PC1 – Drug stability in the clinical environment

Link to EAHP Statements

• Section 1 – Introductory Statements and Governance: Statements – 1.1
• Section 3 – Production and Compounding: Statements – 3.1, 3.2, 3.3, 3.4, 3.5
• Section 4 – Clinical Pharmacy: Statements – 4.1, 4.7
• Section 5 – Patient Safety and Quality Assurance: Statements – 5.1, 5.2, 5.6, 5.9, 5.10, 5.11
• Section 6 – Education and Research: Statement Statements – 6.4

Abstract 

Hospital pharmacists regularly prepare medicines to meet patient-specific clinical needs. Today, ready-to-administer (RTA) parenteral products, such as anticancer medication, anti-infectives, parenteral nutrition admixtures, and medication for intensive care patients, are prepared in pharmacy-based cytotoxic preparation units and intravenous additive services (CIVAS). Other relevant dosage forms prepared in pharmacies for the special need of patients are eye preparations and oral liquid preparations. For each product, the shelf-life, or in-use stability, is to be assessed and given on the label by the responsible pharmacist. Therefore, knowledge and expertise about stability of different dosage forms, degradation pathways, stability testing, and assessment of physicochemical, microbiological, and pharmacological stability, is relevant. Stability assessment depends on the type of preparation, the preparation procedure, storage conditions, and the availability of stability data in the literature. Relevant information can be retrieved from databases, original publications or even stability studies performed by the pharmacy department itself. There are several guidelines published regarding the ‘Good Stability Testing’ of ready-to-administer parenteral preparations derived from licensed products. In each case, a stability-indicating and validated method must be used. Published physicochemical stability data can be used to assess the in-use stability of an individual preparation, the better the more similar the internal and external stability-determining factors are.

When standardised preparations and dose-banded preparations are prepared in series or batches in advance, long-term stability data is needed. However, it will be harder to find literature data as quality controls are mandatory in batch production. Shelf-life of ophthalmic solutions and liquid oral dosage can also be assessed based on literature data. The safest way is to do the preparation and the labelling according to magistral formularies.

Our utmost goal is to use knowledge on stability and compatibility in conjunction with our expertise in pharmaceutical technology in order to ensure the safe and efficacious administration of pharmaceutical preparations. In the first part of the seminar, general aspects of stability assessment will be presented. In the second part, good and bad examples of stability studies of pharmaceutical preparations and pitfalls of stability assessment will be discussed.   

Learning objectives

After the session, participants should be able to:

• Describe, analyse, and assess present and future developments in the field of stability and compatibility of pharmaceutical preparations
• List, describe, compare, and use relevant databases reporting stability and compatibility data
• Formulate, plan, perform, document, publish, and disseminate data on stability and compatibility of pharmaceutical preparations 

Educational need addressed

To learn and understand present and future developments in the field of stability and compatibility of pharmaceutical preparations, appraise and apply relevant databases regarding stability and compatibility, and develop research projects on stability/compatibility of pharmaceutical preparations.

Keywords

Pharmaceutical preparation, stability, compatibility, database, research, hospital pharmacy