Allergens and Excipients: Mandatory Declaration in Compounded Medicines

In the preparation of compounded medicines, patient safety is our utmost priority. A fundamental, and often complex, aspect is the correct identification and management of allergens and excipients requiring mandatory declaration. Do you know how to ensure your compounded medicines comply with regulations and protect the most sensitive patients?

The Importance of Excipients in Formulation

Excipients are essential components in any medicine, including compounded medicines. Although they do not possess direct pharmacological activity, they perform critical functions such as providing bulk, improving stability, facilitating absorption, or masking flavours. However, some of them can be responsible for adverse reactions, including allergies or intolerances, in susceptible patients. Therefore, their correct identification and declaration are vital for patient safety.

Current regulations demand rigorous attention to these components, especially when dealing with patients with known sensitivities. An error in identification or communication can have serious consequences, from mild reactions to anaphylaxis. It is our responsibility as pharmacists to ensure that each compounded medicine is safe and appropriate for the individual patient.

Mandatory Declaration Excipients: What are they and why?

The Spanish Agency of Medicines and Medical Devices (AEMPS), following European guidelines, establishes a list of excipients that must be mandatorily declared on the labelling of medicines, including compounded medicines. These excipients have been identified for their potential to cause adverse reactions in specific populations. Common examples include lactose (in intolerant individuals), gluten (in coeliacs), aspartame (in phenylketonurics), or certain colourings and preservatives.

The mandatory nature of their declaration allows the prescribing doctor and the pharmacist to assess the risk-benefit for each patient and, if necessary, seek alternatives or adapt the formulation. It is essential to consult the summary of product characteristics (SmPCs) of raw materials and the AEMPS guidelines to stay up-to-date with the complete list and their declaration thresholds. (UK pharmacists should consult their own regulator, the MHRA, for relevant guidance.) You can consult detailed information on drug safety in special populations in our pregnancy and lactation section, which also addresses sensitivities.

Procedures for Allergen Management in the Pharmacy

To ensure effective management of allergens and mandatory declaration excipients in compounded medicines, it is essential to establish a clear protocol in the pharmacy. This includes:

1. 1
   Identification of Raw Materials

   Review the summary of product characteristics (SmPCs) and certificates of analysis for all raw materials to identify the presence of mandatory declaration excipients and potential allergens.
2. 2
   Record and Documentation

   Maintain an updated record of the excipients present in each raw material and in each compounded medicine prepared. Document any substitution or adaptation.
3. 3
   Communication to the Patient

   Clearly inform the patient about the composition of the compounded medicine, highlighting the presence of any mandatory declaration excipient or relevant allergen.
4. 4
   Continuous Training

   Ensure that all personnel involved in the preparation of compounded medicines are trained and updated on regulations and good practices.

Traceability is key. From the receipt of the raw material to the dispensing of the compounded medicine, every step must be documented. This not only complies with regulations but also provides an additional layer of safety for the patient and for the pharmacist themselves. For comprehensive management, you can rely on tools such as our medicines formulary to consult SmPCs.

Practical Tips for the Community Pharmacy

Implementing a robust system for managing allergens and excipients requires attention to detail. Here are some practical tips:

• Clear Labelling: Ensure that the labelling of your compounded medicines is legible and contains all required information, including mandatory declaration excipients.
• Cleaning Protocols: Establish strict cleaning and disinfection protocols for equipment and formulation areas to prevent cross-contamination between different compounded medicines.
• Patient History: Maintain a detailed record of your patients' allergies and intolerances. This is fundamental for personalised pharmaceutical care and to avoid errors.
• Consult Official Sources: Periodically review publications from the AEMPS and other health authorities (UK pharmacists should consult the MHRA) to stay abreast of any updates to the excipient list or regulations.

Effective communication with the patient is as important as correct preparation. Always explain the purpose of the compounded medicine, how to use it, and what precautions to take, especially if it contains any excipient that may be problematic for them.

Frequently Asked Questions about Excipients and Allergens