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Adherence to standard medication infusion concentrations and its impact on paediatric intensive care patient outcomes
G Model AUCC-382; No. of Pages 5
ARTICLE IN PRESS Australian Critical Care xxx (2017) xxx–xxx
Contents lists available at ScienceDirect
Australian Critical Care journal homepage: www.elsevier.com/locate/aucc
Adherence to standard medication infusion concentrations and its impact on paediatric intensive care patient outcomes Michele L. Cree BPharm BSci Grad Dip Clin Pharm a,b,∗ Christian F. Stocker MD IMHCHICICM AUS b Quyen M. Tu BPharm a,b Loretta F. Scaini MNICUDip (Nurs Ed)Mast (Nurs) Paed Crit Care b a b
Lady Cilento Children’s Hospital, Pharmacy Department, Australia Lady Cilento Children’s Hospital, Paediatric Intensive Care Unit, Australia
article information Article history: Received 25 February 2017 Received in revised form 17 July 2017 Accepted 17 July 2017 Keywords: Standard concentrations Medication infusions Medication safety Dose error reduction software Pediatric intensive care unit Fluid balance
a b s t r a c t Aim: To review compliance with the DERS, and to evaluate the impact on daily fluid balances as a standard outcome in paediatric intensive care. Method: A prospective audit of patients admitted to our tertiary level PICU over a 10 day period. The audit tool collated information on patient’s weight, diagnosis, medication infusions, whether standard concentrations were selected, daily fluid balance, target fluid balance, and renal support including use of diuretics. Results: Seventy-seven (84%) of patients weighed less than 10 kg. On average, there were 7 medication infusions per patient and 98% of the medication infusions adhered to standard concentrations for medication infusions and DERS. In 2% of medication infusions staff opted not to use the DERS, or selected non-standard concentration, and 2% of patients had no labels on the syringe. 90% of patients had a minimal positive balance of 0.5 mL/kg/h, averaged over 24 h; 48% of patients received renal support and 16% of patients were 24 h post cardiac surgery, where a negative fluid balance was recorded. It is standard practice post cardiac surgery to receive diuretics. Standard concentrations did not have a significant impact on patients’ daily fluid balance. Conclusions: The use of standard concentrations and short infusions in PICU using DERS is feasible & achievable as demonstrated by high compliance, and does not have a negative impact on patient outcome, especially fluid balance. Crown Copyright © 2017 Published by Elsevier Ltd on behalf of Australian College of Critical Care Nurses Ltd. All rights reserved.
1. Background Calculations using “rule of six” and the preparation of individualised medication infusions have been a source of medication errors, especially for high-alert medications, in paediatrics.1 The Institute for Safe Medication Practices (ISMP) medication safety alert2 advises to avoid preparing medication infusions using the “rule of six”, and advocates the use of standard concentrations for medications as a medication safety initiative. Standard concentrations for medication infusions are when a medication is prepared
∗ Corresponding author at: Level 2 Pharmacy Department, Lady Cilento Children’s Hospital, 501 Stanley Street, South Brisbane, Queensland 4101, Australia. E-mail address: [email protected] (M.L. Cree).
exactly the same; e.g. morphine 5 mg in 50 mL of 5% glucose, where as an individualised concentration is when morphine 0.5 mg/kg in 50 mL of 5% glucose, the latter uses the “rule of six” principles. Providing standard concentrations for medication infusions improves and assists medication libraries for infusion devices in the paediatric intensive care unit (PICU) and aims to minimise administration errors.3–5 In Canada and the United States, standard concentrations for medication infusions are a requirement for accreditation for the hospital.6,7 The Australian Commission on Safety and Quality in Health Care (ACSQHC)8 have not proposed or adopted this in their national medication standards. However, vigorous application of standard concentrations for continuous medication infusions using dose error reduction software (DERS) for infusion devices improves medication safety and has been standard practice in our PICU since 2008. In November 2014 the DERS
http://dx.doi.org/10.1016/j.aucc.2017.07.003 1036-7314/Crown Copyright © 2017 Published by Elsevier Ltd on behalf of Australian College of Critical Care Nurses Ltd. All rights reserved.
Please cite this article in press as: Cree ML, et al. Adherence to standard medication infusion concentrations and its impact on paediatric intensive care patient outcomes. Aust Crit Care (2017), http://dx.doi.org/10.1016/j.aucc.2017.07.003
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drug library for Lady Cilento Children’s Hospital (LCCH) infusion devices was revised and updated for PICU patients, to include a bedside medication guide and pre-printed medication infusion labels for over 100 standard concentrations for medication infusions, previously this was limited to inotropes, opioids and sedative agents. There are 127 medication profiles that have a standard concentration for medication infusions out of the existing 213 medication profiles in DERS, these include but are not limited to high-risk medications. ACSQHC define high-risk medications as medications that have a low therapeutic index, medications that have high risk when administered the wrong route or when system errors occur.8 Examples of high-risk medication categories listed by ACSQHC are opioids and sedative agents, electrolytes, insulin, chemotherapy, and anti-infectives.8 The 86 medications profiles with no standard concentration are mainly antimicrobials, or short infusion considered less than 15 min, where dose of medication is considered important and this is reflected in DERS. Although there is evidence that standard concentrations for medication infusions improve medication safety in the PICU, this approach has not been universally adopted in the 6 PICUs in Australia and New Zealand. Perceived barriers to adoption of standard concentration for medication infusions in paediatrics has been its impact on fluid balance, however this is not supported in the literature. A positive fluid balance is seen as a major predictor of clinical outcome for patients in and after intensive care. Several studies9,10 found that having positive fluid balance in ICU increased patients’ mortality risk, and this is particularly important for postoperative management of congenital heart disease patients.11 Holliday and Segar12 identified the 4/2/1 rule; (4 mL/kg for the first 10 kg + 2 mL for kg 11–20 kg + 1 mL/kg for every kg above 20 = hourly rate) for maintenance fluid rates for children and this standard has been adopted internationally for hourly and daily requirements in paediatrics. We investigated the use of standard concentrations for medications infusions in our paediatric intensive care and it’s impact on patients’ daily fluid balance as a clinical outcome.
2. Method The LCCH is a paediatric tertiary teaching hospital in Brisbane, Queensland. In 2015, there were 2097 patients admitted to the PICU. Ethics approval was obtained, and a prospective audit of admitted patients was conducted over 10 days between November 2015 and April 2016. All PICU patients could be selected, however patients not receiving intravenous therapy were excluded, and all PICU admissions were selected on the ten days of the audit. The 10 days were selected at random, and data were collected only when the pharmacist and nurse educator were available. A clinical ® information system (CIS, metavision Version5.46) assisted prescribers with selection of standard concentrations for medications that match the DERS, and the PICU pharmacist and clinical nurse educator collected the required data from the same CIS and infusion devices at the patient bedside. The use of a CIS and DERS with standard concentrations for medication infusions has been standard practice in our PICU since 2008. The pharmacist and nurse educator collected adherence to standard concentrations for medication infusions at each patient bedside. Patients’ daily target fluid balance is documented in the CIS during morning ward rounds and each patient’s actual fluid balances is cumulated daily in the CIS. We compared the actual and target fluid balance for each patient. Information collected was the patient’s weight, presenting diagnosis for PICU admission, medication infusions, whether standard concentrations for medication infusions were selected, whether the medication infusion label matched the medication infusion prescribed, the patient’s actual daily fluid balance, the patient’s target fluid balance, whether renal support was indicated and if diuretics
Table 1 Medication Infusions. Medication categories
Medication
Number of infusions
Opioids (77)
Morphine Fentanyl Hydromorphone Methadone Ketamine
55 13 1 2 6
Sedation (81)
Midazolam Dexmedetomidine Propofol Thiopentone
27 45 8 1
Ionotropes (96)
Adrenaline Noradrenaline Dopamine Dobutamine Milrinone
10 25 20 4 37
Paralysing agent (21)
Cisatracuriium Vecuronium
20 1
Cardiovascular (9)
Sodium nitroprusside (SNP) Esmolol Glyceryl trinitrate (GTN) Epoprostenol Alprostadil
2 1 1 1 4
Electrolytes (70)
Potassium Calcium Bicarbonate Sodium chloride 3% Glucose 50%
33 27 3 2 5
Anticoagulants (161)
Heparin Alteplase Defibrotide Hep saline
29 1 1 130
Fluids and PN (77)
Fluids Parental Nutrition (PN) Lipids
48 14 15
Endocrine & metabolic (12) Insulin Arginine Octrotide
10 1 1
Bloods product (8)
Cryoprecipitate Albumin 20% Albumin 4%
2 3 3
Diuretics (22)
Frusemide
22
Other (3)
Naloxone Cyclosporin Tranexamic acid
1 1 1
were required. Note this is standard practice in the post operative period for congenital heart disease patients. This was collected using an in house data collection form. Data analysis compared the target and actual fluid balance for each patient audited. Assessment of compliance with DERS, and whether standard concentrations for medication infusions was selected on the infusion pumps and CIS. A telephone survey of the other dedicated PICUs in Australian & New Zealand was undertaken by the nurse educator to assess if; other sites currently use DERS for their infusion devices, if DERS compliance was regularly reviewed, whether standard concentration medication infusions were used, if yes for which medications, and whether they would like to expand standard concentrations for their medication infusions. 3. Results Ninety-two patients were audited over the 10 days between November 2015 and April 2016, when the PICU pharmacist and nurse educator were available. Majority of the patients 77 (84%)
Please cite this article in press as: Cree ML, et al. Adherence to standard medication infusion concentrations and its impact on paediatric intensive care patient outcomes. Aust Crit Care (2017), http://dx.doi.org/10.1016/j.aucc.2017.07.003
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Table 2 The standard medication infusions. Medication
Standard concentration
Medication
Standard concentration
Adrenaline Adrenaline adolescent alPROStadil aLTEplase aminoCAProic Acid amINOPHYLLine amIODAROne CVL
1 mg/50 mL 8 mg/50 mL 100 g/50 mL 50 mg/50 mL 1000 mg/50 mL 250 mg/50 mL 300 mg/50 mL
anIODAROne PIV Arginine Art Hep Saline aTROpine Calcium CHLORIDE Calcium GLUCONate
100 mg/50 mL 5000 mg/50 mL 100 unit/50 mL 6 mg/20 mL 6.8 mmol/10 mL 2.2 mmol/20 mL
LIGnocaine LIGnocaine adolescent Liothyronine T3 LORazepam Magnesium sulphate Metabolic insulin meTAraminol meTAraminol adolescent Methadone MeTHYLprednisolone metoPROLol MIDazolam MIDazolam STRONG Milrinone
Chronic epoprostenol CISatracurium CISatracurium adolescent cloNIDine Danaparoid desFERRioxamine
500 g/50 mL 50 mg/50 mL 100 mg/50 mL 300 g/50 mL 750 unit/50 mL 2000 mg/50 mL
Morphine Morphine STRONG
200 mg/50 mL 500 mg/50 mL 20 g/50 mL 4 mg/50 mL 25 mmol/50 mL 100 unit/50 mL 2 mg/50 mL 20 mg/50 mL 100 mg/50 mL 100 mg/50 mL 20 mg/50 mL 10 mg/50 mL 50 mg/50 mL 10 mg/50 mL PIV 25 mg/50 mL CVL 5 mg/50 mL 30 mg/50 mL
dexMEDETomidine DOBUTamine DOBUTamine adolescent DOPamine DOPamine adolescent Epoprostenol
200 g/50 mL 75 mg/50 mL 250 mg/50 mL 60 mg/50 mL 200 mg/50 mL 500 g/50 mL & 150 g/50 mL 500 mg/50 mL 500 g/50 mL 1000 g/50 mL 50 mg/50 mL 150 mg/50 mL 500 g/20 mL 100 mg/50 mL 250 mg/50 mL 50 unit/50 mL 1 mg/50 mL 25 g/50 mL 50 mg/50 mL 5000 units/50 mL & 25,000 units/50 mL 10 mg/50 mL 50 mg/50 mL 10 mg/50 mL 25 mmol/50 mL 1 mg/50 mL 3 mg/50 mL 200 mg/50 mL 100 mg/20 mL 100 units/50 mL 100 mg/50 mL 1000 mg/50 mL 2.5 mg/50 mL
Naloxone niMODIPine NORadrenaline NORadrenaline adolescent ocTREOtide Omeprazole
200 g/50 mL 10 mg/50 mL 1 mg/50 mL 8 mg/50 mL 500 g/10 mL 20 mg/50 mL
PA Hep Saline
100 unit/50 mL
phenTOLamine
100 mg/50 mL
phenylEPHRINE Potassium chloride Pralidoxime proCAINamide
10 mg/50 mL 20 mmol/20 mL 1000 mg/40 mL 200 mg/50 mL
propOFol OT propOFol PICU
500 mg/50 mL 200 mg/50 mL
remiFentanil salBUTamol SMOF Sodium BENZoate Sodium BICARBonate
2 mg/50 mL 50 mg/50 mL 20gram/100 mL 2500 mg/50 mL 25 mmol/50 mL CVL 5 mmol/50 mL PIV 10 mg/50 mL 200 mg/50 mL 60 mg/50 mL 500 mg/50 mL 25 mg/50 mL 10 g/50 mL 1000 mg/50 mL 10 unit/50 mL 20 unit/50 mL 50 mg/50 mL 100 unit/50 mL 50 mg/50 mL
eSMOlol fentaNYL Fentanyl > 45 kg Flecainide Flecainide adolescent fluMAZenil Frusemide Frusmide adolescent GI vasopressin glucAGON Glucose 50% Glyceryl trinitrate Heparin hydrALAZINe hydroCORTisone hydroMORPHone Hypertonic saline 3% Isoprenaline Isopreanline > 10 kg Ketamine Labetalol LA Hep Saline Lepirudin levoCARNitine levoSIMendan
were infants who weighed under 10 kg. Patients’ presenting issues were; 68 (74%) congenital heart disease, 10 (11%) oncology, 10 (11%) infective (sepsis), 2 (2%) respiratory, 1 (1%) metabolic and 1 (1%) orthopaedic. There were 637 medication infusions audited, the range was 2–14 medication infusions per patient with an average of 7 medication infusions per patient. Twelve (2%) medication infusions had the syringe label obscured, so we could not confirm the medication infusion in the syringe. One of 637 medication infusions was detected as the wrong medication concentration infusion, where the syringe was labelled as milrinone 25 mg in 50 mL, whilst prescribed 10 mg in 50 mL, this was immediately addressed and a new syringe was prepared and replaced as prescribed. The majority of medication infusions audited were considered high-risk medications, and having a standard concentration approach for these medications should minimise medication inci-
Sodium nitrPRUSSide Sodium valproate Status MIDazolam thioPENTone Thymoglobulin TOX lipid 20% Tranexamic acid Vasopressin Vasopressin > 20 kg VECuronium Venous Hep Saline Verapamil
dents with preparation and administration. Table 1, displays the breakdown of the medication infusions into the following categories: opioids 12%, sedation 13%, inotropes 15%, paralysing agents 3%, cardiovascular 2%, electrolytes 11%, anticoagulants 25%, fluids and parenteral nutrition 12%, endocrine and metabolic 2%, blood products 1.5%, diuretics 3% and other 0.5%. In our DERS drug library, there are 127 medication profiles that have two standard concentrations for medication infusions, one preferred standard concentration, and the other an option for adolescent patients. Table 2 displays the standard concentrations for medication infusions used in the PICU at LCCH. There is an individualised concentration option available if concerned about fluid overload, but this is not the preference in our PICU. Our audit found 98% of the medication infusions audited adhered to standard concentrations for medication infusions in the DERS
Please cite this article in press as: Cree ML, et al. Adherence to standard medication infusion concentrations and its impact on paediatric intensive care patient outcomes. Aust Crit Care (2017), http://dx.doi.org/10.1016/j.aucc.2017.07.003
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for the infusion devices. In the 2% of non-adherence, 1.7% was for parenteral nutrition where currently no medication profile exists, as consensus could not be achieved prior to DERS implementation in 2014. For 0.1% there was no option for standard concentration for immunosuppressant medication infusions and 0.2% were metabolic medications infusions where we are developing standard concentration for medication infusions to improve medication related incidents associated with medications thoughout Queensland. Parenteral nutrition and standard concentrations for metabolic medication infusions will be incorporated in the updated version of DERS in 2017. In the cohort 48% (43) received enteral frusemide and spironolactone, or a continuous infusion of frusemide. There were 38 of 43 (88%) patients who received diuretics (these were postoperative patients for congenital heart disease where frusemide is indicated to assist the pre load pressure on the heart following heart surgery). The target fluid balance post heart surgery is usually negative to avoid effusions in the post-operative phase. Only 2 of 43 (5%) patients on diuretics had acute kidney injury associated with infective cause e.g. sepsis and 3 of 43 (7%) had a pre-existing renal disease. Of the patients requiring renal replacement therapy 4% (4) were oncology patients who presented with fluid overload due to hyper-hydration following chemotherapy on the ward as presenting compliant for PICU. Additionally 3% (3) of the cohort required extra-corporal life support primarily for sepsis and/or post surgery for complex congenital heart disease where oxygenation could not be adequately achieved with standard ventilation. Standard concentrations for medication infusions did not have an impact on care for the renal and extra-corporal life support patients. The actual daily fluid balance of the patient was compared with the target fluid balance to help evaluate the clinical impact of fluid balance on standard concentrations for medication infusions in the PICU. The patients’ average daily fluid balance was positive at 0.5 mL/kg/h, where 90% recorded this. There were several patients who received a fluid bolus during the 24 h audit period for a hypotensive crisis, however the preceding 24 h the same patients remained in a neutral fluid balance. 84% of patients audited were less than 10 kg and their overall actual daily fluid balance was positive at 1.3 mL/kg/h. This includes continuous nasogastric nutrition and in these infants the target fluid balance required adjustments to assist with growth. A negative fluid balance was achieved in 16% (14) of patients following cardiac surgery and is recommended in the first 24 h. Target fluid balances are usually under 4 mL/kg/h, for the under 10 kg patients, who are predominantly congenital heart disease patients in our cohort. The medication related incidents that occurred at the time of the audit were associated with not utilising the standard concentrations for medication infusions approach in PICU, e.g. the milrinone medication order and medication profile in the pump was 10 mg in 50 mL, but the syringe label was 25 mg in 50 mL. All six PICUs in Australia and New Zealand were surveyed and 100% sites had adopted DERS for infusion devices, 100% reported that evaluation of compliance of DERS was labour intensive and challenging with a limited reporting capabilities at each site due to limited staff resources. Our site acknowledges the challenges involved with auditing compliance and staff resources required for this to occur. Adoption of standard concentrations for medication infusions had occurred with a limited group of focused medications: inotropes, opioids and sedatives, at the other five sites. Only our centre had expanded standard concentrations for medication infusions in their DERS to 127 of the 213 medication infusions. Feedback from the five sites that they were eager to obtain our standard concentrations for medication infusions, to see if they could be adopted at their site(s).
4. Discussion The safety benefits to hospitals using the standard concentrations for medications infusions will reduce medication error risk.1,3,5 Our unit has a safety focus and actively promotes the use of standard concentrations for medication infusions to assist with improvement of patient safety and this has led to no accidental or intentional non-adherences at the time of the audit demonstrated by the 98% adherence to standard concentrations for medication infusions. Although this was not extensively reviewed it is noted that the recorded medication incidents over the audit period were not attributed to selection of standard concentrations for medication infusions. The one medication incident around milrinone was a result of selection of the incorrect line label, non-adherence to hospital policy of double-checking syringe label, and did not result in any harm to the patient. As the referral centre for Queensland it is important that we highlight and assist with development of standard concentrations for medication infusions, to improve medication safety, for critically ill paediatric patients. The more sites that adopt standard concentrations for medication infusions will provide the necessary impetus for manufacturers to offer commercially prepared standard concentrations for medications, thus reducing the risk of compounding errors, with preparation especially in the PICU. Certainly the latter is something we hope the future will offer for paediatric sites in Australia. Lack of adoption of standard concentrations for medication infusions at other PICUs, could be attributed to concerns relating to risk of fluid overload in paediatric patients, however our study shows that standard concentrations for medication infusions has not had significant impact on the daily fluid balance, where 90% had a slightly positive daily fluid balance of 0.5 mL/kg/h. It is important when developing standard concentrations for medication infusions that it suits the PICU patients to ensure that the risk of fluid overload is minimal, whilst improving medication safety. The use of standard concentrations for medication infusions reduces the potential for preparation errors, and translates to fewer opportunities to make medication errors.5 Our study showed that standard concentrations for medication infusions appears to not have a significant effect on actual daily fluid balance, as the majority of patients had mild positive fluid balance. Having adolescent and paediatric standard concentrations for medication infusions allows us to manage infusion rates, and ensures that fluid overload is not experienced in the infant and adolescent PICU group. Having a daily target fluid balance enables the bedside nurse to manage fluid volume whilst using the standard concentrations for medication infusions; only 2 of 92 patients required the bedside nurse to concentrate the medication infusions to ensure the target fluid balance was not exceeded. 38 (88%) patients of the cardiac cohort received diuretics, which is standard clinical care, to assist with pre load pressures on the heart for this patient group. The actual fluid balance for patients audited remained mildly positive and it appears that the use of standard concentrations for medication infusions did not significantly impact on patients’ target fluid balance as a clinical indicator. Positive fluid balances have been seen as a clinical outcome of PICU patients, putting them at risk of complications such as effusions. In the group audited no patient experienced an effusion associated with mild positive fluid balance recorded. ISMP supports dose error reduction software technology with standard concentrations for medication infusions as a medication safety initiative to minimise medication errors. In this audit, compliance with DERS and standard concentrations for medication infusions in the PICU was 98%. Developing a medication profile for parenteral nutrition and standardising an approach to managing metabolic paediatric patients will improve compliance with DERS and should improve medication safety with these medication infusions.
Please cite this article in press as: Cree ML, et al. Adherence to standard medication infusion concentrations and its impact on paediatric intensive care patient outcomes. Aust Crit Care (2017), http://dx.doi.org/10.1016/j.aucc.2017.07.003
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5. Conclusion It is feasible to use standard medication concentrations in the paediatric intensive care, with 90% of patients having 0.5 mL/kg/h as the average daily fluid balance. Although 48% of the cohort received diuretics, this group were primarily post-operative congenital cardiac patients, where the use of diuretics is standard management of care. Incorporating daily patient goals for fluid balance, ventilation and vital signs has been adopted as standard practice in February 2017 and future audits are anticipated. Limiting standard concentrations for medication infusions for adolescent and paediatric patients has allowed us to successfully adopt DERS and standard concentrations for medication infusions. Further expansion of the DERS will assist with future compliance. Acknowledgment No financial support was used in the study including institutional department funds.
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2. Preparing infusions using the rule of 6 or Broselow tape. ISMP Medicat Saf Alert 2005;10(4). 3. Christie-Taylor S, Tait P. Implementation of standard concentration medication infusions for preterm infants. Infant 2012;8(5):155–9. 4. Irwin D, Vallancourt R, Dalgleish D, et al. Standard concentrations of high-alert drug infusions across acute care. Paediatr Child Health 2008;13(5):371–6. 5. Borthwick M, Keeling S, Keeling P, et al. Toward standardisation of drug infusion concentrations in UK critical care units. JICS 2009;10(3):2–4. 6. A National Collaborative: Advancing Medication Safety in Paediatrics. Institute for Safe Medication Practices Canada ISMP. 7. Standard Concentrations of neonatal drug infusions. Institute for Safe Medication Practices and Vermont Oxford Network. ismp.org. 8. Australian Commission of Safety and Quality in Healthcare. https://www. safetyandquality.gov.au/our-work/medication-safety/medication-alerts/. 9. Brotfain E, Kopyfman L, Toledano R, et al. Positive fluid balance as a major predictor of clinical outcome of patients with sepsis/septic shock after ICU discharge. Am J Emerg Med 2016;34(11):2122–6. 10. Acheampong A, Vincent JL. A positive fluid balance is an independent prognostic factor in patients with sepsis. Crit Care 2015;19:251. 11. Hazie MA, Gajaeski RJ, Yu S, et al. Fluid overload in infants following congenital heart surgery. Pediatr Crit Care Med 2013;14(1):44–9. 12. Kudsioglu T, Coskun F, Yapici N. Perioperative and postoperative fluid management in pediatric cardiac surgery. J Anesth Crit Care 2016;4(5):00155.
References 1. Larsen G, Parker H, Cash J, et al. Standard drug concentrations and smartpump technology reduce continuous-medication-infusion errors in paediatric patients. Pediatrics 2005;116(1):e21–5.
Please cite this article in press as: Cree ML, et al. Adherence to standard medication infusion concentrations and its impact on paediatric intensive care patient outcomes. Aust Crit Care (2017), http://dx.doi.org/10.1016/j.aucc.2017.07.003
ARTICLE IN PRESS Australian Critical Care xxx (2017) xxx–xxx
Contents lists available at ScienceDirect
Australian Critical Care journal homepage: www.elsevier.com/locate/aucc
Adherence to standard medication infusion concentrations and its impact on paediatric intensive care patient outcomes Michele L. Cree BPharm BSci Grad Dip Clin Pharm a,b,∗ Christian F. Stocker MD IMHCHICICM AUS b Quyen M. Tu BPharm a,b Loretta F. Scaini MNICUDip (Nurs Ed)Mast (Nurs) Paed Crit Care b a b
Lady Cilento Children’s Hospital, Pharmacy Department, Australia Lady Cilento Children’s Hospital, Paediatric Intensive Care Unit, Australia
article information Article history: Received 25 February 2017 Received in revised form 17 July 2017 Accepted 17 July 2017 Keywords: Standard concentrations Medication infusions Medication safety Dose error reduction software Pediatric intensive care unit Fluid balance
a b s t r a c t Aim: To review compliance with the DERS, and to evaluate the impact on daily fluid balances as a standard outcome in paediatric intensive care. Method: A prospective audit of patients admitted to our tertiary level PICU over a 10 day period. The audit tool collated information on patient’s weight, diagnosis, medication infusions, whether standard concentrations were selected, daily fluid balance, target fluid balance, and renal support including use of diuretics. Results: Seventy-seven (84%) of patients weighed less than 10 kg. On average, there were 7 medication infusions per patient and 98% of the medication infusions adhered to standard concentrations for medication infusions and DERS. In 2% of medication infusions staff opted not to use the DERS, or selected non-standard concentration, and 2% of patients had no labels on the syringe. 90% of patients had a minimal positive balance of 0.5 mL/kg/h, averaged over 24 h; 48% of patients received renal support and 16% of patients were 24 h post cardiac surgery, where a negative fluid balance was recorded. It is standard practice post cardiac surgery to receive diuretics. Standard concentrations did not have a significant impact on patients’ daily fluid balance. Conclusions: The use of standard concentrations and short infusions in PICU using DERS is feasible & achievable as demonstrated by high compliance, and does not have a negative impact on patient outcome, especially fluid balance. Crown Copyright © 2017 Published by Elsevier Ltd on behalf of Australian College of Critical Care Nurses Ltd. All rights reserved.
1. Background Calculations using “rule of six” and the preparation of individualised medication infusions have been a source of medication errors, especially for high-alert medications, in paediatrics.1 The Institute for Safe Medication Practices (ISMP) medication safety alert2 advises to avoid preparing medication infusions using the “rule of six”, and advocates the use of standard concentrations for medications as a medication safety initiative. Standard concentrations for medication infusions are when a medication is prepared
∗ Corresponding author at: Level 2 Pharmacy Department, Lady Cilento Children’s Hospital, 501 Stanley Street, South Brisbane, Queensland 4101, Australia. E-mail address: [email protected] (M.L. Cree).
exactly the same; e.g. morphine 5 mg in 50 mL of 5% glucose, where as an individualised concentration is when morphine 0.5 mg/kg in 50 mL of 5% glucose, the latter uses the “rule of six” principles. Providing standard concentrations for medication infusions improves and assists medication libraries for infusion devices in the paediatric intensive care unit (PICU) and aims to minimise administration errors.3–5 In Canada and the United States, standard concentrations for medication infusions are a requirement for accreditation for the hospital.6,7 The Australian Commission on Safety and Quality in Health Care (ACSQHC)8 have not proposed or adopted this in their national medication standards. However, vigorous application of standard concentrations for continuous medication infusions using dose error reduction software (DERS) for infusion devices improves medication safety and has been standard practice in our PICU since 2008. In November 2014 the DERS
http://dx.doi.org/10.1016/j.aucc.2017.07.003 1036-7314/Crown Copyright © 2017 Published by Elsevier Ltd on behalf of Australian College of Critical Care Nurses Ltd. All rights reserved.
Please cite this article in press as: Cree ML, et al. Adherence to standard medication infusion concentrations and its impact on paediatric intensive care patient outcomes. Aust Crit Care (2017), http://dx.doi.org/10.1016/j.aucc.2017.07.003
G Model AUCC-382; No. of Pages 5
ARTICLE IN PRESS M.L. Cree et al. / Australian Critical Care xxx (2017) xxx–xxx
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drug library for Lady Cilento Children’s Hospital (LCCH) infusion devices was revised and updated for PICU patients, to include a bedside medication guide and pre-printed medication infusion labels for over 100 standard concentrations for medication infusions, previously this was limited to inotropes, opioids and sedative agents. There are 127 medication profiles that have a standard concentration for medication infusions out of the existing 213 medication profiles in DERS, these include but are not limited to high-risk medications. ACSQHC define high-risk medications as medications that have a low therapeutic index, medications that have high risk when administered the wrong route or when system errors occur.8 Examples of high-risk medication categories listed by ACSQHC are opioids and sedative agents, electrolytes, insulin, chemotherapy, and anti-infectives.8 The 86 medications profiles with no standard concentration are mainly antimicrobials, or short infusion considered less than 15 min, where dose of medication is considered important and this is reflected in DERS. Although there is evidence that standard concentrations for medication infusions improve medication safety in the PICU, this approach has not been universally adopted in the 6 PICUs in Australia and New Zealand. Perceived barriers to adoption of standard concentration for medication infusions in paediatrics has been its impact on fluid balance, however this is not supported in the literature. A positive fluid balance is seen as a major predictor of clinical outcome for patients in and after intensive care. Several studies9,10 found that having positive fluid balance in ICU increased patients’ mortality risk, and this is particularly important for postoperative management of congenital heart disease patients.11 Holliday and Segar12 identified the 4/2/1 rule; (4 mL/kg for the first 10 kg + 2 mL for kg 11–20 kg + 1 mL/kg for every kg above 20 = hourly rate) for maintenance fluid rates for children and this standard has been adopted internationally for hourly and daily requirements in paediatrics. We investigated the use of standard concentrations for medications infusions in our paediatric intensive care and it’s impact on patients’ daily fluid balance as a clinical outcome.
2. Method The LCCH is a paediatric tertiary teaching hospital in Brisbane, Queensland. In 2015, there were 2097 patients admitted to the PICU. Ethics approval was obtained, and a prospective audit of admitted patients was conducted over 10 days between November 2015 and April 2016. All PICU patients could be selected, however patients not receiving intravenous therapy were excluded, and all PICU admissions were selected on the ten days of the audit. The 10 days were selected at random, and data were collected only when the pharmacist and nurse educator were available. A clinical ® information system (CIS, metavision Version5.46) assisted prescribers with selection of standard concentrations for medications that match the DERS, and the PICU pharmacist and clinical nurse educator collected the required data from the same CIS and infusion devices at the patient bedside. The use of a CIS and DERS with standard concentrations for medication infusions has been standard practice in our PICU since 2008. The pharmacist and nurse educator collected adherence to standard concentrations for medication infusions at each patient bedside. Patients’ daily target fluid balance is documented in the CIS during morning ward rounds and each patient’s actual fluid balances is cumulated daily in the CIS. We compared the actual and target fluid balance for each patient. Information collected was the patient’s weight, presenting diagnosis for PICU admission, medication infusions, whether standard concentrations for medication infusions were selected, whether the medication infusion label matched the medication infusion prescribed, the patient’s actual daily fluid balance, the patient’s target fluid balance, whether renal support was indicated and if diuretics
Table 1 Medication Infusions. Medication categories
Medication
Number of infusions
Opioids (77)
Morphine Fentanyl Hydromorphone Methadone Ketamine
55 13 1 2 6
Sedation (81)
Midazolam Dexmedetomidine Propofol Thiopentone
27 45 8 1
Ionotropes (96)
Adrenaline Noradrenaline Dopamine Dobutamine Milrinone
10 25 20 4 37
Paralysing agent (21)
Cisatracuriium Vecuronium
20 1
Cardiovascular (9)
Sodium nitroprusside (SNP) Esmolol Glyceryl trinitrate (GTN) Epoprostenol Alprostadil
2 1 1 1 4
Electrolytes (70)
Potassium Calcium Bicarbonate Sodium chloride 3% Glucose 50%
33 27 3 2 5
Anticoagulants (161)
Heparin Alteplase Defibrotide Hep saline
29 1 1 130
Fluids and PN (77)
Fluids Parental Nutrition (PN) Lipids
48 14 15
Endocrine & metabolic (12) Insulin Arginine Octrotide
10 1 1
Bloods product (8)
Cryoprecipitate Albumin 20% Albumin 4%
2 3 3
Diuretics (22)
Frusemide
22
Other (3)
Naloxone Cyclosporin Tranexamic acid
1 1 1
were required. Note this is standard practice in the post operative period for congenital heart disease patients. This was collected using an in house data collection form. Data analysis compared the target and actual fluid balance for each patient audited. Assessment of compliance with DERS, and whether standard concentrations for medication infusions was selected on the infusion pumps and CIS. A telephone survey of the other dedicated PICUs in Australian & New Zealand was undertaken by the nurse educator to assess if; other sites currently use DERS for their infusion devices, if DERS compliance was regularly reviewed, whether standard concentration medication infusions were used, if yes for which medications, and whether they would like to expand standard concentrations for their medication infusions. 3. Results Ninety-two patients were audited over the 10 days between November 2015 and April 2016, when the PICU pharmacist and nurse educator were available. Majority of the patients 77 (84%)
Please cite this article in press as: Cree ML, et al. Adherence to standard medication infusion concentrations and its impact on paediatric intensive care patient outcomes. Aust Crit Care (2017), http://dx.doi.org/10.1016/j.aucc.2017.07.003
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Table 2 The standard medication infusions. Medication
Standard concentration
Medication
Standard concentration
Adrenaline Adrenaline adolescent alPROStadil aLTEplase aminoCAProic Acid amINOPHYLLine amIODAROne CVL
1 mg/50 mL 8 mg/50 mL 100 g/50 mL 50 mg/50 mL 1000 mg/50 mL 250 mg/50 mL 300 mg/50 mL
anIODAROne PIV Arginine Art Hep Saline aTROpine Calcium CHLORIDE Calcium GLUCONate
100 mg/50 mL 5000 mg/50 mL 100 unit/50 mL 6 mg/20 mL 6.8 mmol/10 mL 2.2 mmol/20 mL
LIGnocaine LIGnocaine adolescent Liothyronine T3 LORazepam Magnesium sulphate Metabolic insulin meTAraminol meTAraminol adolescent Methadone MeTHYLprednisolone metoPROLol MIDazolam MIDazolam STRONG Milrinone
Chronic epoprostenol CISatracurium CISatracurium adolescent cloNIDine Danaparoid desFERRioxamine
500 g/50 mL 50 mg/50 mL 100 mg/50 mL 300 g/50 mL 750 unit/50 mL 2000 mg/50 mL
Morphine Morphine STRONG
200 mg/50 mL 500 mg/50 mL 20 g/50 mL 4 mg/50 mL 25 mmol/50 mL 100 unit/50 mL 2 mg/50 mL 20 mg/50 mL 100 mg/50 mL 100 mg/50 mL 20 mg/50 mL 10 mg/50 mL 50 mg/50 mL 10 mg/50 mL PIV 25 mg/50 mL CVL 5 mg/50 mL 30 mg/50 mL
dexMEDETomidine DOBUTamine DOBUTamine adolescent DOPamine DOPamine adolescent Epoprostenol
200 g/50 mL 75 mg/50 mL 250 mg/50 mL 60 mg/50 mL 200 mg/50 mL 500 g/50 mL & 150 g/50 mL 500 mg/50 mL 500 g/50 mL 1000 g/50 mL 50 mg/50 mL 150 mg/50 mL 500 g/20 mL 100 mg/50 mL 250 mg/50 mL 50 unit/50 mL 1 mg/50 mL 25 g/50 mL 50 mg/50 mL 5000 units/50 mL & 25,000 units/50 mL 10 mg/50 mL 50 mg/50 mL 10 mg/50 mL 25 mmol/50 mL 1 mg/50 mL 3 mg/50 mL 200 mg/50 mL 100 mg/20 mL 100 units/50 mL 100 mg/50 mL 1000 mg/50 mL 2.5 mg/50 mL
Naloxone niMODIPine NORadrenaline NORadrenaline adolescent ocTREOtide Omeprazole
200 g/50 mL 10 mg/50 mL 1 mg/50 mL 8 mg/50 mL 500 g/10 mL 20 mg/50 mL
PA Hep Saline
100 unit/50 mL
phenTOLamine
100 mg/50 mL
phenylEPHRINE Potassium chloride Pralidoxime proCAINamide
10 mg/50 mL 20 mmol/20 mL 1000 mg/40 mL 200 mg/50 mL
propOFol OT propOFol PICU
500 mg/50 mL 200 mg/50 mL
remiFentanil salBUTamol SMOF Sodium BENZoate Sodium BICARBonate
2 mg/50 mL 50 mg/50 mL 20gram/100 mL 2500 mg/50 mL 25 mmol/50 mL CVL 5 mmol/50 mL PIV 10 mg/50 mL 200 mg/50 mL 60 mg/50 mL 500 mg/50 mL 25 mg/50 mL 10 g/50 mL 1000 mg/50 mL 10 unit/50 mL 20 unit/50 mL 50 mg/50 mL 100 unit/50 mL 50 mg/50 mL
eSMOlol fentaNYL Fentanyl > 45 kg Flecainide Flecainide adolescent fluMAZenil Frusemide Frusmide adolescent GI vasopressin glucAGON Glucose 50% Glyceryl trinitrate Heparin hydrALAZINe hydroCORTisone hydroMORPHone Hypertonic saline 3% Isoprenaline Isopreanline > 10 kg Ketamine Labetalol LA Hep Saline Lepirudin levoCARNitine levoSIMendan
were infants who weighed under 10 kg. Patients’ presenting issues were; 68 (74%) congenital heart disease, 10 (11%) oncology, 10 (11%) infective (sepsis), 2 (2%) respiratory, 1 (1%) metabolic and 1 (1%) orthopaedic. There were 637 medication infusions audited, the range was 2–14 medication infusions per patient with an average of 7 medication infusions per patient. Twelve (2%) medication infusions had the syringe label obscured, so we could not confirm the medication infusion in the syringe. One of 637 medication infusions was detected as the wrong medication concentration infusion, where the syringe was labelled as milrinone 25 mg in 50 mL, whilst prescribed 10 mg in 50 mL, this was immediately addressed and a new syringe was prepared and replaced as prescribed. The majority of medication infusions audited were considered high-risk medications, and having a standard concentration approach for these medications should minimise medication inci-
Sodium nitrPRUSSide Sodium valproate Status MIDazolam thioPENTone Thymoglobulin TOX lipid 20% Tranexamic acid Vasopressin Vasopressin > 20 kg VECuronium Venous Hep Saline Verapamil
dents with preparation and administration. Table 1, displays the breakdown of the medication infusions into the following categories: opioids 12%, sedation 13%, inotropes 15%, paralysing agents 3%, cardiovascular 2%, electrolytes 11%, anticoagulants 25%, fluids and parenteral nutrition 12%, endocrine and metabolic 2%, blood products 1.5%, diuretics 3% and other 0.5%. In our DERS drug library, there are 127 medication profiles that have two standard concentrations for medication infusions, one preferred standard concentration, and the other an option for adolescent patients. Table 2 displays the standard concentrations for medication infusions used in the PICU at LCCH. There is an individualised concentration option available if concerned about fluid overload, but this is not the preference in our PICU. Our audit found 98% of the medication infusions audited adhered to standard concentrations for medication infusions in the DERS
Please cite this article in press as: Cree ML, et al. Adherence to standard medication infusion concentrations and its impact on paediatric intensive care patient outcomes. Aust Crit Care (2017), http://dx.doi.org/10.1016/j.aucc.2017.07.003
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for the infusion devices. In the 2% of non-adherence, 1.7% was for parenteral nutrition where currently no medication profile exists, as consensus could not be achieved prior to DERS implementation in 2014. For 0.1% there was no option for standard concentration for immunosuppressant medication infusions and 0.2% were metabolic medications infusions where we are developing standard concentration for medication infusions to improve medication related incidents associated with medications thoughout Queensland. Parenteral nutrition and standard concentrations for metabolic medication infusions will be incorporated in the updated version of DERS in 2017. In the cohort 48% (43) received enteral frusemide and spironolactone, or a continuous infusion of frusemide. There were 38 of 43 (88%) patients who received diuretics (these were postoperative patients for congenital heart disease where frusemide is indicated to assist the pre load pressure on the heart following heart surgery). The target fluid balance post heart surgery is usually negative to avoid effusions in the post-operative phase. Only 2 of 43 (5%) patients on diuretics had acute kidney injury associated with infective cause e.g. sepsis and 3 of 43 (7%) had a pre-existing renal disease. Of the patients requiring renal replacement therapy 4% (4) were oncology patients who presented with fluid overload due to hyper-hydration following chemotherapy on the ward as presenting compliant for PICU. Additionally 3% (3) of the cohort required extra-corporal life support primarily for sepsis and/or post surgery for complex congenital heart disease where oxygenation could not be adequately achieved with standard ventilation. Standard concentrations for medication infusions did not have an impact on care for the renal and extra-corporal life support patients. The actual daily fluid balance of the patient was compared with the target fluid balance to help evaluate the clinical impact of fluid balance on standard concentrations for medication infusions in the PICU. The patients’ average daily fluid balance was positive at 0.5 mL/kg/h, where 90% recorded this. There were several patients who received a fluid bolus during the 24 h audit period for a hypotensive crisis, however the preceding 24 h the same patients remained in a neutral fluid balance. 84% of patients audited were less than 10 kg and their overall actual daily fluid balance was positive at 1.3 mL/kg/h. This includes continuous nasogastric nutrition and in these infants the target fluid balance required adjustments to assist with growth. A negative fluid balance was achieved in 16% (14) of patients following cardiac surgery and is recommended in the first 24 h. Target fluid balances are usually under 4 mL/kg/h, for the under 10 kg patients, who are predominantly congenital heart disease patients in our cohort. The medication related incidents that occurred at the time of the audit were associated with not utilising the standard concentrations for medication infusions approach in PICU, e.g. the milrinone medication order and medication profile in the pump was 10 mg in 50 mL, but the syringe label was 25 mg in 50 mL. All six PICUs in Australia and New Zealand were surveyed and 100% sites had adopted DERS for infusion devices, 100% reported that evaluation of compliance of DERS was labour intensive and challenging with a limited reporting capabilities at each site due to limited staff resources. Our site acknowledges the challenges involved with auditing compliance and staff resources required for this to occur. Adoption of standard concentrations for medication infusions had occurred with a limited group of focused medications: inotropes, opioids and sedatives, at the other five sites. Only our centre had expanded standard concentrations for medication infusions in their DERS to 127 of the 213 medication infusions. Feedback from the five sites that they were eager to obtain our standard concentrations for medication infusions, to see if they could be adopted at their site(s).
4. Discussion The safety benefits to hospitals using the standard concentrations for medications infusions will reduce medication error risk.1,3,5 Our unit has a safety focus and actively promotes the use of standard concentrations for medication infusions to assist with improvement of patient safety and this has led to no accidental or intentional non-adherences at the time of the audit demonstrated by the 98% adherence to standard concentrations for medication infusions. Although this was not extensively reviewed it is noted that the recorded medication incidents over the audit period were not attributed to selection of standard concentrations for medication infusions. The one medication incident around milrinone was a result of selection of the incorrect line label, non-adherence to hospital policy of double-checking syringe label, and did not result in any harm to the patient. As the referral centre for Queensland it is important that we highlight and assist with development of standard concentrations for medication infusions, to improve medication safety, for critically ill paediatric patients. The more sites that adopt standard concentrations for medication infusions will provide the necessary impetus for manufacturers to offer commercially prepared standard concentrations for medications, thus reducing the risk of compounding errors, with preparation especially in the PICU. Certainly the latter is something we hope the future will offer for paediatric sites in Australia. Lack of adoption of standard concentrations for medication infusions at other PICUs, could be attributed to concerns relating to risk of fluid overload in paediatric patients, however our study shows that standard concentrations for medication infusions has not had significant impact on the daily fluid balance, where 90% had a slightly positive daily fluid balance of 0.5 mL/kg/h. It is important when developing standard concentrations for medication infusions that it suits the PICU patients to ensure that the risk of fluid overload is minimal, whilst improving medication safety. The use of standard concentrations for medication infusions reduces the potential for preparation errors, and translates to fewer opportunities to make medication errors.5 Our study showed that standard concentrations for medication infusions appears to not have a significant effect on actual daily fluid balance, as the majority of patients had mild positive fluid balance. Having adolescent and paediatric standard concentrations for medication infusions allows us to manage infusion rates, and ensures that fluid overload is not experienced in the infant and adolescent PICU group. Having a daily target fluid balance enables the bedside nurse to manage fluid volume whilst using the standard concentrations for medication infusions; only 2 of 92 patients required the bedside nurse to concentrate the medication infusions to ensure the target fluid balance was not exceeded. 38 (88%) patients of the cardiac cohort received diuretics, which is standard clinical care, to assist with pre load pressures on the heart for this patient group. The actual fluid balance for patients audited remained mildly positive and it appears that the use of standard concentrations for medication infusions did not significantly impact on patients’ target fluid balance as a clinical indicator. Positive fluid balances have been seen as a clinical outcome of PICU patients, putting them at risk of complications such as effusions. In the group audited no patient experienced an effusion associated with mild positive fluid balance recorded. ISMP supports dose error reduction software technology with standard concentrations for medication infusions as a medication safety initiative to minimise medication errors. In this audit, compliance with DERS and standard concentrations for medication infusions in the PICU was 98%. Developing a medication profile for parenteral nutrition and standardising an approach to managing metabolic paediatric patients will improve compliance with DERS and should improve medication safety with these medication infusions.
Please cite this article in press as: Cree ML, et al. Adherence to standard medication infusion concentrations and its impact on paediatric intensive care patient outcomes. Aust Crit Care (2017), http://dx.doi.org/10.1016/j.aucc.2017.07.003
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5. Conclusion It is feasible to use standard medication concentrations in the paediatric intensive care, with 90% of patients having 0.5 mL/kg/h as the average daily fluid balance. Although 48% of the cohort received diuretics, this group were primarily post-operative congenital cardiac patients, where the use of diuretics is standard management of care. Incorporating daily patient goals for fluid balance, ventilation and vital signs has been adopted as standard practice in February 2017 and future audits are anticipated. Limiting standard concentrations for medication infusions for adolescent and paediatric patients has allowed us to successfully adopt DERS and standard concentrations for medication infusions. Further expansion of the DERS will assist with future compliance. Acknowledgment No financial support was used in the study including institutional department funds.
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2. Preparing infusions using the rule of 6 or Broselow tape. ISMP Medicat Saf Alert 2005;10(4). 3. Christie-Taylor S, Tait P. Implementation of standard concentration medication infusions for preterm infants. Infant 2012;8(5):155–9. 4. Irwin D, Vallancourt R, Dalgleish D, et al. Standard concentrations of high-alert drug infusions across acute care. Paediatr Child Health 2008;13(5):371–6. 5. Borthwick M, Keeling S, Keeling P, et al. Toward standardisation of drug infusion concentrations in UK critical care units. JICS 2009;10(3):2–4. 6. A National Collaborative: Advancing Medication Safety in Paediatrics. Institute for Safe Medication Practices Canada ISMP. 7. Standard Concentrations of neonatal drug infusions. Institute for Safe Medication Practices and Vermont Oxford Network. ismp.org. 8. Australian Commission of Safety and Quality in Healthcare. https://www. safetyandquality.gov.au/our-work/medication-safety/medication-alerts/. 9. Brotfain E, Kopyfman L, Toledano R, et al. Positive fluid balance as a major predictor of clinical outcome of patients with sepsis/septic shock after ICU discharge. Am J Emerg Med 2016;34(11):2122–6. 10. Acheampong A, Vincent JL. A positive fluid balance is an independent prognostic factor in patients with sepsis. Crit Care 2015;19:251. 11. Hazie MA, Gajaeski RJ, Yu S, et al. Fluid overload in infants following congenital heart surgery. Pediatr Crit Care Med 2013;14(1):44–9. 12. Kudsioglu T, Coskun F, Yapici N. Perioperative and postoperative fluid management in pediatric cardiac surgery. J Anesth Crit Care 2016;4(5):00155.
References 1. Larsen G, Parker H, Cash J, et al. Standard drug concentrations and smartpump technology reduce continuous-medication-infusion errors in paediatric patients. Pediatrics 2005;116(1):e21–5.
Please cite this article in press as: Cree ML, et al. Adherence to standard medication infusion concentrations and its impact on paediatric intensive care patient outcomes. Aust Crit Care (2017), http://dx.doi.org/10.1016/j.aucc.2017.07.003