The Gold Standard editorial staff develops clinically-based drug information content through an independent, peer-reviewed process. The peer-review process represents an objective analysis of clinically-relevant drug information. The content development cycle mimics the peer-review process in effect for major scientific publications. In general, editorial content follows the style of other peer-reviewed medical publications, including the style of the American Medical Association Manual of Style: A Guide for Authors and Editors. Ninth ed. Baltimore, Md: Williams & Wilkins; 1998. Modifications to this style reflect recognized needs of database production, standardized within our internal policy.

Our editorial team includes the following basic categories:

• Editor-in-Chief
• Managing Editor
• Senior Editor
• General Editor
• Freelance Writer
• Editorial Assistant

To ensure the most up-to-date drug information is included, the editorial team updates clinical content in a “real time” format rather than working against quarterly deadlines. This allows for tremendous flexibility when establishing priorities for client updates and the ability to be responsive to late breaking medical news, trials and previously unannounced drug label changes.

Content updates to the database include new FDA-approved drugs, new non-prescription and herbal therapies, newly published information regarding FDA label changes and relevant clinical studies affecting off-label utilization. Each member of the editorial staff is responsible for monitoring certain therapeutic categories for pertinent information to be included in the database.

Editorial Review Process

Every update made to the database undergoes a strict editorial review process. This process utilizes a system of double checks to substantiate timely and accurate drug information accessed by the end user. The editorial process is ongoing, with quality assurance activities throughout the content development cycle. At the close of each calendar deadline, the Senior Editors, Managing Editor and Editor-in-Chief review the editorial process for system improvements. The following is a list of reviewed indicators:

• Significant updates per therapeutic category
• Time from information release (FDA/Journals) to final content approval
• Number and type of corrections required during the review process
• Sections within the monograph requiring revisions
• Corrections required per editor
• Random sampling of references against monograph updates

For specialty medications (e.g., oncology or HIV treatments), a Senior Editor with expertise in the corresponding field often provides an additional review of the clinical content before it is finalized by the Managing Editor. Preferentially, support and documentation for Off-label uses (i.e., the use of a drug outside its FDA-approved indications) occurs through specific citations from the primary literature (please see Off-Label Data for Drug Information Products Policy).

Gold Standard monitors editor performance and reports performance during content review meetings, addressing significant issues immediately with the editorial team.

Because relationships between authors and pharmaceutical manufacturers can bias written content, it is important to reemphasize the principles that underlie the editorial process. The editorial staff acknowledges that some level of interaction between Gold Standard and the pharmaceutical industry may facilitate the dissemination of scientific knowledge relating to drug therapy within database content. The internal and independent peer- review process eliminates manufacturer bias in drug information reporting. Gold Standard has implemented a single division of contact for all pharmaceutical manufacturer queries/submissions and has assigned this responsibility to Gold Standard team members not directly responsible for clinical data/monograph production, to eliminate industry bias in content development. Editors do not have any significant financial relationships with the industry that would introduce bias in the editing or review of database content (please see Pharmaceutical Industry/Conflict of Interest Relationship Policy below).

Editorial Staff

Gold Standard employs clinical pharmacists with experience in drug information on its Editorial Team. All editors are clinical pharmacists who have undergone extensive training. Many have experience in leadership positions in the country’s largest hospitals and retail pharmacy chains, have held academic positions with top universities, and have attained board certification in specialty areas. They have received awards, authored original papers, and have published books targeted to healthcare professionals and/or consumers. The majority of our editors have attained the degree of Doctor of Pharmacy.

Gold Standard implements a number of steps to develop the expertise of the editorial staff. Gold Standard provides continuing education support for state licensure or certification requirements for all editorial staff members. Gold Standard additionally provides training and support for all editor staff attaining a Board Certification as a Pharmacotherapy Specialist (via the Board of Pharmaceutical Specialties, BPS).

References and Resources

Content development is a continuous process of reviewing many forms of drug/medical data from multiple resources and distilling it down to usable and concise information. Derived data inputs result from a variety of sources, including but not limited to:

• Primary medical journals (e.g., New England Journal of Medicine, Annals of Internal Medicine, JAMA, etc.)
• Primary pharmacy journals (e.g., J Am Pharm Assoc., Pharmacotherapy, Annals of Pharmacotherapy, etc.)
• Medical texts (e.g., Harrison’s Principles of Internal Medicine, Mandel’s Infectious Disease, etc.)
• Drug information and pharmacology texts (e.g., Goodman & Gilman, USP-DI, etc.)
• Specialty texts (e.g., drug interaction texts, IV compatibility texts, etc.)
• Abstracting services (e.g., FDA’s MedWatch, ADATABASE Journal Club, Journal Watch, etc.)
• Trade magazines (e.g., Drug Topics, etc.)

Determining credible inputs to content is critical to the quality of our drug information data. Acceptable references are approved by the Editor-in-Chief and are reiterated through content development policy. The editorial team establishes a hierarchy of data credibility with preference given to those publications embracing a peer-reviewed publication methodology. Gold Standard maintains internal data files for content updates and these include relevant data used in content development.

Pharmaceutical Industry/Conflict of Interest Relationship Policy

Gold Standard is committed to providing unbiased, complete, and accurate drug information. It is important to define the Editorial Team policy regarding relationships with manufacturers of drug products. Please refer to the Editorial Content Development Process Summary, which outlines the editorial peer-review process for our database content.

Individual editorial team members may have past relationships with the industry, as the knowledge and skills obtained from such a position are beneficial to the mission of the Gold Standard team: provision of complete, timely, and accurate drug information. Current direct relationships with any pharmaceutical company or their representative are not acceptable. Editors may not be employees or receive payment for rendered services from such companies. Sponsored programs, events, publications, or the like can be presented/written by editors as long as the content is not dictated, suggested, or reviewed by the sponsoring company; the program must be supported by an unrestricted grant from the pharmaceutical industry corporation sponsoring the service. Editors may receive benefits from the pharmaceutical industry extended to any participant attending a professional conference or continuing education session. Gold Standard editorial team members cannot accept individualized gifts or benefits.

Further information regarding this policy, including past employment relationships, is on file at Gold Standard. Any financial information contained in the file is confidential.

The information above is an overview only of Gold Standard’s Editorial Policy. For documentation on our complete Editorial Policy, please contact us at 1-800-375-0943, 813-258-4747 or email info@goldstandard.com.