An Information Technology Architecture for Drug Effectiveness Reporting and Post-Marketing Surveillance

Adverse drug events impose a large cost on the society in terms of lives and health care costs. In this article, we propose an information technology architecture for enabling the monitoring of adverse drug events in an outpatient setting as a part of the post marketing surveillance program. The proposed system architecture enables the development of a Web-based drug effectiveness reporting and monitoring system that builds on previous studies demonstrating the feasibility of a system in which community pharmacists identify and report adverse drug events. We define the key technical requirements of such a monitoring and reporting system, identify the critical factors that influence the successful implementation and use of the system, and propose information technology solutions that satisfy these requirements.

[1]  D. Marrero,et al.  Issues in conducting randomized controlled trials of health services research interventions in nonacademic practice settings: the case of retail pharmacies. , 2002, Health services research.

[2]  S. G. Bryant,et al.  Patient‐Initiated Postmarketing Surveillance: A Validation Study , 1987, Journal of clinical pharmacology.

[3]  T. Kent,et al.  Patient Drug Attributions and Postmarketing Surveillance , 1994, Pharmacotherapy.

[4]  R S Evans,et al.  Prevention of adverse drug events through computerized surveillance. , 1992, Proceedings. Symposium on Computer Applications in Medical Care.

[5]  D W Bates,et al.  Incidence and preventability of adverse drug events in nursing homes. , 2000, The American journal of medicine.

[6]  George Hripcsak,et al.  Review Paper: Detecting Adverse Events Using Information Technology , 2003, J. Am. Medical Informatics Assoc..

[7]  P. Corey,et al.  Incidence of Adverse Drug Reactions in Hospitalized Patients , 2012 .

[8]  Nir Menachemi,et al.  Adoption Factors Associated with Patient Safety‐Related Information Technology , 2004, Journal for healthcare quality : official publication of the National Association for Healthcare Quality.

[9]  C. Gaither,et al.  Community pharmacists' work activities in the United States during 2000. , 2002, Journal of the American Pharmaceutical Association.

[10]  S. G. Bryant,et al.  Postmarketing Surveillance Of Adverse Drug Reactions: Patient Self-Monitoring , 1992, The Journal of the American Board of Family Medicine.

[11]  Joshua Borus,et al.  Adverse drug events in ambulatory care. , 2003, The New England journal of medicine.

[12]  M M Cohen,et al.  Medication safety program reduces adverse drug events in a community hospital , 2005, Quality and Safety in Health Care.

[13]  Drummond Rennie,et al.  Postmarketing surveillance--lack of vigilance, lack of trust. , 2004 .

[14]  Marilyn M. Anderson,et al.  Research Paper: Evaluating the Capability of Information Technology to Prevent Adverse Drug Events: A Computer Simulation Approach , 2002, J. Am. Medical Informatics Assoc..

[15]  A. Geissbuhler Clinical information systems--what is the bottom line? , 1998, Journal of the American Medical Informatics Association : JAMIA.

[16]  J. A. Johnson,et al.  Drug-Related Morbidity and Mortality: A Cost-of-Illness Model , 1995 .

[17]  B. Petty Identifying and reducing complications of outpatient medications , 2000, Journal of General Internal Medicine.

[18]  R S Evans,et al.  Computerized surveillance of adverse drug events in hospital patients. 1991. , 1991, Quality & safety in health care.

[19]  T. Kent,et al.  Postmarketing surveillance by patient self-monitoring: trazodone versus fluoxetine. , 1993, Journal of clinical psychopharmacology.

[20]  K. Farris,et al.  Outcomes-based pharmacist reimbursement: reimbursing pharmacists for cognitive services part 1. , 2002, Journal of managed care pharmacy : JMCP.

[21]  G A Colditz,et al.  Postmarketing surveillance and adverse drug reactions: current perspectives and future needs. , 1999, JAMA.

[22]  David W. Bates,et al.  Reducing the frequency of errors in medicine using information technology. , 2001, Journal of the American Medical Informatics Association : JAMIA.

[23]  M. D. Murray,et al.  Research Paper: Effects of Computer-based Prescribing on Pharmacist Work Patterns , 1998, J. Am. Medical Informatics Assoc..

[24]  Kathleen A. Johnson,et al.  Pharmacist time requirements for counseling in an outpatient pharmacy. , 2002, American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists.

[25]  George Hripcsak,et al.  Detecting adverse events for patient safety research: a review of current methodologies , 2003, J. Biomed. Informatics.

[26]  S. G. Bryant,et al.  Postmarketing surveillance: Accuracy of patient drug attribution judgments , 1990, Clinical pharmacology and therapeutics.

[27]  David W. Bates,et al.  Research Paper: Using Computerized Data to Identify Adverse Drug Events in Outpatients , 2001, J. Am. Medical Informatics Assoc..

[28]  E. Cook,et al.  Drug complications in outpatients , 2000, Journal of general internal medicine.

[29]  P. Barach,et al.  Reporting and preventing medical mishaps: lessons from non-medical near miss reporting systems , 2000, BMJ : British Medical Journal.

[30]  T. Kent,et al.  Postmarketing surveillance by patient self-monitoring: preliminary data for sertraline versus fluoxetine. , 1995, The Journal of clinical psychiatry.