International Journal of Risk & Safety in Medicine

Patient Safety - Pharmacovigilance - Liability

Impact Factor
2023
1.7
CiteScore
2023
1.8

Volume

34, 4 issues

Latest issue

35:1 online 01 March 2024

Next issue

35:2 scheduled for June 2024

Back volumes

From volume 1, 1990

ISSN print

0924-6479

ISSN online

1878-6847

Aims & Scope

The International Journal of Risk and Safety in Medicine is concerned with rendering the practice of medicine as safe as it can be; that involves promoting the highest possible quality of care, but also examining how those risks, which are inevitable, can be contained and managed ideally considering how they can be used when applied to an international audience.

This is not exclusively a drugs journal. As indicated by the journal's subtitle, there is a focus on patient safety, pharmacovigilance and liability. The journal publishes high quality interdisciplinary papers related to patient safety, not ones for domain specialists. Basic research reports of clinical experience and overviews, new items and letters to the editor will be considered for publication. Please see the author guidelines for more information about the article types and requirements.

The journal in particular welcomes submissions about balancing the benefits AND risks of any treatment/management that should be considered by clinical practitioners and which can also aid understanding by patients when agreeing to their clinical care.

Editorial Board

Editor-in-Chief

Liliya E. Ziganshina
Russian Medical Academy for Continuing Professional Education (RMANPO)
Moscow, Russian Federation
Email: lezign@gmail.com

Former Editors-in-Chief

C.J. van Boxtel
I. Ralph Edwards
Marie Lindquist

Founding Editor

M.N.G. Dukes

Associate Editors

Carlo Bottari
Pharmaceuticals Policy and Law
University of Bologna
Bologna, Italy

Maxine Gossell-Williams
Pharmacology and Pharmacovigilance
The University of the West Indies at Mona
Kingston, Jamaica

Federico Laus
Pharmaceuticals Policy and Law
University of Bologna
Bologna, Italy

Mecit Can Emre Simsekler
Patient Safety
Boston Children’s Hospital
Boston, MA, USA

Editorial Board

Peter R. Breggin
Psychiatry
Private Practice of Psychiatry
Clinical Psychopharmacology and Forensics
Ithaca, NY, USA

Elliot Brown
Medicine, Clinical Pharmacology and Regulatory Affairs
Elliot Brown Consulting Ltd
Leeds, UK

Rebecca Chandler
Pharmacovigilance, Infectious Diseases and Vaccines
Uppsala Monitoring Centre
Uppsala, Sweden

Andrzej Czarnecki
Pharmacovigilance and Internal Medicine
Eli Lilly and Company
Windlesham, UK

Edzard Ernst
Complementary Medicine
University of Exeter
Exeter, UK

Ulrich Hagemann
Pharmacovigilance
International Society of Pharmacovigilance
Berlin, Germany

Rokuro Hama
Internal Medicine and Patient Safety
Japan Institute of Pharmacovigilance
Osaka, Japan

Ambrose Isah
Medicine and Clinical Pharmacology
University of Benin
Benin, Nigeria

Donald Harvey Marks
Internal Medicine and Microbiology
University of Pittsburgh
Pittsburgh, PA, USA

Aleksandr Matveev
Pharmacovigilance and Evidence-Based Medicine
Russian Medical Academy for Continuing Professional Education (RMANPO) Moscow, Russian Federation

Priscilla Patricia Nyambayo
Pharmacovigilance and Clinical Trials
Munyaradzi Medicines Control
Authority of Zimbabwe
Harare, Zimbabwe

Emmanuel Okoro
Medicine and Clinical Pharmacology
University of Ilorin
Ilorin, Nigeria

Abimbola Olowofela-Opadeyi
Clinical Pharmacology and Therapeutics
University of Benin
Benin, Nigeria

Eugène van Puijenbroek
Pharmacovigilance
University Groningen
Groningen, The Netherlands

Elena Rocca
Philosophy of Science and Health Care
NMBU University
Ås, Norway

Mulugeta Russom
Pharmacovigilance
Eritrean Pharmacovigilance Centre
Asmara, Eritrea

Ruth Savage
Clinical Pharmacology and Epidemiology
University of Otago
Christchurch, New-Zealand

Anders Sundström
Pharmacoepidemiology
Karolinska Institutet
Solna, Sweden

Michael Tatley
Pharmacovigilance, Public Health and Vaccines
Otago University
Dunedin, New Zealand

Mauro Venegoni
Internal Medicine and Pharmacovigilance
University of Verona
Verona, Italy

Author Guidelines

SUBMISSION OF MANUSCRIPT

By submitting my article to this journal, I agree to the Author Copyright Agreement, the IOS Press Ethics Policy, and the IOS Press Privacy Policy.

Authors are requested to submit their paper through the journal’s online submission system.

Submission of an article is understood to imply that the article is original and unpublished and is not being considered for publication elsewhere.

All submissions are peer reviewed (single-blind) and checked for plagiarism using the iThenticate tool. The peer review comments are published alongside the accepted article in the journal as supplemental files.

Publication fee
The International Journal of Risk & Safety in Medicine does not charge a publication fee.

Artificial intelligence policy
Text generated from artificial intelligence (AI), machine learning, or similar algorithmic tools cannot be the original content in papers submitted to the journal. Nor does the journal accept figures, images, or graphics produced by such tools. However, AI tools can be used in the writing process to improve the readability and language. A disclosure should be added to the paper in case AI tools were used, specifying the AI tool in detail.

AI programs should not be included in the author list, nor should they be cited. The authors are ultimately responsible for the contents of the paper. For more information, see the IOS Press Ethics Policy.

Changes to authorship
Please note that changing the authors list (i.e. adding / removing authors, or changing the order) is not allowed after submission of the manuscript, unless the journal editor and all co-authors are informed and are in agreement with this change. Please see the IOS Press authorship policy for further information.

Required files
The following electronic files are required:
- a Word processor file of the text, such as Word, WordPerfect, LateX (If using LaTeX, please use the standard article.sty as a style file and also send a pdf version of the LaTeX file)
- separate files of all figures (if any); see "Preparation of manuscripts" for the required file formats.

Colour figures
It is possible to have figures printed in colour, provided the cost of their reproduction is paid for by the author.

PREPARATION OF MANUSCRIPTS

1. Organization of the paper and style of presentation

Manuscripts must be written in English. Authors whose native language is not English are advised to consult a professional English language editing service or a native English speaker prior to submission. Please use first person language (i.e. a person with an injury, not an injured person) and active voice.

2. Manuscript formatting

Manuscripts should be prepared with wide margins and double spacing throughout, including the abstract, footnotes and references. Every page of the manuscript, including the title page, references, tables, etc., should be numbered. However, in the text no reference should be made to page numbers; if necessary, one may refer to sections. Try to avoid the excessive use of italics and bold face.

3. Manuscripts should be organized in the following order:

  • Title page
  • Abstract
  • Keywords
  • Body of text (divided by subheadings: Introduction, Methods, Results, Discussion, Conclusion)
  • Acknowledgements and conflict of interest statements
  • References
  • Tables and captions
  • Figures and captions 

4. Title page

The title page should provide the following information:

  • Title (should be clear, descriptive and not too long)
  • Name(s) of author(s); please indicate who the corresponding author is
  • Full affiliation(s)
  • Present address of author(s), if different from affiliation
  • Complete address of corresponding author, including e-mail address
  • Abstract
  • Keywords (6-8 terms from the MeSH database)

5. Abstract
The abstract should be clear, descriptive, self-explanatory and not longer than 200 words, it should also be suitable for publication in abstracting services.
The abstract for research papers should follow the “structured abstract” format. Section labels should be in bold uppercase letters followed by a colon, and each section will begin on a new line.
BACKGROUND:
OBJECTIVE:
METHODS:
RESULTS:
CONCLUSIONS:

6. Materials and methods

Ethical considerations
Please include an explicit statement in the materials and methods section that procedures involving experiments on human subjects are done in accord with the ethical standards of the Committee on Human Experimentation of the institution in which the experiments were done or in accord with the Declaration of Helsinki of 1964 and its later amendments or comparable ethical standards. The approval number of the Ethics Committee or the institutional review board and its affiliation together with the date of approval, or alternative identifiers, must be added as part of the statement. Studies exempt from Institutional Review Board approval should report the reason for exemption, e.g. “This study, as a literature review, is exempt from Institutional Review Board approval”. Editors reserve the right to reject papers if there is doubt whether appropriate procedures have been used.

Informed consent
Patients have a right to privacy that should not be infringed without informed consent. Identifying information, including patients' names, initials, or hospital numbers, should not be published in written descriptions, photographs, and pedigrees unless the information is essential for scientific purposes and the patient (or parent or guardian) gives written informed consent for publication. Informed consent for this purpose requires that a patient who is identifiable should be shown the manuscript before it is published. When informed consent has been obtained it should be indicated in the Methods section.

Reporting guidelines
Manuscripts should adhere to the EQUATOR Network reporting guidelines relevant to the research design.

Acknowledgments
Specify the acknowledgements. If there are none, you can still include this section and insert "The authors have no acknowledgments".

Conflict of interest
Statement of any potential conflicts should be clearly identified at the end of the paper. If there is no conflict of interest to declare, you must still include this section and insert the following statement: "The authors declare that they have no conflict of interest."

A conflict of interest statement asks authors to disclose four types of information:
(1) Associations with commercial entities that provided support for the work reported in the submitted manuscript (the timeframe for disclosure in this section of the form is the lifespan of the work being reported).
(2) Associations with commercial entities that could be viewed as having an interest in the general area of the submitted manuscript (in the 36 months before submission of the manuscript).
(3) Any similar financial associations involving authors’ spouses, partners, their children under 18 years.
(4) Non-financial associations that may be relevant to the submitted manuscript.

Funding
Specify sources of funding. If there are none, you can still include this section at the end of the paper and insert "The authors report no funding".

7. Article types

Research articles
Research articles should be structured as outline above.

Review articles
Review articles should be authoritative and topical and provide comprehensive and balanced coverage of a timely and/or controversial issue. For systematic reviews, authors should consult PRISMA (prisma-statement.org) and prepare their reviews as per the PRISMA Checklist. We recommend the EQUATOR Network (equator-network.org) and the NLM’s Research Reporting Guidelines and Initiatives (nlm.nih.gov/services/research_report_guide.html) as good sources for reporting guidelines. Submissions must not exceed 7500 words and include no more than 80 references and a maximum of 10 tables and figures.

Case reports
Case reports explain the diagnosis, treatment, and outcome of an individual case which has not been previously published in the medical literature. Administered treatments should be supported by previously published research. Case reports should be 2000 words or less.

Brief reports
Brief reports are articles of original scholarship of unusual interest of less than 1500 words (not including references). They should be structured as research articles (see above) and may have a structured abstract. A total of two tables and/or figures are allowed.

Commentaries
Commentaries are short opinion pieces representing the author’s viewpoint. Commentaries should be 1000 words or less with an abstract and no other subdivisions.

Book reviews
Book reviews should be 750 words or less and without sections.

Position papers
Position Papers provide readers with a snapshot update of a highly topical subject in which the author shares their perspective and thoughts on advances and critical issues in the field and speculates on potential outcomes and future developments. These articles are not intended to provide a comprehensive review, but rather help foster debate and discussion around the subject area. Position papers present an arguable opinion about an issue and can be supported by reasonable preponderance of empirical evidence. Position papers should have a maximum of 1000 words (excluding the abstract and references) and should have an abstract and 3–5 keywords. The format follows that for research articles.

8. Tables
- Number as Table 1, Table 2 etc, and refer to all of them in the text.
- Each table should be provided on a separate page of the manuscript. Tables should not be included in the text.
- Each table should have a brief and self-explanatory title.
- Column headings should be brief, but sufficiently explanatory. Standard abbreviations of units of measurement should be added between parentheses.
- Vertical lines should not be used to separate columns. Leave some extra space between the columns instead.
- Any explanations essential to the understanding of the table should be given in footnotes at the bottom of the table.

9. Figures

- Number figures as Fig. 1, Fig. 2, etc and refer to all of them in the text.
- Each figure should be provided on a separate sheet. Figures should not be included in the text.
- Colour figures can be included, provided the cost of their reproduction is paid for by the author.
- For the file formats of the figures please take the following into account:

  • Line art should be have a minimum resolution of 600 dpi, save as EPS or TIFF
  • Grayscales (incl photos) should have a minimum resolution of 300 dpi (no lettering), or 500 dpi (when there is lettering); save as tiff
  • Do not save figures as JPEG, this format may lose information in the process
  • Do not use figures taken from the Internet, the resolution will be too low for printing

- Do not use colour in your figures if they are to be printed in black & white, as this will reduce the print quality (note that in software often the default is colour, you should change the settings)
- For figures that should be printed in colour, please send a CMYK encoded EPS or TIFF
- Figures should be designed with the format of the page of the journal in mind. They should be of such a size as to allow a reduction of 50%.
- On maps and other figures where a scale is needed, use bar scales rather than numerical ones, i.e., do not use scales of the type 1:10,000. This avoids problems if the figures need to be reduced.
- Each figure should have a self-explanatory caption. The captions to all figures should be typed on a separate sheet of the manuscript.
- Photographs are only acceptable if they have good contrast and intensity.

REFERENCES

1. Place citations as numbers in square brackets in the text. All publications cited in the text should be presented in a list of references following the text of the manuscript. Only articles published or accepted for publication should be listed in the reference list. Submitted articles can be listed in the text as (author(s), unpublished data).

2. All authors should be listed in the reference list.

3. References must be listed in Vancouver style:

[1] Rose ME, Huerbin MB, Melick J, Marion DW, Palmer AM, Schiding JK, Kochanek PM, Graham SH. Regulation of interstitial excitatory amino acid concentrations after cortical contusion injury. Brain Res. 2002; 935(12): 406.
[2] Murray PR, Rosenthal KS, Kobayashi GS, Pfaller MA. Medical microbiology. 4th ed. St. Louis: Mosby; 2002.
[3] Berkow R, Fletcher AJ, editors. The Merck manual of diagnosis and therapy. 16th ed. Rahway (NJ): Merck Research Laboratories; 1992.
[4] Meltzer PS, Kallioniemi A, Trent JM. Chromosome alterations in human solid tumors. In: Vogelstein B, Kinzler KW, editors. The genetic basis of human cancer. New York: McGrawHill; 2002. p. 93113.
[5] Canadian Cancer Society [homepage on the Internet]. Toronto: The Society; 2006 [updated 2006 May 12; cited 2006 Oct 17]. Available from: http://www.cancer.ca/.

Footnotes
Footnotes should only be used if absolutely essential. In most cases it is possible to incorporate the information in the text.
If used, they should be numbered in the text, indicated by superscript numbers and kept as short as possible.

COPYRIGHT

Copyright of your article
Authors submitting a manuscript do so on the understanding that they have read and agreed to the terms of the IOS Press Author Copyright Agreement.

Article sharing
Authors of journal articles are permitted to self-archive and share their work through institutional repositories, personal websites, and preprint servers. Authors have the right to use excerpts of their article in other works written by the authors themselves, provided that the original work is properly cited. The consent for sharing an article, in whole or in part, depends on the version of the article that is shared, where it is shared, and the copyright license under which the article is published. Please refer to the IOS Press Article Sharing Policy for further information.

Quoting from other publications
Authors, when quoting from someone else's work or when considering reproducing figures or tables from a book or journal article, should make sure that they are not infringing a copyright. Although in general authors may quote from other published works, permission should be obtained from the holder of the copyright if there will be substantial extracts or reproduction of tables, plates, or other figures. If the copyright holder is not the author of the quoted or reproduced material, it is recommended that the permission of the author should also be sought. Material in unpublished letters and manuscripts is also protected and must not be published unless permission has been obtained. Submission of a paper will be interpreted as a statement that the author has obtained all the necessary permission. A suitable acknowledgement of any borrowed material must always be made.

PROOFS AND PRE-PRESS

The corresponding author will receive a PDF proof and is asked to check this proof carefully (the publisher will execute a cursory check only). Corrections other than printer's errors, however, should be avoided. Costs arising from such corrections will be charged to the authors.

The corrected proof is published online in the journal’s pre-press module shortly after the proof is created and author corrections are implemented. This is not the final version. As soon as the article is assigned to an issue, the final bibliographic information will be added and the pre-press file will be replaced by the updated, final version. Pre-press articles are fully citable by using their DOI number.

PURCHASES

How to order reprints, a pdf file, journals, or IOS Press books
For each contribution the corresponding author will receive a complimentary Author’s Copy (watermarked) pdf of their published article. This pdf is for personal use only. Free copies will not be provided for conference proceedings and abstract issues. An order form for reprints, additional journal copies or a pdf file will be provided along with the pdf proof.

If you wish to order reprints of an earlier published article, please contact the publisher for a quotation. Email: editorial@iospress.nl.

An author is entitled to 25 % discount on IOS Press books. See Author's Discount (25%) on all IOS Press book publications.

KUDOS

Authors of published articles (non-prepress, final articles) will be contacted by Kudos. Kudos is a service that helps researchers maximize the impact and visibility of their research. It allows authors to enrich their articles with lay metadata, add links to related materials and promote their articles through the Kudos system to a wider public. Authors will receive no more than three emails: one invitation and a maximum of two reminders to register for the service and link the published article to their profile. Using and registering for Kudos remains entirely optional. For more information, please have a look at our authors section.

HOW TO PROMOTE YOUR WORK

Would you like some pointers on how to help your research achieve a wider reach and greater impact? Please consult our Promotional Toolkit for Authors for tips.

Please visit the IOS Press Authors page for further information.

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Open Access

By default, articles published in the International Journal of Risk & Safety in Medicine are available only to institutions and individuals with access rights. However, the journal offers all authors the option to purchase open access publication for their article as part of the IOS Press Open Library. This means that the final published version will be freely available to anyone worldwide, indefinitely, under a Creative Commons license and without the need to purchase access to the article. This is also referred to as “gold” open access.

Gold open access pricing
Authors who choose gold open access publication will be subject to an article publication charge of € 1500 / US$ 1500 for publication under the CC BY-NC 4.0 license or € 2150 / US$ 2150 for publication under the CC BY 4.0 license. Pricing is exclusive of possible taxes. After an article is accepted for publication, the corresponding author will be informed regarding the open access option during the production stages, and will have the opportunity to purchase open access for their article. It could be that the open access fee of an article is waived completely due an institutional agreement IOS Press has with the corresponding authors' institution. Please check the institutional agreements page for details.

Green open access
Authors who do not make use of the gold open access option may still make their article freely available using self-archiving, also referred to as green open access. Authors may make their final accepted manuscript available for free download from their personal or institutional website or institutional archive. This model is free for the author.

PubMedCentral deposits
This journal deposits all open access articles in PubMedCentral (PMC) as part of the IOS Press Open Library. If an author chooses to publish their paper with open access then the publisher will deposit the article in PMC upon publication.

Peer Review Policy

The International Journal of Risk & Safety in Medicine is a peer-reviewed journal. Articles submitted to the journal undergo a single-blind peer review process. This means that the identity of the authors is known to the reviewers but the identity of the reviewers is not communicated to the authors. The journal publishes the referee reports inclusive with the final article, as supplemental files alongside the article PDF. The referees have to agree with this process before being able to review, and have the option to remain anonymous. Please visit our reviewer guidelines for further information about how to conduct a review.

After automatic plagiarism screening through iThenticate, all submitted manuscripts are subjected to initial appraisal by the Editor-in-Chief and, if found suitable for further consideration, to rigorous peer review by independent, anonymous expert referees. Reasons to reject a paper in the pre-screening process could for example be that the work does not fall within the aims and scope, the writing is of poor quality, the instructions to authors were not followed or the presented work is not novel.

Papers deemed suitable to be reviewed will be assigned to a handling editor. The handling editor will then invite reviewers to comment on the work and might consider inviting the reviewers suggested by the author(s). Editors and reviewers are asked to excuse themselves from reviewing a submission if a conflict of interest makes them unable to make an impartial scientific judgment or evaluation. Conflicts of interest include but are not limited to: collaboration with the authors in the past three years; any professional or financial affiliations that may be perceived as a conflict of interest; a history of personal differences with the author(s).

As a standard policy, decisions are based on three reviews, in some specific circumstances a minimum of two reviews may be deemed sufficient to make a decision on a paper. The Editor-in-Chief strives to ensure a typical turnaround time of three months.

Reviewers are asked to judge a paper on at least:

  • Logical, concise ordering of ideas
  • Use of sound research methods
  • Adequacy of documentation    
  • Material has good applied use in the field    
  • Readability and interest level

Based on the received reviews the handling editor will propose a recommendation to the Editor-in-Chief:

  1. Accept article as submitted
  2. Accept article revision by the author according to suggestions made in review
  3. Revise and resubmit
  4. Reject
  5. Consider for another issue/publication

They mean the following:

  1. The manuscript is suitable for publication and only requires minor polishing; thus, no further reviews are requested.
  2. The authors are required to make moderate changes to their manuscript. The manuscript becomes acceptable for publication if the changes proposed by the reviewers and editors are successfully addressed. The revised manuscript will be examined by the Editor-in-Chief and possibly sent back to all (or a selection of) reviewers for a second round of reviews. Authors are requested to provide a letter to the reviewers detailing the improvements made for the resubmission.
  3. In its current form, the manuscript is not suitable for publication. A resubmission would require substantial revisions and is only encouraged in special cases. The resubmitted manuscript will be considered as a new submission.
  4. The manuscript is rejected as it is deemed to be out of scope, not relevant, or not meeting the journal’s quality standards in terms of significance, novelty, and/or presentation.
  5. The manuscript is rejected as it is deemed to be better suited for a different journal or publication.

Authors are notified by the Editor-in-Chief, whose decision is final.

Former Editors-in-Chief of The International Journal of Risk & Safety in Medicine, Prof. Dr. Christoffel Jos van Boxtel, has passed away on the 23rd of January 2020. He will be greatly missed. We have published an In Memoriam, which can be found here. We are very pleased to announce that the Editor-in-Chief of The International Journal of Risk & Safety in Medicine, I. Ralph Edwards, was awarded the Honorary Doctor of Science Degree by the University of Benin, Nigeria in 2020. We congratulate him on this achievement. For more information, please see here.

The International Journal of Risk & Safety in Medicine is putting out a call for papers on the following topics: Evaluations of the risks versus benefits of any medical intervention Understanding and communication of vaccine risks Understanding and communication of uncertainty in medicines Risk and harm of medical care to clinical care practitioners

Latest Articles

Discover the contents of the latest journal issue:

2024, a year for furthering the value of independent health policy research to minimize risks and ensure safety in medicine for better global health
Liliya Eugenevna Ziganshina

Associations of antidepressant medication consumption with changes in personality pathology and quality of life among community-dwelling adults
Robin B. Jarrett, Jeffrey R. Vittengl, Eunyoe Ro, Lee Anna Clark

A medication reconciliation failure: A case report and incident analysis
P. Lopes Vaz, R. Ascenção, C. Pereira Gomes, J. Costa, P. Broeiro-Gonçalves

Research of Russian physicians’ opinions on tuberculosis pharmacogenetics
E.M. Bogorodskaya, B.I. Kantemirova, M.S. Poptsova, D.A. Sychev, E.A. Tsimbal, N.A. Stepanova

Pharmacogenetic markers of development of angioneurotic edema as a secondary side effect to enalapril in patients with essential arterial hypertension
Natalia P. Denisenko, Ivan V. Sychev, Anastasiya A. Kachanova, Anna V. Lapshtaeva, Sherzod P. Abdullaev, Ludmila N. Goncharova, Karin B. Mirzaev, Dmitry A. Sychev

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