Pius E. N. Jimmy, M.D.

Title:

Ethical Challenges in Pain Management: Balancing Opioid Prescribing Practices and Patient Well-Being in Family Medicine

Summary:

This research explores the intricate ethical landscape of pain management in Maltese family medicine, emphasizing the delicate balance between opioid prescribing practices and patient well-being, and aiming to balance effective patient care while minimizing the risk of addiction. Rooted in Beauchamp and Childress’ ethical principles, the study aims to provide nuanced insights into local and global considerations, including deontological theories, rights-based ethics, communitarianism, and ethics of care. By employing a mixed-

methods approach, the research seeks to inform evidence-based guidelines, enhance practitioner training, and foster community dialogue. Through a comprehensive exploration, the findings aspire to contribute not only to the refinement of local practices but also to the broader international discourse on responsible and patient-centred pain management.

Background:

Overview

The healthcare industry, specifically in pain management, demands ethical examination due to the potential risks associated with opioid prescribing practices. Although opioids are necessary for relieving patient distress, misuse and addiction are possible hazards. Malta's unique cultural values and healthcare system contribute to distinct challenges in this area that require investigation. This study endeavours to deeply explore these moral dilemmas so as to advance responsible pain management protocols. The CDC’s 2022^[1] guideline provides an updated, evidence-based approach toprescribing opioids, emphasizing the need for clinicians to have comprehensive resources and trainingto offer appropriate care to patients with pain.

Existing Research

Despite existing studies shedding light on the ethical considerations of opioid use, there is still a notable gap in understanding how these apply within Malta's specific context. Existing research highlights the importance of localized studies to address this. The CDC's 2022^[1] guidelines also discuss the disparities in pain treatment, which suggests the necessity for research that considers local cultural, legal, and healthcare peculiarities to enhance the ethical framework for pain management protocols. Recent findings highlight the necessity for more localized research that considers Malta's unique cultural, legal and healthcare peculiarities. This study is designed to fill this gap by providing insights that are both locally relevant and internationally significant.

Rationale

Ethical Challenges in Pain Management

Pain management presents intricate ethical challenges, especially in navigating the fine line between addressing patients' pain adequately and mitigating the risks associated with opioid prescriptions, which can be informed by Beauchamp and Childress’s exploration of ethical principles in healthcare^[2]. Understanding and addressing these challenges are crucial for fostering ethical and effective pain management practices.

Malta's Unique Healthcare Context

Within Malta's distinctive healthcare landscape, cultural nuances and the commitment to patient well- being further complicate the ethical considerations of pain management. This research aims to explore how local factors influence ethical decision-making in opioid prescribing practices, and considers Malta’s cultural nuances in healthcare decision-making, drawing from Rundle et al.'s^[3] guide on cultural competence in healthcare.

Insights from Existing Literature

Drawing insights from existing literature and ethical frameworks, the research builds a foundation for understanding universal ethical principles within the specific context of pain management in Maltese family medicine. The study is framed within global health ethics and guided by the World Health Organization’s Global Health Ethics^[4].

Practical Realities of Pain Management

Bridging theoretical ethical principles with the practical challenges faced by healthcare professionals, this research seeks to enhance daily pain management practices while considering the unique characteristics of Malta's healthcare system. Comparative analysis with IASP and EFIC guidelines will ground ethical discussions in the practicalities of Malta’s healthcare^[5].

1. Centers for Disease Control and Prevention (CDC). (2022). CDC Clinical Practice Guideline for Prescribing Opioids for Pain — United States, 2022. MMWR. Retrieved from https://www.cdc.gov/mmwr/volumes/71/rr/rr7103a1.htm

2. Beauchamp TL, Childress JF. Principles of Biomedical Ethics. Oxford University Press; 2019

3. Rundle A, Carvalho M, Robinson M. Cultural Competence in Health Care: A Practical Guide. Jossey-Bass; 2008

4. World Health Organization. Global Health Ethics: Key Issues. WHO; 2015

5. International Association for the Study of Pain. Pain Management Guidelines. IASP; 2020. European Pain Federation EFIC. Position Papers and Guidelines. EFIC; 2020

Addressing Disparities in Pain Management

Acknowledging potential disparities, the research aims to identify and address any inequities in ethical considerations related to opioid prescribing, ensuring universal access to ethical pain management practices for all patients which is inspired by global calls for justice in healthcare, as stated by the World Health Organization^[6].

Global Relevance

By exploring the ethical challenges in pain management, Malta contributes to global healthcare standards. The research findings aim not only to benefit local practitioners but also to provide valuable perspectives to the broader international dialogue on ethical considerations in pain management, highlighting the global relevance of localized research.

Aims

Primary Aim:

To conduct a methodical analysis on the ethical challenges that arise in pain management within Malta. The study will particularly scrutinize opioid prescription practices against the backdrop of Beauchamp and Childress's "Principles of Biomedical Ethics"^[2], as well as patient welfare concerns and evaluate adherence to principles pertaining to medical ethics.

Secondary Aims:

• Investigate Cultural Nuances: Explore how cultural values in Malta influence ethical decision- making in pain management utilizing "Cultural Competence in Health Care: A Practical Guide" by Rundle et al^[3].

• Assess Legal and Policy Frameworks: Examine existing legal and policy frameworks shaping pain management ethics in Malta, inspired by global guidelines and local statutes.

• Evaluate Practitioner Perspectives: Understand healthcare practitioners' perspectives on ethical dilemmas in pain management, emphasizing communication and shared decision-making.

• Propose Context-Adapted Guidelines: Develop context-specific ethical guidelines for pain management in Malta, "Guidelines on the management of chronic pain in children"^[7] ensuring a harmonious balance between opioid prescriptions and patient well-being.

• Investigate the ethical dilemmas faced by healthcare professionals in opioid prescribing, identifying key factors that influence decision-making.

• Examine patient perceptions on opioid use and its management, focusing on ethical considerations from their perspective.

Overall Objectives

• Conduct a comprehensive exploration of the ethical dimensions inherent in pain management within the unique sociocultural context of Malta.

• Provide evidence-based insights to inform the development or refinement of policies related to pain management ethics in Malta.

• Contribute to and enhance the education and training of healthcare practitioners, integrating ethical considerations into pain management practices.

• Facilitate and encourage dialogue within the Maltese community regarding pain management ethics, encouraging an inclusive and participatory approach to decision-making.

6. World Health Organization. Addressing Global Health Equity in Global Health Research and Policy. WHO; 2020.

7. World Health Organization. Guidelines on the management of chronic pain in children. World Health Organization, 2020.

Ethical Exploration Continuum

This research aims to position itself along the continuum of ethical exploration, from the theoretical foundations provided by the WHO’s "Global Health Ethics: Key Issues^[4] to practical application fostering a holistic understanding that benefits not only the academic realm but, more importantly, the day-to-day ethical practices in pain management in Malta.

Hypotheses

We hypothesize that cultural values significantly influence opioid prescribing practices and patient perceptions of pain management, with specific ethical dilemmas arising from these cultural contexts."

fostering a holistic understanding that benefits not only the academic realm but, more importantly, the day-to-day ethical practices in pain management in Malta.

Methodology

Study Design

This study will use a mixed-methods research design, which will be a combination of quantitative and qualitative insights into Malta's pain management ethics (Ivankova & Plano Clark, 2018)^[8] to gain a comprehensive understanding of the ethical challenges in pain management within the healthcare context of Malta. The initial qualitative phase employs thematic analysis (Braun & Clarke, 2006)^[9] to explore healthcare professionals' and patients' perspectives. Findings then inform the subsequent quantitative survey phase, analysed for statistical patterns (Field, 2013)^[10], ensuring a comprehensive understanding of ethical dilemmas in opioid prescribing and pain management strategies. This approach will assist in providing an insight into numerical trends and distinct perspectives of those involved. We will employ a concurrent triangulation strategy, treating both qualitative and quantitative data with equal weight to ensure a holistic understanding of the research questions.

Sequential Exploratory Study

The study will adopt a methodology that comprises two separate phases. The first phase is dedicated to qualitative data collection while the second involves quantitative analysis. This allows the initial findings from the qualitative data collection phase to be used in the development of a structured survey that contains questions that are relevant to real-world experiences and concerns of healthcare professionals and patients, allowing insightful exploration of both quantitative trends and qualitative perspectives.

4.1.1.2 Phase 1: Qualitative Exploration

By use of thematic analysis, as detailed by Braun and Clarke^[9], this phase aims to uncover underlying themes in ethical considerations of opioid prescribing, through interviews with healthcare professionals and patients. This phase will involve carrying out semi-structured interviews with healthcare professionals and patients on purposefully selected samples. These in-depth interviews willinvolve approximately 30 participants to ensure a diverse range of perspectives is captured. The primary goal of these interviews is to delve deeper into the ethical considerations involved in opioid prescribing and pain management while also revealing any challenging decision-making processes encountered during actual practice. The qualitative data collected through these face-to-face conversations aim at uncovering themes or patterns that may not have been immediately perceivable via quantitative research alone.

4.1.1.2 Phase 2: Quantitative Analysis

Employing statistical analysis tools and techniques highlighted by Andy Field^[10], the second phase will analyse survey data to validate themes identified in the qualitative phase and explore prevalence

8. Ivankova, N. V., and V. L. Plano Clark. "Teaching mixed methods research: using a socio-ecological framework as a pedagogical approach for addressing the complexity of the field." International Journal of Social Research Methodology 21.4 (2018): 409-424.

9. Braun, Virginia, and Victoria Clarke. "Using thematic analysis in psychology." Qualitative research in psychology 3.2 (2006): 77-101.

10. Field, Andy. Discovering statistics using IBM SPSS statistics. sage, 2013.

and attitudes toward opioid prescription practices. We plan to survey at least 100 healthcare professionals and 50 patients, selected through purposive sampling to ensure representation across different demographics and professional experiences. The said survey tool will target a wider range of healthcare professionals and patients to determine the prevalence of certain ethical quandaries, attitudes surrounding opioid prescription practices, and evaluations regarding pain management efficacy. Statistical examination of responses gathered via this questionnaire shall deliver empirical proof for validating or questioning findings established in prior phases; thus, providing an all- encompassing perspective on matters related to ethics within pain relief administration strategies.

Data Collect

Semi-structured interviews that last 30-60 minutes will gather qualitative data on ethical considerations and personal pain management experiences. Likewise, surveys with both Likert scaleand open-ended questions distributed through digital or physical modes are the methods to obtain quantitative information while capturing insights qualitatively. To ensure a high response rate motivating factors such as personalized engagement techniques like follow-up reminders along witheasy accessibility are being considered for implementation strategies.

Sampling Strategy

To enrich the study's findings, a diverse and representative sample of healthcare professionals such as family medicine physicians, pain management specialists, nurses and mental health professionals, patients with various pain management experiences, including those with acute and chronic pain conditions, and other stakeholders directly involved in pain management is selected using purposive sampling. The selection criteria encompass professional experience, type of pain suffered by participants under investigation, duration spent on managing their respective pains as well as opioid usage history alongside demographic factors. Furthermore, saturation points are used to adjust this sample size when conducting qualitative research so that varied perspectives can be included.

Ethical Considerations

The study will ensure participant confidentiality through secure storage and anonymization of data, with access restricted to the research team. Participants will be fully informed about the study's aims, methods, risks, and benefits, and must consent voluntarily, with the ability to withdraw at any time. Recruitment emphasizes voluntary participation without penalty for withdrawal. Ethical approval will be obtained from a relevant ethics committee or IRB, ensuring compliance with ethical standards, including the Declaration of Helsinki^[11] and local Maltese regulations, with particular attention to ethical issues in pain management research such as those stated by Buhagiar and Angele in Physiotherapy for patients with chronic pain: ethical aspects^[12] and A review of the National pharmacovigilance system in Malta by Tanti et al^[13].

Analysis

During the analysis phase, thematic and statistical approaches are utilized. To identify significant themes and gain insights into ethical considerations regarding pain management, qualitative data extracted from surveys and interviews is subjected to thematic analysis. The process involves analysing coded data for relevant patterns using specialized software such as ATLAS.ti or NVivo that can efficiently handle textual information. The study's quantitative data gathered from the survey will undergo analysis through descriptive statistics to provide an overview of attitudes and perceptions.

Additionally, inferential statistics - which may encompass regression analysis - shall be conducted in order to investigate correlations between variables tied to pain management ethics. To facilitate these analytical processes whilst ensuring thorough examination of data trends and hypothesis testing, statistical software packages including SPSS or R shall serve as indispensable tools. By employing this integrated technique, a comprehensive comprehension of the research's topics is guaranteed. This

11. Goodyear, Michael DE, Karmela Krleza-Jeric, and Trudo Lemmens. "The declaration of Helsinki." Bmj 335.7621 (2007): 624-625.

12. Buhagiar, Angele. Physiotherapy for patients with chronic pain: ethical aspects. MS thesis. University of Malta, 2020

13. Tanti, Amy, et al. "A review of the National pharmacovigilance system in Malta–implementing and operating a pharmacovigilance management system." Expert Opinion on Drug Safety 16.1 (2017): 65-76.

strategy elevates the credibility of conclusions while backing up the formation of knowledgeable proposals suitable for Malta's healthcare environment.

To enhance the validity and reliability of our study, we'll implement pilot testing of the survey instrument to refine questions and layout, ensuring clarity and effectiveness. Additionally, for our thematic analysis, we will conduct inter-rater reliability checks, involving multiple researchers in the coding process to confirm consistency in theme identification. Theoretical frameworks, such as grounded theory, will guide our qualitative data analysis, allowing for a systematic and in-depth exploration of emerging patterns and themes within the context of Malta's pain management ethics.

Triangulation

1. Methodological Triangulation

This will be used to ensure reliable research outcomes by incorporating qualitative and quantitative data. This approach permits cross-validation in which findings from one method can confirm or diverge with those of another, leading to a broader comprehension of the moral complexities involved in pain management.

Data Triangulation

To ensure that the study's outcomes encompass a diverse array of experiences and perspectives, data triangulation will be employed. This entails gathering information from various sources such as healthcare professionals, patients, and family members using both interviews and surveys. Such an approach would enrich the findings obtained through this investigation with rich insights from all angles involved in patient care delivery.

Interdisciplinary Insights

The study aims to draw from various fields, including ethics, sociology, and public health, to provide a comprehensive interpretation of its results. By adopting an interdisciplinary approach such as this one, the research hopes to enhance our comprehension of how pain management poses complex ethical dilemmas such as those stated by Ferrell, Betty R., et al. in the Journal of Pain^[14], and Humphreys and Keith in the ethical dilemma of pain medicine^[15].

Expected Outcomes

Informed Opioid Prescribing Practices

Gain nuanced insights into the ethical dimensions surrounding opioid prescribing practices, exploring factors influencing decisions and the role of shared decision-making.

Enhanced Ethical Guidelines

Identify gaps and propose recommendations for enhancing ethical guidelines in pain management, considering challenges related to opioid prescriptions, patient autonomy, and practitioner responsibilities.

Patient-Centred Pain Management

Explore ways to make pain management more patient-centred, considering the subjective nature of pain and the importance of personalized care.

Improved Communication Strategies

Evaluate communication dynamics among healthcare providers, patients, and stakeholders in pain management, addressing ethical considerations related to treatment choices, informed consent, and shared decision-making.

14. Ferrell, Betty R., et al. "Ethical dilemmas in pain management." The Journal of Pain 2.3 (2001): 171-180.

15. Humphreys, Keith. "Reconciling the present and the future in opioid prescription policy: an ethical dilemma." Pain Medicine 19.8 (2018): 1514-1515.

Conclusion

In conclusion, this research on ethical challenges in pain management aims to illuminate the intricate landscape of decision-making for patients in Malta. By aligning universal ethical principles with Malta's unique healthcare context, the study aims to bridge the gap between global ethical standards and local practices as well as foster responsible and patient-centred pain management practices.

Drawing insights from existing literature and ethical frameworks, this research aims not only to enhance local practices but also to contribute valuable perspectives to global discussions on ethical considerations in pain management. Ultimately, the findings aspire to catalyse positive shifts in pain management practices, ensuring the well-being of patients in Malta and beyond.

References

1. Centers for Disease Control and Prevention (CDC). (2022). CDC Clinical Practice Guideline for Prescribing Opioids for Pain — United States, 2022. MMWR. Retrieved from https://www.cdc.gov/mmwr/volumes/71/rr/rr7103a1.htm

2. Beauchamp TL, Childress JF. Principles of Biomedical Ethics. Oxford University Press; 2019

3. Rundle A, Carvalho M, Robinson M. Cultural Competence in Health Care: A Practical Guide.

Jossey-Bass; 2008

4. World Health Organization. Global Health Ethics: Key Issues. WHO; 2015

5. International Association for the Study of Pain. Pain Management Guidelines. IASP; 2020.

European Pain Federation EFIC. Position Papers and Guidelines. EFIC; 2020

6. World Health Organization. Addressing Global Health Equity in Global Health Research and Policy. WHO; 2020.

7. World Health Organization. Guidelines on the management of chronic pain in children. World Health Organization, 2020.

8. Ivankova, N. V., and V. L. Plano Clark. "Teaching mixed methods research: using a socio- ecological framework as a pedagogical approach for addressing the complexity of the field." International Journal of Social Research Methodology 21.4 (2018): 409-424.

9. Braun, Virginia, and Victoria Clarke. "Using thematic analysis in psychology." Qualitative research in psychology 3.2 (2006): 77-101.

10. Field, Andy. Discovering statistics using IBM SPSS statistics. sage, 2013.

11. Goodyear, Michael DE, Karmela Krleza-Jeric, and Trudo Lemmens. "The Declaration of Helsinki." Bmj 335.7621 (2007): 624-625.

12. Buhagiar, Angele. Physiotherapy for patients with chronic pain: ethical aspects. MS thesis.

University of Malta, 2020

13. Tanti, Amy, et al. "A review of the National pharmacovigilance system in Malta–implementing and operating a pharmacovigilance management system." Expert Opinion on Drug Safety 16.1 (2017): 65-76.

14. Ferrell, Betty R., et al. "Ethical dilemmas in pain management." The Journal of Pain 2.3 (2001): 171-180.

15. Humphreys, Keith. "Reconciling the present and the future in opioid prescription policy: an ethical dilemma." Pain Medicine 19.8 (2018): 1514-1515.