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Confidence in Safety
International Roundtable and Discussion Forum
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InterAction Meeting Session, held in Philadelphia, USA, 11 October 2005
chaired by Sidney Kahn (PvRM, Inc.) |
Discussion Panel:
Sidney Kahn, M.D., President (PvRM, Inc.)
A. Leander Fontaine, M.D., President (pharmiceutics, LLC)
James Averback, President (Life Science Integration Partners)
with live virtual participation from the Mayo Clinic by Professor Peter Elkin (Mayo Clinic)
| InterAction Meeting Session, held in Basel, Switzerland, 9 November 2005
chaired by Saad Shakir, Professor of Medicine & Director (Drug Safety Research Unit, UK)
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Discussion Panel:
Barry Hardy, Community of Practice Manager (Douglas Connect)
with live virtual participation from the USA by Sidney Kahn, M.D., President (PvRM, Inc.), Professor Peter Elkin (Mayo Clinic) and A. Leander Fontaine, M.D., President (pharmiceutics, LLC)
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Confidence in Safety is the level of assurance that you
* know and understand the safety information available to your organization
* know what information is missing
* know of the missing information, and what you can get when and from where
* can measure organizational effectiveness in applying safety knowledge to support the development and clinical use of novel medicinal products
Drug Safety is not absolute, but rather reflects an individualized decision to use a given drug in a specific patient in whom the expected benefits outweigh the risks. The InnovationWell Drug Safety Community of Practice (DSCoP) defines “Confidence in Safety” as the degree of assurance, based on objective assessment criteria, that the best possible medically relevant benefit and risk information is available to support the prescribing decision, and that all known or reasonably suspected adverse outcomes are understood.
The Community has established an initiative to help improve Confidence in Safety by:
* developing and/or enhancing a standardized terminology for communicating benefits and risks
* enhancing methodologies for assessing what is and is not known about a drug’s risks
* identifying technologies that improve internalization and dissemination of safety knowledge
* defining objective measures of how effectively an organization utilizes knowledge of benefits and risks
Pharmaceutical companies, regulatory authorities, physicians, and patients will benefit from an improved basis for understanding and communicating Confidence in Safety, both before a drug enters the market and as it is dynamically enhanced by new medically relevant information.
The following topics will be discussed at both the US meeting session (Bryn Mawr College, Philadelphia; 11 October 2005) and the European meeting session (Swissotel L’entrée Conference Center, Basel (9 November 2005):
Discussion Session - Part I: Sources of Drug Safety Knowledge
Do we need to have a truly shared, comprehensive and global body of drug safety knowledge?
Is there a truly shared body of drug safety knowledge?
* What is shared? And why?
* What is not shared? And why Not?
What are the role of clinicians, industry, regulators and other drug information providers in contributing to a common drug safety knowledge base? Do we have a common understanding of our roles? Should the roles change? Are we prepared to take on a different role?
Discussion Session - Part 2: Stakeholders in Drug Safety Evaluation
Do we need multiple and largely independent drug safety evaluation systems serving the needs of distinct but collaborative stakeholders?
How do the needs of drug safety evaluation constituencies align or diverge?
* Industry/Regulators
* Clinicians/Medical Societies
* Information Vendors
Do we speak the same language? Do the terms risk, adverse reaction, or drug interaction mean the same to clinicians, patients, industry, regulators and other information vendors? Do we all evaluate risk in the same way? If not, how do we improve the overall understanding of risk for all stakeholders?
Discussion Framework: Patient/Clinician Safety Criteria
* What is a clinician’s safety decision tree when prescribing?
* What is a patient’s safety decision tree?
* What are a clinician’s sources for trusted drug safety information?
* Do I know the criteria the pharmaceutical industry, regulators and information providers use when deciding which information is relevant and needs to be communicated?
* Is the safety information currently provided by industry, regulators and other information vendors sufficiently useful in clinical practice?
* What would industry, regulators and other information providers have to do to build “confidence in the safety” from the information they generate and communicate?
Discussion Framework: Pharmacovigilance Safety Information
* What makes it difficult for us to provide the information expected by clinicians and patients?
* To what extent do regulations, regulatory guidelines and the general legal framework support the generation of the information needed by clinicians and patients?
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