Archives for June 2016

Case Study: Hospital Upgrades Cleanroom for a fraction of the anticipated Time and Cost.

Aseptic-Enclosures-HEPAcirc-Case-Study-v11

FDA approves Epclusa for treatment of chronic Hepatitis C virus infection

The U.S. Food and Drug Administration approved Epclusa to treat adult patients with chronic hepatitis C virus (HCV) both with and without cirrhosis (advanced liver disease). For patients with moderate to severe cirrhosis (decompensated cirrhosis), Epclusa is approved for use in combination with the drug ribavirin. Epclusa is a fixed-dose combination tablet containing sofosbuvir, a drug approved in 2013, and velpatasvir, a new drug, and is the first to treat all six major forms of HCV.

FDA panel to vote whether diabetes drug cuts cardiac death

(Reuters) – An advisory panel to the U.S. Food and Drug Administration will be asked to vote next week on whether a diabetes drug made by Eli Lilly & Co and Boehringer Ingelheim cuts the risk of cardiovascular death, according to documents posted on the agency’s website on Friday.

Two Alabama pharmacists sentenced in case of tainted drugs linked to 9 deaths

Two former Jefferson County pharmacists were sentenced to federal prison – one to 12 months and the other 10 months – for their roles in the distribution of tainted drugs in 2011 that authorities say contributed to the deaths of nine patients at various Birmingham-area hospitals who developed bloodstream infections.

Hospital Upgrades Cleanroom for a fraction of the anticipated time and cost.

The Situation:  A hospital pharmacy had an existing cleanroom that was not meeting the USP<797> requirements(1) for an ISO class 7 (2) grade cleanroom.  The existing cleanroom was deficient in both Air Changes Per Hour (ACPH) and lacked low wall returns.

FDA Approves Cholera Vaccine

FDA approved Vaxchora, a vaccine for the prevention of cholera caused by serogroup O1 in adults, the agency said in a June 10, 2016 press announcement. Although cholera is rare in the United States, FDA said travelers to countries with poor sewage and sanitation treatment are at risk for the disease. Vaxchora is the only FDA-approved vaccine for the prevention of cholera.

Drug company recalls popular vitamins for salmonella concerns

NORTHRIDGE, CA – A number of Nature Made vitamins are being recalled due to possible salmonella contamination.

The recalled products were distributed nationwide to various major retailers.

For a full list of recalled vitamin visit Nature Made’s website.

Teva halts production at sterile injectables plant to address FDA concerns

Sterile injectable products are notoriously difficult to produce, and the FDA has little tolerance for plant issues that might lead to contamination. Just ask companies like Hospira and Mylan. Now, the FDA has found serious enough problems at a Teva sterile injectables plant in Hungary that it has banned most of its products from the U.S., leading Teva to suspend operations there as it works to get issues resolved.

FDA approved ‘permanent’ birth control causing lifelong recurring pain

When it comes to effectively preventing unwanted pregnancies, women simply don’t have a lot of good options. Now, women who have turned to the permanent birth control procedure known as Essure in an effort to avoid the harmful effects of birth control pills, are finding that the alternative can actually be even worse.

Essure is a small device that is inserted by a doctor through a woman’s cervix into the Fallopian tubes. Over the course of a few months, it leads to the formation of scar tissue around the coils, which blocks sperm from getting to the eggs. The company’s website brags that most women can go home just 45 minutes after the procedure. There are no hormones in the coil; it’s 99 percent effective at preventing pregnancy; and no anesthesia is required.

On the surface, this sounds like a good choice for many women, but the reality is very different. First of all, the coils contain a nickel-titanium alloy that is a common allergen. While the packaging warns that this could lead to allergic reactions such as itching, hives or rash, many patients won’t end up seeing this warning, because the device is inserted by their physician – much like the warning labels on vaccines, which most patients also never see.

KXAN Austin recently profiled several women who had experienced adverse effects from the device. One woman believes it caused an ovarian cyst rupture, and is also responsible for a serious depletion in her energy, as well as weight loss and constant fatigue. She regrets getting the device because she no longer has the energy to keep up with her two young children.

Meanwhile, a Liberty Hill mother also reports suffering from fatigue, bloating and severe menstrual pain. She describes pain that builds up in her pelvis before working its way down her legs. Countless women interviewed for the article stated that they, too, had experienced horrific side effects that even necessitated a hysterectomy in some cases.

Aseptic Technique

Definition

Aseptic technique is a set of specific practices and procedures performed under carefully controlled conditions with the goal of minimizing contamination by pathogens.

Purpose

Aseptic technique is employed to maximize and maintain asepsis, the absence ofpathogenic organisms in the clinical setting. The goal of aseptic technique is to protect the patient from infection.