메뉴 건너뛰기




Volumn 64, Issue 12, 2007, Pages 1302-1310

Review of eight restricted-access programs and potential implications for pharmacy

Author keywords

[No Author keywords available]

Indexed keywords

ALOSETRON; BOSENTAN; BUPRENORPHINE; BUPRENORPHINE PLUS NALOXONE; CLOZAPINE; DOFETILIDE; ISOTRETINOIN; OXYBATE SODIUM; SUBUXONE; THALIDOMIDE; UNCLASSIFIED DRUG; DRUG;

EID: 34547646667     PISSN: 10792082     EISSN: None     Source Type: Journal    
DOI: 10.2146/ajhp060149     Document Type: Note
Times cited : (5)

References (52)
  • 1
  • 2
    • 0035514243 scopus 로고    scopus 로고
    • The risk revolution: challenges and opportunities for pharmacists. J Am Pharm Assoc. 2001; 41(6 suppl 1):S18-23.
    • The risk revolution: challenges and opportunities for pharmacists. J Am Pharm Assoc. 2001; 41(6 suppl 1):S18-23.
  • 3
    • 34547679235 scopus 로고    scopus 로고
    • Food and Drug Administration, accessed May 15
    • Food and Drug Administration. Subutex and Suboxone approved to treat opiate dependence. www.fda.gov/bbs/topics/ANSWERS/2002/ANS01165.html (accessed 2006 May 15).
    • (2006) Subutex and Suboxone approved to treat opiate dependence
  • 4
    • 33645048485 scopus 로고    scopus 로고
    • Support for buprenorphine and methadone prescription to heroin-dependent patients among New York City physicians
    • Coffin PO, Blaney S, Fuller C et al. Support for buprenorphine and methadone prescription to heroin-dependent patients among New York City physicians. Am J Drug Alcohol Abuse. 2006; 32:1-6.
    • (2006) Am J Drug Alcohol Abuse , vol.32 , pp. 1-6
    • Coffin, P.O.1    Blaney, S.2    Fuller, C.3
  • 5
    • 33745183130 scopus 로고    scopus 로고
    • Characteristics of U.S. substance abuse treatment facilities adopting buprenorphine in its initial stage of availability
    • Koch AI, Arfken CL, Schuster CR. Characteristics of U.S. substance abuse treatment facilities adopting buprenorphine in its initial stage of availability. Drug Alcohol Depend. 2006; 83:274-8.
    • (2006) Drug Alcohol Depend , vol.83 , pp. 274-278
    • Koch, A.I.1    Arfken, C.L.2    Schuster, C.R.3
  • 6
    • 22244473954 scopus 로고    scopus 로고
    • Pharmacists' and technicians' perceptions and attitudes toward dispensing buprenorphine/naloxone to patients with opioid dependence
    • Raisch DW, Fudala PJ, Saxon AJ et al. Pharmacists' and technicians' perceptions and attitudes toward dispensing buprenorphine/naloxone to patients with opioid dependence. J Am Pharm Assoc. 2005; 45:23-32.
    • (2005) J Am Pharm Assoc , vol.45 , pp. 23-32
    • Raisch, D.W.1    Fudala, P.J.2    Saxon, A.J.3
  • 7
    • 34547709620 scopus 로고    scopus 로고
    • Food and Drug Administration, accessed May 15
    • Food and Drug Administration. Information for pharmacists about Suboxone and Subutex. www.fda.gov/cder/foi/label/2002/20732pharmacist.pdf (accessed 2006 May 15).
    • (2006) Information for pharmacists about Suboxone and Subutex
  • 9
    • 30344472431 scopus 로고    scopus 로고
    • Cataplexy associated with narcolepsy: Epidemiology, pathophysiology, and management
    • Thorpy MJ. Cataplexy associated with narcolepsy: epidemiology, pathophysiology, and management. CNS Drugs. 2006; 20:43-50.
    • (2006) CNS Drugs , vol.20 , pp. 43-50
    • Thorpy, M.J.1
  • 11
    • 30144441282 scopus 로고    scopus 로고
    • National Drug Intelligence Center, accessed Nov 8
    • National Drug Intelligence Center. National drug threat assessment 2005. www.usdoj.gov/ndic/pubs11/12620/12620p.pdf (accessed 2005 Nov 8).
    • (2005) National drug threat assessment 2005
  • 12
    • 21244505497 scopus 로고    scopus 로고
    • Snead OC III, Gibson KM. Gammahydroxybutyric acid. N Engl J Med. 2005; 352:2721-32. [Erratum, N Engl J Med. 2006; 354:537.]
    • Snead OC III, Gibson KM. Gammahydroxybutyric acid. N Engl J Med. 2005; 352:2721-32. [Erratum, N Engl J Med. 2006; 354:537.]
  • 13
    • 0033857366 scopus 로고    scopus 로고
    • Potential novel uses of thalidomide: Focus on palliative care
    • Peuckmann V, Fisch M, Bruera E. Potential novel uses of thalidomide: focus on palliative care. Drugs. 2000; 60:273-92.
    • (2000) Drugs , vol.60 , pp. 273-292
    • Peuckmann, V.1    Fisch, M.2    Bruera, E.3
  • 14
    • 0032922147 scopus 로고    scopus 로고
    • S.T.E.P.S.: A comprehensive program for controlling and monitoring access to thalidomide
    • Zeldis JB, Williams BA, Thomas SD et al. S.T.E.P.S.: a comprehensive program for controlling and monitoring access to thalidomide. Clin Ther. 1999; 21:319-30.
    • (1999) Clin Ther , vol.21 , pp. 319-330
    • Zeldis, J.B.1    Williams, B.A.2    Thomas, S.D.3
  • 15
    • 0032885912 scopus 로고    scopus 로고
    • The return of thalidomide: Can birth defects be prevented?
    • Lary JM, Daniel KL, Erickson JD et al. The return of thalidomide: can birth defects be prevented? Drug Saf. 1999; 21:161-9.
    • (1999) Drug Saf , vol.21 , pp. 161-169
    • Lary, J.M.1    Daniel, K.L.2    Erickson, J.D.3
  • 16
    • 0041923722 scopus 로고    scopus 로고
    • Dermatologic and nondermatologic uses of thalidomide
    • Nasca MR, Micali G, Cheigh NH et al. Dermatologic and nondermatologic uses of thalidomide. Ann Pharmacother. 2003; 37:1307-20.
    • (2003) Ann Pharmacother , vol.37 , pp. 1307-1320
    • Nasca, M.R.1    Micali, G.2    Cheigh, N.H.3
  • 17
    • 0036080871 scopus 로고    scopus 로고
    • Mechanisms of action and potential therapeutic uses of thalidomide
    • Mujagic H, Chabner BA, Mujagic Z. Mechanisms of action and potential therapeutic uses of thalidomide. Croat Med J. 2002; 43:274-85.
    • (2002) Croat Med J , vol.43 , pp. 274-285
    • Mujagic, H.1    Chabner, B.A.2    Mujagic, Z.3
  • 18
    • 0034822474 scopus 로고    scopus 로고
    • Thalidomide is distributed into human semen after oral dosing
    • Teo SK, Harden JL, Burke AB et al. Thalidomide is distributed into human semen after oral dosing. Drug Metab Dispos. 2001; 29:1355-7.
    • (2001) Drug Metab Dispos , vol.29 , pp. 1355-1357
    • Teo, S.K.1    Harden, J.L.2    Burke, A.B.3
  • 19
    • 0029021685 scopus 로고
    • A pregnancy-prevention program in women of childbearing age receiving isotretinoin
    • Mitchell AA, Van Bennekom CM, Louik C. A pregnancy-prevention program in women of childbearing age receiving isotretinoin. N Engl J Med. 1995; 333:101-6.
    • (1995) N Engl J Med , vol.333 , pp. 101-106
    • Mitchell, A.A.1    Van Bennekom, C.M.2    Louik, C.3
  • 20
    • 18544383329 scopus 로고    scopus 로고
    • Trends in adherence to a revised risk management program designed to decrease or eliminate isotretinoin-exposed pregnancies: Evaluation of the Accutane SMART program
    • Brinker A, Kornegay C, Nourjah P. Trends in adherence to a revised risk management program designed to decrease or eliminate isotretinoin-exposed pregnancies: evaluation of the Accutane SMART program. Arch Dermatol. 2005; 141:563-9.
    • (2005) Arch Dermatol , vol.141 , pp. 563-569
    • Brinker, A.1    Kornegay, C.2    Nourjah, P.3
  • 21
    • 23444434537 scopus 로고    scopus 로고
    • Depression and suicidal behavior in acne patients treated with isotretinoin: A systematic review
    • Marqueling AL, Zane LT. Depression and suicidal behavior in acne patients treated with isotretinoin: a systematic review. Semin Cutan Med Surg. 2005; 24:92-102.
    • (2005) Semin Cutan Med Surg , vol.24 , pp. 92-102
    • Marqueling, A.L.1    Zane, L.T.2
  • 22
    • 23844539331 scopus 로고    scopus 로고
    • Acne, depression, and suicide
    • Hull PR, D'Arcy C. Acne, depression, and suicide. Dermatol Clin. 2005; 23:665-74.
    • (2005) Dermatol Clin , vol.23 , pp. 665-674
    • Hull, P.R.1    D'Arcy, C.2
  • 23
    • 10644240083 scopus 로고    scopus 로고
    • Can we ensure the safe use of known human teratogens? Introduction of generic isotretinoin in the US as an example
    • Honein MA, Moore CA, Erickson JD. Can we ensure the safe use of known human teratogens? Introduction of generic isotretinoin in the US as an example. Drug Saf. 2004; 27:1069-80.
    • (2004) Drug Saf , vol.27 , pp. 1069-1080
    • Honein, M.A.1    Moore, C.A.2    Erickson, J.D.3
  • 24
    • 34547706546 scopus 로고    scopus 로고
    • Food and Drug Administration, accessed Jan 15
    • Food and Drug Administration. FDA letter approving and outlining the iPledge program. www.fda.gov/cder/foi/appletter/2005/018662s056ltr.pdf (accessed 2006 Jan 15).
    • (2006) FDA letter approving and outlining the iPledge program
  • 25
    • 34547664402 scopus 로고    scopus 로고
    • iPledge. Homepage of iPledge. www.ipledgeprogram.com/Default.aspx (accessed 2006 Jan 15).
    • iPledge. Homepage of iPledge. www.ipledgeprogram.com/Default.aspx (accessed 2006 Jan 15).
  • 26
    • 22944451162 scopus 로고    scopus 로고
    • Drug treatment of pulmonary arterial hypertension: Current and future agents
    • Hoeper MM. Drug treatment of pulmonary arterial hypertension: current and future agents. Drugs. 2005; 65:1337-54.
    • (2005) Drugs , vol.65 , pp. 1337-1354
    • Hoeper, M.M.1
  • 27
    • 26944465386 scopus 로고    scopus 로고
    • Risk management strategies in the postmarketing period: Safety experience with the US and European bosentan surveillance programmes
    • Segal ES, Valette C, Oster L et al. Risk management strategies in the postmarketing period: safety experience with the US and European bosentan surveillance programmes. Drug Saf. 2005; 28:971-80.
    • (2005) Drug Saf , vol.28 , pp. 971-980
    • Segal, E.S.1    Valette, C.2    Oster, L.3
  • 28
    • 34547698506 scopus 로고    scopus 로고
    • accessed 2007 Feb 21
    • Tracleer prescribing information. www.tracleer.com/pdf/ Tracleer_PI_080706.pdf (accessed 2007 Feb 21).
    • Tracleer prescribing information
  • 29
    • 0037077917 scopus 로고    scopus 로고
    • Alosetron: A case study in regulatory capture, or a victory for patients' rights?
    • Moynihan R. Alosetron: a case study in regulatory capture, or a victory for patients' rights? BMJ. 2002; 325:592-5.
    • (2002) BMJ , vol.325 , pp. 592-595
    • Moynihan, R.1
  • 30
    • 1942531973 scopus 로고    scopus 로고
    • Reassessing the benefits and risks of alosetron: What is its place in the treatment of irritable bowel syndrome?
    • Andresen V, Hollerbach S. Reassessing the benefits and risks of alosetron: what is its place in the treatment of irritable bowel syndrome? Drug Saf. 2004; 27:283-92.
    • (2004) Drug Saf , vol.27 , pp. 283-292
    • Andresen, V.1    Hollerbach, S.2
  • 31
    • 85007758050 scopus 로고    scopus 로고
    • Commentary: The reintroduction of Lotronex for diarrhea-predominant irritable bowel syndrome
    • Woodstock J. Commentary: the reintroduction of Lotronex for diarrhea-predominant irritable bowel syndrome. BMJ. 2003; 327:163-4.
    • (2003) BMJ , vol.327 , pp. 163-164
    • Woodstock, J.1
  • 32
    • 85007724464 scopus 로고    scopus 로고
    • Palmer JB. Alosetron for irritable bowel syndrome. Senior vice president of GlaxoSmithKline responds. BMJ. 2003; 326:51. Letter.
    • Palmer JB. Alosetron for irritable bowel syndrome. Senior vice president of GlaxoSmithKline responds. BMJ. 2003; 326:51. Letter.
  • 33
    • 85120113913 scopus 로고    scopus 로고
    • a fatal erosion of integrity
    • and the FDA
    • Horton R. Lotronex and the FDA: a fatal erosion of integrity. Lancet. 2001; 357:1544-5.
    • (2001) Lancet , vol.357 , pp. 1544-1545
    • Lotronex, H.R.1
  • 34
    • 0035806749 scopus 로고    scopus 로고
    • Galson S, Kweder S, Houn F et al. The FDA and the Lancet: an exchange. Lancet. 2001; 358:415. Letter.
    • Galson S, Kweder S, Houn F et al. The FDA and the Lancet: an exchange. Lancet. 2001; 358:415. Letter.
  • 35
    • 34547672424 scopus 로고    scopus 로고
    • Food and Drug Administration, accessed Jan 22
    • Food and Drug Administration. Patient-physician agreement for Lotronex. www.fda.gov/cder/drug/infopage/lotronex/pt_physicianAgreement200502.pdf (accessed 2006 Jan 22).
    • (2006) Patient-physician agreement for Lotronex
  • 36
    • 0027238608 scopus 로고
    • Clozapine-induced agranulocytosis. Incidence and risk factors in the United States
    • Alvir JM, Lieberman JA, Safferman AZ et al. Clozapine-induced agranulocytosis. Incidence and risk factors in the United States. N Engl J Med. 1993; 329:162-7.
    • (1993) N Engl J Med , vol.329 , pp. 162-167
    • Alvir, J.M.1    Lieberman, J.A.2    Safferman, A.Z.3
  • 37
    • 0032818658 scopus 로고    scopus 로고
    • Hematologic side effects of psychotropics
    • Oyesanmi O, Kunkel EJ, Monti DA et al. Hematologic side effects of psychotropics. Psychosomatics. 1999; 40:414-21.
    • (1999) Psychosomatics , vol.40 , pp. 414-421
    • Oyesanmi, O.1    Kunkel, E.J.2    Monti, D.A.3
  • 38
    • 0031471159 scopus 로고    scopus 로고
    • Neutrophil cytotoxicity of the chemically reactive metabolite(s) of clozapine: Possible role in agranulocytosis
    • Williams DP, Pirmohamed M, Naisbitt DJ et al. Neutrophil cytotoxicity of the chemically reactive metabolite(s) of clozapine: possible role in agranulocytosis. J Pharmacol Exp Ther. 1997; 283:1375-82.
    • (1997) J Pharmacol Exp Ther , vol.283 , pp. 1375-1382
    • Williams, D.P.1    Pirmohamed, M.2    Naisbitt, D.J.3
  • 39
    • 0029775615 scopus 로고    scopus 로고
    • Neutropenia and agranulocytosis in patients receiving clozapine in the UK and Ireland
    • Atkin K, Kendall F, Gould D et al. Neutropenia and agranulocytosis in patients receiving clozapine in the UK and Ireland. Br J Psychiatry. 1996; 169:483-6.
    • (1996) Br J Psychiatry , vol.169 , pp. 483-486
    • Atkin, K.1    Kendall, F.2    Gould, D.3
  • 40
    • 16844379774 scopus 로고    scopus 로고
    • Sedky K, Shaughnessy R, Hughes T et al. Clozapine-induced agranulocytosis after 11 years of treatment. Am J Psychiatry. 2005; 162:814. Letter.
    • Sedky K, Shaughnessy R, Hughes T et al. Clozapine-induced agranulocytosis after 11 years of treatment. Am J Psychiatry. 2005; 162:814. Letter.
  • 41
    • 34547672423 scopus 로고    scopus 로고
    • Food and Drug Administration, accessed Jan 23
    • Food and Drug Administration. Important drug warning and new information about Clozaril. www.fda.gov/medwatch/safety2006Clozaril_chart_letter_final12- 2005.pdf (accessed 2006 Jan 23).
    • (2006) Important drug warning and new information about Clozaril
  • 42
    • 10944261265 scopus 로고    scopus 로고
    • Pharmacological cardioversion of atrial fibrillation: Current management and treatment options
    • Boriani G, Diemberger I, Biffi M et al. Pharmacological cardioversion of atrial fibrillation: current management and treatment options. Drugs. 2004; 64:2741-62.
    • (2004) Drugs , vol.64 , pp. 2741-2762
    • Boriani, G.1    Diemberger, I.2    Biffi, M.3
  • 43
    • 34547692231 scopus 로고    scopus 로고
    • Food and Drug Administration, accessed Feb 20
    • Food and Drug Administration. Drug approvable letter for Tikosyn. www.fda.gov/cder/foi/appletter/1999/20931ltr.pdf (accessed 2006 Feb 20).
    • (2006) Drug approvable letter for Tikosyn
  • 45
    • 34547671723 scopus 로고    scopus 로고
    • home accessed Feb 20
    • Pfizer. Tikosyn (dofetilide) homepage. www.tikosyn.com/ (accessed 2006 Feb 20).
    • (2006) Tikosyn (dofetilide)
    • Pfizer1
  • 47
    • 33645469813 scopus 로고    scopus 로고
    • Thalidomide use in the US: Experience with pregnancy testing in the S.T.E.P.S. programme
    • Uhl K, Cox E, Rogan R et al. Thalidomide use in the US: experience with pregnancy testing in the S.T.E.P.S. programme. Drug Saf. 2006; 29:321-9.
    • (2006) Drug Saf , vol.29 , pp. 321-329
    • Uhl, K.1    Cox, E.2    Rogan, R.3
  • 48
    • 32644436054 scopus 로고    scopus 로고
    • Adherence to black box warnings for prescription medications in outpatients
    • Lasser KE, Seder DL, Yu DT et al. Adherence to black box warnings for prescription medications in outpatients. Arch Intern Med. 2006; 166:338-44.
    • (2006) Arch Intern Med , vol.166 , pp. 338-344
    • Lasser, K.E.1    Seder, D.L.2    Yu, D.T.3
  • 49
    • 0035512248 scopus 로고    scopus 로고
    • Legal issues and impact of restricted access and distribution
    • Kracov DA. Legal issues and impact of restricted access and distribution. J Am Pharm Assoc. 2001; 41(6 suppl 1):S11-5.
    • (2001) J Am Pharm Assoc , vol.41 , Issue.6 SUPPL. 1
    • Kracov, D.A.1
  • 50
    • 0035514243 scopus 로고    scopus 로고
    • The risk revolution: challenges and opportunities for pharmacists. J Am Pharm Assoc. 2001; 41(6 suppl 1):S18-23.
    • The risk revolution: challenges and opportunities for pharmacists. J Am Pharm Assoc. 2001; 41(6 suppl 1):S18-23.
  • 51
    • 19544394711 scopus 로고    scopus 로고
    • Potential determinants of drug-drug interaction associated dispensing in community pharmacies
    • Becker ML, Kallewaard M, Caspers PW et al. Potential determinants of drug-drug interaction associated dispensing in community pharmacies. Drug Saf. 2005; 28:371-8.
    • (2005) Drug Saf , vol.28 , pp. 371-378
    • Becker, M.L.1    Kallewaard, M.2    Caspers, P.W.3
  • 52
    • 20844457796 scopus 로고    scopus 로고
    • Food and Drug Administration, accessed Jun 10
    • Food and Drug Administration. Natalizumab (marketed as Tysabri) information. www.fda.gov/cder/drug/infopage/natalizumab/default.htm (accessed 2006 Jun 10).
    • (2006) Natalizumab (marketed as Tysabri) information


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.