Development and Validation of the Medical Affairs Pharmaceutical Physician Value (MAPPval) Instrument

The current lack of a measure for MAPP performance in the pharmaceutical industry as well as their potential undervaluation in the pharmaceutical industry and vulnerability to role replacement (Jandhyala R, MBBS, unpublished data, 2020) necessitated the development and validation of the MAPPval instrument. While MAPPs have been recognized as playing an important role in the pharmaceutical industry in terms of ensuring the predominance of scientific integrity over commercial interests and the transition of drugs from R&D to commercial [25, 26], their role and value have not been formally characterized. Conceptualizing and operationalizing a new construct such as the MAPPval requires careful selection of indicators to ensure complete accuracy. Neutral theory describes the need for the generation of an exhaustive list of relevant indicators, being careful to exclude any irrelevant information from its observation [27, Jandhyala (2020, unpublished data)]. Neutral theory has been successfully operationalized using the Jandhyala method in the development of similar instruments for the measurement of disease-specific quality of life [23] and disease severity of a rare disease [24]. The MAPPval instrument was generated by the consensus of 10 MAPPs with at least 2 years of experience in UK pharmaceutical companies and contained 22 unique indicators of MAPP value to pharmaceutical companies. The discriminant validity of the MAPPval instrument was shown in a retrospective study by answering the following research questions. (1) Is the MAPP the only internal stakeholder who has been classified as accountable for at least one activity benefiting each of the four external stakeholders? (2) Has the MAPP been classified as accountable for activities benefiting significantly more external stakeholders than each of the other internal stakeholders? (3) Is the number of times the MAPP has been classified as ‘consulted about’, ‘responsible for’ or ‘informed about’ significantly greater than each of the other internal stakeholders?

First, the MAPP was the only internal stakeholder classified as accountable for at least one activity involving each of the four external stakeholders. MAPPs partner with pharmacists, access providers, diagnostic groups, insurance providers, patients and patient advocacy groups, technology companies, and entrepreneurs, as well as the general community, to enhance patient-centric healthcare [28]. Thus, influencing external stakeholders through their job activities is key to their role, which was reflected in the findings of this study. Medicine adoption, the ultimate goal of pharmaceutical companies, requires successful engagements with the four stakeholders (regulators, payors, prescribers, and patients) [29, 30], therefore MAPPs can be seen as having unique value to pharmaceutical companies as the only internal stakeholder accountable for activities engaging with all four stakeholders. As employee performance has been defined as ‘the behaviors and actions that support organizational goals’ [31], the MAPPval instrument can also be said to accurately reflect the performance of MAPPs in this respect. MAPPs play a critical role in guaranteeing that key messages are informed by sound scientific evidence and no disingenuous assertions are made [32], which explains their high level of accountability for pharmaceutical company activities. MAPPs also design and implement RWE to answer questions unanswered by registered clinical trials [33, 34], therefore their value is not only in their ability to influence successful medicine adoption but to do so in many different ways. Thus, the findings of this study suggested that MAPPs were of key value to pharmaceutical company success and they were the only internal stakeholder of those studied able to deliver this value.

Second, MAPPs were classified as accountable for activities targeting significantly more external stakeholders than other internal stakeholders, even when their activities did not influence all four external stakeholders. Observations within this study suggested some variation between MAPPs regarding the overall degree of accountability they held, which may explain why some MAPPs were accountable only for activities that influenced fewer than all four stakeholders. This may have been driven by variation between the scope of MAPP job roles, for example if a regulatory affairs role was being fulfilled by a pharmaceutical physician or if the MAPP reported into a more senior MAPP in the organization, who carried the accountability for certain activities. These MAPPs were observed to be accountable for activities that targeted three and two external stakeholders, respectively. Despite this, the comparative value of the MAPP function in terms of its influence of external stakeholders was higher than that of other internal stakeholders to a statistically significant degree (Fig. 1). Additionally, the findings of this study reflected the role responsibilities of stakeholders other than MAPPs. Commercial stakeholders were the most ‘consulted’ (30.13%) and ‘informed about’ (37.12%) activities, and, apart from MAPPs, the least ‘not informed’ (17.4%) about activities. This reflected the nature of their role within pharmaceutical companies, as commercial departments are almost exclusively led by program facilitators who must meet commercial targets by coordinating projects involving many different internal stakeholders. Patient advocacy was ‘not involved in’ most (66.81%) activities. This was expected, as this role is emergent and currently has a narrow scope. The patient is the ultimate beneficiary of pharmaceutical company activities and there is an ever-increasing emphasis on their inclusion as a stakeholder, therefore patient advocacy may become more involved in activities over time.

Third, MAPPs were classified as ‘consulted about’, ‘responsible for’, or ‘informed about’ fewer times than other internal stakeholders. This was because the MAPP was almost always classified as accountable for activities in which they were involved. Of the total 229 activities performed, MAPPs were classified as accountable for 187 (81.7%). Consequently, they showed value at every level: accountable, consulted, responsible, and informed, as described in Table 6. The MAPP has traditionally been considered a role that supports other stakeholders within pharmaceutical companies [2]; however, the results of this study were more in line with the idea that MAPPs lead the pharmaceutical company activities that influence external stakeholders and are supported in these activities by other stakeholders [2]. For regulatory affairs, market access, and commercial stakeholders, this support was in the form of consulting on 31.88%, 30.57%, and 30.13% of activities, respectively (Table 6). Additionally, internal stakeholders were classified as not involved in a fairly large proportion of MAPP job activities: regulatory affairs (51.53%), market access (40.61%), commercial (17.47%), and patient advocacy (66.81%). The relatively narrow scope of the role of these internal stakeholders in comparison with MAPPs was reflected by the fact that they were classified as accountable for activities that only generally benefited one or two external stakeholders, while half the MAPPs were accountable for at least one activity that benefited all four external stakeholders. The centrality of the four external stakeholders to pharmaceutical company success supports the unique value of MAPPs in terms of their sole accountability for activities that benefit a higher number of stakeholders than regulatory affairs, market access, commercial, and patient advocacy.

Outlook and Future Work

The MAPPval instrument can be used to measure MAPP performance within pharmaceutical companies to assess and enhance the development of MAPPs and demonstrate their value as well as providing a benchmark against which to standardize and develop the utility of MAPPs to stakeholders in the pharmaceutical industry in the UK. Work performance measures are commonly used in performance management and organizational decision-making [35], and the MAPPval instrument could be applied to these purposes. It may be useful to explore the construct validity of the measure with a larger sample of MAPPs and to adapt the measure to other geographical contexts, especially those in which the development of the MAPP role within pharmaceutical companies may enhance industry practices and accountability. This tool has demonstrated the need to view MAPPs as valuable and unique members of the multidisciplinary team within pharmaceutical companies, especially in terms of their accountability for vital activities that benefit all external stakeholders.

Study Limitations

The study was limited, as it considered the MAPP role and pharmaceutical company activities only from the MAPP’s perspective. Thus, the focus was on intrinsic rather than extrinsic value. While this limits the scope of the measure to applications that utilize measures of intrinsic value, it does not necessarily affect its validity, and intrinsic measures are commonly used in work performance measurement [35]. Furthermore, MAPPs fulfil a regulatory role within pharmaceutical companies in respect of engagements with external stakeholders, therefore they are likely to be involved in virtually all pharmaceutical company activities involving external stakeholders. As pharmaceutical company success is dependent on successful engagements with external stakeholders, it can be argued that the scale is valid in this respect. Further research could develop the measure to include extrinsic parameters, widening its potential application. Additionally, it was possible that the retrospective study was subject to recall bias, which may lead to between-participant variation in quality and quantity of data. However, all MAPPs who completed the retrospective study participated in the first phase of the study, which involved a Consensus Round that standardized awareness of MAPP professional activities between participants, mitigating this concern to some extent. Additionally, while all participants had at least 2 years of experience within a UK pharmaceutical company at a regional or global level, detailed information on their career stage was not collected, and this may have influenced the scope of their role and their perceptions of it. Finally, the study was conducted in a UK context, therefore the results cannot be said to be generalizable to other countries, which may vary in terms of pharmaceutical company engagement with external stakeholders and professional regulation of MAPPs.

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