Safety Cannot Be Sacrificed for Speed

Kate Kelly, PharmD
Published Online: Thursday, September 1, 2005
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Problem

Typically, pharmacies have developed well-established methods for monitoring the accuracy of the dispensing process. Today, however, pharmacy work is increasingly stressful, and these checks and balances can easily be strained beyond capacity. With an increasing number of prescriptions and a shortage of qualified pharmacists, the situation is ripe for potentially unsafe working conditions—long hours without breaks; multitasking, including answering phones, overseeing other pharmacy staff, dispensing prescriptions, and counseling patients; and ever-increasing time spent attending to insurance issues. Inevitably, these conditions can increase the chance for dispensing errors.

One pharmacy's staff knows all too well about this problem, because a 5-year-old boy died as a result of an order-entry and medication-compounding error that was not caught by the usual verification process. In this case, imipramine was dispensed in a concentration 5 times greater than prescribed. Imipramine is a tricyclic antidepressant used to treat adults, but it also is used to treat childhood enuresis.

An extemporaneous solution was to be prepared at this pharmacy that specialized in compounded prescriptions, since a liquid formulation is not commercially available. A pharmacy technician incorrectly entered the concentration of the prescribed solution into the computer as 50 mg/mL instead of 50 mg/5 mL, along with the prescribed directions to give 2 teaspoonfuls at bedtime. He then proceeded to prepare the solution, using the incorrect concentration on the label rather than the concentration indicated on the prescription. When the compound was completed, the technician placed it in a holding area to await a pharmacist's verification. At this time, 1 of the 2 pharmacists on duty was at lunch, and the high workload of the pharmacy made it difficult for the other pharmacist to check the prescription right away.

When the child's mother returned to pick up the prescription, the cash register clerk retrieved the prescription from the holding area without telling a pharmacist and gave it to the mother, unaware that it had not yet been checked. At bedtime, the mother administered 2 teaspoonfuls of the solution (500 mg instead of the intended 100 mg) to the child. When she went to wake him the next morning, the child was dead. An autopsy confirmed imipramine poisoning.

Many factors contributed to this error, including inaccurate order entry and issues related to high workload. A critical breakdown in safety processes occurred, however, when the cash register clerk took the prescription from the pharmacy holding area (to prevent the mother from waiting any longer for the prescription), thereby circumventing the usual pharmacist verification process.

Whereas this error underscores a growing problem in health care, the problem was clearly evident to this pharmacy owner—even a year before the error occurred. When interviewed for an article that appeared in a national publication, he vented his frustrations about the scant attention paid in this society to pharmacist workload difficulties in today's health care environment. On the day of the interview, 49 prescriptions were in the process of being prepared, and about a dozen patients were standing in line or milling about the store waiting for prescriptions. Yet, this was a slow day. The owner also said that, although managed care had reduced profits considerably over the past several years, prescription volume had increased by 50%. (At the time of the error, the pharmacy was dispensing about 10,000 prescriptions per month versus 7000 per month during the prior year, without an increase in staffing.) Medication regimens and drug interactions also had become more complex.

To overcome these barriers, the owner added private consultation areas for patient counseling; installed a $175,000 robot that accurately dispenses the 200 most common drugs; and diversified sales to offset full-time pharmacists' salaries. These efforts, however, could not have prevented this tragic fatal error that circumvented the normal safety processes.

Safe Practice Recommendations

The environment and demands placed on health professionals significantly affect their ability to provide safe health care services. Although technology such as robots can help, over-stressed professionals cannot consistently perform at the maximum level of safety. Therefore, it is important that the public and health care leadership understand this problem and be more open to tradeoffs—such as a pharmacist working with 1 patient at a time and incurring longer turnaround times—which are necessary to enhance patient safety.

With a shortage of qualified professionals, we as pharmacists need to demand more rapid adoption of computerized prescribing to reduce time spent with prescription transcription. We should identify the biggest distractions that occur in our workplaces and strive to eliminate or reduce the sources by batching common tasks that cause interruptions and reorganizing work areas. Staff members need to be properly trained to understand safety procedures that are in place and to know the limits of their specific duties. Fail-safe processes to ensure an independent double-check before dispensing medications and performing other critical processes are a must.

The pharmacy where this particular error occurred now requires 2 pharmacists to check every prescription. Unfortunately, this level of vigilance typically is implemented only after a patient has been harmed from an error. In other pharmacies, especially where only 1 pharmacist is on duty, technicians may be involved in the double-check process.

A few other strategies can be used to prevent similar errors:

  • Have one person perform order entry, and have a different person prepare the prescription, if possible, to add an independent validation of the order-entry process
  • Do not prepare prescriptions using only the computer-generated label, because the order entry may have been incorrect
  • Ensure that the original prescription, the computer-generated label, the prepared product, and the manufacturer's product(s) remain together throughout the preparation process
  • Verify dispensing accuracy by comparing the original prescription with the labeled patient product and the manufacturer's product(s) used.

Dr. Kelly is the editor of ISMP Medication Safety Alert! Community/Ambulatory Care Edition.

Report Medication Errors

The reports described here were received through the USP Medication Errors Reporting Program, which is presented in cooperation with the Institute for Safe Medication Practices (ISMP). ISMP is a nonprofit organization whose mission is to understand the causes of medication errors and to provide time-critical error-reduction strategies to the health care community, policy makers, and the public. Throughout this series, the underlying system causes of medication errors will be presented to help readers identify system changes that can strengthen the safety of their operation. If you have encountered medication errors and would like to report them, you may call ISMP at 800-324-5723 (800- FAILSAFE) or USP at 800-233-7767 (800-23-ERROR). ISMP's Web address is www.ismp.org.

Subscribe to Newsletter

Pharmacy Times and the Institute for Safe Medication Practices (ISMP) would like to make community pharmacy practitioners aware of a publication that is available.

The ISMP Medication Safety Alert! Community/ Ambulatory Care Edition is a monthly compilation of medication-related incidents, error-prevention recommendations, news, and editorial content designed to inform and alert community pharmacy practitioners to potentially hazardous situations that may affect patient safety. Individual subscription prices are $45 per year for 12 monthly issues. Discounts are available for organizations with multiple pharmacy sites. This newsletter is delivered electronically. For more information, contact ISMP at 215-947-7797, or send an e-mail message to community@ismp.org.



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