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Thread: Brand-Name vs Generic Agents: The Pharmacist Experience

  1. #1
    PharmD Year 1 TomHsiung's Avatar
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    Default Brand-Name vs Generic Agents: The Pharmacist Experience

    Pharmacists, prescribers, and patients often voice concerns about the safety and efficacy of generic drugs that are substituted for brand-name drug products. No matter where they fall on the spectrum, most clinicians, however, acknowledge that they are here to stay. The US Food and Drug Administration (FDA) approves a generic substitute if it has proven to be "identical, or bioequivalent, to a brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use."[1]

    The FDA's Orange Book provides the latest information on generic approvals. Approved generic agents have been demonstrated to have therapeutic equivalence -- although many clinicians have questioned whether that equivalence extends to all patients and all clinical scenarios. Jenny Van Amburgh, PharmD, an Associate Clinical Professor of Pharmacy at Northeastern University in Boston, Massachusetts, reminded readers in a previous discussion on Medscape that generic products are only compared with their brand-name products and not with generics made by other manufacturers.

    Drugs that are known to exhibit a narrow therapeutic index (NTI), including levothyroxine, warfarin, phenytoin, and digoxin, are of greatest concern. Switching between generic NTI products made by different manufacturers may require particular vigilance to recommended monitoring.

    James Lindon, PharmD, PhD, JD, in an earlier article on Medscape discussing pharmacist liability in the selection of generic agents, noted that the product liability law applied to prescription drug products usually only requires the manufacturer to disclose "adequate warning and instruction" to the prescriber or dispenser. There may be no duty for the drug product manufacturer to warn the patient.[2] In contrast, both the pharmacist and the prescriber may have a duty to counsel the patient when a particular generic product is prescribed or selected by the pharmacy. Laws regarding substitution vary by state.

    What if the generic substitution is required by a patient's insurance carrier? Or the switch to a generic drug from a different manufacturer is made at the pharmacy and the prescriber is not aware of it? Is the pharmacist liable?

    We asked our readers to participate in a survey describing their experience with generic agents and their opinions on the appropriateness of their use. Here is what the pharmacists had to say.

    This message comes from Medscape http://www.medscape.com/viewarticle/775138?src=mp

  2. #2

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    Fine Tom. I think it must be very interesting to write an paper about Brand-Name vs Generic Agents from the perspective of pharmacoeconomics.

  3. #3
    PharmD Year 1 TomHsiung's Avatar
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    Thank you Janis for your reply.

  4. #4
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    Basically Most (but not all) pharmacists habitually tell patients that generic medicine area unit a dead ringer for brand medications. that's hardly shocking. this is often what pharmacy students area unit told throughout their education method. it's conjointly what the bureau states on its web site "A drug is identical--or bioequivalent--to a brand drug in dose kind, safety, strength, route of administration, quality, performance characteristics and meant use. though generic medicine area unit with chemicals a dead ringer for their branded counterparts, they're generally sold-out at substantial discounts from the branded value."

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