Pharmacies that provide Medicare Part B
Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) to
their patients would be exempt from posting $50,000 surety bonds under
legislation recently introduced. U.S. Senators Jon Tester (D-MT) and Pat
Roberts (R-KS) have sponsored a companion bill to H.R. 1970, the Preserve
Patents Access to Reputable DMEPOS Providers Act of 2009. In response,
National Community Pharmacists Association (NCPA) Executive Vice President
and CEO Bruce T. Roberts, RPh, issued the following statement:

“This legislation is important to maintaining patient access to essential
medical supplies, such as diabetes testing strips. It allows patients to
continue relying on their trusted local pharmacies as a one-stop shop
where prescription drugs, medical advice and supplies are available and
health outcomes are maximized. We deeply appreciate the leadership of
Senators Jon Tester and Pat Roberts and their continued efforts to help
pharmacists continue to play a vital role in the health care chain.

“The bond requirement should not apply to pharmacists, who are already
subject to state regulations and are not associated with violations.
Fourteen other medical providers are already exempted from this
time-consuming and expensive requirement, and this bill would add
pharmacists to that list.

“NCPA encourages the Senate and House to move these bills in an
expeditious fashion. This will ensure patient access to medical supplies
is not endangered.”

The Centers for Medicare & Medicaid Services (CMS) issued a DMEPOS final
rule that requires pharmacies to obtain a surety bond to continue selling
DMEPOS by October 2, 2009. The average independent community pharmacy’s
DMEPOS-generated revenue only comprises a small percentage of its gross
annual sales. In fact, many independent community pharmacies’ percentages
fall well below that threshold.

Fourteen other medical professions are exempted from the surety bond
requirement because of their state licensure, expertise and training-all
qualities that pharmacists share. In rural and urban areas independent
community pharmacies are often the only health care provider that provides
access to health care supplies.

Source
The National Community Pharmacists Association

SAN FRANCISCO, April 24 — Intraoperative margins assessment may be possible with an experimental device that measures light scattering to determine tissue composition, researchers said.

• Explain to interested patients that margin assessment allows surgeons to determine whether any residual disease was left in the breast.
• Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

The optical imaging device correctly identified 80% of pathologically positive or close margins and 67% of the pathologically negative margins, Quincy Brown, Ph.D., of Duke University in Durham, N.C., and colleagues found in a small pilot study.

The technology also identified eight out of nine margins with ductal carcinoma in situ, they reported at the American Society of Breast Surgeons meeting.

These preliminary results from 55 imaged specimens were promising given that standard pathological margin assessment usually takes about a week, said co-author Lee G. Wilke, M.D., also of Duke University.

The “research-grade” device takes about five minutes to analyze a specimen, Dr. Wilke said. If validated in further study, it could enable surgeons to correct margins if needed during the initial procedure and prevent revision surgeries, she said.

Shawna Willey, M.D., president of the American Society of Breast Surgeons, and moderator of a press conference at which the findings were presented, agreed that this is an area of unmet need for surgeons and patients.

Positive margins send women back to the operating room after about 40% of lumpectomies, Dr. Brown noted.

“Currently there are no rapid noninvasive imaging technologies for margin assessment,” Dr. Wilke said. “In the operating room, the most simplistic is physician palpation of the lumpectomy specimen.”

Mammography of the specimen has also been used, but it is only two-dimensional unless multiple views are taken, she noted.

In contrast, with this kind of X-ray or MR imaging, light in the visible spectrum cannot penetrate more than a few centimeters into solid tissue.

Although this makes it unsuitable for breast cancer screening, Dr. Brown noted that it’s fine for margin assessment, which is typically measured to a depth of 2 mm.

Optical imaging technology can also be used at the point of care, is of modest cost, and can provide immediate results, the researchers noted.

The imaging device they developed is comprised of a broadband light source, an imaging spectrograph, and a CCD camera. The tumor specimen is placed in a box with a grid of holes to orient the imaging fiber optic probe.

The spectrographic data — how much of the light is reflected, absorbed, and fluoresced by the tissue at each wavelength — maps out the biochemical composition across the surface of the tumor specimen.

For example, a map of scattering characteristic of beta-carotene, a component of fatty tumor cells, reflects cell density, while scattering associated with hemoglobin reflects tissue vascularity.

The pilot study included 55 margins measured in surgically resected tumors of 48 patients who underwent breast-conserving surgery.

At the thresholds chosen for these biochemical markers of tumor presence, the researchers found that their device predicted positive margins with a P-value of 0.002 and an area under the curve of 0.77.

Dr. Brown said the sensitivity was 80% with a specificity of 70% for detecting positive margins in the cohort.

However, he said, the model is still being revised as further data come in from the full 100 patients they plan to study.

Dr. Wilke noted that the device will need to be tested for use with women who have had neoadjuvant treatment to determine how it is affected by the tissue alterations that occur with preoperative therapy.

Dr. Wilke reported being the principle investigator on a small business technology transfer grant given to Duke University to develop the device and being on the pending patent for it.

Primary source: American Society of Breast Surgeons

Source reference:
Wilke L, et al “Rapid non-invasive imaging of the biochemical composition in breast tumor margins” ASBS 2009.

The AMA is urging Australians not to stockpile antiviral medicines.

AMA President, Dr Rosanna Capolingua, said it was understandable that people would seek to be prepared, but it was essential that distribution be done properly.

“This is a time for Australians to stick together as a community and consider our fellow Australians who are in greatest need,” Dr Capolingua said.

“In the event that Australians do become sick with this virus, it will be essential that anti viral medications are available for those who are immediately exposed or suffering symptoms.

“Having Tamiflu or Relenza in your cupboard when you do not need it may mean that it is not available to someone who does.

“It is in everyone’s best interests to follow the advice of the health authorities and to ensure sufficient supplies are available if and when they are required.

“Doctors have been advised that, in consultation with local public health units, the current recommendation for the prescription of Tamiflu and Relenza is as follows:

- close contacts of confirmed or probable cases within 48 hours of contact
- suspected cases if started within 48 hours of onset of symptoms, until influenza A is excluded or an alternative diagnosis is made
- there is no current recommendation for Tamiflu or Relenza to be used prophylactically by travellers visiting affected countries, apart from Mexico

“The AMA joins with Government in urging Australians to keep calm and not seek to stockpile.”

Source
Australian Medical Association

View drug information on Relenza; Tamiflu capsule.