LAUSR

BACKGROUND Failure of the Falsified Medicines Directive (FMD) in the UK could mean that substandard and falsified medicines (SFs) enter the legitimate supply chain. Does this risk UK patients' health? Readiness to implement FMD, prevalence of SFs vs. regulator detection were assessed. RESEARCH DESIGN AND METHODS 12,040 primary care pharmacies across England were invited (Apr 2021-Mar 2022). Respondent postcodes were used to extract deprivation scores. Information request was placed with the medicine's agency. Survey findings were used to calculate probability and power of a simulated fictitious trial. RESULTS 208 participants responded: Of the 7 who identified SFs, all but 1 reported it, 61% were ready to implement FMD, 74.1% had adequate resources, 54.8% considered FMD would improve patient safety, 17.8% had ever reported SFs. SFs were prevalent in deprives areas. Bayesian simulation shows 438 (p=0.030) incidences with a 3% probability of UK SFs prevalence. The agency identified 15,238 units in the legitimate supply chain in 2019 and 2020. Results are credibility, reliability and generalizable, with corroborated longitudinal persistence. CONCLUSIONS FMD or equivalent processes need to be urgently reinstated. Deprived children maybe more affected. Pharmacists are worried about liability. All health consultations should assess safety, and effectiveness of medicines. Findings should inform policy, systems planning, surveillance and evaluations.