Error-Avoidance Recommendations for Medications used in Pediatric
1
Populations

The recommendations for avoiding medication errors as presented in this document are based on medication error reports received at the United States Pharmacopeia (USP). The recommendations were reviewed by the USP Pediatric Expert Committee and the Safe Medication Use Expert Committee. These recommendations may be applied and adopted in various health care settings.

  1. Marketed Formulations & Compounded Products

    1. Pharmaceutical manufacturers are encouraged to develop pediatric-specific formulations [when they are aware of pediatric use]. Marketed products with multiple formulations and/or concentrations should be clearly differentiated from one another especially where adult and pediatric products are available (e.g., Hepatitis B vaccine adult formulation versus Hepatitis B vaccine pediatric/adolescent formulation).

    2. Products intended for use in pediatric populations and repackaged by health care facilities should be clearly differentiated from adult formulations.

    3. Dosage forms and/or preparations, that are compounded (including all intravenous admixtures and oral solutions), prepared in serial dilutions, and/or extensively manipulated should be prepared in the pharmacy, and verified by a pharmacist. Where possible, a second health care professional familiar with dilutions and compounding should verify the product preparation and labeling.

      • If automation is used in the preparation of medications, tubing connections, as well as tubing flushing procedures, should be verified and documented by a pharmacist and a second licensed or certified healthcare professional.

      • Other independent checks such as refractometry and product weight should be incorporated into the verification process. Healthcare institutions should standardize product concentrations available in the facility. Product labeling should clearly differentiate between age-specific standard concentrations (e.g., neonatal versus pediatric) and a non-standard concentration when one must be employed (e.g., for a fluid-restricted patient).

      • Commercially available formulations and concentrations should be utilized where ever available and feasible, rather than preparing the same medication through extemporaneous compounding, thus minimizing opportunity for error and enhancing standardization.

  2. Packaging and Storage

    1. Policies and procedures should be developed and implemented where automated dispensing machines are being used for pediatric medications. These should include but are not limited to:

      • Double independent verification of medications loaded into the machines.

      • Inability to override system safeguards (e.g., automated dispensing systems located on pediatric and neonatal floors can be programmed so they will not dispense medications for patients without a review of the order by pharmacy, except in specified circumstances, such as in cases where medications are required urgently).

    2. When possible, medications should be prepared and dispensed as "Unit dose" and/or "Unit of use"* containers for all pediatric medications in all health care facilities.

      • Oral liquid medications that are dispensed in multi-dose bottles should be avoided for pediatric patients.

      • Oral liquid medications should be unit-dosed.

      • Oral syringes should be clearly labeled for the oral route only.

      • The oral syringes should be unable to connect to standard intravenous tubing, stopcocks, and injection ports of any sort.

    3. Liquid medications dispensed in the outpatient setting should be dispensed with appropriate measuring devices and instructions for use. When possible, use of the measuring device should be demonstrated to the patient/caregiver.

    4. The use of bar coding or similar technology should be encouraged as an added safety measure.

  3. Medication/Prescription Orders

    1. Standard procedures that clearly identify prescription orders for pediatric patients should be in place.

    2. The prescription order should be reviewed by a healthcare professional for appropriateness and dosage accuracy using the patient's weight, age, and other appropriate dose indicator(s) before dispensing and administering each dose and/or refill for pediatric patients.

  4. Dosing and Administering

    1. The patient's weight, age, and other appropriate dose indicator(s) should be available and clearly identified on all prescriptions and orders before dispensing and administering.

    2. Healthcare professionals administering medications should never use syringes for injection to manipulate doses intended for the oral route, (e.g. for feeding tube administration or when a child is unable to drink medication dispensed in a unit dose cup).

    3. Healthcare professionals administering medications should not only abide by the five-rights for administering a medication (right patient, right drug, right dose, right time, and right route), but should also be knowledgeable of the proper administrative technique for each medication before administering to the patient.

    4. Wherever possible, pediatric dosages should be calculated by a validated computer algorithm as part of an integrated medication order entry system. When manual dosage calculations must be performed for pediatric patients, prescribers should write out the dosage unit amount followed parenthetically by the information used to calculate the final dosage (e.g., Amoxicillin Oral Suspension 250 mg by mouth every eight hours [20 mg/kg/day, in divided doses]).

      • Calculations, whether computerized or manual, should be independently double-checked by a pharmacist and signed off by at least one other licensed healthcare professional to confirm accuracy. Healthcare professionals should receive periodic calculation competency testing as determined at each institution.

      • The Apothecary system of measurement should never be used for calculations, dosage expressions, and directions (e.g., use milliliters not fluid ounces or minims; use milligrams not grains).

  5. General

    1. Abbreviations, acronyms, and symbols used throughout an organization should be standardized and be available. A list of abbreviations, acronyms, and symbols that should not be used should also be available.

    2. To prevent ten-fold overdoses, a terminal or trailing zero should never be used after a decimal. A leading zero should always precede a decimal expression of less than one.

    3. Health care practitioners who prescribe and provide medications to pediatric patients should have specific and ongoing training in drugs and dosing for this population.

    4. Appropriate, up-to-date pediatric drug references must be accessible in all areas where medications are prescribed, dispensed, or administered to children. A pediatric dosing reference must be consulted any time the health professional prescribing, dispensing, or administering the medication is not familiar with age and weight-appropriate dosing of a medication.

    5. In all health care settings, patients, parents, and/or caregivers should be provided verbal and written information about the pediatric patient's medication, the common side effects, and the adverse events that should be reported to a health care professional.

    6. More stringent safeguards, such as protocol-driven ordering, dosing tables, independent professional double-checks of pump settings and the dose/volume/concentration to be administered, are indicated for high-risk medications (e.g., anticoagulants, chemotherapy, digoxin, insulin, narcotics, intravenous concentrated electrolytes, and vasoactive infusions).

    7. Organizations that provide health care services or products for pediatric patients should adopt the recommendations for error avoidance in the medication use process published by the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP)- www.nccmerp.org, listed under "Council Recommendations." Additional resources:

      Principles of Patient Safety in Pediatrics, American Academy of Pediatrics. www.aap.org/policy/re060027.html

      Levine, S. 2001. Guidelines for preventing medication errors in pediatrics. J Pediatr Pharmacol Ther, 6:426-42 www.ppag.org, listed under the Journal of Pediatric Pharmacology and Therapeutics.

    USP is a dedicated partner in the University of North Carolina's Centers for Education and Research on Therapeutics — Rational Therapeutics for the Pediatric Population

    1 FDA defines "pediatric" for purposes of certain regulations on content and format of labeling for human prescription drugs to include persons from birth to 16 years of age [(21 C.F.R.s.201.57(f)(9)].

    * Terms as defined in General Notices, pg. 11, The United States Pharmacopeia and the National Formulary

    Unit-Dose Container - A unit-dose container is a single-unit container for articles intended for administration by other than the parenteral route as a single dose, direct from the container.

    Unit-of-Use Container - A unit-of-use container is one that contains a specific quantity of a drug product and that is intended to be dispensed as such without further modification except for the addition of appropriate labeling. A unit-of-use container is labeled as such.