A Validated Risk-Based Inspection Model for Cannabis Derivative Manufacturers in Colombia: A Mixed-Methods Pre–Post Study

Abstract

Background: Colombia has constructed one of the most developed legal frameworks for medicinal cannabis in Latin America, anchored in Law 1787 of 2016 and elaborated through Decree 811 of 2021 and Resolution 227 of 2022. Despite this regulatory architecture, the UAE Fondo Nacional de Estupefacientes (FNE) had inspected only 32 of all active licensed cannabis derivative manufacturers prior to 2024, leaving the sector without validated, standardized oversight and exposing patients and the productive chain to unverified quality and diversion risks. Objective: To design, validate, and evaluate a risk-based Inspection, Surveillance, and Control (IVC) model — operationalized as a weighted inspection instrument — applied to cannabis derivative manufacturers registered before the FNE in Colombia. Methods: A five-phase mixed-methods study was conducted between 2022 and 2024. Instrument content validity was established through a Delphi panel of 12 experts (4 rounds; 92% consensus threshold). Two cross-sectional field samples — a pilot (n = 30) and a final evaluation (n = 30) — were collected across 12 Colombian departments. Quantitative analysis compared regulatory compliance percentages across nine normative dimensions using Welch's independent-samples t-test and Cohen's d. Qualitative data from 12 semi structured interviews and 2 focus groups were analysed via thematic coding and triangulated with quantitative findings. Results: Mean global compliance increased from 46.33% (SD = 38.11) at baseline to 84.20% (SD = 15.30) at final evaluation, an absolute gain of 37.87 percentage points (95% CI: 22.69–53.04). Welch's t(38.11) = −5.05, p = 1.13×10⁻⁵; Cohen's d = 1.30 (Hedges' g = 1.29), indicating a large effect. Qualitatively, 83% of actors cited greater clarity of inspection criteria and 75% reported reduced inspector discretionality. Conclusions: A validated, risk-based IVC instrument produced statistically significant and operationally meaningful improvements in regulatory compliance among cannabis derivative manufacturers in Colombia, establishing a transferable model for other jurisdictions developing controlled-substance oversight systems.