메뉴 건너뛰기




Volumn 108, Issue 5, 2013, Pages 642-646

What gastroenterologists should know about the gray market, herbal remedies, and compounded pharmaceuticals and their regulation by the food and drug administration

Author keywords

[No Author keywords available]

Indexed keywords

COUNTERFEIT DRUG;

EID: 84877310802     PISSN: 00029270     EISSN: 15720241     Source Type: Journal    
DOI: 10.1038/ajg.2012.348     Document Type: Article
Times cited : (5)

References (34)
  • 1
    • 84877253417 scopus 로고    scopus 로고
    • About Code of Federal Regulations
    • Federal Digital System. About Code of Federal Regulations. http://www.gpoaccess.gov/cfr/about.html
    • Federal Digital System
  • 2
    • 0042557758 scopus 로고    scopus 로고
    • US Food and Drug Administration
    • US Food and Drug Administration. Federal Food, Drug, and Cosmetic Act. http://medical. cms.itri.org.tw/pdf/u01.pdf
    • Federal Food, Drug, and Cosmetic Act
  • 3
    • 85172065794 scopus 로고
    • US Food and Drug Administration
    • US Food and Drug Administration. Text of the Prescription Drug Marketing Act of 1987. http://www.fda.gov/RegulatoryInformation/Legislation/ FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/ PrescriptionDrugMarketingActof1987/ucm201702.htm
    • (1987) Text of the Prescription Drug Marketing Act of
  • 5
    • 80053278729 scopus 로고    scopus 로고
    • The global counterfeit drug trade: Patient safety and public health risks
    • Mackey TK, Liang BA. The global counterfeit drug trade: patient safety and public health risks. J Pharm Sci 2011;100:4571-9.
    • (2011) J Pharm Sci , vol.100 , pp. 4571-4579
    • MacKey, T.K.1    Liang, B.A.2
  • 6
    • 67649099744 scopus 로고    scopus 로고
    • Spurious and counterfeit drugs: A growing industry in the developing world
    • Gautam CS, Utreja A, Singal GL. Spurious and counterfeit drugs: a growing industry in the developing world. Postgrad Med J 2009;85:251-6.
    • (2009) Postgrad Med J , vol.85 , pp. 251-256
    • Gautam, C.S.1    Utreja, A.2    Singal, G.L.3
  • 7
    • 0005248386 scopus 로고    scopus 로고
    • Department of Health and Human Services Drug Safety: An Update from the FDA
    • Sharfstein JM, US Food and Drug Administration, Department of Health and Human Services. Drug Safety: An Update from the FDA. http://www.hhs.gov/asl/ testify/2010/03/t20100310a.html
    • US Food and Drug Administration
    • Sharfstein, J.M.1
  • 8
    • 85172045210 scopus 로고    scopus 로고
    • US Food and Drug Administration
    • US Food and Drug Administration. FDA Initiative to Combat Counterfeit Drugs. http://www.fda.gov/Drugs/DrugSafety/ucm180899.htm
    • FDA Initiative to Combat Counterfeit Drugs
  • 10
    • 77953838979 scopus 로고    scopus 로고
    • Dirt cheap and without prescription: How susceptible are young US consumers to purchasing drugs from rogue internet pharmacies?
    • [online] doi:10.2196/jmir.1520
    • Ivanitskaya L, Brookins-Fisher J, O'Boyle I. Dirt cheap and without prescription: how susceptible are young US consumers to purchasing drugs from rogue internet pharmacies? J Med Internet Res [online] 2010;12:e11 (doi:10.2196/jmir.1520).
    • (2010) J Med Internet Res , vol.12
    • Ivanitskaya, L.1    Brookins-Fisher, J.2    O'Boyle, I.3
  • 11
    • 80053504215 scopus 로고    scopus 로고
    • Quality of online pharmacies and websites selling prescription drugs: A systematic review
    • [online] (doi:10.2196/jmir.1795)
    • Orizio G, Merla A, Schulz PJ et al. Quality of online pharmacies and websites selling prescription drugs: a systematic review. J Med Internet Res [online] 2011;13:e74 (doi:10.2196/jmir.1795).
    • (2011) J Med Internet Res , vol.13
    • Orizio, G.1    Merla, A.2    Schulz, P.J.3
  • 12
    • 84873611214 scopus 로고    scopus 로고
    • US Department of Justice DEA Warning-Buying Drugs Online May Be Illegal and Dangerous
    • US Department of Justice, Office of Diversion Control. DEA Warning-Buying Drugs Online May Be Illegal and Dangerous .
    • Office of Diversion Control
  • 14
    • 64649092126 scopus 로고    scopus 로고
    • US Food and Drug Administration
    • US Food and Drug Administration. Dietary Supplement and Nonprescription Drug Consumer Protection Act. http://www.fda.gov/RegulatoryInformation/ Legislation/Federal-FoodDrugandCosmeticActFDCAct/ SignificantAmendmentstotheFDCAct/ucm148035.htm
    • Dietary Supplement and Nonprescription Drug Consumer Protection Act
  • 15
    • 79960733448 scopus 로고    scopus 로고
    • US Food and Drug Administration
    • US Food and Drug Administration. Current Good Manufacturing Practices (CGMPs). http://www.fda.gov/food/guidancecomplianceregulatoryinformation/ currentgoodmanufacturingpracticescgmps/default.htm
    • Current Good Manufacturing Practices (CGMPs)
  • 16
    • 84855344258 scopus 로고    scopus 로고
    • Characterisation of complementary and alternative medicine use and its impact on medication adherence in inflammatory bowel disease
    • Weizman AV, Ahn E, Thanabalan R et al. Characterisation of complementary and alternative medicine use and its impact on medication adherence in inflammatory bowel disease. Aliment Pharmacol Ther 2012;35:342-9.
    • (2012) Aliment Pharmacol Ther , vol.35 , pp. 342-349
    • Weizman, A.V.1    Ahn, E.2    Thanabalan, R.3
  • 17
    • 49249086590 scopus 로고    scopus 로고
    • Complementary and alternative medicine use and cost in functional bowel disorders: A six month prospective study in a large HMO
    • [online] doi:10.1186/1472-6882-8-46
    • van Tilburg MA, Palsson OS, Levy RL et al. Complementary and alternative medicine use and cost in functional bowel disorders: a six month prospective study in a large HMO. Complement Altern Med [online] 2008;8:46 (doi:10.1186/1472-6882-8-46).
    • (2008) Complement Altern Med , vol.8 , pp. 46
    • Van Tilburg, M.A.1    Palsson, O.S.2    Levy, R.L.3
  • 18
    • 80052155410 scopus 로고    scopus 로고
    • Management of irritable bowel syndrome (IBS) in adults: Conventional and complementary/alternative approaches
    • Yoon SLJ, Grundmann O, Koepp L et al. Management of irritable bowel syndrome (IBS) in adults: conventional and complementary/alternative approaches. Altern Med Rev 2011;16:134-51.
    • (2011) Altern Med Rev , vol.16 , pp. 134-151
    • Yoon, S.L.J.1    Grundmann, O.2    Koepp, L.3
  • 19
    • 75749140935 scopus 로고    scopus 로고
    • Complementary and alternative medicine use in chronic liver disease patients
    • Ferrucci LM, Bell BP, Dhotre KB et al. Complementary and alternative medicine use in chronic liver disease patients. J Clin Gastroenterol 2010;44:e40-5.
    • (2010) J Clin Gastroenterol , vol.44
    • Ferrucci, L.M.1    Bell, B.P.2    Dhotre, K.B.3
  • 20
    • 82555192535 scopus 로고    scopus 로고
    • Effect of red pepper on symptoms of irritable bowel syndrome: Preliminary study
    • Bortolotti M, Porta S. Effect of red pepper on symptoms of irritable bowel syndrome: preliminary study. Dig Dis Sci 2011;56:3288-95.
    • (2011) Dig Dis Sci , vol.56 , pp. 3288-3295
    • Bortolotti, M.1    Porta, S.2
  • 21
    • 73849085585 scopus 로고    scopus 로고
    • A randomized, double-blind, placebo-controlled trial of St John's wort for treating irritable bowel syndrome
    • Saito YA, Rey E, Almazar-Elder AE et al. A randomized, double-blind, placebo-controlled trial of St John's wort for treating irritable bowel syndrome. Am J Gastroenterol 2010;105:170-7.
    • (2010) Am J Gastroenterol , vol.105 , pp. 170-177
    • Saito, Y.A.1    Rey, E.2    Almazar-Elder, A.E.3
  • 22
    • 33644918277 scopus 로고    scopus 로고
    • Review article Complementary and alternative therapies for inflammatory bowel disease
    • Langmead L, Rampton DS. Review article. Complementary and alternative therapies for inflammatory bowel disease. Aliment Pharm Ther 2006;23:341-9.
    • (2006) Aliment Pharm Ther , vol.23 , pp. 341-349
    • Langmead, L.1    Rampton, D.S.2
  • 23
    • 78651313689 scopus 로고    scopus 로고
    • Randomized, placebo-controlled, double-blind trial of Boswellia serrata in maintaining remission of Crohn's disease: Good safety profile but lack of efficacy
    • Holtmeier W, Zeuzem S, Preiss J et al. Randomized, placebo-controlled, double-blind trial of Boswellia serrata in maintaining remission of Crohn's disease: good safety profile but lack of efficacy. Inflamm Bowel Dis 2011;17:573-82.
    • (2011) Inflamm Bowel Dis , vol.17 , pp. 573-582
    • Holtmeier, W.1    Zeuzem, S.2    Preiss, J.3
  • 24
    • 0036210384 scopus 로고    scopus 로고
    • Wheat grass juice in the treatment of active distal ulcerative colitis: A randomized double-blind placebo-controlled trial
    • Ben-Arye E, Goldin E, Wengrower D et al. Wheat grass juice in the treatment of active distal ulcerative colitis: a randomized double-blind placebo-controlled trial. Scand J Gastroenterol 2002;37:444-9.
    • (2002) Scand J Gastroenterol , vol.37 , pp. 444-449
    • Ben-Arye, E.1    Goldin, E.2    Wengrower, D.3
  • 25
    • 34548381819 scopus 로고    scopus 로고
    • STW 5/Iberogast: Multi-target-action for treatment of functional dyspepsia and irritable bowel syndrome
    • (German)
    • Allescher H-D, Wagner H. [STW 5/Iberogast: multi-target-action for treatment of functional dyspepsia and irritable bowel syndrome] (German). Wien Med Wochenschr 2007;157:310-7.
    • (2007) Wien Med Wochenschr , vol.157 , pp. 310-317
    • Allescher, H.-D.1    Wagner, H.2
  • 26
    • 28844466671 scopus 로고    scopus 로고
    • Coffee and tea consumption are associated with a lower incidence of chronic liver disease in the United States
    • Ruhl CE, Everhart JE. Coffee and tea consumption are associated with a lower incidence of chronic liver disease in the United States. Gastroenterology 2005;129:1928-36.
    • (2005) Gastroenterology , vol.129 , pp. 1928-1936
    • Ruhl, C.E.1    Everhart, J.E.2
  • 27
    • 79960139109 scopus 로고    scopus 로고
    • Review on efficacy and health services research studies of complementary and alternative medicine in inflammatory bowel disease
    • Joos S. Review on efficacy and health services research studies of complementary and alternative medicine in inflammatory bowel disease. Chin J Integr Med 2011;17:403-9.
    • (2011) Chin J Integr Med , vol.17 , pp. 403-409
    • Joos, S.1
  • 28
    • 70449133964 scopus 로고    scopus 로고
    • Herbal and dietary supplement hepatotoxicity
    • Navarro VJ. Herbal and dietary supplement hepatotoxicity. Semin Liver Dis 2009;29:373-82.
    • (2009) Semin Liver Dis , vol.29 , pp. 373-382
    • Navarro, V.J.1
  • 29
    • 84857005852 scopus 로고    scopus 로고
    • US Food and Drug Administration Sec. 460.200 Pharmacy Compounding
    • US Food and Drug Administration. Compliance Policy Guidance for FDA Staff and Industry. Sec. 460.200 Pharmacy Compounding. http://www.fda.gov/ICECI/ ComplianceManuals/CompliancePolicyGuidanceManual/ucm074398.htm
    • Compliance Policy Guidance for FDA Staff and Industry
  • 32
    • 84877285574 scopus 로고    scopus 로고
    • Reuters Accessed 23 February 2012
    • Gargis P. Nine die in Alabama during bacteria outbreak. Reuters (2011). Accessed 23 February 2012. http://www.reuters.com/article/2011/03/30/us-alabama- bacteriadeaths-idUSTRE72T0CW20110330
    • (2011) Nine Die in Alabama during Bacteria Outbreak
    • Gargis, P.1
  • 33
    • 84869401476 scopus 로고    scopus 로고
    • Regulating compounding pharmacies after NECC
    • Outterson K. Regulating compounding pharmacies after NECC. N Engl J Med 2012;367:1969-72.
    • (2012) N Engl J Med , vol.367 , pp. 1969-1972
    • Outterson, K.1
  • 34
    • 84877285298 scopus 로고    scopus 로고
    • US Food and Drug Administration
    • US Food and Drug Administration. Counterfeit Medicine. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/ CounterfeitMedicine/default.htm
    • Counterfeit Medicine


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.