Computerized Order Entry Can Contribute to Medical Error
Technology Brings New Promises, But Also New Risks of Harm
By Armand Leone Jr. and Jessica E. Choper, New Jersey Law Journal
May 14, 2014
Between 210,000 and 400,000 hospital patients per year suffer some type of preventable harm that contributes to their death, making medical errors the third leading cause of death in the United States. James, John T., Ph.D., “A New Evidence-Based Estimate of Patient Harms Associated With Hospital Care,” Journal of Patient Safety, 2013-Vol. 19-Issue 3:122-128; Marshall Allen, “How Many Die From Medical Mistakes in U.S. Hospitals?” ProPublica, Sept. 20, 2013.
A Variety of Problems
Medication errors can arise from administration of the wrong drug, dosage, frequency and duration. Computerized Physician Order Entry (CPOE) systems have reduced sources of medication errors but have also introduced new ones. Medication errors can be reduced by eliminating illegible handwriting, preventing incomplete prescription information, tracking drug interactions and identifying contraindications. Understanding the benefits and limitations of CPOE systems is essential in investigating potential claims.
- System Incompatibility Problems
Risk reduction from computerized checking for all drug interactions requires integration into the institution’s Electronic Medical Records (EMR). Stand-alone systems that do not integrate into another vendor’s EMR prevent access to patient information. Some systems do not allow the prescribing process to be electronic from beginning to end, creating the possibility for error at points of information transfer. Integration limitations may prevent the coordination and crosscheck of patient information as to any contraindications to the prescribed drug.
- Customization Problems
Bad customization choices during installation of the CPOE are sources of medication errors. Purchasers must select clinical guidelines, rules and templates. Usual dosages, routes, frequency of administration and the number and types of alerts must be decided at the time of installation. Physicians are often unaware of the drug safety information used to populate the database.
- Change of Medication Problems
Ordering and cancelling medication is usually done on different CPOE screens. Adding medication or changing a dose does not automatically cancel existing orders, resulting in a risk of overdose or administration of contraindicated drugs.
- Stop and Start Problems
CPOE errors can occur in relation to procedure-linked medication discontinuation, immediate orders and postoperative orders. If a procedure is cancelled, CPOE systems do not automatically cancel pre-medication orders, and medications are still administered. Immediate orders for medications are often not entered in the CPOE because of urgency and can result in improper dosing. When postoperative patients go to a postanesthesia care unit before returning to their rooms, they may not receive intended medications. The CPOE will suspend the order if a physician ordered it based on the patient’s real location instead of computer-listed location. The physician must access the CPOE and re-enter postop medications, creating another opportunity for error.
- Premature Antibiotic Discon-tinuation Problems
Antibiotics administered in hospitals must be approved for use, limited in duration and periodically renewed for continued treatment. Bright warning stickers on charts are used to alert physicians to the expiration of an antibiotic order. CPOE systems often lack “electronic” warning stickers to alert for antibiotic renewals, and chart stickers may go unread. Unintentional gaps in coverage can continue indefinitely because it is unknown whether the discontinuation was intentional or inadvertent.
- Wrong Patient Problems
CPOE display problems can make ordering medication difficult. Drop down lists usually have patient names listed alphabetically and drugs displayed in small font close together. Different screens may use different typefaces and colors for the same patient information. The combination of small font, different screens and busy schedules can result in the wrong patient being selected and the wrong drug administered. Similarly, the small screen displayed on handheld devices creates visibility problems. Vital information may not be visible on the initial screen, and physicians may not scroll down to find it. Accessing patient records with handheld devices can increase medication errors.
- Computer Downtime Problems
Hospital CPOE systems crash weekly, rendering the CPOE nonfunctional. Orders being entered when the system crashes or is undergoing maintenance are lost and cannot be re-entered until the CPOE is operational. If the system is nonfunctional when a patient relocates, the CPOE cannot alert the pharmacy of the change. Medications can be sent to the “wrong” room, resulting in delay or erroneous administration of medication.
- Delayed Charting Problems
CPOE systems require nurses to stop work, find terminals, log on, locate patient records and enter administration times. If a medication was not given, nurses have to go through additional screens to document nonadministration. These disruptions, coupled with time constraints, often result in separate paper documentation and can result in loss of information.
- Alert Fatigue Problems
Physicians are desensitized to medication alerts and often override them. Physician overrides occur largely because the CPOE does not discriminate among minor and serious alerts. Physicians may also override alerts if a patient previously received a medication or in an attempt to avoid disruption to their work flow.
- Inconsistent Information Trans-mission Problems
The entry of inconsistent information during the ordering process is another source of error. This occurs when there are differences between dose and frequency in the structured field and the free text field where physicians enter individualized instructions. For example, a physician selects a standard order for 10 mg of Coumadin daily on the drop down list and writes in the free text field “take 7.5 mg a day on Monday–Friday only.” If the patient fails to reduce the dose Monday through Friday, excessive anticoagulation and hemorrhagic injury can occur. Free text comments printed on the label can cause confusion if the medication administration schedule is not properly understood. Training physicians and nurses on the use of complex orders is essential.
- Unregulated Database Problems
Many states preclude suit against a drug manufacturer for negligent design or failure to warn because the FDA approved information in the product package insert. The CPOE is not required to use the FDA-approved drug safety databases for dose checks. Despite regulation for medical devices that incorporate software as a component of another device, prescribing software is exempt from FDA regulation on the ground that it is only intended for use in performing “library” functions traditionally carried out by using medical textbooks.
Vendors can use a combination of medical and pharmaceutical sources of drug safety information that differ from the FDA-approved usage. Physicians should not assume that the information provided by the CPOE conforms to the FDA-approved usage or dosage limits. When drug safety information comes from sources that conflict with the FDA, physicians may prescribe a dose based on the erroneous belief that it is based on the FDA- approved product package insert. Reliance on non-FDA approved information for maximum dosing can prove fatal. Litigation ensued after a patient was prescribed 1.5 times the maximum daily dosage provided by the FDA-approved product package insert which was filled without incident by software whose database was based on a separate publication. The patient died from an excess dosage of narcotic. Patient safety requires national regulation of software.
Tips and Traps
Filling prescriptions in most retail pharmacies has become only nominally short of an Orwellian computer-controlled process, where the licensed pharmacist is surrounded by techs, all of whom rely on the computer to think for them about what constitutes an appropriate prescription and what drug interactions should impact the filling of the prescription. Yet pharmacists remain licensed professionals, and a claim for professional malpractice is almost always in order. Still, a jury could be swayed by the fact that the prescribing software failed to provide a warning. Claims for simple negligence and product liability against the prescribing program provider/manufacturer, the provider of the software database and the prescribing physician are appropriate when there is a belief that the prescription should not have been filled. Any chair to which the defense may point must not be unoccupied.
At the start of discovery, focus on the hard drive or backup tapes of the prescribing system. Request copies in native format as well as metadata. Metadata will reveal who logged on and when, what was reviewed and for how long, what changes were made and when they occurred. Utilize an e-discovery consultant to provide screen captures reflecting what the pharmacist saw when the prescription was filled. Knowing exactly what the system provided to those who relied upon it is critical. Determine the program’s basis for its user interface responses, which could include diverse materials and publications about dosage limits and drug interactions. After identifying sources, determine the system’s motivation because many purposes exist besides drug interaction and dosage. Safety may be an afterthought.
Database providers may claim they are not subject to claims of negligence, malpractice or product liability because they are a “publisher” of medical information, protected by the same immunity applicable to publishers of books, magazines and newspapers. But attorneys can argue that database providers are analogous to manufacturers of component parts, akin to the maker of brakes installed in vehicles. Before drafting your complaint, consider the different roles of the players that ultimately impact the computerized entry and filling of prescriptions to avoid focusing the wrong claim upon the necessary defendant in your case.
Leone is a partner, and Choper is counsel, at Britcher, Leone & Roth in Glen Rock. The firm handles a full range of personal injury and medical malpractice cases.