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After completing this program, participants should be able to:
This activity has been designed to meet the educational needs of health system pharmacists.
The Joint Commission’s National Patient Safety Goals (NPSGs) highlight serious patient safety issues to be addressed by health care organizations. One of the goals for 2010 is to accurately and completely reconcile medications across the continuum of care. Medication reconciliation is of particular concern for extended-dose medications—for example, erythropoietin-stimulating agents (ESAs)—because they are often overlooked during the reconciliation process, resulting in therapeutic duplications and unnecessary increases in expenditures. Studies have indicated that implementing an ESA continuity-of-care program can help to abate these problems, thereby improving therapeutic consistency and decreasing unnecessary medication expenditures.
Facilities that would like to implement such an initiative might follow a five-pronged approach, which involves identifying the opportunity, developing the plan, implementing the plan, measuring the success of the initiative, and sustaining the gains.
The Joint Commission accredits and certifies more than 17,000 health care programs in the U.S. Requiring accredited organizations to adhere to certain performance standards helps to ensure that these facilities provide safe and effective health care of the highest quality and value.1
In 2002, the Joint Commission established National Patient Safety Goals (NPSGs), which highlight serious safety concerns to be addressed by health care organizations. The goals are updated annually, based on systematic literature reviews conducted by a patient safety advisory group. This group consists of an expert panel of widely recognized patient safety experts as well as nurses, physicians, pharmacists, risk managers, and other professionals experienced in addressing these issues in a variety of health care settings. Suggested recommendations are then forwarded to the Joint Commission’s Board of Commissioners for approval.2
The 2010 NPSGs, as applicable to the hospital setting, are presented in Table 1.3 There are currently 16 NPSGs, eight of which have components pertaining to the hospital setting. In addition, the Universal Protocol addresses measures that should be taken to prevent inappropriate surgical procedures. Although no new NPSGs were developed for 2010, these goals underwent extensive review and modification in 2009, with certain changes that took effect on January 1, 2010. For instance, as of 2010, organizations are expected to have fully implemented the requirements (established in 2009) related to health care–associated infections.2
NPSG No. 8, which pertains to medication reconciliation for patients in all health care settings, was established to create smoother transitions in patient care. Patients are often treated by myriad health care providers;4 unfortunately, however, our current health care infrastructure does not lend itself to effective coordination and communication among these practitioners, particularly in matters of pharmacotherapy.5 This deficiency often leads to fragmented care.6 Thus, it is crucial that health care providers, including pharmacists, address these gaps, to improve the quality of patient care.4
In light of this situation, in June 2003, the American Society of Health-System Pharmacists (ASHP) released a policy statement related to continuity of care in medication management (CCMM):
To recognize that continuity of care is a vital requirement in the appropriate use of medications; further, to strongly encourage pharmacists to assume professional responsibility for ensuring the continuity of pharmaceutical care as patients move from one setting to another (e.g., ambulatory care to inpatient care to home care); further, to encourage the development of strategies to address the gaps in continuity of pharmaceutical care.7
In response to this statement, ASHP established a Continuity of Care Task Force in December 2003. Members of this task force were responsible for identifying practice gaps and barriers contributing to the discontinuity of patient care and recommending actions for improving or implementing CCMM. CCMM was defined as “a longitudinal process that is coordinated and provided among practitioners and organizations over time, consistent with the ongoing needs of the individual patients;” medication management was considered an essential component of continuity of care.4
As shown in Table 2, the task force identified several barriers that were contributing to inconsistent patient care as well as an array of recommendations designed to overcome these gaps. Importantly, one of these recommendations supported accreditation standards calling for an improvement in continuity of care.4 NPSG No. 8, a Joint Commission standard requiring providers to accurately and completely reconcile medications across the continuum of care, does just this.
Medication reconciliation is “the process of comparing a patient’s [inpatient] medication orders to all of the medications that the patient has been taking.”8 Without medication reconciliation, confusion and incomplete medication information may cause interrupted or inappropriate drug therapy, patient discomfort, adverse drug reactions, clinical deterioration, or all of these. Patients are at high risk for harm from adverse drug events when communication about medications is unclear, particularly when there is a change of clinicians involved in the patient’s care. Medication reconciliation can help to reduce medication errors, thereby bridging gaps in continuity of care.9
Medication reconciliation should be completed each time an individual is transferred to a new patient-care setting (i.e., upon admission, upon discharge to a new facility, or upon discharge home). Data suggest that 60% of hospitalized patients have at least one discrepancy in their medication history10,11 upon admission and that more than a quarter of hospital prescribing errors are caused when an incomplete medication history is obtained at the time of admission. Furthermore, results of a systematic literature review revealed that from 11% to 59% of all errors concerning medication history were clinically important.12
Thus, obtaining an accurate medication history upon admission is an important component of medication reconciliation. A structured interview should be conducted to ensure that information is not erroneously inferred from prescription vials or drug lists.10 Because conducting comprehensive medication reviews may be time-consuming for physicians or nurses, pharmacists may play an important role in this process.12
Discrepancies in medication reconciliation may also occur at the time of discharge or transfer. In one study, nearly one in five patients experienced adverse events during their transition from the hospital to the home; two-thirds of these events were drug-related, and 12% were preventable or ameliorable. Moreover, system design flaws contributed to all preventable or ameliorable adverse events, the most common problem being poor communication between the hospital caregivers and the patient or primary care physician.13 Improved communication is required at all interfaces for medication information transfer to prevent these problems from occurring. As illustrated in Figure 1, these interfaces may include the patient, the physician or the ambulatory clinic, the hospital pharmacist, the clinical pharmacist, or the community pharmacist.14
NPSG No. 8, which requires health care providers to reconcile medications across the continuum of care, ensures that this task is performed upon hospital admission as well as when patients are transferred home or to another facility. This standard also facilitates communication between the aforementioned interfaces and encourages the appropriate documentation for this communication.
Table 3 outlines the four components of NPSG No. 8 as well as the rationale behind each of these components.3 Although this goal was first instituted in 2005, many organizations are still struggling to develop and implement effective and efficient processes to meet the intent of the goal. Thus, additional work is ongoing to evaluate and refine the medication reconciliation expectations for accredited organizations.
Although NPSG No. 8 is evaluated during on-site surveys (as of January 1, 2009), its requirements are not yet in effect, and survey findings have not been factored into the organization’s accreditation decision. The Joint Commission hopes to implement a revised version of this goal by the spring of 2010.2
Health care providers often focus on the reconciliation of daily medications; however, it is just as imperative to ensure that less frequently administered medications, such as ESAs, are appropriately reconciled to establish a smooth continuity of care. Because ESAs are used primarily in patients with chronic conditions requiring frequent hospital stays, such as cancer patients receiving chemotherapy, medication reconciliation is particularly important to ensure therapeutic consistency in both inpatient and outpatient settings.15
ESAs are typically prescribed to treat anemia associated with cancer chemotherapy and chronic kidney disease (CKD). Maintaining an ESA dosing regimen during the transition between the inpatient and outpatient settings is necessary to prevent fluctuations in hemoglobin levels, to avoid administering unnecessary ESA doses, and to minimize the need for blood transfusions. Continuity of care is especially crucial in this patient population, because anemia is associated with increased morbidity, mortality, and fatigue. Anemia may also beget chemotherapy dose reductions, which may compromise clinical outcomes in cancer patients.16–22
Darbepoetin alfa (Aranesp, Amgen), a long-acting ESA, can provide therapeutic effects for up to three weeks in oncology patients23 and for up to one month in nephrology patients (with off-label use).24,25 Unfortunately, many facilities dispense an inpatient order for ESAs without checking when the last out-patient dose was administered. This often results in unnecessary therapeutic duplication as well as increased hospital expenditures. Because inpatient facilities operate under a capitated reimbursement model, they receive a fixed fee based on a given patient’s Diagnosis-Related Group (DRG) and length of stay (LOS). Thus, duplication of therapy may be very costly, because institutions are not reimbursed for these medications.
Cancer patients who are treated with a long-acting ESA once every three weeks in the outpatient setting can sometimes avoid the first week of an inpatient ESA dose administration if they are admitted to the hospital within 14 days of receiving the ESA in the outpatient setting. Saint Barnabas Health Care System (SBHCS), a large patient-care network in New Jersey, conducted a study to determine the theoretical cost savings associated with this type of medication reconciliation. This retrospective analysis, performed between January 2006 and December 2006, included all SBHCS inpatients and outpatients with a DRG for oncology and a charge code for darbepoetin alfa. The study excluded inpatients with a LOS of less than 24 hours as well as all patients with myeloid malignancies. All data were obtained from Trendstar®, the health system’s billing database.
Table 4 presents data for outpatient-to-inpatient medication reconciliation. Nearly $1.3 million in expenses (based on wholesale acquisition costs) might have been saved if therapeutic duplication could have been prevented, thereby eliminating administration of unnecessary inpatient doses.26 Similarly, patients with CKD who were treated with a long-acting ESA once every four weeks in the clinic setting could possibly have avoided receiving an inpatient ESA dose in the first week if they had been admitted within 21 days of receiving the ESA in the outpatient setting.
The SBHCS subsequently sought to determine the theoretical cost savings associated with this type of medication reconciliation. This retrospective analysis included all SBHCS inpatients and outpatients with a DRG for CKD (with or without dialysis) and a charge code for darbepoetin alfa. The study excluded patients without documented CKD staging, inpatients with a LOS of less than 24 hours, and outpatients without a corresponding inpatient hospitalization. Again, all data were obtained from Trendstar®. Results showed that approximately $1.1 million in expenses (based on wholesale acquisition costs) could have been saved if all unnecessary patient doses had been avoided (Table 5).26
A retrospective, descriptive study was conducted at the SBHCS between November 2006 and January 2008 to characterize patterns of darbepoetin alfa use in patients with chemotherapy-induced anemia (CIA) during inpatient hospital admissions. The study included all CIA patients receiving outpatient darbepoetin alfa who were subsequently hospitalized in the SBHCS.27
A total of 726 patients were included in the analysis, and 55% of the patients were women. The mean age was 66 years, and the mean LOS was 10.5 days. Eighty-five percent of patients received darbepoetin alfa during their stay, and 15% did not. For those who received inpatient darbepoetin alfa, the median dose was 100 mcg/week. Most patients received only one dose, administered five days after admission. Their previous outpatient darbepoetin alfa dose (median, 300 mcg) was administered at a mean of 17.1 days prior to hospitalization. Patients had a mean LOS of 10.9 days; their next outpatient dose was administered at a mean of 29.6 days after discharge.
The mean hemoglobin level before post-discharge darbepoetin alfa administration was 9.95 g/dL. For patients who did not receive inpatient darbepoetin alfa, the previous outpatient darbepoetin alfa dose (median, 500 mcg) was administered at a mean of 10.8 days prior to hospitalization. Patients had a mean LOS of 8.3 days; their next outpatient dose was administered at a mean of 30.1 days after discharge. The mean hemoglobin level before post-discharge administration of darbepoetin alfa was 9.86 g/dL.27
Five percent of patients in the study were receiving out-patient darbepoetin alfa doses on a weekly basis; 59% received a dose every two weeks, and 36% were treated every three weeks. Of the 110 patients who did not receive darbepoetin alfa during their stay, approximately 69% were receiving outpatient doses every three weeks, compared with 30% every two weeks and 1% once every week (Figure 2). These data indicate that inpatient doses were more commonly avoided when darbepoetin alfa was given less frequently in the outpatient setting. Furthermore, approximately 30% of patients receiving the drug every three weeks avoided a dose during hospitalization, compared with only 3% of patients who received the drug weekly and 8% of those who were treated every two weeks. The results suggest that there are increased opportunities for avoiding ESA doses in the inpatient setting when darbepoetin alfa is administered less frequently in the outpatient setting (Figure 3).27
Prior to December 2007, most SBHCS outpatients with CIA received darbepoetin alfa every two weeks. Since December 2007, however, dosing this medication once every three weeks has become the standard of care. Based on the findings of the previous study, it was expected that a greater opportunity for inpatient dose avoidance—and, consequently, improvements in appropriate dosing, administration, and cost savings—could be expected upon evaluation of subsequent data.
Retrospective analyses conducted at Saint Barnabas Health Care System (SBHCS) have shown that hospitals can avoid large expenditures by eliminating unnecessary inpatient administration of ESAs. Medication reconciliation is often challenging for therapies that are not taken on a daily basis, because patients are often unable to recall when the last dose was administered. Therefore, using ESA reconciliation can help to ensure continuity of care.
Successful implementation of an ESA continuity-of-care program involves five major steps: (1) identifying the opportunity, (2) developing the plan, (3) implementing the plan, (4), measuring the success of the initiative, and (5) sustaining the gains. The following text describes each of these stages in detail.
The first step toward improving management of ESA therapy is to assess current practices and identify opportunities for reconciliation and dose avoidance in the inpatient setting. This involves ascertaining each patient’s outpatient administration regimen and determining whether the inpatient protocol is consistent with this regimen. Specific questions to consider are presented in Table 6.
If the patient is being treated at an outpatient clinic owned by the hospital, drug information may be obtained via electronic files or chart abstraction. If the patient is being treated at a physician’s office, this information can be obtained via electronic files, chart abstraction, or a direct interview of the physician or other office staff members. The facility should also identify the measures in place to ensure appropriate ESA utilization and steps that can be taken to improve this process. Hospitals may consider exploring extended dosage intervals for out-patients receiving ESAs every one or two weeks.
After establishing that the opportunity for ESA reconciliation or dose avoidance exists, pharmacists must develop a feasible strategy to address this issue. The approach should be convenient and straightforward so that it fits seamlessly into the existing hospital admission process. For an ESA continuity-of-care program to be implemented successfully, the existing system can be modified to enhance communication between inpatient and outpatient health care practitioners and between the practitioners and patients.
The facility must develop a standardized process for obtaining medication histories and should ensure that this reconciliation process captures drugs with extended dosing frequencies. Medication histories may be obtained either manually or electronically. If a manual process is used, hospital support personnel can telephone outpatient clinics or physicians’ offices to determine when an ESA was last administered in the outpatient setting. If an electronic process is utilized, facilities may conduct real-time queries through secondary computer systems or may obtain electronic weekly reports from outpatient clinics or physicians’ offices to determine the patient’s outpatient dosing regimen. This information should be clearly documented and must be made available to the pharmacy.
Before filling an order for an ESA, the pharmacist should review the order as well as the previous date of administration. A computerized warning should appear if it is too early for administering medication.
After the reconciliation process has been developed and put into place, the hospital staff (i.e., physicians, pharmacists, pharmacy technicians, and nurses) and outpatient health care providers must be informed about the new policy and operational processes to ensure that the program runs smoothly. Pharmacists can provide instruction through training programs and publications. Patients should be taught the importance of consistency in ESA dosing so that they become active participants in the reconciliation process.
Finally, ESA administration should be documented manually or electronically into both the clinical information system and the pharmacy intervention system. Documentation is an important activity in the health care setting; thorough and accurate documentation of ESA reconciliation can aid in facilitating patient monitoring and evaluation, communication among health care practitioners involved in patient care, and data collection for research and education. Dose avoidance and cost savings data should also be documented to assist in future evaluations of the reconciliation process.
A medication use evaluation (MUE) should be conducted before and after the ESA continuity-of-care program is implemented in order to assess ESA usage and to evaluate the initiative’s success. A MUE is a systematic process designed to maintain the appropriate and effective use of medications. Its ultimate goal is to improve the medication use in order to achieve optimal patient outcomes.28
Before and after implementation of the program, ESA dosing and cost information should be recorded to determine whether ESA dose avoidance has improved and whether cost savings have increased as a result of the reconciliation initiative. Findings should be disseminated to pharmacists and other health care practitioners because positive results can help to motivate staff and maintain compliance.
Pharmacists should periodically re-educate hospital staff members about the importance of ESA reconciliation to ensure that the program stays successful. Pharmacists should also continue to track outcomes to demonstrate the positive effects associated with the ESA program. Using recurring reminders helps to ensure that health care practitioners remain aware of the benefits of appropriate ESA dosing administration and continue to fulfill their roles vis-à-vis the initiative.
Following implementation of a manual ESA continuity-of-care program at a large teaching facility within SBHCS, a concurrent evaluation was conducted over a period of six months to assess the outcomes of the initiative. This analysis included all nephrology patients admitted to the facility with a DRG for CKD (with or without dialysis) and a charge code for darbepoetin alfa. The study excluded patients without documented CKD staging or a LOS of less than 24 hours.
A total of 241 patients with a mean LOS of seven days were included in the analysis, and 289 doses of darbepoetin alfa were administered during hospitalization. The average dose was 71.1 mcg, and the median dose was 60 mcg. Two hundred sixteen patients received darbepoetin alfa within 21 days of admission, and 260 doses were avoided during the first week of hospitalization. Ninety percent of unnecessary darbepoetin alfa doses (19,670 mcg) were prevented. Based on a wholesale acquisition cost of $4.82 per microgram, $94,809 was saved as a result of the ESA initiative.29
These findings substantiate the theoretical benefits of establishing a reconciliation program, both from a clinical and financial perspective. Facilities throughout the U.S. are likely to benefit from adopting such a practice.
One of the Joint Commission’s National Patient Safety Goals (NPSGs) for 2010 is to accurately and thoroughly reconcile medications across the continuum of care. Appropriate medication management and reconciliation can help to bridge gaps in continuity of care, thereby reducing medication errors and improving patient care. This is particularly important for extended-dose medications, such as ESAs, that are used to treat anemia associated with cancer chemotherapy and chronic kidney disease. Specifically, maintaining an ESA dosing regimen in the transition between outpatient and inpatient settings is important to prevent fluctuations in hemoglobin levels and unnecessary therapeutic duplications as well as to reduce hospital costs. Analyses conducted within the Saint Barnabas Health Care System indicate that less frequent outpatient ESA dosing increases opportunities for avoiding unnecessary doses.
Actual and theoretical studies conducted in our health care system highlight the clinical and financial benefits associated with an ESA continuity-of-care program. These benefits may be generalized to other hospitals and health care institutions in the U.S. Facilities wishing to implement this type of program might consider using this five-pronged strategy—identifying the opportunity, developing the plan, implementing the plan, measuring the success of the initiative, and sustaining the gains.
Disclosure: The content and views presented in this educational activity are those of the authors and do not necessarily reflect those of Medical Education Resources or Plexus Communications. The authors have disclosed whether any discussion of published and/or investigational uses of agents are not indicated by the FDA in their presentations. The opinions expressed in this educational activity are those of the faculty and do not necessarily represent the views of Medication Education Resources, Plexus Communications, or Amgen Inc.
Before any medicine is prescribed, primary references and full prescribing information should be consulted. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications on dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities. The information presented in this activity is not meant to serve as a guideline for patient management.