BETHESDA, MD, 18 October 2002—A shortage of staff pharmacists at a New York hospital may have contributed to a medication error that resulted in the death of a six-day old infant last February, according to state health department investigators.
The state investigated Stony Brook University Hospital in Long Island after an infant with a diagnosis of congenital heart disease died from receiving 10 times the prescribed dose of i.v. potassium chloride, said health department spokesman Robert Kenny.
Unlike the potassium chloride overdoses that have been widely reported for years, this one was not the result of a concentrated solution being kept on the nursing unit. The overdose was prepared by the pharmacy.
As a result of the investigation, the state cited Stony Brook for 27 violations and in July fined the institution $54,000the $2,000 maximum fine per violation.
Quantifying the Staffing Shortage
Several recent national surveys have reported that health systems across the country are struggling with a pharmacy work-force shortage.
A poll of U.S. hospitals conducted in fall 2001 by First Consulting Group found a pharmacist vacancy rate of 12.7% for budgeted positions. More than 1000 chief executive officers responded to the survey, which was commissioned by the American Hospital Association and three other health care groups. According to an anecdotal account from one Los Angeles medical center, it took two years to fill a night-shift pharmacist position.
Pharmacy directors at nonfederal health systems responding last spring to an American Society of Health-System Pharmacists (ASHP) survey indicated that they had the most difficulty hiring experienced frontline pharmacists and managers. That survey found that New York had a pharmacist vacancy rate of 9% for budgeted positions, higher than the national average of 6.9% reported by pharmacy directors. The state's vacancy rate for pharmacy technicians was 6.8%.
New York's midstate region, including Syracuse, Rochester, and Albany, has felt the greatest impact of the pharmacist shortage, said Thomas P. Lombardi, a past president of the New York State Council of Health-system Pharmacists.
The New York State Board of Pharmacy reported that there are 18,491 pharmacists licensed by the state. But according to survey results released by the board in September, almost 13% of those pharmacists work in pharmacy-related jobs outside the state; another 11% are retired, unemployed, or work in areas other than pharmacy.
The Aggregate Demand Index, a project supported by the Pharmacy Manpower Project, a consortium of professional organizations and the U.S. Bureau of Health Professions, reported in September that the Northeast is better off than other regions but has had some difficulty filling pharmacist positions.
Congress mandated in 1999 that the Health Resources and Services Administration investigate the pharmacist shortage. The agency's 2000 report to Congress identified increased vacancy rates and employers' difficulties in hiring pharmacy staff.
The 504-bed hospital, Kenny said, "lacked an adequate number of pharmacists and had serious issues involving a lack of training and supervision." But, he noted, "the problems we found at this hospital were systemic by nature and not just isolated to the pharmacy department."
The circumstances and problems that led to the potassium chloride overdose at Stony Brook, said Kasey K. Thompson, director of ASHPs Center on Patient Safety, "exist in a lot of hospitals."
"It could happen to anybody," he said. "It just so happened that everything lined up in such a way a patient was actually harmed and died, which is extremely unfortunate. To look at this as an isolated set of circumstances would be greatly misguided."
A report released last spring summarizing medication-error information submitted to the United States Pharmacopeias MedMARx system, a Web-based database for hospitals to anonymously report and track medication errors in a standardized format, found that staffing issues accounted for 33% of the factors contributing to medication errors.
A short-staffed department. Stony Brooks pharmacy department, according to the states report, had "been operating with one less pharmacist for a long period of time and the lack of another pharmacist may have contributed to the overdosing and demise" of the infant.
The hospital had been without a permanent pharmacy director from May 2001 until July 2002. An interim director had been in charge at the time the error occurred last February, Kenny said.
"Nevertheless," he declared, "the hospital and interim pharmacy director were responsible for ensuring that the pharmacy department was provided an adequate number of pharmacists to meet the hospitals pharmaceutical needs and to make sure pharmacy staff were properly trained."
Stony Brook spokesman Dan Rosett argued that it is unclear whether a shortage of pharmacists contributed to the potassium chloride overdose. He declined, however, to comment on specific numbers of pharmacists and pharmacy technicians at Stony Brook.
But, he said, the hospital was "in the midst of recruiting additional staff prior to the tragedy."
"Since that time," he said, "we have added [more] pharmacists to the staff. We meet or exceed levels for staffing at other similar-sized hospitals."
According to the hospitals plan of correction, Stony Brook had filled a vacant pharmacist position on the night shift and had recruited for an additional night-shift position.
The hospital had also advertised in 2001 for an associate director for clinical service. Stony Brooks advertisement stated that the associate director would be responsible for staff inservice education and training, among other duties.
"While the position of associate director of pharmacy had been advertised," Rosett said, "we focused more on a national intensive search for a new director."
The hospitals new pharmacy director oversees staff inservice and education activities, Rosett said, adding that those responsibilities can be "delegated to other senior colleagues."
"The next associate director is likely to assume these responsibilities under the direct supervision of the department director," he said.
What went wrong. Stony Brooks pharmacy department, Kenny said, violated a state law last February when a "poorly supervised and unlicensed" pharmacy technician prepared the i.v. potassium chloride solution.
New York law forbids pharmacy technicians to "measure, weigh, compound, or mix ingredients" and "perform any other function involving the exercise of professional judgment."
The supervising night pharmacist, investigators said, permitted the pharmacy technician "to function beyond his scope of practice."
Hospital policy was violated, the investigators reported, when the Stony Brook nurse practitioner prescribing the potassium chloride for the infant failed to obtain the attending physicians approval.
The nurse practitioners handwritten order had the correct equation for determining the appropriate dose of potassium per kilogram of body weight, the states report said, but the decimal point was omitted in the final figure, and the prescription read 35 meq instead of 3.5 meq.
According to investigators, the pharmacy technician who mixed the potassium chloride solution did not identify the error, and the registered nurse who administered the drug apparently did not recognize the dosage as excessive for the infants age and weight. In two separate areas of the infants medical record, the nurse documented the 35-meq dose, the report noted.
"At three points, the error could have been noticed by staff and would have been avoided," Kenny said.
[At the interviewee's request, AJHP deleted details of another medication error because of incorrect information provided to him by the New York health department.]
Investigators noted in their report that a review of the hospitals internal pharmacy records disclosed 81 medication incidents recorded between July and December 2001. Kenny defined those incidents as "near misses" and not generally something that must be reported to the state.
"We do hope that hospitals will voluntarily report any near misses to us," he said.
New York law requires hospitals to report certain types of medication errors, including those that result in permanent patient harm or the near death or death of a patient to the health departments electronic adverse-event reporting systemNew York Patient Occurrence Reporting and Tracking System (NYPORTS).
Hospitals can access NYPORTS data to create comparative analyses of facilities in their region or state, according to the New York health department. However, the hospitals names are not disclosed.
According to the National Academy for State Health Policy, a nonprofit organization that analyzes public policy, 20 states have mandatory medical-error reporting programs.
New York health department investigators also noted in their report that there was "no evidence of a working relationship among medical staff, nursing staff and staff of other departments or services to assure that all patient care needs were met" at Stony Brook.
Hospitals actions. In a written statement responding to the states report, the hospital said it has "taken a number of significant steps to reinforce patient safety and address the concerns that hospitals are facing nationally in regard to this issue."
Stony Brook, Rosett said, has worked closely with the New York health department "to develop an effective corrective action plan." The state has accepted the plan "fully and completely," he added.
Profession Faces Escalating Demand
As the pharmacy profession moves toward an increased role in providing clinical services to patients, one of the greatest challenges facing the profession is the work-force shortage, according to a recent Health Affairs report.1
The shortage is exacerbated by the rise in prescription medication use, particularly in older adults, the report said.
In their article, the authors noted that the production of new pharmacists is dependent on issues that are difficult to predict, such as educational funding support, the number of pharmacy school applicants, and faculty recruitment and retention.
The use of automated systems can improve pharmacists' productivity and improve patients' safety by enhancing operational efficiencies, the authors suggested. A larger number of pharmacy technicians per pharmacist would also free pharmacists to spend more time with patients. In most private settings, the ratio of pharmacy technicians to pharmacists is 2:1.
However, the report said, pharmacists have been reluctant to delegate many dispensing tasks because of the highly variable and often limited training of some technicians. In most states, technician credentialing is voluntary.
The report's authors suggested that a demonstration project conducted by the U.S. military, in which training issues were addressed by combining strong and graded pharmacy-technician training with a career track, could be implemented in other settings. In the demonstration project, according to the report, the ratio of pharmacy technicians to pharmacists was 6:1.
- Cooksey JA, Knapp KK, Walton SM et al. Challenges to the pharmacist profession from escalating pharmaceutical demand. Health Aff. 2002; 21(5):182-8.
Even before last Februarys tragic event, Rosett said, the hospital "had begun new programs geared to avoiding error and enhancing patient safety."
Some of the steps the hospital has taken to enhance working relationships among various disciplines, he said, include the addition of more interdisciplinary committees.
Stony Brook has established a patient safety committee and organized a medication-ordering improvement group, according to the hospitals statement.
The hospital is also providing more education and training for its staff, Rosett said.
Under its plan of correction, the institution has agreed to implement a "double check" policy that requires all weightbased preparations of high-alert medications, including potassium chloride, to be reviewed by other authorized prescribers and nursing staff before the drug is administered, according to the state.
Stony Brook has contracted for $25 million with Cerner Corp. of Kansas City, Missouri, for installation of new information technology systems, including a Millennium Pharmnet system that will identify wrong dosages and provide computerized prescriber order entry and an electronic patient record system.
The pharmacys old system, the states report noted, did not have any way to automatically alert pharmacy staff to dosage errors for children younger than 30 days.
Once installation of the new system is completed, Rosett said, Stony Brook will be among only 5% of hospitals nationwide to have the advanced technology.
The hospital has also contracted with Cardinal Health Inc. to assist in identifying and addressing operational and quality issues in the pharmacy.
Health systems need to keep in mind that patient safety improvement is "not a one-time thing," said ASHPs Thompson.
"Its an ongoing activity," he said. "You have to be willing to constantly measure, monitor, and improve interventions and recognize that sometimes when you implement new things, they could create opportunities for error. There is no such thing as a quick fix in patient safety."