Reasons for patients’ generic drug switching at the pharmacy counter: a pilot study

2021 ◽  
Vol 10 (3) ◽  
pp. 119-122
Author(s):  
Pieter J Glerum ◽  
Mert Hayta ◽  
David M Burger ◽  
Cees Neef ◽  
Marcel L Bouvy ◽  
...  
Keyword(s):  
Pilot Study ◽  
The Netherlands ◽  
Generic Drug ◽  
Active Substance ◽  
Drug Product ◽  
Product Distribution ◽  
Economic Incentives ◽  
Drug Shortages ◽  
Drug Products ◽  
Drug Switching

Background: Drug switching describes switching between drug products with the same active substance. Drug switching occurs commonly in the Netherlands and mostly between generic drug products, however, the specific reasons for switching are incompletely understood. Methods: To document reasons for drug switches between products with the same active substance in the Netherlands. Results: In total, 207 drug switches were recorded. Most drug switches were caused by nationwide drug shortages (32%, n = 66) and the Dutch price-based tender system (23%, n = 47). Other reasons for switching included deals between pharmacists and wholesalers (12%, n = 25), distribution issues at wholesalers (11%, n = 22), and a financially favourable margin for pharmacists (11%, n = 21). Conclusion: This study indicates that drug shortages and the Dutch price-based tender system are likely to be major causes of drug switches in the Netherlands. However, other reasons, such as drug product distribution issues and local economic incentives, were also identified.

scholarly journals In vitro release of diclofenac diethylamine from gels: evaluation of generic semisolid drug products in Brazil

2013 ◽  
Vol 49 (2) ◽  
pp. 211-219 ◽  
Author(s):  
Karin Goebel ◽  
Mayumi Eliza Otsuka Sato ◽  
Dayse Fernanda de Souza ◽  
Fábio Seigi Murakami ◽  
Itamar Francisco Andreazza
Keyword(s):  
Drug Release ◽  
Generic Drug ◽  
Drug Product ◽  
In Vitro Release ◽  
Performance Testing ◽  
Vertical Diffusion ◽  
Reference Drug ◽  
Drug Products ◽  
Vitro Release

In order for the pharmacological action of a topical dermal drug product to occur, the drug must first be released from the vehicle to be available to penetrate the skin layers and reach the site of action. Drug release is mainly dependent on the characteristics of the formulation. Currently, to register a generic or a similar drug product in Brazil performance testing of topical drug products for local action is not required. In this context, this aim of this study was to evaluate the in vitro release of commercial diclofenac diethylamine gel products available on the Brazilian pharmaceutical market, using the vertical diffusion cell method. Factors which may influence the test, such as the type of membrane used, and the effect of the formulation characteristics on the diffusion rate were evaluated. Brazilian legislation currently allows generic drug products to contain excipients other than the reference drug, which may affect the drug release from the vehicle. Only one of the four generic drug products tested could be considered equivalent to the reference Cataflam Emulgel®. The cellulose acetate and polyethersulfone membranes tested were found to be interchangeable in the in vitro release studies carried out on this product.

scholarly journals Comparison of SARS‐CoV ‐2 neutralizing antibody testing of convalescent plasma donations in the Netherlands and England: A pilot study

2021 ◽  
Vol 4 (4) ◽  
Author(s):  
Heli Harvala ◽  
Robin Gopal ◽  
Monika Patel ◽  
Maria Zambon ◽  
David Roberts ◽  
...  
Keyword(s):  
Pilot Study ◽  
The Netherlands ◽  
Neutralizing Antibody ◽  
Antibody Testing

scholarly journals Container Closure and Delivery Considerations for Intravitreal Drug Administration

2021 ◽  
Vol 22 (3) ◽  
Author(s):  
Ashwin C. Parenky ◽  
Saurabh Wadhwa ◽  
Hunter H. Chen ◽  
Amardeep S. Bhalla ◽  
Kenneth S. Graham ◽  
...  
Keyword(s):  
Adverse Events ◽  
Product Development ◽  
Drug Product ◽  
Healthcare Providers ◽  
Standard Of Care ◽  
Volume Determination ◽  
Common Procedure ◽  
Drug Products ◽  
Fill Volume ◽  
Container Closure

AbstractIntravitreal (IVT) administration of therapeutics is the standard of care for treatment of back-of-eye disorders. Although a common procedure performed by retinal specialists, IVT administration is associated with unique challenges related to drug product, device and the procedure, which may result in adverse events. Container closure configuration plays a crucial role in maintaining product stability, safety, and efficacy for the intended shelf-life. Careful design of primary container configuration is also important to accurately deliver small volumes (10-100 μL). Over- or under-dosing may lead to undesired adverse events or lack of efficacy resulting in unpredictable and variable clinical responses. IVT drug products have been traditionally presented in glass vials. However, pre-filled syringes offer a more convenient administration option by reducing the number of steps required for dose preparation there by potentially reducing the time demand on the healthcare providers. In addition to primary container selection, product development studies should focus on, among other things, primary container component characterization, material compatibility with the formulation, formulation stability, fill volume determination, extractables/leachables, and terminal sterilization. Ancillary components such as disposable syringes and needles must be carefully selected, and a detailed administration procedure that includes dosing instructions is required to ensure successful administration of the product. Despite significant efforts in improving the drug product and administration procedures, ocular safety concerns such as endophthalmitis, increased intraocular pressure, and presence of silicone floaters have been reported. A systematic review of available literature on container closure and devices for IVT administration can help guide successful product development.

scholarly journals Regulatory requirement for the approval of Generic Drug in Cambodia as per ASEAN Common Technical Dossier (ACTD)

2018 ◽  
Vol 6 (2) ◽  
pp. 67-71 ◽  
Author(s):  
Ravish Patel ◽  
Amit Patel ◽  
Tejasvini Gohil
Keyword(s):  
Generic Drug ◽  
Drug Product ◽  
Regulatory System ◽  
Drug Approval ◽  
Oral Dosage ◽  
Market Regulation ◽  
Product Analysis ◽  
Regulatory Requirement ◽  
Generic Drug Product ◽  
Asean Countries

Drug approval process differs from one country to another country. In some countries only single body regulates the drug as well as responsible for all regulatory work which is a challenging task for the pharmaceutical companies to prepare single dossier that can be simultaneously submitted in many countries for approval. In all countries there is a similar characteristic in regulatory environment but there is a difference in their registration requirements. The purpose of this study is to give a comparative overview on generic drug market regulation in ASEAN Countries Cambodia and Malaysia. The aim of study is to facilitate proper knowledge regarding main critical issues, differences as well as similarities of related drug regulation. There is a different requirement for registration of generic product in each regulatory system but also comprises of some similar outline that includes some common rules. These are variances and regulatory hurdles such as Number of batches for submission in dossier, stability conditions, registration of product, analysis, bioequivalence and clinical study requirement. ASEAN countries for generic drug product approval ACTD submitted to country specific authority. For solid oral dosage forms as per ASEAN guideline there are 4 parts have to be submitted. Part I contains Administrative requirements which is not a part of common technical document. Part II is Quality contains 3 sections that are a) Table of Content b) Quality overall Summary c) Body of data. Part III contains Non clinical. Part IV contains Clinical data. For the generic drug product Part III and Part IV is not required.

scholarly journals Rotulagem de medicamentos industrializados: uma análise das diretrizes legais brasileiras e contribuições para a qualidade de produtos

2020 ◽  
Vol 20 (81) ◽  
Author(s):  
Márcia Lombardo
Keyword(s):  
Drug Product ◽  
Regulatory Agencies ◽  
Quality And Safety ◽  
Sources Of Information ◽  
Normative Documents ◽  
Drug Products ◽  
Legal Provisions ◽  
Product Surveillance ◽  
Study Results ◽  
Regulatory Knowledge

RESUMOObjetivos: a rotulagem é um aspecto de qualidade fundamental no uso de medicamentos, seja pelo profissional de saúde, seja pelo paciente. Este trabalho propôs uma análise crítica do tema com base na legislação em vigor, bem como a triagem de documentos normativos úteis no processo de elaboração ou de avaliação da conformidade da rotulagem de medicamentos. Métodos: foi realizada uma pesquisa documental empregando-se como fonte de informações os sítios eletrônicos oficiais do Ministério da Saúde e da Agência Nacional de Vigilância Sanitária. Os documentos contendo itens pertinentes a rotulagem de medicamentos e classificados como vigentes ou vigentes com alteração foram selecionados para a realização do estudo. Resultados: os quesitos mais relevantes das disposições gerais e das disposições específicas da norma vigente para rotulagem de medicamentos foram sistematizados, verificando-se suas contribuições na qualidade e segurança de produtos. Embora a padronização da rotulagem de medicamentos seja necessária, a ocorrência de elevados graus de semelhança entre rótulos, embalagens ou mesmo nomenclaturas é discutida no âmbito da prática clínica e esta questão merece atenção especial. A busca de material complementar à legislação vigente resultou no levantamento de um total de 20 documentos, incluindo normas, guias, bancos de consulta e planilhas, que podem auxiliar no cumprimento dos requisitos de rotulagem de medicamentos. Conclusão: rótulos de medicamentos são recursos técnicos que contribuem na eficácia e na segurança do tratamento. Os esforços das Agências Reguladoras têm permitido a consolidação de diretrizes legais para que informações e formatos adequados de rotulagem sejam aplicados nas embalagens de medicamentos industrializados. A elaboração ou a análise da rotulagem de medicamentos requer amplo conhecimento regulatório, o qual é dinâmico e, portanto, um grande desafio.Palavras-chave: Rotulagem de Medicamentos. Legislação de Medicamentos. Vigilância de Produtos Comercializados. Segurança do Paciente. ABSTRACTObjectives: the labeling of drug products is an aspect of quality that is fundamental to the use of medicines, whether by the health professional or by the patient. This work proposed a critical analysis of the current legislation on the labeling of drug products, as well as the screening of normative documents useful for the process of preparing or assessing the conformity of labels. Methods: a documentary research was carried out using the official websites of the Ministry of Health and the National Health Surveillance Agency (Brazil) as sources of information. The documents containing relevant items on labeling of drug products and classified as current or current with changes were selected for the study. Results: the most important requirements of the general and specific provisions from the current legislation have been systematized, and their contributions to the quality and safety of products have been verified. Although the standardization of the labeling is necessary, the occurrence of high degrees of similarity between labels, packaging or even nomenclatures is discussed in the context of clinical practice and this issue deserves special attention. The search for material complementary to the current legislation resulted in the collection of a total of 20 documents, including normative documents, guides, databases and spreadsheets, which might help in complying with the requirements for the labeling of drug products. Conclusion: the labeling of drug products are technical resources that contribute to the effectiveness and safety of treatment. The efforts of the Regulatory Agencies have allowed the consolidation of legal provisions for the dissemination of appropriate information and labeling formats in the packaging of drug products. The drafting or analysis of the labels requires extensive regulatory knowledge, which is dynamic and, therefore, a great challenge.Keywords: Drug Labeling. Legislation, Drug. Product Surveillance, Postmarketing. Patient Safety.

scholarly journals Rapid microbiological testing method

2020 ◽  
Vol 11 (3) ◽  
pp. 3927-3932
Author(s):  
Raghuprakash P ◽  
Gowrav M P ◽  
Gangadharappa H V ◽  
Hemanth Kumar S
Keyword(s):  
Clinical Laboratory ◽  
Drug Product ◽  
Free Products ◽  
Hygienic Condition ◽  
Cycle Times ◽  
Drug Products ◽  
Microbiological Methods ◽  
Wide Range ◽  
Microbiological Testing ◽  
Microorganism Identification

Classical microbiological methods currently have unacceptably long cycle times. Rapid microbiological strategies are accessible within the marketplace for about 10 years and are mostly used in the clinical laboratory and in food industries. However, their reapplication in the pharma industry has wide range of advantage. A comparison with ancient strategies to be conjointly performed. During this review, data concerning the validation of RMM strategies described within the document was given in addition as proof of the issue of validation of those strategies. A comparison with ancient strategies is additionally mentioned. This data is beneficial to the industries and in the labs which will doubtless be adopted. These strategies for microorganism free products. This methodology for microorganism identification will be delicate, accurate and fast. How the laboratory should be maintained for carrying out different tests, there should be good hygienic condition maintained. This article also includes different methods for identifying bacteria which is present in drug products as well as the material which are used for doing test. Presence of bacteria may affect the activity of drug product and bio availability may decreases and potency the drug may loss. How the laboratory should be maintained for carrying out different tests, there should be good hygienic condition maintained.

scholarly journals Liposome Characterization, Applications and Regulatory landscape in US

2021 ◽  
Vol 9 (2) ◽  
pp. 81-89
Author(s):  
Amit Kumar ◽  
Madhu Gupta ◽  
Simran Braya
Keyword(s):  
Drug Product ◽  
Drug Carrier ◽  
Current Status ◽  
Liposomal Drug ◽  
Drug Products ◽  
Target Drug Delivery ◽  
Target Drug ◽  
Conventional Drug ◽  
Regulatory Guidelines ◽  
Reduced Toxicity

Liposomes are lipid based drug carrier whose therapeutic performance depends on their structure. Liposomes offer several advantages over the conventional drug like target drug delivery, reduced toxicity, and extended pharmacokinetics. Characterization and Identification of critical attribute of liposomal formulation and suitable strategies for control during product development is important for quality of the liposomal drug product. This paper discusses the current status of the liposomal drug product and strategy used in regulating liposome product. Despite of lack of regulatory guidelines many liposome formulations get approved which shows the potential of liposome drug products.

Sign in / Sign up

Export Citation Format

Share Document