Mandatory pharmacosurveillance - A Canadian model for access to therapy and research

Clinical and Experimental Rheumatology

Volumn 22, Issue 5 SUPPL. 35, 2004, Pages

  Barr, Susan G ^b   Martin, Liam ^b   Chung, Cecilia ^a   Maksymowych, Walter P ^a  

^a UNIVERSITY OF ALBERTA   (Canada)

^b UNIVERSITY OF CALGARY   (Canada)

Author keywords

Biological therapy; Observational study; Pharmacovigilance; Rheumatoid arthritis

Indexed keywords

ANTIRHEUMATIC AGENT; ETANERCEPT; INFLIXIMAB; LEFLUNOMIDE; METHOTREXATE; NEW DRUG;

ARTICLE; CANADA; CLINICAL PRACTICE; COST BENEFIT ANALYSIS; DRUG EFFICACY; DRUG FORMULARY; DRUG INDUSTRY; DRUG RESEARCH; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FINANCIAL MANAGEMENT; GOVERNMENT; HEALTH CARE ACCESS; HUMAN; INTERNET; LONG TERM CARE; MEDICAL DECISION MAKING; PHARMACOEPIDEMIOLOGY; PRIORITY JOURNAL; RHEUMATOID ARTHRITIS; SURVIVAL RATE; CLINICAL DECISION MAKING; CONTROLLED CLINICAL TRIAL (TOPIC); HEALTH ASSESSMENT QUESTIONNAIRE; HEALTH CARE DELIVERY; HEALTH CARE SYSTEM; INFLAMMATION; PHARMACOSURVEILLANCE; RHEUMATIC DISEASE; RHEUMATOLOGIST;

ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; CANADA; HUMANS; MANDATORY PROGRAMS; PRODUCT SURVEILLANCE, POSTMARKETING;

EID: 4944235165     PISSN: 0392856X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (17)

1. VERSTRAETEN T, DeSTEFANO F, CHEN RT, MILLER E: Vaccine safety surveillance using large linked databases: opportunities, hazards and proposed guidelines. Expert Review of Vaccines 2003; 2: 21-9.
2. CRONK CE, MALLOY ME, PELECH AN et al.: Completeness of state administrative databases for surveillance of congenital heart disease. Birth Defects Res 2003; 67: 597-603.
3. VAN VOLLENHOVEN RF, ERNESTAM S, HARJU A, BRATT J, KLARESKOG L: Etanercept versus etanercept plus methotrexate: a registry-based study suggesting that the combination is clinically more efficacious. Arthritis Res Therapy 2003; 5: R347-51.
4. GOMEZ-REINO JJ, CARMONA L, VALVERDE VR, MOLA EM, MONTERO MD and the BIO-BADASER Group: Treatment of rheumatoid arthritis with tumor necrosis factor inhibitors may predispose to significant increase in tuberculosis risk: a multicenter active-surveillance report. Arthritis Rheum 2003; 48: 2122-7.
5. SILMAN A, SYMMONS D, SCOTT DG, GRIFFITHS I: British Society for Rheumatology Biologics Register. Ann Rheum Dis 2003; 62 (Suppl. 2): 28-9.
6. WEST R, BORDEN EK, COLLER JP, RAWSON NSB, TONKS RS: "Cost-effectiveness" estimates result in flawed decision-making in listing drugs for reimbursement. Can J Pub Health 2002; 93: 421-5.
7. National Institute for Clinical Excellence: Guidance for the use of etanercept and infliximab for the treatment of rheumatoid arthritis. 2002: Technology Appraisal Guidance No. 36 [www.nice.org.uk].
8. WOLFE F, LASSERE M, VAN DER HEIJDE D et al.: Preliminary core set of domains and reporting requirements for longitudinal observational studies in rheumatology. J Rheumatol 1999; 26: 484-9.
9. SILMAN A, SYMMONS D: Reporting requirements for longitudinal observational studies in rheumatology. J Rheumatol 1999; 26: 481-3.
10. SANGHA O, STUCKI G, LIANG MH, FOSSEL AH, KATZ JN: The self-administered comorbidity questionnaire: A new method to assess comorbidity for clinical and health services research. Arthritis Rheum 2003; 49: 156-63.
11. WOLFE F: Which HAQ is best ? A comparison of the HAQ, MHAQ, and RA-HAQ, and a rescored 20 item HAQ (HAQ20): analyses in 2491 rheumatoid arthritis patients following leflunomide initiation. J Rheumatol 2001; 28: 982-9.
12. PINCUS T, SWEARINGEN C, WOLFE F: Toward a multidimensional Health Assessment Questionnaire (MDHAQ): assessment of advanced activities of daily living and psychological status in the patient-friendly health assessment questionnaire format. Arthritis Rheum 1999; 42: 2220-30.
13. SMOLEN JS, KALDEN JR, SCOTT DL et al.: Efficacy and safety of leflunomide compared to placebo and sulfasalazine in active rheumatoid arthritis: a double blind randomized, multimember trial. Lancet 1999; 353: 259-66.
14. EMERY P, BREEDVELD FC, LEMELL EM et al.: A comparison of the efficacy and safety of leflunomide and methotrexate for the treatment of rheumatoid arthritis. Rheumatology 2000; 39: 1-11.
15. SIVA C, EISEN SA, SHEPHERD R et al.: Leflunomide use during the first 33 months after food and drug administration approval: experience with a national cohort of 3,325 patients. Arthritis Rheum 2003; 15;49: 745-51.
16. GEBOREK P, CRNKIC M, PETERSSON IF, SAXNE T: Etanercept, infliximab, and leflunomide in established rheumatoid arthritis: clinical experience using a structured follow up programme in southern Sweden. Ann Rheum Dis 2002; 61: 793-8.
17. VAN ROON EN, JANSEN TL, MOURAD L et al.: Leflunomide in active rheumatoid arthritis: a prospective study in daily practice. Brit J Clin Pharmacology 2004; 57: 790-7.