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

{"title":"Patients’ perceptions of community pharmacists’ role: A cross-sectional study in Lebanon","authors":"Ali Kalash, Georges Hatem, Mohammad Chaheen, S. Awada, S. Rachidi, Roula Ajrouche","doi":"10.1177/17411343241265924","DOIUrl":"https://doi.org/10.1177/17411343241265924","url":null,"abstract":"Recognizing, fostering, and maintaining a favorable public image is crucial for developing strong connections between patients and pharmacists, ultimately enhancing the pharmacist’s influence on healthcare results. Consequently, this research seeks to evaluate how the community perceives the role of pharmacists in Lebanon. A cross-sectional study was conducted among the Lebanese residents over 2 months. One-way analysis of variance assessed the relationship between the perception score and the general characteristics of the study sample. A multivariate analysis was performed using linear regression models to evaluate the combined effect of predictors on the perception score. The study comprised exclusively Lebanese participants, with a slightly higher proportion of males (53.4%) than females (46.6%) and a diverse age distribution, ranging from 18 to 65 years old, with 9.1% being 65 years or older. After adjusting for covariates, females scored 0.25 points lower than males (CI (−0.65, 0.15); p = .217), while individuals aged 40–49 and 50–65 had perception scores of 0.18 and 0.55 points lower than those aged 18–29, respectively (CI (−0.83, 0.48); p = .595 and CI (−1.29, 0.20); p = .153, respectively). Participants from Nabatiyeh had a perception score increase of 0.82 compared to those in Beirut (CI (0.15–1.49); p < .017), and those working in non-medical fields scored 0.90 points lower than others (CI (−1.49, −0.32); p = .002). Individuals with at least one comorbidity scored 0.83 points lower (CI (−1.44, −0.21); p = .008), while patients with public insurance and those with a treatment duration of 6 months had perception scores 0.57 and 0.66 points lower, respectively, compared to their counterparts (CI (−1.12, −0.03); p = .039 and CI (−1.29, −0.03); p = .040). Findings stress the significance of tailored healthcare and consistent patient-pharmacist relationships, especially for managing complex conditions, underscoring the importance of understanding these dynamics to bolster trust and appreciation for community pharmacists in Lebanon.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"19 20","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141817444","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":"Impact of the economic crisis on the health-related quality of life of adults in Lebanon: An observational cross-sectional study","authors":"Rand Sukarieh, Georges Hatem, Nisrine Hajar, Amal Al-Hajje, Mouna Chehabeddine, Mohamad Bassam Sukarieh, S. Awada","doi":"10.1177/17411343241248277","DOIUrl":"https://doi.org/10.1177/17411343241248277","url":null,"abstract":"Background: The economic crisis imposed changes to afford necessities like food, housing, and healthcare, leading to a decline in the physical and mental health of the population. Objectives: This study assessed the impact of the economic crisis on Lebanese adults’ health-related Quality of Life (QoL) and the predictors of lower scores. Methods: A cross-sectional study targeted 561 adults using a uniform questionnaire for data collection and a Short Form 8-item survey. Results: The sample comprised 77.9% females and 22.1% males. More than half of the sample reported a decrease in their income compared to the period before the crisis, and most participants reported that the economic turmoil highly impacted their access to healthcare services (63.0%), medication (51.5%), and food (56.5%) in addition to other necessities. Participants had lower Mental Component (MC) than Physical Component (PC) scores (55.5 and 69.0, respectively). Those highly impacted by the economic crisis in accessing medication had 1.76 times higher odds of lower PC scores than others (OR 1.76, 95% CI: 1.07–3.21). As regards the impact of the economic crisis on the MC scores, significantly higher odds of a lower MC score were noted among those highly impacted by the economic crisis in terms of access to medication (OR 2.12, 95% CI: 1.14–3.95), to food (OR 1.79, 95% CI: 1.1.12–2.87), and encountering water shortage (OR 1.65, 95% CI: 1.01–2.71). Conclusion: Lebanese adults’ QoL suffered physically and psychologically amid the economic crisis. The study underscores the need for accessible and affordable essential healthcare services and necessities.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"4 13","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140674406","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":"Comparison of a brand-name drug and its generic drugs - Impact of anti-human immunodeficiency virus drug exposure on the intestinal epithelial barrier","authors":"Yusuke Takizawa, Yuka Nagai, Miho Ishii, Satoshi Yasunaga, Yuki Aizawa, Takahito Furuya, Takuro Kurita, Junichi Masuda, Takanori Nakajima","doi":"10.1177/17411343241240044","DOIUrl":"https://doi.org/10.1177/17411343241240044","url":null,"abstract":"The use of unapproved anti-human immunodeficiency virus (HIV) drugs for its treatment and prevention has recently increased in Japan. Our research group investigated generic drugs of the Truvada combination tablet (TVD) that have not been approved in Japan, and reported differences in the pharmaceutical properties of their formulations. We also demonstrated that the pharmaceutical excipients in generic drugs may differ from those in TVD, and showed that some pharmaceutical excipients may affect epithelial cell barrier function. The present study investigated differences in the effects of TVD and its generic drugs (Generic A and Generic B) on epithelial cell barrier function. No significant differences were observed in epithelial cell barrier function following exposure to TVD, Generic A, and Generic B. However, significant increases in the mRNA levels of ABCB1 and Occludin, which regulate the epithelial cell barrier, were detected following exposure to Generic B. Therefore, the administration of Generic B for a longer duration or at a higher concentration may lead to changes in epithelial barrier function. Since the treatment and prevention of HIV requires the long-term (chronic) administration of drugs, the drugs used may change, such as from a brand-name drug to a generic drug and also from one generic drug to another. The present results suggest that the effects of brand-name and generic drugs, such as on intestinal epithelial barrier function, may differ with changes in the drugs being administered.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"38 4","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140231652","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":"Factors influencing the creation of an industry 4.0 strategy in the generic pharmaceutical industry","authors":"John Graham","doi":"10.1177/17411343241238178","DOIUrl":"https://doi.org/10.1177/17411343241238178","url":null,"abstract":"This study aims to identify how technological, organizational, and environmental factors influence the creation of an Industry 4.0 (I4.0) strategy in the generic pharmaceutical manufacturing industry. In this study, the technology-organization-environment (TOE) framework is used to explore the factors that influence the creation of an I4.0 strategy in generic pharmaceutical manufacturing organizations. A semi-structured interview case study approach was used to gather data from a generic pharmaceutical company using the company’s creation of a digital strategy as the focus of analysis. The study identifies a paradox where Regulatory Compliance serves both as a driving force for I4.0 strategy creation, aligned with stakeholder pressure, and a potential barrier due to complexity and implementation costs. The impact of regulatory changes, such as those in environmental, social, and governance (ESG) reporting, also contributes to the adoption of I4.0 technologies. The importance of organizational executive leader alignment on the broader environmental context and technical benefits for creating an I4.0 strategy is a key driver to overcome the investment barriers and risks that come with I4.0 strategy implementation in the context of a generic pharmaceutical manufacturing organization.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"241 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140274081","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 Journal of Generic Medicines – Editorial March 2024","authors":"B. Tempest","doi":"10.1177/17411343241231650","DOIUrl":"https://doi.org/10.1177/17411343241231650","url":null,"abstract":"","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"6 7","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140477393","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":"Decoding the perception of prescribers towards generic medicine: A bibliometric study","authors":"Aditya Prasad T, Ashwani Panesar","doi":"10.1177/17411343231226122","DOIUrl":"https://doi.org/10.1177/17411343231226122","url":null,"abstract":"2008 can be considered a watershed year for generic medicine in India, as it saw the launch of the Jan Aushadi scheme, to provide cost-effective quality medicines to its populace, through special stores called Jan Aushadi stores. With more than 8800 stores, the scheme is touted as one of the world’s largest pharmaceutical retail chains. Since then, many generic medicine start-ups have also launched operations in the country- Zeno Health, One India Pharmacy, Generic Aadhaar and StayHappi Generics. These supply side developments will however have to be complemented with commensurate demand side responses for it make a sustainable impact towards the push for affordable and accessible healthcare for all (Sustainable Development Goal 3). Many studies have established that, on the demand side, owing to the lack of requisite medical knowledge on part of the patients, there exists a strong agency relationship, where patients rely heavily on their physicians (prescribers) to make decisions on choice of treatments. Though promotion of generic medicines requires a coordinated effort from many stakeholders, analysis reveals that the prescribers, and hence their perception of generics, plays a pivotal role in their adoption. This study undertakes a bibliometric analysis of the top 100 most-cited research papers published between 2012 and 2022 on the perception of prescribers towards generic medicine from SCOPUS database. Suitable keywords have been incorporated to reach the relevant publications and VOSviewer (version 1.6.10) has been used for analysis. The findings of the study recommend further research on interventions aimed at improving prescriber’s perception towards generic medicines to enhance their adoption and promote cost effective healthcare delivery.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"64 47","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139600326","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":"Lebanese pharmacists’ knowledge of generic drugs and factors affecting their use and selection following the pandemic and the economic crisis: A pilot cross-sectional study","authors":"Maribelle Mansour, Georges Hatem, S. Ballout, Sarah Tarhini, A. Henaine, S. Awada","doi":"10.1177/17411343231199194","DOIUrl":"https://doi.org/10.1177/17411343231199194","url":null,"abstract":"Pharmacists are crucial in lowering pharmaceutical expenditures by substituting brand-name drugs for generic drugs. They are expected to understand the principles and practices of generic drug substitution for high-quality patient care. Some key areas of knowledge include bioequivalence and therapeutic equivalence, regulatory requirements, drug interchangeability, and adequate patient counseling. This study aims to assess the knowledge, perception, and practice of generic drug substitution among pharmacists in Lebanon following the crises and the factors affecting the prescription and selection of generic drugs. A pilot descriptive cross-sectional study targeting 80 Lebanese pharmacists was conducted over 2 months (September-October 2022), in which data were collected using a uniform survey. Overall, pharmacists had a good knowledge of generic drugs in terms of active ingredients (97.5%), pharmaceutical form (85.0%), lower cost (88.7%), bioequivalence to the brand before (95.0%), and therapeutic equivalence. Nevertheless, 22.5% reported that generic drugs are less safe than brands, and 22.5% said they cause side effects or did not know. Among the possible factors that influence the prescription of generic drugs, 35.0% of pharmacists reported that the financial situation of the patient is among the least important factors, while the lack of possible alternatives (45.0%) and the difference in prices (40.0%) were the most important ones. The price of different generics on the market was among the most important factors (36.3%) affecting the selection of generic drugs, followed by the patient’s. preference (26.3%). Only 11.2% considered the information given by pharmaceutical firms could affect their choice, and 10.0% considered the presence or not of excipients with known effects in the formulation. Most pharmacists in Lebanon were familiar with generic drugs and supported generic drug substitution. Factors affecting generic drug use and prescription should be further explored to clarify misconceptions and reduce possible adverse events.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"2 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77790391","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":"Comparison of pharmaceutical characteristics and membrane permeability of truvada combination tablets and its generic drugs","authors":"Y. Takizawa, Naruya Kunii, Junya Oguri, Yuki Aizawa, Takahito Furuya, Takuro Kurita, J. Masuda, Takanori Nakajima","doi":"10.1177/17411343231191653","DOIUrl":"https://doi.org/10.1177/17411343231191653","url":null,"abstract":"Pre-exposure prophylaxis (PrEP) prevents HIV infection through the daily administration of anti-HIV drugs, such as Truvada combination tablets (a combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF)). However, since PrEP is not approved in Japan, generic drugs sold overseas are imported and used by individuals. Then, the present study investigated the pharmaceutical equivalence of two generic drugs of Truvada (Generic A and Generic B). Tablet properties were examined by X-ray diffraction and differential scanning calorimetry. The dissolution behaviors and membrane permeabilities of FTC and TDF were assessed by the dissolution test using the paddle method and a membrane permeation experiment using Caco-2 cell monolayers, respectively. The dissolution behaviors of FTC and TDF differed between Truvada and its generic drugs. Furthermore, the membrane permeation rates of FTC and TDF in Generic B were slower than those in Truvada, and the AUC of FTC in Generic B was significantly smaller than that in Truvada. Differences were observed in the dissolution behaviors and membrane permeabilities of FTC and TDF in generic drugs (particularly Generic B) from those in Truvada. Since there are concerns regarding the clinical implications of these results, further studies, including in vivo experiments, are needed to ensure the safety of generic drugs.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"32 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78733688","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":"EU Legal and Regulatory Update January 2023","authors":"R. Milchior, S. Charbonnel","doi":"10.1177/17411343231158184","DOIUrl":"https://doi.org/10.1177/17411343231158184","url":null,"abstract":"Compiled and written by SCP Herald Herald Avocats is a French law firm involved in intellectual property law, pharmaceutical law and European Union law that provides services to healthcare, biotech and pharmaceutical companies. This section is intended to be a synopsis of recent developments and is not intended to be all comprehensive. If any (issue) information referred to in this section is to be relied upon, specific advice should be sought. Please contact the Editor: Richard Milchior and Séverine Charbonnel SCP Herald 91 rue du Faubourg Saint Honore 75008 Paris France Tel: +33 (0)1 53 43 15 15 Fax: +33 (0) 1 53 43 15 00 Email: r.milchior@herald-avocats.com Email: s.charbonnel@herald-avocats.com","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"41 1","pages":"51 - 59"},"PeriodicalIF":0.0,"publicationDate":"2023-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76112871","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":"Considerations for filing U.S. patent applications in DOCX format","authors":"J. Bousquet","doi":"10.1177/17411343231157315","DOIUrl":"https://doi.org/10.1177/17411343231157315","url":null,"abstract":"Compiled and written by Greenblum & Bernstein PLC AUS intellectual property law firm which provides a full range of services in IP-related matters across all industries, including the biotech and pharmaceutical industries, including: Inter partes Review (IPR) and Post Grant Review (PGR) Abbreviated new drug applications (ANDAs) and Notice Letters Patent and trademark litigation Patent drafting and prosecution Patent infringement and validity opinions Patent reexamination proceedings and interferences New drug strategies Market entry strategies Joint venture strategies Licensing","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"42 1","pages":"46 - 50"},"PeriodicalIF":0.0,"publicationDate":"2023-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77641318","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}