European Journal of Integrative Medicine: Research Paper
European Journal of Integrative Medicine: Research Paper
Research paper
Keywords: Introduction: In China, Traditional Chinese Medicine (TCM) is an integral part of the health system in parallel
Traditional Chinese Medicines with Western medicine (WM). However, pharmacists’ duty of care at this interface has not been fully explored.
Professional This qualitative study aimed to explore key stakeholders’ perceptions about the challenges and enablers to
Pharmacy practice pharmacists’ adopting a professional role in patient care associated with the concurrent use of herbal medicines
China
(HMs).
Perceptions
Methods: Participants were recruited from the expert pool of the National Research Center for Licensed
Safety
Integrative medicine Pharmacist Development using purposive sampling and snowballing. Participants targeted included government,
academics and practicing pharmacists. An interview guide was developed following a literature review and face-
to-face, audiotaped interviews conducted with key stakeholders.
Results: Fourteen semi-structured interviews with both practicing pharmacists and key stakeholder re-
presentatives were conducted in China in 2017. Thematic analysis identified 6 main themes which focused on
how TCM was integrated with WM in China. Participants agreed that pharmacists should at least assume a role in
drug safety associated with concurrent use of TCM and WM. However, barriers were identified within the
government, education, pharmacy, pharmacist and research sectors, indicating a lack of coordinated strategies
to improve this area of healthcare. A lack of clarity in defining the pharmacists’ role in this area and a disconnect
between current regulatory standards and education/training system were the prominent themes. Participants
looked towards the government to facilitate actions in the development of policies that support pharmacy
practice and practice guidelines, and the review of competency standards, and registration criteria as being the
most important enablers.
Conclusion: Guiding principles that outline standards for pharmacy practice regarding HMs in an integrated
healthcare system are considered a priority, requiring a joint effort from the government, professional organi-
zations and universities.
1. Introduction maintaining health and wellbeing through the use of several therapies
including herbal medicines (HMs) [3].
In China, Traditional Chinese Medicine (TCM) is an integral part of For the purpose of this exploratory study that focuses on the pro-
the health system in parallel with Western medicine (WM) across all fessional role of pharmacists, HMs will be the central focus. HMs are
sectors [1]. In 2015, there were 3966 TCM hospitals including 446 commonly consumed in the form of raw materials, plant extracts (de-
hospitals of integrated TCM and WM, 42,528 TCM clinics including coctions), and Chinese traditional patent medicines (CTPM) [4]. CTPM
7706 clinics of integrated medicine, and an estimated 60,000 TCM and are standardized herbal formulations and often sold as over-the-counter
other herbal preparations approved for use in the country [2]. Devel- (OTC) medicines to patients in community pharmacies for self-man-
oped over thousands of years ago, TCM has a unique theoretical basis agement [5]. At the same time, on the Essential Drugs List of China
and comprehensive clinical approach to treating disease and (2018) which is a key component of the China’s healthcare reform, 268
⁎
Corresponding author at: State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, Room 2058, N22 Building,
University of Macau, Taipa, Macao SAR, China.
E-mail addresses: yb57515@um.edu.mo (D. Yao), haohu@um.edu.mo (H. Hu), joanna.harnett@sydney.edu.au (J.E. Harnett),
carolinaung@um.edu.mo (C.O.L. Ung).
1
Co-first authors.
https://doi.org/10.1016/j.eujim.2020.101063
Received 7 October 2019; Received in revised form 4 February 2020; Accepted 4 February 2020
1876-3820/ © 2020 Elsevier GmbH. All rights reserved.
D. Yao, et al. European Journal of Integrative Medicine 34 (2020) 101063
of the 685 drugs were CTPM [6]. In the clinical setting, HMs may also all members within the expert pool who were asked to contact the re-
be given as individualized traditional prescriptions containing raw search team for information about the study and interviews. Nine out of
materials prescribed by the TCM practitioners [7]. Under this “one the 30 invited members agreed to participate in the study. Time con-
country, two (medical) systems” healthcare setting whereby TCM is straints was the reason provided by those who were invited but unable
deeply rooted in the culture [1], the use of HMs continues to be em- to participate. An additional recruitment method of snowballing was
braced by the public and used frequently for both disease management employed to identify licensed pharmacists from across all sectors who
and health maintenance. had worked for a minimum of 6 months [31].
It is a common perception among the Chinese population that HMs
are “natural” and therefore “safe” or have minimal risks [8,9]. How-
ever, adverse drug reactions (ADR) associated with the use of HMs are 2.3. Interview guide
not uncommon in China. Official statistics shows that in 2017, around
253,000 of the 1,571,000 ADR reports involved HMs administered as The interview guide was developed by conducting a careful review
intravenous preparations (54.%) and oral preparations (39.4 %); among of the literature related to the integration of traditional and com-
the 17,000 serious ADR reports associated with HMs, 59,000 cases in- plementary medicines into pharmacy practice in the US and Australia
volved elderly patients [10]. Similar safety concerns about HMs misuse [28,30,32,33], and pharmacy practice in China [34–36] (see Ap-
associated with kidney and liver injury have been repeatedly reported pendix). The interview questions focused on key areas including: (1)
[11–16]. Furthermore, HMs and conventional medicines are often integrative medicine; (2) community pharmacists’ responsibilities with
prescribed together for the treatment of disease or used informally as regards to HMs; (3) factors that prevented community pharmacists from
part of a self-care practice [17]. Pharmacokinetic interactions that re- taking up such role; and (4) what it would take to improve their
sult in the inhibition or induction of drug-metabolizing enzymes and practice. Five pilot interviews were conducted with 3 pharmacists and 2
transporters raise safety concerns and may impact treatment outcomes pharmacy students separately. Based on their feedback, interview
[18–20]. In addition to potential interactions, the component com- questions were revised for clarity and prompts were added to guide the
plexity of HMs and uncertainties regarding their safety and efficacy discussion in a standardized but not restrictive manner.
raises a need for healthcare professionals to be involved in stewarding
the judicious use of HMs.
2.4. Interview procedures
Pharmacists’ involvement in the safe and proper use of traditional
and complementary medicines has been proposed to be a legitimate
Two investigators (1 PhD student and 1 Associate Professor) ex-
part of their established role of pharmaceutical care [21] and supported
perienced in qualitative research methodology and familiar with the
by international authorities [22,23]. Research in the US, Australia,
context of pharmacy practice in China conducted the interviews. Some
Canada and Thailand, have been initiated to explore, define and review
participants were known to the interviewers through professional net-
pharmacists’ duty of care (if any) with respect to T&CM products.
works but not related or otherwise. The interviews were conducted
[24–28]. Despite the high level of integration of TCM that includes
face-to-face in private conference rooms at the participants’ choice,
HMs, and modern medicine in China, few studies have explored this
each lasting for 35−45 min. With the participants' written consent
area in depth. Therefore, this study aimed to identify key stakeholders’
obtained prior to commencing, each interview was audio-recorded and
opinions about pharmacists who practice in China adopting a profes-
conducted until saturation was reached for the key emergent themes.
sional role in relation to patients use of HM and conventional medi-
cines.
2.5. Data analysis
2. Methods
The audio recordings of the interviews were transcribed verbatim
2.1. Ethics approval prior to analysis. In order to avoid reflexivity and to minimize bias, two
other investigators fluent in both English and Chinese oversaw thematic
A grounded theory approach involving in-depth, semi-structured analysis using an inductive approach. Key themes were determined
interviews was employed in this study to obtain detailed, nuanced and using open coding, grouping and categorizing. Constant comparison
rich insights from key stakeholders [29]. The ethical approval was within and between themes were used to ensure the analysis re-
granted by the China Pharmaceutical University (CPU20171101) and presented all perspectives. Analysis results were discussed and checked,
the project was also approved by the University of Macao (MYRG2018- and the coding was reviewed and refined within the research team.
00012-ICMS).
In order to optimize the depth and breadth of the findings, the key 3.1. Participant demographics
stakeholder categories and the participants were selected within the
cultural context and modelled on earlier studies [26,28,30]. A purpo- Fourteen semi-structured interviews were conducted in Beijing
sive sampling strategy was employed to recruit participants from the China in 2017 with: 4 community pharmacists (2 junior pharmacists
expert pool of the National Research Center for Licensed Pharmacist and 2 pharmacist-in-charge), 3 clinical pharmacists (2 chief pharma-
Development which was jointly established by the China Pharmaceu- cists and 1 junior pharmacist), 1 regulatory authority representative (a
tical University, the China Pharmaceutical Materials Association and deputy director), 2 pharmacy school representatives (2 associated
the Licensed Pharmacist Qualification Center of the State Food and professors), 1 professional organization representative (an executive
Drug Administration. This exclusive pool is composed of expert gov- board member), 2 chain pharmacy representatives (1 headquarter di-
ernment officials, academics, and practicing pharmacists who occupy rector overseeing 700 community pharmacies and 1 regional director
middle to high level management positions in their respective organi- overseeing 20 community pharmacies) and 1 key opinion leader (a
zations and considered influential in informing the future direction of consultant to the pharmacist regulatory authority and an academic).
pharmacy practice. No exclusion criteria was defined a-priori, as po- According to the thematic analysis of the qualitative data collected
tential participants were chosen strategically in order to obtain insight from the interviews, 6 main codes were identified, each of which have
from a range of expert perspectives. These invitations were extended to its own themes as shown in Table 1.
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D. Yao, et al. European Journal of Integrative Medicine 34 (2020) 101063
Table 2
Major challenges and important enablers.
Barriers Stakeholder sectors Enablers
• Lack of legal definition of integrative medicine Government • Clear definition of integrative medicine
• Mismatch of regulation with patients’ needs • Clear definition of pharmacist’s professional role in patient care
• Lack of a reasonable remuneration system • Aservices
reasonable remuneration system for pharmacist’ professional
• Lack of training/education standards and internship program Education • Teaching about the concurrent use in the undergraduate course
• Lack of education about integrative medicine and CPE
• Lack of related CPE • Revision of the internship requirements
• Lack of a professional image Pharmacy
• Only one type of pharmacists on duty
• Lack of the competence to provide professional service Pharmacist • Being more motivated to learn continuously
• Lack of knowledge about Chinese medicines or conventional medicines
• Lack of professional image
• Lack of motivation or interests in direct patient care
• Lack of information source
• Lack of practice guideline
• Lack of research about the concurrent use of Chinese medicines and
conventional medicines
Research • More research to support the development of practice guideline
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D. Yao, et al. European Journal of Integrative Medicine 34 (2020) 101063
main areas that have a major influence on community pharmacist’s services are provided.
adoption of a role in relation to HMs:
(1) Lack of professionalism
(1) Lack of legal definition of integrative medicine
“In most of the community pharmacists, both conventional medi-
“The discussion about integrative medicine has stagnated in medical cines and Chinese medicines are available concurrently. The way
practice for many years now, not to mention pharmaceutical care. pharmacist practice at the moment, however, is still very much re-
Theoretically, the definition of integrative medicine at different tail orientated.” (Professional organization representative)
settings should be clearly defined in the national policy. But we are
(2) Only one type of pharmacists on duty
just lacking such clarification at the moment.” (Regulatory authority
representative) “There is usually one type of pharmacist on duty whether it be at
clinical setting or community pharmacy. If you are a pharmacist of
(2) Mismatch of regulation with patients’ needs
Chinese medicines, of course there is only so much you can do about
“There are two types of licensed pharmacists: general pharmacists conventional medicines. If you are a general pharmacist, of course
and pharmacists of Chinese medicines. Is there any cross over in you will not know much about Chinese medicines neither.”
their practice or are they allowed to cross over? In terms of pro- (Community pharmacist 1)
fessional scope of practice, of course they are separated. However, it
Within the pharmacist sector, it was a common perception that
is hardly feasible in practice and the general public does not have
community pharmacists lacked the competence, the interests and the
the clear differentiation about medicines in their perception.”
support to provide professional service.
(Regulatory authority representative).
(3) Lack of a reasonable remuneration system (1) Lack of professional competency
“The government will not give me any remuneration even if I pro- “Most of the licensed pharmacists really don’t know much about
vide the patients with any advice or professional services. It is not medicines, not to mention the pharmaceutical care they are ex-
something that can be evaluated easily at least not from an eco- pected to provide. They are probably not involved in any profes-
nomic point of view.” (Chain pharmacy representative 2) sional duties.” (Clinical pharmacist 2)
Within the professional sector, some participants emphasized on the (2) Lack of expertise in both HMs and conventional medicines
importance of practice guidelines which are currently lacking in many
“It is highly difficult because we have two types of pharmacists:
areas of pharmacist practice.
general pharmacists and pharmacists of Chinese medicines. General
“Many of the practice guidelines are designed specifically for doc- pharmacists do not know much about Chinese medicines, and
tors and nurses but not pharmacists. The overall development of pharmacists of Chinese medicines do not know much about con-
pharmacist profession suffers because pharmacists are seldom ventional medicines. So, when Chinese medicines and conventional
mentioned in the practical approach clinically.” (Key opinion medicines are used together, how would any of these pharmacists
leader) manage?” (Community pharmacist 1)
Within the education sector, there were mainly complaints about a (3) Professional verse retail role
lack of standardization in education and training and an internship
“It doesn’t matter how you see it, even in the perspective of quality
program. Topics about the interface between HMs and conventional
control, all they (pharmacists) do is sale. From what I can tell, more
medicines were not taught and continuing professional development
than 95 % of pharmacists are retail oriented.” (Key opinion leader)
(CPD) on this topic was also very limited.
(4) Lack of motivation or interests in direct patient care
(1) Lack of training/education standards and internship program
“For pharmacist, if you work at front of shop and your salary counts
“Licensed pharmacists may have very different training background. on the commission you receive, there is always a detachment from
They might only have a diploma degree or other higher degrees. In your professional standards.” (Clinical pharmacist 2)
practice, they might not even know what the rational use of drugs or
(5) Lack of access to reliable information resources
drug safety are. They might have the license but not the professional
competency. Without proper internship program, what they know “I have the same concerns during my practice as well. When you try
will only be theories.” (Chain pharmacy representative 1) to find out information about possible interactions of the conven-
tional medicines from the product insert, there is only very limited
(2) Lack of a pedagogical approach to integrating TCM education
information.” (Regulatory authority representative)
“How are we going to teach the theories of TCM? Is it just a brief
Within the research sector, participants were concerned about the
introduction of the TCM theories? To be able to do the job, you need
limited evidence base to inform the concurrent use of HMs and con-
to learn about TCM thoroughly. A light touch on the subject won’t
ventional medicines.
serve the purpose. But it is very hard to develop such teaching
system.” (Regulatory authority representative) “According to modern science, any technology must be validated
through a process of clinical research. Even though we have been
(3) Limited coverage in continuing professional development
using TCM so many years, and TCM development has been going on
“The level of basic knowledge about pharmacy among pharmacists for so many years, clinical experiments and research about the
maybe uncertain especially when many of them learned about concurrent use of Chinese medicines and conventional medicines
pharmaceutical care through distant learning or online.” are really very limited. (Regulatory authority representative)
(Community pharmacist 1)
Within the pharmacy sector, most participants believed that the 3.5. Enablers to support pharmacists’ practice
community pharmacy was heavily retail orientated rather than on
pharmaceutical care related to HMs. Moreover, the pharmacy is usually Participants’ opinions about how to support pharmacists assuming a
attended by only one type of pharmacist, and minimal professional more professional role related to HMs weighted heavily within the
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D. Yao, et al. European Journal of Integrative Medicine 34 (2020) 101063
medicines is not supported by evidence to suggest a benefit, or that such reform plan highlighted the responsibilities of community pharmacies
combinations are safe and effective has previously been raised. [42–45] and pharmacists in providing primary healthcare [76–78].
While such benefits may exist, the complexities of multi-constituent With pharmacists playing an increasingly important role in patient
HMs poses significant challenges for researchers in establishing the care, it is important for the legal and professional obligations of li-
strength of evidence that is required to make confident recommenda- censed pharmacists stipulated by law to fully correspond to the needs of
tions [46–48]. This being said, many preclinical studies do report po- the general public and the consideration should include the use of HMs,
tential drug-herb interactions including the inhibitory effects of specific conventional medicines and their concurrent use [33,79]. Appropriate
HMs on a range of cytochrome P450 enzymes involved in drug meta- training and education should also be in place. Training in both TCM
bolism [49–53]. Multiple medicines use also raises another important and WM would allow pharmacists to play a role in both HMs and
role for pharmacists in minimizing the risks of drug related problems conventional medicines, promote a more collaborative relationship
associated with polypharmacy [54,55], predisposing conditions such as with other health-care disciplines and assume greater responsibility in
chronic or other serious diseases [56–58], and delay of necessary prospering a well-defined model of integrative medicine [80,81] This
treatment [59–61]. The role of pharmacists as custodians of safe med- further highlights the need for pharmacists to engage in continuous
icines use, specifically as it relates to the concurrent use of T&CM and learning to develop their competence and professional role in the
conventional medicines, is supported by others. [24,62,63]. pharmacy. As stated in the Good Pharmacy Practice, “pharmacists should
In order to provide a solid foundation for pharmacists in realizing take steps to update their knowledge and skills about complementary and
this extended role, the ethical and professional responsibilities, as well alternative therapies” as part of their role in maintaining and improving
as standard of practice related to traditional and complementary professional performance [23].
medicines should be considered a priority. This finding is consistent
with what Popattia et al. and Ung et al. have previously proposed.
[26,30,64] Professional organizations in some countries have already 5. Limitations
released statements to raise pharmacists’ awareness about the extension
of their professional roles. For instance, the position statement by the This study has several limitations affecting the generalizability of
American Society of Health-System Pharmacists urges pharmacists in- the findings across the country. TCM is not the only traditional medi-
creasing efforts to prevent interactions between dietary supplements cine practiced in China, and other ethnic minority medicine may also be
and prescription drugs [65]. Similarly, the position statement by the used even more frequently than TCM in some parts of China. Even
Pharmaceutical Society of Australia (PSA) confirmed pharmacists’ re- though saturation was achieved, the opinions and comments provided
sponsibility in supporting consumers making informed decisions about by the limited number of participants in this study might only refer to
the use complementary medicines [66]. In China, the importance of areas where pharmacists’ role is more developed. In addition, the in-
developing documents to provide a foundation for decision-making in clusion of up to 2 representatives from the key stakeholder categories
integrative medicine is also recognized, but limited to medical practice may not be able to provide the full capacity to reflect on the complete
[67,68]. view about the interview questions to the groups they are representing,
For pharmacists in China, to address the gaps in practice guidelines, warranting wider sampling in future studies. Furthermore, due to
the development of professional practice standards (PPS) should be constraints of this study, the perspectives of patients and consumers
made a priority with a view to fostering pharmacists’ critical role in were not included. Nevertheless, the qualitative approach met the ob-
drug safety. PPS articulate the values of the pharmacy profession and jectives of collecting rich, in-depth information about the dilemma
expected standards of professional behavior of pharmacists towards pharmacists in China are currently facing with regards to HMs. The
individuals, the community and society. [69] On the one hand, PPS can findings can serve to inform policy makers, professional organizations
help guide the development of professional practice guidelines. Such and research institutes about the relevance of HMs when deciding
guidelines can be used to inform competency standards which may then pharmacist’s legal role, ethical and professional responsibilities, and
be used to inform education and training design. Once PPS are estab- practice standards in relation to TCM. Subsequent studies are planned
lished, the pharmacist’s extended role may be formalized, and they will that will focus on the general public including patients and consumers
be bound to seeking continuous learning opportunities and improving of HM to gain an understanding of the expectations for pharmacists in
practice according to the informed standards. Although it was not dis- the area of HMs.
cussed explicitly, the collective actions suggested by the key stake-
holders confirmed the need for a joint effort to support pharmacists’
practice in ensuring the safe use of HMs [28,67], and the process should 6. Conclusion
be guided by a systematic methodology to yield high-quality evidenced
instructive documents [32,68]. HMs feature prominently within the daily practice of community
The discussion about pharmacists’ role in the area of HMs and more and hospital pharmacy in China. Despite their prominence, key stake-
broadly, raises concerns over the competence of the overall workforce. holders report that there are gaps in pharmacists knowledge and
Within the community sector, there are two types of regulated phar- therefore professional capacity to provide comprehensive pharmaceu-
macists: Licensed Pharmacist and Licensed Pharmacist of Chinese Medicine. tical care that facilitates the safe use of both HMs and conventional
Although they are subject to prescribed obligations and responsibilities medicines. Guiding principles that outline standards for such use in an
in the regulatory system and assessment process [32], they were often integrated healthcare system are required. Such standards would serve
found ill-equipped to provide professional services [70–72]. The im- as a baseline for professional expectations within existing practice, and
plications of this argument has been discussed in detail in previous serve as a framework for teaching institutions to model pharmacy
studies [33–36] What is relevant to the focus of this study was whether education for undergraduate and continuing professional development
these pharmacists are positioned and supported to address the patients’ programs. Given the pharmacy profession is largely policy-driven in
needs in a coordinated manner. Ideally, a holistic approach that en- China, the governing authorities are encouraged to take this opportu-
gages both types of pharmacists skillsets in patient care is encouraged nity to initiate future work in developing practice standards and foster
[73,74]. However, the current regulation clearly defines their scope of collaborations between key stakeholders including research institutes,
practice in either HMs or conventional medicine depending on their universities, pharmaceutical organizations and other healthcare stake-
specialty. More critically, their responsibilities, as currently defined in holders to build capacity in this area that ultimately addresses the needs
the SFDA regulations, do not include the duty to provide and maintain of the public who use HMs.
proper care for patients [75]. This is despite the fact that the healthcare
6
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