Five Scary Things You Didn’t Know about Hospital Errors

Doctors and other medical personnel are in unique positions of trust; when we’re ill or injured, we trust these men and women with our very lives. But in recent years, several studies have revealed an alarmingly high number of medical errors, many of which lead to life-threatening complications. Consider these eye-opening statistics:

• More than 400,000 people die each year as a result of medical errors, according to a study published in the Journal of Patient Safety. That alarmingly high figure places preventable medical errors as the third leading cause of death in the U.S. Heart disease and cancer are the top two causes.

• Each year, more than 700,000 patients acquire an infection while hospitalized, and about 75,000 of those patients die, according to data from the Centers for Disease Control and Prevention (CDC).

• Hospital errors occur more frequently in critical care units, according to a study by Harvard University Medical School, which found preventable errors occurred in nearly half of all ICU patients. Most errors were due to simple “slips and lapses” and not due to lack of knowledge.

• The Institute of Medicine says about $400 billion is wasted each year in medical costs in the U.S. due to unnecessary services, inefficient delivery of services and missed prevention opportunities, all of which can be related to medical errors.

• Jackson Healthcare Survey found 92 percent of doctors reported they made medical decisions based on fear of being sued rather than care based on their patients’ best interests – a disturbing trend called “defensive medicine.”

Some experts hope the expansion of electronics in the healthcare industry may help reduce medical errors, but only time will tell if electronic devices provide a benefit to patients or become just another source of potential errors.

Exploring the Impact of New Regulations: Where Are We Now Regarding Compounding Pharmacies?

As we have blogged for the past several years, the emergence of compounding pharmacies created an unexpected danger for consumers because there were practically no controls or standards governing the manufacturing of these medications. Compounding pharmacies came into existence to create personalized medication for patients.

The dangers of compounding pharmacies first became evident in 2012, when a large outbreak of fungal meningitis was discovered in the United States. The source was traced back to contaminated medications packaged by the New England Compounding Center, a large compounding pharmacy based in Massachusetts. The medications in question, methylprednisolone used in injections, eventually led to 64 confirmed deaths, over 700 injuries, and more than 400 lawsuits filed against the New England Compounding Center, resulting in over $100 million dollars in settlements.

Of greater importance for consumers, the outbreak prompted congressional leaders and federal health officials to review the regulations that govern compounding pharmacies. This review led to the passage of the Drug Quality and Security Act, designed to amend the Federal Food, Drug, and Cosmetic Act to provide new levels of FDA oversight regarding the operation of compounding pharmacies.

As explained by the FDA, “compounding is a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient.” Due to the rising cost of many injectable drugs such as methylprednisolone, many health providers are turning to non-traditional, large scale compounding pharmacies, which many argue transforms the process into large-batch manufacturing as opposed to individualized chemistry.

Although FDCA changes are intended to make medicine safer, most compounding pharmacies do not fall under the regulatory umbrella of the FDA, and rely on state-run boards for oversight. However, “Firms that register with FDA as “outsourcing facilities” under section 503B will be regulated by FDA and inspected by FDA according to a risk-based schedule.” This change was designed to prevent large non-traditional pharmacies from committing errors similar to those in 2012. Traditional compounding pharmacies continue to operate much as they had before 2012.

In addition, the Drug Quality and Security Act created a Pharmacy Compounding Advisory Committee, which “provides advice on scientific, technical, and medical issues concerning drug compounding under sections 503A and 503B. The committee advises, as required, on any other product for which the FDA has regulatory responsibility, and makes appropriate recommendations to the Commissioner of Food and Drugs.”

Congress has worked to help prevent tragedies arising from non-traditional compounding pharmacies, but consumers must still be aware of the risks of compounded drugs. Traditional compounding pharmacies often have no FDA oversight, and as the FDA cautions, “There can be health risks associated with compounded drugs that do not meet federal quality standards. Compounded drugs made using poor quality practices may be sub- or super‑potent, contaminated, or otherwise adulterated. Additional health risks include the possibility that patients will use ineffective compounded drugs instead of FDA-approved drugs that have been shown to be safe and effective.”

As consumers of any medication, we should make certain that we know all the details of any medication before beginning use, including having knowledge of the pharmacy which compounded the product, the expected side effects, and all of the ingredients and drugs contained.

New Dietary Guidelines Call for a Drastic Reduction in Sugar Intake – Cholesterol and Fat Limits Raised

The Dietary Guideline Advisory Committee (DGAC) has changed its recommendations for the U.S. Department of Health and Human Services’ dietary guidelines, which are used to create menus for schools and public food services and to outline food assistance programs like WIC and SNAP.

The Committee seeks to heavily restrict the amount of added sugar Americans use on a daily basis, along with some other changes:

• The guidelines recommend no more than 12 teaspoons of added sugar per day. Currently the average American consumes between 22-30 teaspoons.

• Sugary drinks and sodas will no longer be available in schools. A tax may be imposed on these products.

• Nutritional labels will now be required to have a line clearly defining the amount of added sugar. Labels may be moved to the front of packaging.

• SNAP and WIC policies may restrict people from buying “unhealthy” foods.

Previous guidelines have failed consumers by doing nothing for the population’s obesity and sickness rates. The guidelines – new and old — have been met with skepticism from contradicting research:

• When the guidelines were first issued in 1980, they encouraged Americans to cut back on fats. Trying to restrict fats led to the creation of highly processed foods, a staple of the American diet that is packed with sugars and stripped of fats. Last fall, the committee admitted that it is no longer following this restriction.

• The long-standing cholesterol-intake restrictions told Americans to stay away from foods with high dietary cholesterol, like egg yolks and shellfish. The claims that these foods drastically raise blood cholesterol have been debunked, and the committee finally acknowledged that by removing the restrictions.

• In 2013, an Institute of Medicine Study contraindicated the guideline’s sodium restrictions. The study initially found that lowering dietary salt intake too much may actually lead to adverse health effects.

• Several studies have found that saturated fats may not be directly linked to heart disease, and that replacing saturated fats with polyunsaturated fats could exacerbate blood cholesterol problems and cause inflammation.

Diet is not the only element that can influence heart heath: check out Broken Heart Syndrome Leads to Increased Risk of Cardiovascular/Other Illnesses

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