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    Generic drugs gain acceptance

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    There are some big names among the brand drugs that have recently come off patent and joined the burgeoning generics market. As usual, pharmacists will play a central role in educating patients about the availability of the new generics and will be keeping the peace between doctors, payers, patients, formularies, government programs, and pharmaceutical companies. And did we mention the billions of dollars involved? Just another day in the life of a pharmacist.

    Significant medications that have recently received approval from the FDA's Office of Generic Drugs include:

    • Ibutilide fumarate injection (Corvert)
    • Imiquimod cream (Aldara)
    • Ketorolac tromethamine ophthalmic solution (Acular)
    • Lansoprazole delayed-release capsules (Prevacid)
    • Oral transmucosal fentanyl citrate (Actiq)
    • Polyethylene glycol 3350 powder for oral solution (MiraLax)
    • Tamsulosin hydrochloride (Flomax)


    Charlie Mollien
    Drug Topics solicited comments from members of our Frontline editorial advisory board and other leading pharmacists about the significance of these newer generics.

    "Most of these drug products are commonly prescribed and extremely expensive branded products. The generic equivalents for these 7 medications will reduce costs for the overall U.S. healthcare system," said Frontline editorial advisory board member Charlie Mollien, PharmD, MSc, Pharmacy Team Leader, Meijer Pharmacy, Jenison, Mich.

    "Cash-paying patients see immediate savings by reducing out-of-pocket expenses. Patients with prescription insurance will see their savings passed on to them through reduced co-pays or co-insurance."

    Proton pump inhibitors such as lansoprazole are commonly prescribed, Mollien said, but there is controversy about their overuse.

    "They are an easy drug to start a patient on and forget about," he said.

    "Prescribers and pharmacists need to be more diligent to guard against the unnecessary use of lansoprazole and other proton pump inhibitors. In the meantime, if we want to see more savings with the use of lansoprazole, insurance companies should begin paying for the over-the-counter [OTC] formulation, since it has a lower cost — although, unfortunately, it's only available in the less popular 15-mg strength."

    Resistance vs. price difference

    Mollien expects the generic formulation of imiquimod cream to take off with fairly little resistance. "If there is any [resistance], it will be from dermatologists," he said. "Patients are sometimes leery to try generics when they are cosmetic agents, but the price difference between the brand and generic is usually enough to convince them to try the generic first."

    Frontline editorial advisory board member Sam Duncan, RPh, PhD, owner of the independent pharmacy Ritzville Drug Company, Ritzville, Wash., offers blunt assessments of the new generics.

    "The polyethylene glycol has not been a big mover. When MiraLax lost its Rx status, it lost its appeal as the best thing going," he said. "When third parties stopped paying, so did the general population. Plus it was too long in getting to market to make an impact."

    Duncan said that tamsulosin, on the other hand, has many users and is making good progress in the marketplace. "Even though it currently enjoys about 85% of the brand-name price, third parties are paying and customers are using it," he said.

    Ketorolac tromethamine ophthalmic solution is "not going to be a big deal," Duncan said. However, lansoprazole will continue to be a big seller, although many consumers are self-selecting the 15-mg OTC version.


    Jim Scanlon
    Jim Scanlon, BS, RPh, pharmacist manager, Target Pharmacy, Lowell, Mass., and Frontline editorial advisory board member, said that he doesn't even stock the brand-name medications once the generics become available. His pharmacy no longer carries branded Flomax or Aldara, and the only branded Prevacid and MiraLax he stocks are the OTC versions.

    "Massachusetts is an interchange-mandatory state, and we also have a midstream substitution policy here," Scanlon said. "If patients come in for refills and their doctors never indicated that they wanted the brand-name drug, we inform the patients and substitute for the generic right then and there. The interchange mandatory rule makes it very easy to substitute without push-back from the patient, and the generic substitution rate in Massachusetts is phenomenally high because of that."

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