Medicamentos intercambiables en Perú. Un estudio de revisión

La intercambiabilidad de medicamentos representa una necesidad en países en vías de desarrollo, porque brinda la posibilidad de acceder a productos de menor costo, además, permite asegurar eficacia y seguridad en los tratamientos farmacoterapéuticos. El estudio recolectó investigaciones realizadas en el estado peruano, publicadas en bases de datos de alto impacto como Scielo, Sciencedirect, Scopus y Pubmed. De las 553 investigaciones encontradas, sólo diez artículos cumplieron con los criterios de inclusión y exclusión, se identificaron medicamentos como diazepam, prednisona, amoxicilina, doxiciclina, fluconazol, fenitoína sódica, alprazolam, amlodipino, carbamazepina sódica, glibenclamida, moxifloxacino y ácido acetilsalicílico. Todos los artículos analizaron el perfil de disolución mediante el cálculo del factor de similitud f2, mientras, en otros casos, estimaron parámetros como variación de peso, friabilidad, dureza, cuantificación, uniformidad de contenido y perfil de disolución. Los resultados evidencian que nueve medicamentos incluidos en el estudio fueron analizados mediante estudios in vitro a diferentes pH (1,2; 4,5 y 6,8), y cumplieron con presentar un factor de similitud f2 mayor a 50. Se concluye que aún se encuentra en proceso la intercambiabilidad de medicamentos en el estado peruano, y que, mediante alianzas estratégicas con el sector privado, se podría tener una mayor cantidad de alternativas farmacéuticas en la recuperación del paciente.

The medicines' interchangeability represents a necessity in developing countries, because it offers the possibility of accessing lower cost products, it allows to ensure efficacy and safety in pharmacotherapeutic treatments. The study gather researches carried out in the Peruvian state published in high-impact databases such as Scielo, Sciencedirect, Scopus and Pubmed. Of the 553 researches found, only 10 articles met the inclusion and exclusion criteria, drugs such as diazepam, prednisone, amoxicillin, doxycycline, fluconazole, phenytoin sodium, alprazolam, amlodipine, carbamazepine sodium, glibenclamide, moxifloxacin and acetylsalicylic acid were identified. All the articles analyzed the dissolution profile by calculating the similarity factor f2, while, in other cases, they estimated parameters such as weight variation, friability, hardness, quantification, content uniformity, and dissolution profile. The results show that 9 drugs included in the study were analyzed by in vitro studies at different pH (1.2; 4.5 and 6.8), and complied with presenting a similarity factor f2 greater than 50. It is concluded that, the interchangeability of medicines in the Peruvian state is still in process, and that, through strategic alliances with the private sector, a greater number of pharmaceutical alternatives could be had in the patient's recovery.

Feasibility of treatment-free remission with generic imatinib: Results of generic imatinib-free trial-in-chronic myeloid leukaemia chronic phase study

Background & objectives: Both innovator and generic imatinib are approved for the treatment of Chronic Myeloid Leukaemia-Chronic phase (CML-CP). Currently, there are no studies on the feasibility of treatment-free remission (TFR) with generic imatinib. This study attempted to determine the feasibility and efficacy of TFR in patients on generic Imatinib. Methods: In this single-centre prospective Generic Imatinib-Free Trial-in-CML-CP study, twenty six patients on generic imatinib for ?3 yr and in sustained deep molecular response (BCR ABLIS ?0.01% for more than two years) were included. After treatment discontinuation, patients were monitored with complete blood count and BCR ABLIS by real-time quantitative PCR monthly for one year and three monthly thereafter. Generic imatinib was restarted at single documented loss of major molecular response (BCR ABLIS>0.1%). Results: At a median follow up of 33 months (interquartile range 18.7-35), 42.3 per cent patients (n=11) continued to be in TFR. Estimated TFR at one year was 44 per cent. All patients restarted on generic imatinib regained major molecular response. On multivariate analysis, attainment of molecularly undetectable leukaemia (>MR5) prior to TFR was predictive of TFR [P=0.022, HR 0.284 (0.096-0.837)]. Interpretation & conclusions: The study adds to the growing literature that generic imatinib is effective and can be safely discontinued in CML-CP patients who are in deep molecular remission.

Review of the competitive generic drug incentive system in the United States and its enlightenment to China / 中国药房

OBJECTIVE To provide ideas and inspiration for promoting the development of the generic drug industry and legal system of China. METHODS With text analysis， empirical research and other methods， the competitive generic drug incentive system in the United States was combed， its implementation effect and successful experience were analyzed， and the reference was provided for the implementation of relevant systems in China. RESULTS The competitive generic drug incentive system in the United States had achieved a satisfactory effect in three aspects： encouraging generic drug applications， accelerating the listing of generic drugs， and promoting drug price reduction， which was ultimately conducive to improving drug accessibility by publishing List of Off-Patent，Off-Exclusivity Drugs without an Approved Generic， while accelerating the development and review of generic drugs with insufficient competition and giving market exclusivity periods. CONCLUSIONS China’s reference to the competitive generic drug incentive system in the United States meets the needs of the current situation of domestic drug supply and also has the basis for industry practice. Therefore， we can refer to it， improve the system of releasing the catalog of encouraged generic drugs to be imitated， optimize the approval process for them， and authorize the exclusive period incentive to them.

Comparison of efficacy，safety and economics of bid-winning and original Moxifloxacin hydrochloride tablets in the treatment of outpatient community-acquired pneumonia / 中国药房

OBJECTIVE To compare the efficacy， safety and economics of bid-winning and original Moxifloxacin hydrochloride tablets in the treatment of outpatient community-acquired pneumonia （CAP）. METHODS A retrospective cohort study was conducted to screen and include CAP outpatients during the period of January to December 2021 in Lianyungang First People’s Hospital. They were divided into generic drug group （1 058 cases） and bid-winning drug group （1 121 cases） according to the drug source. Two groups were respectively given original and bid-winning Moxifloxacin hydrochloride tablets， 0.4 g each time， once a day. The efficacy indexes （clinical effective rate， remission time， treatment course， revisiting rate） and safety indexes （allergy， nervous system symptoms， etc.） were compared between the two groups； and the influence factors of clinical treatment failure were analyzed with multi-factor modified Poisson regression model. The economic indicators of the two drugs [quantity， consumption sum， defined daily doses （DDDs）， defined daily dose cost （DDDc）， price ratio， replacement rate] were compared. RESULTS There were no significant differences in the clinical effective rate， treatment course， revisiting rate， the incidence of nervous system symptoms and Q-T interval prolongation between the two groups （P＞0.05）. The remission time of original drug group was significantly shorter than that of bid-winning drug group， and the incidence of total adverse drug reaction， allergy reaction， gastrointestinal symptom reaction and hyperglycemia were significantly lower than those in bid-winning drug group（P＜0.05）. Multivariate Poisson regression analysis showed that bid-winning drug did not increase the risk of clinical treatment failure in CAP outpatients [RR＝1.132， 95%CI （0.883， 1.542）， P＝0.327]. However， antibiotic exposure history， more than 2 items of abnormal clinical manifestations and auxiliary examination all increased the risk of clinical treatment failure （P＜0.05）. Compared with before the implementation of centralized volume-based procurement policy， the quantity and DDDs of Moxifloxacin hydrochloride tablets increased significantly， while the consumption sum decreased significantly， DDDc of bid-winning drug decreased significantly， the price ratio of it to original drug decreased to 0.117， and the replacement rate increased to 69.44% after the implementation of centralized volume- based procurement policy. CONCLUSIONS Compared with original drug， bid-winning Moxifloxacin hydrochloride tablet shows reliable efficacy and obvious price advantage in the treatment of outpatient CAP， but the incidence of adverse drug reactions is higher.

Status quo and improvement countermeasures of the priority review system for encouraged generic drug in China / 中国药房

OBJECTIVE To provide reference for better implementation of the priority review system for generic drugs of encouraged generic drug catalogues. METHODS Based on literature research， practical status of the priority review system for generic drugs in two batches of encouraged generic drug catalogues in China was analyzed， and the problems existing in the application of the system were compared to propose corresponding solutions. RESULTS & CONCLUSIONS China has issued two batches of encouraged generic drug catalogues， and there were 49 varieties of generic drugs included in the catalogues. In the implementation of the priority review system for generic drugs of encouraged generic drug catalogues， there were some problems in legislation， incentive system for the first generic drug， post-marketing re-evaluation system， and cross-departmental coordination and linkage mechanism. It is suggested to strengthen legislation， improve the “first generic market exclusivity period” system， perfect the post-marketing re-evaluation system and form a normalized cross-departmental coordination mechanism so as to ensure the safety， effectiveness and accessibility of generic drugs in China.

A real-world study of effectiveness and safety of generic and original clopidogrel in the treatment of acute coronary syndrome / 中国药房

OBJECTIVE To evaluate the clinical effectiveness and safety of domestic generic and imported original clopidogrel for antiplatelet therapy in patients with acute coronary syndrome （ACS）. METHODS The clinical data of ACS patients in Nanjing Drum Tower Hospital of China Pharmaceutical University from January 2020 to June 2021 were retrospectively collected by using electronic medical record system， and the patients were divided into original drug group （321 cases） and generic drug group （328 cases） according to the drug use. Both groups were given dual antiplatelet therapy with clopidogrel and aspirin. The effectiveness and safety outcomes of the two groups were followed up for 12 months and compared， the related influential factors were analyzed. RESULTS Major adverse cardiovascular events （MACE） occurred in 16 and 22 patients in original drug group and generic drug group respectively， including nonfatal myocardial infarction （4 and 5 cases）， stroke （2 and 4 cases）， revascularization （8 and 3 cases）， cardiovascular related death （2 and 4 cases）， and all-cause death （4 and 6 cases）. There were 12 and 7 patients with major bleeding events， 38 and 29 patients with minor bleeding events， and 33 and 21 patients with non-bleeding adverse events. There was no statistically significant difference in the cumulative incidence of related events （P values of Log-Rank tests were all greater than 0.05）. Cox regression analysis showed that the use of generic clopidogrel did not increase the risk of MACE and major bleeding events in ACS patients [hazard ratio of 1.305 and 0.416， 95% confidence interval of （0.678， 2.512） and （0.155， 1.117）， respectively， P＞0.05]， and the combination of proton pump inhibitors （PPI） could reduce the risk of major bleeding events [hazard ratio of 0.196， 95% confidence interval of （0.063， 0.611）， P＜0.05]. CONCLUSIONS Compared with imported original drug， domestic generic clopidogrel has similar clinical effectiveness and good safety. Combined use of PPI may be a beneficial factor to reduce the occurrence of major bleeding events in patients.

Medicamentos genéricos ¿buenos y usables? La percepción de los estudiantes de medicina en un estado mexicano

Introducción: el conocimiento y la percepción hacia los medicamentos genéricos son temas que surgen como un factor importante a explorar en los estudiantes de medicina. Objetivo: determinar las diferencias entre los estudiantes de medicina de universidades públicas y privadas sobre la percepción y el uso de las Especialidades Farmacéuticas Genéricas (EFG). Materiales y métodos: se realizó un estudio cuantitativo de tipo observacional, transversal, analítico y comparativo en un universo de 858 estudiantes matriculados durante 2019-2020 en cinco escuelas de medicina del estado mexicano de Tabasco. A través de Google Forms se recolectaron los datos de un formulario auto aplicado con base a un cuestionario previamente validado. Se emplearon estadísticas descriptivas para evaluar las percepciones de los estudiantes y pruebas no paramétricas a través de un modelo de análisis de diferencia de medias para comparar el resultado entre las universidades. Resultados: la percepción de las dimensiones de calidad (8= 12,51) y eficacia (8=6,06) muestran una postura indecisa en general. En la fiabilidad (8=6,99), los alumnos estuvieron de acuerdo. Las dimensiones de preferencia-experiencia (8=10,649) y la de accesibilidad (X=7,01), colocan a los alumnos en el grupo de indecisos. En la comparación de medias de la escala de percepción de EFG (prueba t de estudent), la universidad pública presentó una media baja (8=24,72), mientras que en el grupo de universidades privadas fue mayor (8=26,06). En cuanto al uso de EFG, la universidad pública presentó una media 8=38,22, mientras que el grupo de universidades privadas fue menor (8=36,70). Conclusiones: se requiere incluir en los contenidos curriculares de los futuros profesionales de la medicina, mayor información sobre calidad, seguridad y eficacia de las EFG, lo que contribuirá a elevar el nivel de confianza en su prescripción.

Introduction: Knowledge and perception towards generic drugs are topics that emerge as an important factor to explore in medica students. Objective: To determine the differences between medical students from public and private universities on the perception and use of Generic Pharmaceutical Specialties (GFE). Materials and methods: A quantitative observational, cross-sectional, analytica and comparative study was conducted in a universe of 858 students enrolled during 2019-2020 in five medical schools in the Mexican state of Tabasco. Through Google Forms, data were collected from a self-applied form based on a previously validated questionnaire Descriptive statistics were used to assess student perceptions, and nonparametric tests through an analysis model for difference of means to compare the result between universities. Results: The perception of the dimensions of quality (8= 12,51) and efficacy (8=6,06) shows an indecisive position in general. On reliability (8=6,99), students agreed. The dimensions of preference-experience (8=10.649) and accessibility (8=7,01), place students in the group of undecideds. In the comparison of means of the GFE perception scale (student's t test), the public university presented a low mean (8=24,72), while in the group of private universities it was higher (8=26,06). Regarding the use of GFE, the public university presented a mean 8=38,22, while the group of private universities was lower (8=36,70). Conclusions: It is necessary to include in the curricular contents of future medical professionals more information on quality, safety and efficacy of GFE, which will contribute to raising the level of confidence in their prescription.

Febrile neutropenia incidence and the variable toxicity profile between brand and generic docetaxel in the adjuvant treatment of breast cancer with docetaxel and cyclophosphamide regimen

ABSTRACT Objective To assess the incidence of febrile neutropenia without primary granulocyte colony-stimulating factor prophylaxis in patients undergoing chemotherapy with adjuvant docetaxel and cyclophosphamide, and to evaluate the toxicity profile of brand-name docetaxel (Taxotere ® ) and the generic formulation. Methods This retrospective study was conducted using data obtained from electronic medical records of patients treated at a Brazilian cancer center. Patients with breast cancer who underwent adjuvant treatment between January 2016 and June 2019 were selected. Data were analyzed using chi-square and Fisher correlation of variables, and multivariate analyses were adjusted for propensity score. Results A total of 231 patients with a mean age of 55.9 years at the time of treatment were included in the study. The majority (93.9%) had luminal histology, 84.8% were at clinical stage I, and 98.2% had a good performance status. The overall incidence of febrile neutropenia in the study population was 13.4% (31 cases). The use of brand-name docetaxel (Taxotere ® ) was the only factor associated with febrile neutropenia occurrence (OR= 3.55, 95%CI= 1.58-7.94, p=0.002). Conclusion In patients with breast cancer who require treatment with adjuvant docetaxel and cyclophosphamide regimen, the toxicity profile differs between brand-name and generic docetaxel. Regardless of the formulation used, the incidence of febrile neutropenia was less than 20%, which may allow for the omission of primary prophylactic granulocyte colony-stimulating factor use in this setting.

Research on dynamic on-line monitoring method of moisture attribute in three honey-processed Chinese herbal slice based on in-situ general model / 药学学报

Aiming at the hysteresis and destructiveness of off-line static detection of critical quality attribute of the moisture content of the raw material unit of the traditional Chinese medicine manufacturing process, honey-processed Tussilago farfara, honey-processed Astragalus and honey-processed Glycyrrhiza uralensis were used as the research carriers, and the drying method was used to measure the moisture content as a reference value. The moving stage was used to simulate the movement process of samples on the conveyor belt in the actual on-site production process, and near-infrared (NIR) spectra were collected, combined with machine learning, to establish NIR on-site dynamic detection model of moisture content in multi-variety honey-processed Chinese herbal slice. The results show that the second derivative method is used to preprocess the spectrum. The number of decision trees (ntree), the number of random features (max feature), and the minimum number of samples for generating leaf nodes (node size) are selected: 46, 76, and 8, respectively. The quantitative analysis model of moisture content has the best effect. The prediction coefficient of determination (the prediction coefficient of determination, R2pre) and the root mean square error of prediction (root mean square error of prediction, RMSEP) of the model were 0.903 2 and 0.330 2, respectively. The NIR quantitative model for the moisture content of multi-variety honey-processed Chinese herbal slice established in this study has good predictive performance, and can achieve rapid, accurate and non-destructive quantitative analysis of the moisture content of honey-processed Tussilago farfara, honey-processed Astragalus and honey-processed Glycyrrhiza uralensis at the same time, and provides a method for determining the moisture content of honey-processed Chinese herbal slice of the raw material unit of the traditional Chinese medicine manufacturing process.

Analysis of the incentive effect of the patent linkage system on the application of generic drugs in China and suggestions for countermeasures / 中国药房

OBJECTIVE To optimize the system of patent linkage system and provide a reference for encouraging generic drugs to apply for listing. METHODS On the basis of literature research， combined with the author’s work experience， the situation of generic drug application and patent challenge were analyzed comparatively after the implementation of the patent linkage system in China. Based on the patent linkage system， the reasons for the insufficient incentive for the challenge of generic drug patents in China were analyzed； corresponding countermeasures and suggestions were proposed. RESULTS & CONCLUSIONS The patent linkage system in China was implemented in 2021， but due to the implementation of the system being still in its initial stage， the relevant documents for practical guidance are not yet complete， and the supporting incentive mechanism is not yet sound， resulting in a weak willingness of generic pharmaceutical enterprises to initiate patent challenges. It is suggested that China can further improve the patent linkage system by improving the patent information registration platform of generic drugs， developing professional drug patent agencies， and establishing the patent common challenges platform of the first generic drug， in order to incentivize Chinese generic drug enterprises to increase innovation motivation， challenge original research drug patents， and apply for listing， achieving the effect of suppressing drug prices and benefiting the people through full competition.

Knowledge, Attitude and Practice of generic medicines- an explorative study among Interns of a Tertiary care teaching hospital of Central Karnataka

Background: Health care related expenditure is increasing with a rapid pace in which much proportion of expenses is on medicines. The expenditure can be reduced by prescribing generic medicines (Janaushadi). In India less prescription of generic medicines can be correlated to less knowledge. Hence this study was carried out among Interns who will be future practitioners to know their perception and practice about generic medicines. Objectives: To assess the Knowledge, Attitude and practice of Interns regarding generic medicines. Methodology: A cross sectional study was carried out among Interns using a pre-tested semi structured questionnaire containing questions related to their Knowledge, Attitude and their practice regarding generic medicines. Data was entered in MS Excel and analysed using SPSS version 20. Descriptive statistics were used. Results: Among the study participants, majority (90%) knew the correct meaning of the generic medicine. 97% of them felt that generic medicines can be prescribed instead of branded medicines. Majority (92%) of the study subjects felt that there should be one Janaushadi (generic medicines) store at every government hospital. Not many (19%) were aware of the law in India for prescribing generic medicines but majority (87%) knew about the Janaushadi Scheme of Government of India. 87% of the Interns had prescribed generic medicines to patients and among them they (85%) felt that generic medicines are easy to prescribe than branded medicines. Conclusion: This study showed that the Interns have good perception regarding generic medicines. Minor proportion of the study participants knew about the law in India for prescribing generic medicines. Majority of the participants have prescribed generic medicines to patients and felt that it is easy to prescribe generic medicines.

Drug use pattern and quality of life in patients with migraine at a tertiary care hospital in India: An observational study

Background: Migraine is a debilitating neurological disorder. As a leading cause of disability worldwide, it affects health-related quality of life (HRQoL). There are limited studies assessing the prescription pattern and improvement in HRQoL post-treatment. Aims and Objectives: This study aims to evaluate the drug use pattern and compare the effects of medications on HRQoL as per Migraine Disability Assessment Score (MIDAS). Materials and Methods: A prospective observational cross-sectional study was conducted on migraine patients attending neurology OPD at a tertiary care hospital. One hundred and seven patients were recruited by periodic sampling over 6 months. Prescription indicators assessed were number of antimigraine drugs per prescription, frequency of prescribed drugs, prescriptions by generic name, etc. Data were analyzed using descriptive statistics. The HRQoL was assessed after 3 months of medications by telephonic questionnaire. The change was analyzed by Wilcoxon matched pair signed-rank test. Results: Majority patients were in the third (40.2%) and fourth decade (32.7%) with a female preponderance (72.9%). Nonsteroidal anti-inflammatory drugs were commonly prescribed for aborting acute attacks with naproxen (24.1%) followed by diclofenac (2.71%). Prophylactically topiramate (27.51%), amitriptyline (18.6%), and propranolol (3.1%) were prescribed. About 36.43% of drugs were prescribed by generic names. Improvement in HRQoL was reflected by a significantly reduced MIDAS (13.95 ± 5.20 to 11.39 ± 5.07 [P < 0.05]). Conclusion: In our study, there was low generic prescribing. Naproxen was most prescribed for acute migraine and topiramate for prophylaxis. The HRQoL significantly improved after 3 months of antimigraine medications causing lesser disease burden.

Elaboration of guideline for monitoring in relative bioavailability / pharmaceutical bioequivalence study by the sponsor / Elaboração de diretriz para monitoramento em biodisponibilidade relativa / estudo de bioequivalência farmacêutica pelo patrocinador / Elaboración de la directriz para el seguimiento en la biodisponibilidad relativa / estudio de bioequivalencia farmacéutica por parte del promotor

For registration of generic and similar drugs, it is necessary to carry out pharmaceutical equivalence (PE) tests and pharmaceutical bioequivalence (PB). To carry out these tests, duly qualified research centers are contracted, which need to be monitored by the sponsor who is legally responsible for the activities. To this end, it is the recommendation of the Document of the Americas, periodic monitoring to verify compliance with quality requirements, Standard Operating Procedures, Good Clinical Practices (GCP), Good Laboratory Practices (GLP), of the applicable regulatory framework, as well as of compliance with the study protocol. Thus, monitoring is a methodical and documented process to evaluate the degree of adhesion of the center to the planned design for the evaluation of the formulations. To this end, the implementation of a standardized and easily completed guideline is a very important tool to guarantee a consistent evaluation and maintain the organizational memory of the evaluated items by monitors designated by the sponsor, contributing to the constant improvement of the contracted centers and supporting traceability of the studies. This work provided a systemic view of the evidence process related mainly to pharmaceutical bioequivalence, with the monitoring guideline summarizing the items of greatest relevance to be verified.

Para registro de medicamentos genéricos e similares, é necessária a realização de testes de equivalência farmacêutica (EF) e bioequivalência farmacêutica (BF). Para a realização desses testes, são contratados centros de pesquisa devidamente habilitados, que precisam ser monitorados pelo patrocinador legalmente responsável pelas atividades. Há também a recomendação do Documento das Américas de realizar monitoramentos periódicos para verificar o cumprimento dos requisitos de qualidade, Procedimentos Operacionais Padrão, Boas Práticas Clínicas (BPC), Boas Práticas de Laboratório (BPL), de marco regulatório aplicável, bem como de cumprimento do protocolo do estudo. Assim, o monitoramento é um processo metódico e documentado para avaliar o grau de adesão do centro ao desenho planejado para a avaliação das formulações. Para tanto, a implantação de uma diretriz padronizada e de fácil preenchimento é uma ferramenta muito importante para garantir uma avaliação consistente e manter a memória organizacional dos itens avaliados por monitores designados pelo patrocinador, contribuindo para a melhoria constante dos centros contratados e apoiando rastreabilidade dos estudos. Este artigo forneceu uma visão sistêmica do processo de evidência relacionado principalmente à bioequivalência farmacêutica, com a diretriz de monitoramento resumindo os itens de maior relevância a serem verificados.

Para el registro de medicamentos genéricos y similares, es necesario realizar pruebas de equivalencia farmacéutica (EP) y de bioequivalencia farmacéutica (PB). Para llevar a cabo estas pruebas se contratan centros de investigación debidamente cualificados, que deben ser supervisados por el promotor, que es el responsable legal de las actividades. Para ello, es la recomendación del Documento de las Américas, el monitoreo periódico para verificar el cumplimiento de los requisitos de calidad, los Procedimientos Operativos Estándar, las Buenas Prácticas Clínicas (BPC), las Buenas Prácticas de Laboratorio (BPL), del marco regulatorio aplicable, así como del cumplimiento del protocolo del estudio. Así, la monitorización es un proceso metódico y documentado para evaluar el grado de adhesión del centro al diseño previsto para la evaluación de las formulaciones. Para ello, la implantación de una pauta estandarizada y de fácil cumplimentación es una herramienta muy importante para garantizar una evaluación consistente y mantener la memoria organizativa de los elementos evaluados por parte de los monitores designados por el promotor, contribuyendo a la mejora constante de los centros contratados y apoyando la trazabilidad de los estudios. Este trabajo proporcionó una visión sistémica del proceso de evidencia relacionado principalmente con la bioequivalencia farmacéutica, con la pauta de monitoreo que resume los ítems de mayor relevancia a ser verificados.

Audit and quality assessment of prescriptions in a tertiary care hospital of Junagadh

Background: Analysis of prescription of doctors is done to determine, evaluate, and improve the care of patients in a well-organized way and it estimates on-going practice against a defined standard. Aim and Objective: The aim of the study was to provide the broad outline of performance and delineate parameter as per the check list of prescription audit. Materials and Methods: An observational and non-interventional study was carried out from July 2021 to November 2021 at peripheral medical college, Gujarat. Randomly, we have selected 500 prescriptions. This prescriptions were evaluated as per World Health Organization prescribing indicators and then it were analyzed for errors in prescription writing. Results: In this study, total 500 prescriptions were analyzed and total 1839 drugs were prescribed. Average number of drugs per prescription was 3.67. The percentage of drugs prescribed by generic name was 94.6%. The percentage of encounters with an antibiotic prescribed was 29%. In our prescription audit study, 39.16% (1762 count) prescriptions were non complete and 60.84% (2738 count) prescription were having complete details. Conclusion: If the drug is prescribe by generic name and from essential drug list chances of dispensing error decrease and hand out of incorrect drug to patient is reduced. Minimizing drug per prescription attenuates chances of drug-drug interactions. Regular prescription audit should be conducted regularly which increase the awareness in prescriber and effective, safe, and economics therapeutic practice.

Competencias sociales, emocionales e interculturales como parte fundamental del perfil integral de estudiantes de pregrado / Social, Emotional, and Intercultural (SEI) Competences as a Fundamental Part of the Integral Profile of Undergraduate Students

Resumen En el perfil profesional de los programas educativos de todas las disciplinas se señala que las competencias de los estudiantes universitarios tendrán que reflejar sus conocimientos, capacidades y habilidades para operar en un mundo más interconectado globalmente. Las competencias Sociales y Emocionales, como parte fundamental del ser y de la memoria social dan a los estudiantes de pregrado un punto de partida para su formación y al mismo tiempo influye en la constitución de la inteligencia Intercultural que le permitirá al futuro profesional desempeñarse en un contexto global, como parte fundamental del perfil integral.

Abstract: In the professional profile of educational programs of all disciplines, it is pointed out that the competences of undergraduate students will have to reflect their knowledge, abilities, and skills to operate in a more globally interconnected world. The Social and Emotional competences, as a fundamental part of the being and of the social memory give undergraduate students a starting point for their formation, and at the same time, influence the constitution of Intercul tural intelligence that will allow the future professional to perform in a global context, as a fundamental part of the integral profile.

Exploring the knowledge and perception towards generic medicines among undergraduate medical and nursing students – A questionnaire-based comparative study

Background: Healthcare providers are still hesitant in prescribing generic medicines due to several misconceptions about bioequivalence, efficacy, quality, and safety of generic medicines as compared to their branded counterparts. Proper teaching and training help in positive changes in perception as well as the prescribing and dispensing practices of healthcare providers. Aim and Objectives: The aims of this study were to study the knowledge and perception about the generic medicine among 2nd year MBBS and nursing students and to find out the differences between the student’s responses. Materials and Methods: An observational cross-sectional study was conducted involving 83 2nd year MBBS students and 60 2nd year nursing students in Bundelkhand Medical College, Sagar (M.P.), India. Assessment of knowledge and perception about generic medicines using the normal 5-point Likert scale and calculation using the independent-samples Mann–Whitney U-Test and P < 0.05 was considered statistically significant for differences observed among the two groups. Results: Only 33% of MBBS students and 17% of nursing students were select correct answer for bioequivalence limits. Almost 82% of MBBS and 53% of nursing students were agreed toward generic medicines are less expensive than brand name medicines (P = 0.00). Only 45% of MBBS students and 15% of nursing students were disagreed toward generic medicines are of inferior quality to branded drugs (P = 0.001). About 37% of MBBS students and 20% of nursing students were disagreed toward generic medicines are less effective and less safe than brand name medicines (P = 0.01) and only 12% of MBBS students and 7% of nursing students were disagreed toward brand name medicine which are required to meet higher safety standards than generic medicines (P = 0.09). Conclusion: In our study, we found that significant knowledge gap with regard to the regulatory bioequivalence limits for generic medicines and misconceptions about generic drugs is also quite prevalent. Educational interventions are most important tool to improve knowledge and change in perceptions among healthcare students about generic medicines and eventually promote practice of prescribing cost-effective generic drugs.

A cross-sectional study to evaluate the drug prescription pattern of outpatient department patients in tertiary care teaching hospital

Background: Prescription pattern monitoring studies are tool for assessing the prescribing, dispensing, and distribution of medicines prevailing in a particular area. The main aim of such studies is to facilitate rational use of medicines. Irrational prescribing leads to increased incidence of adverse effects, drug interactions, and emergence of drug resistance. Aim and Objectives: This study aims to evaluate drug prescription pattern of outpatient department patients as per the drug use indicators developed by the World Health Organization (WHO) and also the occurrence of different medication errors. Materials and Methods: 662 prescriptions were evaluated. The WHO core drug prescribing indicators analyzed were Average number of medicines prescribed per patient encounter, percentage of medicines prescribed by generic name, percentage of encounters with an antibiotic, injections, or fixed-dose combination (FDC), score of generic prescription, and justification for the use of brand names. The categories of prescription errors which were studied were legibility, absence of doctor identity, diagnosis, drug dosage, and duration. Results: The most common medication error was lack of treatment duration (75.1%) and illegibility of the prescriptions (61.9%). Most of the drugs were prescribed in generics. About 72.5% of the prescriptions had 100% generic score. Although the use of brand names was not justifiable in most cases. The use of injectables, antibiotics, and FDC was 0.9%, 46.5% and 76.8%, respectively. Conclusion: Such studies should be done regularly to evaluate the lacunae in drug prescribing patterns and improve them.

An open randomized cross over study to compare the clinical effectiveness and safety of economical generic with branded generic telmisartan in essential hypertension

Background: Hypertension is a chronic disease and is a major risk factor for chronic heart disease, stroke, coronary heart disease, and its complications include heart failure, peripheral vascular disease, renal impairment, retinal hemorrhage, and visual impairment. Antihypertensive drugs are important to avoid such complications but compliance of patient is needed which may depend on the cost of therapy. Aim and Objective: This study aimed to assess the efficacy and safety of a branded generic with an economical generic. Materials and Methods: Out of 110 patients, 105 patients (53 patients in group A and 52 patients in group B) completed the study with follow-up over a period of 6 months. Group A patients received generic Telmisartan 40 mg in the beginning (0th day) which was continued for 12 weeks, cross-over was done with branded generic Telmisartan (Telma 40) which was given for further 3 months. Group B patients received the branded generic followed by generic Telmisartan in that sequence for 3 months each. Blood pressure (BP) was recorded at the baseline visit and at the end of 4, 8, 12, 16, 20, and 24 weeks. The adverse events were assessed throughout the study period. Results: Intra-group comparison show significant reduction in systolic (SBP) and diastolic BP (DBP) in each groups (P < 0.001) but when we compare the reduction of SBP and DBP in between the two groups the difference was not significant. Common adverse events were headache, dizziness, light-headedness, and vertigo. Conclusion: There was a huge difference between the prices of branded generic and unbranded generic. This study showed that both branded generic and unbranded generic are comparable in terms of efficacy, safety except the cost of therapy. Thus substitution of a Pharmacological generic (unbranded generic) drug could save lot of expenses.

Quality Control Study of Different Products from Famotidine Tablets in the Iraqi Market / Estudio de Control de Calidad de Diferentes Productos de Tabletas de Famotidina en el Mercado Iraquí

Background: In developing countries, particularly in Iraq, the use of generic medicines has been increasing in recent years, primarily as a cost-saving measure in healthcare provision. In the Iraqi market, famotidine tablets are available from different pharmaceutical companies. As a result, regular pre-marketing quality testing is required to check the quality and identify which product might safely substitute the innovator product in the event of the innovator brand's unavailability or high cost. Objective: various quality control tests have been conducted to determine the Pharmaceutical Equivalence of the different generic and brands of Famotidine film-coated tablets marketed in Iraq. Materials and Methods: Four different samples of the most commonly available Famotidine 20 mg tablets in the Iraqi market were tested for drug contents, friability, and hardness. Additionally, the in-vitro drug release and kinetics were evaluated. Results: slight differences in the products' content were found; however, they were within the acceptable requirement of British Pharmacopeia (BP) and The United States Pharmacopoeia (USP) 30, NF 25. Similarly, the friability and hardness were within the excellent range according to the B.P. and USP. The results of our study indicated that the tested brand (Famodin) and the three generic products (Famosam, Ulceran, and Famodar) of Famotidine tablets have a unique pattern of in-vitro release profiles. However, all the tested brands and generic pills complied with the USP specifications for the immediate release dosage forms except for Famosam. Release kinetic for the four tested products indicates first-order kinetic models. Conclusion: The findings revealed that nearly all of the tested Famotidine tablet brands and generics met the pharmacopeial requirements for oral tablets. As a result, if acquiring the innovative brand of famotidine tablets is difficult to obtain, healthcare providers may be advised to use the tested products instead

Antecedentes: En los países en vías de desarrollo, especialmente en Irak, el uso de medicamentos genéricos ha aumentado en los últimos años, principalmente como medida de ahorro en la prestación de servicios sanitarios. En el mercado iraquí, los comprimidos de famotidina están disponibles en diferentes empresas farmacéuticas. Por ello, es necesario realizar periódicamente pruebas de calidad previas a la comercialización para comprobar la calidad e identificar qué producto podría sustituir con seguridad al producto innovador en caso de que éste no esté disponible o tenga un coste elevado. Objetivo: se han realizado varias pruebas de control de calidad para determinar la Equivalencia Farmacéutica de los diferentes genéricos y marcas de Famotidina comprimidos recubiertos con película comercializados en Irak. Materiales y métodos: Se analizaron cuatro muestras diferentes de los comprimidos de 20 mg de Famotidina más comunes en el mercado iraquí para determinar el contenido de fármaco, la friabilidad y la dureza. Además, se evaluó la liberación in-vitro del fármaco y su cinética. Resultados: Se encontraron ligeras diferencias en el contenido de los productos; sin embargo, estaban dentro de los requisitos aceptables de B.P. y de la Farmacopea de Estados Unidos (USP) 30, NF 25. Así mismo, la friabilidad y la dureza estaban dentro del rango excelente según la B.P. y la USP. Los resultados de nuestro estudio indicaron que la marca probada (Famodin) y los tres productos genéricos (Famosam, Ulceran y Famodar) de comprimidos de famotidina tienen un patrón único de perfiles de liberación in-vitro. Sin embargo, todas las marcas y los comprimidos genéricos probados cumplieron con las especificaciones de la USP para las formas farmacéuticas de liberación inmediata, excepto Famosam. La cinética de liberación de los cuatro productos probados indica modelos cinéticos de primer orden. Conclusiones: Los resultados revelaron que casi todas las marcas y genéricos de comprimidos de Famotidina probados cumplían los requisitos farmacopeicos para los comprimidos orales. En consecuencia, si resulta difícil adquirir la marca innovadora de comprimidos de famotidina, se puede aconsejar a los profesionales sanitarios que utilicen los productos probados en su lugar

Effectiveness and safety of generic and original drugs of atorvastatin ：a systematic review / 中国药房

OBJECTIVE To systema tically evaluate the effectiveness and safety of gen eric and original drugs of atorvastatin ， and to provide the latest evidence-based reference for drug selection in clinic. METHODS Retrieved from PubMed ，Cochrane Library，Embase，CNKI，VIP and Wanfang database ，intervention trials and observational studies about generic and original drugs of atorvastatin were collected during the inception to Apr. 2021. After data extraction of literatures met inclusion criteria ，the Cochrane risk bias evaluation tool 5.1.0 was used to evaluate the quality of intervention trials ；Newcastle-Ottawa Scale （NOS）was used to evaluate the quality of observational studies. RevMan 5.4 software was used to conduct meta-analysis ，and descrptive analysis was performed at the same time. RESULTS A total of 24 studies were included ，involving 21 randomized controlled trials （RCTs）and 3 retrospective cohort studies （RCSs），with 20 001 patients involved. Meta-analysis results of RCT showed there was no statistically significant difference between the two groups in reducing low-density lipoprotein cholesterol （LDL-C）levels [MD ＝ － 0.05，95％ CI（－ 0.12，0.02），P＝0.16] and increasing Δ 基金项目：国家重点研发计划项目（No.2017YFC0910004）；山 东省重点研发计划项目（No.2020RKB14165） high-density lipoprotein cholesterol （HDL-C）levels [MD ＝ ＊硕士研究生 。研究方向：临床药学。E-mail：1677032023@qq. － 0.00，95％ CI（－ 0.02，0.01），P＝0.52]；the degree of com reducing total cholesterol （TC）level [MD ＝－0.11，95％CI # 通信作者：主任药师，硕士生导师。研究方向：临床药学、药事 （ － 0.17，－ 0.06），P＜0.000 1] and triglyceride （TG） 管理。电话：0351-89268349。E-mail：13791120711@126.com level [MD ＝－0.05，95％CI（－0.09， －0.01），P＝0.02] in ·358· China Pharmacy 2022Vol. 33 No. 3 中国药房 2022年第33卷第3期 generic drug group was lower than orig inal drug group ，with statistical significance difference. There was no statistical significance difference in total incidence of adverse drug reaction （ADR）[OR＝1.08，95％ CI（0.85，1.37），P＝0.55] and the incidence of other ADR（P＞0.05）. The results of subgroup analysis showed that the reductions of TC and TG of generic drugs produced by Beijing Jialin Pharmaceutical Enterprise （hereinafter refer to Jialin generic drugs ）were less than those of the original drug ，and the difference was statistically significant ；compared with original drugs ，there was no significant difference in other indexes or all indexes of the generic drugs from other manufacturers. Compared with original drugs ，the reductions of TC and TG in 20 mg/d group of Jialin generic drugs were less than original drug group ；the degree of TC reduction at 12 and 24 weeks of follow-up and TG reduction at 24 weeks of follow-up were less than those of the original drugs ，the difference was statistically significant ；there was no significant difference in other indexes. The qualitative description of RCS showed that for elderly patients with death/acute coronary syndrome ，there was no statistical difference between the two groups in terms of cardiovascular events or serious side effects. For the adult patients who switched from original drugs to generic drugs ，the effect of generic drugs instead of original drugs would not be reduced ，but the increase of HDL-C was less than that of original drug. CONCLUSIONS In terms of effectiveness，generic drugs of atorvastatin can replace original drugs and caution should be taken on the levels of HDL-C ，TC and TG for long time use ；in terms of safety ，generic drugs are similar to the original drugs.