1

Drug Shortage

Abdulelah Albukhari

University of San Diego

HCIN-559-01-FA21 - Mgmt HSC Outcome & Pt. Safety

Dr. Jannise T. Baclig

12/12/2021
 2

Drug Shortages

Drug shortages have become one of the standard patient safety issues in the world today.

When people go to doctors, they expect to get their medications from the shelves, whether for flu

or cancer. The extreme case of shortages is regarding life-threatening medications. The pandemic

exposed the naked truth of the flawed supply chain in the drug industry.

The supply issues significantly impact how pharmacies dispense drugs influence the

patients' care when the prescribers are forced to use alternative products or agents. Drug

shortages can have an adverse impact on drug therapy, delay compromise medical procedures,

and lead to medication errors. According to (FDA 2021), shortages of drugs can occur for many

reasons that include quality and manufacturing issues, discontinuations and delay. The

manufacturers always provide information and disclosures about drug shortages and work

closely with the agency to reduce the impact of those shortages.

The world is currently facing the COVID-19 pandemic, which leads to a tremendous

increase in patients in the healthcare sector. In order to ensure proper patients care, drugs need to

be on shelves, which is a problem in the current time given production interruptions and the

supply chain hiccup caused by the pandemic in the US and around the world. Therefore, it is

essential to understand the reasons behind drug shortages since it is one of the significant

challenges in the patient safety section.

Shortages of any sort make people struggle to get commodities they need, and in many

cases, it is usually essential things that are lacking the most. Thus, shortages cause significant

harm to the group that needs it the most, especially if the diminished supply of drugs causes

sedation or pain killers for patients ('ECRI", 2021). As a result, it creates a complex workaround

for the healthcare staff that leads to potential errors. Drug shortages can also result in delays of
 3

patient care or even cancellation in some instances, which is a dangerous outcome for health

care.

It is vital to explore this topic because it provides a broader perception of the underlying

problems in the drug world. Identifying the root causes of the problem creates a better approach

to tackle them. In addition, by highlighting the reasons behind drug shortages, ensure

implementing possible ways to curb those setbacks.

The Purpose of the paper is to investigate the reasons and possible solutions to drug

shortages. The goal is to understand further why drug shortages happen and how to reduce them

for the sake of patients' safety.

Literature Review

Drug shortages have become one of the significant issues in the clinical field. The initial

research has identified three strands of literature regarding drugs shortages. The first strand is

about the root causes of the problem. There is also a strand that shows the influence of drug

shortages on healthcare. Last, it is regarding the general impact of drug shortages on the health

sector. Patients have been suffering for a long, and it is evident that years have gone without a

drastic fix.

The paper titled "Impact of drug shortages on patient and pharmacy operation costs" by

(Shaban et al., 2018) examines how drug shortages threaten health care quality and public health

care in general. It does so by creating barriers to optimal care in the healthcare sector. According

to the article, the frequency of drug shortages has had a drastic increase since 2005, and it

influences broad areas globally. More than 400 generic drug products have been affected, thus

forcing institutions to purchase costly brand-name products (Shaban et al., 2018). The article
 4

further illustrates how costs and scarcity have had a potential negative impact on the availability

of drugs and to the patients.

The article "the impacts of medication shortages on patient outcomes: A scoping review"

by (Phuong et al., 2019), Oldfield, and Moles addresses an essential issue of how the recent

medication shortages have grown to be a global problem. While drug shortages could only affect

patients, it significantly influences economic growth, human labor outcome, and clinical (Phuong

et al., 2019). Patients were commonly reported to have increased out-of-pocket rates of drugs,

costs, mortality, adverse events, and complaints about drugs.

In general, drug shortages occur when the demand exceeds the supply of the same by the

manufacturing companies. It affects all stakeholders of the health care system, such as patients,

clinics, and hospitals. The causes of shortage are caused by factors such as supply issues,

demand issues, and regulatory issues. Supply issues include manufacturing problems,

unavailability of raw materials, logistic problems, and business problems (FDA,2021). In

contrast, demand issues include just-in-time inventory, higher demand for a product, seasonal

demand, and unpredictable demand. For regulatory issues, one important factor is the lack of a

unified definition of a drug shortage, pharmacists, clinicians, the pharmaceutical industry, and

policy.

Common patient safety concerns include medication errors, healthcare-associated

infections, diagnostic errors, surgical errors and postoperative complications, laboratory/blood

testing errors, falls, patient identification, and communication errors. Human and system factors

were identified as contributing to these concerns. Instituting clinical governance, developing and

improving the physical infrastructure of hospitals, providing necessary human resources,

ensuring staff receives patient safety education and promoting 'good' communication and
 5

information systems were, in turn, all identified as processes and strategies critical to improving

patient safety in the Bhutanese healthcare system (ECRI, 2021). Patient safety concerns

described by participants in this study were commensurate with those identified in other low and

middle-income countries. In order to readdress these concerns, the findings in this study suggest

that, in the Bhutanese context, patient safety needs to be conceptualized and prioritized.

The article "the impact of shortages of medication prices: Implications for shortages

prevention" by (Alevizakos et al., 2016) studies the increased frequency of medication shortages

and the financial and clinical ramifications caused by those shortages. While it is known to have

an adverse impact on finances and the clinical sector, the researchers suggest that shortages of

drugs remain unknown (Alevizakos et al., 2016). The researchers examine the progress of

medication that shortages affect, and they find it is clear that price increases are the leading cause

of drug shortages. The increases in prices react to the low profitability of the affected

medication. Hence, drug prices also play a significant role in drug shortages.

The article "Drug Shortage: Causes, Impact, and Mitigation Strategies" by (Shukar et al.,

2021) also acknowledges that drug shortages are a global issue affecting low, middle, and high-

income countries. The researchers indicate that this problem is not limited to only low and

middle-income countries because it affects everyone worldwide. Based on the article, all types of

drugs such as essential life-saving drugs, antimicrobial, oncology, analgesics, and cardiovascular

drugs are liable to the shortages experienced everywhere globally (Shukar et al., 2021). The

article shows how WHO has tried establishing global mitigation and strategies to overcome drug

shortages. Despite all the efforts, the problem remains.

 6

Overall, the literature shows how drug shortages have affected people in terms of

economy, health, and other sectors in the world. Different authors have shown how drug

shortages have led to slow growth in many countries.

Solution of Drug Shortage

Drug shortages have become a significant issue among many problems. Literatures talks

about the shortages and their impacts. In that connection, some talk about supply and prices in

the drug industry. While it can never be easy to have full control of problems that cause

shortages of drugs, a few solutions exist. Given that drug shortages are a global issue, the first

step includes efforts from all countries to ensure sufficient supply at relatively fair prices for

consumers to afford (Dewi et al., 2019). Prices are one of the problems to deal with, but the

government can subsidize the drugs to ensure they reach consumers at affordable rates without

any shortage.

Besides government intervention, there is a need for a good drug inventory planning

system to give efficient budgeting, cost control, avoid shortages, and drug procurement.

Moreover, the system should be capable with the drug shortage reporting to the governmental

authority like FDA (Food and Drug Administration) and the stakeholders to make sure the FDA

can work with stakeholders to solve the shortage in the drug; however, like this reporting feature

is available in FDA under the Drug Shortage Program (DSP), which was developed by the FDA

in 1990 (Shukar et al., 2021). High prices of drugs make drugs stay for long in the

manufacturers' stores until expiration, thus, useless. Therefore, it is essential to make sure that

prices are favorable to move in an easy way. Making sure that prices are favorable for everyone

increases demand and supply (Shukar et al., 2021). The demand and supply curves for drugs

should be at equilibrium to ensure availability and secure drugs at fair prices. Assuming there is
 7

a demand of 600 units priced at $1.5 at equilibrium, prices above $1.5 will shun buyers away due

to affordability. Thus, equilibrium is essential. An inventory planning system will result in a

better supply and demand process and hence stable prices.

Figure 1. Flowchart for the inventory reporting from stockholders to the FDA.

Table 1

Steps in the Process List of All Potential Failure Points

1-Stakeholders raise in the system quarterly report
of inventory of each FDA registered drug they
owned
2-FDA reviews all the reports.
3-The available inventory is for more than six
months.
4-is there any other generic in the market
5- stockholder provide estimated time for how long
this shortage will be
1. Stakeholders fails to raise the report
2. drug not registered
3. missing information
1. Stakeholders gives incomplete information
2. FDA officers fails to review all information.
3. FDA officers are not trained on review
methodology
1. unexpected high demand of the drug
2. The numbers not accurate with the demand
3. The inventory expiry dates not available
1. Health provider do not trust enough in the
generics of the drug
2. Shortage in generic and other similar
formula
3. Patient dose not prefer the generic products
1. The time not accurate
2. The manufacturing cannot give an estimated
time
3. Fails to restock in the given time
 8

6- contact the health providers to find out other
medication plans for the patients
1. Providers took long time to find another
therapy plan.
2. Patients cannot shift to another drug
3. Can not reach to all physicians who
prescribe the drug and inform them early

FMEA
1 Process Step
1-Stakeholders raise in the system quarterly
report of inventory of each FDA registered
drug they owned
2 Potential Failure Mode Stakeholders drug not missing
fails to raise registered information
the report
3 Potential Cause(s) The New drug in The
Process Step #1

responsible the market stockholder

person team does not
forgets or provide all the
not trained. details
4 Severity Major Minor Minor
5 Probability Uncommon Uncommon Occasional
6 Hazard Score 6 2 3
7 Action (Eliminate, Control, or Control Control Accept
Accept)
8 Description of Action delay fines Stop Ask them to
marketing send missing
until they information
register the
drug

1 Process Step
FDA reviews all the reports.
2 Potential Failure Mode Stakeholder FDA officers FDA officers
gives fails to are not trained
incomplete review all on review
information information. methodology

3 Potential Cause(s) Missing Due to high New officers

information load of could make
due to high information the process
number of the officers late or forget
drugs they could not to review all
owned review it the
accurate information
 9

4 Severity Minor Major Major

5 Probability occasional occasional Uncommen
Process Step #2

6 Hazard Score 3 3 6
7 Action (Eliminate, Control, or control eliminate control
Accept)
8 Description of Action Return the Increase the Do not keep
report to the number of training
stockholders workers employee
to completed alone

1 Process Step
The available inventory is for more than six
months.
2 Potential Failure Mode unexpected The numbers The inventory
high demand not accurate expiry dates not
of the drug with the available
demand
Process Step #3

3 Potential Cause(s) Unexpected The The

new study stockholder stockholders
that may s do not do not provide
increase the provide the the expiry
demand of correct dates
consuming number of
demands
4 Severity Catastrophic Major Minor
5 Probability Uncommon Uncommon Uncommon
6 Hazard Score 8 6 2
7 Action (Eliminate, Control, or Control Eliminate control
Accept)
8 Description of Action The Arranged a Returned back
stockholders fine for any to
should be non-correct stockholders
aware of any numbers or to provide the
new studies information expiry dates
and
responsible
for any
increase in
demand

1 Process Step is there any other generic in the market

 10

2 Potential Failure Mode Health Shortage in Patient dose not

provider do generic and prefer the
not trust other similar generic
enough in the formula. products
generics of
the drug.
3 Potential Cause(s) Bad The low of Many patients
experience supply of they want the
with quality active brand drug
of generic ingredients they thought
Process Step #4

drugs could affect it’s quality

the supply of better than the
drugs generic one
4 Severity Minor Major Minor
5 Probability uncommon occasional remote
6 Hazard Score 2 9 1
7 Action (Eliminate, Control, or accept accept accept
Accept)
8 Description of Action Provide for Try to contact Increase the
them with the educate the
enough active patients it’s a
information ingredients same formula
of generic supply to
drug increase
production

1 Process Step stockholders provide estimated time for how

long this shortage will be

2 Potential Failure Mode The time not The Fails to

accurate manufacturing restock in the
cannot give an given time
estimated
time.
3 Potential Cause(s) The active Due to The
ingredients shortage in manufacturin
martial not active g could not
available or ingredients deliver the
delay goods on
time
4 Severity Catastrophic Catastrophic major
5 Probability Occasional Occasional Occasional
6 Hazard Score 12 12 9
 11

7 Action (Eliminate, Control, or control control control

Accept)
Process Step #5

8 Description of Action By request By set a By request

from the lows and from the
stockholders organize the stockholders
to keep at row martial to keep at
least market least
inventory inventory
enough for 6 enough for 6
months months

1 Process Step contact the health providers to find out other

medication plans for the patients

2 Potential Failure Mode Providers Patients Cannot reach

took long cannot shift to all
time to find to another physicians
another drug who prescribe
therapy plan the drug and
inform them
early
3 Potential Cause(s) It’s the only They have Some
therapy in an allergy or physicians
the market other side they didn’t
Process Step #6

for specific effects read about

disease updates in
therapy plans
4 Severity Catastrophic Catastrophic major
5 Probability uncommon uncommon uncommon
6 Hazard Score 8 8 6

7 Action (Eliminate, Control, or control accept control

Accept)
8 Description of Action Make urgent Figure out Increase the
meetings any other education
with options or try martials and
physician’s to block ask the
society some stockholders
quantities to marketing
those kind of team to try
patients reach the
physicians
 12

Quality Management Plan

Objectives Completion of Investigating the Knowledgeable
questionnaire reasons behind understanding of
report to find out drug shortages why drug shortages
cause of drug and find the happen and how to
shortages. possible be solved it to
solutions to the ensure patients
reasons causing safety
drug shortages
Indicator Decrease Decrease percent Increase
percentage of drug of drug competence in the
shortages report shortages and drug shortage
questionnaires. reasons causing reports.
it.
Measure Type  Process Outcome  Process 
Methodology Concurrent Concurrent Concurrent
Data Collection Stockholders Drug Improvement of Monthly
Source shortage report drug shortage improvement
Questionnaire logs assessments
When Daily Weekly End of every month
Frequency of Bi-weekly  weekly Monthly
measure
Responsible Quality assurance Quality Drug shortage
specialist assurance department
specialist  
Reporting To Drug availability Drug availability Drug availability
and shortages team and shortages and shortages team
Leader team Leader Leader

Curbing drug shortages is one of the most critical situations facing the world today. It is

beneficial to make sure the rate of drug shortages reduces by some reasonable percentage.

However, drug shortages have been of great concern among the country leaders. It is the reason

there is a need to ensure questionnaires report from pharmaceutical companies are used to see

their management plans if there is any shortage in their supply. Usually, the cause of the drug

shortage is a logistic situation or surprising high demands of some drugs.

 13

The Lack of an Advanced Warning System Is the Main Cause of Problems. The quality

management plan is to measure the questionnaires report from the pharmaceutical company and

focus on making sure the reporting process is going on the perfect way with increasing

competence in the drug shortage questionnaires report.

The primary indicators for the success of the quality management plan are Decreasing the

percent of drug shortages and the reasons causing it and increasing the competence in the drug

shortage reports.

For the future course of action, it is recommended that the checkpoints and the corrective

details of the drug shortages be considered. There is nothing important like ensuring the country

can provide drugs for the people in the nation. Therefore, the questionnaire report will be

essential in solving the drug shortage problem, and the market has enough supply of

pharmaceutical products. The supplier's inventory is enough for at least six months of demand.

In addition, they should provide the correct data to avoid any drug shortages in the country.
 14

References

FDA. (n.d.). Drug shortages. U.S. Food and Drug Administration. Retrieved October 10, 2021, from

http://www.fda.gov/drugs/drug-safety-and-availability/drug-shortages.

ECRI. (n.d.). Retrieved October 10, 2021, from https://assets.ecri.org/PDF/White-Papers-and-

Reports/ECRI_Top10_Patient-Safety-Concerns_2021_v2.pdf. 

Alevizakos, M., Detsis, M., Grigoras, C. A., Machan, J. T., & Mylonakis, E. (2016). The Impact of

Shortages on Medication Prices: Implications for Shortage Prevention. Drugs, 76(16), 1551–

1558. https://doi.org/10.1007/s40265-016-0651-7

Phuong, J. M., Penm, J., Chaar, B., Oldfield, L. D., & Moles, R. (2019). The impacts of medication

shortages on patient outcomes: A scoping review. PLOS ONE, 14(5), e0215837.

https://doi.org/10.1371/journal.pone.0215837

Shaban, H., Maurer, C., & Willborn, R. J. (2018). Impact of Drug Shortages on Patient Safety and

Pharmacy Operation Costs. Federal Practitioner, 35(1), 24–31.

Shukar, S., Zahoor, F., Hayat, K., Saeed, A., Gillani, A. H., Omer, S., Hu, S., Babar, Z.-U.-D., Fang,

Y., & Yang, C. (2021). Drug Shortage: Causes, Impact, and Mitigation Strategies. Frontiers in

Pharmacology, 12, 693426. https://doi.org/10.3389/fphar.2021.693426

Dewi, E. K., Dahlui, M., Chalidyanto, D., & Rochmah, T. N. (2019). Achieving cost-efficient

management of drug supply via economic order quantity and minimum-maximum stock

level. Expert Review of Pharmacoeconomics & Outcomes Research, 20(3), 289–294.

https://doi.org/10.1080/14737167.2019.1633308