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Information technology in pharmacovigilance: Benefits, challenges, and future directions from industry perspectives.

Lu Z - Drug Healthc Patient Saf (2009)

Bottom Line: Information science promises to deliver effective e-clinical or e-health solutions to realize several core benefits: time savings, high quality, cost reductions, and increased efficiencies with safer and more efficacious medicines.Due to recent high-profile drug safety problems, the pharmaceutical industry is faced with greater regulatory enforcement and increased accountability demands for the protection and welfare of patients.This changing climate requires biopharmaceutical companies to take a more proactive approach in dealing with drug safety and pharmacovigilance.

View Article: PubMed Central - PubMed

Affiliation: Clinical Research Department, Abbott Vascular, Santa Clara, CA, USA.

ABSTRACT
Risk assessment during clinical product development needs to be conducted in a thorough and rigorous manner. However, it is impossible to identify all safety concerns during controlled clinical trials. Once a product is marketed, there is generally a large increase in the number of patients exposed, including those with comorbid conditions and those being treated with concomitant medications. Therefore, postmarketing safety data collection and clinical risk assessment based on observational data are critical for evaluating and characterizing a product's risk profile and for making informed decisions on risk minimization. Information science promises to deliver effective e-clinical or e-health solutions to realize several core benefits: time savings, high quality, cost reductions, and increased efficiencies with safer and more efficacious medicines. The development and use of standard-based pharmacovigilance system with integration connection to electronic medical records, electronic health records, and clinical data management system holds promise as a tool for enabling early drug safety detections, data mining, results interpretation, assisting in safety decision making, and clinical collaborations among clinical partners or different functional groups. The availability of a publicly accessible global safety database updated on a frequent basis would further enhance detection and communication about safety issues. Due to recent high-profile drug safety problems, the pharmaceutical industry is faced with greater regulatory enforcement and increased accountability demands for the protection and welfare of patients. This changing climate requires biopharmaceutical companies to take a more proactive approach in dealing with drug safety and pharmacovigilance.

No MeSH data available.


Related in: MedlinePlus

The good pharmacovigilance processes and workflow in a typical sponsor biopharmaceutical firm supported by information technology. Modern internet and communication technologies have enabled improved clinical safety monitoring in a significant way despite anticipated ongoing challenges.Abbreviations: ADR, adverse drug reaction; DB, database; PV, pharmacovigilance; CRO, clinical research organization.
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f1-dhps-1-035: The good pharmacovigilance processes and workflow in a typical sponsor biopharmaceutical firm supported by information technology. Modern internet and communication technologies have enabled improved clinical safety monitoring in a significant way despite anticipated ongoing challenges.Abbreviations: ADR, adverse drug reaction; DB, database; PV, pharmacovigilance; CRO, clinical research organization.

Mentions: Good pharmacovigilance processes (GPVP) focus on the enhancement of the reports that are most likely to be important. In parallel to any regulatory reporting (submission) triage, these reports need to have both their potential maximized and the value measured. That measurement must be both as an individual and in a case-series. The goal of GPVP is to clearly and accurately identify rare, serious, unusual or unexpected adverse drug reactions such as UADEs as soon as possible after product market launch. Therefore, GPVP in the 21st century is best practices-driven with IT systems-enabling support. Modern internet and communication technologies have allowed these best practices to be joined in a supportable process. They support the ‘clinical art’ of pharmacovigilance by providing service-oriented architecture, powerful data-mining and query tools, and work environments for case-series management and product preparation. Pharmacovigilance technology systems can be effective in detecting what may be otherwise invisible to the human eye, increasing productivity and are less likely to miss important public health information hidden in “haystacks” of data.7 It is demonstrated that full product safety assessment can be conducted by such technologies in an efficient and effective manner (Figure 1).


Information technology in pharmacovigilance: Benefits, challenges, and future directions from industry perspectives.

Lu Z - Drug Healthc Patient Saf (2009)

The good pharmacovigilance processes and workflow in a typical sponsor biopharmaceutical firm supported by information technology. Modern internet and communication technologies have enabled improved clinical safety monitoring in a significant way despite anticipated ongoing challenges.Abbreviations: ADR, adverse drug reaction; DB, database; PV, pharmacovigilance; CRO, clinical research organization.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3108683&req=5

f1-dhps-1-035: The good pharmacovigilance processes and workflow in a typical sponsor biopharmaceutical firm supported by information technology. Modern internet and communication technologies have enabled improved clinical safety monitoring in a significant way despite anticipated ongoing challenges.Abbreviations: ADR, adverse drug reaction; DB, database; PV, pharmacovigilance; CRO, clinical research organization.
Mentions: Good pharmacovigilance processes (GPVP) focus on the enhancement of the reports that are most likely to be important. In parallel to any regulatory reporting (submission) triage, these reports need to have both their potential maximized and the value measured. That measurement must be both as an individual and in a case-series. The goal of GPVP is to clearly and accurately identify rare, serious, unusual or unexpected adverse drug reactions such as UADEs as soon as possible after product market launch. Therefore, GPVP in the 21st century is best practices-driven with IT systems-enabling support. Modern internet and communication technologies have allowed these best practices to be joined in a supportable process. They support the ‘clinical art’ of pharmacovigilance by providing service-oriented architecture, powerful data-mining and query tools, and work environments for case-series management and product preparation. Pharmacovigilance technology systems can be effective in detecting what may be otherwise invisible to the human eye, increasing productivity and are less likely to miss important public health information hidden in “haystacks” of data.7 It is demonstrated that full product safety assessment can be conducted by such technologies in an efficient and effective manner (Figure 1).

Bottom Line: Information science promises to deliver effective e-clinical or e-health solutions to realize several core benefits: time savings, high quality, cost reductions, and increased efficiencies with safer and more efficacious medicines.Due to recent high-profile drug safety problems, the pharmaceutical industry is faced with greater regulatory enforcement and increased accountability demands for the protection and welfare of patients.This changing climate requires biopharmaceutical companies to take a more proactive approach in dealing with drug safety and pharmacovigilance.

View Article: PubMed Central - PubMed

Affiliation: Clinical Research Department, Abbott Vascular, Santa Clara, CA, USA.

ABSTRACT
Risk assessment during clinical product development needs to be conducted in a thorough and rigorous manner. However, it is impossible to identify all safety concerns during controlled clinical trials. Once a product is marketed, there is generally a large increase in the number of patients exposed, including those with comorbid conditions and those being treated with concomitant medications. Therefore, postmarketing safety data collection and clinical risk assessment based on observational data are critical for evaluating and characterizing a product's risk profile and for making informed decisions on risk minimization. Information science promises to deliver effective e-clinical or e-health solutions to realize several core benefits: time savings, high quality, cost reductions, and increased efficiencies with safer and more efficacious medicines. The development and use of standard-based pharmacovigilance system with integration connection to electronic medical records, electronic health records, and clinical data management system holds promise as a tool for enabling early drug safety detections, data mining, results interpretation, assisting in safety decision making, and clinical collaborations among clinical partners or different functional groups. The availability of a publicly accessible global safety database updated on a frequent basis would further enhance detection and communication about safety issues. Due to recent high-profile drug safety problems, the pharmaceutical industry is faced with greater regulatory enforcement and increased accountability demands for the protection and welfare of patients. This changing climate requires biopharmaceutical companies to take a more proactive approach in dealing with drug safety and pharmacovigilance.

No MeSH data available.


Related in: MedlinePlus