Medical Affairs Department Research Articles

Improved Nursing Workload by Introducing a Traceability System to Manage Medical Materials.

This paper reports a case study in which an improvement in nursing work was achieved through the introduction of a traceability system compatible with radio-frequency identification (RFID) and bar codes for the management of medical materials. In verifying the RFID-based system in an operating room, the work time was reduced to approximately one-tenth of that of barcode reading. In the catheterization laboratory, a system consisting of a cartel management system utilizing bar codes and an RFID-compatible inventory management cabinet was introduced. The system eliminates the need to cut and paste packages onto vouchers after the cases are completed and digitizes the data sent to the medical affairs department for secure billing. We are implementing this system at many facilities, and, in addition to improving the work of nurses, we are taking new steps to improve hospital management through data linkage.

Training needs and educational sources of European musculoskeletal specialists: learning outcomes of the IBSA International Academy – MSK Modules

Background: Building a meaningful training program for musculoskeletal (MSK) specialists is a major undertaking to improve the clinicians’ skills and ultimately patients’ outcome. The purpose of this study was to gather direct information from attendants of a training program called IBSA International Academy – MSK Modules on the perceived benefit of such initiative. Methods: The IBSA International Academy has been developed during 2021 by IBSA’s Global Medical Affairs department with the involvement and support of an international faculty composed by experts in the field that has become the scientific Board of the Academy. More than 100 specialists from several European countries attended one or more modules focused on ultrasound (US) and US-guided infiltration and were asked to answer (a) a short survey just after the modules were completed and (b) a more detailed survey several weeks after their return to daily practice. Results: A total of 114 specialists from 12 European countries attended the academy. The post-module evaluation form was completed by 94 (82.4%) and the follow-up survey by 30 (26.3%) participants. Response rate was highest for specialists from Nordic countries (50.0%) and lowest from Balkan countries (11.1%). The overall feedback of the participants to the academy was overwhelmingly positive both immediately and medium–long term after return to daily practice. About 57% of responders indicated mastering US and 30% indicated a better understanding of the anatomy as a key learning outcome of the academy. The added value of networking between peers and of direct contact with the experts in the faculty was mentioned by 77% and 53% respectively.

Contributions of the Medical Affairs Department to Healthcare Professionals and the Effects of the New Coronavirus Disease 2019 Pandemic on the Contributions

Contributions of the Medical Affairs Department to Healthcare Professionals and the Effects of the New Coronavirus Disease 2019 Pandemic on the Contributions

Survey on the Current Activity of Medical Affairs Department in Japan

Survey on the Current Activity of Medical Affairs Department in Japan

Data Science Projects in Pharmaceutical Industry

The purpose of this paper is to discuss the relevance of data science in Medical Affairs (MA) functions in the pharmaceutical industry, where data is becoming more important for the execution of activities and strategic planning in the health industry. This study analyses pharmaceutical companies who have a data science strategy and the variables that can influence the definition of a data science strategy in pharma companies in opposite to other pharmaceutical companies without a data science strategy. The current paper is empirical and the research approach consists of verifying the characteristics and differences between those two types of pharmaceutical companies. A questionnaire specifically for this research was developed and applied to a sample of 280 pharma companies. The development and analysis of the questionnaire was based on a Systematic Literature Review of studies published up to (and including) 2017 through a database search and backward and forward snowballing. In total, we evaluated 2247 papers, of which 11 included specific data science methodologies criteria used in medical affairs departments. It was also made a quantitative analysis based on data from a questionnaire applied to a Pharma organization. The findings indicate that there is good evidence in the empirical relation between Data Science and the strategies of the organization.

Laparoscopic Versus Open Distal Gastrectomy for Locally Advanced Gastric Cancer: Five-Year Update from the Class-01 Randomized Controlled Trial

BACKGROUND: It is not clear whether laparoscopic and open distal gastrectomy produce similar outcomes in patients with locally advanced gastric cancer. Data from a multicenter, randomized, controlled trial (CLASS-01) showed that laparoscopic distal gastrectomy did not result in inferior disease-free survival at 3 years compared with open distal gastrectomy. Here, we present 5-year overall survival data from this trial. METHODS: From September 2012 through December 2014, we randomly assigned 1056 patients with clinical stage T2, T3, or T4a gastric cancer (without bulky nodes or distant metastases) to undergo either laparoscopic distal gastrectomy or open distal gastrectomy with D2 lymphadenectomy in a 1:1 ratio. We compared 5-year overall survival between groups in the intent to treat population. RESULTS: We analyzed data from 1039 patients who received curative therapy. At 5 years, the overall survival rates were 72.6% in the laparoscopic distal gastrectomy group and 76.3% in the open distal gastrectomy group (log-rank P =0.19; hazard ratio [HR], 1.17; 95% CI, 0.93–1.48; P =0.187). After we compared for competing risk events, gastric cancer-related deaths (HR, 1.14; 95% CI, 0.87–1.49; P =0.34) and deaths from other causes (HR, 1.23; 95% CI, 0.74–2.05; P =0.42) did not differ significantly between groups. Overall rates of survival did not differ significantly between groups with each tumor stage. CONCLUSIONS: Laparoscopic distal gastrectomy with D2 lymphadenectomy results in similar 5-year overall survival compared to open distal gastrectomy in patients with locally advanced gastric cancer by experienced surgeons in high-volume specialized institutions. TRIAL REGISTRATION: ClinicalTrials.gov. number, NCT01609309 FUNDING STATEMENT: This work was supported by the National Natural Science of China, Guangdong Provincial Key Laboratory of Precision Medicine for Gastrointestinal Tumor, the Key Clinical Specialty Discipline Construction Program from the National Health and Family Planning Commission of China, and the Program of Global Medical Affairs Department of Johnson & Johnson Medical Ltd. DECLARATION OF INTERESTS: None. ETHICS APPROVAL STATEMENT: Each participating center obtained institutional review board approval, according to local regulations. Patients provided written informed consent.

How to Manage Pediatric Orthopaedic Patients: Strategies to Provide Safer Care During the COVID-19 Outbreak in Wuhan, People's Republic of China.

How to Manage Pediatric Orthopaedic Patients: Strategies to Provide Safer Care During the COVID-19 Outbreak in Wuhan, People's Republic of China.

Medical Science Liaisons (MSL) in Africa: a perspective.

The role of a Medical Science Liaison (MSL) is of growing importance to pharmaceutical, biotechnology, diagnostic and medical device companies. Through scientific engagement MSLs add value to clinical practice, ultimately benefiting patients. The MSL role is dynamic and encompasses in-depth product and disease knowledge together with the ability to communicate relevant, unbiased scientific information concisely and timely. Tasks are focused on contributing towards the advancement of medical knowledge, scientific data generation and dissemination. Professional relationships are developed, fostering collaboration between external experts and typically the medical affairs departments of pharmaceutical companies through a credible liaison. Through such relationships, critical insights are shared that shape the development pipeline, promote successful clinical translation and guide the market deployment strategy of therapeutic interventions through-out their life cycle. Despite the rising number of MSLs in the field and the implicit medical value of the role, there remains a lack of understanding for what the roles of a MSL entails. In Africa, where exponential growth of the pharmaceutical industry is expected, the number of MSLs will increase rapidly. Given the complexities of the African continent, the MSLs in this burgeoning environment will face various challenges including remote locations, time-constraints, regulatory and bureaucratic hurdles and importantly physician misperception of the MSL role that collectively may thwart the goal of meaningful scientific engagement; but these challenges can be surmounted through astute proactive planning and utilization of opportunities including digital communication strategies.

Effectiveness analysis and inspirations of rational administration of carbapenem

The hospital introduced a multi-department synergy in management of the rational use of carbapenems. Specifically, the medical affairs department conducts training and appraisal of doctors along with a monthly checkup of medical records. The pharmaceutical affairs division conducts prior prescriptions checkup and follow-up comment. The clinical microbiology laboratory and the hospital-acquired infection management department monitors and releases such infection and bacterial resistance information of the whole hospital in real time. The results showed increased prescriptions of imipenem and cilastatin sodium, and decreased prescriptions of biapenem for injection. Drug resistance analysis showed that carbapenem resistant strains increased by 28%, but the total number of patients reduced by 10% and total number of patients with multidrug resistance remained unchanged. It is proposed to further antimicrobial stewardship in the hospital to achieve rational drug use and curb bacterial resistance. Key words: Pharmacy administration; Carbapenem; Antibacterial agent; Rational use

Comment on "In Vivo Drug Delivery Performance of Lipiodol-Based Emulsion or Drug-Eluting Beads in Patients with Hepatocellular Carcinoma".

ADVERTISEMENT RETURN TO ISSUEPREVCommunicationNEXTComment on “In Vivo Drug Delivery Performance of Lipiodol-Based Emulsion or Drug-Eluting Beads in Patients with Hepatocellular Carcinoma”Walter González*†, Jean-Marc Idée†, and Sebastien Ballet‡View Author Information† Research Department, Guerbet, 95943 Roissy CDG, France‡ Medical Affairs Department, Guerbet, 95943 Roissy CDG, France*Guerbet, BP 57400, 95943 Roissy CDG Cedex, France. E-mail: [email protected]. Phone: + 33 1 45 91 69 47. Fax: + 33 1 45 91 51 23.Cite this: Mol. Pharmaceutics 2018, 15, 1, 332–335Publication Date (Web):December 1, 2017Publication History Received23 February 2017Accepted2 August 2017Revised28 July 2017Published online1 December 2017Published inissue 2 January 2018https://doi.org/10.1021/acs.molpharmaceut.7b00138Copyright © 2017 American Chemical SocietyRIGHTS & PERMISSIONSArticle Views326Altmetric-Citations4LEARN ABOUT THESE METRICSArticle Views are the COUNTER-compliant sum of full text article downloads since November 2008 (both PDF and HTML) across all institutions and individuals. These metrics are regularly updated to reflect usage leading up to the last few days.Citations are the number of other articles citing this article, calculated by Crossref and updated daily. Find more information about Crossref citation counts.The Altmetric Attention Score is a quantitative measure of the attention that a research article has received online. Clicking on the donut icon will load a page at altmetric.com with additional details about the score and the social media presence for the given article. Find more information on the Altmetric Attention Score and how the score is calculated. Share Add toView InAdd Full Text with ReferenceAdd Description ExportRISCitationCitation and abstractCitation and referencesMore Options Share onFacebookTwitterWechatLinked InReddit Read OnlinePDF (265 KB) Get e-AlertsSUBJECTS:Antineoplastic agents,Cancer,Drug delivery,Pharmacokinetics,Tumors Get e-Alerts

Investigation and analysis on patients of extended stay at 11 hospitals in Beijing

Objective To investigate and analyze the status quo of the patients of extended stay at 11 clinical hospitals of a general university in Beijing, and explore the countermeasures and solutions. Methods Contact with the medical affairs departments of these hospitals to collect information about such patients of extended stay. Results A total of 43 cases of patients were identified as extended stay at these hospitals, accounting for 0.00% to 0.93% of total beds. Their stay ranged from 1 month to 15 years, including 17 cases with medical disputes (39.5%), and 26 cases without (60.5%). Conclusions The phenomenon of extended stay at hospitals deserve enough attention and appropriate actions accordingly. Key words: Clinical hospitals; Extended hospital stay; Investigation and analysis; Medical disputes

The Physician Quality Improvement Initiative: Engaging Physicians in Quality Improvement, Patient Safety, Accountability and their Provision of High-Quality Patient Care.

University Health Network has been working to become a high-reliability organization, with a focus on safe, quality patient care. In response, the Medical Affairs Department has implemented several strategic initiatives to drive accountability, quality improvement and engagement with our physician population. One of these initiatives, the Physician Quality Improvement Initiative (PQII) is a physician-led project designed to provide active medical staff, in collaboration with their physician department chiefs, a comprehensive approach to focused and practical quality improvement in their practice. In this document, we outline the project, including its implementation strategy, logic model and outcomes, and provide discussion on how it fits into UHN's global strategy to provide safe, quality patient care.

Information provided by generic and brand-name pharmaceutical manufacturers in response to a request

To assess the medical information provided by manufacturers in response to a specific request, and to compare the responses between generic and brand-name companies. Community pharmacy in Spain. A systematic request for product monographs was made between 1999 and 2002 to manufacturers registering new medicines in Spain. A standardised letter was sent to the medical affairs departments. If there was no reply after 3 months, a second standardised letter was sent requesting the monograph. Blood derivatives, intravenous medicines, and radiological contrast agents were excluded. The delay that occurred in receiving information and the type of material sent in response to the request was compared between the two types of companies. About of 833 medicines from 185 manufacturers were registered during the time period studied. After applying exclusion criteria, 805 medicines, including 419 (52.0%) generic and 386 (48.0%) brand-name products, were analyzed. No replies were received for 242 (30.0%) requests 183 (43.7%) generics and 59 (15.3%) brand-names; P < 0.005). We received 369 (65.5% of 533) replies after the first request: 140 of 236 (59.3%) generics and 229 of 327 (70.0%) brand-names (P = 0.009). The average response delay was 9.7 days [CI95%: 8.65-10.68]. There was a statistically significant difference between generic and brand-name companies after the first request (P = 0.001), but not after the second request (P = 0.312). Brand-name manufacturers reply more often, more quickly, and with better quality information than generic manufacturers.

TIGECYCLINE USE IN CRITICALLY ILL OLDER PATIENTS: CASE REPORTS AND CRITICAL ANALYSIS

TIGECYCLINE USE IN CRITICALLY ILL OLDER PATIENTS: CASE REPORTS AND CRITICAL ANALYSIS

The Emerging Role of Medical Affairs within the Modern Pharmaceutical Company

Medical affairs groups are an increasingly vital part of the modern pharmaceutical company. This review will highlight the major functions, customary organizational structure, and responsibilities of medical affairs departments. These groups perform a wide range of activities often overlapping with sales, marketing, clinical development, and customer service. Medical affairs personnel must strive for the highest scientific integrity in order to produce successful clinical trials and provide the greatest support for the market. It is important that they well understand the regulations surrounding their activities and appreciate the commercial implications of their work. How well the medical affairs group maintains this delicate balance will determine its overall success.

Medical Affairs and Drug Information Practices Within the Pharmaceutical Industry: Results of a Benchmarking Survey

Pharma or biotech companies that are looking to develop and implement a medical affairs department, or current directors who are looking for ways to assess the performance of their department, find...

Aldesleukin therapy in HIV-infected patients.

Journal Article Aldesleukin therapy in HIV-infected patients Get access David J. Sundin, Pharm.D., David J. Sundin, Pharm.D. Drug Information Associate, Professional Services Department Medical Affairs Department, Chiron Therapeutics, Emeryville, CA Address reprint requests to Dr. Sundin at the Professional Services Department, Chiron Therapeutics, Emeryville, CA 94608, or to david_sundin@cc.chiron.com. Search for other works by this author on: Oxford Academic Google Scholar Maurice J. Wolin, M.D. Maurice J. Wolin, M.D. Director Medical Affairs Department, Chiron Therapeutics, Emeryville, CA Search for other works by this author on: Oxford Academic Google Scholar American Journal of Health-System Pharmacy, Volume 55, Issue 14, 15 July 1998, Pages 1520–1523, https://doi.org/10.1093/ajhp/55.14.1520 Published: 15 July 1998

Weak Data Mire Colon Screening Debate

NEW DATA are not quelling the colon cancer screening controversy. The American Cancer Society is sticking to its advice for fecal occult blood tests to be performed after age 40 and flexible sigmoidoscopy after age 50. This is despite a new Congressional Office of Technology Assessment report. It concludes that screening does not detect enough colon cancer, the second leading cause of cancer death, to justify the cost to Medicare, especially when there is no proof of any impact on mortality ( JAMA . 1990;264:2732). Looking at exactly the same data, we come up with a different conclusion, says Charles M. Huguley, Jr, MD, a consultant to the American Cancer Society's Medical Affairs Department and professor emeritus at Emory University School of Medicine, Atlanta, Ga. Screening proponents at recent gastroenterology meetings have presented studies they say show that more intensive follow-up of positive stools with colonoscopy is mandatory. One analysis says doing

Careers for Pharmacists in the Pharmaceutical Industry: Perspective on Medical Affairs

Pharmaceutical industry represents a potential career path for pharmacists. Industry positions currently available to pharmacists, particularly those for individuals with advanced degrees, are expanding. This article will focus on opportunities for career-oriented pharmacists within a medical department with particular reference to a pharmaceutical company that markets nonprescription drug products. Although the potential responsibilities with this area may vary between companies, this article will focus on the areas of drug information, adverse drug experience reporting, postmarketing surveillance, and medical writing. These topics have been selected because they represent some of the responsibilities of pharmacists within the Medical Affairs Department at McNeil Consumer Products Company, a member of the Johnson &amp; Johnson Family of Companies. In addition to job-related responsibilities, the suitability of a pharmacy education along with potential rewards and frustrations of working within the pharmaceutical industry are also presented.

Rational Use of Methenamine Mandelate

Journal Article Rational Use of Methenamine Mandelate Get access R. M. Gabrielson, M.D. R. M. Gabrielson, M.D. Medical Affairs Department Warner-Lambert Company Pharmaceutical Division 201 Tabor Road Morris Plains, NJ 07950 Search for other works by this author on: Oxford Academic Google Scholar American Journal of Hospital Pharmacy, Volume 36, Issue 12, 1 December 1979, Page 1658, https://doi.org/10.1093/ajhp/36.12.1658 Published: 01 December 1979