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Insulin dosing errors



Parks Medical-legal Presents:INSULIN DOSING ERRORS

Parks Medical-legal Presents:INSULIN DOSING ERRORS



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  • Miller and colleagues found that diet therapy, oral agents alone, and insulin therapy had a 12%, 16%, and 30% prevalence for hypoglycemic symptoms, respectively. Insulin therapy, a decreased HbA1c level at follow-up, younger age, and hypoglycemia at baseline are factors associated with an increased prevalence of hypoglycemia.
  • All healthcare professionals should be educated about the risk for insulin errors and measures that should be taken to prevent or minimize this risk. Education may be provided with the use of written material, video and oral presentations, and one-on-one sessions.
  • It is very important to provide healthcare professionals with problem-solving tools and education to manage situations appropriately (ie, what to do and who to call after normal business hours).

Insulin dosing errors  Insulin dosing errors Presentation Transcript

  • Parks Medical-Legal Consulting Presents
    Insulin Dosing Errors in Medication Therapy For Diabetes
    By Paul Parks RN-Legal Nurse Consultant
    © PMR 2010
  • Introduction: Errors Associated With Insulin Therapy
    • Errors Associated With Insulin Therapy
    • Healthcare professionals regularly care for patients with diabetes, a condition resulting in hyperglycemia due to inadequate insulin production and/or insulin action. Of an estimated 13% of the US population aged 20 years or older that has diabetes, only 60% of cases have been diagnosed. Overall, it is estimated that 8% of the entire population of the United States has diabetes. Diabetes may result in significant morbidity, leading to conditions such as blindness, cardiovascular disease, kidney disease, and premature death. Statistics from 2007 estimated the total cost of diabetes in the United States to exceed $170 billion dollars. An estimated $116 billion dollars were spent on direct medical costs and $58 billion dollars were spent on indirect medical costs (e.g., disability)
  • Insulin is a “ High Alert” Medication
    Diabetes is often successfully managed with lifestyle modifications and drug therapy. Insulin supplementation, required by one fourth of diabetic patients, has been shown to improve patient outcomes by decreasing blood glucose and, potentially, via vasodilatory and anti-inflammatory effects.
  • Insulin Dosing Is Individualized and Complex
    • Due to complex individualized dosing and administration regimens, insulin is not a "one-size-fits-all" medication. Medication errors associated with insulin use have the potential to cause patient harm and are responsible for 80% of inpatient errors caused by glucose-lowering agents and 10% of all harmful drug errors. The Institute for Safe Medication Practices (ISMP) placed insulin, subcutaneous and intravenous (IV), on a list of "High-alert Medications" due to its potential to cause serious patient harm if given in error
  • Causes and Risks For Insulin Errors
    This program will provide clinicians with an understanding of the causes of and risks for insulin errors and tools to prevent such errors.
    A goal of insulin therapy is to achieve the target hemoglobin A1c (HbA1c) without development of hyper- or hypoglycemic episodes. Thus, insulin is available in rapid-, short-, intermediate-, and long-acting types (Table 1).
  • Table 1. Comparison Chart of Selected Insulins
  • Insulin Delivery and Errors
    Insulin is also available in delivery devices, such as injector pens, implanted insulin pumps, and infusion pumps. Insulin dosing generally consists of basal insulin, prandial insulin, and correction-dose insulin. Hospitalized patients may receive insulin intravenously or subcutaneously depending on the clinical condition or based on a "sliding scale," a non-evidence-based practice The above complexities have contributed to a plethora of insulin errors at every step of the prescribing, dispensing, and administration process.
  • Inherent Risks
    The inherent risks associated with insulin use require that patient factors be considered prior to prescription. Patient age and diabetic complications (e.g., impaired eyesight, peripheral neuropathy) should be considered when prescribing insulin to help determine patient adherence and ability to administer insulin and to monitor therapy. In addition, insulin absorption, onset and duration, cost, and associated technology should be evaluated.[9] The clinician should ensure that appropriate interventions are put in place upon initiation of insulin.
  • Stress Hormones and Insulin
    The clinician should be aware that insulin requirements may change, particularly during the stress of hospitalization. Erratic insulin absorption, change in gut motility, and poor coordination of insulin timing with meals could alter insulin requirements. Stress-induced counter-regulatory hormones such as glucagon, corticosteroids, epinephrine/norepinephrine, and growth hormone could markedly elevate blood glucose.
  • Stress Hormones
    • Serotonin. Perhaps the most important neurotransmitter in depression is serotonin. Among other functions, it is important for feelings of well-being. Imbalances in the brain’s serotonin levels can trigger depression and other mood disorders.
    • Other Neurotransmitters. Other neurotransmitters possibly involved in depression include acetylcholine and catecholamines, a group of neurotransmitters that consists of dopamine, norepinephrine, and epinephrine (also called adrenaline). Corticotropin-releasing factor (CRF), which is believed to be a stress hormone and a neurotransmitter, is thought to be involved in depression and anxiety. Increased CRF concentrations appear to interact with serotonin and have been detected in patients with either depression or anxiety.
  • Glands That Release Hormones
  • Insulin Error Facts
    According to Quantros MEDMARX® (formerly, USP MEDMARX®), a hospital medication error database, errors reported for 2003 consisted of 8813 insulin errors, 362 of which resulted in patient harm. Based on the historical average harm threshold for error reports submitted to the Quantros MEDMARX®, an error involving insulin may be twice as likely to result in patient harm.
  • Narrow Margin in Dosing
    Insulin is a medication with a narrow therapeutic window. As such, doses too low may result in hyperglycemia and doses too high may result in hypoglycemia. Both hypo- and hyperglycemia can be serious and may require immediate medical attention. Insulin omission due to error has resulted in serious morbidityand insulin given in error has resulted in fatalities. The following are examples of morbidity or mortality due to insulin error:
  • Morbidity and Mortality in Insulin Administration
    • Two infants died after receiving insulin instead of heparin in their total parenteral nutrition.
    • Two patients died after receiving insulin instead of heparin flush during a vascular-catheter procedure.
    • Sustained profound hypoglycemia developed in a hospitalized patient after an insulin infusion was prepared using insulin glargine (Lantus®) instead of regular insulin.
    • Hospitalizations have resulted from coadministration of insulin lispro (Humalog®) and regular insulin and the coadministration of insulin glargine and twice-daily neutral protamineHagedorn® (NPH) due to patient confusion regarding discontinuation of 1 of the agents.
  • Handwritten Orders
    The nurse read this order for "Insulin SC NPH 15U AM + 6 units PM" as "Insulin SC NPH 15U AM, 46 units PM." The physician, when questioned, mistakenly confirmed the 46 units. The patient became hypoglycemic after the evening dose but was treated appropriately without further consequence.
  • The Do Not Abbreviate List
    • Because the use of medical abbreviations to order insulin has resulted in near-misses and actual errors a "Do Not Abbreviate List" should be required.
    • Do not use "U" for Units:-"4U regular insulin" misread as "44 regular"-"U" has been mistaken for "0," "4," "cc," and "7" -"Humulin U 14 units" misread as "Humulin N 14 units
    • Do not use "IU" for International Units:-"Regular insulin 4 IU" misread as "regular insulin 41 U"-May also be misread as IV instead of IU, then given intravenously in error
    • Do not use slash marks (seen as the number 1):-"NPH 10/12 regular insulin" misread as "NPH 10, 112 regular insulin"
    • Do not use SSRI, SS, or SSI for sliding-scale orders:-"SSRI" (sliding-scale regular insulin) misinterpreted as "selective serotonin reuptake inhibitor";-"SS" (sliding-scale) misread as the number "55"; and-"SSI" (sliding-scale insulin) misinterpreted as "strong solution of iodine" (Lugol's).
  • Examples of inappropriate abbreviation use
  • Inappropriate Abbreviation Use
    The Joint Commission National Patient Safety Goals 2B states that each hospital should standardize a list of abbreviations, symbols, acronyms, and dose designations that are not to be used within the organization.The abbreviation "U" for "unit" is on the official "Do Not Use" list created by The Joint Commission.
  • The Sliding Scale
    • Sliding-scale insulin is often used in hospitals but its use has not been substantiated by clinical evidence. It is a reactive rather than proactive approach to managing blood glucose and does not provide basal insulin. Patients may be at risk for prolonged hyperglycemia due to high thresholds for treatment.
    • The use of sliding-scale insulin has been in question for years. Discontinuation of this practice is recommended. However, if sliding-scale insulin is ordered, precautions should be put into place. Sliding-scale insulin should only be ordered on a preprinted order or computerized order set created and approved by the organization. Long-acting insulin should not be used in a sliding-scale and scheduled insulin should be ordered in patients receiving a sliding-scale.
  • Factors For Errors
    Packaging similarities and mental slips account for the majority of mix-ups between insulin and heparin. For instance, heparin in a concentration of 100 units/mL is often used for implanted port catheter flush. This concentration is identical to the often-used insulin concentration, and both medications are dosed in units.
  • More Factors For Error
    The following factors may also contribute to mix-ups between insulin and heparin
    Look-alike, sound-alike qualities when written or spoken;
    Labels may have similar colors;
    Both are used widely in hospitals; and
    Both are often placed on the same counter, drug cart, or under a laminar flow hood.
    Similarities between heparin and insulin vials.
  • Similarities between heparin and insulin vials.
  • Drug Name Similarities
    The following are examples of insulin products often confused due to look-alike, sound-alike qualities-
    Lantus® and Lente®;
    Humalog® and Humulin®;
    NovoLog® and Novolin®;
    Humulin® and Novolin®;
    Humalog® and NovoLog®; and
    Novolin® 70/30 and NovoLog® Mix 70/30.
  • Insulin and Tuberculin Syringes
    When using a tuberculin syringe to draw up 9 units of insulin, one may mistakenly draw up 0.9 mL of insulin rather than the equivalent of 0.09 mL, a volume not easily or accurately measured with a tuberculin syringe. Additionally, the tuberculin syringe scale is often printed as ".9, .8, .7,..." not "0.9, 0.8, 0.7,..." so that when the syringe barrel is partially turned, the decimal point is not visible and one only sees "9, 8, 7,..."
  • Insulin and tuberculin syringes
  • Proper Syringe is Key for Error Reduction
    • ISMP and the Pennsylvania Patient Safety and Reporting System have received several reports describing errors in which tuberculin syringes were used in place of insulin syringes . Examples include a nurse who selected a tuberculin syringe instead of an insulin syringe and administered 0.9 mL (90 units) of insulin, which resulted in a tenfold overdose. In other cases, 1 patient received 60 units of insulin instead of 6 units; another patient received 40 units of insulin instead of 4 units.
  • Proper Syringe
    Use of the correct insulin syringe is extremely important. The U-100 syringe should not be used to draw up U-500 strength. Clinicians should be aware that patients who require U-500 insulin and use a U-100 syringe may report their doses incorrectly. For example, a reported dose of 50 units (read on the U-100 scale) may actually be a dose of 250 units. U-500 strength should be avoided for insulin doses less than 100 units.
  • Sequence To Draw Insulin
    • Drawing up NPH insulin, followed by regular insulin using the same needle and syringe vial, may contaminate the regular insulin solution with proteins from NPH.
    • The proper sequence for drawing up regular and NPH insulin into a single syringe is to draw up the regular insulin, followed by the NPH insulin. Drawing up NPH insulin, followed by regular insulin using the same needle and syringe vial, may contaminate the regular insulin solution with proteins from NPH.
  • Dosing Errors
    • Patient misadministration of insulin has resulted in insulin error.Error has occurred due to confusion between vials and failure to discontinue insulin that is no longer prescribed. The mistaken assumption that all clear insulins are short-acting has also resulted in patient error.
    • Improper use of diabetes devices may contribute to insulin error. For example, improper administration of insulin may occur due to incorrect programming of infusion pumps.In addition, a study found that miscoding of blood glucose meters may result in significant insulin dosing errors.
  • Proper Injection Technique
    Wet spots" with insulin may occur due to contents from a primed needle, incomplete injection, or leakage from the injection site. When using an insulin pen, the needle should be left in the skin for approximately 6 seconds to ensure complete administration.
    "Wet spots" with insulin may occur due to contents from a primed needle, incomplete injection, or leakage from the injection site. When using an insulin pen, the needle should be left in the skin for approximately 6 seconds to ensure complete administration.
  • Insulin Pens and Errors
    There are many reasons why insulin injector pens can be implicated in insulin error.Multiple insulin pen products are available and have look-alike, sound-alike risks due to similarities in names, contents, and packaging.
  • Types of Insulin Pens for Injection
  • Multiple Insulin Products
  • Multiple insulin products.
    For example, an error occurred when a NovoLog® Mix 70/30 FlexPen was dispensed instead of a NovoLog® FlexPen.Design flaws may contribute to misreading of digital dose information (e.g., a dose of 21 may look like 12 if read upside down) , needlestick injuries are common, and insufficient rolling and tipping of NPH content in insulin pens has the potential for dosing errors.
  • Misreading digital dose information
  • Pen Injector Errors
    • Error associated with pen injectors can occur in the healthcare setting. Caution against using insulin pens like vials by aspirating contents out of the pen cartridge with a needle, and using pens for multiple patients, has been published previously, However, an insulin pen injector error recently made national news when it was found that thousands of patients may have been exposed to bloodborne illness due to the use of insulin pen injectors for multiple patients. Based on reports from the ISMP, the FDA has since released an alert reminding healthcare professionals that single-patient insulin pens and insulin cartridges must not be used for multiple patients, even if the needles are changed between patients, due to the risk of transmitting bloodborne pathogens such as hepatitis and human immunodeficiency virus.
  • Strategies to Avoid Errors
    At the time of prescription, several strategies are recommended to help reduce insulin error. First and foremost, use of standardized insulin regimens and electronic prescribing should be instituted to eliminate confusion due to handwritten orders. If writing insulin orders, the clinician should never use abbreviations (ie, spell out "units") and should never use a trailing zero after the decimal point (eg, "5.0"). The clinician should ensure that appropriate insulin therapies are ordered and appropriate monitoring practices are used.
  • Error-reducing Strategies: Ordering Insulin
    Do not use abbreviations (ie, spell out "units")
    Avoid slash marks to separate insulin orders
    Write brand names for insulin products
    Order insulin according to the patient's mealtime; specify a clear relationship between the insulin dose and mealtime except for long-acting basal insulin
    Order unusual strength insulin (eg, U-500) using concentration (U-500) and both the units of measure and volume per dose (eg, U-500,100 units, 0.2 mL)
  • Error Reduction Continued
    • Consult a diabetologist when patient requires a U-500 concentration, where available
    • Avoid verbal orders for insulin; when a verbal order is received, read back and spell the name to avoid confusion with similar-sounding insulin products
    • Avoid sliding-scale insulin
    • Ensure that prescriber notification occurs if there are changes in a patient's carbohydrate intake
    • Assess caregiver competency
    • Become familiar with insulin products and delivery devices prior to use
    • Use auxiliary labels and computer warnings to alert look-alike, sound-alike qualities of insulin product names
  • Error Reduction
    An example of a mental slip that could occur between insulin and heparin and underscores the importance of reading back verbal orders.
  • Reading back verbal orders
    Many strategies should be followed by pharmacy departments and pharmacists to minimize the risk for insulin errors. Criteria should be established by each institutional pharmacy and therapeutics committee regarding the safe use of insulin. For example, IV insulin should be used only according to institutional policies and procedures
  • Error-reducing Strategies: Intravenous Insulin
    • Use standardized concentration for all adult insulin infusions
    •    -ISMP recommends regular insulin 100 units per 100 mL of fluid
    • Use standardized concentration for all neonatal insulin solutions
    •    -ISMP recommends insulin 1 unit per mL of fluid for doses less than 5 units and 10 units per mL of fluid for doses greater than 5 units
    •    -Doses should be drawn up in a tuberculin syringe with enhanced labeling of special concentration
    • Dispense insulin solutions in glass bottle; minimize possibility of insulin absorption by plastic tubing by thoroughly flushing new tubing with the solution before starting the infusion
    • Do not assume that a clear insulin solution may be administered IV (some basal insulin is clear)
    • Prepare all insulin infusions in the pharmacy
    • Administer subcutaneous insulin dose 1 hour prior to discontinuation of IV insulin infusion
    • Order insulin infusions only according to approved protocols, algorithms, or established procedures
    • Institute an independent double-check for all IV insulin orders
  • Hospital Formularies
    In addition, hospital formularies should restrict use of similar insulin agents.(ie, have either NovoLog® Mix 70/30 or Humalog® Mix 75/25 on the formulary, but not both). Also, avoid availability of Novolog® Mix 70/30 and Novolin® 70/30 on the formulary at the same time. Table 4 lists procedures that should be incorporated into daily pharmacy practice to help reduce risk for insulin error.
  • Error-reducing Strategies: Pharmacy Procedures
    • Dispense patient-specific doses of unusual concentrations of insulin from the pharmacy
    • Dispense patient-specific doses of long-acting insulin from the pharmacy
    • Use tall-man letters (eg, NovoLIN) on computer screens to differentiate differences in drug names
    • Accentuate the word "mixture" or "mix" on computer screens for appropriate products, and incorporate reminders about look-alike, sound-alike insulin therapies
    • Circle or underline distinguishing parts of name when checking product before dispensing
    • Develop procedures for mixing, labeling, and dispensing insulin concentrations used in neonatal intensive care units, including neonatal parenteral nutrition
    • Label storage areas with look-alike, sound-alike reminders
    • Institute an independent double-check procedure of insulin dose before dispensing from the pharmacy
    • Read and spell back verbal insulin orders
    • Confirm indication of insulin prior to dispensing
    • Use barcode scanning for automated compounding, when available
    • Verbal orders should only be accepted in an emergent situation or a sterile situation
  • Error-reducing Strategies: Insulin Storage Considerations
    Remove unusual concentrations (eg, Humulin® R U-500) from patient care areas
    Store insulin and heparin separately on nursing units and in the pharmacy
    Store insulin syringes apart from tuberculin syringes and remove tuberculin syringes from nursing units, if possible
    Label insulin vial with patient's name and vial expiration per institutional guidelines
  • Storage Considerations: Insulin
    • Conduct unit inspections to ensure proper labeling and disposal per institutional guidelines
    • Remove intermediate- and long-acting insulin from nursing stock
    • Do not dispense insulin in original carton, or discard carton upon dispensing or delivery to nursing unit
    • Provide ongoing education and oversight to assure insulin pens are not shared between patients and that cartridges are not used to prepare insulin doses with a conventional insulin syringe
  • Error-reducing Strategies
    • Avoid administering insulin before pharmacist review of order
    • Institute independent double-check of IV insulin doses (including original order, dose, concentration, patient identity, route of administration, pump settings) before administration
    • Read-back all verbal insulin orders (eg, saying "one-five units" instead of "fifteen units," because it has been misheard as "50"; saying "one-four units" instead of "fourteen units" because it has been misheard as "40 units," etc)
    • Confirm patient need for insulin (eg, diabetes, hyperglycemia) before administration
  • Error Reduction
    • Record measurements of blood glucose and insulin doses on appropriate forms or computer screens
    • Confirm compatibility of insulin before mixing
    • Use smart pumps for insulin infusions; if not available, use single-channel pumps, rather than dual-channel pumps, to prevent programming confusion
    • Place insulin tubing away from other tubing to prevent inadvertent rate adjustment or connection with other medications; label all tubing
    • If possible, communicate to the patient the entire insulin name and dose prior to administration; if appropriate, tell the patient the blood glucose level
  • Best Approach to Reduce Insulin Errors
    reducing insulin errors with new insulin products is by conducting a:
    A failure mode and effects analysis is a proactive risk assessment process that should be conducted when considering use of new insulin products and drug devices.
    A failure mode and effects analysis will help determine potential problems and risk-reducing and risk-managing strategies prior to use of the agent. It consists of the following procedures.
  • Failure Mode and Effects Consists of the following:
    Review potential use of product from acquisition to administration;
    Review potential problems that could arise due to packaging, administration, etc;
    Determine likelihood of error occurring;
    Determine the consequences of errors;
    Identify error risk-reduction strategies already in place; and
    Develop procedures to reduce patient risk in event of failure mode.
  • Symlin
    Although not an insulin, Symlin® must only be given to patients on insulin therapy. Symlin® is dosed in micrograms and should be drawn up and administered using the available pen or with a U-100 syringe using manufacturer guidelines. Insulin and Symlin® are not compatible in the same syringe. The Symlin® vial will be discontinued in 2011.
  • Education of Insulin to Patients
    • The entire medication profile should be considered when evaluating patient risk for insulin error. Patient education is a vital and necessary strategy to prevent and minimize the risk for insulin errors. Healthcare professionals should take every opportunity to educate patients about this risk and to confirm patient understanding and knowledge. Before discharging patients from the hospital, clinicians should confirm patient understanding of insulin therapy, administration, and dietary considerations. In addition, clinicians should identify caregivers to support the patient in providing insulin therapy as appropriate.
  • Teaching Points
    • Encourage patients to record point-of-care or laboratory-drawn blood glucose values and all insulin doses on flow sheet
    • Educate patients in structured clinical setting with both spoken and written material
    • Encourage patients to discuss purchase of nonprescription insulin with pharmacist
    • Consider patient eyesight when educating about insulin and encourage use of tactile cues when differentiating types of insulin (eg, use of tape on vial of regular insulin)
    • Have patients demonstrate proper technique of insulin administration
    • Confirm patient knowledge about treatment and prevention of hypoglycemia during special circumstances such as illness, travel, and stress
  • Patient Education
    • Confirm patient knowledge about symptoms and treatment of hyper- and hypoglycemia
    • Educate patients about proper storage of insulin and syringes
    • Educate patients about proper disposal of insulin syringes
    • Educate patients about potential for ambiguous labeling and packaging of insulin products
    • Recommend MedicAlert® bracelet or equivalent
    • Have patient maintain an up-to-date medication history
    • Educate patients about the risk of look-alike, sound-alike insulin products
  • Conclusion
    ISMP is a federally certified Patient Safety Organization.
    Analysis of reported errors to ISMP has led to nationwide hazard alerts; error-reducing education; changes in labeling, systems, and individual practice; and development of national safety guidelines, standards, and goals. Reporting is voluntary and confidential and will not lead to disciplinary measures.
  • Conclusion
    Errors associated with insulin are a major problem and may result in serious morbidity or mortality. A systems approach to minimize and reduce insulin error at each point of the drug delivery process is recommended.Safety criteria should be established by institutions, and policies and procedures should be followed
  • Conclusion
    Guidelines are available to assist in the development of institutional policies and procedures. Any patient taking insulin should be monitored closely for any signs of hypo- or hyperglycemia. Healthcare professionals should be educated about the risk for insulin errors and appropriate measures should be used within the institution and healthcare practice to minimize risk. Patients should be educated about insulin error and given tools to minimize this risk
  • Conclusion
    Finally, any errors associated with insulin should be reported both internally and to ISMP (partners with FDA), who will communicate the error directly to the manufacturer to help prevent recurrence and potential patient harm. Diabetes is a complicated disease with many attenuating factors, it is a ever changing environment with new technology that is both challenging to the patient and healthcare professional. It is imperative for patients on insulin and the healthcare providers who administer it to be well verse in the knowledge and administration of insulin.
  • The End
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