Study on French medical insurance payment policy for innovative medical products paid under DRG / 中国药房

OBJECTIVE To analyze the implementation experience of France’s additional list system for innovative medical products， and to provide reference for China to support medical institutions to use innovative medical products. METHODS Taking France as a case study， using policy analysis method， this paper systematically studied the practice of establishing additional list system to compensate for innovative medical products in France under diagnosis-related group （DRG） payment， including the establishment background， selection procedure and implementation effect. The suggestions were provided on the medical insurance payment methods for innovative medical products in China. RESULTS & CONCLUSIONS The additional list system established a compensation and payment system for innovative medical products with significant clinical efficacy but high treatment cost， covering four stages： application， evaluation， payment and adjustment， which effectively reduced the drug burden on medical institutions， promoted the use of innovative pharmaceutical products by medical institutions， and stimulated the innovation drive of the pharmaceutical industry， but at the same time brought payment pressure to the medical insurance fund. With the rapid spread of our DRG/diagnosis-intervention packet payment reform of China， some regions have also explored the establishment of a compensation and payment mechanism for innovative medical products， but there are still imperfections. We can refer to the implementation experience of the French additional list system and establish an effective compensation and payment system for innovative medical products starting from the establishment of selection criteria， the selection of compensation mode and the implementation of dynamic adjustment.

Post-marketing sampling and testing programs for licensed medicinal products: a narrative review

Abstract The globalization of the pharmaceutical market has enabled access to a considerable number of new medicinal products. Consequently, the circulation of substandard medicinal products has also increased. To minimize this problem, post-marketing quality sampling and testing programs are performed to monitor and confirm that the medicinal products available in the market meet appropriate quality requirements. In this review, the post-approval sampling and testing procedures of six regulatory authorities were compared with the goal of strengthening these market surveillance systems. Similarities were observed between the procedures adopted by different regulatory authorities. However, the agencies were not always transparent about the results of these monitoring procedures. A probable mismatch between the registration procedures and the quality requirements listed in official compendiums was observed, which resulted in dissonance and contradiction between the specifications approved by the regulatory authorities and those required in the pharmacopeias. Therefore, strengthening harmonization projects related to these activities can help minimize such difficulties.

A study to assess the knowledge and awareness regarding safe disposal of pharmaceutical wastes among 2nd year medical and para-medical students in a tertiary care teaching hospital in North India

Background: The use of pharmaceutical products in our day to day life is escalating and one cannot deny their presence in every household. Unfortunately not all the medicines that reach our homes get consumed. Unused, unwanted and expired drugs get accumulated over time and are generally disposed along with other household trash thus contributing to environmental pollution. This turns our attention towards the significance of eco-pharmacovigilance. Assessing the level of knowledge and awareness of students under training as health care professionals regarding safe disposal of pharmaceutical wastes can help us to partly assess the magnitude of the problem of inappropriate disposal methods and help us to plan and initiate steps to prevent the hazards caused by improper disposal of these items.Methods: A questionnaire based cross-sectional study was conducted among medical and paramedical students of a tertiary care teaching hospital using a pre-validated questionnaire from previous studies.Results: Majority of the participants were not aware of the possible hazards of improper disposal of pharmaceutical wastes. They expressed the need for awareness programs regarding the subject.Conclusions: The study revealed the practice of drug accumulation at home. The disposal methods opted by the participants were not the recommended methods. There is a need to address this issue through awareness programs at various levels.

Environmental pharmacology: an emerging science

With continuous rapid expansion of the human population there is escalating demand for resources, including human and veterinary pharmaceuticals. This has lead to rapid development of global pharmaceutical industry and with that increase in issues caused by pharmaceutical products. In recent years a great concern has been expressed over the occurrence and persistence of pharmaceutical products in the environment and their potential impact on environment. Owing to this the new branch of science called environmental pharmacology has sprouted. Environmental pharmacology deals with dispersion and impact of pharmaceutical products on environment. Solutions need to be suggested to save this only liveable planet from ill effects of these pharmaceutical products. This has given birth to the science of Ecopharmacovigilance (EPV).

Patentes e o direito à saúde: análise sobre as discussões de propriedade intelectual na Organização Mundial da Saúde, entre 2006 e 2016 / Patents and the right to health: an analysis of intellectual property discussions in the World Health Organization, between 2006 and 2016 / Patentes y el derecho a la salud: análisis sobre las discusiones de propiedad intelectual em la Organización Mundial de la Salud, entre 2006 y 2016

Objetivo ­ Analisar as discussões realizadas na OMS sobre propriedade intelectual e saúde pública, no período entre 2006 e 2016. Resultados ­ Houve destaque às funções sociais da propriedade intelectual, contudo, observado que países em desenvolvimento e menos desenvolvidos não são capazes de se beneficiar de uma maior proteção à propriedade intelectual, pelo que devem utilizar-se das flexibilidades presentes nas normas regulatórias, como o Acordo TRIPS e reafirmadas na Declaração de Doha. Considerações Finais ­ Observa-se que os debates sobre a propriedade intelectual, em especial acerca produtos farmacêuticos, vem cercada de controvérsias relacionadas ao acesso das populações aos medicamentos essenciais, à promoção da inovação e transferência de tecnologias dos países desenvolvidos aos países em desenvolvimento , Importa assinalar que no contexto brasileiro o reconhecimento de propriedade intelectual promoveu um aumento de custo dos produtos farmacêuticos, em virtude do monopólio, e torna-se um dos elementos de barreira ao acesso e à universalização do direito à saúde

Objective ­ To analyze the discussions held at WHO on intellectual property and public health, between 2006 and 2016. Results ­ The social functions of intellectual property were highlighted, however, observing that developing and less developed countries are not able to benefit from protection of intellectual property, so that the flexibilities in regulatory standards, such as the TRIPS Agreement and reaffirmed in the Doha Declaration, should be used. Final Considerations ­ Discussions on intellectual property, in particular on pharmaceuticals, are surrounded by controversies regarding the access of populations to essential medicines, the promotion of innovation and the transfer of technologies from developed to developing countries, It matters to point out that in the Brazilian context the recognition of intellectual property promoted an increase in the cost of pharmaceutical products, due to the monopoly, and becomes one of the barrier elements to the access and universalization of the right to health.

Objetivo ­ Analizar las discusiones realizadas en la OMS sobre propiedad intelectual y salud pública, en el período entre 2006 y 2016. Resultados ­ Hubo destaque a las funciones sociales de la propiedad intelectual, sin embargo, observó que los países en desarrollo y menos desarrollados no son capaces de beneficiarse una mayor protección a la propiedad intelectual, por lo que deben utilizarse las flexibilidades presentes en las normas regulatorias, como el Acuerdo ADPIC y reafirmadas en la Declaración de Doha. Consideraciones finales ­ Se observa que los debates sobre la propiedad intelectual, en particular sobre productos farmacéuticos, están rodeados de controversias relacionadas con el acceso de las poblaciones a los medicamentos esenciales, la promoción de la innovación y la transferencia de tecnologías de los países desarrollados a los países en desarrollo, señalar que en el contexto brasileño el reconocimiento de propiedad intelectual promovió un aumento de costo de los productos farmacéuticos, en virtud del monopolio, y se convierte en uno de los elementos de barrera al acceso ya la universalización del derecho a la salud.

A Better Form of “Education on the Proper Use of Pharmaceutical Products” and “Drug-Abuse Resistance Education” in Junior High School Students and the Perspective of Educators with Different Types of Jobs / 社会薬学

<p>In junior high school, educators with many different types of specialty jobs are involved in “education on the proper use of pharmaceutical products” and “drug-abuse resistance education”. Examples of these different jobs are physical education teachers, school nurses, school pharmacists. The aim of this study was to elucidate novel ideas and new directions in the future of medicine instructional education by clarifying the aims and thoughts of educators with different jobs on the education of pharmaceutical medicines and drug use. Based on the technique of Personal Attitude Construct (PAC) analysis, junior high school staff members involved in “education on the proper use of pharmaceutical products” and “drug-abuse resistance education” were interviewed regarding their aims and thoughts. Their responses were analyzed qualitatively. Five school pharmacists, five school nurses, and four physical education teachers were interviewed. The responses revealed that school pharmacists engaged in student education from the specialized perspective of pharmacology, school nurses engaged in student education from the perspective of imminent situations, and physical education teachers engaged in student education more from the perspective of student environment. This study suggested that “education on the proper use of pharmaceutical products” and “drug-abuse resistance education” should be a collaborative effort, so there were the different perspectives and aims of educators with different specialty jobs in the instruction of junior high school students on these subjects.</p>

Propuesta para la actualización de las normas de la Junta Revisora de productos farmacéuticos para fortalecer la vigilancia sanitaria de medicamentos / Proposal for updating the standard of the review board of pharmaceutical products for strengthening sanitary surveillance of medicines

Según el Artículo 3° de la Ley del Medicamento (2000), los medicamentos son toda sustancia y sus asociaciones o combinaciones, destinadas a prevenir, diagnosticar, aliviar o curar enfermedades en humanos y animales, a los fines de controlar o modificar sus estados fisiológicos o fisiopatológicos, Para que estos medicamentos puedan ser comercializados deben obtener antes el registro sanitario a través de la autoridad reguladora nacional, el Instituto Nacional de Higiene "Rafael Rangel"; que por medio del cumplimiento de una serie de requisitos reunidos en las Normas de la Junta Revisora de Productos Farmacéuticos y Sistema de Registro Nacional de Productos Farmacéuticos garantiza la seguridad, eficacia y calidad del medicamento y de esta manera pueda ser otorgado el registro sanitario. El objetivo de esta investigación es proponer una actualización de las Normas vigentes de Productos Farmacéuticos, elaboradas por la Junta Revisora, con la finalidad de mejorar la vigilancia sanitaria de los medicamentos en el país. La metodología de investigación a utilizar es de tipo documental. Para llevar a cabo este proyecto nos basaremos en la revisión de algunas de las Normas similares y actualizadas de autoridades reguladoras de otros países y organismos internacionales. En este trabajo se evidenció la necesidad de realizar cambios en las actuales normas de la JRPF y elaborar normas individuales. Además se presenta una versión actualizada de las normas de los textos de etiqueta, empaque y prospecto de productos farmacéuticos.

According to Article 3 of the Medicines Law (2000), medicines are all sustenance and their associations or combinations, are to prevent, diagnose, alleviate or cure diseases in animals and animals, in order to control or modify their physiological states OR Pathophysiological. In order for these medicines to be marketed they must obtain before the sanitary registration through the national regulatory authority, the National Institute of Hygiene Rafael Rangel; By means of the fulfillment of a series of requirements gathered in the Rules of the Revised Board of Pharmaceutical Products and National Registration System of Pharmaceutical Products guarantee of the safety, efficacy and quality of the medicine and this way can be the sanitary registry. The objective of this research is to propose an update of the Current Norms of Pharmaceutical Products, prepared by the Review Board, in order to improve health surveillance of medicines in the country. The research methodology to be used is documentary. To carry out this project we rely on the revision of some of the Norms and updates of regulatory authorities of other countries and international organisms. In this work the need to make changes in the current rules of the JRPF and to develop individual standards was evidenced. In addition, an updated version of the rules of the label, packaging and pharmaceutical package leaflets is presented.

Study on the Status of Proper Medicine Use and Information Provision in the Remote Islands of Nagasaki Prefecture / 医薬品情報学

<b>Objectives: </b>First steps to promote the proper use of medicines in remote islands and rural areas are as follows: (1) recognition of the profession of “pharmacist” from secondary-remote-island residents who do not have a pharmacy or drugstore or the opportunity for pharmacist contact and (2) an understanding by remote-island residents of the advantages of having a “family pharmacist.”<br><b>Methods: </b>Repeated “medicine information and consultation sessions” for secondary-remote-island residents of Japan’s Nagasaki Prefecture were held.  Residents were then surveyed for changes in awareness of or demand for pharmacists and the nature of such changes.<br><b>Results: </b>Before the information sessions, 29.7% of residents did not recognize the profession of pharmacy, but the extent of their recognition increased after information sessions were concluded.  They were asked “Who explains medicines in a way that is easy to understand ?”; more than half responded “doctors” before the information session, but after information sessions were concluded, those who said “pharmacists” increased.<br><b>Conclusion: </b>Conducting “medicine information and consultation sessions” for residents of secondary-remote islands and rural areas enabled them to understand the profession of pharmacy.  The initiatives in the present study are first steps toward promoting proper use of medicines by residents of remote islands and rural areas who use “family pharmacies/pharmacists.”

Review on Application of Nucleic Acid Amplification Techniques in Pharmaceutical Products Analysis.

The aim of this study was to describe application of molecular diagnostic tests based on nucleic acid amplification technologies (NAATs) in pharmaceutical product analysis. NAAT have become widely established in clinical microbiology laboratories in recent years, as well as in quality control (QC) laboratories for food testing, and lately introduced to the pharmaceutical QC laboratories. The number of available nucleic acid and gene amplification-based rapid microbiological methods has increased over the last few years, and for good reason. When compare to standard culture based methods, NAAT provide a rapid, an accurate and reliable means for detecting specific microorganisms of interest, especially in pharmaceutical dosage forms that are required to be free of objectionable or specified pharmacopeial organisms. This article discussed about the different types of nucleic acid amplification techniques and methods available to pharmaceutical microbiologists working on quality control of pharmaceutical products and develop some awareness among other pharmaceutical scientists. This review also highlights limitations of these methods applied in industrial setup.

Recovery of drug residues in equipment and utensils used by compounding pharmacies after standard cleaning procedure / Recuperação de resíduos de drogas em equipamentos e utensílios utilizados por farmácias de manipulação após o procedimento de limpeza padrão

Compounding pharmacies have been cited by some athletes as being responsible for compounding capsules contaminated with drugs banned by the International Olympic Committee (IOC). Therefore, the present study was carried out to quantify the amount of residue remaining in the equipment and utensils used for compounding capsules after standard cleaning procedures. For this purpose, captopril (CAP) and acetylsalicylic acid (ASA) were used since these are hard to clean, in addition to hydrochlorothiazide (HTZ) as a banned drug by the IOC. The amounts of residues found in the equipment were: 181.0 ± 91.8, 1208 ± 483.8 and 431.7 ± 71.3 ppm for ASA, CAP and HTZ, respectively. The continuous compounding of these drugs, followed each time by the standard cleaning procedure, showed a linear accumulation of residues for ASA (r²=0.96) and CAP (r²= 0.88). The residues quantified were greater than the FDA limit for impurities for CAP (>0.1%) but not for HTZ. However, the HTZ residue may be detected in the urine of athletes on IOC tests. Therefore, it was concluded that compounding pharmacies should therefore improve their cleaning procedures and test these in order to attain limits below 10 ppm, thereby avoiding the contamination of other products...

As farmácias de manipulação têm sido citadas por alguns atletas como sendo responsáveis pela manipulação de cápsulas contaminadas com fármacos proibidos pelo Comitê Olímpico Internacional (COI). Portanto, o presente estudo foi realizado para quantificar o montante de resíduo remanescente nos equipamentos e utensílios usados para manipular cápsulas após o procedimento padrão de limpeza. Para este propósito, o captopril (CAP) e o ácido acetilsalicílico (ASA) foram usados por serem fármacos de difícil remoção e a hidroclorotiazida (HTZ), por ser um fármaco proibido pelo COI. As quantidades de resíduos encontradas nos equipamentos após a limpeza foram 181,0 ± 91,8, 1208 ± 483,8 e 431,7 ± 71,3 ppm para ASA, CAP e HTZ, respectivamente. A manipulação contínua dos fármacos seguida pelo procedimento de limpeza mostrou acúmulo de resíduo linear para ASA (r²=0,96) e CAP (r²=0,88). A quantidade de resíduo de CAP foi maior que o limite de impureza sugerido pelo FDA (>0,1%), mas não para HTZ, mas mesmo assim, o resíduo de HTZ pode ser detectado na urina dos atletas submetidos aos testes do COI. Em conclusão, as farmácias de manipulação deveriam, portanto, melhorar o procedimentos de limpeza e testá-los para que alcancem limites abaixo de 10 ppm para evitar contaminação nos outros produtos...

Comparative Study of the Safety Information in the Private Import through the Internet of the Melatonin from which a Classification between Drugs and Food Differs in Japan and the United States / 社会薬学

Classification of food and pharmaceutical products are different. In the proper use of pharmaceutical products, it is essential for a medical consumer to receive the drug information about effectiveness, safety and quality of it. On the other hand, since legal classification between medicines and dietary supplements was based their cultures, the classification of each drug is different in each country. Melatonin is a hormone produced by the pineal gland and used for improvement of the jet lag. We searched melatonin product information of Japan and the United States by using Internet search mainly and investigated the relationship between amount of product information and product classification. Melatonin is classified as a dietary supplement in the United States, the product information of efficacy and safety is displayed as “Supplement Facts” and the use of melatonin in children is not recommended. On the other hand, melatonin is classified as a pharmaceutical product in Japan, but is not produced in Japan. Therefore, it is difficult to have it for Japanese customers, and then they personally import using the Internet with their self-responsibility. However it is difficult to obtain its appropriate information for consumers, because of the regulation of the Pharmaceutical Affairs Law. It has been reported that the poisoning accident by the excessive intake of melatonin already. It will increase the risk of the health problem to purchase melatonin through the Internet more. Therefore, we concluded that Internet purchase of Medicines had a high risk for Japanese customers since there was not sufficient drug information.

Influência da velocidade no torque de remoção de tampas plásticas rosqueáveis para produtos farmacêuticos / Influence of the speed on the removal torque of plastic screw caps for pharmaceutical products

O estudo teve por objetivo avaliar a influência da velocidade empregada durante a determinação do torque de aplicação e remoção de tampas plásticas rosqueáveis de polipropileno (PP), com vedante interno, aplicadas em frascos de vidro e de poli(tereftalato de etileno) (PET) para produtos farmacêuticos, com diâmetros de terminação de 24 e 28 mm. Foi verificada também a influência do material de embalagem (vidro ou PET) e do diâmetro da terminação no torque de retenção estático e dinâmico (após simulação de transporte) em intervalos de tempo após 24 e 48 horas e após 7, 14 e 28 dias da aplicação dos respectivos sistemas de fechamento. Verificou-se que a velocidade não apresenta influência no torque de aplicação desde que o valor máximo seja controlado durante o processo de fechamento da tampa. No torque de remoção imediato, entretanto, a velocidade influencia significativamente nos resultados, sendo recomendado, sempre que possível, a utilização de uma velocidade constante. Foi estabelecido para o estudo a velocidade de 5 rpm para evitar a influência desse parâmetro nos resultados de torque obtidos. O material de embalagem e o diâmetro da terminação evidenciaram influência significativa nos resultados de torque de retenção estático e dinâmico, sendo observados valores superiores para os frascos de vidro comparativamente aos frascos de PET. Esse desempenho pode estar associado às diferenças nas propriedades viscoelásticas e na força de fricção ou atrito entre os materiais da tampa com vedante e a embalagem.

The objective of this study was to ascertain the influence on the measured torque of the speed employed during the tightening and removal of polypropylene (PP) screw caps, with internal liners, used on glass and polyethylene terephthalate (PET) bottles for pharmaceutical products, with mouth diameters of 24 and 28 mm. The influence of the packaging material (glass or PET) and mouth diameter on the static and dynamic torque retention was observed (after transport simulation) at time intervals after 24 and 48 hours and after 7, 14 and 28 days of torque application to each closure system. It was found that the speed did not influence the tightening torque since the torque is controlled during the closing process. However, the speed significantly influenced the immediate removal torque and it is preferable to use a constant speed whenever possible. It was found that a speed of 5 rpm was best, to prevent this parameter affecting the torque results. The packaging material and mouth diameter exerted a significant influence on the retention torque, both in the static and dynamic tests, and higher torques were observed for glass than for PET bottles. This performance may be related to viscoelastic properties and the friction between the lined cap and the packaging material.

Avaliação da influência de microfissuras superficiais em frascos de vidro tipo I para produtos farmacêuticos / Assessment of the influence of microcracks in type 1 glass vials for pharmaceutical products

O objetivo deste estudo foi caracterizar e verificar a influência de microfissuras na manutenção da esterilidade e do desempenho mecânico de frascos de vidro tipo I, de 4 mL e 13 mL (terminação 13 mm) para produtos esterilizáveis e de 7 mL (terminação 20 mm) para produtos liofilizados, após acondicionamento em linha e simulação de transporte. Microfissuras superficiais em frascos de vidro tipo I podem ser formadas devido ao contato entre o vidro e o ferramental, associado a variações na intensidade da chama, durante o processo produtivo da embalagem. Verificou-se que a tensão residual da embalagem não é alterada pela presença das microfissuras e que os sistemas de fechamento apresentam adequada integridade e propriedades de barreira à umidade. Mesmo com microfissuras superficiais, a manutenção da esterilidade do produto simulante, acondicionado nos frascos esterilizados (4 mL e 13 mL), não apresentaram alteração após o envase em linha e simulação de transporte. No caso do frasco de 7 mL, as microfissuras podem ter contribuído para a ocorrência de alteração de 1% do total das embalagens após o processo de liofilização. Uma maior incidência de quebra por carga vertical, localizada na região do ombro/terminação, foi observada devido à presença das microfissuras. O desempenho mecânico e térmico dos frascos estudados, contudo, não foi alterado pela presença das microfissuras.

The objective of this study was to ascertain the influence of microcracks on the maintenance of sterility and echanical performance of type 1 (i.e. borosilicate) glass vials, of 4 mL and 13 mL (neck 13 mm) for sterile pharmaceutical products and 7 mL (neck 20 mm) for freeze-dried products, after in-line filling and transport simulation. Microcracks in type I glass vials can be formed by contact between the glass and metal tools, when variations in the flame temperature occur during manufacturing. It was found that the residual stress in the glass vials is not altered by the presence of microcracks and that the closure systems are secure and have adequate moisture barrier properties. Even with surface microcracking, the sterility of the simulated product in the vials (4 mL and 13 mL) was maintained after the in-line filling and transport simulation; for the 7 mL glass vial, microcracks may have contributed to the loss of sterility of 1% of the products after freeze-drying. A higher incidence of breakage in the region of the shoulder and neck of the glass vials under vertical load was observed in the presence of microcracks. The mechanical and thermal performance of the glass vials, however, was not impaired by the presence of microcracks.

Proposal of managerial standards for new product portfolio management in Brazilian pharmaceutical companies / Proposta de normas gerenciais para a gestão de portfólio de novos produtos em empresas brasileiras de produtos farmacêuticos

New Product Portfolio Management is aimed at helping decision-makers better select projects for new products based on key criteria for the manufacturer. The Brazilian pharmaceutical industry has been undergoing change due to stricter sanitary requirements following the enactment of the Generic Law in 1999. This paper presents the results of a research study aimed at clarifying the rationale employed by national pharmaceutical companies in selecting and prioritizing their new product development projects. Consequently, proposals for an analytical structure that could help these companies better select their products were produced. The research was carried out using case study methodology in which four different companies were investigated. The results of the field study confirmed that these companies had a non-structured Product Development System and that the selection of new product development projects was made on a non-systematic basis. The research also identified key criteria for the selection of projects of new pharmaceutical products, which provided the basis for the preparation of a proposal for a managerial standard for application of New Product Portfolio Management.

A gestão de portfólio de projetos de novos produtos visa a auxiliar os tomadores de decisão a selecionar projetos de novos produtos considerando critérios importantes para a organização. A indústria farmacêutica brasileira tem passado por transformações devido ao aumento das exigências sanitárias após a Lei de Genéricos, de 1999. O objetivo deste trabalho foi entender como as indústrias farmacêuticas brasileiras selecionam seus projetos de desenvolvimento de novos produtos e propor uma estrutura que possa auxiliar estas empresas a selecionar seus projetos de produtos. Foi utilizada a metodologia de estudo de caso e uma mostra de quatro organizações foi investigada. Os resultados indicam que essas empresas apresentam um desenvolvimento de produtos não estruturado e que a seleção de projetos de novos produtos é realizada de forma não-sistemática. Critérios importantes para a seleção de projetos de novos produtos foram identificados e utilizados para elaboração de um padrão gerencial para aplicação da gestão de portfólio de projetos de novos produtos.

Sensitive spectrophotometric assay of simvastatin in pharmaceuticals using permanganate / Ensaio espectrofotométrico sensíveis de sinvastatina em medicamentos utilizando permanganato

Two simple, sensitive, selective and inexpensive spectrophotometric methods are described for the determination of simvastatin (SMT) in bulk drug and in tablets using permanganate as the oxidimetric reagent. In method A, SMT is treated with a measured excess of permanganate in acetic acid medium and the unreacted oxidant is measured at 550 nm, whereas in method B the reaction is carried out in alkaline medium and the resulting manganate is measured at 610 nm. In method A, the amount of permanganate reacted corresponds to the SMT content and the absorbance is found to decrease linearly with the concentration; and in method B, the absorbance increases with concentration. The working conditions of assays were optimized, and the methods were validated according to the current ICH guidelines. Under optimum conditions, SMT could be assayed in the concentration ranges, 1.47 - 17.67x10-5 and 2.27 - 27.18 x10-6 mol/L by method A and method B, respectively. The calculated molar absorptivities are 3.2 x 10³ and 2.5 x 10(4) L/mol/cm for method A and method B, respectively with corresponding Sandell sensitivity values of 0.0387 and 0.0178 μg/cm². The limits of detection (LOD) and quantification (LOQ) have also been reported. Accuracy and precision for the assay were determined by calculating the intra-day and inter-day at three concentrations; the intra-day RSD was < 2 percent and the accuracy was better than 2.15 percent (RE). The methods were applied successfully for the determination of SMT in tablet dosage form with a high percentage of recovery, good accuracy and precision, and without measurable interference by the excipients. The accuracy was further ascertained from placebo and synthetic mixture analysis and also from the spike-recovery method.

Dois métodos espectrofotométricos simples, sensíveis, seletivos e baratos são descritos para a determinação de sinvastatina (SMT) a granel e em comprimidos, utilizando permanganato como reagente oxidimétrico. No método A, a SMT é tratada com excesso conhecido de permanganato em meio de ácido acético e o oxidante que não reage é medido a 550 nm, enquanto no método B, a reação é efetuada em meio alcalino e o manganato resultante é medido a 610 nm. No método A, a quantidade de permanganato que reage corresponde ao conteúdo de SMT e a absorbância diminui linearmente com o aumento da concentração; no método B, a absorbância aumenta com o aumento da concentração. As condições de trabalho do ensaio foram otimizadas e os métodos, validados de acordo com as normas do ICH. Sob condições ótimas, a SMT pode ser ensaiada nas faixas de concentração de 1,47- 17,67x10-5 e de 2,27-27,18 x10-6 mol/L pelo método A e B, respectivamente. As absortividades molares calculadas são 2 x 10³ e 2,5 x 10(4) L/ mol/cm, respectivamente, para os métodos A e B, com os valores correspondentes de sensibilidade de Sandell de 0,0387 e 0,0178 μg/cm². Os limites de detecção (LOQ) também foram relatados. A exatidão e a precisão do ensaio foram determinadas pelo cálculo de três concentrações intra- e inter-dia; a RSD intra-dia foi <2 por cento e a exatidão foi melhor que 2,15 por cento (RE). Os métodos foram aplicados com sucesso à determinação de SMT em comprimidos com alta porcentagem de recuperação, boa exatidão e precisão e sem interferência mensurável dos excipientes. A exatidão foi posteriormente determinada no placebo e na mistura sintética e, também, pelo método de spike recovery.

Survey on stability of pharmaceutical products in national list of essential drugs used in hospitals in Thailand.

A survey on stability problems of essential drugs purchased by 989 hospitals and provincial public health offices in Thailand has been carried out since 1993. During 1990-1997, selective sampling of 1799 cases related to stability problems of 206 drug substances was undertaken through questionnaires sent to 658 government hospitals and from laboratory findings. The stability problems were identified and categorised into pharmacopoeial non-compliance (25.2 per cent) and physical appearances (74.8 per cent). Most problems (91.7 per cent) occur in locally-made drug products. In addition, 84.2 per cent of drugs were found to have no expiration dates stated on the labels and instability was found between < 15 days and over 11 years after manufacturing, with the highest frequency of occurrences falling within 10-12 months (45.6 per cent). For products with a stated shelf-life (15.8 per cent), stability problems occurred from within 2 months after manufacturing to over 5 years; with maximum occurence at 61-70 per cent of shelf-life. Factors affecting the stability of drug products have already been stated in many textbooks on stability. Therefore, to avoid stability problems, proper formulations must be developed using standard quality raw material and packaging under Good Manufacturing Practices requirements. The means of drug transportation to hospitals, drug distribution chains and storage conditions in hospitals have also been considered as factors creating stability problems. The authors suggest that manufacturers should use high-quality active ingredients, suitable formulations and packaging which comply with current Good Manufacturing Practices, in order to prevent stabilty problems occurring in drug products. Proper storage conditions in accordance with the labelling should be strictly practiced in hospitals. Moreover, stability study on transportation factor should be included in stability study protocol for at least 30 days.

Thinking About the Packaging of Pharmaceutical Products and the Safety of Drug Use / 中国药房

OBJECTIVE: To study relation between the packaging of pharmaceutical products and the safety of drug use. METHODS: Analysis was based on the relevant documents, and combined with the actual situations in China. RESULTS & CONCLUSION: Only by selecting the appropriate packaging materials, controlling the packaging process effectively and man- aging the package labels, will the safety of drug use be ensured.