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.

The patient perspective on overactive bladder: a mixed-methods needs assessment.

BACKGROUND: While overactive bladder is often managed in the primary care setting, a number of barriers including embarrassment, poor communication, and low patient adherence contribute to the under-treatment of patients with burdensome urinary symptoms. In order to address these challenges, it is crucial to have a fundamental understanding of patient perspectives toward OAB and urinary symptoms. To meet this aim, researchers designed and conducted a study to identify patients' knowledge, experiences and attitudes, barriers to treatment adherence, and desires and tendencies regarding patient/clinician communications. METHODS: A mixed-methods qualitative/quantitative needs assessment of patients with overactive bladder and/or urinary symptoms. Researchers conducted in-depth qualitative interviews via telephone with 40 patients. Interview results informed the design and dissemination of a quantitative survey, which was completed by 200 self-selected respondents who had previously identified themselves as having overactive bladder or bladder problems. Statistical and qualitative analysis of results were conducted. RESULTS: Among survey respondents, an average of 3.5 years elapsed between symptom onset and seeking diagnosis by a physician. In the long term most patients do not experience improvement in symptoms. Medication non-adherence is common and is related to therapy effectiveness and adverse effects. Patients clearly indicate that communication and patient/physician relationships are important to them and they would prefer the clinician initiate the conversation on overactive bladder. Patient experiences, perspectives, and attitudes toward their bladder symptoms differ in many ways from clinicians' assumptions. CONCLUSIONS: The significant time gap between symptom onset and diagnosis indicates ongoing need for screening and diagnosis of overactive bladder. Contrary to guideline recommendations, urinalysis and physical examination are not widely used in clinical practice. Many patients experience no improvement in symptoms over time. Patients indicate that clinician/patient relationships and communication regarding their condition are important.