ASHP Guidelines for Providing Pediatric Pharmaceutical Services in Organized Health Care Systems
Patient care consists of integrated domains of care, including medical care, nursing care, and pharmaceutical care. The provision of pharmaceutical care involves not only medication therapy but decisions about medication selection, dosages, routes and methods of administration, medication therapy monitoring, and the provision of medication-related information and counseling to individual patients.1 The pediatric patient population poses some unique challenges to the pharmaceutical care provider in terms of these medication-related activities. These challenges include the lack of published information on the therapeutic uses and monitoring of drugs in pediatric patients; the lack of appropriate commercially available dosage forms and concentrations of many drugs for pediatric patients; and the resulting need to develop innovative ways of ensuring that the patient receives the drug in a manner that allows the intended therapeutic effect to be realized.2 These guidelines are intended to assist pharmacists in meeting the special needs of the pediatric patient in any organized health care setting.
The pharmacy service should be organized in accordance with the principles of good management. It should be under the direction of a pharmacist and be provided with sufficient physical facilities, personnel, and equipment to meet the pharmaceutical care needs of the pediatric population. Resources necessary for compounding and testing alternative doses and dosage forms of commercially available products are essential. The pharmacy should comply with all applicable federal, state, and local laws, codes, statutes, and regulations.3 The setting should meet applicable accreditation criteria of the Joint Commission on Accreditation of Healthcare Organizations. Organizations such as the National Association of Children’s Hospitals and Related Institutions, the American Academy of Pediatrics, and the Pediatric Pharmacy Administrative Group are useful sources of further information on pediatric health care services.
Orientation and Training Programs
Orientation, training, and staff development programs for pharmacists providing services to pediatric patients should emphasize dosage calculations, dosage-form selection appropriate to the patient’s age and condition, and specialized drug preparation and administration techniques. Pharmacists should be familiar with the pharmacokinetic and pharmacodynamic changes that occur with age (e.g., in volume of distribution, protein binding, renal elimination, metabolism, muscle mass, and fluid requirements) and with disease-specific conditions that might affect drug choice or administration (e.g., short-gut syndrome, lactose intolerance). A sensitivity to the nature, frequency, and severity of medication-related errors in the pediatric population is important for all pharmacy personnel.4
A lack of availability of commercially prepared dosage forms, combined with the documented risk of calculation errors, requires the use of comprehensive unit dose drug distribution systems and intravenous (i.v.) admixture services for pediatric patients. Appropriate dosage standardization in both oral and parenteral drug distribution systems may facilitate the provision of these services.
Unit Dose System. The pediatric unit dose system must meet the original intent of these systems, which is to minimize errors and provide drugs to the patient care areas in ready-to-administer form. Multidose containers and stock medications should be avoided. An extemporaneous preparation service should facilitate the preparation and packaging of medications according to sound compounding principles.
I.V. Admixture Service. The drugs provided by the i.v. admixture service should include all i.v. push, i.v. minibag, intramuscular, and subcutaneous doses; large-volume injections; antineoplastic agents; parenteral nutrient fluids; ophthalmic products; peritoneal dialysis solutions; and irrigation fluids. Knowledge of pediatric fluid requirements and limitations, drug administration techniques and devices, and acceptable volumes for intramuscular injection is critical. Care should be taken when making dilutions to maximize concentrations of drug products (when safe to do so) for fluid-sensitive patients, as well as to minimize hyperosmolar solutions that might lead to destruction of vasculature or, in the neonate, intraventricular hemorrhage. Quality controls for both manually prepared and computer-driven preparation should exist to ensure that each product contains the ingredients ordered and that they are properly labeled. Knowledge of products that contain benzyl alcohol and the risks of this substance in neonates is essential in a pediatric i.v. admixture service.
The labels of all products should be evaluated for legibility, clarity of expression, and their potential for leading to a medication error.5