SynthesisTherapeutic innovation & regulatory science2026
Stability and Efficacy of Medicines Beyond Their Expiration Dates: A Systematic Review.
Synthesis in Therapeutic innovation & regulatory science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
Abstract
background"Shelf-life" or "expiration dating period" aims to ensure that medicines retain the quality, safety and efficacy parameters throughout that time span. After expiry, medicines become pharmaceutical waste that leads to decreased availability of healthcare products, financial losses and environmental pollution. Increasing evidence shows that medicines stay stable and effective long after their labelled expiry dates.
objectivesThis review was conducted to highlight the stability and effectiveness of medicines beyond the expiration dates granted during the marketing authorization review process.
methodsThis review was registered in PROSPERO (CRD42024629089). Five databases (PubMed, Embase, Web of Science, Scopus, Google Scholar) were searched from inception to 15 December 2024. 43 studies met the inclusion criteria. Risk-of-bias was not formally assessed.
resultsA total of 8125 articles were retrieved, out of which 43 met the criteria for final inclusion. The included articles represent 3786 samples of expired products, of which 89.1% were found stable after expiry or had their shelf-life extended. Four samples were noted to be clinically effective after expiry, although mild side effects were reported occasionally.
conclusionsMany medicines remain stable and effective well beyond their labeled expiration dates, indicating a need to reconsider current shelf-life assignment practices. Extending shelf-lives should be evaluated to minimize pharmaceutical waste and increase medicine access. The final decision to use expired medicines or extend their shelf-life should rest with medicine regulatory agencies after risk-based consideration of available evidence, individual product characteristics and patient safety. The use of expired medicines outside regulatory oversight is not endorsed. The findings provide a rationale for evidence-based shelf-life reassessment.
Indexed as
Identifiers
42234309What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.