Комплексная оценка безопасности лекарственных средств в амбулаторной практики методом активного проспективного мониторинга
Диссертация
Апробация работы проведена на Секции Ученого совета филиала «Клиническая фармакология» ГУ Научного центра биомедицинских технологий РАМН 24 ноября 2008 года. Результаты исследования были представлены в виде тезисов, устных и стендовых сообщений за период с 2006 г. по 2008 г. на российских и международных симпозиумах и конференциях: 13-ая международная специализированная выставка «Аптека — 2006… Читать ещё >
Список литературы
- Андреев Н.А., Моисеев B.C. Антагонисты кальция в клинической медицине. // Москва, РЦ «Фармединфо».- 1995.
- Арабидзе Г. Г., Белоусов Ю. Б., Карпов Ю. А. Артериальная гипертония. // Приложение к журналу «Ремедиум. Журнал о российском рынке лекарств» ЗАО «Информациионно-издательское агенство „Ремедиум“».-1999, 2.
- Астахова А.В. Ингибиторы АПФ: кашель. // Безопасность лекарств.-1996, 10, 17.
- Астахова А.В. Побочные реакции, вызываемые нестероидными противовоспалительными средствами. //Безопасность лекарств.- 1998, 2, 3−8.
- Белоусов Ю.Б., Моисеев B.C., Лепахин В. К. Клиническая фармакология и фармакотерапия. Изд «Универсум паблишинг», Москва, 1997.
- Бурбелло А.Т., Бабак С. В. Неблагоприятные побочные реакции на лекарственные средства // Клиническая фармакология: национальное руководство, 2009, 5, 125−127.
- Геппе Н.А. К вопросу об использовании антипиретиков у детей. // Клин. Фарм. И Тер, — 2000, 5, 51−55.
- Государственный реестр лекарственных средств. Москва, 2004.
- Зайцева З.И., Савельева З. А. Тезисы докладов IV Российского национального конгресса «Человек и лекарство», 1997.
- Инструкция по сбору информации о неблагоприятных побочных реакциях лекарственных средств, средств традиционной медицины и биологически активных добавок. Министерство здравоохранения РФ, 2001.
- Кабалава Ж.Д., Моисеев B.C. Антагонисты кальция, артериальная- ги- пертония и сахарный диабет: новые вопросы. // Клиническая фармакология и терапия, — 1999, 3, 8−11.
- Леонова М.В. Ингибиторы ангиотензинревращающего фермента // Клиническая фармакология: национальное руководство.- 2009, 21, 580.
- Лепахин В.К., Астахова А. В., Зырьянов С. К. Фармаконадзор // Клиническая фармакология: национальное руководство, 2009, 14, 296−298.
- Лепахин В.К., Стуров Н. В., Астахова А. В. Методы выявления и регистрации неблагоприятных побочных реакций на лекарственные средства в период их широкого применения // Трудный пациент. 2008. — Т. 6, № 8. — 42−46.
- Мартынов А.И., Остроумова О. Д., Мамаев В. И., и соавт. Результаты многоцентровых исследований по эффективности и безопасности гипотензивных препаратов у больных с артериальной гипертензией. // Кардиология.- 2000, том 40, 3, 61−67.
- Международная группа по ожирению ВОЗ (IOTF WHO), 1997.
- Метелица В.И., Давыдов А. Б. Препараты нитратов в кардиологии. М. Медицина, 1989.
- Моисеев B.C. Врачебные ошибки. Факторы объективные и субъективные. Когда возможна юридическая ответственность врача. // Практикующий врач.- 1996, 4, 2, 54−55.
- Нестероидные противовоспалительные средства (НПВС) сравнительная оценка безопасности семи НПВС. // Current Problems in Pharma-covigilance.- 1994, 20.
- Пальцев M.A., Кукес В. Г., Герасимов В. Б. Клинико-фармакологическая характеристика нежелательных эффектов лекарственных средств // Молекулярные механизмы нежелательных эффектов лекарственных средств- 2005, 2, 29.
- Пальцев М.А., Кукес В. Г., Сычев Д. А., Раменская Г. В. Молекулярные механизмы взаимодействия лекарственных средств на уровне метаболизма (биотрансформации) // Молекулярные механизмы взаимодействия лекарственных средств, — 2004, 1, 25
- Правила проведения качественных клинических испытаний в Российской Федерации. Стандарт отрасли ОСТ 42−511−99, утв. Минздравом РФ от 29 декабря 1998 года.
- Страчунский JI.C., Рафальский В. В. Аллергические реакции на антибиотики. // Терапевтический архив.- 2000,10, том 72, 36−43.
- Adkinson N.F., Jr. Risk factors for drug allergy //J Allergy Clin Immunol.-1984, — vol. 74, p. 567−572.
- Adverse Reaction Terminology. The Uppsala Monitoring Centre, 2000.
- Anderson J.A., Adkinson N.F., Jr. Allergic reactions to drugs and biologic agents //Jama.- 1987.- vol. 258, p. 2891−2899.
- Anderson J.G., Jay S.J., Anderson M., Hunt T.J. Evaluating the potential effectiveness of using computerized information systems to prevent adverse drug events. //Proc. AMLA Annu. Fall. Symp.- 1997, p. 228−232.
- Anello C., O’Neill R.T. Does research synthesis have a place in drug regulatory policy? synopsis of issues: assessment of safety and postmarketing surveillance. Clin Res Reg Aff 1996−13:13−21.
- Aronson J.K. Anecdotes as evidence //Bmj.- 2003, — vol. 326, p. 1346.
- Aronson J.K., Deny S., Loke Y.K. Adverse drug reactions: keeping up to date //Fundam Clin Pharmacol.- 2002, — vol. 16, p. 49−56.
- Atkin P.A., Shenfield G.M. Medication-related adverse reactions and the elderly: a literature review //Adverse Drug React Toxicol Rev.- 1995.- vol. 14, p. 175−191.
- Bagian J.P., Gosbee J.W. Developing a culture of patient safety at the VA. // Ambul. Outreach.- 2000, Spring, p. 25−29.
- Barranco P., Lopez-Serrano M.C. General and epidemiological aspects of allergic drug reactions //Clin Exp Allergy 1998.- vol. 28 Suppl 4, p. 61−62.
- Bates D.W., Spell N., Cullen DJ., Bnrdick E., Laird N., Petersen L.A., Small S.D., Sweitzer B.J., Leape L.L. The costs of adverse drug events in hospitalized patients. Adverse Drug Events Prevention Study Group //Jama.- 1997,-vol. 277, p. 307−311.
- Bates D.W., Teich J.M., Lee J., et al. The Impact of Computerized Physician Order Entry on Medication Error Prevention. // J. Am. Med. Inform. Assoc.-1999, Jul-Aug, 6(4), p. 313−321.
- Bayard P.J., Berger T.G., Jacobson M.A. Drug hypersensitivity reactions and human immunodeficiency virus disease //J Acquir Immune Defic Syndr.-1992, — vol. 5, p. 1237−1257.
- Belton K.J., Lewis S.C., Payne S., Rawlins M.D., Wood S.M. Attitudinal survey of adverse drug reaction reporting by medical practitioners in the United Kingdom //Br J Clin Pharmacol.- 1995, — vol. 39, p. 223−226.
- Bennett C.L., Kiss J.E., Weinberg P.D., Pinevich A.J., Green D., Kwaan H.C., FeldmanM.D. Thrombotic thrombocytopenic purpura after stenting and ticlopidine //Lancet.- 1998.- vol. 352, p. 1036−1037.
- Bennett C.L., Raisch D.W., Sartor O. Pneumonitis associated with nonsteroidal antiandrogens: presumptive evidence of a class effect //Ann Intern Med.- 2002, — vol. 137, p. 625.
- Bennett C.L., Schumock G.T., Desai A.A., Kwaan H.C., Raisch D.W., Newlin R., Stadler W. Thalidomide-associated deep vein thrombosis and pulmonary embolism //Am J Med.- 2002 vol. 113, p. 603−606.
- Bennett C.L., Weinberg P.D., Rozenberg-Ben-Dror K., Yarnold P.R., Kwaan H.C., Green D. Thrombotic thrombocytopenic purpura associated with ticlopidine. A review of 60 cases //Ann Intern Med.- 1998.- vol. 128, p. 541 544.
- Bent S., Padula A., Avins A.L. Brief communication: Better ways to question patients about adverse medical events: a randomized, controlled trial //Ann Intern Med.- 2006.- vol. 144, p. 257−261.
- Blum M.D., Graham D.J., McCloskey C.A. Temafloxacin syndrome: review of 95 cases //Clin Infect Dis.- 1994.- vol. 18, p. 946−950.
- Bocquet H., Bagot M., Roujeau J.C. Drug-induced pseudolymphoma and drug hypersensitivity syndrome (Drug Rash with Eosinophilia and Systemic Symptoms: DRESS) //Semin Cutan Med Surg 1996.- vol. 15, p. 250−257.
- Brennan T.A., Leape L.L., Laird N.M., Hebert L., Localio A.R., Lawthers A.G., Newhouse J.P., Weiler P.C., Hiatt H.H. Incidence of adverse events and negligence in hospitalized patients: results of the Harvard Medical Practice
- Study I. 1991 //Qual Saf Health Care.- 2004.- vol. 13, p. 145−151- discussion 151−142.
- Brewer Т., Colditz G.A. Postmarketing surveillance and adverse drug reactions: current perspectives and future needs //Jama.- 1999, — vol. 281, p. 824 829.
- British Medical Association Reporting Adverse Drug Reactions. A BMA policy document. British Medical Association. London. 1996, — vol. p.
- Brown R.B., Klar J., Lemeshow S., Teres D., Pastides H., Sands M. Enhanced bleeding with cefoxitin or moxalactam. Statistical analysis within a defined population of 1493 patients //Arch Intern Med.- 1986, — vol. 146, p. 21 592 164.
- Brown R.W. Errors in medicine. // J. Qual. Clin. Pract., 1997.- Mar, 17(1), p. 21−25.
- Caplan R.A., Posner K.L., Cheney F.W. Effect of outcome on physician judgments of appropriateness of care //Jama 1991, — vol. 265, p. 1957−1960.
- Case В., Oszko M.A. Use of an algorithm to evaluate published reports of adverse drug reactions //Am J Hosp Pharm.- 1991.- vol. 48, p. 121−122.
- Classen D.C., Pestotnik S.L., Evans R.S., Burke J.P. Computerized surveillance of adverse drug events in hospital patients //Jama.- 1991.- vol. 266, p. 2847−2851.
- Classen D.C., Pestotnik S.L., Evans R.S., Burke J.P. Computerized surveillance of adverse drug events in hospital patients. 1991 //Qual Saf Healtlf Care.- 2005, — vol. 14, p. 221−225- discussion 225−226.
- Classen D.C., Pestotnik S.L., Evans R.S., Lloyd J.F., Burke J.P. Adverse drug events in hospitalized patients. Excess length of stay, extra costs, and attributable mortality //Jama.- 1997.- vol. 277, p. 301−306.
- Clements C. Mass psychogenic illness after vaccination. // Drug Saf.- 2003, 26(9), p. 599−604.
- Cobert B.L., Biron P. Pharmacovigilance from A to Z. Maiden, MA: Black-well Science- 2002.
- Cohen M.R. Medication errors: prevention and management issues. Platform presentation of the American Pharmaceutical Association Annual Meeting, March 10−14,2000, Washington, DC.
- Cooper J.W. Adverse drug reaction hospitalizations of nursing facility residents: a 4-year study. // South. Med. J.- 1999, 95, p. 485−490.
- Cooper J.W., Wade W.E. Repeated unnecessary NSATO-associated hospitalizations in an elderly female. // J. Geriatr. Drug. Ther.- 1997,12, p. 95−97.
- Cullen D.J., Sweitzer B.J., Bates DW., et al. Preventable adverse drug events in hospitalized patients: a comparative study of intensive care and general-----------care units. // Grit Care Med.-1997, Aug, 25(8), p. 1289−1297.
- Ditto A.M. Drug allergy. In: Grammer LC, Greenberger PA, eds. Patterson’s Allergic diseases. 6th ed. Philadelphia: Lippincott Williams & Wilkins, 2002:295.
- Dovey S.M., Meyers D.S., Phillips R.L., Jr., Green L.A., Fiyer G.E., Galliher J.M., Kappus J., Grob P. A preliminary taxonomy of medical errors in family practice //Qual Saf Health Care.- 2002, — vol. 11, p. 233−238.
- Edlavitch S.A. Postmarketing surveillance methodologies //Drug Intell Clin Pharm.- 1988.- vol. 22, p. 68−78.
- Edvards I.R., Biriell C. Harmonization in pharmacovigilance. // Drag safety.-1994, 10, p. 93−102.
- Einarson T.R. Drug-related hospital admissions //Ann Pharmacother.- 1993.-vol. 27, p. 832−840.
- Evans R.S., Pestotnik S.L., Classen D.C., Bass S.B., Burke J.P. Prevention of adverse drug events through computerized surveillance //Proc Annu Symp Comput Appl Med Care.- 1992, — vol. p. 437−441.
- Evens A.M., Kwaan H.C., Kaufman D.B., Bennett C.L. TTP/HUS occurring in a simultaneous pancreas/kidney transplant recipient after clopidogrel treatment: evidence of a nonimmunological etiology //Transplantation.- 2002,-vol. 74, p. 885−887.
- Falcao H, Lunet N, Gomes E, et al. Drug allergy in university students from Porto, //Portugal. Allergy- 2003- 58:1210
- Feely J., Moriarty S., O’Connor P. Stimulating reporting of adverse drug reactions by using a fee //Bmj.- 1990, — vol. 300, p. 22−23.
- Forster A.J., Murff H.J., Peterson J.F., Gandhi Т.К., Bates D.W. Adverse drug events occurring following hospital discharge //J Gen Intern Med.-2005,-vol. 20, p. 317−323.
- Forster A.J., Murff H.J., Peterson J.F., Gandhi Т.К., Bates D.W. The incidence and severity of adverse events affecting patients after discharge from the hospital //Ann Intern Med.- 2003, — vol. 138, p. 161−167.
- Frazier H.S., Colditz G.A. Oral contraceptives: post-marketing surveillance and rare, late complications of drugs. In: Frazier HS, Mosteller F, eds. Medicine Worth Paying For. Cambridge, Mass: Harvard University Press- 1995:212−219.
- Freemantle S.N., Pearce G.L., Wilton L.V., Mackay F.J., Mann R.D. The incidence of the most commonly reported events with 40 newly marketed drugs a study by Prescription-Event Monitoring. Pharmacoepidemiology & Drug Safety. 1997- 6: Suppl. 1.1−8.
- Friedmann P. S., Strickland I., Pirmohamed M., Park B.K. Investigation of mechanisms in toxic epidermal necrolysis induced by carbamazepine //Arch Dermatol.- 1994, — vol. 130, p. 598−604.
- Gandhi Т.К., Burstin H.R., Cook E.F., Puopolo A.L., Haas J.S., Brennan T.A., Bates D.W. Drug complications in outpatients //J Gen Intern Med.-2000, — vol. 15, p. 149−154.
- Gandhi Т.К., Weingart S.N., Borus J., Seger A.C., Peterson J., Burdick E., Seger D.L., Shu K., Federico F., Leape L.L., Bates D.W. Adverse drug events in ambulatory care //N Engl J Med.- 2003.- vol. 348, p. 1556−1564.
- Glasziou P., Vandenbroucke J.P., Chalmers I. Assessing the quality of research //Bmj.- 2004.- vol. 328, p. 39−41.
- Gleckman R.A., John S., Czachor M.D. Antibiotic Side Effects. // Sem Resp Crit Care Med.- 2000, 21(1), p. 53−60.
- Gomes E, Cardoso MF, Praga F, et al. Self reported drug allergy in a general adult Portuguese population. // Clin Exp Allergy- 2004- 34:1597−1601.
- Good manufacturing practices: supplementary guidelines for the manufacture of herbal medicinal products. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-fourth report. Geneva, World Heath
- Organization, 1996, Annex 8 (WHO Technical Report Series, No. 863). p.134−139.
- Guidelines for the assessment of herbal medicines are provided in Quality assurance of pharmaceuticals: a compendium of guidelines and related materials. Vol. 1. Geneva, World Health Organization, 1997:31−37.
- Gurwitz J.H., Field T.S., Avorn J., McCormick D., Jain S., Eckler M., Benser M., Edmondson A.C., Bates D.W. Incidence and preventability of adverse drug events in nursing homes //Am J Med.- 2000.- vol. 109, p. 87−94.
- Halang W.A., Sniezek M., Colnaric M. Computerised controllers for safety critical medical applications. // Int. J. Med. Inf.- 1998, Apr, 49(2), p. 139−155.
- Hammons Т., Piland N.F., Small S.D., Hatlie M.J., Burstin H.R. Ambulatory patient safety. What we know and need to know //J Ambul Care Manage.-2003.-vol. 26, p. 63−82.
- Hanlon J.T., Schmader K.E., Koronkowski M.J., Weinberger M., Landsman P.B., Samsa G.P., Lewis I.K. Adverse drug events in high risk older outpatients //J Am Geriatr Soc.- 1997.- vol. 45, p. 945−948.
- Harb G.E., Jacobson M.A. Human immunodeficiency virus (HIV) infection. Does it increase susceptibility to adverse drug reactions? //Drug Saf.- 1993.-vol. 9, p. 1−8.
- Hardmeier В., Braunschweig S., Cavallaro M., Roos M., Pauli-Magnus C., Giger M., Meier P. J., Fattinger K. Adverse drug events caused by medication errors in medical inpatients //Swiss Med Wkly.- 2004 vol. 134, p. 664−670.
- Heeley E., Wilton L.V., Shakir S.A. Automated signal generation in prescription-event monitoring //Drug Saf.- 2002.- vol. 25, p. 423−432.
- Hernandez-Diaz S, Rodridguez LAG. Association between nonsteroidal antiinflammatory drugs and upper gastrointestinal tract bleeding/perforation. // Arch Intern Med- 2000- 160:2093−9.
- Hertl M., Merk H.F. Lymphocyte activation in cutaneous drug reactions //J Invest Dermatol.- 1995.-vol. 105, p. 95S-98S.
- Hine L.K., Laird N., Hewitt P., Chalmers T.C. Meta-analytic evidence against prophylactic use of lidocaine in acute myocardial infarction //Arch Intern Med.- 1989.- vol. 149, p. 2694−2698.
- Hoffman J.M., Proulx S.M. Madication errors caused by confusion of drug names. // Drug safety- 2003, 26(7), p. 445−452.
- Hoffman J.R. Rethinking case reports //West J Med.- 1999.- vol. 170, p. 253 254.
- Honigman В., Bates D.W., Light P. Computerized data mining for adverse drug events in an outpatient setting abstract. Proc AMLA Symp. 1998- 1018. 1998, — vol. p.
- Horwitz R.I., Feinstein A.R. Exclusion bias and the false relationship of re-serpine and breast cancer //Arch Intern Med.- 1985, — vol. 145, p. 1873−1875.
- Hutchinson T.A., Flegel K.M., Kramer M.S., Leduc D.G., Kong H.H. Frequency, severity and risk factors for adverse drug reactions in adult outpatients: a prospective study //J Chronic Dis.- 1986, — vol. 39, p. 533−542.
- Inman W., Pearce G. Prescriber profile and post-marketing surveillance //Lancet.- 1993, — vol. 342, p. 658−661.
- Ioannidis J.P., Mulrow C.D., Goodman S.N. Adverse events: the more you search, the more you find //Ann Intern Med.- 2006.- vol. 144, p. 298−300.116. IOTF WHO., 1997
- Jha A.K., Kuperman G.J., Rittenberg E., Teich J.M., Bates D.W. Identifying hospital admissions due to adverse drug events using a computer-based monitor //Pharmacoepidemiol Drug Saf.- 2001.- vol. 10, p. 113−119.
- Johnson S., Chan J., Bennett C.L. Hepatotoxicity after prophylaxis with a nevirapine-containing antiretroviral regimen //Ann Intern Med.- 2002.- vol. 137, p. 146−147.
- Jones E.H., Speerhas R. How physicians can prevent medication errors: practical strategies. // Cleve Clin. J. Med.- 1997, Jul-Aug, 64(7), p. 355−359.
- Jones J.K. Assessing potential risk of drugs: the elusive target //Ann Intern Med.- 1992.- vol. 117, p. 691−692.
- Kaiser H.J. Family Foundation and the Harvard School of Public Health. The Kaiser/Harvard Health News Index, Menlo Park, Calif., 1999, November/December, 6, 4.
- Kanjanarat P., Winterstein A.G., Johns Т.Е., et al. Nature of Preventable Adverse Drug Events in Hospitals: A Literature Review. // American Journal of Health-System Pharmacy.- 2003, 60(17), p. 1750−1759.
- Karch F.E. and Lassagna L. Toward the operational identification of adverse drug reactions. // Clin. Farmacol. Ther.- 1977, 21, p. 247−254.
- Kaufman D.W., Shapiro S. Epidemiological assessment of drug-induced disease. // Lancet.- 2000, Oct, 14, 356(9238), p. 1339−1343.
- Kelly W.N. The quality of published adverse drug event reports //Ann Phar-macother.- 2003, — vol. 37, p. 1774−1778.
- Kessler D.A. Introducing MEDWatch. A new approach to reporting medication and device adverse effects and product problems //Gen Hosp Psychiatry. -1994.- vol. 16, p. 96−101- discussion 102.
- Kilbridge P.M., Campbell U.C., Cozart H.B., Mojarrad M.G. Automated Surveillance for Adverse Drug Events at a Community Hospital and an Academic Medical Center //J Am Med Inform Assoc.- 2006, — vol. 13, p. 372−377.
- Kilbridge P.M., Classen D.C. Automated surveillance for adverse events in hospitalized patients: back to the future //Qual Saf Health Care.- 2006, — vol. 15, p. 148−149.
- Koch K.E. Use of standardized screening procedures to identify adverse drug reactions //Am J Hosp Pharm.- 1990.- vol. 47, p. 1314−1320.
- Kohn L.T., Corrigan J.M., Donaldson M.S. et al. To Err Is Human: Building a Safer Health System. Institute of Medicine Report. 1999, November 29.
- Koopmans P.P., van der Yen A.J., Vree T.B., van der Meer J.W. Pathogenesis of hypersensitivity reactions to drugs in patients with HIV infection: allergic or toxic? //Aids.- 1995, — vol. 9, p. 217−222.
- Kramer M.S., Leventhal J.M., Hutchinson T.A. et. al. An algoritm for the operational assessment of adverse drug reaction. // J. Am. Med. Assoc.- 1979, 24, p. 623−632.
- Lang D.M., Alpern M.B., Visintainer P.F., Smith S.T. Increased risk for anaphylactoid reaction from contrast media in patients on beta-adrenergic blockers or with asthma //Ann Intern Med.- 1991, — vol. 115, p. 270−276.
- Lau J., Antman E.M., Jimenez-Silva J., Kupelnick В., Mosteller F., Chalmers T.C. Cumulative meta-analysis of therapeutic trials for myocardial infarction //N Engl J Med.- 1992.- vol. 327, p. 248−254.
- Lazarou J., Pomeranz B.H., Corey P.N. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies //Jama.- 1998.-vol. 279, p. 1200−1205.
- Leape L.L., Bates D.W., Cullen D.J., Cooper J., Demonaco H.J., Gallivan Т., Hallisey R., Ives J., Laird N., Laffel G., et al. Systems analysis of adverse drug events. ADE Prevention Study Group //Jama.- 1995, — vol. 274, p. 35−43.
- Leape L.L., Cullen D J., Clapp M.D. et al. Pharmacist Participation on Physician Rounds and Adverse Drug Events in the Intensive Cure Unit. // JAMA.-1999, Jul 21, p. 267−282.
- Lloyd E. Adverse Drug Reactions and Dermatologist. The Symposium «Drug Actions, Interactions, Reactions», Canada, Toronto, 2000.
- Localio A.R., Weaver S.L., Landis J.R., Lawthers A.G., Brenhan T.A., Hebert L., Sharp T.J. Identifying adverse events caused by medical care: degree of physician agreement in a retrospective chart review //Ann Intern Med.- 1996.-vol. 125, p. 457−464.
- Loke Y.K., Derry S. Reporting of adverse drug reactions in randomised controlled trials a systematic survey //BMC Clin Pharmacol.- 2001.- vol. 1, p. 3.
- Loke Y.K., Price D., Derry S., Aronson J.K. Case reports of suspected adverse drug reactions—systematic literature survey of follow-up //Bmj.- 2006,-vol. 332, p. 335−339.
- Louie A.K., Lewis T.B., Lannon M.D. Use of low-dose fluoxetine in major depression and panic disorder. II J. Clin. Psychiatry.- 1993, 54(1), p. 435−438.
- Mann R.D. Prescription-event monitoring—recent progress and future horizons //Br J Clin Pharmacol.- 1998.- vol. 46, p. 195−201.
- Mannesse C.K., Derkx F.H., de Ridder M.A. Contribution of adverse drug reactions to hospital admission of older patients. // Age Ageing.- 2000, Jan, 29(1), p. 35−39.
- Maxwell С. J. Differences between males and females in risk of NSAID-related severe gastrointestinal events. // Pharmacoepidemiology and Drug Safety.- 1999, 4, p. 501−507.
- Meyboom R.H., Hekster Y.A., Egberts A.C., Gribnau F.W., Edwards I.R. Causal or casual? The role of causality assessment in pharmacovigilance //Drug Saf.- 1997, — vol. 17, p. 374−389.
- Miller G.C., Britth H.C., Valenti L. Adverse drug events in general practice patients in Australia //Med J Aust.- 2006.- vol. 184, p. 321−324.
- Mills D.H. Medical insurance feasibility study. A technical summary //West J Med.- 1978.- vol. 128, p. 360−365.
- Miremont G., Haramburu F., Begaud В., Pere J.C., Dangoumau J. Adverse drug reactions: physicians' opinions versus a causality assessment method //Eur J Clin Pharmacol.- 1994.- vol. 46, p. 285−289.
- Mitchell A.S., Henry D.A., Sanson-Fisher R., O’Connell D.L. Patients as a direct source of information on adverse drug reactions //Bmj.- 1988.- vol. 297, p. 891−893.
- Moore C., Wisnivesky J., Williams S., McGinn T. Medical errors related to discontinuity of care from an inpatient to an outpatient setting //J Gen Intern Med.- 2003.- vol. 18, p. 646−651.
- Morgan M.Y., Reshef R., Shah R.R., Oates N.S., Smith R.L., Sherlock S. Impaired oxidation of debrisoquine in patients with perhexiline liver injury //Gut.- 1984.- vol. 25, p. 1057−1064.
- Naranjo C., Busto E.M., Seller P., A metod of estimating the probability of adverse drug reaction, // Clin. Farmacol. Ther.- 1981, 30, p. 239−245.
- Neale G., Woloshynowych M. Retrospective case record review: a blunt instrument that needs sharpening //Qual Saf Health Care.- 2003- vol. 12, p. 2−3.
- Nebeker J.R., Barach P., Samore M.H. Clarifying adverse drug events: a clinician’s guide to terminology, documentation, and reporting //Ann Intern Med.- 2004.- vol. 140, p. 795−801.
- New guidelines prevent costly adverse drug reactions, // Healthc. Demand. Dis. Manag.- 2000, Apr, 6(4), p. 59−63.
- Olsen P.M., Lorentzen H., Thomsen K., et al., Medication errors in a pediatric department. //Ugeskr. Laeger.- 1997, Apr, 14, 159(16), p. 2392−2395.
- O’Neil A.C., Petersen L.A., Cook E.F., Bates D.W., Lee Т.Н., Brennan T.A. Physician reporting compared with medical-record review to identify adverse medical events //Ann Intern Med.- 1993, — vol. 119, p. 370−376.
- Park B.K., Pirmohamed M., Kitteringham N.R. Idiosyncratic drug reactions: a mechanistic evaluation of risk factors //Br J Clin Pharmacol.- 1992, — vol. 34, p. 377−395.
- Park B.K., Pirmohamed M., Kitteringham N.R. Role of drug disposition in drug hypersensitivity: a chemical, molecular, and clinical perspective //Chem Res Toxicol.- 1998.- vol. 11, p. 969−988.
- Park B.K., Pirmohamed M., Kitteringham N.R. The role of cytochrome P450 enzymes in hepatic and extrahepatic human drug toxicity //Pharmacol Ther.-1995, — vol. 68, p. 385−424.
- Petri M., Allbritton J. Antibiotic allergy in systemic lupus erythematosus: a case-control study //J Rheumatol.- 1992.- vol. 19, p. 265−269.
- Physician’s Desk Reference, 56 edition, 2003.
- Pini L.A., Sternieri E. Active reporting scheme: an example to evaluate specific adverse drug reactions //Acta Physiol Hung.- 1990, — vol. 75 Suppl, p. 237−238.
- Pirmohamed M., James S., Meakin S., Green C., Scott A.K., Walley T.J., Farrar K., Park B.K., Breckenridge A.M. Adverse drug reactions as cause ofadmission to hospital: prospective analysis of 18 820 patients //Bmj.- 2004.-vol. 329, p. 15−19.
- Pirmohamed M., Kitteringham N.R., Park B.K. The role of active metabolites in drug toxicity //Drug Saf.- 1994, — vol. 11, p. 114−144.
- Pirmohamed M., Madden S., Park B.K. Idiosyncratic drug reactions. Metabolic bioactivation as a pathogenic mechanism //Clin Pharmacokinet.- 1996,-vol. 31, p. 215−230.
- Pirmohamed M., Naisbitt D.J., Gordon F., Park B.K. The danger hypothesis-potential role in idiosyncratic drug reactions //Toxicology.- 2002.- vol. 181 182, p. 55−63.
- Pirmohamed M., Park B.K. Adverse drug reactions: back to the future //Br J Clin Pharmacol.- 2003, — vol. 55, p. 486−492.
- Pohl L.R. Drug-induced allergic hepatitis //Semin Liver Dis.- 1990.- vol. 10, p. 305−315.
- Pohl L.R. Drug-induced allergic hepatitis: does isaxonine fall into this category? //Hepatology.- 1989.- vol. 9, p. 785−788.
- Pohl L.R., Satoh H., Christ D.D., Kenna J.G. The immunologic and metabolic basis of drug hypersensitivities //Annu Rev Pharmacol Toxicol.- 1988.- vol. 28, p. 367−387.
- Pramatarov K.D. Drug-induced lupus erythematosus //Clin Dermatol.- 1998.-vol. 16, p. 367−377.
- Rawlins M.D. Phannacovigilance: paradise lost, regained or postponed? The William Withering Lecture 1994 //J R Coll Physicians Lond.- 1995.- vol. 29, p. 41−49.
- Rawlins M.D., Thompson J.W. Mechanisms of adverse drug reactions. In: Davies DM, ed. Textbook of adverse drug reactions., Oxford: Oxford University Press, 1991:18−45.
- Riedl M.A., Casillas A.M. Adverse drug reactions: types and treatment options //Am Fam Physician.- 2003, — vol. 68, p. 1781−1790.
- Rodriguez-Monguio R., Otero M.J., Rovira J. Assessing the economic impact of adverse drug effects //Pharmacoeconomics.- 2003.- vol. 21, p. 623−650.
- Roger, Claire W., Cabcenell A. Reducing Adverse Drug Reactions. // Cost Engineering Report.- 1999, June, p. 85−89.
- Rossi A.C., Knapp D.E., Anello C., O’Neill R.T., Graham C.F., Mendelis P. S., Stanley G.R. Discovery of adverse drug reactions. A comparison of selected phase IV studies with spontaneous reporting methods //Jama.- 1983.-vol. 249, p. 2226−2228.
- Rothman K.J., Causal inference in epidemiology, // Modern Epidemiology, Boston: Little, Brown and Company.- 1986, p. 7−21.
- Schmitt В., Bennett C., Seidenfeld J., Samson D., Wilt T. Maximal androgen blockade for advanced prostate cancer //Cochrane Database Syst Rev.- 2000,-vol. p. CD001526.
- Schousboe L.P., Tandrup O. Correct documentation of drug prescriptions, // Ugeskr. Laeger.- 1999, Aug 2, 161(31), p. 4389−4392.
- Seeger J.D., Kong S.X., Schumock G.T., Characteristics associated with ability to prevent adverse drug reactions in hospitalized patients. // Pharmacotherapy.- 1998, Nov-Dec, 18(6), p. 1284−1289.
- Shah R.R., Oates N.S., Idle J.R., Smith R.L., Lockliart J.D. Impaired oxidation of debrisoquine in patients with perhexiline neuropathy //Br Med J (Clin Res Ed).- 1982.- vol. 284, p. 295−299.
- Shapiro S. The epidemiological evaluation of drugs //Acta Med Scand Suppl.-1984, — vol. 683, p. 23−27.
- Sharma H, Aqil M, Imam F, Alam MS, Kapur P, Pillai KK. A pharmacovigi-lance study in the department of medicine of a university teaching hospital. // Pharmacy Practice 2007−5(1): 46−49.
- Sills J.M., Tanner L.A., Milstien J.B. Food and Drug Administration monitoring of adverse drug reactions //Am J Hosp Pharm.- 1986 vol. 43, p. 27 642 770.
- Simon L.S. Pharmacovigilance: towards a better understanding of the benefit to risk ratio //Ann'Rheum Dis.- 2002.- vol. 61 Suppl 2, p. ii88−89.
- Stanhope N., Crowley-Murphy M., VinGent C., O’Connor A.M., Taylor-Adams S.E. An evaluation of adverse incident reporting //J Eval Clin Pract.-1999,-vol. 5, p. 5−12.
- Strom B.L. Overview of different logistical approaches to postmarketing surveillance //J Rheumatol Suppl.- 1988, — vol. 17, p. 9−13.
- Strom B.L. Postmarketing surveillance and other epidemiologic uses of drug prescription data in the United States //Ann 1st Super Sanita.- 1991, — vol. 27, p. 235−237.
- Szekendi M.K., Sullivan C., Bobb A., Feinglass J., Rooney D., Barnard C., Noskin G.A. Active surveillance using electronic triggers to detect adverse events in hospitalized patients //Qual Saf Health Care.- 2006, — vol. 15, p. 184 190.
- Tejal K. Gandhi et al., Drug Complications in Outpatients // Journal of General Internal Medicine.- 2005 April- 20(4): 331−333.
- The Institute for Healthcare Improvement, The Quest for Error-Proof Medicine., //DrugBenefit. Trends.- 1997, 9(6), 18, 23, p. 27−29.
- The Institute of Medicine Report on Medical Errors: Misunderstanding Can Do Harm Quality of Health Care in America Committee, /Med. Gen. Med., September 19, 2000.
- The Merk Manual on Geriatrics. Second edition, Merk Reseach Laboratories, 1995.
- Thong B.Y., Leong K.P., Tang C.Y., Cling H.H. Drug allergy in a general hospital: Results of a novel prospective inpatient reporting system //Ann Allergy Asthma Immunol.- 2003, — vol. 90, p. 342−347.
- Thornton P.D., Simon S., Mathew Т.Н., Towards safer drug prescribing, dispensing and administration in hospitals, // J. Qual. Clin. Pract.- 1999, Mar, 19(1), p. 41.
- Tissot E., Cornette C., Demoly P., et al., Medication Errors at the Administration Stage in an Intensive Care Unit, // Intensive Care. Med.- 1999, Apr, 25(4), p. 353−359.
- United States Pharmacopea, volume 1, 19 edition, 2002.
- Ursprung R., Gray J.E., Edwards W.H., Horbar J.D., Nickerson J., Plsek P., Shiono P.H., Suresh G.K., Goldmann D.A. Real time patient safety audits: improving safety every day //Qual Saf Health Care.- 2005, — vol. 14, p. 284 289.
- Vandenbroucke J.P. In defense of case reports and case series //Ann Intern Med.- 2001.- vol. 134, p. 530−334.
- Venning G.R. Identification of adverse reactions to new drugs. IV— Verification of suspected adverse reactions //Br Med J (Clin Res Ed).- 1983.-vol. 286, p. 544−547.
- Venning G.R. Validity of anecdotal reports of suspected adverse drug reactions: the problem of false alarms //Br Med J (Clin Res Ed).- 1982, — vol. 284, p. 249−252.
- Venulet J., ten Ham M. Methods for monitoring and documenting adverse drug reactions //Int J Clin Pharmacol Ther.- 1996.- vol. 34, p. 112−129.
- Walshe A.D., Wilson G.J., Murphy A.J. The validity and reliability of a test of lower body musculotendinous stiffness //Eur J Appl Physiol Occup Physiol.- 1996, — vol. 73, p. 332−339.
- Weiss M.E., Adkinson N.F. Immediate hypersensitivity reactions to penicillin and related antibiotics //Clin Allergy.- 1988.- vol. 18, p. 515−540.
- West E., Organisational sources of safety and danger: sociological contributions to the study of adverse events, // Qual. Health Care.- 2000, Jun., 9(2), p. 120−126.
- WHO Pharmaceuticals newsletter. Anti inflammatory analgesics, hepatic reactions. 2001, 1, p. 12−13.
- Williams D., Kelly A., Feely J., Drug interactions avoided-a useful indicator of good prescribing practice^ // Br J Clin Pharmacol 2000, Apr, 49(4), p. 369−372.
- Williams R.T. The metabolism of foreign compounds and the detoxication mechanisms Detoxication mechanisms., New York: Wiley, 1959:717−740.
- Wilson R.M., Harrison B.T., Gibberd R.W., Hamilton J.D. An analysis of the causes of adverse events from the Quality in Australian Health Care Study //Med J Aust.- 1999, — vol. 170, p. 411−415.
- Wilson R.M., Runciman W.B., Gibberd R.W., Harrison B.T., Hamilton J.D. Quality in Australian Health Care Study //Med J Aust.- 1996.- vol. 164, p. 754.
- Wilson R.M., Runciman W.B., Gibberd R.W., Harrison B.T., Newby L., Hamilton J.D. The Quality in Australian Health Care Study //Med J Aust.-1995,-vol. 163, p. 458−471.
- Wilton L.V., Mackay F., Pearce G., Mann R.D. The outcomes of pregnancy in women prescribed newly marketed drugs in 34 studies conducted by Prescription-Event Monitoring (РЕМ). Pharmacoepidemiology and Drug Safety 1997- 6: Abstract 072.
- Woloshynowych M., Neale G., Vincent C. Case record review of adverse events: a new approach//Qual Saf Health Care.- 2003, — vol. 12, p. 411−415.
- Wong I.C.K., Sweis D. Techniques in pharmacovigilance // The Pharmaceutical Journal Vol 264 No. 7101 p922−923 2000, — vol. p.
- Yawalkar N., Egli F., Hari Y., Nievergelt H., Braathen L.R., Pichler W.J. Infiltration of cytotoxic T cells in drug-induced cutaneous eruptions //Clin Exp Allergy.- 2000.- vol. 30, p. 847−855.