Maria Jose Nino-Orrego1, Daniela Baracaldo-Santamaría2, Claudia Patricia Ortiz3, Heyde Patricia Zuluaga4, Sthefany Alejandra Cruz-Becerra4, Franklin Soler5, Andrés M Pérez-Acosta5, Daniel Ricardo Delgado6, Carlos-Alberto Calderon-Ospina7. 1. Center for Research in Genetics and Genomics (CIGGUR), School of Medicine and Health Sciences, Universidad del Rosario, Bogotá, Colombia. 2. Pharmacology Unit, Department of Biomedical Sciences, School of Medicine and Health Sciences, Universidad del Rosario, Bogotá, Colombia. 3. Corporación Universitaria Minuto de Dios-UNIMINUTO, Programa de Administración en Salud Ocupacional, Grupo de Investigación en Seguridad y Salud en el Trabajo, Neiva, Colombia. 4. Colombian Association of Pharmacovigilance, Bogotá, Colombia. 5. Observatory of Self-Medication Behavior, School of Medicine and Health Sciences, Universidad del Rosario, Bogotá, Colombia. 6. Grupo de Investigación en Dinámicas Sociales, Universidad Cooperativa de Colombia, Campus Neiva, Neiva, Colombia. 7. Center for Research in Genetics and Genomics (CIGGUR), School of Medicine and Health Sciences, Universidad del Rosario, 111221 Bogotá, Colombia. Pharmacology Unit, Department of Biomedical Sciences, School of Medicine and Health Sciences, Universidad del Rosario, Bogotá, Colombia.
Abstract
Background: The COVID-19 pandemic has led to an increase in the behavior of self-medication (SM). Given the massive release of misleading information during the pandemic, some pharmacies recommend drugs such as ivermectin, azithromycin, and hydroxychloroquine that are not useful for preventing or treating COVID-19 and could expose patients to unnecessary adverse drug reactions (ADRs), drug-drug interactions (DDIs), disease masking, and antibiotic resistance. Rationale: SM with drugs advertised for COVID-19 can have consequences, and people should be aware of approved uses, potential contraindications, and ADRs. Thus, the aim of this study was to know the drug therapies including natural products and homeopathic drugs offered by Colombian pharmaceutical establishments for the prevention and treatment of COVID-19, as well as the information provided on the safe use of the product. Methods: An observational, cross-sectional mystery shopping study was carried out to determine the pharmaceutical alternatives for the management of COVID-19 offered by pharmaceutical establishments (drugstores, pharmacies, homeopathic pharmacies, and nutritional supplements stores) in Colombia, and information related to the safe use of the product. The study included 482 pharmaceutical establishments from 16 Colombian departments. Data collection was done through telephone calls to each of the establishments following an interview protocol pretending to be a patient who presents symptoms related to COVID-19. Results: About 57.3% (276) of the establishments recommended a product for the treatment of COVID-19 infection, 66.6% (321) asked whether the caller had COVID-19 symptoms and what they are, and 44.2% (213) suggested taking a COVID-19 test. Of 59 drugs suggested by pharmacies, the most recommended were azithromycin, ivermectin, acetaminophen, ibuprofen, and ASA (aspirin). From the establishments that recommended a product, dosage was indicated in 85.5% (236) of the pharmaceutical establishments and 14.5% (40) of the establishments reported the most common adverse effects of this substance. About 9.4% (26) of the establishments reported possible interactions of the recommended drugs and substances with food, beverages, or supplements. Conclusion: Pharmaceutical establishments in Colombia seem to have significantly contributed to self-medication for COVID-19 in Colombia during the pandemic. This behavior is inappropriate, since the mild forms of the disease do not have a specific treatment. Plain Language Summary: Self-medication induced by pharmaceutical establishments in Colombia during the COVID-19 pandemic Background: The COVID-19 pandemic has led to an increase in the behavior of self-medication (SM). Given the massive release of misleading information during the pandemic, some pharmacies recommend drugs such as ivermectin, azithromycin, hydroxychloroquine among others, which are not useful for preventing or treating COVID-19 and could expose patients to unnecessary side effects and interactions with other medications. People should be aware of the approved and non-approved uses, and potential side effects of these drugs. Rationale: The aim of this study was to know the drugs, including natural products and homeopathic drugs, offered by Colombian pharmaceutical establishments for the prevention and treatment of COVID-19, as well as the information provided on the safe use of the product. Methods: The study was done using the mystery shopping method, collecting data through telephone calls to each of the establishments by a trained individual pretending to be a patient with COVID-19 symptoms. The study included 482 pharmaceutical establishments from 16 Colombian departments. Results: Of 59 drugs suggested by pharmacies, the most recommended were azithromycin, ivermectin, acetaminophen, ibuprofen, and aspirin. The recommended dose was indicated in 85.5% (236) of the pharmaceutical establishments, and 14.5% (40) of them reported the most common adverse effects of the recommended product. About 9.4% (26) of the establishments reported possible interactions of the recommended drugs and substances with food, beverages, or supplements. Conclusion: The majority of the pharmaceutical establishments included in the study promoted inadequate self-medication for COVID-19 in Colombia during the pandemic.
Background: The COVID-19 pandemic has led to an increase in the behavior of self-medication (SM). Given the massive release of misleading information during the pandemic, some pharmacies recommend drugs such as ivermectin, azithromycin, and hydroxychloroquine that are not useful for preventing or treating COVID-19 and could expose patients to unnecessary adverse drug reactions (ADRs), drug-drug interactions (DDIs), disease masking, and antibiotic resistance. Rationale: SM with drugs advertised for COVID-19 can have consequences, and people should be aware of approved uses, potential contraindications, and ADRs. Thus, the aim of this study was to know the drug therapies including natural products and homeopathic drugs offered by Colombian pharmaceutical establishments for the prevention and treatment of COVID-19, as well as the information provided on the safe use of the product. Methods: An observational, cross-sectional mystery shopping study was carried out to determine the pharmaceutical alternatives for the management of COVID-19 offered by pharmaceutical establishments (drugstores, pharmacies, homeopathic pharmacies, and nutritional supplements stores) in Colombia, and information related to the safe use of the product. The study included 482 pharmaceutical establishments from 16 Colombian departments. Data collection was done through telephone calls to each of the establishments following an interview protocol pretending to be a patient who presents symptoms related to COVID-19. Results: About 57.3% (276) of the establishments recommended a product for the treatment of COVID-19 infection, 66.6% (321) asked whether the caller had COVID-19 symptoms and what they are, and 44.2% (213) suggested taking a COVID-19 test. Of 59 drugs suggested by pharmacies, the most recommended were azithromycin, ivermectin, acetaminophen, ibuprofen, and ASA (aspirin). From the establishments that recommended a product, dosage was indicated in 85.5% (236) of the pharmaceutical establishments and 14.5% (40) of the establishments reported the most common adverse effects of this substance. About 9.4% (26) of the establishments reported possible interactions of the recommended drugs and substances with food, beverages, or supplements. Conclusion: Pharmaceutical establishments in Colombia seem to have significantly contributed to self-medication for COVID-19 in Colombia during the pandemic. This behavior is inappropriate, since the mild forms of the disease do not have a specific treatment. Plain Language Summary: Self-medication induced by pharmaceutical establishments in Colombia during the COVID-19 pandemic Background: The COVID-19 pandemic has led to an increase in the behavior of self-medication (SM). Given the massive release of misleading information during the pandemic, some pharmacies recommend drugs such as ivermectin, azithromycin, hydroxychloroquine among others, which are not useful for preventing or treating COVID-19 and could expose patients to unnecessary side effects and interactions with other medications. People should be aware of the approved and non-approved uses, and potential side effects of these drugs. Rationale: The aim of this study was to know the drugs, including natural products and homeopathic drugs, offered by Colombian pharmaceutical establishments for the prevention and treatment of COVID-19, as well as the information provided on the safe use of the product. Methods: The study was done using the mystery shopping method, collecting data through telephone calls to each of the establishments by a trained individual pretending to be a patient with COVID-19 symptoms. The study included 482 pharmaceutical establishments from 16 Colombian departments. Results: Of 59 drugs suggested by pharmacies, the most recommended were azithromycin, ivermectin, acetaminophen, ibuprofen, and aspirin. The recommended dose was indicated in 85.5% (236) of the pharmaceutical establishments, and 14.5% (40) of them reported the most common adverse effects of the recommended product. About 9.4% (26) of the establishments reported possible interactions of the recommended drugs and substances with food, beverages, or supplements. Conclusion: The majority of the pharmaceutical establishments included in the study promoted inadequate self-medication for COVID-19 in Colombia during the pandemic.
COVID-19 is a zoonotic infection caused by the severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2).
It was first reported in Wuhan (China) on 31 December 2019 and declared a
public health emergency of international concern (PHEIC) on 30 January 2020.
This infection, which can be transmitted directly, by talking, coughing, or
sneezing, and indirectly, through contact with different contaminated surfaces or
objects, as of 27 December 2021, has generated around 272 million confirmed cases
and about 5 million deaths worldwide.
Depending on risk factors such as the presence of pre-existing comorbidities,
age, sex, and ethnicity, COVID-19 can cause different clinical presentations, which
can range from asymptomatic infections in most cases to severe infections with
sepsis, disseminated intravascular coagulation, multiorgan failure, and death.Although about 8.6 billion COVID-19 vaccine doses have been administered
COVID-19 has continued to expand rapidly, forcing a change in the behavior of
the different affected communities. In this sense, according to the literature, the
population has assumed three types of protection measures: the first is based on
preventive behaviors such as the use of masks, hand disinfection, and the
administration of vaccines; the second consists of avoidance behaviors, such as
social distancing, and avoiding crowds of people among others; and the third measure
is the consumption of drugs or substances for preventing or treating COVID-19.In the third measure, it is evident that the COVID-19 pandemic has led people to
increase the behavior of self-medication (SM) to take control of their health.
Considering the lack of a definitive treatment, fear of leaving the house,
fear of being infected in the emergency room, and the overwhelmed healthcare
systems, SM has become a primary response to illness and pharmaceutical
establishments the main source of drugs and other substances for the treatment of
COVID-19. Although SM can be beneficial in some cases, it is a behavior that has
associated risks such as adverse drug reactions (ADRs), drug-drug interactions
(DDIs), antibiotic resistance, drug misuse, and drug toxicity, with potential
serious adverse outcomes.
The stress generated by lockdowns and the disproportionate fear of being
infected by the virus can cause dramatic changes in an individual behavior
(excessive house cleaning, misuse of cleaning products, SM with dangerous drugs, and
other products). As an example, there have been reports of increased exposure to
chlorine by poison control centers because of misuse of cleaning products for food
cleaning or personal hygiene.[9,10]On the other hand, SM can also be beneficial for reducing the burden on the
healthcare system when practiced responsibly. The use of over-the-counter (OTC)
drugs in approved conditions, following the instructions of the medicine label, is
part of the criteria for responsible SM according to the WHO.
However, SM during the pandemic does not usually meet these criteria, as
pharmacy personnel may fail to deliver complete information for the appropriate use
of a drug, wrongly suggest the use of an antibiotic, or the individual may simply
not follow the label instructions. This is especially important in Colombia because
the role of pharmaceutical establishments can be as important as that of doctors in
terms of prescribing medicines. Often, individuals prefer to go to the pharmacies to
resolve their symptoms rather than consult a doctor. This is frequently the case in
Colombia because, unlike other countries, most drugs are sold as if they were OTC.
For instance, it is often seen how antibiotics are recommended to individuals by
pharmaceutical establishments for flu symptoms without the need for a prescription
from an authorized health professional.Some authors consider the term ‘self-prescription’ as SM with non-OTC drugs. However,
for the purposes of this study, both terms were used interchangeably. Therefore, the
aim of this study was to evaluate the pharmacological and non-pharmacological
therapies offered by pharmaceutical establishments in Colombia for the prevention
and treatment of COVID-19, the most recommended drugs/substances, and the safety
information provided by the seller. In this regard, we evaluated whether the
pharmacies gave information regarding the drug posology as well as potential ADRs,
contraindications, and drug interactions.
Methods
An observational cross-sectional study was carried out to determine the alternatives
for the management of COVID-19 offered by pharmaceutical establishments in Colombia,
and the possible adverse effects of the recommended products. The study population
were the pharmaceutical establishments such as drugstores, pharmacies, homeopathic
pharmacies, and nutritional supplements stores in the main departments of Colombia,
including their capitals and other towns that had the highest number of reported
COVID-19 cases between July and August 2020. The inclusion criteria were that the
establishments were not found in clinics and hospitals and that they serve
non-hospitalized people. The exclusion criteria were hospital pharmacies or those
that did not have a telephone number available.Stratified randomized sampling was carried out. The sample size was calculated
according to equation 1, assuming a heterogeneity of 50%, a confidence interval of
95% and precision of 5%, extrapolated to a population of 19,249. Thus, the minimum
sample size required is 377 pharmaceutical establishments:where N is the population (19,249), Z is the value
obtained from the normal distribution for a confidence level of 95% (1.96),
σ is the standard deviation of the population (0.5), and
‘e’ is the acceptable limit of the sampling error (0.05).The study included 482 pharmaceutical establishments from 16 Colombian departments
(including their respective capitals) selected by non-probabilistic convenience
sampling, using as sources the records of the chamber of commerce of the
municipalities, the yellow pages, and Internet search engines. Table 1 presents the
number of establishments by department.
Table 1.
Number of pharmaceutical establishments by department (Colombia).
Department
Establishments (n)
Cundinamarca
102
Antioquia
80
Valle del Cauca
50
Santander
36
Huila
32
Nariño
32
Tolima
27
Norte de Santander
24
Atlántico
21
Risaralda
18
Meta
15
Bolívar
14
Caldas
9
Quindio
9
Amazonas
7
Chocó
6
Total
482
Number of pharmaceutical establishments by department (Colombia).Data collection was done through telephone calls to each of the establishments
following an interview protocol designed to guarantee homogeneity in the responses
of the interviewee. This interview protocol was validated through a pilot of 30
interviews. The interviewers were trained in order to act naturally when conducting
the interview by pretending to be a patient who presents symptoms related to the
COVID-19 disease such as general malaise, fever, cough (without dyspnea), also
indicating the possibility of having a strong flu, but with the added risk of having
been in contact with a SARS-CoV-2 positive person. The fake patient (person
pretending to be suffering from symptoms related to COVID-19) started the interview
by stating his or her symptoms and inquiring for a possible recommendation for the
treatment of his or her symptoms. If the response to this question by the
interviewee (establishment employee) was negative (No), the interview was ended
thanking the employee; but if the answer was affirmative (Yes), the interviewer
inquired about the dosage, possible adverse effects, and drug interactions of the
recommended substance. After that, following the interview protocol, the interviewer
asked whether the recommended product could be administered to pregnant women and,
finally, requested recommendations for preventing COVID-19 infection. The
information was included in a physical guide and tabulated for later analysis. The
data were analyzed in the SPSS package (version 23) using frequency statistics.
Results
About 57.3% (276) of the establishments recommended a product for the treatment of
COVID-19 infection. Of all the establishments, 66.6% (321) asked whether the caller
had COVID-19 symptoms and what they were, and 44.2% (213) suggested taking a
COVID-19 test. The number of recommended products can be seen in Table 2.
Table 2.
Number of products recommended by each pharmaceutical establishment to treat
COVID-19.
Number of recommended medications
n (number of pharmaceutical
establishments)
%
0
206
42.7
1
99
20.5
2
62
12.8
3
61
12.6
4
41
8.5
5
10
2.1
6
2
.4
7
1
.2
Number of products recommended by each pharmaceutical establishment to treat
COVID-19.The most frequent drugs and substances suggested for the treatment of COVID-19 are
shown in Table 3,
differentiating between active principles, dietary supplements, homeopathic
products, alternative therapies, and others. The percentages shown in Table 3 were calculated
from a total of 276 the pharmacies that recommended products; the 206 pharmacies
that recommended zero products were not taken into account. Of 59 active principles
suggested by pharmacies, the most recommended were azithromycin, ivermectin,
acetaminophen, ibuprofen, and aspirin. Nine supplements were prescribed, including
vitamin C, transfer factors, and multivitamins. Of 22 alternative therapies, the
most recommended were moringa, ginger, and eucalyptus. Of a total of 9
phytotherapeutic components, the most recommended were totumo, cinchona, and
dragon’s blood.
Table 3.
Suggested substances for treating COVID-19.
Substance
n
%
Drugs
Azithromycin
91
32.97
Ivermectin
75
27.17
Acetaminophen
56
20.29
Ibuprofen
38
13.77
Phenylephrine combinations
32
11.6
ASA (aspirin)
20
7.25
Naproxen
11
3.99
Dexamethasone
9
3.26
Cetirizine
8
2.90
Diclofenac
6
2.17
Minocycline
6
2.17
Acetylcysteine
5
1.81
Clarithromycin
5
1.81
Chloroquine
5
1.81
Hydroxychloroquine
5
1.81
Loratadine
5
1.81
Antibiotic
4
1.45
Dexmethorphan
4
1.45
Betamethasone
3
1.09
Analgesics
2
0.72
Dietary supplements
Vitamin C
50
18.12
Transfer factors
14
5.07
Multivitamin
12
4.35
Vitamin D
8
2.90
Vitamin D3
2
0.72
Vitamins
2
0.72
Phytotherapeutics
Totumo
4
1.45
Quina
3
1.09
Dragon’s blood
2
0.72
Homeopathic products
Homeopathic treatment
15
5.43
Aconitum napellus
1
0.36
Anas barbariae
1
0.36
Arsémicum album
1
0.36
Alternative therapies
Moringa
24
8.70
Lime
7
2.54
Ginger
6
2.17
Eucalyptus
3
1.09
Other
Oral rehydration salts
4
1.45
Liquids
2
0.72
The percentages in this table were calculated based on the number of
pharmaceutical establishments that recommended a drug or substance
(n = 276). Only the most frequently recommended
products were included in the table.
Suggested substances for treating COVID-19.The percentages in this table were calculated based on the number of
pharmaceutical establishments that recommended a drug or substance
(n = 276). Only the most frequently recommended
products were included in the table.Of these drugs and recommended substances, the dosage was indicated in 85.5% (236) of
the pharmaceutical establishments and 14.5% (40) of the establishments reported the
possible adverse effects of these products, but only 7.6% (21) mentioned these side
effects specifically, including allergies and cardiovascular side effects. Regarding
the frequency of possible side effects, 5.8% (16) reported that they almost never
occur and 4.0% reported that they were common. About 90.2% of the establishments did
not report this frequency.About 9.4% (26) of the establishments reported possible interactions of the
recommended drugs and substances with food, beverages, or supplements; of these,
80.8% (21) mentioned the substances with which there would be possible interactions:
71.4% (15) mentioned interactions with alcohol, 9.5% (2) indicated interactions with
dairy products, and 9.5% (2) indicated interactions with antidepressants. Among the
clinical consequences of interactions mentioned were allergies, rash, and
poisoning.About 8.7% (24) of the establishments that recommended substances or drugs for
COVID-19 requested information regarding the medical history of the caller, and in
66.7% (16) of these cases, they established some risks related with the medical
history of the customer, mainly the risk of exacerbating hypertension. In addition,
10.9% (30) of the establishments recommending treatments inquired whether the
consultant had a history of kidney, liver, or heart problems. Of these, 80.0% (24)
recommended taking the medication while 13.3% (4) suggested not taking it.Regarding prevention of COVID-19, 13.9% (67) of the establishments asked about
COVID-19 symptoms in a family member and 31.7% (153) recommended substances,
actions, or medications to prevent contagion by COVID-19. Of these, the dose was
indicated in 58.2% (89) of the establishments. In 59.5% (91) of the establishments
suggesting preventive treatments, these substance and medication recommendations
were given for supposedly pregnant women and posology was indicated in 95.6% (87) of
these cases.In total, 17 active principles, 9 dietary supplements, 6 alternative therapies, 3
homeopathic products, 1 phytotherapeutic product, 7 biosafety measures, and 11
non-classifiable indications were indicated. Table 4 presents the recommended
components, drugs, and substances, along with the number of establishments that
indicate them and the corresponding frequency.
Table 4.
Most common recommendations for the prevention of contagion by Covid-19.
Type of substance recommended
Substance
n
%
Drugs
Azithromycin
9
5.88
Acetaminophen
8
5.23
Ivermectin
8
5.23
ASA (aspirin)
6
3.92
B Complex
6
3.92
Dietary supplements
Vitamin C
25
16.34
Multivitamins
13
8.50
Transfer factors
11
7.19
Cod liveroil emulsion
4
2.61
Vitamin D
3
1.96
Alternative therapies
Moringa
2
1.31
Ganoderma
1
0.65
Lentinula
1
0.65
Homeopathic products
Arsenicum
1
0.65
Vincetoxicum hirundinaria
1
0.65
Phytotherapeutics
Propolis
3
196
Biosafety measures
Use of face masks
27
17.65
Preventive isolation
18
1.,76
Handwashing
7
4.58
Quarantine
3
1.96
Social distancing
2
1.31
Take SARS-CoV-2 test
2
1.31
Other
Hot drinks (with herbs/substances)
15
9.80
Attending the doctor
7
4.58
Self-care
5
3.27
Hydrate
4
2.61
SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.
The percentages in this table were calculated based on the number of
pharmaceutical establishments that recommended a drug or substance
(n = 276).
Most common recommendations for the prevention of contagion by Covid-19.SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.The percentages in this table were calculated based on the number of
pharmaceutical establishments that recommended a drug or substance
(n = 276).In 9.8% (15) of the establishments that gave recommendations, possible adverse events
of the recommended drugs or substances were explained. Some of the adverse events
explained in the case of pregnant women were affectation or harm to the newborn or
risk due to the stage of pregnancy (8 of these establishments; 53.3%), and in 13%
(2) it was mentioned that the intervention would not affect the offspring. In six
establishments (40%), it was indicated that the risk is common.In 84 facilities, the drugs were said to be safe for pregnant women and in 108 that
they were not safe.In 7.8% (12) of the establishments recommending preventive treatments, possible
interactions of suggested drugs and substances were reported with alcoholic
beverages (41.7%, 5), dairy products (8.3%, 1), and moringa (8.3%, 1). In 50.0% (6)
of these establishments, it was reported that these interactions could cause harm to
the baby (in the case of pregnant women), 8.3% (1) explained the possibility of
intoxication was reported, the same as for hypertension. In 12.4% (19) of the
establishments that recommended preventive treatments, it was indicated that the
recommended medications could generate risks for pregnant women: 42.1% (8) of these
indicated possible effects on the baby, 26.3% (5) mentioned complications in
pregnancy, and 10.5% (2) indicated adverse effects. In 15.0% (23) of the
establishments, it was asked whether the pregnant woman had a history of kidney,
liver, or heart problems. After knowing the medical history, 91.3% (21) of them
advised not to take the recommended medication and the others suggested consuming it
with caution.
Discussion
SM is a common behavior that has increased during the pandemic due to fear of
contracting the virus in hospital settings, overwhelmed healthcare systems,
misleading information about drugs that may be effective in COVID-19 and, especially
in Colombia, the uncontrolled sale of almost all medications.
In Colombia, existing regulations ruling the sale of prescription medicines
are not complied with in all cases, for instance, different laws establish that
antimicrobials are medicines that require a medical prescription and that
pharmaceutical establishments should confirm that the prescription has been provided
by a qualified health worker.[12,13] Despite this, we found that
azithromycin was recommended to treat (32.97%) and prevent (5.88%) COVID-19 by
pharmaceutical establishments without prior medical consultation and without asking
for a prescription. Needless to say, beyond the potential interactions and ADRs this
drug can have, it also contributes to antimicrobial resistance. The prescription of
medicines is a scientific and legal act, and there are specific authorized personnel
who can perform it. In Colombia, the Ministry of Health states that the prescription
of medicines should be made in writing, with a previous evaluation of the patient
and registration of their diagnosis in the clinical history by authorized health professionals.
Taking this into consideration, pharmaceutical establishments cannot
prescribe medicines as they do not have the capacity to evaluate a patient,
establish a diagnosis, and make a legal clinical history that supports the
prescription.Among the drugs most recommended by the pharmaceutical establishments were
azithromycin, ivermectin, acetaminophen, and ASA. Azithromycin was the most
recommended treatment, even though many studies have failed to show its efficacy in
COVID-19 as monotherapy.[15,16] Furthermore, although SARS-CoV-2 infection implies an increased
risk of acquiring a bacterial coinfection, the decision to start an antibiotic
therapy in COVID-19 patients should be made by the treating physician based on
clinical outcome, imaging and laboratory results. It is not recommended for the
prevention or as a routine treatment for all COVID-19 patients.[17,18]For its part, ivermectin has shown contradictory results. It has been evaluated in a
Cochrane systematic review where the authors concluded that with the available
evidence, they were uncertain about the efficacy and safety of ivermectin to treat
or prevent COVID-19,
and more evidence is needed to adequately analyze the role of this drug in
COVID-19. Therefore, it should not be administered or sold as an OTC drug. We found
that more than a quarter of the pharmaceutical establishments in Colombia
recommended ivermectin for the treatment of COVID-19 and more than 5% did so for
preventing the illness, even though ivermectin is not in the list of OTC drugs
stated by the Colombian government.
SM with this compound could lead to ADRs such as abdominal pain, diarrhea,
taste alterations, ataxia, orthostatic hypotension, increased transaminases, and
vertigo.[21,22]Similarly, ASA has been proposed as a potential therapy in patients with SARS-CoV-2
infection because of the associated risk of coagulopathy seen in some cases of
COVID-19. Evidence remains variable: some studies demonstrate a reduced risk of
severe COVID-19 with the use of ASA;
however, most studies show no effect on mortality.[24,25] Hemorrhagic complications and
thrombocytopenia in COVID-19 patients have also been documented, so the risk of
bleeding when using antithrombotic therapy in patients with COVID-19 should be
carefully evaluated.[25-27]Other studies have identified some of the same drugs as the most commonly
self-medicated drugs during the pandemic. Quincho-Lopez et al.
performed a systematic review in order to assess SM to prevent or manage COVID-19,
finding that the most common used drugs were antibiotics, chloroquine,
hydroxychloroquine, acetaminophen, vitamins, ivermectin, and ibuprofen.
Furthermore, cross-sectional surveys have found that the reasons for SM in
COVID-19 are emergency illness, proximity to the pharmacy, and long distance to the
healthcare facility, and the contributing factors were fear of discrimination, fear
of being in quarantine, and fear of infection. The most used drugs were
acetaminophen, ibuprofen, azithromycin, penicillin, hydroxychloroquine, and
antiretrovirals.[28,29] The use of antimicrobial medications recommended by the
pharmaceutical establishments in this study, such as ivermectin, azithromycin,
minocycline, clarithromycin, hydroxychloroquine, and chloroquine, can cause
important DDIs, however, they were only mentioned to the individual purchasing the
drug by a minority of the pharmaceutical establishments in this study. For instance,
the use of azithromycin combined with rifabutin, amiodarone, cisapride, or
hydroxychloroquine could cause QTc interval prolongation, potentially leading to
ventricular arrhythmias, and if prescribed, the physician should check for other QTc
interval prolonging drugs the patients may be taking to adequately monitor this
adverse effect, and to evaluate for possible DDIs.[30,31] Furthermore, gastrointestinal
distress, hepatotoxicity, and hypersensitivity reactions have also been described
with the use of azithromycin.
Hydroxychloroquine and chloroquine also increase the risk of QTc prolongation
and should not be co-administered with antiarrhythmics (class IA, III), tricyclic
antidepressants, macrolides, antifungals, quinolones, or antipsychotics, because
they may lead to ADRs such as fatal arrhythmias (Torsades de
pointes).
Furthermore, there have been reports of cases of elevated liver function
tests (LFT) and fulminant liver failure.Vitamins A, C, and D aid various membrane functions such as membrane integrity, gap
junction communication, and membrane repair and have also been implicated in
regulation of IFN (interferon) production. Furthermore, vitamin D has been
associated with immunomodulatory activities with a potential to regulate the immune
response to viral respiratory tract infections. Reduced risk of respiratory tract
infections has been linked with adequate levels of vitamin D;
however, the risk reduction benefit from vitamin D supplementation has only
been seen in vitamin D deficient individuals. This information could be extrapolated
and applied for the prevention of COVID-19, although more studies are needed. We
found that very few of the interviewed establishments recommended vitamin D
supplementation, although as previously stated it may be beneficial in patients with
a documented deficiency. Nevertheless, its administration should not be a decision
made lightly as it has the potential for toxicity causing confusion, recurrent
vomiting, abdominal pain, polyuria, and polydipsia.For its part, vitamin C aids innate immune cells in their differentiation, migration,
and their overall function.[37-39] It further
stimulates the production of interferon gamma and has antimicrobial activities.
Vitamin C deficiency has also been associated with increased risk and
severity of respiratory infections.[37,38] It supports epithelial
barrier integrity, fibroblast migration, and collagen synthesis; has antioxidant
properties; and helps to maintain innate immune cell activities (proliferation, differentiation).
However, there is insufficient evidence to recommend either for or against
the use of vitamin C for the treatment of COVID-19.Studies evaluating the supplementation of vitamins A, B, C, D, and E in patients with
COVID-19 admitted to the intensive care unit have been held, with results showing
improved inflammatory markers and lower rate of prolonged hospitalization.
On the other hand, a randomized controlled clinical trial examining the
effect of vitamin C on severity or duration of COVID-19 symptoms in patients
receiving outpatient care was stopped early because of futility.
Despite this, we found the dietary supplements most recommended by
pharmaceutical establishments were vitamins, especially vitamin C (almost 20%).Regarding homeopathic treatment and alternative therapies, Solange
et al. performed a repertorization (cross-referencing existing
symptoms in the homeopathic repertoire to obtain the most suitable medicine) and
proposed Cinchona officinalis (China officinalis)
as a suitable medicine for COVID-19. Other homeopathic medicines were also suggested
for the management of acute symptoms (Ferrum phosphoricum,
Gelsemium, Justicia adhatoda,
Senega, among others).
However, we found that pharmaceutical establishments in Colombia recommended
Anas barbariae and Arsémicum album, along with
Aconitum napellus, which has modulatory activity on the sodium
voltage-dependent channels and has been associated with fatal arrhythmias.[43-45] Therefore, homeopathic
medicines should also be prescribed by authorized health workers.Finally, it is important to state that SM is a broad concept that represents a
complex behavior and involves practices beyond the prescription by non-medical
professionals. For instance, sharing medications among family and friends, re-use of
old prescriptions, use of leftover medicines, and the use of non-conventional
medicine (home remedies, handmade medications) are also examples of SM. It also has
socioeconomic implications that make SM more common in developing countries where it
is used as a low-cost alternative to consulting a doctor.[46-48] Here, for research purposes
we considered SM as the use of medications prescribed by non-medical professionals,
because this behavior implies the treatment of self-recognized illnesses or
symptoms, that correspond with the definition of SM provided by the WHO.
Nonetheless, the definition of SM has not reached a consensus in the
scientific community and has much broader implications that are beyond the scope of
this review.The limitations of this study are that the establishments were found based on the
information on the Internet or in local directories, so those who did not appear in
these media could not be part of the study. This also implies that there were
regions in which no pharmaceutical establishments were included. Furthermore,
pharmaceutical establishments can vary depending on whether they are drugstores,
health food stores, or homeopathic stores, but it was not possible to obtain a
sufficiently wide sample of each of them, so they were treated in general as
pharmaceutical establishments.
Conclusion
In conclusion, pharmaceutical establishments have contributed in some form to SM in
Colombia, recommending drugs that were advertised at the onset of the pandemic. Many
of the drugs recommended have controversial evidence and are not recommended for the
prevention or treatment of COVID-19. Among the most recommended medications by the
pharmacies were antibiotics, analgesics, antiparasitic, vitamins, and some
homeopathic products. The recommendation and selling of drugs not based on
up-to-date evidence, and to individuals without obtaining their medical history, can
expose patients to unnecessary ADRs and DDIs.
Authors: Davies Adeloye; Omer Elneima; Luke Daines; Krisnah Poinasamy; Jennifer K Quint; Samantha Walker; Chris E Brightling; Salman Siddiqui; John R Hurst; James D Chalmers; Paul E Pfeffer; Petr Novotny; Thomas M Drake; Liam G Heaney; Igor Rudan; Aziz Sheikh; Anthony De Soyza Journal: Lancet Respir Med Date: 2021-08-17 Impact factor: 30.700
Authors: Aditya Sahai; Rohan Bhandari; Matthew Godwin; Thomas McIntyre; Mina K Chung; Jean-Pierre Iskandar; Hayaan Kamran; Essa Hariri; Anu Aggarwal; Robert Burton; Ankur Kalra; John R Bartholomew; Keith R McCrae; Ayman Elbadawi; James Bena; Lars G Svensson; Samir Kapadia; Scott J Cameron Journal: Vasc Med Date: 2021-05-19 Impact factor: 4.739
Authors: Anthony Ike Wegbom; Clement Kevin Edet; Olatunde Raimi; Adeniyi Francis Fagbamigbe; Victor Alangibi Kiri Journal: Front Public Health Date: 2021-06-04