The American Nurses Association (ANA) supports the federal Home Health Care Planning Improvement Act of 2011 (S.227), which has recently received an additional sponsor to the bill. The bill enables advanced practice registered nurses (APRNs), nurse practitioners (NPs), clinical nurse specialists (CNSs), certified nurse midwives (CNMs) and physician assistants (PAs) to order home healthcare services through the Medicare system. Currently, federal law prohibits these professionals from ordering services. The ANA notes that this prohibition causes delays and consequent additional expenses within the Medicare system. This also causes delays in moving patients from expensive institutional settings to less expensive, often preferable, home health care settings.

The bill is sponsored by Senator Susan Collins [R-ME] and is co-sponsored by Daniel Akaka [D-HI], Kent Conrad [D-ND], Daniel Inouye [D-HI], Tim Johnson [D-SD], Jeff Merkley [D-OR], John Reed [D-RI], and Ron Wyden [D-OR]. According to the US federal government, this bill revises limitations for “home health care services. Allows payment for home health services to Medicare beneficiaries by: (1) a nurse practitioner, (2) a clinical nurse specialist working in collaboration with a physician in accordance with state law, (3) a certified nurse-midwife, or (4) a physician assistant under a physician's supervision.” The bill has been referred to the Senate Finance Committee.

New research published in the New England Journal of Medicine concludes that nursing understaffing leads to higher patient mortality rates. A direct relationship between the ratio of nurses to patients is linked to patient safety and a lack of nurses results in deaths. An examination of nearly 200,000 nursing shifts showed that staffing of “RN’s below target levels” is directly and causally related to increased patient mortality.

Cost cutting techniques involve reducing the number of nurses in hospitals and medical clinics. The release of this data now links cost cutting techniques with increased death rates. Nearly a decade ago, another study linked the proper staffing of nurses to better patient outcomes. This follow-up study now highlights the dangers of nursing shortages.

The Results
In one finding, understaffing of nurses leads to inappropriate and dangerous levels of patient transfers and discharges. The study also concludes that nursing shortages are directly linked to higher nursing shift turnover rates. The study concluded the risk of death increased 2% for patients exposed to shifts below target RN staffing levels. The average patient was exposed to 3 nursing shifts below target levels thereby creating a 6% higher risk of death. High turnovers of nursing shifts resulted in a 4% higher death rate.

American Nurses Association
The ANA (American Nurses Association) has commented on this finding by saying that policymakers need to focus on reimbursement systems that reward hospitals for proper nurse staffing levels. The ANA’s recommendations follow an emerging philosophy of creating monetary rewards for better patient outcomes rather than that from cost-per-patient profits.

Reference:
Nurse Staffing and Inpatient Hospital Mortality. Jack Needleman, Ph.D., Peter Buerhaus, Ph.D., R.N., V. Shane Pankratz, Ph.D., Cynthia L. Leibson, Ph.D., Susanna R. Stevens, M.S., and Marcelline Harris, Ph.D., R.N. N Engl J Med 2011; 364:1037-1045.

Japan’s Ministry of Health, Labor, and Welfare has pulled two ‘flu’ vaccines from the market in the wake of the deaths of several children. The two vaccines, Pfizer’s Prevenar and Sanofi-Aventis’ Act-HIB, are widely used in the USA to prevent influenzae type b. The vaccines are used to prevent influenza type b infections, which can be fatal if meningitis or pneumonia develop. A Japanese drug panel has since determined no causal connection between the vaccines and the death of the six infants who received the vaccines. Also, no defects in the vaccine batches were discovered. The vaccines remain banned in Japan pending further investigation. The Japanese drug panel, the Safety Countermeasure Committee and Vaccines Adverse Event Committee, has requested further information as to the safety of administering multiple vaccines simultaneously.

Risk Profile
The vaccines in question generate billions of dollars of revenue every year for the manufacturers. While the vaccines provide protection, a concern remains as to the risk-benefit analysis of the vaccines. Once concern is that several of the children who died received a combination of other vaccines simultaneously including those for diptheria, pertussis, and tetanus. Multiple vaccines pose a potential drug interaction issue. This concern may lead to changes in vaccine schedules to minimize potential adverse effects. By definition, vaccines introduce toxins into the body in an effort to prevent future illness. At question is whether or not the introduction of the vaccine can be safely handled by the immune system of children who are very young, have received multiple vaccines, or who are immunocompromised. The Japanese investigation determined that there were no manufacturer defects in the vaccines at issue.

US Supreme Court
This is a hot issue in light of a current pending vaccine case in the US Supreme Court, Bruesewitz v. Wyeth. In this case, the US Justice Department is siding with Pfizer pharmaceuticals to limit the liability of pharmaceutical manufacturers in cases of illnesses caused by vaccination. At issue is whether or not a pharmaceutical company is liable if they are aware of a better designed vaccine (one with fewer side effects) yet continue to use the less safe vaccination.

The federal Vaccine Court system provides compensation for vaccine injured persons from the money generated by a tax on vaccine manufacturers. In Bruesewitz v. Wyeth, the parents of Hannah Bruesewtiz were denied compensation in the Vaccine Court system and now seek the right to receive compensation through State court. Six month old Hannah received a DPT (diphtheria, pertussis, tetanus) vaccination and immediately suffered a series of 125 seizures over a period of 16 days. Now 18 years of age, Hannah cannot speak or care for herself as a result of her injuries. The vaccine used on Hannah has since been discontinued in favor of safer alternatives. Before the Supreme Court, attorneys for the Bruesewitz family argue that safer alternatives were available at the time Hannah received her vaccine and that the manufacturer had the responsibility of providing the safer alternative and at the very least had the responsibility of providing labeling noting that a safer alternative was available.

Justice Ginsburg showed deep concern in this case, “there were an unusual number of adverse reactions to the particular lot that this child's third vaccine came from, and that those adverse reactions were not disclosed to the doctors. And the doctors -- the child's doctor said if I had known about the unusual number of adverse reactions, I never would have used this vaccine.” Justice Breyer noted that the1986 National Childhood Vaccine Injury Act legally protects drug companies from lawsuits due to unavoidable harm (such as side effects from vaccinations) but that the drug company lawyers in this case are now suggesting that they are also protected from avoidable harm lawsuits. Avoidable harm includes withholding information from the government and the public concerning safer vaccines and also not informing doctors and nurses of high incidences of reactions to particular batches of vaccines. The attorney for the drug company replied that if manufacturers were to be sued for avoidable harm they would be “driven from the market” and she reiterated her position that pharmaceutical manufacturers should only be held liable for manufacturing defects and warning claim issues. The drug company lawyer argued that pharmaceutical companies are not responsible for informing nurses, doctors, the pubilc, and the government if safer vaccines are available.

California State law limits the power of the California Insurance Commissioner to control rate hikes by health insurance companies. Blue Shield plans to raise insurance rates approximately 35 percent in addition to two other recent rate hikes. In total, some Californians will see an increase of up to 60 percent in their health care premiums from 2010 to 2011.

Blue Shield has released a statement that the rate hikes are unrelated to the Affordable Care Act. Blue Shield notes that the rate hikes in California are due to increased medical costs.

“At low intake levels, fluoride has been shown to have therapeutic value in the prevention of dental caries; however, slightly higher levels, particularly in children during the period of enamel development can lead to dental fluorosis, a condition in which the enamel covering of the teeth fails to crystallize properly. Possible resulting problems include enamel defects ranging from barely discernable markings to brown stains and surface pitting. Prolonged high intake of fluoride, at any age, can result in skeletal fluorosis, a condition which may increase bone brittleness, and in a potential increase in risk of bone fracture. In high-dose cases, severe bone abnormalities can develop, crippling the affected individual.”²

The HHS noted that access to fluoride has increased and that health and safety concerns prompted the change in policy. The HHS published, “Water is now one of several sources of fluoride. Other common sources include dental products such as toothpaste and mouth rinses, prescription fluoride supplements, and fluoride applied by dental professionals… This updated recommendation is based on recent EPA and HHS scientific assessments to balance the benefits of preventing tooth decay while limiting any unwanted health effects.”³

Comprehensive evaluations of many patient case studies appear in EPA reports. One patient, for example, was cited as contracting severe dental and skeletal fluorosis due to the fact that he drank a lot of water because he lived in the dry climate of Arizona. The study reads, “He presented with neurological deficits and severe weakness in both legs. Fluorosis was confirmed in an extracted tooth in which fluoride content ranged from 614 to 5299 ppm, depending on the part of the tooth….The characteristic vertebral changes of skeletal fluorosis and severe osteophytosis were probably the basis for the patient’s neurological deficits…. the neurological symptoms are adequately explained by the marked narrowing of the sagittal diameter of the cervical and lumbar spinal cord and the vertebral osteophytosis secondary to fluorosis. Neurological deficits occurred as a manifestation of spinal cord and nerve root bony compression.”⁴

Gov. Brown’s Plan
Gov. Brown’s plan is divided into several tiers of renewable energy projects, which include solar, wind, small hydro, geothermal, and biomass. The first tier is to build 12,000 MWs of localized electricity generation. This focuses on onsite energy systems or systems near the area where the electricity is consumed. This cuts down on costs associated with energy transmission lines and environmental impact. Solar systems on roofs of warehouses, parking lot structures, schools, and commercial buildings can typically handle 2 MW solar systems. Larger public and private lands and solar panels alongside highways can typically handle 20 MW systems. Gov. Brown also notes that legislation to limit rates and protect consumers must accompany this part of the plan.

Large Scale Production
The second tier of Gov. Brown’s system is to build 8,000 MW of large-scale renewable energy production and associated transmission lines. He has several legislative solutions to focus on cutting red tape. Notably, he calls for a general plan with one, large environmental review. Gov. Brown has a fast track plan to cut California’s infamous ‘red tape’ beuracratic burden for new clean energy projects, which currently makes the average large scale project a 6 to 8 year ordeal. His plan will reduce that time to less than three years. Also, he plans to push for legislative standards to require a minimum of 33 percent renewable energy for the State of California.

Jobs
Next, Gov. Brown plans to create 8,500 jobs by incentivizing the development of energy storage systems to offset peak energy demands. Also, he has a plan to increase the energy efficiency of buildings and appliances. Gov. Brown’s energy plan will also incentivize cogeneration. Cogeneration is combined heat and power projects, which makes use of excess heat or electricity generated by industrial and power plants.

The healthcare impact may be substantial if Gov. Brown can achieve his goal of 20,000 new megawatts (MW) of renewable electricity by 2020. Reducing air pollution will reduce asthma rates and other diseases and the subsequent impact on the hospital system, nurses, nursing professionals, doctors, acupuncturists, and many other healthcare professionals.

President Obama has signed the James Zadroga 9/11 Health and Compensation Act (HR 847) while in Hawaii. The Whitehouse released that this new law “extends and expands eligibility for compensation under the September 11th Victim Compensation Fund.” The Department of Health and Human Services is charged with the responsibility of running the World Trade Center Health Program with the passage of the legislation.

The law states that there will be “medical monitoring and treatment benefits to eligible emergency responders and recovery and cleanup workers” and “initial health evaluation, monitoring, and treatment benefits to residents and other building occupants and area workers in New York City who were directly impacted and adversely affected by such attacks.” This law extends benefits to survivors of the 911 attack on the World Trade Center in New York City.

A committee has been established to advise on health related issues concerning survivors and responders. It is composed of 4 occupational physicians (at least 2 of whom have experience treating WTC rescue and recovery workers), 1 physician with expertise in pulmonary medicine, 2 environmental medicine or environmental health specialists, 2 WTC responders, 2 WTC survivors, an industrial hygienist, a toxicologist, an epidemiologist, and a mental health professional.

A Steering committee has been established to coordinate health evaluations, treatment programs, and monitoring. It is comprised of representatives from the Centers for Excellence (servicing WTC responders), firefighters, police, NYC employees, and recovery and cleanup workers (including healthcare professionals such as nurses and nursing practitioners) who responded to the September 11, 2001 terrorist attacks. The steering committee also has 3 representatives from New York City. One will be selected by the NYC police commissioner, another by the NYC health commissioner, and another by the mayor of New York City.

Contamination Oversight
One provision of the Food Safety Modernization Act is a new requirement for manufacturers and farmers to develop anti-contamination protocols. The act also gives the FDA authority to review food industry and farm internal records. Further, the act requires imported food to be certified as meeting US safety standards. The act also increases the frequency of safety inspections at industrial food processing plants. Under current provisions, the FDA inspects plants approximately once every ten years. Under the new proposed law, this will occur at least once every five years at high-risk facilities.

Politics of Food
Sen. Harry Reid notes that 5,000 people die every year in the US due to food poisoning. He notes that the new act empowers the FDA to prevent outbreaks from contaminants such as E. Coli bacteria in the food supply. In an interesting twist, a provision to self-fund the act with user fees collected from food companies was removed from the House version before passage. Republican Rep. Jack Kingston, who has oversight authority of the FDA because he sits on the House appropriations subcommittee, objects to the new law citing that it is too expensive at a cost of $1.4 billion over a period of five years. Had the user fees been included in the proposed law, this issue would not exist. All three GOP lawmakers on the House appropriations subcommittee voted against the Food Safety Modernization Act.

Overview of Provisions
The Food Safety Modernization Act provides for inspection of food production records, registration of food facilities, hazard analysis and risk-based preventive controls, performance standards, standards for produce safety, protection against intentional adulteration of foods, a national agriculture and food defense strategy, food and agriculture coordinating councils, building domestic capacity, sanitary transportation of food, food allergy and anaphylaxis management, and requirements for guidance relating to post harvest processing of raw oysters. Improvements in the capacity to detect and respond to food safety problems include targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; laboratory accreditation for analyses of foods, an integrated consortium of laboratory networks, enhancing tracking and tracing of food and recordkeeping, mandatory recall authority, administrative detention of food, decontamination and disposal standards and plans, improving the training and continuing education of State, local, territorial, and tribal food safety officials, enhancing food safety, and improving the reportable food registry. Improvements to imported food safety include a foreign supplier verification program, a voluntary qualified importer program, authority to require import certifications for food, prior notice of imported food shipments, building capacity of foreign governments with respect to food safety, inspection of foreign food facilities, accreditation of third-party auditors, foreign offices of the Food and Drug Administration, and controls to identify smuggled food. Other provisions include whistleblower protections and methods to determine budgetary effects.

The Votes
The FDA Food Safety Modernization Act, HR 2751, passed in the House on June 9^th and passed in the Senate with changes by voice vote on Dec. 19^th. The act was cleared for the White House on Dec. 21^st, 2010 when the House of Representatives agreed with the Senate’s changes by a vote of 215 Ayes, 144 Nays, and 74 Present/Not Voting. The Dec. 21^st vote was 205 Democrats and 10 Republicans voting in favor of the measure. Opposing the food safety act were 8 Democrats and 136 Republicans.

New research published in the American Journal of Cardiology shows that red yeast rice is as effective in lowering cholesterol levels as statin drugs. The focus of the study compared red yeast rice (Hong Qu, Hong Mi, Chi Qu) with Pravastatin. The study concluded that “red yeast rice was tolerated as well as pravastatin and achieved a comparable reduction of low-density lipoprotein cholesterol in a population previously intolerant to statins.” Patients taking pravastatin had a decrease of of low-density lipoprotein cholesterol (‘bad’ cholesterol) of 27% and the red yeast rice group had a slightly better outcome with a 30% reduction. The study was conducted at the Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania.

The study gives a little history of red yeast rice use noting that sales of red yeast rice were approximately $20 million in the USA in 2008. Patients taking red yeast rice often sought this alternative herbal approach due to the side effects of statin drugs such as muscle pain. The study notes that, “in a previous placebo-controlled study, we demonstrated that 93% of subjects with a history of SAM were able to tolerate red yeast rice for 24 weeks without a recurrence of myalgia.”




References:

Halbert, French, Gordon, Farrar, Schmitz, Patti, Morris, Thompson, Rader, Becker; Tolerability of Red Yeast Rice (2,400 mg Twice Daily) Versus Pravastatin (20 mg Twice Daily) in Patients With Previous Statin Intolerance; American Journal of Cardiology, Volume 105, Issue 2, P. 198-204, 15 January 2010.

Becker DJ, Gordon J, Halbert SC, French B, Morris PB, Rader DJ. Red yeast rice versus placebo in dyslipidemic, statin-intolerant patients enrolled in a therapeutic lifestyle program: a randomized, controlled trial. Ann Intern Med. 2009;150:830–839.