Healthcare Legislation Project: S.185: Promise for Antibiotics and Therapeutics for Health Act or the PATH Act Introduction: The Promise for Antibiotics and Therapeutics for Health Act or the PATH Act was introduced to the 114th Congress (2015 – 2016) by sponsor Senator Orrin Hatch, R-Utah with the support of Senator(s) Michael Bennett (D-Colorado), Kelly Ayottee (R-New Hampshire), John Isakson (R-Georgia), Mark Kirk (R-Illinois), Tom Carper (D-Delaware), and Richard Blumenthal (D-Connecticut) on January 16th, 2015. This legislation is currently being reviewed by the Senate Committee on Health, Education, Labor and Pension. After which, it will be come up for vote in both the Senate and House, before being presented to the President for approval into law. Section 3 of the Promise for Antibiotics and Therapeutics for Health Act or the PATH Act, which call for current PATH Act legislation to be modified so that it “will allow health experts to more easily develop new treatments for antibiotic resistant bacteria, and make real progress in presenting a great number of illnesses and deaths in the United States”1. In addition, this new legislation will impact Section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C 356) by introducing into its current language a new subsection (g) “Limited Population Pathway for Antibacterial Drugs”. Thus creating new avenues for the introduction of alternative treatments for limited populations based on the recommendation of Secretary
Antibiotics are inarguably one of the greatest advances in medical science of the past century. Although the first natural antibiotic Penicillin was not discovered until 1928 by Scottish biologist Alexander Flemming, evidence exists that certain plant and mold growths were used to treat infections in ancient Egypt, ancient India, and classical Greece (Forrest, 1982). In our modern world with the advent of synthetic chemistry synthetic antibiotics like Erithromycin and its derivative Azithromycin have been developed. Antibiotics have many uses including the treatment of bacterial and protozoan infection, in surgical operations and prophylactically to prevent the development of an infection. Through these applications, antibiotics have saved countless lives across the world and radically altered the field of medicine. Though a wonderful and potentially lifesaving tool, antibiotic use is not without its disadvantages. Mankind has perhaps been too lax in regulation and too liberal in application of antibiotics and growing antibiotic resistance is the price we must now pay. A recent study showed that perhaps 70% of bacterial infections acquired during hospital visits in the United States are resistant to at least one class of antibiotic (Leeb, 2004). Bacteria are not helpless and their genetic capabilities have allowed them to take advantage of society’s overuse of antibiotics, allowing them to develop
On July 10, the U.S. House of Representatives overwhelmingly passed a bipartisan bill that would speed the development of new medical devices and drugs, according to Modern Healthcare. The legislation, called the 21st Century Cures Act, passed by a vote of 344-77.
There is a continuing concern in the United States is bacterial resistance to antibiotics. The government continues to research and analyze the use of antibiotics in animals and humans. It is not a fact that the use of antibiotics in animals’ cause resistance in humans. Antibiotics are a necessity in the production of food animals therefore if they completely band antibiotics it would put animal welfare and food safety at a large risk. By implementing the VFD the government can assure people that farmers and ranchers are using antibiotics
Since the introduction of penicillin to the public in 1942, antibiotics have gained widespread use throughout the world. The drug has allowed society to make advancements in medicine, increase an individual’s personal well-being, extend life expectancies, and stop and prevent infections. Antibiotics are one of the largest backbones to maintaining personal health in society today, yet there may be a day when we are no longer able to depend on antibiotics to fight infections. In the essay “Imagining the post antibiotic future”, Maryn McKenna establishes the importance of antibiotics to juxtapose how devastating life would be without them.
I think both the government and hospitals have the responsibility to tracking this dangerous health problem and everyone has right for supporting the research for the new drug. This way we will have a better way to deal with antibiotic resistant. We will have an organize data and reports to know where the resistance is occurring like they do in
Throughout my life, adults have insisted the use of antibiotics to fight against the most inconsequential illnesses, whether it’s the cold or the flu. However, neither illness is due to invasion of bacteria. This misuse can lead to antibiotic resistance, also known as antimicrobial resistance(AMR), currently one of the central issues facing the public health system. While the process for antibiotic resistance occurs naturally through the process of adaptation, the mismanagement of antibiotic resources has accelerated the rate at which the bacteria adapt. The occurrence of this misinformation isn’t limited to a few adults: even some of my peers suggest taking antibiotics when faced with the flu. This leads to asking whether AMR is truly a problem and are present regulations enough to combat the issue.
In Cleveland Clinic, trained pharmacists could monitor patients’ labs and adjust medication dosages based on the lab under the consent. One of the medications was antibiotics, especially vancomycin. The center tried to expand the existed service to home care setting. Therefore, my preceptor and I were talking with the person in the legislative field.
Health-care associated infections (HAI), which individuals obtain while they are receiving healthcare for another condition, have been prevalent for many years in health care. These infections have led to the loss of tens of thousands of lives and have cost the U.S. health care system billions of dollars each year as they are a significant cause of illness and death (ODPHP, 2017). The Healthcare-associated infections Action Plan, developed by the US Department of Health and Human Services, was developed to provide a map for preventing HAIs in these health care facilities. The purpose of this paper is to discuss how the prevention of HAI provision of the ACA is intended to achieve higher value, synthesize evidence that the policy has
President Obama signed in a law, known as the 21st Century Cures Act, on December 13, 2016. The goal of the Cures Act is to decrease the administrative burdens, encourage innovation, and to enhance America’s healthcare field. Lobbying over this bill has been strong between the two political parties. Ultimately, there was bipartisan support for the bill. One part of this Act is aimed at speeding up research review and Institutional Review Board flexibility. To help avoid unnecessary duplications and delays, the Cures Act made it a requirement for the Department of Human Resources and the Food and Drug Administration to coordinate their human research regulations within three years of the law’s enactment. Early versions of the bill included
In the last decade, the number of prescriptions for antibiotics has increases. Even though, antibiotics are helpful, an excess amount of antibiotics can be dangerous. Quite often antibiotics are wrongly prescribed to cure viruses when they are meant to target bacteria. Antibiotics are a type of medicine that is prone to kill microorganisms, or bacteria. By examining the PBS documentary Hunting the Nightmare Bacteria and the article “U.S. government taps GlaxoSmithKline for New Antibiotics” by Ben Hirschler as well as a few other articles can help depict the problem that is of doctors prescribing antibiotics wrongly or excessively, which can led to becoming harmful to the body.
The bill seeks to increase access and improve quality to patients’ health by providing services that are consistent with pharmacists’ education, training, and license. If these services are more accessible and more affordable to patients, they will be able to be implemented into more pharmacies and therefore provide the pharmacists with the means to practice better patient care. The bill would specifically provide access to care for patients who are underserved and have limited access; these services would include prevention services that would minimize long-term healthcare costs for
The Food and Drug Administration has proposed and created several regulations throughout the years. One of them is the regulation to establish a list of qualifying pathogens that may have the potential to propose or cause a great threat. According to the FDA, this proposed rule would implement a provision of the Generating Antibiotic Incentives Now of the FDA. This regulation would assist in reassuring the development of new antibacterial and antifungal drugs. Before the development of new drugs, the FDA must take into consideration the effect on public health due to drug- resistant organisms in humans. The purpose of this paper will be to discuss and highlight what this regulation truly means and the issues surrounding it.
A couple times a year local and national mass media put the spotlight on problems connected to antibiotic overuse. Some people consider those problems to be real and serious, and others think that the discussed topics are nothing more than new “fashionable” subjects to talk about, distracting people from “real” problems, such as climbing gas prices or war expenses. Meanwhile, antibiotic overuse continues as a common practice among US doctors and agribusinesses for the last 20 years. The practice of antibiotic overuse has put patient’s health at risk, contributed to antibiotic resistance and increased bacterial mutation to a new, stronger level; as well as it hitting the economy with new costly expenses in health care. It is time to stop
According the World Health Organization (WHO), antibiotic resistance is one of the world’s greatest health threats to date (Haddox, 2013). In the article, The Health Threat of Antibiotic Resistance, Gail Haddox (2013) discusses the danger antibiotic resistance poses in today’s society and strategies to prevent the expansion of antibiotic resistance. In Europe alone, an estimated 25,000 deaths have been attributed to multi-resistant infections (Haddox, 2013). Common infections are now harder to treat due to the increased resistance to antibiotics across the world, in fact some are becoming untreatable. Antibiotics should be treated like oil, a non-renewable resource (Haddox, 2013).
The overuse of antibiotics has been a problem for well over a decade. This misuse leads to many nonvisible problems arising within the human population. As the use of antibiotics increases, the number of antibiotic resistant bacteria also increases. When bacteria become resistant to an antibiotic, another antibiotic must be used to try and kill it and the cycle becomes vicious. Michael Martin, Sapna Thottathil, and Thomas Newman stated that antimicrobial resistance is, “an increasingly serious threat to global public health that requires action across all government sectors and society” (2409).