Conference Report Published by CareFusion Center for Safety and Clinical Excellence
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- Bu səhifədəki naviqasiya:
- Summary and conclusions
- National Initiative for Children’s Healthcare Quality
- Pediatric medication errors
- Causes of pediatric medication errors
- Responsibility
- Figure 1. Patient Safety Culture Composite—Percentage Responding Favorably
- Survey Areas
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Lessons learned ICPS evaluations revealed many process variations. Five systems had a weight-based heparin protocol, one did not. Results for all were compared. Anticoagulant safety issues among the different hospitals were similar. Correlating actions with outcomes was dif- ficult. The experience and results from this project educated coalition members about systems and processes so that better ques- tions could be asked.
ICPS representatives from six hospital systems developed a consensus about safe practices for anticoagulant use. Four target- ed actions were implemented to assess and improve anticoagulant safety but data-based conclusions were difficult to reach and more questions were raised. The next steps are to reconvene the ICPS to complete another self-assessment to determine whether any progress has been made and to determine if initiatives such as computer alerts have con- tinued to progress at ICPS health systems. If goals are not met, they will be the subject of further investigation. ICPS is now considering how to expand the coalition to include subur- ban hospitals and others in Indiana.
Executive Summary Conference Report
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PROCEEDINGS
Heparin Safety in Children Charles Homer, MD, MPH, Chief Executive Officer, National Initiative for Children’s Healthcare Quality, Cambridge, MA Key points • Medication errors are at least as common in children as in adults. • Infants in neonatal intensive care units (ICUs) and older children with complicated chronic illnesses or severe trauma are at greatest risk. • Root causes of pediatric medication errors include: – The complexity of the medication use process – Variability in the size of pediatric patients, dosing regimens and medication concentrations – Patients’ inability to self-advocate – Insufficient training and customization of treatment and safety technologies – Inadequate patient safety culture – Look-alike/sound-alike medications – Reliance on individual vigilance rather than on systems and technology • Medication errors are a system issue and require a system response. • Government, professional organizations, regulatory bodies, researchers, hospital senior leadership, clinicians and industry need to work together to create systems that maximize medication safety in children. National Initiative for Children’s Healthcare Quality National Initiative for Children’s Healthcare Quality (NICHQ) is an action-oriented organi- zation whose mission is to improve child health. NICHQ's current improvement agen- da focused on four areas: equity, childhood obesity, chronic illness and patient safety. During the past three years NICHQ coor- dinated the Pediatric Affinity Group of the Institute for Healthcare Improvement’s (IHI) Five Million Lives Campaign, working together with the American Academy of Pediatrics, the National Association of Children’s Hospitals and Related Institutions, and the Child Health Corporation of America.
Medication errors in children are at least as common in children as in adults 1 . Studies based on reviews of medical records show that the frequency of medication errors in children is the same as it is for adults 2 . More sensitive tools such as the trigger tool recom- mended by IHI and modified for pediatric patients show that the frequency of medica- tion errors is somewhat higher in children than in adults 3 . The youngest and oldest pediatric patients are at highest risk, namely, infants in neonatal intensive care units (ICUs) and older children with complicated chronic illnesses or severe trauma. The ICU setting is the highest-risk environment 4 . Causes of pediatric medication errors Although several root causes of medica- tion errors in children are similar to those in adults, several characteristics of children and their health care raise additional concerns. • Comparable complexity. The complexity of the medication use process, from diagno- sis and prescribing medicines to adminis- tration and documentation of the dose, is the most common underlying cause. The medication use process involves many steps with the potential for error at any step. As in the adult setting, attention tra- ditionally has focused on vigilance rather than on the system as the strategy for addressing this issue in the pediatric set- ting.
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Executive Summary Conference Report 9th Invited Conference: Improving Heparin Safety Responsibility Some difficult questions experts are often asked are: why, after the first incident, did the same error pediatric medication error happen again? Who was responsible and why was the system not fixed? A failure mode effects analysis (FMEA) performed by the Institute for Safe Medication Practices showed that no single person is responsible for these errors. Medication errors are a system issue and require a system response. There are many places where responsi- bilities lie. There is a responsibility to regulate the pharmaceutical industry. Look-alike or sound-alike medications are not permissible. In keeping with the Joint Commission’s efforts, there need to be hospital standards to ensure patient safety through the use of technology and staff training. Hospitals must be provided with resources to implement these changes. Financial incentives need to be aligned. An example of an emerging alignment of incen- tives to improve patient safety is the Medicare policy of not paying a hospital for the care of a condition resulting from a medication error. • Greater variability. Pediatric patients range in size from the smallest premature infant to adult-sized adolescents. This presents major challenges with regard to medica- tion use. Dosing regimens and medication concentrations used for pediatric patients are therefore highly variable. There is also a lower margin for error with infants and young children compared to adults. • Lack of self-advocacy. Young children are not able to advocate for themselves or ask questions about their medication. A healthy parent may ask questions, so it dif- ficult to determine whether this increases or decreases a child’s risk of harm. • Less research. Pediatric patients represent a smaller market for pharmaceutical com- panies, and there are fewer studies of the safety of medications for this population. Changes in the pediatric drug laws have improved but not resolved this situation. • Insufficiently customized technology. Some medication safety technologies such as computerized prescriber order entry (CPOE) and medication administration systems initially were not sufficiently cus- tomized for the variable sizes of pediatric patients. • Insufficient training and customized treat- ment. Anecdotal evidence suggests that hospitals with both adult and pediatric patients and mixed systems may not have the same level of specialized training, treatments and formulary for pediatric patients that might be found in children’s hospitals. • Inadequate patient safety culture. Differences in patient safety culture may also increase the risk of medication errors in children. An NICHQ analysis of data from the first Agency for Healthcare Research and Quality’s Patient Safety Survey 5 shows that staffs who work on pediatric units report lower levels of patient safety prac- tices in areas such as teamwork and man- agement support for patient safety issues (Figure 1). These results did show improve- ment in the 2008 survey, suggesting that the increased attention to safety and qual- ity in hospital settings serving children may be improving the safety culture. • Look-alike/sound-alike medications. The widely publicized issue that medication vials look alike is another cause of pediatric medication errors, specifically with regard to tragic heparin-related incidents during the past two years. Two vials of heparin may look similar but contain 1,000-fold different concentrations. In these cases, nurses on the pediatric care unit used adult-strength heparin to prepare flushes for intravenous catheters instead of using the low-concentration heparin. The hospi- tals also relied on the vigilance of individu- als to avert medication errors rather than use technology to match patient to medi- cation. For example, barcoding systems could have been used when stocking the automated dispensing cabinet and when medicines were administered to patients. Figure 1. Patient Safety Culture Composite—Percentage Responding Favorably Highest
Pediatrics Lowest
Median 0.9
0.8 0.7
0.6 0.5
0.4 0.3
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Survey Areas Executive Summary Conference Report
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enable professionals to perform to the best of their capacities and desires. Organizations that fund and publish research have a responsibility to support research into pragmatic questions such as whether a specific medication, such as hepa- rin, needs to be administered in a specific set- ting. The study of medication safety systems is still underfunded.
Government, professional organizations, regulatory bodies, researchers, hospital senior leadership, clinicians and industry need to work together to create a future that maximiz- es medication safety in children. Developing specific policies and practices is essential to safeguarding children against medication errors. NICHQ is committed to working col- laboratively to promote the development and widest possible dissemination of these prac- tices.
At the individual hospital there is also responsibility at the executive governance level. This is suggested in the concept of “Getting the Board on board” in the IHI Five Million Lives campaign 6 . IHI also emphasiz- es the importance of having a learning cul- ture. If a major adverse drug event happens, senior leaders in a healthcare organization are responsible for finding out about that event and making sure that it could not occur in their organization. NICHQ believes that if a hospital is committed to caring for children, there is a need to employ every means avail- able to ensure those children will be safe. In a smaller institution it may be particularly difficult for senior leadership to devote the necessary resources for its pediatric patients. Professional responsibility is also involved. A serious medication error often attracts media attention and criticism. Nurses may be criticized for not demonstrating appropri- ate professional responsibility in carrying out their duties. While professionalism is impor- tant, organizations need to ensure appropri-
1. Kaushal R, Bates DW, Landrigan C, et al. Medication errors and adverse drug events in pediatric inpatients. JAMA. 2001;285:2114-20. 2. Woods D, Thomas E, Holl J, et al. Adverse events and preventable adverse events in children. Pediatrics. 2005;115:155-60. 3. Takata GS, Mason W, Taketomo C, et al. Development, testing, and findings of a pediatric-focused trigger tool to identify medication-related harm in US children’s hospitals. Pediatrics. 2008;121:e927-35. 4. Sharek PJ, Horbar JD, Mason W, et al. Adverse events in the neonatal intensive care unit: development, testing, and findings of an NICU-focused trigger tool to identify harm in North America. Pediatrics. 2006;118:1332-40. 5. Agency for Healthcare Research and Quality. Hospital Survey on Patient Safety Culture. 2007. Retrieved January 9, 2009 from http://www.ahrq.gov/qual/hosp- surveydb/. 6. Institute for Healthcare Improvement. Getting Boards on board. Retrieved January 9, 2009 from http://www. ihi.org/IHI/Programs/Campaign/BoardsonBoard.htm. PROCEEDINGS 9th Invited Conference: Improving Heparin Safety 49
The medication-use system consists of a continuum of critical steps, including the selection and storage of medications, order- ing, transcribing, preparing, dispensing and administering medications for patients and monitoring patient response. Though atten- tion to detail is expected by all who are involved in the use of drugs, extra efforts are necessary to improve patient safety with high- alert medications such as anticoagulants. Heparin therapy is particularly susceptible to errors because of the use of units for dos- age, variability in ordering using or not using weight-based dosing, the need to prepare patient-specific doses and the need to moni- tor patient response to therapy. The impact of heparin on each of the critical steps in the medication-use system should be analyzed. Strategies to consider for improving the safety of heparin therapy include: • Selection – Identify and evaluate all stock of hep- arin used, including vials, premixed infusions and components of prepared trays. – Only pharmacy should select the hep- arin products for therapeutic use. – If departments such as materials man- agement or dialysis order heparin in any form for catheter flushing (such as in a prepared tray), pharmacy must provide oversight of the selection and storage of the supplies. – Only concentrations and vial and syringe sizes appropriate for the indi- cations and patient population should be selected. • Storage – Pharmacy should approve all storage locations. – Storage outside of the pharmacy department should be limited. – Prominent warning stickers and other visual cues should be used to minimize the possibility of selecting an incorrect dosage unit. – The availability of heparin before phar- macist review of an order should be avoided. – Vials of 10,000 units/mL concentration should not be stocked outside of the pharmacy. • Ordering – Medical staff-approved protocols should be used whenever possible. – The order sheet listing the approved protocol should be examined by pharmacy, medical records and other appropriate departments to ensure that hospital policies are followed, no Key points • Extra efforts are necessary to improve patient safety with high-risk medicines such as anticoagulants. • Heparin therapy is particularly susceptible to errors because of the use of units for dosing, variability in ordering, the need to prepare patient-specific doses and monitor patient response to therapy. • The activities needed for heparin therapy at each of the critical steps in the medication- use system should be analyzed. • Efforts to standardize heparin dosing need to involve representatives from multiple departments, including surgical services and interventional radiology where heparin is frequently used during critical procedures. • The need for heparin to flush intravenous (IV) catheters for in pediatric and neonatal patients should be assessed, and preparations used for this purpose should be provided to these patient care areas from the pharmacy. Improving Heparin Safety: A Pharmacy Perspective Patricia C. Kienle, RPh, MPA, FASHP, Director, Accreditation and Medication Safety, CareFusion, Center for Safety and Clinical Excellence, San Diego, CA
Executive Summary Conference Report
50 9th Invited Conference: Improving Heparin Safety prohibited abbreviations are used, only standard concentrations are listed and other hospital policies are followed. – Each protocol should be reviewed annually and the evaluation docu- mented. • Dispensing – Pharmacy should dispense unit-of- use, patient-specific doses. Ideally, each dose should be available from a profile-driven automated dispens- ing cabinet, with appropriate warnings available provided by the device in the most expedient manner. – Nursing should receive each ready-to- use dose before the administration time. – If in an urgent situation a dose needs to be obtained before pharmacist review (an override), an independent double-check with two qualified staff members should be required. – Appropriate laboratory data should be available to the nurse or other healthcare professional administering the dose. • Monitoring – Hospital-defined parameters should be established. Most organizations have standardized heparin bolus doses and premixed IV solu- tions in general– and critical care patient units. Other departments including Surgical services, interventional radiology, cardiac catheterization laboratory and dialysis often use heparin during procedures. These areas often have not been involved in efforts to control and standardize heparin dosing. Attention needs to be paid to these areas to ensure patient safety during these critical procedures. Pediatric and neonatal units often need concentrations of heparin flush solutions that are not commercially available in the volume or dosage form required. Use of the agent should be assessed, and preparations pro- vided for these areas by pharmacy. Many organizations have eliminated hepa- rin for flushing peripheral IV catheters. Saline is generally the preferred agent. Conclusion Heparin is a high-alert medicine that should be evaluated throughout the medica- tion-use system within the entire healthcare organization.
PROCEEDINGS
9th Invited Conference: Improving Heparin Safety 51
Executive Summary Conference Report Key points • The combination of a high-volume, high-risk process with many interruptions greatly increases the risk of an unintentional medication error. • Administration of heparin is particularly challenging because of the narrow therapeutic range, complex dosage regimens and potential for patient harm. • An unprecedented combination of factors greatly increases the probability of potentially life-threatening heparin errors. • Challenges affecting heparin administration include: – Complex dosage calculations – Variation in the accuracy of obtaining patient weight – Perceived “need for speed” that can lead to poor compliance with safety technology – Lack of standard protocols – Difficulties recognizing over-anticoagulation and heparin-induced thrombocytopenia • Ensuring the safety of highly complex heparin administration requires a multidisciplinary approach in which nursing concerns and front-line observations are heard and respected in advocating for a culture of safety, nurses’ rights and, most importantly, keeping patient safety at the forefront. A Nursing Perspective on Heparin Safety Vicki S. Good, MSN, RN, CCNS CENP Cox HealthCare System, Springfield, MO Medication administration is a primary function of nursing, and it often causes stress to nurses because of the complexities and potential for patient harm. A nurse may administer up to 50 medications during a single shift, often being distracted and inter- rupted 1,2
. This increases the risk that a nurse will make an unintentional medication error. The Joint Commission and the United States Pharmacopeia report that medication errors continue to be a leading cause of sentinel events and the majority of medication errors occur at the point of administration 7 . The safe administration of heparin is particularly challenging because of the narrow therapeu- tic range, extremely complex dosage regi- mens, frequent dosage adjustments and high potential for patient harm associated with heparin therapy. Nurses have been educated on the 5 Rights of medication administration: right drug, right patient, right dose, right time and right route. These rights have evolved to the 7 Rights of medication administration that also include right reason and right documenta- tion 3
For nurses to consistently practice these 7 Rights, they also have other rights that need to be met. Cook and the Massachusetts Nurses Association published the “Nurses’ Six Rights for Safe Medication Administration” as guidelines to assist nurses 4 . These include: 1. The right to a complete and clearly written order.
2. The right to have the correct drug route and dose dispensed. 3. The right to current information and resources on medications. 4. The right to access medication administra- tion policies. 5. The right to administer medications safely and to identify problems in the system. 6. The right to stop, think and be vigilant when administering medications. Along with reliable systems, multidisci- plinary partnerships are necessary to ensure that both the 7 Rights and Nurses’ 6 Rights are achieved in the interest of patient safety. This is particularly true with regard to heparin.
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