Empleo de la Tarjeta Amarilla y el Formato NOM220 para las notificaciones de sospechas de reacciones adversas a medicamentos / Use of Yellow Card and of NOM220 Format for reporting of suspected adverse drug reactions

Introducción: la notificación de reacciones adversas a medicamentos es una obligación a nivel mundial. Aunque se han establecido muchas metodologías para esta acción, en la actualidad existen problemas. Objetivo: determinar la frecuencia de sospecha de reacciones adversas a la administración de medicamentos en pacientes y comparar la accesibilidad del llenado del formato de la NOM220 de la Secretaría de Salud y la Tarjeta Amarilla propuesta por la Organización Mundial de la Salud. Métodos: estudio transversal y observacional. Participaron 50 médicos responsables de las clínicas de diabetes del Estado de Hidalgo. Inicialmente, los médicos fueron capacitados para identificar las sospechas de reacciones adversas a la administración de medicamentos en los pacientes atendidos. Se realizó un diseño cruzado, en el que el 50 por ciento de los médicos utilizaron por tres meses el formato de la NOM220 y 50 por ciento la Tarjeta Amarilla. Después intercambiaron formatos y los utilizaron durante los tres meses siguientes. Al cabo de este periodo, respondieron un cuestionario para determinar la utilidad, claridad, tiempo de llenado y practicidad de ambos formatos. Se realizó estadística descriptiva y análisis bivariado para determinar los factores asociados a las sospecha de reacciones adversas a medicamentos, con el software SPSS (versión 17). Resultados: se registraron 46 sospechas de reacciones adversas a medicamentos en 46 pacientes con el formato de la NOM220 y 78 sospechas de reacciones adversas a medicamentos con la Tarjeta Amarilla en 78 pacientes. Todas las sospechas de reacciones adversas a la administración de medicamentos fueron tipo A. Los médicos recomiendan la utilización de la Tarjeta Amarilla, consideran claro el formato, sencillo, legible, fácil de llenar, entendible y accesible (p< 0,05). Conclusiones: los resultados permiten proponer la Tarjeta Amarilla como una alternativa más accesible para la notificación de sospechas de reacciones adversas a medicamentos, o se hagan adecuaciones al formato de la NOM220(AU)

Introduction: the reporting of adverse drug reactions is a global obligation. Although many methods have been implemented, there are still problems at present. Objective: to determine the frequency of suspected adverse reactions in patients and to compare the access to filling out the NOM220 formats of the Secretaría de Salud and the Yellow Card suggested by the World Health Organization. Methods: a cross-sectional and observational study was made. Fifty physicians responsible for the diabetes clinics in the state of Hidalgo participated in the study. First, the physicians were trained to identify the suspected adverse drug reactions in their patients. A crossover design was created where 50 percent of physicians used the NOM220 format and 50 percent the Yellow Card. Three months later, they exchanged the formats and used them during the following three months. After this period, questionnaire was administered to determine the usefulness, clarity, filling out time and convenience of the formats. Descriptive statistics and bivariate analyses were applied to determine the factors associated with the suspected adverse drug reactions with SPSS software (version 17). Results: a total of 46 suspected adverse reactions were registered in 46 patients using NOM220 format and 78 with the Yellow Card in 78 patients. All the suspected adverse reactions were type A. The physicians recommended the use of Yellow Card since they considered that it is practical, simple, readable, understandable, accessible and requires less time to fill it out (p< 0.05). Conclusions: the results allow selecting the Yellow Card as the most accessible choice for reporting suspected drug adverse reactions; additionally, they suggest that adjustments should be also made in the NOM220 format(AU)

Effect of diclofenac with B vitamins on the treatment of acute pain originated by lower-limb fracture and surgery.

The aim of this study was to compare the efficacy of diclofenac, for the treatment of acute pain originated by lower-limb fracture and surgery, with that of diclofenac plus B vitamins. This was a single-center, prospective, randomized, and double-blinded clinical trial. Patients with lower-limb closed fractures rated their pain on a 10 cm visual analog scale (VAS). Patients were then randomized to receive diclofenac or diclofenac plus B vitamins (thiamine, pyridoxine, and cyanocobalamin) intramuscularly twice daily. Patient evaluations of pain intensity were recorded throughout two periods: twenty-four hours presurgery and twenty-four hours postsurgical. One hundred twenty-two patients completed the study. The subjects' assessments of limb pain on the VAS showed a significant reduction from baseline values regardless of the treatment group. Diclofenac plus B vitamins combination was more effective to reduce the pain than diclofenac alone. The results showed that the addition of B vitamins to diclofenac increased its analgesic effect. The novelty of this paper consists in that diclofenac and diclofenac plus B vitamins were useful for treatment of acute pain originated by lower-limb fracture and surgery.

Pharmacovigilance of psychoactive medications in a Mexican psychiatric hospital.

Pharmacovigilance is the permanent collection and assessment of the safety data of drugs in the interest of precise knowledge of the safety profile. We monitored notifications of suspected adverse reactions (AR) produced by psychoactive medications (ARPM) in a Psychiatry Hospital, during a 4-month period. Yellow cards for adverse reaction reporting were distributed to the medical personal at the Hospital Psiquiátrico Villa Ocaranza, Pachuca Hidalgo, Mexico. For each notification, the ARPM was analyzed in order to verify causality. One hundred twelve hospitalized patients entered the study (44 male and 68 female). The mean +/- SD age of the patients was 46 +/- 4.5 years. The major diagnoses found were: schizophrenia (35.7%), severe mental retardation (17 %), moderate mental retardation (MMR)/epilepsy (12.5%), MMR (8.03%), and others (26.7%). During the study there were 721 therapeutic regimens prescribed to patients on psychiatric service. Patients were receiving an average of 5.3 +/- 1.1 (range 4 to 8) psychiatric medications. The psychiatrists reported only 5 ARPMs in five patients (prevalence: 4.46%). Among the drugs involved were neuroleptics (47.8%), antiepileptic (39.1%), and others (13.04%). The organs and systems affected by the ARs were the central nervous system, skin, endocrinological and gastrointestinal. A causal association between the medication and the AR were classified as probable in three cases, as possible in one case, as doubtful in one case and as definite in no case.

Effectiveness of diclofenac, ketorolac and etoricoxib in the treatment of acute pain from ankle fracture.

Tissue degeneration, infection, inflammation, cancer, trauma, surgery and limb fractures all produce pain. Each of these physiological abnormalities requires a therapeutic approach different from the last. In acute pain, caused by fracture, several classes of analgesics have been utilized. These basic remedies for analgesia, however, are still confined to a small number of medications, including nonsteroidal anti-inflammatory drugs (NSAIDs), local anesthetics and opioids. In addition, most of these drugs have side effects, limiting their use in clinical practice. The purpose of this study was to compare the efficacy of three NSAIDs to relief acute pain caused by ankle fracture. Sixty subjects with ankle fracture were randomized to receive ketorolac, diclofenac, or etoricoxib, every 12 hours in a prospective, double-blind study. Forty-nine patients completed the study. The subjects' assessments of ankle pain on the visual analog scale and a Likert scale showed a significant reduction from baseline over 24 hr, regardless the treatment group. All treatments showed a similar profile in pain reduction. Etoricoxib, diclofenac and ketorolac twice daily are a rapid and effective treatment for acute pain. All the regimens were well tolerated in this study.

Prevalence and impact of primary dysmenorrhea among Mexican high school students.

OBJECTIVE: To evaluate factors affecting the prevalence of dysmenorrhea in a group of Mexican students. METHOD: A questionnaire was administered to 1152 high school students and the obtained data about severity, symptoms, and medications used were analyzed. RESULTS: Dysmenorrhea had a prevalence of 48.4% and was the cause of school absences for 24% of the affected students. It was mild in 32.9%, moderate in 49.7%, and severe in 17.4% of these students, of whom 28% consulted a physician and 60.9% self-medicated. The most common over-the-counter drugs used were a combination of paracetamol, pamabrom and pyrilamine maleate; metamizol (a nonsteroidal anti-inflammatory drug) plus butylhioscine; and naproxen. We found a significant correlation between the presence of dysmenorrhea and smoking, cycle pattern, cycle duration, flow duration, and amount of flow. CONCLUSION: The prevalence of dysmenorrhea was high in our sample. The condition caused short-term school absences and the students commonly addressed it by self-medicating.

A pilot study of the effect of diclofenac with B vitamins for the treatment of acute pain following lower-limb fracture and surgery.

The aim of this pilot study was to compare the efficacy and tolerability of the non-steroidal anti-inflammatory drug (NSAID), diclofenac (2-(2,6-dichloranilino) phenylacetic acid), for treatment of acute pain originated by lower-limb fracture and surgery, with that of diclofenac plus B vitamins. This clinical trial was single-center, prospective randomized and double-blinded. After giving informed consent, patients with lower-limb closed fractures rated their pain on a 10-cm visual analog scale (VAS). Patients were then randomized to receive 75 mg diclofenac or 75 mg diclofenac plus B vitamins (thiamine, pyridoxine and cyanocobalamin) twice daily (all intramuscularly). Patient evaluations of pain intensity were recorded throughout two periods: twenty-four hours pre-surgically and twenty-four hours postsurgical. Twenty-four hours after the first drug administration, patients underwent elective lower-limb surgery. Standardized general anesthetic techniques were used for all patients. Fourteen patients completed the study. The subjects' assessments of limb pain on the visual analog scale showed a significant reduction from baseline values regardless of the treatment group when surveyed at 12, 24, 36 and 48 hr post operation. All treatments showed a similar profile in pain reduction. There were reports of pain in the administration site, but in general, all the regimens were well tolerated.

Persistent pulmonary hypertension in the newborn: therapeutic effect of sildenafil.

Persistent pulmonary hypertension of the newborn (PPHN) is a cardiopulmonary disorder characterized by systemic arterial hypoxemia secondary to elevated pulmonary vascular resistance with resultant shunting of pulmonary blood flow to the systemic circulation. PPHN is a serious illness that becomes progressively worse and is sometimes fatal. Management of the disease includes treatment of underlying causes, sedation and analgesia, maintenance of adequate systemic blood pressure, and ventilator and pharmacologic measures to increase pulmonary vasodilatation, decrease pulmonary vascular resistance, increase blood and tissue oxygenation, and normalize blood pH. Inhaled nitric oxide (NO) has been one of the latest measures to successfully treat PPHN. If all other treatments fail, extracorporeal membrane oxygenation (ECMO) can be used. Recently, preclinical and clinical studies have demonstrated the utility of the selective inhibitor of phosphodiesterase type 5 (PDE5), sildenafil, in decreasing pulmonary hypertension (HP). Sildenafil was first employed to offset rebound pulmonary hypertension in infants upon withdrawal of NO treatment. Later, several case reports demonstrated the effectiveness of sildenafil in the treatment of PPHN. Two randomized blinded studies with sildenafil in infants with PPHN were published in 2006. In both studies, the patients treated with sildenafil showed a steady improvement in pulse oxygen saturation over time. Likewise, the frequency death was lower in the groups treated with sildenafil. Recent evidence shows the utility of sildenafil in the treatment of PPHN. However, since existing data are limited there is an urgent need for multicenter blinded, placebo controlled, randomized trials.