Pfizer Building Viagra As Pan-European Consumer Health Brand with Rx-To-OTC Switch in Norway TOM GALLEN [email protected]
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No. 34 • 9 September 2019 Pfizer Building Viagra As Pan-European Consumer Health Brand With Rx-To-OTC Switch In Norway TOM GALLEN [email protected] and expertise of its new consumer health joint venture partner GlaxoSmithKline PLC, however, as OTC versions of Viagra are ex- cluded from the scope of the deal. MANDATORY CHECKLIST FOR PHARMACISTS As Norway has classified Viagra Reseptfri as a non-prescription medicine with guid- ance – a new OTC category introduced last year by the country’s medicines agency, Statens legemiddelverk – consumers look- ing to purchase the product will be re- quired to speak to a pharmacist and com- plete a checklist to ensure its suitability. “The purpose [of the checklist] is to clarify whether the consumer has illness- es or uses medicines that prevent him from using Viagra Reseptfri,” the agency fizer Inc.’s blockbuster erectile dys- Norway is the second country in the explained. “If the conditions for non-pre- function treatment Viagra will soon world to switch Viagra, with the UK reclas- scription purchase are not met, the con- Pbe available without a prescription sifying the sildenafil-based drug at the sumer will be advised to contact a doctor.” in Norway after the firm secured the first end of 2017. (Also see “Viagra Connect hits The checklist (in Norwegian) comprises Rx-to-OTC switch into the country’s newly UK shelves” - HBW Insight, 13 Apr, 2018.) seven questions which the pharmacist created “non-prescription medicines with And now there are calls for Sweden to fol- must ask before Viagra Reseptfri can be guidance” category. low its neighbor’s lead in switching Viagra. supplied. If a consumer answers “yes” to Pfizer revealed that it was aiming to Sweden rejected a switch application any of the questions – which include “Have launch OTC sildenafil – under the brand from Pfizer in 2017 but the Association of you had a heart attack or stroke in the last name Viagra Reseptfri, which translates Swedish Pharmacies says the country’s 6 months?” and “Are you taking medicines as Viagra Prescription-free – in Norwegian medicines agency should review its de- containing ritonavir for HIV infection?” – pharmacies “in early 2020.” cision and make the drug available OTC the pharmacist cannot sell the product. Viagra Reseptfri (sildenafil 50mg) will with mandatory pharmacist advice. For those men judged suitable for Vi- be available from a pharmacist (in store The Norwegian approval means Pfizer agra Reseptfri, the pharmacist will still or online) without a prescription for men can now begin to build Viagra as pan- advise a visit to their doctor within six aged 18 years or older suffering from erec- European consumer health brand and months for a check-up given that erec- tile dysfunction. The maximum dose is potentially open up erectile dysfunction tile dysfunction can be an early sign of one tablet a day, with a pack size of up to as a new OTC category across Europe. 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As purchases of Vi- Healthcare products Agency noted at possible abuse of the drug for recre- agra Reseptfri will not be documented the time of the switch. ational purpose. in medical records, pharmacists will rec- Making Viagra Connect available with- Meanwhile in the US, encouraging ommend that consumers inform their out a prescription would “help direct men signs that Pfizer and its France-based doctor that they are using the product. who might not otherwise seek help into rival Sanofi might be gearing up for an the healthcare system”, the MHRA claimed, erectile dysfunction drug switch are yet PHARMACIST GUIDANCE “and away from the risks that come with to lead to anything concrete. In 2016 we REDUCES RISK buying medicines from websites operat- reported that Sanofi was seeding the Commenting on the rationale for approv- ing illegally.” field for potential introduction of an OTC ing OTC sale of Viagra, Statens legemid- Cialis (tadalafil) with a US survey show- delverk said the move would promote SILDENAFIL SWITCH - A ing nearly 75% of men say sexual health self-care, while the requirement for man- GLOBAL OPPORTUNITY is “critical” to their happiness, while at datory pharmacist guidance at the point Around the world sildenafil remains the same time Pfizer was recruiting a of purchase would “reduce the risk of mis- largely a prescription-only drug. Po- “global sexual health” brand manager use and side effects.” land became the first country to allow with responsibilities including shep- The guidance category gives con- men to buy sildenafil OTC in 2016 with herding market expansion through an sumers an extra layer of protection not the switch of Adamed’s MaxOn Active Rx-to-OTC switch. included within Norway’s historical OTC product, which is available at the lower Holding back a US switch could be the categories of pharmacy-only and gen- strength of 25mg. country’s drug classification system which eral sales list. Prior to the ‘true’ prescription-to-OTC does not subdivide its OTC category with Making Viagra available OTC would switch of sildenafil in Poland, New Zealand pharmacy-only and general-sales list clas- help to reduce “illegal and dangerous” had come closest to granting OTC status. sifications as is common across Europe. online purchases of erectile dysfunction Sildenafil, however, remains partially re- Therefore, any firm seeking to switch an drugs, the agency explained. “Illegal drugs stricted in the country. It is still a prescrip- erectile dysfunction treatment must con- are found in one of four controlled mail- tion medicine “except when supplied by a vince the US Food and Drug Administra- ings, and in many cases these are erectile pharmacist who has successfully complet- tion that a consumer can safety self-select dysfunction drugs.