Innovations-Magazine-January-2023 - 9

Since early 2020, United States consumers have faced countless shortages and
supply chain disruptions throughout the economy, from personal protective
equipment to infant formula to cars. Prescription medications are not exempt from
these supply problems. In recent months, hospitals and other health facilities
have struggled to obtain sufficient stock of even basic supplies, such as saline, and
national media outlets have drawn attention to shortages affecting widely prescribed
drugs like amoxicillin and mixed amphetamine salts (Adderall®
).
Drug shortages impose significant costs, both monetary
and to patient safety. Subsequently, not only does
the likelihood of medication errors rise, but people
desperate to obtain a medication are more likely to turn
to questionable sources. By virtue of their professional
position, pharmacists are at the forefront of efforts to
help both health care facilities and individual patients
find alternative sources of needed medications without
compromising patient safety.
Shortages: Not a New Problem
Patients may find the current drug shortages surprising,
but to health care workers, the situation is unfortunately
familiar. Whether defined broadly, as a situation in which
the supply of a commercially available product cannot
meet demand and alternative approved manufacturers
cannot make up the shortfall, or on a more individual
scale, as when a supply situation affects how a pharmacy
prepares or dispenses a drug product or compels a
provider to alter what they otherwise would have
prescribed, shortages are far from a new problem
for the health care industry.
By some metrics, the situation last year even showed
some improvement over earlier decades. In early 2022,
new shortages as listed by Food and Drug Administration
(FDA) had declined to their lowest levels in 14 years.
(FDA adds drugs to its shortage list based on information
provided by manufacturers taking a national-level view
and using the broader definition of shortage mentioned
above.) Nonetheless, overall shortages were still high - at
roughly the same level as in 2017 after Hurricane Maria
damaged pharmaceutical manufacturing facilities in
Puerto Rico - and perceptions at the pharmacist level
suggest that the situation has worsened.
Causes of drug shortages are myriad. The supply chain
is long and complex and involves numerous players,
including raw materials producers, manufacturers,
wholesalers, distributors, transporters, vendors, health
care facilities, and regulators, among others. Historically,
manufacturing quality issues have caused the majority
of drug shortages, with manufacturing production
delays and lack of capacity also frequently to blame.
Indeed, quality problems at one manufacturer can create
capacity issues at others, as customers seek alternative
sources of supply. Those products that do not have
much redundancy built into their manufacturing -
particularly generics - are especially prone to shortages,
as tight production capacity does not leave room for
contingencies. Business decisions, including anticipating
clinical demand, adding or discontinuing a drug product,
and marketing and purchasing allocations, also affect
supply, as do various other factors.
Widely used just-in-time inventory management
helps to control costs when all goes smoothly, but it
magnifies the effects of any supply chain disruptions.
Issues anywhere along the line may have ramifications,
from a raw material producer whose workforce has
been affected by illness or shipping delays for key
ingredients. Demand also plays a role; something
as simple as an unanticipated surge of patients
needing albuterol can quickly overwhelm the supply
chain. During the coronavirus disease 2019 era, the
difficulty of drug shortages has been exacerbated by
challenges in obtaining related supplies - not just
JANUARY 2023 | 7
Innovations-Magazine-January-2023

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