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05543aam a2200457Ii 4500 001 A492FBA2CF3111EB9A1890BA3BECA4DB 003 SILO 005 20210617010040 008 200802t20202020dcuab b 000 0 eng d 020 $a 0309672155 020 $a 9780309672153 035 $a (OCoLC)1179920594 040 $a YDX $b eng $e rda $c YDX $d NRC $d OCLCO $d SOI $d OCLCF $d YDXIT $d OCLCO $d OCL $d OCLCO $d OCLCA $d NUI $d SILO 050 4 $a RB127 $b .N38 2020 060 4 $a WL 704.6 082 04 $a 616/.0472 $2 23 110 2 $a National Academies of Sciences, Engineering, and Medicine (U.S.), $e author. 245 10 $a Compounded topical pain creams : $b review of select ingredients for safety, effectiveness, and use / $c Debra A. Schwinn and Leigh Miles Jackson, editors ; Committee on the Assessment of the Available Scientific Data Regarding the Safety and Effectiveness of Ingredients Used in Compounded Topical Pain Creams, Board on Health Sciences Policy, Health and Medicine Division. 264 1 $a Washington, DC : $b The National Academies Press, $c [2020] 300 $a xxiv, 328 pages : $b color illustrations, maps (chiefly color) ; $c 23 cm 520 $a 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. 520 $a 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.--Publisher's website. 504 $a Includes bibliographical references. 505 0 $a Intro -- FrontMatter -- Reviewers -- Preface -- Acknowledgments -- Contents -- Boxes, Figures, and Tables -- Acronyms and Abbreviations -- Summary -- 1 Introduction -- 2 Role of Topical Pain Creams in Pain Management -- 3 Fundamentals, Use, and Common Ingredients in Compounded Topical Pain Creams -- 4 Gaps in Regulation, Oversight, and Surveillance -- 5 Science of Compounded Topical Pain Creams -- 6 A Review of the Safety and Effectiveness of Select Ingredients in Compounded Topical Pain Creams -- 7 Additional Concerns Related to the Use of Compounded Topical Pain Creams 505 8 $a 8 Recommendations Regarding the Treatment of Patients with Compounded Topical Pain Creams -- Appendix A: Study Approach -- Appendix B: Literature Review -- Appendix C: Commissioned Paper: Topical Dosage Form Development and Evaluation -- Appendix D: Glossary -- Appendix E: 503A and 503B Distribution Supplement -- Appendix F: Adverse Events Table -- Appendix G: Potential Adverse Effects from Oral Administration of 20 Active Pharmaceutical Ingredients Commonly Used in Compounded Topical Pain Creams -- Appendix H: Expanded Discussion on Special Populations to Consider in Pain Management 505 8 $a Appendix I: Biographical Sketches for Committee Members, Fellow, Consultants, and Staff 650 0 $a Pain medicine. 650 0 $a Analgesics $x Effectiveness. 650 2 $a Pain $x drug therapy. $0 (DNLM)D010146Q000188 650 2 $a Analgesics. $0 (DNLM)D000700 650 7 $a Analgesics $x Effectiveness. $2 fast $0 (OCoLC)fst00808274 650 7 $a Pain medicine. $2 fast $0 (OCoLC)fst01050428 710 2 $a National Academies of Sciences, Engineering, and Medicine (U.S.). $b Committee on the Assessment of the Available Scientific Data Regarding the Safety and Effectiveness of Ingredients Used in Compounded Topical Pain Creams, $e issuing body. 710 2 $a National Academies of Sciences, Engineering, and Medicine (U.S.). $b Board on Health Sciences Policy, $e issuing body. 710 2 $a National Academies of Sciences, Engineering, and Medicine (U.S.). $b Health and Medicine Division, $e issuing body. 776 08 $i Online version: $a National Academies of Sciences, Engineering, and Medicine. $t Compounded Topical Pain Creams. $d Washington, D.C. : National Academies Press, 2021 $z 9780309672160 $w (OCoLC)1181845179 700 1 $a Jackson, Leigh Miles. $e editor. 700 1 $a Schwinn, Debra A., $e editor. 941 $a 1 952 $l OVUX522 $d 20220317020234.0 956 $a http://locator.silo.lib.ia.us/search.cgi?index_0=id&term_0=A492FBA2CF3111EB9A1890BA3BECA4DBInitiate Another SILO Locator Search