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Value in Health Regional Issues Sep 2018To provide a detailed overview of the recent reforms in pharmaceutical pricing and reimbursement processes as well as in other important areas of the pharmaceutical...
OBJECTIVES
To provide a detailed overview of the recent reforms in pharmaceutical pricing and reimbursement processes as well as in other important areas of the pharmaceutical policy in Greece.
METHODS
Information was collected via a structured questionnaire. The study used publicly available resources, such as publications, relevant legislation, and statistical data, while health experts were also consulted.
RESULTS
Recent pharmaceutical reforms included significant price cuts, increased co-payments and some provisions for vulnerable groups, rebates/clawbacks, mandatory electronic prescribing and prescription by international nonproprietary name, generics substitution, prescription limits and detailed auditing, centralized procurement, as well as changes in the pricing and reimbursement processes, with the introduction of positive and negative lists and an internal price referencing system. Price lists are compiled by the National Organization for Medicines and are issued by the Ministry of Health (MoH). An advisory pricing committee comprising representatives of stakeholder groups was abolished in early 2018. Nevertheless, under the new provisions, a health technology assessment body for the economic evaluation of reimbursed drugs is to be established for the first time in Greece. The committee is to be staffed by experts appointed by a ministerial decision of the MoH. The specific features of the process are yet to be determined.
CONCLUSIONS
The pricing and reimbursement decision-making processes are centralized under the competence of the MoH. Despite the good intentions of the reformers, there are still some aspects of transparency, equity, and long-term sustainability that remain under question in Greece.
Topics: Costs and Cost Analysis; Delivery of Health Care; Drug and Narcotic Control; Government Agencies; Greece; Health Policy; Humans; National Health Programs; Prescription Drugs; Reimbursement Mechanisms; Surveys and Questionnaires; Technology Assessment, Biomedical
PubMed: 30195093
DOI: 10.1016/j.vhri.2018.06.006 -
Molecular Immunology Aug 2018A systematic nomenclature for allergens originated in the early 1980s, when few protein allergens had been described. A group of scientists led by Dr. David G. Marsh... (Review)
Review
A systematic nomenclature for allergens originated in the early 1980s, when few protein allergens had been described. A group of scientists led by Dr. David G. Marsh developed a nomenclature based on the Linnaean taxonomy, and further established the World Health Organization/International Union of Immunological Societies (WHO/IUIS) Allergen Nomenclature Sub-Committee in 1986. Its stated aim was to standardize the names given to the antigens (allergens) that caused IgE-mediated allergies in humans. The Sub-Committee first published a revised list of allergen names in 1986, which continued to grow with rare publications until 1994. Between 1994 and 2007 the database was a text table online, then converted to a more readily updated website. The allergen list became the Allergen Nomenclature database (www.allergen.org), which currently includes approximately 880 proteins from a wide variety of sources. The Sub-Committee includes experts on clinical and molecular allergology. They review submissions of allergen candidates, using evidence-based criteria developed by the Sub-Committee. The review process assesses the biochemical analysis and the proof of allergenicity submitted, and aims to assign allergen names prior to publication. The Sub-Committee maintains and revises the database, and addresses continuous challenges as new "omics" technologies provide increasing data about potential new allergens. Most journals publishing information on new allergens require an official allergen name, which involves submission of confidential data to the WHO/IUIS Allergen Nomenclature Sub-Committee, sufficient to demonstrate binding of IgE from allergic subjects to the purified protein.
Topics: Allergens; Animals; Databases, Factual; Humans; Immunoglobulin E; World Health Organization
PubMed: 29625844
DOI: 10.1016/j.molimm.2018.03.003 -
Cerebrovascular Diseases (Basel,... 2022Internationally, women are underrepresented as leaders in major scientific organizations and conferences. We aimed to determine gender differences in leadership roles...
INTRODUCTION AND AIM
Internationally, women are underrepresented as leaders in major scientific organizations and conferences. We aimed to determine gender differences in leadership roles and annual scientific conferences of the Stroke Society of Australasia (SSA).
METHODS
In a retrospective review of SSA data (2014-2019), committee members were obtained through the SSA Web site, and moderators, speakers, and award recipients were identified from SSA annual scientific conference programs. Gender was determined by name inspection and Web search. Absolute numbers and proportions of women and men were recorded for all roles examined, overall and per year. Associations between representation of women in conferences and percentage of women in speaking roles were tested using multinomial regression.
RESULTS
Presidential leadership of the SSA was held by men in 2014-2016 and 2019 and women in 2017-2018. SSA committee membership was predominantly women (55%), being lowest (47%) in 2014 and 2019 and highest (65%) in 2017. There was a wide gender variation at scientific conferences, with 41% of keynote speakers being women overall, from 20% in 2016 to 75% in 2015. From 2014 to 2019, 55% of all speakers were women, ranging from 32% (in 2016) to 71% (in 2015). A higher percentage of women as speakers or moderators was associated with a program committee with over a third of its members composed of women (p ≤ 0.044).
CONCLUSIONS
Representation of women varied from 2014 to 2019 in the SSA organization and its conferences, although men are more often elected president in the organization and women are less often keynote speakers. When more women were included in the program committee, the representation of women as speakers increased.
Topics: Australasia; Female; Gender Equity; Humans; Leadership; Male; Physicians, Women; Societies, Medical; Stroke
PubMed: 34265764
DOI: 10.1159/000517453 -
AMA Journal of Ethics Aug 2019Since the 1960s, the United States Adopted Names Program has been assigning generic (nonproprietary) names to all active drug ingredients sold in the United States....
Since the 1960s, the United States Adopted Names Program has been assigning generic (nonproprietary) names to all active drug ingredients sold in the United States. Pharmaceutical names are assigned according to a scheme in which specific syllables in the drug name (called stems) convey information about the chemical structure, action, or indication of the drug. The name also includes a prefix that is distinct from other drug names and that is euphonious, memorable, and acceptable to the sponsoring pharmaceutical firm. Drug names are the product of complex, multiparty negotiations in which the needs and desires of various stakeholders (patients, pharmaceutical firms, physicians, pharmacists, other health care professionals, and US and international regulators) must be balanced.
Topics: Drug Development; History, 19th Century; History, 20th Century; Humans; Pharmaceutical Preparations; Societies, Medical; Terminology as Topic
PubMed: 31397664
DOI: 10.1001/amajethics.2019.686 -
Korean Journal of Urology Dec 2015
Topics: Humans; Names; Periodicals as Topic; Publishing; Republic of Korea; Urology
PubMed: 26682017
DOI: 10.4111/kju.2015.56.12.789 -
Proceedings of the Royal Society of... May 1969
Topics: Abbreviations as Topic; Biology; Medicine; National Library of Medicine (U.S.); Periodicals as Topic; United Kingdom; United States
PubMed: 5770579
DOI: No ID Found -
PharmacoEconomics Oct 2016To provide a framework for addressing payers' criteria during the development of pharmaceuticals. (Review)
Review
OBJECTIVE
To provide a framework for addressing payers' criteria during the development of pharmaceuticals.
METHODS
A conceptual framework was presented to an international health economic expert panel for discussion. A structured literature search (from 2010 to May 2015), using the following databases in Ovid: Medline(®) and Medline(®) In-Process (PubMed), Embase (Ovid), EconLit (EBSCOhost) and the National Health Service Economic Evaluation Database (NHS EED), and a 'grey literature' search, were conducted to identify existing criteria from the payer perspective. The criteria assessed by existing frameworks and guidelines were collated; the most commonly reported criteria were considered for inclusion in the framework. A mnemonic was conceived as a memory aide to summarise these criteria.
RESULTS
Overall, 41 publications were identified as potentially relevant to the objective. Following further screening, 26 were excluded upon full-text review on the basis of no framework presented (n = 13), redundancy (n = 11) or abstract only (n = 2). Frameworks that captured criteria developed for or utilised by the pharmaceutical industry (n = 5) and reimbursement guidance (n = 10) were reviewed. The most commonly identified criteria-unmet need/patient burden, safety, efficacy, quality-of-life outcomes, environment, evidence quality, budget impact and comparator-were incorporated into the summary framework. For ease of communication, the following mnemonic was developed: BEACON (Burden/target population, Environment, Affordability/value, Comparator, Outcomes, Number of studies/quality of evidence).
CONCLUSIONS
The BEACON framework aims to capture the 'essence' of payer requirements by addressing the most commonly described criteria requested by payers regarding the introduction of a new pharmaceutical.
Topics: Abbreviations as Topic; Drug Design; Drug Industry; Guidelines as Topic; Humans; Pharmaceutical Preparations; Reimbursement Mechanisms
PubMed: 27378386
DOI: 10.1007/s40273-016-0427-7 -
Clinical & Experimental Optometry Sep 2018
Topics: Australia; Awards and Prizes; Biomedical Research; Eponyms; History, 20th Century; History, 21st Century; Humans; Optometrists; Optometry; Parent-Child Relations; Societies, Medical
PubMed: 30153706
DOI: 10.1111/cxo.12816 -
Journal of the American Medical... 2014To understand the factors that influence success in scrubbing personal names from narrative text. (Comparative Study)
Comparative Study
OBJECTIVE
To understand the factors that influence success in scrubbing personal names from narrative text.
MATERIALS AND METHODS
We developed a scrubber, the NLM Name Scrubber (NLM-NS), to redact personal names from narrative clinical reports, hand tagged words in a set of gold standard narrative reports as personal names or not, and measured the scrubbing success of NLM-NS and that of four other scrubbing/name recognition tools (MIST, MITdeid, LingPipe, and ANNIE/GATE) against the gold standard reports. We ran three comparisons which used increasingly larger name lists.
RESULTS
The test reports contained more than 1 million words, of which 2388 were patient and 20,160 were provider name tokens. NLM-NS failed to scrub only 2 of the 2388 instances of patient name tokens. Its sensitivity was 0.999 on both patient and provider name tokens and missed fewer instances of patient name tokens in all comparisons with other scrubbers. MIST produced the best all token specificity and F-measure for name instances in our most relevant study (study 2), with values of 0.997 and 0.938, respectively. In that same comparison, NLM-NS was second best, with values of 0.986 and 0.748, respectively, and MITdeid was a close third, with values of 0.985 and 0.796 respectively. With the addition of the Clinical Center name list to their native name lists, Ling Pipe, MITdeid, MIST, and ANNIE/GATE all improved substantially. MITdeid and Ling Pipe gained the most--reaching patient name sensitivity of 0.995 (F-measure=0.705) and 0.989 (F-measure=0.386), respectively.
DISCUSSION
The privacy risk due to two name tokens missed by NLM-NS was statistically negligible, since neither individual could be distinguished among more than 150,000 people listed in the US Social Security Registry.
CONCLUSIONS
The nature and size of name lists have substantial influences on scrubbing success. The use of very large name lists with frequency statistics accounts for much of NLM-NS scrubbing success.
Topics: Confidentiality; Electronic Health Records; Humans; Names; National Library of Medicine (U.S.); Natural Language Processing; United States
PubMed: 24026308
DOI: 10.1136/amiajnl-2013-001689 -
Cytotherapy May 2021The World Health Organization (WHO) assigns International Nonproprietary Names (INN) to pharmaceutical substances, including advanced therapy medicinal products, to... (Review)
Review
The World Health Organization (WHO) assigns International Nonproprietary Names (INN) to pharmaceutical substances, including advanced therapy medicinal products, to ensure that each substance is globally recognized by a unique name. The majority of INN are published in the WHO Drug Information in accordance with the nomenclature rules of the International Union of Pure and Applied Chemistry. However, advanced therapy medicinal products, and in particular cell therapy and cell-based gene therapy substances, cannot be defined by such chemical nomenclature. Instead, they are published together with a textual definition paragraph to unambiguously describe their characteristics. These definitions are an integral part of the INN nomenclature system, and their presence contributes to pharmacovigilance and patient safety, as they help to distinguish regulated substances from cell-based interventions that have no INN and are marketed without regulatory oversight. Particular attention is therefore allocated to these descriptive paragraphs, as they form the basis for defining the uniqueness of a particular cell substance. This review describes the INN nomenclature system for cell-based substances and focuses on the progress made by the WHO INN Programme to develop and harmonize these definition paragraphs, which is reflected in a newly revised INN application form for cell therapy substances.
Topics: Genetic Therapy; Humans; Patient Safety; World Health Organization
PubMed: 33820700
DOI: 10.1016/j.jcyt.2021.02.114