From the March 20, 2003 issue

Along with many worthwhile efforts being showcased last week across the nation during National Patient Safety Week, a number of landmark regulations and legislative efforts were introduced that may prove to be a turning point in healthcare.

In Congress, the House passed two important bills aimed at improving patient safety and access to care. First, the House passed the Patient Safety and Quality Improvement Act of 2003 (HR 663). This bill sets the stage for improved reporting of patient safety information by assuring confidentiality and legal protection of information collected and shared with Patient Safety Organizations (PSOs). The Secretary of Health and Human Services would certify a number of PSOs (ISMP would qualify) to collect patient safety information and voluntarily submit non-identified information to a national Patient Safety Database for research.

The bill also calls for the adoption of standards that promote communication between clinical information technology (IT) systems and provides $25 million in grants (in both 2004 and 2005) for the application of electronic prescribing systems and other clinical IT systems.

Several Democratic senators have suggested that the bill does not go far enough to assure that health systems will use the newly protected information to improve patient safety. However, unlike four patient safety bills that were introduced during 2002, but never passed, this new bill has strong bipartisan support (it passed in the House by a vote of 418-6!), offering renewed hope for its passage in the Senate. To view the bill, visit www.house.gov and search for “HR 663.”

The second bill, which passed in the House last week, addresses tort reform. Entitled the Help Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) Act of 2003 (HR 5), this bill places a $250,000 cap on non-economic damages (pain and suffering), but still allows for full payment of other costs and economic damages. The bill also places limits on the contingency fees collected by plaintiff attorneys. Again, similar legislation had been stalled in Congress for years, but the ever-increasing cost of liability insurance and the subsequent loss of healthcare services in some communities across the US may well prove to be the impetus needed to begin to tackle this very complex issue. To view the bill, visit www.house.gov and search for “HR 5.”

In the regulatory arena, FDA published proposed rules in the Federal Register (March 13, 2003) calling for bar coding on medications and blood products and new pharmaceutical industry requirements for reporting medication safety issues to FDA. The bar-coding rule applies to all prescription medications as well as over-the-counter medications commonly dispensed in hospital settings. The rule requires the bar code to contain the National Drug Code as part of the drug label. For now, the lot number or expiration date are not required, but such requirements could be added later as technology progresses. Another proposed rule would require pharmaceutical companies to submit to FDA all reports they receive of actual or potential medication errors in the US. While practitioners can report directly to a company, all productrelated medication errors submitted to the USP-ISMP Medication Errors Reporting Program are forwarded automatically to the manufacturer. Individual companies are not able to contact reporting practitioners directly unless they indicate their willingness during the reporting process. FDA invites comments on the proposed rules during the next 90 days, after which time the rules will be enacted after being published in the Federal Register in their final form. For details, visit www.fda.gov.

In their own right, each of these efforts can be expected to have an enormous impact on patient safety. But consider their impact together! Not just one, but several significant stumbling blocks to action could be removed from our path if each becomes reality. Implementation of bar code technology during medication use could be affordable for most; we could share our insightful medication error stories without the fear of litigation keeping us silent; our dedicated and knowledgeable workforce could provide healthcare services without enormous economic hardship for liability insurance and fear of inequitable legal settlements; we could learn more quickly about serious medication safety hazards and correct the problems more efficiently on a broad scale; and a culture of safety could evolve sooner in healthcare.

We may well look back in history and realize that we were at a crossroads during the 2003 National Patient Safety Week! These efforts, of course, are not the end of the journey, but patients deserve our support of these strong beginnings.