Examinando por Materia "Farmacovigilancia"

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Aplicabilidad de los procedimientos operativos estándar de farmacovigilancia en la droguería Paquisfarma, Comas-2024
(Universidad Privada Norbert Wiener, 2026-02-05) Escate Campos, Noelia Hormecinda; Figueroa Martel, Fiorela; Alvarado Pinedo, Carlos Marvin
Este estudio tuvo como propósito determinar el grado de aplicabilidad de los procedimientos operativos estándar sobre farmacovigilancia en Droguería Paquisfarma, Comas - 2024. Se utilizó una aproximación numérica, diseño observacional, y transeccional. Como población considerada fue de todos los documentos técnicos relacionados con farmacovigilancia de la droguería para evaluar una muestra seleccionada. Mediante una lista de cotejo validada se recolectó la data, basada en el “Manual de Buenas Prácticas de Farmacovigilancia”. Como resultados, se encontró que el cumplimiento de los Procedimientos Operativos Estándar en aseguramiento de la calidad fue del 85,7%, del cual no se cumplió con la existencia de validación del proceso; en la dimensión del personal, hubo cumplimiento del 50% al cumplirse con contar con plan de capacitaciones pero no con recursos humanos; y en la dimensión de procedimientos, se cumplió al 76,9%, faltando en los siguientes: existencia de procesos administraivos de peticiones de datos requeridos por la Autoridad Nacional de medicamentos, existencia de procedimientos adquiridos para un control de herramientas regulables y existencia de procedimientos para la evaluación permanente del perfil de seguridad. Por ello, se concluyó que hubo un cumplimiento general satisfactorio del 77,3%, aunque hay áreas con margen de mejora, especialmente en la dimensión de recursos humanos.
Acceso abierto
Características de las reacciones adversas de los medicamentos antineoplásicos en el servicio de oncología, del Hospital Nacional Guillermo Almenara Irigoyen – EsSalud. Febrero–julio del 2015
(Universidad Privada Norbert Wiener, 2015) Villacorta Ñaupari, Carlos Martín; Torres Veliz, Ernesto Raúl
The objective of this research was to determine the characteristics of adverse drug reactions (ADRs) associated with antineoplastic agents in the Oncology Service of the “Guillermo Almenara Irigoyen” National Hospital – EsSalud, during the period from February to July 2015. For this study, the antineoplastic drugs available at the Guillermo Almenara Irigoyen National Hospital were considered. Methodology. A prospective descriptive cross-sectional study was conducted. Ninety-two patients diagnosed with cancer and undergoing chemotherapy who met the inclusion and exclusion criteria were analyzed, of which ADRs were detected in 80 patients (87%). These cases were evaluated using the Peruvian Pharmacovigilance Algorithm. Results. The analysis was limited to the 80 patients with ADRs. Male patients presented the highest number of ADRs (70%); the age group of 56–67 years showed 45% of ADRs. The therapeutic subgroup of platinum derivatives accounted for 59% of the total ADRs identified. Nausea (31%) and vomiting (19%) were the most frequent ADRs, and the gastrointestinal system was the most affected (73%). Regarding causality, 77% of ADRs were classified as probable, requiring specific treatment. According to severity, 65% were moderate, and according to the Edwards–Aronson classification, 99% were type A.
Acceso abierto
Características de las reacciones adversas medicamentosas en pacientes con tratamiento antirretroviral de gran actividad en el programa del Centro Materno Infantil San José de Villa El Salvador, de 2006 a 2010
(Universidad Privada Norbert Wiener, 2015) Arnao Rojas, Verónica; Ramírez Mendoza, Tania Alejandrina; Herencia Torres, Victor Reynaldo
The present thesis, entitled Characteristics of Adverse Drug Reactions in Patients Under Highly Active Antiretroviral Therapy at the San José Maternal and Child Center Program in Villa El Salvador, 2006–2010, is an observational, descriptive, retrospective, and cross-sectional study. This thesis considered the antiretroviral drugs available at the Center for the Care and Treatment of Sexually Transmitted Infections and HIV/AIDS (CATITSS), including nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, and protease inhibitors. A total of 420 clinical records of HIV-positive patients who were admitted to CATITSS at the San José Maternal and Child Center and met the inclusion criteria were reviewed. Among these, 268 patients presented one or more adverse reactions to antiretroviral drugs. The method used involved data collection from patient medical records; for each patient, a report form for suspected adverse reactions to antiretroviral drugs was completed. These reports were subsequently evaluated using the Peruvian pharmacovigilance algorithm. Regarding the results, the characteristics of adverse reactions to antiretroviral drugs by sex were 56.3% male and 43.7% female. By age group, 29.5% were 18–25 years, 36.6% were 26–32 years, 36.6% were 33–39 years, 7.1% were 47–53 years, and 7.8% were 54 years and older. By organs and systems affected, 44.78% involved the peripheral nervous system, 42.16% were related to metabolic and nutritional disorders, and 32.09% affected the skin. By type, the most frequent was type C at 89.93%, followed by type A at 61.19%. According to causality, 95.9% were classified as probable cases. Regarding severity, 52.10% were non-serious, 47.41% were serious, and only 0.49% were severe. According to the ATC classification of antiretrovirals, 97.28% of nucleoside reverse transcriptase inhibitors produced adverse drug reactions.
Acceso abierto
Caracterización de reacciones adversas por uso de la combinación sulfametoxazol/trimetoprima/guaifenesina en suspensión oral adquiridos en establecimientos farmacéuticos del distrito de Santa Anita – Lima, 2022
(Universidad Privada Norbert Wiener, 2023-02-02) Huamán Medina, Susan Andrea; Juárez Moreyra, Enrique
The objective of this research was to determine the characteristics of adverse reactions caused by the use of the combination of Sulfamethoxazole / Trimethoprim / Guaifenesin in oral suspension acquired from pharmaceutical establishments in the district of Santa Anita-Lima, 2022. The methodology was developed under a deductive method, with a quantitative approach, basic research type, and a non-experimental, descriptive, observational, and cross-sectional design. The study sample consisted of 384 individuals selected through simple random probability sampling. The instrument used was a questionnaire with Likert-type scales for each variable. Results: The frequency of clinical manifestations was 4.17%. Regarding personal history, a 3.9% predisposition to adverse reactions was found, and 36.2% of events were associated with pathological histories linked to adverse reactions. Failure to complete treatment predisposed to a 4.9% incidence of reactions, while 83.07% of adverse reactions were associated with improper use of the medication. Conclusion: The characterization of adverse reactions caused by the use of the Sulfamethoxazole / Trimethoprim / Guaifenesin combination was determined to be 3.4%, with improper use of the medication accounting for 83.07%, making it the most representative factor.
Acceso abierto
Conocimiento de alertas DIGEMID y su relación con la formación en farmacovigilancia de los educandos del octavo y noveno ciclo de farmacia y bioquímica de la Universidad Norbert Wiener, Perú 2022
(Universidad Privada Norbert Wiener, 2022-05-19) Calzada Bustamante, Ketty María; Oyarce Alvarado, Elmer
In the national context, research regarding pharmacovigilance knowledge among Pharmacy and Biochemistry students is scarce. This research addresses aspects related to the academic training of this discipline within the university setting through knowledge of DIGEMID alerts. The research was developed using the hypothetical-deductive methodology, with a quantitative approach, and a basic, descriptive-correlational design. The sampling was simple random probabilistic, and the sample population consisted of 151 students. The technique used was a survey, and the instrument was a virtual questionnaire with 20 closed questions. Results: Of the 151 respondents, 92.1% identified safety aspects, 76.8% identified counterfeiting aspects, 68.9% identified quality aspects, 79.5% identified detection aspects, 84.1% identified evaluation and comprehension aspects, and 78.8% identified prevention aspects. Conclusion: A relationship was determined to exist between the knowledge of DIGEMID alerts and the pharmacovigilance training of students in the eighth and ninth cycles of Pharmacy and Biochemistry at Norbert Wiener University, Peru, 2022.
Acceso abierto
Cumplimiento de implementación de las buenas prácticas de oficina farmacéutica en boticas del distrito de Lince - Lima, octubre - diciembre 2023
(Universidad Privada Norbert Wiener, 2024-09-20) Avila Castro, Yanira Andrea; Trinidad Peña, Diana Liz; Pinedo Panduro, Lauro Sócrates
Esta investigación se desarrolló con el objetivo de reconocer el cumplimiento de implementación de Buenas prácticas de Oficina Farmacéutica en Boticas del Distrito de Lince - Lima, octubre - diciembre 2023. En nuestra tesis se utilizó el método deductivo, enfoque cuantitativo, de tipo básico, diseño no experimental, corte transversal y prospectiva. La población estuvo conformada por 70 boticas en el distrito de Lince, se utilizó como instrumento una guía de observación que contenía 26 ítems, los que estuvieron distribuidos en 6 dimensiones. En los resultados se obtuvo que el 47,5% presentaba una implementación óptima en la dimensión personal, en la documentación e infraestructura 49,2% era óptimo, en las buenas prácticas de farmacovigilancia el 32,8% fue óptimo. Como conclusión se obtuvo que el 13,1% presento un cumplimiento “óptimo; el 55,7% en proceso y el 31,1% deficiente con respecto a la implementación de las Buenas prácticas de oficina farmacéutica.
Acceso abierto
Cumplimiento de los documentos técnicos de buenas prácticas de farmacovigilancia en la Droguería Corporación Farmacil S.A.C., Lima, 2021
(Universidad Privada Norbert Wiener, 2023-01-01) Cuspascua Grandez, Sonia Enith; Velasquez Sullón, Fabiola Fernanda; Ramos Jaco, Antonio Guillermo
The objective of this research was to determine the degree of compliance with the technical documents on Good Pharmacovigilance Practices at Droguería Corporación Farmacil S.A.C., Lima, 2021. The research method was deductive and of a basic type. The approach was non-experimental. The population consisted of all technical documents from Droguería Corporación Farmacil S.A.C. during late 2021 and early 2022. Results: It was found that the level of compliance with the technical documents on Good Pharmacovigilance Practices was low, with 50% compliance in quality assurance and 25% in personnel. However, after implementation, the compliance significantly increased to 100% in both aspects. Additionally, it was observed that compliance with the technical documents regarding procedures was critical; in the first survey, a compliance rate of 11.5% was recorded, reflecting non-compliance with these processes, while the second survey showed 100% compliance, demonstrating significant improvement in the application of pharmacovigilance procedures. Conclusion: It is concluded that Droguería Corporación Farmacil S.A.C. fully complies with the technical documents on Good Pharmacovigilance Practices, achieving 100% compliance.
Acceso abierto
Determinación cualitativa de cannabinoides (cannabidiol) en veinte aceites medicinales comerciales obtenidos de pacientes durante consulta médica en Lima, Perú, 2021
(Universidad Privada Norbert Wiener, 2023-06-01) Moya Salazar, Milagros del Rosario Marcia; Chávez Flores, Juana Elvira
The objective of this research project was to qualitatively determine the presence of cannabinoids (cannabidiol) in 20 commercial medicinal oils obtained from patients during medical consultations in Lima, Peru, 2021. Materials and Methods: An observational study with a qualitative approach and non-probabilistic sampling was designed at the Specialized Medical Center for Medicinal Cannabis (CANNAVITAL) in Lima, Peru. The inclusion criteria were cannabis oils provided by patients, with various oil matrices, prices, bottles, and with/without a health registration. Fast Blue B and the colorimetric reagent Reaja were used to determine cannabinoids and cannabidiol (CBD), respectively. Results: Of the total oils, 14 (70%) contained cannabinoids, and 4 (20%) showed weak concentrations of cannabinoids. Oils in 15 to 20 ml bottles showed the highest frequency of cannabinoids (n=5, 25%). Additionally, 9 (45%) oils contained CBD, and 1 (5%) had weak concentrations. Oils in 5 to 10 ml bottles showed the highest concentrations of CBD (n=9, 45%). All oils with an olive oil matrix contained cannabinoids. Conclusions: The qualitative determination of cannabinoids in 20 commercial medicinal oils obtained from patients during medical consultations in Lima, Peru, in 2021 demonstrated that 7 out of 10 oils contained cannabinoids in their various commercial presentations.
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Determinación, caracteristicas y análisis de sospechas de reacciones adversas a medicamentos no notificadas durante COVID-19
(Universidad Privada Norbert Wiener, 2022-01-24) Marengo Yarame, Tatiana; Castillo Soto, Pedro Félix
The objective of this study was to establish an underreporting rate of adverse drug reactions (ADRs) during the COVID-19 pandemic. Methodology: An observational, descriptive, and analytical study was designed for this purpose. A validated questionnaire was used to capture first-hand information from medication consumers who were approached in duly authorized pharmaceutical establishments. The study had the approval of an independent ethics committee. Results: The main findings showed an adverse reaction rate of 28.2%, with an accumulation of 34 suspected mild to moderate ADRs. This provided a cumulative incidence of 0.43 (95% CI: 0.330 – 0.538) that was not properly reported to the national pharmacovigilance system. These reactions corresponded to the pharmaceutical product Ivermectin oral solution drops. Conclusion: It is concluded that adequate and participatory surveillance among healthcare professionals must be established so that the information can lead to appropriate decisions regarding medication supply.
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Efectos adversos atribuidos a la vacuna contra el coronavirus (COVID-19) en participantes que acuden al vacunatón en el distrito de San Juan de Miraflores. Lima 2021
(Universidad Privada Norbert Wiener, 2022-07-08) Bautista Santa Cruz, Josselyn Yanet; Chipana Blas, Judith Pamela; Justil Guerrero, Hugo Jesús
COVID-19 has caused many deaths in Peru and worldwide. Since its appearance, the only way to combat it and prevent the severity of its symptoms has been through vaccination. The objective of this research was to analyze the adverse effects attributed to the coronavirus (COVID-19) vaccine in participants attending a vaccination event in the San Juan de Miraflores district. The study was deductive, with a quantitative approach, an applied type, and a non-experimental, observational, and cross-sectional design. The sample was 384 participants selected by systematic probabilistic sampling. The technique was a survey, the instrument was a questionnaire, and the processing of tables and figures was performed using Excel and SPSS statistical software. Results: The most frequent adverse effects at the injection site were pain (83.9%), inflammation (6.3%), and redness (5.7%). The most frequent somatic adverse effects were general malaise (89.3%), muscle pain (64.6%), and fever (24.7%). The intensity of the adverse effects at both the injection site and the somatic level was mild. Women reported more local adverse effects, while men reported more somatic effects. In conclusion, the COVID-19 vaccine administered to residents of the San Juan de Miraflores district at the Vaccinathon presents mild adverse effects, and it is suggested that vaccination continue to protect and immunize the greatest number of residents.
Acceso abierto
Efectos adversos de la inmunización contra el COVID-19 en pobladores que acudieron a vacunarse en el distrito de Villa El Salvador de Lima Metropolitana, 2021–2022
(Universidad Privada Norbert Wiener, 2022-07-07) Vila Alvarez, Daniel; Saldivar Anticona, Leonora Vanessa; Justil Guerrero, Hugo Jesús
The objective was to determine the adverse effects of COVID-19 immunization among residents who went to get vaccinated in the district of Villa el Salvador, Metropolitan Lima, from 2021 to 2022. Method: The study used a quantitative approach with a basic type, a non-experimental design, and an observational, cross-sectional descriptive level. A questionnaire was applied to a sample of 385 people, and the technique was a survey. Result: Of the 385 participants, local reactions reported were: pain (71.2% or 274), numbness (18.7% or 72), inflammation (15.1% or 58), and redness (7.0% or 27). Systemic adverse reactions included muscle pain (37.9% or 146), general malaise (29.4% or 113), headache (28.8% or 111), fatigue (23.1% or 89), fever (15.8% or 61), and chills (13.8% or 53). Conclusion: Both local and systemic adverse reactions were of mild to moderate intensity. There were reports of severe incidence that required medical attention but were resolved within a few days. Young people and adults had a higher incidence of adverse reactions. Women also reported a higher frequency of adverse reactions than men. Additionally, people with nutritional deficiencies, metabolic diseases, and eating disorders tend to have an increased rate of local and systemic adverse reactions.
Acceso abierto
Efectos adversos de los esteroides anabólicos androgénicos en usuarios de gimnasios en Lima – 2023
(Universidad Privada Norbert Wiener, 2024-02-27) Contreras Mendoza, Claudia Maria; Castillo Soto, Pedro Félix
This observational, prospective, analytical, and cross-sectional study aimed to identify suspected adverse reactions in athletic consumers of products containing androgenic steroids. Through participant engagement and follow-up, sociodemographic data, medication history, and background information were collected. First-hand results were obtained regarding the incidence of adverse reactions caused by pharmaceutical products with androgenic and steroidal characteristics, in compliance with national and international standards and ethical considerations applicable to this type of clinical study within Phase IV of drug research and development. Results: An incidence rate of 13.21% (95% CI: 8.40–17.98) was obtained, indicating a notable frequency of adverse drug reactions (ADRs) according to CIOMS standards. The study participants had an average age of 28.2 years; 54.72% were female. The average weight was 60.7 kg, and the average height was 171.8 cm, resulting in a BMI of 22.8, which falls within the normal range for athletes. The most commonly reported adverse reaction was pain at the site of application, which is considered expected. Conclusion:Further clinical studies in the Peruvian population are needed to better understand the risks associated with the consumption of these types of products. This study serves as a starting point.
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Evaluación y análisis de las interacciones medicamentosas en prescripciones médicas atendidas a pacientes ambulatorios período enero–julio 2021: revisión sistemática
(Universidad Privada Norbert Wiener, 2021-08-04) Cusipuma Lozano, Meylin Liset; Yslache Neyra, Lizbeth Thalia; Torres Veliz, Ernesto Raúl
A drug interaction occurs when the effect of a drug is altered by the administration of another, which can cause adverse reactions, putting the patient's health at risk. The objective of this research was to evaluate and analyze studies of drug interactions in medical prescriptions filled for outpatient patients. The study was basic, descriptive, with a retrospective and cross-sectional directionality. Data were collected from research published over the last 10 years on drug interactions in prescriptions for outpatient patients. The results were analyzed based on severity, type of interaction, type of documentary evidence, and frequency of interaction using a data collection form. Results: The predominant drug interactions by severity were moderate (62.4%). By type of documentary evidence, 'Good' predominated at 50.7%. By type of interaction, pharmacodynamic predominated at 53.6%, and by frequency, the most common was once (46%). Conclusion: It is important that a pharmacist be present in pharmaceutical establishments to detect possible drug interactions.
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Evaluar las reacciones adversas medicamentosas del ácido acetilsalicílico en pacientes del consultorio de cardiología de la Clínica Internacional Sede Lima 2022
(Universidad Privada Norbert Wiener, 2023-04-28) Quinde García, Nancy; Melgarejo López, Anne Ursula; Juárez Moreyra, Enrique
In the research study "Evaluation of adverse drug reactions to acetylsalicylic acid in patients from the cardiology outpatient clinic of Clínica Internacional, Lima Branch, 2022," the objective was formulated as follows: To determine the adverse drug reactions to acetylsalicylic acid in patients from the cardiology outpatient clinic of Clínica Internacional, Lima Branch, 2022. Methodology: This study employed a deductive method, a quantitative approach, was of a basic type, at a descriptive level, and used a non-experimental, cross-sectional design. The sample consisted of 269 individuals from the cardiology outpatient clinic of Clínica Internacional, Lima Branch. The survey technique was used, and a questionnaire with dichotomous nominal scale questions was the instrument employed. Data were analyzed using descriptive statistics and presented in tables and figures. Results: The statistical analysis indicated the adverse drug reactions to acetylsalicylic acid in cardiology outpatient clinic patients. Regarding age, the predominant group was 51-61 years old (48.7%), with males making up 59.5%, and 72.9% of the patients having higher education. Among gastrointestinal disorders, 68.4% reported dyspepsia, and 65.4% reported gastrointestinal pain and inflammation. For respiratory disorders, 68.4% reported rhinitis, 68% nasal congestion, and 54.3% dyspnea. For skin and subcutaneous tissue disorders, 7.1% experienced a rash. Regarding the nervous system, 51.7% reported dizziness. Conclusion: It was concluded that the adverse drug reactions to acetylsalicylic acid in patients from the cardiology outpatient clinic of Clínica Internacional, Lima Branch, 2022, included gastrointestinal, respiratory, skin and subcutaneous tissue, and nervous system disorders.
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Eventos supuestamente atribuibles a la vacuna o inmunización contra SARS-COV-2 en la DIRIS Lima Centro 2021
(Universidad Privada Norbert Wiener, 2022-03-17) Castillo Cerrón, Ely Beatriz; Caldas Herrera, Emma
The research aimed to evaluate the events supposedly attributable to vaccination or immunization against SARS-CoV-2 in DIRIS Lima Centro, Lima 2021. The study assessed the quality of notifications regarding SARS-CoV-2 vaccines. The research used the deductive method, a quantitative approach, and was applied research, focusing on preserving knowledge and putting it into practice, with an observational cross-sectional design. The population consisted of 815 notifications, and the sample included 529 notifications of AEFI (Adverse Events Following Immunization) related to SARS-CoV-2. A data collection sheet validated by expert judgment was used as the instrument. Results showed that 394 AEFIs occurred in adults aged 30 to 59, with 95 reporting arm pain, while 78 young individuals aged 18 to 29 reported events, of which 19 had arm pain. Among older adults, 51 events were reported, with 7 indicating arm pain. Additionally, 399 AEFIs were reported in females and 126 in males. AEFI evaluations could improve significantly if healthcare professionals enhance their reporting practices.
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Farmacovigilancia activa del producto farmacéutico Betriderm crema en usuarios de la botica Avi Pharma S.A.C., Lima 2023
(Universidad Privada Norbert Wiener, 2023-11-20) Carrasco Arias, Dana Patricia; Castillo Soto, Pedro Félix
Active pharmacovigilance is one of the methods used to assess information on the safety profile of medicines in relation to the characteristics of their consumers. The objective of this study was to establish the frequency of suspected adverse reactions in users of the pharmaceutical product Betriderm Cream, through an observational, prospective, analytical, and cross-sectional study, conducted in accordance with ethical and clinical guidelines. Sociodemographic characteristics revealed a mean age of 41.9 years (SD 15.2), mean weight of 64.4 kg (SD 12.4), and mean height of 159.0 cm (SD 9.4), with 63.1% being female. Medication use was mainly based on pharmaceutical recommendation (97.9%) and only 2.1% on self-medication, with 95.7% reporting three applications per day, predominantly for 1–3 days (71.9%). Participants reported healthy habits, such as fruit and vegetable consumption at least five days per week (55.6%), but also negative habits, including alcohol and cigarette use in 88.8%. Concomitant medications included naproxen (14.4%), ibuprofen (12.9%), omeprazole (8.6%), valsartan (7.2%), celecoxib (7.2%), paracetamol (7.2%), among others. The prevalence of suspected adverse reactions was 6.47%, corresponding to pruritus. It is concluded that the objectives were achieved, and the frequency observed corresponds to the category defined as very frequent manifestation.
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Farmacovigilancia activa del producto farmacéutico Dolo Farmadic-Forte tabletas recubierta en establecimientos farmacéuticos de Lima Metropolitana
(Universidad Privada Norbert Wiener, 2022-09-09) Jiménez Cárdenas, Elizabeth; Castillo Soto, Pedro Félix
This study, which was observational, prospective, descriptive, and analytical, obtained first-hand results on the incidence of adverse drug reactions (ADRs) in patients consuming the product Dolo Famedic Forte, adhering to national and international standards and ethical aspects involved in a clinical study of Phase IV research and development. An incidence of 12.26% of adverse drug reactions was obtained in a sample with an average age of 41.74 years, a weight of 67.35 kg, and a height of 159.59 cm. The suspected ADRs correspond to those listed in the pharmaceutical product insert, ensuring better safety.
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Farmacovigilancia activa del producto farmacéutico Neo BB® solución gotas pediátricas en establecimientos farmacéuticos de Lima Metropolitana, 2019
(Universidad Privada Norbert Wiener, 2019-11-28) Fayad Pinedo, Sara Silvana; Castillo Soto, Pedro Félix
Objectives: The main objective of this research was to determine the safety profile of the product NEO-BB® Pediatric Drops Solution to ensure its proper use, as well as to determine the frequency of adverse reactions and identify predisposing factors associated with the reported adverse reactions. Methods: First-hand information was obtained through questionnaires applied to a parent or legal guardian of children aged 1 to 3, who were enrolled in various pharmaceutical establishments in metropolitan Lima from February to July 2019. Results: During the follow-up of the 186 enrolled patients, seven individual case reports were filed, which included a total of seven suspected non-serious ADRs (3.76%). No suspected serious ADRs were reported. The reported suspected ADRs corresponded to reactions listed in the NEO-BB® Pediatric Drops Solution product insert. The suspected ADRs were managed by suspension (n=4, 2.15%), reduction of the daily dose (n=1, 0.54%), or continuation of the treatment with no changes (n=2, 1.08%), and no specific treatment was indicated for the ADR. Conclusion: The information obtained allows us to establish that the product's safety profile remains consistent with the authorized information in the insert and provides no reason for an insert update. The benefit-risk profile of NEO-BB® Pediatric Drops Solution remains unchanged and favorable.
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Farmacovigilancia y la notificación oportuna de reacciones adversas a medicamentos en el policlínico Surco Salud, Lima -2023
(Universidad Privada Norbert Wiener, 2024-09-03) Zegarra Azaña, Alex Omar; Castillo Soto, Pedro Félix
The overall objective of this research was to determine the relationship between pharmacovigilance and the timely reporting of adverse drug reactions at the Surco Salud Polyclinic in Lima, Peru, in 2023. The methodology was hypothetical-deductive, with a quantitative approach, basic research, non-experimental design, cross-sectional, and correlational in scope. The study population consisted of 80 pharmacy workers at the Surco Salud Polyclinic, including pharmacologists, nurses, doctors, and other healthcare professionals, who were the sample for this study. The research results determined a moderate direct correlation between pharmacovigilance and timely reporting of adverse drug reactions, with a rho of 0.655. A moderate direct correlation was also identified between data collection and dissemination, with a rho of 0.624. of data and the timely notification of adverse reactions. The administrative activities showed a moderate correlation with a value (Rho = 0.592) with the notifications of adverse drug reactions. Finally, a strong direct correlation was found with a value (Rho = 0.749) between the evaluation of notifications and the preparation of reports with the notifications of adverse drug reactions. Therefore, it is concluded that there is a relationship between pharmacovigilance and the timely notification of adverse drug reactions at the Surco Salud Polyclinic, Lima – 2023. This was determined by the result, with a Spearman's Rho correlation coefficient of 0.655 and a significance level of 0.000.
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Identificación de problemas relacionados a los medicamentos de los tratamientos farmacológicos en los pacientes hospitalizados en la Clínica Internacional sede Lima (enero–marzo, 2016)
(Universidad Privada Norbert Wiener, 2021-02-18) Garcia Sánchez, Sayuri Lizbeth; Torres Veliz, Ernesto Raúl
Drug-related problems (DRPs) are a major concern due to their physical, psychological, and economic burden. The objective of this research was to identify the DRPs in the pharmacological treatments of patients hospitalized at the Clínica Internacional in Lima. The methodology involved a descriptive, observational, and retrospective study that included 265 pharmacotherapeutic follow-up forms from hospitalized patients from January to March 2016. These forms were reviewed for DRP evaluation. The results showed that a total of 241 DRPs were found. Safety DRPs had the highest incidence at 77%, with DRP6 representing 50% of these. Effectiveness DRPs accounted for 17%, and necessity DRPs for 6%. Actual DRPs were also identified at 11%. The most implicated pharmacological group was antibacterials (26%). In conclusion, 241 DRPs were identified, with safety DRPs having the highest incidence, followed by effectiveness and necessity DRPs. The most frequent reason for DRPs was quantitative medication insecurity due to drug interactions and alterations in the dosage, duration, or frequency of the patient's pharmacotherapeutic treatment.