Current evidence in the stability of medicines in dose administration aids: implications for patient safety

ABSTRACT

Introduction: As the elderly population and polypharmacy are increasing, it is predicted that interventions to enhance medication adherence, as dose administration aids (DAA), will grow. One of the limitations of repackaging medicines into DAA is to assure the stability of medicines, and, therefore, their quality, efficacy and safety.

Area covered: This article collects and summarises data of all the stability studies of repackaged medicines into DAAs. Computerized search in databases: PubMed, Google Scholar, SciELO, and reference texts related to the field (keywords: drug stability, DAAs, compliance aids, and repackaging), open access databases and guidelines. Also, it provides recommendations on the suitability of repackaging and compares them with those established.

Expert opinion: Since medicines are removed from primary package, their stability can be compromised due to psychochemical characteristics of the drug substance and product, the dosage form, the type of DAA selected, the co-storage and splitting, the repackaging conditions, and the conditions of storage. This review reflects the need of more standardized stability studies to guarantee the quality of repackaged medicines. In addition, the importance of them to support the pharmacist to make the best decisions in order to maximize outcomes and minimize risks related to patients’ medication when repackaging it.

KEYWORDS:

• Dose administration aids
• drug stability
• medication adherence
• patient safety
• repackaging

Article highlights

• Dose-dispensing services in community pharmacies are growing in attempt to enhance previously selected patient’s adherence.

• Since medicines are removed from their primary package, manufacturer’s expiration date and stability guarantee are invalidated.

• Stability information of repackaged medicines can be laboriously found in original studies along with some open access databases or guidelines of repackaging services.

• Not only the physicochemical characteristics of medicines can affect their stability when repackaged, but also the dosage form, the splitting, the co-storage, the type of DAA used, the repackaging conditions, and the period and conditions of storage.

• More standardized stability studies are needed to guarantee both medicines’ quality and patient’s safety.

This box summarizes key points contained in the article.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.