The Dosage - Second Edition (English)

THE DOSAGE

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.

Bibliography

COVID-19

pandemic.

Available

in:

<https://www.hcrp.usp.br/revistaqualidade/upload s/Artigos/250/250.pdf>. Accessed: Jan. 2022.

2. Nascimento

Costa

CA,

costa

DDSB.

The

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.

Technical

note.

Available

in:

<https://www.arca.fiocruz.br/bitstream/icict/42974/ 2/Desabastecimento_medicamentos.pdf>.

Accessed: Jan. 2022.

6. AMBI.

Guidelines

on

the

management

of

medicines in situations of scarcity in the context of

the

MARTINS,

Maria

Auxiliadora;

FONSECA DE MEDEIROS, Amanda; DIAS CARNEIRO

1. FMRP-USP. Inventory management in coping with the

A.PARREIRAS

Covid-19

pandemic.

Available

DE ALMEIDA, Claudmeire; MOREIRA REIS, Adriano Max. Preparedness of pharmacists to respond to the emergency of the COVID-19 pandemic in Brazil: a comprehensive

overview.

Drugs

and

Therapy

Perspectives, [S. l.] , v. 36, n. 10, p. 455–462, 2020. DOI: 10.1007/s40267-020-00761-7.

Available

in:

https://doi.org/10.1007/s40267-020-00761-7.

10. Badreldin HA, Atallah B. Global drug shortages due to COVID-19: impact on patient care and mitigation strategies. Res Social Adm Pharm. 2020; S1551–7411(20):30569–76.

11. Rosa MB, Reis AM, Perini E. Drug shortage: a public health

problem.

Cad

Saude

Publica.

2016;32(10):e00086916.

12. Shukar S, Zahoor F, Hayat K, Saeed A. Drug Shortage : Causes , Impact , and Mitigation Strategies.

2021;12(July):1–18.

13. Chaves, L. A., Chaves, G.C., Vianna, M. N. S., & Oliveira, M. The.. Drug shortage in the scientific health literature:

a

narrative

health

journal,

PHYSIS:

review.

29,

e

collective

290107,(2019);

https://doi.org/10.1590/S0103-73312019290107.

at

<https://www.ismpbrasil.org/site/noticia/orientacoes-sobre-omanejo-de-medicamentos-em-situacoes-deescassez-no-contexto-da-pandemia-covid-19/ >Accessed jan 14, 2022.

7. CRF. Hospital Pharmacy Commission. Available in: <http://www.crfsp.org.br/comissoesassessoras-/182-comissao-de-farmaciahospitalar.html>. Accessed: Jan. 2022.

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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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13

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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14

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15

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at:

<https://repositorio.usmp.edu.pe/bitstream/handle/20 .500.12727/2956/portocarrero_rmj.pdf? sequence=3&isAllowed=y>

[Accessed

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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(COVID-19).

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

awareness,

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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Report No.: WHO/EMP/IAU/2017.03. Available from: https://www.who.int/medicines/areas/access/Meeting _report_October_Shortages.p df

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