Understanding
& Managing
Drug
Shortages
Proceedings of a
breakfast symposium
held during the 37th ASHP
Midyear Clinical Meeting
on Monday, December 9, 2002
in Atlanta, Georgia
Supported by an educational grant from
1
Understanding
& Managing
Drug
Shortages
Presented by
Linda S. Tyler, Pharm.D., FASHP
Pharmacy Manager, Drug Information Services
University of Utah Hospitals and Clinics
Salt Lake City, Utah
and Scott M. Mark, Pharm.D., M.S.
Director of Pharmacy
Children’s National Medical Center
Washington, D.C.
Learning Objectives
After studying this article, the reader should be able to:
1. Identify the current and emerging trends in drug shortages.
2. List 3 resources for obtaining up-to-date information on drug
shortages.
3. Describe the components of a successful communication strategy
within a health system for managing drug shortages.
4. Define the role of the pharmacist in managing drug shortages.
The American Society of Health-System Pharmacists is approved by
the Accreditation Council for Pharmacy Education as a provider of
continuing pharmaceutical education. The program provides 1.5 hours
(0.15 CEUs) of continuing education credit (program number 204-00003-417-H04). Official certificates of continuing education will be mailed to
attendees within six weeks. This program is provided free of charge. Pharmacists
may complete the CE test at the CE Testing Center on the ASHP web site
(www.ashp.org). The release date for the program is 11/15/03 and expiration
date is 11/15/05. Test code 03417.
Disclosure Statements
ASHP Advantage requires that faculty members disclose any relationships (e.g., shareholder,
recipient of research grant, consultant or member of an advisory committee) that the faculty
may have with commercial companies whose products or services may be mentioned in their
presentations. The existence of these relationships is provided for the information of attendees
and should not be assumed to have an adverse impact on faculty presentations. The faculty
reports the following relationships:
Linda S. Tyler, Pharm.D., FASHP: Dr. Tyler has no affiliations to disclose.
Scott M. Mark, Pharm.D., M.S.: Dr. Mark has no affiliations to disclose.
1. Minor editorial revisions made by Abbott Laboratories.
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Drug Shortages
Linda S. Tyler, Pharm.D., FASHP
Pharmacy Manager, Drug Information Services
University of Utah Hospitals and Clinics
Salt Lake City, Utah
Introduction
Drug shortages are a challenge for the health-care community, particularly since they typically
appear with little or no warning and significant resources may be needed to manage patients
when a particular therapy is in short supply.
Health care professionals define a drug shortage as a change in the drug supply that has the
potential to compromise patient care. Changes in drug supply can alter the way medications
are prepared in the pharmacy, the way they are administered to patients, and, in some cases,
whether patients receive medications at all. When faced with a drug shortage, the ultimate goal
is to avoid the situation in which the patient is told that the drug of choice is not available due
to a shortage.
In this article, Linda S. Tyler, Pharm. D., FASHP will identify current and emerging trends in
drug shortages, describe common reasons why shortages occur, and compare available resources
for obtaining information on drug shortages.
Drug Shortages:
A Problem on the Rise
Dr. Tyler can vividly remember the first drug
shortage she encountered. The pharmacy was
down to a one-week supply of vincristine, even
though the department had tried to get the drug
for six weeks. It got to the point that the department finally had to ask the physicians on staff, a
tough question. “Do we ration what [vincristine]
we have, or do we use it until it’s gone?” The
problem was eventually solved, but Tyler learned
a couple of important lessons from the experience. First, prescribers are more constructive and
cooperative if they are involved in the process,
and second, information regarding the shortage
needs to be disseminated to those who will be
impacted by it as soon as possible.
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Dr. Tyler has become accustomed to
managing drug shortages because there has been
a sharp rise in them over the past few years. Dr.
Tyler shared data collected at The University of
Utah Drug Information Center (UUDIC), and
compared it with national data collected over the
last five years.1 When data collection began in
1996, there were less than 5 drug shortages a year
both nationally and at UUDIC. Between 1997 and
2000, that number crept up to 20 shortages per
year both nationally and at UUDIC.
It should come as no surprise that drug
shortages are expensive. Tyler said her department devoted significant personnel and financial
resources to identifying, tracking and resolving
supply problems. She estimated that many
organizations spend between one-half and three
Understanding and Managing Drug Shortages
■
1
full-time equivalent (FTE) personnel on the
management of drug shortages. These extra FTEs
spend their time investigating the reason for the
shortage, finding alternative agents, working with
wholesalers, finding alternative suppliers,
compounding a replacement product internally,
or communicating with other practitioners. Tyler
said the process could be expedited by involving
other practitioners (i.e., physicians, pharmacists,
nurses) in the decision-making process at the
earliest possible moment. She’s had success with
disseminating information about specific
shortages via a written memorandum to all
affected parties. Not only is a memorandum an
effective communication vehicle, but it also can
be used as a written record of shortages that have
had an impact on the institution. Dr. Tyler
attributes the pharmacy department’s proactive,
problem-solving skills with their success in
managing shortages and preventing the shortages
from having a negative effect on patient care.
Why Drug Shortages Occur
The process of delivering medications to patients
is much more complex than most people realize,
especially patients. By understanding barriers in
the medication supply process, health-care
practitioners can more effectively use the limited
available resources to communicate with each
other as well as with patients. In December of
2001, the Healthcare Distribution Management
Association reported a 23% back-order situation
in the supply of medications.1 For example, for a
facility that orders 300-500 items a day, such as
the University of Utah Hospital (UUH), this
means that approximately 50-100 items will not
be delivered each day. Although back-orders
typically do not result in shortages, it is evident
that good purchasing policies are an important
part of monitoring drug shortages.
Drug shortages are multi-factorial, and
rarely is it possible to pinpoint an exact cause.
Tyler explained how industry consolidations and
supply chain issues can result in shortages.
Some of the factors influencing drug supply
are predictable, while others are not. Following is
a list and explanation of some of the unpredictable factors that can result in shortages:
2
■
Understanding and Managing Drug Shortages
■
Natural Disasters. Natural disasters may
cause a shortage by affecting the plants
involved in the sole production of a product
and inflicting unexpected damage to manufacturing facilities (e.g., hurricanes in the
Caribbean).
■ Raw Materials. Raw material shortages may
have a profound impact on drug supply. This
is especially true when multiple manufacturers are producing a drug product from which
there is only one source of raw materials.
Problems can also arise when the raw
materials are difficult to process (e.g., the raw
material must be extracted from a natural
source, such as tree bark).
■ Non-compliance with Regulatory Standards. Shortages can occur when the primary
or sole manufacturer of a product has its
production halted by the Food and Drug
Administration (FDA) for reasons such as not
adhering with Good Manufacturing Practices
(GMPs).
■ Voluntary Recalls. A recall may create
shortages, particularly when one company
manufactures the majority of a product.
Complying with voluntary recalls can create
ethical dilemmas as well because doing so
may result in a shortage.
Following is a list of predictable factors:
■ Manufacturer Rationing. Occasionally,
manufacturers will temporarily or permanently reduce production of products as they
shift production or re-allocate resources.
■ Restricted Distribution. Post marketing
surveillance programs can yield drug
information that encourages the manufacturer to limit supplies to select patient
populations for which the benefits of the
product outweigh the risks.
■ Manufacturer Discontinuation. A manufacturer might stop production of a drug
product because of lack of financial return,
poor demand, or potential safety concerns.
When this happens, the FDA will perform a
medical necessity evaluation. In addition, the
National Organization for Rare Disorders
(www.rarediseases.org) will work to find
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■
■
■
■
■
another company to manufacture the product
in order to protect those patients that rely on
or need the medication.
Industry Consolidations. Company mergers
may result in decisions to discontinue
products and narrow the focus of the product
line. A subsequent reduction in suppliers can
make a particular marketplace vulnerable to
shortages, should other factors come into play.
Market shifts. Sometimes, the addition of a
generic product to the market may precipitate
a decrease in the manufacturing of the
innovator product and create a temporary
reduction in the supply of a particular
medication. Military conflict may also create
unexpected market shifts. For example,
during the Desert Storm conflict, large
quantities of albumin were diverted overseas,
which significantly diminished the supply in
the United States.2
Unexpected Demand. Occasionally demand
for a product can far exceed the existing
production capacity as can happen when new
unlabeled uses, clinical practices, disease
outbreaks (e.g., anthrax disaster), changes in
a product form or formulation (e.g., sustained
release), or other unpredictable increases in
demand occur. Such shifts in demand may be
further complicated when the manufacturing
process for the product is time consuming or
raw materials needed to produce it are limited
(e.g., blood-based products).
“Grey” Market Vendors. The profitability of
pharmaceuticals attracts vendors who create
artificial shortages by selectively purchasing
excessive quantities of products and thereby
depleting the available stock. These vendors
then re-sell the products back to the users at
inflated prices.
Prime Vendors and Just-in-Time Inventories. The increased use of prime vendors may
have contributed to the drug shortage
situation by reducing the amount of product
available in the supply chain. It is no longer
easy to weather shortages by relying on
stockpiled inventories because both wholesalers and health systems maintain minimum
levels of stock. As a result, manufacturer
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Figure 1. Drug shortages at UUH by therapeutic
categories.
Other 28%
Antibiotics 17%
Autonomic 11%
CV
7%
Vaccines
11%
CNS
15%
Hormones
11%
Source: UUH Drug Information Center.
supply issues are transmitted directly to the
user without the benefit of an inventory
buffer, thereby increasing the number of
short-term shortages that may impact
institutions.
Reasons often given for shortages include
regulatory issues (7%), product discontinuation
(20%), raw materials issues (8%), manufacturing
problems (28%), and supply and demand
problems (10%).1 Interestingly, Tyler noted that
approximately 27% of shortages are unexplained.
Drug companies may sometimes be reluctant to
reveal the details of a shortage because of public
relation, legal, and problem-solving issues. Tyler
said that even though the exact reasons for
shortages may not be known, it is important to
investigate the general circumstances behind a
shortage as part of the assessment and planning
process. For example, knowing that a change in the
supply is secondary to a raw material shortage is a
sign that the shortage will likely be lengthy.
A breakdown of drug shortages at UUH by
therapeutic category was provided (Figure 1).
Tyler said that this information will vary among
institutions because of differences in prescribing
patterns and patient populations. However,
knowing which therapeutic categories of drugs
have been in short supply can provide good
insight into those departments within the
institution that should have a vested interest in
working with the pharmacy to manage a
particular shortage. Interestingly, 70-80% of the
Understanding and Managing Drug Shortages
■
3
Duration (days)
Figure 2. Duration of Shortages at UUH
drugs in short supply nationally have been
parenteral drugs.1 Part of this may have to 140
do with the disproportionate amount of
59%
67%
120
oral drugs in the supply chain and the
% resolved
greater time required to produce inject100
able products. However, it also means that
80
drug shortages are more of an issue for
25%
hospitals and acute care settings than they 60
are in community pharmacy practice.
29%
40
It has been difficult to assess how
Unresolved
long shortages last. Shortages that reach
20
the hospital and patient-care level are
0
often of prolonged duration. Figure 2
Resolved
2001
2001
2002
2002
summarizes some information on
(7/02)
(7/02)
(10/02)
(10/02)
duration of shortages. Of the 120 shortSource: UUH Drug Information Center.
ages identified in 2001, 59% were resolved
by July 2002 and 67% by October 2002.
When calling the manufacturing company,
Tyler
explained that setting reasonable expectations
Unfortunately, institutions do not get a lot of
about
what you hope to learn is key. Getting to
support from outside organizations in managing
the
source
of the problem can be a challenge
shortages. The Food and Drug Administration
because
many
companies do not have a central
has limited authority with respect to shortages
contact
point
for
shortages. Often, the caller is
and only becomes involved if a medication is
sent
to
the
customer
service group. Often the
deemed medically necessary. Professional
person
taking
the
call
is
not aware of the shortage,
organizations and associations often learn of a
does
not
have
an
official
statement, and cannot
problem from their members, which means they
provide
a
timeline
for
resolution.
Tyler has found
do not get involved until late in the game. Drug
that
asking
companies
specific
questions
yields
manufacturers may send letters notifying
the
most
useful
information.
For
example,
asking
practitioners of drug shortages, but these letters
the
company
to
quantify
the
duration
of
the
seldom arrive before the pharmacy is faced with
shortage in days, weeks, or months can often
managing a particular shortage.
Because there is no advance warning system yield more useful information than asking what
date the product will become available. Tyler also
and formulating an effective management plan
takes time, pharmacy practitioners have had to
implement their own systems to proactively
identify drug shortages. Successful outcomes can
be achieved when the shortage is identified in
advance, there is time to notify other practitioners and gather information about the shortage,
and options for preventing adverse effects on
patient care can be investigated.
Resources for Managing Drug
Shortages
Three of the main resources are currently
available for assistance with drug shortages: the
manufacturing company, the Food and Drug
Administration web site, and the American
Society of Health-System Pharmacists.
4
■
Understanding and Managing Drug Shortages
Figure 3. Food and Drug Administration’s Web Site
(www.fda.gov/cder/drug/shortages/default.htm)
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Figure 4. American Society of Health-System
Pharmacist’s Web Site (www.ashp.org/shortage)
Figure 5. Example of Drug Shortage Bulletin on ASHP’s
Web Site
recommends following-up on a regular basis to
find out if new information is available.
Another source is the Food and Drug
Administration’s web site (www.fda.gov/cder/
drug/shortages/default.htm). The site contains
information about current and resolved drug
shortages as well as information about drugs that
are going to be discontinued (Figure 3). The site
lists drugs that are in short supply, but does not
provide any clinical information about how to deal
with a particular shortage. FDA breaks shortage
information into two categories: drugs and biologics. The FDA shortages web page just deals with
drugs. It is important to also check the biologics
section for information on biologics shortages.
ASHP has devoted significant resources to
the management of drug shortages and has
developed several policy positions on the subject.
In addition, the University of Utah Drug Information Center, Novation and ASHP partnered to
create Drug Product Shortage Bulletins, which
are available on the ASHP web site at
www.ashp.org/shortage (Figure 4). The bulletins
provide information about drug product
shortages, implications for patient care, alternative therapies and management, and estimated
re-supply dates, when available. A sample
bulletin is shown in Figure 5.
Pharmacists can also report shortages that
have not already been posted on the site. Tyler
encouraged practitioners to report shortages,
even if they think they may be limited to a
particular region of the country. Future enhancements to the site include search features, which
will allow visitors to search for drugs by date of
last update, trade name, or generic name.
Conclusion
Drug shortages are a concern to pharmacists and
managing them requires significant resources.
Key elements to a successful program for
managing drug shortages include a good
understanding of the reasons behind the
shortages, a proven system for involving the
entire health care organization quickly, and clear
channels for communicating information and
plans with all those involved, especially patients,
when necessary.
References
1. Fox ER, Tyler LS. Managing drug shortages: seven years’ experience at one health system.
Am J Health-Syst Pharm. 2003; 60: 245–53.
2. American Society of Health-System Pharmacists. ASHP guidelines on managing drug product
shortages. Am J Health-Syst Pharm. 2001; 58:1445–50.
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Understanding and Managing Drug Shortages
■
5
Understanding and Managing
Challenges Posed by
Drug Shortages
Scott M. Mark, Pharm.D., M.S.
Director of Pharmacy
Children’s National Medical Center
Washington, D.C.
Introduction
Now more than ever, drug product shortages are posing challenges to pharmacy operations.
As a result, pharmacists are being called upon to establish proactive processes for preventing,
identifying, assessing, and enduring shortages without compromising patient care. When a
shortage occurs, pharmacists are challenged to provide equivalent drug therapy at a comparable cost. Product supply issues are particularly complex in the medical field because of the
large number of monotherapies and mono-products available. Not only can drug shortages
increase cost and delay patient care, but they can also prevent patients from receiving the
medications on which they need and rely.
Drug shortages have always been a way of life in health care, but recent increases in the
frequency and duration of shortages have forced health care professionals and manufacturers to
devote significant resources to resolving them. Said Dr. Mark, “Every health system needs to
develop a preparation strategy and awareness campaign for managing shortage issues that goes
beyond the pharmacy.”
Drug shortages have been receiving more attention lately because they are having a bigger
impact on patient care. In the past, when an institution ran out of a medication, it could borrow
it from another hospital or work through alternate vendors. Rarely was an institution unable to
provide the medication at all. However, today it is becoming more common for practitioners to
come up empty, leaving them in the uncomfortable position of having to inform other health
care professionals and patients that a particular drug therapy is not available.
In this article, Dr. Mark lists factors that can affect the supply and distribution of drugs, explain
how stockpiling can contribute to the prolongation of a shortage, and explain how careful
assessment and communications can assist in the successful management of a shortage.
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Understanding and Managing Drug Shortages
■
7
Effects of Manufacturing
Companies on Shortages
While the increased frequency and longer
duration of shortages are burdensome to the
health-care community, the problems are often
magnified by the absence of advanced warning
from the pharmaceutical industry. The industry
is not currently required to communicate the
availability of products. According to the Food
and Drug Administration (FDA), a manufacturer
is only required to provide advance notice of
plans to discontinue a medication if the manufacturer is the sole producer of a medication (i.e.,
it manufactures 100% of the product on the
market). Mark voiced his position from a
practitioner’s perspective, and said that despite
not being required to notify health care practitioners and patients of impending shortages, he
thinks that companies ought to communicate
such information. In fact, this issue is being
addressed through discussion among practitioners, manufacturers, and the FDA.
Mark is most frustrated by shortages driven
by a manufacturer’s bottom line. For example, a
company may decide to discontinue one product
in favor of another that has a better margin.
Manufacturers are typically most familiar with
market share and alternate therapies for a
particular product, and it would be helpful if the
healthcare community received advance notice of
corporate decisions affecting the drug supply. Not
only is it important to notify health-care practitioners, but it is also essential that manufacturers
inform their competitors as well. By giving
advance warning, a competitor would have
sufficient time to increase production in order to
meet potential increases in product demand.
With the public so focused on health care,
particularly its rising costs, Mark thinks it would
behoove the industry to keep the best interest of
patients at the forefront.
Mark conceded that it would be impossible
for pharmaceutical manufacturers to provide
advance notice of every single shortage, because
of the nature of certain shortages (e.g., lack of
raw materials). Given the proper information and
warnings, health care providers are reasonable
8
■
Understanding and Managing Drug Shortages
and will work with manufactures whose production is limited because of a shortage of raw
material or natural disasters. However, Mark’s
opinion is that many of the shortages occurring
during the last 10 years were within the
manufacturer’s control. As a result, manufacturers have faced animosity from practitioners and
patients, and the press and legislators have a
heightened level of interest on shortages.
As partners in health care, manufacturers
have equal responsibility to patients for ensuring
continuity of care as do health care professionals.
Organizations such as the Health Industry Group
Purchasing Association, The Pharmaceutical
Research and Manufacturers of America
(PhRMA), and Congress have begun to focus on
the responsibilities to patient care. The prevailing
perception in Congress is that the pharmaceutical industry is profit driven, and this is an area
that the industry appears to be doing whatever
possible to sway Congress and the public against
viewing it as primarily a profit-driven business.
Stockpiling
Stockpiling is one of the inherent problems that
occurs when a drug is in short supply. Stockpiling
is the practice of purchasing more product than
would typically be required to fulfill an
institution’s anticipated monthly needs. Stockpiling can actually prolong a drug shortage because
it creates an artificial shortfall by depleting the
available product in the supply chain. Mark
recommended that institutions purchase
sufficient amounts of products to meet their
needs. However, he recognized that the fear of
paying non-contract prices for medications as
well as pressure from administrators and
clinicians within the institution may often
motivate people to buy more product than
they need.
Distribution
One lesson learned from recent shortages is that
larger institutions have an advantage over
smaller institutions with respect to product
availability. The advantage is not only in terms of
learning about shortages sooner, but also in
terms of product distribution.
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Often, large institutions are the last to feel
the impact of a shortage, but the first to receive
shipments when supplies become more plentiful.
A similar trend has been observed across larger
geographic regions. Mark said that drug shortages
rarely affect the health-care industry in a uniform
fashion, and recommended networking as one
solution to addressing imbalances in drug supplies.
Food and Drug Administration’s Web Site.
The FDA’s web site (www.fda.gov/drug/shortages/
default.htm) allows the user to sign up for a push
news service. By signing up for the service, users
receive information about drug shortages via email, can get contact information for manufacturers, as well as get copies of letters
sent to physicians regarding shortages.
Profiteers and the Grey Market
Centers for Disease Control and Prevention
Web Site. The CDC’s web site (www.cdc.gov) is a
good source of information regarding vaccine
shortages and recommendations for modifying
immunization schedules. When a shortage of a
vaccine occurs, health-care practitioners need to
contact patient families and inform them of any
changes that may need to be made in the
immunization schedule. Being proactive goes a
long way to restoring patients’ confidence.
Dr. Mark recalled a situation that occurred at
the Children’s National Medical Center, which
illustrated the importance of good information
and networking. Two years ago the Children’s
National Medical Center experienced a shortage
of influenza vaccine. Explaining the shortage to
the parents of the children was difficult, but the
situation was made worse because a local
pharmacy chain was hosting free vaccination
clinics. In addition many of the larger institutions
in the area were vaccinating their employees.
When fentanyl was in short supply, the staff at
Children’s National Medical Center researched
the shortage and networked and found sources of
the drug well before it became available through
their wholesaler.
The grey market is another problem resulting
from drug shortages that frustrates wholesalers,
practitioners, manufactures, and patients. When
a drug is in short supply, health care institutions
will frequently receive offers to purchase it from
secondary suppliers at inflated prices. Congress is
investigating how these suppliers learn about
shortages before most providers to determine if
they might be purposely contributing to and/or
prolonging shortages to increase their profits.
Resources for Managing
Shortages
Mark explained how pharmacists can prepare for
shortages and highlighted several resources they
can tap for help. These are described below:
Information and Networking. Getting good
information and maintaining a strong network
are two of the best ways to minimize the impact
of a drug shortage. Product buyers should
investigate existing and potential shortages on a
daily basis, they should routinely review information on listservs, network with other buyers,
and maintain contact with wholesalers. When
pharmacists find out about a shortage, they
should be sure to get information about the
reason for it.
American Society of Health-System Pharmacists. The American Society of Health-System
Pharmacists (ASHP) is a good source of information. Their web site (www.ashp.org/shortage)
includes information about drug product
availability, information about alternative agents
and the respective references, links to other
resources, and a mechanism for reporting an
emerging drug shortage. ASHP has developed
Guidelines for Managing Product Shortages, and
these are also included on the site.
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Tips for Managing a Drug
Shortage
Dr. Mark gave an overview of things health-care
practitioners to prepare for and manage drug
shortages. Descriptions of these recommendations follow:
Develop Policies and Teams. Policies within a
hospital that identify which governing body can
mandate practice changes across medical
disciplines need to be developed. It is also
important to determine how communication and
medical education will be managed. Mark
recommended that such policies be medical
Understanding and Managing Drug Shortages
■
9
policies rather than pharmacy department
policies in order to get the support of the
institution and deflect attention from the
pharmacy.
Forming ad hoc committees can aid in
assessing the potential impact of a shortage,
approving alternatives, prioritizing patients, and
rallying support within the institution. Such
committees can be stand-alone committees or
subcommittees of the pharmacy and therapeutics committee. Mark recommended giving
anesthesia, pediatrics, and emergency medicine
departments prominent representation on these
committees because of the disproportional effect
drug shortages tend to have on these disciplines.
individual should be available and prepared to
provide accurate, timely, and consistent information to practitioners who have questions.
The drug shortage coordinator should be
charged with managing all information and
products related to shortages and communicating to staff information related to supply, policy,
alternative products, and decisions made by the
institution. Mark said that during an intravenous
immunoglobulin (IVIG) shortage physicians
worked closely with the drug shortage coordinator to verify product availability, ensuring that
the appropriate amount of product was set aside
so that patients could receive their course of
therapy.
Educate the Staff. When a drug shortage results
in the use of an alternative product, health care
professionals and patients need to be educated
about any differences between the unavailable
product and the alternative product. If not
properly educated, patient care can be compromised because of medication errors. Examples of
the types of errors that can be made include
prescribing errors, dispensing and/or selection
errors (particularly with automated machines),
compliance errors (e.g., patients have to change
the way they take medications), and preparation
errors (e.g., pharmacy personnel must adapt to
new preparation procedures).
Mark, who is affiliated with a pediatric
hospital, said practitioners at his institution are
particularly sensitive to the potential for errors,
because so many of the drugs they use are dosed
according to patient weight. Mark said his facility
relies heavily on education when a new product
is introduced. The pharmacy department also
minimizes to the extent possible variation in vial
sizes and concentrations, and avoids purchasing
products that look alike.
Developing Long- and ShortTerm Strategies
Communicate. Communication is the key to
surviving any medication shortage. Mark said
that the top priority during a shortage is to
establish and maximize communication channels. Staff must get up-to-the minute information
about the problem, proposed solutions, and
progress. Mark recommended designating
someone in the department (e.g., a drug shortage
coordinator) as the primary contact. This
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Understanding and Managing Drug Shortages
Both long- and short-term strategies need to be
developed to deal with shortages effectively.
Short-term Strategies. Finding out how long a
shortage may last needs to be determined early
in the process. Mark said to start with the
manufacturers, even if you may not get a
definitive answer. As was discussed in the
previous article, finding out the cause of the
shortage can often provide clues about its
duration. Wholesalers should also be contacted
to determine if the supply chain is sufficient to
withstand the shortage.
Mark said that, in some cases, through the
course of investigating a shortage he will
determine that no such shortage exists. Mark
said some wholesalers will report that the
“manufacturer is unable to supply” a product,
but the problem may be the result of a temporary outage at the wholesaler, a contract dispute,
or outstanding invoices. Mark recommended
including language in wholesaler contracts that
impose penalties for drug outages. He also
advised pharmacists to contact the manufacturer
directly to confirm the outage and to compare
wholesaler “stock-outs” with other institutions.
After a shortage has been confirmed, a comprehensive evaluation of how the drug shortages
will affect patient care should be conducted (i.e.,
a threat analysis). A threat analysis takes into
account factors such as prescribing trends,
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clinical pathways, or protocols involving the
medication, the location of the medication within
the institution, and other data to determine
which patients are likely to suffer most, which
medical services are at greatest risk, and how
long the existing medication supply will last.
Internal medication supplies should be
sequestered for more effective management,
which means locating all of the medications
within your health-system. If the institution
employs automated dispensing cabinets, a
“hospital wide summary” report can be used to
locate the drugs. Code carts should be searched
and pharmacists should be on the lookout for
medications with short expiration dates that may
have been pulled prematurely.
Mark suggested working with the
institution’s Information Technology department
to streamline data and create customized reports.
Long-term Strategies. If the short-term
assessment determines that a drug shortage
exists, the next step is to formulate a long-term
strategy aimed at protecting the interests of
patients. All the options should be evaluated,
including alternative therapies, contract compounding, priority-driven dispensing, and
rationing. These strategies should be re-evaluated regularly because circumstances will likely
change during the shortage.
Determining which alternative therapies to
use during a shortage can be difficult, especially
if the alternative is not equally effective for all of
the indications for which the drug in short supply
would have been used. Mark recommended
contacting regional and local drug information
centers for assistance in assembling a list of
alternatives and the supporting literature. The
University of Utah provides alternative therapy
guides for the Drug Shortage Bulletins posted on
ASHP’s web site, but this information might be
available more quickly through a local or regional
drug information center.
Mark said other good sources of information
include the manufacturer, in-house clinical staff,
and the ad hoc committees. Pathway committees
and regional protocol groups can also be a good
source of information if it becomes necessary to
modify the institution’s pathways and protocols.
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Some pharmacies use contract-compounding firms to provide substitutions for medications that are in short supply. In addition, Mark
said there have been reports that groups within
some health systems have ordered compounded
formulations without knowledge or oversight of
the pharmacy department. Staff need to be
reminded periodically on the institution’s
policies regarding how drugs are ordered and
received. Although out-sourcing compounding
has been a viable option for some pharmacies,
Mark emphasized the substantial risks assumed
by pharmacies that use these services.
Formulations for compounding are typically
not reviewed by the FDA, which means FDA has
no control over the quality and consistency of the
preparation process used. The potential dangers
were illustrated last when three patients in
California died last year from bacterial meningitis that they contracted from contaminated
betamethasone that had been purchased from a
compounding pharmacy.1 Mark said that any
facility that uses contract compounding services
should consult with its Investigational Review
Board (IRB) who can provide assistance in
informed consent with respect to educating
patients about associated risks.
Both, ASHP and the Joint Commission on
Accreditation of Health Care Organizations
(JCAHO) have guidelines and requirements on
the matter. According to ASHP’s Guidelines on
Outsourcing Pharmaceutical Services, “an
organization’s pharmacy director must take
complete responsibility for patient outcomes for
all medication-related activities performed at or
for the organization.”2 Pharmacy directors are
also responsible for any preparations obtained
from outside pharmacies and have the right to
monitor the quality of medications used in a
hospital. This responsibility, according to ASHP,
should be explicitly stated in all outsourcing
contracts.
The JCAHO requirement is more specific.
According to JCAHO’s Standard L.D.3.50,3
services provided by consultation, contractual
arrangements, or other agreements must be
provided safely and effectively. The elements of
performance also state that leaders approve
sources for the organization’s services that are
Understanding and Managing Drug Shortages
■
11
provided by consultation, contractual arrangements or other agreements.3 The organization
also retains overall responsibility and authority
for services furnished under a contract.3 Mark’s
advice was that it is much better to use an
alternative therapy than a potentially bad-quality
product.
During a severe shortage it is sometimes
necessary to prioritize patients to ensure that the
available medication is dispensed appropriately.
Patient prioritization is one of the most challenging parts of managing a drug shortage. Patients
can be prioritized based on diseases for which an
alternative therapy is available, the acuity of their
condition, or whether the patients have already
received therapy with the drug in short supply.
Mark said it is critical to involve the public
relations and legal departments in the
prioritization process. It is important to keep in
mind that no matter how the prioritization is
performed, the potential for patients to disagree
with methods and take legal action exists.
Knowing when to release supplies is also
difficult and should be decided by the P&T
committee. Mark’s institution experienced this
problem when the supply of phenobarbital was
unpredictable. To ensure that supply would
always be available for patients with status
epilepticus, the institution decided to maintain
two separate stocks. Although this created some
animosity with the medical staff, having a central
coordinator, previously established policies, and
support of the P&T committee kept the hard
feelings to a minimum.
Some manufacturers have developed
rationing programs for products they know will
be in a short supply. It is worth contacting
manufacturers to learn about the programs that
might be available.
Conclusion
Communication is a key component to any
strategy for managing drug shortages. Practitioners can effectively deal with shortages by
establishing a proactive system, developing
institution-wide policies, opening channels for
quick and clear communication, minimizing
liability, and remembering the end goal of
protecting patients.
References
1. California Department of Consumer Affairs. Pharmacy operation restricted by action from the
California State Board of Pharmacy. http://www.dca.ca.gov/press_releases/20010717a. htm.
Accessed 2003 Aug 14.
2. American Society of Health-System Pharmacists. ASHP Guidelines on outsourcing pharmaceutical
services. Am J Health-Syst Pharm. 1998; 55:1611–7.
3. Anon. Accreditation Standards for Hospitals (Prepublication version). Joint Commission on
Accreditation of Healthcare Organizations, 2003 (www.jcaho.org).
12
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Understanding and Managing Drug Shortages
6-052A
Continuing-Education Test
Identify the current and emerging trends
in drug shortages.
1. Which of the following statements is TRUE?
a. The primary reason the incidence drug
shortages has increased drastically
since 1996 is the merging of
manufacturing companies.
b. Drug shortages have a bigger impact
on community pharmacy practice than
hospital and acute care practice.
c. The reason for approximately 27% of
drug shortages is unknown.
d. Greater than 60% of drug shortages
are due to reduced supply of raw
material.
2. Which of the following is NOT considered a
valid reason for drug shortages?
a. Increased demand due to stockpiling.
b. Stricter guidelines imposed on
manufacturers by the FDA in 1999.
c. Regulatory violations by manufacturers.
d. Imbalances in product distribution.
3. According to Dr. Tyler’s presentation, drug
shortages have the biggest impact on drug
supply in which of the following
therapeutic areas?
a.
b.
c.
d.
Central Nervous System
Hormone Therapies
Antibiotics
Vaccines
List 3 resources for obtaining up-to-date
information on drug shortages.
4. Of the three drug shortage resources
reviewed in the program, which is
considered the best source to find the
appropriate contact at a manufacturer?
a. Food and Drug Administration’s Web Site
b. American Society of Health-System
Pharmacy’s Web site
c. Centers for Disease Control and
Prevention’s Web site
d. Wholesaler
5. The best source for clinical guidelines for
dealing with a drug shortage is:
a. Food and Drug Administration’s Web
Site
b. American Society of Health-System
Pharmacy’s Web site
c. Manufacturer
d. Wholesaler
6. Which of the following resources includes
a mechanism for reporting drug shortages:
a. Food and Drug Administration’s Web Site
b. American Society of Health-System
Pharmacy’s Web site
c. Manufacturer
d. Wholesaler
7. Which of the following statements is FALSE
a. The letters practitioners receive from
drug manufacturers are a timely source
of information about drug shortages.
b. The Centers for Disease Control and
Prevention’s web site is the best source
of information regarding vaccine
shortages.
c. ASHP’s web site includes clinical
guidelines for dealing with drug
shortages.
d. The FDA’s web site offers a push-news
service regarding drug shortages.
Describe the components of a successful
communication strategy within a health
system for managing drug shortages.
8. According to Dr. Mark’s presentation, which
of the following is the most important part
of a drug shortage management program?
a. Educating patients about drug
shortages.
b. Implementing a pharmacy department
policy for managing drug shortages.
c. Communication practices.
d. Forming ad hoc committees that consist
of anesthesia, pediatrics, and neurology
disciplines.
9. Which of the following is NOT considered a
part of an effective communication plan?
a. Remind departments within the
institution about appropriate practices
for ordering and receiving products.
b. Provide educational materials to alert
practitioners to differences between the
alternative therapies and the drug in
short supply.
c. Establishing a pharmacy-based
committee to manage drug shortages.
d. Use a written memo to communicate
facts with practitioners.
10. Which of the following statements about
external compounding companies is
FALSE?
a. Formulations are not reviewed by the
FDA.
b. The FDA requires that products provided
by external compounding companies are
done so with the approval of the
Pharmacy and Therapeutics Committee.
c. JCAHO requires that the institution
demonstrate efficacy, toxicity,
bioequivalence, and pharmaceutical
equivalence of compounds.
d. According to JCAHO and ASHP, the
pharmacy director is personally
responsible for the quality of contract
services.
11. Components of a long-term strategy for
dealing with drug shortages include all the
following EXCEPT:
a. Identify and evaluate alternative drug
regimens for the agent in short supply.
b. Identify and centralize the supply of the
drug in short supply.
c. Confirm and evaluate the duration of a
drug shortage.
d. Distribute educational materials to
teach staff about the differences
between the alternative drugs and the
drug in short supply.
Describe the role of pharmacists in
managing drug shortages
12. Which of the following is NOT considered
an acceptable means for managing drug
shortages?
a. Implement systems to proactively
identify drug shortages.
b. Stockpile medications to prevent a
shortage.
c. Ration medications based on a
prioritization plan developed by a
multidisciplinary team.
d. Purchase the product from an external
compounding facility.
13. All of these methods for prioritizing
patients to determine who receives drugs
in short supply are recommended EXCEPT:
a. By disease state for which alternative
therapies are available.
b. Using a lottery system.
c. Based on the acuity of each patient’s
condition.
d. Whether a patient has already received
therapy or not.
14. The goals of a “threat analysis” include all
of the following EXCEPT:
a. Identify patients at the biggest risk.
b. Identify medical services at the biggest
risk.
c. Determine how long the existing
medication supply will last.
d. Identify secondary suppliers as sources
of medication.
15. All of the following statements describe a
good approach to dealing with wholesalers, EXCEPT:
a. Contact the wholesaler weekly to
inquire about drug shortages.
b. Ensure that the wholesaler contract
includes language that imposes
penalties for drug outages.
c. Contact the manufacturer directly to
confirm outages.
d. Benchmark the number of stock-outs
at your institution against other
institutions.
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