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ISSUE 02 MARCH 2022
Addressing Drug Shortages and the impact of COVID-19 Pandemic
Editorial Team MS JOANNE SHEN Pharmacy Education Coordinator PARO 2021-2022
MS GABRIELLE GIMENES Regional Projects Officer PARO 2021-2022
MS MARIA GONZALEZ Regional Media and Publications Officer PARO 2021-2022
PARO ASSOCIATIONS
IPSA-NSU | USA
Thank You IPSF PARO would like to thank everyone that contributed to the second edition of the Dosage. First of all, we would like to thank the writers for your contributions. Thank you for helping us address the topic of drug shortages. Second, we would like to thank the editors who helped review the articles. We would also like to thank the design team for helping to put all of this together. Lastly, we would like to thank the readers for taking the time to read through these articles.
from IPSF PARO
Table of Contents 06
Preface
07
Session of Sentences
08
Drug Shortages in Brazil: In search of combating disinformation and bureaucracy Erick Tavares Marcelino Alves, Sophia Mikiko Oliveira Sueyoshi, Gabrielle Gimenes Lima, Linda Brenda Viríssimo Sirqueira
12
Medication shortage situation in hospitals in the coastal and mountain regions of Peru Aron Francisco Cortez Quispe, Diego Waldir Cabana Huancachoque, Jorge Antonio Quispe Padilla, Melanie Jhenieffer Choquehuanca Mollocondo
17
A Sleep Pharmacist in times of the pandemic Maria de Guadalupe Enriquez Anco
21
The impact of medication shortage over the off-label and unlicensed usage of medications Melissa Núñez Mora
Preface Shortages of medicines – especially essential medicines – have been proven to be an increasing concern worldwide since they pose a challenge to health systems. They account for additional costs and threaten our patients’ safety and health considering that may result in under-treatment, non-treatment and possible medication errors when healthcare professionals attempt to replace missing medications. Although medicines shortages are not a recent phenomenon, the COVID19 pandemic has deepened the hurdles pertaining to that. The main challenges are drug regulation, lack of practices harmonization and assuring drug quality due to exchange of medicines due to the changes, fluctuations and instabilities in medicines supply chains, communication with key stakeholders and the need to implement good practice protocols and guidelines in hospitals. Complimentary to that is the unavailability of data from low- and middleincome countries, which causes difficult stock management and costeffectivity studies, including the lack of notification systems of medicines shortages. Medication shortage in institutions has become a major problem since the pandemic. It was predominantly reported to have adverse economic, clinical, and humanistic outcomes to patients. This has impacted the patient-provider relationship significantly. In order to accommodate patients’ needs to ensure ultimate patient care, it is important for future pharmacists to understand the importance of and learn how to address this issue.
06
Session of Sentences
Drug shortages can result from manufacturing problems, lack of incentive from companies to produce less profitable drugs, and raw material unavailabilities. ...lack of government and market incentive for quality surveillance systems that focus on continuous improvement and early detection of supply chain issues, other business decisions and political issues. In middle and lower-income countries, drug shortages can stem from licensing issues, and drug smuggling. Drug shortages are always going to be interwoven with the practices of healthcare professionals. We can minimize their impact by learning how to prevent them and how to properly deal with them.
07
DRUG SHORTAGES IN BRAZIL: IN SEARCH OF COMBATING DISINFORMATION AND BUREAUCRACY 1 . Erick Tavares Marcelino Alves, 2.Sophia Mikiko Oliveira Sueyoshi, Gabrielle Gimenes Lima, 3.Linda Brenda Viríssimo Sirqueira
2.
1 . Departamento de Farmácia, Faculdade de Ciências Farmacêuticas, Universidade de São Paulo, University of São Paulo, Av Prof Lineu Prestes, 580, Bl. 17, CEP 05508-000, São Paulo (SP), Brazil. erickalves02016@gmail.com; sophiamikiko@gmail.com 2 . Edifício ICB - III, Avenida Prof. Lineu Prestes, 2415 - Cidade Universitária CEP 05508-900, São Paulo, SP. gabrielle.ggimenes@gmail.com 3 . .Universidade Nove de Julho, Rua Vergueiro, 235/249 - Liberdade, São Paulo SP, 01525-000. lindabrenda1000@gmail.com
Introduction
Discussion.
The shortage of medicines is an old problem in Brazil,
Cause of Scarcity
aggravated by the scenario of the pandemic resulting
The World Health Organization (WHO) announced in
from COVID-19 that has been affecting the country
March 2020 that the world was in the midst of the
since
was
pandemic of the SARS-CoV-2 virus, which caused
accompanied by a financial crisis and the lack of
Covid-19 (Figure 1). The first measures taken were
beds, personal protective equipment, respirators,
non-pharmacological
oxygen, as well as insums for the production of
distancing and blocking the movement of people
diagnostic kits, medicines and vaccines have brought
(lockdown), aiming to reduce contamination by the
great
virus. The lack of vaccine or treatment at the time
February
2020.
consequences
The
not
health
only
for
crisis
the
Brazilian
measures,
such
as
social
population, but also for health professionals. (1)
and the lack of knowledge about the action of the
The drugs most susceptible to scarcity were those
virus in the human body made the pandemic a
with low unit value, as they are the most consumed
challenging situation for health professionals. (3,4)
by
of
The Brazilian population, which had a history of self-
pharmaceutical
medication, showed a significant increase compared
companies. (2) In Brazil, some large pharmaceutical
to the years 2018-2019: non-prescription drugs were
companies have ended their activities in the low
used by around 77% of Brazilians. And even among
complexity drug market to invest in the production of
those who received prescriptions, 57% did not make
high-cost, low-volume drugs.
correct use of medications. The beginning of the
the
population,
commercialization
which
interest
causes for
lack
pandemic period was marked by the indiscriminate Objective
use of medications, caused by the feeling of fear that
The aim of this review is to show the panorama of
took care of Brazilians in the search for prevention or
drug shortages in Brazil and worldwide during the
treatment through self-medication. (3)
pandemic period, contextualize and discuss how
The rapidly spread misinformation caused each
Brazilian hospitals were able to deal with the shortage
hypothesis of pharmacological treatment for Covid-
caused by the Covid-19 pandemic, aiming to assess
19 to generate a wave of consumption of a particular
from the causes of shortage to the response of
drug until its inefficacy was proven, leading to
hospitals, especially pharmacists in relation to the
disposal in the domestic environment. This wave of
crisis in the Brazilian public health system.
consumption, in the form of a temporary demand, changed the dynamics of supply and demand of inventories at various levels of the production chain.
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08
The shortage has come a problem because in Brazil,
Such
professionals of
are
policies
fundamental related
to
for
the
the acquisition of medicines is done by a bidding
development
appropriate
process formed by complex stages involving various
prescription and the correct dispensing of such
spheres of power and then distributed in health
medications. 9,10 In a country like Brazil that has
units, where they will be dispensed to patients. Thus,
been taken with a "fever" of fake news. (9) The
any delay or failure in this procedure leads to the
pharmacist should be attentive to prescriptions and
shortage of these health units. (5)
their respective reasons for valuing patients who really need the drugs and who suffer the most due to
Although the increased demand for certain types of
scarcity.
(10)
Furthermore,
this
professional
is
medication has caused shortages of some of these,
responsible for informing the population about the
the fact that many have raw material originating
disease, its form of contagion, symptoms and how to
from distant countries such as India and China also
prevent (figure 2), and the pharmacist is one of the
played an important role in such a shortage. (6)
main agents in this fight against fake news. (9) In addition, it is up to pharmacists with other
Adding to the situation in which the population suddenly
increased
drug
use
momentarily,
the
members of the multidisciplinary health team to evaluate therapies and switch to generic alternative
constant demand of those who made continuous use
medications
of certain drugs, the bureaucratic process for the
therapeutic options during this time of scarcity.
purchase
Because
of
pharmaceutical
inputs,
increased
and
they
to
observe
know
changes
between
pharmacokinetic
and
demand in hospitals for the increase in the number
pharmacological
of hospitalizations caused by the Covid-19 pandemic
fundamental in the use of adjuvant drugs aimed at
and the impossibility of significant storage in a
saving the use of others less present in stock. 10 To do
hospital environment, Brazil has found itself on the
so, it is important that the pharmacist or the health
verge of a collapse in health, especially in hospitals.
professional knows some sets of recommendations
This failure in the structure prevented several patients
aimed
from having access to their adequate treatments,
shortages, such as that published by the American
from patients with mild to severe conditions, faced
Society of Health-System Pharmacists10 and also by
with the need to resort to contingency plans in the
the Brazilian Association of Intensive Care Medicine
hospital pharmacy in order to maintain and continue
(AMIB). (6) An example of exchange that has been
the pharmaceutical services provided. (5,7)
observed in hospitals in Brazil is the cisatracurim
at
aspects,
circumventing
the
pharmacists
problem
of
are
drug
blocking agent for rocuronium. (10) Contour of scarcity
As some measures to meet the need evidenced by
The Hospital and Clinical Pharmacist is responsible
the scarcity of medicines, there is diversification of
for the cycle of the drug and hospital materials within
supply, with the use of predictive analysis to predict
the health unit, since its selection, for example so as
demand
to avoid the scarcity of this medication, as its storage
authorities. (9) It is also necessary to stress the
so that there are no unnecessary losses, and of course
importance of the government's incentive in relation
the dispensing and use with pharmaco-therapeutic
to factories in order to optimise the production of
follow-up of the patient. (8)
medicines without causing harm to good production
Also, pharmacists also serve as a basis for education regarding the use of medications.
and
also
cooperation
with
health
practices. Furthermore, epidemiological forecasting is important and should be adequate for each country in order to ensure the best supply in the right place at the right time. A communication aimed at the flexibility of bureaucratic procedures involving the purchase of medicines has been essential.
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09
It highlights the importance of a union between the
Moreover, dialogue, although it is somewhat cliché, it
Brazilian government, ANVISA and raw material
is the main way to deal with this situation. Whether
exporting countries. (9,11)
Intra-
and
interinstitutional,
government, Dialogue
and
cooperation,
both
intra
and
regulatory
between
agencies
and
the health
professionals, dialogue is the best way to optimize
interinstitutional, is generally fundamental for the
the delivery time of medicines. (13)
functioning
allowing
However, although it is relatively simple to do, there
interinstitutional
is often a great war of egos between politicians and
dialogue was key for industries to obtain medicines
regulatory agencies, especially here in Brazil, which
for those in need. 9 Intra-instiutional meetings are
sometimes interferes directly in the lives of several
also important to provide updates and concerns
people.
of
adjustments.
related
to
the
health
(10,12)
the
In
system,
Europe,
shortage
of
medicines
within
Conclusion and perspective
institutions. (10) In Brazil, in a report obtained from the Children's
With the current pandemic of Covid-19 it is clear the
Institute of the Hospital das Clínicas (ICr) complex, it
need for management from manufacturing to the
was noticed that an increase in communication
moment of dispensing to the patient of supplies and
between the hospital pharmacy and families through
also the regulation of the flow of medicines, health
calls and warnings related to the stock of medicines
and hygiene products and health care services in
was essential to overcome the problem of scarcity.
public
Still,
adequately
such
a
professional
should
support
other
and
private
hospitals,
trained
and
professionals
this
and
involves adequate
professionals and collaborate on a global level
support of equipment and supply of supplies (which
reporting
the
how
to
overcome
the
shortage
of
medicines. (10)
hospital's
purchasing
sector
has
great
responsibility requiring efficient strategies - reducing
The government in general also plays an important role in maintaining the stock of medicines. 11 One of
costs, and leaving no shortage, compromising patient care).
the fundamental measures to be taken would be the creation of a list of medicines that could potentially
Therefore,
become scarce during the pandemic period. 9
implement data analysis for the planning and
Furthermore, together with pharmacists, there could
distribution of resources, in addition to risk analysis
be the establishment of an approach to alternative
and management.
it
is
of
paramount
importance
to
generic bioequivalents that could be nationally
To avoid the shortage of medicines, a selection of
produced. Thus, there should be a channel of rapid
which would be essential for the treatment of more
communication
severe patients can be made, standardization of
ernment,
between
regulatory
institutions,
agencies
facilitating
and
health
these, verification of unit value and quantity in stock
professionals, dialogue is the best way to optimize
of them; availability and delivery time of suppliers
the delivery time of medicines. 13 However, although
remembering the minimum stock (reserve purchase)
it is relatively simple to do, there is often a great war
that should always be analyzed.
of egos between politicians and regulatory agencies,
Partnerships can also be made with other hospitals
especially here in Brazil, which sometimes interferes
and
directly in the lives of several people.
treatment.
mutual
help
to
not
interrupt
a
patient's
Authors' consideration
The pharmacist plays an important role in several contour methods related to the scarcity of medicines.
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10
9.
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pandemic.
Available
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<https://www.hcrp.usp.br/revistaqualidade/upload s/Artigos/250/250.pdf>. Accessed: Jan. 2022. 2. Nascimento
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importance of a contingency plan in the hospital pharmacy in the face of the pandemic by the new coronavirus. Research, Society and Development. 2021;10(7):e59610717098-e59610717098. 3. Moraes TIL, Pinheiro IRB, Damasceno CA. The performance of the pharmacist in the covid-19 pandemic period in Brazil. Brazilian Journal of Development. 2021;7(12):117942-117962. 4. Da Rocha Galucio NC, dos Santos Correa RM, Araújo Moysés D, de Souza Ramos JA, Silva DCPF, Tavares GF, et al. COVID-19: an observational study on the challenges faced by pharmacists in assisting and combating infection in times of pandemic. Research, Society and Development. 2021;10(15):e461101521140-e461101521140. 5. FIOCRUZ.
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MEDICATION SHORTAGE SITUATION IN HOSPITALS IN THE COASTAL AND MOUNTAIN REGIONS OF PERU 1 . Aron Francisco Cortez Quispe, 2. Diego Waldir Cabana Huancachoque, 3. Jorge Antonio Quispe Padilla, 4. Melanie Jhenieffer Choquehuanca Mollocondo 1 . Professional School of Pharmacy and Biochemistry, Universidad Nacional San Luis Gonzaga de Ica, Ica-Peru, 3rd Year, Partner of APEFyB. aroncortezquispe@gmail.com 2 . Professional School of Pharmacy and Biochemistry, Universidad Privada Cayetano Heredia, Lima-Peru, 5th year, Partner of APEFyB. diegocabana835@gmail.com 3 . Professional School of Pharmacy and Biochemistry, Norbert Wiener Private University, LimaPeru, Bachelor, Partner of APEFyB. Jorgequisp3@gmail.com 4 . Professional School of Pharmacy and Biochemistry, Universidad Privada Andina Nestor Caceres Velasquez, Puno-Peru, Graduated in pharmacy and biochemistry, Partner of APEFyB. jhiem312@gmail.com
Introduction
suffered from some comorbidity, whether acute or
The shortage of medicines is a phenomenon that has
chronic,
been
private
throughout the course of the pandemic, likewise
institutions, being that the World Health Organization
encompassing cancer as a comorbidity would not be
(WHO) recognizes it as a global problem. The shortage
counterproductive, this because 19.3 million new
of medicines is understood as "a problem of supply of
cases were registered in 2020, according to the
medicines that demands a change that impacts on
Peruvian Ministry of Health. (4)
resonating
in
both
public
and
are
or
have
been
the
most
affected
patient care and requires the use of an alternative therapeutic agent" [Abarca L. E., Marro R. D. 2016]
It is very clear the deficiencies in the structuring and
being that this problem can be temporary, and that it
management of the Peruvian health system, where
can be solved with the passage of time, such as, the
the response of public hospitals in charge of MINSA
withdrawal of the drug from the market by the owner
is limited, and although measures were taken to
of its commercialization, due to a constant shortage
reduce infections such as social confinement, in 2021,
with the consequence of a permanent cessation, so it
Peru at the forefront in the number of deceased
could alert and even reach a degree of social alarm. (1,
patients, of which it is shown in the specialties of
2)
Covid-19 care, oncological and emergencies.
In recent years, with the Covid-19 pandemic, the
Objectives
problem of drug shortages was accentuated, with hospitals,
health
shortage of opioid, antihypertensive and oncological
establishments in charge of MINSA being immersed
drugs in hospitals nationwide in the context of
in this problem.
recent years (2013 - 2021).
The National Institute of Statistics and Informatics
Methods
(INEI)
in
polyclinics
2020,
and
presented
other
the
public
To determine the factors and solutions on the
results
of
the
Through the review of scientific articles and
Demographic and Family Health Survey (ENDES-
information registered in the database of search
2020) being that the population evaluated is of
engines such as Pubmed, Web of science, SCIELO,
people with an age greater than or equal to 15 years,
Editorial Universidad de Granada, INEI, Peruvian
thus having that 39% of the surveyed population
Ministry of Health, and thesis; likewise, the collection
suffers from at least one comorbidity (risk factor),
of data from the inventory of medicines of the III
being these: obesity and / or diabetes mellitus and / or
Essalud Hospital (Puno) and the Daniel Alcides
hypertension. (3)
Carrión National Hospital (Callao) between 2021 and
Likewise, it was seen that those people who suffer or
2022.
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12
Image 1. Participation in corporate purchases in the budget of
pharmaceutical
products.
PHARMACEUTICAL
MARKET
AND
ACCESS TO MEDICINES IN PERU. MINSA, 2013. [5]
Table 1. Shortages on the inventory of oncological drugs during
the periods 2019-2022. Source: Daniel Alcides Carrion National Hospital (Callao)
Image 2. Main products in the public sector oncology market
Ugarte O. Strategies to improve access to medicines in Peru. An Fac Med (Lima Peru: 1990) [6]
Table 2. Undersupplied opioid medications
Source: Inventory of the Public Hospital III Essalud (Puno)
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4. Barriers in the public sub-market of non-strategic medicines, as reported by DIGEMID in 2013, not all public institutions participate in corporate purchases, only 28.4% of those of minsa, by 622 millions, went through them (6), as shown in figure 1. All this due to problems in management, generating delays in purchases and supply in the public sector: 5. Barriers in public sub-market of oncology drugs, due to high demand and large companies such as "Roche", which have dominant positions in the market (6), as shown in figure 2. Table 3. Undersupplied antihypertensive drugs
Source: Inventory of the Public Hospital III Essalud (Puno)
In 2019 the company "Roche", has a position in the oncology market; which represents 52% of total
Discussion
One of the citizen rights, which are found in the legislation in force at the level of the World Health Organization (WHO), is the ability to obtain the medicines and / or medical devices which are requested in order to promote, preserve and / or restore the health of the individual.
government procurement. (6) This reality occurs in several hospitals, such as the Daniel Alcides Carrión National Hospital (Callao), as shown in Table 1. Table 1 shows the drugs with the highest turnover in
Reports of shortages and shortages of essential medicines have been on the rise in recent years. It has been described in high-, middle- and low-income countries and is linked to manufacturing problems, as well as supply chain and health care financing difficulties, although there are several factors that cause it, these due to invisible barriers, which are the following:
the hospital. It is observed that the figures are reducing since 2020, this due to 2 factors: the Covid19 pandemic and the terrible management of previous years with respect to the supply schedules of oncological medicines, affecting the imports of these medicines directly. This shortage is currently a national
crisis,
with
oncohematological
patients
being the most affected, as shown in figure 3. Access to medicine has been violated through the rise in
1. Barriers in the public sub-market of strategic medicines, due to the high demand by the public sector and high offers by producers. 2. Vaccines, due to the high demand, due to the fact that the public sector assumes these purchases as state policies, and currently enhanced by covid-19, also due to its prioritization, other lines of medicine are left aside.
prices in the pharmaceutical market. It should be noted, for example: Paclitaxel, drug used in Breast Cancer, presentation 100mg in public hospitals has an average cost of 25 soles, currently due to shortage issues its price has been altered up to 500% more than usual, in the same way, it is the case of the public hospital III Essalud (Puno), as shown in table 2 and table 3.
3. Drugs from programs by results (PPR), caused by programming problems and limitations in public funding.
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February
17,
2022]. 8. Aruru M, Truong H-A, Clark S. Pharmacy Emergency Preparedness and Response (PEPR): a proposed framework for expanding pharmacy professionals' roles and contributions to emergency preparedness and response during the COVID-19 pandemic and beyond. Res Social Adm Pharm [Internet]. 2021 [cited February
17,
2022];17(1):1967–77.
Available
in:
https://pubmed.ncbi.nlm.nih.gov/32389631/
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A SLEEP PHARMACIST IN TIMES OF PANDEMIC 1. Maria de Guadalupe Enriquez Anco
1 . Universidad Andina Néstor Cáceres Velázquez, Faculty of Health, Professional School of Pharmacy and Biochemistry
Introduction
Fear was exacerbated by misinformation on social
SARS-CoV-2 is the new coronavirus. Since December
media and the media, often driven by erroneous news
2019, it has been the cause of the current global
and
pandemic of CoVID-19 where more than 9,700 cases
messages. After the declaration of emergency, a study
were confirmed in China and 106 in 19 other countries.
revealed an increase in negative emotions (anxiety,
(1) Although in 2003 SARS-Cov-1 (Predecessor of SARS-
depression and indignation) and a decrease in
Cov-2) had already been reported, which had infected
positive emotions (happiness and satisfaction). This
8422 people in 30 countries causing the death of 916
generated a different behavior among people, which
(World
led many patients to suffer from pathologies related
Health
Organization,
2003),
preventive
measures were not taken to control this disease.
misunderstanding
of
health
care-related
to mental health (3).
Countries such as Italy and Spain were the first to suffer the consequences of the late response to this
The most frequent problems around the world due to
virus, and when they tried to react, the spread had
the pandemic were insomnia and anxiety among
already become uncontrollable, it is worth mentioning
others, it is worth mentioning that in countries such
that in March 2020, the director general of the World
as the United States in 2017, an annual prevalence of
Health Organization (1) declared that Covid-19 went
the misuse of tranquilizers of 2.2% (approximately 6
from being an epidemic to a pandemic. (2) Due to the
million people) is reported in people over 12 years of
high risk of contagion of the virus and the number of
age but only 0.3% (739,000 people) met criteria of
increasingly confirmed patients and deaths in the
abuse or dependence. Similar data were increasing in
world,
spread
other parts of the world 3, and including in South
threatening the mental health of the population.
American countries where BZDs are easily obtained
According to reports of epidemics and pandemics
without a prescription 4. In addition, a progressive
that occurred, it is known that patients and health
increase in these figures can be seen over recent
personnel can suffer situations of fear of death and
times 3.5 on the other hand in Peru, Metropolitan
present feelings of loneliness, sadness and irritability
Lima registers in the adult population a lifetime
and fear.
prevalence of use of "tranquilizers" and "sleeping pills"
negative
emotions
and
thoughts
of 0.6%; the prevalence is similar in adolescents, in At the beginning of the SARS‐CoV‐2 pandemic in
which the age of onset ranges between 12 and 15
China, it caused alarms and stress in the general
years. (4)
population. The fear of the disease could be explained by
the
is
That is why our primary objective is to describe the
generated. The growing number of cases in patients
consumption of benzodiazepines used to record sleep
caused
in patients hospitalized due to the coronavirus
infected.
being the
infected
population
and to
uncertainty worry
about
that
getting
pandemic.
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Methods
This study is a descriptive study with a retrospective design since a collection of research applied to mental health was applied as well as case reports of patients in psychiatric units in times of pandemic. Results
Tables 3. Pathologies patients taking benzodiazepines during
hospitalization. Univariate analysis. (8)
Table 1. Demographic characteristics and co-morbidities of
patients taking and not consuming benzodiazepines (8)
Table 2 Benzodiazepienes consumed by patients
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Analytically, 244 (42.4%) patients had lymphopenia at
Discussion
The main motivation that supports the inappropriate use of BZD is to determine whether the symptoms of psychological distress associated or not with mental health problems (5) in this case lack of sleep. But different patterns of abuse of BZD (benzodiazepines) like in patients who develop some degree of physical dependence as a result of a regular prescription of BZD for an underlying problem such as anxiety or insomnia but who do not manage to modify their prescribed doses, another is in people who initiate a medically
prescribed
inappropriate
use
BZD
and
but
then
increase
their
develop doses
excessively. A third group consisting of people who were never prescribed BZD but use them for recreational purposes. Few cases of patients to BZD pass from group a) to group. A major challenge in differentiating between "misuse" and irrational use of BZD is the broad intersection between legitimate clinical
use,
self-administration
for
therapeutic
purposes and non-medical use(6). In fact, it is usual that the non-prescribed use of controlled drugs is reported as based on reasons that pretend to be therapeutic(6). Causing a tolerance to the sedative effects of the drug more quickly than to the other specific therapeutic effects, which leads to a dose escalation in order to achieve the desired sedation quickly. (7)
during hospitalization. Regarding its evolution, 400 (69.4%) patients required oxygen therapy; 82 (14.2%), invasive ventilation; and 84 (14.6%), admission to the ICU. 127 (22%) died. Additionally, patients who consumed benzodiazepines in Table 1 show the demographic characteristics and comorbidities and their respective differences according to gender at rankin scale(8). Regarding the consumption of BZD, it was seen that it is associated with greater severity of COVID-19 disease, significantly with a greater probability of need
for
oxygen
therapy,
invasive
ventilation,
admission to the ICU, acute respiratory distress syndrome,
severe
illness
due
to
COVID-19,
lymphopenia at the beginning of admission or lymphopenia during according to Table III. Since in all cases the p-value was greater than 0.2, we did not perform multivariate models. According to the 138 patients taking BZD at the time of admission, 39 (28.3%) died, nine (6.5%) were still hospitalized at the time of analysis and 90 (65.2%) were discharged. Of the latter group, 85 (61.6%) patients maintained BZDs at the same dose, two (1.5%) discontinued
The problems of emotional discomfort lower the threshold for emotional crises and thus lead to the increase in doses of the controlled substance, in this case, the BZD and even more in time of pandemic by the alarm of many factors that influence the sedative effect. Currently the journal of neurology published data from a study of 576 patients that within them is a percentage that use benzodiazepines that is 24% with respect to the application of the diagnosis was performed by polymerase chain reaction in 546 (94.8%) patients and / or serology in 175 (30.4%). Of the total, 549 (95.3%) had pneumonia. Disease severity was mild in 32 (5.6%) cases, uncomplicated pneumonia in 142 (24.7%), severe pneumonia in 269 (46.7%) and acute respiratory distress syndrome in 124 (21.5%).
the time of admission and 365 (63.4%) at some point
them, two (1.5%) changed active substances and one (0.7%) reduced the dose. Among the 235 patients younger than 65 years, 41 (17.4%) were taking benzodiazepines, compared with 97/341 (28.4%) over 65 years of age (p = 0.003). Patients under 65 years of age currently treated with benzodiazepines also had no higher mortality (8)(OR: 1,1; 95% CI 0.3-4; p = 0.887) or increased risk of severe illness from COVID-19 (OR: 0.8; 95% CI 0.4-1.6; p = 0.562). In the univariate regression analysis, there was no evidence of an increased risk of acute respiratory distress syndrome in this group (OR: 1.1; 95% CI 0.52.5; p = 0.887) nor an increased need for invasive ventilation (OR: 1; 95% CI 0.4-2.5; p = 0.992) or ICU admission (OR: 0.6; 95% CI 0.2-1.6; p = 0.282). (8)
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Conclusion
Currently our population the vast majority suffers from pathologies in mental health. One of them being,
the
coronavirus
pandemic.
Taking
into
account that the group of drugs of benzodiazepines are used as sedatives or to cause sleep as a result of fear among others, it is very important to mention that research reports that they did not present a higher mortality. Likewise, it is not associated with having a degree of risk in complications of acute respiratory distress syndrome, admission to the ICU or greater lymphopenia.
Salek-Ardakani S, et al. Benzodiazepine augmented γ-amino-butyric acid signaling increases mortality
from pneumonia in mice. Crit Care Med 2013; 41: 162736 7. Millar A, Hughes C, Ryan C. Evaluating the prevalence of potentially inappropriate prescribing in older adults in intermediate care facilities: a crosssectional observational study. Int J Clin Pharm 2017; 39: 527-35 8. Martínez s, E., García D., Trigo J., Talavera B., Valle Peñacoba, G., Hernández I. & ArenillasF. (2021). Effect of benzodiazepine treatment on hospital prognosis of
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1. WHO.
6. Sanders R, Godlee A, Fujimori T, Goulding J, Xin G,
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https://www.paho.org/sites/default/files/202002/2020-feb-28-phe-actualizacion-epi-covid19.pdf 2. Adhanom, T. 2020. "Coronavirus: WHO declares the global pandemic due to Covid-19". Medical writing. https://www.redaccionmedica.com/secciones/sani dad-hoy/coronavirus-pandemia-brote-de-covid19-nivel-mundial-segun-oms-1895 3. Mejia, C. R., Rodriguez, J. F., GarayL., Enriquez, M., Moreno, A., Huaytan-Rojas, K. & Curious, W. H. (2020).
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The association between benzodiazepines
and influenza-like illness-related pneumonia and mortality: a survival analysis using UK Primary Care data. Pharmacoepidemiol Drug Saf 2016; 25:1263-73
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THE IMPACT OF MEDICATION SHORTAGE OVER THE OFF-LABEL AND UNLICENSED USAGE OF MEDICATIONS 1 . Melissa Núñez Mora 1 . the University of Costa Rica. Member of Costa Rican Federation of Pharmacy Students (FECOEF).
Introduction
Also, the usage of off-label and unlicensed
The medication shortage has become a public health medicines is high because of the lack of approved problem since the second decade of the actual century. (1) medicines
for
specific
populations,
such
as
There is no consensus of the actual definition of this neonatal and pediatric patients, where unlicensed phenomenon even though the World Health Organization and off-label prescribing is the only solution. (5) (WHO) met to develop technical definitions of this term on The practice of using off-label and unlicensed October 5th, 2016.
medications is highly spread worldwide, especially
Different events may cause this phenomenon, classified in in
populations
with
rare
illnesses
where
the
four criteria as Acosta et al. defined in their study. The first demand is not enough to produce or investigate one regards the drug's life cycle, which means the specific treatments for these people. Another availability of the treatment depends on whether it is in example is populations that are generally excluded clinical
trials,
under
market
exclusivity,
generic from the clinical trial. As a result, no medicines can
competition, or marketing decline because of a new meet the patients' needs. (6,7) A product is used in product that substitutes the first one. The second one off-label conditions when prescribed in a way that refers to the existence or lack of substitutes—for instance, the country's Health Authority did not approve. An equivalent treatments on the market. The third one unlicensed, unregistered, or unauthorized product discusses problems in the supply chain, whether there is a has no marketing authorization given by the problem in logistics importation, production, or at the country's Health Authority. (8) wholesalers' or retail purchase level. The fourth one
Regarding this idea, when there is no treatment for
considers the demand, prices, and regulatory problems, a patient whose well-being is in danger, the health such as unexpected increases or reduction of prices. (2)
professionals face an ethical situation. Not having
There have been different initiatives around the world for available any medication because of shortage leads solving the medication shortage. Supply chain solutions them to look for an alternative, even knowing that may
include
designing
health
care
networks
that using a medication available but in off-label or
maximize the service level. (2) According to Abarca Lachén unlicensed conditions may also cause adverse and Marro Ramón, an excellent solution for supplying a reactions in the patients. (9) drug with no equivalent or no generic product is to use Also, for pharmacists it is a problem because they magistral formulas. (3) Countries such as Albania, Canada, must tell a patient that their medication is Cyprus,
Czech
Netherlands,
and
Republic, Portugal
Denmark, have
Finland,
established
Italy, unavailable. special responsibility
The are
pharmacists' providing
the
duty patients
and their
permits in order to import and dispense imported treatment as it is known. When they cannot do so, medicines even the patient information leaflet is not in their professional commitment is affected. the country's official language or are unlicensed in the country. (4)
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Pharmacists must judge if there is any available equivalent they can dispense or if the off-label or unlicensed prescription is effective and safe for the patient. (9) This paper aims to examine the impact of medication shortage on the off-label and unlicensed usage of medications and its consequences.
As mentioned, the definition of medication shortage to date does not have an official definition. During the WHO meeting, each participant country gave their definition, which at last did not give a complete definition. Hence, reading the 58 final participants' definitions, it is possible to address some similarities, as Figure 1 shows. (17,20)
Methods
The investigation is a literature review of practical research papers about medication shortage and offlabel and unlicensed drugs. The papers selected were published between 2012 and 2021. The consulted databases were Science Direct, Elsevier, Pubmed, JAMA International Medicine, and the World Health Organization.
For
the
restricted
research,
the
keywords used were drug shortages, pharmacy, pharmacist,
off-label,
unlicensed,
unapproved,
legislation, moral reasoning, pharmacy ethics, and adverse drug reactions. To select the articles, they must address the solutions regarding the drug shortage, definitions of the concept, legislation basis, unlicensed importation, off-label
and
adverse
drug
unlicensed reactions,
usage the
of
medications,
pharmaceutical
perspective of a drug shortage, patients' safety, ethical and moral reasoning of health professionals. Therefore, the articles were categorized following these inclusion criteria.
Therefore, it is possible to describe a medication shortage as a situation where the supply of approved medicines by the country's Health Authority does not meet the current demand, the public health, or the patients' needs. (20) Consequently, this problem directly affects the patients. The study of Said et al. about the incidence of consequences presented by patients after they received a substitute medication. The authors found that 54.9% of community pharmacies and 72.7% of hospital
pharmacies
dispense
less
effective
or
suitable drugs, 15% of community pharmacies and 39.4%
of
hospital
pharmacies
denied
lifesaving
treatments, and 60.4% community pharmacies and 18.2% hospital pharmacies reported adverse drug reactions (ADR) in their patients after they received a substitute medication. (17) Atif et al. also found that medication shortage produces ADR and a high risk of mortality
because
of
inappropriate
medication
substitutes. (18) Using unregistered and off-label medicines is considered a reasonable solution for medication
Results
Twenty papers fulfilled the inclusion criteria. Four addressed adverse drug reactions caused by off-label and unlicensed usage; four described unlicensed importation and legislation basis. Five related the offlabel and unlicensed usage. Three were about the pharmaceutical perspective of a drug shortage ethical and moral reasoning of health professionals. Two discussed patients' safety. Finally, seven papers describe
Discussion
drug
shortage,
causes,
consequences,
solutions, and definitions. In addition, the papers of Mason et al., Gray and Manasse, Vogler and Fischer, Acosta et al., and Whitfield et al. included helpful information to examine more than one category. Table 1 summarizes the information.
shortage in countries worldwide. According to Vogler and Fischer, the regulatory measures to minimize the impact of the medicines shortage of Moldova and Cyprus is to import unlicensed medicines with a special permit. (4) Likewise, Bochenek et al. found out that the 28 countries they studied had the legal possibility to prescribe unregistered medicines if needed because of a shortage. Switzerland also authorizes the import of unlicensed medicines. It is vital to note that the United Kingdom has accepted an
unlicensed
medication
prescription
during
medicine shortages. (19) The legal basis for this action is evident in Article 5 of Directive 2001/83/EC. (1) However, it is not viable to give an unlicensed product to the patient instead of the original licensed prescribed product without the doctor's consent.
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In knowing of the shortage, the physician must expressly prescribe the unlicensed medicine to the
patient of the possible risks of receiving this kind of
patient. (19)
treatment as a way of providing them a solution for
As Gray and Manasse pointed out, the global market
the lack of their initial treatments. (16)
has failed to meet the pediatric patients' necessities.
The
(13) Pediatrics is one of the main areas where off-label
pharmacists and other health professionals must
and unlicensed drugs must be used because of the
address.
shortage
For
pharmacists find it cumbersome to substitute a
instance, Borges et al. found that 50% of the Brazilian
treatment due to shortage since their decision might
pediatric patients that participated in their study
negatively affect the patients' health. Hence, doing
were treated with at least one unlicensed anti-
these evaluations of changing a treatment requires
epileptic drug. (14) Similarly, Acosta et al. saw that
advanced
over 35% of the drug shortage in South America
communication skills to give the patient an efficient
consists of treatments for the nervous system. (2)
explication of the situation and its implications. (9)
Hence, Whitfield et al. discovered that in the United
The medication shortage is a problem that involves
States, one of the main strategies to mitigate the
political efforts and needs the expertise of health
medication shortage was to change the formulations
professionals because this problem directly affects
and dilutions of medications, which is part of the off-
the patients. Denying a lifesaving treatment, giving
label practice. (15)
the patients less effective drugs, or generating ADR is
of
medicines
for
these
patients.
increasing
ADR
Kruijtbosch
represents et
al.
an
issue
demonstrated
pharmaceutical
expertise
that that
and
not a risk that one should be willing to take. (17,18) Since off-label and unlicensed medications are
Consequently, pharmacists must prepare to face
extensively used, the implications must be analyzed.
difficult but scientific-based decisions that care for
Pratico et al. studied the employment of off-label
the patients' health. (9)
medicine in 5060 pediatric patients and concluded that those patients treated with an off-label drug had
Moreover, many patients present ADRs when giving
a 7.3% probability of presenting an ADR, while the
them the off-label or unlicensed alternative. However,
on-label
A
not medicating a patient when necessary is also not
comparable study in the adult population, done by
an option. Consequently, even if a solution for the
Eguale et al., concluded that the rate of ADR was
medicine shortage is to use off-label and unlicensed
higher on the patients who received an off-label
medicines, the more it is accepted and the more the
medication than those using an on-label medication.
medicines shortage,
(11) Bellis et al. also studied the ADR after using off-
the higher the usage of these medicines in different
label and unlicensed medicines and determined that
conditions
these medicines have more probability of causing
following this practice may risk the health of many
ADR than the on-label and authorized medicines.
patients, which is why other solutions should prevail
(10)
over this one.
patients'
probability
was
1.2%.
(12)
Pharmacists and physicians face ethical and moral
from
the
original
ones.
Therefore,
Conclusions
difficulties when there is a medicines shortage. Using
The medications shortage leads to an increase in the
unlicensed and off-label medicines to solve the
off-label and unlicensed usage of medicines, which
medication
patients
represents a risk in patients' lives and may increase
presenting ADR during their treatment. (10–12) Thus,
ADRs' manifestation. However, not looking for a
they
solution
must
treatment,
deficiency guarantee assuring
leads the
that
to
more
patients their
get
health
is
their not
compromised with the decision. Therefore, educating
also
endangers
patients'
health.
These
circumstances lead to an ethical problem: using or not using medicines may damage a patient.
the patient in their alternative treatment is essential since the original medication is unavailable, as well as
to
assure
the
understanding of the
acceptance,
THEandDOSAGE
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23
9. Kruijtbosch M, Floor-Schreudering A, Leeuwen E Pharmacists have the leading role in this issue
van, Göttgens-Jansen W, Bouvy ML. Moral reasoning
because they must conduct a professional and
perspectives of community pharmacists in situations
ethical judgment regarding the risk/benefit and
of drug shortages. Res Soc Adm Pharm [Internet].
consider the patient's health a priority. Doing more
2020;
research
https://www.sciencedirect.com/science/article/pii/S15
on
new
drugs,
new
uses
of
the
commercialized drugs, and clinical trials may help decrease the medications shortage and reduce the usage of unlicensed and off-label medicines.
Available
from:
51741120311979 10. Bellis JR, Kirkham JJ, Nunn AJ, Pirmohamed M. Adverse drug reactions and off-label and unlicensed medicines in children: a prospective cohort study of
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