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.

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.

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.

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.

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.

Analysis on the linkage of 415 generic medicines passing consistency evaluation and essential medicine list ， medical insurance list and centralized procurement list from the perspective of medicine accessibility / 中国药房

OBJECTIV E To in vestigate the situation ，achievements and proble ms of consistency evaluation policy of generic medicines in China. METHODS The descriptive analysis was performed after collecting and sorting out the information of generic medicine passing consistency evaluation （GMPCE） published on the official website of the National Medical Products Administration. The basic information ，the distribution and changes of GMPCE were analyzed statistically in National Essential Medicine List （hereinafter refer to as “essential medicine list ”），Medicine List for National Basic Medical Insurance ，Industrial Injury Insurance and Maternity Insurance （hereinafter refer to as “medical insurance list ”）and the result of the successful selection of centralized medicine procurement organized by the state （hereinafter refer to as “centralized procurement list ”）. RESULTS From 2017 to 2021，415 chemical generic drugs had passed consistency evaluation in China ，including 309 varieties，1 822 specifications， 6 dosage forms ，and 17 pharmacological mechanisms ，basically belonging to 30 provinces，and 492 drug manufacturers （except 12 products had not been found the manufacturers ）；the proportion of GMPCE in essential medicine list increased from 0.96％ in 2012 edition to 25.40％ in 2018 edition；that of GMPCE in medical insurance list increased f rom 2.13％ in 2017 edition to 11.68％ in 2021 edition；in the first 5 batches of centralized procurement list，GMPCE accounted for 81.65％，and the maximum price drop after entering the list was 97.52％. CONCLUSIONS The policy linkage has been achieved with the continual increase of the number of GMPCE and their total amount in three lists in China. The accessibility and affordability of related medicines have been improved with the apparent decrease of the price of those medicines. H owever，total number of GMPCE is a little small，with the higher repetition rate of variety and the low proportion in the three lists ；the guarantee measures of those medicine supply need to be strengthened.

Interference of medicines in laboratory exams / Interferência dos medicamentos nos exames laboratoriais

ABSTRACT Objective: Conduct a survey on the interference of drugs in laboratory tests. Methodology: To identify the interference of each medication in laboratory tests, the Municipal List of Essential Medicines (Remume) of a medium-sized municipality in the state of Minas Gerais was used along with the following sources of information: Dynamed, Micromedex® and Nursing Reference Center. Results: We observed that the majority (67.7%) of Remume drugs can interfere in one or more laboratory tests; among them, the main classes of drugs are diuretics, beta blockers, ß-lactams, sulfonamides, macrolides, tricyclic antidepressants and selective serotonin reuptake inhibitors antidepressants. Conclusion: It is extremely important to disseminate knowledge about these interferences so that health professionals are alert and know how to identify the possible changes, reducing analytical errors and subsequently misdiagnosis and erroneous monitoring. Continued education on drug interference in laboratory tests is equally important.

RESUMEN Objetivo: Llevar a cabo una encuesta acerca de la interferencia de los medicamentos en las pruebas de laboratorio. Métodos: Usamos la Relación Municipal de Medicamentos Esenciales (Remume) de una municipalidad mediana en el estado de Minas Gerais y las siguientes fuentes de información: Dynamed, Micromedex® y Nursing Reference Center. Resultados: Observamos que la mayor parte (67,7%) de los medicamentos de Remume puede interferir en una o más pruebas de laboratorio; entre ellos, las principales clases son los diuréticos, beta bloqueadores, betalactámicos, sulfonamidas, macrólidos, antidepresivos tricíclicos y antidepresivos inhibidores selectivos de la recaptación de serotonina. Conclusión: Es muy importante divulgar el conocimiento respecto a esas interferencias para que los profesionales de la salud puedan identificar las posibles alteraciones en las pruebas, reduciendo errores analíticos y diagnósticos y monitoreos equivocados. Por lo tanto, es necesaria una educación continuada acerca de las interferencias de medicamentos en las pruebas de laboratorio.

RESUMO Objetivo: Realizar um levantamento sobre a interferência dos medicamentos nos exames laboratoriais. Métodos: Utilizamos a Relação Municipal dos Medicamentos Essenciais (Remune) de um município de médio porte do estado de Minas Gerais e as seguintes fontes de informações: Dynamed, Micromedex® e Nursing Reference Center. Resultados: Observamos que a maioria (67,7%) dos medicamentos da Remune pode interferir em um ou mais exames laboratoriais; entre eles, as principais classes de medicamentos são os diuréticos, betabloqueadores, betalactâmicos, sulfonamidas, macrolídeos, antidepressivos tricíclicos e antidepressivos inibidores seletivos da recaptação de serotonina. Conclusão: É muito importante divulgar o conhecimento a respeito dessas interferências para que os profissionais da área da saúde possam identificar as possíveis alterações nos exames, reduzindo erros analíticos e diagnósticos e monitoramentos equivocados. Portanto, faz-se necessária a educação continuada sobre as interferências de medicamentos nos exames laboratoriais.

Benefit Balance and System Construction of In novation and Accessibility of Pharmaceutical Products in China ： Taking the Patent Linking System as an Example / 中国药房

OBJECTIVE：To provide reference for constructing a patent linking system in line with international standards and balancing the interest conflict between original drug enterprises and generic drug enterprises. METHODS ：The relevant supporting systems of patent link in the United States were introduced ；combined with the development status and relevant systems of drug patent protection at home and abroad ，the existing problems of China ’s drug patent management system were analyzed to put forward suggestions for improvement. RESULTS & CONCLUSIONS ：The United States patent linking system included Orange book system ，generic drug patent declaration system ，generic drug approval waiting period and market monopoly period system of the first generic drug. The innovation and accessibility in the field of pharmaceutical products were facing the dilemma of “commons tragedy ”and“anti commons tragedy ”. There were many problems in China ’s drug patent protection ，such as insufficient R&D and innovation ability inhibited the development of the pharmaceutical industry ，imperfect laws and regulations were not conducive to the settlement of medical professional disputes. It is suggested to establish a digital information database of patented drugs ，standardize the existing generic drug patent declaration system ，promote the coordination between patent litigation cycle and approval waiting period ，increase the independent innovation ability of the pharmaceutical industry ，promote the coordination between pharmaceutical innovation and drug accessibility ，and jointly promote the improvement of intellectual property legislation and the development of medical and health undertakings.

Intercambiabilidad de medicamentos en el Perú: panorama actual y perspectivas futuras

Los medicamentos genéricos desempeñan un papel importante en los sistemas de atención de salud, ya que representan una alternativa eficaz más asequible para la población. En el Perú, se estableció un reglamento que regula la intercambiabilidad de medicamentos genéricos (también llamados multifuentes), que define los procedimientos y requisitos a seguir para desarrollar estudios de equivalencia terapéutica in vivo e in vitro, siguiendo el enfoque de aplicación gradual y el criterio de riesgo sanitario. El cumplimiento de este reglamento permitirá un mayor acceso a medicamentos genéricos eficaces, seguros y de calidad. Mientras tanto, se siguen comercializando genéricos en ausencia de estudios de equivalencia terapéutica. Los estudios demuestran que algunos medicamentos fallaron en las comparaciones in vivo e in vitro con el medicamento de referencia. Esta implementación representa un gran desafío para los laboratorios fabricantes y los titulares de registros sanitarios a fin de demostrar la intercambiabilidad de sus productos farmacéuticos con el medicamento de referencia.

Generic drugs play an important role in healthcare systems as they represent an effective and more affordable alternative for the population. In Peru, a regulation of interchangeability of generic drugs (also called multisource drugs) was stablished to define the procedures and requirements for developing in vivo and in vitro therapeutic equivalence studies, following the gradual application approach and sanitary risk criteria. Compliance with the new regulation will allow greater access to effective, safe and quality generic drugs. Meanwhile, drugs continue to be marketed in the absence of therapeutic equivalence studies. Findings show that some drugs failed in in vivo and in vitro comparisons with the reference product. This regulation represents a great challenge for manufacturers and holders of sanitary registrations in order to demonstrate the interchangeability of their pharmaceutical products with the reference product.

Generic Drug: Prescriber’s Perspective

Objective: Knowledge of doctors and their understanding of generic drugs could facilitate in recognizing potential barriers to larger generic medicine prescriptions. Hence, the primary objective of this study was focused to explore knowledge, attitude, and practice (KAP) of doctors toward generic medicines. Methods: It is a cross-sectional questionnaire-based study. The study participants are the doctors working in the hospital during the study period (2016–2017). The questionnaire designed for this study comprised of thirty-five questions related to the knowledge, attitude, and practice (KAP) of generic medicine and about demographic details of the participants. Results: A total of 86 questionnaires were distributed among the health care professionals and the response rate is 37%. The majority of doctors who participated in this survey perceived that generic medicine is effective, safe and need to have the same active component, dose and bioequivalent as the brand name medicines. Most of the doctors (72%) were of the view that generic drugs were manufactured in poor quality than branded medicines. More than three-quarters of doctors (78%) prescribed generic drugs. Conclusion: Majority of the participants had an honest angle about the efficaciousness and safety of generic and though they sometimes prescribe generic medicine, however a high range of doctors (72%) were of the opinion that generic was of poorer quality than brand medicine. To have a better understanding of the generic drug, the doctor must be well informed about the generics during their academic career resulting in savings to healthcare budgets.

Knowledge and perceptions about generic drugs by users of PSF in triple borders / Conhecimento e uso de medicamentos genéricos por usuários do sistema único de saúde brasileiro em região de tríplice fronteira

Abstract Background The Brazilian Ministry of Health, by the National Policy on Medication, Ordinance 3916 from October 30th 1998, reinforces the Law of Generics of February 1999 (Law No. 9787 from February 10th, 1999, aiming, among other things, to reduce the prices and make access to medications easier for population). Objective The main objective was to identify the level of knowledge of the population regarding generic drugs. Method Descriptive, quantitative study, with 520 users interviewed in four health care units that implemented the Brazilian Family Health Program. Such units represent four health districts in Foz do Iguaçu, PR, Brazil. Results Most of the interviewed know and/or have heard about generic drugs. For many people, the generic drug represents only a more affordable type of medication. Conclusion The need for health education to clarify the population's questions was found, so they could identify and acquire their medication safely and with confidence.

Resumo Introdução O Ministério da Saúde, pela Política Nacional de Medicamentos, Portaria no 3.916, de 30 de outubro de 1998, reforça a Lei de Genéricos de fevereiro de 1999 (Lei no 9.787, de 10 de fevereiro de 1999, visando, entre outras coisas, reduzir os preços e facilitar o acesso aos medicamentos para a população). Objetivo Identificar o nível de conhecimento da população em relação aos medicamentos genéricos. Método Estudo descritivo, quantitativo, com 520 usuários entrevistados em quatro unidades de saúde que implementaram o Programa Saúde da Família e que representam quatro distritos sanitários de saúde em Foz do Iguaçu (PR), Brasil. Resultados A maioria dos entrevistados conhece e/ou já ouviu falar do genérico. Para muitas pessoas, o medicamento genérico representa apenas um tipo de medicamento mais acessível. Conclusão Achados indicam a necessidade de educação em saúde para esclarecer a população, para que possam identificar e adquirir seus medicamentos com segurança e confiança.

Prescribing pattern of antibiotics among postoperative patients admitted in gynaecology and obstetrics department of tertiary care hospital in Northern India

Background: The objective of the study was to study the prescribing pattern of the antibiotics in postoperative patients admitted in gynaecology and obstetrics.Methods: Current prospective observational study was conducted in the department of pharmacology, Government Medical College, Kathua in collaboration with department of gynaecology and obstetrics for a period of six months duration from 1st May 2019 to 31st October 2019. The case sheets of all post operated patients above eighteen years of age admitted were studied and analyzed.Results: Total of 1807 case sheets were analyzed and showed that 4245 antibiotics were prescribed with an average of 2.3 antibiotics prescribed. Oral cefuroxime (17.3%) was maximally prescribed in patients who delivered normal presentation with episiotomy and injection ceftriaxone along with tinidazole and gentamycin were prescribed (58.4%) where caesarean section was done. While injection ceftriaxone and sulbactum along with tinidazole and gentamycin (17.09%) was prescribed in patients who were operated for gynaecological diseases. Maximum (80%) of the antibiotics were prescribed under brand name.Conclusions: Cephalosporin’s are commonly prescribed antibiotic and in eighty percent brand names were prescribed. Results underscore that antibiotic in generic name should be encouraged.

Prescription pattern at outpatient department in a tertiary care hospital of Gujarat: a cross-sectional study

Background: Evaluation of drug prescription prototype is a significant feature of patient care, which also provides as an estimate of the quality of care provided. Thus, the current study was carried out to analyze the prescriptions of patients attending outpatient department (OPD) of a tertiary care teaching hospital.Methods: Present cross-sectional study was performed in the OPD of our tertiary care teaching hospital. The study was carrying out for duration of two years. Data was obtained from 850 prescriptions. Data was analysed as per WHO prescribing indicators.Results: Total 1700 prescriptions were analysed, that includes 55.8% males and 40.1% females. The highest numbers of prescriptions were from the age group of 18-40 (53.6%) years of age. Average number of drugs in the current study was found to be (2.1). Percentage of come across with an antibiotic prescribed was 17.12%. Percentage of come across with an injection prescribed was 11.81%.Conclusions: There is necessitate of recuperating the prescribing pattern by maintaining the number of medicines as little as possible, prescribing medicines by generic names, using medicines properly after selecting and deliberately keeping the charge of treatment low.

In vitro comparison test for chemical solid oral generic drugs administered by nasogastric tubes / 国际药学研究杂志

At present, the dosage and administration items in the marketing instructions of some oral solid brand drugs approved in China include related contents for administration via nasogastric tube. In order to achieve consistency with the original drugs in quality and efficacy, the generic drugs investigators should confirm whether the generic drugs and the original drugs have the same in vitro characteristics under the conditions of administration by nasogastric tube. The purpose is to eliminate the clinical risks brought by the way of administration. This article summarizes the experimental design and evaluation points for the in vitro comparative study of the solid oral generic drugs which can be administered by nasogastric tube, while referring to the individual drug guidelines issued by FDA and the related literature published, so as to provide a reference for the technical system construction for the consistency evaluation of oral solid dosage forms.

Application of six sigma quality improvement model in the laboratory research of generic drugs / 药学实践杂志

Objective To improve laboratory research of generic drugs in Chinese pharmaceutical enterprises, avoid the defects in the research process, and explore the feasibility of six sigma management (DMAIC) as improvement model in the process of generic drugs laboratory research. Methods The effectiveness of DMAIC implementation was evaluated through the literature search and case study of a generic API’s process with the DMAIC model. Results The DMAIC model was successfully applied in this case. The model made laboratory research more reasonable, helped R&D personnel to pinpoint key quality attributes and process parameters, etc., ensured the authenticity and completeness of experimental data, and provided valuable data for subsequent industrial production as well as meeting registration requirements. Conclusion DMAIC model can solve the problems, such as poor overall arrangement, poor connection with production, and irregular management. It embodied the idea of Quality by Design (QbD) and can be used as good reference for domestic laboratory research of generic drugs.

Conceptos fundamentales de bioequivalencia y biosimilitud en la normativa chilena y controversias sobre intercambiabilidad / Chilean legislation on bioequivalence and biosimilarity and current controversies related to drug interchangeability

Los medicamentos constituyen un bien económico que forma parte del gasto público y privado y de la toma de decisiones en salud. El aseguramiento de su calidad, eficacia y seguridad resulta fundamental. Sin embargo, la variada oferta disponible en el mercado chileno, donde se reconocen productos innovadores y genéricos, constituye un escenario confuso para consumidores y proveedores en salud. En esta revisión pretendemos aclarar los conceptos de fármacos bioequivalentes (aplicable a compuestos de tamaño molecular pequeño) y fármacos biosimilares (para compuestos biológicos de mayor complejidad molecular). En ambos casos, el comportamiento en el organismo del principio activo debe ser demostrado mediante estudios realizados para este fin. Una aplicación directa del concepto de bioequivalencia es la intercambiabilidad, definida como la posibilidad de utilizar un producto de un mismo principio activo, mientras la forma farmacéutica y esquema de dosificación sean iguales. Las normas relativas a esta materia y los organismos públicos encargados, no solo debieran garantizar la seguridad y la eficacia en el intercambio entre productos, sino también aspectos relacionados con el costo, la accesibilidad a los fármacos y la implementación de una guía de homogeneización de conceptos y criterios de intercambiabilidad basados en la evidencia, lo cual impactaría en una mejor educación para los usuarios, reduciendo la asimetría de información entre el usuario y la industria. La importancia de la intercambiabilidad destaca en Chile en el contexto del Plan de Garantías Explícitas en Salud (GES) y la Ley de Protección Financiera para Diagnósticos y Tratamientos de Alto Costo en Salud (Ley Ricarte Soto). Sin embargo, no es posible garantizar que todos los productos alternativos al innovador presentes en el mercado chileno son bioequivalentes. El conocimiento disponible en esta temática puede impactar y contribuir a la toma de decisiones en los prescriptores y usuarios, así como en la elaboración de políticas públicas en torno a los productos farmacéuticos bioequivalentes y biosimilares en nuestro país.

Medicines are an economic good and a fundamental component of public and private health spending and decision-making. Assurance of their quality, efficiency, and safety is essential. In Chile, the wide variety of available drugs, including innovator products, and generics­some of which are certified as bioequivalent, while others are not­creates a potentially confusing scenario for both consumers and health providers. In this review, we intend to shed light on the concepts of bioequivalency (the standard permitting interchangeability for small-molecule drugs) and biosimilarity (the standard permitting interchangeability for biological compounds of greater molecular complexity). In both cases, how the active substance interacts with the host organism must be demonstrated by studies designed and carried out for this purpose. Interchangeability is defined as the possibility of using a product of the same active principle, as long as the pharmaceutical form and dosage scheme are the same. Regulations related to bioequivalence and biosimilarity must not only guarantee safety and efficacy when products are interchanged but also facilitate cost savings and access to medicines. Implementation of evidence-based guidelines that standardize concepts of interchangeability could lead to more educated usage and reduced information asymmetry between patients (users) and industry. Drug interchangeability is particularly relevant in two government health initiatives in Chile: the Explicit Guarantees in Health Care (GES) plan, and the Law on Financial Protection for High-Cost Diagnostics and Treatment in Health Care (also known as the "Ricarte Soto Law"). Nonetheless, it is not possible to guarantee that all alternative drug products on the Chilean market are bioequivalents of the reference product. Synthesis of the available knowledge on bioequivalent and biosimilar pharmaceutical products in Chile could facilitate and contribute to stakeholder decision-making and the development of better health policies.

Bioequivalence regulation in emerging countries: Example of Moroccan regulations on immediate release formulations and comparison with international guidelines

The purpose of this study was to analyze Moroccan regulations on bioequivalence studies and compare them with someinternational guidelines. It emerged that, as most common guidelines, Moroccan regulations treated essential questionsrelating to the conduct of bioequivalence studies while remaining general. An effort to harmonize the Moroccanregulations as closely as possible with international guidelines such as European Medicines Agency and World HealthOrganization was made. The decree 2-12-198 on bioequivalence studies includes worldwide gold standards such asinclusion and exclusion criteria, study design, choice and number of subjects, conduct of the study, pharmacokineticparameters, BE acceptance criteria, and biowaiver requirements. It specifically addresses issues such as pro-drug,metabolites, urinary samples, and endogenous substances. Specific precisions such as the case of the modified releaseforms, the replacement of subjects on the withdrawal, or drop-out of a volunteer are not covered by this general decreeand should be part of new directives, in the future. For an emerging country, the integration of BiopharmaceuticsClassification System biowaivers within the decree confirms the efforts being made by the Moroccan regulations tojoin the most advanced guidelines on the investigation of bioequivalence and to prepare the International Council onHarmonisation M9 adoption

Prescription auditing and observational study in a tertiary care hospital

Background: Prescription is an important document written by a doctor which if not written properly can lead to various problems such as adverse drug reactions in patients, incompatibility to follow the instructions to take timely medications and sometimes over dosage due to improper prescription can even lead to death of the patient.Methods: This prospective observational cross-sectional study was conducted over a period of 6 months. The study was conducted in Rajendra Institute of Medical Sciences, Ranchi. Various prescriptions were collected from outpatient care facilities of a tertiary care hospital. Results were analyzed and assessed on 150 prescriptions collected.Results: Total 150 prescriptions were evaluated out of which 49.3% were males and 50.7% were females. Various parameters were assessed during the study which showed that there is still a scope of improvement in prescribing patterns in areas of writing complete prescriptions, prescribing generic medications and mentioning drug dosage forms as well as time of administration in each prescription.Conclusions: The results showed there is still a scope of improvement in writing practices of prescription. The doctor should incur the habit of writing generic names of drug in every prescription. They should adopt proper handwriting skills and no mistakes should be done in a prescription. A good prescription written by a doctor will help in legible practice and will also be very helpful in patient’s care.

Knowledge, attitude and practice regarding generic drugs and branded drugs: a cross sectional study

Background: Medicines play a main role in the process of human development. The rational utilization of medicines can decrease morbidity and mortality as well as improve quality of life. In an era of steeply rising health care expenses, generic medicines provide a less expensive alternative to branded medicines. Use of generic drugs can contribute to substantial savings in medicines expenditure and the issue of access and affordability is thus addressed.Methods: A sample of 500 patients selected from out patient department was randomly selected. A self-instructed questionnaire was used for the study for the duration of 1 month. Data was analyzed using IBM SPSS statistics Version 20 New York, United States. Summary statistics were expressed using mean and standard deviation (SD) for numerical variables (median and interquartile ranges [IQRs] when skewed) and counts and percentages for categorical variables.Results: Participants reported with 17.23% knowledge score, 40.65% attitude score, and 7.96% attitude score.Conclusions: In the study it was found that there is significant correlation between knowledge and attitude whereas no correlation was found between knowledge and practice regarding usage of generic drugs.

Clinical and economic impact of generic versus brand name meropenem use in an intensive care unit in Colombia

Abstract Background: Recent studies suggest that sustained use of generic antibiotics may be associated with clinical failure and emergence of antibacterial resistance. The present study was designed to determine the clinical outcome between the use of generic meropenem (GM) and brand-name meropenem (BNM). Additionally, this study evaluated the economic impact of GM and BNM to determine if the former represents a cost-effective alternative to the latter. Methods: Patients treated between January 2011 and May 2014 received GM while patients treated between June 2014 and March 2017 received BNM. Mortality was compared between groups. Total infection cost was defined by the cost of antimicrobial consumption, length of stay, and laboratory and imaging exams until infection resolution. Findings: A total of 168 patients were included; survival rate for the 68 patients treated with GM was 38% compared to 59% in the patients treated with BNM. Multivariate analysis showed that the variables most strongly-associated with mortality were cardiovascular disease (OR 18.18, 95% CI 1.25-262.3, p = 0.033) and treatment with generic meropenem (OR 18.45, 95% CI 1.45-232.32, p = 0.024). On the other hand, total infection cost did not show a significant difference between groups (BNM $10,771 vs. GM $11,343; p = 0.91). Interpretation: The present study suggests that patients treated with GM have a risk of death 18 times higher compared to those treated with BNM. Furthermore, economic analysis shows that GM is not more cost effective than BNM. Summary: More studies measuring clinical outcomes are needed to confirm the clinical equivalence of brand-name versus generic antibiotics, not only for meropenem but also for other molecules.