A retrospective and observational study of the adverse drug reactions reported in a tertiary care hospital

Background: Adverse drug reaction (ADR) is considered a common cause of prolonged hospitalization and death among patients. Pharmacovigilance is essential in the surveillance of adverse drug reactions. The responsibility of a healthcare professional is to report any adverse reaction that occurs with the use of drugs. This helps in providing a database and improving the safety of patients. The aim of the study was to determine the incidence of ADR, assess causality, severity, and preventability of the submitted adverse drug reactions, increase the awareness of preventability of adverse drug reactions in health care professionals by conducting regular workshops on ADR, and document occurrence of a rare ADR. Methods: A retrospective observational study was conducted to assess the ADR reported to the ADR monitoring Centre, for the past 6 years included in the study. The data were entered into Microsoft excel and analyzed using descriptive statistics. Mean and standard deviation were calculated for the categorical data. Drugs were classified according to the class. Reactions were analyzed using scales and presented in descriptive statistics. Results: A total of 95 ADR reports were received and reported. These ADRs were associated with a total of 108 drugs that were prescribed- the occurrence of ADRs dominated among females 60% (57). Antimicrobials were causing the highest number of adverse reactions 21 (19.44%) and antituberculosis drugs and radiocontrast media were associated with the following larger number of the ADRs 19 (17.59%). Intravenous at 40% was the most common route related to the development of ADR. The most common ADR caused by antimicrobials was rash (9), antitubercular therapy commonly caused hepatitis, and chills and rigors were more common with radiocontrast media. Most of the reactions observed in the patients were moderate reactions at 52.63% with 3.16% fatal ones. Conclusions: In this study, the predominant causative drugs associated with ADR were antimicrobials, antitubercular drugs, and radiocontrast media. The number of ADRs reported though was less there was a wide range of drugs causing ADR that were reported which gave a broader spectrum for analysis. There is a requirement for active monitoring of ADRs to understand the occurrence as well as help in prevention.

A case analysis of liver injury induced by gefitinib / 药物流行病学杂志

A 68-year-old male patient with malignant left lung tumor was treated with gefitinib(250 mg,po,qd)for 29 days.Liver function test results showed AST 310 U·L-1,ALT 493 U·L-1,AKP 100 U·L-1,TBil 18 μmol·L-1,GGT 60 U·L-1,INR 1.81.Several liver function indicators of the patient showed abnormal,which was consistent with the clinical manifestations of moderate liver injury.The liver function index of the patient improved after the doctor adopted the suggestion of clinical pharmacists to protect the liver.Clinical pharmacists made a comprehensive and dynamic assessment of the patient's condition,analyzed the correlation between the patient's liver injury and gefitinib,and judged that the patient's liver injury was likely caused by gefitinib.Clinical pharmacists analyzed the drug use of a blind trial patient,proposed the follow-up treatment plan,and discussed the blind trial drugs,which provided references for clinical safe and rational drug use and had important reference significance.

A case of pituitary crisis caused by cadonilimab treatment of advanced gastric cancer / 药物流行病学杂志

A 75-year-old female patient with gastric cancer received cadonilimab(500 mg,iv,d1)combined with albumin-bound paclitaxel(300 mg,iv,d2)and tegafur,gimeracil and oteracil potassium(40 mg,po,bid,d2-15)and 21 days was a cycle.Admission examination at the end of 4 cycles of treatment,laboratory tests showed adrenocorticotropic hormone＜1.00 pg,mL-1,cortisol 0.42 μg·dL-1 and serum sodium 131 mmol·L-1.Immune checkpoint inhibitor-related hypophysitis was diagnosed,and pituitary crisis was developed on the 4th day.The diagnosis of hypophysitis concurrent with pituitary crisis was considered to be related to cadonilimab.High-dose glucocorticoids replacement and symptomatic treatment such as rehydration to maintain electrolyte imbalance were given.On the 9th day after admission,the patient was basically in remission.The administration of cadonilimab may cause pituitary crisis,which is relatively rare in clinical practice.This case reminds that the possibility of hypophysitis when patients emerge with the symptom of fatigue and anorexia along with hyponatremia.Assessment of endocrine gland function,correct diagnosis and proper therapy are of significant clinical value to improve the patients'prognosis.

Mining and analysis of adverse drug event signals of lacosamide / 中国药房

OBJECTIVE To mine adverse drug event （ADE） signals of lacosamide， and to provide references for clinically safe drug use. METHODS ADE data for lacosamide reported to the United States FDA adverse event reporting system from January 1， 2009， to December 31， 2022， were collected. Data mining was conducted using the reporting odds ratio method and Bayesian confidence propagation neural network method. Classification statistics were performed using the system organ class （SOC） and preferred terms （PT） from ADE terminology set of Medical Dictionary for Regulatory Activities （Version 25.0）. RESULTS A total of 21 360 lacosamide ADE reports were received， identifying 203 ADE signals across 24 SOCs， with 19 signals not included in the drug’s instruction. The top five PTs ranked by occurrence frequency were medication overdose， technical errors during device use， product use issues， intentional product misuse， and therapy discontinuation. The top five PTs ranked by signal strength were changes in seizure presentation type， congenital hypoplasia of depressor anguli oris muscle， multidrug resistance， brain surgery， and vagus nerve stimulator implantation. ADEs not recorded in the drug instruction included congenital hypoplasia of depressor anguli oris muscle， multidrug resistance， mitochondrial DNA mutation， dissociative identity disorder， and congenital auricular anomaly. CONCLUSIONS For lacosamide-induced ADEs that occur frequently and are already listed in the drug’s instructions， such as bradycardia and atrioventricular block， the clinical application should be careful and attentive， adjusting the dosage timely according to the patient’s condition to avoid severe ADEs. Newly discovered suspect ADEs， such as congenital hypoplasia of depressor anguli oris muscle， mitochondrial DNA mutation， overmature infant， dissociative identity disorder， pigmenturia， behavioral disorders， and dissociative disorders， should be vigilantly recognized to ensure the safety of drug use.

Participation of clinical pharmacists in QTc interval prolongation induced by gilteritinib / 药学实践与服务

Objective To explore the role of clinical pharmacists involved in the case of a patient with acute myeloid leukemia whose QTc interval prolongation was induced by gilteritinib, and to provide reference for drug treatment and monitoring of those patients. Methods The abnormal electrocardiogram （ECG） of a patient with acute myeloid leukemia was found in time by clinical pharmacists, who participated in clinical diagnosis and treatment by analyzing the patient’s underlying diseases, diagnosis and treatment process, therapeutic drugs and their potential interactions. Results Clinical pharmacists suspected that the prolonged QTc interval was likely to be an adverse reaction caused by gilteritinib, and recommended immediate discontinuation of the drug and re-examination of the electrocardiogram.The physician took the suggestion to stop the suspected drug therapy with gilteritinib promptly, and ECG was rechecked 3 d later, and the QTc value returned to the normal range. Conclusion Clinical pharmacists participating in clinical diagnosis and treatment could provide better pharmaceutical care for patients.

Renal injury caused by tenofovir disoproxil fumarate in a patient with liver cancer complicated with HBV infection：a case report and literature analysis / 中国药房

Tenofovir disoproxil fumarate （TDF） is a first-line treatment for chronic hepatitis B. With increasing use worldwide， the adverse events of renal injury caused by this drug have also attracted industry attention. This article reports a 61- year-old patient with liver cancer complicated with hepatitis B virus （HBV） infection. The patient started using TDF in mid-March 2022 and developed kidney injury after 2 months of treatment， during which he received 2 courses of donafenib combined with sintilimab chemotherapy and irregular administration of diclofenac for pain relief. In this paper， Naranjo’s assessment scale was used to evaluate the drugs that may be associated with renal injury， including TDF and sintilimab， and the drugs that are suspected to be associated with renal injury are donafenib and diclofenac. The renal injury caused by TDF can be judged according to the changes in the patient’s condition， the incidence of drug-induced renal injury， clinical manifestations， occurrence time， occurrence mechanism， drug combination， and high-risk factors. The changes of serum creatinine in patients with liver cancer complicated with HBV infection after TDF should be dynamically monitored in the clinic， and the dose of antiviral drugs should be adjusted if necessary and other antiviral drugs with less impact on renal function can be selected， to provide individualized medication recommendations for tumor patients， reduce the incidence of TDF-related renal injury.

Case analysis of a patient with isavuconazonium-caused pancytopenia / 中国药房

OBJECTIVE To correctly identify and deal with the adverse drug reaction as pancytopenia caused by isavuconazonium and to provide reference for the safe use of isavuconazonium. METHODS Clinical pharmacists analyzed a case of severe infection and renal insufficiency who experienced pancytopenia after using isavuconazonium. Clinical pharmacists screened the drugs used during hospitalization and evaluated the relationship between this adverse drug reaction and isavuconazonium， as well as the possible mechanisms， based on the half-life of the drugs and relevant literature. RESULTS & CONCLUSIONS The relationship between pancytopenia and isavuconazonium was assessed as “possibly related”. When using isavuconazonium， attention should be paid to avoiding the combination of drugs with the same mechanism or potential interaction. For patients who have a course of treatment for more than 2 weeks， have hematological abnormalities or complicated with liver and renal insufficiency， or should use it combined with other drug with same mechanism， it may be considered to increase the frequency of blood routine monitoring.

Establishment and validation of nomogram prediction model of cefoperazone/sulbactam-induced thrombocytopenia / 中国药房

OBJECTIVE To explore the predictive factors of cefoperazone/sulbactam-induced thrombocytopenia in adult inpatients， and to establish and validate the nomogram prediction model. METHODS Data of adult inpatients treated with cefoperazone/sulbactam in Xi’an Central Hospital from Jun. 30th， 2021 to Jun. 30th， 2023 were retrospectively collected. The training set and internal validation set were randomly constructed in a 7∶3 ratio. Singler factor and multifactor Logistic regression analysis were used to screen the independent predictors of cefoperazone/sulbactam-induced thrombocytopenia. The nomogram was drawn by using “RMS” of R 4.0.3 software， and the predictive performance of the model was evaluated by the receiver operating characteristic curve and C-index curve. Hosmer-Lemeshow goodness-of-fit test was used to evaluate the calibration degree of the model. Using the same standard， the clinical data of hospitalized patients receiving cefoperazone/sulbactam in Xi’an First Hospital in the same period were collected for external validation of the nomogram prediction model. RESULTS A total of 1 045 patients in Xi’an Central Hospital were included in this study， among which 67 patients suffered from cefoperazone/sulbactam-induced thrombocytopenia， with an incidence of 6.41%. After the false positive patients were excluded， 473 patients were included finally， including 331 in the training set and 142 in theinternal validation set. Multifactor Logistic regression analysis showed that age [OR＝1.043， 95%CI （1.017， 1.070）]， estimated glomerular filtration rate （eGFR） [OR＝0.988，95%CI（0.977， 0.998）]， baseline platelet （PLT） [OR＝0.989， 95%CI（0.982， 0.996）]， nutritional risk [OR＝3.863， 95%CI（1.884， 7.921）] and cumulative defined daily doses （DDDs） [OR＝1.082， 95%CI（1.020， 1.147）] were independent predictors for cefoperazone/sulbactam-induced thrombocytopenia （P＜0.05）. The C-index values of the training set and the internal validation set were 0.824 [95%CI （0.759， 0.890）] and 0.828 [95%CI （0.749， 0.933）]， respectively. The results of the Hosmer-Lemeshow test showed that χ 2 values were 0.441 （P＝0.802） and 1.804 （P＝0.406）. In the external validation set， the C-index value was 0.808 [95%CI （0.672， 0.945）]， the χ 2 value of the Hosmer-Lemeshow test was 0.899 （P＝0.638）. CONCLUSIONS The independent predictors of cefoperazone/sulbactam-induced thrombocytopenia include age， baseline PLT， eGFR， nutritional risk and cumulative DDDs. The model has good predictive efficacy and extrapolation ability， which can help clinic identify the potential risk of cefoperazone/sulbactam-induced thrombocytopenia quickly and accurately.

Clinical Characteristics and Potential Risk Factors Analysis of Liver Injury Related to Epimedii Folium Preparation / 中国实验方剂学杂志

ObjectiveThis paper aims to analyze the clinical characteristics and medication rationality of liver injury related to Epimedii Folium preparation （EP） and explore the possible risk factors of liver injury， so as to provide a reference for the safe clinical application of Epimedii Folium （EF）. MethodA retrospective analysis was conducted on liver injury cases related to EP from 2012 to 2016. ResultThe number of reported liver injury cases and the proportion of severe cases related to the use of EP show an increasing trend， indicating the objective existence of liver injury caused by EP. There are more cases of liver injury related to EP in women than in men， with an onset age range of 15-91 years old and a median onset age of 60 years old （median onset ages for men and women are 59 and 60 years old， respectively）. The time span from taking EP alone to the occurrence of liver injury is 1-386 days， with a median of 38 days. The time span from taking both EP and Western medicine to the occurrence of liver injury is 1-794 days， with a median of 34 days. EF-related liver injury preparations are mostly composed of traditional Chinese medicines that promote immunity and tonify the liver and kidney， indicating that immune stress in the body may be the mechanism of liver injury caused by the use of EP alone or in combination. There is no increasing trend of toxicity with time or dose in the liver injury caused by EP. By further exploring its risk factors， it is found that patients have unreasonable medication methods such as excessive dosage， repeated use， and multi-drug combination， which may also be one of the important risk factors for EF-related liver injury. ConclusionEP has a certain risk of liver injury and should be emphasized in clinical diagnosis and treatment. Immune stress may be the mechanism of liver injury caused by EP， and in clinical use， it is necessary to be vigilant about the risk of liver injury caused by unreasonable use and combined use with Western medicine.

Real-World Study on Hematological Toxicities of Cyclin-dependent Kinase 4/6 Inhibitors Based on FAERS Database / 医药导报

Objective To evaluate adverse events(AEs)of hematological toxicities in cyclin-dependent kinase 4/6(CDK4/6)inhibitors based on the FDA adverse event reporting system(FAERS)database,and to provide a reference for rational drug use in the clinic.Methods A total of 29 quarterly AEs were extracted from the FAERS database from January 2015 to March 2022.Reported odds ratio(ROR)and proportional reported ratio(PRR)were used for data mining of CDK4/6 inhibitor AEs.Results A total of 7 872 AEs related to CDK4/6 inhibitors were reported,and the proportion of hematological AEs of each inhibitor was palbociclib(80.31%),ribociclib(15.36%),and abemaciclib(4.33%).Neutropenia and anemia were common in hematological toxicities.Palbociclib(2 982/6 322,47.17%)and ribociclib(613/1 209,50.70%)caused more neutropenia than abemaciclib(117/341,34.31%).Hematological toxicities mainly occurred 60 days after drug initiation(1 630,61.86%).Palbociclib had the longest median onset time,and 32.9%of patients still had hematological toxicities after 90 days of treatment.The clinical features and intensity were different among CDK4/6 inhibitors.Conclusions Palbociclib,abemaciclib,and ribociclib all cause significant hematological toxicities,among which abemaciclib has fewest reports of hematological toxicities.Still,the risk of death after anemia caused by abemaciclib should be noted.Complete blood cell count should be closely monitored within the first two months after treatment to monitor the patient's neutrophils and hemoglobin.The occurrence of hematological AEs associated with CDK4/6 inhibitors should be noted in the clinic.

Literature Case Analysis of 44 Patients with Thrombocytopenia Induced by Clopidogrel / 医药导报

Objective To investigate the characteristics of clopidogrel-associated thrombocytopenia to provide references for clinically safe drug use.Methods The case reports of thrombocytopenia induced by clopidogrel published in PubMed,Embase,CNKI,Wanfang and VIP were searched from the establishment of each database to November 2022,and their occurrence was collated and analysed.Results A total of 44 cases from 43 articles were identified and included in the analysis.There were 30 males(68.2％)and 14 females(31.8％).Ages ranged from 37 to 88(65.0±11.4)years,of which 30(68.2％)were ≥60 years old.Thrombocytopenia was found from 8 h to 9 months after medication,of which 29 cases(65.9％)appeared within two weeks.There were 31 cases(70.5％)with severe thrombocytopenia and 38 cases(86.4％)with complications,of which 24 cases(63.2％)with bleeding and 19 cases(50.0％)with thrombotic thrombocytopenic purpura(TTP).The platelet countof41 cases(93.2％)returned to normal after drug withdrawal and symptomatic treatment,and 3 cases(6.8％)died finally.Conclusion Clopidogrel related thrombocytopenia is mainly severe thrombocytopenia,and often accompanied by bleeding or thrombotic thrombocytopenic purpura(TTP),but the overall outcome is good.Platelet count should be regularly monitored within the first two weeks after medication.Clopidogrel should be stopped and symptomatic treatment should be given in case of any abnormality.

Instrumento de consulta sobre reações adversas a antimicrobianos direcionado à farmacêuticos: uma revisão de literatura / Tool for consultation on adverse reactions to antimicrobials aimed at pharmacists: a literature review

A infecção hospitalar, também conhecida como infecção nosocomial, representa uma preocupação significativa para pacientes e profissionais de saúde. Este problema é agravado pela resistência bacteriana, resultante do uso inadequado de antimicrobianos. A negligência nos hospitais e a prescrição excessiva desses medicamentos contribuem para esse cenário, afetando aproximadamente 15% dos pacientes hospitalizados globalmente, segundo a Organização Mundial de Saúde. Com o intuito de contribuir para práticas de segurança relacionadas ao uso de antimicrobianos no ambiente hospitalar, o presente trabalho teve como objetivo elaborar uma ferramenta de informação profissional sobre reações adversas aos antimicrobianos dispensados em um hospital de ensino referência no atendimento adulto e pediátrico no Vale do Jequitinhonha/Minas Gerais. A metodologia foi por meio de revisão bibliográfica, realizada nos Lexicomp. Wolters Kluwer Clinical Drug Information®, Micromedex® e Bulário da da Agência Nacional de Vigilância Sanitária (ANVISA), assim como busca direcionada de artigos realizadas nas plataformas no PubMed®, Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS)®, Google Scholar®, Scientific Electronic Library Online (SciElo)®, Sistema Online de Busca e Análise de Literatura Médica (MEDLINE)® e Biblioteca Virtual em Saúde (BVS)®. Além das informações obtidas no Lexicomp®, Micromedex® e Bulário da ANVISA®, foram selecionados 28 artigos publicados nos últimos 10 anos. As classes de antimicrobianos mais prevalentes foram: penicilinas (27%), cefalosporinas (20%), aminoglicosídeos, quinolonas e sulfonamidas (7% cada). As reações adversas mais relatadas foram: diarreia, vômitos, erupções cutâneas, anafilaxia, síndrome de Stevens-Johnson e alterações hepáticas. Foram identificadas 489 reações adversas para os 30 antimicrobianos padronizados, identificando-se uma média de 15 reações por princípio ativo. Embora algumas reações sejam raras, como síndrome do homem vermelho, síndrome de Stevens-Johnson e lesão hepática induzida por medicamentos, elas têm alto potencial de morbimortalidade. Conclui-se que há uma ampla variedade de reações adversas, registradas na literatura, associadas ao uso dos antimicrobianos pesquisados. Recomenda-se a realização do monitoramento e notificação desses eventos por meio da farmacovigilância para garantir a segurança dos pacientes no hospital em estudo.

Hospital-acquired infection, also known as nosocomial infection, poses a significant concern for patients and healthcare professionals. This issue is exacerbated by bacterial resistance resulting from the inappropriate use of antimicrobials. Neglect in hospitals and the overprescription of these medications contribute to this scenario, affecting approximately 15% of hospitalized patients globally, according to the World Health Organization. With the aim of promoting safety practices related to the use of antimicrobials in the hospital setting, the present study aimed to develop a professional information tool on adverse reactions to antimicrobials dispensed in a teaching hospital that serves adult and pediatric patients in the Jequitinhonha Valley, Minas Gerais. The methodology involved a bibliographic review conducted using Lexicomp, Wolters Kluwer Clinical Drug Information®, Micromedex®, and the Drug Compendium from the Brazilian Health Regulatory Agency (ANVISA), as well as targeted searches for articles on platforms such as PubMed®, Latin American and Caribbean Health Sciences Literature (LILACS)®, Google Scholar®, Scientific Electronic Library Online (SciELO)®, Medical Literature Analysis and Retrieval System Online (MEDLINE)®, and the Virtual Health Library (VHL)®. In addition to the information obtained from Lexicomp®, Micromedex®, and the Drug Compendium by ANVISA®, 28 articles published in the last 10 years were selected. The most prevalent classes of antimicrobials were penicillins (27%), cephalosporins (20%), aminoglycosides, quinolones, and sulfonamides (7% each). The most commonly reported adverse reactions were diarrhea, vomiting, skin rashes, anaphylaxis, Stevens-Johnson syndrome, and hepatic changes. A total of 489 adverse reactions were identified for the 30 standardized antimicrobials, averaging 15 reactions per active ingredient. Although some reactions are rare, such as red man syndrome, Stevens-Johnson syndrome, and drug induced liver injury, they carry a high potential for morbidity and mortality. It is concluded that there is a wide variety of adverse reactions, documented in the literature, associated with the use of the antimicrobials studied. Monitoring and reporting of these events through pharmacovigilance are recommended to ensure patient safety in the hospital under study.

Perceptions of undergraduate medical students of old traditional and new CBME curriculum about pharmacovigilance and adverse drug reactions reporting at a tertiary care teaching hospital: a comparative study

Background: National pharmacovigilance program is an ongoing program to monitor the adverse drug reactions and reporting at the earliest. The effectiveness and success of any pharmacovigilance system depends highly on the participation of all health care professionals. As medical students are future health-care givers, this study is aimed to measure perceptions on Pharmacovigilance and ADR reporting among medical students of two different curriculum. Methods: A validated and standardized KAP Questionnaire based cross sectional study. It consists of 22 questions divided into four sections of total of 22 items (six related to Personal details, eight related to knowledge, four related to attitude, and four related to practice) The filled questionnaires were collected and analyzed by MS excel Results: A comparative sample of 100 from old (phase 4) and 100 from New CBME (phase 3) curriculum undergraduate medical students of Government Medical College are included in our study. The average score of phase 3 and phase 4 medical students for knowledge was 85.37% and 75.87%, for attitude was 95.5% and 84% and for practices was 88.75% and 67.5% respectively. Conclusions: The overall knowledge, attitude and practices of new curriculum students found to be better than old curriculum students as CBME curriculum was introduced from the academic year 2019–2020 in all Medical Institutions of India to impart knowledge, communication and leadership skills using various teaching–learning methods among students.

Knowledge and attitude towards pharmacovigilance among healthcare students at a medical college in Nepal

Background: Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse drug reactions (ADRs) and any other possible drug-related problems. Under reporting of adverse drugs reactions are the global health problem. The adequate knowledge and skills towards pharmacovigilance and adverse drugs reactions reporting are crucial for the health care students to ensure patients’ medication safety. This study aims to assess the knowledge and attitude of the health care students towards pharmacovigilance and ADRs. Methods: A closed ended, structured, self-administered questionnaire was administered to 204 undergraduate health care students to collect the data. Data were analyzed using SPSS version 21. Non-parametric tests (Mann Whitney U test and Kruskal Wallis test) were used for analysis. Results: Among 204 respondents, the majority of them had a poor knowledge (91.18%) and positive attitude (87.25%) towards Pharmacovigilance. The inter quartile range (median) score of the respondents’ knowledge was 5.0±2.211 and attitude was 27.0±2.88 towards Pharmacovigilance and ADRs reporting. The main reason for under reporting of ADRs was difficulty to decide whether ADR has occurred or not (32.4%) due to the lack of appropriate knowledge and training. There is a poor knowledge and positive attitude towards Pharmacovigilance. Conclusions: Adequate coverage of Pharmacovigilance and ADRs reporting issues should be covered in the curriculum as well as hand on training and workshop should be conducted to increase the knowledge and confidence in detecting, monitoring and reporting ADR in their clinical posting.

Aspectos farmacológicos y adherencia al tratamiento antirretroviral en pacientes VIH

Introducción: La adherencia al tratamiento farmacológico favorece la supresión viral y reduce la resistencia a la terapia antirretroviral de gran actividad a largo plazo. Objetivo: Determinar la relación entre los aspectos farmacológicos y la adherencia al tratamiento antirretroviral de una IPS colombiana. Metodología: Estudio analítico transversal en pacientes con diagnóstico de VIH en tratamiento antirretroviral entre los años 2012 a 2020. Se utilizó un modelo de regresión logística binaria múltiple con fines explicativos. Resultados: Se analizaron 9835 pacientes donde la proporción de adherencia fue de 90 % y en el modelo ajustado se evaluó su relación con los antecedentes de no adherencia (ORa:0,52 IC95 °/o:0,40-0,66), grupo farmacológico (2 ITIAN + 1 IP u otro) (ORa:1,22 IC95 %:0,99-1,76), dos tomas al día (ORa:1,02 IC95 %:0,74-1,40), unidades al día (≥ 3) (ORa:0,69 IC95 %:0,47-1,02), reacciones adversas a medicamentos (ORa:0,56 IC95 °%:0,40-0,78), polimedicación (ORa:1,36 IC95 %:1,00-1,85), tiempo TAR (1 a 2 años) (ORa:1,63 IC95 %:1,27-2,09),tiempo TAR (6 a 12 meses) (ORa:1,66 IC95 %:1,27-2,18), tiempo TAR (<6 meses) (ORa:1,36 IC95 %:1,03-1,78), tasa de reclamación de los medicamentos (ORa:0,42 IC95 %:0,32-0,55) y antecedentes PRUM (ORa:0,11 IC95 %:0,09-0,14). Discusión: La proporción de adherencia obtenida es superior a lo descrito para otros países (entre 60-77 %); sin embargo se encuentra que los hallazgos correspondientes al efecto de las variables farmacológicas analizadas son acordes a lo descrito en estudios previos en el tema Conclusión: Los antecedentes de no adherencia, reacciones adversas, tasa de reclamación de los medicamentos y antecedentes de problemas relacionados con el uso de medicamentos son aspectos que reducen la probabilidad de adherencia; mientras que el mayor tiempo de uso del tratamiento aumenta la misma.

Introduction: Adherence to drug treatment promotes viral suppression and reduces long-term resistance to highly active antiretroviral therapy (HAART). Objective: To determine the relationship between the pharmacological aspects and adherence to antiretroviral treatment in a Colombian IPS. Methodology: Cross-sectional analytical study in patients with HIV on antiretroviral treatment between 2012 and 2020. A multiple binary logistic regression model was used for explanatory purposes. Results: A total of 9,835 patients were analyzed where the proportion of adherence was 90 % and in the adjusted model its relationship with history of non-adherence was assessed (ORa: 0,52 95 % CI: 0,40-0,66), pharmacological group (2 NRTI + 1 PI or other) (ORa: 1,22 95 % CI: 0,99-1,76), two doses per day (ORa: 1,02 95 % CI: 0,74-1,40), units per day (≥ 3 ) (ORa: 0,69 95 % CI: 0,47-1,02), adverse drug reactions (ORa: 0,56 95 % CI: 0,40-0,78), polypharmacy (ORa: 1,36 95 % CI : 1,00-1,85), ART time (1 to 2 years) (ORa: 1,63 95 % CI: 1,27-2,09), ART time (6 to 12 months) (ORa: 1,66 95 % CI: 1,27-2,18), ART time (<6 months) (ORa: 1,36 95 % CI: 1,03-1,78), inconsistency in the claim (ORa: 0,42 95 % CI: 0,32-0,55) and PRUM history (ORa: 0,11 95 % CI: 0,09-0,14). Discussion: The proportion of adherence obtained is higher than that described for other countries (between 60-77 %); however, the findings corresponding to the effect of the pharmacological variables analysed are in line with those described in previous studies on the subject. Conclusion: The history of non-adherence, adverse reactions, inconsistencies in the claim fill history and problems related to the use of medications are aspects that reduce the probability of adherence. While the longer time of use of the treatment increases adherence.

Not uncommon but often under-recognized: case report of fixed drug eruption in a child

When re-exposed to the offending drug, fixed drug eruptions (FDEs), a distinctive type of mucocutaneous drug reaction, typically recur in the same places. Often, these eruptions are benign in nature, however the recurrence and appearance of these lesions may be a cause of worry to patients, and in the pediatric population, to their caretakers as well. Lack of awareness among clinicians coupled with suboptimal history taking pertaining to drug usage are the key factors leading to delayed and under-diagnosis of FDEs. We discuss the case of a child whose fixed drug eruption was misdiagnosed as an insect bite for more than a year. This led to parental anxiety, as well as trial of multiple avenues of treatment to no avail. This article aims to raise awareness of the importance of prompt recognition of FDEs, as identification and discontinuation of the offending drug will alleviate the eruptions and prevent recurrence of the condition.

Pantoprazole Induced Black Hairy Tongue: A Case Report

Introduction: Black Hairy Tongue (BHT) is characterized by abnormally hypertrophied and elongated filiform papillae, resulting in a blackish discoloration on the dorsal surface of the tongue. BHT has been reported as an adverse drug reaction to various categories of drugs. Nevertheless, cases of Pantoprazole-induced BHT have been rarely reported. Case Description: We present a case involving a 42-year-old female who was admitted to the Surgery ward due to postoperative wound infection. She had been prescribed oral Clarithromycin and Pantoprazole. On the third day of initiating these medications, she reported experiencing a blackish discoloration on the dorsal surface of her tongue along with a change in her sense of taste. Clinical and microscopic examinations led to a diagnosis of Black Hairy Tongue (BHT). There was a suspicion that BHT might be an adverse drug reaction specifically to Pantoprazole. Consequently, the administration of Pantoprazole was ceased, while Clarithromycin continued for the full prescribed course. The patient received guidance to scrape her tongue thrice daily, maintain proper hydration, and adhere to good oral hygiene practices. By the third day following the discontinuation of Pantoprazole, the black discoloration and taste alterations had completely resolved. Causality assessment using the WHO-UMC (World Health Organization - Uppsala Monitoring Centre) scale indicated a 'probable' association between the adverse drug reaction and Pantoprazole. Conclusion: Physicians need to be vigilant about the potential occurrence of Black Hairy Tongue (BHT) in patients using Pantoprazole, and they should recognize that discontinuing the medication, coupled with mechanical debridement and maintaining proper oral hygiene, leads to complete resolution of the condition.

Metabolic adverse drug reactions in geriatric patients in Odisha

Background: Geriatric patients are at a greater risk of developing adverse drug reaction (ADR) because of changed metabolic activity and renal status associated with aging. As most of the elderly patients suffer from multiple chronic diseases (Diabetes, Hypertension, Arthritis, constipation, peptic ulcer disease, etc.), they are under polypharmacy and the risk of ADRs is exacerbated by multiple medications. Metabolic ADRs include weight gain, hypoglycemia, hyponatremia, hypokalemia, and the endocrinal abnormality are the frequent cause of hospital admission in geriatric patients. Most metabolic ADRs due to drugs are treatable. There are few such studies conducted in India regarding metabolic ADR in geriatric patients. Hence, this study aims to evaluate the metabolic ADRs encountered in geriatric patients with the following objectives in Odisha. Aim and Objectives: The prevalence and spectrum of metabolic ADRs in geriatric population were studied. The causality assessment, severity assessment, and preventability were done using standard scales. Materials and Method: This was a prospective and observational study conducted from September 2016 to September 2018 in Department of Pharmacology in collaboration with Department of Geriatric Medicine and Department of Medicine of SCB Medical College and Hospital. All geriatric patients (?60 years) with ADR, reporting to the above departments, were included in the study. The detailed information of type of ADRs and its characteristics was filled up in Suspected ADR Reporting Form designed by Indian pharmacopeia commission version 1.3. The incidence and spectrum of metabolic ADRs were observed. Their causality, severity, and preventability were evaluated by the WHO-UMC System, Hartwig’s Severity Scale, and Schumock Thornton Preventability Scale, respectively. Result: A total of 236 ADRs were reported in 2 years, out of which 28.8% were metabolic ADRs. Metabolic ADRs were more reported in young old patients and often encountered ADR was hypoglycemia 73.5% due to use of oral anti diabetics. About 29% of the metabolic ADRs had a causal relation of probable association. About 94.2% were moderate in severity and 89.7% metabolic ADRs could be probably preventable. Conclusion: There was a probable causal association of metabolic ADR with the drug used and they were moderate verity. The metabolic ADRs found in our study can be preventable with appropriate means.

Retrospective study on cutaneous adverse drug reactions in a tertiary care center

Background: Cutaneous adverse drug reactions (CADRs) range from mild-to-severe types and occasionally can become fatal. Hence, these incur additional financial burden both to patients and community. Aim and Objective: The aim of the study was to describe the characteristics of CADRs reported to ADR monitoring center (AMC) of a tertiary care center. Materials and Methods: CADRs reported to the AMC over a period of 2 ½ years were retrospectively studied. This study mainly focused on affected age group, gender, various pattern of CADRs, the group and name of drugs causing CADRs, and severity and causality assessment. Results: CADRs contributed 31.6% of the total ADRs reported to the AMC. Among these, 51.7% were females and 40% were of 51–60 years age group. About 37.9% of CADRs were pruritus. Antibacterial drugs were the most common cause of CADRs and beta-lactam antibiotics were responsible for 30% of CADRs. Stevens Johnson syndrome (SJS) constituted 4.9% of CADRs and 20% of this was due to Paracetamol. Drugs were withdrawn in 89% of cases and 85% cases recovered. On causality assessment, 94% were of probable category. Conclusion: Pruritus was the most commonly observed CADR and antibacterial drugs were the most common cause. Beta lactam antibiotic was the most frequent antibacterial drug to cause CADRs. The most common serious CADR was SJS and Paracetamol was the most frequent culprit drug.

Pattern of adverse drug reactions with chemotherapeutic drugs in a tertiary care hospital of North India: a retrospective study

Background: Adverse drug reactions are important causes of mortality and morbidity in the patients. Early detection, evaluation and monitoring of ADRs is essential to improve public health. Methods: This was an observational, non-interventional and retrospective study conducted at the ADR monitoring centre of a tertiary care hospital of North India. Suspected ADR forms reported over a period of 4 years involving at least one chemotherapeutic drug with at least one dose were analyzed. Results: A total of 261 chemotherapeutic drugs associated ADRs were analyzed. Out of these, maximum numbers of ADRs were reported by males (54%). Maximum reporting was done by Skin and VD department (37.93%). Causality assessment was probable in maximum number of cases (54%). Most common ADRs were skin rashes (21.46%), followed by jaundice, urticaria and fixed drug eruptions. Maximum ADRs were suspected to be caused by Anti tubercular drugs (31.42%) followed by anticancer drugs (14.56%). Conclusions: ADRs due to antibiotics and anticancer drugs is a significant health problem.