Ashlee Phillips

English 1010
December 9, 2019
Working Annotated Bibliography

Introduction: Why are there so many drug shortages in the United States? Countless Americans
have been affected by drug shortages in the U.S. for more than a decade now. Patients must wait
patiently for shortages to end in hopes that what they need will start being produced again.
Something needs to be done to fix this.

AAFA. (2018, March). Allergy Facts and Figures. Retrieved December 2, 2019, from
https://www.aafa.org/allergy-facts/.

The article from The Asthma and Allergy Foundation of America, “Allergy Facts and
Figures”, written by the AAFA, was last updated March of 2018. The AAFA states countless
statistics and facts about different allergies and shows the effects of severe allergies. They show
that allergies are the 6th leading cause of chronic illnesses in the United States and that millions
of people experience allergies each year.

I included this article because the drug epinephrine (or an epipen), used for severe
allergies, is currently in a shortage. This is relevant to my topic because millions of people
develop allergies every year and are in need of epinephrine but they may not be able to receive it.
The audience for this article are those with allergies or who would like more information about
them. This article is credible because the AAFA is an organization that studies allergies and the
effects of them. This source relates closely with the sources that include cancer statistics and
sepsis statistics. All three of these articles have organizations that show different illnesses that
have medications experiencing a shortage.

CDC. (2016, August 23). Data & Reports. Retrieved December 2, 2019, from
https://www.cdc.gov/sepsis/datareports/index.html.

The article from the Centers for Disease Control and Prevention, “Data & Reports”,
written by the CDC, was last reviewed on August 23, 2016. The CDC includes reports that
discuss the data taken on the illness sepsis. The CDC states, “Each year, at least 1.7 million
adults in America develop sepsis” (2016). The CDC also states other statistics relating to the
death rate of sepsis.

I used this article because the illness sepsis requires the drug norepinephrine which is
currently in a shortage. The audience of the article is anyone looking for information about
sepsis. This article is credible to this audience because the Centers for Disease Control and
Prevention studies diseases like sepsis and reports statistics and data about illnesses. This report
relates to the topic of drug shortages because anyone who gets an infection has the possibility of
going septic and would be in need of norepinephrine.

FDA. (2019). FDA Drug Shortages. Retrieved December 4, 2019, from

https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm.

The article from The U.S. Food & Drug Administration, “FDA Drug Shortages”, written
by the FDA, is updated constantly with new drugs that are running low. The FDA uses this
report to show current and resolved drug shortages and discontinuations. The FDA reports at
least 150 drugs are in a shortage at any given time.

This source represents the point of view of all parties involved within drug shortages.
This report works with the manufacturers and helps pharmacists and patients be aware of what is
going on within the pharmaceutical industry. The audience for this report is mainly the
pharmacists who rely on medications to distribute to their patients. This report is very credible
for this specific audience and many others because the FDA is an extremely reliable organization
who works directly within the pharmaceutical industry.

Goldberger, M. J., Jensen, V., & Kimzey, L. M. (2002, August 1). FDA's role in responding to
drug shortages. Retrieved November 20, 2019, from
https://pdfs.semanticscholar.org/5c1d/eeee107574dd991c966991ecdb180e839eaf.pdf.

The article from the Am J Health-Syst Pharm--Vol 59 “FDA’s role in responding to drug
shortages” written by Mark J. Goldberg, Valerie Jensen, and Lorene M. Kimsey, was published
on August 1, 2002. In this article, Goldberg, Jensen, and Lorene discuss the many roles the FDA
plays within drug shortages. They explain the common causes of drug shortages, how drug
shortages can be resolved, and what future efforts have been put in place. They take a moment to
show the perspective of manufacturing companies and the reasons why drug shortages are
caused like manufacturing issues, lack of products, or lack of revenue gained from a product.
These authors also describe that the FDA focuses on which products have a potential of a
shortage and research how medically necessary they are. They report that the FDA has put future
efforts into place to hopefully stop shortages from occurring.

This article represents the viewpoint of the manufacturing companies. This source
supports the idea that drug shortages have been happening for years. This article was written 17
years ago and it claims that the FDA has made efforts to help stop drug shortages from
happening, but they are just as relevant, if not more relevant today. This article greatly uses the
rhetorical aspect of ethos. The authors constantly talk about the FDA and all of their
responsibilities and efforts.
The audience for this article are those looking for information about the FDA, especially
pertaining to drug shortages. This source is very credible to this audience and any other
audiences who are interested in learning information about the FDA. It is credible because the
authors are all drug shortage project managers and drug shortage coordinators for the FDA. I
agree with this source that there are many reasons why drug shortages happen. I disagree that the
FDA fully decides which products are medically necessary because important drugs are
unavailable to patients who require it. This source fits into the credibility of this debate about
drug shortages and why they are happening.

Gray, A., & Manasse, H. R. (2012, March 1). Shortages of medicines: a complex global
challenge. Retrieved November 8, 2019, from
https://www.scielosp.org/article/bwho/2012.v90n3/158-158/.

In the article from SciELO, “Shortages of Medicines: A Complex Global Challenge”,

written by Andy Gray and Henri R. Manasse Jr., was published on March 1, 2012. They discuss
the ongoing issue of drug shortages throughout the US. They bring to the reader’s attention that
this issue has been going on for more than a decade. Gray and Manasse explain the many
different underlying factors in these shortages; most being economic. For example, Gray and
Manasse talk about how pharmaceutical companies get to choose whether or not they want to
continue producing something and according to the FDA, they “cannot require firms to report the
reason for shortage or duration of the shortage or any other information about shortages”(2012).
The final thing that Gray and Manasse discuss is that in order to stop this “winner takes all” idea
and giving these firms so much power, a long term solution needs to be put into place.

This article represents the viewpoint of doctors, pharmacists and patients who have to
deal with companies that choose to stop producing generic drugs that are helpful and needed.
This specific source fully supports this debate of drug shortages because countless time it talks
about the amount of drug shortages throughout the United States and solutions that could
potentially help fix this problem. The rhetorical aspects that are important to consider in this
article are ethos and logos. These authors are office bearers of the International Pharmaceutical
Federation, making them very credible for this topic. 18 different resources are used throughout
this article where they quote pharmacists, organizations, and doctors who are constantly dealing
with these shortages.

The audience for this article are those within the health industry and those who can help
come up with solutions for this issue. The credibility these authors have majorly affects how
their audience will view this source. I fully agree with this source on how something needs to be
done and policies need to be changed to lessen the drug shortages that we have. Their viewpoint
of the suffering of patients and the stress put on doctors relates to countless other articles that
have been published in the past and are continuing to be published today.

McCullough, M. (2019, October 17). Shortage of vital children’s cancer drug stirs fear and
outrage. Philadelphia Inquirer, The (PA). Retrieved October 30, 2019, from
 http://search.ebscohost.com.libprox1.slcc.edu:2048/login.aspx?direct=true&db=n5h&AN
=2W62887452522&site=eds-live

The article from the Philadelphia Inquirer, “Shortage of Vital Children’s Cancer Drug
Stirs Fear and Outrage” written by Marie McCullough was published just 13 days ago.
McCullough brings to the reader’s attention that a specific chemotherapy drug for Acute
Lymphoblastic Leukemia, vincristine, is now only being produced by one company instead of
two. McCullough states that “Vincristine is used to treat 80% of the 19,000 children and
adolescents diagnosed with cancer each year”(2019). McCullough reports that without this drug,
countless cancer patients could lose their lives due to this shortage. Therefore, says McCullough,
this shortage is causing prices for this drug to go up and decisions of rationing are being put in
place. She talks about how the Children's Oncology Group's call to action for this problem is to
urge the childhood cancer community to advocate for solutions like creating a stockpile of
pediatric cancer drugs, or allowing the federal government to become a guaranteed, contracted
buyer.
The article shows more about the perspective or viewpoint of someone worried for the
patients and what will happen to them with a shortage of drugs. It is important to look at this
issue through this perspective because these patients, especially the children, are relying on these
pharmacists to save their lives. The only problem is, these pharmacists are not being given the
means to provide for their sick patients. Going along with this idea of saving lives shows a great
amount of Ethos. It is an important rhetorical appeal to consider because feelings of sympathy
causes many people to take action; whether that is signing a petition or donating money.

The audience in this article are those who either look at the Philadelphia Inquirer or who
are interested in topics pertaining to cancer. This source is extremely credible to parents who can
relate to having children who are sick and need help. Other audiences like the government or the
childhood cancer community could find this source very credible to this issue and what is truly
going on within the drug industry. I agree with this article and the idea that sick children need the
help of specific drugs and they are not getting them. This source greatly reveals what is going on
within the medical industry, especially with cancer patients who have Leukemia and why they
need this drug so badly.
 National Cancer Institute. (2018, April 27). Cancer Statistics. Retrieved December 6,
2019, from https://www.cancer.gov/about-cancer/understanding/statistics.

The article from The National Cancer Institute, “Cancer Statistics”, written by the NIH,
was last updated on April 27, 2018. The NIH discusses many different statistics throughout this
report. For example, they speak of statistics about the amount of people diagnosed, the survival
rate of many cancers, the percentage of deaths in the United States from cancer, and many more.
The NIH states, “Approximately 38.4% of men and women will be diagnosed with cancer at
some point during their lifetimes” (2018). The NIH includes statistics like these because cancer
is one of the leading causes of death throughout the entire world.

I used these statistics from this report because cancer is one of the many illnesses that
have medications running low or that have stopped being produced. The rhetorical aspect of this
article is purely logos. The entire report is fully information and statistics that are being stated.
The audience for this article are those looking for more information about cancer. This could be
someone who has been diagnosed with cancer, knows someone who has the illness, or anyone in
the general public who is curious. This report is credible for its specified audience because the
NIH is the National Cancer Institute who studies cancer and everything about it. The source fits
into my debate because it shows that anyone can be diagnosed with cancer. These drug shortages
should be concerning for healthy and sick people because anyone can get sick.

Rabin, R. C. (2019, October 29). U.S. Blames Drug Shortages on Low Prices and a 'Broken
Marketplace'. Retrieved November 22, 2019, from
https://www.nytimes.com/2019/10/29/health/drug-shortages-
generics.html?searchResultPosition=1.

The article from The New York Times, “U.S. Blames Drug Shortages on Low Prices and a
‘Broken Marketplace’”, written by Roni Carryn Rabin, was published on October 29, 2019.
Rabin discusses the many effects of chronic drug shortages. She talks about different drugs that
are in short supply like the chemotherapy drug vincristine, anesthesia, medication for septic
shock, and vaccines. Rabin points out the fact that the government has decided to not have as
much involvement within the medical industry. She also states that the government encourages
pharmacists to pay more for generic brands so the manufacturers will keep producing specific
drugs. She quotes Dr. Yoram Unguru, who treats children with cancer at the Herman and Walter
Samuelson Children’s Hospital at Sinai in Baltimore, “The government has previously stepped
into the marketplace to assist the ailing automotive industry...Why not do the same for our ailing
health care system, specifically the manner in which life-saving medications are manufactured
and distributed?” (2019). Rabin argues that critical drugs should have more focus and monitoring
and there should be more of a supply and demand atmosphere within the drug industry instead of
just focusing on revenue.
 This article represents the viewpoint of people being affected negatively by drug
shortages. This source supports this issue immensely because it discusses many different effects
of drugs being on low supply and what the government is truly doing. The rhetorical aspects that
are important to consider are mainly ethos and logos. The author proves herself to be very
credible by citing her sources and talking about multiple different perspectives instead of only
her own. Logos is used very effectively when she includes recent reports that have been recorded
and by quoting the words of an important doctor who treats cancer. Along with these, she also
uses and cites statistics that increase the rhetoric of this article.

The target audience for this article are those who read The New York Times and are
interested in the issues and problems that are affecting our society. This source is extremely
credible to this audience due to the fact that everything stated within this article supports the idea
that there is a problem and we need to find a solution. Other audiences would also find this
article credible because the data and examples used are very informative and give you a general
idea of the issue. This source caused me to ask questions like; Why is the government not as
involved within the pharmaceutical industry? and What long-term solutions can be put into place
to lessen drug shortages?

Conclusion: Based on all of these articles, I have concluded that within the pharmaceutical
industry, many things need to be addressed and fixed. Some insights I have gained while
studying these articles are that not just patients are affected by drug shortages. Parents,
pharmacists, and the manufacturers are all affected in some type of way. The perspectives I have
identified in this issue are those who are creating the drugs and those who need them. All of
these articles relate to the idea that drug shortages have been occurring for many years and some
progress has been made in stopping them, but not enough. Some additional information I have
found is about statistics of illnesses that have life-saving medications that are in shortages. This
is a life-threatening issue that needs to be solved.