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References
Bäckström M, et al. Attitudes to reporting adverse drug reactions in northern Sweden. Eur J Clin Pharmacol 2000; 56(9): 729–32
Bawazir S, Al-Sultan M. To study hospital pharmacists attitude and behavior toward reporting of adverse drug reactions (ADRs) in different hospitals throughout Saudi Arabia. Saudi Pharmaceutical Journal 2009; 17(1)
Bawazir SA. Attitude of community pharmacists in Saudi Arabia towards adverse drug reaction reporting. Saudi Pharmaceutical Journal 2006; 14(1): 75–83
Free H. Awareness and attitudes of healthcare professionals in Wuhan, China to the reporting of adverse drug reactions. CMJ 2004; 6: 856–61
Granas A, et al. Pharmacists’s attitudes towards the reporting of suspected adverse drug reactions in Norway. Pharmacoepidemiol Drug Saf 2007; 16(4): 429–34
Green C, et al. Attitudes and knowledge of hospital pharmacists to adverse drug reaction reporting. Br J Clin Pharmacol 2001; 51(1): 81
References
Alhazmi N, Naylor IL. (2011) Attitude and awareness of ADR reporting by health professionals in the Holy City of Makkah hospitals Kingdom of Saudi Arabia (KSA). 11 ISoP meeting (International Conference on Pharmacovigilance), Turkey 26-28 October 2011
Al-hassan MA. Look at Community Pharmacy Practice inSaudi Arabia. Research Journal of Medical Sciences 2009; 3: 111–4
Bawazir SA. Attitude of community pharmacists in Saudi Arabia towards adverse drug reaction reporting. Saudi Pharmaceutical Journal 2006; 14: 75–83
Bawazir S, Al-sultan M. To study hospital pharmacists attitude and behaviour toward reporting of advearse drug reactions (ADRs) in different hospitals throughout Saudi Arabia. Saudi Pharmacutical Journal 2009; 17: 1
Granas AG, Buajordet M, Stenberg-Nilsen H, et al. Pharmacists’s attitudes towards the reporting of suspected adverse drug reactions in Norway. Pharmacoepidemiol Drug Saf 2007; 16: 429–34
Davis S, Coulson R. Community pharmacist reporting of suspected ADRs: (1) The first year of the yellow card demonstration scheme. Pharm J 1999; 263: 786–8
References
Strom BL, Hennessy S. Pharmacists Care and Clinical Outcomes for Patients With Reactive Airways Disease. JAMA 2002; 288: 1642–3
Ahmed A, Van Mierlo P, Jansen P. Sleep disorders, nightmares, depression and anxiety in an elderly patient treated with low-dose metoprolol. Gen Hosp Psychiatry 2010; 2(6): 646–6
Medicines.org.uk [hompage on the internet], London. The electronic Medicines Compendium [last updated 2011 January 11, cited 2011 February]. Available from: http://www.medicines.org.uk/EMC/medicine/23055/SPC/Simvastatin+10mg+Tablets/#UNDESIRABLE_EFFECTS
De La Cochetière MF, Durand T, Lalande V, et al. Effect of antibiotic therapy on human fecal microbiota and the relation to the development of Clostridium difficile. Microb Ecol 2008; 56(3): 395–402
Edwards IR, Biriell C. Harmonisation in Pharmacovigilance. Drug Saf 1994; 10(2): 93–102
References
Santangeli P, Di Biase L, Burkhardt JD, et al. Examining the safety of amiodarone. Expert Opin Drug Saf 2012; 11(12): 191–214
Capraro J, Thalmann S. Amiodarone and thyroid. Ther Umsch 2011; 68(6): 309–13
Jackevicius CA, Tom A, Essebag V, et al. Population-level incidence and risk factors for pulmonary toxicity associated with amiodarone. Am J Cardiol 2011; 108(5): 705–10
References
Oertie M. Frequency and nature of drug-drug interactions in a Swiss primary and secondary acute care hospital. Swiss Med Wkly 2012; 142: 0 doi 10.4414/smw.2012.13522
Mateli U, Rajakannan T, Nekkanti H, et al. Drug-drug interactions in Hospitalized Cardiac Patients. J Young Pharm 2011; 3(4): 329–33
Reference
Koski G, Widler B, Olmsted A. A global clinical research framework Regulatory Affairs Pharma 2011 July: 10-4
References
Re Act Action on Antibiotic Resistance. http://www.reactgroup.org Cuidar y curar. Compendio de la resistencia bacteriana a los antibióticos. Versión en español, Cuenca, Ecuador, 2010
Xuesong H, Xuedong Z, Wenyuan S. Oral microbiology: Past, present and future. NIH Public Access. Int J Oral Sci 2009 Jun; 1(2): 47–58
Marsh P, Martin M. Microbiología Oral, 5ta. Edición AMOLCA. 2011: 117-37
Health and drug alerts, people with diabetes should avoid antibiotic gatifloxacin. CMAJ 2006 Apr 11; 174 (8): 1089
Koneman. Diagnóstico Microbiológico. Washington C. Winn, Stephenk D. Allen, William M. Janda, Elmer W. Koneman, Gary W. Procop, Paul C. Schrenckenberger, Gail L. Woods. 6ta Ed. 2008. Editorial Médica Panamericana.ISBN: 978-950-06-0895-4
CLSI — Clinical and Laboratory Standard Institute. Performance standards for antimicrobial susceptibility testing. 16th Informational Suplement, CLSI document
References
Alesso L, Belkahia C, Bignone I, 2007. FARMACOVIGILANCIA: Hacia una mayor seguridad en el uso de los medicamentos. Ed. SAF (Sociedad Argentina de Fármacovigilancia) pp. 313
Boothe DM, 2001. Vigilancia de fármacos terapéuticos. En: Bonagura JD (ed). Terapéutica Veterinaria de Pequeños Animales. McGraw-Hill Inter-americana de España, S.A.U., Madrid, España, Pp 28-35
ISoP abstracts. Drug Saf 2008; 31 (10): 807-960
European Agency for the Evaluation of Medicinal Products, Directive 2001/83/EC and Directive 2001/82/EC. The rules governing medicinal products in the European Union.vol 9. pp 385
Manso G, Hidalgo A, Carbajal A, de Abajo F. (2010). Los primeros 25 años del Sistema Español de Farmacovigilancia de Medicamentos de Uso Humano. Dossier de Farmacovigilancia de Valladolid. Ed. Universidad de Oviedo
OMS 2001 International Drug Monitoring Programme, formed by OMS 2001 International Drug Monitoring Programme
Reference
Duggirala HJ, Herz ND, Canos DA, et al. Disproportionality analysis for signal detection of implantable cardioverter-defibrillator-related adverse events in the Food and Drug Administration Medical Device Reporting System. Pharmacoepidemiol Drug Saf 2012; 21: 87–93
References
Palaian S, Mishra P, Shankar PR, et al. Contribution of the regional drug information center towards drug safety. JNMA J Nepal Med Assoc 2006 Jan–Mar; 45(161): 216–8
Michel DJ, Knodel LC. Program coordinated by a drug information service to improve adverse drug reaction reporting in a hospital. Am J Hosp Pharm 1986 Sep; 43(9): 2202–5
Kondro W. Adverse reaction database has minimal information. CMAJ 2005 Jul 19; 173(2): 137
Jimmy B, Jose J, Rao PG. Short communication: pattern of adverse drug reaction related queries received by the drug information centre of a tertiary care teaching hospital. Pak J Pharm Sci 2007 Oct; 20(4): 333–9
Ortega A, Aguinagalde A, Lacasa C, et al. Efficacy of an adverse drug reaction electronic reporting system integrated into a hospital information system. Ann Pharmacother 2008 Oct; 42(10): 1491–6. Epub 2008 Sep 9
Ghosh P, Dewanji A. Analysis of spontaneous adverse drug reaction (ADR) reports using supplementary information. Stat Med 2011 Jul 20; 30(16): 2040–55. doi: 10.1002/sim.4270. Epub 2011 May 4
References
Rauch A, Nolan D, Martin A, et al. Prospective genetic screening decreases the incidence of abacavir hypersensitivity reactions in the Western Australian HIV cohort study. Clin Infect Dis 2006; 43: 99–102
Nolan D. HLA-B*5701 screening prior to abacavir prescription: clinical and laboratory aspects. Crit Rev Clin Lab Sci 2009; 46: 153–65
Hughes S, Hughes A, Brothers C, et al. PREDICT-1 (CNA106030): the first powered, prospective trial of pharmacogenetic screening to reduce drug adverse events. Pharm Stat 2008; 7: 121–9
Mallal S, Phillips E, Carosi G, et al. HLA-B*5701 screening for hypersensitivity to abacavir. N Engl J Med.
Reference
MHRA website 22.05.2012
References
Agbabiaka TB, Svovic J, Ernst E. Methods for Causality Assessment of Adverse Drug Reactions: A Systematic Review. Drug Saf 2008; 31(1): 21–37
Bogardus ST, Holmboe E, Jekel JF. Perils, pitfalls and possibilities in talking about medical risk. J Am Med Assoc 1999; 281: 1037–41
Kong A, Barnett GO, Mosteller F, et al. How medical professionals evaluate expressions of prabability. N Engl J Med 1986; 315: 740–4
Aronson JK. Risk perception in drug therapy. Br J Clin Pharmacol 2006; 62(2): 135–7
Reyna VF, Nelson WL, Han PK, et al. How Numeracy Influences Risk Comprehension and Medical Decision Making. Psychol Bull 2009; 135(6): 943–73
Reference
Tulkens P, Arvis P, Kruesmann F. Moxifloxacin Safety: an Analysis of 14 Years of Clinical Data. Drugs in Research and Development. In press
References
Rotunda A, Hirsch RJ, Scheinfeld N, et al. Severe cutaneous reactions associated with the use of human immunodeficiency virus medications. Acta Derm Venereol 2003; 83(1): 1–9
Rzany B, Correia O, Kelly JP, et al. Risk of Stevens-Johnson syndrome and toxic epidermal necrolysis during first week of antiepileptic therapy: a casa-control study. The Lancet 1999; 353(9171): 2190–4
References
Afssaps, 2009. Imputabilite des effets indesirables lies aux produit cosmetiques. (online: www.afssaps.fr)
Colipa, 2008. Colipa Guidelines on the Management and reporting of Undesirable Event Reports in the context of EU Cosmetovigilance. (online: http://www.likochema.lt/docs/naujienos/COSVIG_Guidelines_updated.pdf)
Council of Europe, 2009. Cosmetic Regulation 1223/2009. (online: http://eur-lex.europa.eu/)
van Puijenbroek EP, Hepburn PA, Herd TM, et al. Post Launch Monitoring of food products: what can be learned from pharmacovigilance. Regul Toxicol Pharmacol 2007; 47: 213–20
Bons B, Audebert F, Bitaudeau C, et al.; Members of the Colipa Cosmetovigilance Task Force. Assessment of undesirable events in cosmetic market surveillance: background, description and use of a causality assessment method in cosmetovigilance. Regul Toxicol Pharmacol 2010; 58: 349–53
References
BRASIL. Ministério da Saúde. Secretaria de Vigilância em Saúde. Agencia Nacional em Vigilância Sanitária. Protocolo de vigilância epidemiológica de eventos adversos pós-vacinação. Estratégia de vacinação contra o vírus influenza pand emica (H1N1) — Brasília: Ministério da Saúde, 2010. 60 páginas
Portal Saúde. Ministério da Saúde. Brasil. 2010. http://portal.saude.gov.br/portal/aplicacoes/noticias/default.cfm?pg=dspDetalheNoticia&id_area=124&CO_NOTICIA=11562 (accessed 28/07/2010)
Centro de Controle e Prevenção de Doenças. Estados Unidos. 2010. http://www.cdc.gov/h1n1flu/vaccination/factsheet_gbs.htm (accessed 28/07/2010)
Bright on Collaboration https://brightoncollaboration.org/public (accessed 28/07/2010)
National Center for Immunization and Respiratory Diseases, CDC; Centers for Disease Control and Prevention (CDC). Use of influenza A (H1N1) 2009 monovalent vaccine: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2009. MMWR Recom Rep 2009; 58 (RR-10): 1-8
CDC. Swine influenza A (H1N1) infection in two children—south-ernCalifornia, March–April 2009. MMWR 2009; 58: 400–2
References
European Medicines Agency. Guideline on good pharmacovigilance practices (GVP) Module IX — Signal management (draft). 2012: EMA/827661/2011
van Puijenbroek EP, Bate A, Leufkens B, et al. A comparison measures of disproportionality for signal detection in spontaneous reporing systems for adverse drug reactions. Pharmacoepidem Drug Saf 2002; 11: 3–10
Pariente A, Didailler M, Avillach P, et al. A potential competition bias in the detection of safety signals from spontaneous reporting databases. Pharmacoepidemiol Drug Saf 2010 Nov; 19(11): 1166–71
References
International reporting of periodic drug safety update summaries, Final report of CIOMS working group II Geneva, CIOMS, 1992
ICH E2E pharmacovigilance planning document www.ich.org
European Medicines Agency http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000199.jsp&mid=WC0b01ac05800250b3&jsenabled=true
Are PSURs worthwhile? www.who-umc.org
Food and Drug Regulations Health Canada=s Product Vigilance http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/vigilance/index-eng.php
References
Parakkal D, et al. Hepatosplenic T-cell lymphoma in patients receiving TNF-a inhibitor therapy: expanding the groups at risk. Eur J Gastroenterol Hepatol 2011 Nov; 23(12): 1150–6
Kandiel A, et al. Increased risk of lymphoma among inflammatory bowel disease patients treated with azathioprine and 6-mercaptopurine. Gut 2005; 54: 1121–5
Thai A, Prindiville T. Hepatosplenic T-cell lymphoma and inflammatory bowel disease. J Crohns Colitis 2010 Nov; 4(5): 511–22. Epub 2010 Jun 25
Beaugerie L, et al. Lymphoproliferative disorders in patients receiving thiopurines for inflammatory bowel disease: a prospective observational cohort study. Lancet 2009 Nov 7; 374(9701): 1617–25
Herrinton LJ, et al. Role of thiopurine and anti-TNF therapy in lymphoma in inflammatory bowel disease. Am J Gastroenterol 2011 Dec; 106(12): 2146–53. doi: 10.1038/ajg.2011.283. Epub 2011 Oct 25
Rosh JR, et al. Hepatosplenic T-cell lymphoma in adolescents and young adults with Crohn’s disease: a cautionary tale? Inflamm Bowel Dis 2007 Aug; 13(8): 1024–30
References
McNeill C. Introduction. In: Temporomandibular Disorders: Guidelines for Classification, assessment, and Management. Chicago: Quintessense, 1993: 11–3
Okeson J. Tratamiento de oclusión y afecciones temporomandibulares. 6a.ed. Madrid, ES: Elsevier Mosby, 2008
Riva R, Sanguinetti M, Rodríguez A, et al. Prevalencia de trastornos temporo Mandibulares y bruxismo en Uruguay. Odontoestomatología 2011 Mayo; XIII (17)
Lavigne GJ, Khoury S, Abe S, et al. Bruxism physiology and pathology: and overview for clinicians. J Oral Rehabili 2008; 35: 476–94
Romero Benvenuto, María Renée Reacciones adversas a medicamentos en mujeres.Tendencias en Medicina, v.: 37, p.: 148–150, Montevideo; ISSN: 07977271.2010
Pearson Nl. Drug induced disease. A grinding issue: drug induced bruxism. CPJ/RPC September/October 2008. Vol 141, No 5
References
Servier Laboratories Ltd. Ivabradine Summary of Product Characteristics. March 2007
Servier Laboratories Ltd. Ivabradine Summary of Product Characteristics. November 2009
Reference
European Parliament and Council of the European Union. Directive 2001/83/EC of the European parliament and of the council of 6 November 2001 on the community code relating to medicinal products for human use. Official Journal L 2004 Nov 28; 311: 67–128
References
Rogers AS, Israel E, Smith CR, et al. Physician knowledge, attitudes, and behavior related to reporting adverse drug events. Arch Intern Med 1988; 148: 1596–600
Eland IA, Belton KJ, van Grootheest AC, et al. Attitudinal survey of voluntary reporting of adverse drug reactions. Br J Clin Pharmacol 1999; 48: 623–7
Lopez-Gonzalez E, Herdeiro MT, Figueiras A. Determinants of Under-Reporting of Adverse Drug Reactions: A Systematic Review. Drug Saf 2009; 32: 19–31
References
Oteri A, Bussolini A, Sacchi M, et al. A case of atrial fibrillation induced by inhaled fluticasone propionate. Pediatrics 2010; 126: e1237–41
Christiansen CF, Christensen S, Mehnert F, et al. Glucocorticoid use and risk of atrial fibrillation or flutter: a population-based, case-control study. Arch Intern Med 2009; 169: 1677–83
van der Hooft CS, Heeringa J, Brusselle GG, et al. Corticosteroids and the risk of atrial fibrillation. Arch Intern Med 2006; 166: 1016–20
Fujimoto S, Kondoh H, Yamamoto Y, et al. Holter electrocardiogram monitoring in nephrotic patients during methylprednisolone pulse therapy. Am J Nephrol 1990; 10: 231–6
References
Pirmohamed M, James S, Meakin S, et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. BMJ 2004; 329(7456): 15–9
Leone R, Magro L, Moretti U, et al. Identifying adverse drug reactions associated with drug-drug interactions: data mining of a spontaneous reporting database in Italy. Drug Saf 2010; 33(8): 667–75
Almenoff JS, DuMouchel W, Kindman LA, et al. Disproportionality analysis using empirical Bayes data mining: a tool for the evaluation of drug interactions in the post-marketing setting. Pharmacoepidemiol and Drug Saf 2003; 12(6): 517–21
Norén GN, Sundberg R, Bate A, et al. A statistical methodology for drug-drug interaction surveillance. Stat Med 2008; 27(16): 3057–70
Thakrar BT, Grundschober SB, Doessegger L. Detecting signals of drug-drug interactions in a spontaneous reports database. Br J Clin Pharmacol 2007; 64(4): 489–95
Strandell J, Caster O, Bate A, et al. Reporting Patterns Indicative of Adverse Drug Interactions: A Systematic Evaluation in VigiBase. Drug Saf 2011; 34(3): 253–66
References
FDA. FDA ALERT #1: 5/21/2007, updated 11/19/2007: FDA adds a new warning about the risk of myocardial ischemia to the boxed warning for Avandia, for treatment of Type 2 Diabetes. 2007 [21 Nov 2011]; Available from: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm143406.htm#2007_5
EMEA. Press Release: EMEA recommends new warnings and contraindications for rosiglitazone. 2008 [updated 24 Jan 2008]; Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2009/11/WC500015420.pdf
Nissen SE, Wolski K. Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes. N Engl J Med 2007; 356(24): 2457–71. Epub 21 May 2007
Stewart KA, Natzke BM, Williams T, et al. Temporal trends in anti-diabetes drug use in tricare following safety warnings in 2007 about rosiglitazone. Pharmacoepidemiol Drug Saf 2009; 18: 1048–52
Shi L, Zhao Y, Szymanski K, et al. Impact of thiazolidinedione safety warnings on medication use patterns and glycemic control among veterans with diabetes mellitus. J Diabetes Complications 2011; 25: 143–50
Ruiter R, Visser LE, van Herk-Sukel MP, et al. Prescribing of Rosiglitazone and Pioglitazone Following Safety Signals. Analysis of Trends in Dispensing Patterns in the Netherlands from 1998 to 2008. Drug Saf 2012. Epub 27 Apr 2012
References
Di Girolamo G. Drug-induced at interval prolongation: clinical, safety and regulatory updaes. Curr Drug Saf 2010 Jan; 5(1): 41–3
Ponte ML, Keller GA, Di Girolamo G. Mechanisms of Drug Induced QT Interval Prolongation. Curr Drug Saf 2010; 5(1): 44–53
References
Bagnes C, Panchuk PN, Recondo G. Antineoplastic Chemotherapy induced QTc Prolongation. Curr Drug Saf 2010; 5(1): 93–6
Di Girolamo G. Drug-induced at interval prolongation: clinical, safety and regulatory updaes. Curr Drug Saf 2010 Jan; 5(1): 41–3
Ponte ML, Keller GA, Di Girolamo G. Mechanisms of Drug Induced QT Interval Prolongation. Curr Drug Saf 2010; 5(1): 44–53
References
Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet 2000; 356(9237): 1255–9
Evans RS, Pestotnik SL, Classen DC, et al. Preventing adverse drug events in hospitalized patients. Ann Pharmacother 1994 Apr; 28(4): 523–7
Lazarou J, Pomeranz BH, Corey PN. Incidence of Adverse Drug Reactions in Hospitalized Patients: A Meta-analysis of Prospective Studies. JAMA 1998; 279(15): 1200–15
Keller GA, Di Girolamo G, Alvarez PA. Pharmacovigilance and the cardiovascular system: two sides to every story. Curr Drug Saf 2011 Sep 1; 6(4): 224–9
Alvarez PA, Egozcue J, Sleiman J, et al. Severe neutropenia in a renal transplant patient suggesting an interaction between mycophenolate and fenofibrate. Curr Drug Saf 2012; 7: 24–9
References
Andrade SE, Gurwitz JH, Chan KA, et al. Validation of diagnoses of peptic ulcers and bleeding from administrative databases: a multi-health maintenance organization study. J Clin Epidemiol 2002; 55: 310–3
Margulis AV, Garcia Rodriguez LA, Hernandez-Diaz S. Positive predictive value of computerized medical records for uncomplicated and complicated upper gastrointestinal ulcer. Pharmacoepidemiol Drug Saf 2009; 18: 900–9
Coloma PM, Schuemie MJ, Trifiro G, et al. Combining electronic healthcare databases in Europe to allow for large-scale drug safety monitoring: the EU-ADR Project. Pharmacoepidemiol Drug Saf 2011; 20: 1–11
References
Schirm E, Tobi H, de Jong-van den Berg LT. Unlicensed and off label drug use by children in the community: cross sectional study. BMJ 2002 Jun 1; 324(7349): 1312–3
Trifirò G, Fourrier-Reglat A, Sturkenboom MC, et al., EU-ADR Group. The EU-ADR project: preliminary results and perspective. Stud Health Technol Inform 2009; 148: 43–9
Trifirò G, Pariente A, Coloma PM, et al., EU-ADR group. Data mining on electronic health record databases for signal detection in pharmacovigilance: which events to monitor? Pharmacoepidemiol Drug Saf 2009 Dec; 18(12): 1176–84
Coloma PM, Trifirò G, Schuemie MJ, et al., on behalf of the EU-ADR consortium. Electronic healthcare databases for active drug safety surveillance: is there enough leverage? Pharmacoepidemiol Drug Saf 2012 Feb 8. doi: 10.1002/pds.3197. [Epub ahead of print]
References
Luepker RV, Apple FS, Christenson RH, et al. Case definitions for acute coronary heart disease in epidemiology and clinical research studies: a statement from the AHA Council on Epidemiology and Prevention; AHA Statistics Committee; World Heart Federation Council on Epidemiology and Prevention; the European Society of Cardiology Working Group on Epidemiology and Prevention; Centers for Disease Control and Prevention; and the National Heart, Lung, and Blood Institute. Circulation 2003 Nov 18; 108(20): 2543–9. Epub 2003 Nov 10
Kiyota Y, Schneeweiss S, Glynn RJ, et al. Accuracy of Medicare claims-based diagnosis of acute myocardial infarction: estimating positive predictive value on the basis of review of hospital records. Am Heart J 2004 Jul; 148(1): 99–104
Varas-Lorenzo C, Castellsague J, Stang MR, et al. Positive predictive value of ICD-9 codes 410 and 411 in the identification of cases of acute coronary syndromes in the Saskatchewan Hospital automated database. Pharmacoepidemiol Drug Saf 2008 Aug; 17(8): 842–52
Coloma PM, Schuemie MJ, Trifirò G, et al.; on behalf of the EU-ADR Consortium. Combining electronic healthcare databases in Europe to allow for large-scale drug safety monitoring: the EU-ADR Project. Pharmacoepidemiol Drug Saf 2011 Jan; 20(1): 1–11. doi: 10.1002/pds.2053. Epub 2010 Nov 8
References
Platt R, Wilson M, Chan KA, et al. The new Sentinel Network-improving the evidence of medical-product safety. N Engl J Med 2009 Aug 13; 361(7): 645–7. Epub 2009 Jul 27
Stang PE, Ryan PB, Racoosin JA, et al. Advancing the science for active surveillance: rationale and design for the Observational Medical Outcomes Partnership. Ann Intern Med 2010 Nov 2; 153(9): 600–6
Coloma PM, Schuemie MJ, Trifirò G, et al., EU-ADR Consortium. Combining electronic healthcare databases in Europe to allow for large-scale drug safety monitoring: the EU-ADR Project. Pharmacoepidemiol DrugSaf 2011 Jan; 20(1): 1–11. doi: 10.1002/pds.2053. Epub 2010 Nov 8
Meyboom RH, Lindquist M, Egberts AC, et al. Signal selection and follow-up in pharmacovigilance. Drug Saf 2002; 25(6): 459–65
Lindquist M. Use of triage strategies in the WHO signal-detection process. Drug Saf 2007; 30(7): 635–7
Schuemie MJ, Coloma PM, Straatman H, et al., on behalf of the EU-ADR consortium. Using electronic healthcare records for drug safety signal detection: a comparative evaluation of statistical methods. Med Care 2012 [Accepted]
References
Rootman I, Gordon-El-Bihbety D. Executive Summary: A Vision for a Health Literate Canada, in Report of the Expert Panel on Health Literacy. Ottawa: Canadian Public Health Association, 2008
Doak C, Doak L, Root J. Teaching Patients with Low Literacy Skills. Second edition ed. Philadelphia: J.B. Lippincott Company, 1996
Zarcadoolas C. The simplicity complex: exploring simplified health messages in a complex world. Health Promot Int 2010; 26(3): 338–50
References
Blumberg HM, Burman WJ, Chaisson RE, et al. American Thoracic Society/Centers for Disease Control and Prevention/Infectious Discases Society of America treatment of tuberculosis. Am J Respir Crit Care Med 2003; 167:603–62
Yee D, Valiquette C, Pelletier M, et al. Incidence of serious side effects from first-line antituberculosis drugs among patients treated for active tuberculosis. Am J Respir Crit Care Med 2003; 167: 1472–7
Reference
Novartis Europharm Ltd. Aliskiren. Summary of Product Characteristics. 2008
References aui]1._
EMA: European Medicines Agency concludes that benefit-risk balance of Revlimid remains positive. Press release [cited 2011 Nov 07]. Available from: http://www.ema.europa.eu/
References
Chan K, Zhang HW, Lin ZX. Treatments used in complementary and alternative medicine. In: Aaron JK, editor. Side effects of Drugs Annal. Vol. 33. Amsterdam, The Netherlands, 2011: 989-1007
SFDA National Center for ADR monitoring, 2012. Annual Report on National Adverse Drug Reaction Monitoring, 2011
State Administration of TCM of the People’s Republic of China, 2010. Notice on printing and distributing Guidelines on the Clinical Application of TCM. SATCM-MA No.30
State Food and Drug Administration, 2003. Notice on the termination of the medicinal use of Guan Mutong. SFDA-REGISTRATION No. 121
The Ministry of Health, SFDA, SATCM, 2008. Notice on further strengthening the production, management and clinical rational use of TCMI. MOH-MA No.71
Zhang L, Yang XH. Pharmacovigilance should be introduced into the safety monitoring and evaluation of traditional Chinese drugs. J Integr Tradit West Med 2009; 29(9): 863–6
References
Brackett CC, Singh H, Block JH. Likelihood and mechanisms of cross-allergenicity between sulfonamide antibiotics and other drugs containing a sulfonamide functional group. Pharmacotherapy 2004; 24(7): 856–70
Caster O, Norén GN, Madigan D, et al. Large-Scale Regression-Based Pattern Discovery: The Example of Screening the WHO Global Drug Safety Database. Stat Analysis Data Mining 2010; 3(4): 197–208
Norén GN, Hopstadius J, Bate A. Shrinkage observed-to-expected ratios for robust and transparent large-scale pattern discovery. Stat Methods Med Res 2011;doi:10.1177/0962280211403604
Fourches D, Muratov E, Tropsha A. Trust, but verify: on the importance of chemical structure curation in cheminformatics and QSAR modeling research. J Chem Inf Model 2010; 50(7): 1189–204
Naisbitt DJ, Hough SJ, Gill HJ, et al. Cellular disposition of sulphamethoxazole and its metabolites: implications for hypersensitivity. Br J Pharmacol 1999; 126(6): 1393–407
References
Ferrajolo C, Capuano A, Verhamme KM, et al. Drug-induced hepatic injury in children: a case/non-case study of suspected adverse drug reactions in Vigi Base. Br J Clin Pharmacol 2010; 70: 721–8
Trifiro G, Pariente A, Coloma PM, et al. Data mining on electronic health record databases for signal detection in pharmacovigilance: which events to monitor? Pharmacoepidemiol Drug Saf 2009; 18: 1176–84
Coloma PM, Trifirò G, Schuemie MJ, et al., on behalf of the EU-ADR consortium. Electronic healthcare databases for active drug safety surveillance: is there enough leverage? Pharmacoepidemiol Drug Saf 2012 Feb 8; doi: 10.1002/pds.3197. [Epub ahead of print]
Schuemie MJ. Methods for drug safety signal detection in longitudinal observational databases: LGPS and LEOPARD. Pharmacoepidemiol Drug Saf 2011 Mar; 20(3): 292–9. doi: 10.1002/pds.2051. Epub 2010 Oct 13
References
Moride Y, Haramburu F, Requejo AA, et al. Under-reporting of adverse drug reactions in general practice. Br J Clin Pharmacol 1997; 43: 177–81
Martin MR, Kapoor KV, Wilton LV, et al. Underreporting of suspected adverse drug reactions to newly marketed (“black triangle”) drugs in general practice: observational study. BMJ 1998 Jul; 317: 119–20
Hazell L, Shakir SAW. Under-Reporting of Adverse Drug Reactions A Systematic Review. Drug Saf 2006; 29(5): 385–96
Standard ISB 1582 Electronic Yellow Card Reporting. http://www.isb.nhs.uk/documents/isb-1582 [Accessed 2012 May 22]
References
Varricchio F. Vaccine adverse event reporting: the importance of follow-up. Expert Rev Vaccines 2005; 4(4): 445–8
Anton C, Cox AR, Ferner RE. Improving follow-up rates in spontaneous adverse drug reaction reporting: effectiveness of a targeted letter used by a regional centre in the UK. Drug Saf 2009; 32(12): 1135–40
References
Agreement adopted by the Permanent Conference for Relations between State, Regions and Autonomous Provinces of Trento and Bolzanosigned on 28 October 2010
Bandekar MS, Anwikar SR, Kshirsagar NA. Quality check of spontaneous adverse drug reaction reporting forms of different countries. Pharmacoepidemiol Drug Saf 2010Nov; 19(11): 1181–5
Brajovic S, Piazza-Hepp T, Swartz L, et al. Quality assessment of spontaneous triggered adverse event reports received by the Food and Drug Administration. Pharmacoepidemiol Drug Saf 2012 Feb 22
Sara-Lisa F. Documentation grading — how complete are the reports? Uppsala Reports 54 2011 Jul; 14-5
Reference
Agreement adopted by the Permanent Conference for Relations between State, Regions and Autonomous Provinces of Trento and Bolzanosigned on 28 October 2010
References
Bartlett JA, Chen SS, Quinn JB. Comparative efficacy of nucleoside/nucleotide reverse transcriptase inhibitors in combination with efavirenz: results of a systematic overview. HIV Clin Trials 2007; 8(4): 221–6
Horberg MA, Klein DB. An update on the use of Atripla® in the treatment of HIV in the United States. HIV AIDS (Auckl) 2010; 2: 135–40
References
Berger JR. The clinical features of PML. Cleve Clin J Med 2011 Nov; 78 Suppl. 2: S8–12
Fox R. Advances in the management of PML: focus on natalizumab. Cleve Clin J Med 2011 Nov; 78 Suppl. 2: S33–7
References
Copegus [package insert]. South San Francisco, CA: Genentech USA, Inc., 2011
Rebetol [package insert]. Whitehouse Station, NJ: Merck & Co., Inc., 2010
Pecou S, Moinard N, Walschaerts M, et al. Ribavirin and pegylated interferon treatment for hepatitis C was associated not only with semen alterations but also with sperm deoxyribonucleic acid fragmentation in humans. Fertil Steril 2009 Mar; 91(3): 933. e17-22
Reference
Hartigan-Go KY, Wong JQ. Inclusion of therapeutic failures as adverse drug reactions. Side Effects of Drugs. Annual 23. Amsterdam: Elsevier, 2000: xxvii–xxxiii
References
Byard RW. J Forensic Sci 2010 Jan; 55 (1)
Hilal A. Mr Study: Cancer statistics in Morocco (1985–2000) Available from: http://cancer.ma/English/Publications/docs/Etude.aspx
Charlene LW. Effects of Health Disparities in Breast Cancer Among African-American Women in Massachusetts, UMASS Medical School, 2009
Chan T, Chan J. Chinese herbal medicines revisited: a Hong Kong perspective. Lancet 1993; 342: 1532–4
Dasgupta A. Review of abnormal laboratory test results and toxic effects due to use of herbal medicines. Am J Clin Pathol 2003; 120: 127–37
References
Huang CC, Chen YC, Leu HB, et al. Risk of adverse outcomes in Taiwan associated with concomitant use of clopidogrel and proton pump inhibitors in patients who received percutaneous coronary intervention. Am J Cardiol 2010; 105(12): 1705–9
Scheen AJ, Warzée F. Diabetes Is Still a Risk Factor for Restenosis After Drug-Eluting Stent in Coronary Arteries. Diabetes Care 2004; 27(7): 1840–1
Ho P, Maddox TM, Wang L, et al. Risk of adverse outcomes associated with concomitant use of clopidogrel and proton pump inhibitors following acute coronary syndrome. JAMA 2009; 301(9): 937–44
References
Meyboom RHB. Detecting adverse drug reactions [Doctoral Thesis] ’s-Hertogenbosch 1998
Vandenbroucke JP. Case reports in an evidence-based world. J R Soc Med 1999; 92(4): 159–63. Epub 1999/08/18
Vandenbroucke JP. In defense of case reports and case series. Ann Intern Med 2001; 134(4): 330–4. Epub 2001/02/22
EMA. Guideline on good pharmacovigilance practices (GVP) Module VI —Management and reporting of adverse reactions to medicinal products. 2012
EMA. Eudravigilance access policy for medicines for human use. 2011
Edwards IR. Good Pharmacovigi lance Practice and the Curate’s Egg. Drug Safety 2012; 35(6): 429–35
References
Bray GA. Medications for weight reduction. Med Clin North Am 2011 Sep; 95(5): 989–1008
Catoira N, Nagel M, Di Girolamo G, et al. Pharmacological treatment of obesity in children and adolescents: current status and perspectives. Expert Opin Pharmacother 2010; 11(18): 2973–83
Heal DJ*, Gosden J, Smith SL. What is the prognosis for new centrally-acting anti-obesity drugs? Neuropharmacology. In press (2012)
Bays HE, Gadde KM. Phentermine/topiramate for weight reduction and treatment of adverse metabolic consequences in obesity. Drugs Today (Barc) 2011 Dec; 47(12): 903–14
Yulyaningsih E, Zhang L, Herzog H, et al. NPY receptors as potential targets for anti-obesity drug development. Br J Pharmacol 2011 Jul; 163(6): 1170–202. doi: 10.1111/j.1476-5381.2011.01363.x
Gallwitz B. Anorexigenic effects of GLP-1 and its analogues. Handb Exp Pharmacol 2012; (209): 185–207
References
Lindquist M. Data Quality Management in Pharmacovigilance. Drug Saf 2004; 27(12): 857–70
Dyck D, Roithmayr T. Great Safety Performance: an improvement process using leading indicators. AAOHN J 2004 Dec; 52(12): 511–20
References
Bernstein PL. Against the Gods: the Remarkable Story of Risk. New York: John Wiley & Sons., 1996: 383
Frau S, et al. Risk Management Plans: are they a tool for improving drug safety? Eur J Clin Pharmacol 2010; 66: 785–90
Kasap Y, et al. The Drugs Monitored by TUFAM with Risk Management Plan (RMP). Drug Saf 2011; 34(10): 906–7
References
Muppidi K, Pumerantz AS, Wang J, et al. Development and stability studies of novel liposomal vancomycin formulations. ISRN Pharmaceutics 2012; 1-8
Rybak M, Lomaestro B, Rotschafer JC, et al. Therapeutic monitoring of vancomycin in adult patients: A consensus review of the American Society of Health-System Pharmacists, the Infectious Diseases Society of America, and the Society of Infectious Diseases Pharmacists. Am J Health-Syst Pharm 2009; 66: 82–98
Elyasi S, Khalili H, Dashti-Khavidaki S, et al. Vancomycin-induced nephrotoxicity: mechanism, incidence, risk factors and special populations. A literature review. Eur J Clin Pharmacol 2012 Mar 13 [Epub ahead of print]
References
Elias LS, Konzen D, Krebs JM, et al. The impact of polymyxin B dosage on in-hospital mortality of patients treated with this antibiotic. Antimicrob Chemother 2010; 65: 2231–7
Carvalho VC, Oliveira PR, Dal-Paz K, et al. Gram-negative osteomyelitis: clinical and microbiological profile. Braz J Infect Dis 2012 Jan–Feb; 16(1): 63–7
Knueppel RC, Rahimian J. Diffuse Cutaneous Hyperpigmentation Due to Tigecycline or Polymyxin B. Clin Infect Dis 2007; 45: 136–8
Reference
Silva AEBC, Reis AMM, Miasso AI, et al. Adverse Drug Events in a Sentinel Hospital in the State of Goiás, Brazil. Rev Latino-Am Enfermagem 2011 Mar–Apr; 19(2): 378–86
References
Subramanian G, Adams MD, Ventnre JC, et al. Implications of the human genome for understanding human biology and medicine. J Am Med Assoc 2001; 286: 2296–307
Ge D, Fellay J, Thompson AJ, et al. Genetic variation in IL28B predicts hepatitis C treatment-induced viral clearance. Nature 2009; 461: 399–401
Albanell J, Baselga J. Trastuzumab, A humanized anti-HER 2 monoclonal antibody for the treatment of breast cancer. Drugs Today 1999; 35: 931–46
Grillo-Lopez AJ, Hedrick E, Rashford M, et al. Rituximab: Ongoing and Future Clinical Development. Semin Oncol 2002; 29: 105–12
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/brgtherap/pharmaco_guid_ld-eng.pdf)
References
Forlee MV, Grouden M, Moore DJ, et al. Stroke after varicose vein foam injection sclerotherapy, Dublin, Ireland
Ceulen RPM, Sommer A, Vernooy K. Microembolism during Foam Sclerotherapy of Varicose Veins, Maastricht, the Netherlands
References
Begaud B, Martin K, Haramburu F, et al. Rates of spontaneous reporting of adverse drug reactions in France. JAMA 2002; 288(13): 1588
McAdams M, Staffa J, Dal Pan G. Estimating the extent of reporting to FDA: A case study of statin-associated rhabdomyolysis. Pharmacoepidemiol Drug Saf 2008; 17(3): 229–39
References
OMS (2012). From http://www.who.int/en/
Goosens H, Ferech M, VanderStichele R, et al. Outpatient antibiotic use in European association with resistance: a cross-national data base study. Lancet 2005; 365: 579–85
Weber JT. Appropriate Use of Antimicrobial Drugs: a better prescription is needed. JAMA 2006; 294(18): 2354–6
References
Lindquist M. Vigibase, the WHO Global ICSR Database System: Basic Facts. Drug Inf J 2008; 42(5): 409–19
WHOCC. The WHO Collaborating Centre for Drug Statistics Methodology. 2012 [cited 2012 29th May]; Available from: http://www.whocc.no/
Newcomer JW. Second-generation (atypical) antipsychotics and metabolic effects: A comprehensive literature review. CNS Drugs 2005; 19: 1–93
Simon V, van Winkel R, De Hert M. Are weight gain and metabolic side effects of atypical antipsychotics dose dependent? A literature review. J Clin Psychiatry 2009; 70(7): 1041–50
References
Abbo L, Sinkowitz-Cochran R, Smith L, et al. Faculty and resident physicians’ attitudes, perceptions, and knowledge about antimicrobial use and resistance. Infect Control Hosp Epidemiol 2011; 32(7): 714–8
Cortoos PJ, De Witte K, Peetermans WE, et al. Opposing expectations and suboptimal use of a local antibiotic hospital guideline: a qualitative study. J Antimicrob Chemother 2008; 62(1): 189–95
World Health Organization, W. Antibiotic Resistance. 2012 [cited 2012 02-05-2012]; Available from: http://www.who.int/mediacentre/factsheets/fs194/en/
Livermore DM. Minimising antibiotic resistance. Lancet Infect Dis 2005; 5(7): 450–9
Tonkin-Crine S, Yardley L, Little P. Antibiotic prescribing for acute respiratory tract infections in primary care: a systematic review and meta-ethnography. J Antimicrob Chemother 2011; 66(10): 2215–23
References
Goldkind L, Laine L. A systematic review of NSAIDs withdrawn from the market due to hepatotoxicity: lessons learned from the bromfenac experience. Pharmacoepidemiol Drug Saf 2006; 15(4): 213–20
Lee CH, Wang JD, Chen PC. Increased risk of hospitalization for acute hepatitis in patients with previous exposure to NSAIDs. Pharmacoepidemiol Drug Saf 2010; 19(7): 708–14
Traversa G, Bianchi C, Da Cas R, et al. Cohort study of hepatotoxicity associated with nimesulide and other non-steroidal anti-inflammatory drugs. BMJ 2003; 327(7405): 18–22
Gulmez SE, Lignot-Maleyran S, Devries CS, et al. Administrative complexities for a European observational study despite directives harmonising requirements. Pharmacoepidemiol Drug Saf 2012
Martin-Latry K, Begaud B. Pharmacoepidemiological research using French reimbursement databases: yes we can! Pharmacoepidemiol Drug Saf 2010; 19(3): 256–65
Theophile H, Laporte JR, Moore N, et al. The case-population study design: an analysis of its application in pharmacovigilance. Drug Saf 2011; 34(10): 861–8
References
Lacroix I, Hurault C, Sarramon MF, et al. Prescription of drugs during pregnancy: a study using EFEMERIS*, the new French database. Eur J Clin Pharmacol 2009; 65: 839–46
Kasirsky G, Tansy MF. Teratogenic effects of methamphetamine in mice and rabbits. Teratology 1971; 4: 131–4
Nora JJ, Vargo TA, Nora AH, et al. Dexamphetamine: a possible environmental trigger in cardiovascular malformations. Lancet 1970; 1: 1920
Heinonen OP, Slone D, Shapiro S. Birth Defects and Drugs in Pregnancy. Littleton, MA: Publishing Sciences Group Inc, 1977
Nora JJ, McNamara DG, Fraser FC. Dextroamphetamine sulfate and human malformations. Lancet 1967; 1: 570–1
Little BB, Snell LM, Gilstrap LC 3rd. Methamphetamine abuse during pregnancy: outcome and fetal effects. Obstet Gynecol 1988; 72: 541–4
Reference
Thérapie 2005, 60, 39
References
Danan G, Benichou C. Causality assessment of adverse reactions to drugs: I. A novel method based on the conclusions of international consensus meetings: application to drug-induced liver injuries. J Clin Epidemiol 1993; 46: 1323–30
Chalasani N, Björnsson E. Risk factors for idiosyncratic drug-induced liver injury. Gastroenterology 2010; 138: 2246–59
References
Ortiz R, et al. Fingerprinting of sildenafil citrate and tadalafil tablets in pharmaceutical formulations via X-ray fluorescence (XRF) spectrometry. J Pharm Biomed Anal 2012 Jan 25; 58: 7–11
Low M, et al. Safety and quality assessment of 175 illegal sexual enhancement products seized in red-light districts in Singapore. Drug Saf 2009; 32(12): 1141–6
Oh S, et al. Detection of sildenafil analogues in herbal products for erectile dysfunction. J Toxicol Environ Health A 2006 Nov; 69(21): 1951–8
Twohig M, et al. Rapid detection and identification of counterfeit and [corrected] adulterated products of synthetic phosphodiesterase type-5 inhibitors with an atmospheric solids analysis probe. Drug Test Anal 2010 Feb; 2(2): 45–50
Reference
Tannirandorn P, Epstein S. Drug-Induced Bone Loss. Osteoporos Int 2000; 11:637–59
References
Jones JK. Drugs in the elderly in Reichel, Clinical Aspect of Aging, third edition, pp. 41–59, Baltimore, 1989
Routledge PA, O’Mahony MS, Woodhouse KW. Adverse drug reactions in elderly patients. Br J Clin Pharmacol 2004 Feb; 57(2): 121–6
Reference
Leandro MJ, et al. Reconstitution of peripheral blood B cells after depletion with rituximab in patients with rheumatoid arthritis. Arthritis Rheum 2006; 54: 613–20
Reference
Ioannidis JP, Evans SJ, Gøtzsche PC, et al., CONSORT Group. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med 2004 Nov 16; 141(10): 781–8
References
Collaborative Group on Hormonal Factors in Breast Cancer. Breast cancer and hormonal contraceptives: collaborative reanalysis of individual data on 53 297 women with breast cancer and 100 239 women without breast cancer from 54 epidemiological studies. Collaborative Group on Hormonal Factors in Breast Cancer. Lancet 1996; 347: 1713–27
Collaborative Group on Hormonal Factors in Breast Cancer. Breast cancer and hormonal contraceptives: further results. Contraception 1996; 54 (3 Suppl.): 1S–106S
GPRD. The database. 2010. www.gprd.com/products/database.asp
References
WHO Expert Committee. The Selection of Essential Drugs. Geneva: World Health Organization. Technical Report Series, 1977; 615
World Health Organization. Safety of medicines — A guide to detecting and reporting adverse drug reactions — Why health professionals need to take actions. Geneva: World Health Organization, 2002
References
Sherman E, Rossi S, Szasz B, et al. Changes in cerebral neurotransmitters and metabolites induced by acute donepezil and memantine administrations: A microdialysis study. Brain Res Bull 2005 Dec; (69): 204–13
Hayslett RL, Tizabi Y. Effects of donepezil, nicotine and haloperidol in the central serotonergic system in mice: Implications for Tourette’s syndrome. Pharmacology, Biochemistry and Behavior 2005; (81): 879–86
SPC for donepezil (Aricept). URL: http://emc.medicines.org.uk. Accessed: 9 November 2011
Cross AJ, Crow TJ, Ferrier IN, et al. Serotonin receptor changes in dementia of the alzheimer type. J Neurochem 1984 Dec; 43(6): 1574–81
References
References
Health Ministry. Comisión Federal para la Protección contra Riesgos Sanitarios http://www.cofepris.gob.mx/ (Consulted on 11/04/12)
Inman WH. Attitudes to adverse drug reaction reporting. Br J Clin Pharmacol 1996 May; 41(5): 434–5
Lopez-Gonzalez E, Herdeiro MT, Figueiras. Determinants of underreporting of adverse drug reactions: a systematic review. Drug Saf 2009; 32(1): 19–31
Spector PE. Summated Rating Scale Construction. An Introduction 1992; Sage Publications
Carmines EG, Zeller RA. Reliability and Validity Assessment 1979. Sage Publications
Cronbach LJ. Coefficient alpha and the internal structure of tests. Psychometrika 1951; 16: 297–334
References
Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis and management. Lancet 2000; 356: 1255–9
Naranjo CA, Busto U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981; 30: 239–45
Hartwig SC, Seigel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Health Syst Pharm 1992; 49(9): 2229–32
Hallas J, Harvald B, Gram LF, et al. Drug related hospital admissions: the role of definitions and intensity of data collection, and the possibility of prevention. J Intern Med 1990; 228: 83–90
Lagnaoui R, Moore N, Fach J, et al. Adverse drug reactions in a department of systemic diseases-oriented internal medicine: Prevalence, incidence, direct costs and avoidability. Eur J Clin Pharmacol 2000; 55: 181–6
Nicholas M, Dominique L, Catherine N, et al. Frequency and cost of serious adverse drug reactions in a department of general medicine. Br J Clin Pharmacol 1998; 45: 301–8
References
Howland JS, Baker MG. Poe T. Does patient education cause side effects? A controlled trial. Journal of Famyly Practice 1990
Krag A, Nielsen HS, Norup M, et al. Research report: do general practitioners tell their patients about side effects to common treatments? Soc Sci Med 2004 Oct; 59(8): 1677–83
Gandhi, et al. Drug Complications in Outpatients. J Gen Intern Med 2000; 15: 149–54
References
Charles Mackenzie et al, Where next with Loa loaencephalopathy? Data are badly needed, letter (2007), Trends in Parasitology Vol. 23 No.6
David H. Molyneux, et al. Mass drug treatment for lymphatic filariasis and onchocerciasis, Trends in Parasitology Vol.19, No.1 1 November 2003
Myeler’s Side Effects of Drugs, 15th edition: 1950-1951
Tropical Medicine 2003, 202-205
Harrison’s Manual of Medicine, 17th edition
References
Waller P, Bahri P. Regulatory pharmacovigilance in the EU. In: Mann RD, Andrews E, editors. Pharmacovigilance. Chichester: John Wiley & Sons, 2002: 183–94
Bäckström M, Mjörndal T, Dahlqvist R. Spontaneous reporting of adverse drug reactions by nurses. Pharmacoepidemiol Drug Saf 2002; 11: 647–50
Sullivan KM, Spooner LM. Adverse-drug-reaction reporting by pharmacy students in a teaching hospital. Am J Health Syst Pharm 2008; 65: 1177–9
Figueiras A, Herdeiro MT, Polonia J, et al. An educational intervention to improve physician reporting of adverse drug reactions: a cluster-randomized controlled trial. JAMA 2006; 296: 1086–93
Herdeiro MT, Polonia J, Gestal-Otero JJ, et al. Improving Reporting of Adverse Drug Reactions: a Cluster-Randomized Trial among Pharmacists. Drug Saf 2008; 31(4): 335–44
References
Bloss E, et al. Adverse events related to multidrug-resistant tuberculosis treatment, Latvia, 2000–2004. The International Journal of Tuberculosis and Lung Disease 2010 Mar; 14(3): 275–81
WHO. A practical handbook on the pharmacovigilance of medicines used in the treatment of tuberculosis, 2012, p.ix
References
Schwabe U, Paffrath D. (Hrsg.): Drug prescribing report 2011. Berlin, Heidelberg: Springer Medizin Verlag, 2011
Arzneimittelkommission der deutschen Ärzteschaft: “Aus der UAW-Datenbank”: Leberschäden unter Flupirtin. Dtsch Arztebl 2007; 104: A 3200
Puls F, Agne C, Klein F, et al. Pathology of flupirtine-induced liver injury: a histological and clinical study of six cases. Virchows Arch 2011; 458: 709–16
Michel MC, Radziszewski P, Falconer C, et al. Unexpected frequent hepatotoxicity of a prescription drug, flupirtine, marketed for about 30 years. Br J Clin Pharmacol 2012; 73: 821–5
Anderson N, Borlak J. Correlation versus causation? Pharmacovigilance of the analgesic flupirtine exemplifies the need for refined spontaneous ADR reporting. PLoS One 2011; 6: e25221
Fontana RJ, Seeff LB, Andrade RJ, et al. Standardization of nomenclature and causality assessment in drug-induced liver injury: summary of a clinical research workshop. Hepatology 2010; 52: 730–42
References
Geer MI, Shah MY. Guiding Principles for the formulation of a Drug Policy in the state of J& K. Journal of Pharmacovigilance and Drug Safety 2009; 6(1): 22–6
Geer MI. Mushrooming of medical stores in J& K state — reasons and solutions. Physicians Academy 2010; 4(7): 75–6
Geer MI. Deficiencies in the draft Drug Policy of J& K government. Physicians Academy 2011; 5(2): 16–9
Geer MI. Magnitude of spurious drug trade in J& K — Mountain or a molehill? Physicians Academy 2012; 6(1): 2–9
Geer MI. Approved drug policy of J& K government — A Review. Physicians Academy 2012; 6(2): 27–37
Geer MI. Generic Drug Prescribing in J& K — Boone or bane? Physicians Academy 2012; 6(5): 82–7
References
Gan TJ. Pharmacokinetic and pharmacodynamic characteristics of medications used for moderate sedation. Clin Pharmacokinet 2006; 45(9): 855–69
Devlin JW, Mallow-Corbett S, Riker RR. Adverse drug events associated with the use of analgesics, sedatives, and antipsychotics in the intensive care unit. Crit Care Med 2010 Jun; 38 (6 Suppl.): S231–43
Hostynek JJ, Maibach HI. Fentanyl transdermal patches: overview of cutaneous adverse effects in humans. Cutan Ocul Toxicol 2010 Dec; 29(4): 241–6. Epub 2010 Jun 16
Norma Oficial Mexicana NOM-220-SSA1-2002, Instalacion y operacion de la Farmacovigilancia
Laxenaire MC. Epidemiology of anesthetic anaphylactoid reactions. Fourth multicenter survey (July 1994–December 1996). Ann Fr Anesth Reanim 1999 Aug; 18(7): 796–809
References
FDA: establishing pregnancy exposure registry, Aug.2002
EMEA: guideline on the exposure to medicinal products during pregnancy.Need for post-authorization data
References
Norma Oficial Mexicana NOM-220-SSA1-2002, Instalacion y operacion de la Farmacovigilancia
MMU Standars. Joint Comission International
References
Consensus Committee of the Third Granada. Consensus of Granada on Drug Related Problems (DRP) and Negative Outcomes associated with medication (MRI). Ars Pharm 2007; 1(48): 5–17
Research Group on Pharmaceutical Care. University of Granada Pharmaco-therapy follow: Dader (3rd Revision) Phamacy practice. 2006; 1(4): 44–53
References
Lee A, Thomson J. Adverse Drug Reactions. Drug-Induced Skin Reactions. 1st ed. Barcelona, Spain: Pharma Publishers, 2007: 123–51
Moore N, Lecointre D, Noblet C, et al. Frequency and Cost of Serious Adverse Drug Reaction in Department of General Medicine. Br J Clin Phamacol 1998; 45: 301–8
Segura O, Maldonado C. Adverse Drug Reactions An Approach from Economic Viewpoint. Biomedical 2003; 23: 401–7
Reference
Avery AJ, Anderson C, Bond CM, et al. Evaluation of patient reporting of adverse drug reactions to the UK ‘Yellow Card Scheme’: literature review, descriptive and qualitative analyses, and questionnaire surveys. Health Technol Assess 2011; 15: 1–234
Reference
Star K, et al. Suspected Adverse Drug Reactions Reported For Children Worldwide: An Exploratory Study Using VigiBase. Drug Saf 2011; 34(5): 415–28
References
Frenkel M, Ben-Arye E, Carson C, et al. Integrating complementary and alternative medicine into conventional primary care: the patient perspective. Explore 2008; 4(3): 178–86
Meijerman I, Beijnen JH, Schellens JHM. Herb-Drug Interactions in Oncology: Focus on Mechanisms of Induction. The Oncologist 2006; 11(7): 742–52
Damery S, et al. The use of herbal medicines by people with cancer: a cross-sectional survey. Br J Cancer 2011; 104(6): 927–33
Spadacio C, Barros NFD. Uso de medicinas alternativas e complementares por pacientes com câncer: revisão sistemática. Revista de Saúde Pública 2008; 42: 158–64
Cassileth B, Yeung K, Gubili J. Herbs and Other Botanicals in Cancer Patient Care. Curr Treat Options Oncol 2008; 9(2): 109–16
Richardson MA, Sanders T, Palmer JL, et al. Complementary/Alternative Medicine Use in a Comprehensive cancer Center and the Implications for Oncology. J Clin Oncol 2000; 18(13): 2505–14
References
WHO. Safety monitoring of medicines. Guidelines for setting up and running a pharmacovigilance centre. Geneva: World Health Organization, 2000
Kelly WN, Arellano FM, Barnes J, et al. Guidelines for submitting adverse event reports for publication. Drug Saf 2007; 30(5): 367–73
References
Mazzanti G, et al. Hepatotoxicity from green tea: a review of the literature and two unpublished cases. Eur J Clin Pharmacol 2009; 65: 331–41
Jimenez-Saenz M, et al. Acute hepatitis associated with the use of green tea infusions. J Hepatol 2006; 44: 616–7
References
Thai Vigibase, the national adverse drugs reactions database, Food and drug Administration, Ministry of Public Health, Thailand
www.fda.gov in medwatch accessed 30 May 2012
Reference
Trenque T, et al. Population pharmacokinetics of pyrimethamine and sulfadoxine in children with congenital toxoplasmosis. Br J Clin Pharmacol 2004; 57: 735–41
References
Ghozzi H, et al., les effets indésirables dus aux antibiotiques: étude rétrospective sur 3 ans, au centre régional de Pharmacovigilance de Sfax, revue tunisienne d’infectiologie, 2011 Jan; 5(1): 16–21
Aronson JK. Meyler’s Side effects of Drugs, 15th edition
Reference
Aclasta® Basic Prescribing Information. Novartis Pharma_Nov-2011
References
Chalasani N, Fontana RJ, Bonkovsky HL, et al. Causes, clinical features, and outcomes from a prospective study of drug-induced liver injury in the United States. Gastroenterology 2008; 135: 1924–34
Ferrajolo C, Capuano A, Verhamme KM, et al. Drug-induced hepatic injury in children: a case/non-case study of suspected adverse drug reactions in Vigibase. Br J Clin Pharmacol 2010; 70: 721–8
Reference
Blake KV, Devries CS, Arlett P, et al. Increasing scientific standards, independence and transparency in post-authorisation studies: the role of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. Pharmacoepidemiol Drug Saf 2012 Apr 23
References
6th Periodic Safety Update Report for desvenlafaxine (PRISTIQ®) from 01 Mar 2011 to 29 Feb 2012
Prescribing Product Information CDS 7.0/Prist07/nov 09 Clave SSA IPP 093300415D0248
NOM 220 SSA1 2004 Installation and Operation of Pharmacovigilance
Data on file, Pfizer Pharmaceuticals Inc
References
Periodic Safety Update Report Lipitor from November 2010 to Apr 2011
Data on file, Pfizer Pharmaceuticals, Inc, from 2010 to 2012
Summary of Product Characteristics for Lipitor, Pfizer
References
Summary of Product Characteristics for PREVENAR, Wyeth Pharmaceuticals, Inc.
Data on file, Pfizer Pharmaceuticals Inc.
Sistema Informático de Farmacovigilancia Pfizer (Legacy Wyeth), México
Periodic Safety Update Report Prevenar, from Aug 2009 to April 2010
Sucher AJ, Chahine EB, Nelson M, et al. Prevenar 13 the New 13-Valent Pneumococcal conjugate vaccine. Ann Pharmacother 2011; 45: 1516–24
References
Progressive multifocal leuko-enchephalopathy induced by monoclonal antibodies: A systematic review of literature: Preliminary data. Socal MP, Vargas AP, Laporte EA, Costa AF, Picon PD; Health Technology Assessment International. Meeting (5th: 2008: Montrèal, Canada)
Ebook Abstr Health Technol Assess Int Meet 5th 2008 Montr Can. 2008; 5: Abstract No. 422
References
Frau S, Font Pous M, Luppino MR, et al. Risk Management Plans: are they a tool for improving drug safety? Eur J Clin Pharmacol 2010 Jun 25; 66(8): 785–90
Farmacovigilancia 4° Boletín Informativo, COFEPRIS, Mexico, 2010
Briggs AH. Pharmacoeconomics and Pharmacoepidemiology. Pharmaceoeconomics 2006; 24(11): 1079–86
Fingolimod Safety Risk Management Plan, Novartis Pharmaceuticals, 2011
http://www.portalfiscal.com.mx/joomla/principal/transferencias, Unitary costs, Accessed June 2012
References
Côelho HLL. Farmacovigilância: um instrumento necessário. Cad Saúde Pública 1998; 14(4): 871–5
Nunes AMC. Conceitos básicos de farmacovigilância. In: Castro LLC. Fundamentos de Farmacoepidemiologia. Campo Grande: Grupuram, 2001: 106–26
World Health Organization. Promoting Safety of Medicines for Children. Geneva: WHO, 2007
World Health Organization. Safety Monitoring of Medical Products: reporting system for the general public. Geneva: WHO, 2012
Brazilian Health Surveillance Agency (Anvisa) [homepage on the Internet]. Alerts, 2004 [accessed 2012 Jan 26]. Available from: http://portal.anvisa.gov.br/wps/portal/anvisa/anvisa/posuso/farmacovigilancia (in Portuguese)
References
Kozer E, et al. Prospective observational study on the incidence of medication errors during simulated resuscitation in a paediatric emergency department. BMJ 2004 Dec 4; 329(7478): 1321
Leape LL, et al. The nature of adverse events in hospitalized patients. Results of the Harvard Medical Practice Study II. N Engl J Med 1991; 324: 377–84
Questionnaire Prévention Erreurs Médicamenteuses. http://spreadsheets.google.com/viewform?formkey=dGpaZTlsZlhmcjBJd2UzZUNtdlkxMEE6MQ [Accessed 2011 Apr 19]
References
Mora Arias Tania Teresa, Lilia OA, Alfredo BCR. Medicamentos Biológicos en artritis reumatoide. Med Int Mex 2010; 26(3): 259–68
Barragán-Garfias José Alberto. Tratamiento con terapia biológica en enfermedades reumatológicas y su relación con la tuberculosis. Med Int Mex 2011; 27(1): 52–7
Internal data of Drug Safety Unit, Pfizer, México
References
Palella Jr F, Delaney K, Moorman A, et al. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. N Engl J Med 1998; 338: 853–60
Lemly DC, Shepherd BE, Hulgan T, et al. Race and sex differences in antiretroviral therapy use and mortality among HIV-infected persons in care. J Infect Dis. 2009 Apr 1; 199(7): 991–8
Abdella SH, Wabe NT, Yesuf EA. Management of common adverse effects in the era of highly active antiretroviral therapy in south east Ethiopia. N Am J Med Sci 2011 Nov; 3(11): 499–502
References
Faculty of Sexual and Reproductive Healthcare Clinical Effectiveness Unit(FSRH). Guidance Emergency Contraception, August 2011
http://ec.princeton.edu/worldwide/default.asp#country (please visit this website and update the information regarding available emergency contraceptives in your country)
References
Yam FK, Eraly SA. Syndrome of inappropriate antidiuretic hormone associated with moxifloxacin. Am J Health Syst Pharm 2012; 69(3): 217–20
Gross R, Strom BL. Toward improved adverse event/suspected adverse drug reaction reporting. Pharmacoepidemiol Drug Saf 2003; 12(2): 89–91
Rosebraugh CJ, et al. Improving the quality of adverse drug reaction reporting by 4th-year medical students. Pharmacoepidemiol Drug Saf 2003; 12(2): 97–101
Durrieu G, et al. Perception of risk of adverse drug reactions by medical students: influence of a 1 year pharmacological course. Br J Clin Pharmacol 2007; 64(2): 233–6
Thompson DA, et al. Planning and implementing a systems-based patient safety curriculum in medical education. Am J Med Qual 2008; 23(4): 271–8
Kathleen K, et al. Comités de farmacoterapia: Guía Práctica. WHO, 2004
References
International Programme on Chemical Safety (IPCS). Naphthalene. Poisons Information Monograph. PIM 363. WHO: Geneva, 2000
Canadian Centre for Occupational Health and Safety (CCOHS). Naphthalene, Cheminfo.2005
Martindale, the complete reference of drug, 2007
Lim HC, Poulose V, Tan HH. Acute naphthalene poisoning following the non-accidental ingestion of mothballs. Singapore Med J 2009; 50(8): e298–301
Drugs Benefits and Risks. International Textbook of Clinical Pharmacology. Revised 2nd edition, 2008: 275-84
References
World Health Organisation Collaborating Centre for International Drug Monitoring (2007) The importance of pharmacovigilance. Available at http://www.who-umc.org
Krumholz HM, Ross JS, Presler AH, et al. What have we learnt from Vioxx? Br Med J 2007; 334: 120–3
Ray WA, Stein CM. Reform of drug regulation: beyond an independent drug-safety board. N Engl J Med 2006; 354: 194–201
Avorn J. Paying for drug approvals: who’s using whom? N Engl J Med 2007; 356: 1697–700
Strom BL. How the US drug safety system should be changed. JAMA 2006; 295: 2072–5
Raine JM. Risk management: a European regulatory view. In: Mann R, Andrews E, editors. Pharmacovigilance. 2nd ed. Wiley, Chichester: 2007
References
Bern C, Montgomery SP, Katz L, et al. Chagas disease and the US blood supply. Curr Opin Infect Dis 2008 Oct; 21(5): 476–82
Reference
Eckman A, Dobs A. Expert Opin. Drug Saf 2008; 7(6): 691–702
References
Bocquet H, Bagot M, Roujeau JC. Drug-induced pseudolymphoma and drug hypersensitivity syndrome (drug rash with eosinophilia and systemic symptoms: DRESS). Semin Cutan Med Surg 1996 Dec; 15(4): 250–7
Chen YC, Chiu HC, Chu CY. Drug reaction with eosinophilia and systemic symptoms: a retrospective study of 60 cases. Arch Dermatol 2010 Dec; 146(12): 1373-9
Begon E, Roujeau JC. Syndrome d’hypersensibilité médicamenteuse ou DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms). Ann Dermatol Venereol 2004; 131: 293–7
References
Szczeklik A, Nizankowska-Mogilnicka E, Sanak M. Hypersensitivity to Aspirin and Non-Steroidal Antiinflammatory Drugs. In Middleton’s Allergy, Principles & Practice, Seventh editionAntiinflammatory Drugs. In Middleton’s Allergy, Principles & Practice, Seventh edition
Pichler WJ. Drug hypersensitivity. Basel: Kaper, 2007
References
Maroy B. Lymphocytic colitis probably due to etifoxine. A case with relapse after reintroduction. Therapie 2009; 64: 137–8
Moch C, Rocher F, Lainé P, et al. Etifoxine-induced acute hepatitis: a case series. Clin Res Hepatol Gastroenterol 2012 May 23; [Epub ahead of print]
References
John Camm A. Review of the cardiovascular safety of zoledronic acid and other bisphosphonates for the treatment of osteoporosis. Clin Ther 2010; 32(3): 426–36
Loke YK, Jeevantham V, Singh S. Bisphosphonates and atrial fibrillation: systematic review and meta-analysis. Drug Saf 2009; 32: 219–28
References
DiMario Jr FJ, Hajjar M, Ciesielski T. A 16-year-old girl with bilateral visual loss and left hemiparesis following an immunization against human papilloma virus. J Child Neurol 2010 Mar; 25(3): 321–7
World Health Organization WHO — Adverse Events Following Immunization (AEFI): Causality Assessment available at http://www.who.int/vaccines-documents/DocsPDF05/815.pdf
Manzotti F, Menozzi C, Porta MR, et al. Partial third nerve palsy after Measles Mumps Rubella vaccination. Ital J Pediatr 2010 Sep 10; 36: 59
References
Alghabban, A. Diccionario de farmacovigilancia. Primera edición, Madrid. Pharma Editores; 2007
Buenas Prácticas de Farmacovigilancia. Gaceta Oficial N° 39.579, 2010, resolución 191. República Bolivariana de Venezuela
Cardona, R. Farmacovigilancia. Editorial CIFAR. 2005. Pág. 27-49.Instituto Nacional de Higiene “Rafael Rangel”. CENAVIF. Página web en línea: http://www.inhrr.gob.ve/ce/ctro_efectores.html. Consulta: 2 Abril, 2011
Lee, A. Reacciones adversas a los medicamentos. Primera edición, Barcelona-España. Pharma Editores; 2007. Página
Ley de Medicamentos. 2000. Gaceta Oficial N° 37.006, 2000. República Bolivariana de Venezuela
OMS. Farmacovigilancia: Garantía de seguridad en el uso de los medicamentos- perspectivas políticas de la OMS sobre medicamentos. Página web en linea http://apps.who.int/medicinedocs/en/d/Js6166s/1.html. Consulta: abril 7, 2011
References
Kane A, Niang S, Kébé M, Ly F, Diallo M, Dieng MT, Ndiaye B. Cutaneous side effects of antiretroviral drugs study of 280 cases in Mali 2007
Mouhari-Toureś A, Saka B, Kombat K, et al. Clinical safety of a generic fixed-dose combination of stavudine/l amivudine/nevirapine (Triomune): study of 297 cases in Togo. Bull Soc Pathol Exot 2008; 101: 404
Barner A, Myers M. Nevirapine and rashes. Lancet 1998; 351: 1133
Martindale: The Complete Drug Reference
References
Schüler-Faccini L, Soares RCF, Souza ACM, et al. New cases of thalidomide embriopathy in Brazil. Birth Defects Res A 2007; 79: 671–2
Souza, N. Dispensação da Talidomida no Distrito Federal. Fortaleza: UFC, 2005.Dissertação — Mestrado em Saúde Pública, Faculdade de Medicina, Universidade Federal do Ceará, Fortaleza, 2005
Brasil, Agência Nacional de Vigilância Sanitária, RDC n° 11 de 22 de marçode2011
References
World Health Organization Collaborating Center for International Drug Monitoring. The importance of Pharmacovigilance Safety Monitoring of medicinal products. Geneva: World Health Organization, 2002
Wiffen P, Gill M, Edwards J, et al. Adverse drug reactions in hospital patients: A systematic review of the prospective and retrospective studies. Bandolier Extra 2002 Jun; 1-15
Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. J Am Med Assoc 1998; 279: 1200–5
Pirmohamed M, Sally J, Meakin S, et al. Adverse drug reactions as cause of admission to hospital. Br Med J 2004; 329: 15–9
Patel KJ, Kedia MS, Bajpai D, et al. Evaluation of the prevalence and economic burden of adverse drug reactions presenting to the medical emergency department of a tertiary referral centre: a prospective study. BMC Clinical Pharmacology 2007; 7: 8
WHO. Safety of Medicines. A guide to detecting and reporting adverse reactions. Why health professionals need to take action. WHO/EDM/QSM/2002.2
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Abstracts. Drug Saf 35, 877–970 (2012). https://doi.org/10.1007/BF03261983
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DOI: https://doi.org/10.1007/BF03261983