Pediatric Infusion Standards

Download as pdf or txt
Download as pdf or txt
You are on page 1of 20

PEDIATRIC CONTINUOUS

INFUSION STANDARDS
STANDARDIZE 4 SAFETY INITIATIVE The Standardize 4 Safety initiative began in 2008 when a multi-
stakeholder IV summit was held to address preventing patient harm
Standardize 4 Safety is the first national, interprofessional effort to and death from intravenous (IV) medication errors. Among the
standardize medication concentrations to reduce errors, especially recommendations made by the participants was to establish national
during transitions of care. standards for IV medications in hospitals including standardized
concentrations and dosing. In addition, it was recommended that
These national standards will cover: the national standards be created in collaboration with the Food
and Drug Administration (FDA), the pharmaceutical industry, and
• Concentrations and dosing units for intravenous continuous other stakeholders. Since the summit, establishing standardized
medications for adult patients. concentrations has garnered strong support from ASHP members, the
• Concentrations for compounded oral liquid medications. Joint Commission, the Institute for Safe Medical Practices (ISMP), and
others. 1 2 3 4
• Concentrations and dosing units for intravenous continuous
medications for pediatric patients. In 2015 the FDA, through its Safe Use Initiative, awarded ASHP a grant
to develop and implement national standardized concentrations for IV
• Doses for oral liquid medications. and oral liquid medications. The aims of the grant were to: (1) identify
a nationwide expert interprofessional panel consisting of physicians,
• Concentrations for intravenous intermittent medications. nurses, and pharmacists; (2) create standards for adult continuous IV
• Concentrations for PCA and epidural medications. infusions, compounded oral liquid medications, pediatric continuous
IV infusions, doses for liquid medications, intravenous intermittent
infusions, and PCA and epidural medications; (3) disseminate the
standards and assess their adoption.

1 ASHP Best Practices: Position and guidance documents of ASHP. 2014. ASHP, Bethesda, Maryland.
2 Larsen GY, Parker HB, Cash J. et.al. Standard Drug Concentrations and Smart-Pump Technology Reduce Continuous-Medication-Infusion Errors in Pediatric Patients. Pediatrics 2005;116:e21–e25.
3 Joint Commission. New and Revised Standards for Pediatric Population Improvement Initiative. 2011. https://www.jointcommission.org/-/media/deprecated-unorganized/imported-assets/tjc/system-folders/assetmanager/ped_field_
reviewpdf.pdf?db=web&hash=670BC65546F15F2D1D643263E0C85648. (accessed September 20, 2020)
4 Shekelle PG, Wachter RM, Pronovost PJ, et.al. An Updated Critical Analysis of the Evidence for Patient Safety Practices. Comparative Effectiveness Review No. 211. (Prepared by the Southern California-RAND Evidence-based Practice
Center under Contract No. 290-2007-10062-I.) AHRQ Publication No. 13-E001-EF. Rockville, MD: Agency for Healthcare Research and Quality. March 2013. www.ahrq.gov/research/findings/evidence-based-reports/ptsafetyuptp.html.
(accessed September 20, 2020)

ashp.org/standardize4safety
© 2020 American Society of Health-System Pharmacists®. All Rights Reserved.
Funded by FDA Safe Use Initiative.
PEDIATRIC CONTINUOUS INFUSION STANDARDS

WHY STANDARDIZE PRINCIPLES FOR PEDIATRIC CONTINUOUS INFUSION


STANDARDS
To Err is Human was published in 1999 and highlighted the harm to
patients from healthcare error. In that report, medication errors were
stated to be responsible for one of 131 outpatient and one of 854
inpatient deaths.5 Healthcare continues to struggle to eliminate harm
to patients. A systematic review and meta-analysis in 2019 estimated Safety first — use Try to limit to one
one in 20 patients are exposed to preventable medical harm with commercial when concentration when
the highest incidence of events due to medications. Compounded possible possible
medications,6 especially those given intravenously, are known to be high
risk for error due to added complexity and multiple steps required for Patient/
determining dosing when ordering, concentrations for preparation, and Clinical
rates of infusion for administering.7 8 Using standardization as a quality Consider Needs
improvement tool decreases variation, improves safety, and is the concentration
Consider operational
foundation for using clinical pathways and evidence-based guidelines. relative to fluid status.
dispensing aspects and
Standardization allows providers to manage excessive and unintended steps including waste
variation as they customize care for patients.9 Use more concentrated
when possible

5 Kohn LT, Corrigan J, Donaldson Molla S, eds; Institute of Medicine Committee on Quality of Health Care in America. To Err is Human: Building a Safer Health System. Washington, DC: National Academy Press; 2000.
6 Panagioti, M, Khan K, Keers RN, et.al. Prevalence, severity, and nature of preventable patient harm across medical care settings: systematic review and meta-analysis. BMJ 2019;366:l4185 | doi: 10.1136/bmj.l4185.
7 Hedlund N, Beer I, Hoppe-Tichy T, Trbovich P. Systematic evidence review of rates and burden of harm of intravenous admixture drug preparation errors in healthcare settings. BMJ Open. 2017; 7(12): e015912.
8 Sutherland A, Canobbio M, Clarke J, et.al. Incidence and prevalence of intravenous medication errors in the UK: a systematic review. Eur J Hosp Pharm. 2020 Jan; 27(1): 3–8.
9 Lloyd R. Does Standardization Mean the End of Autonomy? Institute for Healthcare Improvement. http://www.ihi.org/communities/blogs/does-standardization-mean-the-end-of-autonomy. (accessed September 15, 2020.

ashp.org/standardize4safety 2
PEDIATRIC CONTINUOUS INFUSION STANDARDS

HOW THE NATIONAL MEDICATION PRINCIPLES FOR EXPERT PANEL DELIBERATIONS


CONCENTRATION STANDARDS WERE
DEVELOPED

A comprehensive environmental scan was


conducted to identify the appropriate medications
to be addressed in the respective standard
concentrations. A multi-disciplinary expert panel
was convened for each standard concentration
category. Members were selected based on their Operational
expertise in the subject matter and identified with considerations
assistance from organizations such as The American (costs and waste)
Society of Anesthesiologists, Society of Critical Care
Medicine, and American Association of Critical-
Care Nurses. Each expert panel was charged to
establish standard principles to guide their decisions Use more concentrated
in creating the respective standard concentration when possible
recommendations. Once a draft of standards was
established, it was released for public comment and
review by ASHP staff and ISMP. The expert panel
subsequently met to address all comments and
generate the National Medication Concentration Limit to one concentration when possible
Standards.

FDA-approved commercial products

Patient clinical needs

ashp.org/standardize4safety 3
PEDIATRIC CONTINUOUS INFUSION STANDARDS

EXPERT PANEL
PHYSICIANS NURSES PHARMACISTS

Mitchell Goldstein Wendy Cross Jared Cash


Loma Linda University Health American Association of Critical-Care Nurses Primary Children’s Hospital

Randi Trope Rebecca Isbell Regine Cauthers White


Cohen Children’s Northwell Health Wolters Kluwer
Rachel Joseph
Vinay Vaidya Brandon Clubb
Phoenix Children’s Hospital Kimberly Whalen Riley Hospital for Children
Massachusetts General Hospital
Kim Jeong-eun
Lori Williams New York Presbyterian Hospital
University of Wisconsin Health
Jake Luke
Primary Children’s Hospital

Rachel Meyers
Rutgers

Shelly Morvay
Nationwide Children’s Hospital

ashp.org/standardize4safety 4
PEDIATRIC CONTINUOUS INFUSION STANDARDS

DISCLAIMERS CONSIDERATIONS IN USING THE


PEDIATRIC CONTINUOUS INFUSION
• Suggested concentrations may differ from the package insert (PI) information
for a drug. This is due to clinical needs that may have transpired postmarket.
STANDARDS
When this is the case, studies are available to support the use of a concentration
different than what the parent company originally pursued through the new The 80/20 rule was applied by the expert panel to
drug application (NDA) process. determine recommended standard concentrations.
The concentrations listed reflect those applicable
• Please use the utmost caution when using a concentration different than the PI, to most patient care circumstances. The panel
especially if rate information is used from the PI. recognizes situations occur where the most
appropriate concentration for a patient may not be the
• Dosing units were derived from PI information, commonly used drug-reference
recommended standard.
guides, and clinical practice guidelines.
Whenever possible one standard infusion concentration
• Of special note, the expert panel is recommending that weight-based dosing be
is the recommendation. When more than one
used for vasopressors (i.e., per kg, per minute), which may differ from institution
standard concentration was recommended it was to
specific guidelines. We strongly encourage that drug libraries and electronic
accommodate patient care needs for extremely small
health records (EHRs), including the electronic medication administration
neonates, fluid restrictions, differences required for
record, make distinct differences for weight-based vs. non-weight-based dosing
peripheral versus central lines, to simplify calculations
so nurses can easily distinguish what pump programming is needed.
and accommodate limitations of pump infusion rates.
• These concentrations are guidelines only and are not mandatory. It is our
Medications with more than one recommended
hope that organizations will voluntarily adopt these concentrations and join
concentration are listed from lowest to highest
a national movement to use standardization across the care continuum as an
concentration, with the numbering corresponding to
error-prevention strategy for patient safety.
the respective stability reference(s).
• The information contained in this table is subject to the professional judgment
The concept of bracketing was employed for references
and interpretation of the practitioner. ASHP has made reasonable efforts
for stability. For more information review: https://www.
to ensure the accuracy and appropriateness of the information presented.
fda.gov/regulatory-information/search-fda-guidance-
However, any reader of this information is advised that ASHP is not responsible
documents/q1d-bracketing-and-matrixing-designs-
for the continued currency of the information, for any errors or omissions,
stability-testing-new-drug-substances-and-products.
and/or for any consequences arising from the use of the information in the
self-assessment tool. Any user of the table is cautioned that ASHP makes no The Pediatric Continuous Infusion Standards are
representation, guarantee, or warranty, express or implied, as to the accuracy intended for children less than 50 kg.
and appropriateness of the information contained in it, and will bear no
responsibility or liability for the results or consequences of its use.

ashp.org/standardize4safety 5
PEDIATRIC CONTINUOUS INFUSION STANDARDS

Concentration Dosing Commercially Concentration vs.


Drug References
Standards units available unit mismatch

Alprostadil 1. 5 mcg/mL mcg/kg/min No Possibly 1. Pharmacia & Upjohn Company. Prostin VR


depending on vial Pediatric® (alprostadil sterile solution) injection
2. 10 mcg/mL prescribing information. Kalamazoo, MI; 2013
April. AHFS
2. Pharmacia & Upjohn Company. Prostin VR
Pediatric® (alprostadil sterile solution) injection
prescribing information. Kalamazoo, MI; 2013
April. AHFS
Alteplase 1 mg/mL mg/kg/hour No No 1a. Frazen BS, Maximal Dilution of Activase. Am J
Hosp Pharm, 1990;47:2016.
1b. Product Information: Activase(R) intravenous
injection, alteplase intravenous injection.
Genentech, Inc.(per Manufacturer), South San
Francisco, CA, 2015- Micromedix
Amiodarone 1. 1.8 mg/mL mcg/kg/ Yes - 1.8 mg/ Yes 1a. Campbell S, Nolan PE, Bliss M et al. Stability of
min* mL amiodarone hydrochloride in admixtures with
2. 3.6 mg/mL other injectable drugs. Am J Hosp Pharm. 1986;
43:917–21.
1b. Product Information: amiodarone HCl
intravenous injection, amiodarone HCl
intravenous injection. Teva Canada Limited (per
Health Canada), Toronto, ON, Canada, 2016. -
Micromedix
2. Product Information: amiodarone HCl
intravenous injection, amiodarone HCl
intravenous injection. Teva Canada Limited (per
Health Canada), Toronto, ON, Canada, 2016. -
Micromedix

ashp.org/standardize4safety 6
PEDIATRIC CONTINUOUS INFUSION STANDARDS

Concentration Dosing Commercially Concentration vs.


Drug References
Standards units available unit mismatch

Argatroban 1 mg/mL mcg/kg/ Yes Yes 1a. Product Information: argatroban injection,
min* argatroban injection. GlaxoSmithKline, Research
Triangle Park, NC, 2009.
1b. Product Information: argatroban IV injection
aqueous solution, argatroban IV injection
aqueous solution. The Medicines Company (per
DailyMed), Parsippany, NJ, 2011.
Bumetanide 1. 0.04 mg/mL mcg/kg/ Yes - 0.25 mg/ Yes 1. Cornish LA, Montgomery PA, Johnson CE.
hour* mL undiluted Stability of Bemetanide in 5% dextrose injection.
2. 0.25 mg/mL drug from the AJHP 1997;54:422-3
vial 2. Roche Laboratories. Bumex® (bumetanide)
tablets and injection prescribing information.
Nutley, NJ; 1999 Feb.

Cisatracurium 2 mg/mL mg/kg/hour Yes, undiluted Yes 1. Abbvie. Nimbex® (cisatracurium besylate)
from the 2 injection prescribing information. North Chicago,
mg/mL vial IL; 2016 Dec.
Dexmedetomidine 4 mcg/mL mcg/kg/ Yes 1. Hospira. Precedex® (dexmedetomidine) injection
hour prescribing information. Lake Forest, IL; 2016
Apr.
DOBUTamine 1. 1000 mcg/mL mcg/kg/min Yes Possibly, 1. Hospira. Dobutamine in 5% dextrose injection
depending on prescribing information. Lake Forest, IL; 2006
2. 2000 mcg/mL pharmacy or June.
outsourcing 2. Hospira. Dobutamine in 5% dextrose injection
3. 4000 mcg/mL facility lab prescribing information. Lake Forest, IL; 2006
June.
3. Hospira. Dobutamine in 5% dextrose injection
prescribing information. Lake Forest, IL; 2006
June.

ashp.org/standardize4safety 7
PEDIATRIC CONTINUOUS INFUSION STANDARDS

Concentration Dosing Commercially Concentration vs.


Drug References
Standards units available unit mismatch

DOPamine 1. 800 mcg/mL mcg/kg/min Yes Possibly, 1. Hospira. Dopamine hydrochloride and 5%
depending on dextrose injection prescribing information. Lake
2. 1600 mcg/mL pharmacy or Forest, IL; 2014 May.
outsourcing 2. Hospira. Dopamine hydrochloride and 5%
3. 3200 mcg/mL facility label dextrose injection prescribing information. Lake
Forest, IL; 2014 May.
3. Hospira. Dopamine hydrochloride and 5%
dextrose injection prescribing information. Lake
Forest, IL; 2014 May.

EPINEPHrine1 1: 20 mcg/mL mcg/kg/min No Possibly, 1a. Allwood MD. The stability of four
depending on catecholamines in 5% glucose infusions. J Clin
2: 40 mcg/mL pharmacy or Pharm Ther. 1991:16:337-40.
outsourcing 1b. VanMatre ET, Ho KC, Lyda C, et.al. Extended
facility label Stability of Epinephrine Hydrochloride Injection
in Polyvinyl Chloride Bags Stared in Amber
Ultraviolet Light-Blocking Bags. Hospital
Pharmacy. 2017;52:570-573.
2a. Carr RR, Decarie D, EnsomMHH. Stability of
Epinephrine at Standard Concentrations. Can J
Hosp Pharm. 2014;67:197-202.
2b. Peddicord TE, Olsen KM, ZumBrunnen TL,
et.al. Stability of high-concentration dopamine
hydrochloride, norepinephrine bitartrate,
epinephrine hydrochloride and nitroglycerin
5% dextrose injetion. Am J Health-Syst Pharm.
1997;54:1417-19.

ashp.org/standardize4safety 8
PEDIATRIC CONTINUOUS INFUSION STANDARDS

Concentration Dosing Commercially Concentration vs.


Drug References
Standards units available unit mismatch

Esmolol 1. 10 mg/mL mcg/kg/ Yes Yes 1. Baxter. Brevibloc® injection (esmolol


min* hydrochloride) prescribing information. (dated
2. 20 mg/mL 1998 Jun). In: Physicians’ desk reference. 54th
ed. Montvale NJ: Medical Economics Company
Inc; 2000:655-7.
2. Baxter. Brevibloc® injection (esmolol
hydrochloride) prescribing information. (dated
1998 Jun). In: Physicians’ desk reference. 54th
ed. Montvale NJ: Medical Economics Company
Inc; 2000:655-7.
FentaNYL 1. 10 mcg/mL mcg/kg/ Yes, as Possibly 1. Extedned Stability for Parenteral Drugs 6th
hour undiluted from depending on Edition, 2017. Ed. Bing, CD et. al. ASHP, 4500
2. 50 mcg/mL 50 mcg/mL pharmacy or East-West Highway, Suite 900, Bethesda, MD
vial oursourcing 20814
facility label 2. Hospira, INC. Fentanyl Citrate injection, solution.
prescribing information. Lake Forest, IL; 2019,
December.
Furosemide 1. 2 mg/mL mg/kg/hour Yes, as No 1. Negro S, Rendon AL, Azuara M, et.al.
undiluted from Compatibility and Stability of Furosemide and
2. 10 mg/mL 10 mg/mL vial Dexamethasone Comined in Infusion Solutions.
Arzneimittelforschung. 2006;56:714-20.
2. American Pharmaceutical Partners, Inc.
Furosemide Injection, USP prescribing
information. Schaumburg, IL; 2002 Apr.
Heparin 1. 50 units/mL units/kg/ Yes No 1. B.Braun Medical Inc. Heparin Sodium in Dextrose
hour Injection prescribing information. Bethlehm, PA.
2. 100 units/mL 2018. April
2. B.Braun Medical Inc. Heparin Sodium in Dextrose
Injection prescribing information. Bethlehm, PA.
2018. April

ashp.org/standardize4safety 9
PEDIATRIC CONTINUOUS INFUSION STANDARDS

Concentration Dosing Commercially Concentration vs.


Drug References
Standards units available unit mismatch

HYDROmorphone2 1. 0.2 mg/mL mg/kg/hr No, but many Possibly 1. Ensom MHH, DeCarie D, Leung K, et al. Stability
pharmacies depending on of hydromorphone-ketamine solutions in
2. 1 mg/mL purchase from pharmacy label glass bottles, plastic syringes, and IV bags
outsourcing or oursourcing for pediatric use. Can J Hosp Pharm. 2009;
3. 5 mg/mL facilities facility label 62(2):112b.
2. Extended Stability for Parenteral Drugs 6th
Edition, 2017. Ed. Bing, CD et. al. ASHP, 4500
East-West Highway, Suite 900, Bethesda, MD
20814
3. Extended Stability for Parenteral Drugs 6th
Edition, 2017. Ed. Bing, CD et. al. ASHP, 4500
East-West Highway, Suite 900, Bethesda, MD
20814
Insulin (regular) 1. 0.2 units/mL units/kg/ Yes Possibly 1. Product Information: HUMULIN(R) R
hour depending on subcutaneous injection, intravenous injection,
2. 1 unit/mL pharmacy label insulin human subcutaneous injection,
or oursourcing intravenous injection. Lilly USA LLC (per FDA),
facility label Indianapolis, IN, 2018. Micromedex
2a. Nolan PE, Hoyer GL, LeDoux JH et al. Stability
of ranitidine hydrochloride and human insulin
in 0.9% sodium chloride injection. Am J Health-
Syst Pharm. 1997.
2b. Product Information: HUMULIN(R) R
subcutaneous injection, intravenous injection,
insulin human subcutaneous injection,
intravenous injection. Lilly USA LLC (per FDA),
Indianapolis, IN, 2018. Micromedex

ashp.org/standardize4safety 10
PEDIATRIC CONTINUOUS INFUSION STANDARDS

Concentration Dosing Commercially Concentration vs.


Drug References
Standards units available unit mismatch

Isoproterenol 1. 20 mcg/mL mcg/kg/min No Possibly 1. Isuprel (isoproterenol hydrochloride injection,


depending on USP) [prescribing information]. Lake Forest,
2. 64 mcg/mL pharmacy label IL: Hospira Inc; March 2013. Pediatric Injectable
or oursourcing drugs 11th edition
facility label 2a. Sinclair-Pingel J, Grisso AG, Hargrove FR,
Wright L. Implementation of standardized
concentrations for continuous infusions using
a computerized provider Order Entry System
[published correction appears in Hosp Pharm.
2007; 42:84-85]. Hosp Pharm. 2006;41:1102-
1106.
2b. Sturgill MG, Kelly M, Notterman DA.
Pharmacology of the cardiovascular system.
In: Fuhrman BP, Zimmerman JJ, eds. Pediatric
Critical Care. 4th ed. Philadelphia, PA: Elsevier
Saunders; 2011. Pediatric Injectable Drugs 11th
edition
Ketamine 1. 2 mg/mL mg/kg/hour Yes, undiluted Possibly 1. Product Information: KETALAR intravenous
drug from the depending on injection, intramuscular injection, ketamine HCl
2. 10 mg/mL vial of 10 mg/ pharmacy label intravenous injection, intramuscular injection.
mL or oursourcing Par Pharmaceutical (per FDA), Chestnut Ridge,
facility label NY, 2017.
2. Product Information: KETALAR intravenous
injection, intramuscular injection, ketamine HCl
intravenous injection, intramuscular injection.
Par Pharmaceutical (per FDA), Chestnut Ridge,
NY, 2017.

ashp.org/standardize4safety 11
PEDIATRIC CONTINUOUS INFUSION STANDARDS

Concentration Dosing Commercially Concentration vs.


Drug References
Standards units available unit mismatch

Labetalol 1. 1 mg/mL mg/kg/hour Yes, undiluted Possibly 1. Product Information: labetalol HCl intravenous
drug from the depending on injection, labetalol HCl intravenous injection.
2. 5 mg/mL vial of 5 mg/ pharmacy label Hospira, Inc. (per DailyMed), Lake Forest, IL,
mL or oursourcing 2015.
facility label 2. Product Information: labetalol HCl intravenous
injection, labetalol HCl intravenous injection.
Hospira, Inc. (per DailyMed), Lake Forest, IL,
2015.
Lidocaine3 1. 4 mg/mL mcg/kg/ Yes, with 1a. Smith FM, Nuessle NO. Stability of lidocaine
min* commercially hydrochloride in 5% dextrose injection in plastic
2. 8 mg/mL available product bags. Am J Hosp Pharm. 1981; 38:1745–7.
1b. Product Information: Lidocaine HCl dextrose
5% intravenous injection, lidocaine HCl dextrose
5% intravenous injection. Baxter Healthcare
Corporation (per FDA), Deerfield, IL, 2017.
2a. Stewart JT, Warren FW. Stability of ranitidine
hydrochloride and seven medications. Am J
Hosp Pharm. 1994; 51:1802–7.
2b. Product Information: Lidocaine HCl dextrose
5% intravenous injection, lidocaine HCl dextrose
5% intravenous injection. Baxter Healthcare
Corporation (per FDA), Deerfield, IL, 2017.

ashp.org/standardize4safety 12
PEDIATRIC CONTINUOUS INFUSION STANDARDS

Concentration Dosing Commercially Concentration vs.


Drug References
Standards units available unit mismatch

Midazolam 1. 0.03 mg/mL mg/kg/hour Yes, undiluted Possibly, 1. Bianchi C, Airaudo CB, Gayte-Sorbier A,
(easier pump drug from the depending on “Sorption studies of dipotassium clorazepate
programming vial of 1 mg/ pharmacy or salt (Tranxene) and midazolam hydrochloride
than 0.035 mg/ mL vial and 5 outsourcing (Hypnovel) in polyvinyl chloride and glass
mL less decimal) mg/mL vial facility label infusion containers,” J Clin Pharm Ther, 1992;
Volume 17: pp. 223-7.
2. 1 mg/mL 2a. Karlage K, Earhart Z, Green-Boesen K, Myrdal
PB. Stability of midazolam hydrochloride
3. 5 mg/mL injection 1-mg/mL solutions in polyvinyl chloride
and polyolefin bags. Am J Health Syst Pharm.
2011;68(16):1537-1540.[PubMed 21817086].
2b. McMullin ST, Schaiff RA, and Dietzen DJ,
“Stability of Midazolam Hydrochloride in
Polyvinyl Chloride Bags Under Fluorescent
Light,” Am J Hosp Pharm, 1995, 52(18), 2018-20.
3a. Pramar YV, Loucas VA, & El-Rachidi A: Stability
of midazolam hydrochloride in syringes and IV
fluids. Am J Health-Syst Pharm 1997; 54:913-915.
3b. Product Information: MIDAZOLAM HCl
intravenous intramuscular injection, midazolam
HCl intravenous intramuscular injection. Heritage
Pharmaceuticals (per DailyMed), Eatontown, NJ,
2017.

ashp.org/standardize4safety 13
PEDIATRIC CONTINUOUS INFUSION STANDARDS

Concentration Dosing Commercially Concentration vs.


Drug References
Standards units available unit mismatch

Milrinone 1. 100 mcg/mL mcg/kg/min Yes - 200 No 1. Wilson TD, Forde MD. Stability of milrinone
mcg/mL and epinephrine, atropine sulfate, lidocaine
2. 200 mcg/mL hydrochloride, or morphine sulfate injection. Am
J Hosp Pharm. 1990;47(11):2504-7.
2a. Wilson TD, Forde MD, Crain AVR, Dombrowski
LJ, Joyce MA. Stability of milrinone in 0.45%
sodium chloride, 0.9% sodium chloride, or
5% dextrose injections. Am J Hosp Pharm.
1986;43(9):2218-2220.
2b. Wong F, Gill MA. Stability of milrinone lactate
200 mcg/mL in 5% dextrose injection and
0.9% sodium chloride injection. Int J Pharm
Compound. 1998; 2(2):168b
Morphine 1. 0.04 mg/mL mg/kg/hour Yes, undiluted Possibly 1. Veechio M, Walker SE, Iazzetta J et al. The
drug from depending on stability of morphine intravenous infusion
2. 0.5 mg/mL the vial of 1 pharmacy label solutions. Can J Hosp Pharm. 1988; 41:5–9.
mg/mL vial or oursourcing 2a. McMullin ST, Schaiff RA, and Dietzen DJ,
3. 1 mg/mL or ready-to- facility label “Stability of Midazolam Hydrochloride in
use products Polyvinyl Chloride Bags Under Fluorescent
or premix Light,” Am J Hosp Pharm, 1995, 52(18), 2018-20.
products 2b. Altman L, Hopkins RJ, Ahmed S, et al: Stability
available of morphine sulfate in Cormed III (Kalex)
intravenous bags. Am J Hosp Pharm 1990;
47:2040-2042
3. Stiles ML, Tu YH, & Allen LV Jr: Stability of
morphine sulfate in portable pump reservoirs
during storage and simulated administration.
Am J Hosp Pharm 1989; 46:1404-1407.

ashp.org/standardize4safety 14
PEDIATRIC CONTINUOUS INFUSION STANDARDS

Concentration Dosing Commercially Concentration vs.


Drug References
Standards units available unit mismatch

Naloxone4 1. 16 mcg/mL mcg/kg/ Yes, 0.4 mg/ Yes 1a. Product Information Naloxone Hydrochloride
hour mL vials, Injection, solution. Hospira Inc. Lake Forest, IL.
2. 40 mcg/mL however will 9/2019. 4 mcg/ml.
most likely 1b. Lewis JM, Klein-Schwartz W, Benson BE,
3. 400 mcg/mL compound et al. Continuous naloxone infusion in
from 1 mg/mL pediatric narcotic overdose. Am J Dis Child.
vials 1984;138(10):944–946. 8 mcg/ml
2. American Pain Society. Principles of Analgesic
Use in the Treatment of Acute Pain and Cancer
Pain. 6th ed. Glenview, IL: American Pain
Society; 2008.
3. Product Information Naloxone Hydrochloride
Injection, solution. Hospira Inc. Lake Forest, IL.
9/2019.
NiCARdipine 1. 0.1 mg/mL mcg/kg/ Yes - 0.1 mg/ Yes 1. Product Information: CARDENE(R) IV solution
min* mL for IV infusion, nicardipine HCL solution for IV
2. 0.2 mg/mL infusion. EKR Therapeutics, Inc, Bedminster, NJ,
2014.
3. 0.5 mg/mL 2. Product Information: CARDENE(R) IV solution
for IV infusion, nicardipine HCL solution for IV
infusion. EKR Therapeutics, Inc, Bedminster, NJ,
2014.
3. Baaske DM, DeMay JF, Latona CA, et al.
Stability of Nicardipine Hydrochloride in
Intravenous Solutions. Am J Health Syst
Pharm. 1996;53(14):1701-1705
Nitroglycerin 1. 200 mcg/mL mcg/kg/min Yes No, product 1. Product Information: Nitroglycerin Injection.
does have Abbott Laboratories, North Chicago, IL, October
2. 400 mcg/mL concentration in 2014
mcg/mL 2. Product Information: Nitroglycerin Injection.
Abbott Laboratories, North Chicago, IL, October
2014

ashp.org/standardize4safety 15
PEDIATRIC CONTINUOUS INFUSION STANDARDS

Concentration Dosing Commercially Concentration vs.


Drug References
Standards units available unit mismatch

Nitroprusside 1. 200 mcg/mL mcg/kg/min Yes Possibly 1. Product Information: NIPRIDE RTU intravenous
depending on injection, sodium nitroprusside intravenous
2. 500 mcg/mL pharmacy label injection. Exela Pharma Sciences, LLC (per FDA),
or oursourcing Lenoir, NC, 2017.
facility label 2. Product Information: NIPRIDE RTU intravenous
injection, sodium nitroprusside intravenous
injection. Exela Pharma Sciences, LLC (per FDA),
Lenoir, NC, 2017.
Norepinephrine 1. 16 mcg/mL mcg/kg/min Yes Possibly 1. Tremblay M, Lessard MR, Trepanier CA, et al:
depending on Stability of norepinephrine infusions prepared
2. 32 mcg/mL pharmacy label in dextrose and normal saline solutions. Can J
or oursourcing Anaesth 2008; 55(3):163-167.
3. 64 mcg/mL facility label 2. Hasegawa GR, Eder JR. Visual compatibility of
dobutamine hydrochloride with other injectable
drugs. Am J Hosp Pharm 1984;41:949-51.
3. Walker SE, Law S, Garland J, et al: Stability of
norepinephrine solutions in normal saline and
5% dextrose in water. Can J Hosp Pharm 2010;
63(2):113-118.
Octreotide 1. 2.5 mcg/mL mcg/kg/ No, however Possibly 1. Novartis Pharmaceuticals. Sandostatin®
hour the 50 mcg/ml depending on (octreotide acetate) injection prescribing
2. 10 mcg/mL concentration pharmacy label information. East Hanover, NJ; 2012 March.
may be used or oursourcing 2. Novartis Pharmaceuticals. Sandostatin®
3. 50 mcg/mL undiluted from facility label (octreotide acetate) injection prescribing
the available information. East Hanover, NJ; 2012 March.
vial/ampule. 3. Novartis Pharmaceuticals. Sandostatin®
(octreotide acetate) injection prescribing
information. East Hanover, NJ; 2012 March.

ashp.org/standardize4safety 16
PEDIATRIC CONTINUOUS INFUSION STANDARDS

Concentration Dosing Commercially Concentration vs.


Drug References
Standards units available unit mismatch

Pantoprazole 0.8 mg/mL mg/kg/hour No No 1a. Donnelly RF. Stability of pantoprazole sodium
in glass vials, polyvinyl chloride minibags, and
polypropylene syringes. Can J Hosp Pharm. 2011;
64:192-8.
1b. Wyeth. Protonix® (pantoprazole sodium) I.V. for
injection prescribing information. Philadelphia,
PA; 2012 May.
PENTobarbital 1. 8 mg/mL mg/kg/hour Yes, undiluted no 1. Walker SE, Iazzetta J. Compatibility and stability
drug from the of pentobarbital infusions. Anesthesiology. 1981;
2. 50 mg/mL 50 mg/mL vial 55:487–9.
2a. Gupta VD. Stability of pentobarbital sodium
after reconstitu tion in 0.9% sodium chloride
injection and repackaging in glass and
polypropylene syringes. International Journal of
Pharmaceutical Compounding. 2001, 5(6): 482-
484.
2b. Nembutal(R) Sodium intravenous injection,
intramuscular injection, pentobarbital sodium
intravenous injection, intramuscular injection.
Akorn, Inc. (per DailyMed), Lake Forest, IL, 2012.
Phenylephrine 1. 80 mcg/mL mcg/kg/min No Possibly 1a. West-Ward Pharmaceuticals. Phenylephrine
depending on hydrochloride injection prescribing information.
2. 400 mcg/mL pharmacy label Eatontown, NJ; 2012 Dec.
or oursourcing 1b. Éclat Pharmaceuticals. Vazculep® (phenylephrine
facility label hydrochloride) injection prescribing information.
Chesterfield, MO; 2014
2. Jansen JJ, Oldland AR, Kiser TH. Evaluation of
phenylephrine stability in polyvinyl chloride
bags. Hosp Pharm. 2014; 49:455-7.
Propofol 10 mg/mL mcg/kg/ Yes Yes 1. Fresenius Kabi USA, LLC. Diprivan® (propofol)
min* injectable emulsion prescribing information.
Lake Zurich, IL; 2017 Nov.

ashp.org/standardize4safety 17
PEDIATRIC CONTINUOUS INFUSION STANDARDS

Concentration Dosing Commercially Concentration vs.


Drug References
Standards units available unit mismatch

Remifentanil 1. 50 mcg/mL (non- mcg/kg/min No Possibly 1. Mylan Institutional LLC. Ultiva® (remifentanil
recon vial straight depending on hydrochloride) prescribing information.
drug) pharmacy label Rockford, IL; 2017 Dec.
or oursourcing 2. Mylan Institutional LLC. Ultiva® (remifentanil
2. 250 mcg/mL facility label hydrochloride) prescribing information.
Rockford, IL; 2017 Dec.
Rocuronium 10 mg/mL mcg/kg/ Yes, undiluted Possibly 1. Hospira. Rocuronium bromide injection
min* drug from the depending on prescribing information. Lake Forest, IL: 2014
vial of 10 mg/ pharmacy label Feb.
mL or oursourcing
facility label
Sodium Bicarbonate 1. 0.5 mEq/mL mEq/kg/ Yes, undiluted No 1. Hospira. Rocuronium bromide injection
hour if using the prescribing information. Lake Forest, IL: 2014
2. 1 mEq/mL prefilled 0.5 Feb.
mEq/mL 2. Hospira. Rocuronium bromide injection
syringes and prescribing information. Lake Forest, IL: 2014
as undiluted Feb.
drug from the
1 mEq/mL vial
Sodium Chloride 0.5 mEq/mL (3%) mL/kg/hour Yes, as 500 Yes, based on 1. Product information: sodium chloride 3%
vs. mEq/ mL bags dosing units used 5% intravenous injection, Baxter Healthcare
kg/hour, Corporation (per DailyMed) Deerfield, IL, 20014.
depending
on
institution
protocols
Tacrolimus 0.02 mg/mL mg/kg/day No Possibly 1. Astellas Pharma US, Inc. Prograf® (tacrolimus)
depending on capsules and injection prescribing information.
pharmacy label Northbrook, IL; 2015 May.
or oursourcing
facility label

ashp.org/standardize4safety 18
PEDIATRIC CONTINUOUS INFUSION STANDARDS

Concentration Dosing Commercially Concentration vs.


Drug References
Standards units available unit mismatch

Terbutaline 1 mg/mL mcg/kg/ Yes, undiluted Possibly 1. Glascock JC, DiPiro JT, Cadwallader DE et al.
min* from the 1 mg/ depending on Stability of terbutaline sulfate repackaged in
mL vial pharmacy label disposable plastic syringes. Am J Hosp Pharm.
or oursourcing 1987; 44:2291–3.
facility label
Tranexamic Acid 100 mg/mL (straight mg/kg/hour Yes, undiluted No 1. Pfizer Injectables. Cyklokapron® (tranexamic
drug) from the 100 acid) injection prescribing information. New
mg/mL vial York, NY; 2013 May.
Vasopressin 1. 0.04 units/mL milliunits/ No Yes 1. Wise-Faberowski L, Soriano SG, Ferrari L, et
kg/min* al. Perioperative management of diabetes
2. 0.2 units/mL insipidus in children. J Neurosurg Anesthesiol.
2004;16(3):220-225.
3. 1 units/mL 2. ASHP Interactive Handbook on Injectable Drugs
Accessed July 13, 2020
3. Par Pharmaceutical Companies, Inc. Vasostrict®
(vasopressin) injection prescribing information.
Spring Valley, NY; 2015 Mar.

Vecuronium 1 mg/mL mcg/kg/ No, but when Yes 1. Product InformationL Vecuronium bromide
min* the vial is ntravenous injection lyophilized powder
diluted then for solution. Fresenius Kabi USA, LLC (per
no further DailyMed) Lake Zurich, IL. 2016
dilution is
needed

*BOLD - dosing units differ from concentration units

Updated: August 2022

ashp.org/standardize4safety 19
PEDIATRIC CONTINUOUS INFUSION STANDARDS

NOTES
1 The expert panel and ISMP recommend different concentrations of epinephrine vs. norepinephrine given different indications despite same dosing units.
2 The hydromorphone standard concentrations are intended for continuous infusion devices and NOT via PCA.
3 The recommended concentrations are intended for cardiac indications only.
4 The panel recognizes these two concentrations are 10x differences, however these are the only two concentrations studies for stability.

ashp.org/standardize4safety 20

You might also like