Key Steps to Write Better Pharmaceutical Documents
Anyone who purchases a medication from a pharmacy receives educational materials about the medication and how it should be used. How can you ensure that the information needed by medication users or administrators (in the case of medical professionals or caretakers) is easily accessible and accurate? Whether you’re writing a white paper, regulatory document, article, abstract, or medical education materials, clearly communicating the specific purpose and intention of the document requires some additional work and specific intent. When it comes to medical documents, the information is vital to ensure the continuation or improvement of people’s health, and mistakes can be fatal. So, how do you write a better pharmaceutical document?
Write for the End-User
First, know who is going to use the document. If you’re writing a document to send to a pharmacist or for review by nurses in a hospital setting, you can communicate more complex health information, and it should be formatted in a familiar style so that they can find the dosing information quickly. If you’re writing a packet of information to distribute with a medication that will be administered at home, you need to be mindful of the accessibility of your word choices and eliminate jargon. Keep your target audience in mind as you design the format and select the wording of the document.
Pharmaceutical documents need to clearly communicate pertinent information, and they function better when they are designed in a consistent layout, for a specific user. Be precise and concise to clearly communicate with your intended audience.
Adhere to Regulations
Medical documents are heavily regulated by the FDA, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and other regulatory bodies, depending on the type of document. Familiarize yourself with the applicable regulations before beginning your pharmaceutical document, and create a checklist to ensure that you stay consistently within the guidelines and requirements of any applicable regulatory authority.
The FDA provides guidance about formatting, language, specific headings, and more. Weeding through requirements and recommendations to determine which apply to a specific medication or type of document is a dedicated effort. Reading and applying regulatory standards is a skill that writers and researchers develop over years, and you must put in the upfront work to learn the regulations and then continue referring to them for each new document, staying up-to-date with the newest versions or updates to previous regulations. Adhering to those standards is necessary for the health of patients and the continuation of your business.
Organize the Material Logically
Some headings and organizational structure features are dictated by regulations or by the specific type of document. If you have choices about how to organize your content, focus on clarity and logical flow. Keep the structure of your document simple, and use the organization to help the end-user find the information they need.
Check that headings accurately describe the text following them, and be consistent in how you format the document. You can convey scientific information in an easy-to-follow structure. The Federal Plain Language Guidelines recommend organizing information chronologically or with general information first, followed by exceptions or deviations. Whichever organizational method you choose, be consistent, and structure the content in a way that makes sense for the end-user.
For more information about how to write a better pharmaceutical document, refer to the following resources:
If you need a professional writer or editor to help you create better pharmaceutical documents, we can help. We have more than 20 years’ experience writing for the end-user, researching and applying standards from various regulatory agencies, and organizing complex subject matter in accessible formats.
Contact us today to see how we can help you with your pharmaceutical documentation needs.