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Practitioner-only products: a retrospective analysis of social media comments from natural medicine practitioners.

[ILLUSTRATION OMITTED]

Practitioner-Only Products (POPs) 'can be defined as therapeutic goods that:

a) are marketed exclusively or ostensibly to practitioners, and/or

b) fall within the 'For Practitioner Dispensing Only' (1) or 'Extemporaneous Compounding' (2) (provisions in regulations under the Therapeutic Goods Act 1990 Cth).

This definition has led some practitioners to believe that POPs are therapeutically different from normal TGA natural medicines. However, according to the TGA there is one rule that governs all listable products, whether POPs or normal listable natural medicine that can be found in a health food aisle in a supermarket or in a health food store. The only difference between POPs and any other listable natural medicine is that POPs have slightly different labels. POPs are designed to be 'over-labelled' by practitioners so that practitioners themselves can accurately represent dosage for their patients. Also, POPs do not have, nor do they need to have, therapeutic claims about the product on their labels, the intention being that the POP will be formally prescribed by a natural medicine practitioner. For example, a POP vitamin C does not need to contain a therapeutic claim like, 'This product may shorten the duration of the common cold.'

In short, the only difference between POP natural medicines and other natural medicines in health food stores are their labels and not their ingredients. POPs were formulated as a marketing strategy for natural medicine companies and, except for their labels, are subject to the same natural medicine laws as any other natural medicine found in a health food store or a supermarket. Natural medicine companies set up these products to create a niche market for practitioners who might purchase from the company because POPs were formulated specifically for them. Companies use innovative nutrients in POPs, relying on practitioners' knowledge of their therapeutic value to prescribe them. This means that natural medicine companies can release innovative products without the education programs that often accompany their release. Today a more knowledgeable public has less need of practitioners' services.

The use and misuse of POPs and practitioner-only advertising, particularly their use in retail and other nonclinical settings, is of great interest to naturopaths, herbalists and nutritional medicine practitioners. In a study by Wardle et al. (3) naturopaths were interviewed about their perceptions of challenges to their industry. Interviewees reported that the natural medicine industry was undergoing rapid change for both practitioners and their clients. They argue that the increasing prevalence of an evidence-based clinical approach is changing how natural medicine is being practised and by whom, but the precise way in which this change is occurring is unclear.

Naturopaths, nutritionists and herbalists may be unaware of the legislative and regulatory framework underpinning the sale of POPs. In the absence of precise legislative and regulatory guidelines the generally accepted belief is that manufacturers prescribe and adhere to retail policies designed to ensure that 'POPs are sold and marketed exclusively or osensibly to practitioners'. However, policies differ among manufacturers. The advent of the internet and increasing popularity of natural medicines has fostered a subculture of POP advertising and sales that appears to have little interest in adhering to restrictive retail policies.

One private invitation-only Facebook group was established as a forum of practitioners designed to address specific issues associated with POPs. The opinions of over 200 practitioner members of the group will contribute to a better understanding of prevailing opinions about POPS, justification for their use by appropriate healthcare practitioners, regulations governing their use, and public safety. The aim of this project was to investigate experiences and opinions of naturopaths, herbalists and nutritionists on the use of POPs outside clinical consultation settings through this online closed discussion forum.

Methodology

A qualitative approach is appropriate in order to understand experiences and perspectives of practitioners. Permission to extract de-identified comments was sought from contributors to a private invitation-only online Facebook group established to discuss POPs. The group had 230 members at the time of data collection. All members were adults over 18 years of age who were qualified naturopaths, nutritionists or herbalists.

An invitation to participate in the research was posted on the Facebook group discussion forum, along with participant information and an informed consent form. Comments of those group members who gave consent were extracted from the forum, de-identified and emailed to a team of four researchers.

Participants' Facebook comments were read and re-read independently by members of the research team to identify common concepts. Concepts were grouped into themes through constant comparison. (4) The researchers then met to discuss, compare and refine emergent themes. The process continued until key themes had been identified by consensus. Finally two researchers discussed the identified themes with a key stakeholder who contributed perspectives of companies manufacturing and supplying the products.

The study was conducted with approval of the Southern Cross University Human Ethics Research Committee (Approval number: ECN-13226).

Results

In the following section, names of specific companies who manufacture and/or supply POPs have been replaced with 'POP company'. The following key themes emerged from the data:

Loss of identity of naturopaths, herbalists and nutritionists

Naturopaths, herbalists and nutritionists as experts

Naturopaths, herbalists and nutritionists consider themselves to be the most qualified practitioners for prescribing POPs. Participants in the study described spending many years attending company seminars, learning about POPs and developing protocols for treatment. Their professional practices were closely tied to prescribing pre-formulated POPs, although always in the context of a complete naturopathic assessment and treatment specifically tailored to suit individual patients' needs. Practitioners were concerned that the professional status of naturopaths, herbalists and nutritionists as experts in prescribing herbal and nutritional supplements was being undermined. The following comment illustrates the perceived role of the practitioner in prescribing products for patients:

A19 / was not ever happy with products from only one or two brands, so I sourced from all. This took a lot of research in the beginning to find that perfect supplement for each patient, but you do get to know most of the products in most of the POP ranges, and I felt that it was an integral part of my art of healing to match supplement to individuals.

The trend to prescribing POPs from retail outlets (e.g. clients getting repeats of practitioner-prescribed products from pharmacies, health food outlets, and online sites) effectively by-passed practitioners, diminishing their professional status and threatening the viability of their practices. Moreover, participants felt that their exclusive role as sole prescribers of POPs was being usurped by other health professions. Many participants used emotive expressions like 'feeling lost', the industry is being destroyed', 'we are going under', 'they are destroying our reputation', 'we look like idiots', 'I'm on the verge of tears', 'feeling lied to' and 'overwhelmed', suggesting a sense of despair about their perceived loss of professional identity.

A2 / cannot believe that most health food shops are employing naturopaths as glorified sales assistants so they can sell the POPs. That is just horrid.

Lack of support from natural medicine companies

It was assumed that the requirement for a practitioner consultation and re-labeling before sale to patients was specified in company policies. Participants felt that company policies were vague and inconsistently enforced. Although there were anecdotes about POP supply being restricted or withdrawn from various retail shops, most practitioners were sceptical about POP companies' sincerity about supporting naturopaths, herbalists and nutritionists through restricting sales.

A2 We need to question the underlying policies of all our [POP] companies and ask them to stand up for the value and ethical principles of professional consultation before prescribing any product...the more these principles are overlooked the more natural medicines are devalued.

Safe and ethical prescribing of POPs

Unqualified practitioners

Participants were concerned about compromised public safety through prescribing by unqualified people. There was a unanimous belief that the POP class of therapeutic goods was more potent and therefore needed to be prescribed by practitioners with appropriate training in herbal medicine, nutritional biochemistry, herb-drug interactions and contraindications. There were examples of POP companies training non-TGA approved natural medicine practitioners, such as pharmacy assistants, to sell POPs. The comments below exemplify how practitioners viewed the need for formalised education to safely prescribe POPs.

A1 I have been told that one of my patients who needs to be monitored closely is buying it [POP] from a health food store.

A19 ... the level of biochemistry that is required to correctly utilise POPs requires trained professionals.

All I'm just waiting for the day that someone is harmed by being prescribed St John's Wort in a health food store when they already are on meds ... due to lack of consultation with the naturopath in the health food.

A27 I am concerned about chiropractors having no more than a day on nutrition yet selling POP products. They have no idea about herbs, absolutely no idea of interactions but they are qualified health professionals so there is nothing we can do. The pharmacist I worked with had no idea about supplements with licorice, for example, interacting with the [contraceptive] pill. Everyone thinks they are safe to just prescribe.

Consultation

The consultation was seen as essential for the safe prescribing of POPs and the ongoing management of the patient.

There were many examples of what was considered unethical selling of POPs and of insufficient consultation before products were dispensed. According to participants, company policies had failed to specify what constitutes a naturopathic consultation and to distinguish between a 5-minute encounter with a client on a shop floor and a 60-minute consultation in a clinic room. Examples of practices considered unethical were prescription without prior or adequate consultation as could occur with online questionnaires, failure to record case notes, prescription by a shop assistant without supervision or duty of care (whether a trained naturopath or not), and prescription without authorisation by the consulting practitioner to sell POPs to patients. The following quotation illustrates the ease with which patients can purchase POPs online:

A19 ... to buy POPs you have to provide your practitioner's details.... do we know whether each customer's practitioner is being contacted and consulted about whether they want their client to have the product dispensed to them?

A3 As far as I can tell, the most egregious example of the totally transparent and fake consultation is the consultation-by-questionnaire that is apparently satisfying retail policies.

Particularly evident were concerns about unrevised or unsupervised continuing use of a medicine, and the violation of core principles of naturopathy in such settings that drive a protocol-based, supplement-only or symptomatic approach rather than an holistic, individualised, causally focused treatment aligned with the core principles of naturopathy.

A2 ... they keep repeating medicines elsewhere and then before you know it they have taken 100 bottles of something when you only prescribed a few.

Discussion

Threatened professional status and practice viability

The findings of this study have contributed to our understanding of the effect of POPs on the naturopathic, herbal medicine and nutrition professions, namely that current practices are threatening the professional status and livelihood of these practitioners. Company policies specify that a practitioner consultation and re-labeling are required before sale to patients. However, as the market for POPs has grown, suppliers have developed innovative strategies to encourage sales. Free short consultations with a qualified practitioner and discounted online sales after completing a brief online survey are now readily available.

What is clear from the results is that there are varying interpretations of what constitutes a consultation. The Royal College of General Practice (5) refers to the consultation as 'the central setting through which primary care is delivered'. Consultations provide opportunities for practitioners to identify any significant illness in its early and undifferentiated stage' or 'where urgent intervention is needed'. In our study, participants described consultations that consisted of brief online questionnaires or short face-to-face meetings without written record. For many natural medicine practitioners, such practices are in breach of their professional associations' Code of Ethics. Moreover, written case files are a requirement of medical benefit funds that provide rebates for natural medical services. Short consultations without a written record might be more appropriately characterised as sales assistance rather than natural medicine consultation, even in cases when the sales assistant is a qualified natural medicine practitioner. Tensions between employers' and companies' expectations on the one hand and professional codes of conduct on the other could arise.

Unethical prescribing and public safety

Historically, natural medicine practitioners have been the sole dispensers of natural medicines. Practitioners learn to prescribe and dispense these medicines in clinical practice in accordance with core naturopathic principles after a lengthy consultation with a client. The shift to evidenced-informed practice has coincided with product prescription (3) and with an increase in public acceptance of natural medicines. (6,7) It has also coincided with the encroachment by other health practitioners on prescribing and dispensing POPs without adequate education in their applications. (8) Many comments highlighted the disregard of traditional knowledge on the part of other health practitioners when prescribing POPs and the consequences of this for patients. Such consequences include loss of supervision of patients' treatment; a shift in the role of private practice as the primary provider of health care; and loss of professional identity for traditional prescribers and dispensers. These concerns are reiterated by other studies including one that identified losing control of the CAM occupational domain and of personal and professional status and legitimacy as key concerns of practitioners. (9)

Professional associations require practitioners to continually update their knowledge and skills. (10) In a recent survey, practitioners reported acquiring their continuing education through professional newsletters (91%), reference textbooks (72%) and manufacturers' seminars (70%)." Manufacturers' seminars are often associated with product sales (e.g. providing information to support safe and clinically relevant dispensing).

However, relying on POP companies' for continuing education may lead to decision-making that is inappropriately influenced. (12) Moreover, practitioners may be increasingly relying on and promoting products in their treatments. (3)

Patients are increasingly requesting specific brands from their practitioners, perhaps as a result of aggressive marketing by manufacturers and suppliers of natural medicine products. (3) Patients are increasingly taking advantage of the availability of medicines in retail stores or online where consultations are free and the POPs are often discounted. Comments in our study showed a concern for public safety caused by the retail or online supply of POPs, often with minimal consultation or long after their recommendation by a practitioner.

The practice vs product debate

Natural medicine is increasingly recognised as a commercial healthcare product. (3,16) Many POP companies were viewed by our participants as fostering and profiting from this growing market and, as a by-product, diminishing the role of the practitioner. Some patients no longer saw value in paying for a consultation with a practitioner. There were reports of patients accusing practitioners of financially 'ripping them off', and of asking practitioners to 'price-match' POP medicines.

Ninety-eight percent of naturopaths surveyed in another study considered a dispensary to be an important part of their profession, with 78% always advising their patients to purchase products from their clinics. (13) The drive towards evidence-based practice has questioned long-standing traditional evidence in naturopathic practice, reportedly regarded as essential by 99% of practitioners. (13) As products become increasingly available, the core naturopathic principles that are embodied in naturopathic consultations are at risk of becoming attenuated in the eyes of both the practitioner and the public. Wardle et al. (3) argued that the core naturopathic principles are not defined by the substances used but rather by the principles that underlie and determine naturopathic practice. (14,15)

Limitations

Data may not represent all naturopaths, herbalists, and nutritionists in the profession and comments may be restricted because of POP company presence on the site and by the personal views of the facebook group administrator. It is also possible that findings from this study do not represent all issues relating to POPs such as the ethics of profiting from POPs which is a theme that has been raised in other naturopath-related facebook groups.

Conclusion

According to participants, the practice of allowing any health practitioner who has completed a short training provided by manufacturers and suppliers to prescribe POPs undermines the role of naturopaths, herbalists and nutritionists in Australian health care, encourages some health practitioners to practice beyond their scope, and potentially places consumers at risk. Misconceptions about what POPs are and the legal and regulatory framework associated with their use needs to be addressed. To minimize misunderstandings, we suggest a campaign to educate practitioners about the legal considerations that underpin the supply of various classes of therapeutic goods, particularly those carrying meanings defined in law, and the responsibilities of current professional associations and Therapeutic Goods Administration. Participants' concerns also highlighted more fundamental concerns about survival of clinical natural medicine practice.

Acknowledgements

We would like to thank Ben Greening for evaluating legal information relevant to TGA-regulation acts and for his contributions to collecting raw data, and support in formatting the discussion.

References

(1) Therapeutic Goods Order No. 69--General requirements for labels for medicines. Sect. 3(2)(m)(ii).

(2) Hunt RG. Australia's first lady of chiropractic: there is more to the story! Chiropractic Journal of Australia. 1997June 1997;27(2):42-50.

(3) Wardle JL, Adams J, Lui CW, Steel AE. Current challenges and future directions for naturopathic medicine in Australia: a qualitative examination of perceptions and experiences from grassroots practice. BMC complementary and alternative medicine. 2013;13:15.

(4) Glaser BG, Strauss AL. The Discovery of Grounded Theory: Strategies for Qualitative Research. Chicago: Aldine Publishing; 1967.

(5) Royal College of General Practitioners' Curriculum. The GP consultation in practice. 2010 [cited 2014 October 19]; Available from: http://www.gmc-uk.org/2_01_The_ GP_consuitation_in_practice_May_2014. pdf_56884483.pdf.

(6) Xue CC, Zhang AL, Un V, Da Costa C, Story DF. Complementary and alternative medicine use in Australia: a national population-based survey. Journal of alternative and complementary medicine. 2007JuiAug;13(6):643-50.

(7) MacLennan AH, Myers SP, Taylor AW. The continuing use of complementary and alternative medicine in South Australia: costs and beliefs in 2004. The Medical journal of Australia. 2006 Jan 2;184(1):27-31.

(8) Bolton S. A backward glance--the Western Australian Story. Chiropractic Journal of Australia. 1996 Dec 1996;26(4):l52-3.

(9) Wiese M, Oster C. 'Becoming accepted': The complementary and alternative medicine practitioners' response to the uptake and practice of traditional medicine therapies by the mainstream health sector. Health. 2010 Jul;14(4):415-33.

(10) Australian Traditional Medicine Society. Continuing Education Policy. 2014 [cited 2014 October 18]; Available from: http://www.atms. com.au/wp-con ten t/uploads/2012/09/CE_ ATMS-Continuing-Professionai-EducationProgram-Poiicy-_-August-2014.pdf.

(11) Steel A, Adams J. The application and value of information sources in clinical practice: an examination of the perspective of naturopaths. Health information and libraries journal. 2011 Jun;28(2):110-8.

(12) Rhee J. The Influence of the Pharmaceutical Industry on Healthcare Practitioners' Prescribing Habits. The Internet Journal of Academic Physician Assistants. 2008;7(1).

(13) Harvey KJ, Korczak VS, Marron LJ, Newgreen DB. Commercialism, choice and consumer protection: regulation of complementary medicines in Australia. The Medical journal of Australia. 2008 Jan 7;188(1):21-5.

(14) Pizzorno JE, Murray MT. Textbook of natural medicine. St. Louis, Mo.: Eisevier/Saunders,; 2013. Available from: http://ezproxy.library. usyd.edu.au/login?URL=http://www. nursingconsult.com/public/book/view?title=T extbook+of+Natural+Medicine.

(15) Sards J, Wardle J. Clinical naturopathy: an evidence-based guide to practice. Sydney: Churchill Livingstone/Elsevier; 2010.

(16) CollyerF. The corporatisation and commercialisation of CAM. in: Tovey. P. EG, Adams. J., editor. The mainstreaming of complementary and alternative medicine: Studies in social context. London: Routledge;2003. p. 81-99.

Vlass A [1], Grace S [2], Eddey S [3], Harris T [4].

[1] Helping Nature Heal, Melbourne;

[2] Southern Cross University, Lismore;

[3] Health Schools Australia, Helensvale;

[4] Australian Institute of Applied Sciences
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Author:Vlass, A.; Grace, S.; Eddey, S.; Harris, T.
Publication:Journal of the Australian Traditional-Medicine Society
Date:Dec 1, 2014
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