Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector最新文献

{"title":"Physician and patient’s insights towards generic prescribing: The scenario in the United Arab Emirates","authors":"Abduelmula R Abduelkarem, Amna M Othman, Sara M. Elgendy, Raneem E Moustafa, Noor M Al-Areqi","doi":"10.1177/1741134319882722","DOIUrl":"https://doi.org/10.1177/1741134319882722","url":null,"abstract":"Objective To assess the perspectives and perceptions of physicians and patients towards generic prescribing in the United Arab Emirates. Founding those views can help in improving medicines prescription to provide the best cost-effective healthcare services in the country. Methods A cross-sectional study targeted physicians and patients across the United Arab Emirates. Two different questionnaires were conducted in 25 clinics, government healthcare centres and private hospitals. Collected data were analysed by descriptive analysis and Chi-square test. Key findings: Around half of 225 patients, agreed that generic medications have the same efficacy as branded medications. However, 54.7% believes that medications have been on the market longer are safer than newer ones. Majority of patients agreed that physicians’ advice would influence their choice when choosing between a generic and brand medication, though only a third of the participants agreed that the pharmacist’s advice would influence their choice. Of the 100 physicians, a preponderance reported that they actively prescribe generic medications. Moreover, they reported that the patient’s financial status would affect their decision when prescribing medications. Additionally, they identify medical representatives (64%) as their main sources of information regarding generic medications in the UAE. Conclusions The results showed somewhat negative views of physicians and patients towards generics prescriptions. Hence, measures should be taken by the Health Regulatory Authorities to clear up the misconceptions. This could be done by providing valid sources of information and assurance to the public about generic medications.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"49 18","pages":"193 - 202"},"PeriodicalIF":0.0,"publicationDate":"2019-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91406270","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessment of knowledge, attitude and practice among pharmacy professionals towards generic medicines in Addis Ababa, Ethiopia","authors":"B. B. Nasir, O. Muhammed, M. S. Buseir","doi":"10.1177/1741134319875764","DOIUrl":"https://doi.org/10.1177/1741134319875764","url":null,"abstract":"Background Suboptimal knowledge and attitude of healthcare professionals about generics reduce utilization of these drugs. The objective of this study was to assess the knowledge gap, attitude and practice among pharmacy professionals toward generic medicine in Addis Ababa, Ethiopia. Method The study was conducted in Addis Ababa from 10 April to10 July 2018 among 424 pharmacy professionals. Self-administered questionnaire was used to collect the data. Data were analyzed by using statistical package for social sciences version 24 and multi-variable binary logistic regression was used to identify predictors of the dependent variables. Result Majority (77.1%) of the participants claimed that they have had knowledge on the concept of generic medicine. Knowledge was significantly associated with participants’ educational qualification and work experience. More than half (55%) of them have an attitude that brand medicines are of higher quality compared to generics and 37.6% of them believe generic medicines are less effective than brand medicines. About 80% of the participants claimed that locally manufactured generics are cheaper than imported generics. Affordability to the customer, cost effectiveness of generic medicine and consumer preference/demand were the commonest reasons to dispense generic medicines. Conclusion Though vast majority of the study participants have had knowledge on the concept of generic medicine, their attitude and practice seem suboptimal that will influence utilization of generic products.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"26 1","pages":"185 - 192"},"PeriodicalIF":0.0,"publicationDate":"2019-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85843548","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Biosimilars and federal preemption in the USA","authors":"J. Bousquet","doi":"10.1177/1741134318776436","DOIUrl":"https://doi.org/10.1177/1741134318776436","url":null,"abstract":"Summary This article reports on the recent decision by the Court of Appeals for the Federal Circuit (“Federal Circuit”) in Amgen v. Sandoz on remand from the U.S. Supreme Court. The Supreme Court held that a biosimilar applicant cannot be compelled under federal law to provide a copy of its abbreviated biologics license application (“aBLA”) and manufacturing information to the reference product sponsor (“RPS”) as required by the Biologics Price Competition and Innovation Act (“BPCIA”). The Supreme Court remanded the case to the Federal Circuit to determine whether there was any remedy under California state law available to Amgen, and if so, whether such remedy is preempted by the BPCIA. The Federal Circuit held that the BPCIA preempts state law remedies for a biosimilar applicant’s failure to comply with the BPCIA. This article also briefly discusses three other recent cases involving situations where the biosimilar applicant initiates the BPCIA information exchange process but provides only partial or no manufacturing information to the RPS or fails to complete the process by opting out at some later stage of the process.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"46 1","pages":"138 - 144"},"PeriodicalIF":0.0,"publicationDate":"2019-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85945056","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Latest Top 20 Read Articles","authors":"","doi":"10.1177/1741134319875901","DOIUrl":"https://doi.org/10.1177/1741134319875901","url":null,"abstract":"","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"60 1","pages":"155 - 157"},"PeriodicalIF":0.0,"publicationDate":"2019-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86615779","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Deviations handling and corrective actions and preventive actions: Case studies for parenteral dosage form","authors":"Shah Kavina, K. Charmy, M. Chirag, Shah Manan","doi":"10.1177/1741134319869404","DOIUrl":"https://doi.org/10.1177/1741134319869404","url":null,"abstract":"In the pharmaceutical industry, each and every activity is done according to standard operating procedures and protocols. Standard operating procedures are the pre-established stepwise instructions to carry out routine operations while protocols are predefined written document used for design and execution of experiments. In the current scenario, pharmaceutical industry wants to manufacture quality product as per good manufacturing practice guidelines. To achieve six sigma qualities, deviations are very important to consider. Deviations have to be addressed, investigated, and based on investigation data, suitable corrective actions and preventive actions are applied for prevention of its reoccurrence. Corrective actions and preventive actions are important part of quality management system. Corrective actions and preventive actions is a system which falls under good manufacturing practice and many International Standard Organization business standards. Corrective actions and preventive actions include route cause analysis for resolving deviation, which includes its cause of identification, and helps to prevent its occurrence in future. Corrective actions and preventive actions is a combination of ideas and tools to correct deviation. Inappropriate initial route cause identification and application of corrective actions and preventive actions lead to extra work, time, and cost. There are some exceptional cases in which corrective actions and preventive actions are not required, for instance one-time deviation, where only corrective actions are done. The corrective actions and preventive actions system improves and maintains processes, procedures, organization, and business in a systematic, organized, well-documented, and actionable way. In this article, case studies of deviations in pharmaceutical industry helped in identification and evaluation of deviation and based on that application, suitable corrective actions and preventive actions are shown which give thorough understanding of deviation and application of corrective actions and preventive actions in pharmaceutical industry. So, corrective actions and preventive actions are not only regulatory requirements but they make good business sense to the pharmaceutical industry.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"22 1","pages":"165 - 176"},"PeriodicalIF":0.0,"publicationDate":"2019-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77559393","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Courts continue to clarify what is patent eligible subject matter","authors":"S. Hamidinia","doi":"10.1177/1741134319868802","DOIUrl":"https://doi.org/10.1177/1741134319868802","url":null,"abstract":"","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"43 1","pages":"203 - 206"},"PeriodicalIF":0.0,"publicationDate":"2019-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83681696","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The effect of patent expiration on sales of branded competitor drugs in a therapeutic class","authors":"Jeffrey Fujimoto, D. Tien, Sophie Snyder, Jeppe A Hertz, S. Schweitzer","doi":"10.1177/1741134319856408","DOIUrl":"https://doi.org/10.1177/1741134319856408","url":null,"abstract":"Background Generic entry can lower pharmaceutical prices and yield significant cost savings for both patients and health systems. The effect of generic entry has often been measured by sales of the branded drug whose patent has expired, but what is less clear is how branded competitors within the same therapeutic class respond. Methods We analyzed the effect of patent expiration of the first innovative drug in a therapeutic class on competitor sales within the same therapeutic class for five major therapeutic classes using data obtained from IMS Health. Results Composite quantity sales decreased by 49%, 65%, and 67% in the first three years, respectively, following patent expiration. However, the effect of patent expiration was not uniformly negative; competitors were often able to obtain dominant market share. Additionally, factors beyond patent expiration may affect the rate and timing of branded market contraction which holds significant implications for drug pricing and sales. Conclusion Patent expiration is a consequential event for not only the drug undergoing patent expiration, but also the therapeutic class in which the drug is contained. Market dynamics change significantly for competitor-branded products which warrant further research.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"15 1","pages":"177 - 184"},"PeriodicalIF":0.0,"publicationDate":"2019-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84500930","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Lessons learnt from providing technical assistance to Chinese generic medicines manufactures to achieve the WHO Prequalification standards","authors":"Baobin Huang, Sarah Louise Barber, Christina Foerg-Wimmer","doi":"10.1177/1741134319859394","DOIUrl":"https://doi.org/10.1177/1741134319859394","url":null,"abstract":"The World Health Organization (WHO) Prequalification sets a benchmark of generic medicines quality standards for both local utilization and international procurement. So far in China, there are only 35 medicines prequalified by WHO among around 400 eligible products. With a large volume of generic medicines production capacity, WHO has been paying great attention to Chinese firms by providing technical assistance to achieve WHO Prequalification standards. In 2009–2011, Bill and Melinda Gates Foundation sponsored a project to scale up tuberculosis control in China. The adoption of anti-tuberculosis medicines in fixed dose combinations form was selected as an important intervention tool. In order to have quality assured anti-tuberculosis medicines available, four Chinese anti-tuberculosis generic manufacturers were selected for technical assistance as a pilot. The maturity of each generic manufacturers to achieve WHO standards was used to evaluate the role of WHO’s technical assistance. The maturity was measured from the perspective of production and dossier. The WHO’s technical assistance contributes to the maturity of manufacturers. In production, it increased from an average of 53% to 80% for quality management system, and 70% to 80% for good manufacturing practices; in regulatory dossier, it increased from 28% to 67% for quality part, and 0% to 75% for efficacy and safety part. It also found out the factors having impact on the effect of technical assistance. The sustainability of technical interventions was influenced by guaranteed market share and support of two key partners: active pharmaceutical ingredients producers and clinical research organizations. The pressure of upgraded national drug regulatory standards has an impact on the effect of technical assistance.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"14 1","pages":"133 - 137"},"PeriodicalIF":0.0,"publicationDate":"2019-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86957859","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Generic drugs, a need to the public: USA and India – Government plans to reduce the price of abbreviated new drug application and list of generic drugs approved in year 2018","authors":"Russell Martin, K. Bahmani","doi":"10.1177/1741134319848811","DOIUrl":"https://doi.org/10.1177/1741134319848811","url":null,"abstract":"Health is the prime component for every person, and in the world, there are different traditions that have their own approaches to treat and cure illness. The dosage form of the drug may appear different but medically, however, a generic medicament has the same mechanism in the body as that of the costlier brand-name drugs. They acquire the equal active ingredient an have the identical quality asd must pass the same satisfactory standards with respect to manufacturing and packaging of medicaments. The generic medicinal drug beneath the regulation of U.S. Food and Drug Administration must have the equal quality and performance as that of the brand-name drugs. The Food and Drug Administration states: ‘Generics have the identical quality as brand identify drugs’. When a generic drug product is approved, it has met rigorous standards established via the Food and Drug Administration with respect to identity, strength, quality, purity and potency. India started Jan Aushadhi scheme to make quality medicines handy to the shoppers at affordable prices. Given the socio-economic conditions and the level of ignorance and illiteracy with vast disparities of income in the country, the advantage of the scheme can be taken by the consumers or should reach the consumers particularly the poor and the needy, only when a proper multimedia publicity programmed is mounted to educate the consumers of all strata of society. India is still a developing country where quality and inexpensive remedy are still major issues.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"63 1","pages":"115 - 132"},"PeriodicalIF":0.0,"publicationDate":"2019-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78256727","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Generic dRug Adoption Framework: Framework to assess perceptions and identify high-quality generic drugs in oncology","authors":"Amit Garg, Ashutosh Kumar Singh, Shyamal S Kadukkatt, Juan Pablo, S. Akku","doi":"10.1177/1741134319833122","DOIUrl":"https://doi.org/10.1177/1741134319833122","url":null,"abstract":"Perceptions in physicians and pharmacists are a common impediment to the utilization of generic medicines in clinical practice. As a multinational initiative to accelerate access to high-quality generic medicines, Dr Reddy’s Laboratories Ltd has developed the Generic dRug Adoption Framework. Currently available in four languages (English, Portuguese, Spanish, and Russian) and four (Malaysia, Brazil, Colombia, and Ukraine) countries, the framework will enable physicians and pharmacists to identify high-quality generics and help towards switching from originator to generic medicines. This can help to increase the adoption and access for generic medicines. The platform is not intended to guide treatment decisions but can help healthcare providers to differentiate a high-quality generic medicine based on parameters of effectiveness, safety, quality, and costs.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"72 1","pages":"69 - 75"},"PeriodicalIF":0.0,"publicationDate":"2019-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74954011","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}