NEWSLETTER 6: MED ERRORS

The Institute of Medicine's report "To Err is Human"² cited studies indicating that medical errors result in between 44,000 and 98,000 deaths per year in U.S. hospitals. Medical errors can be costly in an economic sense as well. National health care costs due to medical error were estimated to be over $8 billion annually. Another cited study states that the average increased hospitalization cost of Adverse Drug Events, whether harmful or not, was $4,700 per admission. The Institute of Medicine is a private, nonprofit institution that provides health policy advice under a congressional charter as part of The National Academies.

There has been some controversy over the actual numbers of deaths attributed to medical errors. Recently, two articles appeared in the same July 5, 2000 issue of JAMA with conflicting interpretations of the IOM medical error statistics. In the first article, Clement MacDonald of the Indiana University School of Medicine presents his view that the cited studies overestimate the effect of medical errors. He claims that the report did not differentiate between people killed by medical errors and those who died regardless of errors. The number of such deaths "could be very small," according to his paper.³ In the second article, Lucian Leape of the Harvard School of Public Health and an author of "To Err is Human" defends the estimates in the report. Leape estimates that medical errors were a major factor in 86% of the deaths cited in the report, and "tipped the balance" in the rest.⁴ Some of the controversy in interpreting the numbers stems from the fact that the error numbers from individual institutions were extrapolated to cover the entire U.S.

We agree with Leape when he states "Is it somehow better if the number is only 20,000 deaths? No, that's still horrible, and we need to fix it." Even if the number of deaths is in dispute, no one denies that reducing the frequency of medical errors when possible will have positive effects on patient morbidity, improve efficiency of care, and reduce unnecessary cost. Automated clinical systems can reduce errors by checking information, automating the healthcare workflow, and providing tools to alert providers and analyze outcomes.

Following the IOM report, President Clinton announced several governmental steps to reduce medical errors. The Federal Employee Health Benefits Program was ordered to require 300 participating plans to institute quality improvement and patient safety initiatives. Agencies that administer federal health plans were urged to inventory good ideas for reducing errors. The Quality Interagency Coordination (QuIC) Task Force was established to ensure that all Federal agencies involved in purchasing, providing, studying, or regulating health care services are working in a coordinated manner toward the common goal of improving the quality of care. The Report to the President on Medical Errors produced by the QuIC5 is now available.

Another resource on the issue of medication errors is The Advisory Board Company in Washington, D.C. The Clinical Initiatives Center of The Advisory Board has developed written materials that focus on the medication error problem and provide "best practice" recommendations that can be implemented at individual sites. They produced a document entitled Prescription For Change, Best Practices for Medication Management.⁶

INDUSTRY RECOMMENDATIONS

The Institute of Medicine made a goal of 50% reduction in medical errors in 5 years. To achieve this, they propose the following:

• Create a Center for Patient Safety.
• Mandate a reporting system for medical errors.
• Encourage voluntary reporting.
• Provide greater legal protection for data collected for patient safety & quality improvement purposes.
• Promote performance standards (people & organizations) that emphasize safety.
• Emphasize safe use of drugs through the FDA.
• Establish goals of continuous safety improvement for all health care organizations (with named executive responsibility).

The Quality Interagency Coordination Task Force (QuIC) Recommendations:

• Report endorses the IOM recommendations, and describes some new allocations of funding to assist.
• VA will further invest in the completion of order entry system and bar-code-based blood/medication administration system.

The Advisory Board Recommendations–a 22-step program of continuous improvement attempts to:

• Raise institutional awareness
• Establish continuous quality improvement
• Increase automation

It includes:

• Zero tolerance for substandard orders
• Order entry systems
• Pharmacy robotics

Case studies indicate cost savings in addition to quality improvements.

COMMON SOURCES OF MEDICAL ERRORS

Citing data from The Advisory Board, Adverse Drug Events (ADEs) make up the largest group in the distribution of adverse incidents. The total adverse events per 1000 hospital admissions are broken down as follows:

• 65 incidents are Adverse Drug Events,
• 60 are due to Nosocomial (hospital acquired) Infections,
• 51 are due to Procedural Complications,
• 40 involve Readmissions,
• 22 result in Mortality, and
• 15 are due to Falls.

ADEs have a broad range of causes due to the complex process of processing medication orders and getting the medicine to the patient. Some ADEs can result in mortality, but the majority do not. The next two categories, Nosocomial Infections and Procedural Complications, can be affected by provider training or experience and hospital policies on hand-washing and infection control. Certainly these categories will be harder to reduce because there is no specific identifiable cause in many of these cases. The last 3 categories only make up about 30% of all adverse incidents combined. Readmissions in some cases may be related to hospital length of stay policies or provider judgment. As pressure to reduce costs by shortening stays increases, this category percentage may not be expected to decrease by much. The mortality category is not designated in this study as death from errors. It is possible that errors could have contributed in some of these cases, but all causes of death are included here. The final category, Falls, has been shown to be decreased by instituting fall control precautions on likely classes of patients such as the elderly.

The largest cause of adverse events in hospitals is ADEs, which account for over 25% of all adverse hospital incidents according to this research. When looking at ADEs only:

• 56% could be attributed to the physician,
• 34% were due to the nurse,
• 6% were due to the unit secretary,
• 4% were attributed to the pharmacy staff.

While ADEs do not always lead to death, they usually do increase the length of the hospital stay and add significant cost. Categorizing types of problems that occurred with physician orders:

• 78% had illegible signature,
• 58% were missing the order time,
• 24% of the orders were incomplete, and
• 20% of the orders were illegible.

With nursing-related ADEs, the causes include math errors calculating dose, administering the wrong dose or medicine, or missing doses. Unit secretary errors are mainly transcription errors. Pharmacy dispensing errors occurred least frequently.

Combining above statistics, up to 36 ADEs can be attributed to physician causes per 1000 admissions. This is the largest subgroup of ADEs that occur in hospitals, and we will show that many are preventable. More than seven of these can be due to illegible writing of orders on paper charts. Workflow automation and process improvement can help reduce this large class of adverse drug events in several ways. The following sections will deal with methods of preventing and identifying ADEs by automating and improving the ordering process.

There are a variety of steps in the ordering process that can introduce sources for error. The typical process for pharmacy orders in most hospitals today, even those with automated systems; involve many steps by several different people. This contributes to the high error rate associated with medication orders, and this is a good place to eliminate steps and reduce errors. Typically, the provider still scrawls his orders on a paper form on rounds then flags the chart. The unit secretary scans the charts for flags periodically, then checks the order for completeness, places a copy of the paper form in the Medication Administration Record (MAR), sends a copy to the pharmacy, and notifies the nurse. For Stat orders, the nurse may do some of this process. The pharmacist then attempts to decipher the order, and if there is a computerized pharmacy system, will enter the order at this point. If pharmacy decision support is provided, then the pharmacist or order entry clerk may be presented with an allergy or clinical drug alert. They will either override the alert or contact the ordering physician for clarification of conflicts. Finally the appropriate form of the drug is dispensed by the pharmacist and sent to the floor where it is stored for administration. The nurse will typically refer to the current medication dosing list to decide when and how much medication to deliver. There are obviously many ways to improve this process.

AUTOMATING THE PROCESS AND PHYSICIAN ORDER ENTRY

An automated system can provide online chart availability, results reviewing, order entry checking and workflow automation. These can result in improved efficiency and reduction of errors similar to that which occurred when other industries were computerized such as banking and airline reservations. There is often improved access to clinical data when and where it is needed. Patient and outcomes data are made available in a form that can be reported and analyzed, enabling policy evaluation and quality improvement at the enterprise level. Since ADEs are the largest class of preventable adverse events, improving the order process and providing feedback to warn of potential drug related ADE’s are highly recommended. Instituting systems that provide physician order entry (POE) and knowledge based pharmacy rules can be very rewarding. There is a national mandate to reduce medical errors. Many medical errors are avoidable, simple errors, and a significant category of preventable errors occurs as adverse drug events. While many of these ADEs are not serious, they are often costly and some may result in significant patient morbidity or death. Medical errors can be reduced by automated systems in a variety of ways. Physician order entry can be particularly effective at producing impressive reductions in adverse drug events. It does this by several mechanisms including introducing order process simplification, guiding providers through the process with prompting and error checks, elimination of illegibility and most incomplete orders, and by providing clinicians with immediate feedback from clinical decision support systems. It is possible to broadly deploy computer assisted physician order entry systems. Physician acceptance of such systems can be good if the system is carefully implemented, and they are likely to result in reduced errors and process improvements. Decision support can include entry or dose checking, allergy or drug interaction alerts, or more complex knowledge-based clinical rules. Each type of decision support can provide measurable error reduction and potential cost savings which can be additive. These conclusions are supported by data from clinical studies. There is significant potential for automated systems employing physician order entry and clinical decision support to reduce common types of medical error, and lower cost or improve efficiency.

REFERENCES

1. National Center for Vital and Health Statistics Testimony, 22-24 June 1999, (obtained via Internet)
2. Kohn LT, Corrigan JM, ed., Donaldson M, ed., (1999). To Err Is Human: Building a Safer Health System, Washington, DC: Institute of Medicine
3. Clement J. McDonald; Michael Weiner; Siu L. Hui, (July 5, 2000). Deaths Due to Medical Errors Are Exaggerated in Institute of Medicine Report, JAMA, Vol. 284, No. 1
4. Lucian L. Leape,(July 5, 2000). Institute of Medicine Medical Error Figures Are Not Exaggerated, JAMA, Vol. 284 No. 1
5. Donna Shalala, Alexis Herman (Co-chairs), (2000), The Report to the President on Medical Errors–Doing What Counts for Patient Safety: Federal Actions to Reduce Medical Errors and Their Impact, Rockville, MD, Quality Interagency Coordination Task Force (QuIC)
6. The Clinical Initiatives Center, Prescription For Change, Best Practices for Medication Management, Washington, D.C., The Advisory Board Company, (202) 672-5920
7. Jonathan Teich, MD, PhD, John Glaser, PhD, et al., (1996), Toward Cost-Effective, Quality Care: The Brigham Integrated Computing System, Chapter 1, Computer-based Patient Record Institute

Sincerely:

Joseph Saponaro, MD, DABIM, FACP, CPI, CCI, CCTI, CCRC, CCRP
Expert Medical Witness, ExpertMD
PI (Principal Investigator), DSI (Drug Study Institute)
Board Certified Internist, JPMC (Jupiter Preventive Medicine Center)
DABIM (Diplomat American Board of Internal Medicine)
FACP (Fellow American College of Physicians)
CPI (Certified Physician Investigator) by the AAPP (American Academy of Pharmaceutical Physicians)
CCTI (Certified Clinical Trial Investigator) by the ACRP (Association of Clinical Research Professionals)
CCI (Certified Clinical Investigator) by the DIA (Drug Information Association)
CCRC (Certified Clinical Research Coordinator) by the ACRP (Association of Clinical Research Professionals)
CCRP (Certified Clinical Research Professional) by SoCRA (Society of Clinical Research Associates)
Member, SIMPD (Society for Innovative Medical Practice Design)
Member, ACPM (American College Preventive Medicine)
Ethics Committee Member, Jupiter Medical Center
IRB Member, Jupiter Medical Center
Founder, CertifiedResearchers.com