Abstracts

Rationale: Best practice pharmaceutical treatment maximizes therapeutic response while minimizing adverse drug effects. In our changing healthcare delivery system, this is complicated by multiple factors including, but not limited to, 1) insurance requirements necessitating use of generics and/or 90-day mail-order generic prescriptions; 2) existence of multiple generics; 3) pharmacy dispensing practices in which inappropriate misbranding (21 U.S. Code Section 325) and adulteration may occur. Antiepileptic drugs (AEDs), the principal treatment for epilepsy, are frequently prescribed for pain and psychiatric disorders. This report describes two bipolar disorder patients treated with AEDs in whom efficacy and adverse effects were impacted by all three factors. Methods: Case analyses with literature review were employed. Results: Case 1: 38-year-old male diagnosed with Bipolar Disorder NOS, Generalized Anxiety Disorder, and Anxiety Disorder NOS stabilized on aripiprazole 15mg qhs, bupropion 100mg qam, and lamotrigine 450mg qhs noted significant improvement in cognition when he switched from mail-order generics to local pharmacy generics. All pharmaceuticals were identical between the pharmacies excluding the local pharmacy dispensing different generic lamotrigine. Patient described cognitive change "like night and day." Case 2: 49-year-old female diagnosed with Bipolar Disorder, Panic Disorder, Generalized Anxiety Disorder, and PTSD maintained on lamotrigine 350mg qhs, oxcarbazepine 300mg bid, escitalopram 25mg qd, and alprazolam 1mg qid PRN developed a mixed bipolar episode with suicidal ideation. Detailed review of psychotropics revealed the patient having been dispensed misbranded mixed generics for both AEDs, temporally correlated to the onset of the mixed episode. Conclusions: With increasing AED generics and insurance requirements, these cases emphasize the need for pharmacovigilance by patients/clinicians/pharmacists. Therapeutic drug monitoring in the acute and maintenance phase of illness is recommended to ascertain optimal therapeutic dose/concentration and to track potential aberrations in AED levels which may lead to increased adverse effects and decreased efficacy during pharmacologic treatment of epilepsy, pain, and psychiatric disorders.