CRED NPM

06/11/2024

OTC Model

• Prescription Viagra dosing is to start therapy at 50mg under medical supervision and down/up-titrate to 25mg/100mg based on tolerability and effect • However certain populations ie users of alpha blockers should not be given 50mg • Initial Viagra centralised procedure included all men, and included directions in labelling for men to self-recognise the need to up/down-titrate

• Fitness for sex needed to be determined

• These factors added complexity to the labelling

• Pharmacy questionnaire was lengthy

SOLUTION: Needed to remove complexity by limiting the population eligible for OTC use

The Organisation for Professionals in Regulatory Affairs

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Reason to Switch

• In the original centralised Rx to OTC switch submission THE key benefit of switching was around reducing counterfeit supply by providing access to legitimate product without prescription • In 2010, approximately six million men in Europe bypassed the healthcare system to obtain PDE5 inhibitors (genuine or counterfeit) through alternative routes* • 77% to 83% of sildenafil samples ordered via the internet were counterfeit** • This argument was not well received → reducing counterfeit usage is outside of the competency of the Health Authority

SOLUTION: Needed to find another primary benefit of expanding access and availability

*Schnetzler G, et al. Characteristics, behaviors, and attitudes of men bypassing the healthcare system when obtaining phosphodiesterase type 5 inhibitors. J Sex Med. 2010;7:1237-46. ** Campbell N, et al. Internet-ordered Viagra (sildenafil citrate) is rarely genuine.Campbell N, et al. Internet-ordered Viagra (sildenafil citrate) is rarely genuine. J Sex Med. 2012;9:2943-51.

The Organisation for Professionals in Regulatory Affairs

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