NEWSWIRE
• European Union Healthcare Supplier of the Year: Smiths Medical International Ltd.
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WHO: Defining the syndrome associated with congenital Zika virus infection The World Health Organization (WHO) defines the Zika virus infection in humans as usually mild or asymptomatic. However, some babies born to women infected with Zika virus have severe neurological sequelae. An unusual cluster of cases of congenital microcephaly and other neurological disorders in the WHO Region of the Americas, led to the declaration of a public health emergency of international concern by the WHO on February 1, 2016. By May 5, 2016, reports of newborns or fetuses with microcephaly or other malformations — presumably associated with Zika virus infection — have been described in the following countries and territories: Brazil (1271 cases); Cabo Verde (3 cases); Colombia (7 cases); French Polynesia (8 cases); Martinique (2 cases) and Panama (4 cases). Additional cases were also reported in Slovenia and the U.S., in which the mothers traveled to Brazil during their pregnancies. Zika virus is an intensely neurotropic virus that particularly tar-
gets neural progenitor cells but also — to a lesser extent — neuronal cells in all stages of maturity. Viral cerebritis can disrupt cerebral embryogenesis and result in microcephaly and other neurological abnormalities. Zika virus has been isolated from the brains and cerebrospinal
fluid of neonates born with congenital microcephaly and identified in the placental tissue of mothers who had had clinical symptoms consistent with Zika virus infection during their pregnancies. Existing evidence and unpublished data shared with WHO highlight the wider range of congenital abnormalities probably associated with the acquisition of Zika virus infection in utero. In addition to microcephaly, other manifestations include craniofacial disproportion, spasticity, seizures, irritability and brainstem dys- function including feeding difficulties, ocular abnormalities and findings on neuroimaging such as calcifications, cortical disorders and ventriculomegaly. Similar to other infections acquired in utero, cases range in severity; some babies have been reported to have neurological abnormalities with a normal head circumference. Preliminary data from Colombia and Panama also suggest that the genitourinary, cardiac and digestive systems can be affected. The range of abnormalities seen and the likely causal relationship
with Zika virus infection suggest the presence of a new congenital syndrome. WHO has set in place a process for defining the spectrum of this syndrome. The process focuses on mapping and analysing the clinical manifestations encompassing the neurological, hearing, visual and other abnormalities, and neuroimaging findings. The scope of the syndrome will expand as further information
and longer follow-up of affected children become available. The surveillance guidance has been expanded to include a spectrum of congenital malformations that could be associated with intrauterine Zika virus infection besides microcephaly.
8 July 2016 • HEALTHCARE PURCHASING NEWS •
hpnonline.com Thirty-seven countries and territories in the Region of the Ameri-
cas now report mosquito-borne transmission of Zika virus and risk of sexual transmission. With such spread, it is possible that many thousands of infants will incur moderate to severe neurological disabilities. Therefore, routine surveillance systems and research protocols need to include a larger population than simply children with microcephaly. The health system response, including psycho- social services for women, babies and affected families will need to be fully resourced. A coordinated approach to data sharing, surveillance and research
is needed. WHO has thus started coordinating efforts to define the congenital Zika virus syndrome and issues an open invitation to all partners to join in this effort. Visit
www.who.int/bulletin/ volumes/94/6/16-176990/en/.
Unapproved wound care products flood the market Treating nonhealing, unresponsive wounds requires that physicians have an intimate knowledge of the products available to stimulate healing and stop chronic wounds from advancing to the point of widespread infection and limb amputation. But in order for clini- cians to do their jobs to the best of their ability, it is imperative that the wound care products they use do what they say they do. An array of wound care products has flooded the marketplace in
recent years, with untested and unproven claims about their wound healing capabilities. The manufacturers of these allograft products have effectively bypassed years of careful research and clinical trials requiring hundreds of millions of dollars in investment, as well as the regulatory authorizations necessary to be legally marketed as wound healing therapies. On the flip side, a small number of manufacturers have done
things the right way and developed products that are rigorously tested and FDA-approved. These advanced living-cell products have been scientifically proven to heal chronic wounds when less expensive and less sophisticated options have failed. Due to a current regulatory loophole, non-FDA-approved prod-
ucts are able to make the same wound healing claims as FDA- approved living cell therapies, and many doctors do not know or understand the difference because of the way the products are marketed. Allograft products have flown largely under the regula- tory radar due to a longstanding FDA process that’s long overdue for revision. Under this process, companies are permitted to self- designate their own products under one of two categories: either human cell and tissue products (“HCT/Ps”) that require FDA premarket approval, or those that do not (referred to as “Section 361 HCT/Ps”). By self-designating “Section 361” status for products that do not,
in fact, qualify as such, allograft distributors have been able to skirt the FDA approval process while making unproven claims about their wound healing capabilities. Doctors and their patients need to know this, and the FDA has an opportunity — and a responsibil- ity — to stop it from happening. The real-life consequences of this muddy policy issue are pretty straightforward: When presented with two products claiming the same outcomes, providers will of course lean toward choosing the less expensive option. But making the wrong choice when a com- pany has offered misleading efficacy claims ultimately impacts the patient. When unproven or clinically inferior products are used, patients lose healing time, infection can worsen, and the risk of amputation becomes greater. The FDA must act to make regulatory changes to keep patients
safe. The agency has the opportunity to do so as it works to finalize industry guidance that will clarify what qualifies as a true Section 361 HCT/P. HPN
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