Luigi Sto Domingo
11/10/15
HCA 202
Drug Shortage Despite being an important part of our healthcare, the lack of access to vital medication should not become a common occurrence in any country, nevertheless, drug shortages have become a significant global issue. This can be best describe by a quote from Katherine Eban, in which she says that “imagine surgeons running out of anesthetic drugs, cancer patients who can't get lifesaving chemotherapy, and doctors scrambling for the most basic antibiotics.” This is even more troubling where in the U.S. and many other developed nations, where many of their healthcare providers and their patients have become even less accustomed to having access to routinely obtain necessary and life-saving medications.
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One of the reasons for these drug shortages can be factored by the unavailability of raw materials to produce these drug products. “In 2012, 67 % of US drug shortages were related to quality issues, which included manufacturing delays/capacity and manufacturing quality issues followed by product discontinuation and raw material issues. Similarly, in 2013, quality-related issues remained the most prominent reason for shortages.” These raw materials would have impurities, microbial contamination, and chemical instability that make them unusable to make these drugs; and if these drugs are uncovered after a finished drug product has already been distributed to pharmaceutical companies or customers, a product recall could occur if it is determined that the risk of having the drug in the market outweighs the benefits of the medication. This would lead to a shortage involuntarily at the expense of patient …show more content…
In addition, over 80 percent of are from foreign countries, making even harder to regulate quality control for these raw materials. An example would be “the market for Chinese active pharmaceutical ingredients (APIs) was reduced by nearly 50% in 2010, partly attributable to concerns over quality issues with Chinese APIs, exemplified by heparin contamination in 2008”( ). Another reason for the drug shortage is manufacturer issues, such as ceasing operations of producing a certain drug. Some factors that lead to this conclusion could be by discontinuing API due to investments required for new quality requirements imposed by FDA, diminishing demands for the product, cost-effectiveness, liability reasons, and desires to utilize their resources somewhere else. Furthermore, manufacturers are not obligated to inform FDA about their plans to discontinue their product, which leads to regulatory issues because manufacturers either routinely don’t provide any notice of an impending drug shortage or no estimate of the projected duration of the product. Without any advanced warning of any awaiting drug supply problems, the FDA cannot become engaged with the issue unless it is when a shortage begins to
In general the drug manufacturing industry is very risky. In order companies to stay in business they need to research and develop new products. Firstly companies need to develop new compounds, however only one on every ten thousand compounds becomes approved and it takes years to do this. Then only 3 out of 20 drugs make enough revenue to cover their development cost and only 1 out of every 3 drugs generates enough money to cover the costs of previously failed 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
More than often, American’s argue that if we have the technology to gain access to these “miracle meds”, then we should take advantage of it. To receive an opposing view, the National Institute of Drug Abuse asked teens around America why they think prescription drugs are overused, and the results were shocking; 62%: “Easy to get from parent's medicine cabinets”, 51%: “They are not illegal drugs”, 49%: “Can claim to have prescription if caught”, 43%: “They are cheap”, 35%: “Safer to use than illegal drugs”, 33%: “Less shame attached to using”, 32%: “Fewer side effects than street drugs”, 25%: “Can be used as study aids”, and 21%: “Parents don't care as much if caught”. I believe the major problem here isn’t the medication, but instead the fact that our nation is extremely uninformed on the “do’s and dont’s” of prescription medication. When “the United States is 5 percent of the world’s population and consumes 75 percent of the the world's prescription drugs” (CDC), there is a problem present, no matter the reason. Clearly, many critics believe the breathtaking amount of pills we consume in America is simply for the better good, but tend to forget the effects that are soon to follow.
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.
Pharmaceuticals are also located in a highly cyclical industry. Governments worldwide cut healthcare spending to revive public budgets and so companies like Johnson and Johnson cannot afford to become overextended with debt in the face of an inevitable downturn in the economy sales and profits.
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.
There are at least 700 companies in China that make drug products that will go to the U.S. The F.D.A. does not have enough manpower to conduct more than 20 inspections every year to see if they are certified to make the products or not. The director of a Pharmaceutical Company in China has guessed that half of the active medicinal ingredients sold in China are made by uncertified chemical companies. Many of these uncertified Chinese chemical manufacturers advertise ingredients in medicine. This is illegal as they are not certified to make medicine. They are qualified to make chemicals. One ingredient they advertise is diethylene glycol which is included in cough syrup, fever medication, injectable drugs, etc (Bogdanich et
Pharmacy is a booming field when it comes to medicine, but it certainly has controversial issues such as compounding drugs. While the practice of making drugs customized to a patient seems ethical, there are problems that come along with it. Drug compounding was the norm in the past, but over time consumers began to see issues with it. Drug compounding still occurs to this day because some patients do need medicine specifically tailored to their needs. Compounding has also been the focus of recent disasters, some of which occurred less than two years ago. Whatever side one may take on this issue, it is clear that compounding medicine will be a polarizing issue for years to come.
For a drug to get to market it must go through several stages of research and development (Abbott and Vernon). Starting with discovery research, preclinical testing on animals, three phases of clinical trials on humans, and finally FDA (Food and Drug Administration) approval (Abbott and Vernon). Out of several thousands of drugs only a few will make it to the FDA approval stage (Abbott and Vernon). Testing is a highly regulated, time consuming, and expensive process. From beginning to end the process can take fifteen years and less than one of five compounds will make it to market where it is still not guaranteed to succeed (Abbott and
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.
We are in a society where we take a pill for everything, i.e., to lose weight, to get rid of a headache. Whatever we need a pill for, it is there. In United States, the abuse of painkillers and other prescription drugs has reached epidemic levels and become one of the top causes of death every year. In 2010, more than 38,000 deaths were due to overdosing. These include drugs like methadone, oxydone, or morphine. Death rates from prescription drugs were highest among people from middle-aged groups.
It is also easy to see the American people’s infatuation with drugs by simply looking at our current number of prescriptions filled at pharmacies annually. An active data table hosted by The Henry J. Kaiser Family Foundation states that about four billion prescriptions are filled annually (Kaiser). This is enough prescriptions for every person in the country, children and adults, to have twelve each. Once a person is on a drug, it is often hailed as an immediate fix to the problem, but many don’t think or just don’t care about the long-term side effects it could hold.
Other companies cannot replicate the drug and therefore they are forced to either wait until the patent expires or they must find an alternative drug that carries out the same purpose.... ... middle of paper ... ... It is clear to see that there are many pros and cons to patents in the pharmaceutical industry.