“As FDA has recognized, various FDA regulations require pharmacies to provide patients several different types of written information, developed by different sources that may be duplicative, incomplete, or difficult for patients to read and understand. This current system is not adequate to ensure that patients receive essential information about the medications they are taking,” the letter stated.
In the letter, NACDS urged the FDA to expeditiously develop, adopt and implement a single PMI document system or “One-Document Solution” for prescription medications dispensed at pharmacies so patients have a useful document - designed and written for them.
“We [NACDS] urge FDA to elevate the transition from Medication Guides (MedGuides), Patient Package Inserts (PPI) and other Consumer Medication Information (CMI) to the “one-document solution” PMI to be among FDA's highest priorities,” continued the letter.
NACDS first proposed the development of a “One-Document Solution” in 2007 along with a number of other patient and industry stakeholders. This “One-Document Solution” would provide patients with useful and focused information on their prescription medications and allow pharmacies to advise and counsel patients on adhering to prescription medication. A 2009 report by the New England Healthcare Institute (NEHI) found that poor medication adherence cost roughly $290 billion a year in additional healthcare costs.
“NACDS remains committed to working with the Food and Drug Administration to advance a 'One-Document Solution,' said NACDS President and CEO Steven C. Anderson, IOM, CAE. “The development and implementation of a 'One-Document Solution' is an important patient safety recommendation and should be a top priority.”