Question

Consider this format:

(1) an evaluation of the U.S. opioid epidemic’s impacts on stakeholders

(2) an assessment of the pharmaceutical industry and other stakeholders’ commitments to corporate social responsibility (CSR) as well as the ethical dilemmas posed by the manufacture, distribution, and sale of opioids

(3) a set of action recommendations that address each of the elements of corporate social responsibility in coming to a resolution regarding how to mitigate the opioid epidemic.

Answer 1

1) Opioid addiction and overdose rates are reaching unprecedented levels in the United States, with 47 736 overdose deaths in 2017, and having the highest rates in West Virginia, Ohio, and Pennsylvania. The United States faces three opioid epidemics—one from misuse of prescription opioids, one from synthetic opioids such as fentanyl, and the other due to illegally produced opioids such as heroin—all contributing to the high number of overdose deaths in this country. Although the supply of prescription opioids has decreased, the use of heroin and synthetic opioids, which are more potent than prescription opioids, continues to grow and has raised the rate of opioid overdoses. While, opioid-related deaths driven by synthetic opioids have been on the rise in recent years and fentanyl has fueled the opioid epidemic, less attention has been given to this line of drugs. Moreover, the supply of illicit and synthetic drugs and the interventions to suppress them have not been studied in detail. Additionally, current interventions, such as educational programs, lack comprehensive consideration of all factors contributing to opioid use trajectories and have not stemmed the epidemic.
The complexity of the opioid epidemic is multifactorial and includes poorly understood and unpredictable interactions among (1) stakeholders (e.g. patients (users), providers, and policymakers); (2) demographic and spatial factors, such as providers’ locations; and (3) transitions between health states of opioid users such as light and heavy users. For instance, regarding opioid diversion and recruitment of new users, opioid users have the tendency to recruit new users. They may provide the pills to their friends and relatives, increasing the diversion of prescription opioids from intended use. Moreover, opioid users may acquire higher doses from physicians or illegally from drug traffickers, also increasing drug diversion. Patients with misuse/use disorders may “doctor shop,” visiting several doctors to obtain opioids;
this phenomenon increases diversion, as well as recruitment. These facts about this segment of the opioid epidemic—recruitment and diversion—are clearly indicating the complexity of this problem and because of this complexity, no one organization can solve the problem on its own. Moreover, this epidemic is dynamic as before 2010 most opioid-related deaths were among middle-aged people, largely among women and African Americans. Currently, however, the epidemic is affecting younger individuals; predominantly males and whites. Also, the geographic patterns of opioid-related deaths vary in different states; heroin and synthetic-related deaths are higher in the northeastern United States. Therefore, we need to adopt a multifaceted, holistic approach to address this dynamic, complex epidemic while considering all contributing factors.

Adopting a more comprehensive approach and predictive analysis toward policy and evaluation could prevent many of the tens of thousands of deaths caused by opioid overdose in the United States every year. Providing a comprehensive list of interventions and key findings of previous modeling works to researchers and modelers would facilitate the development of future models for this crisis and other drug epidemics.

2) CSR is of increasing importance for multinational pharmaceutical firms yet understanding of the array of CSR strategies employed and their effects is nascent. Our study points to the need to (i) develop clearer and more standardized definitions of CSR in global health (ii) strengthen indices to track CSR strategies and their public health effects in developing countries and (iii) undertake more country level studies that investigate how CSR engages with national health systems.
Businesses and corporations in many sectors are initiating programs and strategies aimed at enhancing social welfare, protecting the environment and defending human rights. There is evidence worldwide of the growing importance and impact of corporate social responsibility (CSR). For example, the recent United Nations (UN) Global Compact on Corporate Sustainability seeks to align objectives and interests of the business world and global community to develop innovative policies aimed at harnessing and leveraging the momentum of CSR. Even more recently, the Government of India mandated CSR by requiring for-profit entities to give 2% of their net profits to charitable causes. While there is extensive published literature on CSR and international development the literature on CSR and global health is limited. A number of papers have explored whether pharmaceutical companies are living up to their human rights obligations, however, this literature falls short in considering CSR comprehensively, instead focusing narrowly on drug pricing or product licensing. Other papers on CSR in multinational pharmaceutical companies have evaluated specific CSR activities, focused on the creation of economic opportunity, or presented more of an industry perspective.

CSR is plagued by a multitude of definitions rooted in different sources. At its broadest, CSR has been defined as “the overall contribution of business to sustainable development”, characterized as economic development that does not undermine “the ability of future generations to meet their own needs”. Others have envisaged it along a spectrum, which ranges from giving because it is the “right thing to do,” to risk management, all the way to creating shared value (CSV) which embeds social responsibility in the core of all corporate operations attempting to simultaneously create benefits for the company and society. This study adopts the European Commission’s definition of CSR as “the responsibility of enterprises for their impacts on society.” This definition further recommends that firms put in place processes “to integrate social, environmental, ethical, human rights and consumer concerns into their business operations and core strategy in close collaboration with their stakeholders”. The notion of CSR rests upon the premise that most modern firms likely create “bads” as well as goods, and accordingly should conduct activities that deliver social or environmental benefits to offset any adverse consequences of their business.

Pharmaceutical companies are special cases because their business decisions directly impact human health, making CSR efforts particularly important. These firms have been criticized for specific behaviors such as setting prohibitively high prices and sluggishness in responding to demands to provide access to life saving drugs for poor populations. In response, at least in part, during the past two decades pharmaceutical companies have significantly increased CSR efforts, particularly in low- and middle-income countries (LMICs) that bear the large majority of the global disease burden. Recent epidemiological and demographic shifts, notably the HIV/AIDS pandemic, have magnified pressures to actively work to promote societal well-being.
3) The number of overdoses per year might be roughly proportional to the number of people who currently had an active OUD, but this number would not be proportional to the current inflow of new people developing OUD, which is what many interventions aimed at controlling the misuse of prescription opioids would affect most directly. Those interventions would not instantly change the prevalence of OUD and hence would generally not have an immediate effect on overdose. By contrast, interventions that reduced the likelihood that an overdose would occur, or that it would be fatal, might reduce fatalities right away. A fair comparison of the effectiveness of interventions designed to reduce diversion with those designed to reduce the frequency or lethality of overdoses requires a true systems model, not just simple statistics. Constructing such models is a major research endeavor in its own right, and the committee is unaware of any existing model that incorporates all of the strategies discussed in this chapter; therefore, the relative effectiveness of these strategies cannot be compared. Creating such models would have important advantages: it would guide and strengthen surveillance and research, foster a common policy vocabulary among all agencies with decision-making authority over opioid regulation and enforcement (federal, state, and local), and facilitate the exchange of information among them. Investing in research and possible development of such a model is worthy of consideration by the U.S. Food and Drug Administration (FDA) and other agencies. In any event, since no formal systems model now exists, the committee provides an overview of the key conceptual features and implications of a systems approach (without a formal model) to identify some of the considerations that need to be taken into account in reviewing the possible impact of alternative strategies. However, empirical analysis of the various strategies reviewed in this chapter relies on the traditional statistical methods outlined in the previous section.