacist who supports that change who is now a practising homeopath and, scarily, was previously employed by the Pharmacy Council as their Professional Standards Advisor even while they were practising as a homeopath. However I don’t know if they have made a submission.

I’m also aware that the Pharmaceutical Society has made a submission. Whereas the Pharmacy Council regulates pharmacists, the Pharmacy Guild and Pharmaceutical Society are membership organisations; the Guild represents pharmacy owners and the Society represents pharmacists in general. Although I have tried to get in touch with them, I haven’t seen the Pharmaceutical Society’s submission and can’t provide comment. I will update this article if that changes.

However, I am aware that the Pharmaceutical Society has close ties to the New Zealand Medical Association, even to the point where they have a joint agreement for members to abide by both organisations’ codes of ethics. So I expect that if they have made a submission it may be along similar lines to the NZMA’s submission.

If anyone knows of any more information that I’ve missed in this article, please leave a comment below.

Ethical Pharmacy Practice 5: Looking for Leadership

Pharmacy
Pharmacy by russellstreet on Flickr CC BY-SA 2.0

In New Zealand, the Pharmacy Council is legally responsible under section 118(i) of the Health Practitioners Competence Assurance Act 2003 for setting standards of ethical conduct for New Zealand pharmacists. As part of this, they’ve written a Safe Effective Pharmacy Practice Code of Ethics, which requires that:

YOU MUST:

Only purchase, supply or promote any medicine, complementary therapy, herbal remedy or other healthcare product where there is no reason to doubt its quality or safety and when there is credible evidence of efficacy.

Safe Effective Pharmacy Practice Code of Ethics Section 6.9

Last November, a case was brought to our attention at the Society for Science Based Healthcare of a salesperson in an Auckland pharmacy recommending and selling a homeopathic product to someone who didn’t realise until they’d bought the product and taken it home that it was homeopathic and that there is no credible evidence of its efficacy. The society wrote a formal letter of complaint to the Pharmacy Council about this, alleging that it was a clear violation of this section of their code of ethics.

As part of this complaint, we made a series of recommendations:

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:

  1. Advise [the pharmacy] of their ethical obligation not to purchase, supply, or promote any healthcare product where there is not credible evidence of efficacy.
  2. Recommend that [the pharmacy] review their stock, starting with [the homeopathic products we found in their store], to ensure that they meet this ethical obligation. If they are not currently aware of credible evidence of efficacy for these products, they should request it from the manufacturer and, if they are not supplied with credible evidence of efficacy within a certain specified timeframe (we recommend 10 working days) to remove the products from sale.
  3. Recommend that [the pharmacy] undertake training of their staff to ensure that no one is giving unfounded healthcare advice to customers.
  4. Relay these recommendations to other New Zealand pharmacies so that they are also given the chance to ensure that they meet this ethical obligation.
  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.

The Society for Science Based Healthcare

The Pharmacy Council said that creating a guideline for standards of evidence was not their role, although they suggested that it may be appropriate for the Pharmacy Guild or the Pharmaceutical Society to create such a guideline and forwarded the letter of complaint on to these organisations. To my knowledge, neither of them has created any such guideline.

The Pharmacy Council also wrote to the pharmacy in question. When I visited it some months later I found the same homeopathic products were still for sale, although they had at least been moved behind the counter.

I don’t know if that particular pharmacy still actively promotes and tries to sell these products, but on Twitter the other night I was told of another case where a sales assistant at a New Zealand pharmacy tried to sell a homeopathic product while clearly lacking any useful knowledge about homeopathy:

In response to the Society for Science Based Healthcare’s complaint, the Pharmacy Council also offered to remind pharmacists of their obligations with respect to selling any alternative medicines in their next newsletter. Last week, 9 months after having received our complaint, they finally published this newsletter. Here’s what they said:

Complementary and Alternative Medicines — Best Practice Guidance for Pharmacists

As medicines experts, pharmacists have built their reputation on providing accurate, unbiased information on the use, safety and effectiveness of all medicines, including complementary and alternative medicines. Pharmacists must be familiar with the latest information on the medications they supply to their patients, and seek independent information to maintain an objective viewpoint so they can help individuals make informed choices (Competence Standard O1.2.4).

Homeopathy in particular has had much attention over recent times, specifically regarding its plausibility and efficacy. Nonetheless, many people, including some healthcare professionals, continue to use or practise homeopathic medicine and advocate its safety and efficacy.

It is not Council’s purpose to endorse any particular complementary or alternative medicine or practice; however, Council believes it is necessary for pharmacists to have a basic knowledge of complementary and alternative medicines to engage with and advise patients appropriately.

This approach also ensures pharmacists can meet their duty of care to patients and the profession. Pharmacists should be able to counsel patients about complementary and alternative medicines’ general use, the current evidence and any safety issues, including their use with other medications.

Pharmacy Council July 2015 Newsletter

Although I’m glad to finally see a statement from the Pharmacy Council about homeopathy, I am disappointed at the weakness of this statement. Especially in contrast with their clear and strong code of ethics that requires pharmacists only sell healthcare products with credible evidence of efficacy – something that is clearly not the case for homeopathy.

However, I’m aware that the Pharmacy Council’s role is restricted to the responsibilities set out in the Health Practitioners Competence Assurance Act. So perhaps it would be better to expect professional organisations representing pharmacists to speak out against this. We have recently seen this to be the case with organisations of other healthcare professionals, such as the New Zealand Medical Association whose chair recently agreed on national radio that homeopathy is “just rubbish”.

In New Zealand there are two professional organisations (that I’m aware of) that represent pharmacists: the Pharmacy Guild and the Pharmaceutical Society. They are not so limited in position by the law as the Pharmacy Council, so I would hope to see stronger positions supporting science based healthcare from them.

Over the weekend, the annual Pharmacy Awards were held, hosted by both the trade magazine Pharmacy Today and by the Pharmacy Guild. Surely, at an event like this we should expect to see a celebration of outstanding examples of pharmacies providing quality healthcare services, right? For the most part, I hope, that may have been the case, but I was rather disheartened to see one award that flies in the face of this goal.

The official description for the Best Complementary Healthcare Campaign award is (with my emphasis added):

To win this award you need to have come up with a complementary health promotion or ongoing programme that has contributed to improved retail result, in areas such as, vitamins, supplements, sports nutrition or homeopathy.

Pharmacy Awards | Best Complementary Healthcare Campaign

I was shocked and dismayed to see this. Pharmacists should win awards for providing an excellent healthcare service. Not for selling more fake medicine.

Of the previous winners listed, one is Auckland pharmacist Martin Harris. I’ve written about him briefly before in another article about homeopathy being sold in New Zealand pharmacies, quoting him from a Pharmacy Today article in which he defended the practice:

Auckland pharmacist Martin Harris says there is good evidence for homeopathy in the field of quantum physics.

“There’s no placebo-controlled, double-blind randomised controlled trials using one remedy and one result because homeopathy doesn’t work that way, it works on energy,” Mr Harris says.

Conventional medicines have been proven to have side effects and contraindications, but pharmacies still sell them, he says.

Mr Harris, who specialises in nutrition medicine, admits he is no expert when it comes to homeopathy, and his Massey pharmacy sells only a few homoepathy products.

But he would be very disappointed if he was not allowed to sell the products as an option, he says.

Pharmacists support patient choice with homeopathy – Pharmacy Today

Mr Harris last won the “Best Complementary Healthcare Campaign” award in 2012, but perhaps you could hope the pharmacist community has since stopped celebrating such massively misguided interpretations of the evidence (and ethics) surrounding homeopathy. Unfortunately, this does not seem to be the case, as Mr Harris took home the Supreme Award at this year’s Pharmacy Awards despite selling homeopathic products in his pharmacy and appearing to be proud of it.

The pharmacist community makes no secret of the fact that it wants to play a larger role in New Zealand’s healthcare system, calling for changes such as allowing pharmacists to dispense contraceptive pills without a prescription and and provide a substitute for a GP’s services in some circumstances. From my position as an external onlooker, it does seem like there is a certain degree of pharmacists wanting to extend their practice and doctors trying to defend their turf, although I also think both sides have good arguments to make. So long as any changes primarily act to serve the healthcare needs of the public, I’m happy.

However, running a successful pharmacy is a balancing act between running a profitable retail store and providing a reliable healthcare service. Pharmacies can do a great job at improving access to essential healthcare services such as vaccinations and smoking cessation, but on the other hand many of them also boost their profits by selling healthcare products that do nothing aside from emptying your wallet. A recent opinion piece in Pharmacy Today that acknowledged this balance recommended upselling Vitamin C when customers asked about cold/flu products. While this would surely increase the pharmacy’s profits, the best available evidence doesn’t show that Vitamin C supplementation can help with the common cold or influenza.

There is a clear need for leadership within the pharmacist community regarding putting customers’ healthcare needs before profits. We trust pharmacies to provide us with reliable healthcare products and advice, but so long as they keep fake medicine on their shelves I’m not convinced they deserve this trust. To quote the hover text of this relevant xkcd strip:

I just noticed CVS has started stocking homeopathic pills on the same shelves with–and labeled similarly to–their actual medicine. Telling someone who trusts you that you’re giving them medicine, when you know you’re not, because you want their money, isn’t just lying–it’s like an example you’d make up if you had to illustrate for a child why lying is wrong.

Randall Munroe – xkcd: Alternative Literature

I believe pharmacists generally do care about providing the best health outcomes for their customers. What I want to see is more pharmacists putting patients before profits, following in the footsteps of Australian pharmacist Grant McGill by choosing to remove homeopathic products from their shelves.