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The life of his nine-year-old daughter, deathly ill with a cancerous tumor, hangs in the balance: the doctors have prescribed chemotherapy, but two of the five drugs needed for treatment are unobtainable in Cuba. Both medications are readily available in Miami, only a minute flight away, but the year-old U. When he spots her at last, he bursts into tears. Four hours later, his daughter is undergoing her first treatment session. The long-respected health-care system in Cuba is faltering under the combined impact of the U. While Cuba can still boast of having 51, doctors — 1 for every inhabitants — it suffers from a critical shortage of medications and medical supplies. Pharmacy shelves are bare, even of common-cold remedies. Doctors complain about shortages of antibiotics and approximately other medications, ranging from simple Mercurochrome to sophisticated cancer and heart drugs. Aspirin has been rationed to 20 pills per person per year 40 pills for Havana residents, no doubt because of urban stress. Even such rudimentary supplies as sutures, syringes and surgical gloves are scarce, as are anesthetics. The government once tried to gloss over the shortages, but not any longer. In many cases, diagnostic equipment stands idle for lack of spare parts and readout paper. Mammograms were cut back last year because of chronic X-ray-film shortages. Physicians fear that deteriorating sanitary conditions will bring back dysentery and typhoid, since soap and detergents are in short supply, as is chlorine to treat the water supply. The incidence of hepatitis A and diarrhea is on the rise, and infant tuberculosis is a growing problem in poor sections of Havana. As the U. A U. A Canadian firm was even barred from selling Cuba a U. Medical journals are included under the embargo. With the shortage of modern drugs, herbal medicines — Cuba produces different types — are making a vigorous comeback. Majmud Gomez, a family doctor in Pinar del Rio. He uses herbal preparations to treat a variety of conditions, from parasites to a problem caused by the soap shortage, an itch for which he prescribes a pomade made from the majagua tree. As the medical scarcities multiply, discontent over the pride of the revolution is bound to increase. Contact us at letters time. Join Us. Customer Care. Reach Out. Connect with Us. Is Adrenal Fatigue Real? Home U. All Rights Reserved. TIME may receive compensation for some links to products and services on this website. Offers may be subject to change without notice.
Turnage Drug Store is pictured on Main Street, June 13, , in Water Valley, Mississippi.
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Official websites use. Share sensitive information only on official, secure websites. 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. Information on demographics, ADRs, outcomes, behavioral, and health-related factors was collected using a validated questionnaire and clinical records. Sex odds ratio OR : 0. SARS-CoV-2, discovered in Wuhan, China, is a highly contagious pathogen that spread quickly throughout the world, and which caused a pandemic of global concern. According to the World Health Organization, countries have been affected, with nearly million people infected worldwide. There is a lack of a specific treatment for SARS-CoVinduced severe acute respiratory syndrome, but effective vaccines became available by late \[ 1 — 3 \]. People infected with SARS-CoV-2 can be asymptomatic or can present symptoms with varying severity, which is possibly associated with the patients' age and underlying comorbidities. The most commonly reported symptoms are as follows: fever, dry cough, headache, myalgia, fatigue, and diarrhea. Many host cellular factors have been identified that are involved in the viral infection and in the various steps of the lifecycle or viral products that interfere with the homeostasis of cell metabolism. These factors cause significant cellular stress to the host cell, which induces cell and tissue damage \[ 6 \]. These were considered to be drug repurposing or off-label, compassionate use drugs because there was a lack of clinical trial data supporting the use of these drugs in COVID \[ 7 , 8 \]. Hence, these drug treatment schemes and posologies must be carefully investigated to maximize their benefits with minimal toxicity or adverse drug reactions. Previous reports have shown that the treatment of COVID patients with preexistent, noncommunicable diseases was complex \[ 9 \] and that they had an increased risk for drug-related adverse reactions \[ 10 , 11 \]. In early , in Cuba, the option of drug repurposing and off-label, compassionate use was discussed and approved by an ad hoc commission of the Cuban Research and Science Ministry of Health. The recommended drugs, such as HIV protease inhibitors, interferon, and chloroquine have previously shown complex DDI \[ 13 , 14 \]. Drug safety must never be ignored, especially when there is still doubt about the drug's efficacy against the pathogen, as was the case for COVID The drug's benefits must always outweigh its risks \[ 15 \]. ADRs are described for the three recommended drugs, and they range from mild to life-threatening and short- to long-term effects, according to previous use worldwide \[ 10 , 11 , 16 \]. In low- and middle-income countries, the main priority is securing access to drugs for treatment, which leaves limited resources for pharmacovigilance \[ 18 , 19 \]. Thus, it is clear that drug safety data should be collected and analyzed to obtain the necessary information for decision-making, to manage potential risks associated with certain drugs or their combinations. A specific system was set up, where patient notification reports are routinely collected and analyzed for potential ADRs in infectious disease treatments \[ 20 \]. This sentinel surveillance system aims to solve the problems of underreporting, undue delays, and miscommunication that were observed in the previous passive surveillance system on ADRs. Better reporting systems and the rapid analysis of information will have a positive effect on rational drug use in hospitals \[ 21 \]. Our results obtained on drug safety will provide a solid basis for decision-making by the Cuban Ministry of Health about drug risk management in COVID treatment. Moreover, our data are important for enhancing current treatment regimens by reconfiguring the recommended therapeutic combinations and to provide potential information for personalized treatments. This study was done in accordance with the principles of the Declaration of Helsinki and the Good Clinical Practice Guidelines of the International Conference on Harmonization. If patients tested SARS-CoV-2 positive, they were hospitalized and could be included in this study, dependent upon their time of presentation and admission to the hospital. An exclusion criterion was participation in another clinical trial within the last three months. There was no sample size estimated, as all patients in the study locations who gave consent were included in the study. To evaluate the factors associated with ADRs, a point paper-based questionnaire was used, which explored factors related to 11 domains, such as general health, demographics, and risk behaviors. Aspect 1-patient demographic characteristics age, sex, and ethnic group ; Aspect 2-patient clinical status; Aspect 3-suspected drugs and concomitant medications for each one, administration route, therapy duration, dosage, and therapeutic indication were recorded ; Aspect 4-ADR description; Aspect 5-ADR outcome improvement, complete resolution, unchanged or worsened event, resolution with sequelae, and death. It also assessed their attitudes toward risk and protective behaviors \[ 22 \]. We obtained permission from Arrivillaga et al. Four members of our research team were trained as interviewers to ensure uniformity in data collection. When conducting the survey, they introduced themselves to the participants and explained by phone the purpose of the survey. Data related to aspects 1 and 2 were obtained from health records. Data for aspects 3, 4, and 5 were collected by phone. The pharmacologists and physicians who reviewed the ADRs were specifically involved in this study for this purpose. A concomitant medication may not necessarily be associated with the ADRs. Moreover, each case was evaluated with the aim of identifying the presence of DDI, which may have contributed to ADRs. For each case, the physicians consulted the source documents that were archived in the hospital medical record system. A detailed written explanation of the questionnaire process, the researchers' names and institutions, and possible benefits for the patients and others were clearly explained to the participants, and additional information was provided upon request. Informed participants were asked to sign a written informed consent. All patients were codified and anonymized to protect the confidentiality of individual participants. The questionnaire was performed while the patients were in the hospital, just before their discharge from the hospital. The ADR reports were reviewed by pharmacologists and physicians that were specialized in pharmacovigilance. Other characteristics of the COVID patients time of admission, length of stay, sex, age, disease diagnoses, etc. The Hartwig's Severity Assessment Scale contains the following levels: level 1: an ADR occurred but required no change in treatment with the suspected drug; level 2: the ADR required that treatment with the suspected drug be held, discontinued, or otherwise changed. No antidote or other treatment requirement was required. No increase in length of stay LOS ; level 3: the ADR required that treatment with the suspected drug be held, discontinued, or otherwise changed. OR the ADR was the reason for the admission; level 5: any level 4 ADR which requires intensive medical care; level 6: the adverse reaction caused permanent harm to the patient; level 7: the adverse reaction either directly or indirectly led to the death of the patient. Only cases categorized as certain, probable, and possible were included in our study. Potential DDI were those classified according to risk level: X contraindicated association , D consider modification of therapy , and C monitoring therapy. Data were stored digitally using an entry program developed with the WPS software package. All data were processed using Microsoft Access. Bivariate analysis was carried out to evaluate the associations of potential risk factors with the presence of ADRs. Results were presented as percentages and frequencies. Two hundred patients were included in this study Table 1. Underlying diseases such as hypertension, cardiovascular disease, diabetes, asthma, cerebrovascular disease, cancer, chronic kidney disease, chronic liver disease, obesity, epilepsy, arthritis, and others were identified in Source: completed surveys that were accessed in a digital database and printed surveys. ADR, adverse drug reaction. P values in bold italic show variables that are statistically significant. OR odd ratio. CI confidential interval. Underlying diseases included hypertension, cardiovascular disease, cerebrovascular disease, diabetes, and allergy. Source: completed surveys accessed in a digital database and printed surveys. Period of hospitalization from April to July Of the patients, 65 showed asymptomatic progression of COVID, and presented low or moderate symptoms. A total of ADR manifestations were identified in patients. The number of supportive drugs used in the hospital OR 2. There were no significant differences in the proportions of skin color, toxic habits alcoholism and smoking , and COVID progression between the two groups. The results of the bivariate analysis are also shown in Table 1. Drug-related adverse reactions, as categorized by manifestations, are shown in Figure 1. Gastrointestinal GI disorders diarrhea, vomiting, and nausea were the most frequent ADRs with an occurrence of For the onset of the ADRs, 9. N number of patients. Other drugs in total, 63 used by patients for treatment of comorbidities are listed in Table 3 , as well as the frequencies of DDI by drug, together with the descriptions of each interaction according to the following lists: mechanism of action, risk level, effect, and recommendations. A risk level X was identified in only 1 patient, the risk level D was identified in 30 of 61 cases Frequencies of DDI by drug, together with the description of each interaction according to: mechanism, risk level, effect, and recommendations. Risk level: X contraindicated association , D consider modification of therapy , and C monitoring therapy. CYP, Cytochrome AUC, area under curse. C max : drug maximum or peak serum concentration that achieves in a specified compartment. QTc: the interval is a measurement made on an electrocardiogram in relation to cardiac frequency using the beginning of the QRS complex to the end of the T wave. A more detailed stratification of the adverse-related events of prescribed drugs to treat COVID is required \[ 8 \]. In this study in Cuba, we used for the first time a comprehensive survey to identify potential drug safety issues for off-label drugs that were used to treat COVID We aimed to obtain evidence for a specific combined drug approach that could be used for the prevention and treatment of COVID Our study actively recorded ADR symptoms in hospitalized patients in hospitals in Cuba under continuous monitoring, and data were directly reported to the National Pharmacovigilance Centre, to avoid any potential under-reporting or miscommunication. We ensured that there was no bias in the inclusion of COVID patients in this study, so our study results may also be applicable in other contexts. Some of the main reasons for nonreporting in other settings included: a lack of time, no access to documentation, insufficiently trained personnel, the personnel being busy with other tasks, failure to recognize an ADR, patient confidentiality concerns, biosafety resolution regarding clinical history use quarantine , and fear of blame. Various studies on drug safety monitoring in COVID patients have been published \[ 9 , 13 , 15 , 17 , 27 — 31 \]. Results obtained from other studies differ slightly from ours. This may be due to differences in population, context, and sex-age composition \[ 32 \], or ancestry genotypic polymorphisms as have been observed in other viral diseases in Cuba \[ 33 \]. The safety monitoring data obtained in previous studies for lopinavir mainly focused on HIV patients and healthy people \[ 13 \]. This supports the need to closely monitor potential changes in blood lipids in patients undergoing treatment. In our study, ten serious ADRs were observed in patients who each suffered from 3 or 4 underlying diseases. As ADRs are the most common reason for poor adherence to treatment, identification of risk factors for the occurrence of ADRs is essential for optimizing the initial choice of drug regimen. The majority of ADRs observed in our study are in correspondence with previously reported adverse reactions or the recognized safety profiles for these drugs \[ 10 , 11 , 24 \]. Only 2 ADRs were identified as rare and 3 as occasional in our study. In accordance with our study, a significant association between age, sex, and comorbidities and the occurrence of ADRs was also observed in studies by Kojima et al. Alterations in age are typically concomitant with underlying changes in the human body, such as a reduction in renal clearance, liver size, lean body mass, and other factors which may impact biological processes and, in consequence, alter drug distribution, metabolism, and pharmacodynamic responses \[ 36 \]. In our study, an association of ADRs and sex was found, which was in concurrence with the results obtained by Jing et al. This could be explained by differences in fat distribution, greater plasma volume, organ perfusion, and hormone-related regulation of drug metabolizing enzymes, as has been reported in other studies \[ 37 \]. Preexisting or underlying diseases, or comorbidities, have also been identified as associating factors. Comorbidities produce pathophysiological changes that could have an effect on drug pharmacodynamic and pharmacokinetic properties, and hence patients could be given unsuitable drug prescriptions \[ 36 \]. Polypharmacy has been reported to be a strong risk factor for ADRs in several studies in relation to possible DDI \[ 1 , 18 \]. The DDI identified in our study are potentially related to the modifications in drug concentrations, and this could affect their antiviral activity or influence on comorbidities. The DDI could also cause an increase in toxicities. Indeed, for 28 of the 29 drugs used, it is strongly recommended to monitor or avoid their use due to increased toxicities. Some researchers have suggested that the application of a survey could be a useful method for collecting patient reported ADRs \[ 21 \]. Reporting by the patients generally implies the use of the Internet or phone. For those patients who are not comfortable using Internet tools or where computers are not available in the hospitals involved in the study, another option should be made available, such as reporting by phone using a survey adapted to that case \[ 21 \]. The last variant was the one used in our study. The vast majority of COVID patients in previous studies were hospitalized because of fever \[ 9 , 15 , 17 \]. Hence, in this study, this bias was not present, as most of the hospitalized individuals were nonsymptomatic contact tracing individuals. In univariate analysis from previous studies, the length of the hospital stay was reported to be significantly associated with the occurrence of ADRs \[ 27 , 31 \]. No association was found in our study in relation to the duration of hospital stays, which was likely because hospitalization and duration of hospitalization were not dependent upon symptomatology or severity of infection. Toxic habits such as alcoholism and smoking, which have a high incidence in the Cuban population, could also impact ADRs, but we found no association between ADRs and these toxic habits. The interpretation of our results is limited to the context from which participants were recruited. We mainly studied COVID patients that were hospitalized in occidental provinces, which may not be representative for patients hospitalized across different regions in Cuba. In our study, both physicians and researchers made an effort to carefully make a distinction between drug effects and COVID infection symptoms. Furthermore, we only observed ADRs during hospitalization, after the drugs had been administered \[ 30 \]. Also, late-stage retinopathy caused by chloroquine may occur many years after discontinuation of the treatment. Further studies with longer follow-up periods are required to assess the longer-term implications of ADRs. For DDI, some discrepancies were found compared to published drug guidelines, which could influence recommendations for therapy. Another limitation is that the analysis of interactions was done with only two drugs. It needs to be considered that multiple drug combinations could result in additional ADR effects. It still remains a challenge to design an effective, low-toxicity, and well-tolerated drug regimen for COVID using off-label drugs \[ 7 , 13 \]. Additionally, our results have also provided data that could inform individualized therapies and could lead to better COVID symptom management. The majority of the ADRs were drug-induced gastrointestinal disorders and general symptoms. Age, sex, and underlying diseases were the main independently associated factors for the occurrence of ADRs in patients. The reported characterization and incidence reflected the adverse reactions of patients with symptomatic and asymptomatic COVID, providing a reference for clinically safe medication. The authors would like to thank all the patients that contributed to this study and Bronwen Martin for the revision of the paper on English language. There are specific legal and ethical requirements related to Cuban populations that prohibit public sharing of a dataset. Data contains personal information on human subjects. Confidentiality and any specific access restrictions are typically specified by an Institutional Review Board. The authors declare that there are no conflicts of interest regarding the publication of this paper. All co-authors revised the manuscript. This section collects any data citations, data availability statements, or supplementary materials included in this article. As a library, NLM provides access to scientific literature. Adv Pharmacol Pharm Sci. Find articles by Lizette Gil-del-Valle. Find articles by Pablo Sariol-Resik. Find articles by Tatiana Prieto-Dominguez. Find articles by Mario Manuel Delgado-Guerra. Find articles by Faustina Fonseca-Betancourt. Find articles by Odalys Orraca-Castillo. Find articles by Xaveer Van Ostade. Find articles by Wim Vanden Berghe. Find articles by Veerle Vanlerberghe. Open in a new tab. Use with caution and therapeutic monitoring of propafenone is recommended. Chloroquine increases the toxicity of propafenone by QTc interval. Moderately clinically significant. Potential for increased toxicity. Use alternatives if available. No a priori dosage adjustment is recommended but monitor adverse effects Chloroquine increases the toxicity of amitriptyline by QTc interval. Chloroquine increases the toxicity of sertraline by QTc interval. Chloroquine is a moderate inhibitor of CYP2D6. Chloroquine and ciprofloxacin both increase QTc interval. Similar articles. Add to Collections. Create a new collection. Add to an existing collection. Choose a collection Unable to load your collection due to an error Please try again. Add Cancel. Underlying diseases chronic heart disease, asthma, stroke, hypertension, and diabetes. Hydrochlorothiazide can cause electrolyte disturbances and thereby increase the risk of QT interval prolongation. Thus, caution and electrolyte monitoring are needed when administering lopinavir and chloroquine The risk or severity of neutropenia and thrombocytopenia can be increased when hydrochlorothiazide is combined with interferon alpha-2b. Lopinavir could potentially increase propranolol concentrations, although to a moderate extent. Avoid or use an alternate drug. P-glycoprotein inhibition. Prolonged PR clinical and therapeutic drug monitoring of digoxin concentrations is recommended. Thrombotic risk, an alternative antiplatelet agent should be considered. Risk of hyperglycemia due to insulin resistance with protease inhibitors as chloroquine may enhance the effects of a hypoglycemic treatment, a decrease in doses of insulin or other antidiabetic drugs may be required. Risk of hypoglycaemia as chloroquine may enhance the effects of a hypoglycemic treatment, a decrease in doses of insulin or other antidiabetic drugs may be required. Lopinavir-ritonavir oral will increase the level or effect of loratadine oral by altering drug metabolism Monitoring is required chloroquine metabolism can be decreased when combined with loratadine. Cimetidine increases levels of chloroquine by decreasing metabolism. Lopinavir will decrease the level or effect of lamotrigine by increasing metabolism. Ritonavir may decrease the blood levels and effects of valproate. Usually avoid combinations; use it only under special circumstances. Consider lowering benzodiazepine dose. Lower doses of drugs metabolized by CYP2D6 may be required when used concomitantly. Chloroquine increases toxicity of pimozide by QTc interval. The risk or severity of nephrotoxicity can be increased when lopinavir is combined with metamizole also increased risk of haematological toxicity had to be considered. It will also increase the level or effect of tramadol. Levonorgestrel is metabolized by CYP3A4 and is glucuronidated to a minor extent; coadministration is predicted to increase levonorgestrel.
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Little is known about the incidence of ADRs to these drugs when used in COVID patients. In the literature, ADRs reaching 20–40% are reported.
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