International Society for Pharmacoepidemiology
 
International Society for Pharmacoepidemiology
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NEWS ARTICLES


Royal Society Study on Pharmacogenetics

The Royal Society is an independent scientific academy of the U.K. dedicated to promoting excellence in science. The Royal Society is seeking submissions for its investigation into the potential for designing drug treatments based on a person's genetic makeup. Developments in understanding the biology and mechanisms of disease, together with increased knowledge of genes, may all have a significant role to play in tailoring healthcare to a particular genetic profile. Personalising pharmaceutical treatment may therefore be feasible in theory, but there may be a number of significant constraints to its development and implementation within modern health care systems. This study aims to provide a balanced assessment of the future potential and limitations of this technology.

Most current drugs are not effective for 100 per cent of the population and some work in as few as 30 to 50 per cent of cases. Pharmacogenetics, the study of how genetic factors influence a person's response to a drug, is seen as a way of making treatments as safe and effective as possible for every individual. However, reservations have been expressed about the ability of this technology to fulfil such claims, what it might cost, how soon it could be achieved and if it would impact negatively on the modern healthcare system.

A working group of international experts, chaired by Sir David Weatherall FRS will consider the evidence collected and guide the production of the report. The Royal Society aims to publish the report by Summer 2005.

Details about the study can be obtained from http://www.royalsoc.ac.uk/policy/pharmacogenetics.htm


FDA issues Two Guidances on QT Prolongation

Title Docket No. 2004D-0377, CDER 200495.
International Conference on Harmonisation; Draft Guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs; Availability.
Summary Pages 55163-55164 [FR Doc. 04-20565] [TXT] [PDF] [PRE-PUB]
The Draft Guidance (Word)
The Draft Guidance (PDF)
Action Comments on draft guidance by December 13, 2004
Date of Publication September 13, 2004

Title Docket No. 2004D-0378, CDER 200494.
International Conference on Harmonisation; Draft Guidance on S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals; Availability.
Summary Pages 55164-55165 [FR Doc. 04-20564] [TXT] [PDF] [PRE-PUB]
The Draft Guidance (Word)
The Draft Guidance (PDF)
Action Comments on draft guidance by December 13, 2004
Date of Publication September 13, 2004


USP Issues Call for Committee Candidates

The United States Pharmacopeia (USP) has issued a call for candidates to serve on the USP Council of Experts and its Expert Committees. USP is seeking qualified candidates for 53 Expert Committees. The USP Council of Experts and its Expert Committees form the scientific decision-making body of USP.

The USP Nominating Committee will select qualified nominees to stand for election to the Council of Experts. Expert Committees address standards, patient safety issues and other issues of interest.

ISPE members are encouraged to consider submitting nominations or self nominating as potential candidates for the Council of Experts and its Expert Committees. Nominations can be submitted online at http://www.usp.org/volunteers/nominate/.

The application deadline is November 1, 2004 for the Council of Experts, and March 15, 2005 for Expert Committee members.


U.S. Department of Health and Human Services (DHHS) Awards $139 Million to Help Improve Patient Safety and Quality of Care

The US DHHS recently announced $139 million in grants and contracts to promote the use of health information technology (HIT). Awarded through HHS' Agency for Healthcare Research and Quality (AHRQ), this multi-year program builds on the initiative to use HIT to improve the nation's health care system.

These awards will provide insight into how best to use health information technologies to improve patient safety by reducing medication errors; increasing the use of shared health information between providers, laboratories, pharmacies and patients; helping to insure safer patient transitions between health care settings, including hospitals, doctors' offices, and nursing homes; and reducing duplicative and unnecessary testing.

In addition to improving care for patients and giving health care providers additional support, health information technology has the potential to produce savings of up to 10 percent of the country's total annual spending on health care. These awards are geared towards provision of electronic health records for most Americans within 10 years and thus enhance the capability to do large population-based pharmacoepidemiology studies.

The recipients of the awards include ISPE members Bram Hartzema, and Jerry Gurwitz.

For specific information on each grant, go to http://www.ahrq.gov/research/hitfact.htm.


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