Background: Failure of the Falsified Medicines Directive (FMD) in the UK could mean that substandard and falsified medicines (SFs) enter the supply chain. Does this risk patients' health? Readiness to implement FMD, and prevalence of SFs vs. regulator detection were assessed.
Research Design And Methods: A total of 12,040 primary care pharmacies across England were invited (April 2021-March 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 trial.
Results: A total of 208 participants responded: Of the seven who identified SFs, all but one reported it; 61% were ready to implement FMD, 74.1% had adequate resources, 54.8% expected improved patient safety, and 17.8% had ever reported SFs. SFs were prevalent in deprived areas. Bayesian simulation shows 438 ( = 0.030) incidences with a 3% probability of SFs prevalence. The agency identified 15,238 SFs units in the supply chain (2019 and 2020). Results are credible, reliable, and generalisable, with corroborated longitudinal persistence.
Conclusions: FMD or equivalent processes need to be urgently reinstated. Deprived children may be 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.
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