2 children’s deaths after surgery raise concerns about safe medication use

Likely morphine overdoses put spotlight on drug policies

At an Oklahoma hospital, two children died within a few days of each other after having routine outpatient surgical procedures. One child died from toxic effects of morphine with a probable primary myopathy as a contributing cause,1 and the other child died from probable codeine and morphine toxicity, along with acute and chronic bronchitis with evolving pneumonia, according to the autopsy reports.2

One child had undergone surgery on his toenails, and the other had undergone tonsillectomy with adenoidectomy and bilateral myringotomy. The post-anesthesia standing orders form at SouthCrest Hospital in Tulsa had space for the physician to choose morphine, Demerol, or Tylenol for pain control. In both cases, a physician had not indicated which medication was to be administered, according to the investigation by the state health department.

That investigation indicated that the facility failed to follow accepted standards of practice for administering drugs, including a requirement that a physician’s order specify the drug, the dosage, and the route of administration.3 The facility also failed to administer drugs in accordance with state and federal laws, according to the investigation.3

The investigators reviewed the medical staff bylaws and regulation, the pharmacy policies and procedures, and the ambulatory surgery policies and procedures and found the hospital didn’t have any written policy or regulation on the use of standing orders. Also, the hospital failed to ensure post-anesthesia evaluations were performed, the investigation reported.3 The hospital, when contacted for comment, released a statement that the hospital has been conducting an ongoing internal review.

SouthCrest Hospital isn’t alone in its difficulty. Many facilities, even accredited ones, have problems meeting the standard of care for medication administration. In 2003, 41% of hospitals accredited by the Joint Commission on Accreditation of Healthcare Organizations received the worst possible score, a 1, for standards related to prescribing, preparing, dispensing, and administering drugs, according to the Joint Commission web site (www.jcaho.org).

For its part, SouthCrest Hospital has revised the standing orders for pediatric outpatient surgeries to clarify drug dosage and route, according to the investigation report.3 Also, the hospital has added to its post-anesthesia care unit policy that nurses will calculate and document the maximum dose for each medication ordered on the standing orders. In addition, the facility, which did not self-report the deaths, is conducting a root-cause analysis that will be reviewed by the Joint Commission, explains Mark Forstneger, spokesman for the Joint Commission.

"Most people don’t come into an organization saying, What can I mess up today?’" says Michael Jarema, associate project director of the Division of Standards and Survey Methods at the Joint Commission. "When you have an error, while individuals are still accountable, we want organizations to go beyond the individual and ask, What underlying processes led to the error occurring? Was this a process issue?’"

This concept is labeled "proactive risk assessment," Jarema says. For example, in the Oklahoma cases, "the point is that the nurse, or physician, or organization didn’t deliberately or willfully or by design intend for an error to occur, but an error did occur. What can they do to make sure the next 1,000 patients that come through door are safer?"

To avoid medication errors, adapt a medication safety protocol, urges Dorothy Fogg, RN, BSN, MA, perioperative nursing specialist at the Center for Nursing Practice at the Association of periOperative Registered Nurses in Denver. (For information, see resources at the end of this article.)

In addition, there are systems available to help same-day surgery providers reduce the likelihood of medication errors. They include:

Unit dosing systems.

Highland Hospital in Shreveport, LA, uses unit dosing through the Pyxus system (Cardinal Health, San Diego). The system provides acceptable unit doses if a physician orders the wrong dosage, says F. Dean Griffen, MD, FACS, surgeon at the Highland Clinic, also in Shreveport.

"For the nurse to alter that dosage would prompt a query," such as a question about why the nurse has ordered a dose that is 10 times as much as the default dose, he says. In that case, the physician’s order might have had the decimal in the wrong place, Griffen says.

"This is a fairly inexpensive way to provide safe dosing," he says. However, this technology only addresses some of the medication safety problems, Griffen acknowledges. For example, it doesn’t address issues such as writing orders illegibly, giving medications to the wrong patient, failing to recognize allergic reactions in a timely manner, and administering medications subcutaneously instead of intravenously when an intravenous line is misplaced, he says.

Computerized physician order entry (CPOE).

About 15% of hospitals in the United States have at least partial CPOE systems, Griffen points out. With CPOEs, a physician enters a drug, dose, and administration into a computer, which eliminates the problem of legibility, he says. The CPOE lists acceptable dose ranges, frequencies, and routes, he notes. There are many advantages, Griffen states. "CPOEs can provide default doses, which is helpful when a physician thinks he knows the doses, but he doesn’t," he says.

Also, physicians can provide a patient’s background information, such as allergies and other medications, to the CPOE, Griffen explains. If a physician subsequently tries to prescribe a medication to which a patient is allergic or which is incompatible with medications the patient already is taking, the computer alerts the physician.

The system also can provide default doses to meet patient’s specific needs; for example, if a dosage is toxic for a patient with kidney failure, the system will provide default doses for those patients. The system also provides information on lower-cost medications that are clinically equivalent, he continues. On the downside, CPOEs must be integrated into facilities’ current computerized system, he says. Also, the systems are expensive, Griffen acknowledges.

Brigham and Women’s Hospital in Boston spent $1.9 million setting up a CPOE in the early 1990s, says David Bates, MD, MSC, chief of the division of the general internal medicine at Brigham and Women’s. Ongoing costs for a CPOE are approximately $500,000 a year, he says. However, in 1994, the cost of an adverse drug event was estimated to be about $5.6 million, he explains. CPOE allowed Brigham and Women’s to reduce adverse events, over a three-year period, from 14.7 per 1,000 hospitals days to 9.6 per 1,000 hospitals days, Bates says.

While the CPOE doesn’t eliminate adverse events, it is cost-effective, Griffen maintains. "And who cares about cost if you save one life?" he asks. About 14% of adverse drug events end in the death of a patient, he says.

More help is one the way. The Food and Drug Administration (FDA) is issuing a final rule requiring bar codes on the labels of medications. The bar-code rule will encourage widespread adoption of advanced information systems that, in some hospitals, have reduced medication error rates by as much as 85%, according to the Department of Health and Human Services.4 With these systems, patients are provided with identification bracelets that bear a bar code. The health care provider scans the patient’s bar code and scans the medication’s bar code. The information system verifies that the right patient is getting the right medication at the right time, the right dose, and via the right route of administration.

In a study conducted at a Veterans Affairs Medical Center, using such a bar-code scanning system, 5.7 million doses of medication were administered to patients with no medication errors.4 The FDA estimates that the bar-code rule, when fully implemented, will help prevent nearly 500,000 adverse events and transfusion errors over 20 years.

"We have to make systems that are foolproof so human error can be mollified," Griffen says.

References

  1. Board of Medicolegal Investigations — Office of the Chief Medical Examiner. Report of Investigation by Medical Examiner: Nicholas Marlow. Tulsa, OK; 2003.
  2. Board of Medicolegal Investigations — Office of the Chief Medical Examiner. Report of Investigation by Medical Examiner: Steven Tyler Verdin. Tulsa, OK; 2003.
  3. Department of Health and Human Services, Centers for Medicare & Medicaid Services. Statement of Deficiencies and Plan of Correction: Southcrest Hospital. Rockville, MD; 2003.
  4. Department of Health and Human Services. HHS Announces New Requirements for Bar Codes on Drugs and Blood to Reduce Risks of Medication Errors. Rockville, MD; 2003.

Resources

For information on medication safety, contact:

  • F. Dean Griffen, MD, FACS, Surgeon, Highland Clinic, 1455 E. Bert Kouns, Shreveport, LA 71105.

For a sample protocol on medication safety, go to the Association of periOperative Registered Nurses web page (www.aorn.org). At the bottom of the page, click on "patient safety first," then "information resources," then "AORN Guidance Statements," then "Safe Medication Practices in Perioperative Practice Settings."