The specialized competency framework for industry pharmacists (SCF-IP): validation and pilot assessment

Abstract

Objectives

This study aimed to validate a specialized competency framework for industry pharmacists and assess correlates related to the competency domains in a pilot sample.

Methods

A team of experts assessed the old framework and improved its content validity after a thorough literature review, using the Delphi technique. Domains and their respective competencies and behaviors were re-defined in the framework. Afterward, a web-based cross-sectional study was carried out between March and October 2022, enrolling a convenient sample of ten industry pharmacists who worked in Lebanese pharmaceutical plants. Participants were contacted through the Syndicate of the Pharmaceutical Industries in Lebanon.

Results

The specialized competency framework for Lebanese industry pharmacists comprised seven domains. Behavioral items had appropriate loading on their respective factors, which could involve one, two or three competencies. Cronbach alpha values for all domains were close to one, showing appropriate reliability. Each domain was correlated with at least another one, except for domains related to pharmaceutical and industrial development and emergency preparedness, which were not correlated with other domains. The lowest confidence was found in the research and development domain, particularly among participants with only a PharmD.

Conclusions

This study validated the specialized competency framework for Lebanese industry pharmacists. Some domains, specifically those related to industrial development and emergency preparedness, were found to diverge from others. Therefore, it would be recommended to include additional education in the emergency preparedness, research and development fields and to integrate industry-specific skills, courses, and training programs into academic curricula. Furthermore, specialized postgraduate degrees may be necessary to produce practice-ready pharmacists to operate effectively in this vital setting.

Introduction

Professional competence definition has long been debated. However, a stable concept is that a set of skills, including knowledge, abilities, and behaviors, indicates a specific competency that leads to better performance in a particular career. Competency-based education is currently trending as it allows universities to produce practice-ready professionals. The competency-based model is thus a widely used approach for defining professional effectiveness at individual and organizational levels [1].

Pharmacy competencies often comprise pharmaceutical knowledge, leadership/managerial aspects, and professional/functional skills [2]. Developing one competency framework that suits all countries is hard to achieve due to cross-cultural, educational, historical, and perceptional differences of the pharmacy profession [3, 4]. Therefore, the International Pharmaceutical Federation (FIP) released the Global Competency Framework, which comprises a generic set of behavioral abilities that could be relevant for the pharmacy workforce globally [2]. This framework does not suggest that there should be a single global curriculum that applies to all nations. It was established as a global mapping tool; it is updated as the career develops and may be customized to meet regional or national needs.

Worldwide, several countries are working to strengthen the competencies of their pharmacists to serve some specific employment tasks [5,6,7,8,9]. The differences between work settings suggest the need for different sets of competencies related to each specialty [10, 11], thus the need for specialized competency frameworks addressing all pharmacy specialties, particularly industry pharmacists. Indeed, industry pharmacists work in different areas, including research and development, sales and marketing, corporate administration, all phases of clinical trials research, drug information, manufacturing, regulatory affairs, health policy, and quality control [12].

In high-income nations, competency-based developmental frameworks are becoming more popular in industrial careers and are widely used to create requirements for training, education, and career advancement [3, 4, 13, 14]. These frameworks include an organized collection of behavioral abilities that can assist practitioner growth and enable efficient and long-lasting performance. In Japan, industry pharmacists agreed on the importance of activities related to their profession, particularly pharmacovigilance, risk–benefit analysis, regulatory affairs and strategy, and electronic document management. They also reported the necessity of having an understanding of economics, management, finance, process analysis, interpersonal and customer service capabilities, the requirements for project management and finance, intellectual property rights, and the need for specialization in different industrial roles [3]. In addition to having the necessary technical competencies, the ideal industry pharmacist should also be able to manage international projects, be familiar with global registration requirements, and comprehend the drug development processes [3]. Moreover, industry pharmacists may transition into various specialized fields of employment in the pharmaceutical and related sectors throughout their careers. Several competencies, including managerial, leadership, analytical and communication abilities, knowledge of health policies, and economics, are required in addition to their technical expertise [15].

In developing countries, the landscape of pharmacy practice often differs from that of developed nations. While some developing countries have made efforts to develop core competency frameworks for pharmacists, there has been a limited focus on developing specialized frameworks specifically tailored for professionals working in pharmaceutical manufacturing [16, 17]. In general, core competency frameworks for pharmacists may touch upon some aspects of pharmaceutical manufacturing, but they often do not provide an in-depth and specialized framework tailored to the unique requirements of professionals working in this field [18]. This oversight can be attributed to a stronger emphasis on patient-centered care, resource limitations, regulatory challenges, and the need for industry-specific expertise. Nevertheless, recognizing the importance of this area, some countries have made efforts to address this gap through targeted initiatives and collaborations that cater specifically to professionals working in pharmaceutical manufacturing settings [19, 20].

In Lebanon, the mismatch between educational curricula and the job market needs is unequivocal in all professional sectors, including industrial pharmacy. A specialized competency framework adapted to the local context was previously suggested by the Order of Pharmacists of Lebanon (OPL, the official pharmacists’ association) [21]. It comprised five domains (research and development, pharmaceutical and industrial development, analytical development, industrial pharmaceutical production, and quality management that encompassed quality assurance and control), structured into several competencies and related behaviors. This competency framework was previously developed based on relevant international literature, information from a nationwide survey, and the different roles of industry pharmacy experts in Lebanon [21].

This framework has not been validated or piloted, although it would help bridge the gap between traditional pharmacy education and the constantly evolving needs of the pharmaceutical industry [22]. It would also inform the creation of competency-based curricula by adding specialized tracks, offering opportunities for career planning, and adapting postgraduate studies accordingly [23]. Despite some universities offering degrees related to industrial pharmacy, few pharmacists choose to enroll in these majors [24]; also, these programs need to be honed after consultation with the local industry to produce practice-ready industry pharmacy graduates [22, 25]. Given the socioeconomic crisis, the deterioration of the healthcare system, and the skyrocketing prices of imported medications in Lebanon, cost-effective medications should be procured from local pharmaceutical manufacturers. In this context, it was anticipated that industry pharmacists would face high pressures to meet the local market needs. Consequently, the growth of the Lebanese pharmaceutical manufacturing sector is needed now more than ever. Hence, assessing the competencies of industry pharmacists is essential to bridge the gap between theoretical courses and industrial practice and build competent pharmacists capable of advancing and expanding pharmaceutical manufacturing in Lebanon.

In light of the above, it was deemed necessary to validate and pilot the competency framework for industry pharmacists after adding a section related to emergency preparedness to complement the set of competencies required from industry pharmacists, as suggested by the FIP revised framework [2]. Therefore, this study aimed to update and validate the specialized competency framework for industry pharmacists (SCF-IP) and to assess correlates related to the competency domains in a pilot sample. Relevant authorities could use our findings to implement this framework and improve education and professional development.

Methods

Initial framework

Inspired by a French model [26], the initial framework was derived from OPL’s 2018 postgraduate competency program that included five domains and related competencies distributed as follows [21]:

Domain 0: Research and Development (3 competencies: Process Implementation; Mastering Analytical and Extraction Techniques; Mastering Characterization Techniques); Domain 1: Pharmaceutical and Industrial Development (4 competencies: Drug Formulation Expertise; Packaging Expertise; Industrial Scale Transposition; Process Development and Optimization); Domain 2: Analytical Development (2 competencies: Analytical Protocols and Techniques Expertise; Analytical Project Development and Implementation); Domain 3: Industrial Pharmaceutical Production (5 competencies: Process Engineering and Equipment Technology; Organization and Production Management; Health, Safety, and Environment; Continuous Improvement; Cross-Disciplinary Functions); Domain 4: Quality Management (5 competencies: Program Management and Implementation; Program Quality Assurance; Documentation and Traceability Expertise; Financial Analysis; Risk Management Expertise).

Industry stakeholders confirmed the suggested document through semi-structured interviews. These stakeholders also expressed the lack of relevant postgraduate studies locally, leading graduates to pursue education abroad or undergo onsite training for several months.

Tool update and content validity

A team of experts that comprised four academics and two industry pharmacists gathered and reviewed the content of the previously suggested industrial pharmacy framework. After a thorough literature review, domains, competencies, and behaviors (items) were reviewed, updated, restructured, and adapted to the Lebanese setting. Two competencies of the previously suggested tool, i.e., Quality Assurance and Quality Control, which were under the same domain (Industrial Pharmaceutical Production), were extracted and put under a new domain termed “Quality Assurance and Control” (sixth domain). In the absence of research and development for innovative drugs in the country, this framework did not include a section on the different phases of clinical trials, as industry pharmacists in Lebanon are not involved in this role, since R&D departments exclusively focus on the development of generic medications.

Furthermore, since the pandemic occurred and multiple crises hit the country after the previous framework was diffused, a seventh domain (Domain 6: Pharmacist Preparedness and Response in Emergency Situations) inspired by several studies and frameworks was added and included competencies related to the pharmacist during emergencies [27,28,29,30].

Using a Delphi technique, the framework was circulated to experts for more than five rounds until a consensus of 90% or more was reached on all items. The Delphi technique is a structured communication method used to gather and analyze the opinions of a group of experts on a particular topic [31]. Its goal is to achieve a high level of consensus among the experts, which adds credibility and reliability to the final version of the framework. The experts were asked to review the framework and provide their feedback, opinions, and suggestions during each round. The collected feedback was analyzed, and the framework was revised accordingly. This iterative process continued for more than five rounds. Questions and minor inconsistencies were resolved by a final discussion. The final framework that was agreed upon comprised 77 behaviors organized over 25 competencies, which were grouped into seven domains:

Domain 0: Research and Development (3 competencies, i.e., Process Implementation; Mastering Analytical and Extraction Techniques; Mastering Characterization Techniques);

Domain 1: Pharmaceutical and Industrial Development (4 competencies: Drug Formulation Expertise; Packaging Expertise; Industrial Scale Transposition; Process Development and Optimization);

Domain 2: Analytical Development (2 competencies: Analytical Protocols and Techniques Expertise; Analytical Project Development and Implementation);

Domain 3: Industrial Pharmaceutical Production (5 competencies: Process Engineering and Equipment Technology; Organization and Production Management; Health, Safety, and Environment; Continuous Improvement; Cross-Disciplinary Functions);

Domain 4: Quality Assurance and Control (2 competencies: Quality Assurance; Quality Control);

Domain 5: Quality Management (5 competencies: Program Management and Implementation; Program Quality Management; Documentation and Traceability Expertise; Financial Analysis; Risk Management Expertise);

Domain 6: Pharmacist Preparedness and Response in Emergency Situations (4 competencies: Emergency Preparedness and Response; Operations Management; Patient Care and Population Health Interventions; Evaluation, Research, and Dissemination for Impact and Outcomes).

The finalized framework was subsequently adapted to be administered to industry pharmacists through standardized online questionnaires.

Study design

To validate the structure of the framework, a web-based cross-sectional study from March to October 2022 enrolled a convenient sample of ten industry pharmacists working in Lebanese pharmaceutical plants. Participants were contacted through the Syndicate of the Pharmaceutical Industries in Lebanon (SPIL). Respondents were briefed about the topic and the different aspects of the questionnaire in the introductory section of the questionnaire. They gave their consent before proceeding to the survey. All industry pharmacists with managerial positions and living in Lebanon were eligible to participate. Anonymity and confidentiality were ensured across the entire data collection process.

Questionnaire

The questionnaire was in English, a language commonly spoken by healthcare professionals in Lebanon. It comprised three sections. In the first section, participants were asked about their general sociodemographic data, including their age, gender, nationality, area of work, university of graduation, highest educational level, years of experience, number of working hours per day, and number of working days per week. The second part consisted of the scale-based framework, including the seven domains divided into competencies and related behaviors. The last section involved four questions about, where these competencies were acquired (Questionnaire in Additional file 1).

Statistical analysis

Data were analyzed using SPSS software version 25. Exploratory factor analysis using the principal component analysis technique was conducted for behaviors based on competencies and domains. The Kaiser–Meyer–Olkin (KMO) coefficient, Bartlett’s sphericity test, and the total percentage of variance explained were reported for each analysis. In addition, Cronbach alpha values were calculated for each competency to assess internal consistency (reliability); Cronbach alpha assesses reliability by comparing the amount of shared variance, or covariance, among the items that make up an instrument to the amount of total variance [32]. Acceptable values range from 0.7 to 0.95 [33]. Spearman correlation coefficients were calculated to assess the correlation of the domains with each other and with the overall framework (structural validity).

Afterward, a descriptive analysis was performed using the counts and percentages for categorical variables and means and standard deviations for continuous measures. Means were compared using the Mann–Whitney test, while percentages were compared using the Chi-square test (or the Fisher exact test when necessary) to assess correlates of competencies. A p value less than 0.05 was considered significant.

Results

Table 1 presents the main characteristics of the ten participants who answered the survey. All were females, 3 had only a BS, and 4 had a PhD. Most participants worked in Beirut, were English educated, and graduated from Beirut Arab University. The mean age was 34.5 years, with a mean experience duration in the field of 5.5 years (Table 1).

Table 1 Sociodemographic and other characteristics of industry pharmacists (N = 10)

Table 2 presents the construct validity of the framework. Competencies were analyzed using factor analysis with Varimax/Promax rotations, showing appropriate loading of all items on respective factors (which could harbor one, two or three competencies). The following domains and factors were found:

Table 2 Factor analysis of the Lebanese Industry pharmacist competencies’ (Varimax rotated component matrix)

Domain 0: Research and Development (2 factors: Process Implementation; Process management);

Domain 1: Pharmaceutical and Industrial Development (2 factors: Formulation and Process Development; Industrial Scale Transposition and Packaging);

Domain 2: Analytical Development (1 factor: Analytical Project Development and Implementation);

Domain 3: Industrial Pharmaceutical Production (3 factors: Process Engineering and Equipment Technology; Process Management and Improvement; Cross-Disciplinary Function);

Domain 4: Quality Assurance and Control (2 factors: Quality Assurance; Quality Control);

Domain 5: Quality Management (3 factors: Program Quality Management; Economics and Risk Management; Quality System Improvement);

Domain 6: Pharmacist Preparedness and Response in Emergency Situations (4 factors: Workplace Emergency Adaptation; Emergency Training and Research; Local and Global Recommendations Application; Answering Local Needs).

Moreover, Cronbach alpha values for all domains were close to one, showing appropriate reliability (Table 2).

Table 3 shows the structural validity of the framework. Each domain was correlated with at least another one, except for Domains 1 and 6, which were not correlated with other domains. The overall Cronbach alpha was acceptable (0.742).

Table 3 Structural validity of the competencies’ framework (Spearman correlation)

The descriptive results in Table 4 show that the domain of Research and Development had the lowest confidence (61/100), while Pharmaceutical Production had the highest confidence (85/100).

Table 4 Descriptive results

In bivariate analysis, pharmacists with only a PharmD reported the lowest confidence in Domains 0, 1, and 2 (Research and Development, Pharmaceutical and Industrial Development, and Analytical Development), while those who graduated from University 2 reported low confidence in Domain 5 (Quality Management) (Table 5).

Table 5 Bivariate analysis taking the industry pharmacists’ competencies domains as the dependent variables

Finally, the median percentages for the declared sources of competencies were 20% for undergraduate studies, 55% for postgraduate studies, 17.5% for continuing education, and 87.5% for experience. The highest confidence in overall competencies was found to be best correlated with postgraduate studies (r = 0.909; p < 0.001), while continuing education programs had a lower correlation (r = 0.634; p = 0.049); however, gaining competencies by experience was associated with lower confidence (r = − 0.755; p = 0.012) (results not shown).

Discussion

This study validated the specialized competency framework for Lebanese industry pharmacists, consisting of six domains. Domains were analyzed using factor analysis with Varimax/Promax rotations, showing appropriate loading of all items on respective factors. One factor could include more than one competency. Moreover, Cronbach alpha values for all domains were close to one, showing appropriate reliability. The overall Cronbach alpha was also acceptable. Each domain was correlated with at least another one, except for two domains, i.e., pharmaceutical and industrial development and emergency preparedness, which were not correlated with other domains, showing that they are not parallel. Thus, more efforts are needed to homogenize the competencies of industry pharmacists in Lebanon in all necessary domains at the educational level.

Upon investigating the confidence of participants in each domain, the data revealed that the lowest recorded confidence was the one related to research and development (61/100). This result may be explained by the lack of training activities relevant to this domain in internship programs, which, in turn, is due to the scarcity of research and development activities in many Lebanese pharmaceutical plants [34]. Moreover, pharmaceutical production was reported with the highest confidence (85/100), indicating that the activities relevant to this domain were considered of primary importance and most extensively performed by Lebanese industry pharmacists. This finding aligns with the results of a previous European study, showing that manufacturing processes received the highest importance rates among pharmaceutical industry activities [35].

In our study, pharmacists with only a PharmD degree had the lowest declared confidence in domains related to research and development and industrial and analytical development (p < 0.05). Knowing that PharmD is the gate to clinical practice, pharmacists earning this degree may not be eligible to carry out industrial processes, research and pharmaceutical analysis procedures. Consequently, their role may be limited to the follow-up of routine production processes and quality issues. In educational institutions, additional efforts are needed to recognize the importance of industrial pharmacy. Over the last two decades, the role of the industry pharmacist in developed countries has expanded to cover multiple domains and was recognized as a vital professional role in the provision of healthcare [36]. Hence, the industrial field is gaining considerable attention from academic institutions teaching pharmacy. For instance, pharmacy fellowship programs in the U.S. are classified into traditional and industrial, where the latter target competencies relevant to the industrial field, supporting the pharmaceutical industrial career [37]. However, in developing countries, the role of the industry pharmacist remains underestimated [36].

Furthermore, all industry pharmacists in our sample reported low confidence in emergency preparedness. To address this gap and improve their readiness, it is essential to adapt undergraduate studies and continuing professional development (CPD) and create postgraduate programs specific to emergency preparedness. However, the efficacy of these measures relies on their integration into a national strategy that encompasses all stakeholders, including pharmacists from different sectors. Collaborative efforts between regulatory bodies, industry associations, academic institutions, and government agencies are crucial for a coordinated approach. This approach allows for the development of standardized guidelines, regulations, and protocols to strengthen emergency preparedness across the pharmaceutical industry. Furthermore, engaging with pharmacists from diverse sectors facilitates the sharing of experiences and best practices, ensuring comprehensive emergency response capabilities that address the unique challenges faced by each pharmacy setting. By adopting this collective approach, the emergency preparedness of industry pharmacists can be improved, ensuring uninterrupted medication supply and bolstering the overall resilience of the pharmaceutical industry during crises.

Pharmacy schools principally direct students to the clinical aspects of the pharmacy profession, which may affect their willingness to follow an industrial career path [38]. This fact is confirmed by our findings, where most respondents were graduates of University 2 in Lebanon, indicating that pharmacists from this university show more interest in the pharmaceutical industry due to some embedded courses within the curriculum being relevant to pharmaceutical manufacturing. Thus, educational curricula would gain from being revised and complemented with components more specific to industrial pharmacy.

The median percentage for the declared source of competency was the highest for experience (87.5%); however, competencies acquired through experience were correlated with lower confidence in performing tasks. The highest confidence in overall competencies was found to be best correlated with postgraduate studies. Furthermore, continuing education was the lowest declared source of competency (17.5%) and had a weak correlation with confidence. These findings indicate that postgraduate programs have contributed to preparing competent industry pharmacists able to perform various industrial tasks appropriately. Nevertheless, well-structured internship programs are essential to prepare industry pharmacists with high-level competencies in all domains. Although such programs are implemented in some Lebanese pharmacy schools, a limited number of students can be enrolled, likely due to the lack of communication between universities and pharmaceutical plants and the limited number of local pharmaceutical plants [39]. Similarly, a previous study in Saudi Arabia revealed that most pharmacy graduates (83.6%) are not competent enough to work in the pharmaceutical industry as they had never enrolled in any training program, which has been mainly attributed to the lack of connection between academic bodies and the industrial field [36].

In some countries, a tangible academic collaboration exists between several US pharmacy schools and pharmaceutical manufacturing plants aiming to provide students with pharmacy fellowships and prepare them for the pharmaceutical industry profession [37]. Accordingly, educational systems must be capable of graduating pharmacists with the appropriate competencies at the right time [35]. Thus, Lebanese pharmacy schools need to make more efforts to increase internship opportunities to improve and expand the pharmaceutical industry in Lebanon. This goal can be achieved by integrating the industrial competencies of newly graduated pharmacists into the evolving professional requirements of the pharmaceutical industry, with the help and input of stakeholders from the industry [40].

Limitations

Despite its importance, this pilot study has several limitations. A selection bias is possible, given the low number of participants in the assessment; nevertheless, the adequate structure, good reliability, and significant associations and differences found are not expected to change with larger samples. Moreover, an information bias is also possible, given the length of the questionnaire and possible fatigue of participants added to the self-declared nature of the information. However, this bias would be non-differential and only direct the results toward the null. Finally, no multivariable analysis could be conducted to decrease confounding during the assessment of associations. Thus, further large-scale studies are recommended to overcome these limitations.

Conclusion

This study validated the specialized competency framework for Lebanese industry pharmacists. Some domains, specifically those related to industrial development and emergency preparedness, were found to diverge from others. Therefore, it would be recommended to include additional education in the emergency preparedness, research and development fields and to integrate industry-specific skills, courses, and training programs into academic curricula. Furthermore, specialized postgraduate degrees may be necessary to produce practice-ready pharmacists to operate effectively in this vital setting.