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. 2021 May 27;16(5):e0251982. doi: 10.1371/journal.pone.0251982

Perspectives of nurses’ role in interprofessional pharmaceutical care across 14 European countries: A qualitative study in pharmacists, physicians and nurses

Elyne De Baetselier 1,*, Tinne Dilles 1, Luis M Batalha 2, Nienke E Dijkstra 3, Maria I Fernandes 2, Izabela Filov 4, Juliane Friedrichs 5, Vigdis A Grondahl 6, Jana Heczkova 7, Ann Karin Helgesen 6, Sue Jordan 8, Sarah Keeley 9, Thomas Klatt 5, Petros Kolovos 10, Veronika Kulirova 7, Sabina Ličen 11, Manuel Lillo-Crespo 12, Alba Malara 13, Hana Padysakova 14, Mirko Prosen 11, Dorina Pusztai 15, Jorge Riquelme-Galindo 12, Jana Rottkova 14, Carolien G Sino 3, Francesco Talarico 13, Styliani Tziaferi 10, Bart Van Rompaey 1
Editor: Carl Richard Schneider16
PMCID: PMC8158867  PMID: 34043650

Abstract

Objectives

To understand healthcare professionals’ experiences and perceptions of nurses’ potential or ideal roles in pharmaceutical care (PC).

Design

Qualitative study conducted through semi-structured in-depth interviews.

Setting

Between December 2018 and October 2019, interviews were conducted with healthcare professionals of 14 European countries in four healthcare settings: hospitals, community care, mental health and long-term residential care.

Participants

In each country, pharmacists, physicians and nurses in each of the four settings were interviewed. Participants were selected on the basis that they were key informants with broad knowledge and experience of PC.

Data collection and analysis

All interviews were conducted face to face. Each country conducted an initial thematic analysis. Consensus was reached through a face-to-face discussion of all 14 national leads.

Results

340 interviews were completed. Several tasks were described within four potential nursing responsibilities, that came up as the analysis themes, being: 1) monitoring therapeutic/adverse effects of medicines, 2) monitoring medicines adherence, 3) decision making on medicines, including prescribing 4) providing patient education/information. Nurses’ autonomy varied across Europe, from none to limited to a few tasks and emergencies to a broad range of tasks and responsibilities. Intended level of autonomy depended on medicine types and level of education. Some changes are needed before nursing roles can be optimised and implemented in practice. Lack of time, shortage of nurses, absence of legal frameworks and limited education and knowledge are main threats to European nurses actualising their ideal role in PC.

Conclusions

European nurses have an active role in PC. Respondents reported positive impacts on care quality and patient outcomes when nurses assumed PC responsibilities. Healthcare professionals expect nurses to report observations and assessments. This key patient information should be shared and addressed by the interprofessional team. The study evidences the need of a unique and consensus-based PC framework across Europe.

Introduction

Effective team communication and clear definitions of roles are two of the fundamental prerequisites for effective collaboration among nurses, physicians and pharmacists to deliver high quality care and better meet patients’ needs [1, 2]. Unclear role boundaries hinder collaboration on different levels: quality of interprofessional communication and collaboration in daily clinical practice; transnational collaboration in research, education and innovation; and labor mobility of nurses [14]. A clear description of roles in pharmaceutical care (PC) and medicines optimisation, however, is not always available [2, 57]. In this study PC is defined as ‘Healthcare professionals’ contribution to the care of individuals in order to optimize medicines use and improve health outcomes’. This definition is based on the definition of the Pharmaceutical Care Network Europe (PCNE) [8], which, however, was limited to the contribution of pharmacists, as well as the original definition of Hepler and Strand in 1990 [9]. After all, the need for interprofessional collaboration in PC is broadly recognised [3, 1014].

Large variations in nurses’ roles exist, as was demonstrated in a cross-country comparative study in 39 countries. In two third of the countries, nurses took up advanced roles from physicians, but the extent varied. A trend towards expanding nurses’ scope-of-practice in primary care was evolving [4]. The large variation in nurses’ roles was corroborated in the EUPRON-study investigating nurses’ current clinical practices in interprofessional pharmaceutical care (PC). This showed that monitoring medicines effects, monitoring medicines adherence, prescribing medicines and providing patient education/information about medicines are already part of nurses’ clinical practice, and nurses’ contribution to PC differs between countries, in both law and practice [13].

Nurses’ scope of practice is considered as the full range of roles, responsibilities and tasks that nurses are educated, competent and authorized to perform [15]. Within this scope of practice, a framework for nurses’ ideal roles in interprofessional PC would allow insights into current and potential roles in PC, and facilitate discussions in clinical practice, education, research, international comparisons, policy-making and legislation. Additionally, this framework could be used to develop an assessment to evaluate nurse competences in PC, as a guidance to evaluate nurse education, as a tool for nurse educators, for benchmarking and nurse labour mobility. To date, we have not identified such a framework in the published literature. To develop a robust framework, adapted to the needs of clinical practice, insights in the preferences of the most important stakeholders (nurses, physicians and pharmacists) are necessary. Exploring those preferences, requires in-depth qualitative research.

This study is the second part of the DeMoPhaC project, an international Erasmus + collaboration to investigate nurses’ role in interprofessional PC in 14 countries. Within this project several large-scale quantitative and qualitative studies are being undertaken with healthcare workers and nursing students. The overall aim of the project is the Development of a Model for nurses’ role in interprofessional Pharmaceutical Care in Europe and the development of an assessment to evaluate nursing curricula and final year nursing students’ competences in PC. The first part of the project focused on the current clinical practice of nurses in PC without insights into strenghts, weaknesses, opportunities and threats from nurses’ involvement in PC [13]. In-depth qualitative research through case studies can close this gap. Therefore, we aimed to perform a qualitative study, to understand pharmacists’, physicians’ and nurses’ experiences and perceptions of nurses’ potential or ideal roles in PC.

By considering the ‘potential or ideal roles’, we aimed to investigate nurses’ responsibilities and tasks within–but also beyond–nurses’ current legal scope of practice, taking into account all necessary contextual factors.

Methods

Study design

This study was conducted and reported according to the Consolidated Criteria for Reporting Qualitative Research (COREQ) [16].

We explored nurses’, physicians’ and pharmacists’ expectations about nurses’ role in PC, and related strengths, weaknesses, opportunities and threats through a qualitative descriptive research design with a phenomenological case study approach. Case study as a research method has been widely used for preliminary and exploratory stages of research [1719]. Multiple case studies allow cross-case comparisons and the identification of themes across cases. A phenomenological approach using in-depth semi-structured interviews within the case studies support high quality data collection [2022]. Phenomenology is well suited for exploring perspectives of healthcare professionals [23]. This research approach was chosen as an appropriate way to describe the essence of the phenomenon “nurses’ role in interprofessional PC”, by exploring it from the perspective of those who have experienced it, namely pharmacists, physicians and nurses themselves. Interviewing this study population enables studying and understanding healthcare professionals’ lived experiences in interprofessional PC. Only by understanding their personal experiences and perceptions of nurses’ responsibilities and tasks, and interprofessional collaboration and communication, we will be able to provide detailed examination of the current strengths and weaknesses, together with the future opportunities and threats from nurses’ involvement in PC [23].

Setting

The study took place in 14 European countries: Belgium, Czech Republic, Germany, Greece, Hungary, Italy, the Republic of North Macedonia, the Netherlands, Norway, Portugal, Slovakia, Slovenia, Spain and the United Kingdom (England and Wales). In each country in-depth interviews were conducted in four different settings: hospitals, community care, long-term residential care, and mental health care.

Participants

‘Key informant’ pharmacists, physicians and nurses were purposively sampled [24]. They could only be selected on the condition that they were named as expert in PC by at least two other healthcare professionals, with local knowledge of PC, and insights into the nature of problems and possible solutions. This allowed us to get information about nurses’ roles in interprofessional PC and to understand the motivations and beliefs of a large number of healthcare professionals with diverse backgrounds and opinions. Representatives of professional associations for nurses, physicians and pharmacists, and healthcare providers in different healthcare institutions were asked to identify key informants. Researchers contacted the persons identified as potential participants by email or telephone, informed them about the study, and about being named as a key informant on nurses’ role in interprofessional PC. If they agreed with being able to serve as a key informant, written information was provided to fully inform the potential participants about the study details.

We aimed for at least two interviews per profession (n = 3) per healthcare setting (n = 4), per country (n = 14), resulting in 24 in-depth face-to-face interviews per country. These numbers were aimed for in order to compile a sample with perspectives as diverse as possible. Data saturation was reached in each participating country. There were no restrictions as to gender or age. No reimbursement was provided for participation. Exact numbers of those approached and declining were not registered in all countries.

Interview guide development

An interview guide (S1 Appendix) was developed in English based on literature and the results of a previous quantitative study about nurses’ practices in interprofessional PC (Fig 1, step 1) [13]. During a meeting with all European partners, the interview guide was adjusted until consensus was reached (Fig 1, step 2).

Fig 1. International approach to increase methodological quality.

Fig 1

To ensure conformity across twelve languages, the concept of PC was described at the beginning of the interview: “healthcare professionals’ contribution to the care of individuals in order to optimize medicines use and improve health outcomes”. This description was derived from the Pharmaceutical Care Network Europe definition of 2013, taking into account the interprofessional aspect of PC [8, 14].

Responsibilities and tasks were defined based on the literature, together with discussions with an expert in health law, liability law and ethics and an expert in legal philosophy and ethics: “The role of nurses involves several responsibilities. A responsibility for nurses is an obligation that they have by virtue of their role as a nurse. Their central responsibility is to be the patient’s health advocate and to provide high quality care, using sound professional judgement and taking into account the relevant legal and moral considerations. The other responsibilities of nurses derive from this central responsibility. Nurses can be made to answer for failing in their responsibilities, which could result in disciplinary, civil, and criminal liability. Specific tasks may have to be performed in order to fulfill a responsibility.” [25, 26].

The interview guide consisted of four main topics.

  • Topic 1: Responsibilities. Respondents were asked what responsibilities would be part of the ideal role of nurses in PC and what these responsibilities would imply. Preparation and administration of medicines by nurses was considered as an obvious part of PC and therefore outside the study’s scope. After open reflections, four responsibilities were presented: 1) monitoring and following-up of therapeutic and adverse effects of medicines; 2) monitoring and following-up medicines adherence; 3) decision making on medicines use, including prescribing medicines, excluding preparation and administration; 4) providing patient education and information about medicines. Respondents were asked what they would like to change, add, or remove. This structuring ensured uniformity across 14 countries and 12 languages.

  • Topic 2: Tasks. Specific tasks within the previously defined responsibilities were elicited. A similar strategy as above, with open and then more guided reflections, was used. The predefined tasks for reflection were: 1) detecting clinical change, healthcare problems or assessing patient needs; 2) registration; 3) interprofessional communication (including reporting, alerting and discussion); 4) patient communication; 5) intervention in emergency cases; 6) follow-up; 7) self-care support; 8) ‘dependent’ nurse prescribing; 9) ‘independent’ nurse prescribing; 10) reporting medication errors and safety issues.

  • Topic 3: Interprofessional team working. Ideal communication and collaboration between pharmacists, physicians and nurses, when aiming for high quality PC and predefined interactions were suggested: 1) nurses reporting observations to physicians and pharmacists; 2) physicians providing information and instruction to nurses; 3) pharmacists giving advice to nurses.

  • Topic 4: SWOT analysis. Finally, respondents were asked to reflect on strengths, weaknesses, opportunities and threats (SWOT) of nurses’ current and ideal roles.

Data collection

Nurse researchers in each country were trained in qualitative research and in-depth interviewing during a joint one-week training program at University of Antwerp in November 2019 (Fig 1, step 3). When agreed, the interview guide was translated into all national languages and pilot tested in each country by at least one pharmacist, physician and nurse (Fig 1, step 4–5). The test interviews were not included in the data analysis. No significant adjustments were made after the pilot interviews. Between December 2018 and October 2019 interviews were conducted by two to four interviewers per country (Fig 1, step 6). Participants were mostly interviewed at their workplace, or another location, such as participant’s home or the researcher’s workplace. Regardless of location, confidentiality was maintained. Only the interviewer and the interviewee were present during the interview. Interviews lasted from 30 to 90 minutes, and were audio recorded. Field notes were taken. No interviews were repeated. Audio recordings were transcribed verbatim by the interviewer or a professional transcriber (Fig 1, step 7). They were not returned to participants for member checking.

Data analysis

The qualitative analysis started after the first interview [27]. The transcripts were coded by labelling lines of text in order to group and compare similar or related data segments. To create an international code book for data analysis, 12 interviews were fully translated into English and coded by the local researchers from 4 countries (one pharmacist, one physician, one nurse per country) (Fig 1, step 8). The English codes were then collected to create a common first code book, to be used as a guide for analysing subsequent interviews (Fig 1, step 9). Consensus was achieved within the consortium, and the next 30 interviews were analysed (Fig 1, step 10–11). Extra codes and themes could be added if new content arose. The final code book consisted of 11 themes, combined with 49 sub-themes, addressing nurses’ roles and the related SWOT analysis (S2 Appendix; Fig 1, step 12).

To improve the confirmability of the study, every first interview per professional group per country was analysed by two researchers [2830]. In that way, at least three interviews per country (one nurse, one physician, one pharmacist) were analysed by two researchers. All other transcripts and coding were at least checked by a colleague. After the data were analysed at national level, by coding the transcripts, researchers in each country selected quotations for each theme and sub-theme (Fig 1, step 14). To store the quotations, add labels and arrange the data, Microsoft Excel® tables were created. To accomplish an overall view on the data, the preselected citations were reviewed by two researchers (first and second author) to reassess the code labels for accuracy and to compare the different opinions throughout Europe. All assumptions were taken into account, regardless the number of times they occurred (Fig 1, step 16). The national data per country, as well as the overall international data, were presented at an international meeting with all partners to discuss the completeness and interpretation of the results per country, and achieve international consensus (Fig 1, step 17).

Ethics approval

The Ethics Committee for Social Sciences and Humanities of the University of Antwerp approved the study design (reference SHW_19_30). Depending on local regulations in Slovenia, the UK and Portugal, additional approval was obtained from the Medical Ethics Committee of the Republic of Slovenia (reference 0120-516/2018/6), Health and Care Research Wales (reference 19/HCRW/00) and the Ethics Committee of the Escola Superior de Enfermagem in Coimbra (reference 543/12-2018). National regulations and laws applying to the other countries didn’t require additional permits or approvals. All respondents received information on the purpose, design and execution of the study. Written informed consent was given by all study participants.

Results

The characteristics of the 340 healthcare professionals interviewed are presented in Table 1: 113 pharmacists, 111 physicians and 116 nurses, employed in hospital care (45%), community care (26%), residential care (14%), mental healthcare (9%), and other settings, such as a (10%). Healthcare professionals involved were equally distributed across participating countries. Most respondents worked in clinical practice (80%) and spent an estimated mean of 29 ± 15.1 hours/week on PC.

Table 1. Population characteristics.

n (%)
Country
 Belgium 28 (8.2)
 Czech Republic 29 (8.5)
 Germany 22 (6.5)
 Greece 24 (7.1)
 Hungary 21 (6.2)
 Italy 24 (7.1)
 The Netherlands 24 (7.1)
 Norway 24 (7.1)
 Portugal 24 (7.1)
 Republic of North Macedonia 24 (7.1)
 Slovakia 24 (7.1)
 Slovenia 24 (7.1)
 Spain 24 (7.1)
 United Kingdom 24 (7.1)
Profession
 Pharmacist 113 (33.2)
 Physician 111 (32.6)
 Nurse 116 (34.1)
Gender
 Female 206 (60.6)
 Male 134 (39.4)
 Other 0 (0)
Healthcare setting*
 Hospital care 154 (45.3)
 Community care 88 (25.9)
 Residential care 46(13.5)
 Mental healthcare 29 (8.5)
 Other / no specific healthcare setting** 35 (10.3)
Main field*
 Clinical practice 272 (80.0)
 Policy 67 (19.7)
 Education 41 (12.1)
 Research 28 (8.2)
 Politics 10 (2.9)
Mean (SD) Median (min-max)
Age (years) 45.9 (10.6) 46.0 (24–76)
Expertise in main field (years) 19.1 (10.7) 18 (2–48)
Work related to pharmaceutical care (hours/week) 28.3 (15.3) 30 (1–105)

* Total is different from 100% because more than one answer was possible.

** academic setting, education, research, politics, national health services, individual practice (not community care) or not specified

In response to questions about the ideal role of nurses in clinical practice, the four main responsibilities, developed in previous work, remained substantially unchanged. Within each responsibility, several tasks and contextual factors were reported. Opinions differed regarding expectations of nurses. An overview of all nurse responsibilities and tasks in interprofessional PC reported by pharmacists, physicians and nurses is given in Table 2.

Table 2. Existing or potential nurse responsibilities and tasks in interprofessional pharmaceutical care (beyond medication preparation and administration).

Responsibilities Tasks
1. Monitoring therapeutic and adverse effects of medicines
2. Monitoring medicines adherence
3. Decision making on medicines use, including (de)prescribing, medication reconciliation and medication review
4. Providing patient education and information about medicines
a. Detecting, addressing, reporting clinical change and healthcare problems
b. Assessing patients’ needs
c. Identifying, reporting and addressing drug related problems and safety issues
d. Follow-up assessments of patients
e. Intervention in emergencies
f. Documentation in patient records
g. Communication with patient, informal caregiver and family
h. Selfcare support and therapeutics education
i. Interprofessional communication, including reporting, advising, informing, alerting and discussing
j. Communication within the nursing team
k. Supervising and coaching new healthcare workers and less qualified team members

Responsibility 1: Monitoring therapeutic and adverse effects of medicines

Some respondents considered monitoring patients for the benefits and harms of medicines administered as part of basic nursing care, whereas others disagreed.

I think pharmacists are better placed to report about unwanted effects, since we are committed to report on pharmacovigilance. Pharmaceutical care is pharmacists’ work, and nobody else’s

(Pharmacist-05, Slovenia)

The clinical evaluation and follow-up is something nurses currently do on a daily basis and which is often the trigger of alarm to physicians. It is already part of nurses’ skills and it is being done well.”

(Physician-01, Portugal)

Within monitoring, nurses’ tasks were defined as medication anamnesis, detecting clinical change and healthcare problems and assessing patient needs. Early recognition of signals and linking with medicines was seen as vital to patients’ safety. Reporting observations to the team (physician and pharmacist) and to patients or their informal caregivers and family, as well as registration and follow-up of medicines’ desirable and undesirable effects were recognized as nurses’ tasks. Follow-up was suggested as either a nursing or shared responsibility or solely a medical task.

Pharmacists won’t notice side effects, only one person will–it’s the nurse.”

(Pharmacist-20, Hungary)

Nurses don’t only distribute medicines like a trained monkey. They are able to realize that somehow a problem could arise and preventive interventions might be necessary.”

(Nurse-04, Germany)

To monitor therapeutic and adverse effects of medicines, respondents perceived a certain level of knowledge about medication to be needed, and therefore high quality nurse education must be provided. In addition, some felt clear legal frameworks, policies and regulations, allocating nurses clear roles in monitoring, are necessary.

Responsibility 2: Monitoring medicines adherence

Many respondents considered adherence monitoring to be a clear and obvious aspect of nurses’ roles, while some were convinced that this was a physician-only responsibility or even the sole responsibility of the patient.

Monitoring and following-up medication adherence, this is probably clear. This is an area which is the least controversial, I see no problem in it.”

(Nurse-12, Czech Republic)

Within monitoring medication adherence, one important nursing task was to detect and alert the interprofessional team of any non-adherence. Nurses may also motivate patients to adhere to their prescribed regimen. Motivational interviewing of patients with targeted open questions would identify reasons of non-adherence, determine patients’ needs, and support self-care.

When the nurse is with the patient, she realizes whether the pill is too big for the patient and he would prefer to take two smaller ones twice a day.”

(Pharmacist-02, Italy)

Prerequisites of adherence monitoring by nurses included: clear guidelines about the responsibilities of nurses, pharmacists and physicians in monitoring adherence within a legal framework; open, blame-free culture; open dialogue between pharmacists, physicians and nurses; appropriate nurse training in PC; and a manageable workload, resulting in time to care and explore issues with patients.

Responsibility 3: Decision making on medicines use, including (de)prescribing, medication reconciliation and medication review

A wide variation in opinions was reported, with more positive views in countries with existing nurse prescribing. Differences in opinion were not confined to any one profession. A small number of respondents considered nurses already possessed the required competences, and advocated nurse-prescribing for a wide range of medicines, usually within their specialist fields.

Doctors, especially in hospitals, got used to giving their stamps to the head nurse to write prescriptions.”

(Pharmacist-01, Greece)

We have an internal deal with the nurses on my ward, that they are allowed to give some medicines to patients on their own, under specific circumstances and specific medicines that we agreed on.”

(Physician-06, Slovenia)

Others favoured nurse prescribing, but only after extra training and under specific conditions, e.g. emergencies, low risk medicines (often those that can be purchased without a prescription) or confined to nurses with high levels of nursing education. A further group would never–under any circumstances—give nurses a role in decision making or prescribing. They considered this responsibility to be too complex and a medical responsibility, in which collaboration with nurses was not desirable.

Experiences with nurse prescribing in other countries are not of that kind, that we need to be scared of it.”

(Pharmacist-02, Belgium)

It scares me… it is probably just my feeling… I cannot imagine nurse prescribing.”

(Pharmacist-10, Czech Republic)

Respondents considering decision making on medicines to be a part of nurses’ ideal roles described possible tasks within this responsibility: nurses could decide on the route, formulation and brand; add or deprescribe treatments; adjust and titrate doses; prepare prescriptions (to be validated by a physician); and prescribe repeat prescriptions. Respondents predominantly reflected on the selection of products, the level of autonomy and the level of emergency: local and low-risk medicines from a limited list were preferred to systemic and high-risk medicines; supervision by physicians or pharmacists and shared responsibility were favoured above full autonomy for nurses; and life-threatening emergencies warranted increased autonomy. Others felt that more complex thinking is required in these situations, arguing against more responsibility for nurses. There were calls for flexible practice guidelines. Knowledge was mentioned as a crucial prerequisite for decision-making in PC. As an initial step, more pharmacology is needed in pre- and post-registration nurse education. Level 6 (Bachelor) nurses [31], nurse specialists and nurse practitioners were suggested as having the minimum level of education to prescribe.

Nurse prescriptions should be very limited. I would understand nurse prescribing, but only in very specific restricted situations.”

(Pharmacist-03, Spain)

What responsibilities would be part of the ideal role of a nurse in interprofessional pharmaceutical care? In my ambulatory practice I think nurses can prescribe ‘repeating prescriptions’ within control consultations. I think nurses can decide about routine medicines, within a certain spectrum, within their specialization in the field.”

(Physician-22, Slovakia)

Nurses could have autonomy on the renewal of chronic therapies, previously prescribed by a doctor.”

(Nurse-10, Italy)

Nurses have the right to give emergency therapy when the patient’s life is endangered, e.g. in case of major bleeding.”

(Nurse-02, Republic of North-Macedonia)

I would increase the level of knowledge, because if we don’t have the proper level of knowledge, we can’t prove to doctors and pharmacists that we are competent to prescribe and right now they don’t trust us enough to prescribe.”

(Nurse-07, Slovenia)

Responsibility 4: Providing patient education and information about medicines

Some respondents were convinced that responsibilities for educating and informing patients were the professional territory of physicians or pharmacists, while others believed these responsibilities should be shared with nurses. Opinions were based on the very limited content in pharmacotherapeutics in nurse education.

Patient education about medicines would be better done by a pharmacist, they go to school for 5 years and learn everything about medicines, while nurses have only one course in school.”

(Pharmacist-01, Slovenia)

With improved education, nurses could: explain medical diagnoses; inform patients and their caregivers about short- and long-term advantages and disadvantages of their medicines; support self-care; counsel patients at discharge; encourage and empower patients to take their medicines.

A nurse has a responsibility to the patient to keep the patient fully informed about what has been prescribed, the risks associated, side effects associated and benefits likewise.”

(Physician-04, UK)

I think patient education and providing information is already done, it is common that nurses educate patients. We can discuss about the quality and the way, but I think, the role of nurses should be enhanced here.”

(Nurse-12, Czech Republic)

Nurses should provide patient education and information on drugs, because doctors are too complicated for patients.”

(Nurse-02, Slovakia)

Interactions between nurses, physicians and pharmacists in an ideal interprofessional collaboration

Interprofessional communication, including reporting, advising, informing, alerting and discussing was considered of major importance in interprofessional PC. Collaboration, coaching and supervising within the nursing team was also reported as important.

Multidisciplinary communication works, nurses are irreplaceable, they ensure that information and documentation is effectively passed between team members.”

(Nurse-03, Slovakia)

Three-dimensional communication is missing. Clinical pharmacists have been collaborating mainly with physicians, discussion with nurses is missing.”

(Physician-10, Czech Republic)

Contextual factors allowed nurses to have a role in interprofessional collaboration, e.g. confidence in nurses’ knowledge, self-confidence of nurses, an open blame-free culture, clear roles and responsibilities, availability of team members, involvement of nurses in PC team meetings, absence of hierarchic attitudes, and equality between professionals. Written communication was recommended to ensure proper communication.

The working atmosphere is crucial. This must ensure openness and honesty and give room for clear feedback to each other.

(Physician-08, the Netherlands)

I don’t know who my nurses are in my two local surgeries. It would be nice to know their names, I don’t think that’s the nurses’ fault I think it’s the way we get used to working.”

(Pharmacist-24, UK)

Strengths, weaknesses, opportunities and threats of nurses’ role in interprofessional PC

Strengths

The proximity of nurses to patients was a strength of nurses’ contribution to PC. Nurses spend a lot of time with patients and these frequent contacts could facilitate screening for symptoms, monitoring adherence, making decisions and informing or educating patients and their informal caregivers.

The nurse regularly visits the patient and therefore is the first in line to recognize adverse effects of medicines and to act upon them. Physicians don‘t spend as much time near the patients’ beds, so, they don’ t always see the effect of medicines, compared to a nurse on a ward, who walks in the patient’s room for about 10 times a day.”

(Physician-23, the Netherlands)

Nurses were seen as well-positioned to take up responsibilities in interprofessional PC. They have key information to share, which can trigger interventions by themselves or other team members, in order to optimize medication use and improve health outcomes. Nurses’ reinforcement of physicians’ words to patients is important in their role in patient education.

I, as a pharmacist, I am a real expert in medication. The GP is an expert in pathology. But nurses, they are ‘the eyes’ because they SEE patients, they can report to other professionals. Without you, nurses, the healthcare sector is dead. Without you, we are nothing!”

(Pharmacist-05, Belgium)

Weaknesses

Firstly, the absence of a legal framework for nurse’s roles in PC was evident in several countries. Some professionals reported absence of diagnostic mindsets, PC competences and poor education. Inadequate education promoted a lack of confidence in nurses from some pharmacists, physicians and nurses. Open dialogue with adequate interaction between nurses, pharmacists and physicians seemed to be missing. Although respondents believed that there was more communication than in the past, some hierarchical attitudes persisted.

There must be an open dialogue, without throwing remarks, such as ‘I am a professional, I am first, you are last.’ An open dialogue to be able to say ‘Hey guys, who can deal with this part?’ It’s a puzzle. A brainstorming session to create clear abilities and job descriptions.”

(Pharmacist-01, Greece)

Opportunities

Further, opportunities for nurses’ roles in an ideal interprofessional PC were identified. Each professional looking at the patient from his/her own perspective makes the involvement of multiple professionals of added value. Nurse consultations to monitor medicines effects and adherence, and care coordination by nurses were suggested as facilitators of PC. This would align complementary knowledge of team members, and reduce contradictory messages from different professionals.

"I could not imagine independent prescribing, because of interactions between body systems. A nurse alone cannot order pharmaceuticals, but a team is involved. Each team member has its own perspective; putting knowledge together will lead to much better results.”

(Nurse-11, Hungary)

Multidisciplinary teams are the ones who do all the work. It is never a one man’s success. Nurses have the capacity to lead, gather and organize multidisciplinary collaborations for the patient’s benefit.”

(Nurse-02, Greece)

Nurses taking up more responsibilities in PC could have a positive impact on care quality and patient outcomes: an increase of professional support for patients (including in areas where few physicians are available e.g. rural or post-industrial areas), a substitute for physicians’ input, reduction of waiting times and stress for patients, and, in case of nurse prescribing, a facilitation of prescription changes in emergencies.

I completely agree that making decisions on medicines would take some weight off doctors shoulders

(Physician-04, Slovenia)

The benefits of interprofessional co-operation with nurses, pharmacists and physicians are rapid response, patient satisfaction and quality of care.”

(Nurse-02, Republic of North-Macedonia)

In addition, shared digital patient files, interprofessional ward rounds and integrating interprofessional collaboration and communication into education of all professionals would be great opportunities for the future.

Training with all the professionals is needed, we finish our degree without connecting directly to the other professionals and that is not what we see in the practice.”

(Nurse-02, Spain)

Threats

However, lack of time (to care), shortage of nurses and limited financial compensation for the time spent in PC roles, in combination with the current high burden of nursing responsibilities threaten the realisation of nurses’ ideal roles in PC.

I don’t understand why things should change, nurses want to prescribe and they don’t even have time to do what they are already competent to do…”

(Pharmacist-01, Slovenia)

Those who bear more responsibility should also receive more money, which is not yet the case in today’s collective agreements.”

(Nurse-06, Germany)

Finally, the absence of a legal framework for nurses’ roles and some physicians or pharmacists worrying about “their territory” in PC must be addressed.

Interactions should be more lubricated and should be encouraged and I think they should be even legislated because it seems that nobody does anything if it is not an obligation… in order to boost public health… but a diagram needs to be made for people understood how it works.. so it will be better to be legislated….”

(Pharmacist-06, Portugal)

The barriers are quite clear, professional conflicts have always been there. Every time one tries to get into a subject to another profession then they put up a stop that “this is my area of responsibility, you shouldn’t have anything to do with”.”

(Nurse-01, Norway)

My experience is that hospital nurses think they are like physicians and I don’t like it. They are also elevated to us as pharmacists, while the role of both our professions is very important. Everybody is better in different area and nobody is the subordinate.”

(Pharmacist-02, Slovakia)

Discussion

Four main responsibilities for nurses in PC were evaluated. Many different tasks were described as part of nurses’ ideal practice, yet many professionals were ambivalent over their implementation.

The extent of nursing autonomy depended on type of medicine and country-specific governance structures, and varied from no authority to authority and responsibility for broad ranges of activities. Not every nurse would be capable of performing every task in every situation. Several contextual factors should be taken into account while translating nurses’ ideal roles in PC into clinical practice. Important prerequisites which were also already discussed in the literature were: sufficient education [32, 33], knowledge (more pharmacology and pharmacotherapeutics) [34, 35], an interprofessional collaborative approach [1, 36], confidence in nurses [37, 38], an open blame-free culture with clarity of team composition and roles [39, 40], equality between professionals [41], adjusted legislation [42], readiness of professionals and patients to allow nurses to have responsibilities in PC [43], and a manageable workload leaving “time to care” [44, 45]. Lack of time, shortage of nurses, absent legal frameworks and limited education and knowledge were described as main threats. However, a positive impact on care quality and patient outcomes was associated with nurses taking up responsibilities in PC. Nurses’ observations and assessments could convey key patient information to the interprofessional team, as was also shown in previous research [46].

Fourteen countries were included in the study. Despite all of these being in Europe, it cannot be assumed that the education of nurses in each of these countries is uniform. A systematic review of nurse education in European presented differences on both level and duration of education [33]. Two thirds of all nursing education programs are offered at the higher education level, while one third is offered at diploma-level. The duration of full-time nursing education programs varies from two to four years, with the majority (58%) lasting for three years. Also, different education pathways lead to the same level of nursing qualification in some countries and specialist qualifications are offered at both undergraduate and graduate degrees [33]. Although the participants in this study raised the issue of the need for sufficient education before nurses could have a role in pharmaceutical care, experiences on the specific differences between the levels of education in each country were not addressed in the interviews. Only for nurse prescribing did some respondents formulate minimum conditions in terms of educational level. Further research investigating differences in nursing responsibilities between levels of nurse education can offer significant added value to the development of a framework for level-specific roles of nurses in interprofessional PC.Nurses’ roles have expanded in Europe over the last decade. An international comparative analysis of reforms of nurse prescribing concluded that 13 European countries already had legislation on nurse prescribing, eight since 2010. The extent of prescribing rights ranged from nearly all medicines within nurses’ specialisations to a limited set of medicines. All countries had regulatory and minimum educational requirements in place to ensure patient safety; the majority required some form of physician oversight [47]. Our study included four countries with legal prescribing rights for some nurses or some products at the time of data collection: the Netherlands, Norway, Spain and the United Kingdom. Different participant perspectives, however, were not related to country or any one profession.

Regardless of whether or not nurses are able to prescribe, they can have a pivotal role in initiating and supporting deprescribing [48, 49]. However, nurses’ roles in providing patient information about deprescribing are not always well considered, but nurses may be as effective as physicians at discussing medicines discontinuation with patients [50]. When nurses are aware of the medicines that are most appropriate for deprescribing, for example antipsychotics for behaviour disturbance, they can monitor these patients to ascertain the benefits no longer outweigh the harms [48, 49].

We consciously chose to start the interviews with a definition of PC. This strategy has both advantages and disadvantages. Predefining PC ensured uniformity across 14 countries and 12 languages. On the other hand, we were unable to extract the participants’ conceptualizations of the definition. However, we did encourage open reflections about the interpretation of role fulfilment within PC. The phenomenological approach of this study incorporates the supposition that there may be multiple truths or realities as perceived by multiple participants [51, 52]. Additionally, the conceptualization of PC responsibilities may differ between healthcare professionals, as was already investigated for the concept of ‘medication monitoring’ [53]. Monitoring from a nursing perspective is a dynamic, ongoing, day-to-day activity, while pharmacists and physicians typically associate monitoring with structured medication reviews and an intermittent, planned activity [53]. In our study, we were unable to explore any differences in how the concepts or themes were conceptualised by participants. Nevertheless, we described many ambiguous opinions on PC responsibilities and tasks, and participants elaborated on a broad range of subthemes that needed to be specified in order to define nurses’ role in PC.

Strengths and limitations

To our knowledge, this is the first pan-European qualitative interview study about PC by nurses. The quality of the research can be demonstrated based on the qualitative research quality criteria of Lincloln and Guba [28]. Firstly, triangulation of sources and analyst triangulaton indicate credibility. Secondly, the extensive focus on the PC context of the participants resulting in thick descriptions will facilitate transferability of the study findings. Thirdly, the dependability is confirmed by investigator triangulation: coding of the first interviews by multiple researchers within one country, plus a non-country specific reassessment of the code labels linked to preselected citations by a team of researchers.

The confirmability of this research could only be partially achieved. Researchers from all countries were trained in qualitative research, in-depth interviewing, and ‘bracketing’ their own beliefs about nurses’ role in PC during a joint one-week training program. However, since interviewers and respondents often shared work environments, contextual intersecting relationships between the participants and the researchers cannot be ignored. As we wanted to avoid the profession of the researchers influencing the responses from physicians, pharmacists, and other nurses, interviewers were asked not to inform interviewies about their profession unless directly questioned [54].

Another limitation is the absence of structured integration of the field notes, that have been made during the process of transcribing, critical reflecting and coding. Therefore, the researchers might have missed important non-verbal indicators, such as participants’ body language and tone of voice.

The selected participants were ‘key informant’ experts in PC, who knew best what was happening in PC in clinical practice. However, findings cannot be generalised to more junior clinicians or managerial staff. No reimbursement was provided for participation, leading to occasional refusal to participate. Exact numbers of those declining to participate were not registered, leading to an unknown selection bias. Despite the limited number of participants per professional group at national level, no new themes were generated in the last interviews reviewed, suggesting sufficient information power [55]. Socio-cultural influences, mainly in terms of attitudes towards other professions might affect perspectives related to interprofessional collaboration, as was demonstrated in several studies [43, 56]. In this research, no information was sought on cultural and/or ethnic identities of respondents. We wished to avoid sensitive questions and any possibility that respondents might be identified by local readers. Diversity should be taken into account in future research.

Implications for clinical practice and future research

Our results offer opportunities to create a framework for discussion in clinical practice, collaboration in research, and labour mobility. Nurses, pharmacists and physicians should openly discuss allocation of specific responsibilities and tasks. Our list of responsibilities and tasks is not exhaustive. Medication safety management [57], care coordination [58], overseeing patient medication self-management [59, 60], assessing patients’ competences [61], coaching and training patients [62], discharge planning [63] and interprofessional referrals [64] are additional nursing responsibilities and tasks identified in the literature. A scoping review of research about PC by nurses would be useful to confirm the completeness of the role described or supplement with additional responsibilities and tasks. Further research should also address the differences in nurses’ roles within different levels of nurse education.

Exploring nurses’ ideal role in PC is not intended to remove responsibilities from other professional groups. On the contrary, the benefits of interprofessional collaboration and communication between pharmacists, physicians and nurses and its major impact on care quality and patient outcomes have already been amply demonstrated [48, 49, 6569]. Yet, healthcare systems are historically hierarchical in nature with physicians regularly assuming leadership positions and decision-making roles. Frustrations, lack of confidence, lack of organization and structural hierarchies hinder interprofessional relationships and communication [41]. Power imbalance between professions is an important factor in nurses’ professional roles when discussing PC and its formalisation. To address this source of conflict, it may be helpful for team members to discuss and agree roles and responsibilities [40]. Increasing the awareness of all team members’ potential roles would allow pharmacists, nurses and physicians to benefit from teamwork [65]. Also, educators hesitate to address the reality of hierarchies in healthcare [70]. The training of healthcare professionals remains largely single discipline, which may reduce the ability to collaborate interprofessionally [71]. Therefore, we call for more interprofessional education, as well as rigorous research on interprofessional PC to tackle the remaining barriers.

Conclusion

Nurses have an active role in monitoring patients for the impact of their medicines, monitoring adherence, making decisions on medicines, and providing patient education and information. Different tasks within these responsibilities have been described, although contextual, knowledge and training factors have to be considered before nurses can perform this ideal role. Lack of time, shortage of nurses, an absent legal framework and limited education and knowledge were the main threats for nurses’ roles in PC. Nevertheless, a positive impact on care quality and patient outcomes was associated with nurses taking up responsibilities in PC. Nurses’ observations and assessments could lead to key information about patients being shared and addressed by the interprofessional team. The outcomes of this study evidence the need for a consensus-based PC framework across Europe.

Supporting information

S1 Appendix. Interview guide of the interview study in 14 countries.

English version and 12 translations.

(PDF)

S2 Appendix. Acknowledgements: List of interviewers, manuscript reviewers, people facilitating access to the field and other contributors.

(PDF)

S3 Appendix. Demographics database.

(XLSX)

S1 Table. Code book of the interview study.

Codes S001 to S042 were the codes of the first code book, codes S043 to S049 were added to the final code book.

(PDF)

Acknowledgments

The authors explicitly thank all interviewers for their valuable contribution in collecting data and other contributors for reviewing the manuscript and giving us access to the field (S3 Appendix).

Data Availability

Ethical restrictions have been imposed on data sharing by the Ethics Committee for Social Sciences and Humanities of the University of Antwerp, the Medical Ethics Committee of the Republic of Slovenia and the UK NHS Research Ethics Committee that approved this study. The data contain potentially identifying and sensitive information. Also, investigators from the other countries confirmed that making these sensitive data publicly available without having requested the consent of the interviewees beforehand, is impossible for ethical and legal concerns. UK data are stored at Swansea University, Swansea, UK. All proposals to view the data are subject to review by Swansea University’s Research Governance department and the PI. Before any data can be accessed, approval must be given. The application process is via the Academic Lead for Research Integrity Research Engagement & Innovation Services, Swansea University and the PI or Neil Carter. Contacts: Swansea University, Swansea SA2 8PP Tel: +44 /0 1792 606060 and 518541 or 295610 Email: researchgovernance@swansea.ac.uk, s.e.jordan@swansea.ac.uk or n.carter@swansea.ac.uk Data from the other 13 countries are stored at the University of Antwerp, Antwerp, Belgium. All proposals to view the data are subject to review by University of Antwerp’s Research Governance department and the PI. Before any data can be accessed, approval must be given. The application process is via the data protection officer, Antwerp University and the PI. Contacts: University of Antwerp, Prinsstraat 13, 2000 Antwerp, Belgium. Email: privacy@uantwerpen.be, Tinne.Dilles@uantwerpen.be.

Funding Statement

The research was supported by the Erasmus+ Programme of the European Union [grant number 2018-1-BE02-KA203-046861] and MDMJ accountants, an accountancy service in Belgium that financially supported the Belgian authors (www.mdmj.be). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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Decision Letter 0

Carl Richard Schneider

24 Feb 2021

PONE-D-20-36633

Perspectives about nurses' role in interprofessional pharmaceutical care across 14 European countries: a qualitative study in pharmacists, physicians and nurses

PLOS ONE

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- Please ensure the manuscript conforms to qualitative research reporting standards e.g. COREQ guidelines.

- Please comment on how qualitative research quality criteria of credibility, applicability/transferability, consistency/dependability, neutrality/confirmability (adapted from Lincoln and Buga, 1985) are considered in your methods e.g. triangulation, member checking, 'thick' description and/or other techniques.

- Please pay careful attention to Review 1's comment of the profession of the researchers and how that may influence how the research was conducted (reflexivity)

- A phenomenological approach was undertaken which incorporates the supposition that there may be multiple truths as perceived by multiple participants. Throughout the results, were there any differences in how the concepts/themes were conceptualised by the participants? For instance, we identified that nurses conceptualised 'monitoring' of medication differently to pharmacists and physicians (Langford AV, Ngo GT, Chen TF, Roberts C, Schneider CR. Nurses', Pharmacists' and Family Physicians' Perceptions of Psychotropic Medication Monitoring in Australian Long-Term Care Facilities: A Qualitative Framework Analysis. Drugs & Aging. 2020 Dec 14.) Differences or commonality in conceptualisation of concepts such as pharmaceutical care, monitoring, adherence as explored by this research, across professions and practice settings/countries, would be of interest to the audience. This also may speak to Reviewer 1's comment on expanding beyond the initial (gold standard) definition of pharmaceutical care by Hepler&Strand. Do participants' conceptualisations align with this definition or diverge? In what ways?

Specific comments:

- consider changing the title to "Perspectives of nurses' roles in interprofessional pharmaceutical care across 14 European countries: a qualitative study in pharmacists, physicians and nurses"

- line 184: consideration of reliability is made. Reliability is primarily a positivist concept, however a phenomenological paradigm was adopted. There appears to be an inherent paradigmatic contradiction apparent. Please review.

- line 513-515: please provide supporting evidence for these statements

Overall, this is an important piece of work, and thank you for the submission to PLOS ONE, it is a pleasure to be the Academic Editor of this manuscript.

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Reviewer #1: Partly

Reviewer #2: Yes

**********

2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: N/A

Reviewer #2: Yes

**********

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Reviewer #1: Yes

Reviewer #2: Yes

**********

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Reviewer #1: Yes

Reviewer #2: Yes

**********

5. Review Comments to the Author

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Reviewer #1: Dear Authors

Thank you for submitting this interesting manuscript. It is generally well written, however, in my opinion, there are several points for development. These are listed below:

1. The study centres on pharmaceutical care and the perceived actual or potential role that nurses play in this. Hepler and Strand's 1990 (page 4) definition is used to provide the context to this, yet, this definition could be considered both dated and limited in its scope. Is there a more recent definition that could be used?

2. I am uncertain what the purpose of establishing a framework for nurses' roles in interprofessional pharmaceutical care is, and this is not explained in the manuscript. Perhaps, some background discussion of the benefits of this or why it is needed would be helpful.

3. It is stated that the study is part of the DeMoPhaC project, yet very little information is provided about this. For a reader who has not read previous reports of this project, some additional information would be useful.

4. It is clearly identified that a phenomenological case study design has been used as the study approach. Again, more detail of how this was applied as well as justification for its use is needed.

5. Fourteen (14) countries were included in the study. Despite all of these being in Europe, it cannot be assumed that the education and roles of the registered nurses in each of these countries is uniform. This needs to be discussed in light of both the findings and the discussion. Not doing this is a considerable weakness of the study.

6. Explanation of the recruitment process lacks detail. How were participants recruited and informed about the study- who provided this information and how?

7. How was the sample size determined? It is stated that "We aimed for at least two interviews per profession (no.3) per healthcare setting". How was this number decided on? Was the issue of data saturation considered?

8. Throughout the manuscript the phrase "nurses potential and/or ideal ideal roles in pharmaceutical care" is used. It is unclear what is meant by these descriptors, which are very subjective and somewhat meaningless. Are the authors' referring to nurses "scope of practice" in pharmaceutical care ?

9. I found a lack of clarity/ distinction between what is considered a role, responsibility or task, and there is clearly some overlap. For example" Providing patient education and information about medications could be considered all three. Consideration around choice of words is recommended.

10. The Discussion section is brief and limited. Some important points have been alluded to, however these have not been followed up/ explored with adequate discussion or links to the literature. For example: the very long sentence on page 23 (lines 494-499) states: "Most important pre-requisites were: sufficient education, knowledge (more pharmacology and pharmacotherapeutics), an interprofessional collaborative approach, confidence in nurse, an open blame- free culture with clarity of team composition and roles, equality between professionals, adjusted legislation, readiness of professionals and patients to allow nurses to have responsibilities in PC, and a manageable workload leaving "time to care". There are some very important issues that have been identified but not discussed or elucidated.

11. There are several minor grammatical and punctuation issues throughout that careful proof-reading may assist to identify.

12. Table 1 has some additional, misplaced numbers (211, 212, 213, 214) that need removal.

Reviewer #2: The purpose of this study was to assess the role of the nurse in pharmaceutical care in European healthcare settings based on the perspective of pharmacists, physicians, and other nurse healthcare professionals. Overall, this paper was informative and comprehensive with good emphasis on balanced professional diversity. I particularly appreciated how the different viewpoints of pharmacists, physicians, and nurses were captured in the paper. Specifically, the role of nurses in pharmaceutical care can be a controversial topic as the authors describe, and I appreciated that the paper captured many opinions and weaknesses and strengths on the topic.

Suggested changes are described below:

1. (lines 145, 454): The term interprofessional should be used rather than multidisciplinary. Multidisciplinary refers to activities performed by members of different academic disciplines. As previously defined, the term interprofessional should be used in this healthcare context. (see https://interprofessional.global/wp-content/uploads/2019/10/Guidance-on-Global-Interprofessional-Education-and-Collaborative-Practice-Research_Discussion-Paper_FINAL-WEB.pdf)

2. (line 205) The text of the results section, reads that 43% of the participants were employed in hospital care and 24% of the participants were employed in community care, however, this is not consistent with the results in Table 1 in the Healthcare settings section (48.6% and 27.0%, respectively).

Also, regarding that same section (Healthcare settings) in Table 1, the n-values total 313 rather than at least 340 interviews. What is the reason for this number being less than the total interviews? Did some people not respond to the question? Why would it not be 340 or greater particularly given that many of these healthcare professionals may be employed in more than one healthcare setting?

3. (line 165-167) As interviews were conducted in the workplace or an alternative location, can you comment on participant body language, tone of voice, and/or other non-verbal cues that might be important indicators to the responses to the research questions?

4. Did you collect information about cultural and/or ethnic diversity of the study participants? Did you consider that some participants might identify with a gender other than male or female? Could either or both cultural/ethnic background or gender identity affect perspectives related to interprofessional collaboration in pharmaceutical care?

5. Limitations:

i) (line 518) As the interviews were conducted by nurses, this could be a limitation as this may have potentially affected the responses from physicians, pharmacists, and other nurses. This limitation should be mentioned in the limitations section of the paper.

6. Overall, there are a few formatting errors such as in Table 1 the line numbers 211-214 are inside the cell.

Also, the writing could be further edited for clarity and conciseness for the reader.

**********

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Reviewer #1: No

Reviewer #2: Yes: Kathleen M. MacMillan

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PLoS One. 2021 May 27;16(5):e0251982. doi: 10.1371/journal.pone.0251982.r002

Author response to Decision Letter 0


26 Mar 2021

26 March 2021

Dear editor, dear reviewers,

Thank you for reviewing our manuscript (PONE-D-20-36633) entitled “Perspectives of nurses' role in interprofessional pharmaceutical care across 14 European countries: a qualitative study in pharmacists, physicians and nurses". Your comments have allowed us to improve the content and the clarity of the manuscript. The changes we made to our original manuscript are documented below.

General comments

- Please ensure the manuscript conforms to qualitative research reporting standards e.g. COREQ guidelines.

� In our first submission we didn’t mention this reporting standard, although it was used to report the study. We have added the following sentence to the methods: “This study was conducted and reported according to the Consolidated Criteria for Reporting Qualitative Research (COREQ).” We also added the appropriate reference.

- Please comment on how qualitative research quality criteria of credibility, applicability/transferability, consistency/dependability, neutrality/confirmability (adapted from Lincoln and Guba, 1985) are considered in your methods e.g. triangulation, member checking, 'thick' description and/or other techniques.

� Thank you for drawing our attention to the lack of a clear description of these quality criteria. In our revised manuscript, we have elaborated on these concepts in the discussion (strengths and limitations) and referred to Lincoln and Guba (1985).

* Credibility

Triangulation of sources: In this study, people with different perspectives have been interviewed: three different professional groups in four healthcare settings

Analyst triangulation: In each country, every first interview for each professional group (nurses, physicians, pharmacists) was analysed by two researchers independently. In that way, at least three interviews for each of the 14 countries were analysed by two researchers independently.

Coding of all other transcripts was checked by co-authors in each country. After all interviews were coded, two researchers of the Belgian team (EDB, TD) reviewed all preselected and translated citations to assess the code labels for accuracy.

* Transferability

The interviews consisted of open-ended questions, focusing on the pharmaceutical care context of the healthcare workers. The resulting thick descriptions will facilitate transferability of findings.

* Dependability

Investigator triangulation was achieved by multiple researchers within each country coding the first interviews, plus a non-country specific reassessment of the code labels linked to preselected citations by a team of researchers.

* Confirmability

Triangulation of sources and analyst triangulation as described above.

Reflexivity: Researchers in all countries were trained in qualitative research, in-depth interviewing and ‘bracketing’ their own beliefs about nurses’ role in pharmaceutical care during a joint one-week training program. However, since interviewers and respondents often shared work

environments, potential contextual intersecting relationships between the participants and the researchers cannot be ignored. As we wanted to avoid the profession of the researchers influencing the responses from physicians, pharmacists, and other nurses, interviewers were asked not to

inform interviewees about their profession unless directly questioned. By acknowledging this limitation in the discussion, we aimed to establish the transparency in our study.

- Please pay careful attention to Review 2's comment of the profession of the researchers and how that may influence how the research was conducted (reflexivity)

� Thank you for this comment. As indicated in the answer on the previous comment, we have addressed this limitation transparently in the discussion.

- A phenomenological approach was undertaken which incorporates the supposition that there may be multiple truths as perceived by multiple participants. Throughout the results, were there any differences in how the concepts/themes were conceptualised by the participants? For instance, we identified that nurses conceptualised 'monitoring' of medication differently to pharmacists and physicians (Langford AV, Ngo GT, Chen TF, Roberts C, Schneider CR. Nurses', Pharmacists' and Family Physicians' Perceptions of Psychotropic Medication Monitoring in Australian Long-Term Care Facilities: A Qualitative Framework Analysis. Drugs & Aging. 2020 Dec 14.) Differences or commonality in conceptualisation of concepts such as pharmaceutical care, monitoring, adherence as explored by this research, across professions and practice settings/countries, would be of interest to the audience. This also may speak to Reviewer 1's comment on expanding beyond the initial (gold standard) definition of pharmaceutical care by Hepler&Strand. Do participants' conceptualisations align with this definition or diverge? In what ways?

� Thank you for these considerations. We have refined our methods and discussion based on this comment.

� We consciously chose to start the interviews with a definition of PC. This strategy has both advantages and disadvantages. Predefining PC ensured uniformity across 14 countries and 12 languages. On the other hand, we were unable to extract the participants’ conceptualizations of the definition. However, we did encourage open reflections about the interpretation of role fulfilment within PC. We have added to the methodology the PC definition that was presented to the participants: “To ensure conformity across twelve languages, the concept of PC was described at the beginning of the interview: “healthcare professionals’ contribution to the care of individuals in order to optimize medicines use and improve health outcomes”. This description was derived from the Pharmaceutical Care Network Europe definition of 2013, taking into account the interprofessional aspect of PC, as recently (2020) acknowledged by the New Council of Europe resolution to promote pharmaceutical care in Europe .[references are added in the reference list]”

� In the discussion we have elaborated on our choice to start the interviews with the same definition of PC for all participants. We acknowledged the ‘multiple truths’ within our phenomenological approach and referred to the example of ‘medication monitoring’, which is differently conceptualized by nurses, physicians and pharmacists. Thank you for this reference.

� In our study, we were unable to explore any differences in how the concepts or themes were conceptualised by participants. Nevertheless, we described many ambiguous opinions on PC responsibilities and tasks, and participants elaborated on a broad range of subthemes that needed to be specified in order to define nurses’ role in PC.

Specific comments

- Consider changing the title to "Perspectives of nurses' roles in interprofessional pharmaceutical care across 14 European countries: a qualitative study in pharmacists, physicians and nurses"

� Thank you for this comment. We changed “Perspectives about nurses’ role” into “Perspectives of nurses’ role”.

- Line 184: consideration of reliability is made. Reliability is primarily a positivist concept, however a phenomenological paradigm was adopted. There appears to be an inherent paradigmatic contradiction apparent. Please review.

� We acknowledge that reliability, as a positivistic concept, was not the best choice of terminology. We have replaced “reliability” by “confirmability” and we also adjusted the citation. We cited Lincoln & Guba (1985), Tracy (2010) and Korstjens & Moser (2018) to support the use of ‘confirmability’.

- Line 513-515: please provide supporting evidence for these statements

� We have now cited the study of Wright, Scott, Buck, et al (2019).

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� We have carefully considered the formatting of the documents and the file naming to ensure that all PLOS ONE’s style requirements are met.

2. During our internal checks, the in-house editorial staff noted that you conducted research or obtained samples in another country. Please check the relevant national regulations and laws applying to foreign researchers and state whether you obtained the required permits and approvals. Please address this in your ethics statement in both the manuscript and submission information. In addition, please ensure that you have suitably acknowledged the contributions of any local collaborators involved in this work in your authorship list and/or Acknowledgements. Authorship criteria is based on the International Committee of Medical Journal Editors (ICMJE) Uniform Requirements for Manuscripts Submitted to Biomedical Journals - for further information please see here: https://journals.plos.org/plosone/s/authorship.

� First, the study protocol was approved by the Ethics Committee for Social Sciences and Humanities of the University of Antwerp. Then, the researchers in each of the participating countries checked the research ethics requirements in their own countries. Based on local regulations, additional approval was needed in the UK, Slovenia and Portugal. None of the other 10 countries requested additional ethical approval for this interview study.

� The three Research Ethics Committees are mentioned in the last section of the methods. We clarified that “national regulations and laws of the other countries didn’t require other permits or approvals.”

� No-one collected data outside their own country.

3. Please include a copy of the interview guide used in the study, in both the original language and English, as Supporting Information, or include a citation if it has been published previously.

� The English version of the interview guide is in the Supporting information ‘S1 Appendix’. This has now been augmented by the translations into all 12 other original languages: Dutch (Belgium and the Netherlands), Czech, German, Greek, Hungarian, Italian, Macedonian, Norwegian, Portuguese, Slovak, Slovenian and Spanish.

4. Thank you for stating the following in the Financial Disclosure section:

"The research was supported by the Erasmus+ Programme of the European Union [grant number 2018-1-BE02-KA203-046861] and MDMJ accountants, an accountancy service in Belgium that financially supported the Belgian authors (www.mdmj.be). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript."

We note that you received funding from a commercial source: MDMJ accountants.

Please provide an amended Competing Interests Statement that explicitly states this commercial funder, along with any other relevant declarations relating to employment, consultancy, patents, products in development, marketed products, etc.

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Please include your amended Competing Interests Statement within your cover letter. We will change the online submission form on your behalf.

� We have added an amended Competing Interest Statement, explicitly mentioning MDMJ accountants as a commercial funder of this study, and we have included the statement in our cover letter.

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� Ethical restrictions have been imposed on data sharing by the Ethics Committee for Social Sciences and Humanities of the University of Antwerp, the Medical Ethics Committee of the Republic of Slovenia and the UK NHS Research Ethics Committee that approved this study. The data contain potentially identifying and sensitive information. Also, investigators from the other countries confirmed that making these sensitive data publicly available without having requested the consent of the interviewees beforehand, is impossible for ethical and legal concerns.

1) UK data are stored at Swansea University, Swansea, UK. All proposals to view the data are subject to review by Swansea University’s Research Governance department and the PI. Before any data can be accessed, approval must be given.

The application process is via the Academic Lead for Research Integrity Research Engagement & Innovation Services, Swansea University and the PI or Neil Carter.

Contacts: Swansea University, Swansea SA2 8PP

Tel: +44 /0 1792 606060 and 518541 or 295610

Email: researchgovernance@swansea.ac.uk, s.e.jordan@swansea.ac.uk or n.carter@swansea.ac.uk

2) Data from the other 13 countries are stored at the University of Antwerp, Antwerp, Belgium.

All proposals to view the data are subject to review by University of Antwerp’s Research Governance department and the PI. Before any data can be accessed, approval must be given.

The application process is via the data protection officer, Antwerp University and the PI

Contacts: University of Antwerp, Prinsstraat 13, 2000 Antwerp, Belgium.

Email: privacy@uantwerpen.be, Tinne.Dilles@uantwerpen.be

� There are no restrictions on sharing the de-identified demographic data, which we have uploaded as a supplementary file.

6. We note that Figure 1 in your submission contain map images which may be copyrighted.

We require you to either (1) present written permission from the copyright holder to publish these figures specifically under the CC BY 4.0 license, or (2) remove the figures from your submission:

� Thank you for you comment. After careful consideration, we decided to remove the copyrighted map from Figure 1. The adjusted figure is added to this submission.

5. Review Comments to the Author

Reviewer #1:

1. The study centres on pharmaceutical care and the perceived actual or potential role that nurses play in this. Hepler and Strand's 1990 (page 4) definition is used to provide the context to this, yet, this definition could be considered both dated and limited in its scope. Is there a more recent definition that could be used?

� Thank you for this comment. In 2013, the Pharmaceutical Care Network Europe (PCNE) held an expert consensus meeting, during which a new European definition for Pharmaceutical Care was created, based on Hepler and Strand’s definition from 1990. Both definitions, however, were limited to the contribution of pharmacists. More recently, in March 2020, the New Council of Europe resolution to promote pharmaceutical care in Europe, broadened the definition and acknowledged the need for interprofessional collaboration in pharmaceutical care. In our revised manuscript, we have referred to this more recent definition, which is less limited in its scope. Based on the original definition of Hepler and Strand, the adjusted definition of PCNE and the extended definition of the New Council of Europe resolution, we have used the following definition of pharmaceutical care in the interviews, as well as in the manuscript: ‘healthcare professionals’ contribution to the care of individuals in order to optimize medicines use and improve health outcomes. (Hepler and Strand, 1990; Allemann, 2013; Council of Europe, 2020)

2. I am uncertain what the purpose of establishing a framework for nurses' roles in interprofessional pharmaceutical care is, and this is not explained in the manuscript. Perhaps, some background discussion of the benefits of this or why it is needed would be helpful.

� Thank you for this comment, which indicates that we didn’t sufficiently elaborate on the importance of the proposed framework. Because of the existing obfuscation of role boundaries, collaboration on different levels is hindered: quality of interprofessional communication and collaboration in daily clinical practice; transnational collaboration in research, education and innovation; and labour mobility of nurses. We want to investigate which responsibilities nurses are allowed to assume, and which responsibilities nurses are able to assume (legally or otherwise). In the introduction, we mentioned that ‘a framework for nurses’ ideal roles in interprofessional pharmaceutical care would facilitate discussions in clinical practice, education, research, international comparisons, policy-making and legislation.’ We added that 1) a framework would allow insights into current and potential roles and 2) this framework could be used to: develop an assessment to evaluate nurses’ competences in pharmaceutical care, guide evaluation of nurse education, support nurse educators, benchmark practice standards, and underpin nurses’ labour mobility.

3. It is stated that the study is part of the DeMoPhaC project, yet very little information is provided about this. For a reader who has not read previous reports of this project, some additional information would be useful.

� During this revision, we have elaborated on the overall DeMoPhaC project and its overall aim in the introduction: ‘The DeMoPhaC project is an international Erasmus+ collaboration to investigate nurses’ role in interprofessional pharmaceutical care in 14 countries. Within this project, several large-scale quantitative and qualitative studies are being undertaken with healthcare workers and nursing students. The overall aim of the project is the development of nursing curricula and final year nursing students’ competences in pharmaceutical care.’

4. It is clearly identified that a phenomenological case study design has been used as the study approach. Again, more detail of how this was applied as well as justification for its use is needed.

� Thank you. In the methods section we expanded on how and why a phenomenological approach was adopted, together with the appropriate references: “Phenomenology is well suited for exploring perspectives of healthcare professionals. This research approach was chosen as an appropriate way to describe the essence of the phenomenon “nurses’ role in interprofessional PC”, by exploring it from the perspective of those who have experienced it, namely pharmacists, physicians and nurses themselves. Interviewing this study population facilitates studying and understanding healthcare professionals’ lived experiences in interprofessional PC. Only by understanding their personal experiences and perceptions of nurses’ responsibilities and tasks, and interprofessional collaboration and communication, we will be able to provide detailed examination of the current strengths and weaknesses, together with the future opportunities and threats from nurses’ involvement in PC.” (Neubauer, 2019)

5. Fourteen (14) countries were included in the study. Despite all of these being in Europe, it cannot be assumed that the education and roles of the registered nurses in each of these countries is uniform. This needs to be discussed in light of both the findings and the discussion. Not doing this is a considerable weakness of the study.

� We acknowledge the importance of discussing the differences in education and roles of nurses throughout Europe. Before starting this study, we mapped the levels of nursing education in the participating countries. Despite theoretically comparable levels, the quality and the PC-related content could not be evaluated. In this study, the focus was on healthcare workers’ expectations of nurses in clinical practice. This should allow the needs of practice to be more closely aligned with nurse education. Future research within the DeMoPhaC project will address the differences in nurses’ roles within different levels of nurse education. Also, we elaborated on the importance of discussing the differences in education and roles of nurses throughout Europe in the discussion: “A systematic review of nurse education in Europe presented differences on both level and duration of education. Two thirds of all nursing education programs are offered at the higher education level, while one third is offered at diploma-level. The duration of full-time nursing education programs varies from two to four years, with the majority (58%) lasting for three years. Also, different education pathways lead to the same level of nursing qualification in some countries, and specialist qualifications are offered as both undergraduate and graduate degrees. Although the participants in this study raised the issue of the need for sufficient education before nurses could have a role in pharmaceutical care, experiences on the specific differences between the levels of education in each country were not addressed in the interviews. Only for nurse prescribing did some respondents formulate minimum conditions in terms of educational level. Further research investigating differences in nursing responsibilities between levels of nurse education can offer significant added value to the development of a framework for level-specific roles of nurses in interprofessional PC.”

6. Explanation of the recruitment process lacks detail. How were participants recruited and informed about the study, who provided this information and how?

� We have added the following explanation in the methods: “Representatives of professional associations for nurses, physicians and pharmacists and health care providers in different healthcare institutions were asked to identify key informants. Researchers contacted the persons, identified as potential participants, by email or telephone, informed them about the study, and about being named as a key informant on nurses’ role in interprofessional PC. If they agreed with being able to serve as a key informant, written information was provided to fully inform the potential participants about the study details.”

7. How was the sample size determined? It is stated that "We aimed for at least two interviews per profession (no.3) per healthcare setting". How was this number decided on? Was the issue of data saturation considered?

� This sample size was chosen in order to compile a sample with perspectives as diverse as possible. Therefore, as a part of ‘triangulation of sources’, we aimed for more than one interview per professional group in each of four main healthcare settings (hospital care, ambulatory community care, residential care and mental healthcare). We estimated that this sample size would lead to data saturation. We have added the sample size determination in the methods.

� Yes, the issue of data saturation was considered and reached in all countries. We have now mentioned this in the manuscript (methods).

8. Throughout the manuscript the phrase "nurses potential and/or ideal roles in pharmaceutical care" is used. It is unclear what is meant by these descriptors, which are very subjective and somewhat meaningless. Are the authors' referring to nurses "scope of practice" in pharmaceutical care?

� Thank you. In the revised manuscript we have clarified the meaning of “nurses’ potential or ideal roles”. We consider nurses’ scope of practice as the full range of roles, responsibilities and tasks that nurses are educated, competent and authorized to perform. Within this scope of practice we also want to look beyond the legal framework. This is a combination of nurses’ current scope of practice and the future/potential/ideal scope of practice. In clinical situations we cannot assume that current roles correspond with how all healthcare workers’ would like this role to be fulfilled. Our focus is on quality of care and how nurses could achieve the best patient outcomes. In a previous quantitative study, we described nurses’ current practices in pharmaceutical care; in this study we wanted to extend the current practice with the perspectives of healthcare workers about the ideal role of a nurse. (For example, nurse prescribing is legal in some countries. In other countries nurses do prescribe, without this being a part of their legal scope of practice. Therefore, nurse prescribing is part of the potential/ideal role of nurses in countries without a current legal framework or without other prerequisites to allow nurses to prescribe. (De Baetselier, et al. 2020))

� We have added 1) a description of ‘scope of practice’: Nurses’ scope of practice is considered as the full range of roles, responsibilities and tasks that nurses are educated, competent and authorized to perform (CMA, 2003; College of Licensed Practical Nurses of Alberta, 2003) and 2) the following sentence in the introduction (aim) of the revised manuscript: “By considering the ‘potential or ideal roles’, we aimed to investigate nurses’ responsibilities and tasks within – but also beyond – nurses’ current legal scope of practice, taking into account all necessary contextual factors.

9. I found a lack of clarity/ distinction between what is considered a role, responsibility or task, and there is clearly some overlap. For example" Providing patient education and information about medications could be considered all three. Consideration around choice of words is recommended.

� Thank you for pointing out this obfuscation. In the methods, we have added the following paragraph together with the appropriate references to the literature: “Responsibilities and tasks were defined based on the literature, together with discussions with an expert in health law, liability law and ethics and an expert in legal philosophy and ethics: ‘The role of nurses involves several responsibilities. A responsibility for nurses is an obligation that they have by virtue of their role as a nurse. Their central responsibility is to be the patient’s health advocate and to provide high quality care, using sound professional judgement and taking into account the relevant legal and moral considerations. The other responsibilities of nurses derive from this central responsibility. Nurses can be made to answer for failing in their responsibilities, which could result in disciplinary, civil, and criminal liability. Specific tasks may have to be performed in order to fulfill a responsibility.’” (Nursing and Midwifery Board of Ireland, 2015; Krautscheid, 2004)

10. The Discussion section is brief and limited. Some important points have been alluded to, however these have not been followed up/ explored with adequate discussion or links to the literature. For example: the very long sentence on page 23 (lines 494-499) states: "Most important pre-requisites were: sufficient education, knowledge (more pharmacology and pharmacotherapeutics), an interprofessional collaborative approach, confidence in nurse, an open blame- free culture with clarity of team composition and roles, equality between professionals, adjusted legislation, readiness of professionals and patients to allow nurses to have responsibilities in PC, and a manageable workload leaving "time to care". There are some very important issues that have been identified but not discussed or elucidated.

� Thank you. The various discussion elements, raised by the editor and both reviewers, were explored in greater depth, which allowed us to improve the content and the clarity of the discussion.

� The following changes were made: we linked literature to the different contextual factors that were extracted from the interviews; we elaborated on the differences in education and roles of nurses throughout Europe; we acknowledged the existence of ‘multiple truths’ within our phenomenological approach; we reflected on how the qualitative research quality criteria of credibility, transferability, dependability and confirmability were considered in our methods; and we transparently described the limitations of our study.

11. There are several minor grammatical and punctuation issues throughout that careful proof-reading may assist to identify.

� After the adjustments based on the remarks of the editor and reviewers, the manuscript was thoroughly reviewed by one of the co-authors (SJ), a native English speakers (SJ). Oxford grammar and Fowler’s reference was used.

12. Table 1 has some additional, misplaced numbers (211, 212, 213, 214) that need removal.

� The misplaced numbers are line numbers which have been automatically moved during the creation of the overall pdf in the submission system. In the original Microsoft Word file, these numbers are absent in the table.

Reviewer #2:

1. (lines 145, 454): The term interprofessional should be used rather than multidisciplinary. Multidisciplinary refers to activities performed by members of different academic disciplines. As previously defined, the term interprofessional should be used in this healthcare context. (see https://interprofessional.global/wp-content/uploads/2019/10/Guidance-on-Global-Interprofessional-Education-and-Collaborative-Practice-Research_Discussion-Paper_FINAL-WEB.pdf)

� Thank you for your comment and for sharing this reference. Indeed, we didn’t mean ‘multidisciplinary’ but ‘interprofessional’. We have adjusted this in the methods and the results.

2. (line 205) The text of the results section, reads that 43% of the participants were employed in hospital care and 24% of the participants were employed in community care, however, this is not consistent with the results in Table 1 in the Healthcare settings section (48.6% and 27.0%, respectively).

Also, regarding that same section (Healthcare settings) in Table 1, the n-values total 313 rather than at least 340 interviews. What is the reason for this number being less than the total interviews? Did some people not respond to the question? Why would it not be 340 or greater particularly given that many of these healthcare professionals may be employed in more than one healthcare setting?

� Thank you for identifying these inconsistencies. The numbers and corresponding percentages were not correct in both the text and the table and have been adjusted and double checked. Based on your comment, we have also checked the other numbers to be sure no errors or inconsistencies were reported. The total n for the variable ‘healthcare setting’ is indeed more than 340 (n= 352) and the total percentage 103.5% because of some respondents were employed in more than one setting.

3. (line 165-167) As interviews were conducted in the workplace or an alternative location, can you comment on participant body language, tone of voice, and/or other non-verbal cues that might be important indicators to the responses to the research questions?

� Field notes were made during the interviews and included in the transcripts. During the process of transcribing, critical reflection and coding, these notes were taken into account, but, without specific overall analysis of these non-verbal cues. We acknowledge this limitation and have added the following text to the discussion: “Another limitation is the absence of structured integration of the field notes that have been made during the process of transcribing, critical reflecting and coding. Therefore, we might have missed important non-verbal indicators, such as participants’ body language and tone of voice.”

4. Did you collect information about cultural and/or ethnic diversity of the study participants? Did you consider that some participants might identify with a gender other than male or female? Could either or both cultural/ethnic background or gender identity affect perspectives related to interprofessional collaboration in pharmaceutical care?

� We thought some participants might identify with a gender other than male or female. The answering options for ‘gender’ were: male, female, other. No respondents answered ‘other’. In the revised demographic table, we have added the category ‘other’ and indicated that no participants chose this option.

� It is true that either or both cultural/ethnic background or gender identity could have affected perspectives related to interprofessional collaboration. However, we didn’t ask cultural or ethnic diversity in the short demographic questionnaire before the interview. This might have been an added value in the interpretation of the answers. We have acknowledged this in the limitations of the study as follows: “Socio-cultural influences, mainly in terms of attitudes towards other professions might affect perspectives related to interprofessional collaboration, as was demonstrated in several studies.(Irajpour, 2015; Schwappach, 2016) In this research, no information was sought on cultural and/or ethnic identities of respondents. We wished to avoid sensitive questions and any possibility that respondents might be identified by local readers. Diversity should be taken into account in future research.

5. Limitations:

(line 518) As the interviews were conducted by nurses, this could be a limitation as this may have potentially affected the responses from physicians, pharmacists, and other nurses. This limitation should be mentioned in the limitations section of the paper.

� Thank you. By acknowledging this limitation in the discussion, we aimed to establish transparency. We have added the following paragraph to the discussion (limitations): “Researchers from all countries were trained in qualitative research, in-depth interviewing and ‘bracketing’ their own beliefs about nurses’ role in pharmaceutical care during a joint one-week training program. However, potential contextual intersecting relationships between the participants and the researchers cannot be ignored. As we wanted to avoid that the profession of the researchers would influence the responses from physicians, pharmacists, and other nurses, interviewers were asked not to inform interviewees about their profession if not questioned by the interviewee. By acknowledging this limitation in the discussion, we aimed to establish the transparency in our study.”

6. Overall, there are a few formatting errors such as in Table 1 the line numbers 211-214 are inside the cell.

Also, the writing could be further edited for clarity and conciseness for the reader.

� The misplaced numbers are line numbers which have been automatically moved during the creation of the overall pdf in the submission system. In the original Microsoft Word file, the numbers are absent.

� After the adjustments based on the remarks of the editor and reviewers, the manuscript was thoroughly reviewed by co-author Professor Susan Jordan, a native English speaker.

Attachment

Submitted filename: Response to Reviewers.docx

Decision Letter 1

Carl Richard Schneider

7 May 2021

Perspectives of nurses' role in interprofessional pharmaceutical care across 14 European countries: a qualitative study in pharmacists, physicians and nurses

PONE-D-20-36633R1

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Acceptance letter

Carl Richard Schneider

12 May 2021

PONE-D-20-36633R1

Perspectives of nurses’ role in interprofessional pharmaceutical care across 14 European countries: a qualitative study in pharmacists, physicians and nurses

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Associated Data

    This section collects any data citations, data availability statements, or supplementary materials included in this article.

    Supplementary Materials

    S1 Appendix. Interview guide of the interview study in 14 countries.

    English version and 12 translations.

    (PDF)

    S2 Appendix. Acknowledgements: List of interviewers, manuscript reviewers, people facilitating access to the field and other contributors.

    (PDF)

    S3 Appendix. Demographics database.

    (XLSX)

    S1 Table. Code book of the interview study.

    Codes S001 to S042 were the codes of the first code book, codes S043 to S049 were added to the final code book.

    (PDF)

    Attachment

    Submitted filename: Response to Reviewers.docx

    Data Availability Statement

    Ethical restrictions have been imposed on data sharing by the Ethics Committee for Social Sciences and Humanities of the University of Antwerp, the Medical Ethics Committee of the Republic of Slovenia and the UK NHS Research Ethics Committee that approved this study. The data contain potentially identifying and sensitive information. Also, investigators from the other countries confirmed that making these sensitive data publicly available without having requested the consent of the interviewees beforehand, is impossible for ethical and legal concerns. UK data are stored at Swansea University, Swansea, UK. All proposals to view the data are subject to review by Swansea University’s Research Governance department and the PI. Before any data can be accessed, approval must be given. The application process is via the Academic Lead for Research Integrity Research Engagement & Innovation Services, Swansea University and the PI or Neil Carter. Contacts: Swansea University, Swansea SA2 8PP Tel: +44 /0 1792 606060 and 518541 or 295610 Email: researchgovernance@swansea.ac.uk, s.e.jordan@swansea.ac.uk or n.carter@swansea.ac.uk Data from the other 13 countries are stored at the University of Antwerp, Antwerp, Belgium. All proposals to view the data are subject to review by University of Antwerp’s Research Governance department and the PI. Before any data can be accessed, approval must be given. The application process is via the data protection officer, Antwerp University and the PI. Contacts: University of Antwerp, Prinsstraat 13, 2000 Antwerp, Belgium. Email: privacy@uantwerpen.be, Tinne.Dilles@uantwerpen.be.


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