Author: Maureen Shaffer
So, what do best practices for patient education materials have to do with Good Promotional Practices, or GPP? Plenty. GPP is all about transparency, communication and disclosure to our ultimate customer, the patient. Objective and meaningful patient education is a win for patients, a must for manufacturers, and critical to stemming the flow of medical malpractice suits. If you are involved in pharmaceuticals, biotechnology or medical devices (medtech), in healthcare as a nurse practitioner or other healthcare practitioner (HCP) or as a vendor touching patients, like a clinical research organization (CRO), here are four best practices for you to improve your patient education materials and help patients make the best medical decisions:
- Use the Criteria Checklist from International Patient Decision Aid Standards: A terrific and thorough Criteria Checklist (PDF) was developed for patient education materials by IPDAS with 100 people in 14 countries. It is based on a review of 34 randomized controlled trials evaluating patient decision aids with real patients facing health decisions and fundamental studies. For more on their research, check out their resources page.
- Read the Helpful FDA Guidances: Yes, they are helpful. I have read them and applied them, really. In fact, I found the labeling guidances helpful with writing and reviewing disease awareness materials and websites. For medical devices, consult this Patient Labeling Guidance. For pharma, try the Consumer Medication Information Guidance (PDF). Heck, both industries should read both. I would also consider their well-written Risk Communication Guidance which talks in detail about how to format and present risk-benefit information with fair balance to both consumers and HCPs. It aggregates many of the more difficult-to-find opinions on what FDA perceives as appropriate and fair balance.
- Double-Check Your Work: Take what you have penned based on #1 and #2, and check out the recent DDMAC warning and notice of violation letters from the great blog, Eye on FDA. They will give you a sense of what not to do. Make your final draft edits, and now you are ready for step #4.
- Go Talk to The Patient, or the Closest Facsimile: The patient needs to be at the forefront. These are, in some cases, life-or-death decisions. If you have the funds, fire up a focus group of folks relevant in the critical aspects to the target patient population to review the draft patient guide and decision aids and provide comments. If your company lacks the funds, as I have at certain start-up companies in the past, ask friends and family who fit the target population profile and ask your co-workers to ask their friends and family. If you are creating materials for patient decision-making, for the best answer, ask the actual patients who have already received the therapy or an alternate therapy, “what do you wish you had known before you had this [treatment, drug, medical device]?”
More to come on patient education. What are your best guides and resources for creating impactful patient education materials? Share yours in the comments!