The 1.5-hour training included a refresher on smoking cessation counseling and included in depth information on cessation medication options, how to use each product, and potential side effects. Cessation Champions provided onsite support for clients, including referring potential interested clients to our study, and liaised with the study staff on behalf of clientele. They received a $50 gift card after completing the training and a $75 gift card upon study completion. The Phase 3 medication assistance program took place at the two pilot shelters between August 2020 and June 2021; intervention roll-out at the two sites was staggered by 6 months. At each site, Cessation Champions completed training prior to the roll-out. We partnered with a community pharmacy that had pharmacists who could counsel for smoking cessation, prescribe NRT, and deliver medications on-site to the shelters. We recruited participants via word of mouth, flyers, and targeted outreach to known smokers by the Cessation Champion at that site. Participants were eligible if they were 1) at least 18 years old, 2) residents at one of the sites, 3) currently smoking at least 5 cigarettes per day, 4) interested in quitting within the next month, and 5) willing to use medications for smoking cessation. Upon enrollment, study staff placed a referral to the pharmacy using a secure online portal. Once the pharmacy received the referral, study staff facilitated an interaction between the pharmacist and the participant in which the pharmacist assessed smoking history, provided counseling, and determined appropriate NRT dosing. In most cases,hydroponic stands pharmacists offered combination NRT with the long-acting patch and short-acting gum/lozenge, unless the participants requested a specific form of NRT.
Pharmacists then prescribed the NRT, and arranged for delivery of NRT to the site within one week.Pharmacists had follow-up phone calls with some participants who wanted their prescription NRT dose tapered. We evaluated Phase 1 using process measures including number of shelters participating and number of staff trained. In Phase 2, we evaluated the number of Cessation Champions trained. We did not ask shelter staff to complete questionnaires after their trainings in Phase 1 or Phase 2. In Phase 3, study staff administered an online questionnaire to resident participants at baseline, during 11 weekly follow-up visits, and at 3-months follow-up. Additionally, study staff kept informal notes during the implementation process in Phase 3 on barriers to and facilitators of obtaining medications; we report these as process measures. Participants received a $15 gift card for completing the baseline questionnaire, a $5 gift card for each weekly follow-up questionnaire, and a $20 gift card for the questionnaire at 3-months follow-up. We described sample characteristics and tobacco use at baseline using proportions for categorical variables and median for continuous variables. We estimated cumulative proportions of quit attempts, encounters with study staff on smoking, use of NRT, type of NRT used, median number of days used, and reasons for not using. We used mixed effects Poisson and logistic regression models, accounting for repeated measures within participants to examine factors associated with weekly cigarette consumption and quit attempts , respectively. We adjusted for age, gender, baseline time to first cigarette after waking, baseline cigarette consumption as fixed effects in the model, and cigarette consumption, encounters with shelters staff on smoking, and use of NRT in the past week as random effects. Intra-subject correlation of repeated observations was accommodated using a random intercept for each subject.
Statistical analysis results are described using predicted counts and probabilities for interpretability. We conducted analyses in Stata 16. In this uncontrolled pilot study, we explored the feasibility of implementing a community pharmacy-linked smoking cessation program to improve access for PEH. We found that the program was feasible to implement and reduced cigarettes per day. Onsite access to medications and encounters with staff about smoking were the primary factors associated with reduction in tobacco use. These findings highlight a role for interventions that increase shelter capacity to offer cessation services linked with community pharmacist-delivered interventions. Clinical practice guidelines for smoking cessation recommend behavioral counseling combined with pharmacotherapy given that NRT effectiveness without smoking cessation counseling is limited. More frequent counseling encounters, regardless of clinician type, are positively associated with cessation. Consistent with these guidelines, we used a phased approach of building capacity to provide cessation counseling among shelter staff, followed by medication assistance for participants provided by pharmacists. In a previous capacity-building intervention for shelter staff, we found that training staff to provide cessation counseling was associated with fewer barriers and increased efficacy in delivering counseling. About half of the participants reported conversations with staff about smoking, and interactions with staff were associated with a 40% reduction in consumption. These findings suggest that fostering shelter staff counseling support for clients interested in smoking cessation is feasible and effective. Future research will query staff on their experience with counseling clientele on smoking cessation, which may influence counseling quality. Medication use in the past week was significantly associated with both reduction in consumption and an increase in quit attempts. Most quit attempts among PEH are unassisted, highlighting the need to improve medication access.
On average, study participants used NRT four days per week, and over 50% reported using medications for greater than 7 days in at least one week. Consistent with previous studies, the most common reasons for not using medications were concerns about access, side effects, and lack of efficacy. The primary barrier to receiving on-time delivery of medications for cessation was connecting community pharmacists with participants by phone. Despite study staff facilitating these interactions, pharmacists were often unable to provide point-of-care counseling or participants had competing priorities at the time of referral, leading to delays in initiating treatment. Over 70% of PEH report having cell phones,grow table however inconsistent service limits their use. Future studies could consider providing participants with cell phones to facilitate communication with members of their healthcare and social services teams. Our study had limitations. The sample size was small and involved two shelters in a single city, limiting generalizability. Only one participant had quit at the end of the study, however, point prevalence abstinence was not a primary outcome in this study. We assessed tobacco use, quit attempts, staff encounters, and medication use using self-report. Future studies could verify these findings by assessing biochemically verified abstinence, as well as considering longer-term outcomes. To our knowledge, this study is the first to explore a smoking cessation care model for PEH where community pharmacists partnered with shelters. The findings have implications for expanding access to cessation services at different service sites for PEH and suggest that community pharmacy-linked model of cessation care can increase access to services and medications. Expanding access to cessation services is the first step to reducing tobacco use among PEH,a population disproportionately impacted by tobacco use and that faces substantial structural barriers to receiving healthcare services. Health professional shortage areas are communities identified by the U.S. Human Resources and Services Administration in which there is a shortage of primary care health professionals.These shortages are accompanied by an absence of a consistent source of care, difficulty accessing care when needed, and a lack of outpatient preventative care, leading to increased hospitalizations.Multiple interventions have been attempted to increase access to care in HPSAs, including increased use of nonphysician providers. During the opioid epidemic, increasing access to naloxone furnishing has been viewed as critical in rural areas where opioid misuse is disproportionately high, including California’s Central Valley.In the United States, pharmacists at community pharmacies are one of the most accessible points of care, with 90% of Americans living within 5 miles of a pharmacy.People seeking care have expressed interest in services at pharmacies not only because of ease of accessibility but also the availability of multilingual staff and extended hours that make it possible to access care on evenings and weekends.Previous studies have also shown that pharmacy-based care can extend services for patients in medically under served rural areas to reduce inappropriate prescribing, improve disease management, and enhance medication adherence and knowledge.
In 2013, the California legislature passed SB 493, known as the Pharmacy Practice Bill, which expanded the role of pharmacists by giving them authority to furnish naloxone, hormonal contraception, nicotine replacement therapy, and travel medications, specifically prescription drugs and immunizations that are recommended by the Centers for Disease Control and Prevention to prevent or treat disease when travelling outside of the United States.California uses the term “furnish” to describe pharmacist-initiated prescription of medications.Expansion of pharmacist furnishing capabilities provides access to those in need, including people who use opioids.Past studies have sought to determine rates of pharmacist furnishing given its potential impact on access to care. However, these studies have focused on urban areas; 2 previous studies of pharmacist furnishing of naloxone in California sampled primarily urban pharmacies ; 3 previous studies on naloxone, hormonal contraception, and post exposure prophylaxis/preexposure prophylaxis furnishing were conducted in the San Francisco Bay Area only.As of the date of this study, there has been no prior research assessing furnishing rates in California’s Central Valley, a largely rural area, with a shortage of primary care physicians.However, understanding furnishing in these communities and those like it, particularly for naloxone, is critical given the disproportionate impact of the opioid epidemic in rural communities. For example, the age-adjusted rate of opioid-related overdose deaths in Fresno, one of the Central Valley’s largest counties, increased by 46%, from 48.6 per 100,000 residents in 2019 to 71 per 100,000 residents in 2020.This study sought to address this existing gap in research by assessing the extent of pharmacist furnishing, with a focus on naloxone, in the Central Valley. Research focused on the Central Valley due to the high potential impact of furnishing to increase access to care. It first assessed the extent of naloxone furnishing through a phone survey, then identified barriers and facilitators to implementation through interviews with a subset of furnishing pharmacists identified in the phone survey. We expected that rates of naloxone furnishing would be lower in disproportionately rural Central Valley pharmacies than in urban pharmacies evaluated in previous research, given the effects of high out-of-pocket costs in an area where people have lower incomes and social stigma surrounding opioid use disorders in more politically conservative communities.The first step of data collection was a telephone survey of all pharmacies with the potential to furnish naloxone in the Central Valley, to identify overall furnishing rates. Four authors who were PharmD students, in collaboration with undergraduate researchers at the University of California Merced Nicotine & Cannabis Policy Center , first contacted all pharmacies that met inclusion criteria using the telephone number listed in the Board of Pharmacy license database. Using an existing screening question from previously published research on naloxone furnishing, upon initial contact an interviewer posed the question, “I heard that you can get naloxone from a pharmacy without a prescription from yourdoctor. Can I do that at your pharmacy?” 19,20 Contact with each pharmacy was attempted up to 3 times. To identify potential interview contacts in the second step of data collection, interviews of furnishing pharmacists, each person at a pharmacy who that indicated it furnished naloxone was asked whether a furnishing pharmacist at the store would be interested in being interviewed for the study. If a pharmacist expressed interest, they received a cover letter, consent forms to sign by email or fax, and a list of interview questions. Researchers scheduled a time to interview after receiving this written consent. Pharmacies that did not furnish naloxone were not asked for interviews on the grounds that they would be unable to identify facilitators to furnishing naloxone at their store.Participants were interviewed in a semistructured manner using an interview instrument used in previously published research to study furnishing of other medications and modified to address naloxone.This instrument included a list of questions, however each interview was conducted in a semi-structured format that allowed for a natural flow of discussion and gave participants opportunities provide additional information that may not have been specifically addressed in the prepared questions.Topics included the following: characteristics of the pharmacy and staff ; description of the furnishing process; perceptions regarding the effectiveness, advantages, disadvantages, facilitators, and barriers to furnishing; whether respondents also furnished other medications; and recommendations for reproducibility or improvement.