The evolution of multiple sclerosis disease-modifying therapies: An update for pharmacists.

PURPOSE: Multiple sclerosis (MS) and the evolution of disease-modifying therapies (DMTs) and their indications, mechanisms of action, efficacy, pregnancy class, and cost are discussed. SUMMARY: MS is an immune-mediated, demyelinating, and progressive neurological disorder that can cause both motor and cognitive deficits. Onset of MS typically occurs between the ages of 20 and 40 years, and the disease can result in significant disability over time. Since the introduction of the first DMT for the treatment of MS in 1993, significant progress has been made in the development of new classes of DMTs with different mechanisms of action, higher efficacy, and simpler administration schedules, offering patients better alternatives. However, drawbacks with the use of DMTs include their increasing cost and formulary restrictions. CONCLUSION: The treatment landscape of MS has significantly changed over the past 2 decades, and the introduction of newer classes of DMTs provides an opportunity for pharmacists to play an important role in the management of this patient population.

Enhancing epilepsy self-management and quality of life for adults with epilepsy with varying social and educational backgrounds using PAUSE to Learn Your Epilepsy.

PURPOSE: People with epilepsy (PWE) come from a wide variety of social backgrounds and educational skillsets, making self-management (SM) education for improving their condition challenging. Here, we evaluated whether a mobile technology-based personalized epilepsy SM education intervention, PAUSE to Learn Your Epilepsy (PAUSE), improves SM measures such as self-efficacy, epilepsy SM behaviors, epilepsy outcome expectations, quality of life (QOL), and personal impact of epilepsy in adults with epilepsy. METHODS: Recruitment for the PAUSE study occurred from October 2015 to March 2019. Ninety-one PWE were educated using an Internet-enabled computer tablet application that downloads custom, patient-specific educational programs from Epilepsy.com. Validated self-reported questionnaires were used for outcome measures. Participants were assessed at baseline (T0), the first follow-up at completion of the PWE-paced 8-12-week SM education intervention (T1), and the second follow-up at least 3 months after the first follow-up (T2). Multiple linear regression was used to assess within-subject significant changes in outcome measures between these time points. RESULTS: The study population was diverse and included individuals with a wide variety of SM educational needs and abilities. The median time for the first follow-up assessment (T1) was approximately 4 months following the baseline (T0) and 8 months following baseline for the second follow-up assessment (T2). Participants showed significant improvement in all SM behaviors, self-efficacy, outcome expectancy, QOL, and personal impact of epilepsy measures from T0 to T1. Participants who scored lower at baseline tended to show greater improvement at T1. Similarly, results showed that participant improvement was sustained in the majority of SM measures from T1 to T2. CONCLUSION: This study demonstrated that a mobile technology-based personalized SM intervention is feasible to implement. The results provide evidence that epilepsy SM behavior and practices, QOL, outcome expectation for epilepsy treatment and management, self-efficacy, and outcome expectation and impact of epilepsy significantly improve following a personalized SM education intervention. This underscores a greater need for a pragmatic trial to test the effectiveness of personalized SM education, such as PAUSE to Learn Your Epilepsy, in broader settings specifically for the unique needs of the hard-to-reach and hard-to-treat population of PWE.

Self-management skills and behaviors, self-efficacy, and quality of life in people with epilepsy from underserved populations.

PURPOSE: People with epilepsy (PWE) from underserved populations face significant barriers to epilepsy management and therefore may lack knowledge about epilepsy and self-management (SM) of epilepsy. This paper evaluates SM practices, self-efficacy, outcome expectancy, quality of life, and personal impact of epilepsy in PWE from underserved populations as compared with all PWE. METHODS: Recruitment for the Managing Epilepsy Well (MEW) Network PAUSE to Learn Your Epilepsy study occurred from October 2015 to March 2019. Participants were assessed at baseline; after SM education intervention; and 6-, 9-, and 15-month postbaseline assessment. Baseline data from 112 PWE were analyzed for this report. RESULTS: Study population was diverse: 63% were women, 47.3% were non-Hispanic black, 24.1% were Hispanic, and 57.4% had public healthcare coverage. Participants on average had epilepsy for 14 years, and 49.1% reported at least one seizure within the past month, but only 27% reported having used a seizure diary or calendar for seizure tracking. Self-management practices & behaviors were significantly lower among PWE from underserved populations than all PWE, though self-efficacy among PWE from underserved populations was significantly higher. CONCLUSION: This study identifies the unique epilepsy SM needs of PWE from underserved populations. We discuss the need for a personalized approach for developing SM skills and behaviors among these PWE.

The Impact of Psychoactive Drugs on Seizures and Antiepileptic Drugs.

Psychiatric comorbidities are very common in patients with epilepsy, and in fact, a bidirectional relationship between epilepsy and some psychiatric disorders have been identified. However, despite their high prevalence, these comorbidities are not routinely recognized or adequately treated causing a significant burden for these patients. Atypical presentations of some of these psychiatric comorbidities in epilepsy, the concern that some psychotropic drugs may lower seizure threshold worsening frequency of seizures, possibility of many drug-drug interactions, and the negative impact of some antiepileptic drugs on psychiatric conditions are some of the challenges faced by clinicians. Although the main focus in epilepsy has remained on treatment of seizures, acknowledgment of these comorbidities and their timely diagnosis and appropriate treatment not only can impact patients' quality of life but also may improve their response to antiepileptic therapies.

Management of multiple sclerosis and the integration of related specialty pharmacy programs within health systems.

PURPOSE: The management of multiple sclerosis (MS) and the integration of related specialty pharmacy programs within health systems are discussed. SUMMARY: MS is a progressive immune-mediated inflammatory disease of the central nervous system. Current treatment strategies include the use of disease-modifying therapies (DMTs) that have various degrees of efficacy and tolerability. These DMTs also differ with respect to frequency and route of administration, which can significantly impact patient compliance and ultimately their response to therapy. The introduction of oral and injectable DMTs requiring less-frequent injections and having better adverse-effect profiles may help patients improve adherence to therapy; however, access to these therapies is often restricted due to both their high cost and limited distribution. These DMTs include fingolimod, teriflunomide, dimethyl fumarate, and pegylated interferon beta-1a. All others, with the exception of fingolimod, have limited distribution. Pharmacists in health-system pharmacy programs can play a significant role in assisting patients with MS manage their disease efficiently and safely by educating them about their therapies, ensuring compliance with the associated risk evaluation and mitigation strategy (REMS) program, and helping them access these therapies in a timely manner. CONCLUSION: MS is a progressive neurologic disorder that requires lifelong treatment with DMTs. Good compliance, compliance with the associated REMS program, and timely access to these drugs may positively influence patient care and outcomes and provide an opportunity for the health-system pharmacists to have a active role in caring for these patients.

Integrated clinical and specialty pharmacy practice model for management of patients with multiple sclerosis.

PURPOSE: An integrated clinical and specialty pharmacy practice model for the management of patients with multiple sclerosis (MS) is described. SUMMARY: Specialty medications, such as disease-modifying therapies (DMTs) used to treat MS, are costly and typically require special administration, handling, and storage. DMTs are associated with high rates of nonadherence and may have associated safety risks. The University of Illinois Hospital and Health Sciences System developed an MS pharmacy practice model that sought to address the many challenges of coordinating care with multiple entities outside the health system. Several key features of the integrated model include a dedicated clinical pharmacist on the MS specialty team, an integrated specialty pharmacy service, direct access to the electronic medical record, and face-to-face interaction with patients. Through the active involvement of the neurology clinical pharmacist and an onsite specialty pharmacy service, targeted assessments and medication and disease education are provided to the patient before DMT initiation and maintained throughout therapy. In addition, the regular point of contact and refill coordination encourages improved compliance, appropriate medication use, ongoing safety monitoring, and improved communication with the provider for quicker interventions. This fosters increased accessibility, convenience, and patient confidence. Improving patient outcomes--the priority goal of this service model--will be assessed in future planned studies. Through this new practice model, providers are empowered to incorporate specialty medication management into transitions in care, admission and discharge quality indicators, readmissions, and other core measures. CONCLUSION: An integrated pharmacy practice model that includes an interdisciplinary team of physicians, nurses, and pharmacists improved patient compliance with MS therapies.

Influence of body weight, ethnicity, oral contraceptives, and pregnancy on the pharmacokinetics of azithromycin in women of childbearing age.

Women of childbearing age commonly receive azithromycin for the treatment of community-acquired infections, including during pregnancy. This study determined azithromycin pharmacokinetics in pregnant and nonpregnant women and identified covariates contributing to pharmacokinetic variability. Plasma samples were collected by using a sparse-sampling strategy from pregnant women at a gestational age of 12 to 40 weeks and from nonpregnant women of childbearing age receiving oral azithromycin for the treatment of an infection. Pharmacokinetic data from extensive sampling conducted on 12 healthy women were also included. Plasma samples were assayed for azithromycin by high-performance liquid chromatography. Population data were analyzed by nonlinear mixed-effects modeling. The population analysis included 53 pregnant and 25 nonpregnant women. A three-compartment model with first-order absorption and a lag time provided the best fit of the data. Lean body weight, pregnancy, ethnicity, and the coadministration of oral contraceptives were covariates identified as significantly influencing the oral clearance of azithromycin and, except for oral contraceptive use, intercompartmental clearance between the central and second peripheral compartments. No other covariate relationships were identified. Compared to nonpregnant women not receiving oral contraceptives, a 21% to 42% higher dose-adjusted azithromycin area under the plasma concentration-time curve (AUC) occurred in non-African American women who were pregnant or receiving oral contraceptives. Conversely, azithromycin AUCs were similar between pregnant African American women and nonpregnant women not receiving oral contraceptives. Although higher levels of maternal and fetal azithromycin exposure suggest that lower doses be administered to non-African American women during pregnancy, the consideration of azithromycin pharmacodynamics during pregnancy should guide any dose adjustments.