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Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use (2020)

Chapter: Appendix H: Expanded Discussion on Special Populations to Consider in Pain Management

« Previous: Appendix G: Potential Adverse Effects from Oral Administration of 20 Active Pharmaceutical Ingredients Commonly Used in Compounded Topical Pain Creams
Suggested Citation:"Appendix H: Expanded Discussion on Special Populations to Consider in Pain Management." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
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Appendix H

Expanded Discussion on Special Populations to Consider in Pain Management

ELDERLY AND PEDIATRIC POPULATIONS

Overall findings from the pain research field suggest that pain experienced by pediatric and geriatric populations is understudied and often inadequately managed. Estimates suggest that more than half of older adults in the United States experience regular bothersome pain (Kaye et al., 2010; Patel et al., 2013). Similarly, pediatric studies suggest that up to one-third of children and young people experience chronic or recurrent pain that is often underrecognized and undertreated (King et al., 2011; McCarthy and Rastogi, 2017).1

Certain U.S. Food and Drug Administration–approved pain products may be unsuitable for elderly or pediatric patients—individuals who may have difficulty swallowing oral medications and/or who lack the muscle mass to receive frequent injections (Liu et al., 2014). In addition, the functionality of organ systems (either in developing or aging patients) and the absorption profiles of skin are of great relevance, and a simple extrapolation of pharmacokinetic or pharmacodynamics data from healthy adults is likely to be inadequate. As a result, pain management plans for these populations tend to be more complex and may result in suboptimal treatments.

Adding complexity to the situation, pain products formulated for adults may not be appropriate in infants and children who have sensitivities or allergies, or who need more palatable or age-appropriate formulations

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1 Evaluating and managing pain is particularly challenging in neonates, in preverbal children, and in children with complex neurodevelopmental needs (Quinn et al., 2018).

Suggested Citation:"Appendix H: Expanded Discussion on Special Populations to Consider in Pain Management." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×

(Berde et al., 2012; Liu et al., 2014; McBane et al., 2019; O’Donnell and Rosen, 2014). Elderly patients who have comorbidities that require polypharmacy further complicates health providers’ efforts to effectively and appropriately treat their pain (Borsheski and Johnson, 2014).2 Importantly, the prevalence of chronic pain is likely to increase as Americans live longer, which may profoundly affect morbidity and health care expenditures,3 and although pain management is a critical part of palliative care, studies suggest that pain experienced by people at end of life is often inadequately assessed and treated (IOM, 2011; Wilkie and Ezenwa, 2012).

GENDER, RACE, AND ETHNICITY

The experience of pain and the quality of pain management are also shaped by sociodemographic factors of gender, race, and ethnicity (Mossey, 2011). In the United States, women and racial and ethnic minorities report more pain complaints than men (Dahlhamer et al., 2018; Mansfield et al., 2016) and experience chronic illnesses (e.g., diabetes, cancer) associated with chronic pain, aging, and disability more frequently and at an earlier age than their White male counterparts. Women who are pregnant commonly experience chronic pain, but the evidence-based guidance on how to best provide safe and effective pain management in pregnant women is understudied, as is the potential effect on their unborn children (Ray-Griffith et al., 2018; Shah et al., 2015). To complicate matters further, gender differences in response to analgesics suggest that biological, sociocultural, and psychological mechanisms underline those differences.

Racial and ethnic minorities who experience certain chronic illnesses associated with chronic pain are more likely to have poorer overall access to primary care and are less likely to be referred for specialty pain care, as compared to nonminority patients (Ezenwa and Fleming, 2012). When their pain is assessed, women and patients of color received less medication for pain (including opioids) and suboptimal pain care in all clinical settings (Green et al., 2003, 2005). Variability in clinicians’ attitudes toward women and racial/ethnic minorities are suggested to reflect clinicians’ implicit, conscious, and unconscious biases that further complicate pain therapy for those groups (Green et al., 2003; Hoffman et al., 2016).

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2 Older adults commonly experience pain caused by health conditions associated with aging, such as musculoskeletal conditions, Parkinson’s disease, Alzheimer’s disease, cancer, joint surgeries, compression fractures, and advanced chronic diseases such as end-stage renal disease (Husebo et al., 2016; Smith et al., 2010).

3 The prevalence of chronic pain will increase as the global population ages, driving increases in morbidity and health care expenditures. For example, by 2030, the number of hip and knee replacements is expected to grow by 174 percent (572,000 procedures) and by 673 percent (3.48 million procedures), respectively (Kurtz et al., 2007).

Suggested Citation:"Appendix H: Expanded Discussion on Special Populations to Consider in Pain Management." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×

ADDITIONAL SUBPOPULATIONS

In addition to the patient populations listed above, there are additional subpopulations who may also experience disparities in accessing quality pain care, pain assessment, pain treatment, or outcomes of care. For example, many patients living in underserved communities (e.g., rural or urban areas) receive their care in the primary care arena and may have difficulty accessing specialized multidisciplinary and multimodal pain care (Eaton et al., 2018). The potential absence of health services, health care insurance, and other resources (e.g., wealth, positive social support), as well as the potential presence of specific stressors (e.g., social roles, comorbidities), can influence health care access and use, quality of care, and short- and long-term health outcomes (Leeds et al., 2017; Nguyen et al., 2005).

Managing chronic and acute pain experienced by people with current or prior substance use disorder can be challenging because of both the patients’ attitudes and providers’ practical and ethical concerns related to addiction and drug-seeking behavior (Cheatle et al., 2014). Other populations that may have more complex management pain plans include patients with an increased risk of kidney-related complications, or individuals with spinal cord injuries, patients with cognitive disorders (e.g., Alzheimer’s), military veterans, or individuals for which English is not their first language (Davison, 2019; Hama and Sagen, 2012; IOM, 2011; NASEM, 2017).

REFERENCES

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Borsheski, R., and Q. L. Johnson. 2014. Pain management in the geriatric population. Missouri Medicine 111(6):508–511.

Cheatle, M., D. Comer, M. Wunsch, A. Skoufalos, and Y. Reddy. 2014. Treating pain in addicted patients: Recommendations from an expert panel. Population Health Management 17(2):79–89.

Dahlhamer, J., J. Lucas, C. Zalaya, R. Nahin, S. Mackey, L. DeBar, R. Kerns, M. Von Korff, L. Porter, and C. Helmick. 2018. Prevalence of chronic pain and high-impact chronic pain among adults—United States, 2016. Morbidity and Mortality Weekly Report 67:1001–1006.

Davison, S. N. 2019. Clinical pharmacology considerations in pain management in patients with advanced kidney failure. Clinical Journal of the American Society of Nephrology 14(6):917–931.

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Ezenwa, M. O., and M. F. Fleming. 2012. Racial disparities in pain management in primary care. Journal of Health Disparities Research and Practice 5(3):12–26.

Suggested Citation:"Appendix H: Expanded Discussion on Special Populations to Consider in Pain Management." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×

Green, C. R., J. R. Wheeler, and F. LaPorte. 2003. Clinical decision making in pain management: Contributions of physician and patient characteristics to variations in practice. The Journal of Pain 4(1):29–39.

Green, C. R., R. C. Tait, and R. M. Gallagher. 2005. The unequal burden of pain: Disparities and differences. Pain Medicine 6(1):1–2.

Hama, A., and J. Sagen. 2012. Combination drug therapy for pain following chronic spinal cord injury. Pain Research and Treatment 2012:840486.

Hoffman, K. M., S. Trawalter, J. R. Axt, and M. N. Oliver. 2016. Racial bias in pain assessment and treatment recommendations, and false beliefs about biological differences between blacks and whites. Proceedings of the National Academy of Sciences 113(16):4296–4301.

Husebo, B. S., W. Achterberg, and E. Flo. 2016. Identifying and managing pain in people with Alzheimer’s disease and other types of dementia: A systematic review. CNS Drugs 30(6):481–497.

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Kaye, A. D., A. Baluch, and J. T. Scott. 2010. Pain management in the elderly population: A review. Ochsner Journal 10(3):179–187.

King, S., C. T. Chambers, A. Huguet, R. C. MacNevin, P. J. McGrath, L. Parker, and A. J. MacDonald. 2011. The epidemiology of chronic pain in children and adolescents revisited: A systematic review. Pain 152(12):2729–2738.

Kurtz, S., K. Ong, E. Lau, F. Mowat, and M. Halpern. 2007. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. Journal of Bone and Joint Surgery 89(4):780–785.

Leeds, I. L., Y. Alimi, D. R. Hobson, J. E. Efron, E. C. Wick, E. R. Haut, and F. M. Johnston. 2017. Racial and socioeconomic differences manifest in process measure adherence for enhanced recovery after surgery pathway. Diseases of the Colon and Rectum 60(10):1092–1101.

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McCarthy, K. F., and S. Rastogi. 2017. Complex pain in children and young people: Part I—assessment. BJA Education 17(10):317–322.

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NASEM (National Academies of Sciences, Engineering, and Medicine). 2017. Pain management and the opioid epidemic: Balancing societal and individual benefits and risks of prescription opioid use. Washington, DC: The National Academies Press.

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Suggested Citation:"Appendix H: Expanded Discussion on Special Populations to Consider in Pain Management." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×

Patel, K. V., J. M. Guralnik, E. J. Dansie, and D. C. Turk. 2013. Prevalence and impact of pain among older adults in the United States: Findings from the 2011 National Health and Aging Trends Study. Pain 154(12):2649–2657.

Quinn, B. L., J. C. Solodiuk, D. Morrill, and S. Mauskar. 2018. CE: Original research: Pain in nonverbal children with medical complexity: A two-year retrospective study. American Journal of Nursing 118(8):28–37.

Ray-Griffith, S. L., M. P. Wendel, Z. N. Stowe, and E. F. Magann. 2018. Chronic pain during pregnancy: A review of the literature. International Journal of Women’s Health 10:153–164.

Shah, S., E. T. Banh, K. Koury, G. Bhatia, R. Nandi, and P. Gulur. 2015. Pain management in pregnancy: Multimodal approaches. Pain Research and Treatment 2015:987483.

Smith, A. K., I. S. Cenzer, S. J. Knight, K. A. Puntillo, E. Widera, B. A. Williams, W. J. Boscardin, and K. E. Covinsky. 2010. The epidemiology of pain during the last 2 years of life. Annals of Internal Medicine 153(9):563–569.

Wilkie, D. J., and M. O. Ezenwa. 2012. Pain and symptom management in palliative care and at end of life. Nursing Outlook 60(6):357–364.

Suggested Citation:"Appendix H: Expanded Discussion on Special Populations to Consider in Pain Management." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×

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Suggested Citation:"Appendix H: Expanded Discussion on Special Populations to Consider in Pain Management." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×
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Suggested Citation:"Appendix H: Expanded Discussion on Special Populations to Consider in Pain Management." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×
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Suggested Citation:"Appendix H: Expanded Discussion on Special Populations to Consider in Pain Management." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×
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Suggested Citation:"Appendix H: Expanded Discussion on Special Populations to Consider in Pain Management." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×
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Suggested Citation:"Appendix H: Expanded Discussion on Special Populations to Consider in Pain Management." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×
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Suggested Citation:"Appendix H: Expanded Discussion on Special Populations to Consider in Pain Management." National Academies of Sciences, Engineering, and Medicine. 2020. Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25689.
×
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Pain is both a symptom and a disease. It manifests in multiple forms and its treatment is complex. Physical, social, economic, and emotional consequences of pain can impair an individual’s overall health, well-being, productivity, and relationships in myriad ways. The impact of pain at a population level is vast and, while estimates differ, the Centers for Disease Control and Prevention reported that 50 million U.S. adults are living in pain. In terms of pain’s global impact, estimates suggest the problem affects approximately 1 in 5 adults across the world, with nearly 1 in 10 adults newly diagnosed with chronic pain each year.

In recent years, the issues surrounding the complexity of pain management have contributed to increased demand for alternative strategies for treating pain. One such strategy is to expand use of topical pain medications—medications applied to intact skin. This nonoral route of administration for pain medication has the potential benefit, in theory, of local activity and fewer systemic side effects. Compounding is an age-old pharmaceutical practice of combining, mixing, or adjusting ingredients to create a tailored medication to meet the needs of a patient. The aim of compounding, historically, has been to provide patients with access to therapeutic alternatives that are safe and effective, especially for people with clinical needs that cannot otherwise be met by commercially available FDA-approved drugs.

Compounded Topical Pain Creams explores issues regarding the safety and effectiveness of the ingredients in these pain creams. This report analyzes the available scientific data relating to the ingredients used in compounded topical pain creams and offers recommendations regarding the treatment of patients.

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