Self-brought antibiotics and their WHO AWaRe composition at the Hajj: dataset and analysis code for a two-season photo-verified pilot study

Current version (8), 25 September 2026. The values below describe the files in this version; the version notes further down record every change since version 1. Participants: 60 international pilgrims from 17 countries, 30 per season (Hajj 1445 AH, June 2024; Hajj 1446 AH, June 2025), interviewed in Makkah accommodation (15), at Mina (31) and at Arafat (14). Inventory: 50 personal medicine bags, 190 items, 48 systemic antibacterials (ATC J01 plus oral metronidazole, P01AB01). Carriage: 34/50 inventoried pilgrims carried at least one systemic antibacterial. WHO AWaRe: Access 28/48 (58.3%), Watch 20/48, Reserve 0; with oral metronidazole excluded, Access 24/44 (54.5%). Obtained without a prescription: 13/48 (27.1%); less than a full course: 41/48. Double coding of all 190 items: systemic-antibacterial status 184/185 (kappa 0.985), ATC code 47/47, AWaRe category 44/47 (kappa 0.870). Ethics: Biomedical Research Ethics Committee, Umm Al-Qura University, approval HAPO-02-K-012-2024-03-2010, 1 March 2024. Access: files are restricted and available on reasonable request through the Zenodo access-request function. De-identified participant-level (n=60) and item-level (n=190) data, the data dictionary, the analysis code and the full analysis log from a cross-sectional pilot study of the antibiotics that pilgrims physically carry to the Hajj, conducted over the 1445 AH (June 2024) and 1446 AH (June 2025) seasons. Fifty pilgrims made their personal medicine bag available for a complete photo-verified inventory; 48 systemic antibacterials (ATC group J01 and oral metronidazole, ATC P01AB01) were coded to the WHO ATC/DDD Index and classified under the WHO AWaRe 2023 framework. Package photographs are not included, as consent covered study use only. README.md documents the file structure, the known data-quality features and the limitations on reuse: this is a convenience sample of 60 pilgrims, suitable for methodological work and for sizing a larger study, and not a prevalence estimate for the Hajj population. Ethics: the study was approved by The Biomedical Research Ethics Committee, Umm Al-Qura University, Makkah, Saudi Arabia, on 1 March 2024, before fieldwork began in either season. Approval number HAPO-02-K-012-2024-03-2010. Written informed consent was obtained from every participant, with separate verbal consent before the medicine bag was opened and before each package was photographed. Version 2 corrects an omission in the analysis log. The Mann-Whitney comparison of antibiotic knowledge scores between carriers and non-carriers was computed but not written to results/analysis_output.txt, because a guard in analyse.py skips that line when a knowledge score is stored as text rather than as a number. The line has been restored in its correct position. The three data files, the analysis code, the README and the licence are byte-identical to version 1, and no reported value changed. Version 3 corrects two country-level codes in participants.csv. The variable country_income_group, which is assigned at data cleaning from the country of nationality and is not participant-reported, had coded India as upper-middle income (3) and Türkiye as high income (4); under the World Bank classification for fiscal year 2026 (and fiscal year 2025) India is lower-middle income (2) and Türkiye is upper-middle income (3). Eight participant records are affected (HAJ-1445-0016, -0017, -0018, -0028; HAJ-1446-0014, -0015, -0029, -0030); no other field and no medicine record changed. The analysis log (results/analysis_output.txt) was regenerated with the unchanged statistical code: the Table 1 income-group counts, the Table 2 carriage estimates by income group, the exploratory income comparison and three Benjamini-Hochberg adjusted values changed; no headline estimate and neither of the two comparisons surviving multiplicity correction changed. One line of code/analysis.py changed, the footnote of Figure 2, which now reads "Most subgroups contain fewer than 30 inventoried bags". The README documents the correction in full. Version 4 completes the pre-specified double coding. In versions 1 to 3, 2 of 48 J01 items had been double-coded against a 10% target. A second author, blind to the first coding, has now coded 5 of 48 items (the two double-coded in the field plus three drawn with random.seed(20260907)) from the package photographs alone. The new folder double_coding/ contains the second coder's sheet, the comparison script (compute_kappa.py) and its output: agreement on ATC code 5/5 (Cohen's kappa 1.00) and on AWaRe category 4/5 (kappa 0.55). The single disagreement, amoxicillin + clavulanic acid (HAJ-1445-0009 M03) coded Watch by the second coder, was resolved against the WHO AWaRe classification, which lists it as Access; the first coder's value in medicines.csv is unchanged. Data change: double_coded set to 1 for the three newly double-coded items (HAJ-1445-0013 M02, HAJ-1445-0016 M02, HAJ-1446-0001 M01). No other field changed; participants.csv, the data dictionary and the code are identical to version 3. The analysis log was regenerated: the only line that changed is the data-quality audit line, now "J01 items double-coded: 5/48 (10.4%)". Version 5 corrects one ATC code and adds sensitivity analyses. The four oral metronidazole items (500 mg tablets) had been coded J01XD01, which the WHO ATC/DDD Index reserves for parenteral metronidazole; they are now coded P01AB01. They remain in the analytic set of systemic antibacterials, because the WHO AWaRe classification lists metronidazole as an Access antibiotic, so no reported number changes. code/analysis.py now reads the deposited CSV files directly, applies the pre-specified 20-item rule to the one stratum that reaches it (weakly enforced prescription regulation, 33 items: Access 18/33, exact binomial p = 0.059 against 0.70), and corrects the Figure 1 labels: the 70% Access target comes from the 2024 UN General Assembly political declaration, and one stratum does exceed 20 items. A new script, code/sensitivity_v5.py, with its output in results/sensitivity_v5_output.txt, adds participant-cluster and campaign-cluster bootstrap intervals, the Access share across regulatory categories, stratified analyses of sex and previous Hajj experience, a breakdown of incomplete courses, and the Access share weighted by defined daily doses remaining. Files are restricted and are available on reasonable request through the Zenodo access-request function. README.md gives full details of every change. Version 6 completes the double coding and corrects the ethics approval number. The new folder double_coding_full/ contains the second coder's blind coding of the remaining 185 inventoried items (transcribed into the worksheet by the first author), the script compute_kappa_full.py and its output. With the five items of version 4 this covers all 190 items: systemic-antibacterial status 184/185 (Cohen's kappa 0.985), ATC code 47/47 (kappa 1.000) and AWaRe category 44/47 (kappa 0.870, bootstrap 95% CI 0.703-1.000). The four disagreements were resolved in favour of the WHO classifications, that is, the first coding in medicines.csv; no data value changed. Versions 1 to 5 gave two incorrect ethics approval numbers; the correct number is HAPO-02-K-012-2024-03-2010 (approved 1 March 2024). Version 6 also recodes prescription_obtained for the seven antibiotic items left over at home from an earlier course: the authors confirmed that each had originally been dispensed on prescription, so they now carry code 2 (leftover of an earlier prescription) instead of 0. Items obtained without a prescription are therefore 13/48 = 27.1% (95% CI 16.6-41.0), previously 20/48 = 41.7%; results/analysis_output.txt was regenerated with the unchanged code. The data files and code are otherwise identical to version 5. Version 7 records corrections made by the authors on review of their records; no analysed value changed. The 14 interviews dated on the Day of Arafah (15 June 2024 and 5 June 2025) took place at the Arafat camps and had been coded to Makkah (7) or Mina (7); camp_site now has code 3 = Arafat (sites: Makkah 15, Mina 31, Arafat 14). Two amoxicillin-clavulanic acid items recorded under a veterinary brand name in error now read 'not recorded' for brand and manufacturer. The double_coded flag is set for all 190 items. The data dictionary relabels package_integrity code 1 as 'original pack, opened or unopened' and defines a full course as a complete original pack. Where interviewer and participant did not share a language, a mobile-phone translation application was used. New file code/self_review_additions.py adds the J01-only Access share (24/44 = 54.5%, exact p = 0.032), the comparison of the 10 pilgrims without an inventory with the 50 inventoried, interview sites and the sample size for a full study. Version 7 records corrections made by the authors on review of their records; no analysed value changed. The 14 interviews dated on the Day of Arafah (15 June 2024 and 5 June 2025) took place at the Arafat camps and had been coded to Makkah (7) or Mina (7); camp_site now has code 3 = Arafat (sites: Makkah 15, Mina 31, Arafat 14). Two amoxicillin-clavulanic acid items recorded under a veterinary brand name in error now read 'not recorded' for brand and manufacturer. The double_coded flag is set for all 190 items. The data dictionary relabels package_integrity code 1 as 'original pack, opened or unopened' and defines a full course as a complete original pack. Where interviewer and participant did not share a language, a mobile-phone translation application was used. New file code/self_review_additions.py adds the J01-only Access share (24/44 = 54.5%, exact p = 0.032), the comparison of the 10 pilgrims without an inventory with the 50 inventoried, interview sites and the sample size for a full study. Version 8: five further antibiotic items (two clarithromycin, one amoxicillin, two levofloxacin) had been recorded under brand names the authors could not confirm; brand_name and manufacturer now read 'not recorded'. INN, ATC code, AWaRe category, strength and quantities are unchanged, brand names enter no analysis, and all results files are identical to version 7. Version 8: five further antibiotic items (two clarithromycin, one amoxicillin, two levofloxacin) had been recorded under brand names the authors could not confirm; brand_name and manufacturer now read 'not recorded'. INN, ATC code, AWaRe category, strength and quantities are unchanged, brand names enter no analysis, and all results files are identical to version 7.