"Lab Briefs"

Lab Tests in Pharmacies, Genzyme, Healthe, Singing River Hospital, VA

Lab tests in pharmacies are now a reality in Manchester, England

IT IS OFTEN SUGGESTED that pharmacies are a logical place to combine laboratory testing with prescription services. Such an arrangement would be consumer-friendly and has the potential to improve patient care while lowering costs.

In Great Britain, the National Health Service has launched a pilot program to test this concept. Earlier this year, it began remodeling 22 pharmacies to accommodate laboratory testing. Four primary care trusts in Manchester, England were selected to participate in the program. The pharmacies are located in the vicinity of these primary care clinics. Remodeling in the first four pharmacies was expected to be done this summer, with lab testing services to start shortly thereafter.

Based in pharmacies, the diagnostic services will be clinical management and point-of-care testing (POCT) for diabetes (including HbA1c), cardiovascular disease (including cholesterol, HDL-cholesterol), and anticoagulation (including INR).

The pilot project will require information technology support. In the first phase, a communication capability will be established to link the 22 pharmacies with primary care clinics and secondary care pathology laboratories. (In the United Kingdom, the term “pathology” encompasses both clinical laboratory and anatomic pathology services.)

There will also be an information technology solution developed to capture the POCT results generated in the pharmacy, along with outcomes of the clinical consultations, and performance management data.

The performance management data is important and relates to the speed with which patients are served. A major issue in the United Kingdom is the time required for patients to access healthcare services. Consumers have made their unhappiness about long wait times known to politicians.

That is why one primary objective of putting laboratory testing into pharmacies is to reduce the time required for patients to provide laboratory test specimens, get the test results, and receive prescriptions.

In the United States, only a limited number of situations are known where a pharmacy offered laboratory testing. However, in recent years, pharmacists in several states have pushed for legislation to expand their scope of practice to include laboratory testing.

New pharmacogenomic assay launched by Genzyme Corp.

PHARMACOGENOMICS IS BEING PUSHED another step forward by Genzyme Corporation, which announced last week that it was offering a genetic test to help physicians predict which patients will respond better to specific cancer drugs.

Genzyme’s EGFR Mutation Assay “will help to identify patients likely to respond to therapies targeted for the treatment of non-small cell lung cancer (NSCLC)…EGFR mutations have been shown to correlate with clinical response to certain drugs, including Tarceva® (erlotinib) and IRESSA® (gefitinib), used in treating this deadly form of cancer.”

Genzyme’s actions are sure to intensify the debate over personalized medicine. Genzyme has not submitted its new lab tests to the FDA for approval and no drug manufacturer has yet endorsed the use of Genzyme’s tests in conjunction with its drug.

Genzyme licensed rights to the test, which is based on research done at the
Dana-Farber Cancer Institute and Massachusetts General Hospital in Boston, Massachusetts. However, other researchers, including Fred Hirsch at the University of Colorado Cancer Center, are expected to produce commercial laboratory tests based on their work with the EGFR gene.

Genzyme’s new test demonstrates that the time from research to clinical test continues to shorten. Further, it seems Genzyme chose to bring this test to market as soon as possible to beat other companies preparing similar types of diagnostic tests. That is further confirmation that the development and introduction cycle for new molecular assays is growing shorter and shorter.

BIG KANSAS CITY FIRMS PROPOSE MAJOR HEALTH INFO NETWORK

MAJOR EMPLOYERS IN KANSAS CITY are taking a proactive role in developing a Regional Health Information Organization (RHIO). The goal is to create an electronic community health record.

The initiative is called “Healthe.” Among the 12 private sector employers participating are Cerner Corp., Children’s Mercy Hospitals and Clinics, and Truman Medical Centers. The project is in the talking stage, with no set timetable for implementation.

Organizers are discussing an RHIO informatics platform that would include claims data, prescription data, patient demographics, allergies, and laboratory test data. Employers hope
this initiative would accelerate adoption of electronic medical records (EMRs) by physicians in the Kansas City area. As currently proposed, an independent, not-for-profit organization would be created to develop and manage the Healthe project.

The initiative in Kansas City to create a regional health informatics platform is not unusual. Similar efforts to create RHIOs are underway in com- munities throughout the United States. This market development reinforces the need for all laboratories and pathology group practices to have an effective strategy for enhancing information-based services and capabilities.

HURRICANE KATRINA TESTS HOSPITAL EMR SYSTEMS

IN THE WEEKS FOLLOWING Hurricane Katrina, news has slowly emerged about how hospitals with EMR systems maintained clinical services and access to essential patient records.

On the Mississippi Gulf Coast, the two-hospital Singing River Hospital System operates an EMR system installed in 2003. The hospitals are linked by two independently-routed fiber optic lines, configured into a SONET ring. When the hospital closest to the Gulf was hammered by the storm, full access to patient records was maintained. Only when the power supply failed on two occasions, did hospital staff need to use paper forms.

In New Orleans, the Veterans Administration hospital was evacuated after the first floor flooded. Back-up tapes of the VISTA system had been prepared on Friday, before the storm, and Monday, before the levees broke. These tapes were flown to Houston. Programmers wrote a special program and within a few days, information on the VA patients from New Orleans was available to VA clinicians anywhere.

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