The increasing number and high prices of orphan drugs have triggered concern among patients, payers, and policymakers about the affordability of new drugs approved using the incentives set by the Orphan Drug Act (ODA) of 1983. This study evaluated the factors associated to the differences in the treatment cost of new orphan and non-orphan drugs approved by the FDA from 2017 to 2021. A generalized linear model (GLM) with the Gamma log-link analysis was used to ascertain the association of drug characteristics with the treatment costs of orphan and non-orphan drugs. The results of the study showed that the median and interquartile range (IQR) drug cost was USD 218,872 (IQR = USD 23,105) for orphan drugs and USD 12,798 (IQR = USD 57,940) for non-orphan drugs (p < 0.001). Higher market entry prices were associated with biologics (108%; p < 0.001), orphan status (177%; p < 0.001), US sponsor companies (48%; p = 0.035), chronic use (1083%; p < 0.001), treatment intent (163%; p = 0.004), and indications for oncology (624%; p < 0.001) or genetic disorders (624%; p < 0.001). Higher market entry treatment cost for newly approved drugs were associated with biologics, orphan status, US sponsor companies, chronic use, therapeutic intent, and indications for oncology or genetic disorders.

Background: The purpose of this study was to describe the impact of an Advanced Practice Pharmacist (APh) on lowering hemoglobin A1c (HbA1c) in patients with type 2 diabetes within a patient centered medical home (PCMH) and to classify the types of therapeutic decisions made by the APh. Methods: This was a retrospective study using data from electronic health records. The study evaluated a partnership between Chapman University School of Pharmacy and Providence St. Joseph Heritage Healthcare that provided diabetes management by an Advanced Practice Pharmacist in a PCMH under a collaborative practice agreement. Change in the HbA1c was the primary endpoint assessed in this study. The type of therapeutic decisions made by the APh were also evaluated. Descriptive analysis and Wilcoxon signed rank test were used to analyze data. Results: The study included 35 patients with diagnosis of type 2 diabetes mellitus managed by an APh from May 2017 to December 2017. Most of the patients were 60-79 years old (68.5%), 45.7% were female, and 45.7% were of Hispanic/Latino ethnicity. The average HbA1c was 8.8%±1.4% (range=6.0%-12.4%) and 7.5%±1.4% (range=5.5%-12.4%) at the initial and final APh visit, respectively (p<0.0001). Therapeutic decisions made by the APh included drug dose increase (35.5% of visits), drug added (16.4%), drug dose decrease (6.4%), drug switch (5.5%), and drug discontinuation (1.8%). Conclusion: The Advanced Practice Pharmacist’s interventions had a significant positive impact on lowering HbA1c in patients with type 2 diabetes mellitus in a PCMH. The most common therapeutic decisions made by the APh included drug dose increase and adding a new drug.   Article Type: Pharmacy Practice

Objectives: The purpose of this study was to identify abuse-related post-marketing reports associated with gabapentinoids use in the Middle East and North Africa (MENA) region countries. Methods: A retrospective cross-sectional analysis of abuse-related adverse drug event (ADE) reports from the Middle East and North Africa (MENA) region. It was performed using the Food and Drug Administration Adverse Event Reporting System (FAERS) database from January 2008 through June 2020. Abuserelated ADE reports for gabapentin and pregabalin were extracted from the FAERS database. Descriptive statistics were performed, and the proportional reporting ratio (PRR) was calculated to detect disproportional attribution of abuse-related ADEs for gabapentin versus pregabalin. Results:We identified 559 all-cause ADE reports for gabapentinoids, including 205 (36.7%) abuse-related ADE reports reported to FAERS in the period of analysis. FAERS included 139 (67.8%) pregabalin and 66 (32.2%) gabapentin abuse-related ADE reports. Among MENA region countries, Turkey (55, 39.6%) and Saudi Arabia (34, 23.7%) had the highest number of abuse-related ADE reports for pregabalin. The most pregabalin abuse-related ADE reports involved adult male patients. The PRR of pregabalin versus gabapentin abuse-related ADE reports was 1.11, indicating that the number of abuse-related events was higher for pregabalin compared to gabapentin. Conclusion: Over 200 cases of abuserelated gabapentinoids events were reported to FEARS from the MENA region in the study period. Further studies should assess risk factors and potential programs to reduce gabapentinoids abuse.

the good follow-up of diabetes patients in Sweden with continuous treatments adaptations to keep HbA1c low. Conclusions: Progression of HbA1c is slower with the SNDR equation. We advise to use this equation to do health policy analyses where treatment changes are inherent to the policy. To define HbA1c progression in costeffectiveness analysis, we advise to use the UKPDS68 equation, which is a better representation of the progression without treatment adaptations.

protecting children against both serotypes was introduced, after which the model estimated shifts in the new postvaccine serotype distribution equilibrium. Default parameters were identified, and scenario analyses were tested on vaccine coverage rate, levels of adult-to-child transmission rates, and relative population sizes. Results: The distributions between the two serotypes prior to vaccination were 25%:75% in children and 50%:50% in adults, and the proportions infected were 43% and 33%, respectively. For the default parameters, 80% vaccine coverage reduced the proportion of children infected by 92% and shifted the child serotype distribution at equilibrium toward the adult distribution to 47%:53%. Similar results were observed for all parameter scenarios, with the serotype distribution among infected children shifting closer to the adult distribution as vaccine coverage increased. Conclusions: The model demonstrates that serotype distribution in children after vaccination may be influenced by the adult serotype distribution, with higher vaccine coverage shifting the child distribution closer to the adult distribution. As adult-to-child infection becomes more common than childto-child infection, the adult serotype distribution becomes more prominent in the child population. These results support the hypothesis that rotavirus exposure from adult populations contributes to observed shifts in rotavirus serotype distributions in children after vaccine introduction.