U.K. pharmacy chain Alliance Boots expanded its program to sell Pfizer's Viagra erectile dysfunction drug without a prescription through pharmacists.

Boots' nonprescription sale of Viagra, however, likely will not change Pfizer's November 2008 decision to withdraw the switch application it submitted to the European Medicines Agency for the 50 mg sildenafil citrate drug, Pfizer says.

Boots extended the program, established through a "patient group direction" allowed under the country's Quality Care Commission regulations, from a three-store pilot launched in 2007 to 29 sites across the country, the firm said June 19.

Graham Marshall, Boots' medical director, said the pilot showed pharmacists effectively could determine whether customers should use Viagra and that the program would prevent abuse by consumers trying to buy the drug for recreational purposes.

"This really isn't a service attractive to people who want to use it for some sort of dodgy enterprise," Marshall, a physician, said in an interview.

The program allows customers to initially buy four 50 mg tablets after their consultations, for a charge of 55 U.K. pounds ($192.81). Customers can buy one 4-pill refill for $93.21 before a second consultation with a pharmacist is required to determine whether the treatment is effective, including whether the dosage is appropriate.

While customers are not required to have prescriptions from doctors, they must register for the service with Boots and agree to have their doctors notified that they are buying Viagra. "We keep the family doctor in the loop," Marshall said.

Pfizer Not Part Of Program

Pfizer provided Boots with information on Viagra, including the product's safety record, but did not encourage or consult with the chain about the patient group direction for nonprescription sales.

"It's between the pharmacy and the regulators. It's got nothing to do with the manufacturer," said Pfizer's U.K. spokesman, Andrew Widger.

Widger said the firm does not intend to use information from Boots' program to support a switch application in Europe.

He added Pfizer has no plans to resubmit the Viagra switch application it made in November 2007, then withdrew a year later after EMEA's Committee for Medicinal Products for Human Use raised concerns about OTC availability of the drug (¹ Also see "Pfizer Pulls Back On European Viagra Switch As Questions Linger" - Pink Sheet, 24 November, 2008.).

CHMP said unsupervised use of OTC Viagra could delay the diagnosis of underlying diseases, such as coronary artery disease, for which ED can be an indicator. The committee also said OTC sales could lead to increased recreational usage, Viagra's package insert is complex and patients may require a physician's input to avoid unintentional misuse.

Widger said CHMP raised those questions despite Viagra's safety record, and Boots' nonprescription program will add little to the record. "This is a drop in the ocean," he said.

Checkups And Checkouts

At the participating stores, Boots pharmacists check customers' blood pressure and glucose and cholesterol levels to determine if they should receive Viagra. Men at risk of cardiovascular disease or with signs of diabetes are advised against using Viagra and other ED drugs.

However, problems in any of those areas do not automatically block a customer from nonprescription access, Marshall explained. Pharmacists use their judgment to decide whether to dispense Viagra to customers while also determining whether customers should address other possible health problems, he said.

Pharmacists' responsibilities and Viagra's safety record are central factors in the patient group direction that Boots' medical division organized.

"The PGD protocol doesn't stop us from treating the patients. We can still sort out the ED," Marshall said.

While Boots did not state the number of people who bought Viagra in the nonprescription pilot, Marshall said four out of five Viagra customers in the pilot showed possible problems in at least one of the three areas pharmacists checked.

However, few were turned away from buying the drug. "There's not that many, to be quite honest," Marshall said.

Nothing Similar In U.S.

The U.K.'s Quality Care Commission allows "independent medical agencies" operated by pharmacy chains, hospitals and other health care entities to establish patient group directions to allow nonprescription access to drugs that otherwise remain under prescription status.

Boots also has PGDs for nonprescription sales of Rx drugs Zithromax (doxycycline) or generics for Chlamydia and Propecia (finasteride) for baldness, as well as the Cervarix cervical cancer vaccine and seasonal influenza vaccines. The chain may halt its PGD for Xenical (orilstat) for weight loss now that GlaxoSmithKline's alli nonprescription orlistat is approved in the European Union (² 'The Tan Sheet' April 27, 2009).

The U.S. does not have a program similar to PGD and does not allow pharmacists to prescribe drugs.

However, several states allow doctors to establish ongoing arrangements with pharmacies to dispense some drugs to particular consumers without prescriptions, a mechanism that was used in some states to provide emergency contraception before it was available OTC.

Emergency contraceptive Plan B now is sold without a prescription by pharmacists to consumers age 18 and older. However, in that unique case, the pharmacists' only screening task is enforcing an age restriction (³ Also see "Plan B Lightning May Strike Again: Complying Will Not End Political Storm" - Pink Sheet, 27 April, 2009.).

The role of pharmacists is a key issue in discussions on whether to establish a third class of drugs - behind the counter - in the U.S. Professional and industry trade groups say a regulation creating a third class should codify both pharmacists' consultation responsibilities and how they are paid for BTC services (⁴ Also see "Behind The Counter Debate Raises Questions Of Pharmacist Role In Diagnosis" - Pink Sheet, 5 January, 2009.).

- Malcolm Spicer (m.spicer@elsevier.com)

Pharmacy-Based Nonprescription Viagra Sales Expand In U.K.

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