ABSTRACT
RESUMEN Objetivo: Identificar las características clínicas de los pacientes con gota y la forma de utilización de los medicamentos antigotosos en Colombia. Métodos: Estudio de corte transversal en el que se analizaron 310 historias clínicas de pacientes atendidos en el último trimestre del 2016 y que recibieron un medicamento antigotoso. Se identificaron variables sociodemográficas, clínicas, farmacológicas, comorbilidades y paraclínicas. Para cada medicamento antigotoso se determinó si el uso fue según las recomendaciones aprobadas por la Federal Drug Administration (FDA). Se realizaron análisis descriptivos, bivariados y multivariados. Resultados: Se evaluaron pacientes de 14 diferentes ciudades de Colombia, con un predominio masculino del 70,3% (n = 218) y una mediana de edad de 64 arios (RIC: 26-94 arios). El antigotoso más frecuentemente utilizado fue alopurinol (n = 255; 82,3%), seguido de colchicina (n = 54; 17,4%). Los diagnósticos hallados como indicación fueron: hiperuricemia (n = 181; 58,4%), gota (n = 34; 11%), artritis gotosa (n = 28; 9%). El 74,5% (n = 231) de las prescripciones tenía un uso aprobado según la FDA, especialmente alopurinol en el manejo de gota e hiperuricemias, mientras que colchicina se encontró siendo utilizada en indicaciones no aprobadas (n = 44; 81,4%). Las comorbilidades más frecuentes fueron hipertensión (68,4%) y dislipidemia (55,8%). Conclusiones: Los pacientes con gota en tratamiento farmacológico tienen una elevada frecuencia de comorbilidades cardiovasculares, y están siendo tratados con alopurinol para la prevención a largo plazo, mientras que una menor proporción recibe colchicina que comúnmente es utilizada para indicaciones no aprobadas por las agencias reguladoras.
ABSTRACT Objective: To identify the clinical characteristics of patients with gout, and the prescription patterns of anti-gout medications in Colombia. Methods: Cross-sectional study, that analysed the data from 310 medical records of patients treated in the last quarter of 2016, and who received an anti-gout medication. Sociodemographic, clinical, pharmacological, comorbidities, and paraclinical variables were identified. For each anti-gout drug used, it was determined whether the use was in accordance with Federal Drug Administration (FDA) approved recommendations. Descriptive, bivariate and multivariate analyses were performed. Results: Patients from 14 different cities in Colombia were evaluated, with a male predominance of 70.3% (n = 218) and a median age of 64 years (RIC: 26-94 years). The most frequently used anti-gout medication was allopurinol (n = 255; 82.3%), followed by colchicine (n = 54; 17.4%). The main diagnoses found as an indication were: hyperuricaemia (n=181, 58.4%), gout (n = 34; 11.0%), and gouty arthritis (n = 28; 9.0%). Almost three-quarters (74.5%; n = 231) of the prescriptions had an approved use according to the FDA, especially allopurinol in the management of gout and hyperuricaemia, while colchicine was found to be used in unapproved indications (n = 44, 81.4%). The most frequent comorbidities were hypertension (68.4%) and dyslipidaemia (55.8%). Conclusions: Patients with gout who are under pharmacological treatment have a high frequency of cardiovascular comorbidities. They were being treated with allopurinol for long-term prevention, while a smaller proportion received colchicine, which is often used for indications not approved by regulatory agencies.
Subject(s)
Humans , Adolescent , Adult , Middle Aged , Aged , Pharmaceutical Preparations , Colombia , Gout , Therapeutics , Colchicine , Multivariate Analysis , Diagnosis , PrescriptionsABSTRACT
Se realizó un estudio de utilización de medicamentos sobre hábitos y calidad de la prescripción, con el fin de describir las características y potencial uso no adecuado de los antibióticos en el servicio de consulta externa de un hospital de segundo nivel de la ciudad de Bogotá, D.C. En las 8077 prescripciones analizadas se encontraron 613 (8%) con al menos un antibiótico de uso sistémico. Los antibióticos más dispensados fueron: Amoxicilina, Cefalexina, Ciprofloxacina, Dicloxacilina, Doxiciclina. Se prescribieron combinaciones de dos antibióticos en el 3% de las fórmulas, siendo la más frecuente macrólido-penicilina. Todas las prescripcion esanalizadas cumplieron con los requisitos de calidad y el 0,4% de los tratamientos no tenían el tiempo de duración del tratamiento. La frecuencia de uso de los antibióticos en el servicio de consulta externa fue más baja que en otros estudios. Se identificaron potenciales usos no adecuados como la falta de diagnóstico infeccioso, combinación de antibióticos no documentada, interacciones de medicamentos y falta de información adecuada en la administración de tetraciclinas.
A study on drug use habits and quality of prescribing was conducted to describe the characteristics and potential inadequate use of antibiotics in the outpatient service of one of the Bogota's second-level hospitals. In 8077 prescriptions analyzed it was found 613 (8%) with at least one antibiotic for systemic use. Amoxicillin, Cephalexin, Ciprofloxacin, Dicloxacillin, and Doxycycline were the most dispensed antibiotics. Combinations of two antibiotics were prescribed for 3% of the formulas; the most common of these was macrolide-penicillin. All prescriptions analyzed met the quality requirements and only 0.4% of the treatments did not have the time duration of treatment. The found frequency of use of antibiotics in outpatient services was lower than in other studies. Potential not suitable uses as the lack of infectious diagnosis, antibiotic combination unreported, drug interactions and lack of adequate information on the administration of tetracyclines were identified.
ABSTRACT
Using foreign clinical trial data in new drug submission, new drug can be approved with a few observations of Japanese patients. In current Japanese drug development situation, the importance of post-marketing surveillance (PMS) for Japanese patients has been increased. Rigid PMS system in Japan which has no selective options should be rescinded. In order to perform primary role of PMS which is to keep in safety and efficacy of pharmaceutical and medical devices, the Japanese PMS should change from standard form to selection of study design according to scientific consideration. The paper proposed that new pharmaco-epidemiology research design was applied to PMS and PMS were conducted by independent and integrated data center based disease registry.
ABSTRACT
Background: Prescription auditing studies are a part of drug utilization studies, are beneficial in clinical practice for rational prescribing of drugs and helpful for minimizing the medication errors. They are important tool to promote rational prescribing. Methods: This was a prospective drug utilization study conducted by the Department of Pharmacology in Psychiatry out-patient department at Shri Guru Ram Rai Institute of Medical and Health Sciences, Dehradun for a period of 6 months. A total of 311 prescriptions were evaluated for prescribing pattern using World Health Organization drug indicators and National Essential Medicine List (NEML) 2011. Results: A total of 311 prescriptions were evaluated, 157 (50.48%) were females, and 154 (49.52%) were males, mean age was 37.14±0.8 years. Majority of patients were married 207 (66.56%), housewife 116 (37.30%) and belong to middle socioeconomic group 205 (65.92%). A total of 1250 drugs were prescribed, anti-anxiety (anti-A) 379 (30.32%), anti-depressants (anti-Ds) 348 (27.84%), anti-psychotics (anti-Ps) 118 (9.44%), anti-epileptics (anti-Es) 64 (5.12%), mood stabilizer 20 (1.6%), anticholinergics 28 (2.24%) and others 293 (23.44%). Oral formulations 1247 (99.76%), 4.02 drugs/prescription, 100% drugs were prescribed by brand names. 220 (17.6%) fixed dose combinations were prescribed. Most frequently prescribed among anti-A drugs were propranolol 160 (42.22%) and diazepam 105 (27.70%), among anti-Ds drugs were amitriptyline 65 (18.68%) and escitalopram 59 (16.95%) and among anti-Ps risperidone 49 (41.53%) and olanzapine 38 (32.20%), respectively. About 51.36% drugs were prescribed from the NEML 2011. Result has revealed polypharmacy in the practice. Conclusions: Anti-A drugs were the most commonly prescribed drugs followed by anti-Ds, anti-Ps and anti-Es respectively. Rational prescribing requires further consideration with special reference to polypharmacy and providing feedback to the physicians.
ABSTRACT
Aim: The financial burden of malignant diseases treatment has increased remarkably over the years. This is due to, among many reasons, the costs of drugs, especially those of the new classes. Thus, it is of interest to assess the availability and differential cost of anti-cancer drugs in developing countries compared to developed countries. Study Design: The study was designed to determine the anti-cancer drugs availability in the world, in the United States of America (USA), the United Kingdom (UK) and the Republic of Serbia (RS), with the aim to get insights into the similarities and differences between developed and developing countries toward anti-cancer drugs availability, as well as the prices of these drugs. This analysis was based on three drug data bases for anti-cancer drugs that were available during 2011 and 2012 year in the world, USA, UK, and RS. Results: About 37% of anti-cancer drugs that were present in the world market in 2011 year were also present in the RS (the drugs that were reimbursed by the state health insurance), compared to 74.8 and 67.4% that were available in the USA and the UK, respectively. Furthermore, out of all drugs registered in 2012 in the UK, 62.8% were present in the RS and almost all pharmacological groups were represented with some drugs, including very expensive ones like the biological agents. Most of the drugs in the RS were cheaper, regardless of whether they belonged to nonproprietary or brand-name drugs. These findings could be the result of the very low national gross domestic product in the RS and thus, the small funds earmarked for the health care. Conclusion: The Republic of Serbia, which belongs to developing countries, face some difficulties in taking care of patients with malignant diseases where the prominent place have drugs for malignant diseases treatment, especially the newer classes, which are usually more expensive and generally do not provide the first-line treatment.
ABSTRACT
Background: Irrational prescribing is a common phenomenon, seen among medical practitioners. Knowledge, awareness, and attitude denote the practicing trends among the practitioners. The objective of this study was to describe the prescribing practices in Ophthalmology outpatient department (OPD) to promote rational prescribing. Methods: This study was conducted between January 2011 to June 2011, in Department of Pharmacology and Ophthalmology, SGRRIM and HS, Dehradun, Uttarakhand. A total number of 255 prescriptions were randomly collected from the Ophthalmology OPD and were analyzed for various parameters using national essential medicine list 2011 and World Health Organization drug use indicators. Results: A total number of 255 prescriptions were evaluated for prescribing pattern, 153 (60%) patients were between 16 and 45 years of age, the male: female ratio was 1.13:1. 237 (93%) patients from middle socioeconomic status. Diseases pattern observed were conjunctivitis 102 (40%), refractive error 45 (17.64%), stye 12 (4.7%), cataract 9 (3.52%), and miscellaneous 87 (34.12%). One hundred and thirty-eight (54.11%) patients received antimicrobial agents, fluoroquinolone (ofloxacin, moxifloxacin, gatifloxacin, etc.) were the most frequently prescribed antimicrobial drugs, analgesics (diclofenac and ketorolac) were prescribed to 45 (17.64%) patients, 54 (21.17%) received steroids (dexamethasone and prednisolone), 96 (37.64%) patients received other drugs (carboxymethylcellulose [CMC], multi-vitamins, zinc preparations, acyclovir, and anti-allergics). Fixed dose combinations (FDCs) were used in 90 (35.29%) patients, the most common combination was antimicrobials with steroids. All the drugs were prescribed by brand names and 1.9 drug/prescription was used. Conclusion: Topical antimicrobial agents are the most commonly used drugs in ophthalmic OPD in our setup; the most common FDCs prescribed were antimicrobials with steroids, the other commonly used drugs were analgesics, CMC and anti-allergic drugs.
ABSTRACT
The scope of this paper was to analyze the profile of medical consultations and drugs used for the treatment of comorbidities in patients with diabetes attended in the Brazilian Unified Health System. This was a pharmaco-epidemiological cross-sectional study conducted between March 2006 and February 2007 All patients with diabetes attended in the western sanitary district of Ribeirao Preto in the state of São Paulo were included in the study. The types of medical attendance (primary, secondary and emergency care) and the drugs prescribed for the treatment of comorbidities were analyzed. The drugs were classified according to the Anatomical Therapeutic Chemical Classification System and 3,198 patients were identified. The mean age was 60.4 years and more than 55% of the patients were 60 years or older. The cardiovascular drugs most used were captopril or enalapril (60%). About 40.6% of the patients used acetylsalicylic acid in platelet antiaggregant doses. The patients had an average of 5.1 medical consultations per year (primary care, secondary care and emergency care). The utilization of statins and acetylsalicylic acid was less than that reported in the literature and the data indicate a high prevalence of admission to emergency care.
Analisar o perfil de consultas médicas e de medicamentos para o tratamento de comorbidades em pacientes com diabetes atendidos no Sistema Único de Saúde. Estudo farmacoepidemiológico e transversal realizado de mar/2006 a fev/2007. Foram incluídos no estudo portadores de diabetes atendidos no Distrito Sanitário Oeste de Ribeirão Preto (SP), sendo analisadas as consultas médicas realizadas na atenção primária, secundária e emergência, além dos medicamentos prescritos para tratamento de comorbidades associadas ao diabetes. Foram identificados 3.198 pacientes, com idade média de 60,4 anos e aproximadamente 55,0% idosos. Os medicamentos do sistema cardiovascular foram os mais prescritos, sendo que 60,0% dos pacientes utilizavam captopril ou enalapril. Além disso, 40,6% dos pacientes faziam uso de ácido acetilsalicílico em dose antiagregante plaquetário. Em relação às consultas médicas, os pacientes apresentaram média de 5,1 visitas ao ano, na atenção primária, na atenção secundária e no atendimento de emergência. A utilização de ácido acetilsalicílico e estatina foram menores do que a relatada na literatura e os dados indicam uma alta prevalência de admissão no atendimento de emergência.
Subject(s)
Female , Humans , Male , Middle Aged , Diabetes Complications/therapy , Diabetes Mellitus/therapy , Referral and Consultation , Cross-Sectional Studies , Retrospective StudiesABSTRACT
Introducción: publicar en revistas médicas nacionales las reacciones adversas observadas con medicamentos patentados en Cuba permite a los profesionales cubanos mayor acceso a la información; la magnitud de esta actividad no se conoce. Objetivos: identificar artículos sobre farmacovigilancia de medicamentos patentados en Cuba en revistas médicas nacionales y describir algunas de sus características. Métodos: estudio observacional descriptivo y transversal, se localizaron artículos publicados hasta enero de 2012 e indexados en la biblioteca electrónica Scielo-Cuba, con los términos farmacovigilancia, seguridad, reacciones adversas, efectos adversos, eventos adversos o efectos indeseables en los campos título o materia. Se excluyeron los que no eran resultados de investigaciones o reportes de casos. Se examinaron variables como medicamento objeto, diseño realizado, tipo de vigilancia, si al menos uno de los autores es productor del medicamento, nombre de la revista y año de publicación. Resultados: se identificaron 23 artículos; 47,8 % referían la farmacovigilancia sobre diversas vacunas, 73,9 % correspondieron a series de casos y 26,1 % a ensayos clínicos, 91,3 % eran estudios post comercialización, en 60,8 % al menos uno de los autores era productor del medicamento, 52,2 % se publicó entre los años 2000-2005 y 30,5 % en la Revista Cubana de Farmacia. Conclusiones: el número de artículos encontrados fue escaso, incluso para las vacunas. La publicación en revistas médicas nacionales de estudios de farmacovigilancia de los medicamentos patentados en Cuba debe aumentar. Como mejor vía para generalizar sus resultados deben tenerse en cuenta ciertas consideraciones para mejorar la calidad de la información que se publica.
Introduction: publishing in the national medical reviews the adverse reactions observed in medicines patented in Cuba allows the Cuban professionals a better access to the information; the magnitude of this activity is not very well known. Objective: identifying articles on pharmaco-surveillance of the medicines patented in Cuba published in national medical journals and describing some of their characteristics. Method: cross-sectional, descriptive, observational study. We found articles published up to 2012 and indexed at the electronic library Scielo-Cuba, with the terms pharmaco-surveillance, security, adverse reactions, adverse events or undesirable effects in the fields title or matter. We excluded those that were not results of investigations or case reports. We examined variables like medicine object, made design, kind of surveillance, if at least one of the authors is the medicine producer, journal title and year of publication. Results: we identified 23 articles; 47,8 % referred the pharmaco-surveillance on several vaccines, 73,9 % dealt with case series and 26,1 % were about clinical assays; 91,3 % were post-commercialization studies. In 68, 9 % of them, at least one of the authors was the medicine producer. 52,2 % were published in the period 2000-2005 and 30,5 % of them in the Revista Cubana de Farmacia (Cuban Journal of Pharmacy). Conclusions: the number of articles found was scarce, even for the vaccines. The publication in national medical journals of the pharmaco-surveillance studies of the medicines patented in Cuba should be increased. Certain considerations should be taken into account for improving the published information, as a better way to generalize their results.
ABSTRACT
Los cambios fisiológicos asociados al envejecimiento producen modificaciones de la farmacocinética y estados de especial susceptibilidad del adulto mayor a presentar reacciones adversas a medicamentos e interacciones medicamentosas. Las comorbilidades inducen mayor riesgo ya que pueden afectar la absorción, excreción y metabolización de fármacos y la necesidad de ampliar las terapias complican la prescripción segura. Existen criterios en literatura internacional que describen fármacos inapropiados para el adulto mayor, ya sea por su toxicidad como por que existen alternativas más seguras en este grupo etario. Factores no farmacológicos como las redes sociales de apoyo, el deterioro cognitivo, los trastornos de órganos de los sentidos, entre otros, pueden influir importantemente en el éxito o fracaso de una terapia.
The physiological changes in elderly, affects the pharmacokinetics, and increase the susceptibility to present adverse effects or drug interactions. Co morbidities is another agent that affects the drugs absorption, excretion and metabolization, difficulting the safe prescription and enlarge therapies. There are criteria in international literature describing inappropriate drugs for the elderly, either because of their toxicity and because safer alternatives exist in this age group. Non-pharmacological factors such as social support networks, cognitive impairment, disorders of sense organs, etc. can influence in the success or failure of therapy.
Subject(s)
Humans , Aged , Aging , Pharmaceutical Preparations , Polypharmacy , Comorbidity , Drug Interactions , Drug Prescriptions , Drug-Related Side Effects and Adverse Reactions , PharmacoepidemiologyABSTRACT
The objective of this study was to evaluate studies on the occurrence of adverse drug events (ADEs) in hospitals in order to learn about their frequency and characteristics, comparing the methods for identifying them and the various definitions. A search was conducted on MEDLINE and identified studies published from 2000 to 2009. Inclusion criteria were: studies in populations not selected for specific diseases or drugs and ADEs that occurred during hospitalization. Twenty-nine studies were selected, displaying multiple sources of heterogeneity, including differences in the study populations, surveillance techniques, definitions of ADEs, and indicators. The proportion of patients with ADEs ranged from 1.6 percent to 41.4 percent of inpatients and the rates ranged from 1.7 to 51.8 events/100 admissions. A considerable share of these events could have been avoided. The findings show that ADEs in inpatients are a public health problem. However, further studies are needed to monitor these adverse events in order to effectively promote safe drug use.
O objetivo foi avaliar estudos sobre a ocorrência de eventos adversos a medicamentos (EAM) em hospitais para conhecer as suas freqüências e características, comparando os métodos de identificação e as definições utilizadas para caracterizá-los. A busca foi realizada no MEDLINE e identificou estudos publicados entre 2000 e 2009. Os critérios de inclusão foram estudos em população não selecionada por patologias ou medicamentos específicos e os EAM ocorridos durante a internação. Foram selecionados 29 estudos e encontradas múltiplas fontes de heterogeneidade entre eles, incluindo diferenças nas populações estudadas, nas técnicas de vigilância, nas definições de EAM e nos indicadores. A freqüência de pacientes com EAM está entre 1,6 por cento e 41,4 por cento dos pacientes internados e as taxas entre 1,7 e 51,8 eventos/100 internações. Uma parte considerável desses eventos poderia ter sido evitada. Os resultados mostram que EAM em pacientes internados são um problema de saúde pública. Entretanto, são necessários novos estudos de monitoramento desses eventos adversos para a efetiva promoção do uso seguro dos medicamentos.
Subject(s)
Humans , Adverse Drug Reaction Reporting Systems/statistics & numerical data , Drug-Related Side Effects and Adverse Reactions/epidemiology , Hospitalization/statistics & numerical data , Hospitals/statistics & numerical data , Pharmaceutical Preparations/adverse effects , Brazil/epidemiology , Pharmaceutical Services/statistics & numerical data , Quality Assurance, Health CareABSTRACT
Objective : To examine the association between the combination therapy of calcium antagonists with angiotensin converting enzyme (ACE) inhibitors and underlying diseases for hypertensive patients.<BR>Design : Cross-sectional survey of the drug utilization.<BR>Methods : This survey included 603 hypertensive patients who had visited Toyama Medical and Pharmaceutical University Hospital, Toyama, Japan more than twice from January to June in 1996 and received the prescriptions of calcium antagonists and/or ACE inhibitors. Main outcome measure was the combined medication of calcium antagonists with ACE inhibitors. Underlying diseases under consideration were diabetes mellitus (DM), hyperlipidemia (LIPID), ischemic heart disease (IHD), chronic heart failure (CHF), and ischemic stroke (STROKE).<BR>Results : Out of 603 hypertensive patients, 57.5% received only calcium antagonists, 23.7% received only ACE inhibitors, and 18.7% received both of them. Patients with either IHD or CHF tended to receive the combination therapy as compared to DM or LIPID. Although men tended to receive the combination therapy, a gender effect might be a confounder for the association. Logistic regression showed a 33% increase (P=0.265) in frequency of the combination therapy in patients with IHD after adjusting for age and gender.<BR>Conclusion : Some underlying diseases were associated with more frequent prescriptions of the combination therapy for hypertensive patients, especially with ischemic heart diseases. This result should be regarded as an exploratory stage although the pattern of antihypertensive drug use could be reasonably explained from the pharmacological sense.