Introduction: The public health threat of substandard and falsified medicines has been well known in the last two decades, and several studies focusing on the identification of products affected and preventing consumption have been published. However, the number of these products reaching patients and causing health consequences and adverse drug reactions is not a well-researched area.Objectives: Our aim was to identify and describe the characteristics of cases that are related to adverse drug reactions potentially originating from counterfeit medication using publicly available pharmacovigilance data.Methods: A descriptive study was performed based on pharmacovigilance data retrieved from Individual Case Safety Reports (ICSRs) identified in the European Medicines Agency’s EudraVigilance and FDA Adverse Event Reporting System (FAERS) databases in April 2022 using selected MedDRA preferred terms: counterfeit product administered, product counterfeit, product label counterfeit, product packaging counterfeit, suspected counterfeit product, adulterated product, product tampering, and suspected product tampering. ICSRs were analyzed by age and gender, by year of reporting, region of origin, reporter’s profession, and severity of the outcome. The disproportionality method was used to calculate pharmacovigilance signal measures.Results: A total of 5,253 cases in the FAERS and 1,049 cases in the EudraVigilance database were identified, generally affecting middle-aged men with a mean age of 51.055 (±19.62) in the FAERS and 64.18% of the cases between 18 and 65 years, while the male to female ratios were 1.18 and 1.5. In the FAERS database, we identified 138 signals with 95% confidence interval including sildenafil (n = 314; PRR, 12.99; ROR, 13.04; RRR, 11.97), tadalafil (n = 200; PRR, 11.51; ROR, 11.55; RRR, 10.94), and oxycodone (n = 190; PRR, 2.47; ROR, 2.14; RRR, 2.47). While in the EV data 31, led by vardenafil (n = 16, PRR = 167.19; 101.71–274.84; 95% CI, RRR = 164.66; 100.17–270.66; 95% CI, ROR = 169.47; 103.09–278.60; 95% CI, p < 0.001), entecavir (n = 46, PRR = 161.26, RRR = 154.24, ROR = 163.32, p < 0.001), and tenofovir (n = 20, PRR = 142.10, RRR = 139.42, ROR = 143.74, p < 0.001).Conclusion: The application of pharmacovigilance datasets to identify potential counterfeit medicine ADRs can be a valuable tool in recognition of potential risk groups of consumers and the affected active pharmaceutical ingredients and products. However, the further development and standardization of ADR reporting, pharmacovigilance database analysis, and prospective and real-time collection of potential patients with health consequences are warranted in the future.

The heavy metal biosorption of dried Chlorella vulgaris and Spirulina platensis-Spirulina maxima cells was studied under various experimental conditions. The effect of biosorbent dosage, pH, adsorption time, temperature, initial metal concentration on biosorption was studied. Biosorption process can be divided into two parts: the first part follows zero-order, the second part pseudo second-order kinetics. Characterization of biosorption equilibrium was evaluated with Langmuir and Dubinin-Radushkevich models using non-linear regression. The optimum pH range was found to be 5.0 ? 6.0 for Pb(II) and 4.0 ? 6.0 for Cu(II) and Cd(II) adsorption. The maximum adsorption capacities for Pb(II), Cd(II) and Cu(II) were 144, 161 and 138 mg g-1 by Chlorella cells and 370, 201 and 165 by Spirulina cells, based on the experimental data. The same values for activated carbon were 86, 134 and 43 mg g-1, respectively.

Biosorption of Cd(II) and Pb(II) ions from aqueous solution using lyophilized Pseudomonas aeruginosa (PAOI) cells were observed under various experimental conditions. The effect of pH, initial metal concentration, equilibration time and temperature on bioadsorption was investigated. The optimum pH value for Pb(II) adsorption was found to be 5.0, and for Cd(II) 5.0 ? 6.0. The Pb(II) and Cd(II) bioadsorption equilibrium were analyzed by using Freundlich and Langmuir model using nonlinear least-squares estimation. The experimental maximum uptake capacity of Pb(II) and Cd(II) was estimated to be 164 mg g-1 and 113 mg g-1, respectively. For biosorption kinetic study the pseudo second-order kinetic model was applied at various temperatures. The temperature had no significant effect on Pb(II) bioadsorption. In case of Cd(II) bioadsorption the adsorbed amount decreased with increasing temperature.

The adsorption capacities of alginate, chitosan and immobilized Spirulina platensis-maxima cells were studied in a continuous packed-bed column, under dynamic condition. The composition of alginate and chitosan beads was optimized. Various operating conditions were applied; the effect of flow rate, column height and initial metal ion concentration were investigated. The alginate beads have the highest adsorption capacity for Cu(II), Cd(II) and Pb(II) ions, 3.4, 2.3 and 3.1 mmol g⁻¹ per dry weight, respectively. The alginate-Spirulina system has slightly decreased adsorption capacity 3.1, 1.9 and 3 mmol g⁻¹. The uptake of Cu(II), Cd(II) and Pb(II) by chitosan and chitosan-Spirulina beads is 0.8, 0.9, 0.7 and 1, 0.8, 0.6 mmol g⁻¹. The Thomas and Yoon–Nelson models have been applied to analyse the breakthrough data. The results indicate feasible reuse of the beads at least in five sorption cycles.