Observing expert opinion of medical affairs pharmaceutical physicians on the value of their clinical experience to the pharmaceutical industry using the Jandhyala method

Abstract

Background

The pharmaceutical industry requires a highly qualified workforce with diverse skillsets. Medical affairs pharmaceutical physicians (MAPPs) have unique qualifications among pharmaceutical company employees, but the exact contribution of their education and training is unknown. This study aimed to identify the medical education and training competencies MAPPs use in the pharmaceutical industry in relation to the four external stakeholders, regulators, payors, prescribers, and patients.

Method

Ten MAPPs were recruited using convenience sampling via professional networks. A systematic literature review and the Jandhyala method, a two-stage qualitative online consensus method, identified which of MAPPs’ medical education and training competencies they used in their work with each external stakeholder. Statistical analyses determined heterogeneity in the relevance of competencies and competency categories to each stakeholder.

Results

Nine MAPPs completed the study. Of the 59 competencies identified, 54 were relevant to all external stakeholders. Relevance of competencies varied significantly between external stakeholders (p = .0434). Binary competency scores varied significantly for three pairs of stakeholders, “patient vs. payor” (p = .025), “prescriber vs. regulator” (p = .013) and “prescriber vs. payor” (p = .008). Between-stakeholder overall frequency count varied significantly for two of the nine competency categories.

Conclusion

MAPPs develop a highly specialized set of competencies during medical education and training from which they use distinct subsets to meet the needs of external stakeholders in the pharmaceutical industry. Undergraduate and postgraduate competency-based medical education appears to prepare MAPPs for cognitive and technical work. Further exploration may aid understanding of how they develop soft skills.

PLAIN LANGUAGE SUMMARY

Medical affairs pharmaceutical physicians (MAPPs) are of key importance in promoting patient centricity in the pharmaceutical industry. Their competency-based medical education and clinical experience give them a unique skillset among pharmaceutical company employees. MAPPs utilize their training to benefit pharmaceutical companies as well as the four external stakeholders in medicine adoption: regulators, payors, prescribers and patients. Previous work has suggested that their education and training may account for their ability to benefit all external stakeholders; however, this has not been explored in detail. The aim of this study was to identify competencies MAPPs develop during medical education, training and clinical experience and which of these they use in their work with each of the four external stakeholders.

To do this, first, we reviewed the literature and asked MAPPs to self-report the competencies they developed during medical education and training, and which were relevant to their work with each of the four stakeholders. We found that 54 of the 59 identified competencies were relevant to work with all external stakeholders. However, the relevance of individual competencies varied between external stakeholders, with further analysis showing that the difference appeared to be accounted for by differences between three main pairs of stakeholders. These were “patient vs. payor”, “prescriber vs. regulator” and “prescriber vs. payor. In other words, MAPPs were likely to use different competencies in their work with each stakeholder. With our analysis of competency categories, we concluded that MAPPs use a highly specialized combination of competencies adapted to each external stakeholder.

Keywords:

• Medical education
• pharmaceutical industry
• clinical competency
• clinical skill
• medical specialty
• medical field training

Introduction

Relevance of medical affairs pharmaceutical physicians (MAPPs) to the pharmaceutical industry

In recent years, there has been growing emphasis on the need for a specially trained multi-professional workforce to address inefficiencies in medicines development and clinical research¹. The pharmaceutical industry requires a workforce with diverse skillsets due to its scientific-medical approach, which must deliver positive commercial as well as patient outcomes². Despite growing advocacy for a patient-centric approach, the pharmaceutical industry faces challenges in implementing patient-centred practices, including difficulties in navigating change from a disease-centred approach, which has been standard until recently³. Medical affairs pharmaceutical physicians (MAPPs) are uniquely qualified among internal stakeholders in the pharmaceutical industry⁴ and may be well-positioned to facilitate this shift, as their medical education and specialty training aims to prepare them for patient-centred practice in pharmaceutical medicine. Although their medical affairs practice covers functions and processes essential for successful medicine adoption⁵, there is a lack of recognition of this expertise and its relevance to pharmaceutical companies⁶.

Relevance of medical education and clinical experience to the pharmaceutical industry

Competency-based medical education has become the dominant approach in many medical schools worldwide since discourse began over fifty years ago⁷. Its aim is to prepare graduates with the skills necessary to meet the demands of their practice area and context, especially regarding patient and societal needs⁷. Patient-centricity is intrinsic to the core competencies of major medical regulatory boards, and competency in ethics and patient-centred care is integrated into accredited medical school curricula in their jurisdictions^8–11. Additionally, physicians practise medicine in a series of interactions characterized by privileged presence, which is the intangible experience of “being with” patients in times of extreme emotion elicited on the frontline of life and death¹². Privileged presence can only be experienced during clinical practice, as such interpersonal conditions cannot be simulated, and may help medical graduates develop moral attitudes that form the basis for lifelong ethical practice^13–15. Navigating privileged presence during healthcare delivery in the complex psychological and emotional landscape of vulnerability may help physicians develop empathy and enhance their care of patients but may elicit emotional distress and burnout^16,17. Physicians may experience moral distress when care requires them to violate their existing ethical framework, especially when they perceive themselves as being an agent of harm, even when a treatment strategy is in a patient’s best interests according to local and national protocols^18,19. They may also feel distress when experiencing ethical dilemmas and double binds, where feelings of powerlessness over outcomes involving patients at high risk of morbidity or mortality may coexist with negative feelings of power and culpability arising from being the one to break the bad news^18,20. Implementing coping strategies may help physicians manage distress arising from this emotionally challenging work^21,22.

MAPPs’ clinical experience in the pharmaceutical industry context

These experiences of emotional and ethical challenge and mastery are unique to physicians’ experiences of delivering medical care to patients in healthcare settings and create a vastly different occupational environment to the pharmaceutical industry. While MAPPs’ educational experiences may give them the requisite skills of self-reflective learning and continuous professional development to adapt to various work contexts^11,23, there are practical elements of transitions that cannot be learned through an educational curriculum. For example, physicians construct a professional identity through medical training and experience, and transitioning to work that conflicts with this identity may require a process of psychological adaptation^14,24,25. Additionally, the development of competence through decreasing levels of supervision towards being entrusted to practise unsupervised within predetermined technical and ethical standards aims to produce physicians who can safely and effectively assume accountability for patients’ lives^26,27. However, medical education and training cannot simulate the lived experience of making, for example, prescribing errors and the impact these may have on physicians’ understanding of the meaning of accountability in the context of practising rather than learning to practise medicine^28–30. On average, MAPPs have accrued 7 years of clinical experience before entering the pharmaceutical industry⁴, during which time, they appear to undergo a professional socialization process that adapts them to the organizational context³¹. These processes and experiences give MAPPs a unique skillset for work in the pharmaceutical industry that may enhance their value to companies while presenting emotional and psychological challenges during non-clinical practice that may need to be addressed.

Relevance of pharmaceutical medicine competencies to the pharmaceutical industry

As well as being the basis for undergraduate medical education and training for junior doctors, a competency-based approach for training has been proposed by the International Federation of Pharmaceutical Physicians and Pharmaceutical Medicine and others that has been implemented in specialty training curricula, where competencies may also be referred to as learning outcomes and capabilities in practice^1,32–35. Competency-based pharmaceutical medicine education requires MAPPs to demonstrate a range of business, scientific and healthcare competencies, putting ethics and patients at the forefront of practice across domains including healthcare, drug safety, the healthcare marketplace, medicines discovery, regulatory affairs, communication and management, drug development and clinical trials³². After qualifying, MAPPs apply this expertise to ensure that the needs of pharmaceutical companies are balanced with the needs of the four external stakeholders, regulators, payors, prescribers and patients^36–38. MAPPs are the only internal stakeholder in the pharmaceutical industry whose job activities, as a whole, satisfy the needs of all four external stakeholders³⁹, which are distinct³⁷, but it is not known what accounts for their ability to complete these job activities. Previous work has suggested that MAPPs’ education and training could account for this, as their education has been shown to distinguish them from other internal stakeholders⁴. The aim of this study was to investigate whether and how MAPPs’ education and training enables them to meet the demands of their practice area by determining the relevance of competencies developed during medical training to their work with external stakeholders in the pharmaceutical industry.

Methods

A literature review and consensus of expert opinion on competencies used by MAPPs in their work in the pharmaceutical industry were conducted.

Sample size

Sample size was determined by data saturation, the point at which there is no empirical merit of collecting further data from new participants. The failure of further data collection to add anything meaningful to results was operationally defined as no new items generated by a minimum of one participant; at this point, saturation was said to have been reached. Saturation was established via the recruitment procedure, which dictated that sample size increase until this condition was fulfilled. Data saturation was selected as an appropriate way to ensure data quality and adequate sample size, as this was in line with the methodological approach of Grounded Theory^40,41, which aligned with study objectives. Previous, conceptually similar applications of the Jandhyala method suggested that a sample size of nine to 12 is necessary to achieve exhaustive data capture, broadly in line with recommended numbers for expert panels in consensus studies⁴² and sufficient to generate enough data to meet the conditions of data saturation. The unit of analysis in this study was items generated by the consensus method, and each participant was required to contribute at least three. Sample size was in line with other qualitative studies using data saturation to determine exhaustiveness of data capture⁴³.

Participants and recruitment

A total of 10 MAPPs were recruited using convenience sampling via professional networks to participate in the MAPP evidence-generating programme. The programme comprised several research projects on the professional role of MAPPs in the pharmaceutical industry and was carried out over a period of time commencing in December 2020. All MAPPs recruited into the evidence-generating programme participated in this study. This project was carried out between February and May 2022. To be included, participants had to have a minimum of two years of medical affairs experience at a UK pharmaceutical company at the regional or global level. There was no geographic limitation for inclusion, but participants were located in the UK at the time of this study. Participants were informed that taking part in the study was voluntary, and written informed consent was obtained from all participants. Responses were anonymized, and consensus round list items were not identifiable as being contributed by particular participants. In accordance with international regulations, ethical approval for this study was granted by the King’s College London Research Ethics Committee (MRA-21/22-28431).

Relevance of MAPP competencies to each of the four external stakeholders

MAPPs were invited to complete a two-stage qualitative online survey to identify a list of key competencies obtained during medical training and experience that they felt were relevant to their work in the pharmaceutical industry using a consensus method known as the Jandhyala method⁴⁴. The Jandhyala method is a validated novel approach distinct from other consensus methods, such as Delphi and modified-Delphi, as it contains metrics at the awareness and consensus stages to quantify participants’ awareness of, and agreement with, each list item generated⁴⁵. It has been used to develop an instrument that measures the value of MAPPs’ work to the pharmaceutical industry as well as disease-specific construct measures^39,46,47. In Awareness Round 1, MAPPs were asked to provide at least three and up to 50 free text responses, each referring to one competency, in response to the following questions: What competencies gained from a MAPP’s previous clinical practice are most relevant to their role within the pharmaceutical industry? What are the specific situations MAPPs find themselves in where their actions are informed by these clinical competencies? For the second question, MAPPs were asked to list the situation and the action.

All responses in round one were thematically analyzed and assigned a unique item code by two research analysts, with discrepancies settled by an author. Participants’ survey responses received a score of 1 for each code they referred to. This was converted to an awareness score, which showed how aware participants were of each competency; low scores indicated high awareness. Competencies identified in the literature review were thematically coded, in the same manner as described above, and merged with the competencies suggested by MAPPs and duplicates were removed. In Consensus Round 2, aggregated coded responses were presented to MAPPs in an anonymized online survey. They were asked to rate their agreement with each item on a 5-point Likert scale from strongly agree to strongly disagree, and responses were converted into a consensus index. A high consensus index indicated high levels of agreement. Indicators that reached a consensus index of >50% (CI > =0.51) were retained in the list of competencies. In a final exercise, the final list of competencies was sent to MAPPs, and they were asked to indicate which they used when working on job activities that benefited each of the four external stakeholders: regulators, payors, prescribers and patients. If a competency was used by a MAPP in their work with a particular stakeholder, it was considered relevant to engagements with that stakeholder.

Statistical analysis

Frequency counts of competencies were calculated for all MAPPs for each external stakeholder. A Kruskal–Wallis rank sum test determined whether the summation of frequency counts of competencies for all MAPPs varied significantly between each of the four external stakeholders. A binary code was allocated to competencies where the use of a competency for a stakeholder equaled one and the non-use of a competency for a stakeholder equaled zero. A Wilcoxon signed rank test used the binary competency score for each MAPP to determine significant differences between pairs of stakeholders that could explain between-stakeholder variation in summed competency frequency count for all MAPPs. In other words, use of the binary competency score facilitated a finer grain analysis to determine what differences accounted for the overall difference in frequency counts between stakeholders.

Competencies were grouped into nine categories relevant to pharmaceutical industry practice. A Cochran’s Q test was used to determine whether the binary competency score for each MAPP varied significantly in relation to each of the four external stakeholders. A binomial regression was used to determine significant differences in frequency count for each competency, using “a non-judgemental attitude” as the reference category for significance, whereby a significant difference indicated that a competency was irrelevant. All analyses were conducted using R software version number 4.0.2, and p ≤ .05 was significant for all tests apart from the binomial regression, which was p < .10.

Results

List of competencies generated

In total, MAPPs generated 51 unique competencies (Table 1). The literature review identified eight items (Items 7, 15, 23, 32, 44 and 57–59), giving a total of 59 competencies generated in Awareness Round 1. For competencies suggested by MAPPs, awareness indices ranged from 0.06 (Items 4, 8, 12, 13, 20, 21, 25–27, 34–36, 40–43, 45, 46 and 53–55) to 1.00 (Items 9 and 16), which all participants mentioned in Awareness Round 1. Only three other items had awareness indices of more than 0.5, including Items 11 (0.78), 19 (0.78) and 56 (0.67). In Consensus Round 2, all items apart from Items 2 (0.78), 6 (0.89), 13 (0.89), 15 (0.56), 16 (0.89), 23 (0.89), 27 (0.89) and 53 (0.89) received unanimous agreement for inclusion in the list of competencies. Therefore, since all items generated in Awareness Round 1 met the threshold for inclusion in the final definition. All MAPPs apart from Participant 6 provided unique items in Awareness Round 1 (Figure 1). Therefore, data saturation, defined as the point at which no further unique items were generated, was reached by a total of nine participants after 10 had provided responses.

Figure 1. Data saturation. Unique competencies (%) suggested by order of participant entry into the study (bars). Cumulative saturation (%) in order of descending unique responses.

Table 1. Unique competencies generated by MAPPs with awareness and consensus scores.

Item	Statements	A	C
Item 1	Takes a full history from a patient	3	1
Item 2	Performs a full clinical examination	3	2
Item 3	Applies clinical pharmacology and therapeutics to safe prescribing of medicines	3	1
Item 4	Follows hospital guidelines for patient management	4	1
Item 5	Diagnoses medical conditions	3	1
Item 6	Executes medical and surgical procedures	3	2
Item 7	Promotes health and illness prevention	5	1
Item 8	Prioritizes tasks on clinical urgency	4	1
Item 9	Applies medical knowledge and theory to clinical decision making	1	1
Item 10	Able to empathize with patients	3	1
Item 11	Works within a multidisciplinary team	2	1
Item 12	Understands the principles of and need for quality and safety improvement	4	1
Item 13	Manages a clinical emergency	4	2
Item 14	Maintains high standards in documentation and record keeping	3	1
Item 15	Infection control	5	2
Item 16	Develops and maintains a doctor-patient relationship	1	2
Item 17	Delivers bad news appropriately	3	1
Item 18	Manages complaints and clinical errors	3	1
Item 19	Communicates clearly with colleagues	2	1
Item 20	Communicates clinical information to others in a clear and concise manner	4	1
Item 21	Protects patients’ interests at all times	4	1
Item 22	Applies the principles of medical ethics to clinical practice and research	3	1
Item 23	Respects doctor-patient confidentiality	5	2
Item 24	Obtains valid informed consent from a patient when necessary	3	1
Item 25	Understands the legal framework for medical practice	4	1
Item 26	Develops evidence-based guidelines for patient management	4	1
Item 27	Conducts an audit of service delivery	4	2
Item 28	Engages in teaching and training of staff and students	3	1
Item 29	Maintains disease-specific knowledge	3	1
Item 30	Publishes in peer-reviewed journals	3	1
Item 31	Maintains medical and surgical knowledge	3	1
Item 32	Leadership	5	1
Item 33	Resilience	3	1
Item 34	Emotional intelligence	4	1
Item 35	Attention to detail	4	1
Item 36	Professionalism	4	1
Item 37	Effective stress-management	3	1
Item 38	Curiosity and seeking self-improvement	3	1
Item 39	Empathy	3	1
Item 40	A non-judgemental attitude	4	1
Item 41	Accountable	4	1
Item 42	Respectful	4	1
Item 43	Humble	4	1
Item 44	Reflection on personal behaviour and its impact on others	5	1
Item 45	Understands the healthcare system structure and the management thereof	4	1
Item 46	Understands budget management	4	1
Item 47	Manages time efficiently	3	1
Item 48	Able to mitigate risk	3	1
Item 49	Can manage a crisis situation	3	1
Item 50	Displays leadership through staff interaction and teaching	3	1
Item 51	Understands the needs of healthcare professionals	3	1
Item 52	Able to formulate a management plan	3	1
Item 53	Understands reimbursement procedures	4	2
Item 54	Has a knowledge of patient pathways in therapeutic area	4	1
Item 55	Has an understanding of the health service and healthcare systems in the four countries	4	1
Item 56	Understands the results of clinical research and is able to apply them	2	1
Item 57	Applying biomedical scientific principles	5	1
Item 58	Applying psychological principles	5	1
Item 59	Applying social science principles	5	1

Abbreviations. A, Awareness score; C, Consensus score.

Overall relevance of competencies to each of the four external stakeholders

The Kruskal–Wallis rank sum test showed that overall, the number of competencies used for each external stakeholder was significantly different (p = .0434). The Wilcoxon signed rank test showed that the binary competency scores of each MAPP were significantly different for three of the pairs of stakeholders, “patient vs. payor” (p = .025), “prescriber vs. regulator” (p = .013) and “prescriber vs. payor” (p = .008), which drove the overall heterogeneity between stakeholders (Table 2).

Table 2. Wilcoxon Signed rank test for summation of binary scores from all participants compared between stakeholders.

Paired stakeholders	p-Value
Patient vs. regulator	.075
Patient vs. prescriber	.107
Patient vs. payor	.025
Prescriber vs. regulator	.013
Prescriber vs. payor	.008
Payor vs. regulator	.672

Bold values are those that met the threshold for statistical significance.

Relevance of competency categories to each of the four external stakeholders

Of the nine categories of competencies identified as relevant to the pharmaceutical industry, only two (“personal attributes” and “leadership”) were significantly different between stakeholders in terms of their overall frequency count (Table 3). Therefore, seven of the nine were relevant to all stakeholders.

Table 3. Difference in relevance of competency categories.

Categories	KW Chi-Sq	df1	p-Value
Basic clinical competencies	5.102	3	.165
Integrated clinical practice and patient safety	4.545	3	.208
Communication	1.609	3	.657
Legal and ethical aspects of care	4.345	3	.227
Standards of care and education	3.189	3	.363
Personal attributes	13.608	3	.003
Management and leadership	9.940	3	.019
Health economics	6.079	3	.108
Professional knowledge	3.501	3	.321

Bold values are those that met the threshold for statistical significance.

Differences in relevance of individual competencies to external stakeholders

The Cochran’s Q test showed that across all MAPPs, there were different levels of agreement regarding the relevance of each of the 59 individual competencies between the patient, regulator and payor stakeholders but not the prescriber (Table 4).

Table 4. Cochran’s Q test for binary responses in 59 competency categories among all MAPPs.

	N	Statistic	Df	p-Value
Patient	9	82.4	58	.0194
Regulator	9	157	58	4.18E-11
Prescriber	9	52	58	.698
Payor	9	162	58	9.91E-12

Bold values are those that met the threshold for statistical significance.

Irrelevant competencies

Only five competencies were identified by MAPPs as irrelevant to some stakeholders (Figure 2). One was irrelevant to patients (“publishes in peer-reviewed journals”, p = .066); two to regulators (“performs a full clinical examination”, p = .666 and “delivers bad news appropriately”, p = .028) and four to payors (“infection control”, “delivers bad news appropriately”, “performs a full clinical examination” and “takes a full history from a patient”, p = .027). Overall, 54 of the 59 competencies identified were relevant to all stakeholders.

Figure 2. Competency indices with respect to stakeholders. Stakeholders are highlighted in black on the plot and * on the x axis.

Discussion

MAPPs have specialist education, training and experience in pharmaceutical medicine that aims to help them meet the contextual demands of the pharmaceutical industry, which centre around meeting the needs of four external stakeholders: regulators, payors, prescribers and patients. While MAPPs are of unique value to the pharmaceutical industry due to their accountability for activities that benefit all external stakeholders, their expertise is not well-recognized, and it is not known whether and how the competencies developed during their medical careers are relevant to pharmaceutical company activities. In this study, MAPPs reported using a highly specialized set of 59 competencies adapted to the needs of different stakeholders, as shown by the significant difference in the relevance of competencies between them. Of the 59 competencies, 54 were rated by all MAPPs as relevant to all stakeholders, and of the nine categories, MAPPs rated seven as relevant to all stakeholders. Additionally, MAPPs rated individual competencies as being of different relevance to different stakeholders.

The number of competencies and categories identified were largely in line with previous research that identified 60 pharmaceutical medicine competencies across seven categories³². Competencies identified here extended the work of the International Federation of Associations of Pharmaceutical Physicians (IFAPP) and PharmaTrain, who proposed only cognitive aspects of competencies needed for pharmaceutical medicine practice as identified by expert educators and other key stakeholders in medical training and education³². In contrast, this study identified the skills, behaviours and qualities MAPPs reported using in their day-to-day practice. Although most of the concepts and domains are common to both sets of competencies, their respective focus on theoretical and practice aspects of pharmaceutical medicine accounts for variation in their organization, with the list here forming a skills framework rather than a proposed curriculum. Despite this, most competencies were identifiable in the Faculty of Pharmaceutical Medicine’s list of capabilities in practice, which comprise the standards that must be met by pharmaceutical medicine trainees at the end of their training³⁵. MAPPs identified some competencies, such as “takes a full history from patients”, “works within a multidisciplinary team” and “manages a clinical emergency”, that were common to the General Medical Council’s outcomes for graduates¹¹. MAPPs agreed almost unanimously that competencies identified by MAPPs and the literature review were salient to their work in the pharmaceutical industry. This suggested that MAPPs were using competencies developed during their undergraduate and postgraduate training in their work with external stakeholders in the pharmaceutical industry.

Some competencies reported by MAPPs were not mentioned explicitly in published training standards but were implicit in representing personal qualities required to execute competencies successfully, such as “empathy”, “humble”, “emotional intelligence” and “resilience”. This was in line with previous findings that physicians develop interpersonal competencies to navigate the emotionally complex life and death situations that arise during medical care that cannot be taught as part of an educational curriculum^12,15. Findings here have shown for the first time that MAPPs use these competencies in the non-clinical environment of the pharmaceutical industry despite the identity conflict this may cause²⁵. The use of these competencies during clinical care may result in moral and emotional distress, and further work is needed to determine whether this distress is experienced by MAPPs when using these competencies in the pharmaceutical industry. Interventions have been shown to be effective in helping physicians manage such distress to prevent burnout^21,22, and research is needed to determine whether such interventions could be needed in non-clinical contexts and if so, how effective interventions for MAPPs could be created.

MAPPs reported using a highly specialized set of competencies adapted to the needs of different stakeholders, as shown by the significant difference in the relevance of competencies between “patient vs payor” (p = .025), “prescriber vs regulator” (p = .013) and “prescriber vs. payor” (p = .008), which drove the overall heterogeneity between stakeholders (Table 4). This supported previous work suggesting the distinctiveness of these stakeholders with regards to their needs³⁷. The difference in competencies between these stakeholders can be explained by the variation between them and confirmed the higher level of homogeneity between patients and regulators found by previous work³⁷. Heterogeneity between prescriber and regulator/payor could reflect variation in how engagements between MAPPs and these external stakeholders tend to occur. Work with prescribers is conducted during meetings with key opinion leaders, attending and presenting at conferences and designing and conducting medico-marketing sessions^48,49. In contrast, work with regulators and payors is less likely to draw on interpersonal and communication competencies, as it is conducted by preparing dossiers and participating in defined decision-making processes governed by the bodies. This is supported by the fact that of all nine competency categories, the two that varied were personal attributes and management and leadership.

Heterogeneity between patient and payor can be explained by a varying focus on patient-centricity; work with payors focuses on cost-benefit calculation to protect the interests of the health economy, while work with patients, regulators and prescribers tends to share a focus on protecting the interests of the patient^50,51. MAPPs’ undergraduate and postgraduate medical education involves explicit training in the healthcare marketplace, reimbursement, regulatory affairs and the development of psychological and interpersonal skills needed to communicate effectively about medicines and drug development within the ethical context of protecting patients’ interests^8–11,32,35. As shown, this provides them with a bank of highly specialized competencies they use in various combinations according to the dynamic context of their work in the pharmaceutical industry and the varied demands of external stakeholders. Some disagreement was present between MAPPs regarding the relevance of each competency to external stakeholders, which explains why overall, all competencies were relevant to all stakeholders. The only external stakeholder for which there was no variation in the relevance of individual competencies between MAPPs was the prescriber, which may be because MAPPs have trained and practised as prescribing physicians.

Limitations and future work

Some limitations of this study include the small sample size. However, given the agreement of the findings with previous work and the fact that data saturation was reached, the data can be considered valid. While MAPPs were English speaking, and the majority were based in the UK at the time of study, they were responsible for MAPP professional practice across a range of global territories. Additionally, competency-based medical education is delivered in many if not most regions worldwide, and phenomena such as privileged presence are not limited by geographical location, although they may be conceptualized differently by different researchers and practitioners. IFAPP is an international body, and while some regions have less well-developed curricula, their framework for education and training has been implemented in Japan, Australia, Switzerland, Hungary, Italy, and the UK among others. It may be interesting to conduct further study of MAPPs in countries where pharmaceutical medicine curricula are less well developed.

Additionally, while beyond the scope of this study, it may be interesting to determine a ranking of competencies with regards to their importance during pharmaceutical medicine practice. Selection of the most important competencies for inclusion in a basic curriculum could promote a standardized, foundational level of competency across global regions with varying capacities for pharmaceutical medicine training. Additionally, further work could consider the perspectives of the cross-functional team on competencies useful for MAPPs.

Further exploration of MAPPs’ experiences of working in the pharmaceutical industry may be helpful in determining whether their use of clinical interpersonal competencies in a non-clinical environment is associated with work-related distress. Qualitative investigation of MAPPs’ identity negotiations, competency development and professional socialization processes may aid the development of interventions to promote coping and prevent burnout. A better understanding of how physicians develop empathy and other interpersonal competencies that can only be learned during clinical practice may contribute towards the development of practices to support this type of learning in newly qualified MAPPs and medical students and facilitate progression to specialty training, which some students may avoid due to negative experiences during their core medical training⁵².

Conclusions

MAPPs reported using a highly specialized set of competencies adapted to the distinct needs of external stakeholders in the pharmaceutical industry. Their medical education and unique clinical experience appear to explain their ability to be accountable for activities that benefit all external stakeholders, especially patients. Competencies identified suggested that undergraduate and postgraduate competency-based medical education successfully prepared MAPPs for their work in the pharmaceutical industry in terms of cognitive and technical capabilities. Further qualitative exploration of MAPPs’ clinical and non-clinical experience may be useful in understanding how they develop the soft skills needed to execute cognitive and technical tasks successfully and to develop strategies to help them navigate identity conflict in the pharmaceutical industry.

Transparency

Author contributions

RJ conducted the study and developed and approved the manuscript. RR developed and approved the manuscript. The authors affirm that the manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted, and any discrepancies from the study as planned (and, if relevant, registered) have been explained.

Ethical approval

In accordance with international regulations and the Declaration of Helsinki, ethical approval was sought and obtained from King’s College London Research Ethics Committee (MRA-21/22-28431).

Acknowledgements

The authors would like to thank the MAPP advisory board – John Bolodeoku, Phillip Cruz, Arun Mistry, Lisa Moore-Ramdin, Pundalik Nayak, Jan Sabbat, Guy Yeoman and Maciej Zatonski - for participating in the study. Additionally, gratitude is extended to Omolade Femi-Ajao for study management, Mohammed Kabiri for data analytics and Lauri Naylor for medical writing.

Declaration of funding

The authors received no funding for this work.

Declaration of financial/other relationships

Dr. Ravi Jandhyala is a visiting senior lecturer at the Centre for Pharmaceutical Medicine Research at King’s College London and is responsible for research into real-world evidence approaches. He is also the founder and CEO of Medialis Ltd, a medical affairs consultancy and contract research organization involved in the design and delivery of real-world evidence in the pharmaceutical industry. Dr. Raj Rout is the Executive Director, Global Medical Affairs at Vertex Pharmaceuticals. No conflict of interest has been registered from either author.

A reviewer on this manuscript has disclosed that they are the Medical Director CEE of Medison and is an owner of Alcon shares. Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Data availability statement

The data that support the findings of this study are available from the corresponding author, RJ, upon reasonable request.