Compounded Topical Pain Creams Review of Select Ingredients for Safety, Effectiveness, and Use (2020) / Chapter Skim
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Appendix B: Literature Review
Appendix B: Literature Review
Pages 247-256
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From page 247... ...
In this search, the committee also included ketamine as an API of interest. This focused search used the same six databases as the broad search, as well as the same inclusion and exclusion parameters, and produced 240 articles with potential relevance to the committee's charge.
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APIs of priority to FDA: • Amitriptyline • Baclofen • Clonidine • Cyclobenzaprine • Gabapentin • Meloxicam • Memantine • Orphenadrine • Topiramate • Tramadol It is the committee's understanding that the FDA-presented ingredi ents were identified from examples of commonly compounded topical pain medication formulas and that the list was generated through online research efforts, as well as through personal communications with other government agencies (e.g., Centers for Medicare & Medicaid Services, U.S. Department of Defense, and U.S.
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From page 249... ...
Factors that influenced the committee's deci sions included, but were not limited to • Appropriate representation between and within relevant drug classes; • Sufficient evidence base to address the committee's research questions; • Common appearance in formulations for compounded topical pain creams in online advertisements and prefilled prescription pads; • Representation in the National Association of Boards of Pharmacy (NABP) -reported top five dispensed compounded products from 503A and 503B pharmacies requesting an NABP inspection; • Use in compounded topical pain cream products linked to adverse events within the U.S.
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250 FIGURE B-1 Literature search and article selection process flowchart.
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Search Strategies FDA-Priority Ingredients Broad Search Date performed: January 9, 2019 Articles obtained: 1,476 Databases: Embase, Medline, PubMed, Scopus, Toxnet, ClinicalTrials.gov Search Parameters: 1900 to present Peer-reviewed articles English language International 1 For more information on the risk of bias assessment used, see Sterne, J
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Pharmacokinetics e. Safety FDA-Priority Ingredients Focused Search Date performed: April 22, 2019 Articles obtained: 240 Databases: Embase, Medline, PubMed, Scopus, Toxnet, ClinicalTrials.gov Search Parameters: 1900 to present Peer-reviewed articles English language International Search Terms: 1.
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Pharmacokinetics c. Pain management Additional Ingredients Broad Search Date performed: May 31, 2019 Articles obtained: 7,103 Databases: Embase, Medline, PubMed, Scopus, Toxnet, ClinicalTrials.gov Search Parameters: 1900 to present Peer-reviewed articles English language International Search Terms: 1.
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Pharmacokinetics e. Safety Additional Ingredients Focused Search Date performed: April 30, 2019 Articles obtained: 203 Databases: Embase, Medline, PubMed, Scopus, Toxnet, ClinicalTrials.gov Search Parameters: 1900 to present Peer-reviewed articles English language International Search Terms: 1.
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absorption Skin v. Transdermal drug administration 3.
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