RxCe - Compounding for Pediatric Patients Materials

COMPOUNDING FOR THE PEDIATRIC PATIENT

Faculty:

Liz Fredrickson, PharmD, BCPS

Liz Fredrickson, PharmD, BCPS, is an Associate Professor of Pharmacy Practice and Pharmaceutical Sciences at the Northeast Ohio Medical University (NEOMED) College of Pharmacy, where she is course director of the Parenteral Products and Basic Pharmaceutics Lab courses.

Pamela Sardo, PharmD, BS

Pamela Sardo, PharmD, BS, is a freelance medical writer and licensed pharmacist. She is the founder and principal at Sardo Solutions in Texas. Pam received her BS from the University of Connecticut and her PharmD from the University of Rhode Island. Pam’s career spans many years in retail, clinics, hospitals, long-term care, Veterans Affairs, and managed health care responsibilities across a broad range of therapeutic classes and disease states.

Abstract

Unique medication needs often arise within the pediatric population, and pharmaceutical compounding is important in providing solutions for these patients. Pharmacists and pharmacy technicians who compound preparations for pediatric patients should be skilled in the techniques and knowledge necessary to provide safe and efficacious therapies. This continuing education program will discuss the importance of compounding for pediatric patients and the challenges associated with preparing medications for this population. Common pediatric dosage forms, flavoring strategies for medications, and pharmacy technician tips will also be reviewed.

Accreditation Statements

In support of improving patient care, RxCe.com LLC is jointly accredited by the Accreditation Council^TM for Continuing Medical Education (ACCME^®), the Accreditation Council for Pharmacy Education (ACPE^®), and the American Nurses Credentialing Center (ANCC^®), to provide continuing education for the healthcare team.

Joint Universal Activity Number: The Joint Accreditation Universal Activity Numbers assigned to this activity are as follows:

Pharmacists: JA4008424-0000-26-171-H07-P

Pharmacy Technicians: JA4008424-0000-26-171-H07-T

Credits: 2 contact hour(s) (0.2 CEU(s)) of continuing education credit.

Credit Types:

Pharmacy - 2 Credits

Type of Activity: Knowledge

Media: Computer-Based Training (i.e., online courses)

Estimated time to complete activity: 2 contact hour(s) (0.2 CEU(s)), including Activity Pre-Test, Post-Test, and Activity Evaluation.

Release Date: July 20, 2026 Expiration Date: July 20, 2029

Target Audience: This educational activity is for Pharmacists and Pharmacy Technicians

How to Earn Credit: From July 20, 2026, through July 20, 2029, participants must:

Read the “learning objectives” and “author and planning team disclosures;”

Take the “Educational Activity Pre-Test;”

Study the section entitled “Educational Activity;” and

Complete the Educational Activity Post-Test and Activity Evaluation. The Educational Activity Post-Test will be graded automatically. Following successful completion of the Educational Activity Post-Test with a score of 70% or higher, a statement of participation will be made available immediately. (No partial credit will be given.)

CE Credits: Credits for this course will be uploaded to CPE Monitor^® for pharmacists and pharmacy technicians.

Statement of Need

Learning Objectives: Upon completion of this educational activity, participants should be able to:

Recall reasons to compound for pediatric patients

Describe common dosage forms compounded for pediatric patients

Describe how to flavor and sweeten compounded preparations for pediatric patients

Identify important considerations when compounding for pediatric patients

Disclosures

The following individuals were involved in planning, developing, and/or authoring this activity: Liz Fredrickson, PharmD; and Pamela Sardo, PharmD, BS. None of the individuals involved in developing this activity has a conflict of interest or financial relationships related to the subject matter. There are no financial relationships or commercial or financial support relevant to this activity to report or disclose by RxCe.com or any of the individuals involved in the development of this activity.

Educational Activity Pre-Test

Which of the following is a benefit of compounding for pediatric patients?

Reducing the cost of medications for caregivers

Improving adherence by flavoring medications

Preparing copies of commercially available medications

Preparing medications without a prescription

Which of the following excipients can cause central nervous system effects in pediatric patients?

Sucrose

Coloring agents

Lactose

Ethanol

Children prefer which of the following tastes?

Sweet

Bitter

Umami

Sour

Educational Activity

Compounding for Pediatric Patients

Introduction

Pharmacists and pharmacy technicians who prepare compounded preparations for pediatric patients should be skilled in the techniques and knowledge required to ensure safe and effective medication delivery. It is also crucial that pharmacy personnel work closely with caregivers and providers to ensure compounded preparations are safe and effective for pediatric patients. This continuing education program will discuss the importance of compounding for pediatric patients and the challenges associated with preparing medications for this population. Common pediatric dosage forms, flavoring strategies for medications, and pharmacy technician tips will also be reviewed.

Overview of Pharmaceutical Compounding

Pharmaceutical compounding is the art and science of preparing customized medications based on a patient’s unique and individual health needs, and drug compounding is formally defined as the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient.¹ While compounding is important for many individuals, it is often crucial for special populations, including pediatric patients. Due to a dearth of Food and Drug Administration (FDA) approved drugs for children, unique medication needs often arise within the cohort.¹ Children make up approximately 20% of the population in the United States (US) and are large consumers of medications, with an estimated 250 million prescriptions filled for children yearly.^2,3 Unfortunately, half of all available medications are not labeled for use in children.⁴ Because of this, children are often prescribed medications in an “off-label” fashion, meaning the medication is given in a different way than intended.⁴ The prevalence of off-label medication use for children has been estimated at upwards of 95%.⁵ This can result in unsafe and/or ineffective therapies.

Challenges of Compounding for Pediatric Patients

Pharmaceutical compounding plays an important role in providing medication solutions for pediatric patients.¹ There are numerous challenges to confront when preparing compounded medications for pediatric patients. In general, much more research and data are needed pertaining to evidence-based compounding for children. Specific challenges compounding personnel may encounter include the following:

A lack of reliable, documented formulations⁴

A lack of or insufficient medical history for a patient⁴

Determining the appropriate dosage form, administration volume, size of the dose, and taste of the medication⁴

Ensuring the safety of excipients with regard to age and developmental stage⁴

Ensuring regulatory compliance⁴

There are also numerous safety issues to consider. Various studies have identified safety issues that often result from inadequately prepared compounded preparations for children.¹ A review of articles identified that between 26% and 63% of information in formulations was found to be missing or inadequate, respectively.¹ Because of this, pharmacy personnel may not feel confident utilizing available formulas. A cross-sectional study of compounded pediatric medications prepared in Michigan pharmacies uncovered considerable variation in oral pediatric liquid compounding practices.⁶ This variability poses a significant risk to patient safety.

Pediatric Physiological and Anatomical Considerations

Pediatric patients are not “small adults,” and doses cannot always be extrapolated from those intended for adult patients.⁷ To properly prepare compounded medications, it is crucial for pharmacy personnel to understand how pediatric physiology and anatomy correspond to the pharmacokinetics of drug therapies.⁷

Pediatric patients are regarded as a special population when it comes to drug therapies due to the major physiologic and anatomical differences between adults and children.⁸ These differences can and do have major impacts on the pharmacokinetic profiles of drugs.⁸ Broadly, pediatric patients are defined as those from birth to less than 16-18 years old.⁵ Even within the pediatric population, various categories have been identified, and these age groups should themselves be considered their own population (Table 1).⁸

Table 1

Pediatric Age Categories⁸

Category	Age Range
Preterm newborn	Under 39 weeks gestation
Newborn	0-28 days
Infant	>28 days - 12 months
Toddler	>12 months - 23 months
Preschool child	2-5 years
School-age child	6-11 years
Adolescents	12-18 years

Caution should be noted when determining dosage forms or drug doses based solely on age; however, more importantly, renal and hepatic function, body weight, volume of distribution, and other factors play important roles and should be considered.^4,8 The processes that can impact drug concentrations in tissues include absorption, distribution, metabolism, and excretion (“ADME”).^4,8 Because these processes differ in children, they will have effects on the pharmacokinetic profiles of medications. Key differences in these processes will be summarized below.

Absorption

Absorption is defined as the movement of a drug from its site of administration to circulation.⁸ Factors that can alter the absorption of a drug include gut transit time and the composition of intestinal fluid.⁸ Because younger children have shorter intestinal transit times, this may reduce drug absorption in some cases, such as with theophylline.⁸ Metabolism that occurs in the gut wall and lumen as a result of CYP450 enzymes can also decrease drug absorption for agents such as nifedipine and midazolam, among others.⁸

Saliva is critical for the absorption of oral and oral transmucosal dosage forms, as it facilitates drug release, dissolution, and absorption.⁴ The flow rate of saliva typically increases until approximately age five, and then it declines.⁴ Finally, the pH of the GI tract varies depending on age and affects drug solubility and diffusion.⁴ pH can also be affected by drug use, nutrition, and saliva-flow rate.⁴

Distribution

Distribution is the movement of a drug from circulation to its site of action.⁸ Studies have identified that children within all age groups tend to have larger volumes of distribution.⁹ The body composition of various pediatric groups also impacts distribution.⁸ For example, infants have higher levels of fat compared to older children.¹⁰ Because of this, lipophilic drugs such as diazepam have a larger volume of distribution in infants, and hydrophilic drugs have larger volumes of distribution in older children. Protein binding can also impact drug distribution, and the variables influencing protein binding are detailed in Table 2.⁸

Table 2

Comparative Protein Binding in Pediatric Populations in Comparison to Adult Values⁸

Parameter	Neonate	Infant	Child
Total protein	Decreased	Decreased	Equivalent
Plasma albumin	Decreased	Equivalent	Equivalent
Plasma globulin	Decreased	Decreased	Equivalent
α1-acid glycoprotein	Decreased	No data available	Equivalent
Free fatty acids	Increased	Equivalent	Equivalent
Unconjugated bilirubin	Increased	Equivalent	Equivalent

Metabolism

Metabolism is defined as the breakdown of a drug into compounds that are easier for the body to eliminate.⁸ Hepatic clearance of drugs is normally higher in infants and younger children compared with adults, and this has the potential to increase first-pass effects.⁸ In these cases, dosing based on body weight may not be appropriate.⁸

Excretion

Excretion is the removal of drugs from the body, either as the parent compound or metabolites.⁸ Unchanged drugs have lower excretion rates in newborns because of their immature renal function.⁸ Compared to adults, preschool-aged children and older children have either similar or higher rates of excretion.⁸

Pharmacokinetic differences among pediatric populations are summarized in Table 3.⁸

Table 3

Pharmacokinetic Differences Among Pediatric Populations⁸

	Developmental Change	PK Consequence	Drugs Affected	Examples
Absorption	↓Intestinal transit	↓Cmax and ↓AUC	Poorly soluble drugs	Theophylline
			Sustained release formulations
	↓Gastric pH	↑Cmax for weak acids	Weak acids	Penicillin
		↓Cmax for weak bases	Weak bases	Itraconazole
	↓Intestinal bile concentration	↓Cmax and ↓AUC	Poorly soluble drugs	Hydrocortisone
Distribution	Body composition	–Vd (neonates have relatively reduced fat, whereas infants have relatively increased fat compared with adults; extracellular water is relatively higher in neonates compared with preschool children)	Lipophilic drugs ↓Vd in neonates and ↑Vd in infants compared with adults; Hydrophilic drugs ↑Vd in infants compared with neonates	Diazepam Aminoglycosides (e.g., gentamycin)
Distribution	↓plasma protein	↑free fraction of drug in plasma; ↑Vd	Highly protein-bound drugs	Phenytoin, salicylates, ampicillin, nafcillin, sulfisoxazole, and
Metabolism	Larger relative size of the liver	↑hepatic clearance of drugs		Theophylline, caffeine, carbamazepine, and valproic acid
	Ontogeny* of liver enzymes	–hepatic metabolism of drugs		Chloramphenicol
	Bacterial colonization of the intestine	↑Cmax and ↑AUC		Digoxin
Elimination	Larger relative size of the kidney	↑renal clearance in infants and preschool children
Elimination	Ontogeny of tubular transporters	–renal clearance of drugs

*Ontogeny in humans is the origination and development of an individual, beginning with human embryogenesis.

Benefits of Compounding for Pediatric Patients

Improved Medication Adherence

An estimated 30-70% of children suffering from a chronic illness are non-adherent to their medication regimens.¹¹ Pharmaceutical compounding offers numerous solutions to improve adherence in this population, including flavoring medications to enhance taste, altering the dosage form to facilitate administration, and potentially combining one or more medications into a single dosage form.¹¹ Pharmacy personnel can also help improve adherence by counseling caregivers about the purpose, proper administration, and potential side effects of a patient’s medication.

Provision of Unavailable Dosage Forms

Medications are typically produced as oral dosage forms, such as tablets or capsules; however, these forms are often inappropriate for pediatric patients who may have difficulty swallowing or refuse to take pills.¹² An estimated ten percent of children between the ages of 6 and 11 are unable to swallow a pill.¹² Reasons for this are variable and include fear, anxiety, developmental stage, and medication taste.¹² Additionally, even though some capsules can be opened and their contents added to food, this practice has an added risk of the entire dose not being taken.¹³ Compounding pharmacists can select a tolerable dosage form for the patient while also not adversely affecting the stability and compatibility of the medication.¹² Preferred dosage forms include chewable, solutions, and suspensions.¹²

Sensory Processing Disorders

Some children have sensory processing disorders (SPD) that include autism and attention-deficit hyperactivity disorder (ADHD).¹² This neurological condition prevents sensory input from being appropriately processed. Because of this, certain tastes or textures of medications may cause issues for these children and produce gagging, nausea, or vomiting.¹² For some children, changing the flavor to one preferred can mitigate this issue. For others who are sensitive to texture, an entirely different dosage form may be required.¹² As an example, a more palatable base can be selected, such as glycerin, fatty base, or polyglycol.¹² Pharmacists should discuss patient preferences with the caregiver and prescribing physician to ensure the medication is prescribed safely and effectively.

Allergies and Intolerance

Pharmaceutical compounding allows for the preparation of medications without ingredients that may cause allergic reactions or intolerances in patients. As an example, pharmacists can remove high-fructose corn syrup from formulations for patients with corn allergies. In some cases, parents may prefer to avoid using colored dyes in their children's medications, and compounding personnel can also remove them from formulations.

Preparing Pediatric Dosage Forms

The pediatric patient population is heterogeneous. Because of this, taste preferences, medication side effects, and patient response to active pharmaceutical ingredients (API) and excipients can vary widely.⁴ Additionally, age-related compliance needs to be considered.⁴ Medication adherence can be caregiver-dependent depending on the age and ability of the patient.⁴ Cognitive levels change as patients age, and the selection of age-appropriate formulations is key to adherence.⁴

One of the biggest obstacles is selecting the best formulation for the patient’s age.⁴ The dosing regimen (dose accuracy, flexibility, frequency), route of administration, ingredients, stability, compatibility, and compliance are all crucial considerations. Compounding personnel should recognize that children may also reject large volumes of liquids.⁴ Compounding personnel should also consider the following when preparing a pediatric compounded preparation:⁴

The taste and color of the preparation

Packaging requirements

Storage requirements

Provision of administration devices or demonstration of administration techniques

Cost-effectiveness

Oral Dosage Forms

For most pediatric patients, oral dosage forms are preferred, but they can present their own challenges.⁴ Tablets are not suitable for children under the age of four, and older children may require tablets that aren’t available in the correct strength.⁴ Breaking and splitting tablets can result in under- or overdosing.⁴ Medications provided as powders for reconstitution require the correct amount of diluent to be added and appropriate storage conditions post-reconstitution.⁴ Pharmacists have responsibilities not only to prepare these medications safely but also to counsel caregivers on correct administration and storage. The ability of children to swallow various dosage forms also must be taken into consideration.⁵ For example, children less than five years old typically cannot swallow tablets that are larger than 10 mm in size.⁴ Suppositories are alternative options for children with poor swallowing abilities, but these are also challenging to administer to children as they are uncomfortable.⁴

Among oral dosage forms, oral liquids are the most popular. Thus, it is vital that compounding pharmacists recognize how to prepare these properly.⁵ Oral liquids are susceptible to various stability issues, including interactions between the active ingredients and excipients, photodegradation, crystallization of the active ingredient(s), and microbial growth.¹³ Therefore, pharmacists should utilize documented formulas and verify the stability of the active pharmaceutical ingredients within the specific formula before compounding.¹³ When creating a solution or suspension for a child, it is important to always start with a bulk drug substance rather than use powders from triturated tablets or capsules, if possible.¹³ The added ingredients, or excipients, in these dosage forms can alter the medication's stability and/or solubility.¹³ If a tablet or capsule is used as the API, it is recommended to make a suspension rather than a solution in those cases.¹³

Buccal dosage forms include lozenges, gummies, and lollipops. These have the benefits of being easy to administer, being prepared from formulas that can be changed to be patient-specific, and allowing the drug to stay in contact with the oral cavity for a long time.⁴

Excipients

Excipients used in pediatric formulations must be thoroughly reviewed for safety. Pharmacy personnel should consider daily exposure and treatment duration when evaluating the safety of formulation excipients.⁴ The majority of children will tolerate these ingredients, but others may experience either intolerances or adverse effects. A particularly important consideration is the use of solvents such as ethanol, propylene glycol, glycerin, and low-molecular-weight polyethylene glycols.¹³ Ethanol can cause hypoglycemia and acute toxic effects in children, and the amount used in children should be minimized to less than 5%.¹³ Formulations prepared with castor oil, cod liver oil, and mineral oil are also not recommended for children.¹³ Use of these preparations can cause potential nutrition absorption issues and lipid pneumonia if the preparation is aspirated.¹³ Finally, certain preservatives should be avoided in pediatric patients as well.¹³ These include parahydroxybenzoates, which can cause hypersensitivity reactions.¹³ The STEP: Safety and Toxicity of Excipients for Pediatrics database can be referenced when determining the safety of excipients.¹⁴ Excipients and their potential adverse effects are detailed below.⁴

Preservatives:⁴

Benzyl alcohol and sodium benzoic acid: Gasping syndrome.

Methylparaben and polyparaben: Kernicterus. At high doses, it may cause hyperbilirubinemia and estrogenicity. It should be avoided in pediatric patients with jaundice.

Polysorbate 80: E-Ferol syndrome.

Ethanol: Central nervous system (CNS) depression.

Sweeteners:⁴

Sucrose: Dental cavities and dissolving of tooth enamel.

Sorbitol: Gastrointestinal (GI) disorders, such as abdominal pain, bloating, vomiting, and diarrhea, when used in high concentrations. In young infants, sorbitol accumulation can also lead to diabetic complications, such as retinopathy and cataracts.

Aspartame: Harmful for pediatric patients with phenylketonuria. Neurotoxic, as it may induce seizures.

Glycerol: In high concentrations, it will cause electrolyte disturbances, resulting in diarrhea.

Coloring agents:⁴

Potential Attention-deficit disorder (ADHD) affects

Diluents:⁴

Microcrystalline cellulose: Potential intestinal absorption; should not be used in children < 2 years.

Lactose: Hypersensitivity reactions in children and young infants. In infants with lactose intolerance (lactase deficiency), symptoms may include severe abdominal pain, flatulence, distention or bloating, and diarrhea, in addition to systemic symptoms such as muscle and joint pain and eczema. It can be substituted with calcium hydrogen phosphate dehydrate, starch, powdered cellulose, and erythritol.

Cosolvents:⁴

Alcoholic solvents, such as sorbitol, propylene glycol, polyethylene glycol (PEG), and others, could cause CNS depression, hypoglycemia, lactic acidosis, seizure, hypoglycemia, and hemolysis.

Pause and Ponder

When an excipient is used in pediatric formulations, what review must the compounder do?

If you are not sure how to answer this question, review again the section Excipients above

Flavoring Medications for Pediatric Patients

Many medications taste bitter or unappealing to children. While this serves an important role in the prevention of medication poisoning, it does often lead to poor medication adherence in this cohort.¹² Taking medications in the form of a pill or tablet is a useful way to cover the unappealing tastes, but this is not a viable option for children, as many are averse to swallowing pills, and the contents of pills cannot be broken up or crushed.¹² Thus, the ability of personnel to appropriately flavor medications for children is crucial.

Flavoring has been described as more art than science, and it extends beyond merely adding flavoring and/or sweetening agents to a medication product.¹ The ability to sense flavor involves a combination of all of our senses–taste, smell, sight, and sound–and our tongue is able to recognize five general tastes: sweet, sour, bitter, salty, and umami (savory).¹ Notably, children have more taste buds than adults, which makes the sensation of unpleasant tastes heightened.¹³ Flavor, odor, and texture (mouth feel) are all key factors when preparing oral medications for children.¹³ Research has found that sweet and salty are preferable to children compared to adults.¹²

While it may seem logical to add sweeteners to children's medications, pharmacy personnel should recognize that this is not always advisable. Sweeteners can lead to numerous issues, including dental cavities, the potential over-consumption of medications children find palatable, and harm to children who must reduce sugar intake, such as those with diabetes mellitus.¹² Commonly utilized sweeteners include saccharin, sucrose, sorbitol, aspartame, and fructose.¹² Caloric sweeteners include sucrose, fructose, and glycerol, while noncaloric sweeteners include aspartame, stevia, saccharin, and sucralose. Pharmacy personnel should check with the caregiver and provider to ensure use of the selected sweetening agent(s) is safe and preferred. For example, sorbitol can cause diarrhea and abdominal cramping in some patients, and children with diabetes will need to avoid caloric sweeteners such as fructose.¹³ If a medication is going to be prescribed over a long time period, noncaloric sweeteners are recommended to avoid tooth decay.¹³ Aspartame should be avoided in phenylketonuria.¹³

Flavoring medications should involve a combination of appropriate flavor(s) that complement the medication well, do not adversely affect the stability or compatibility of the formulation, and are preferable to the patient.¹ Pharmacy personnel can first check with caregivers regarding children’s flavor preferences or could potentially have children sample one or more options for their medication.

If a flavor is disliked, it should be noted and changed for future prescriptions. Table 5 details flavors used to mask specific tastes.¹

Table 5

Flavors that Mask Tastes of Pediatric Medications¹

Taste	Flavor
Sweet	Berry, bubblegum, fruit, grape, vanilla
Acid/sour	Acacia, cherry, lemon, lime, orange
Salty	Butter, butterscotch, maple, nut, spice
Bitter	Cherry, chocolate, coffee, grapefruit, licorice
Oily	Anise, peppermint, wintergreen

Coloring can be used, but compounding personnel should note this will not improve the taste of the medication. Oftentimes, parents prefer that coloring agents NOT be used in their children’s medications. Some coloring agents have been associated with hypersensitivity reactions in pediatric patients, including angioedema, skin rash, vomiting, and dermatitis.¹³ There are also hypothesized links between coloring agents and hyperreactivity in children.¹³ Potential culprit agents include FD&C Yellow 5, Yellow 6, Red 36, Red 17, Blue 1, Blue 2, and Green 3.¹³ If a color is selected, it should preferably match the flavor of the medication–for example, a cherry formulation could be colored red–and documented on the compounding record to keep note for future prescriptions. Overall, it is important for pharmacy personnel to work with the patient’s provider and caregiver to determine flavoring and coloring preferences.

Regulations Pertaining to Flavoring Medications

An estimated 200 million medications have been flavored over the past 25 years, with no reported adverse events.¹⁵ Currently, most state pharmacy boards (49 of 52) have determined that compounding does not apply to flavoring medications.¹⁵ However, the California Board of Pharmacy is looking to require stricter regulations regarding medication flavoring.¹⁶ It is important for pharmacy personnel to follow the rules and regulations of their state board or boards of pharmacy, as they are responsible for enforcing USP <795> standards.

Trends for Compounded Nonsterile Preparations for Children (CNSP)

Trends within pediatric compounding continue to emerge. A recent article identified several trends in CNSPs among children.¹⁷ These include:

Standardizing nomenclature, formulations, and doses

Re-purposing old medications

Reformulating older drugs

Increasing federal oversight of pharmacy compounding

Changes to broaden the scope of indication in a product’s label

Additionally, several emerging priorities have been identified for children’s medications.¹⁷ These include the use of compounded medications to treat and manage the following conditions:

Anxiety

Asperger’s syndrome

Attention-deficit hyperactivity disorder (ADHD)

Bipolar disorder

Depression

Obesity

Pharmacy personnel engaged in research can assist the pharmacy community in establishing best practices for pediatric compounding and in developing safe and effective treatments for the aforementioned disease states.

Role of Pharmacy Staff

In appropriate settings and with oversight by pharmacists, pharmacy technicians have successfully assumed larger roles within pharmacy practice. This includes preparing compounded nonsterile and compounded sterile preparations for pediatric patients. A pharmacy technician's workflow should include inquiring about culture, religion, allergies, or personal preferences. Some populations avoid animal products or byproducts that may be found in compounding.

Pharmacy technicians are critical in maintaining a clean work environment in compliance with regulatory standards. A pharmacy technician's workflow includes prescription entry into the computer system. This function requires accurately adding the required quantities of compounded ingredients to the formulation and pharmacy labels and affixing appropriate auxiliary labels. Auxiliary labels can indicate whether to keep the compounded prescription refrigerated, whether to shake it, or provide the compound's expiration date. Pharmacy technicians routinely handle insurance billing and may communicate with the family whether a compounded preparation will be covered by insurance. Pharmacy technicians' compounding knowledge and skills ensure the safe and effective preparation of quality medications for children.

References to Consider

For more information, consider checking the following resources:

The International Journal of Pharmaceutical Compounding (www.ijpc.com)

Llyod Allen. The Art, Science, and Technology of Pharmaceutical Compounding

USP <795>

U.S. Food and Drug Administration Human Drug Compounding (https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-compounding)

Summary

Pharmaceutical compounding is the art and science of preparing customized medications based on a patient’s unique health needs. Drug compounding is formally defined as the process of combining, mixing, or altering ingredients to create a medication tailored to an individual patient's needs. Children make up approximately 20% of the population of the US and are large consumers of medications, with an estimated 250 million prescriptions filled for children yearly. Half of the available medications are not labeled for use in children, so pharmaceutical compounding plays a vital role in providing medication solutions for pediatric patients.

Pharmacists and pharmacy technicians who compound preparations for pediatric patients should be skilled in the techniques and knowledge necessary to provide safe and efficacious medications. It is also crucial that pharmacy personnel work closely with patients’ caregivers and providers to ensure compounded preparations are safe and effective.

References

Allen L. The Art, Science, and Technology of Pharmaceutical Compounding. The American Pharmacists Association. 2016.

Children make up one-third of the population in the United States (US) ChildStats. America's Children: Key National Indicators of Well-Being, 2023. Demographic Background. 2023. https://www.childstats.gov/americaschildren/demo.asp. Accessed January 26, 2024.

Chai G, Governale L, McMahon AW et al. Trends of outpatient prescription drug utilization in US children, 2002–2010. Pediatrics. 2012;130(1):23–31.

Malkawi WA, AlRafayah E, AlHazabreh M, AbuLaila S, Al-Ghananeem AM. Formulation Challenges and Strategies to Develop Pediatric Dosage Forms. Children (Basel). 2022;9(4):488. Published 2022 Apr 1. doi:10.3390/children9040488

Allen HC, Garbe MC, Lees J, et al. Off-Label Medication use in Children, More Common than We Think: A Systematic Review of the Literature. J Okla State Med Assoc. 2018;111(8):776-783.

Rood JM, Engels MJ, Ciarkowski SL, Wagenknecht LD, Dickinson CJ, Stevenson JG. Variability in compounding of oral liquids for pediatric patients: a patient safety concern. J Am Pharm Assoc (2003). 2014;54(4):383-389. doi:10.1331/JAPhA.2014.13074

O'Hara K. Paediatric pharmacokinetics and drug doses. Aust Prescr. 2016;39(6):208-210. doi:10.18773/austprescr.2016.071

Batchelor HK, Marriott JF. Paediatric pharmacokinetics: key considerations. Br J Clin Pharmacol. 2015;79(3):395-404. doi:10.1111/bcp.12267

Ginsberg G, Hattis D, Sonawane B, Russ A, Banati P, Kozlak M, Smolenski S, Goble R. Evaluation of child/adult pharmacokinetic differences from a database derived from the therapeutic drug literature. Toxicol Sci. 2002;66:185–200.

Puig M. Body composition and growth. In: Walker WA, Watkins JB, editors. Nutrition in Pediatrics. 2nd edn. Hamilton, ON: BC Decker; 1996. pp. 122–141.

Gardiner P, Dvorkin L. Promoting medication adherence in children. Am Fam Physician. 2006;74(5):793-798.

Mennella JA, Beauchamp GK. Optimizing oral medications for children. Clin Ther. 2008;30(11):2120-2132. doi:10.1016/j.clinthera.2008.11.018

Fonseca S Rph, Ferreira Ade O. Pediatric oral liquid preparations. Int J Pharm Compd. 2005;9(6):437-442.

EUPFI. STEP Database. Accessed January 2024. http://www.eupfi.org/step-database-info/. Accessed January 30, 2024.

Flavor Rx. Board of Pharmacy Positions Towards Flavoring on November 1, 2023. https://www.flavorx.com/regulatory/. Accessed January 30, 2024.

Meara K. Pharmacists in California Stop Flavoring Medication for Children Due to New Rules. Drug Topics. https://www.drugtopics.com/view/pharmacists-in-california-stop-flavoring-medication-for-children-due-to-new-rules. Accessed January 30, 2024.

Parrish RH 2nd. Current Trends and Emerging Priorities in Compounded Preparations for Children. Int J Pharm Compd. 2018;22(5):358-366.

DISCLAIMER

The information provided in this course is general in nature, and it is designed solely to provide participants with continuing education credit(s). This course and materials are not meant to substitute for the independent, professional judgment of any participant regarding that participant’s professional practice, including but not limited to patient assessment, diagnosis, treatment, and/or health management. Medical and pharmacy practices, rules, and laws vary from state to state, and this course does not cover the laws of each state; therefore, participants must consult the laws of their state as they relate to their professional practice.

Healthcare professionals must consult their employer, healthcare facility, hospital, or other organization for guidelines, protocols, and procedures to follow. The information provided in this course does not replace those guidelines, protocols, and procedures, but is for academic purposes only, and this course’s limited purpose is for the completion of continuing education credits.

Participants are advised and acknowledge that information related to medications, their administration, dosing, contraindications, adverse reactions, interactions, warnings, precautions, or accepted uses is constantly changing. Any person taking this course understands that such a person must make an independent review of medication information before any patient assessment, diagnosis, treatment and/or health management. Any discussion of off-label use of any medication, device, or procedure is informational only, and such uses are not endorsed hereby.

Nothing contained in this course represents the opinions, views, judgments, or conclusions of RxCe.com LLC. RxCe.com LLC is not liable or responsible to any person for any inaccuracy, error, or omission with respect to this course or course material.

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