Climate, β-lactam stability, and antimicrobial resistance in Nigeria: a review protocol

Title: Climate, β-lactam stability, and antimicrobial resistance in Nigeria: a review protocol Research question: Does the available evidence support a demonstrated causal chain from tropical climate/storage exposure, through β-lactam chemical degradation, to reduced antimicrobial exposure, altered pharmacokinetic/pharmacodynamic target attainment, and resistance selection in Nigeria — or only individually plausible components of that chain? Eligibility criteria: Population/setting: Nigerian clinical, environmental, or pharmaceutical-quality studies as primary evidence; non-Nigerian studies eligible only as explicitly labeled mechanistic or regional comparator evidence, never as substitutes for Nigerian data. Exposure/topic: β-lactam chemical stability, storage/climatic conditions, medicine quality, antimicrobial resistance (phenotypic or genotypic), and PK/PD modelling. Publication types included: primary research articles, authoritative regulatory/institutional documents (WHO, ICH, national regulators), high-quality systematic reviews for pooled estimates. Excluded: sources whose findings cannot be verified against the original primary record; non-English-language sources; conference abstracts without retrievable full text. Databases/sources to be searched: PubMed/MEDLINE, Embase, Scopus, WHO Global Index Medicus, African Journals Online (AJOL), plus institutional websites (WHO, ICH, NAFDAC) for regulatory documents. Search strategy (draft, to be finalized per database syntax): (beta-lactam* OR penicillin* OR cephalosporin* OR amoxicillin OR ceftriaxone) AND (stability OR degradation OR potency OR storage) AND (Nigeria* OR "sub-Saharan Africa" OR tropical) AND (resistance OR AMR) Date restriction: none — mechanistic/chemistry literature may predate the surveillance literature substantially. Screening: title/abstract screening followed by full-text screening against the eligibility criteria above; second-reviewer screening if available, otherwise single-reviewer with documented reasoning per exclusion. Planned synthesis approach: narrative synthesis organized around a tiered evidentiary framework (established in general literature / indirectly supported in Nigeria / not demonstrated in Nigeria) rather than meta-analysis, given the heterogeneity of study types.