Loss of response after switching from brand name to generic formulations: three cases and a discussion of key clinical considerations when switching

Abstract

Generic formulations of medications are marketed as therapeutically equivalent and less expensive than branded ones. Multiple studies and case reports have described relapses and worsening clinical outcome in patients after a switch from a brand name to a generic medication. Recent studies have shown that generics do not always lead to the expected costs savings, reducing the impetus to proceed with compulsory generic switching. We report on three patients who experienced clinical deterioration after commencing the generic formulation of their previous brand name psychotropic medication. We discuss key clinical differences between original and generic formulations of the same medication. The use of bioequivalence as an indicator of therapeutic and clinical equivalence, the lack of appropriate studies comparing generic and brand name medications and differences in excipients are some of the factors that could explain variation in clinical response between generic and brand name medications. Generic switching should be decided on a case-by-case basis with disclosure of potential consequences to the patient.

Potential Clinical and Economic Impact of Switching Branded Medications to Generics

“…Generic switching should be assessed on an individual basis, and with disclosure of possible consequences to the patient and a plan to implement the change and assess its ultimate impact through education and monitoring. 53 …”

Variations in Pill Appearance of Antiepileptic Drugs and the Risk of Nonadherence

“…We also could not examine other changes within the pills, such as changes in the coating or filler, that might accompany changes in color and affect the way that patients with epilepsy perceive their medication. Such changes have anecdotally increased the risk of nonadherence in patients with epilepsy, 47 but not conclusively demonstrated to reflect legitimate differences in the drugs. 48 We limited our definition of nonpersistence to 5 days, although the results were consistent at 10 days, and even such a short break in therapy can be dangerous, particularly for patients with seizure disorders.…”

Pharmaceutical evaluation of glibenclamide products available in the Jordanian market

“…Interestingly, some studies have shown that the effect of substandard preparations might not be limited to inadequate physicochemical behavior, but can also be extended to influence the clinical outcome of the use of that preparation (Margolese et al, 2010). According to the current regulations issued by the Jordan Food and Drug Administration (JFDA), only random batches of each product are tested after establishing a record for successful testing results for a particular product.…”