PATIENT LABELING/ PATIENT PACKAGE INSERTS (PPIs)
Patient-Friendly Brief Summaries
“EDUCATION EQUALS COMPLIANCE
Explain risk information in non-threatening language. It is possible to meet FDA requirements and write at the Grade 6 level so the majority of consumers can understand it– and translate the side effect information into symptoms they recognize.”
The Brief Summary is meant for health professionals – not consumers! Consumers need good patient information about your product written in language they can understand.
Pharmaceutical companies are developing Patient Package Inserts (PPIs) for their products. Like Brief Summaries, PPIs discuss the risks and benefits of the product. But the PPI presents patient information in precise, understandable language developed specifically for consumers.
FDA Says Consumers Need DTC Ads They Can Understand
The FDA “believes that FDA-approved patient labeling is a better vehicle for communicating risk information to consumers than lengthy, technical FDA-approved professional labeling.” ~FDA Draft Guidance, January 2004
Patient Labeling Done Right the First Time
We have developed Patient Labeling for many of today’s top brands … successfully meeting the needs of patients, pharmaceutical companies and the FDA.
- Patient Labeling requires precision wording that is clinically accurate, “consumer friendly” and meets all of your marketing, legal and regulatory requirements.
- All of our clients have received speedy FDA approval, saving them time and money.
- We have 20 years of actual clinical experience in counseling patients about their medications, as well as internationally-recognized expertise in patient education, patient compliance and behavior modification. We know what patients need.
- We can save you precious DTC advertising dollars by keeping the PPI to one page while still meeting all FDA and patient education requirements.
- Our expertise in patient information and patient education can add a unique perspective to your DTC strategic planning and help give your product a competitive edge.
Consumer Health Information Corporation has expertise in:
- Customized Corporate Guidelines for Patient Labeling
- Development of patient information that meets health literacy and patient comprehension
- FDA-approved Patient Package Inserts (PPIs)
- Patient infromation presented in “Patient-friendly” Brief Summaries
- FDA review process
EDUCATION EQUALS COMPLIANCE
Explain risk information in non-threatening language. It is possible to meet FDA requirements and write at the Grade 6 level so the majority of consumers can understand it– and translate the side effect information into symptoms they recognize.
Related articles on Patient Labeling/Patient Package Inserts:
- Patient Labeling Is Here to Stay
- Your Patient Package Insert: Does It Help or Hinder?
- Are You Teaching Patients to Manage Side Effects?