Mediterranean Journal of Pharmacy & Pharmaceutical Sciences

www.medjpps.com ISSN: 2789-1895 online ISSN: 2958-3101 print

Original article

Pharmaceutical situation of the pharmacological treatment of hospitalized patients

with COVID-19 in Libya

Hudam A.M. Elhouni* and Sarah A. Shabu

Department of Pharmaceutics, Faculty of Pharmacy, University of Tripoli, Tripoli, Libya

*
Author to whom correspondence should be addressed

Received: 70-02-2022, Revised: 28-02-2022, Accepted: 13-03-2022, Published: 31-03-2022

Copyright © 2022 Elhouni & Shabu. This is an open access article distributed under the Creative Commons Attribution
License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly
cited.

HOW TO CITE THIS

Elhouni & Shabu (2022) Pharmaceutical situation of the pharmacological treatment of hospitalized patients with COVID-19 in
Libya. Mediterr J Pharm Pharm Sci. 2 (1): 91 - 99. https://doi.org/10.5281/zenodo.6399936

Keywords: Coronavirus, indicator, Libya, national treatment guidelines, World Health indicators

Abstract: By January 2020, severe acute respiratory syndrome coronavirus-2 has spread internationally to a
pandemic that mainly targets the respiratory system. The relevant infectious disease has been identified as
coronavirus disease-2019 (COVID-19) by World Health Organization and declared as a global pandemic. In
Libya, National Center for Disease Control reported the first case of coronavirus disease-2019 on 24th March,
2020. The authorities decided to close borders and activate designated treatment centers to deal with COVID-
19 cases and contain the outbreak of SARS-COV-2. This study aimed to assess and evaluate the pharmaceutical
situation of medications used in pharmacological management of hospitalized COVID-19 patients in Tripoli,
Libya. Three WHO availability indicators were selected to be studied and reported. A comprehensive list of
medicines used in the management of hospitalized COVID-19 patients was constructed after reviewing and
comparing seven national and international pharmacological management protocols and guidelines for
hospitalized COVID-19 patients. This comparison revealed that nearly 50 medications are intended for use in
COVID-19 inpatient pharmacological management. They all agreed about the use of three medications,
representing one from each main class. This list was used to cross check their availability at the chosen
designated COVID-19 treatment center. This study proved that local treatment center’s protocol is more in
line with international guidelines than the national treatment guideline. The later was issued on March 2020.
The Libyan National Essential Medicines’ List contained 25 out of 50 medications of the comprehensive list
based on the last update in April 2019. This study recommends that national treatment guidelines and National
Essential Medicines’ list require updating. Not all medications used in COVID-19 inpatient management were
available in local treatment centers, although, the Emergency Management Department of Ministry of Health
in Libya is responsible for the supply of the required medical supplies and medications to the COVID-19
treatment centers.

Introduction
At the end of December 2019, a wide number of Wuhan, China. A few days after the incident, the
idiopathic pneumonia cases have been reported in causative agent of this pneumonia was determined
as a novel coronavirus [1]. This causative virus has been named as severe acute respiratory syndrome
Elhouni & Shabu (2022) Mediterr J Pharm Pharm Sci. 2(1): 91-99. 91-99
 Mediterranean Journal of Pharmacy & Pharmaceutical Sciences
www.medjpps.com ISSN: 2789-1895 online ISSN: 2958-3101 print

coronavirus-2 (SARS-COV-2) and the relevant their local standard treatment protocols. In
infectious disease has been identified as coron- addition, these facilities are expected to extract
avirus disease-2019 (COVID-19) by the their local medicines’ list from the national
International Committee for Taxonomy of Viruses medicines’ list. This study aimed to assess and
and World Health Organization (WHO) [2, 3]. By evaluate the pharmaceutical situation of
January 2020, COVID-19 has spread medications used in the pharmacological
internationally to become a pandemic that mainly management of hospitalized COVID-19 patients in
targets the respiratory system. On 24th March, 2020, Tripoli using WHO availability indicators.
the National Center for Disease Control reported
the first case of coronavirus disease-2019 in Libya. Materials and methods
By the middle of March 2020, Libyan authorities
This is a prospective observational assessment
decided to close the borders, suspend classes in
study. It was conducted in Tripoli, Libya during the
public and private schools and universities
period from October to the middle of December,
throughout the country and activate the country’s
2021.
lockdown. In response to providing medical
management to the diagnosed cases, Ministry of
Study design: WHO operational package for
health and through its emergency management
assessing, monitoring and evaluating country
activated designated COVID-19 treatment centers
pharmaceutical situation was used to determine the
across all of Libya. In Tripoli, Tripoli Central Hospital
targeted indicators and the specific forms were
and Zawiat-Al-Dahmani centers were firstly activated
accordingly modified and adjusted for the purpose
followed by Mitiga center and Souq-Altholatha
and scale of the study [4]. The study involved
center to contain the outbreak and deliver healthcare
multiple steps including documents reviewing, data
services and medical management for the
collection, physicians’ interviews and data
confirmed COVID-19 cases requiring hospital-
analysis. The following indicators were defined for
ization. Currently, there are six COVID-19
this study: availability of standard treatment
treatment centers in Tripoli. At the early beginning
guidelines, availability of medications in Nationa
of the pandemic, there was no well-established
Essential Medicines’ list (nEML), WHO Essential
treatment protocol for the emerging disease but
Medicine List (WHO EML) and British National
soon after declaring it as a global pandemic, WHO
Formulary (BNF), as well as availability and
has issued guidelines for clinical management
affordability of medicines in public COVID-19
guideline. It was all started as a symptomatic
treatment Centers.
treatment then evidence-based treatment
recommendations developed. Therefore, some
medications were withdrawn from COVID-19 Study indicators
treatment guidelines after they were used at the
beginning of the pandemic. These medicines have Availability of standard treatment guidelines: An
proved no clinical improvement or serious side online search was conducted to obtain Libyan
effects and it is now recommended against their pharmacological management protocol for
use. At the same time, other treatments and hospitalized COVID- 19 patients. WHO guidelines
medications were gaining approval and the for treating COVID-19 hospitalized patients was
COVID-19 treatment panel at WHO recommends also used and to be able to generate a
their use. WHO encourages countries to have comprehensive list of medicines for hospitalized
updated national standard treatment guidelines COVID-19 patients. Relevant guidelines and
(nSTG) with medications included in an updated protocols from the United States, United Kingdom,
National Essential Medicines’ list. On the other Ireland and Germany were also attained. Local
hand, local healthcare facilities are expected to treatment protocol from designated COVID-19
adopt the national standard treatment guidelines in treatment centers was planned to be obtained via an

Elhouni & Shabu (2022) Mediterr J Pharm Pharm Sci. 2(1): 91-99. 91-99
 Mediterranean Journal of Pharmacy & Pharmaceutical Sciences
www.medjpps.com ISSN: 2789-1895 online ISSN: 2958-3101 print

official request letter. An official letter requesting obtained via an official letter requesting ‘the
‘the treatment guidelines used by physicians for treatment guidelines used by physicians for
hospitalized COVID-19 patients’ was oriented to hospitalized COVID-19 patients. Because of the
one of these centers in Tripoli. It was confirmed that sensitive nature of the specialty of these centers and
all centers apply the same treatment protocol. All of their highly restricted accessibility, it was only
the above mentioned pharmacological feasible to deal with one center. However, they
management protocols and guidelines were orally confirmed that all COVID-19 designated
reviewed and compared. A comprehensive list of treatment centers in Tripoli apply the same
medications used in the management of treatment protocol. Although they did not have an
hospitalized COVID-19 patients was also official written internal document of this protocol to
generated. share to us in response to our request, instead they
were able to reply with actual treatment applied for
certain cases. The analysis of the seven protocols
Availability of medications in the nEML, WHO
and guidelines revealed that total of 50
eML and BNF: Medications that are included in the
medications are used in the pharmacological
adopted comprehensive list of medicines used in
management of COVID-19 in-patients. They
the management of hospitalized COVID-19
were all registered in a comprehensive list of
patients were checked for availability in the nEML,
pharmacological used in the management of
WHO EML 22nd list and BNF-81 [5, 6].
hospitalized COVID-19 patients. The distribution
of these medications per each guideline and
Availability and affordability of medicines in public percentage of agreement and disagreement are
treatment centers: The comprehensive list of shown in Tables 1 and 2. All guidelines have
medications was used to cross check their agreed about the use of the three medications:
availability and pricing at the chosen designated remdesivir, methylprednisolone and enoxaparin.
COVID-19 treatment center. These medications represent one of each main class
of medications used in COVID-19 management.
Local treatment center protocol and National
Statistical analysis: All data obtained were entered Treatment Guideline have eight medications in
into a Microsoft Office (2007) Excel file. A common. It is also evident from the results that the
statistical descriptive included frequency and local treatment center’s protocol is more in-line
percentage of agreements and disagreements in with other international guides than the national
availabilities were used. COVID-19 management guidelines.

Results
Indicator 2: Availability of medications in nEML,
Indicator 1: Availability of standard treatment WHO eML and BNF: The nEML (LML), WHO
guidelines: A total of seven protocols and EML and BNF-81 have been obtained. The
guidelines have been obtained, six of them were comprehensive COVID-19 medications list was
documented and available online (WHO, US, UK, compared against these documents and the results
Irish, German and National treatment guidelines about their medications availability and inclusion
[7]. Whereas, the local treatment protocol from are shown in Tables 3 and 4.
designated COVID-19 treatment center was

Table 1: Distribution of COVID-19 medications among treatment guidelines and protocols

Elhouni & Shabu (2022) Mediterr J Pharm Pharm Sci. 2(1): 91-99. 91-99
 Mediterranean Journal of Pharmacy & Pharmaceutical Sciences
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Local National
Treatment Treatment US UK Irish German WHO
Center Guideline Guidelines Guidelines Guidelines Guidelines Guidelines

No. of
Medications 24/50 16/50 23/50 25/50 18/50 27/50 30/50
per total (%) 48.0% 32.0% 46.0% 50.0% 36.0% 54.0% 60.0%
VTE prophylaxis
(9) 05 02 03 04 05 07 05
(55.6%) (22.2%) (33.3%) (44.4%) (55.6%) (77.8%) (55.6%)
Systemic
Corticosteroids(6) 02 01 06 06 05 05 06
(33.3%) (16.7%) (100%) (100%) (83.3%) (83.3%) (100%)
Antibiotics 06 02 02 07 02 08 11
(11) (54.6%) (18.1%) (18.2%) (63.6%) (18.2%) (72.7%) (100%)
Antiviral and 01 02 04 03 04 04 04
MABs (6) (16.7%) (33.3%) (66.7%) (50.0%) (66.7%) (66.7%) (66.7%)
IL-2 receptor 01 01
blockers (1) NIL NIL NIL NIL NIL
100% 100%
IL-6 receptor 01 02 02 01 01 02
0.00% (50.0%) (100%)
blockers (2) (50.0%) (100%) (100%) (50.0%)
Vitamins and 04 03 04 01
supplements (66.7%) (50%) (66.7%) NIL NIL (16.7%) NIL
(6)
Others* 05 05 01 01 01
(9) NIL NIL
(55.6%) (55.6%) (11.1%) (11.1%) (11.1%)

*Others: Hydroxychlorquine, Colchicine, Ipratropium bromide, hypertonic saline solution, N-acetylcystein, Omeprazole, Famotidin,
Bromhexine.

Table 2: Availability of COVID-19 medications in different protocols and guidelines

Local National
Treatment Center Treatment US UK Irish German WHO
Protocol Guidelines Guidelines Guidelines Guidelines Guidelines Guidelines

Local
treatment 24/24 8/16 10/23 12/25 7/18 15/27 13/30
Center Protocol (100%) (50.0%) (43.5%) (48.0%) (38.9%) (55.6%) (43.3%)
National
Treatment 8/24 16/16 8/23 6/25 4/18 7/27 8/30
Guidelines (33.3%) (100%) (34.8%) (24.0%) (22.2%) (25.9%) (26.7%)

US 10/24 8/16 23/23 17/25 14/18 13/27 19/30

Guidelines (41.7%) (50.0%) (100%) (68.0%) (77.8%) (48.2%) (63.3%)
UK 12/24 6/16 17/23 25/25 16/18 18/27 21/30
Guidelines (50.0%) (37.5%) (73.9%) (100%) (88.9%) (66.7%) (70%)
Irish 7/24 4/16 14/23 16/25 18/18 15/27 17/30
Guidelines (29.2%) (25.0%) (60.8%) (64.0%) (100%) (55.6%) (56.7%)
German 15/24 7/16 13/23 18/25 15/18 27/27 24/30
Guidelines (62.5%) (43.8%) (56.5%) (72.0%) (83.3%) (100%) (80.0%)
WHO 13/24 8/16 19/23 21/25 17/18 24/27 30/30

Guidelines (54.2%) (50.0%) (82.6%) (84.0%) (94.4%) (88.9%) (100%)

Table 3: Distribution of COVID-19 medications among the medicine's lists

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 Mediterranean Journal of Pharmacy & Pharmaceutical Sciences
www.medjpps.com ISSN: 2789-1895 online ISSN: 2958-3101 print

National Essential WHO Essential British National

Medicine’s List nEML Medicine’s List WHO EML Formulary
(2018-2019) ( 2021) (BNF 81, March 2021)
No. of medications 26/50 28/50 42/50
per total (%) (52.0%) (56.0%) (84.0%)

VTE prophylaxis 2/9 6/9 7/9

(9) (22.2%) (66.7%) (77.8%)
Systemic 5/6 5/6 6/6
corticosteroids (6) (83.3%) (83.3%) (100%)
Antibiotics (11) 9/11 9/11 11/11
(81.8%) (81.8%) (100%)
Antiviral and MABs 1/6 3/6
NIL
(6) (16.7%) (50.0%)
IL-6 receptor 1/2 2/2
NIL
Blockers (2) (50.0%) (100%)
Vitamins and 3/6 2/6 5/6
supplements (6) (50.0%) (33.3%) (83.3%)
Others* 6/9 5/9 8/9
(9) (66.7%) (55.6%) (88.9%)
*Others: Hydroxychlorquine, Colchicine, Ipratropium bromide, hypertonic saline solution, N-acetylcystein,
Omeprazole, Famotidin, Bromhexine.

Table 4: Comparing availability of COVID-19 medications in different medicines

lists with percentageof agreement
National Essential WHO Essential British National
List Medicine’s List Medicine’s List Formulary (BNF 81)

National Essential 26/26 20/28 26/42

Medicine’s List (100%) (71.4%) (61.9%)
WHO Essential 20/26 28/28 27/42
Medicine list (76.9%) (100%) (64.3%)
British National 26/26 27/28 42/42
Formulary (100%) (96.4%) (100%)

The BNF-81 has most of the medications listed in Indicator 3: Availability and affordability of
the comprehensive COVID-19 medications list medicines in public treatment centers: COVID-19
representing of 84.0% (42 out of 50). While the medications for in-patients were surveyed for
WHO and the National EML included 56.0% and availability in one treatment center, it is reported
52.0% of medications listed in the comprehensive that the pharmacy store at the surveyed center had
COVID-19 medications list, respectively. The 24 medications available out of 50 (48.0%). The
number of medications in common between WHO availability of medications used in the treatment
EML, nEML and BNF-81 was 21, representing protocol of the designated treatment center reached
42.0% of the 50 medications intended for use for to 75.0% (18/24). All of the treatment center
COVID-19 in-patient pharmacological management medications are listed in the BNF-81
management. However, six medications that were [6], while WHO EML and nEML contained 16/24
not listed in WHO EML, nEML nor BNF, namely: (66.7%) and 15/24 (62.5%), respectively. The
LMWH certoparin, vitamin C IV, bromhexien, affordability could not be extensively studied
casirivimab, imdevimab and favipiravir. because the medication prices results are not

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 Mediterranean Journal of Pharmacy & Pharmaceutical Sciences
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conclusive. However, the affordability of treatment treatment center have overall higher percentage of
is illustrated through case of pharmacological medications-inclusion agreement with other
management and treatment for one day. This international treatment guidelines compared to that
clinical case details has been obtained from the of the national COVID-19 treatment guideline. It is
treatment center with the pharmacological evident that treatment protocol in the local
management applied. Thus, a case study is male treatment center is more in-line with others (WHO
patient age is not reported who is a known case of and international guidelines) than the national
hypertension and diabetes mellitus type II was treatment guideline. This is because the national
admitted because of COVID-19 diagnosis treatment guideline has not been updated while the
confirmed by PCR on admission and his vital signs local treatment center’s physicians were up to date
and laboratory investigations were as follows: with recent medications added or withdrawn from
Temperature: 37 oC, Sp O2: 88.0%, Blood pressure: the WHO guidelines. The national treatment
140/90 mmHg, D Dimer: 1500, PCT: - 0.350, CRP: guideline and the local treatment center protocol
110. The pharmacological management of the case have eight medications in common. According to
involved: anti-inflammatory medication: methyl- physicians at the treatment center, methyl-
prednisolone 50 mg IV 1 x 2, antibiotics: prednisolone showed beneficial effect with severe
meropenem 1 gm IV 1 x 3 and ciprofloxacin 200 and critical COVID-19 hospitalized patients with
mg IV 1 x 2. Anti-coagulant: enoxaparin 6000 IU inflammatory responses in addition to
SC 1 x 2. Paracetamol 1 gm IV 1 x 3 and insulin dexamethasone. However, methyl prednisolone
sliding scale. The cost of the pharmacological was much more available in the treatment center’s
treatment for one day is 293 LYD, and in case of store. Whereas, other guidelines are flexible
early diagnosis and remdesivir is added, the cost recommending dexamethasone, prednisolone,
would be 1173 LYD (based on prices from the methylprednisolone or hydrocortisone, having
private sector). dexamethasone as first-line for the treatment of
critical cases in their advanced stages. Although,
Discussion national treatment guidelines included two
After reviewing and analyzing the seven anticoagulants; enoxaparin and tinzaparin, the
guidelines, the comprehensive list of medications COVID-19 treatment center protocol included five
used in the management of hospitalized COVID-19 different medications as anticoagulants for
patients has contained 50 medications. The national thromboprophylaxis. On the other hand, there were
treatment guidelines revealed the least percentages of only unfractionated heparin and fondaparinux
agreement with the other guidelines. The lowest available in the stores because these anticoagulant
percentage of agreement was between the Irish medications are approved in the current nEML.
guideline and the national treatment guideline. The The treatment center protocol and the national
reason is that the Irish guideline and the national treatment guideline included the antiviral
treatment guideline have the least total number of remdisivir, which was first granted approval by the
medications 18 and 16 medications respectively, Food and Drug Administration of the US to be used
therefore their probability of matching is the least. for the treatment of COVID-19 hospitalized
Highest percentage of agreement was between the patients, however, WHO published conditional
Irish guideline and the WHO guideline. This is recommendation against the use of remdisivir in
expected knowing that WHO guideline contains hospitalized COVID-19 patients on 20th November
wide range of medications and the Irish guidelines 2020. The panel explained the reasons as the
is last updated in July 2021. On the other hand, the absence of conclusive evidence on the effect on
national treatment guideline [7] which has not been mortality, need for mechanical ventilation,
updated since March 2020, has 16 medications and recovery from symptoms and other patient-
only eight of which are present in the WHO important outcomes [8]. This medication is
guideline. The local treatment protocol at the available in the local treatment center stores

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although it is not on the nEML nor the WHO EML COVID-19 medications list and the three essential
for the reasons explained above. The national medicine’s lists (nEML, WHO EML and BNF-81)
treatment guideline included favipiravir, although confirmed that there are six medications are not
at the time of its issue there was no international listed in all of them. Casirivimab and imdevimab
professional bodies recommend the use of were approved in September 2021, therefore it is
favipiravir for the treatment of COVID-19. A very possible that they are listed in the BNF-82
systematic review and meta-analysis suggested that (September 2021 edition) as they are included in
in in-patients with mild-to-moderate COVID-19, the UK guideline (October, 2021). They are not
favipiravir can stimulate viral clearance within listed in WHO EML (October 2021) probably
seven days and clinical improvement within 14 because they have conditional recommendation [8]
days yet recommended further investigation to and of their high cost. Favipiravir is still under
assess the effect in patients with different levels of clinical trials and this is more likely reason for not
disease severity and the different doses and being listed. The reasons for certoparin, vitamin C
durations of therapy [9]. IL-6 receptor blocker are and bromhexien not being listed are not certainly
newly emerging classes in the management of known but it is possible that there is no enough
hospitalized COVID-19 patients and up to the date supporting evidence for their use or the presence of
of this research, tolcilizuma and sarilumab are more cost effective alternatives. Certoparin was
strongly recommended for use in COVID-19 present in the Irish and German COVID-19
patients by the WHO [8]. Monoclonal antibodies; treatment guidelines only.
sarilumab and imdevimab are also not used for The availability of COVID-19 management
COVID-19 in-patients in Tripoli. There are medications was checked in the treatment center
multiple factors that should be considered before stores, about 50% of the medications are available.
recommending these agents’ inclusion in the The treatment center stores had 75% of the center’s
national treatment guideline and nEML, two of protocol medications. Central public supply stores
which are cost effectiveness and health equity. IL- do not directly supply the designated COVID-19
2 receptor blockers are only mentioned as class of treatment centers, the reason why the treatment
medication in the US guideline [10] and the WHO center stores included remdesivir when it is not on
guideline [8]. The findings confirmed that the the nEML. The emergency management
BNF-81 [6] included most of medications used in department at ministry of health supplies the
COVID-19 management for hospitalized patients, treatment centers with medications but because of
because it is updated regularly. nEML represented time constrain it wasn’t possible to obtain regarded
the lowest percentage of inclusion (52.0%), its last information for comprehensive central availability
update was in April, 2019 which explains the and affordability analysis. The cost of pharmaco-
absence of new medications recently approved for
ogical treatment for one day of a specific case is
COVID-19 treatment such as remdesivir. Although calculated as 293 LYD if remdesivir is not used
WHO EML edition was updated in 2021, the otherwise it will be 1173 LYD. This cost does not
percentage of medication inclusion was 56.0% include the clinical management cost required. This
medications included. This is because some high cost is calculated according to the private stores
cost medications are not listed in the WHO EML prices and it is relatively expensive to be
and limited to treatments that the panel strongly maintained by patients in private sector. This
recommends their use. The WHO EML, nEML and emphasizes the urgency to maintain continues supply
BNF-81 have 21 medications (42.0%). For the of medications to the stores at the treatment centers
same above explained reasons, it was found that all with the required medications stocks.
of the treatment center management medications Conclusion: This study succeeded to report WHO
are listed in BNF-81 [6] but lower number of them availability indicators as part of assessing and
are in WHO EML (65.0%) and the nEML (60.0%). evaluating the pharmaceutical situation of the
Further comparison between the comprehensive pharmacological treatment of the COVID-19. This

Elhouni & Shabu (2022) Mediterr J Pharm Pharm Sci. 2(1): 91-99. 91-99
 Mediterranean Journal of Pharmacy & Pharmaceutical Sciences
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study proved that the applied local treatment center need to update the nEML and the national COVID-
protocol is more in-line with the international 19 treatment guidelines. This would encourage
guidelines. However, they are required to document application of cost effective and evidence based
their up to date treatment protocol to support internal practices and bring best utilization of human and
auditing and reviewing. In addition, there is urgent financial resources.

Acknowledgements: The authors would like to thank healthcare professionals for their collaborative and support of this study.
Author contributions: Both author contributed equally.
Author declarations: The authors confirm all relevant ethical guidelines have been followed and any necessary IRB and/or
ethics committee approvals have been obtained.
Conflict of interest: The authors declare absence of any commercial or financial relationships that could be construed as a
potential conflict of interest.
Ethical issues: Including plagiarism, informed consent, data fabrication or falsification and double publication or submission
have completely been observed by authors.
Data availability statement: The data that support the findings of this study are available from the corresponding author upon
reasonable request.

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