The widespread sale of complementary medicines in community pharmacy raises important questions regarding the responsibilities of pharmacists when selling complementary medicines. This study reviews the academic literature that explores a pharmacist's responsibilities when selling complementary medicines.
International Pharmaceutical Abstracts, Embase, PubMed, Cinahl, PsycINFO and Philosopher's index databases were searched for articles written in English and published between 1995 and 2017. Empirical studies discussing pharmacists’ practices or perceptions, consumers’ expectations and normative studies discussing ethical perspectives or proposing ethical frameworks related to pharmacists’ responsibilities in selling complementary medicines were included in the review.
Fifty-eight studies met the inclusion criteria. The majority of the studies discussing the responsibilities of pharmacists selling complementary medicines had an empirical focus. Pharmacists and consumers identified counselling and ensuring safe use of complementary medicines as the primary responsibilities of pharmacists. No formal ethical framework is explicitly employed to describe the responsibilities of pharmacists selling complementary medicines. To the degree any ethical framework is employed, a number of papers implicitly rely on principlism. The studies discussing the ethical perspectives of selling complementary medicines mainly describe the ethical conflict between a pharmacist's business and health professional role. No attempt is made to provide guidance on appropriate ways to resolve the conflict.The authors conclude
There is a lack of explicit normative advice in the existing literature regarding the responsibilities of pharmacists selling complementary medicines. This review identifies the need to develop a detailed practice-specific ethical framework to guide pharmacists regarding their responsibilities when selling complementary medicines.'Community pharmacists’ views on the regulation of complementary medicines and complementary‐medicines practitioners: a qualitative study in New Zealand' by Joanne Barnes and Rachael Butler in the same journal comments on an examination of community pharmacists’ perspectives on CMs regulation in New Zealand
where proposals for CMs regulations had recently been suspended and where, currently, CMs are only weakly regulated.The authors report on
Qualitative, in-depth, semi-structured interviews with New Zealand practising community pharmacists are identified through purposive and convenience sampling. Data were analysed using a general inductive approach.
Participants held mixed views regarding harmonisation of CMs regulations across Australia and NZ; some supported an NZ national regulatory framework for CMs, based on the Australian system. Participants recognised the current CMs regulatory framework in NZ as inadequate, that regulation was required to some extent, and that mandatory regulation was not necessarily required. A key reason given in support of CMs regulations was the need for greater assurances around quality of CMs. Participants also supported a regulatory framework that incorporated assessment of the safety of CMs, but were less convinced of the need for, or feasibility of, requiring evidence of efficacy from clinical trials. Participants believed that regulation of CMs practitioners, such as herbalists, and CMs retailers was important, although there were mixed views as to whether regulation should be statutory or whether self-regulation would be adequate.
On the basis of these findings, pharmacists would be expected to welcome proposals for national regulations for CMs in NZ: such regulations should address concerns regarding product quality, inappropriate health claims and supporting evidence, and therefore should support pharmacists in meeting their obligations under the NZ Pharmacy Council's Code of Ethics.They note that
In the early 2000s, there were proposals for a joint medicines regulatory agency with Australia – the Australia New Zealand Therapeutic Products Authority (ANZTPA) – which would have regulated all medicines, including CMs, blood products and medical devices, across the two countries; as Australia already had regulations for CMs, ANZTPA would have introduced regulations for CMs in NZ. However, following political, industry, media and public opposition, due to concerns around perceived loss of NZ sovereignty, and increased manufacturing costs, the ANZTPA initiative failed to achieve support in the NZ Parliament and was suspended in 2006.
Thus, in NZ, CMs remain only weakly regulated. Herbal and homoeopathic remedies are defined in the NZ Medicines Act 1981, but are exempt from requirements to obtain premarket Ministerial approval through provision of satisfactory evidence of quality, safety and efficacy, and are not currently required to adhere to the principles of good manufacturing practice (GMP). Further exemptions in the Medicines Act allow ‘natural health’ practitioners (not defined) to make herbal remedies and other ‘individualised’ natural health treatments for specific patients, but these exemptions are not intended to allow large-scale manufacturing. Most CMs are currently regulated as ‘dietary supplements’ under the Dietary Supplement Regulations 1985 and the Food Act 1981. These regulations provide some restrictions on ingredients of dietary supplements; no therapeutic claims are allowed and, in general, do not require adherence to GMP nor premarket approval or notification of products. New regulations for CMs in NZ were proposed in 2010 (see note 2), but it is now unclear if they will ever be introduced into legislation.
Most community pharmacies in NZ sell CMs, and pharmacists working in community pharmacies (irrespective of whether the pharmacy sells CMs) are a source of information and advice on CMs for consumers. Users may also access CMs through consultations with CMs practitioners, such as herbalists, naturopaths, traditional Chinese medicine practitioners or other traditional healers; some CMs practitioners practise within pharmacies.
At the time of this study, the New Zealand Pharmacy Council's Code of Ethics (2004) included statements indicating that pharmacists are expected to stock, sell and supply only CM products that are safe, are effective and meet appropriate (i.e. GMP) quality standards. It is important to understand pharmacists’ views on current and future regulation of CMs in NZ, as medicines regulation is the framework that underpins and provides assurances on quality, safety and efficacy.