Organizational Readiness to Implement Community Pharmacy-Based Opioid Counseling and Naloxone Services: A Scoping Review of Current Practice Models and Opportunities.

The purpose of this study was to explore existing practice models and opportunities surrounding community pharmacist-delivered opioid counseling and naloxone (OCN) services in the U.S., with the goal of enhancing organizational readiness and improving patient access. A scoping literature review was conducted. English-language articles published in peer-reviewed journals from January 2012-July 2022 were sought via PubMed, CINAHL, IPA, and Google Scholar using permutations of terms such as "pharmacist/pharmacy", "opioid/opiate", "naloxone", "counseling", and "implement/implementation". Original articles reporting the resources/inputs (personnel; pharmacist full-time equivalents; facilities and expenses; in-house versus outsourced personnel), implementation processes (legal source of pharmacist authority; patient identification strategies; intervention procedures; workflow strategies; business operations), and programmatic outcomes (uptake and delivery; interventions made; economic impact; patient or provider satisfaction) of pharmacist-delivered OCN services in community (retail) settings were retained. Twelve articles describing ten unique studies were included. The studies primarily used quasi-experimental designs and were published from 2017 to 2021. The articles described seven broad program elements/themes: interprofessional collaboration (n = 2); patient education format including one-on-one patient education (n = 12) and group education sessions (n = 1); non-pharmacist provider education (n = 2); pharmacy staff education (n = 8); opioid misuse screening tools (n = 7); naloxone recommendation/dispensing (n = 12); and opioid therapy and pain management (n = 1). Pharmacists screened/counseled 11-2716 patients and provided 11-430 doses of naloxone. Limited implementation costs, patient/provider satisfaction, or economic impact measures were reported. This review may serve as a guide for community pharmacists in implementing OCN services in their own practices. Future studies should clarify OCN program implementation costs, patient/provider satisfaction, and the economic impact.

Knowledge of Kratom among Alabama Pharmacists.

Kratom (Mitragyna speciosa) is a botanical substance whose leaves produce stimulant- and opioid-like effects. Kratom use has increased precipitously in the United States (U.S.) over the last decade, yet, in our experience, many pharmacists are unfamiliar with this herb. The purpose of this study was to assess pharmacists' awareness and knowledge of kratom. This cross-sectional study used an online questionnaire to preferentially solicit community pharmacists' knowledge of kratom and collect demographic information. The survey was sent via email to approximately 10,000 pharmacists, targeting those in the state of Alabama, U.S. Data were analyzed using descriptive statistics, and the Chi Square test was used to compare nominal data. A total of 257 participants responded to the survey. Almost 50% of participants had heard of kratom, and 50% had not. Compared to females, males were more likely to have heard of kratom (64% vs. 42%; p = 0.0015), as were pharmacists who worked for an independent pharmacy vs. a chain (61% vs. 41%; p = 0.025). Of the participants who had heard of kratom, only 14% considered themselves knowledgeable or very knowledgeable about the herb, and only 44% knew it was illegal in Alabama. These data indicate a need to further kratom education among community pharmacists in Alabama.

A state-wide education program on opioid use disorder: influential community members' knowledge, beliefs, and opportunities for coalition development.

BACKGROUND: Deep South states, particularly Alabama, experience disproportionately higher opioid prescribing rates versus national rates. Considering limited opioid use disorder (OUD) providers in this region, collaborative efforts between non-healthcare professionals is critical in mitigating overdose mortality. The Alabama Opioid Training Institute (OTI) was created in 2019 to empower community members to take action in combatting OUD in local regions. The OTI included: 1) eight full-day in-person conferences; and 2) an interactive mobile-enabled website ( https://alabamaoti.org ). This study assessed the impact of the OTI on influential community members' knowledge, abilities, concerns, readiness, and intended actions regarding OUD and opioid overdose mitigation. METHODS: A one-group prospective cohort design was utilized. Alabama community leaders were purposively recruited via email, billboards, television, and social media advertisements. Outcome measures were assessed via online survey at baseline and post-conference, including: OUD knowledge (percent correct); abilities, concerns, and readiness regarding overdose management (7-point Likert-type scale, 1 = strongly disagree to 7 = strongly agree); and actions/intended actions over the past/next 6 months (8-item index from 0 to 100% of the time). Conference satisfaction was also assessed. Changes were analyzed using McNemar or Marginal Homogeneity tests for categorical variables and two-sided paired t-tests for continuous variables (alpha = 0.05). RESULTS: Overall, 413 influential community members participated, most of whom were social workers (25.7%), female (86.4%), and White (65.7%). Community members' OUD knowledge increased from mean [SD] 71.00% [13.32] pre-conference to 83.75% [9.91] post-conference (p < 0.001). Compared to pre-conference, mean [SD] ability scale scores increased (3.72 [1.55] to 5.15 [1.11], p < 0.001) and concerns decreased (3.19 [1.30] to 2.64 [1.17], p < 0.001) post-conference. Readiness was unchanged post-conference. Attendees' intended OUD-mitigating actions in the next 6 months exceeded their self-reported actions in the past 6 months, and 92% recommended the OTI to others. CONCLUSIONS: The Alabama OTI improved community leaders' knowledge, abilities, and concerns regarding OUD management. Similar programs combining live education and interactive web-based platforms can be replicated in other states.

Part Two: Diabetes Part 2: A Review of Insulin Therapy in Older Patients.

Diabetes mellitus is a common disease state among older people, with type 2 diabetes making up most cases. As the disease progresses, many patients will need to transition to insulin therapy. Pharmacists can play a pivotal role in the care of older people with diabetes by providing recommendations related to insulin therapy. Senior care pharmacists need to be knowledgeable about the pharmacokinetics, dosing, adverse effects, and cost concerns related to insulin therapy.

Effect of Interprofessional Clinical Debates on Attitudes of Interprofessional Teams.

INTRODUCTION: Current evidence supports the notion of debates as a pedagogical method to teach literature evaluation skills in health care education; however, there are no reports of this method as an interprofessional approach and its potential benefits. The aim of this study was to assess the impact of interprofessional clinical debates on attitudes toward interprofessional teamwork and perceived literature evaluation skills. METHODS: We invited third-year family medicine residents and fourth-year pharmacy students to complete a survey before and after participating in an interprofessional clinical debate. The anonymous survey was composed of the Students' Perceptions of Interprofessional Clinical Education-Revised (SPICE-R2) instrument to evaluate perceptions of interprofessional teamwork, literature evaluation, and other skills gained through the process. We evaluated matched responses for change in attitudes toward interprofessional teams. RESULTS: We evaluated 41 matched responses, which indicated improvement in attitudes toward interprofessional teams and was statistically significant ( P<.001). This finding held true for subscales of roles/responsibilities for collaborative practice and patient outcomes from collaborative practice (P<.001). Participants also perceived improvements in literature evaluation, problem-solving, critical thinking, teamwork, and communication skills. CONCLUSION: The interprofessional clinical debate activity positively impacted medical residents and pharmacy students, and improved attitudes toward interprofessional teams.

Overview of venous thromboembolism.

Venous thromboembolism (VTE) describes the diagnoses of deep vein thrombosis (DVT) or pulmonary embolism (PE). DVT is the formation of thrombi in the deep veins, most commonly the large veins of the legs or pelvis. PE develops when thrombi dislodge from clots in vein walls and travel through the heart to pulmonary arteries. In many patients, the presenting manifestation of PE is sudden death. VTE may be categorized as provoked or unprovoked. This categorization influences the risk of recurrent VTE and duration of anticoagulation therapy. It is important for primary care providers to clearly understand the pathogenesis and causes of thrombosis in order to create evidence-based therapeutic and prophylactic patient care plans that adequately prevent recurrent VTE.

Acquired Thrombophilia.

Acquired thrombophilia is associated with an increased risk of venous thromboembolism (VTE). Antiphospholipid syndrome (APS) is the most prevalent acquired thrombophilia and is associated with both venous and arterial thromboses. Human immunodeficiency virus (HIV) is another form of acquired thrombophilia. Risk factors associated with VTE in this population include those related to the disease itself, host factors, and the pharmacotherapy for HIV. A significant proportion of VTE events occur in patients with malignancies. There is an increase in mortality associated with patients having cancer who experience VTE when compared to patients having cancer without VTE. Combination oral contraceptive (COC) use infers risk of thromboembolic events. The risk is dependent upon the presence of an underlying inherited thrombophilia, the estrogen dose, and generation of progestin. Patients at highest risk of VTE include those receiving high-dose estrogen and fourth-generation, progesterone-containing contraceptives. With the exception of APS, thrombophilia status does not alter the acute treatment of an initial VTE in nonpregnant patients.

Pregnancy-Related Venous Thromboembolism.

Pregnancy is associated with an increased risk of venous thromboembolism (VTE), with a reported incidence ranging from 0.49 to 2 events per 1000 deliveries. Risk factors include advanced maternal age, obesity, smoking, and cesarian section. Women with a history of previous VTE are at a 4-fold higher risk of recurrent thromboembolic events during subsequent pregnancies. Additionally, the presence of concomitant thrombophilia, particularly factor V Leiden (homozygosity), prothrombin gene mutation (homozygosity), or antiphospholipid syndrome (APS), increases the risk of pregnancy-related VTE. Low-molecular-weight heparin (LMWH) and unfractionated heparin (UFH) are the drugs of choice for anticoagulation during pregnancy. LMWH is preferred due to ease of use and lower rates of adverse events. Women with high thromboembolic risk particularly those with a family history of VTE should receive antepartum thromboprophylaxis. Women with low thromboembolic risk or previous VTE caused by a transient risk factor (ie, provoked), who have no family history of VTE, may undergo antepartum surveillance. Postpartum anticoagulation can be considered in women with both high and low thromboembolic risk.

Inherited Thrombophilia.

Thrombophilia alters normal hemostasis, shifting the balance in favor of thrombus formation. Inherited conditions include factor V Leiden (FVL), prothrombin G20210A mutation, deficiencies in natural anticoagulants (antithrombin [AT], protein C, and protein S), hyperhomocysteinemia, and elevations in clotting factors (factors VIII and XI). Although FVL and prothrombin mutation are common disorders, deficiencies in the natural anticoagulants are rare. The risk of initial thrombosis conferred by inherited thrombophilia varies with the highest risk in those homozygous for either FVL or prothrombin mutation, or with AT deficiency. In the nonpregnant patient, the presence of a thrombophilia does not affect treatment of an acute event. Although vitamin B supplementation has been shown to decrease the levels of homocysteine, the treatment has failed to show a benefit in thrombus prevention and is therefore not recommended.

Thrombophilia Screening.

Although controversial, screening for thrombophilia has become common. Testing for antiphospholipid antibodies is indicated in order to guide treatment decisions if there is clinical suspicion for antiphospholipid syndrome. The utility of identifying other thrombophilias in symptomatic venous thromboembolism (VTE) is questionable, as the risk of recurrence does not appear to be increased by an appreciable degree with the most common disorders (heterozygosity for factor V Leiden or prothrombin mutation). Although recurrence appears to be increased in those with homozygous or multiple abnormalities and potentially deficiencies in natural anticoagulants, screening to detect these conditions is difficult to justify based on their rarity. The American College of Chest Physicians' current guidelines note the increased risk of recurrence with idiopathic, proximal events regardless of thrombophilia status. They suggest duration of anticoagulation therapy be based on location and provoking factors rather than whether or not the individual has a thrombophilia. Because routine prophylaxis in asymptomatic individuals with thrombophilia is not recommended, screening of asymptomatic family members is difficult to justify. Screening prior to prescribing combination oral contraceptives is not cost effective, may result in unwanted pregnancies, and may have little effect on the overall rate of VTE.

Mitiglinide for type 2 diabetes treatment.

INTRODUCTION: Mitiglinide , a rapid-acting insulin secretion-stimulating agent, is approved in Japan for the treatment of type 2 diabetes (T2DM). Rapid-acting insulin secretion-stimulating agents, also known as meglitinides, are not recommended as monotherapy, however, may be added to metformin therapy for those patients with continued postprandial hyperglycemia. Currently, repaglinide (Prandin®) and nateglinide (Starlix®) are the only US Food and Drug Administration-approved agents in this class of drugs. AREAS COVERED: This review describes the pharmacology, pharmacokinetics, efficacy, safety, and potential role in therapy of mitiglinide therapy. Phase II and III clinical studies have demonstrated that A1C levels should be expected to decrease by 0.17 - 1.1% with mitiglinide therapy. The most common adverse effects in these studies were hypoglycemia related. EXPERT OPINION: Meglitinides are limited by their cost, frequency of administration, and minimal available data assessing clinical impact; however, mitiglinide shows selective action on the pancreatic ß-cells, has greater affinity for ß-cells, and limited metabolism when compared to other meglitinides. These properties may allow more utility in patients with chronic kidney disease or at high risk of hypoglycemia. The primary role in therapy for mitiglinide is the treatment of elevated postprandial glucose in patients with T2DM.

Rivoglitazone: a new thiazolidinedione for the treatment of type 2 diabetes mellitus.

OBJECTIVE: To review the pharmacology, pharmacokinetics, efficacy, and safety of the thiazolidinedione rivoglitazone, a peroxisome proliferator-activated receptor-γ (PPAR-γ) agonist, to determine its potential role in the treatment of type 2 diabetes mellitus. DATA SOURCES: A MEDLINE search (1966-February 2013) was conducted for English-language studies in humans, using the terms rivoglitazone and CS011. Abstracts presented at the American Diabetes Association and European Association for the Study of Diabetes annual meetings from 2007 to 2012 were also evaluated for relevant data. STUDY SELECTION AND DATA EXTRACTION: Articles pertinent to the pharmacology, pharmacokinetics, efficacy, and safety of rivoglitazone were reviewed. DATA SYNTHESIS: Rivoglitazone has been shown, through small clinical studies, to decrease hemoglobin A(1c) (A1C) by 0.11-1.1% when compared with placebo and may provide greater A1C reduction than pioglitazone. Rivoglitazone reduces hyperglycemia, hyperinsulinemia, and hypertriglyceridemia by acting as an agonist of PPAR-γ. Rivoglitazone is the most potent PPAR-γ agonist; the initial recommended dose is 1 mg daily, with adjustment as needed to a maximum dose of 2 mg daily. Additionally, rivoglitazone has a longer half-life than other PPAR-γ agonists. Similar to those of the other PPAR-γ agonists, rivoglitazone's adverse effects include peripheral edema and weight gain. CONCLUSIONS: Rivoglitazone is the fourth agent in the thiazolidinedione class of antidiabetes drugs. Although rivoglitazone appears to be more potent in its ability to lower A1C levels compared with other thiazolidinediones, further studies of longer duration are needed to fully assess the risks associated with this drug. Until these can be completed, we cannot recommend rivoglitazone over currently approved drugs in this class.

Development of an antibiogram in a long-term care facility.

OBJECTIVE: To create an antibiogram-a profile of an organism's susceptibility/resistance to a panel of antibiotics- for a long-term care facility to assess the prevalence of resistance of bacteria present at the facility. DESIGN: Retrospective analysis of culture and sensitivity data from July 1, 2009, through June 30, 2010. SETTING: A long-term care facility in Huntsville, Alabama. PATIENTS AND PARTICIPANTS: Residents of the long-term care facility that had one or more culture and sensitivity test performed. MAIN OUTCOME MEASURE: Susceptibility of bacteria to each antimicrobial tested. RESULTS: Results were compiled and reported according to the Clinical and Laboratory Standards Institute Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data. The most commonly seen bacteria in our long-term care facility were Escherichia coli, Staphylococcus aureus, Enterococcus faecalis, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Proteus mirabilis. Resistance rates for these bacteria were high and included the presence of methicillinresistant S. aureus and extended-spectrum beta-lactamase-producing bacteria. CONCLUSION: Resistance rates were high among all organisms reported. This poses a serious threat to the health care team's ability to effectively treat residents of this facility. Development of an antibiogram to assist physicians in antimicrobial selection will be beneficial in helping evaluate trends in drug resistance to current available treatments. Implementing clinical pathways for empiric treatment of infections could improve the ability to provide consistent treatment for all residents in the facility.

A quality improvement course review of advanced pharmacy practice experiences.

OBJECTIVES: To determine strengths of and quality improvements needed in advanced pharmacy practice experiences (APPE) through a systematic course review process. DESIGN: Following the "developing a curriculum" (DACUM) format, course materials and assessments were reviewed by the curricular subcommittee responsible for experiential education and by key stakeholders. Course sequence overview and data were presented and discussed. A course review worksheet was completed, outlining strengths and areas for improvement. ASSESSMENT: Student feedback was positive. Strengths and areas for improvement were identified. The committee found reviewing the sequence of 8 APPE courses to be challenging. CONCLUSIONS: Course reviews are a necessary process in curricular quality improvement but can be difficult to accomplish. We found overall feedback about APPEs was positive and student performance was high. Areas identified as needing improvement will be the focus of continuous quality improvement of the APPE sequence.

Triple therapy: boon or bane for high-risk CV patients?

The combination of 2 antiplatelet agents and warfarin may be beneficial to a select group of patients, but its use remains controversial. Here's why.

Mitiglinide: a novel agent for the treatment of type 2 diabetes mellitus.

OBJECTIVE: To review the pharmacology, pharmacokinetics, efficacy, and safety of mitiglinide, a rapid-acting insulin secretion-stimulating agent to determine its potential role in therapy for the treatment of type 2 diabetes mellitus. DATA SOURCES: A MEDLINE search (1966-May 2010) was conducted for English-language, human studies using the terms mitiglinide, KAD 1229, S 21403, and meglitinide analogs. Abstracts presented at the American Association and European Association for the Study of Diabetes annual meetings from 2005 to 2009 were also evaluated for relevant data. STUDY SELECTION AND DATA EXTRACTION: Articles pertinent to the pharmacology, pharmacokinetics, efficacy, and safety of mitiglinide were reviewed. DATA SYNTHESIS: Mitiglinide has been shown through small clinical studies (N <400) to modestly decrease hemoglobin A(1c), postprandial hyperglycemia, and oxidative stress and inflammatory markers associated with postprandial hyperglycemia. Mitiglinide exerts its hypoglycemic activity by closing adenosine triphosphate (ATP)-sensitive potassium channels in the ß-islet cells of the pancreas. This agent has a rapid onset and short duration of action, mimicking a physiologic pattern of insulin release in nondiabetic people. Studies suggest a starting dose of 5 mg 3 times daily with meals and a maximum dose of 20 mg 3 times daily. Overall, mitiglinide is well tolerated, with the most common adverse effect being hypoglycemia. CONCLUSIONS: Mitiglinide is the third agent in the class of meglitinides that targets postprandial hyperglycemia. Because of a more intensive dosing regimen, potential cost, and lack of studies assessing the clinical impact of mitiglinide therapy on oxidative stress and inflammatory markers secondary to postprandial hyperglycemia, we cannot recommend this therapy over currently approved therapies.

Efficacy and safety of i.v. alteplase therapy up to 4.5 hours after acute ischemic stroke onset.

PURPOSE: The efficacy and safety of i.v. alteplase up to 4.5 hours after acute ischemic stroke (AIS) onset were evaluated. SUMMARY: Stroke is the leading cause of disability in the elderly, and i.v. alteplase (recombinant tissue plasminogen activator) is the only Food and Drug Administration (FDA)-approved thrombolytic agent for the treatment of AIS. Alteplase has been shown to decrease the percentage of patients disabled by a stroke. Until recently, the use of alteplase was only recommended within 3 hours of the onset of AIS symptoms. However, two clinical trials published in 2008 demonstrated that therapy with i.v. alteplase remains safe and effective when given 3-4.5 hours after AIS onset. Although FDA has not yet approved expanding the time interval to 4.5 hours for treatment with i.v. alteplase, the American Stroke Association recently published a statement recommending administration of alteplase in eligible patients 3-4.5 hours after symptom onset. There is clinical evidence supporting the safety and efficacy of i.v. alteplase administration to eligible patients who present within 4.5 hours of AIS symptom onset. Treatment with alteplase decreases the likelihood of disability from an AIS and is not associated with an increased rate of mortality. Expanding the time window for treatment with alteplase would likely increase the percentage of AIS patients who are able to receive alteplase and thus ultimately decrease the percentage of those left disabled from an AIS. CONCLUSION: Evidence supports the safety and efficacy of i.v. alteplase administration to eligible patients within 4.5 hours of AIS symptom onset.

Comparison of the modification of diet in renal disease and Cockcroft-Gault equations for antimicrobial dosage adjustments.

BACKGROUND: Direct measurement of glomerular filtration rate (GFR) is considered to be the most accurate method of assessing kidney function, albeit difficult and costly. With the derivation of the Modification of Diet in Renal Disease (MDRD) equation to estimate GFR in patients with chronic kidney disease, questions exist as to whether this method should be preferred over the Cockcroft-Gault (CG) equation when making dosage adjustments for renally eliminated antimicrobials. OBJECTIVE: To determine whether a difference exists when making antimicrobial dosage adjustments in patients with chronic kidney disease based on estimation of GFR using the MDRD and CG equations. METHODS: We conducted an observational analysis of 409 patients with chronic kidney disease who were admitted to a tertiary care facility with an inpatient dialysis center and nephrology unit. GFR was calculated using both the 4- or 6-variable MDRD equation and the CG equation and compared using correlation and Bland-Altman methodology. Dosage discordance rates of the selected antimicrobials were determined on the basis of manufacturer renal dose recommendations. RESULTS: Average +/- SD GFR for all patients using the CG equation was 34.8 +/- 12 mL/min and, using the MDRD equation, was 40.2 +/- 12 mL/min (absolute mean difference 5.40; 95% CI 4.66 to 6.15; p < 0.001). The correlation coefficient between the 2 estimations, among all patients, was excellent (r = 0.80). The Bland-Altman plot yielded limits of agreement of -9.8 and 20.6; thus, the MDRD estimation may range from 9.8 mL/min below to 20.6 mL/min above the CG estimation for 95% of the cases. A discordance rate of 21-37% (p < 0.001) existed among the recommended dosing adjustments of the selected antimicrobials. CONCLUSIONS: This analysis demonstrated statistically significant differences between the CG and MDRD equations, resulting in different dosing recommendations in 21-37% of patients. The clinical significance of these differences is uncertain in the absence of data regarding clinical outcomes that would result from the use of the discordant doses.