Standardization Drives IV Safety


November 2013 - Vol. 10 No. 11 - Page #36

In the current cost-conscious environment, health systems are continually challenged to perform more efficiently and to accomplish more despite limited resources. Given this mandate, standardizing processes, doses, and concentrations to the greatest extent possible is not only attractive from a cost perspective, but also provides myriad workflow and safety benefits. Applying uniformity and consistency can reduce human error, eliminate duplication of efforts, and simplify processes while controlling costs. While standardization may be most effective at a national or industry level, tackling standardization at the hospital and health system level is an appropriate starting point. 

Beginning the Process
Although standardization may initially appear to be a complex process, many organizations provide guidance. For example, the Institute for Safe Medication Practices (ISMP) and the Vermont Oxford Network have developed standard concentrations of neonatal drug infusions to guide practice.1 Beginning with established intravenous (IV) policies and procedures (P&Ps) can be an ideal starting point. 

Standardization allows processes to be modeled after best practices and provides consistency in outcomes. Creating standard IV processes increases patient and caregiver safety via increased consistency in training, workflow, and the medication use process. Given the immense amount of data health care providers are required to retain (especially as a result of The Health Information Technology for Economic and Clinical Health [HITECH] Act,2 which has expanded the role of technology in healthcare), the resulting increase in technology use necessitates an increase in standardizing systems and processes to improve consistency, safety, and patient outcomes.

Potential Areas of Benefit
Each health care facility must map out their processes to identify areas within their organization that will benefit most from standardization. Areas that are ideal for standardization may include: IV room workflow, order-processing systems, automated dispensing cabinets, intelligent infusion pumps and pump libraries, distributive processes, formularies, order sets and protocols, directions for use, products, concentrations, nomenclature, dosing units, dose ranges, minimum and maximum rates, weight limits, and volume limits. 

Review near misses and medication errors routinely, and conduct failure mode effects analyses to help identify additional areas that may benefit from standardization. Some institutions have a performance improvement department that can assist in the mapping processes. Utilizing a lean methodology to assist with standardization and process improvement also may be valuable.

Standardizing Concentrations
Developing standardized concentrations requires the efforts of a multidisciplinary team, including nurses, pharmacists, and physicians. The first step is to identify the most commonly used medication concentrations and determine which are commercially available. In addition, review alerts from ISMP and The Joint Commission (TJC) and conduct a thorough literature review. Look for case reports or studies reviewing standard concentrations and errors, as well as guidelines or position statements, such as the Pediatric Pharmacy Advisory Group’s Statement on Standardized Drug Concentrations to guide decision-making.3 ISMP recommends designating a single standard concentration, and in those situations where more than one is necessary, limiting the standard concentrations to two. ISMP also suggests avoiding concentrations that vary by a factor of 10 to prevent confusion and reduce the possibility of error.4

Once the standard concentrations have been identified they must be reviewed and approved by the pharmacy and therapeutics (P&T) committee or a similar committee. Following approval, custom concentrations should be removed from IV pump libraries and order entry systems.4 IV pump libraries should be updated on a regular basis; depending on the size of the institution, this could be monthly or quarterly. Medications and concentrations that are no longer utilized should be removed once the product is no longer available to prevent accidental use. New formulations and concentrations should be added to the pump library prior to dispensing from the pharmacy. Hospitals with intelligent infusion pumps that are integrated with the wireless network are able to push updates to the pumps through the network, which improves the efficiency of updating pump libraries.5

Running reports regularly is still necessary to identify any pumps that are out of service, out of range, or have not been updated for another reason. Hospitals that do not have intelligent infusion pumps with network capabilities, or do not have a wireless network, must coordinate routine pump updates with the pharmacy and biomedical departments, which may involve removing the pumps from the nursing floors to update them.6 Regardless of your system, document the changes made, systems affected, and any pumps that were not updated. 

Weight-based Dosing Standards
Developing and implementing weight-based dosing standards where applicable will improve hospital-wide standardization efforts. Begin by performing a literature review and assembling a team to review medication safety profiles, dosing limits, and dose ranges. The goal is to create an algorithm or dosing table based on the relevant information, such as patient weight, to guide dosing. Standardized doses and dose-rounding policies should then be established. Dosing standardization should be approved by the P&T committee initially, and thereafter should be reviewed biannually, at which time an up-to-date review of the literature also should be conducted. Once dosing standards have been established, they can be built into the electronic medical systems to assist health care providers in selecting the appropriate dose. Ideally, these doses would be automatically calculated and rounded; if your hospital utilizes CPOE, rounding parameters can be built into dosing sets. 

Standardizing Order Forms 
Standardized order forms, including standardized forms for therapeutic use, can improve patient safety and outcomes. When beginning this process, research best practices to ensure order sets are evidence-based, and assemble a multidisciplinary team. Both electronic and paper copies should appear in an identical format, and out-of-date copies must be removed from circulation immediately. The use of standardized order forms for therapeutic use can be linked into order sets electronically to enable all order sets to be updated at one time. Vet standardized order forms carefully to ensure they are error-free, comply with hospital P&Ps, and are based on best practices and prescriber consensus. Be sure to remove non-formulary medications, unapproved abbreviations, medications with an approved therapeutic substitution, orders by volume or tablets only, and blanket orders (eg, “take home meds” or “resume pre-op medications”). ISMP has published recommendations to guide the process of standardizing order sets.7

Dosing Standardization
Creating a process map for dosing standardization can be a useful method for initiating the project. Include a process improvement specialist, if one is available. To create a process map, several elements must be identified: product information and flow; a list of tasks that must be completed and how much time each requires; tasks that are value-added, non-value added, or vital; dosage forms and strengths available; a review of medication errors; historical purchases; and utilization data. A comparison of the current  and proposed processes is useful to identify areas for improvement. For example, the team may identify an infrequently used dose, providing an opportunity to standardize to the most commonly used dose. Additional opportunities also may be identified to improve efficiency, such as changes to product batching procedures or storage location.  

A review of medication errors to identify trends also should be considered. Best practices, ISMP, and TJC recommendations can be utilized when determining standardization of dosing units, rates, and calculations. To prevent confusion, only standard metric units should be used. Utilize technology to the fullest extent to ensure patient safety and improve outcomes. Standardized order sets and CPOE can help ensure patient safety and improve outcomes by prompting the caregiver to complete tasks, review the need for a medication, and provide a record to justify why a medication was not selected. For example, the Centers for Medicare and Medicaid Services (CMS) and TJC expect hospitals to provide prophylaxis to patients at risk for deep venous thrombosis (DVT). Technology can be used to prompt the caregiver to review the patient’s DVT risk, and based on that assessment, require an action that may reduce the occurrence of DVT.

Standardization Considerations in Critical Care
Critical care areas require special consideration during the standardization process. These patients frequently have unique needs that must be taken into consideration—for example, fluid restriction, sedation, and pain control. These issues must be considered when determining maximum concentrations and dose limits for critical care patients. For example, some facilities may carry only one concentration of a vasoactive drug, such as norepinephrine; however, other facilities may require additional concentrations to treat fluid-restricted patients. The anesthesiology department may require a different concentration for surgeries. If your facility requires a second concentration, it is critical that the product is clearly labeled, includes warnings, and is scanned upon administration to reduce the risk of error. Intelligent infusion pumps can be programmed with additional concentrations for specific areas, such as critical care or surgery. Ideally, the BCMA-verified product and concentration would be automatically communicated to the intelligent infusion pump.

Label Standardization 
Standardizing medication labels is especially vital, as failure to do so can lead directly to medication errors; in fact, an Institute of Medicine (IOM) report8 identified poor labeling as one of the central causes of errors. Possible quality concerns include incomplete or inconsistent information, inconsistent units of measure, formatting challenges, various font sizes, differences in terminology and nomenclature, omitted warnings, and differences in interpretation of information. Labels should be consistent throughout your facility, based on guidelines set by ASHP, ISMP, and TJC, and follow a standard format.

ASHP recommends the following for sterile product labeling9

  • For patient-specific products: the patient’s name and any other appropriate patient identification (eg, location, identification number); for batch­prepared products: control or lot number 
  • All solution and ingredient names, amounts, strengths, and concentrations (when applicable) 
  • Expiration date and time (when applicable)
  • Prescribed administration regimen, when appropriate (including rate and route of administration) 
  • Appropriate auxiliary labeling (including precautions)
  • Storage requirements 
  • Identification of the responsible pharmacist and technician (eg, initials) 
  • Device-specific instructions (when appropriate)
  • Any additional information, in accordance with state or federal requirements—for example, a prescription number for products dispensed to ambulatory care, long-term care, and home care patients. The label should be legible and affixed to the final container in a manner enabling it to be read while the sterile product is being administered (when possible). Written P&Ps should address proper placement of labels on containers.

Ready-to-use Products 
Utilizing ready-to-use (RTU) products can help improve patient safety; additional benefits include increased convenience, availability of standardized concentrations, expedited delivery, and extended beyond-use dating. Product selection should include a cost-benefit analysis, ease-of-use review, evaluation of expiration dating, and a review of the complementary products required for use. 

Seek input from physicians, pharmacists, nurses, and supply chain management when evaluating the utility of RTU products. Specific issues that should be evaluated include ease of use, the capacity for full product transfer from vial to bag, potential administration failures (ie, product not activated), the number of compatible products, and how well the product fits within the current workflow. Additionally, you may want to evaluate historical disruptions in manufacturing and what alternatives will be available should the product become unavailable. Facility standards for color coding, symbols or warnings, and bar code format and readability also should be included in the product review.10 The number or types of IV bags that will need to be stocked for the product line also may be a relevant consideration. The goal is to standardize the IV bags and products stocked, reduce the number of line items, increase turnover, minimize errors, and reduce waste. Utilizing a product assessment questionnaire that allows nursing to provide feedback of the systems reviewed may aid in decision-making (see FIGURE 1).



While some RTU products are available from multiple manufacturers, a facility should try to limit their purchasing to a single product line to increase standardization, reduce errors, increase inventory turns, and reduce the number of line items required to improve cost savings. The ideal choice is one that is simple to use; requires minimal training and manipulation; meets the needs of the majority of nursing, pharmacy, and patients; may be utilized with different products; and is available for purchase from multiple manufacturers in the event of contract changes or a drug shortage. 

Standardization across Technologies 
Standardization efforts can be particularly challenging when they occur after technologies such as eMAR, BCMA, CPOE, and intelligent infusion pumps have been implemented. To create consistency across various types of automation, it is important to understand how changes to one system can affect other systems. For example, identical terms must be used across systems; if the use of abbreviations is eliminated in the CPOE system, all other systems will require the same changes. Likewise, formatting must be common across systems; if changes are made to limit the choice of concentrations on an IV order form, for example, the same changes must appear in the smart pump menu. Developing a flow chart that demonstrates how the systems work together is especially useful for this process. Consider reviewing the use of unique identifiers to ensure they remain consistent across all systems.

Timely maintenance of system and software updates is critically important when standardizing across technologies. Facilities must carefully review processes to evaluate which systems need to be manually updated. The ability for information to flow among technologies without the need for manual intervention is key to managing workload when updates are required. If automated updates are not possible, plan to have sufficient staff available to conduct the manual updates in an efficient manner that does not adversely impact patient care.

Many standardization challenges across technologies are driven by the lack of interoperability that exists between patient-care technologies that utilize medication-related databases. The lack of standards for health information technology, medication databases, and medication libraries means significant efforts are required on the part of pharmacy and IT to ensure the safe operation of these technologies. The establishment of consistent standards across technologies would be valuable. The benefits of data interoperability include increased access to warnings and notifications to pharmacy (eg, an IV drip needs to be prepared and delivered), the availability of electronic documentation from smart pumps to the EHR, increased documentation for quality improvement initiatives, and reduced redundancy, as rules for clinical decision support can be built once and shared throughout the health system. 

Formulary Standardization
The purpose of a standard, system-wide formulary is to improve patient safety, provide inventory control, and increase stewardship. An additional benefit is that formulary maintenance—including dictionary, software, order set, and protocol changes—occurs at the system level, reducing manual interventions at each individual hospital. Standardization of the formulary can help establish best practices, reduce the volume of inventory carried, create efficiency gains, and increase contracting power.11,12 However, standardizing a formulary—especially across facilities—can be a daunting task. Establish teams to review medication classes, utilizing best practices and evidence-based medicine. The process of standardizing a formulary requires a significant time and resource commitment. Define the various classes of medications (for example, by American Hospital Formulary Service classification), and then determine how to best sort them to meet the needs of your hospital—medication classes could be ranked by difficulty, safety, or cost—and then establish a timeline for review. Assign each group to a team, and be sure to set expectations and deadlines for the review and recommendations. 

In establishing a multi-facility formulary, seek out leaders that recognize the benefits of standardization, utilize evidence-based medicine, and are willing to lead change. Facilities, as well as health care providers, will have different opinions, but having a clear understanding of the goal—improving patient outcomes—is vital to success. Because representation from all facilities may not be possible depending on the size of the organization, careful selection of the committee members is important when developing the recommendations. 

Conclusion
Increasing uniformity and consistency in pharmacy processes in general and IV medication management specifically can reduce the potential for error and improve safety at the hospital and health system level. While standardization efforts can be complex and challenging, the benefits of evaluating where such efforts can best improve processes—and then implementing standardization in these areas—can be significant.

References

  1. Standard Concentrations of Neonatal Drug Infusions. Institute for Safe Medication Practices (ISMP) and Vermont Oxford Network. http://www.ismp.org/tools/PediatricConcentrations.pdf Accessed September 6, 2013.
  2. Health Information Technology for Economic and Clinical Health (HITECH) Rules and Regulations. HealthIT.gov http://www.healthit.gov/policy-researchers-implementers/final-rules-regulations Accessed September 6, 2013.
  3. Statement on Standardized Drug Concentrations. Pediatric Pharmacist Advocacy Group. http://www.ppag.org/standardconcentrations/ Accessed October 7, 2013.
  4. ISMP’s Medication Safety Alert! Smart Pump Custom Concentrations Without Hard “Low Concentration” Alerts. http://www.ismp.org/newsletters/acutecare/showarticle.asp?id=16 Accessed September 6, 2013.
  5. Larsen GY, Parker HB, Cash J, O’Connell M, Grant MC. Standard drug concentrations and smart-pump technology reduce continuous-medication-infusion errors in pediatric patients. Pediatrics. 2005;116(1):e21-e25.
  6. Best Practice Recommendations for Infusion Pump-Information Network Integration. Healthcare Safety Technology Institute. http://www.aami.org/htsi/SI_Series/Infusion_Pump_Network_Integration.pdf Accessed October 16, 2013.
  7. ISMP Guidelines for Standard Order Sets. http://www.ismp.org/tools/guidelines/standardordersets.pdf Accessed September 6, 2013.
  8. Preventing Medication Errors: Quality Chasm Series. Institute of Medicine of the National Academies. http://iom.edu/Reports/2006/Preventing-Medication-Errors-Quality-Chasm-Series.aspx Accessed September 6, 2013.
  9. ASHP Guidelines on Quality Assurance for Pharmacy-Prepared Sterile Products. http://www.ashp.org/DocLibrary/BestPractices/PrepGdlQualAssurSterile.aspx Accessed September 6, 2013. 
  10. Filiatrault, P. Does colour-coded labeling reduce the risk of medication errors? Can J Hosp Pharm. 2009;62(2):154-156.
  11. Kleiss J. Standardizing the formulary across a health system. Pharm Purch Prod. 2009;6(9):2,4.
  12. Lowe C. Herding Cats – Formulary Considerations in a Large Health System. Presented at: 45th ASHP Clinical Meeting & Exhibition (Midyear Conference). Anaheim, CA; December 5-9, 2010.

Ginger J. Ertel, PharmD, is a director for clinical pharmacy services at MedAssets. She received her doctorate of pharmacy from the University of Missouri-Kansas City and completed a PGY1 pharmacy practice residency at the The Johns Hopkins Hospital. Ginger’s professional interests include applying technology, implementing change, and improving medication safety practices.

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