Pediatric Pharmaceutical Compounding: When and How Prescribers Can Use Customized Medications

Pediatric prescribing presents distinct challenges. Differences in physiology, developmental stage, and administration needs can present challenges to relying solely on commercially available medications. In some cases, pharmaceutical compounding may be considered as an option to help address these gaps and support individualized patient care.

In this context, prescribers may need to assess when a compounded preparation is appropriate, how it should be specified, and what factors should be considered to support its safe and effective use in pediatric populations.

When Compounding May Be Considered

Children may require dosage strengths or formulations that are not commercially available in pediatric dosing or dosage forms. In these situations, compounding may be appropriate when, in the prescriber’s clinical judgment, it is necessary to meet a specific patient need.

Potential scenarios include:

• The need for patient-specific dosing based on age, weight or clinical parameters
• Difficulty swallowing solid oral dosage forms
• Sensitivity or intolerance to certain excipients
• Situations where no suitable commercial alternative is available
• Medication shortages

As with all prescribing decisions, the use of compounded medications should be based on a careful assessment of the individual patient and available therapeutic options.

Potential Benefits and Limitations

Compounded preparations may offer certain advantages, including:

• The ability to adjust dosage strength or formulation to individual patient needs
• Alternative dosage forms (e.g., oral liquids, topical preparations) to those commercially available
• The option to exclude certain non-active ingredients (e.g. propylene glycol, ethanol) if deemed problematic or undesirable

However, it is important to recognize that compounded medications:

• Are not reviewed or approved by regulatory authorities in the same manner as commercially manufactured drugs
• May have limited or no published data on stability, compatibility, and beyond-use dating (BUD) depending on the formulation
• Can vary based on compounding practices and materials used

Prescribers are encouraged to consider both the potential benefits and limitations when determining whether a compounded preparation is appropriate.

Importance of Quality and Evidence-Based Practices

When prescribing compounded medications, collaboration with a qualified compounding pharmacy is essential. Pharmacists play a key role in preparing formulations in accordance with applicable standards and guidelines.

Prescribers are advised to:

• Confirm that formulations are prepared using recognized compounding practices
• Request information on stability and beyond-use dating (BUD) where available
• Discuss excipient selection and suitability for pediatric patients
• Ensure clear communication regarding dosing, administration, and storage
• Be aware of the “track record” of the compounding pharmacy, including years of experience, reputation and issues which may have arisen in the past

Access to evidence-based formulation data, when available, may help support more informed prescribing decisions.

Collaboration in Pediatric Care

Effective communication between prescribers and pharmacists can help support safe and appropriate use of compounded medications. This may include:

• Specifying the desired dosage form and strength in relation to the specific needs of the patient
• Identifying any known sensitivities or contraindications
• Discussing administration considerations to support adherence
• Reviewing any available data relevant to the compounded preparation

Such collaboration is intended to support continuity of care and appropriate use within the clinical context.

Resources to Support Compounding Practices

A number of organizations provide products, data, and technical support intended for use by compounding professionals. For example, Medisca offers materials and resources that may be used by pharmacists in the preparation of compounded medications, including:

• ORA-Plus® and ORA-Sweet® (ORA bases): Oral vehicles commonly used by compounding professionals to prepare liquid formulations
  • With access to over 150 ORA stability studies
• Beyond-use date (BUD) library: A searchable database of validated stability studies that may support pharmacists in determining how long a compounded medication can safely be used and in assigning beyond-use dates in accordance with applicable guidelines
• Formulation and compounding support services: Educational and informational resources intended for healthcare professionals

These resources are designed to support compounding practices; prescribers should rely on their professional judgment and applicable regulations when making treatment decisions.

A Collaborative Approach

Pharmaceutical compounding may offer a flexible option for addressing select pediatric prescribing challenges. Its use should be guided by clinical judgment, patient-specific factors, and collaboration with qualified pharmacy professionals, with careful consideration of risks, benefits, and available evidence to support appropriate patient care.

As a partner in personalized care, Medisca provides resources, products, and technical expertise to support healthcare professionals and pharmacies and is available for guidance and support when needed.

Disclaimer: This blog is for general informational and educational purposes only and does not constitute professional, regulatory, or medical advice. Any third-party sites referenced in this blog are not monitored or controlled by Medisca and Medisca shall not be held responsible or liable for any content resulting therefrom. Medisca is not liable for any loss or damage arising from the use of or reliance on this content. Medisca makes no guarantees regarding the accuracy or completeness of the information contained herein.