Analysis of 111 cases of aristolochic acids nephropathy / 药学实践与服务

Objective To analyze the clinical characteristics and regularity of aristolochic acid nephropathy (AAN) induced by drugs containing aristolochic acid. Methods The clinical data of 111 patients with AAN induced by aristolochic acid were reviewed. The clinical features, medication and treatment of AAN were analyzed. Results Among 111 patients, there were more females than males (2.58∶1), 101 cases (90.99%) were over 50 years old； the mean age was (63.70±11.67) years old;the average duration of medication was (8.08±6.94) years. The drugs involved were Guanxinsuhe pill and Longdanxiegan pill in 106 cases (95.50%). Serum creatinine increased in 108 cases, urea nitrogen increased in 106 cases and hemoglobin decreased in 103 cases, most of which were hypogravity urine, mild to moderate proteinuria and occult blood. Ultrasonic examination revealed that the kidneys were damaged to varying degrees. Pathological biopsy of kidney showed renal tubular damage. Most patients had an insidious onset and varying degrees of progression, which were not proportional to the age and the duration of taking the medicine. In clinical, the renal function was progressively damaged, most of which were irreversible and with a poor prognosis. Conclusion Patients with renal impairment differed greatly individually, and the renal damage was not paralleled with the medication duration and dose of drugs containing aristolochic acid.AAN progressed rapidly, and the disease still progressed even after stopping taking drugs containing aristolochic acid. Strengthening pharmacovigilance, implementing early diagnosis and effective intervention could help to reduce the occurrence of AAN and attenuate its development.

National competent authority regulation and practice of drug benefit-risk communication in the United States,European Union and China / 药物流行病学杂志

Safer drug use relies on the sustained vigilance and continual awareness of all individuals,and drug benefit-risk communication plays a pivotal role in facilitating this process.Foreign exploration on drug benefit-risk communication started relatively earlier.Upon scrutinizing the websites of drug regulatory authorities in the United States and Europe Union,it appears that these regions have established comprehensive communication regulation and practice systems,developed strategic plans and guidance,and communicated with healthcare professionals,patients and the public via various tools and channels,mainly including drug statutory information,new safety information,potential safety signals,etc.In China,drug benefit-risk communication is involved in the legislation,but the relevant guidelines and specific implementation rules are still lacking,and the evidence-based communication research and communication tools are relatively insufficient.We could learn from the experience of other countries,which involves enhancing regulatory implementation,establishing a communication framework,developing scientific evidence,assessing communication effectiveness,refining communication tools,and diminishing information barriers,in order to ultimately support patient and health care professionals to make informed decisions about medication.

Mining pharmacovigilance signals for asthma adverse events in underage population based on the FAERS database / 药物流行病学杂志

Objective To conduct data mining of asthma-inducing medications in underage populations based on the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)database,so as to provide reference for the clinical application of related medications.Methods Adverse drug event(ADE)reports from the first quarter of 2013 to the fourth quarter of 2022 in the FAERS database were collected and screened for reports of asthma adverse events in the this population(under 18 years old),which were categorized into infants,toddlers,children,and adolescents according to different age groups,and were subjected to medication signal mining by using the reporting odds ratio method,the composite standardized method,and the information component method.Results A total of 1 915 reports were obtained after screening,involving 1 042(54.41％)males and 831(43.39％)females;the highest percentage of the reporting population was between 12 and under 18 years old,with a total of 762(39.79％);60.78％of the reports were reported by health professionals;and the results of the clinical referrals showed that serious adverse events occurred in 85.90％of the cases.306 suspected drugs were screened,52 drugs were determined to be valid signals,and 1 044 adverse events were reported,of which 16 drug inserts did not mention the risk of asthma,in order of elosulfatase alpha,canakinumab,tobramycin,vancomycin,ceftriaxone,cetirizine,phenylephrine,imiglucerase,cefuroxime,betamethasone,atropine,tadalafil,riscovastatin,cyclophosphamide,octreotide,and omeprazole.Conclusion The FAERS database was mined for adverse drug event signals and evaluated using the proportional disequilibrium method to identify 16 medicines that may trigger pharmacogenetic asthma and are not documented in the specification,which can be used to provide a good early warning for the clinic.At the same time,focusing on special populations,strengthening the assessment of lung function before medication and monitoring during and after medication,timely interventions were taken to reduce the harm of drug-derived adverse reactions and ensure the safe use of medication.

Data mining of hematological adverse events related to antibody-drug conjugate based on FAERS / 药物流行病学杂志

Objective Based on the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)database,data mining was conducted on hematological adverse events related to antibody drug conjugates(ADC),providing reference for the safe use of ADC drugs in clinical practice.Methods The report data from the third quarter of 2011 to the fourth quarter of 2022 were retrieved from the FAERS database.After data cleaning such as deduplication and name standardization,extract hematological adverse events related to ADC,and use report odds ratio method and the information component method for signal detection.Results A total of 101 610 adverse event reports were extracted,with 8 ADC drugs as the primary suspected drugs,and 5 768 ADC related hematological adverse event reports.Among them,3 423 cases of agranulocytosis were involved,and the signal intensity from strong to weak were sacituzumab govitecan(SG),gemtuzumab ozogamicin(GO),brentuximab vedotin(BV),polatuzumab vedotin(PV),enfortumab vedotin(EV),trastuzumab deruxtecan(TD),inotuzumab ozogamicin(IO)and ado-trastuzumab emtansine(TDM-1).There were 2 327 cases hematopoietic cell deficiency,with signals ranging from strong to weak were IO,SG,BV,EV,PV,TD,TDM-1,and GO.Report with clinical outcome of death of ADC drug related hematological adverse events included BV 179(16.84％),TDM-1 102(13.01％),TD 88(27.08％),GO 12(16.90％),IO 8(11.59％),EV 54(24.32％),PV 22(27.16％),and SG 84(21.05％).Adverse event time analysis showed that the number of events on the first day of TD,IO,and SG medication accounts for ≥ 40％of the total number of cases.The median time of hematological adverse events in TD,GO,IO,EV,PV,and SG was within one treatment course(21 days).Conclusion Attention should be paid to the risk of ADC drug-related hematological adverse event,during the clinical medication process,blood cell count changes should be closely monitored,and any abnormalities should be promptly diagnosed and treated.

Research on signal mining of adverse events of tizanidine based on FAERS database / 药物流行病学杂志

Objective Based on U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)database,the signal mining of tizanidine adverse drug events(ADEs)was conducted to explore the occurrence characteristics of ADE,hoping to provide references for the safe clinical application of tizanidine.Methods The reporting odds ratio(ROR)and medicines and healthcare products regulatory agency methods(MHRA)were used to analyse the ADE of tizanidine using FAERS registration data from the first quarter of 2004 to the second quarter of 2022.After valid signals were obtained,the MedDRA was used for translation and system organ classification.Results A total of 7 135 reports of tizanidine ADE were obtained,including 1 732 patients,1 304 ADE types were involved.According to the results of 2 ADE signal mining methods,at the preferred term(PT)level,177 signals were detected.There were 32 PT signals not included in the drug instructions,including potassium wasting nephropathy,cardio-respiratory arrest,and foetal growth restriction etc.In 1 732 patients,the number of ADE cases of female was 2.37 times that in male(1 057 vs.446),and the age group between 40 and 64 accounted for a large proportion(36.03％).The highest proportion(32.79％)reported by consumers.The system organ class involved mainly included various neurological diseases and psychosis.The median time to onset of tizanidine-related ADEs was 75 d(interquartile range:28-223 d),but it was necessary to be vigilant that ADE may still occur 1 year after starting the drug(13.38％).Conclusion This study aims to suggest that clinical application of tizanidin-related ADE should be paid full attention to the occurrence of ADE such as potassium-wasting nephropathy and suicidally completed,as well as key populations such as women and patients of 40-64 years old.

Investigation and Analysis of Pharmacovigilance Inspection of Drug Marketing Authorization Holders / 医药导报

Objective To investigate the current situation,problems and suggestions of pharmacovigilance activities conducted by drug marketing authorization holders(MAH)and pharmacovigilance inspections carried by regulatory authorities.Methods A questionnaire survey was conducted on relevant institutions and personnel responsible for pharmacovigilance inspections in 31 provinces,autonomous regions,municipalities and the Xinjiang Production and Construction Corps.The MAH pharmacovigilance activities were rated from 5 aspects(5 major items and 27 specific items).Results The average overall score for 5 major items was 3.46;The average score for 27 specific activities was 3.50.The MAH scored the highest in terms of pharmacovigilance organization,personnel,and resources,and scored the lowest in terms of drug risk identification and assessment.Conclusion MAH needs to further strengthen their awareness of primary responsibility,gradually improve the pharmacovigilance system,and constantly improve the ability and level of pharmacovigilance;The drug regulatory department should also provide guidance to enterprises,establish and improve the team of inspectors,and systematically advanced various aspects of pharmocovigilance inspection.

Atención farmacéutica en pacientes con inmunodeficiencia adquirida y/o tuberculosis en el área ambulatoria de un hospital pediátrico / Pharmacovigilance in patients with acquired immunodeficiency and/or tuberculosis in the outpatient area of a pediatric hospital

La Atención farmacéutica (AF) ayuda a los pacientes a alcanzar objetivos terapéuticos reduciendo los problemas relacionados al medicamento (PRM). Objetivos: analizar los PRM en la práctica de la AF a pacientes con inmunodeficiencia adquirida (IDA) y/o tuberculosis (TBC) y evaluar su impacto. Método: estudio, descriptivo, observacional, en el área ambulatoria de Farmacia. Se incluyeron pacientes con IDA y/o TBC con: inicio de tratamiento, polifarmacia, reinternaciones frecuentes, regular/mala adherencia, reacciones adversas a medicamentos (RAM) previas y/o comorbilidades. Se entrevistaron pacientes o cuidadores y se registraron PRM, errores, grados de adherencia y conocimiento farmacoterapéutico, retiro oportuno de medicamentos y parámetros clínicos. Se registró la intervención farmacéutica y entregó material educativo. Se repitieron las mediciones en una segunda entrevista. Resultados: Se estudiaron 54 pacientes (28 con IDA y 26 con TBC). Se realizaron 93 intervenciones (29.9% dirigidas al prescriptor, 27.8% a otros profesionales) y se detectaron 8 RAM y 53 errores (28 IDA y 25 TBC), el principal PRM fue la mala/regular adherencia con bajo porcentaje de conocimiento farmacoterapéutico completo. Después de la AF, en IDA el grado de adherencia tuvo una mejora estadísticamente significativa (p= 0.012), también fue significativa la mejora en el retiro oportuno de la medicación (28.6% a 71.4% p=0.005 IDA). Se obtuvieron resultados favorables de carga viral (CV) en 72% pacientes con IDA y aumento de peso en 92% pacientes con TBC, aunque no fueron estadísticamente significativos. Conclusiones: mediante AF se mejoró la adherencia y la comunicación en pacientes pediátricos con IDA y/o TBC (AU)

Pharmacovigilance (PV) helps patients achieve therapeutic goals by reducing drug-related problems (DRP). Objectives: to analyze DRPs in the practice of PV in patients with acquired immunodeficiency (AIDS) and/or tuberculosis (TB) and to evaluate its impact. Methods: A descriptive, observational study was conducted in the outpatient pharmacy area. Patients with AIDS and/or TB with: treatment initiation, polypharmacy, frequent readmissions, regular/poor adherence, previous adverse drug reactions (ADR) and/or comorbidities were included. Patients or caregivers were interviewed, and DRP, errors, adherence and pharmacotherapeutic knowledge, timely drug withdrawal, and clinical parameters were recorded. The pharmaceutical intervention was recorded and educational material was delivered. Measurements were repeated in a second interview. Results: We studied 54 patients (28 with AIDS and 26 with TB). Ninety-three interventions were performed (29.9% addressed to the drug prescriber, 27.8% to other professionals) and 8 ADRs and 53 errors were detected (28 AIDS and 25 TB). The main DRP was poor/regular adherence together with a low level of complete pharmacotherapeutic knowledge. After PV, in patients with AIDS the degree of adherence statistically significantly improved (p= 0.012). The improvement in timely medication withdrawal was also significant (28.6% vs. 71.4% p=0.005 AID). Favorable viral load results were obtained in 72% of patients with AIDS and weight gain in 92% of patients with TB, although they were not statistically significant. Conclusions: PV improved adherence and communication in pediatric patients with AIDS and/or TB (AU)

Prescripción de fármacos cardiotóxicos en pacientes con enfermedades cardiovasculares / Prescription of cardiotoxic drugs in patients with cardiovascular diseases

Introducción: El uso de fármacos con potencial cardiotóxico para tratar enfermedades no cardiovasculares coexistentes resulta un agravante evitable. Objetivo: Evaluar la prescripción de 5 fármacos cardiotóxicos en pacientes con enfermedades cardiovasculares. Métodos: Se realizó un estudio descriptivo transversal (enmarcado en los estudios de utilización de medicamentos) de marzo a diciembre de 2020 en el Policlínico Santa Cruz (Artemisa, Cuba), en una población de 234 sujetos con enfermedades cardiovasculares que habían sido tratados con domperidona, azitromicina, ciprofloxacina, ibuprofeno y diclofenaco. Las variables estudiadas fueron: sexo, edad, consumo de fármacos cardiotóxicos, motivo de indicación, enfermedades cardiovasculares, forma farmacéutica, dosis diaria, intervalo de las dosis y duración del tratamiento. Se realizó un análisis estadístico descriptivo. Resultados: Los fármacos más prescritos fueron la azitromicina (n= 63), el ibuprofeno (n= 59) y la ciprofloxacina (n= 57). Sus principales motivos de indicación fueron, respectivamente, la neumonía adquirida en la comunidad (38,1 por ciento), las infecciones de piel y tejidos blandos (28,8 por ciento), y las infecciones del tracto urinario (43,8 por ciento). La principal enfermedad cardiovascular fue la hipertensión arterial. Para los 5 fármacos seleccionados se reportó su esquema terapéutico (forma farmacéutica, dosis diaria, intervalo de dosis y duración del tratamiento). Conclusiones: Aunque en todos los casos el motivo de indicación es el adecuado, los fármacos pueden sustituirse por otros de menor riesgo cardiovascular. En su mayoría, los esquemas terapéuticos son correctos, salvo en los casos de la domperidona (duración prolongada) y el diclofenaco (altas dosis)(AU)

Introduction: The use of drugs with cardiotoxic potential to treat coexisting noncardiovascular diseases results in avoidable aggravation. Objective: To assess the prescription of 5 cardiotoxic drugs in patients with cardiovascular disease. Methods: A cross-sectional descriptive study (framed in the studies of drug utilization) was carried out from March to December 2020 in the Policlínico Santa Cruz (Artemisa, Cuba), in a population of 234 subjects with cardiovascular diseases who had been treated with domperidone, azithromycin, ciprofloxacin, ibuprofen and diclofenac. The variables studied were: sex, age, consumption of cardiotoxic drugs, reason for indication, cardiovascular disease, pharmaceutical form, daily dose, dose interval, and duration of treatment. Descriptive statistical analysis was performed. Results: The most prescribed drugs were azithromycin (n= 63), ibuprofen (n= 59) and ciprofloxacin (n= 57). Their main reasons for indication were, respectively, community-acquired pneumonia (38.1 percent), skin and soft tissue infections (28.8 percent), and urinary tract infections (43.8 percent). The main cardiovascular disease was arterial hypertension. For the 5 selected drugs, their therapeutic scheme (pharmaceutical form, daily dose, dose interval and duration of treatment) was reported. Conclusions: Although in all cases the reason for indication was adequate, the drugs can be substituted by others of lower cardiovascular risk. For the most part, the therapeutic regimens are correct, except in the cases of domperidone (prolonged duration) and diclofenac (high doses)(AU)

Pharmacovigilance: How aware are the prescribers?

Background: Adverse drug reactions (ADRs) is one of the important factors contributing to morbidity and mortality among patients and is a major public health burden. Spontaneous ADR reporting plays an important role in detection of ADRs, reducing their incidence and improving patient safety. India has one of the lowest ADR reporting rates in the world. Aim and Objective: The aim of the study was to assess the knowledge, attitude and practice (KAP) of doctors towards pharmacovigilance. Materials and Methods: A KAP questionnaire validated by subject experts was given to the doctors outside the teaching profession within 50 km of Government TD Medical College, Alappuzha, who consented to be a part of the study. The questions were structured to obtain the demographic details of the doctors, their KAP toward pharmacovigilance. No identifiable information regarding the participants was collected and the participants were assured of their confidentiality. A week’s time was given to the participants to answer the questions. Results: During the period of 1 year from June 2019 to May 2020, a total of 121 doctors responded to the questionnaire. The respondents aged from 26 to 67 years with the mean age being 37.31 ± 14.15 years. 94 (77.7%) thought that anyone could report an ADR while 16 (13.2%) thought that only doctors could report ADRs. Only 76 (62.8%) were aware of the existence of National Pharmacovigilance Centre in India. Ninety-eight (81%) did not know how to submit the ADR form to the nearest pharmacovigilance center. A vast majority 99 (81.8%) thought that ADRs to drugs of any system of medicine could be reported, while 20(16.5%) felt that only ADRs to modern medicines need to be reported. Among the factors discouraging doctors from reporting ADRs, lack of training to report an ADR 99 (81.8%) and lack of time during practice 83 (68.5%) were cited as the common reasons. A vast majority 116 (95.9%) had not received any formal training on ADR reporting and 114 (94.2%) opined that they would like to receive a formal training on the same. Conclusion: Doctors were largely aware of pharmacovigilance but had lack of KAP of reporting ADRs and filling up an ADR form. It emphasizes the need for regular mandatory education and training on ADR reporting among healthcare workers, and also the need to run continuous awareness campaigns on spontaneous reporting of ADRs to enhance reporting rate.

A step toward revamping MD pharmacology curriculum by National Medical Commission: An envisioned transition from bench-side training to bedside training

With a vision to meet the changing trends and recent developments in the field of pharmacology and therapeutics, the postgraduate medical education board of the national medical commission has put forth amendments to the existing guidelines for the MD pharmacology course. Major changes include introducing a district residency-based program for 3 months apart from the clinical postings and more focus is given to the areas of rational prescribing, pharmacovigilance, and ethical aspects of research. These amendments come as a new ray of hope in developing the postgraduate student as a complete professional equipped to meet the increasing standards in the workplace be it a hospital or a research arena. Including the simulation-based approaches for training as a lesson learned from the pandemic and adopting patient-oriented learning during the course are some of the key changes in the new guidelines. This review focuses on highlighting these amendments and correlating the same with the current scenario and discusses the future areas that can be improved for comprehensive development in the pharmacology curriculum.

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.

Heart Smart Diabetes Care

The world is growing smarter day by day, and so is health care. In spite of innumerable inventions and tech-tools, however, we struggle to contain chronic illnesses like diabetes and heart disease. We need to work together and design a rational, scientific and socially sustainable Heart Smart diabetes care ecosystem, with Heart Smart management strategies, to ensure happiness and harmony in persons who live with diabetes.

Reacciones adversas a múltiples antibióticos / Adverse drug reactions to multiple antibiotics

Resumen La información sobre reacciones adversas es fundamental para conocer la seguridad real de los medicamentos comercializados. Existen casos de pacientes con síndrome de intolerancia a múl tiples drogas, una entidad poco reportada, la que puede presentarse cuando en un mismo paciente ocurren reacciones adversas a más de dos medicamentos no relacionados farmacológicamente. Se describe el caso de una mujer con diagnóstico de endocarditis por Staphylococcus aureus multisensible, que cursó con reacciones adversas a cinco antibióticos estructuralmente no relacionados y con mecanismos de acción diferentes, en dos internaciones consecutivas. Las reacciones fueron secundarias a cefazolina (tricitopenia), vancomicina (injuria renal), daptomicina (elevación de creatina fosfoquinasa) y linezolid (hepatotoxicidad) en la primera internación, y a cotrimoxazol (plaquetopenia) en la segunda. En todos los casos se observó daño transitorio en diferentes sistemas de órganos. Finalmente, se otorgó alta hospitalaria con clindamicina sin nuevas intercurrencias hasta finalizar tratamiento. Este caso podría corresponder al síndrome antes mencionado o a una entidad aún no caracterizada.

Abstract Adverse reaction reporting is essential to understand the actual safety of marketed medicines. There are cases of patients with multidrug intolerance syndrome, an under-reported entity, which can occur when adverse reactions to more than two pharmacologically unrelated drugs occur in the same patient. We describe the case of a woman diagnosed with multisensitive Staphylococcus aureus endocarditis who experienced adverse reactions to five structurally unrelated antibiotics with different mechanisms of action in two consecutive hospitalisations. The reactions were secondary to cefazolin (tricytopenia), vancomycin (renal injury), daptomycin (elevated creatine phosphokinase) and linezolid (hepatotoxicity) in the first hospitalization, and to cotrimoxazole (thrombocytopenia) in the second. Transient damage to different organ systems was observed in all cases. Finally, hospital discharge was granted with clindamycin without further intercurrences until treatment was completed. This case could cor respond to the aforementioned syndrome or to an as yet uncharacterized entity.

Reacciones adversas medicamentosas en ancianos de Matanzas, Cuba 2014-2019 / Adverse drug reactions in the elderly of Matanzas, Cuba 2014-2019

Resumen Objetivo: Caracterizar las sospechas de reacciones adversas a medicamentos que se presentaron en los adultos mayores en Matanzas, en el periodo 2014 al 2019. Materiales y Método: Estudio de serie de casos en Farmacovigilancia (FV). Se revisó la base de datos de reportes de sospecha de reacciones adversas a los medicamentos de la Unidad Coordinadora Provincial de Farmacovigilancia, entre 2014 y 2019. Resultados: Se evaluaron un total de 1926 reportes de reacciones adversas por medicamentos en ancianos, representaron el 24,3 % del total. Predominaron las mujeres (56,7 %) y el grupo de edad entre 60 y 69 años (51,4%). Prevaleció la erupción cutánea (13,4 %). Los antimicrobianos y los antiinflamatorios no esteroideos, fueron los que se asociaron más con las RAM en piel, así como del sistema digestivo. La tos estuvo relacionada con el captopril. Predominaron las reacciones adversas por medicamentos de baja frecuencia (55,2%), moderadas (83,8%) y las probables (77,1%) según imputabilidad. Conclusiones: El perfil de seguridad en ancianos en la provincia de Matanzas muestra un predominio de reacciones adversas frecuentes, moderadas y probables en mujeres con edades entre 60 a 69 años. Los antimicrobianos, los inhibidores de la enzima convertidora de angiotensina y los antiinflamatorios no esteroideos fueron los fármacos más notificados por los médicos y farmacéuticos produciendo síntomas a nivel del sistema digestivo y la piel.

Abstract Objective: To characterize suspected adverse drug reactions that occurred in older adults in Matanzas, from 2014 to 2019. Materials and methods: Pharmacovigilance (FV) case series study. The database of reports of suspected adverse drug reactions of the Provincial Pharmacovigilance Coordinating Unit, between 2014 and 2019, was reviewed. Results: A total of 1926 reports of adverse drug reactions in the elderly were evaluated, representing 24, 3% of the total. Women (56.7%) and the age group between 60 and 69 years (51.4%) predominated. Skin rash prevailed (13.4%). Antimicrobials and non-steroidal anti-inflammatory drugs were the ones most associated with ADRs in the skin, as well as in the digestive system. Cough was related to captopril. Adverse drug reactions of low frequency (55.2%), moderate (83.8%) and probable (77.1%) prevailed according to immutability. Conclusions: The safety profile in the elderly in the province of Matanzas shows a predominance of frequent, moderate and probable adverse reactions in women aged between 60 and 69 years. Antimicrobials, angiotensin-converting enzyme inhibitors and non- steroidal anti-inflammatory drugs were the drugs most reported by doctors and pharmacists, producing symptoms at the level of the digestive system and the skin.

Prescripciones potencialmente inapropiadas en pacientes geriátricos hospitalizados en el servicio de medicina interna en un hospital de referencia en México / Potentially inappropriate prescriptions in geriatric patients hospitalized in the internal medicine department of a referral hospital in Mexico

Resumen Antecedentes: Una prescripción potencialmente inapropiada (PPI) constituye un riesgo de presentar efectos adversos por un fármaco que superan los beneficios de este, pudiendo considerarse como uso inadecuado de medicamentos. Objetivo: Describir la prevalencia de prescripciones potencialmente inapropiadas en pacientes geriátricos hospitalizados en el servicio de medicina interna de un hospital de referencia en México. Material y métodos: Diseño descriptivo transversal, con asignación simple de expedientes clínicos de pacientes hospitalizados mayores de 65 años, entre enero de 2016 y agosto de 2017. Se aplicaron los criterios STOPP y START para identificar el número de PPI, cantidad de medicamentos prescritos, presencia, cantidad y tipo de comorbilidades, así como días de estancia hospitalaria. Resultados: Se encontró una prevalencia de 73.3 % de PPI y las principales comorbilidades fueron hipertensión arterial y diabetes mellitus tipo 2. Se cuantificaron 1885 medicamentos prescritos; la estancia hospitalaria media fue de 6.3 días. Conclusiones: Se identificó alta prevalencia de PPI en los pacientes geriátricos hospitalizados, de ahí la importancia de aplicar los criterios STOPP y START y del papel del farmacéutico en la validación de la prescripción antes de la administración de medicamentos.

Abstract Background: Potentially inappropriate prescription (PIP) constitutes a risk for the development of adverse effects of a drug that outweigh its benefits, which can be considered inappropriate medication use. Objective: To describe the prevalence of PIP in geriatric patients hospitalized at the internal medicine department of a referral hospital in Mexico. Material and methods: Cross-sectional, descriptive design, with simple allocation of medical records from patients older than 65 years hospitalized between January 2016 and August 2017. The STOPP/START criteria were applied to identify the number of PIPs, the number of prescribed medications, number and type of comorbidities, as well as days of hospital stay. Results: A prevalence of PIP of 73.3% was identified, with main comorbidities being hypertension and type 2 diabetes mellitus. A total of 1,885 prescribed medications were quantified; mean hospital stay was 6.3 days. Conclusions: A high prevalence of PIP was identified in hospitalized geriatric patients, hence the importance of applying the STOPP/START criteria and of the role of the pharmacist for validating the prescription prior to drug administration.

A study on the knowledge, attitude, and practice on adverse drug reactions and pharmacovigilance among nursing staff

Background: Lack of knowledge of pharmacovigilance and underreporting of adverse drug reaction (ADR) are worldwide problems of big concern. Gross underreporting of ADR in India led to increased hospital admissions, increase in length of hospital stay, and increase in healthcare cost burden. Aims and Objectives: This study was planned to assess knowledge, attitude, and practice on ADR and pharmacovigilance among nursing staff in Gandhi Medical College and Associated Hospitals, Bhopal Madhya Pradesh. Materials and Methods: A questionnaire-based, cross-sectional, and observational study was conducted among nursing staff in a tertiary care Centre. Data were collected in the form of a validated questionnaire comprised of 17 questions regarding knowledge, attitude, and practice of nursing staff toward ADR and Pharmacovigilance. Data were analysis by descriptive statistics and result was computed. Results: Around 33% of respondents were aware of Pharmacovigilance program of India and 99% of them had knowledge about main objective of pharmacovigilance. Out of total filled questionnaire received, only 12% nurses practiced reporting ADR. The major factor discouraging participants from reporting ADR was lack of time to report. The majority of nursing staff had a positive attitude toward awareness of pharmacovigilance and ADR reporting. Conclusion: Our study has shown that there is lack of correct knowledge regarding ADR reporting and pharmacovigilance among staff nurses. Although, the attitude toward ADR reporting was adequate, the actual practice of ADR reporting is unsatisfactory. Hence, it is essential to train staff nurses regarding pharmacovigilance and ADR reporting

Naltrexona em baixa dose (LDN): tendência de consumo nas capitais brasileiras e Distrito Federal, 2014-2020 / Low-dose naltrexone (LDN): consumption trend in Brazilian capitals and the Federal District, 2014-2020

Resumo Estudo ecológico com objetivo de determinar o consumo de naltrexona em baixa dose (LDN) nas 26 capitais brasileiras e Distrito Federal e acompanhar a tendência entre os anos de 2014 e 2020. A coleta de dados da dispensação de naltrexona manipulada, se deu por meio do Sistema Nacional de Gerenciamento de Produtos Controlados, publicizado em 2020, considerando-se baixa dose prescrições de até 5 mg. O cálculo dos coeficientes de dispensação utilizou as estimativas populacionais do Instituto Brasileiro de Pesquisa Geografia e Estatística. Utilizou-se análise estatística descritiva e de regressão generalizada de Prais-Winsten para a série temporal. As tendências observadas foram classificadas em crescentes, estáveis ou decrescentes, com intervalo de confiança de 95% e nível de significância de 5%. Os resultados demonstraram maiores coeficientes de consumo de LDN nas regiões Centro-Oeste, Sul e Sudeste e menores nas Norte e Nordeste. Observou-se dispensação de LDN crescente em 55,6% das capitais, estacionária em 44,4% e ausência de coeficientes decrescentes. Apesar das evidências limitadas quanto à farmacoterapia de LDN e da sua prescrição off-label, os dados demonstram que a prescrição, dispensação e consumo vem crescendo no Brasil, com ênfase nas regiões centro-sul do país.

Abstract The scope of this paper is an ecological study to determine the consumption of low-dose naltrexone (LDN) in the 26 Brazilian capitals and the Federal District and monitor the trend between the years 2014 to 2020. Data collection on the dispensation of manipulated naltrexone was done through the National Management System of Controlled Products, published in 2020, considering low-dose prescriptions of up to 5 mg. The calculation of the dispensation coefficients used the population estimates of the Brazilian Institute of Geography and Statistics. Descriptive statistical analysis and generalized Prais-Winsten regression analysis were used for the time series analysis. The trends observed were classified as increasing, stable, or decreasing, with a 95% confidence interval and 5% significance level. The results showed higher LDN consumption coefficients in the Mid-West, South and Southeast regions and lower coefficients in the North and Northeast. Increasing dispensation of LDN was observed in 55.6% of the capitals, being stationary in 44.4%, with no decreasing coefficients. Despite the limited evidence regarding LDN pharmacotherapy and its off-label prescription, the data show that prescription, dispensing, and consumption have been on the increase in Brazil, with emphasis on the central-south regions of the country.

Política de medicamentos de alto costo en un hospital público pediátrico: Análisis de utilización y costos / High-cost medication policy at a public pediatric hospital: utilization and cost analysis

Objetivos. Analizar el circuito de utilización de los medicamentos de alto costo (MAC) y los resultados clínicos obtenidos en un hospital de pediatría público de alta complejidad de Argentina y presentar una estrategia de selección replicable para otras instituciones de similares características de la región. Métodos: Estudio prospectivo, descriptivo, aleatorizado, conducido en el Hospital de Pediatría Juan P. Garrahan de la Ciudad Autónoma de Buenos Aires en el período entre el 1 de setiembre de 2018 y el 31 de marzo de 2019. Se evaluaron dos unidades de estudio, la unidad paciente y la unidad MAC. Resultados: Los MAC consumen 7.921.200 dólares estadounidenses (USD) anuales y representan el 41% del costo de los medicamentos del hospital de alta complejidad. El 50% del costo de los MAC estuvo representado por la gammaglobulina (medicamento utilizado en diferentes enfermedades). Los pacientes proceden de toda la Argentina y otros países y un 44% tiene cobertura de salud. Los diagnósticos para los que se prescribieron MAC con mayor frecuencia fueron los relacionados con patología oncológica (leucemia linfoide aguda, leucemia mieloblástica aguda). El 54% de los pacientes presentó mejoría atribuible directamente a la administración de los MAC, 39% no presentó cambios y el 7% empeoró. Conclusiones: La efectividad en los resultados clínicos y el análisis de los circuitos de aprobación indican que, además de la aprobación por las entidades nacional e internacionales, la evaluación responsable por parte de las instituciones efectoras, mediante la discusión interdisciplinaria basada en la mejor evidencia, contribuye a optimizar la utilización de los MAC y la seguridad de los pacientes (AU)

Objectives. To analyze the utilization circuit of high-cost medications (HCM) and the clinical results obtained in a tertiarycare public pediatric hospital in Argentina and to present a selection strategy that may be disseminated to other institutions of similar characteristics in the region. Methods: A prospective, descriptive, randomized study was conducted at Hospital de Pediatría Juan P. Garrahan in Buenos Aires between September 1, 2018 and March 31, 2019. Two study units were evaluated, the patient and the HCM. Results: HCMs account for 7,921,200 US dollars (USD) per year and represent 41% of the cost of drugs in this tertiary-care hospital. Gamma globulin (a drug used for different diseases) accounted for 50% of the cost of HCMs. Patients came from Argentina and other countries and 44% had a health insurance. Cancer (acute lymphoid leukemia, acute myeloblastic leukemia) was the diagnosis for which HCMs were most frequently prescribed. Fifty-four percent of patients showed improvement directly attributable to the administration of HCMs, 39% showed no change, and 7% worsened. Conclusions: The effectiveness in clinical outcomes and the analysis of approval circuits show that, in addition to approval by national and international entities, responsible evaluation by the effector institutions through interdisciplinary discussion based on the best evidence contributes to optimizing the use of HCMs and patient safety (AU)

Fármacovigilancia de la carbamazepina en el Policlínico Marta Abreu. Santa Clara, 2022

Fundamento: en la práctica, el término estupefaciente se aplica a las especialidades farmacéuticas que contienen principios activos que actúan sobre el sistema nervioso central modificándolo y a las fórmulas magistrales con los mismos principios activos. Objetivo: caracterizar clínica y epidemiológicamente los pacientes que consumen carbamazepina en un área de salud del municipio de Santa Clara. Métodos: estudio descriptivo, transversal, en pacientes que consumen carbamazepina, pertenecientes al Policlínico Docente Marta Abreu, en el período del 1 de enero de 2021 al 1 de abril de 2022. Se incluyeron 209 pacientes y se midieron las siguientes variables: edad, sexo, número de pacientes según diagnósticos, número de pacientes según nuevos protocolos y tiempo de consumo del tratamiento. Resultados: predominó el grupo de edades de 51 a 60 con 43 pacientes (20,5 %), dentro de este grupo el sexo femenino (11,0 % del total); el diagnóstico predominante fue la epilepsia generalizada (93 pacientes). Predominó el sexo femenino, con 59 pacientes, y en ellas se encontró la mayor cantidad de expedientes vencidos, con un total de 16. Según nuevos protocolos, prevalecieron los pacientes con diagnóstico de neuralgia trigeminal, glosofaríngeo o facial (7 pacientes). En cuanto al tiempo de consumo predominaron los pacientes con igual diagnóstico a los anteriores y trastorno del comportamiento debido a enfermedad médica, ambos grupos con tratamientos de hasta tres años. Conclusiones: es importante el conocimiento sobre el uso y abuso de los estupefacientes así como mantener actualizado a todo el personal sanitario para lograr el óptimo control sobre estas sustancias.

Background: in practice, the term narcotic is applied to pharmaceutical specialties that contain active ingredients that act on the central nervous system, modifying it, and to master formulas with the same active ingredients. Objective: to characterize clinically and epidemiologically the patients who consume carbamazepine in a health area of the Santa Clara municipality. Methods: descriptive, cross-sectional study in patients consuming carbamazepine, belonging to the Marta Abreu Teaching Polyclinic, from January the 1st, 2021 to April the 1st, 2022. 209 patients were included and the following variables were measured: age, sex, number of patients according to diagnoses, number of patients according to new protocols and time of consumption of the treatment. Results: the age group from 51 to 60 predominated with 43 patients (20.5%), within this group the female sex (11.0% of the total); the predominant diagnosis was generalized epilepsy with a total of 93 patients. The female sex predominated with a total of 59 patients and in them the largest number of expired files was found, with a total of 16. According to new protocols, patients with a diagnosis of trigeminal, glossopharyngeal or facial neuralgia (7 patients) predominated. Regarding the time of consumption, patients with the same diagnosis as the previous ones and behavioral disorder due to a medical illness predominated, both groups with treatments of up to three years. Conclusions: knowledge about the use and abuse of narcotic drugs is important, as well as keeping all health personnel updated to achieve optimal control over these substances.

El largo y sinuoso camino de la farmacia clinica en Chile / The long and winding road of the clinical pharmacy in Chile

Clinical pharmacy is a health discipline in which pharmacists provide patient care that optimizes rational medication use and promotes health, wellness and disease prevention. The beginnings of clinical pharmacy in Chile were inspired by the origin in the School of Pharmacy of the University of California, San Francisco (UCSF), in the mid-1960s. However, the historical development in our country, both in teaching and in the professional field, was accompanied by difficulties and success, which became a long and winding road. This article shares the events that gave rise to its beginnings in Chile, first through teaching, then in pharmacovigilance and clinical pharmacokinetics, to later describe its professional expansion and recognition as a specialty of pharmacy. This article briefly recounts the history of the Chilean clinical pharmacy to this day. Some names of people or institutions were not mentioned. Therefore the authors apologize in advance to pharmacists and organizations whose contribution cannot be recognized in this way. However, we know that this specialty has not been forged only by the names that appear, but by all those who love and respect the work of the clinical pharmacy.