Quetiapine Misuse and Abuse: Is It an Atypical Paradigm of Drug Seeking Behavior?

Recent case reports in medical literatures suggest that more and more second-generation atypical antipsychotics (AAs) have been prescribed for off-label use; quetiapine (Brand name: Seroquel®) showed increase in its trend for off-label use. Little is known about the reasons behind this trend, although historical sedative and hypnotic prescription patterns suggest that despite relatively superior safety profiles of quetiapine (especially for movement disorders), it may be used for treating substance abuse disorder. In addition, recent studies have shown a strong potential for misuse and abuse (MUA) of quetiapine beyond Food and Drug Administration-approved indications. This includes drug-seeking behaviors, such as feigning symptoms, motivated by quetiapine and use of quetiapine in conjunction with alcohol. Quetiapine appears to be the most documented AA with street values bartered illicitly on the street. A recent report from the Drug Abuse Warning Network has shown a high prevalence of quetiapine-related emergency department visits involving MUA. Several other case studies have found that quetiapine causes seeking behaviors observed in substance use disorder. In fact, the majority of quetiapine MUA involved patients diagnosed with substance use disorder. In the absence of a definitive mechanism of action of quetiapine\u27s reinforcing properties, it is imperative to gather robust evidence to support or refute increasing off-label use of AAs

Performance-Based Risk-Sharing Arrangements (PBRSA): Is it a Solution to Increase Bang for the Buck for Pharmaceutical Reimbursement Strategy for Our Nation and Around the World?

© 2020, Springer Nature Switzerland AG. Due to the risks involved in not achieving desired health outcomes for the dollar spent on drugs, healthcare decision makers, including payers, providers, drug manufacturers, and patients, need a mechanism to share this financial risk among the involved parties. Performance-based risk-sharing arrangements (PBRSAs) are agreements that can potentially reduce the ‘drug lag’ in which patients wait for an unknown amount of time until a particular drug is covered under their health plan. In addition, PBRSAs can mitigate the risk of investing heavily in drugs that are ineffective or do not deliver good value or “bang for the buck”. This review describes and evaluates PBRSAs for drugs in the USA and juxtaposes to other developed nations (i.e. Germany) that adopted PBRSAs in their healthcare model. There are different types of outcomes-based health schemes, namely conditional coverage, which can be further broken down into coverage with evidence development (CED), conditional treatment continuation (CTC), and performance-linked reimbursement, which includes outcomes guarantees. Both CED and CTC are ‘conditional’ on the collected evidence of the new drug’s effectiveness, offering discount only if the drug delivers desirable results. The outcomes guarantee scheme offers discount or even a full refund if the outcome is less than expected, forcing the drug to meet the expected effectiveness. The USA can follow the German reference pricing model in which the assessment of new drugs is centralized and done collectively by representatives from a group of healthcare decision makers. In any shape or form, PBRSA is a clever mechanism to cope with uncertainty if drug price is scaled appropriately based on value

Urinary bisphenol A versus serum bisphenol A concentration and ovarian reproductive outcomes among IVF patients: Which is a better biomarker of BPA exposure?

© 2017, The Korean Society of Toxicogenomics and Toxicoproteomics and Springer Science+Business Media B.V., part of Springer Nature. Bisphenol A (BPA) is an endocrine-disrupting compound (EDC) that is used widely in commercial products in the production of polycarbonate plastics for baby and water bottles, epoxy resins for lacquer lining of food and beverage cans and water pipes, dental sealants, dental composites and thermal receipts paper. There is inhibitory effect of BPA on nuclear estrogen (E2) production in granulosa cells of developing follicles that disrupt normal development to the antral follicles via suppression of E2 in granulosa cells of developing follicles during the menstrual cycle followed by reduction in the number of oocytes retrieved in in-vitro fertilization (IVF) patients. Several studies corroborate an inverse association between serum and/or urinary BPA concentration and the IVF outcome: Peak E2 levels and the number of oocytes retrieved. Upon oral ingestion, 99.5% of unconjugated parent BPA (free BPA) is metabolized to either BPA glucuronide (BPA-G) or BPA sulfate (BPA-S). The unconjugated BPA can bind to the estrogen receptors (ER) while conjugated BPA (biologically inactive BPA) do not bind the estrogen receptor (ER). The challenge is to assess the relationship between BPA exposure among infertile patients with respect to follicular response and health during IVF. The establishment of temporal sequence between BPA exposure and infertility would be the research question to answer: Which route is a better biomarker? The advantages of urine BPA collection would provide pragmatic advantages for clinicians in order to practice cost-effective medicine. However, unconjugated BPA measurement (compared to total BPA) introduces challenges in measurement accuracy since unconjugated BPA requires higher magnitude of limit of detection (LOD) with higher risk of contamination from the medical equipment. The difference in route of BPA assessment could introduce bias in the interpretation of results in terms of the association between BPA levels and the number of oocytes. Fujimoto et al. and Bloom et al. analyzed the relationship between serum BPA and IVF outcome in infertile women. It may sound hypothetically justified due to utilizing serum unconjugated BPA, this strategy is not successful in choosing a practical biomarker of BPA exposure due to toxicokinetic properties of BPA metabolism and excretion in humans

Prescription Drug Price Paradox: Cost Analysis of Canadian Online Pharmacies versus US Medicare Beneficiaries for the Top 100 Drugs

© 2017, Springer International Publishing AG. Background and objectives: Despite the introduction of Medicare Part D (MPD) and 2012 Affordable Care Act (ACA), patients have a cost burden due to increases in drug prices. To overcome cost barriers, some patients purchase their medications from Canadian online pharmacies as Canadian prescription drug prices are believed to be lower than US prescription drug prices. The objective of this study was to determine which top 100 Medicare drugs can be imported to the USA legally, and to determine which type of prescription drug would be more beneficial to be purchased from Canadian online pharmacies. Moreover, we also deemed it important to compare MPD beneficiary annual expenses with expenses patients would have when obtaining their prescriptions from Canadian online pharmacies. Methods: We conducted a cost analysis from a patient perspective. A list of the top 100 Medicare drugs was compiled and information on drug prices was collected from three Canadian online pharmacies and four MPD plans in Virginia. The annual cost of each Medicare drug and percent change between Canadian online pharmacies and MPD were compared. Results: A total of 78 drugs from the top 100 Medicare drugs were included in the final analysis. Seventy-six prescription drugs (97.4%) that could be purchased from Canadian online pharmacies showed a significantly lower average drug price percent change of −72.71% (P \u3c 0.0001). The heart health/blood pressure subgroup had the highest number of drugs that could be purchased from Canadian online pharmacies. Conclusion: The majority of prescription drugs can be purchased at lower prices from Canadian online pharmacies when compared to Medicare beneficiaries’ potential expenses. Purchasing medications from Canadian online pharmacies may be a viable option to address cost barriers

Systematic Review and Meta-analysis of Pharmacist-Led Transitions of Care Services on the 30-Day All-Cause Readmission Rate of Patients with Congestive Heart Failure

© 2019, Springer Nature Switzerland AG. Background and Objective: A systematic review and meta-analysis were performed to determine the cumulative effect of pharmacist-led transitions of care on the 30-day all-cause readmission rates of patients with congestive heart failure with the objective to isolate and assess the effect of pharmacy intervention to a condition-specific service. Previous studies that review pharmacist-led transitional care services involve multiple condition-specific services or a pharmacy service integrated into the healthcare team that presents complications in interpreting the independent effectiveness of component services by pharmacy professionals. Methods: A systematic review was conducted using articles identified from MEDLINE, CINAHL, Web of Science, Embase, the Cochrane Library, and clinicaltrials.gov databases for studies on congestive heart failure readmission rates based on transitions of care pharmacist services using detailed inclusion and exclusion criteria. Abstracts were screened for outcome of interest and appropriate transitions of care program structure. Practice and patient characteristics were described and compared to identify current practice trends. A meta-analysis was then performed utilizing previously identified studies from systematic analysis that reported the required data to calculate the effect size. Evidence was reviewed and appraised according to the Newcastle-Ottawa Scale for cohort studies. Results: The database search produced 443 potential articles for inclusion. Six articles were identified for inclusion in the systematic review based on abstract screening. Of the six articles included in the systematic review, three studies met inclusion criteria for a meta-analysis. Two studies in the meta-analysis stated a significant reduction in the 30-day all-cause readmission rate for patients with congestive heart failure, while the third depicted a reduction in readmission that was found to be non-significant. The pooled effect of the included articles found that pharmacist-led transitions of care services for patients with congestive heart failure had an increased odds to have lower all-cause readmission rates of patients with congestive heart failure (odds ratio = 2.19, 95% confidence interval 1.50–3.20). Based on the meta-analysis of three studies, pharmacist-led transitions of care services significantly reduced the odds of 30-day all-cause readmission rates in patients with congestive heart failure compared with standard-of-care discharge protocols. Conclusion: Results of the meta-analysis demonstrate the capacity for pharmacist-led transitions of care programs to reduce 30-day all-cause readmission rates in patients with congestive heart failure compared with non-pharmacist discharge care. The financial implications of transitions of care pharmacist involvement have yet to be validated. In general, existing database search results highlight the lack of evidence detailing specific clinical outcomes of pharmacist-led transitions of care services in distinct chronic conditions. Future studies may serve to compare patient-centered outcomes between condition-specific services or across disciplines to provide the most cost-effective delivery of care