FDA is urged to “Put Patients First”
McLean, VA – Consumer Health Information Corporation participated in the FDA public hearing on “Development and Distribution of Patient Medication Information for Prescription Drugs” (Docket No. FDA 2010-N-0437). Dr. Dorothy L. Smith, President and CEO, expressed concern that the proposed Patient Medication Instructions (PMIs) will not meet the needs of patients, health professionals or pharmaceutical manufacturers. The patient is the most important stakeholder.
Consumer Health Information Corporation’s statement was based on the company’s experience in three areas:
- Clinical pharmacy practice including one-on-one patient counseling and development of cost-effective patient counseling programs.
- Development of thousands of evidence-based patient education programs that have increased patient adherence.
- Development of 23 books containing patient medication instructions for health professionals and consumers and development of FDA-approved Patient Package Inserts (PPIs).
Consumer Health Information Corporation agreed with FDA that the current Consumer Medication Instructions (CMIs) and Medication Guides (MedGuides) are “not adequate to ensure that patients receive the essential medication information that is needed to use the drug safely.”
Dr. Smith disagreed with FDA that the Patient Package Inserts (PPIs) have failed. She stated, “We know of no research that proves PPIs have failed. We urge FDA to not rule out PPIs just yet or attempt to replace them with the currently proposed PMIs.”
Consumer Health Information Corporation does not believe that the proposed PMIs will meet the patient’s needs, health professional needs – nor FDA’s goal – to use the drug safely because:
- The proposed PMIs do not provide patients with fair balance so they can weigh the risks against the benefits and make an informed decision.
- The proposed PMIs do not provide patients with adequate information on how to recognize the early warning signs of possible side effects or what to do if they occur.
- The proposed PMIs do not contain “how to use” information on either the drug or the device. This omission introduces a huge element of risk for patients, health professionals and the pharmaceutical industry.
- The proposed PMIs will not provide health professionals with one complete time-saving patient counseling tool. They will still have to give patients instructions on “how to use” the medication/device and how to manage side effects. Who will provide health professionals with this information?
Dr. Smith raised the question, “Since at least 10% of patients decide in the physician’s office to not fill the initial prescription, should informing patients about risk start in the physician’s office before the drug is even prescribed?”
Dr. Smith stated that a high-quality PMI will increase patient adherence and made the following recommendations:
PMIs must meet the needs of patients.
Behavior must become the focus. The PMIs must be more than a series of facts. They must be motivational. Evidence-based behavior modification techniques must be integrated into both the content and design to help guide patients to the desired behavioral outcomes.
The rigid box templates currently proposed be replaced with the freedom to develop a PMI that allows the incorporation of illustrations, dose charts, photos, etc. that are most appropriate for a specific product. The content must be reinforced with good design. This will lead to increased patient comprehension and patient recall.
FDA-approved Patient Package Inserts (PPIs) should be re-examined as an alternative to the proposed PMIs because 1) PPIs contain all the content and design elements missing in the proposed PMIs; 2) PPIs have already been developed for many drugs and approved by FDA as official patient labeling; and 3) The FDA approval process is already in place.
PMIs can increase patient adherence. It is in the best interest of the pharmaceutical manufacturer to develop PMIs. A high quality PMI should increase patient adherence by at least 10%. When a PMI is reinforced with high quality patient counseling and patient education programs, adherence should increase 25% – 50%.
Patients must be able to rely on PMIs. The PMI will often be the only written information patients receive on their prescription medication.
All PMIs should be reviewed and approved by FDA.
Patient mismanagement of prescription drugs is one of the most serious problems facing our health care system. It is a national patient safety problem. The quality of the PMI is just as critical to patient safety as the quality of the drug.