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Medication safety efforts advance

Donald Levick, M.D., MBA

By Christopher Guadagnino, Ph.D.

Even before the Pa. data is collected and analyzed, and interventions are recommended, various entities already recognize that one error category in particular is of central importance to patient safety improvement: medication error.

Experts and industry leaders note that medication error is one of the most significant sources of medical errors, including the Institute of Medicine, which drafted the report that brought national attention to the subject of medical errors in Nov. 1999, and the Institute for Safe Medication Practices (ISMP), a national organization that has been brought on as a subcontractor by the PSA to analyze data related to medication errors. The IOM report concluded that medical errors of all kinds cost as many as 98,000 American lives each year and that medication-related errors alone account for up to 7,000 deaths.

Since the IOM report, two large regional medication error reduction initiatives have been launched in Pa.: a medication safety component of the Pittsburgh Regional Healthcare Initiative, which involves the collaboration of 33 hospitals in western Pa.; and the Regional Medication Safety Program for Hospitals, in which 70 hospitals in southeastern Pa. have participated. Both initiatives have yielded concrete interventions.

Various agencies are increasingly endorsing information technology-based medication error reduction systems. The Food and Drug Administration recently passed a regulation requiring bar codes on all medications as a safeguard against medical errors, while the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) is considering expanding its hospital patient safety criteria to include medication bar code technology at the bedside. The ISMP advocates both medication bar-coding and computerized prescriber order-entry (CPOE) system implementation, while the Leapfrog Group has called on hospitals to implement a CPOE system as one of its initial three goals that hospitals need to fulfill to earn the group’s stamp of approval for large employers purchasing health care.

This endorsement trend is likely to spur movement by Pa. hospitals to invest in CPOE or point-of-care prescription bar-coding systems. It is estimated, however, that fewer than 10 percent of Pa. hospitals currently have CPOE or medication bar-coding systems, which are expensive – ranging from $1 million to well over $5 million in startup costs and $0.5 million to over $1 million in annual support and maintenance costs. An investment of that size is a significant financial burden on smaller hospitals, or those with negative margins, which according to the Pa. Health Care Cost Containment Council comprised 48 percent of the state’s acute care hospitals in 2003, up from 42 percent in 2002 and 34 percent the previous year.

Successfully using the technologies also poses challenges. CPOE systems directly alter physician workflow, and can produce complications and frustrations serious enough to lead to its abandonment.

Despite these obstacles, even some modest-sized Pa. hospitals are acting on confidence in their ability to afford and successfully implement such systems and some institutions are seeing tangible payoffs in the form of errors prevented and expensive follow-up care obviated.

Regional Medication Safety Initiatives

Even before PSA reporting activities commence, collaborative efforts to enhance medication safety in hospitals have emerged in the Pittsburgh and Philadelphia regions.

In a project of the Pittsburgh Regional Healthcare Initiative, 33 southwestern Pa. hospitals are sharing over 5,000 medication error reports each quarter using a reporting system known as United States Pharmacopeia’s MEDMARx, allowing them to examine errors by hospital and region while comparing to national aggregate data, according to PRHI Policy Director Ken Segel.

PRHI’s medication safety program, begun in 2001, consists of Regional Working Groups, five medication safety researchers and a patient safety evaluation team from the University of Pittsburgh School of Pharmacy and Purdue University, while data collection is handled by the Data Coordinating Center of the University of Pittsburgh School of Pharmacy. PRHI hospitals receive quarterly MEDMARx reports that describe their reported errors and trends over time, while the Regional Working Groups provide a forum for regional learning about medication patient safety in each hospital. The initiative’s patient safety team, which has received a grant from the Agency for Healthcare Research and Quality (AHRQ), is currently evaluating the effectiveness of reporting systems and hospital cultures for patient safety within PRHI.

Based on a review of medication error reports by groups of experts tapped from the medical community, PRHI found that four drug classes (antibiotics, glycemic agents, anticoagulants and opioids) were involved in nearly 45 percent of all errors resulting in serious harm.

PRHI has developed, using a survey of best practices across the nation and within Pittsburgh, region-wide guidelines for: avoiding seven most commonly misused drug abbreviations, proper use of the fentanyl transdermal patch, and safe practices involving patient controlled analgesia (PCA), says JoAnn Narduzzi, M.D., co-chair of the PRHI Medication Safety Committee and vice president of academic affairs for Pittsburgh Mercy Health System. Narduzzi says that regional compliance with the drug abbreviation guidelines is very high, while compliance with safe PCA practices is progressing. Future plans include region-wide safety programs for insulin use, anticoagulation and standards for surgical prophylaxis, she adds.

Because MEDMARx is a trending database that collects data for analysis in quarterly batches, it is not well-suited for real-time reporting, making follow-up and root cause analysis more difficult, the further removed an incident is from its analysis, says Narduzzi.

In response to that challenge, six of the region’s hospitals have agreed to begin sharing medication error and intervention data on a daily basis, while PRHI hopes that number will increase, says Segel.

There is not a unified approach to reporting and learning from errors across different reporting systems, and there needs to be, Segel believes, noting that hospitals currently enter data into various systems, including health insurer risk reporting and JCAHO sentinel events reporting. Hospitals participating in the PRHI medication safety reporting program are concerned about the cost and burden of duplicate data entry, he notes, but see value in being part of its regional and national database.

As the PSA’s error reporting system rolls out and presents hospitals with yet another data entry obligation, Segel believes the PSA program is a logical place to look for a single error reporting system, if it engenders trust among institutions that it will be used to support learning rather than punitive purposes. Segel was impressed with the PSA’s first feedback report to hospitals, which he says drew important attention to near-miss reporting and using narrative description to report events in detail.

In June 2001, 65 hospitals in southeastern Pa. began collaborating in the Regional Medication Safety Program for Hospitals, launched by the Health Care Improvement Foundation, an affiliate of the Delaware Valley Healthcare Council (DVHC), to focus on 16 consensus action goals to reduce medication errors. Involving the partnership of ISMP and ECRI, the initiative offered hospitals a series of tools and educational programs – including nine major educational seminars, individual on-site safety reviews and assistance in developing individualized action plans – addressing four aspects of medication safety: institutional culture, infrastructure, clinical practice and technology, according to DVHC President Andrew Wigglesworth.

Collaborating hospitals received a medication safety “solutions kit” that includes a binder with supporting information on how to meet the 16 objectives, materials used to train hospital staff in error prevention – including four videotapes, a series of ten safe practices campaign posters that can be placed strategically throughout the hospital, and a procurement guide to computerized prescriber order-entry (CPOE) systems.

The materials cite ISMP’s warning that some 20 drugs are responsible for 80 percent of medication error fatalities, and include safety checklists for high-alert medications such as warfarin, insulin and chemotherapy. One of the initiative’s 16 action goals incorporates another ISMP finding that medication errors are reduced by 66 percent when a senior pharmacist accompanies physicians on rounds in an intensive care unit.

Other action goals include such measures as providing medication safety education for all professional employees, designing area-specific guidelines for unit-stocked medications, eliminating dangerous abbreviations and dose designations, limiting and creating safeguards for verbal orders, implementing safety checklists for high-alert medications and infusion pumps, eliminating infusion pumps without free-flow protection, and preparing for implementation of CPOE systems.

Funding for the program’s $1.5 million budget was provided in equal parts by the participating hospitals, Independence Blue Cross, and other donors including private foundations and local businesses. Hospitals had the choice to fund and implement their individual plans in accordance with their local resources and environment, while Wigglesworth says some institutions have already implemented many of the program’s threshold objectives and he expects that all hospitals in the region will eventually do so. DVHC will soon send out a self-assessment survey to its members to chart program participation and will hold an educational session based on the survey findings, he says. DVHC has packaged the program’s materials for sale to other regions and has customers in 41 states and eight countries, Wigglesworth adds.

DVHC has also recently inaugurated an annual patient safety award, including a $5,000 cash prize to the winning hospital, to recognize and help advance innovative efforts, says Wigglesworth. Applicants for the award have entered such projects as color-coded stickers for high alert-medications, a medication safety fair for hospital employees, standardized care protocols and order sets for coronary bypass surgery antibiotics, a chemotherapy process improvement, enhanced documentation and verification of patient allergy information, and various web-based medication safety interventions.

Information Technology Solutions

Industry incentives on hospitals to acquire and implement information technology-based drug safety systems are intensifying and, while some obstacles remain, analysts expect an increasing number of Pa. hospitals to make the investment.

The principal obstacle to the widespread use of point-of-care drug bar-coding systems, according to the ISMP, has been the absence of bar codes on unit-dose medications, as hospitals and other health care providers have delayed buying the hardware and software necessary to process bar-coded information because manufacturers had not always provided bar-coding of medications, while pharmaceutical manufacturers had delayed bar-coding such labels on the grounds that so few hospitals are equipped to make effective use of them.

New FDA regulations have broken that “chicken-and-egg” delay cycle. The FDA published regulations in late February requiring drug manufacturers by April 2006 to add bar codes to single units of medication given to patients in hospitals, while newly approved drugs must include the bar codes within 60 days of approval. The new regulations will facilitate medication safety by allowing hospitals to use a computer system to scan bar-coded drugs and patient bracelets to verify that the correct drug is being dispensed to the correct patient, in the correct dose, at the correct time, and without conflicting with anything in the patient’s medical record. The FDA estimates the new regulations will save $5 billion a year by reducing errors and will prevent 500,000 adverse events and transfusion errors over 20 years.

Although the regulations do not require hospital participation, the ISMP believes that bedside bar code scanning of medications is one of the most promising technologies to reduce medication errors, and in November 2002 had urged all U.S. acute care facilities to implement such a system within three years. Noting that about a third of medication errors involve drug administration, the ISMP says that bar coding technology is likely to be especially useful for reducing the incidence of errors at that stage, and calls it “inexcusable” to continue to neglect the technology’s potential for preventing patient harm.

Hospitals may soon have an additional incentive to acquire bar-coding capabilities, as the JCAHO is proposing significant revisions to the patient safety goals that hospitals must meet as part of its accreditation process, including the requirement that hospitals develop a plan for implementing bar code technology at the bedside, to be made operational by January 2007.

After introducing a bedside bar-coding system last fall and implementing it house-wide this February, Erie’s Hamot Medical Center has already seen the system produce significant results, says James Donnelly, Hamot’s chief quality officer. Out of about 120,000 doses of medication per month dispensed at Hamot, the bar code system has prevented 150 cases per month in which a nurse scanned the wrong patient for a particular medication, 100 cases per month in which the wrong medication would have been administered to a patient, 250 adverse drug events per month, and 300 undocumented doses per month – in which medications were due but not administered to patients, Donnelly notes. The hospital is currently aggregating the data and creating interventions with Hamot’s clinical leadership, he adds.

Hamot will also begin to roll out a newly-acquired computerized prescriber order entry (CPOE) system this summer to “close the loop” of the medication process, addressing the three phases prior to drug administering, namely, drug ordering, transcribing and dispensing, Donnelly says.

The ISMP advocates CPOE as an effective strategy for eliminating illegible or easily misinterpreted handwritten prescriptions, which it says is a major source of errors at the beginning of the medication use system. CPOE can also automate the process of checking a prescription against relevant drug and patient information stored in electronic databases that otherwise may not be readily available to the prescriber, alerting them to patients at risk of allergic reactions to prescribed medications, or who are at risk for adverse interactions with other medications.

The ISMP says that use of CPOE programs resulted in huge improvements in detecting errors, citing a 1998 study at Boston’s Brigham and Women’s hospital that demonstrated a 55 percent reduction in error rate after implementing such a system – from 10.7 to 4.9 per 1,000 patient days; and another study of intensive care patients in which a computerized system helped physicians reduce the incidence of allergic drug reactions and excessive drug dosages by more than 75 percent, with the average time patients spent in the unit dropping from 4.9 days to 2.7, slashing costs by 25 percent.

CPOE system implementation is also one of the three initial patient safety goals promulgated by the Leapfrog Group, a consortium of Fortune 500 companies and other large health care purchasers, that began surveying patient safety efforts at hospitals in June 2001 and publishes findings in the hope of leveraging employer purchasing power in ways that nudge hospitals to adopt the group’s safety goals. The group currently surveys 24 regions across the country, accounting for over 1,200 hospitals providing care to almost half of the U.S. population. More than 410 hospitals outside of the 24 regions also voluntarily respond to Leapfrog surveys, including 19 hospitals in Pa.

Other Obstacles Remain

Despite various incentives to adopt technology-based medication safety systems, the up-front cost of developing and implementing such a system is high, and the vast majority of hospitals have not yet done so.

The ISMP acknowledges that computers cannot be a foolproof solution to medication errors because they are only as good as their designers and end users. In a 1998 study of pharmacists nationwide, ISMP asked them to process a hypothetical prescription using their hospitals’ computer systems. The test resulted in up to 67 percent of the hospitals’ computer systems processing a series of fatal overdoses without any on-screen warnings.

Clinicians may also overlook or ignore the computer system’s warnings, or choose to rely on their own experience instead of taking guidance from the computer, and the ISMP has published alerts that some hospital personnel have been working around their bedside bar-coding systems by using preprinted cards with commonly used medications and their bar codes because some scanners could not effectively read curved surfaces on intravenous solutions, ampules, or wristbands.

Hospitals must not underestimate the degree to which systems such as CPOE can disrupt clinician work flow, or the importance of cultivating clinician support, as well as not bringing the system up too quickly, cautions Donald Levick, M.D., MBA, physician liaison for information services at Lehigh Valley Hospital, which started implementing CPOE and electronic charting of medication administration in its transitional trauma unit in June 2001 and, three years later, has the system operating for about 60 percent of the beds at Lehigh Valley Hospital and Health System’s three campuses.

One of the reasons Lehigh Valley went unit-to-unit with the system so gradually, Levick says, was to give physicians time to adapt positively to the change in workflow. With the system operational for some hospital units and not others, some pressure is taken off any given physician’s learning curve by allowing him or her to order medications using hand-written orders for patients in one unit while requiring the use of the new computer system for those in another unit.

A considerable amount of Lehigh Valley’s effort was spent tailoring the system to the unique needs of physicians and other clinicians in each unit, particularly the dialysis and critical care units, which deal with continuous infusions of particularly complex medications, says Levick. Some physicians embraced the system early on, while others withheld their support until it seemed inevitable that the system was going to work, he notes.

The biggest concern among physicians was that the system slowed them down during the time it took them to learn and become proficient with it – which ranged from as quickly as two weeks to as long as six months, depending in part on how frequently the physician had rounds in the hospital and was exposed to the system, Levick says. Infectious disease specialists, for example, learned the system rather quickly.

The medical staff was also concerned that the hospital provide adequate access to computer workstations to avoid data entry tie-ups, a concern which Levick says was addressed by robust wireless technology involving laptops on mobile carts, as well as computer notebooks which could be carried by physicians. Once physicians begin to rely on electronic data, they become intolerant of unscheduled down time of the system, which Levick says rarely occurs.

To facilitate physician buy-in to the system, says Levick, Lehigh Valley involved its medical staff for more than a year prior to implementation in choosing and designing the product and its user interface screens. Even then, physician response was mixed, with some experiencing trepidation in trying to imagine what working with such a system would be like. As physicians started to use the system, the number of their requests for tweaks increased, such as having the system conspicuously alert the physician when someone else had discontinued a medication – particularly since there is almost always more than one physician involved in a particular inpatient’s care.

Levick says Lehigh Valley is seeing significant reductions in medication errors in all areas: ordering, transcribing, dispensing and administering, and hopes to have the CPOE system fully implemented sometime next year.

While some institutions have seen favorable results after implementing a CPOE system, the technology is still unused by the vast majority of institutions. Fewer than two percent of U.S. hospitals have CPOE completely or partially available and require its use by physicians, while only five percent of hospitals in the Leapfrog Group’s survey regions have fully met the group’s CPOE standard, according Leapfrog spokesperson Claire Turner. The group’s CPOE standard requires that physicians enter at least 75 percent of medication orders via a computer system that includes prescribing error-prevention software; that the system can alert physicians to at least 50 percent of common, serious prescribing errors; and that physicians electronically document a reason for overriding an interception prior to doing so.

The Leapfrog Group seeks to accelerate CPOE adoption by urging its members to choose hospitals that meet the group’s patient safety goals, and hopes that increased purchaser attention to the importance of CPOE may stimulate CPOE vendors to hasten product improvements and reduce implementation costs.

Although the Hospital & Healthsystem Association of Pennsylvania (HAP) does not have firm numbers, it estimates that around 10 percent of Pa. hospitals are currently implementing either bar-coding or CPOE systems, while it expects acquisition of the bar-coding system to accelerate in the wake of the new FDA regulations, according to John Combes, M.D., HAP’s senior medical advisor.

For a 300-bed hospital, the startup cost of a bedside drug bar-coding system is about $1 million and the annual maintenance cost is about $500,000, while a CPOE system runs at least three times those costs, says Combes. The Rendell administration is offering $25 million in first-year funding for low-cost loans to Pa. institutions acquiring health care information technology, while HAP is working with the state to define eligibility criteria for the loans, Combes adds.

Delaware County’s Riddle Memorial Hospital, a mid-sized institution with 250 beds, has devoted $2 million of its $7 million annual capital budget to implement and maintain both a patient bar code-based robotic pharmacy dispensing system, which it installed this February, and an electronic clinical documentation system, which it hopes to roll out next May to integrate physician drug ordering with laboratory, radiology and other clinical activities, according to Robert Santilli, Riddle’s chief operating officer. The clinical documentation system costs $14 million, to be paid over ten years, and involves partnering with a data system vendor in Kansas City.

Santilli notes that Riddle in the past has put up $20 million for building new facilities, and regards the computerized clinical documentation system investment as equal in importance, in terms of making the hospital a more efficient health care provider in the long term.

The cost of such systems may yet remain out of reach for many institutions, particularly for smaller rural hospitals in Pa., and for those that did not escape negative operating margins last year, as Riddle did.

CPOE implementation goals such as those pushed by Leapfrog were promoted without sufficient cost/benefit analysis relevant to the needs of particular institutions, according to Combes. He also cites a hospital in California that had to suspend the use of a CPOE system after physicians balked at the extent to which it disrupted their workflow.

Defining the value of health care information technology and where to “draw bright lines between where it would make sense and where it would be an undue burden,” is only now being investigated, says Combes, who points out that AHRQ is issuing new grants for research investigating the issue.

There is very little data currently available to define the cost/benefit threshold for a health information technology investment, beyond studies of one or two institutions that saw improvements using a particular technology, according to Scott Young, M.D., AHRQ’s director for health information technology. The “value” of systems such as bedside bar-coding and CPOE, he says, involves a calculation based on many different measures, including system cost burdens, increased burdens on health care providers, impact on drug costs, impact of adverse drug event reductions, and impact on health and wellness improvement of patients.

The AHRQ is offering up to $10 million in grants this year to research that addresses such issues, and is also offering up $7 million in grants for institutions planning to implement health care information technology, and up to $24 million for institutions ready to implement such systems, adds Young.

The ISMP notes that other strategies for helping health care institutions deal with the cost of CPOE systems include vendors charging a relatively low monthly subscription fee for access to a range of electronic prescribing capabilities, and having electronic prescribing tools underwritten by a third-party stakeholder, such as a pharmacy, pharmacy benefits manager, or pharmaceutical manufacturer.

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