For more than a decade America has struggled and continues to struggle with reducing and eventually eliminating drug shortages. According to the FDA, drug shortages are defined as a situation in which the total supply of all clinically interchangeable versions of FDA-regulated drugs is inadequate to meet current demand at the patient level. Consequently, throughout the years various stake and shareholders have experienced a roller coaster ride, some tremendously affected by high spikes of drug shortages, while others are fortunate that the numbers remain low. Unfortunately, drug shortages produce numerous barriers for manufactures, patients, doctors, investors, and the health care organizations. For example, manufacturers face the pressures …show more content…
In response to the tremendous increase of drug shortages in 2011, an executive order 13588 was constructed in order to prevent future prescription drug shortages. Soon followed by new policies and procedures implemented through the FDA, known as the Safety and Innovation Act, Strategic Plan to Mitigate Shortages, and the Final Rule created on July 8, 2015. Below will discuss a brief overview of each policy implemented by the FDA in the third annual reports to Congress.
FDA Policies and Procedures for Drug Shortages
Causes and Effect of Drug Shortages
Various factors play a part in why drug shortages occur, some instances are inevitable. For instance, when a natural disaster hits, protecting drugs, are equally important as protecting lives, which in many cases are impossible. In this event, thousands of drugs can be damaged and ruined. In addition, other shortages occur from the production from an offset of supply and demand, which accounts for an approximated 13% of
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Accordingly, death is a major concern, and has come as a consequence of the absence of appropriate drugs needed for treatment. Ventola (2011) reported, “Drug shortages can affect the ability of health care professionals to keep patients alive, particularly in emergency departments, intensive-care units, and oncology wards” (p. 751). Furthermore, multiple reported deaths have been associated to drug shortages. For this reason, alternative treatments are not an option for everyone, and can require days of hospital inpatient care, such as cancer patients who can’t receive chemotherapy. On the other hand, pharmacist and providers are working three times as hard to provide patients with alternative treatment methods that can be pricey. According to Fox (2014), “The economic effect can also be felt by patients when the formulary preferred agent on their managed care plan becomes unavailable and a more costly alternative must be prescribed” (Fox et al, p 365). Many alternative prescriptions are available due to the rationing of drugs. As a result, patients have an adequate measure to stabilize, and in some cases treat their condition. Lastly, safety risk is another health hazard that adversely affects patients and puts a strain on professional relationship. Alternatives are not always the best options, and in some cases cause significant damage. As reported by Ventola (2011), “A shortage often
Dr. John Abramson’s book Overdosed America debunks the myths about the excellence of American medicine. Abramson backs up this claim by closely examining research about medicine, closely examining the unpublished details submitted by drug manufacturers to the FDA, and discovering that the unpublished data does not coincide with the claims made about the safety and effectiveness of commonly used medicines. Abramsons purpose is to point out the flaws of the pharmaceutical industry in order to warn the readers about the credibility of the drugs they are buying. Given the critical yet technical language of the book, Abramson is writing to an audience that may include academic physicians as well as those who want to learn about the corruption of the pharmaceutical industry.
The Prescription for Disaster is written, directed, produced, and hosted by Gary Null. Gary Null received an associate’s degree in business administration. His alma mater is a Mountain State, a 2-year college. He later goes to Union Institute and University for his Ph.D. in human nutrition , but he still does not have enough education or experience to speak on medical drugs compared to others in this field. He offers valid issues in the pharmaceutical industry, but most of his complaints are exaggerated and generalized to all in the medical field. The extreme bias of the Prescription for Disaster puts the validity of this documentary into
In the recent years the drug industry underwent a significant transformation. Many of the big companies generate high revenues, which allow them to expand. Some of them expand on their own others through mergers and the buying of smaller companies.
In some instances, the pharmaceutical industry in the United States misleads both the public and medical professionals by participating in acts of both deceptive marketing practices and bribery, and therefore does not act within the best interests of the consumers. In America today, many people are in need of medical help. In fact,the Federal Trade Commission estimates that 75% of the population complain of physical problems (Federal Trade Commission 9). They complain, for example, of fatigue, colds, headaches, and countless other "ailments." When these symptoms strike, 65% purchase over-the-counter, or OTC, drugs.
The United States of America accounts for only 5% of the world’s population, yet as a nation, we devour over 50% of the world’s pharmaceutical medication and around 80% of the world’s prescription narcotics (American Addict). The increasing demand for prescription medication in America has evoked a national health crisis in which the government and big business benefit at the expense of the American public.
Doctors work under intense pressure, and if a pill could fix a patient’s problems than many saw nothing wrong with that. What exacerbated the problem was that many hospitals also changed their modus operandi with regards to treatment. In some hospitals, “doctors were told they could be sued if they did not treat pain aggressively, which meant with opiates (95). However once the patient became addicted and could no longer get their prescription legally refilled, the drug dealers saw their chance. What is surprising is the fact that pharmaceutical companies acted in the same manner as drug dealers. Both sides did not care about the end user, and the problems they would have to deal with after using what was given to them. Their motive was purely to profit as much as possible, and they did not care about who would get hurt as a result of their
and to issue recommendations for improvements. The committee was composed of 16 experts, including leaders in clinical medicinemedical research, economics, biostatistics, law, public policy, public health, and the allied health professions, as well as current and former executives from the pharmaceutical, hospital, and health insurance industries. The authors found major deficiencies in the current FDA system for ensuring the safety of drugs on the American market. Overall, the authors called for an increase in the regulatory powers, funding, and independence of the FDA. Some of the committee's recommendations have been incorporated into drafts of the PDUFA IV bill, which was signed into law in 2007.
In America, it has become a battle to earn a high paying job to cope with the expenses of a typical American. It has become even more of a battle for some people to afford medical prescriptions to keep healthy. Health becomes a crucial issue when discussed among people. No matter what, at one point or another, everyone is going to stand as a victim of the pharmaceutical industry. The bottom line is Americans are paying excessive amounts of money for medical prescriptions. Health-Care spending in the U.S. rose a stunning 9.3% in 2002, which is the greatest increase for the past eleven years. (Steele 46) Many pharmaceutical companies are robbing their clients by charging extreme rates for their products.
Third is performing reckonable accident errors that have been impaired on patients whereas the amount also was listed at $1.7 Million from 2008.Fourth the U.S. reckless spends about 100-200 billion a year in curing uninsured patients. Fifth, the most commonly talked about drug of all is tobacco, which amounts to about 96 billion. Healthcare not only does give patients the importance of everything but we also have technology along with so many life-enhancing benefits is ridiculously high and is way over the line. Which is why so many of our medical learners are not being trained enough to understand the importance of procuring and delivering prescription drugs that have cost about 1.3 billion dollars. The Question we should ask ourselves this how is it going to look when those are in need of a serious medical issue of having what’s required of them to take in order to ease their pain.
In the business of drug production over the years, there have been astronomical gains in the technology of pharmaceutical drugs. More and more drugs are being made for diseases and viruses each day, and there are many more drugs still undergoing research and testing. These "miracle" drugs are expensive, however, and many Americans cannot afford these prices.
"Reducing Demand for Drugs." UN General Assembly Special Session on the World Drug Problem. May 1998. Web. 02 Mar. 2011. .
When a drug does make it to market and is successful, companies need to make up for the money spent in development as well as the cost of drugs which did not make it to market. After all investments are taken care of, there is still the need for profit. Some are concerned that if the United States government implements control over prescription drug costs, then private firms will be less motivated to invest in pharmaceutical development, fearing they will not make their investment back. This would supply pharmaceutical companies with less finances for the research and development process. According to the information collected by Abbott and Vernon, a drop in the price of pharmaceuticals would result in significant loss in investment in research and development (Abbott and Vernon).
Many of the drugs on shortage are used on a day to day basis. Besides that, the amount of drugs on shortage have increased significantly over the years. On a nationwide survey, the majority of anesthesiologists confirmed at least one drug on shortage, and also reported that the substitute affected the patient more than the actual drug would have (“Grassroots Group Says Anesthesia Drug Shortage Caused by GPOs”). This means that patients would have longer recovery time, which lowers the number of surgeries that can be performed within a specific time period. The drug shortage has become so widespread that even the federal government is interested now. The fact that the federal government has gotten involved shows just how serious the issue has become. Between 2005 and 2010, the drug shortage has become so severe that it has almost tripled (“Drug Shortages Fact Sheet”). The majority of hospitals reported experiencing a drug shortage which affected the patients’ surgeries, cancer treatments and pain control. Examples of the drugs on shortage include propofol, which is a short-acting sedative, and succinylcholine, which is used in rapid sequence intubation. The drug propofol is ideally used in ambulatory situations (Rabinowitz). Another sh...
The rate of death due to prescription drug abuse in the U.S. has escalated 313 percent over the past decade. According to the Congressional Quarterly Transcription’s article "Rep. Joe Pitt Holds a Hearing on Prescription Drug Abuse," opioid prescription drugs were involved in 16,650 overdose-caused deaths in 2010, accounting for more deaths than from overdoses of heroin and cocaine. Prescribed drugs or painkillers sometimes "condemn a patient to lifelong addiction," according to Dr. Tom Frieden, director of the U.S. Centers for Disease Control and Prevention. This problem not only affects the lives of those who overdose but it affects the communities as well due to the convenience of being able to find these items in drug stores and such. Not to mention the fact that the doctors who prescribe these opioids often tend to misuse them as well. Abusing these prescribed drugs can “destroy dreams and abort great destinies," and end the possibility of the abuser to have a positive impact in the community.
Gandey, Allison. “New National Drug Control Policy Includes More Prescription Monitoring.” Medscape Today. Web MD, 7 May 2010. Web. 24 Jan. 2012. .