Compounded topical pain creams :: review of select ingredients for safety, effectiveness, and use /
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 popula...
Gespeichert in:
| Weitere Verfasser: | , |
|---|---|
| Format: | Elektronisch E-Book |
| Sprache: | English |
| Veröffentlicht: |
Washington, DC :
The National Academies Press,
[2020]
|
| Schriftenreihe: | Consensus study report.
|
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Zusammenfassung: | 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. |
| Beschreibung: | 1 online resource (1 PDF file (xxiv, 328 pages)) : illustrations |
| Bibliographie: | Includes bibliographical references. |
| ISBN: | 9780309672160 0309672163 9780309672184 030967218X |
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| 245 | 0 | 0 | |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. |
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| 490 | 1 | |a Consensus study report of the National Academies of Sciences, Engineering, Medicine | |
| 504 | |a Includes bibliographical references. | ||
| 520 | 3 | |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. 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. | |
| 536 | |a This activity was supported by a contract between the National Academy of Sciences and the U.S. Food and Drug Administration. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project. | ||
| 588 | 0 | |a Online resource; title from PDF title page (viewed November 20, 2020). | |
| 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 | |
| 650 | 0 | |a Pain medicine. |0 http://id.loc.gov/authorities/subjects/sh2003008504 | |
| 650 | 0 | |a Transdermal medication. |0 http://id.loc.gov/authorities/subjects/sh85043050 | |
| 650 | 0 | |a Outcome assessment (Medical care) |0 http://id.loc.gov/authorities/subjects/sh94002382 | |
| 650 | 1 | 2 | |a Analgesics |x therapeutic use |
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| 650 | 2 | 2 | |a Pain |x drug therapy |
| 650 | 2 | 2 | |a Skin Cream |x therapeutic use |
| 650 | 2 | 2 | |a Administration, Cutaneous |
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| 650 | 2 | 2 | |a Safety Management |
| 651 | 2 | |a United States |0 https://id.nlm.nih.gov/mesh/D014481 | |
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| contents | 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 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 |
| ctrlnum | (OCoLC)1182515653 |
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| dewey-raw | 616.0472 |
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| genre | Systematic Review Revues systématiques. rvmgf |
| genre_facet | Systematic Review Revues systématiques. |
| geographic | United States https://id.nlm.nih.gov/mesh/D014481 |
| geographic_facet | United States |
| id | ZDB-4-EBA-on1182515653 |
| illustrated | Illustrated |
| indexdate | 2024-11-27T13:30:01Z |
| institution | BVB |
| institution_GND | http://id.loc.gov/authorities/names/n2020186242 |
| isbn | 9780309672160 0309672163 9780309672184 030967218X |
| language | English |
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| publishDate | 2020 |
| publishDateSearch | 2020 |
| publishDateSort | 2020 |
| publisher | The National Academies Press, |
| record_format | marc |
| series | Consensus study report. |
| series2 | Consensus study report of the National Academies of Sciences, Engineering, Medicine |
| spelling | Compounded topical pain creams : review of select ingredients for safety, effectiveness, and use / 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. Washington, DC : The National Academies Press, [2020] 1 online resource (1 PDF file (xxiv, 328 pages)) : illustrations text txt rdacontent computer c rdamedia online resource cr rdacarrier Consensus study report of the National Academies of Sciences, Engineering, Medicine Includes bibliographical references. 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. This activity was supported by a contract between the National Academy of Sciences and the U.S. Food and Drug Administration. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project. Online resource; title from PDF title page (viewed November 20, 2020). 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 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 Pain medicine. http://id.loc.gov/authorities/subjects/sh2003008504 Transdermal medication. http://id.loc.gov/authorities/subjects/sh85043050 Outcome assessment (Medical care) http://id.loc.gov/authorities/subjects/sh94002382 Analgesics therapeutic use Analgesics administration & dosage Pain drug therapy Skin Cream therapeutic use Administration, Cutaneous Drug Compounding standards Treatment Outcome Safety Management United States https://id.nlm.nih.gov/mesh/D014481 Outcome and Process Assessment, Health Care. Outcome Assessment, Health Care. Médecine de la douleur. Médicaments Administration par voie transdermique. Évaluation des résultats (Soins médicaux) Transdermal medication fast Outcome assessment (Medical care) fast Pain medicine fast Systematic Review Revues systématiques. rvmgf Jackson, Leigh Miles, editor. Schwinn, Debra A., editor. National Academies of Sciences, Engineering, and Medicine (U.S.). Committee on the Assessment of the Available Scientific Data Regarding the Safety and Effectiveness of Ingredients Used in Compounded Topical Pain Creams, issuing body. http://id.loc.gov/authorities/names/n2020186242 Print version: 0309672155 9780309672153 (OCoLC)1179920594 Consensus study report. http://id.loc.gov/authorities/names/n2017188206 FWS01 ZDB-4-EBA FWS_PDA_EBA https://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&AN=2591574 Volltext |
| spellingShingle | Compounded topical pain creams : review of select ingredients for safety, effectiveness, and use / Consensus study report. 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 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 Pain medicine. http://id.loc.gov/authorities/subjects/sh2003008504 Transdermal medication. http://id.loc.gov/authorities/subjects/sh85043050 Outcome assessment (Medical care) http://id.loc.gov/authorities/subjects/sh94002382 Analgesics therapeutic use Analgesics administration & dosage Pain drug therapy Skin Cream therapeutic use Administration, Cutaneous Drug Compounding standards Treatment Outcome Safety Management Outcome and Process Assessment, Health Care. Outcome Assessment, Health Care. Médecine de la douleur. Médicaments Administration par voie transdermique. Évaluation des résultats (Soins médicaux) Transdermal medication fast Outcome assessment (Medical care) fast Pain medicine fast |
| subject_GND | http://id.loc.gov/authorities/subjects/sh2003008504 http://id.loc.gov/authorities/subjects/sh85043050 http://id.loc.gov/authorities/subjects/sh94002382 https://id.nlm.nih.gov/mesh/D014481 |
| title | Compounded topical pain creams : review of select ingredients for safety, effectiveness, and use / |
| title_auth | Compounded topical pain creams : review of select ingredients for safety, effectiveness, and use / |
| title_exact_search | Compounded topical pain creams : review of select ingredients for safety, effectiveness, and use / |
| title_full | Compounded topical pain creams : review of select ingredients for safety, effectiveness, and use / 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. |
| title_fullStr | Compounded topical pain creams : review of select ingredients for safety, effectiveness, and use / 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. |
| title_full_unstemmed | Compounded topical pain creams : review of select ingredients for safety, effectiveness, and use / 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. |
| title_short | Compounded topical pain creams : |
| title_sort | compounded topical pain creams review of select ingredients for safety effectiveness and use |
| title_sub | review of select ingredients for safety, effectiveness, and use / |
| topic | Pain medicine. http://id.loc.gov/authorities/subjects/sh2003008504 Transdermal medication. http://id.loc.gov/authorities/subjects/sh85043050 Outcome assessment (Medical care) http://id.loc.gov/authorities/subjects/sh94002382 Analgesics therapeutic use Analgesics administration & dosage Pain drug therapy Skin Cream therapeutic use Administration, Cutaneous Drug Compounding standards Treatment Outcome Safety Management Outcome and Process Assessment, Health Care. Outcome Assessment, Health Care. Médecine de la douleur. Médicaments Administration par voie transdermique. Évaluation des résultats (Soins médicaux) Transdermal medication fast Outcome assessment (Medical care) fast Pain medicine fast |
| topic_facet | Pain medicine. Transdermal medication. Outcome assessment (Medical care) Analgesics therapeutic use Analgesics administration & dosage Pain drug therapy Skin Cream therapeutic use Administration, Cutaneous Drug Compounding standards Treatment Outcome Safety Management United States Outcome and Process Assessment, Health Care. Outcome Assessment, Health Care. Médecine de la douleur. Médicaments Administration par voie transdermique. Évaluation des résultats (Soins médicaux) Transdermal medication Pain medicine Systematic Review Revues systématiques. |
| url | https://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&AN=2591574 |
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