Drug information journal : DIJ / Drug Information Association最新文献

{"title":"Content Analysis of Television Advertising for Drugs That Switch From Prescription to Over-the-Counter: Balancing Information and Appeals","authors":"A. Faerber, D. Kreling","doi":"10.1177/0092861512438765","DOIUrl":"https://doi.org/10.1177/0092861512438765","url":null,"abstract":"This study explored the content of advertising for drugs that switched from prescription to over-the-counter (OTC). Unique advertisements from the Vanderbilt TV News Archive were selected for drugs that switched from prescription to OTC from 1996 through 2009 (98 ads for 3 products). Each advertisement was analyzed for the presence of 11 types of drug information and for repetition of 23 types of drug-specific advertising appeals. Prescription and OTC ads had 1 or 2 types of information, and all ads contained the name of the condition the drug is intended to treat. Each ad contained, on average, 7.75 drug appeals, and OTC ads had more appeals (9.1) than prescription ads (6.0). The most often used appeals were symptom control, convenience, and long-lasting. Almost one-third of OTC advertisements (31%) advertised the product had recently switched to OTC. The authors concluded that prescription ads did not contain more drug information than OTC ads, and OTC ads contained more appeals to consumers as to the benefits of the product.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"34 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129395200","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":"Transparency in Drug Submission Processes of 3 Asian Countries: A Survey of Industry Views","authors":"Martin Solberg, Frances J. Richmond","doi":"10.1177/0092861512436583","DOIUrl":"https://doi.org/10.1177/0092861512436583","url":null,"abstract":"This study evaluated drug-registration transparency in 3 Pharmerging markets, South Korea, China and India, using the US as a comparator. Focus group methods were used to identify factors perceived by regulatory experts as important in defining transparency in regulatory agencies. This input was used to guide the development of a survey to evaluate drug-registration transparency, which was administered to 64 regulatory professionals responsible for international drug registration. Respondents viewed the US as most transparent, South Korea as intermediate in transparency, and China and India as least transparent. The survey instrument appears to provide a novel way to study regulatory transparency, based on 3 key aspects of transparency: clarity, accessibility, and accountability. With minor change, it could be adapted to study the transparency of more countries and product categories including medical devices and in vitro diagnostics.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"142 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116047859","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":"Survey of Real-World Research Workforce, Training, and Education: Report from the DIA Real-World Outcomes Task Force","authors":"R. Gliklich, J. Glennie, P. Mattox, J. Graff, S. Garner, C. Marrone, F. Shaya, J. E. Hansen, Jack Lewin, S. Blackburn, M. Berger, N. Dreyer","doi":"10.1177/0092861512437760","DOIUrl":"https://doi.org/10.1177/0092861512437760","url":null,"abstract":"The demand for real-world research (RWR) from many stakeholders has resulted in an increasing need for well-trained professionals who understand how to perform and evaluate RWR and to interpret the results of such data. The Drug Information Association (DIA) Real World Outcomes Task Force (RWOTF) developed a survey to explore North American workforce and training needs in RWR for DIA’s constituencies. The primary goals of the project were to assess current and future capacity to perform and interpret real-world outcome studies and identify the educational needs and the potential role of DIA in the RWR arena. The survey confirmed that the use of RWR is growing, and identified key barriers to using RWR. Organizational needs for RWR are increasing and a well-trained workforce to perform or use RWR is critical. However, the current workforce is not considered sufficient and there appear to be significant gaps in available training programs. There are clear opportunities for organizations like DIA to help meet the demand for training and education.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"221 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129755934","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":"Editor’s Commentary: Ethics in Clinical Research","authors":"J. R. Turner","doi":"10.1177/0092861512438841","DOIUrl":"https://doi.org/10.1177/0092861512438841","url":null,"abstract":"Ethics are often thought of as ‘‘something for someone else to be concerned about.’’ Nothing could be further from the truth. Everyone involved in clinical research must be concerned with ethics, whatever his or her role in the overall spectrum of medical product development. Identification of areas in which the highest ethical conduct is paramount is easier in some cases than others. Consider the manner in which subjects participating in clinical trials must be treated. Guiding ethical principles include clinical equipoise, respect for persons, beneficence, and justice. Clinical equipoise exists when all of the available evidence about an investigational drug does not show that it is more beneficial than an alternative and, equally, does not show that it is less beneficial than the alternative. For example, to be able to conduct a clinical trial that involves administering a drug to some individuals and a control treatment (often a placebo) to others, there cannot be any evidence that suggests the investigational drug shows greater efficacy than the control treatment or that it leads to greater side effects than the control treatment. When individuals agree to participate in a clinical trial they do so with the understanding that all of the treatments in the trial are assumed to be of equal value. By the end of the trial (or at the time an interim analysis is conducted, discussed in due course), there may be compelling evidence that the drug is acceptably safe and more effective than the control treatment, but the trial must be started with a good faith belief that the drug and the control treatment are of equal merit. The second principle, respect for persons, necessitates that investigators give potential subjects all pertinent information about the study and answer any questions. If an individual then agrees to participate voluntarily (ie, he or she is not coerced in any real or implied manner), informed consent is obtained. This involves obtaining the subject’s written permission (or the written permission of a parent or guardian) to participate in the study. It also necessitates protecting subjects with possibly impaired decision-making capacity and maintaining confidentiality of all information obtained at every stage of the study procedures. The principle of beneficence requires that the study design is scientifically sound and that any risks of the research are acceptable in relation to the likely benefits from the study at the public health level, and the principle of justice requires that the burdens and benefits of participation in clinical trials are distributed evenly and fairly. Historically, populations that were easily and conveniently accessed by researchers, such as prison inmates, nursing home residents, and people with poor access to general health care, have been used when they should not have been. Vulnerable populations should not be deliberately chosen for participation in clinical trials when nonvulnerable populations wo","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"13 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134053296","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":"Quantum of Effectiveness Evidence in FDA’s Approval of Orphan Drugs","authors":"F. J. Sasinowski","doi":"10.1177/0092861511435906","DOIUrl":"https://doi.org/10.1177/0092861511435906","url":null,"abstract":"One of the key underlying issues facing the development of effective for their intended uses. all drugs, and particularly orphan drugs, is what kind of evidence the Food and Drug Administration (FDA) requires for FDA has for many decades acknowledged that there is a need approval. The Federal Food, Drug, and Cosmetic [FD&C] Act provides that for FDA to grant approval for a new drug, there ample, one of FDA’s regulations states that: “FDA will apmust be “substantial evidence” of effectiveness derived from prove an application after it determines that the drug meets the “adequate and well-controlled investigations.” This language, statutory standards for safety and effectiveness... While the which dates from 1962, provides leeway for FDA medical restatutory standards apply to all drugs, the many kinds of drugs viewers to make judgments as to what constitutes “substantial that are subject to the statutory standards and the wide range -","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"228 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"126133379","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":"Review of Genotoxic Impurities: Strategies for Identification and Control\u0000","authors":"T. Allio","doi":"10.1177/0092861512436582","DOIUrl":"https://doi.org/10.1177/0092861512436582","url":null,"abstract":"","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128781764","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":"Associate Editor’s Commentary: PEEKABOO—ETASU!","authors":"Peter J. Pitts","doi":"10.1177/0092861512438840","DOIUrl":"https://doi.org/10.1177/0092861512438840","url":null,"abstract":"Risk management cannot exist without a more holistic understanding and acceptance of the ‘‘Responsibility of Risk.’’ Risk management means more than Risk Evaluation and Mitigation Strategies (REMS) and tactics, and more than validated methodologies and therapeutic registries. It is not about the management of risk, but assuming the mantle of responsibility. Risk management cannot solely be about doing what is necessary to get a product approved and abiding by outdated adverse event reporting mechanisms. We need more than MedWatch and MedGuides. Accepting the responsibility of risk means that we must stop being translucent and start being transparent. Risk management is more than just doing what we’re told, of being in compliance. We know better. The responsibility of risk is a shared responsibility. It must be more than what the FDA expects from industry and more than what industry expects from the FDA. It is what all parties to the public health conversation must expect from themselves, which means going far beyond anything to do with marketing or sales or stock price or legislative authority. It means doing what’s right in addition to what is required. The responsibility of risk, therefore, means doing what’s in the best interest of the patient fully and completely and beyond what is required—even when it is contrary (or viewed as such) to short-term sales and marketing objectives. If we allow either profit or politics to trump the best interests of the public health, we should change jobs. Abraham Lincoln said that patents ‘‘add the fuel of interest to the passion of genius.’’ To paraphrase, accepting the responsibility of risk adds the fuel of interest to the passion for serving the public health. The responsibility of risk means appreciating and actualizing the philosophy of the safe use of drugs. For example, the responsibility of risk means not just detailing—but detailing the label. Traditional risk management means finding ways to avoid risk, to mitigate it. That is certainly important, but it’s tactical— and very 20th Century. In the 21st Century we have to invent new strategies, which starts with embracing risk just as we embrace benefit. Otherwise all we are left with is an inadequate system of early safety signal communications. The responsibility of risk is global. Acknowledging the responsibility of risk means embracing the urgency for harmonized global pharmacovigilance. Other than that, it’s pretty easy and straightforward.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"114 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122508213","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":"Complex Drugs and Biologics: Scientific and Regulatory Challenges for Follow-on Products","authors":"J. Nicholas","doi":"10.1177/0092861512437759","DOIUrl":"https://doi.org/10.1177/0092861512437759","url":null,"abstract":"Since the passage of the Health Care Reform Act, the Food and Drug Administration has been working to develop consistent regulations for the approval of biosimilar drugs. However, there has been little public discussion of the scientific challenges associated with approval of follow-on versions of non-biologic complex drugs (NBCDs), which more closely resemble biologics than small-molecule drugs. Abbreviated new drug applications (ANDAs) are appropriate for low-molecular-weight, well-characterized drugs. In contrast, some complex drugs, including synthetic proteins and polypeptides, are not characterizable or amenable to therapeutic equivalence testing. Essential to new regulations for biosimilars are guidelines for the necessary degree of similarity to the innovator drug, and the extent of testing needed to demonstrate safety and efficacy of the follow-on product. These issues also apply to follow-on NBCDs, as exemplified by experience with members of the glatiramoid class. As the FDA and Congress develop legislation for biosimilars, regulatory guidelines for follow-on versions of NBCDs should be addressed.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"12 2","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"120896590","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":"2012 EuroMeeting Student Poster Abstracts","authors":"","doi":"10.1177/0092861512437910","DOIUrl":"https://doi.org/10.1177/0092861512437910","url":null,"abstract":"","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"57 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116226806","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":"An Exploratory Analysis of Pharmaceutical Drugs as Basic Research Tools","authors":"J. Calfee, E. Dupré","doi":"10.1177/0092861512436581","DOIUrl":"https://doi.org/10.1177/0092861512436581","url":null,"abstract":"Drug development is usually seen as following a more or less linear path from publicly subsidized basic research to costly preclinical and clinical research by for-profit firms, which usually fails but occasionally succeeds in bringing highly profitable drugs to market. This study describes an additional feedback process in which pharmaceutical drugs serve as research tools. Diverse examples illustrate that the tools function of pharmaceuticals supports important advances in basic research. These often lead in turn to practical uses including new drug development.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"4 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125260514","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}