Safe Use Initiative report summarizes views to promote patient medication safety

December 21, 2010

A recently released Institute of Medicine workshop summary indicates there are myriad ideas, including better use of EMRs and research to focus action on the most common elements associated with adverse events.

What are the best directions now to promote patient medication safety?

A recently released Institute of Medicine workshop summary indicates there are myriad ideas, including better use of electronic medical records (EMRs) and research to focus action on the most common elements associated with adverse events. The workshop, titled “The Safe Use Initiative and Health Literacy,” was held in April 2010.

Joshua Sharfstein, MD, FDA’s principal deputy commissioner, said that the agency wanted input on its new Safe Use Initiative, which aims to minimize the risk of medications to improve the ratio of benefits to risks. “The idea is to tackle one drug at a time in order to make progress, working within structures and systems to achieve the goal of patient safety,” Sharfstein said in the report.

He emphasized the need to collaborate and build partnerships with various stakeholders, including pharmacists, insurers, pharmaceutical companies, and patient and consumer groups. It is also important to include those involved in developing and deploying EMRs, he said.

To develop initiatives to advance patient drug safety, the Centers for Disease Control and Prevention (CDC) created an electronic system to document hospitalizations and emergency department (ED) visits that resulted from adverse drug events in 2004 and 2005. CDC documented approximately 117,000 hospitalizations and 700,000 ED visits during that period. Of the most severe effects leading to hospitalizations, approximately half were attributed to overdoses. Of these overdoses, 60% were caused by drugs within narrow therapeutic indexes, such as warfarin and antidiabetic medications, according to Daniel Budnitz, MD, MPH, director of the Medication Safety Program with the Division of Healthcare Quality Promotion at CDC.

“More adverse events occur in older populations,” said Budnitz in the report. “Among this older population, the severity of adverse events is greater, resulting in 7 times the hospitalization rate among adults ages 67 and older than those younger. More than half of these are unintentional overdoses, which are likely preventable. Three drugs account for one-third of these ED visits among the older population: insulin, warfarin, and digoxin.”

Budnitz emphasized the need to identify causes of harm and to focus on the most common ones, such as the use of anticoagulation agents by older adults. He suggested in the report that dosing instructions should be improved using health literacy concepts.

Consumer medication information (CMI) is the most widely used supplemental approach for communicating medication use information. However, the lack of health literacy is a major barrier to understanding safe medication use in CMI, according to Gerald McEvoy, PharmD, assistant vice president of Drug Information for the American Society of Health-System Pharmacists (ASHP). He has served as editor-in-chief of ASHP’s federally recognized drug compendium.

ASHP has developed several recommendations for improvement of CMI, McEvoy said, including:

• Involvement of stakeholders to improve the quality, consistency, and simplicity of CMI

• Development of a single, comprehensible document

• Validation of CMI models in actual-use studies in relative patient populations

• Collaboration with state boards of pharmacy to ensure compliance with FDA-established standards for content, format, and distribution at the point of dispensing

Will Ross, MD, associate professor of medicine at Washington University School of Medicine, suggested greater involvement by EMR developers. “For example, there needs to be linkage of EMRs and appropriate dispensing and accurate recording of medications,” Ross said in the report. FDA’s Sharfstein noted that there is evidence that EMRs are useful for avoiding specific medical errors.

The workshop summary, like similar IOM summaries, reflects the discussion but not a consensus.

“The Safe Use Initiative and Health Literacy: Workshop Summary,” is available as a free download at.