Purpose Research has shown that academic detailing (AD), which includes repeated in-person educational messages in an interactive format in a physician's office, is among the most effective continuing medical education (CME) forms for improving prescribing practices and reducing drug costs. The purpose of this paper is to investigate AD's feasibility and acceptability as an educational tool among psychiatrists and its ability to facilitate positive changes in antipsychotic prescribing. Design/methodology/approach All psychiatrists practicing in Southwestern Ontario, Canada were invited to participate. Participants (32/299(10.7 percent)) were provided with two educational sessions by a healthcare professional. Participants evaluated their AD visits and completed a pre- and post-AD questionnaire measuring various prescribing practice aspects. Findings A total of 26 out of 32 (81.3 percent) participants completed the post-AD evaluation; most of them (61.5 percent, n=16) felt that AD gave noteworthy information on tools for monitoring side-effects and 50.0 percent ( n=13) endorsed using these in practice. In total, 13 participants (50.0 percent) felt that the AD sessions gave them helpful information on tools for documenting polypharmacy use, which 46.2 percent ( n=12) indicated they would implement in their practice. No significant differences were found between participants' pre- and post-assessment prescribing behaviors. Practical implications There is great need for raising AD program's awareness and improving physician engagement in this process locally, provincially and nationally. Originality/value To the authors' knowledge, this is the first AD program in Canada to target specialists solely. Participant psychiatrists accepted the AD intervention and perceived it as a feasible CME method.
Abstract:Introduction: Intramuscular (IM) olanzapine has been approved for the management of acute agitation/psychosis secondary to schizophrenia, bipolar disorder, and dementia, in a dose not to exceed 10 mg per injection and 30 mg per day. Many other clinical situations exist in which patients are acutely agitated and in whom IM olanzapine might be warranted at recommended or higher doses. We systematically reviewed data on 8 such patients, during 10 inpatient admissions, to assess the overall safety and tolerability of this approach. Methods: Using a standardized data recording sheet, we retrospectively collected information on 10 inpatient admissions between 2004 and 2007, in which IM olanzapine was administered outside of product dosing and/or indication guidelines. We present composite data and the details of each case individually. Results: Records of eight patients (5 males, 3 females; mean age/age range = 43.9/18-77 years) were reviewed over 10 inpatient admissions, 5 to Psychiatry, 4 to Surgery, and one to Internal Medicine. Indications for admission were mania (2), schizophrenia (1), schizoaffective disorder (2), brain injury (2), sepsis (1), sepsis with respiratory failure (1), and cancer (1). Five patients were intoxicated with or experienced withdrawal from alcohol and/or drugs, likely adding to their agitation. Only one symptomatic episode of orthostatic hypotension occurred, in a patient with comorbid C. difficile colitis, which resolved when antibiotics were initiated and olanzapine discontinued; olanzapine IM was successfully reinstituted 2 days later, without incident. No other significant adverse events or side effects were ascribed to IM olanzapine. Conclusions: Intramuscular olanzapine may be safe to use outside of product dosing and indication guidelines. Randomized clinical trials are warranted to study such off-label use further.
Paliperidone palmitate is a second generation antipsychotic, approved for the treatment of schizophrenia in the form of the long-acting injectable (LAI) products INVEGA SUSTENNA® (once monthly injection) and INVEGA TRINZA® (once every 3 months injection). Paliperidone palmitate dissolves slowly after deep intramuscular injection before being hydrolyzed to paliperidone and absorbed into the systemic circulation. The pharmacokinetic (PK) profile of the INVEGA SUSTENNA® formulation is biphasic, comprised of an initial relatively fast zero-order input, which allows rapid attainment of therapeutic concentrations without oral supplementation; and a subsequent maintained second-stage, first-order input, allowing for once monthly administration. Changes to the manufacturing processes can substantially alter the release characteristics of paliperidone palmitate LAI and consequently its PK profile. As an example, larger or smaller particle sizes of paliperidone palmitate can result in a delayed or accelerated release of paliperidone into the systemic circulation, respectively. Such changes are clinically relevant, as transient excursions above therapeutic plasma concentrations can be associated with an increased risk of adverse effects, including tachycardia, hypotension, QT prolongation, and extrapyramidal symptoms. Conversely, a delay in attaining therapeutic plasma concentrations of paliperidone on initiation of treatment, or a return to low plasma concentrations before the end of a dosing interval during repeated dosing, increases the risk of relapse. Given the integral relationship of the PK profile to the product’s clinical effects, it is important to have bioequivalence standards that reflect the complexity of the paliperidone palmitate LAI PK profile if one is to consider therapeutic equivalence based on simple bioequivalence testing. Although both the EMA and U.S. FDA have product-specific guidelines to determine bioequivalence, their requirements differ substantially. In Canada, no LAI product-specific bioequivalence guidance exists for multiphasic medication delivery systems, and the recently revised Comparative Bioavailability Standards: Formulations Used for Systemic Effects guidance applies only to oral and non-injectable formulations. We recommend that new Canadian standards be developed for multiphasic and biphasic intramuscular / subcutaneous (IM/SC) products, including paliperidone palmitate LAI products, because, similar to modified-release oral dosage forms, a different PK profile in modified-release IM/SC products can result in clinically meaningful differences in safety, efficacy, and tolerability. To ensure bioequivalence for both newly initiated and switch patients, this paper proposes bioequivalence standards that could be adopted in Canada that include two studies, a multiple-dose cross-over study, and a single-dose study with partial AUC metrics.
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