The Value of Patient-Centred Registries in Phase IV Drug Surveillance

In the past, postmarketing surveillance of drugs relied mainly on the spontaneous reporting of adverse drug reactions. There are now several other approaches used, including databases with individual prescription data (or prescription event monitoring systems), electronic health records and record linkage between health databases. The recent drug withdrawals have continued to highlight the inadequacies of current postmarketing surveillance and the need for better strategies to monitor the safety of new drugs. One such strategy is the use of drug registries.Drug registries facilitate a special form of prospective observational cohort study of patients exposed to a particular drug. They are particularly useful in establishing the safety of orphan drugs and ascertaining the safety of drugs in specific populations. To minimize bias, patient eligibility is defined and data capture is standardized. All patients are followed up systematically over a pre-defined time period, either manually or using electronic record linkage to other health databases. To establish the incidence of any adverse events using a drug registry, there should be complete follow-up of all patients.Drug registries may play an important role in postmarketing surveillance of new drugs. Unlike spontaneous reporting systems they have the benefit of being able to determine the incidence of one or more outcomes in the patient population. Drug registries do, however, have some limitations, including a potential for bias and confounding, long periods of follow-up and high cost.

[1]  S. Shakir,et al.  Safety and Drug Utilization Profile of Varenicline as Used in General Practice in England , 2009, Drug safety.

[2]  S. Shakir,et al.  Risk Management and Outcomes of Adverse Events to Pioglitazone in Primary Care in the UK , 2009, Drug safety.

[3]  M. Levine,et al.  Registries that show efficacy: good, but not good enough. , 2008, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[4]  B. Billah,et al.  The Safety of Recombinant Factor VIIa in Cardiac Surgery , 2010, Anaesthesia and intensive care.

[5]  A. Silman,et al.  European biologicals registers: methodology, selected results and perspectives , 2008, Annals of the rheumatic diseases.

[6]  J. Allison,et al.  Risk of serious bacterial infections among rheumatoid arthritis patients exposed to tumor necrosis factor alpha antagonists. , 2007, Arthritis and rheumatism.

[7]  J. McNeil,et al.  Recombinant activated factor VII in critical bleeding: experience from the Australian and New Zealand Haemostasis Register , 2008, Internal medicine journal.

[8]  R. Platt,et al.  The new Sentinel Network--improving the evidence of medical-product safety. , 2009, The New England journal of medicine.

[9]  S. Shakir,et al.  Safety of Zafirlukast , 2007, Drug safety.

[10]  D. Sargent,et al.  Bevacizumab beyond first progression is associated with prolonged overall survival in metastatic colorectal cancer: results from a large observational cohort study (BRiTE). , 2008, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[11]  H. Kremers Methods to analyze real-world databases and registries. , 2009, Bulletin of the NYU hospital for joint diseases.

[12]  S. Shakir,et al.  The Safety Profiles of Orlistat and Sibutramine: Results of Prescription‐Event Monitoring Studies in England , 2007, Obesity.

[13]  Steven J. Jacobsen,et al.  The Vaccine Safety Datalink: A Model for Monitoring Immunization Safety , 2011, Pediatrics.

[14]  A. Silman,et al.  Rates of serious infection, including site-specific and bacterial intracellular infection, in rheumatoid arthritis patients receiving anti-tumor necrosis factor therapy: results from the British Society for Rheumatology Biologics Register. , 2006, Arthritis and rheumatism.

[15]  M. Harrison‐Woolrych,et al.  The role of the New Zealand Intensive Medicines Monitoring Programme in identification of previously unrecognised signals of adverse drug reactions. , 2006, Current drug safety.

[16]  D. Kao What can we learn from drug marketing efficiency? , 2008, BMJ : British Medical Journal.

[17]  F. Mackay Post-Marketing Studies , 1998, Drug safety.

[18]  M. Hetland,et al.  DANBIO: a nationwide registry of biological therapies in Denmark. , 2005, Clinical and experimental rheumatology.

[19]  P. Austin,et al.  Reader's guide to critical appraisal of cohort studies: 2. Assessing potential for confounding , 2005, BMJ : British Medical Journal.

[20]  John W. Glasser,et al.  Vaccine Safety Datalink project: a new tool for improving vaccine safety monitoring in the United States. The Vaccine Safety Datalink Team. , 1997, Pediatrics.

[21]  M. Humbert,et al.  Results of European post-marketing surveillance of bosentan in pulmonary hypertension , 2007, European Respiratory Journal.

[22]  Jeffrey N Katz,et al.  Anti-tumor necrosis factor alpha therapy and the risk of serious bacterial infections in elderly patients with rheumatoid arthritis. , 2007, Arthritis and rheumatism.

[23]  L. Klareskog,et al.  Swedish registers to examine drug safety and clinical issues in RA , 2006, Annals of the rheumatic diseases.

[24]  W. Ray,et al.  Evaluating medication effects outside of clinical trials: new-user designs. , 2003, American journal of epidemiology.

[25]  J. Kremer,et al.  Interpreting registry-derived drug studies: does societal context matter? , 2009, Arthritis and rheumatism.

[26]  W. Sandborn,et al.  Serious infections and mortality in association with therapies for Crohn's disease: TREAT registry. , 2006, Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association.

[27]  J. Schein,et al.  Reducing clozapine-related morbidity and mortality: 5 years of experience with the Clozaril National Registry. , 1998, The Journal of clinical psychiatry.

[28]  I. Macdougall,et al.  Erythropoiesis-stimulating agents and antibody-mediated pure red-cell aplasia: here are we now and where do we go from here? , 2004, Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association.

[29]  Mark McClellan,et al.  Drug safety reform at the FDA--pendulum swing or systematic improvement? , 2007, The New England journal of medicine.

[30]  Sebastian Schneeweiss,et al.  Anti-tumor necrosis factor α therapy and the risk of serious bacterial infections in elderly patients with rheumatoid arthritis , 2007 .

[31]  R. Weintraub,et al.  The bosentan patient registry: long‐term survival in pulmonary arterial hypertension , 2011, Internal medicine journal.

[32]  H. Sørensen,et al.  The Nordic countries as a cohort for pharmacoepidemiological research. , 2010, Basic & clinical pharmacology & toxicology.

[33]  N. Dreyer,et al.  Registries for Evaluating Patient Outcomes: A User’s Guide , 2010 .

[34]  Katsutoshi Tanaka,et al.  Drug use investigation (DUI) and prescription‐event monitoring in Japan (J‐PEM) , 2001, Pharmacoepidemiology and drug safety.

[35]  I. Macdougall,et al.  Erythropoiesis-stimulating agents and antibody-mediated pure red-cell aplasia: here are we now and where do we go from here? , 2004, Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association.

[36]  J. Lieberman,et al.  Clozapine-induced agranulocytosis. Incidence and risk factors in the United States. , 1993, The New England journal of medicine.

[37]  J. Allison,et al.  Confirmation of administrative claims-identified opportunistic infections and other serious potential adverse events associated with tumor necrosis factor alpha antagonists and disease-modifying antirheumatic drugs. , 2007, Arthritis and rheumatism.