A bibliometric analysis of publication output in selected South American countries.

Research output provides an insight into the development of the scientific capability of a country. Budget allocation for research and development (R&D) is directly proportional to the research output of a country. Bibliometric analysis of South American countries has not been done in many studies. The purpose of this paper was to analyse research outputs from South American countries on various metrics. An analysis was done for a period of 11 years from 2010 to 2020. The analysis revealed that Brazil with highest percentage of research spend has lowest Field Weighted Citation Impact (FWCI). This contrasts with Uruguay, whose FWCI is high despite comparatively lower spend on R&D and lower publication output. Although Argentina has the highest percentage of researchers per million population (1202), it has the least papers per researchers (0.3 per year) among the countries studied. A huge disparity in terms of percentage of research spent, research output, papers per researcher, and output with national and international co-authorship was observed.

A Systematic Literature Review of Gaps and Challenges in Value Assessment of Biosimilars: An ISPOR Special Interest Group Report.

OBJECTIVES: This study aims to provide an overview of the gaps and challenges in the value assessment of biosimilars and to identify potential approaches to address them. METHODS: A multidisciplinary, international team of biosimilar experts identified gaps and challenges. A systematic review was conducted of the peer-reviewed literature in PubMed, EMBASE, Web of Science Core Collection, EBSCOhost Business Source Complete; and of the gray literature. Preliminary results were presented at ISPOR conferences and this article benefited from 2 review rounds among ISPOR Biosimilar Special Interest Group members. RESULTS: Given that a biosimilar is highly similar to its reference biologic, health technology assessment agencies should accept the comparability exercise approved by regulatory authorities and, thus, conduct a price comparison when biosimilar reimbursement is requested for the same indication as the reference biologic. If the reference biologic is not reimbursed or is not the standard of care, a full economic evaluation of the biosimilar versus a relevant comparator needs to be conducted. To date, little consideration has been given to specific challenges, such as how biosimilar value assessment can account for the nocebo effect, potential differences between biologic-naive and biologic-experienced patients, the availability of intravenous and subcutaneous administration forms or different administration devices for the same active compound, value-added services, and the contribution of biosimilars for generating health gain at the population level. CONCLUSIONS: There is a need to gather further insights in the methodology of value assessment for biosimilars, and health technology assessment agencies need to develop more elaborate guidance on biosimilar value assessment in specific circumstances.

Review on 505(b)(2) Drug Products Approved by USFDA from 2010 to 2020 Emphasizing Intellectual Property and Regulatory Considerations for Reformulations and New Combinations.

Repurposing is considered an attractive approach for developing new drug products. However, it consists of challenges relating to intellectual property (IP) protection, and regulatory approvals. This study aimed to analyze the recent trends in repurposed drugs approved by USFDA from 2010 to 2020 and to assess the challenges connected with bridging study requirements, patent protection, and exclusivities. Out of 1001 NDAs, 570 were approved via 505(b)(2) pathway. Of 570 NDAs, the highest number of approvals are allied to type 5-new formulations (42.4%), followed by type 3-new dosage forms (26.4%) and type 4-new combinations (13.1%). Of 570 NDAs, 470 are considered to examine the patent and exclusivity protection of which 341 have patent and/or exclusivity. A total of 97 type-3 and type-5 and 14 type-4 drugs have been approved based on human bioavailability/bioequivalence (BA/BE) data. For 131 type-3 and type-5 and 34 type-4 drugs, the applicants conducted new clinical (efficacy and/or safety) studies along with BA/BE (100 drugs) or without BA/BE (65 drugs) studies. In this review, mechanistic reasons for conducting new clinical investigations, IP and regulatory considerations along with broader perspective on new pharmaceutical approaches employed in 505(b)(2) drugs are illustrated that provide guidance for development of reformulations and combinations.

Publication analysis in Bay for Bengal Initiative for Multi-Sectoral Technical and Economic Cooperation Nations.

Background: Research output provides an insight into the development of the scientific capability of a country. Budget allocation for research and development (R&D) is directly proportional to the research output of a country. While developed countries spend a significant percentage of their GDP on R&D, developing countries do not have enough resources to invest in R&D. Countries in the Bay of Bengal Initiative for Multi-Sectoral Technical and Economic Cooperation (BIMSTEC) Nations has received significantly less attention from outside the region in studying R&D and research publication scenario of the region. The research output of BIMSTEC countries was analyzed using various metrics in this paper. Methods: Data on citation per paper, Field Weight Citation Impact (FWCI), paper per researcher, collaborative publications, and output in top 10 percent journals was extracted from one of the largest abstract and citation database of peer-reviewed literature, Scopus and its affiliate SciVal, for a period of 6 years between 2012-2017. Percentage of R&D spend, researchers per million population, and total scientific output were extracted from World Bank data. Results: India and Thailand have a higher quantum of publications compared to other countries. Subjects like clinical, technology, Computer Science have a larger publication number as compared to other subject areas like Social Science, Arts, Education, Law, and Physiology. The researcher population and research spend of a nation have an evident implication on the publication though no direct relation can be derived. Conclusion: Huge disparities in terms of percentage of research spent, research output, papers per researcher, and output with national and international authorship differ for countries. Higher research spent and publication count are not positively correlated with better FWCI.

A bibliometric study on the research outcome of Brazil, Russia, India, China, and South Africa.

Background: Publication is one of the quantitative measures of countries' contribution to research and innovation. This paper attempts to understand the publication related information of the BRICS countries (Brazil, Russia, India, China, and South Africa). Methods: Detailed analysis of publications on the basis of collaboration, research area, number of publications, percentage of Gross Domestic Product (GDP) spent on research, and citation is presented in the paper. An attempt is also made to understand the relations between each of the parameters and the overall performance of the country. Results: Times Higher Education global ranking is considered as a measure to validate the claims of this paper. This study shows that among the BRICS nations, China with the highest percentage of GDP spent on research has also the highest number of researchers and publication output whereas South Africa excels in terms of number of international collaborative publications and publications in high impact journals. This article has highlighted the distribution of publications as per the subject area with India leading in the area of Computer Science.  Discussion: Results showed a strong relationship between each of the parameters discussed on the research performance of a country.

Identifying dispensing errors in pharmacies in a medical science school in Trinidad and Tobago.

BACKGROUND: A dispensing error can be defined as an inconsistency between the drug prescribed and drug dispensed to a patient. These errors can lead to ineffective and sometimes unwanted pharmaceutical outcomes. Dispensing errors can be harmful or even fatal to patients. CASE PRESENTATION: The objective to this study was (a) to determine the types and frequency of dispensing errors at the Eric Williams Medical Sciences Complex (EWMSC), (b) to explore the reasons for the occurrence of dispensing errors, and (c) to make suitable recommendations for their prevention. An observational study for a period of 2 weeks was carried out at various in- and outpatient departments of the EWMSC. The observations were carried out during 7:00 am to 3:00 pm. Dispensing errors identified during this period were recorded and analyzed. RESULTS: Sixty-eight errors were identified in the adult outpatient pharmacy of the EWMSC; 19 errors in the pediatric outpatient pharmacy, whereas 22 errors were found in inpatient pharmacy. The most common plausible causes for the dispensing errors include high workload, failure to verify patient information, incorrect data in the pharmacy's record system, inadequate notes made by pharmacists during prior patient visit, and in a few cases, uncomfortable working conditions. CONCLUSION: Dispensing errors were encountered in 2.1% of all the prescriptions filled at the EWMSC pharmacies. The factors which influenced these dispensing errors include but are not limited to a heavy workload, distractions, failure to verify patient information, and uncomfortable working conditions.

Analysis of FDA Warning Letters Issued to Indian Pharmaceutical and Medical Device Companies: A Retrospective Study.

BACKGROUND: FDA issues warning letters to pharmaceutical manufacturers, distributors, or clinical investigators if it observes serious violations of federal regulations. These warning letters contain the details about the nature of the violations observed and the corrective actions recommended by the FDA. A follow-up inspection may be requested by the recipient after taking the corrective actions. METHODS: Analysis of warning letters issued to Indian pharmaceutical companies from January 1, 2005, to December 31, 2018, was carried out. The warning letters were extracted from FDA's public database. RESULTS: Across the 14-year study period, the number of warning letters issued to Indian pharmaceutical and medical device manufacturers has gradually increased. Of all the violations listed in these warning letters, 85.87% were related to the failure of compliance with the cGMP guidelines. Moreover, 80.72% of these warning letters were not followed by a close-out warning, which indicated that the violations listed in these warning letters could not be resolved. CONCLUSION: As the inability of the recipients to comply with the cGMP guidelines formed the majority of the violations observed in the warning letters, more resources and manpower have to be assigned to the manufacturing process of the pharmaceutical products.

Bachelor of pharmacy graduates' perceptions of the pharmacy administration curriculum in Trinidad and Tobago.

INTRODUCTION: As the profession of pharmacy has evolved, pharmacy education has developed to include competencies and skills related to pharmacy administration services. Competencies taught in pharmacy administration courses are expected to provide graduates with skills to effectively undertake administrative functions. Our study aimed to assess perceptions about knowledge and skills gained by the pharmacists during the Pharmacy Administration course at the School of Pharmacy, the University of the West Indies (UWI), Trinidad and Tobago. METHODS: A cross-sectional survey was carried out among pharmacists working in hospitals and community pharmacies in Trinidad using non-probability convenience sampling. A structured questionnaire was distributed to 262 pharmacists who completed the Pharmacy Administration course. Two-hundred eighteen (83%) usable responses were included for analysis. RESULTS: Many (45.4%) respondents agreed that the course provided them with the knowledge of running a business, 78% said they were able to apply the skills in their practice, and 80% mentioned that the course should be mandatory. Pharmacists found that the course on business management enhanced their knowledge in the fields of managing human resources, conflict management, marketing, project management, corporate turnaround, inventory, and financial management. CONCLUSIONS: The Pharmacy Administration course in the bachelor of science degree in pharmacy programme at the School of Pharmacy, UWI remains relevant in the areas of marketing, human resource management, and inventory management. The programme can be extended to a full time masters course to interested pharmacy graduates.

Analysis of FDA Warning Letters Issued to Indian Pharmaceutical and Medical Device Companies: A Retrospective Study.

BACKGROUND: FDA issues warning letters to pharmaceutical manufacturers, distributors, or clinical investigators if it observes serious violations of federal regulations. These warning letters contain the details about the nature of the violations observed and the corrective actions recommended by the FDA. A follow-up inspection may be requested by the recipient after taking the corrective actions. METHODS: Analysis of warning letters issued to Indian pharmaceutical companies from January 1, 2005, to December 31, 2018, was carried out. The warning letters were extracted from FDA's public database. RESULTS: Across the 14-year study period, the number of warning letters issued to Indian pharmaceutical and medical device manufacturers has gradually increased. Of all the violations listed in these warning letters, 85.87% were related to the failure of compliance with the cGMP guidelines. Moreover, 80.72% of these warning letters were not followed by a close-out warning, which indicated that the violations listed in these warning letters could not be resolved. CONCLUSION: As the inability of the recipients to comply with the cGMP guidelines formed the majority of the violations observed in the warning letters, more resources and manpower have to be assigned to the manufacturing process of the pharmaceutical products.

Informed consent: Issues and challenges.

Informed consent is an ethical and legal requirement for research involving human participants. It is the process where a participant is informed about all aspects of the trial, which are important for the participant to make a decision and after studying all aspects of the trial the participant voluntarily confirms his or her willingness to participate in a particular clinical trial and significance of the research for advancement of medical knowledge and social welfare. The concept of informed consent is embedded in the principles of Nuremberg Code, The Declaration of Helsinki and The Belmont Report. Informed consent is an inevitable requirement prior to every research involving human being as subjects for study. Obtaining consent involves informing the subject about his or her rights, the purpose of the study, procedures to be undertaken, potential risks and benefits of participation, expected duration of study, extent of confidentiality of personal identification and demographic data, so that the participation of subjects in the study is entirely voluntary. This article provides an overview of issues in informed consent: The obligations of investigator, sponsor and Institutional Review Board to protect rights and welfare of human research subjects. It discusses about the basic elements of informed consent and the process to be followed while obtaining informed consent. Some of the circumstances under which informed consent can be waived and ethical challenges faced by physicians in obtaining informed consent from subjects are also highlighted in this article.

Medical device vigilance systems: India, US, UK, and Australia.

The term medical device includes a wide category of products ranging from therapeutic medical devices exerting their effects locally such as tissue cutting, wound covering or propping open clogged arteries, to highly sophisticated computerized medical equipment and diagnostic medical devices. To achieve uniformity among the national medical device regulatory systems and increase the access to safe, effective, and clinically beneficial medical technologies, the Global Harmonization Task Force (GHTF) was conceived in 1992 by five members: European Union, United States, Australia, Japan, and Canada. All regulated countries have clearly defined medical devices, as has the GHTF. Although GHTF has tried to achieve harmonization with respect to medical devices, some differences still exist in the national laws of the countries of GHTF. Further, regulated countries have classified medical devices on the basis of their associated risk. In the Indian regulatory system, medical devices are still considered as drugs. In 2006, the Medical Device Regulation Bill was recommended to consolidate laws for medical devices and to establish the Medical Device Regulatory Authority of India. In addition, medical devices are not classified by any Indian regulatory authority. Although India has moved towards harmonizing its medical device regulations with those of regulated countries, this study aims to identify whether India should have a vigilance system in harmony with those of GHTF or develop its own system for medical devices.