Are Brand-Name and Generic Drugs Really the Same? The Prescriber Perspective

Brand-Name vs Generic Agents: The Prescriber Experience

Prescribers and patients often voice concerns about the safety and efficacy of generic drugs that are substituted for brand-name drug products. Love 'em or hate 'em, they are with us 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 providers 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 prescribers 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, 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, the prescriber and pharmacist 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 prescriber liable? Prescribers may not know which generic product was dispensed at the pharmacy or why that agent was chosen. They may not be aware of any concerns about the product selected.
We asked our prescribing readers to participate in a survey describing their experience with generic agents and their opinions on the appropriateness of their use. Here is what they had to say.

Who Participated?

Over 1400 physicians (64% of the sample), nurse practitioners (32%), and physician assistants (4%) completed the survey. Respondents were fairly equally divided in their practice settings. Approximately 27% indicated that they practiced in a private primary care practice, 27% in a private specialty practice, and 27% in a nonprivate clinic (hospital, federally qualified health center, or public health); the remaining 19% were hospital-based (emergency medicine or hospitalist). The respondents were an experienced bunch: More than one half -- 56% -- had been in practice for over 16 years. An additional 16% reported 6-15 years' experience. Only 8% reported practicing for 2 years or less.source medscape.com