Boundaries of innovation implantation in PSV

1.      Introduction

Modern medicine is constantly looking for new ways to improve patients’ health and quality of life. Continuous improvements in the health care system have increased life expectancy significantly – from the global average age of 45.7 years in 1950 to the average age of 72.6 years in 2019 (Roser, Ortiz-Ospina & Ritchie, 2019). Fast-paced lifestyles, aging society, and an increasing number of chronic conditions challenge health care systems to innovate in order to sustain emerging patients’ needs.

Changes in populations’ longevity led to the worldwide pandemic of chronic conditions. Chronic conditions exceed 70 % of all disease burden globally, and it is estimated that chronic conditions are accountable for about 40 % of deaths every year (WHO, 2017; Ritchie & Roser, 2018; Hariss, 2019). Chronic conditions last over an extended period of time. In most cases, these conditions require sophisticated treatment methods. Complicated pharmacotherapy may require co-administration of few medicinal products or unusual drug administration timing. With more complex treatment methods, patients will comply with prescribed treatment decreases. About half of patients receiving treatment, fail to follow treatment regimens. Thus patients are not improving their health and life quality. Failing to adhere to treatment causes negative clinical and economic outcomes. Also, it is difficult to tell whether therapy or medicine is working. Multiple factors influence non-adherence to medicines – patients simply forget to take medicine or lack health literacy, physicians do not communicate the importance of the therapy in an understandable way for the patient, health care system is not able to ensure proper compliance due to shortages in resources (Brown & Bussell, 2011). Patient support programs as an additional tool to routine regimens were introduced to help patients to follow complex treatments and ease the burden of chronic disease.

Patient support programs are designed to help patients to comply with their treatment. European Medicine Agency guidelines (2011) describe patient support programs as an “organized system” (p. 39), allowing companies to collect data related to the administration of medicinal products. Companies sponsoring patient support programs declare it as tools assisting patients in improving treatment outcomes via adherence to medication, education, and awareness of the disease. Moreover, patient support programs are beneficial to health care specialists – using the programs they can provide better care to their patients. Some patient support programs provide financial aid to patients to ensure better adherence to the treatment (Portnoff & Lewis, 2017). The tools provided to the patient vary depending on the specific patient support program. Patient support programs started with tools like a calendar with stickers to mark next medicine administration, leaflet on disease awareness, or with an educational purpose. Also, a patient support program can be carried out as additional communication alongside regular treatment – reminders from a call center or a nurse to use medicine on time. Nowadays, digital innovations patient support programs can provide more sophisticated tools to track correct medicine dosage and timely administration time through various mobile applications, wearables, and smart devices.

Pharmaceuticals and biotechnology industry investments in research and development are increasing. Pharmaceuticals and biotechnology industry globally spend approximately 160 billion dollars in 2018 and, consequently, 177 billion dollars in 2019 on research and development and ranked as the second-biggest investor in research and development after the information technology industry (Skillicorn, 2019; WIPO, 2019). Despite huge investments into innovative solutions to provide better treatment outcomes, there is a substantial gap between innovation development and its market presence, and there is also a difference between awareness and its application and the dissemination of innovation (Berwick, 2003; Life Science Technology, 2019). The literature points out main innovation implementation theories and models applicable to the health care sector – theory of disruptive innovation, technology acceptance model, diffusion and dissemination of innovation theories by Rogers (1962). Theoretical frameworks suggest that successful implementation is defined by characteristics of the innovation. The health care system is a sophisticated organization operating in a complex environment; therefore, innovation implementation is conditioned by external and internal environmental factors.

Patient support programs are a relatively new concept and have not been implemented widely in health care settings; thus, there are limited attention and knowledge about innovation implementation within these programs. The main research question of this thesis is focused on the following: “what are the main barriers to innovation implementation in patient support programs”?

The aim of this thesis is to explore the main barriers of innovation implementation in patient support programs. Main objectives of the thesis are the following:

1.  An extensive review of literature related to patient support programs, existing theoretical frameworks of innovation implementation with the focus on the health care system to identify boundaries in implementation of innovation.
2.  Empirically evaluate obstacles in innovation implementation in patients’ support programs in the health care sector.
3. To stipulate managerial implications for health care managers and health care policymakers.
4. To mitigate barriers of innovation implementation in patient support programs.

This is exploratory research to gain comprehensive insights into innovation implementation in the patient support programs. For this type of research, a qualitative research design is pursued to get a broader understanding of the topic. Interviews with health care professionals and industry representatives are considered keeping in mind that they are the main stakeholders and subject matter experts in patient support programs. Interviews with health care sector professionals provide valuable insights, experience, and challenges within the innovation implementation process in patient support programs.

Structure of the thesis is as follows:

1. Literature review. This part is dedicated to an academic literature overview in order to define the implementation and dissemination of innovation, identify barriers to innovation implementation diffusion. Also, the relevance of the research is described.
2. Research methodology. In this part of the thesis, research design, and theoretical methods/frameworks are described.
3. Empirical Research Results. This part of the thesis is dedicated to the analysis of empirical research findings.
4. Discussion. The thesis is finalized with the results of empirical research and managerial implications for health care managers and policymakers.

2.      Literature review

This section was aimed at analyzing and reviewing the existing literature concerning support programs for patients, models, and theories of implementation and the spread of innovations focusing on the health care field. It was essential to review academic articles to get the understanding and theoretical background of the innovation’s imperative parts spread and the application in the support programs for patients. The focus of this thesis was an exploration of implementation for the innovations seen in the support programs for patients. Innovation barriers identification assisted implications informing management for health care policymakers and managers. Again, barriers identification in the implementation of innovation served as a basis for constructs mitigations.

2.1.Adherence

Annually, new, more effective, and more innovative pharmaceutical products are introduced to treat disease, enhance different adverse conditions, and in fulfilling medical needs that are unmet. Each treatment that is prescribed is required to give favorable results on a given patient. In order to accomplish the needed results with certain forms of treatment, one more vital element exists. According to Brown and Busell (2011), the element is referred to as adherence and is as illustrated at the center, but the most significant is the section between initial treatment and the results needed, as in Figure 1 below.

Figure 1. Treatment scheme- simplified (Brown and Bussell, 2011).

For a given treatment to function or gain the needed results, treatment prescription regimens adherence should be enforced. The WHO refers to adherence as the will by the patients to follow the guidance of health care physicians with restrictions to dietary or regimens’ pharmacological (Sabaté, 2003). The review of literature indicates that adherence process as the being divided into three sections: a) Initiation starting with the initial prescription or the first initiation and filling of treatment as agreed mutually with the professional involved; b) Implementation where the patients follow the accepted method and schedule of administration for the product of medicine; c) Discontinuation or persistence that is the treatment remaining as illustrated by the professional or therapy termination with no initial consultation to the professional (Vrijens et al., 2012; Feldman et al., 2017).

It is vital to adhere to every regimen of treatment, but a significant role is played in chronic condition treatment among patients. There can be the management of chronic conditions for a given time and needs complex treatment and attention; hence the role of adherence is more important on chronic conditions treatment among patients. There are several complex recommendations that can be challenging for patients in real life. Currently, studies have shown that adults possessed a lower rate of adherence to treatment schedules compared to children, which is 70.7% for children and 55% for adults (Yang et al., 2018).

Other studies have researched on the causes of patients ignoring adherence to the given treatment plan, and the result was that the main factor for this was non-intentional like being forgetful and treatment complexity (Barfod, Sørensen, Nielsen, Rodkjær & Obel, 2006; Julian et al., 2009; Lam & Fresco, 2015; Demoly, Passalacqua, Pfaar, Sastre &Wahn, 2016), but still there were some few cases of intentional aspects. The association of intentional aspect involved side effects’ anxiety, and factors that were psychological like inadequacy of health care professional and relationship to the patients, history of previous failure, mental well-being, condition denial were some other factors involved (Demoly et al., 2016; Arlt, Nestoriuc & Rief, 2017).

Concerning rising cases of non-adherence, scholars have commenced questioning treatment’s ineffectiveness on patients’ non-adherence and the patient leading to it being ineffective (Lam & Fresco, 2015). It has been agreed that the behavior of taking medication is a complex process, and it is essential to address it to accomplish the needed results for treatment (Sabaté, 2003; Brown & Bussell, 2011; Khan, Kohn & Aslani, 2019).

2.2.Support Program for Patient

A vital part of clinical therapy is adherence to the treatment prescription. There are ways of tackling non-adherence to treatment, like the introduction of support programs for patients. This has been defined European Medicine Agency for guidelines on good pharmacovigilance as a system organized in that a marketing authorization holder collects and receives data and information concerning the utilization of products, medicinal (Sabate, 2003, p. 29). The support program for patients is a tool that assists in the enhancement of the experience of patients and the results of the treatment. Several researchers describe the programs as interventions for motivation (Gerega et al., 2016) to comply with the treatment prescription.

The design of the programs is for several purposes, like assisting the patient in adhering to the treatment prescription regime, aid in the management of the disease they possess, and service provision. Mainly, the support programs for patients are aimed at chronic conditioned patients (Demoly et al., 2016; Schwarz et al., 2016), since they have an extended treatment regime and which are usually sophisticated compared to the normal treatment prescriptions. There has been a case study carried out on if the programs enhance adherence to treatment and the persistence they have as performed by Zhou, Yeaw, Karkare, DeKoven, Berhanu & Reid (2018). The involved comparison was between diabetes, type 2, about patients in support programs, and the ones outside the programs. For a period of about one year, the determination was that enrolled patients had higher adherence to treatment prescription in comparison to the one outside the programs together with the rate of persistence. Again, Gerega et al. (2016) stated that in the first year period of treatment, statistic importance increase existed in adherence accrued to patients calling by the nurses.

Several researches indicate that (Haynes et al., 2002; Sackett et al., 1978; Yang et al., 2018) approximately fifty percent of the chronic conditioned patients ignored to comply with the regime of treatment, hence, ignored compliance with the treatment prescription increasing the complication risks, reducing life quality, and increased patient’s healthcare expenditure. Referring to WHO’s report, by 2020, 65% of the global total medical conditions would be as a result of chronic diseases. Enhancing adherence by patients to treatment improves the safety of the patient, clinical efficacy is improved, and expenditure on healthcare section is reduced (Sabaté, 2003).

2.2.1.      Economic value of patient support programs.

The benefits of results for clinical treatment from the programs are broadly reported, although it is essential to note that the said support programs have an economic value creation. As evaluated by Ostor, Garg, Yang, Chamberlain & Skup (2018), was the support programs for patients utilized for the treatment of Rheumatoid Arthritis in the UK. The estimation was that about ten thousand people enrolled in the programs were associated with about two million pounds of savings per year. The larger percent of the saving was by the hospitalization of the patients. The support programs for patients have aided in complying with the recommendations of the given treatment by the professionals of the healthcare, therefore, resulting in several hospitalizations as they related to decreasing their conditions enormously and leading to about two million as savings. The other larger percent, about thirty percent and amounting to about 0.7 million pounds, was as a result of work productivity seen in the support programs for the patients. The other savings were segregated between joint assessment of images (about 1.70%) and in reduced visits by the specialists (about 1.90%) (Ostor et al., 2018).

Table 1. Enrollment support program for patient estimated annual savings Ostor, A., Garg, V., Yang, M., Chamberlain, C., & Skup, M. (2018).

There have been studies about programs designed for patients with conditions of immunology by researchers in the UK, aimed at determining the adherence by the patients to products (medical) and medical cost direct evaluation. Rubin, Mittal, Davis, Johnson, Chao & Skup (2017) stated that enrolled patients in the support programs had reduced direct conditions as relating to cost with about twenty percent as compared to the out of the program patients. The conclusion of several other support programs for patients’ evaluation was that on top of improving the health, the support programs had a significant role to play in financial savings as they related to the direct cost of medication (Ganguli et al., 2016; Martinez-Sesmero et al., 2017). Again, in accordance with the European Federation of Pharmaceutical Industries and Associations (EFPIA, 2013), the data presented was that the government (European) was losing about 124 billion euros annually following non-adherence to the treatment prescription. The review of the existing literature indicates that support programs for patients were the beneficial financial, personal, and clinical point of view.

2.2.2.      Patient Support Programs Innovations

The description of innovation is mainly novel, like new processes, behavior, and technologies (Nolte, 2018). West (1990) explained that innovation is the intentional application and introduction within an organization, group, or role of ideas, which are unique to the relevant adoption units, aimed at enormously assisting people, individuals, or the higher society (p. 16). Thakur, Hsu, and Fontenot (2012) assessed different possible definition of innovation focusing on health care innovation setting and the conclusion was that in the health care field, the consideration was any change that assists practitioners in health care aim at the patients through assisting the professionals in health care to perform their duties better, cost-effectively, faster, and smarter (p. 564).

The support programs for the patients could be easy as a patient’s handout, stickers on calendars, automatic messages, or calls that act as reminders for medication administration. Regarding the advancement in technology, it has been seen that the programs end up as more sophisticated and innovative. Currently, the involved in the programs are able to be trained and educated concerning drug administration and diseases, are able to participate in platforms for digital social networking for patients, assess to support of clinics, and management of side effect of their treatment in an effective manner (Ocvirk, 2016). Again, they can assess smart devices, for an instant, innovative medication or tablets containers to aid in treatment prescription adherence (Demeloy et al., 2016).

Modern technologies and innovations are a current issue in the field of health care.  Innovations and modern technologies are emerging in the healthcare industry. United States Food and Drug Administration (FDA), in 2017, allowed aripiprazole pill containing sensors that could be digitally tracked and recorded utilizing smartphones on a wearable patch, whether the ingestion of the medication by the patient was for adverse mental illness (FDA press release, 2017). The award-winning, in 2018, for the most innovative support program for patients conditioned with an inoperable brain tumor or the glioblastoma multiforme was a device (wearable) that transmits electric signals (low) reducing the proliferation of cells. On the same note, the device, when combined with various treatment prescriptions, raised the program participates’ life span with about fifteen months to five years (Chapman, 2018). Modern technology applications in the programs could aid, especially in delicate or chronic conditions.

There are arguments by researchers in that the current advancements in digital world and tools could assist in decreasing the rate of non-adherence to treatment prescription but create less value, the solutions given are temporary, and the extra challenge is created for the professional in the health care (van Mierlo, Fournier & Ingham, 2015). The conclusion of researchers is that the digital programs are designed aimed at the different needs of the patients, different patterns of adherence to treatment prescription instead of the systematic approach. However, there are criticisms about the programs being inflexible, asking for personalization for the personal adjustment in non-adherence patterns in treatment prescription. The clinical value for the support programs for the patient was not dismissed.

Again, researches on patients with musculoskeletal measured the level of adherence to regime exercise through comparison of paper sheet exercise version to the motivational text and mobile application. However, clinical importance was not vivid in the involved research following non-pharmacological regimen study, and digital devices indicated higher adherence to regiment paper version comparison (Lambert et al., 2017). It is clear that support programs have an additional economical and clinical value to the general healthcare system and the patients involved. The current advancement in technology has rendered the support programs more innovative, and the support programs for patients could enormously enhance the quality of life for the patient. The expectation is that the innovations are to make the programs more desirable to the involved patients and the professionals at health care, but innovation implementation and diffusion is slow in the sector of health care.