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This paper analyzes the laws, regulations and concre measures of Traditional Chinese Medicine (TCM) in Canada, so as to provide reference for TCM products to enter Canada, and for the establishment of TCM regulation system and the improvement of its detailed rules in China. The regulation of TCM in Canadian, on the one hand, supervision is to provide guidance for the protection of consumers' rights and interests, including the guidance of rational drug use and rational purchase for consumers; on the other hand, it is to supervise enterprises, including the safety, effectiveness and quality certification of TCM products, labeling and packaging requirements, as well as the site certification of product manufacturing, packaging, labeling and import. The Ministry of health of Canada takes evidence as the core of evaluation, and ensures the safe and effective use of TCM products in Canada through product and site licensing evaluation. In the supervision of TCM, relevant departments in China should further strengthen the protection of consumers' drug rights and interests, strengthen the construction of TCM registration evidence system, and pay attention to the risk management of drug production quality.
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OBJECTIVE：To provide reference for further improving the national drug quality disclosure system. METHODS ： The national drug quality disclosure system was analyzed in respects of general information ，implementation procedure ， implementation situation and effects ，and existing problems. The improvement suggestions were put forward. RESULTS & CONCLUSIONS：The national drug quality disclosure system had gone through the bulletin stage ，notice stage and announcement stage. At present ，it had become drug regulatory measure with timely release ，rigorous procedures and sanctions. The process of national drug quality disclosure included five steps ，ie. informing the sampling enterprises of the fact that the drugs were unqualified，controlling the risk of unqualified drugs ，providing legal relief to the notified units ，preparing the contents of the national drug quality notice ，and releasing the national drug quality notice to the public. In recent years ，National Medical Products Administration had made greater efforts to release the national drug quality notice. The release of the national drug quality notice has played an important role on forcing drug manufacturers to improve drug quality and enhance the credibility of drug regulatory departments. However ，there are also some problems ，such as the non-conforming report is not delivered in time ，the tracing time for suspected counterfeit TCM pieces is too long ，and the provincial drug regulatory bureau does not strictly control the first trial of complaints. It is suggested that National Medical Products Administration strengthen the training ，review and punishment of provincial drug regulatory departments ；at the same time ，provincial drug regulatory departments also need to strengthen responsibility and business capacity-building ，pay attention to relevant work and strengthen daily supervision.
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OBJECTIVE：To provide reference for improving the operation efficiency of drug quality sampling and inspection in China . METHODS ：Starting from the application and management situation of inspection standards/methods in provincial inspection institutions ，the problems existing in the application and management of inspection standards/methods in provincial inspection institutions were analyzed ；the inspection standards/methods database of provincial inspection institutions is attempted to build，combining with the relevant experience and practices of FDA. RESULTS & CONCLUSIONS ：The inspection methods involved in drug sampling and inspection could be divided into official standards and non-standard methods. Official standards were the main standards for drug sampling and inspection ，and were mainly used for routine inspection. Such kind of standards could be classified according to the characteristics of compiled ，single-page and later-issued supplementary ；an electronic catalogue should be established for unified management. Non-standard methods were only used for sample preliminary screening ，verification of official inspection results ，quality evaluation and inspection of unknown or suspicious samples in emergency inspection. Its tracking，collection and management mechanisms were not yet complete. It is recommended to draw on the experience of drug sampling and inspection in the United States so as to establish method database hierarchically. For the mature method established in drug supervision system ，an electronic catalog and document content database should be established and the method should be confirmed before use ；for national standards and the recommended methods published by authoritative institutions in other industries，and mature methods published in scientific and technological literature ，the retrieval channels should be listed ，the methods should be verified ，reviewed and approved before use ，and an electronic catalogue should be established and recorded in time after use. The electronic catalogue format of non-standard methods generally include controlled number ，applicable variety name，method name ，inspection items ，etc.
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OBJECTIVE：To provide re ference for the relevant personnel of drug quality sampling and testing to understand and implement the new requirements in the Management of Drug Quality Sampling and Testing . METHODS ：The test and retest requirements were compared between the Management of Drug Quality Sampling and Testing and the Regulation of Drug Quality Sampling and Testing. The revised and newly added contents were analyzed ，and the recommendations for implementation were put forward. RESULTS & CONCLUSIONS ：Referring to drug regulation need ，related requirements of test and retest in the Management of Drug Quality Sampling and Testing were modified and supplemented on the basis of the Regulation of Drug Quality Sampling and Testing . In the requirements for test ，the requirements for test items were revised ，the requirements for test time limit were confirmed ，the requirements for test report ，original record and quality management system ，the definition of “serious risk ” and its reporting requirements were added newly. The requirements for exploratory research were put forward for test institutions， as well as new requirements for test institutions and inspectors ’behaviors. In the requirements for retest ，the materials to be submitted for retest were revised ，and the identity certificate of the manager and time limit certificate were added ；the situation of no-retest were revised ，and the treatment method were added when obviously visible foreign matters were detected ；transfer requirements for retest report were added newly. It is suggested that the relevant personnel should pay more attention to the above changes，strengthen the construction of test capacity a nd the management of tes t time and quality ，attach importance to serious quality risks ，actively carry out exploratory research ，and mind their own test behaviors ；strictly review retest materials ， pay attention to the newly revised no-test and comprehensively transfer the retest report according to the requir ements and actual situation ，conduct and implement the Management of Drug Quality Sampling and Testing actively.
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OBJECTIVE: To analyze the main measures of the drug quality and safety risks management in the national drug sampling and testing, and provide reference for improving the drug sampling and testing after listing. METHODS: Using retrospective research methods to analyze the effects of the deadline management, special item (special topic) sampling and testing, serious quality risk disposal mechanism, nonserious quality risk warning mechanism, information disclosure on drug quality and safety risk management during the national drug sampling and testing in 2014-2019. RESULTS: A series of measures improved a timely, efficient and complete closed-loop response chain of risk identification-disposal-disclosure. CONCLUSION: The main measures can help reduce public drug safety risks and have good demonstration and guiding significance for local drug sampling and testing. It is recommended to continuously improve the risk management mechanism, such as learning from the US and EU drug regulatory experience, strengthening the sampling and testing of vaccines, imported drugs and consistency evaluated drugs, and personalized designing test and research strategies.
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Two dimensional liquid chromatography (2D-LC) has become an important way to achieve the separation of complex samples due to higher peak capacity, higher selectivity and better separation ability compared with one-dimensional liquid chromatography(1D-LC). 2D-LC has been developing rapidly in many fields, such as medicine, food, metabolites in vivo or in vitro and so on. This review illustrates various separation modes of 2D-LC and its applications and developments, with emphases on the research of quality control of drugs.
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Introduction: We came across patients inquiring with oncologists about cheap copy medicines. These were of recently licensedinnovator drugs that should have been available from original company holding their patents. In fact these copy medicines weremanufactured in our neighboring countries and made available in India. We investigated further and this manuscript puts together thestartling information that we were able to find regarding the thriving grey market for fake generic medicines.
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OBJECTIVE:To provide reference and basis for strengthening the drug quality supervision of medical institutions.METHODS:The problems about the drug quality supervision of the medical institutions were analyzed from the angle of legislation.Countermeasures for strengthening drug quality supervision of medical institutions in China as well as legislative suggestions on improving drug quality supervision of medical institutions in China were put forward.RESULTS & CONCLUSIONS:At present,the existing problems about drug quality supervision in medical institutions include that pharmacy setting lack mandatory standards;routine drug quality supervision is mainly the formal regulation;the punishment of drug related illegal behavior in medical institutions is too light,etc.To strengthen drug quality supervision of medical institutions in China,it is suggested that the government should establish the mandatory standards for medical institution pharmacy setting,add administrative inspections,and formulate Good Using Practice applicable to the whole country.When perfecting the law of drug quality supervision in medical institutions in China,relevant provisions may be added in The Drug Administration Law of the PRC,Regulations for the Implementation of Drug Administration Law,and the subordinate laws and regulations of Management Regulation of Medical Institutions so as to strengthen drug quality supervision of medical institutions.
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OBJECTIVE:To control the drug quality risk in drug withdrawal links of hospital pharmacy,and provide reference for the application of quality risk management(QRM)in hospital pharmacy. METHODS:Drug QRM was developed in drug with-drawal links through risk identification,risk assessment,risk control,risk assessment and other steps. Using the incidence of risk factors and reusable rate of withdrawal drug as indexes,related data of before(Jul.-Dec. 2015)and after(Jan.-Jun. 2016)devel-oping QRM in our hospital were compared to evaluate the effect of drug QRM. RESULTS:Determining whether specific storage drugs kept the required storage conditions,whether the numbers of withdrawal drugs counted to minimal packaging and other 5 fac-tors were high-risk factors(the risk score of each factor>4 points);control measures were taken separately for high risk factors, then high-risk factors were reduced to acceptable levels(risk score<4 points). After developing QRM,the incidence of risk factors were reduced than before(reduce 1.35%-6.19%),reusable rate of withdrawal drug was increased(98.64% vs. 86.32%)(all P<0.05). CONCLUSIONS:Developing QRM in drug withdrawal links of hospital pharmacy can reduce the drug quality risk.
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Objective:To understand the medication safety events about cephalosporin in our hospital in order to provide evidence for the better medication safety of cephalosporin. Methods:Adverse drug reaction ( ADR) reports, medication error ( ME) reports and drug quality problem records about cephalosporin in our hospital were collected and the critical indicators in the reports were analyzed. Re-sults:The ADR reports selected in our hospital were mainly reported by pharmacists. More males were involved in the related patients, and young adults were in the majority. Second and third-generation cephalosporin were the major drugs used in the reports. The damages in skin and its appendages were the major damages in organs. The ME reports selected in our hospital were totally reported by pharma-cists. Errors in frequency and dose of drug administration were the most common, and the main causes were lack of knowledge and train-ing. No serious quality problem in cephalosporin was found in our hospital, and the inner and outer packaging in damaged conditions was the most common problems in our records. Conclusion:Cephalosporin as one widely used antibacterial agent is considered safe and effec-tive. Because of its large amount of application, cephalosporin should be paid more attention by health care professionals. MEs should be avoided as far as possible. ADRs should be treated timely and properly in order to decrease medical disputes. More attention should be paid to ensure security of drug use for patients.
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OBJECTIVE: To summarize and analyze the internal quality control methods and judgment cretiria used by drug quality control laboratories. METHODS: The detailed methods of using five kinds of quality control methods, ie, quality control chart, personnel comparison, equipment comparison, recovery test, and retest the retained sample were described. The experience in judgment cretiria for quality control was summarized. RESULTS AND CONCLUSION: To meet the demands of quality management in drug control laboratories, the above-mentioned five kinds of internal quality control methods need to be adopted flexibly, and cover all the related test fields.
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OBJECTIVE: To improve the method of national drug sampling and testing system, Enhance the work efficiency of national drug sampling and testing, improve early warning ability of drug quality risk. METHODS: By using relevant data of national drug sampling and testing in the past 3 years, to analysis the tredency of drug quality situation. Through summarizing the effect of national drug sampling and testing work, put forward suggestions and countermeasures. RESULTS AND CONCLUSION: Strengthening efforts on sampling and testing, improving the efficiency by using varied and flexible sampling form, enhancing the application effects of sampling and testing through multi forms and channels, further perfect drug quality announcement releasing mechanism, enriching the form and content of drug quality announcement, increasing the interpretation and analysis of sampling data, in order to enhance the effective cohesion between the sampling and testing work and supervision management.
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Objective:To improve the work of drug quality sampling and testing. Methods:The regulation of testing related work in Drug Quality Sampling and Testing Regulation was analyzed and discussed. Results and Conclusion: Some suggestions were pro-vided in order to improve the regulation of testing work in Drug Quality Sampling and Testing Regulation.
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OBJECTIVE:To compare and analyze the ADR in Chinese Pharmacopoeia(2010 edition)(ChPD)and non-phar-macopoeia quality standard drugs(NChPD)and its standard. METHODS:In respective study,ADR reports and drug utilization da-ta in our hospital from 2012 to 2014 were collected and divided into ChPD group and NChPD group,the index differences were an-alyzed. RESULTS:The percentages of reported ADR to product regulation [(0.27 ± 0.10)%] and to drug use frequency [(0.15 ± 0.06)%] in ChPD group were significantly lower than NChPD group [(0.62 ± 0.08)%、(0.32 ± 0.07)%],with statistical signifi-cance (P0.05);the percentage of new severe reported ADR to drug use frequency in ChPD group [(0.04 ± 0.01)%] was significantly lower than NChPD group [(0.27 ± 0.05)%],with statistical significance (P0.05). CONCLU-SIONS:Drug quality standards should be payed more attention,from the perspective of which to reduce the incidence of adverse drug reactions. While the drugs introduced to hospital should be strictly controlled and timely adjust the drug structure;the pharma-copoeia standard drugs should be generalized among doctors to reduce ChPD drug reactions and ensure the drug safety.
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Globally, the expanding issues over the extent of substandard or spurious medicines remain a challenge. It is operated largely by encompassing wrong therapeutic doses or adulterated formulations that necessitates routine monitoring to avoid any potential public health adversity. This study was aimed to determine the diclofenac sodium content in generic products available in northern Indian market. Therefore, 32 commercially available generic products of diclofenac sodium tablet were procured from the open market and subjected to assay evaluation using in-house developed and validated high performance liquid chromatography (HPLC) method. Product identification was confirmed by thin layer chromatography (TLC) method; and the quantitative results by validated in-house HPLC method showed 34.37% (11/32) products as out of Indian Pharmacopoeia specification including 15.62% (5/32) substandard products. This makes the health situation miserable for public and their trust. On comparing the assay with price of each tablet, it was noticed that quality of products was irrespective of price. People rely completely on manufacturer quality promises and on regulatory process. However, such substandard products which still exist in the market for use by the patient; unfortunately not identified yet, poses a serious issue and require some interventions to stop them in entering into market. So there is an urgent need to carry out the quality evaluation on regular and large scale by the state and national drug authorities to ensure better quality medicines.
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El Departamento de Vacunas y Biológicos de la OMS ha desarrollado una herramienta de evaluación para identificar el estado de las funciones básicas en las autoridades reguladoras y tanto la OMS como la OPS, proponen lineamientos para el entrenamiento de las autoridades reguladoras de medicamentos. La función relacionada con la autorización de ensayos clínicos ha sido desarrollada en Cuba y existe la experiencia y calificación pertinente para esta actividad. El propósito es desarrollar entrenamientos para que las autoridades de países en desarrollo, puedan implementar con éxito su función básica en la autorización de ensayos clínicos con vacunas. Se tomaron como fuentes bibliográficas, las referencias de la OMS, la Conferencia Internacional de Armonización, Unión Europea, Consejo de la Organización Internacional de Ciencias Médicas, la Administración de Drogas y Alimentos de los Estados Unidos y otros documentos reguladores de interés. Se describen los cinco indicadores que evalúan el contenido y función de las autoridades reguladoras de medicamentos, sus características y aspectos relevantes a tener en consideración en cada uno de ellos, se brinda un resumen sobre los aspectos esenciales de los estudios clínicos en vacunas según la guía de la OMS así como la experiencia de la autoridad reguladora cubana en la autorización de ensayos clínicos en vacunas y se hace referencia a las modificaciones que actualizan estos indicadores. En resumen la Autoridad Reguladora de Medicamentos es la encargada de garantizar que los medicamentos y en particular las vacunas que se administran a los seres humanos cumplan con la calidad, seguridad y eficacia, conforme los estándares y requerimientos reguladores vigentes de cada país
The Department of Vaccines and Biologics in the World Health Organization has developed an evaluation tool to identify the condition of the regulatory functions and the training of drug regulatory authorities to comply with their functions. This article was intended to provide the drug regulatory agencies from the non-developed countries with the necessary training, so that they can successfully perform their basic function in giving authorization to clinical trials with vaccines. Literature from WHO, the International Conference of Harmonization, the European Union, the Council of the International Organization of Medical Sciences, the US Food and Drug Administration and other regulatory documents of interest was reviewed. Data related to those indicators evaluating the performance of the drug regulatory authorities in giving permission for clinical trials with vaccines were collected and the five indicators assessing the contents and function of these authorities, their characteristics and relevant aspects were described. Furthermore, a summary of the essential aspects of the clinical trials with vaccines according to the WHO guideline as well as the experience of the Cuban regulatory authority in authorizing the conduction of these clinical trials was provided. The Drug Regulatory Authority is the responsible for assuring that vaccines for human beings meet the regulatory requirements of the country in the first place, and then for the research, commercialization or introduction of the vaccine in the National Immunization Program
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Functioning Authorization , Quality of Homeopathic Remedies , Randomized Controlled Trials as Topic , VaccinesABSTRACT
OBJETIVO: Validar metodologia por cromatografia líquida de alta eficiência para determinação do teor de sinvastatina em cápsulas manipuladas. MÉTODOS: Foram avaliadas 18 amostras de cápsulas de sinvastatina 40 mg de farmácias magistrais de São Paulo, Guarulhos, São Bernardo do Campo e Campinas, SP, prescritas para pacientes fictícios. As análises basearam-se na Farmacopéia Brasileira e no método da cromatografia, otimizado e validado de acordo com as normas nacionais e internacionais, para os ensaios de identificação, e quantificação em cápsulas manipuladas. RESULTADOS: O peso médio das cápsulas variou de 70 mg a 316 mg; quatro amostras apresentaram variação de peso em desacordo com a especificação. O teor de sinvastatina nas cápsulas estava de acordo com a especificação em 11 amostras; em seis, esse teor variou entre 4 por cento e 87 por cento do valor declarado, descumprindo os requisitos de teor do princípio ativo; a determinação do teor e uniformidade de conteúdo de uma amostra não foram realizadas. No teste de uniformidade de conteúdo, 15 amostras apresentaram valores menores que 85 por cento e com os desvios-padrões relativos maiores que 6 por cento; três farmácias atendiam a especificação desse ensaio. No ensaio de dissolução, oito amostras apresentaram resultados insatisfatórios no primeiro estágio do ensaio e as demais apresentaram resultados inconclusivos. CONCLUSÕES: O método utilizado mostrou boa adequação para aplicação em controle de qualidade, revelando a falta de qualidade de cápsulas de sinvastatina produzidas por algumas farmácias de manipulação.
OBJETIVO: Validar metodología por cromatografía líquida de alta eficiencia para determinación del tenor de sinvastatina en cápsulas manipuladas. MÉTODOS: Fueron evaluadas 18 muestras de cápsulas de sinvastatina 40 mg de farmacias magistrales de Sao Paulo, Guarulhos, Sao Bernardo do Campo y Campinas, Sureste de Brasil, prescriptas para pacientes ficticios. Los análisis se basaron en la Farmacopéia Brasileña y en el método de la cromatografia, optimizado y validado de acuerdo con las normas nacionales e internacionales, para los ensayos de identificación, y cuantificación en cápsulas manipuladas. RESULTADOS: El peso promedio de las cápsulas variaron de 70 a 316 mg; cuatro muestras presentaron variación de peso en desacuerdo con la especificación. El tenor de sinvastatina en las cápsulas estaba de acuerdo con la especificación en 11 muestras; en seis, ese tenor varió entre 4% y 87% del valor declarado incumpliendo los requisitos de tenor del principio activo; la determinación del tenor y uniformidad de contenido de una muestra no fue realizada. En la prueba de uniformidad de contenido, 15 muestras presentaron valores menores que 85% y con los desvíos-patrones relativos mayores que 6%; tres farmacias atendían la especificación del ensayo. En el ensayo de disolución, ocho muestras presentaron resultados insatisfactorios en la primera fase del ensayo, y las demás presentaron resultados inconclusitos. CONCLUSIONES: El método utilizado mostró buena adecuación para aplicación en control de calidad, revelando la falta de calidad de cápsulas de sinvastatina producidas por algunas farmacias de manipulación.
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Drug Compounding , Capsules/chemistry , Quality of Homeopathic Remedies , Chemistry, Pharmaceutical , Simvastatin/standardsABSTRACT
Objetivo - A vacinação tem como finalidade reduzir a morbimortalidade causada pelas doenças previníveis através da imunização. Para manutenção da qualidade da vacina é necessário uma cadeia de frios eficiente, que compreende o armazenamento, conservação, distribuição, transporte, e manipulação dos imunobiológicos.Verificar os equipamentos de conservação e armazenamento das vacinas (geladeira de estoque, uso diário e caixas térmicas) nas Unidades Básicas de Saúde (UBSs) do Distrito Sul de Campinas. Métodos - Pesquisa realizada através de visitas em17 UBSs para a inspeção dos equipamentos utilizados na conservação e armazenamento dos imunobiológicos, utilizando o roteiro de inspeção(Programa de Avaliação do Instrumento de Supervisão. Sala de Vacinação - PAISSV). Resultados - Observou-se se que 47% das UBSs apresentavam uma boa avaliação na qualidade de armazenamento e conservação dos imunobiológicos e 53% obtiveram um conceito de regular. Observaram-se não conformidades dos equipamentos disponíveis nas UBSs, sendo que em 21% desses não apresentavam bom estado de conservação e 7,67% não apresentava ideal estado de funcionamento. Em uma das unidades não havia refrigerador de estoque e em seis não se utilizava o refrigerador de uso diário. Conclusão - Evidenciou-se neste trabalho que em muitas situações o conhecimento teórico quase sempre se apresentava vasto e enriquecido, porém muitas vezes não se aplicava à prática cotidiana. É necessário o caminhar conjunto, tanto do avanço tecnológico e do conhecimento cientifico, ambos devem ser sustentados pelos recursos governamentais e mantidos pelos profissionais da saúde.
Objective - Vaccination aims to reduce morbidity and mortality caused by diseases preventable through immunization. To maintain the quality of the vaccine requires a cold chain efficient, which includes the storage, conservation, distribution, transportation, and handling of biopharmaceuticals. To determine the equipment maintenance and storage of vaccines (refrigerator inventory, daily use and coolers) in the Basic Health Units the Southern District of Campinas. Methods - A survey conducted by primary care units in 17 visits to inspect equipment used for the preservation and storage of biological, using the script for inspection (Evaluation Program Monitoring Tool. Room Vaccine) - PAISSV. Results - It was observed that 47% of primary care units had a good rating as storage and conservation of biological and 53% hada concept of regular. Observed non-compliance of the equipment available in primary care units, and in 21% of these did not have good state of repair and 7.67% had no ideal state of operation. In one of the units did not stock cooler and six was not used the fridge every day. Conclusion - There was this work that in many situations the theoretical knowledge is almost always presented broad and enriched, but oftendid not apply to daily practice. You need to walk together, both the technological and scientific knowledge, both must be supported by government funds and maintained by health professionals.
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Objetivo: Determinar la cantidad de medicamentos falsificados detectados en el Centro Nacional de Control de Calidad (CNCC) (Instituto Nacional de Salud, Perú) en el periodo 2005-2008 y determinar sus tipos y características. Métodos: Se preparó una ficha para la recolección de los datos pertinentes, los cuales fueron tomados directamente de los informes emitidos por el CNCC. Estos informes fueron sometidos a un proceso de revisión y evaluación, y aquellos en los que se confirmó la falsificación fueron clasificados en cuatro grupos, según el tipo de falsificación. Resultados: El porcentaje de medicamentos falsificados con relación al total de medicamentos analizados fue de 3,0 por ciento en 2005, 5,0 por ciento en 2006, 7,3 por ciento en 2007 y 9,2 por ciento en 2008. Los principales grupos de medicamentos falsificados según la clasificación ATC de la OMS fueron: tracto alimentario y metabolismo, 34,5 por ciento (29,1 por ciento-39,8 por ciento); antiinfecciosos para uso sistémico, 21,1 por ciento (16,5 por ciento-25,7 por ciento); sistema nervioso, 17,1 por ciento (12,8 por ciento-21,3 por ciento); y sistema musculoesquelético, 15,4 por ciento (11,3 por ciento-19,5 por ciento). Los tipos de falsificación predominantes fueron aquellos donde el medicamento contenía la dosis correcta del principio activo pero el fabricante era distinto al declarado (62,4 por ciento, sobre el total de medicamentos falsificados), y aquellos donde el medicamento no contenía ningún principio activo (22,4 por ciento). El 61,0 por ciento (56,0 por ciento-67,0 por ciento) de los medicamentos falsificados fueron nacionales y 39,0 por ciento (33,0 por ciento-44,0 por ciento), importados. Las formas farmacéuti-cas con mayores tasas de falsificación incluyeron comprimidos, 66,0 por ciento (60,0 por ciento-71,0 por ciento), inyectables, 19,0 por ciento (14,0 por ciento-23,0 por ciento) y cápsulas, 7,0 por ciento (4,0 por ciento-10,0 por ciento)...
Objective: To determine the quantity of counterfeit pharmaceutical drugs found by the National Quality Control Center (Centro Nacional de Control de Calidad (CNCC), Instituto Nacional de Salud, Peru) during the period from 2005&2008, and the types and properties of these drugs. Methods: A form was created to amass the relevant data collected directly from CNCC reports. The reports underwent a review and analysis process, and where counterfeiting was confirmed, it was categorized by type into one of four groups. RESULTS: The percentage of counterfeit drugs relative to the total drugs evaluated was: 3.0 percent in 2005, 5.0 percent in 2006, 7.3 percent in 2007, and 9.2 percent in 2008. The main groups of counterfeit drugs, classified according to the World Health Organization Anatomical Therapeutic Chemical Classification System, were: alimentary tract and metabolism, 34.5 percent (29.1 percent&39.8 percent); antiinfectives for systemic use, 21.1 percent (16.5 percent&25.7 percent); nervous system, 17.1 percent (12.8 percent&21.3 percent); and musculo-skeletal system, 15.4 percent (11.3 percent&19.5 percent). The most common type of forgery occurred in cases where the drug contained the correct amount of active ingredients, but the manufacturer was one other than the one indicated (62.4 percent of the total counterfeit drugs); and medications that did not contain any active ingredient (22.4 percent). Of the counterfeit drugs, 61.0 percent (56.0 percent&67.0 percent) were national brands and 39.0 percent, (33.0 percent&44.0 percent) were imported. The pharmaceutical formulations with the highest rate of forgery were tablets, 66.0 percent (60.0 percent&71.0 percent); injectables, 19.0 percent (14.0 percent&23.0 percent); and capsules 7.0 percent (4.0 percent&10.0 percent). Conclusions: From 2005&2008, drug counterfeiting had an average annual variation of 45 percent. Drug counterfeiting was shown to be most prevalent among national brands...
Subject(s)
Fraud/statistics & numerical data , Pharmaceutical Preparations , PeruABSTRACT
A Política Nacional de Medicamentos tem como importante diretriz a qualidade dos medicamentos oferecidos à população. Objetivou-se definir prioridades para análise pelo Programa Nacional de Verificação da Qualidade de Medicamentos. Como critério, utilizou-se a presença do medicamento em, no mínimo, três Programas de Assistência Farmacêutica do Ministério da Saúde. Critérios adicionais foram a presença na Relação Nacional de Medicamentos Essenciais de 2002 (RENAME) e a indicação para as vinte principais causas de Anos de Vida Perdidos Ajustados por Incapacidade (DALY). Informações do Ministério da Saúde e legislação foram fontes da pesquisa. Classificaram-se os medicamentos segundo o Anatomical Therapeutic Chemical Classification System (ATC) da OMS. Nos 13 programas de assistência farmacêutica, existiam 893 produtos classificados em 449 diferentes códigos ATC. Foram considerados prioritários 28 fármacos, 26 constantes na RENAME e 12 indicados nas causas de DALY. Recomenda-se, à Agência Nacional de Vigilância Sanitária e à Secretaria de Ciência, Tecnologia e Insumos Estratégicos, estabelecer estratégia integrada para garantia de qualidade integral desses medicamentos, abrangendo qualidade laboratorial, registro, boas práticas de fabricação e informações para profissionais de saúde e população.
A key objective of the Brazilian National Drug Policy is the quality of medicines supplied to the population. This study aimed to set priorities for the analysis of the National Program for Quality Control of Medicines. The main criterion was the drug's presence in at least three Pharmaceutical Care Programs under the Ministry of Health. Additional criteria were presence on the National List of Essential Drugs (RENAME) in 2002 and its indication for the 20 main causes of disability-adjusted life years (DALY). The sources were data from the Ministry of Health and related legislation. The drugs were classified according to the Anatomical Therapeutic Chemical Classification System (ATC) of the WHO. The 13 pharmaceutical care programs included 893 products classified in 449 different ATC codes. Twenty-eight drugs were considered priorities, 26 of which were listed on the RENAME and 12 indicated as causes of DALY. It is recommended that the National Health Surveillance Agency and Secretariat of Science, Technology, and Strategic Inputs establish an integrated strategy to guarantee comprehensive quality of these drugs, including laboratory quality, registration, good manufacturing practices, and information for health professionals and the general population.