ISMP, AHA lead national program on drug safety

Spotlight focusing on medication error

The president of the Institute for Safe Medica tion Practices (ISMP), Michael Cohen, MS, FASHP, says he’s very happy that the issue of medication safety has come to the forefront of public knowledge, helped largely by headlines in major media outlets over the past few months.

Cohen was at the White House Dec. 7, along with American Hospital Association president Dick Davidson, to announce a joint national initiative to help hospitals assess and improve medication safety.

He explains that a series of events led up to the announcement, including a report by the Institute of Medicine that contained this headline-grabbing statistic: Up to 98,000 deaths a year in the United States are caused by errors, including medication mistakes and other adverse drug events. The report also estimated that medical errors cause more deaths than breast cancer, traffic accidents, and AIDS combined.

Captivating the national media

During the last few months, the statistics resulted in high-profile articles in TIME magazine, The New York Times, and the Wall Street Journal, among other mainstream news organizations.

Cohen says that report, along with several highly publicized hospital accidents, seemed to galvanize the public, the U.S. Congress, and several major foundations. All parties have agreed that preventing medication errors is a crucial component in improving health care.

That in and of itself is nothing new. Agencies such as ISMP, the National Patient Safety Partner ship, and the Institute for Healthcare Improve ment have been studying medication safety for quite some time. Cohen says pharmacists have always talked about medication errors among themselves, but they limited their conversations to health professionals, for fear of alarming the public or breaching confidentiality. In retrospect, he says, perhaps pharmacists did not do a good enough job of bringing the issue to the public.

"When we did talk to patients about medication errors, we were criticized by hospital administrators. They accused us of scaring patients, and we bought into that. But now the medical establishment has gotten behind it and it has gelled all at once, and that is good news for all Americans."

"The issue of medication errors has been at the forefront in a lot of individual places, but the Institute of Medicine report pulled things together and served as a catalyst to unify all the agencies," says Rick Wade, AHA senior vice president. "We were presented with the opportunity to unveil something we’d been working on for months with ISMP. The timing was coincidental with the Institute of Medicine report. The White House was aware of what we were doing and asked us to join in the unity on a national scale."

The AHA takes action

The first step in that campaign came in the form of a letter Davidson sent to hospital CEOs, advising them of the joint initiative. The letter included successful practice recommendations compiled from several respected sources. It is posted on AHA’s Web site at

The recommendations include:

• fully implement unit dose systems that include systems for labeling and order screening;

• limit the variety of doses and equipment;

• develop special procedures and written protocols for high-alert drugs;

• ensure the availability of up-to-date drug information;

• educate all clinicians involved in the medi cation administration process about ordering, dispensing, administering, and monitoring med ications;

• educate patients about their medications and how to use them safely;

• ensure the availability of pharmacy expertise by having a pharmacist on call if the pharmacy does not operate 24 hours a day. Also, make pharmacists more visible in patient care areas. Consider having them make rounds or enter orders directly into computer terminals on patient care units;

• standardize prescribing and communication practices.

Other recommendations focus on long-term changes that require substantial modifications to existing systems. Many focus on computerization in the physician order-entry and pharmacy dispensing processes, such as using machine-readable codes (i.e. bar coding) and computerized drug profiling in the pharmacy. One suggestion is instituting 24-hour pharmacy service.

To get started, the advisory suggests hospitals organize a senior management team consisting of the CEO, chief medical officer, chief nurse executive, director of pharmacy, risk manager, director of information systems, and others to review and discuss the recommendations.

The advisory also recommends hospitals review their policies and procedures for reporting and investigating errors and create a nonpunitive culture so errors can be thoroughly evaluated and corrected. Executive behavior also counts; leaders are advised to declare the goal of safety to be a specific priority and to keep the board and organized medical staff up-to-date on what actions they are taking.

The letter also advised CEOs to make sure their staff "is aware of the tremendous amount of information available from organizations like ISMP, the Institute for Healthcare Improvement, the FDA, the National Coordinating Council on Medication Error Reporting, The Massachusetts Hospital Association, The National Patient Safety Partner ship, The National Patient Safety Founda tion, The American Society of Health-System Pharmacists and the American Society for Healthcare Risk Management." (Web sites for several of the organizations mentioned are listed in the box, above.)

The initiative’s next step is to develop a "Medi cation Safety Awareness Test" that surveys hospitals’ current status and future progress on medica - tion error prevention. Cohen says it will help hospital CEOs look at systems directly so they can assess risks. He hopes over time they will continue to reassess and make changes as needed.

"Hospitals in this country range from 10-bed facilities to the most sophisticated medical centers in the world," says Wade. "Information and tools vary. This self-assessment tool will be very useful to many members in helping them look at their strengths and weaknesses."

The ISMP/AHA campaign also aims to:

• track implementation of the practices for reducing and preventing errors within the hospital and health system field;

• work with national experts to develop a nonpunitive model for a medication error prevention process;

• serve as a clearinghouse of information and resources for the hospital field on medication errors.

"We think it is great news that we have a voice directly to hospital CEOs," says Cohen. "They have been contacting us and asking us to come out to their facilities. They want to know what to do about medication errors; it has become a major issue for them. We hope to communicate with CEOs on a regular basis to alert them to problems or discuss our thoughts on how to create a nonpunitive reporting system and how to process and analyze error reports."

As the partnership progresses, the model reporting system is going to be of crucial importance. The Institute of Medicine’s report recommends the establishment of a mandatory stan- dardized public reporting system for all errors leading to serious injury or death, in an effort to foster knowledge about treatments and systems that lead to such mistakes. Currently, about one-third of states have mandatory reporting systems. In addition, the IOM said those error reports should be available to the public.

Clearly, making such information public raises concerns about confidentiality, liability, and punishment, concerns Wade says must be addressed.

"There are criteria for mandatory reporting. It cannot be punitive or a conduit for malpractice lawyers to go trolling," he says. "In order for it to work, people must not be afraid to report. Our hospitals already know things happen that don’t get reported because people are afraid of punishment. It also must include resources for analysis and the use of that analysis to help prevent future errors. It can’t just collect information; it must include a timely way to look at that information and help at the point of patient care.

"Also, there must be an avenue for making this information available to the public in a way that informs people something is being done. That is what the public wants to know. People don’t want to see lives ruined for a mistake, they want to know the mistake won’t happen again."

The message in the Institute of Medicine’s report is also clear: Punitive action and blaming individuals does not reduce medical errors. The only way to increase safety is to focus on hospital systems.

The report also recommends the creation of a patient safety center within the Department of Health and Human Services. The center would collect and distribute medical errors and models for the prevention of errors; it would be similar to the federal agencies that monitor airline and workplace safety.

The federal government already is taking some action. President Clinton’s health care quality task force has been analyzing the Institute of Medicine study, and the White House has announced that the 300 private health plans participating in the Federal Employee Health Benefits program will be required to institute quality improvement and patient safety initiatives. Clinton also signed leg islation providing $25 million for research to improve health care quality and prevent medical errors and directed his budget and health care advisors to develop quality and patient safety initiatives for this year’s budget. In March, a national conference with state health officials is scheduled to convene to promote the best prac tices in preventing medical errors.

In his Rose Garden remarks in December, Clinton said, "Ensuring patient safety is not about fixing blame. It is about fixing problems in an increasingly complex system; about creating a culture of safety and an environment where medical errors are not tolerated."

Those were welcome words for Cohen. "There isn’t one pharmacist who hasn’t been aware of this problem," he says. "And we couldn’t have gotten this far without the bravery of those who were willing to report errors. They did this for no other reason than pure altruism."

Michael R. Cohen, RPh, MS, President, Institute for Safe Medication Practices, Warminster, PA. Tele phone: (215) 947-7797.

Rick Wade, Senior Vice President, American Hospital Association, Washington, DC. Telephone: (202) 638-1100.