Patient Safety Facts & Figures (Zebra Technologies)

Medical errors are a pervasive, persistent, and deadly problem, as the following facts and figures illustrate. Many patient safety problems are caused by inaccurate or outdated information. Bar code and radio frequency identification (RFID) systems can prevent many of these errors because they provide an extremely accurate, convenient way to collect and share real-time information in patient-care settings.

Medication Errors

• Medical errors of all kinds claim as many as 98,000 American lives each year and are the eighth leading cause of death in the United States (Source: “To Error is Human: Building a Safer Health System,” a November 1999 report from the Institute of Medicine [IOM]).
• Up to 7,000 of these deaths are attributed to adverse drug events (ADEs) from medication errors (ibid).
• At least 1.5 million preventable ADEs happen in the United States each year (Source: “Preventing Medication Errors: Quality Chasm Series,” a July 2006 report from the IOM).
• The number of serious adverse drug events reported to the Food and Drug Administration totaled 89,842 in 2005, more than double the amount in 1998. Additionally, the number of fatal adverse drug events more than doubled over the same period to 15,107. While 1,489 drugs were associated with adverse events, 20 percent of them accounted for 87 percent of the reports (Source: “Serious Adverse Events Reported to the Food and Drug Administration, 1998-2005,” Archives of Internal Medicine, 2007; 167:1752-1759).
• There are approximately 1.25 million annual medication errors in the U.S. (U.S. Food and Drug Administration Bar Code Label Requirements for Human Drug Products and Biological Products; Final Rule, 2004).
• Approximately 39% of medication errors occur during the ordering process; 12% occur during the order verification process; 11% occur during the preparation and dispensing process; and 38% occur at administration (Source: “Analysis of Adverse Drug Events, JAMA, 1995; 274, 35-43).
• Almost one in five medication doses administered in hospitals is given in error. The two most common errors were dispensing medicine at the wrong time (43% of incidents) and omitting a dose (30%) (“Medication Errors Observed in 36 Healthcare Facilities,” Archives of Internal Medicine, 2002;162:1897-1903).
• Between 2.4% and 6.5% of patients admitted to U.S. hospitals experience an ADE according to data presented by the FDA in 2004. The mean rate is 4.3%.

Impact of Errors and ADEs

• The average cost of an ADE is $2,257 (FDA 2004).
• Adverse drug events cost the United States $37.6 billion each year, and approximately $17 billion of these costs are associated with preventable errors (Source: “To Error is Human: Building a Safer Health System,” a November 1999 report from the Institute of Medicine [IOM]).
• The extra medical costs of treating drug-related injuries occurring in hospitals alone conservatively amount to $3.5 billion a year. This estimate does not take into account lost wages and productivity or additional healthcare costs (Source: “Preventing Medication Errors: Quality Chasm Series,” a July 2006 report from the IOM).
• Medication errors are the source of 5% of malpractice claims (Byron J. Bailey. “Medical Liability Issues: Where Malpractice Claims Come From and How to Survive Them,” July 2002).
• The average jury award for medication error cases is $636,844 (Jury Verdict Research, “2000 Current Award Trends in Personal Injury,” June 2001).

Laboratory Errors

• There are an average of 414 annual blood transfusion errors in the U.S., approximately one per 38,000 transfusions (U.S. Food and Drug Administration Bar Code Label Requirements for Human Drug Products and Biological Products; Final Rule, 2004).
• Studies have shown that 68% of lab errors are related to pre-analytical procedures, and about half of those errors are the result of misidentification of the patient or mislabeling of the specimen (BBI Newsletter, August 1, 2003).
• Approximately 160,900 adverse events occur in U.S. hospitals annually because of sample identification errors (“Identification Errors Involving Clinical Laboratories: A College of American Pathologists Q-Probes Study of Patient and Specimen Identification Errors at 120 Institutions,” Archives of Pathology and Laboratory Medicine, 2006; Vol. 130, No. 8: 1106-1113).
• One in 18 sample identification errors lead directly to an adverse event (ibid).
• 5.8% of phlebotomy samples are mislabeled (“Phlebotomy Issues and Quality Improvement in Results of Laboratory Testing,” Clinical Laboratory, 5+6/2006).
• Sample errors cost hospitals an estimated $200 to $400 million per year in redraws, retesting and additional treatment (“Reducing Specimen and Medication Error with Handheld Technology,” presented at 2001 HIMSS Annual Conference and Exhibition).
• Specimen labeling errors account for 55.5% of identification errors (“Identification Errors Involving Clinical Laboratories: A College of American Pathologists Q-Probes Study of Patient and Specimen Identification Errors at 120 Institutions,” Archives of Pathology and Laboratory Medicine, 2006; Vol. 130, No. 8: 1106-1113).

Prevention and Bar Code Effectiveness

• Up to 77% of medication errors are preventable (Source: “To Error is Human: Building a Safer Health System,” a November 1999 report from the IOM).
• The FDA concluded that bar code medication administration processes will reduce medication errors by 50% (2004).
• Using current and projected admissions data, the FDA predicted in 2004 that bar code medication administration processes will prevent 478,000 adverse drug events over 20 years. Patients would avoid pain, suffering, and extensions of hospital stays with an estimated value of $93 billion over the next 20 years. In addition, hospitals are expected to avoid litigation associated with preventable adverse events, reduce malpractice liability insurance premiums, and increase receipts from more accurate billing procedures.
• The U.S. Department of Veterans Affairs (VA) hospital system reported it reduced drug-dispensing errors by 86.2% with a bar code tracking system (Source: FDA Public Hearing, Bar Coding: A Regulatory Initiative, July 26, 2002).
• The American Society of Health-System Pharmacists (ASHP) 2015 Initiative, which was launched in September 2003, calls for 75% of hospitals to use machine-readable coding to verify medications before dispensing.
• The ASHP Pharmacy 2015 Initiative also sets a goal that 75% of medications be automatically recorded prior to administration.
• The Joint Commission National Patient Safety Goal to Improve the Safety of Using Medications includes a new requirement for 2006 to label all medications and medication containers, including syringes and medicine cups.
• A Joint Commission National Patient Safety goal for 2006 is to use two patient-specific identifiers whenever taking blood or other samples from a patient, and to label the sample collection container in the presence of the patient.
• Bar coding can reduce specimen labeling and patient misidentification errors by one third (BBI Newsletter, August 1, 2003).
• Bar code technology can reduce all potential adverse drug events by 63% and target potential adverse drug events – those the technology is designed to address – by 74% (Source: “Medication Dispensing Errors and Potential Adverse Drug Events Before and After Implementing Bar Code Technology in the Pharmacy,” Annals of Internal Medicine, 2006, Volume 145, Issue 6: 426-434).
• 13.2% of pharmacy directors report using a bar coded medication administration system at their organization (Source: 2006 American Society of Health-System Pharmacists National Survey).
• A recent study at Brigham and Women’s Hospital shows the cost of a bar code medication administration system was $2.24 million over a five-year period, but the net benefit during the same period, based on the decrease in adverse drug events from dispensing errors, was $3.49 million (Source: “Cost-Benefit Analysis of a Hospital Pharmacy Bar Code Solution,” Archives of Internal Medicine, 2007;167:788-794).

Counterfeit Medication

• Counterfeits make up more than 10% of the global medicines market (World Health Organization/FDA, 2003).
• The FDA Anti-Counterfeiting Task Force 2004 report called radio frequency identification (RFID) technology “the most promising approach to reliable product tracking and tracing.”

Miscellaneous Info

• There has been an average of more than one wrong-site surgery (in which the wrong surgical procedure is performed on a patient, or surgery is performed on the wrong patient) reported per week since 2000 (The Joint Commission Sentinel Event Data, 2004).
• The pharmaceutical industry handles $2 billion worth of returns annually (Healthcare Distribution Management Association, 2002).