CRED NPM
06/11/2024
External Engagement
• Initiated dialogue with key EU Health Authorities to share the revised strategy & OTC model
Health Authority
• Identified RMS and potential CMS markets for a DCP
• Provided assurance that the previous issues could be addressed in those EU markets open and supportive to the benefits of broader access • Initiated extensive HCP engagement with key Pharmacists, Clinicians, Urologists, Sexual Health experts to understand the role OTC Viagra could play in Primary care • Arranged Advisory boards to understand what needed to be true for optimal OTC access → no lengthy pharmacy questionnaires!!
HCPs
The Organisation for Professionals in Regulatory Affairs
27
OTC Model: Pharmacy Checklist designed based on “WWHAM” Principle used by UK pharmacists
Male >18yrs
Taking PDE5s already eg via internet, or supplements?
Confirm ED / misuse
• Who is the medicine for? • What are the symptoms? • How long have you had the symptoms? • What Action have you taken? • Are you taking any other Medication ?
Determine where in CV progression pathway individual may be
Assess any Contraindicated medications
Not covered directly by WWHAM:
1. CV health + Fitness for sex 2. Contraindicated conditions 3. Follow up advice for men
The Organisation for Professionals in Regulatory Affairs
28
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