Refine Drug Information

Provide pharmacy-tailored medical writing and review, ensure drug information is aligned and consistent across all documents (e.g. protocol, IB, pharmacy manual, training materials, patient consent language), and meets healthcare writing standards and guidelines. Reduce the number of reviews for the Product Development Team.

A plethora of documents are owned by cross-functional groups. Discrepancies arise and are carried forward, despite multiple reviewers. Here’s the Tale of the Troublesome Trailing Zero (e.g. 25.0 mg).

While it is perfectly acceptable to use trailing zeros in scientific documents, this is discouraged in pharmacy. Due to serious medication errors, the FDA and Institute of Safe Medication Practices issued guidance to avoid them. The troublesome trailing zero travels as drug information from a scientific paper into the Investigator’s Brochure which is then inserted into the Protocol and finally into the Pharmacy Manual. The implications of this can vary over a wide range. Hospitals are held to regulatory standards, which bans trailing zeros in their medication safety policies and procedures. And if regulatory considerations are not enough, if the site pharmacist does not correct these trailing zeros, a compounding/dosing error may put study patients at risk. If a patient is hospitalized due to a 10-fold dose increase, how will that affect results? And while these scenarios are less likely, simply keeping a trailing zero within documentation leaves the unflattering impression that the sponsor is not familiar with nomenclature, safety, and prescribing rules inherent to healthcare.