Compliance Resources to Help you Stay Current

In an alarming revelation, statistics have proved that one out of every seven Medicare patients hospitalized suffers from some kind of physical or mental harm during the stay at the hospital, and adverse circumstances at the hospitals contribute to 180,000 deaths every year, according to a recent study undertaken by the government.

Investment advisers previously omitted in the Securities and Exchange Commission (SEC) horizon have come under the SEC scanner with new rules proposed. They are intended to strengthen this omission and fill key gaps in the regulatory landscape.

The Securities and Exchange Commission today voted to propose new rules to strengthen the SEC's oversight of investment advisers and fill key gaps in the regulatory landscape.

Seven organizations were nominated to receive the nation’s highest presidential honor for performance excellence through innovation, improvement and visionary leadership - the 2010 Malcolm Baldrige National Quality Award. The mission of the Baldrige Program is to enhance the competitiveness and performance of U.S. organizations. The award is not extended to particular products or services.

Rite Aid Corporation, charged with failing to protect its customers’ and employees’ sensitive and financial privacy, received a final order approved by the Federal Trade Commission (FTC) to settle charges. Members of the public who put forward commends on the order received letters from the FTC. In line with the order, Rite Aid is obligated to ensure several measures. This includes setting up a comprehensive information security program that will protect the integrity, confidentiality, and security of the personal information collected from employees and customers.

Propoxyphene, which is sold under the brand names Darvocet, Darvon, Darvon-N, and Dolene is a narcotic pain-reliever. It is a cough suppressant but is weaker than morphine. Its precise mechanism of action is not known but may involve the stimulation of opioid (narcotic) receptors in the brain. Propoxyphene increases pain tolerance and decreases discomfort but the presence of pain is apparent. Additionally, propoxyphene causes sedation and respiratory depression. The FDA approved propoxyphene in August 1957. An estimated 10 million patients have used propoxyphene-based products since.

Anticipated Troubles Caused by Propoxyphene

New clinical data shows that when propoxyphene is taken at therapeutic doses, there are significant changes to the electrical activity of the heart: prolonged PR interval, widened QRS complex and prolonged QT interval. These changes can increase the risk for serious abnormal heart rhythms. At a press conference, John Jenkins, MD, director of the Office of New Drugs, said the new numbers tipped the risk–benefit ratio against the drug.

The US Food and Drug Administration (FDA) has therefore revoked its approval of the drug and asked Xanodyne Pharmaceuticals to recall it from the US market containing. This decision will also affect generic manufacturers and the makers of Propoxyphene- products.  The latter should also recall their products. FDA has notified healthcare professionals that Xanodyne Pharmaceuticals had agreed to withdraw propoxyphene, with the new data showing that it can cause serious cardiac toxicity, even at therapeutic doses.

Health care professionals have been advised by the FDA to stop prescribing and dispensing propoxyphene-containing products to patients. Further, they have also been requested to contact patients, currently on propoxyphene-containing products and advise them of the risks associated with propoxyphene, and discuss alternative pain management strategies. Patients have been advised to dispose of unused propoxyphene in household trash in line with the Federal Drug Disposal Guidelines.

Propoxyphene gives rise to the following side effects:

• Lightheadedness
• Dizziness
• Sedation
• Nausea
• Vomiting
• Drowsiness,
• Constipation
• Propoxyphene can depress breathing and should be used with caution in elderly, debilitated patients and in patients with serious lung disease.
• It can impair thinking and the physical abilities required for driving or operating machinery.
• Propoxyphene may be habit-forming.

Petitions against Darvon till Date

In June 2008, the consumer interest group Public Citizen filed a federal lawsuit against the U.S. Food and Drug Administration in Washington, D.C. The lawsuit alleged that the agency violated the law by failing to act on a petition it filed in 2006.  The petition sought the withdrawal of Darvocet , Darvon , and generic propoxyphene drugs from the market.  They had been associated with over 2,000 accidental deaths; they were physically addictive and no more effective than other safer painkillers. According to data compiled by the Federal Drug Abuse Warning Network, deaths related to Darvocet, Darvon and other generic propoxyphene drugs accounted for over 5% of all drug-related deaths between 1987 and 2006. In November 2010, four years after the petition was filed, the FDA mandated the withdrawal of Propoxyphene.

Sources:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm234389.htm 

The Securities & Exchange Commission is to propose new rules on the modus operandi of reporting and publicly disseminating security-based swap transactions. Security-based swaps are swaps based on a single security or loan or a narrow-based group or index of securities or events relating to a single issuer or issuers of securities in a narrow-based security index.

In Florida, nutrient pollution has contributed to severe water quality degradation. The U.S. Environmental Protection Agency (EPA) has laid down protective standards to check water pollution. Phosphorus and nitrogen pollutants, leaching into waterways from excess fertilizer, storm water and wastewater, foster harmful algae blooms. These blooms produce toxins that can harm the flora and fauna across the state. Currently, more than 1,900 rivers and streams, 375,000 acres of lakes, and 500 square miles of estuaries are known to have been polluted by nutrients.

The standards will help reduce nutrient pollution in lakes and flowing waters - Florida’s communities and businesses all set to benefit from strong environmental protection and significant flexibility.

President and CEO of the Advanced Medical Technology Association (AdvaMed), Stephen J. Ubl, released a statement on November 18, 2010, on a new study that evaluates the impact of device regulation on continued medical innovation.

The Patient Protection and Affordable Care Act (PPACA), a federal statute signed into law in the United States by President Barack Obama on March 23, 2010 along with the Health Care and Education Reconciliation Act of 2010, is an outcome of the health care reform agenda of the Obama administration.

FDA has issued a notification to healthcare professionals - in particular those working in emergency and critical care settings. According to the notification, FDA has received reports to the effect that compatibility problems arise when certain needleless pre-filled glass syringes are used with some needleless intravenous (IV) access systems.

General Mills set for itself new five-year environmental goals recently. The goals are meant to make its operations more efficient by 2015. The firm desires to bring down greenhouse gas emissions by 20 percent. It will bring down consumption of water and energy too –by 20 percent in each case. By 2015, it intends to bring down solid waste generation by 50 percent. Normalized per metric ton of the product, these efficiency goals imply that the firm can consume more energy and water in absolute terms even as they help the firm achieve its goals.

The intention behind the 8-month-old health care law passed by the Congress was to push doctors and hospitals to jointly take the responsibility for bringing down the cost and improving the quality of patient care and possibly reward them with bonuses for achieving it.

Commercial production of Chevrolet Volt has commenced at the Detroit plant of General Motors. These cars are intended for sale or lease to consumers. But the actual sale has to wait – until the issue concerning the EPA fuel economy label is resolved, that is.

EPA commenced site mobilization for removal of soil at the Parker Street Waste Site, last week. Involving removal of contaminated soil from residential properties, the activity will continue until December. Work commenced last week to establish EPA’s command post and equipment staging areas and interact with property owners on specific plans.

The FDA says in a news release that it will launch a program to promote manufacture of safer and superior external defibrillators. Defibrillators are used to correct heart rhythms. External defibrillators are used thousands of times a year to treat cardiac arrest. Automated external defibrillators (AEDs) are conspicuous in public places. They are even more conspicuous in homes, airports and office buildings. Complex external defibrillators are handled by health care professionals in hospitals. Almost 300,000 Americans suffer cardiac arrest each year. They may die if normal rhythm is not restored promptly. Amongst the many steps taken immediately to revive the patient is the delivery of a high-energy shock from an external defibrillator.

Health professionals and lawmakers have welcomed FDA’s declaration that caffeine is an illegal and unsafe additive to manufactured alcoholic beverages. But critics see in the declaration an infringement of consumer rights.

In recent years, the FDA has come across a number of harmful products marketed as dietary supplements for sexual enhancement. These products actually contain active ingredients present in FDA-approved drugs or variations of these ingredients which have nothing to do with dietary supplements. Sexual enhancement supplements promising rapid or long-lasting effects are likely to contain a contaminant. The FDA has urged consumers who have experienced negative side effects to stay away from such sexual enhancement products and seek help from a health care professional.

134 chemical were identified by the U.S. Environmental Protection Agency (EPA) for screening. The purpose is to identify possible disruptive effects on the endocrine system. Chemicals that may interference with the body’s endocrine system, disrupting its development, reproduction, neurology, and immunity are called endocrine disruptors. The safety of the identified chemicals is crucial, and the next step in the EPA process.