Drug Safety

The ACR Hotline is intended to provide a succinct, balanced, timely, evidence-based review of novel information relevant to rheumatologists and allied rheumatology professionals before it is readily available from other sources, such as peer-reviewed literature.

When appropriate, Hotlines will be coordinated with other communication efforts of the college such as editorials, commentary, debates, literature reviews, and communications from the ACR president in Arthritis Care & Research, Arthritis & Rheumatism, the ACR newsletter and other publications.

Hotline is produced by the Communications and Marketing Committee (CMC) of the ACR. Topics are chosen by the CMC and the Hotline editors. Topics for ACR Hotlines come from various sources including issues in the media related to rheumatology, deliberations of regulatory agencies (e.g. the USA Food and Drug Administration), and new information from scientific meetings. Any ACR member may submit a topic for consideration or may volunteer to write a Hotline by emailing pr@rheumatology.org.

The authors (which may include the editors) are chosen by the editors for their expertise in the relevant field and are invited to summarize and synthesize new information for members. Hotline editors work closely with the authors to maintain consistency in format, quality, and impartiality.

The primary audience for Hotline is the busy practicing clinician. Therefore, in addition to rigorous selection of topic, brevity, quality, and lack of bias in the presentation are essential.

Hotlines must have the following format:

• Title
• Introduction (i.e., why is this such a "hot" topic that it justifies an ACR Hotline)
• Focused, relevant, background and history.
• Summary information (e.g., results of clinical trials, information in press releases, consensus of regulatory agencies, etc.) and an analysis of the strengths and limitations of the available data.
• For therapeutic agents: An evaluation of the efficacy and toxicity of therapeutic agents with emphasis on absolute as well as relative risks of treatments.
• Practical issues: Cost concerns, comparisons of efficacy and cost with other agents, applicability to the general population, number needed to treat/harm for presumed benefit/toxicity
• The Bottom Line: A few key bullet points with the most relevant information
• Authors
• Editors
• Disclaimer

Please note: Patient Information or recommendations, if appropriate, are sent out as a separate publication.

The CMC is responsible for setting the communication agenda for the ACR and making decisions about the most effective venue(s) for communications with members. The choice of topics for Hotline will be the decision of the editors with the approval of the CMC chair. Topics related to drug or device safety, FDA approval, or new therapeutics will also be referred to the Drug Safety Committee (DSC) or its representative for their input during the planning and writing process with a 48-hour turnaround for DSC review and input.

Hotlines will be initially reviewed by the CMC (and the DSC if the topic is relevant to a therapeutic agent) with a 48-hour turn around and will then be forwarded to the Executive Committee (EC) for approval.

Disagreements about the information or summary statements contained in Hotline will be mediated by the chair of the CMC. If the CMC chair is unable to resolve the disagreement in a manner acceptable to the editors and/or authors, the issue will be referred to the Executive Committee. If the resolution reached by the EC is unacceptable to the authors or editors, they have the option to remove their name from the Hotline and it will be published as a communication from the CMC.

The chair of the CMC will work with the EC, the DSC, the ACR newsletter editor, and the editors of Arthritis Care & Research and Arthritis & Rheumatology to coordinate with other forms of communications such as editorials, more in depth reviews, commentaries, debates, and communications from the ACR president and leadership.

Choice of Hotline Editors: Hotline editors will be chosen by the chair of the CMC with two year staggered terms and the option of reappointment for a second term.

Conflicts of Interest: Attention must be given to minimize conflicts of interest as well as the appearance of conflicts of interest. Authors and editors will provide disclosures regarding such conflicts and the editors will attempt to find authors and/or reviewers/editors with no conflicts of interests. All Hotlines will be reviewed by the editors and possibly by guest editors for balance of the presentation.

Dr. X has no conflict of interest regarding the material in this ACR Hotline; or

Dr. Y has disclosed the following information relevant to potential conflicts of interest regarding the material in this ACR Hotline; Dr X is a paid consultant for......, or has investments in XX;.YY;

ACR Hotlines will include the following disclaimer:

The ACR Hotline is provided by the ACR Communications and Marketing Committee as a service to members. This Hotline reflects the views of the author(s) and does not represent a position statement of the College.