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Unvaccinated caused shortages!
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This is what the unvaccinated are doing to all of us!

<https://www.uspharmacist.com/article/drug-shortages-amid-the-covid19-pan
demic>

<https://tinyurl.com/ydnu4jft>

PUBLISHED FEBRUARY 12, 2021.
INFECTIOUS DISEASE.
Drug Shortages Amid the COVID-19 Pandemic.
Christina M. Bookwalter, PharmD, BCPS.
Clinical Pharmacist.
Womack Army Medical Center.
Fort Bragg, North Carolina.

US Pharm. 2021;46(2):25-28.

ABSTRACT: The uncertainty of coronavirus disease 2019 (COVID-19) caused
anticipatory purchasing of medications around the world, driving demand
to an unprecedented high. Meanwhile, drug factories shut down in order
to prevent the spread of COVID-19, the drug-supply chain was disrupted,
and drug shortages resulted. In the face of these drug shortages,
pharmacy personnel responded by initiating local policy changes,
implementing detailed antibiotic stewardship, and enacting quantity
limits for in-demand medications. Pharmacists are indispensable during a
drug shortage because of their unique skills and ability to bridge
shortage gaps with effective action plans that will not imperil patient
safety.

“‘There’s a shortage of everything’: Pharmacies in New York City
struggle to keep key medications stocked amid coronavirus outbreak.”1
“Coronavirus pandemic is causing ‘unacceptable’ shortages in US drug
supplies.”2 These headlines and many others have overwhelmed news
outlets, social media, and general conversation among the American
public for months. When pharmacy personnel hear about drug shortages,
panic, fear, and frustration begin to set in. Pharmacy’s primary
responsibility is to supply patients with life-saving medications. When
drugs run out, pharmacy personnel may feel responsible for failing to
supply the patient with a life-saving pharmaceutical. Accordingly, when
pharmacy professionals encounter drug shortages, there is a call to
action to be prepared. Pharmacies prepare by purchasing available
product, looking for alternatives, implementing protocols to save stock,
and finding creative solutions to conserve valuable resources. The
uncertainty of coronavirus disease 2019 (COVID-19) has highlighted the
difficulties inherent in having a global drug-supply chain and has
caused an increase in global demand for certain medications. It is
imperative for pharmacists to understand the causes of drug shortages
during the COVID-19 pandemic, key medications affected at this time, and
how to ensure patient safety during a shortage.

Causes of Drug Shortages
Drug shortages have been an ongoing problem for the medical community
for decades; however, drug-shortage concerns have been exacerbated by
this worldwide pandemic. Drug manufacturing follows standard business
practices in order to make a profit. Excess stock in the warehouse is
risky from a business standpoint. It costs money to store and maintain
product in anticipation of sales and profit. Therefore, businesses may
operate on a just-in-time model by manufacturing the product when it is
needed in order to keep costs down and maintain efficiency. With no
on-hand reserve, if anything alters supply or increases demand, a
shortage can occur.3

The supply of goods to the market directly relates to the quantity of
goods coming off the production lines over a given time. In order to
produce a drug, raw materials must be acquired. The drug-manufacturing
process is wholly dependent on the supplier of the raw materials. Often,
there are multiple manufacturers for a drug, but there may be only one
producer of the raw material. Therefore, any interruption in the supply
of the raw material will affect all manufacturers of the drug.4
Currently, about 80% of the raw materials for drugs are imported from
abroad, making the American drug supply highly dependent on other
countries.4

Even when adequate raw materials are available, there is a maximum
capacity or a limited number of units that can be manufactured at a
given time. Because the FDA approves a specific manufacturing line to
produce a specific drug at a specific facility, a manufacturer cannot
set up additional production of a drug in short supply elsewhere in the
facility.4 Further limitations to production include the good
manufacturing practices, chemical reactions, and in-process controls
that must be in place to turn out a quality product.5

The spread of COVID-19 to the level of a global pandemic impacted the
acquisition of raw material and caused manufacturing shutdowns around
the world. China is a major source of active pharmaceutical ingredients,
finished dosage forms, and raw materials.6 In response to COVID-19,
roughly 37 pharmaceutical factories in China that manufactured active
ingredients for U.S. drug products were shut down.7 Consequently,
manufacturers in other parts of the world were forced to depend on
current stock or find alternative supply sources. India, which imports
roughly 70% of its raw materials from China and is the world’s largest
producer of generic drugs, began to experience delays in receiving
ingredients and could not keep up with global demand under these
conditions.7 In anticipation of drug shortages, the Indian government
restricted the exportation of medications to other parts of the world in
order to prevent a potential shortage in its own country.7 The limiting
of drug exports from India amplified shortages in other areas of the
world that depend on that supply.

With factory doors closed and COVID-19 a global threat, supplies start
to run low. Not knowing when and where the next COVID-19 surge will
occur, everyone is trying to be prepared. Pharmacies prepare by managing
the inventory of critical drugs required for providers to adequately
treat the virus. As soon as evidence surfaces to support a potential
treatment, pharmacies begin procuring the drug, and global demand starts
to increase. Some drugs that have been in high demand in association
with COVID-19 include albuterol metered-dose inhalers (MDIs),
azithromycin, hydroxychloroquine and chloroquine, and sedation
medications.

Drugs in Demand for COVID-19 Treatment
Albuterol MDIs: Treatment of COVID-19 often involves the use of
bronchodilators owing to the specific lung cells targeted by the virus.
Given that nebulizers increase the generation of aerosolized virus in
COVID-19 patients and potentially escalate the spread of the virus, MDI
use is preferred. Inhaler shortages are occurring because of increased
demand by hospitals for treatment of COVID-19.8 To combat potential
shortages, hospitals can conserve supply by creating local policies that
would allow patients to bring their inhaler supply from home to use
during their inpatient stay.9 Another way to conserve supply is when an
inpatient pharmacy dispenses an inhaler for hospital use, then gives it
to the patient upon discharge, eliminating the need for the patient to
obtain a new prescription from the outpatient pharmacy.9 The possibility
of using one MDI for multiple patients has been discussed. The Institute
for Safe Medication Practices (ISMP) currently recommends against a
common MDI-canister protocol.9 Common canister protocol involves using
the same MDI for multiple patients by disinfecting the MDI mouthpiece
with an alcohol pad before inserting it into a patient-specific spacer
with a one-way valve, administering the medication, and disinfecting the
MDI mouthpiece after use.9 Studies have found rates of bacterial
contamination on the disinfected mouthpiece of up to 5%.9 The ISMP
states that using a common canister for patients on isolation or those
who are immunocompromised may not be appropriate and that the methods in
previous studies have been aimed at preventing bacterial contamination,
which would not be applicable to COVID-19.9 Given the elevated demand
for MDIs because of COVID-19, it is imperative that pharmacists consider
their current inventory and plan to conserve supplies if needed.

Azithromycin: Azithromycin has been used as adjunctive therapy to
provide antibacterial coverage and potential immunomodulatory and
anti-inflammatory effects in the treatment of some viral respiratory
tract infections.10 Many trials are testing the effect of azithromycin
in conjunction with hydroxychloroquine in COVID-19 patients.10 The
increasing number of reports on azithromycin has led to an increased
demand for the drug. On April 14, 2020, the FDA reported that there was
currently a shortage of azithromycin owing to high demand.11 Although
the intention to acquire supplies to keep on hand in case of a COVID-19
surge is laudable, it is important to remember that in 2018 the United
States dispensed 38.5 million azithromycin prescriptions for conditions
other than COVID-19.12 In order to reserve a supply of azithromycin, it
is imperative that pharmacists practice good antibiotic stewardship and
ensure that patients who receive azithromycin have an appropriate
indication. In the U.S. alone, the CDC estimates that at least 30% of
outpatient antibiotic prescriptions are unnecessary, commonly being
written for viral respiratory infections when therapy is not
indicated.13 Some other examples of inappropriate antibiotic prescribing
include the use of non–first-line antibiotics and the use of an
antibiotic with excessively broad-spectrum activity for which a
narrow-spectrum drug could be substituted.13 Pharmacists should review
all azithromycin prescriptions to ensure that there is a proper
indication and, when appropriate, recommend other proven therapy
alternatives in order to help conserve the azithromycin supply.

Hydroxychloroquine and Chloroquine: Hydroxychloroquine and chloroquine
are indicated for a very small population of patients with uncommon
conditions such as lupus, rheumatoid arthritis, and malaria. Therefore,
typical purchasing quantities are minimal. However, COVID-19 research
involving hydroxychloroquine and chloroquine has heightened the demand
for these drugs. Many small trials began testing the use of these drugs
in COVID-19 patients because their mechanisms of action include
targeting of lysosome, which can control graft-versus-host disease;
inhibition of entry of the virus; prevention of virus cell fusion;
anti-inflammatory effects; and reduction of cytokine storm.10 On March
20, 2020, the FDA issued an Emergency Use Authorization (EUA) for
hydroxychloroquine and chloroquine from the Strategic National Stockpile
to be used by licensed healthcare providers to treat patients
hospitalized with COVID-19.14 An analysis of outpatient retail pharmacy
transaction data found that the prescribing of these drugs increased
from 383,435 prescriptions in February 2020 to 759,186 prescriptions in
March 2020.14 With demand doubling over 1 month, shortages followed, and
the FDA published information on the shortages on March 31, 2020.15 In
response, certain state boards of pharmacy established new rules to
control use by requiring a diagnosis for the indicated disease to be
written on the prescription, placing quantity limits for COVID-19
prescriptions, and restricting refills.16 On June 15, 2020, the FDA
rescinded its EUA because the federal COVID-19 Treatment Guidelines
Panel issued recommendations against the use of hydroxychloroquine and
chloroquine to treat COVID-19 and noted that, at the time, no medication
could be recommended for COVID-19 preexposure or postexposure
prophylaxis outside the clinical-trial setting.14 Following the release
of this information, dispensing trends began to return to prepandemic
levels, and the shortage resolved in late June 2020.14

Sedation Medications: COVID-19 can result in acute respiratory distress,
and in extreme cases it requires the use of mechanical ventilation.
Anticipation of an increase in mechanically ventilated patients and
heightened demand for analgesics, sedatives, and paralytics created the
perfect conditions for drug shortages. One way to save drug product is
to minimize waste. Inpatient pharmacies should consider purchasing or
compounding smaller drug volumes, when applicable, in order to minimize
waste. Pharmacists should also review current hospital protocols and
work with key stakeholders to make contingency plans for shortages of
sedation medications. Traditionally, IV administration of opioids is
preferred in mechanically ventilated patients; however, to conserve
resources and keep opioid use to a minimum, hospitals can establish
protocols for intermittent bolus analgesia, enteral administration of
opioids, or implementation of adjuvant therapies.17 In ventilated
patients, light sedation—which helps conserve drug supply—is preferred
over deep sedation.17 Nonbenzodiazepine sedatives such as propofol and
dexmedetomidine are preferred, but contingencies should be put in place
to use other agents, such as ketamine, benzodiazepines, and
pentobarbital.17 Awakening trials with reassessment of sedation needs
should be performed daily. This practice may result in a reduction in
sedation requirements while effectively conserving drug supply.17 In
addition to analgesics and sedatives, some patients with COVID-19 will
require paralytics. In order to conserve resources, hospital guidelines
should be established for the use of continuous infusion versus
intermittent bolus use of paralytic agents.17 In general, when a drug
shortage arises, it is imperative that pharmacists familiarize
themselves with all alternative products and assist in creating
contingency plans.

Patient Safety During a Drug Shortage
A drug shortage commonly requires the substitution of an item that is
ordered, prepared, or dispensed differently than the standard product.
When prescribing practices switch to less-familiar alternative
agents—especially those that are less efficacious, have a worse
adverse-effect profile, or require an unusual or difficult dosing
regimen—medication errors are more likely to occur.18 To minimize
medication errors and maximize patient safety, the American Society of
Health-System Pharmacists (ASHP) guidelines on managing drug-product
shortages recommend implementing a drug-product shortage team, creating
a resource-allocation committee, and establishing a process for
approving alternative therapies and addressing ethical considerations.18
The product-shortage team would have multiple responsibilities,
including the purchasing of alternative agents, decisions on conserving
or rationing supplies, implementation of technology updates, and
communication of changes.18 The resource-allocation committee would
create a framework for rationing drug resources in advance, thereby
eliminating the need for bedside decisions during a shortage.18 The
final ASHP recommendation is to have a process in place for approving
alternative therapies and addressing ethical considerations. A
multidisciplinary team would be responsible for establishing ethical
procedures and protocols before they are needed in order to ensure that
the rationing of life-saving drugs reflects the fundamental healthcare
principles of justice, beneficence, and nonmaleficence.18

The overarching recommendation for preventing medication errors and
ensuring patient safety is to focus on communicating information about
the drug shortage. Communication updates should include all pertinent
information about the shortage, such as the drug affected and the
substitution or rationing plan.18 If a new drug is being selected,
educational references about prescribing differences should be
distributed, and pharmacists should be prepared to answer questions
about the new agent. When information is being disseminated, it is
important to include all potential stakeholders across all shifts. With
drug shortages on the rise during the COVID-19 pandemic, it is
imperative that the pharmacy profession take a proactive leadership role
in developing and implementing processes to address drug shortages and
ensure patient safety.

Conclusion
The pharmacy profession has been dealing with drug shortages for years.
However, no past experience could have adequately prepared pharmacists
for the drug shortages and unprecedented high demand resulting from the
extensive disruptions caused by COVID-19. The pandemic crippled the
global drug-supply chain by leading to factory closings, limited access
to raw materials, and altered import and export rates of final dosage
forms. With an inadequate supply chain and high demand worldwide,
prescription drug shortages became a common topic in the pharmacy realm.
Fear of not having enough supplies to battle the virus motivated
pharmacy personnel to change current practices by initiating local
policy changes, focusing on antibiotic stewardship, and implementing
quantity limits in order to conserve drug stock. Overall, the need to
combat historic drug shortages during the COVID-19 pandemic has led to
innovation and critical thinking in an effort to conserve valuable
supplies without sacrificing patient safety under less-than-ideal
circumstances. Pharmacists are indispensable during a drug shortage
because of their unique skills and ability to bridge shortage gaps with
effective action plans that will not imperil patient safety.

REFERENCES
1. Kimball S. ‘There’s a shortage of everything’: pharmacies in New York
City struggle to keep key medications stocked amid coronavirus outbreak.
www.cnbc.com/2020/04/04/coronavirus-pharmacies-struggle-to-meet-demand-am
id-supply-shortages.html. Accessed November 12, 2020. 2. Erdman SL.
Coronavirus pandemic is causing ‘unacceptable’ shortages in US drug
supplies, report says.
www.cnn.com/2020/10/22/health/drug-shortages-coronavirus/index.html.
Accessed November 12, 2020. 3. Mullins TD, Cook AM. Drug shortages:
causes and cautions. Orthopedics. 2011;34(9):712-714. 4. Ventola CL. The
drug shortage crisis in the United States: causes, impact, and
management strategies. P T. 2011;36(11):740-757. 5. Wichrowski NJ,
Fisher AC, Arden NS, Yang X. An overview of drug substance manufacturing
processes. AAPS PharmSciTech. 2020;21(7):271. 6. Van Arnum P. API
sourcing: the supply side for US-marketed drugs.
www.dcatvci.org/6213-global-api-sourcing-which-countries-lead. Accessed
January 8, 2021. 7. Center for Infectious Disease Research and Policy
(CIDRAP). COVID-19: The CIDRAP Viewpoint. Part 6: ensuing a resilient US
prescription drug supply. Minneapolis, MN: University of Minnesota;
2020. 8. American College of Allergy, Asthma and Immunology. A message
to asthma sufferers about a shortage of albuterol metered dose inhalers.
https://acaai.org/news/message-asthma-sufferers-about-shortage-albuterol-
metered-dose-inhalers. Accessed November 12, 2020. 9. Institute for Safe
Medication Practices. Revisiting the need for MDI common canister
protocols during the COVID-19 pandemic.
https://ismp.org/resources/revisiting-need-mdi-common-canister-protocols-
during-covid-19-pandemic. Accessed November 12, 2020. 10. Wu R, Wang L,
Kuo HC, et al. An update on current therapeutic drugs treating COVID-19.
Curr Pharmacol Rep. 2020:1-15. 11. FDA. FDA drug shortages. Azithromycin
tablets.
www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.
cfm?AI=Azithromycin&Tablets&st=c#. Accessed November 12, 2020. 12. CDC.
Outpatient antibiotic prescriptions—United States, 2018.
www.cdc.gov/antibiotic-use/community/programs-measurement/state-local-act
ivities/outpatient-antibiotic-prescriptions-US-2018.html. Accessed
November 12, 2020. 13. CIDRAP. Overuse and overprescribing of
antibiotics.
www.cidrap.umn.edu/asp/overuse-overprescribing-of-antibiotics. Accessed
November 12, 2020. 14. Bull-Otterson L, Gray EB, Budnitz DS, et al.
Hydroxychloroquine and chloroquine prescribing patterns by provider
specialty following initial reports of potential benefit for COVID-19
treatment—United States, January–June 2020. MMWR Morb Mortal Wkly Rep.
2020;69(35):1210-1215. 15. FDA. FDA drug shortages. Hydroxychloroquine
sulfate tablets.
www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.
cfm?AI=Hydroxychloroquine&Sulfate&Tablets&st=r. Accessed November 12,
2020. 16. Arthritis Foundation. Hydroxychloroquine (Plaquenil) shortage
causing concern.
www.arthritis.org/drug-guide/medication-topics/plaquenil-shortage.
Accessed November 12, 2020. 17. Ammar MA, Sacha GL, Welch SC, et al.
Sedation, analgesia, and paralysis in COVID-19 patients in the setting
of drug shortages. J Intensive Care Med. 2021;36(2):157-174. 18. Fox ER,
McLaughlin MM. ASHP guidelines on managing drug product shortages. Am J
Health Syst Pharm. 2018;75(21):1742-1750.

The content contained in this article is for informational purposes
only. The content is not intended to be a substitute for professional
advice. Reliance on any information provided in this article is solely
at your own risk.

To comment on this article, contact ***@uspharmacist.com.

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Post by a322x1n
This is what the unvaccinated are doing to all of us!
<https://www.uspharmacist.com/article/drug-shortages-amid-the-covid19-pan
demic>
<https://tinyurl.com/ydnu4jft>
PUBLISHED FEBRUARY 12, 2021.
INFECTIOUS DISEASE.
Drug Shortages Amid the COVID-19 Pandemic.
Christina M. Bookwalter, PharmD, BCPS.
Clinical Pharmacist.
Womack Army Medical Center.
Fort Bragg, North Carolina.
US Pharm. 2021;46(2):25-28.
ABSTRACT: The uncertainty of coronavirus disease 2019 (COVID-19) caused
anticipatory purchasing of medications around the world, driving demand
to an unprecedented high. Meanwhile, drug factories shut down in order
to prevent the spread of COVID-19, the drug-supply chain was disrupted,
and drug shortages resulted. In the face of these drug shortages,
pharmacy personnel responded by initiating local policy changes,
implementing detailed antibiotic stewardship, and enacting quantity
limits for in-demand medications. Pharmacists are indispensable during a
drug shortage because of their unique skills and ability to bridge
shortage gaps with effective action plans that will not imperil patient
safety.
“‘There’s a shortage of everything’: Pharmacies in New York City
struggle to keep key medications stocked amid coronavirus outbreak.”1
“Coronavirus pandemic is causing ‘unacceptable’ shortages in US drug
supplies.”2 These headlines and many others have overwhelmed news
outlets, social media, and general conversation among the American
public for months. When pharmacy personnel hear about drug shortages,
panic, fear, and frustration begin to set in. Pharmacy’s primary
responsibility is to supply patients with life-saving medications. When
drugs run out, pharmacy personnel may feel responsible for failing to
supply the patient with a life-saving pharmaceutical. Accordingly, when
pharmacy professionals encounter drug shortages, there is a call to
action to be prepared. Pharmacies prepare by purchasing available
product, looking for alternatives, implementing protocols to save stock,
and finding creative solutions to conserve valuable resources. The
uncertainty of coronavirus disease 2019 (COVID-19) has highlighted the
difficulties inherent in having a global drug-supply chain and has
caused an increase in global demand for certain medications. It is
imperative for pharmacists to understand the causes of drug shortages
during the COVID-19 pandemic, key medications affected at this time, and
how to ensure patient safety during a shortage.
Causes of Drug Shortages
Drug shortages have been an ongoing problem for the medical community
for decades; however, drug-shortage concerns have been exacerbated by
this worldwide pandemic. Drug manufacturing follows standard business
practices in order to make a profit. Excess stock in the warehouse is
risky from a business standpoint. It costs money to store and maintain
product in anticipation of sales and profit. Therefore, businesses may
operate on a just-in-time model by manufacturing the product when it is
needed in order to keep costs down and maintain efficiency. With no
on-hand reserve, if anything alters supply or increases demand, a
shortage can occur.3
...snip

New Study Shows no Relationship between Infection rates and Vaccination
Rates: From European Journal of Epidemiology --

....paste content....

European Journal of Epidemiology (2021)Cite this article
* 1.04m Accesses
* 17412 Altmetric
* Metrics details

Vaccines currently are the primary mitigation strategy to combat COVID-19 around the world. For instance, the narrative related to the ongoing surge of
new cases in the United States (US) is argued to be driven by areas with low vaccination rates [1]. A similar narrative also has been observed in
countries, such as Germany and the United Kingdom [2]. At the same time, Israel that was hailed for its swift and high rates of vaccination has also
seen a substantial resurgence in COVID-19 cases [3]. We investigate the relationship between the percentage of population fully vaccinated and new
COVID-19 cases across 68 countries and across 2947 counties in the US.

Methods

We used COVID-19 data provided by the Our World in Data for cross-country analysis, available as of September 3, 2021 (Supplementary Table 1) [4]. We
included 68 countries that met the following criteria: had second dose vaccine data available; had COVID-19 case data available; had population data
available; and the last update of data was within 3 days prior to or on September 3, 2021. For the 7 days preceding September 3, 2021 we computed the
COVID-19 cases per 1 million people for each country as well as the percentage of population that is fully vaccinated.

For the county-level analysis in the US, we utilized the White House COVID-19 Team data [5], available as of September 2, 2021 (Supplementary Table 2).
We excluded counties that did not report fully vaccinated population percentage data yielding 2947 counties for the analysis. We computed the number
and percentages of counties that experienced an increase in COVID-19 cases by levels of the percentage of people fully vaccinated in each county. The
percentage increase in COVID-19 cases was calculated based on the difference in cases from the last 7 days and the 7 days preceding them. For example,
Los Angeles county in California had 18,171 cases in the last 7 days (August 26 to September 1) and 31,616 cases in the previous 7 days (August 19–25),
so this county did not experience an increase of cases in our dataset. We provide a dashboard of the metrics used in this analysis that is updated
automatically as new data is made available by the White House COVID-19 Team (https://tiny.cc/USDashboard).

Findings

At the country-level, there appears to be no discernable relationship between percentage of population fully vaccinated and new COVID-19 cases in the
last 7 days (Fig. 1). In fact, the trend line suggests a marginally positive association such that countries with higher percentage of population fully
vaccinated have higher COVID-19 cases per 1 million people. Notably, Israel with over 60% of their population fully vaccinated had the highest COVID-19
cases per 1 million people in the last 7 days. The lack of a meaningful association between percentage population fully vaccinated and new COVID-19
cases is further exemplified, for instance, by comparison of Iceland and Portugal. Both countries have over 75% of their population fully vaccinated
and have more COVID-19 cases per 1 million people than countries such as Vietnam and South Africa that have around 10% of their population fully
vaccinated.
a322x1n
2021-10-22 00:53:47 UTC
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