Running Head: DRUG SHORTAGES

Drug Shortages: How They Affect Health Care and What Pharmacists Can Do to Help Prevent
Them and Improve Patient Care
Erin Dudolevitch
Northeastern University

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Abstract

The health care field is currently going through a drug shortage crisis. The number of shortages
has risen significantly in recent years, leading to decreased quality of patient care. While there is
a myriad of reasons for these shortages, many of them could be avoided with stricter laws and
regulations on drug manufacturing. Pharmaceutical companies are part of the health care field
and because of this they should be held to higher standards than other companies. They should
have an obligation to provide effective and affordable patient care. Instead they are typically only
concerned with making a large profit. On the other hand, pharmacists play an important role in
managing drug shortages, especially in hospitals. They are in charge on finding appropriate
treatment alternatives and helping set up a system for deciding which patients should qualify to
receive the drug on shortage and which patients should be given an alternative medication.
Overall, everyone in the health care field, including those in charge at drug manufacturers,
should be focused on helping patients receive quality care. Changes must be made to ensure the
number of drug shortages does not keep exponentially rising.

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Introduction

Currently, drug shortages are a major health crisis in the United States. Both the Food
and Drug Administration (FDA) and the American Society of Health-System Pharmacists
(ASHP) track these shortages. The way both of these organizations define a drug shortage,
however, differs slightly. According to ASHP, a drug shortage is a supply issue that affects how
the pharmacy prepares or dispenses a drug product or influences patient care when prescribers
must use an alternative agent (Ventola, 2011). The FDA, on the other hand, only considers a
drug on shortage if it is a product used to prevent or treat a serious or life-threatening disease or
medical condition for which there is no other available source with sufficient supply of that
product or alternative drug available (Ventola, 2011). Because of this difference in definition,
there is also a difference in the number of drug shortages reported. For instance in 2010, the FDA
reported 178 drug shortages, while the ASHP reported 211 (Hoffman, 2012). While the ASHP
reported number might be a more accurate representation of how patient care is truly affected,
the FDA reported number is the one that is most widely accepted.
Background
Historically, drug shortages have always been an issue. This is because there are some
elements of drug manufacturing that are beyond the industrys control (Ventola, 2011). For
example, if a hurricane hits and damages the building of a manufacturer, there is inevitably going
to be a temporary halt on production, ultimately leading to temporary shortages. Cases like this,
however, only make up a very small percentage of drug shortages and in recent years, the drug
shortage problem has become significantly worse. Between 2005 and 2010 the number of drugs
listed as on shortage almost tripled from 61 to 178 (Caulder, Mehta, Bookstaver, Soms, &
Stevenson, 2015). This is a growing epidemic that needs to quickly be addressed and corrected in

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the near future, as it has a major and negative impact on the treatment of patients across the
country.
Issues Leading to Drug Shortages
Drug shortages occur for a wide variety of reasons. According to a report put out by the
University of Utah Drug Information Service, manufacturing problems are the reason for 23% of
shortages, supply and demand changes represent 13% of shortages, 6% of shortages are due to
discontinuation of production by manufacturers, 3% result from the lack of availability of raw
materials, and an astounding 55% of shortages are for unknown reasons (Hoffman, 2012).
The lack of reported reason for more than half of all drug shortages is largely due to the
fact that, by law, the FDA is currently not authorized to require manufacturers to report an
explanation for drug shortages (Hoffman, 2012). This reporting must be done voluntarily,
making it difficult to get a full and accurate picture of why these shortages occur. This, in turn,
also makes it more difficult to predict when shortages will occur and what steps can be taken to
prevent them from happening.
Additionally, companies are only required to report a future potential drug shortage if
they are planning to stop manufacturing a drug that is single-sourced and considered a medical
necessity (Hoffman, 2012). If this is the case, the manufacturer is supposed to give the FDA a
notice at least six months in advance. However, this policy is heavily criticized due to a variety
of reasons. First, the term medical necessity is not defined. Because of this, it is left to the
manufacturers discretion to decide if a drug should be deemed medically necessary. This leads
to a very small percentage of shortages being reported ahead of time. Also, even if a company is
found to have not reported a shortage that required notification, there is no penalty (Hoffman,
2012). This is unacceptable because if a manufacturer knows a shortage is possible and does not

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give proper notification, the problem often becomes worse. The reason is that when one drug is
put on shortage, there are typically others that are turned to as replacement therapy. If the
manufacturers of these replacement therapies are not aware that there could potentially be an
increased demand for their product, they may not be prepared to keep up with the greater number
of orders. This could lead to an additional shortage of the replacement therapy, making it even
more difficult for patients to get the drugs and treatment they need. Health care professionals are
then often forced to find yet another reasonable and effective alternative. Without reformed laws
and policies for reporting both the reason for drug shortages and warnings of potential drug
shortages, it will continue to be difficult to prevent these shortages from happening.
The most common types of drugs on shortage are chemotherapy agents, anesthetics,
analgesics, cardiovascular agents, and anti-invectives (Schweitzer, 2013). This is in part due to
the nature in which these drugs are made. For example, the injectable forms of many generic
drugs are made in a complex manner, often using multiple intricate processes (Lipworth &
Kerridge, 2013). Because of this, there is a much higher probability of having quality control
issues compared to other, easier to make drugs. While this is an understandable issue,
manufacturers should be doing everything in their power to avoid these types of problems. When
manufacturers do enforce stricter policies, however, they often end up spending more money. In
turn, this typically leads to them wanting to lower costs in other ways, often by reducing their
inventory, outsourcing production, or even halting production of the drug altogether (Lipworth &
Kerridge, 2013). As a result, there are even more drug shortages. This seemingly endless cycle
points out the deeper issues involved in the drug manufacturing process.

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Ethical Issues in Drug Manufacturing

A drug manufacturers top priority should be creating effective and affordable drug
therapies for patients. Unfortunately, this is typically not the case in the United States.
Manufacturers in the drug industry are almost always looking for a way to profit. While it is
understandable to want to make up for the costs of creating drugs, greed should not be a factor in
the healthcare industry. Drug companies should not be allowed to function like other free market
systems. Drug manufacturers are part of the health care field. This area should be held to higher
standards than any other discipline. While it would not be easy to reform this field, it is
becoming increasingly necessary. Society has a moral obligation to make sure equal and quality
care is available to all patients. This cannot happen if pharmaceutical companies are continually
allowed to run their businesses however they want. Patient care will remain in a rapidly
deteriorating state and these companies will continue to gain more power. There needs to be
more laws and restrictions on how they are allowed to operate. The main concern of the health
care industry should be effectively treating patients, not making a significant profit.
How Pharmacists Deal With Drug Shortages
A major part of a pharmacists job is to make sure patients are getting quality care that is
appropriate for their medical condition. Drug shortages can make this a difficult task. In fact,
more than half of health care professionals believe that these shortages have negatively affected
patient care (Caulder et al,. 2015). When a drug for a life-threatening disease is on shortage, such
as a chemotherapy agent, difficult decisions must be made. According to the ASHP Guidelines
on Managing Drug Product Shortages in Hospitals and Health Systems, pharmacists need to
take a leadership role in efforts to develop and implement appropriate strategies and processes
for informing practitioners of shortages and ensuring the safe and effective use of therapeutic

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alternatives (Fox, Birt, James, Kokko, Salverson, & Soflin, 2009). Once a drug is identified as
on shortage, it is up to the pharmacy department to analyze the threat to patients and the cost that
will be associated with finding another appropriate therapy. When an appropriate alternative is
identified, they must communicate all relevant information with the rest of the hospitals clinical
staff. They must also communicate with other regional hospitals and health systems to make sure
all pharmacies are aware of the available alternatives and where they can be acquired. Next, the
pharmacists prioritize which patients will get the drug on shortage. These drugs are typically
reserved for patient groups where all available alternatives are undesirable. For help with this,
hospitals may turn to national organizations, such as the Center for Disease Control (CDC), for
guidance (Fox et al., 2009). To select the criteria for which patients get the drug, a
multidisciplinary team including pharmacists, physicians, nurses, and other medical personnel
should be established. Finally, the hospital pharmacy must try to avoid stockpiling the
medication. When this happens, it often leads to two major issues. It can make the shortage
worse, especially if it is only an anticipated shortage, by emptying the supply chain. Additionally,
increasing the inventory by too much can be costly and may lead to having more stock than can
reasonably be used, particularly if a shortage does not last for as long as originally anticipated
(Fox et al., 2009). In order to successfully deal with drug shortages, pharmacists must gather as
much information as possible, assess all options from both a therapeutic and financial standpoint,
and communicate with all health care providers and patients.
While it is important for pharmacist to know how to deal with drug shortages, it is a
waste of time and resources to have to constantly be looking for the most effective, both
therapeutically and financially, alternatives to drugs that could easily be fully stocked if

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pharmaceutical companies were more diligent and cared more about their patients than their
profit margins.
Conclusion
One of the most important issues health care is currently faced with is the rapidly
increasing number of drug shortages. These shortages negatively impact patient care and make it
difficult for pharmacists and other health care professionals to efficiently do their jobs. Too much
time is put into finding alternative treatments for important and necessary drugs. Laws and
policies need to be changed to make pharmaceutical companies more responsible for safely and
consistently making necessary medications. While some drug shortages are inevitable, there is
no reasonable explanation behind why the number has exponentially risen in recent years. Greed
should not be a factor in the health care industry. Drug manufacturers should not be allowed to
continually, barely meet the standards for safety. Repeated lack of proper quality control should
have major consequences, especially when these manufacturing errors lead to drug shortages.
Pharmaceutical companies also need to be more tightly controlled than other industries. As
important as it is to have a free market, it is more important to have safe, effective, and
affordable medications for those who need it. A major problem lies in the fact that these
companies value money more than peoples lives and laws and regulations need to be adjusted to
help fix this problem.

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References

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Fox, E., Birt, A., James, K., Kokko, H., Salverson, S., & Soflin, D. (2009). ASHP Guidelines on
Managing Drug Product Shortages in Hospitals and Health Systems. American Journal
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Health-System Pharmacy, 66, 1399-1406.

Hoffman, S. (2012). The Drugs Stop Here: A Public Health Framework to Address the Drug
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