California Law “Designates Pharmacists as Health Care Providers”

A pharmacist must undergo eight years of education in order to obtain a doctorate in pharmacy. Until recently, pharmacists could only fill prescriptions. However, pharmacists across the nation have been taking on a more direct role in patient care. States such as North Carolina, California and New Mexico have implemented laws that allow a pharmacist to perform additional duties, and not just “fill a bottle with pills.” Some claim that allowing pharmacists more responsibility will alleviate the strain on resources experienced by both primary care physicians and hospitals. Others are concerned that pharmacists are being given too much responsibility.

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Antibiotics in Food Animals May Pose “High Risk” to Humans

The Natural Resources Defense Council (NRDC), an environmental advocacy group, has compiled a report on the safety of antibiotics used by American farmers to treat food animals. The report reflects the finding of Food and Drug Administration (FDA) scientists that 18 out of 30 antibiotics being given to the animals pose a “high risk” to human beings, by exposing them to antibiotic-resistant bacteria in the food supply. In addition, all 30 of the antibiotics studied, when used for non-therapeutic purposes (such as increasing an animal’s size), expose humans to antibiotic-resistant bacteria, and violate the FDA’s own safety guidelines on non-therapeutic use.

The NRDC claims that FDA efforts to “phase out” the administration of non-therapeutic drugs to food animals are not swift enough to protect the public. In December 2013, the FDA stated that it is taking action to promote “the judicious use of important antimicrobials to protect public health, while ensuring sick and at-risk animals receive the therapy they need.”

Read more here and here.

Berg and Icahn Medical School to Use Biological Data to Impact Health Care Policies

Pharmaceutical company, Berg, has partnered with the Icahn School of Medicine at Mount Sinai (Icahn), in order to implement a “data driven, biological research approach” to medicine, which they claim could change the face of health care. Berg and Icahn will use Berg’s Interrogative Biology platform to analyze biological data from human beings. The Interrogative Biology platform combines a patient’s biological data with his clinical and demographic data in order to create a biomarker library. A biomarker is a quantifiable substance in an organism that predicts disease or infection.

The biomarker library is intended to allow the partners to detect disease patterns in a given population. The identification of disease patterns would help doctors, insurance companies and government agencies identify the most efficacious diagnostics and treatments for patients.

Read more here and here.

Australian Government Seeks to Stop Spread of Superbugs

Superbugs are organisms that are resistant to antibiotics, and they have the capacity to cause dangerous infectious diseases. There have been numerous confirmed cases of superbugs in America and Europe, and the Australian government is taking action to keep them out. Peter Collignon, an infectious disease expert from the Australian National University, stated that the most probable way for a superbug to enter Australia would be through imported seafood.

The Department of Agriculture, Fisheries and Forestry will conduct an investigation into antibiotic use in livestock and farmed fish, as well as their resistance to antibiotics. The Senate committee recommended that the government require mandatory reporting of antibiotic use in agriculture, and develop an independent body for disease control in order to administer the requirements.

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PPACA’s Limit on Consumers’ Expenses Delayed Until 2015

The PPACA incorporates mechanisms intended to protect consumers from insurance company abuses. One such mechanism limits patients’ out-of-pocket (OOP) spending for major medical coverage. However, as posted on the Department of Labor’s website, the cap on OOP expenses for consumers will not go into effect until 2015. Some claim that the delay is meant to help businesses and consumers adapt to the PPACA, while others claim that the Administration is catering to employers and businesses at the expense of consumers.

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FDA Safety over Sequestration (SOS) Bill Introduced in the House

A substantial portion of the budget for the Food and Drug Administration (FDA) is comprised of user fees, collected from the industries that the agency regulates. The FDA spends the money collected from the user fees for specific purposes, such as the expedited review and approval of drugs or medical devices. At present, the user fees are not exempt from the sequester, which went into effect in January of this year. Rep. Anna Eshoo, (D-Calif.), is a lead sponsor of a bipartisan House bill, the FDA Safety over Sequestration (SOS) Act, which would exempt the user fees from sequestration. She stated that “private dollars” should not be sacrificed in the name of policy. Proponents of the Act maintain that applying the sequester to the user fees would stifle medical innovation and patient access to “timely therapies.” The SOS Act has found support amongst prominent medical device groups as well.

To read more click here and here.

Gonorrhea Close to Becoming Untreatable in the U.S.

Gonorrhea, once considered eminently curable, is “dangerously close” to becoming untreatable according to the CDC. Untreatable gonorrhea has cropped up in both Europe and Asia, and federal health officials fear that the U.S. may be next. Gonorrhea has existed for centuries and over the years has been treated with drugs such as penicillin, tetracycline, doxycycline and ampicillin. Yet, most drugs have ceased to cure the disease, including the aforementioned medicines, as well as almost every other new drug implemented. One reason that gonorrhea evades treatment is that the bacterium responsible for causing gonorrhea can mutate rapidly in order to defend itself.  Gonorrhea’s growing resistance to treatment has been furthered by the over-prescription of antibiotics.

At present there are only two – or possibly one only — effective treatments for gonorrhea. Evidence recently emerged that gonorrhea has developed a resistance to cefixime, leaving ceftriaxone as the only known, effective treatment. Gail Bolan, head of the CDC’s STD prevention division, stated that it is only a matter of time before ceftriaxone becomes ineffective as well. The CDC declared that doctors should stop the use of cefixime as a first-line regimen for treatment of gonorrhea, and believes a “critical step” is necessary to preserve the efficacy of ceftriaxone. The CDC recommends that doctors administer ceftriaxone (delivered through an intra-muscular shot) with either azithromycin or doxycycline. If cefixime is used as an alternative agent, the doctor must monitor the patient to ensure that he or she is cured.

To read the news source click here.   To read the CDC’s guidelines click here.


An Antibiotic Dilemma

Practically incurable “nightmare bacteria” are on the rise and antibiotics to fight them are limited.  In fact, only seven new antibiotics are currently being developed to fight superbugs such as carbapenem-resistant Enterobacteriaceae (CRE), Enterobacter aerogenes, and Carbapenem-resistant Klebsiella pneumonia (CRKP) – which is almost completely resistant to existing antibiotics.  In particular, the Director of the Centers for Disease Control and Prevention, Dr. Thomas Frieden, recently referred to CRE as a “nightmare bacteria” because of its antibiotic resistance, ability to spread its resistance and high mortality rate. To put the risk of superbugs in perspective, Methicillin-resistant Staphylococcus aureus (MRSA) “kills more Americans each year than HIV/AIDS, emphysema, Parkinson’s disease, and homicide combined.

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