Comparison of effectiveness,safety,and economy of generic and original levetiracetam concentrated solution for injection:a real-world study / 药物流行病学杂志

Objective To evaluate the effectiveness,safety and economy of the clinical application of levetiracetam(LEV)concentrated solution for injection generic drug and the original drug in the national centralized volume-based procurement.Methods The information of inpatients using original LEV concentrated solution for injection in the Xuanwu Hospital of Capital Medical University(original drug group)and inpatients using generic LEV concentrated solution for injection in the First Affiliated Hospital of Wannan Medical College(generic drug group)was retrospectively analyzed after the implementation of the procurement policy(from November 2021 to March 2022).To compare the effectiveness,safety and economy of the two in the prevention and treatment of epilepsy.Results In the original drug group and the generic drug group,18 and 17 patients were enrolled in the treatment of epilepsy respectively,the effective rates were 50.00％and 58.82％,the incidence of adverse reactions were both 0％,and the median daily cost was 255.00(255.00,510.00)yuan and 131.78(131.78,131.78)yuan.After propensity score matching,both the original drug group and the generic drug group had 76 patients each received preventive medication,the effective rates were 97.37％and 100％(P＞0.05),and the incidence of adverse reactions were both 0％.The median daily fee for the original the generic drug group was 170.00(170.00,170.00)yuan and 131.78(131.78,131.78)yuan,there were significant difference(P＜0.01).Conclusion The clinical effect of generic and original LEV concentrated solution for injection in preventing epilepsy is basically the same,the clinical safety are equivalent,the generic has better economy than the original.The effective rate of the treatment of epilepsy is similar,while the sample size needs to be further expanded to verify the results.

Comparison of clinical effectiveness and safety between generic and branded dienogest tablets in the treatment of endometriosis / 中国临床药理学与治疗学

AIM:To evaluate the clinical effective-ness and safety of generic and branded dienogest in the treatment of endometriosis.so as to provide the basis for clinical use of dienogest.MEHTODS:The data of patients admitted to Third Affiliated Hospital of Zhengzhou University from August 2022 to August 2023 who received dienogest(2 mg/d,orally,for 6 months)for treatment of endometrio-sis were collected.The clinical efficacy and adverse reactions of generic drugs and original drugs in the treatment of endometriosis-related pain were com-pared through follow-up surveys of the two groups of patients at 3 months and 6 months respectively.RESULTS:There was highly significant reduction in pelvic pain in both groups with mean of similar in generic group(34.0±3.0)mm and branded group(34.5±3.9)mm.The most frequent drug-related ad-verse effects in generic dienogest was vaginal bleeding(93%)which was no statistical difference with branded dienogest(90%).CONCLUSION:The generic and branded dienogest have the same clini-cal effectiveness and similar safety.

Evaluación comparativa de perfiles de disolución del medicamento genérico lamivudina tableta 150 mg comercializado en Perú frente al innovador Epivir / Comparative evaluation of dissolution profiles of the generic drug lamivudine 150 mg tablet marketed in Peru vs. the innovative Epivir

RESUMEN La lamivudina es uno de los medicamentos más prescritos en el mundo, se utiliza para tratar la inmunodeficiencia humana y la hepatitis B. El objetivo del estudio fue evaluar los atributos de calidad y comparar los perfiles de disolución de dos lotes (A y B) del medicamento genérico lamivudina 150 mg tabletas con el medicamento innovador Epivir 150 mg tabletas. Se realizó un estudio analítico, experimental y de corte transversal, se usó un método espectrofotométrico a una longitud de onda de máxima absorción (λ) correspondiente a 270 nm, para medir el porcentaje de fármaco disuelto. El estudio evaluó identificación, contenido, disolución y uniformidad de masas. Se usó el aparato 2 USP (Paleta) 75 rpm, 900 mL de medio de disolución (37 ± 0,5 °C) a en tres medios de disolución: pH 1,2; 4,5 y 6,8. Se retiraron muestras de 5 mL a los 5, 10, 15, 20 y 30 min. Se encontró que ambos lotes de lamivudina genérico (A y B) presentan el mismo perfil cinético de disolución que el medicamento innovador. Ambas formulaciones cumplen con el criterio de medicamentos de disolución muy rápida (85% disuelto en 15 min), y de disolución rápida (85% disuelto en 30 min). Por lo tanto, no fue necesario calcular el factor de similitud. Se concluye que los medicamentos genéricos A y B son equivalentes in vitro con el medicamento innovador Epivir.

ABSTRACT Lamivudine is one of the most prescribed drugs in the world, and is used to treat human immunodeficiency and hepatitis B. This study aimed to evaluate the quality attributes and compare the dissolution profiles of two batches (A and B) of generic lamivudine 150 mg tablets with the innovator drug Epivir 150 mg tablets. We conducted an analytical, experimental, cross-sectional study, and used a spectrophotometric method at a wavelength of maximum absorption (λ) corresponding to 270 nm, to measure the percentage of dissolved drug. The study evaluated identification, content, dissolution and mass uniformity. Apparatus 2 USP (Paddle) 75 rpm, 900 mL of dissolution medium (37 ± 0.5 °C) was used in three dissolution media: pH 1.2; 4.5 and 6.8. Samples of 5 mL were obtained at 5, 10, 15, 20 and 30 min. Both batches of generic lamivudine (A and B) were found to have the same dissolution kinetic profile as the innovator drug. Both formulations met the criteria of very fast dissolving (85% dissolved in 15 min), and fast dissolving (85% dissolved in 30 min) drugs. Therefore, it was not necessary to calculate the similarity factor. We concluded that generic drugs A and B are in vitro equivalents to the innovator drug Epivir.

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.

The Effect of Pharmacists’ Explanation on Young Patients Switching to Generic Drugs Usage / 医薬品情報学

Objective: To keep medical costs down, it is important to promote the use of generic drugs at pharmacies, where prescription volumes are high. However, many parents do not opt for generic drugs. This study examines the effectiveness of pharmacists’ explanations to parents, with the aim of promoting the use of generic drugs among young patients under the age of 20.Method: A questionnaire-based survey was conducted from November 25 to December 1, 2019, at 129 pharmacies.Results: During the survey period, 91 pharmacies received 4,491 prescriptions from young patients. The percentage of generic drugs dispensed per prescription was lower for the young patients than for adult patients (65.4% vs. 70.4%; p < 0.001). Statistically, the percentage of prescriptions dispensed using generic drugs was higher in pharmacies that explained costs, equivalence of quality and efficacy, safety, side effects, and the trial system (divided dispensing), compared to pharmacies that did not use these explanations. Conversely, the percentage of prescriptions dispensed using generic drugs was lower at pharmacies that explained dosage form and ease of swallowing. Many pharmacies explained the equivalence of quality and efficacy (85.7%), with many questions from parents (82.4%). However, only a few pharmacies explained the trial system (divided dispensing) (1.1%), with no questions raised by parents (0.0%).Conclusion: This study found that pharmacists’ explanations are effective in promoting the use generic drugs for young patients. However, there is a lack of awareness among parents about the trial system (divided dispensing), and public institutions and pharmacists are not responding appropriately. To promote generic drug usage among young patients, it is important to develop educational tools regarding the trial system (divided dispensing), create awareness campaigns for parents, and revise medical fee. Furthermore, to ensure safe drug therapy, pharmacists should also provide information on the appearance and taste of generic drugs.

Influence of Parent’s Sex, Patient’s Age, and Use of Children’s Medical Expense Subsidy System on Young Patients Being Switched to Generic Drug Use / 社会薬学

Objective: The proportion of young patients in Japan in whom generic drugs are used is lower than that of other age groups. To promote the use of generic drugs in young patients, we need to change the parents’ attitude toward generic drugs. Therefore, we aimed to contribute to the maintenance and reform of the Japanese social security system by investigating the effects of parent’s sex, patient’s age, and use of the children’s medical expense subsidy system on the selection of generic drugs. Method: We surveyed parents of young patients (<20 years) whose prescriptions were filed at pharmacies from November 25 to December 1, 2019. Results: Of the 712 valid questionnaires retrieved, 74.3% of parents reported using generic drugs for young patients. Approximately 92.2% of the parents reported using the children’s medical expense subsidy system. The highest (51.4%) reason for switching to generics was “recommendation from a pharmacist, etc.” Cognitive methods using online content were higher among male parents than among female parents (28.0% vs. 11.5% ; P<0.001). Regarding catchphrases that make them want to hear, female parents were more likely to hear about generic drugs than male parents were if the catchphrases quality and safety were used (38.1% vs. 23.8% ; P＝0.007). Compared to parents of 7-19-year old children (6.8%), parents of 0-6-year old children (13.1%) reportedly switched to generic drugs because they were easier to ingest (P＝0.022). Conclusion: Recommendations from medical professionals such as pharmacists are effective in convincing parents of young patients to switch to generic drug use. To promote the use of generic drugs in young patients, in addition to explaining and publicizing its financial benefits, pharmacists need to explain the added value of generic drugs such as the ingenuity of its dosage form. In addition, it is essential to adopt a multifaceted approach that considers the parents’ background including (1) publicity using the internet for male parents, (2) reaching out to female parents with preschool children, (3) increasing publicity using tickets for children’s medical expenses subsidy system, and (4) drug education that matches the growth of children.

The Implementation Effect and Optimization of the Policy of Encouraging Generic Drug Catalogue in China / 中国卫生经济

Objective:To explore the implementation effect and problems of the policy of encouraging generic drug list in China,in order to further improve the policy of generic drug list.Methods:The selection principle of encouraging generic drug list in China,the characteristics and implementation status of included drugs,and the existing problems are analyzed.Results:The therapeutic fields of drugs included in the two batches of catalogs are relatively concentrated in the nervous system,respiratory system,tumor,en-docrine and metabolic diseases and infectious diseases.Among the 50 drugs,there are 24 new applications for generic drugs,2 drugs are included in the priority review,19are approved for listing,and 20 are included in the medical insurance catalog.At present,there are still problems in the development of the two batches of catalogs,such as the ineffective implementation of the second batch of cata-log policies,the phenomenon of"polarization"in the research and development of some generic drugs,the lack of priority review sys-tem,and the coordination and linkage between departments to be strengthened.Conclusion:It is necessary to improve the system de-sign,strengthen the selection management of reference preparations,improve the supporting incentive measures,mobilize the enthusi-asm of enterprises in research and development,dynamically adjust the generic drug catalog,and strengthen the coordination and link-age of departments.

Experience and enlightenment of generic drug substitution promotion policy in drug use in typical foreign countries / 中国卫生政策研究

Objective:From the link of drug use to improve China's generic drug substitution promotion policy to provide suggestions.Methods:Literature research method was used to explore the ideas and typical measures of promoting generic drug substitution in Europe,the United States,Japan and other countries.Combined with the existing problems in the process of generic drug substitution in China,specific suggestions were put forward to improve the promotion policy of generic drug substitution in the process of drug use in China.Results and conclusions:Through the experience research of Europe,the United States,Japan and other countries,it is found that typical countries outside the region have formed the idea of"accepting generic drugs-scientific and reasonable substitution-continuous feedback and improvement"in the process of promoting generic drug substitution.It is suggested that China incorporate the opinions of doctors and patients into the generic drug substitution decision-making,establish generic drug substitution rules based on risk,strengthen the real-world data research and monitoring and evaluation of generic drug substitution,strengthen the disclosure of generic drug information and policy publicity,further improve the promotion policy of generic drug substitution in the drug use process in China,and promote the alternative use of generic drugs.

Determination of related substances of zolmitriptan tablets by HPLC and study of quality evaluation / 中国药师

Objective To evaluate the quality of zolmitriptan tablets,establish an HPLC method for the determination of related substances in zolmitriptan tablets,improve the quality standard,and provide technical support for drug regulation.Methods The Superlco Ascentis Express90 Phenol Hexy chromatography column(10 cm×3.0 mm,2.7 μm)was recommended.The mobile phase was phosphate buffer containing sodium hexanesulfonate(pH 2.0)-acetonitrile,with gradient elution.The detection wavelength was 220 nm,the flow rate was 0.8 mL·min-1,the column temperature was 40℃,and the injection amount is 10 μL.The method was used to test 40 batches of zolmitriptan tablet samples and substance taken from all over the country.Results Zomitriptan had a goog linear relationship in the range of 0.840-1.260 μg·mL-1(r=0.999 9),and its detection limit was 1 ng.The detection limits for impurities 1-5 were 0.11,0.52,10.91,1.04 and 2.18 ng,respectively.Conclusion The method is specific,and was used to evaluate the quality of commercially available zolmitriptan tablets.The critical control points and the effect of coating technology on the quality of zolmitriptan tablets were found,and it is suggested that the storage condition of the product should be defined as"cool and dark place".

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.

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.

General considerations for bioequivalence studies with pharmacokinetic methods for anti-schizophrenic drugs / 中国临床药理学与治疗学

On account of the characteristics of anti-schizophrenic drugs, combined with the technical guidelines for bioequivalence studies of anti-schizophrenic generic drugs in different regulatory institutions at home and abroad, taking some drugs as examples, this paper discusses the key points to be considered in carrying out bioequivalence studies from the perspective of experimental design, so as to provide certain reference for the research and development and evaluation of related products.

Intercambiabilidad de medicamentos en el Perú: panorama actual y perspectivas futuras / Interchangeability of drugs in Peru: current outlook and future perspectives

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.

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.

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.