The roles of type 2 diabetes and obesity in disease activity and progression of non-alcoholic fatty liver disease/non-alcoholic steatohepatitis.

OBJECTIVE: We examined the roles of type 2 diabetes (T2D) and obesity in disease activity and fibrosis progression/regression in patients with non-alcoholic fatty liver disease/non-alcoholic steatohepatitis (NAFLD/NASH). METHODS: This multi-center, retrospective study included patients with suspected or histologically proven NAFLD/NASH from the NASH Clinical Research Network. Outcomes included disease activity and rate of fibrosis, assessed using liver-biopsy driven measures (NAFLD activity score [NAS] and fibrosis score [FS]). Logistic regression and doubly robu estimation of causal effects tested relationships among T2D, obesity, and NAFLD/NASH. RESULTS: The analytical sample included 870 adult patients with baseline biopsy data and 157 patients with multiple biopsy data. Patients with NAFLD/NASH and T2D had significantly higher baseline average NAS (4.52 vs. 4.13; p = 0.009) and FS (2.17 vs. 1.56; p < 0.0001); those with T2D had a significantly greater reduction in average NAS over time (-0.77/year vs. -0.17/year; p = 0.0008). Change in FS over time did not differ significantly by T2D status (-0.23/year vs. -0.04/year; p = 0.34). Baseline NAS, baseline FS, and change in average NAS over time did not differ significantly by obesity status (4.17 vs. 4.47; p = 0.16; 1.73 vs.1.92; p = 0.31; -0.40/year vs. -0.59/year; p = 0.62, respectively). Patients with obesity had a slight increase in FS but those without obesity had a reduction in average FS over time (0.07/year vs. -0.27/year; p = 0.008). CONCLUSIONS: Patients with NAFLD/NASH and T2D had greater baseline disease activity versus those without T2D, but there was greater regression of disease activity over time among those with T2D. Patients with NAFLD/NASH and obesity had worsening of fibrosis versus those without obesity. NCT00063622.

The impact of community pharmacy utilization of immunization information systems on vaccination rates: Results of a clustered randomized controlled trial.

BACKGROUND: Adult immunization rates in the United States remain low. More convenient access to immunization information systems (IIS) may improve vaccination rates. OBJECTIVE: The objective of this multilevel, clustered, randomized controlled study was to measure the impact of providing pharmacists with software and training to query IIS for patient vaccine history/recommendations on adult influenza, pneumococcal, herpes zoster, and Td/Tdap vaccination rates. METHODS: California Rite Aid pharmacy districts were randomized into intervention/control groups using stratified randomization based on baseline influenza vaccination rates. Store demographic characteristics were collected at baseline (January 1-December 31, 2018). During follow-up (April 1, 2019-March 31, 2020), intervention group stores received access to ImmsLink, software that allows health care providers to review immunization records from IIS and identify a patient's recommended vaccinations. The difference-in-difference between intervention and control groups compared the changes in vaccination rates from baseline to follow-up by calculating adjusted ratios of risk ratios (RRRs). Analysis was performed at the store level. RESULTS: Thirty-six districts comprising 501 Rite Aid stores (intervention: n = 244 stores; control: n = 257) were included. We found no significant differences in vaccination rates between groups: influenza, 19-64 years (adjusted RRR 0.99 [95% CI 0.83-1.17]); influenza, ≥65 years (1.02 [0.86-1.22]); herpes zoster (1.07 [0.90-1.28]); pneumococcal (0.95, 0.80-1.14); and Td/Tdap (0.88, 0.73-1.05). Reasons that recommended vaccines were not given in the intervention group included patient being deferred to future visit, patient declining, patient having already received the vaccination, patient declining because of cost, or vaccine being unavailable. Overall, pharmacist engagement with ImmsLink was low. CONCLUSION: Providing pharmacists with software and training to query IIS did not improve vaccination rates compared with control pharmacies in this study. Factors such as an inconvenient interface or inadequate training or motivation may have caused low engagement with the software and should be considered in future interventions.

Physician-approved protocols increase naloxone dispensing rates.

OBJECTIVE: To measure the impact of the implementation of a law that allows pharmacists to provide naloxone under a physician-approved protocol on naloxone dispensing rates in an all-payer population across the United States. METHODS: Prescription claims from a national grocery chain for 31 states and Area Heath Resource File were used for this retrospective study. The study sample included all patients who filled at least one naloxone prescription during the study period from July 16, 2014 to January 16, 2017. A stepwise autoregression was performed for 30 consecutive months to evaluate the change in naloxone prescription dispensing rate. The primary independent variable was "implementation of the physician-approved protocol." The primary outcome measure was the rate of naloxone prescriptions dispensed per month per state. Secondary outcome measures were naloxone dispensing rates by each payer. RESULTS: Number of patients who received naloxone prescriptions in the states with physician-approved protocol was 423% higher compared to states without the protocol. The overall model showed that the naloxone dispensing rate was 6 times higher in the states with a physician-approved protocol. In the payer-based models, comparing states with and without protocol, the dispensing rate was highest for Medicare (9.0 times) followed by Private (4.6 times), Medicaid (3.2 times), and Cash (3.1 times). The number of prescriptions dispensed in the low-employment states with the protocol was 17.59 times higher compared to states without the protocol. CONCLUSIONS: Implementation of physician-approved protocol was strongly associated with an increase in naloxone dispensing rates, especially in the low-employment states.

Challenges and Facilitators of Implementing a Physician-approved Naloxone Protocol: A Mixed-methods Study.

OBJECTIVES: In 2015, the State of Ohio passed legislation to allow pharmacists to dispense naloxone under a physician-approved protocol. The legislation allows all individuals authorized under a physician-approved protocol to personally furnish naloxone without requiring clients to be seen by a licensed prescriber, thus expanding the capacity of Ohio's community distribution programs. We aimed to evaluate the implementation of legislation allowing for a physician-approved protocol in pharmacies and other naloxone distribution sites in Ohio, and to compare barriers and facilitators of implementing the law changes among sites that implemented a physician-approved protocol versus sites that did not. METHODS: The study used a convergent parallel mixed-method design. Random samples from all pharmacies registered with the State of Ohio Board of Pharmacy and community naloxone distribution sites were selected. Quantitative data were collected via survey (n = 168) and qualitative data were collected via semi-structured interviews (n = 17). RESULTS: Most survey respondents agreed that the policy has expanded access to naloxone at their site for individuals who want or need the medication. Both pharmacies and other naloxone distribution sites identified that leadership and organizational support facilitated protocol implementation and cost, stigma, and lack of naloxone demand challenged protocol implementation. CONCLUSIONS: The study identified barriers and facilitators to the implementation of a physician-approved protocol within Ohio. The majority of respondents stated they could implement a protocol. However, barriers of cost, lack of public awareness of naloxone availability, and stigma remain for pharmacies and other naloxone distribution sites.

Association Between a State Law Allowing Pharmacists to Dispense Naloxone Without a Prescription and Naloxone Dispensing Rates.

Importance: Between 2015 and 2017, Ohio had the second highest number of opioid-related deaths. In July 2015, the Ohio General Assembly approved a law allowing pharmacists to dispense naloxone without a prescription in accordance with a physician-approved protocol. This change in the law allowed pharmacists to have more opportunity to participate in the management of patients who were addicted to opioids. Objective: To determine the association between the implementation of an Ohio law allowing pharmacists to dispense naloxone without a prescription in accordance with a physician-approved protocol and naloxone dispensing rates. Design, Setting, and Participants: A segmented regression analysis of an interrupted time series was performed for 30 consecutive months to evaluate the change in the naloxone dispensing rate before and after the implementation of the state law. Ohio Medicaid naloxone claims and Kroger Pharmacy naloxone claims for all 88 counties in Ohio were examined. Any patient 18 years or older with at least 1 naloxone order dispensed through Ohio Medicaid or by a Kroger Pharmacy in Ohio during the study period of July 16, 2014, to January 15, 2017, was included in the study. Data were analyzed from April 23, 2018, to July 7, 2019. Exposures: The primary independent variable was implementation of an Ohio law allowing pharmacists to dispense naloxone without a prescription in accordance with a physician-approved protocol, which took effect in July 2015. Main Outcomes and Measures: The primary outcome measure was the naloxone dispensing rate per month per county. Results: In the Ohio Medicaid population, the number of naloxone orders dispensed after the policy was implemented increased by 2328%, from 191 in the prepolicy period to 4637 in the postpolicy period. The rate of naloxone orders dispensed per month per county after the policy was implemented increased by 4% in the Ohio Medicaid population and 3% in the Kroger Pharmacy population compared with the prepolicy period. The rate of naloxone orders dispensed after the policy was implemented increased by 18% per month in low-employment counties compared with high-employment counties in the Ohio Medicaid population. Conclusions and Relevance: The implementation of a state law allowing pharmacists to dispense naloxone without a prescription in accordance with a physician-approved protocol was associated with an increase in the number of naloxone orders dispensed in the Ohio Medicaid and Kroger Pharmacy populations. Moreover, a significant increase was observed in the naloxone dispensing rate among the Ohio Medicaid population in counties with low employment and high poverty.

Marked Variation Exists Among Surgeons and Hospitals in the Use of Secondary Cleft Lip Surgery.

OBJECTIVE: To identify child-, surgeon-, and hospital-specific factors at the time of primary cleft lip repair that are associated with the use of secondary cleft lip surgery. DESIGN: Retrospective cohort study. SETTING: Forty-nine pediatric hospitals. PARTICIPANTS: Children who underwent cleft lip repair between 1999 and 2015. MAIN OUTCOME MEASURE: Time from primary cleft lip repair to secondary lip surgery. RESULTS: By 5 years after primary lip repair, 24.0% of children had undergone a secondary lip surgery. In multivariable analysis, primary lip repair before 3 months had a 1.22-fold increased hazard of secondary surgery (95% confidence interval [CI]: 1.02-1.46) compared to repair at 7 to 12 months of age, and children with multiple congenital anomalies had a 0.77-fold decreased hazard of secondary surgery (95% CI: 0.68-0.87). After adjusting for cleft type, age at repair, presence of multiple congenital anomalies, and procedure volume, there remained substantial variation in secondary surgery use among surgeons and hospitals (P < .01). For children with unilateral cleft lip repaired at 3 to 6 months of age, the predicted proportion of children undergoing secondary surgery within 5 years of primary repair ranged from 4.9% to 21.8% across surgeons and from 4.5% to 24.7% across hospitals. CONCLUSIONS: There are substantial differences among surgeons and hospitals in the rates of secondary lip surgery. Further work is needed to identify causes for this variation among providers.

Assessment of community pharmacists' confidence, foundational knowledge, and coordination of care activities in patients with cancer as a chronic condition.

OBJECTIVES: To develop and deliver a series of structured educational programs to community pharmacists to build on current foundational knowledge of cancer and cancer therapy. The specific objectives were to: 1) develop and provide an educational program focused on oncology pharmacy practice in the community; and 2) measure the program impact on participants' confidence, foundational knowledge, and coordination of cancer care activities. PRACTICE INNOVATION: A structured, in-person, 6-hour educational program tailored for community pharmacists was developed and delivered along with two 20-minute online webinar sessions. The topics identified for the webinars were based on solicited feedback from participants attending the live educational program. EVALUATION: A pre- and post-survey was used to evaluate the participant's assessment of the live educational program, and a retrospective survey was used to evaluate the education sessions. RESULTS: Twenty-one pharmacists attended the in-person session. Participants indicated that they were more confident and able to coordinate care after the educational intervention. There was a nonsignificant improvement in foundational knowledge. CONCLUSION: The educational sessions provided current relevant information for community pharmacists to build on knowledge of oncology pharmacy practice and resources. This increased the pharmacists' confidence to address needs and facilitate coordination of care for individuals with cancer. Delivery of education tailored to community pharmacy is important as the advancing cancer care model continues to adapt with new medications and innovations.