001- Real-World Evidence for Regulatory Purposes: A Survey of Patients to Evaluate the Effectiveness of the Viagra Connect National Additional Risk Minimization Measure in the United Kingdom

A national additional risk minimization measures (aRMMs) program was implemented to train pharmacists for safe supply of non-prescription Viagra Connect® (VC) to erectile dysfunction (ED) patients in United Kingdom (UK). This survey evaluated the effectiveness of aRMMs. This cross-sectional, web-based survey enrolled ED patients who purchased ≥1 supply of VC in UK, using a structured self-administered questionnaire. Patient responses were analyzed using descriptive statistics. The final sample had 297 patients, who reported that pharmacists assessed their suitability for VC by inquiring about their blood pressure and heart comorbidities (91.9%), other relevant illnesses (87.9%), medications (86.5%) and ED diagnosis (82.2%) and advised them to consult their doctor regarding ED (51.2%). Additionally, 65.0% of patients had either consulted (19.2%) or planned to consult (45.8%) their doctors; 85.5% were advised on how to take VC correctly, 82.2% on possible side effects for which they might have to discontinue taking VC and consult their doctor, 80.1% were informed that ED can be caused by underlying conditions such as high BP, diabetes, high cholesterol, and heart disease, and 68.7% received advice on lifestyle modifications from their pharmacists. In general, if the participants reported having ED, the pharmacists were more likely to assess their suitability for VC and provide advice on appropriate use of VC and on their need to see doctors. Additional results were presented at ICPE 2022. Overall, the results from this survey provide reasonable confirmation of the effectiveness of the VC aRMMs program and assurance that ED patients, when requesting and purchasing VC in UK pharmacies, were assessed appropriately for suitability of VC and receive the appropriate advice from pharmacists.

Disclaimer:
This study was sponsored by Upjohn, a legacy Pfizer division, now merged with Mylan to be Viatris. The views and opinions expressed in this presentation are the author's own and should not be attributed to Viatris, its directors, officers, employees, or affiliates, or any organization with which the presenter is employed or affiliated.

Additional Risk Minimization Measure

Effectiveness

Erectile Dysfunction

Survey

Viagra Connect