Lauren J. Lee

and 9 more

Objectives: The Medicines and Healthcare Products Regulatory Agency in the United Kingdom (UK) formally reclassified sildenafil citrate 50 mg tablets as a pharmacy medicine (sildenafil-P) in 2017 for adult men with erectile dysfunction (ED). A one-year prospective real-world observational study was conducted to track men’s health behavior, particularly their healthcare resource utilization (HCRU) and quality-of-life (QoL) before and after the availability of sildenafil-P. Methods: Adult men with ED aged ≥18 years provided data at baseline (prior to launch of sildenafil-P) and every three months after the launch. Demographics, health characteristics, treatments at baseline and HCRU, including number of pharmacist and physician/nurse practitioner visits over time are reported. QoL-related outcomes were assessed via Self-Esteem and Relationship Questionnaire (SEAR), 2-Item Patient Health Questionnaire, and ratings of sexual satisfaction. Generalized linear models were used to assess the association of sildenafil-P use with total physician/nurse practitioner and pharmacist visits and QoL-related outcomes at 12 months. Results: Overall, 1162 men completed the survey at all 5 time-points. The mean ± SD age was 59.02 ± 12.06 years; 55.42% reported having a moderate-to-severe ED. Hypertension (37.52%) and hypercholesterolemia (31.50%) were the most common risk factors for ED. At baseline, 62.99% were not using any ED treatment. After adjusting for baseline visits/other covariates, mean physician/nurse practitioner (3.68 vs 2.87; P = .003) and pharmacist visits for any reason (2.10 vs 1.34; P < .001) at 12 months were significantly higher among sildenafil-P users than those who never used sildenafil-P. Sildenafil-P users had significantly higher SEAR total and domain (sexual relationship and self-esteem) scores at 12 months. Conclusion: Following the reclassification to pharmacy medicine in the UK, sildenafil-P was associated with a higher number of physician/nurse practitioner and pharmacist visits for any reason. Sildenafil-P use was also associated with better QoL, although group differences were small in magnitude.