Ensuring Pediatric Medication Safety

November 2012 - Vol.9 No. 11 - Page #4
Category: Medication Tracking Software

Although it may seem instinctive that children and adolescents are simply smaller versions of adult patients, requiring identical, albeit scaled-to-size treatment, this is not the case; rather, children require specialized, informed pharmacy services. This care can be challenging to provide, as specific medication use data in pediatrics is often lacking, and drug concentrations and dosage forms may have to be compounded by manipulating adult doses. Equally challenging is that although doses of medications are most often calculated based on the patient’s weight, at times the age and the changing physiology of children’s bodies also must be considered; for example, neonates in particular have immature renal and hepatic function that affects the clearance and metabolism of medications. Doses must be accurately measured and delivered in a manner that is appropriate for each child; taste preferences, volume, liquid versus tablet formulation, and medication delivery method—such as IV drug delivery versus the intramuscular route—are key considerations. Careful examination of the needs of the pediatric population is necessary to avert serious patient risk, medication errors, noncompliance, and poor outcomes. 

Children’s Medical Center is a private, not-for-profit, pediatric health care provider, the fifth largest in the nation. As the only academic health care facility in North Texas dedicated exclusively to the comprehensive care of pediatric patients, Children’s provides patient care ranging from eye exams to specialized treatment in areas such as heart disease, hematology-oncology, and cystic fibrosis. In addition, Children’s is a major pediatric kidney, liver, intestine, heart, and bone marrow transplant center. Two retail pharmacies handle discharge and outpatient prescription needs, including compounding. The system is licensed for 559 beds and has more than 50 subspecialty programs spanning two campuses. The facilities serve nearly 600,000 patient visits annually, and pharmacy staff dispenses three million doses a year through a network of central pharmacy services and satellite pharmacies located in areas where intensive pharmacy care is needed. As a large, pediatric-focused health system, ensuring appropriate and safe medication is provided to our vulnerable patients is our most critical priority. 

Pediatric-specific Concerns
Several issues must be considered to ensure pediatric medication safety. Dosing and ordering decisions, as well as compounding and drug delivery methods, are especially important when providing care to pediatric patients.

Employ Weight-based Dosing
As pediatric patients include newborns to age 18, the weight of these patients varies greatly, and all pharmacists treating them must fully understand the critical nature of obtaining an accurate weight and utilizing weight-based dosing. Orders for children should never be processed without a current weight available. All weights should be documented on the order or in the CPOE system by the prescriber. 

Verify Dosing Using Pediatric-specific References
Medication orders for pediatric patients should be checked against the patient weight using a pediatric dosing reference rather than a reference intended for adult patients (see Suggested Reading List). 

Order in Milligrams
Medication doses should be ordered as milligrams. Liquid dosage forms often are available in multiple concentrations, and a dose designated as milliliters is not adequate to ensure dispensing of the correct dose. Pharmacy order entry systems and CPOE should be built to allow for entry of milligram dosing or calculate milliliters to milligrams so that the dose is displayed in both. Drug orders that do not provide a milligram dose and require an assumption of the correct dose should be returned to the ordering provider for clarification.

Use a Recipe for Compounding
If a medication must be compounded into a liquid form, it is critical to use a recipe or formula from a reliable source—such as a compounding reference, a journal article, or correspondence from the manufacturer of the active ingredient—to ensure the drug is compounded safely and correctly. Simply crushing and adding a drug to a flavored syrup does not ensure the stability and potency of the drug.

Choose the Appropriate Dosage Form
The pharmacist must carefully determine which dosage form is most suitable for the patient. Questions to consider include: 

  • Can the child swallow a tablet or does he or she require a liquid? 
  • Is there a chewable or oral-disintegrating tablet available that might be better suited for the child? 
  • Is it appropriate to give the child an intramuscular injection or should the drug be administered intravenously? 
  • How concentrated should an intravenous drug be so as to not fluid overload the child?

Choose the Best Delivery Method
Medications prepared for children should be administered in an appropriate device, such as an oral syringe. In addition, increase safety by preparing medications in a ready-to-administer form so that no dilution or manipulation is required at the patient’s bedside. When partial doses are ordered, such as a half or quarter tablet, they should be sent as the exact dose. However, if a tablet cannot be broken or made into a stable liquid, instructing the nurse to dissolve the tablet in water and immediately giving the correct dose/volume may occasionally be required.

Seek Guidance from a Pediatric Pharmacist
Pharmacists who work full time in pediatric hospitals are a valuable source of compounding information for specific products, as well as a resource for any questions related to pediatric pharmacy practice. Reach out to a pediatric pharmacy colleague when pediatric practice or compounding questions arise.

Drug Standardization
Standardization of drug concentrations and available doses is a key safety requirement. Medications delivered intravenously should be available in a limited number of standard concentrations to avoid error (see Table 1). In most instances, no more than two concentrations should be necessary, and in many cases, choices can be limited to one. In addition, standardizing concentrations to those that are commercially available is the best choice. For example, pediatric patients should utilize commercially available premixed drips, such as dopamine and most antibiotics, as limiting the amount of compounding necessary to achieve a desired concentration reduces risk for the pharmacy and the patient. Standard drip concentrations should be built into the IV pump library, eliminating the need for the nurse to program the correct concentration—another method of reducing risk.



Standardization of doses also helps increase efficiency by allowing the pharmacy to pre-package or outsource packaging of standard doses while providing an accurate dose for the patient’s weight (see Table 2). For example, a 75 mg/2.34 mL dose of acetaminophen would be difficult to measure, but rounding the dose automatically to 80 mg would allow for a 2.5 mL pre-packaged syringe to be dispensed. 

Educating Staff
Pharmacists working in general care hospitals, who may have responsibility for pediatric patients in NICUs, newborn nurseries, and general pediatric units, should take time to properly educate themselves on pediatric pharmacy practice. Ensure you have access to reliable pediatric dosing and compounding references, and use these references every time an order is reviewed. Attending Webinars and in-services, visiting a pediatric specialty hospital pharmacy department, and networking at local professional meetings to get to know pediatric pharmacists who can serve as resources over the phone will improve staff education. Pharmacists on code or trauma teams that may respond to pediatric patients should become Pediatric Advanced Life Support (PALS)-certified.1

Creating Policies and Procedures
Although established medication management policies and procedures should be inclusive of pediatric patients, it may be necessary to develop policies or guidelines to cover specific pediatric issues, such as dose standardization, standard concentrations, expectations for pharmacist review of pediatric orders, and other issues that may require guidelines for managing complex therapies. It may also be important to develop an order clarification/escalation process for pediatric medication orders. If satisfactory clarification of an order is not provided through discussion with or supporting evidence from the ordering clinician and the reviewing pharmacist is still concerned about the patient’s safety, the issue should be escalated to the next highest level of provider, such as a fellow or attending. In some cases, escalation may need to proceed to the chair of the P&T committee, the chief of service, or the medical executive of the organization until resolution is obtained. 

Benefits of Automation Use
Drug dispensing at Children’s Medical Center is performed via automated technology, comprising CPOE, ADCs, BCMA, and carousels—including those with refrigeration and high-speed packaging devices. In addition, a just-in-time distribution system is employed, with an every-two-hour cart fill process. Using automation in the distribution of pediatric medications provides sophisticated safety and inventory management benefits. 

Using carousel technology, including refrigerated carousel automation, not only allows for separation of pediatric concentrations of medications, but also takes advantage of pick-to-light technology and bar code scanning to ensure that the correct medication is dispensed. Carousel technology is particularly helpful when selecting from a vast array of insulin products, vaccines, or blood factor products. High-speed packagers that utilize bar code technology to select the correct drug for packaging also can reduce the risk of errors in the pharmacy. In addition, some high-speed packagers allow the user to package partial doses, such as half tabs and rarely used medications, through the use of a tray instead of a dedicated canister. This allows for consistency and streamlining of packaging processes without having to use a manual process for partial doses.

Inventory Management
In addition to improving patient safety, pharmacy automation systems effectively assist in inventory management. We use our system to track inventory in all of our non-retail pharmacies. The technology permits us to examine stock levels at any time, so we have accurate counts in any of our pharmacy distribution areas; typically we run a monthly inventory across all of our pharmacies. This real time inventory management has been indispensable when dealing with ongoing drug shortages. Although it was a large undertaking to build and implement such a robust automation system—through providing online access to the inventory system and scanning technology in all areas of drug distribution, including satellite pharmacies, cleanrooms, and surgery centers—the improved inventory management capacity is significant.

Overall, automation is important to patient safety because it assists staff in choosing the right medication and delivers it right to the picker. The use of pick-to-light technology and bar code scanning in and out of supply areas—when used consistently—also can increase the accuracy of dispensing. In addition, using automation to increase the visibility of available inventory has been vital in handling drug shortages and managing the drug budget. 

Surveyor Focus
Although medication management standards, including medication storage and security expectations, are equally as applicable to pediatric patients as they are to adults, it is prudent to observe certain pediatric-specific precautions. Medications should be provided to pediatric patients in the most ready-to-administer form, and, most importantly, do not store highly concentrated doses of medications on the patient unit when a suitable, less concentrated form is available. In our experience, surveyors will pull repackaged doses of drugs in patient care areas and evaluate them for volume accuracy. Be especially aware of confusing volume measurements to the 10th versus the 100th (0.3 mL vs 0.03 mL). There are oral syringes available that can accommodate measurements below 0.1 mL, which can help improve dosing accuracy without introducing additional risk, such as having to dilute a medication in order to be able to accurately measure it.

In areas where pneumatic tube stations may be accessible to the public and pediatric patients, be sure to secure the tube station either through the use of codes to release the tube, doors over the station, or card readers. Surveyors also may focus on chemotherapy processes, from pharmacist review to order entry through final checks. Be certain that any pharmacist working with pediatric patients has documented competencies related to the care of those patients.  

Future Goals
Pediatric care can be challenging, and at times daunting, for pharmacists who do not work in a pediatric environment full time. If in doubt about a pediatric patient’s care, utilize specific pediatric references and consult a pediatric pharmacy practitioner in your area. 

Children’s Medical Center is continuing to grow. In the coming year, we will  expand our retail services and open two new inpatient pharmacies with cleanrooms to support our cardiac and hematology/oncology service lines. The complexity of pediatric pharmacy practice continues to increase, and the need for pediatric specialists, both at freestanding children’s hospitals and traditional general care hospitals, is a necessity to improve the safety and outcomes for all children we are privileged to care for. 


  1. American Heart Association Web site. Pediatric Advanced Life Support (PALS). http://www.heart.org/HEARTORG/CPRAndECC/HealthcareTraining/Pediatrics/Pediatric-Advanced-Life-Support-PALS_UCM_303705_Article.jsp Accessed September 28, 2012.


Michelle Kromelis, RPh, has served as the senior director of pharmacy for Children’s Medical Center since 2005, providing operational and clinical oversight to all three campuses. Prior to this role, Michelle was a member of the Children’s pharmacy management team since 1993, as well as functioning as the investigational drug pharmacist. A pediatric pharmacist throughout her career, Michelle graduated from Drake University. 

Suggested Reading: Pediatric Drug References 

  • Bradley JS, Nelson JD, eds. Nelson’s Pediatric Antimicrobial Therapy. 19th ed. Elk Grove Village, IL: American Association of Pediatrics; 2012-2013.
  • Nahata MC, Pai VB. Pediatric Drug Formulations. 6th ed. Cincinnati, OH: Harvey Whitney Books; 2011.
  • Phelps SJ, Hak EB, Crill CM, eds. Pediatric Injectable Drugs: The Teddy Bear Book. 9th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2010.
  • Taketomo CK, Hodding JH, Kraus DM. Pediatric & Neonatal Dosage Handbook: A Comprehensive Resource for all Clinicians Treating Pediatric and Neonatal Patients. 19th ed. Hudson, OH: Lexi-Comp, Inc; 2012. 
  • Thomson Reuters Clinical Editorial Staff. NEOFAX. 24th ed. Montvale, NJ: PDR Network; 2011.
  • Tschudy MM, Arcara KM, eds. The Harriet Lane Handbook: A Manual for Pediatric House Officers. 19th ed. Philadelphia, PA: Mosby Inc, an affiliate of Elsevier Inc; 2012.  

Tips for Ensuring Pediatric Medication Safety

  • Use oral syringes to administer oral medications to pediatric patients. Pharmacy also should use oral syringes when preparing oral liquid drugs. Be sure oral syringes are available on patient care units when as-needed medications are prepared.
  • When storing bulk medications, avoid stocking multiple strengths in the same bin. This is particularly crucial with high-alert medications such as heparin—if a wrong dose is picked the results could be catastrophic to a newborn.
  • Separate and label look-alike/sound-alike and high-alert drugs. Some organizations may find it worthwhile to store pediatric-specific medications in a completely separate storage area.
  • If carousels or bar coding technology is available for picking stock, it is critical to employ its use every time a medication is picked. This practice applies to pharmacy dispensing areas and ADCs in patient care areas.
  • Safe distribution practice for pediatrics includes sending medications in a ready-to-administer form. Do not send adult-sized doses that require dilution or manipulation by the nurse.
  • All orders should be reviewed by a pharmacist who has access to pediatric references and checks every dose against the patient weight.
  • Separating batch work for pediatric patients can also be helpful.For example, prepare those medications in a designated laminar flow hood or on a designated work space.
  • Consider storing, separating, and preparing NICU medications separately from all other pediatric doses.


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