Journal of Pharmacy Technology

Includes bibliographical references.

Stability of Olmesartan Medoxomil Extemporaneous Suspensions -- Risk Factors Associated With Nephrotoxicity During Outpatient Intravenous Vancomycin Administration -- A Continuing Education Activity Durably Addressed Knowledge Gaps Related to Penicillin Allergies Among Pharmacists and Pharmacy Technicians -- Examination of the Effectiveness of Direct Oral Anticoagulants in Comparison to Warfarin in an Obese Population -- Pharmacist Hypertension Management Quality Review at an Ambulatory Care Clinic -- Media Generation and Pharmacy Regulatory Authority Awareness -- The Comparative Dosing and Glycemic Control of Intermediate and Long-Acting Insulins in Adult Patients With Type 1 and 2 Diabetes Mellitus -- Opioids and the Risk of Motor Vehicle Collision: A Systematic Review.

[Article Title: Stability of Olmesartan Medoxomil Extemporaneous Suspensions / Prapanna Bhattarai, Timothy McPherson, Marcelo Nieto and William M Kolling, p. 3-9]

Abstract:

Background: Olmesartan medoxomil (OLM) is only available in the United States as tablets. The United States Pharmacopoeia (USP) has placed OLM on its priority list of preparations that require stability data to support practitioner compounding. Objective: The purpose of the study was to develop a stability-indicating assay and then determine the beyond-use date (BUD) for an extemporaneous OLM suspension. Methods: A reverse-phase high-performance liquid chromatography (HPLC) assay was developed and validated according to guidelines for USP official compounded monographs. OLM 2 mg/mL suspensions were compounded with Ora-Sweet and Ora-Plus and stored at room temperature or in a refrigerator. Suspensions were assayed periodically over 90 days for OLM concentration and observed for physical stability. The pH was measured at the beginning and end of the study. Results: The OLM concentration remained above 97% of the starting concentration for 90 days when stored in the refrigerator and above 94% of the starting concentration for 90 days when stored at room temperature. The suspension pH did not change and indicators of physical stability were unchanged for 90 days. Conclusion: OLM 2 mg/mL suspensions were chemically and physically stable at room temperature and in the refrigerator for 90 days. The BUD may be set at 90 days under either storage condition.

https://doi.org/10.1177/87551225211051756

[Article Title: Risk Factors Associated With Nephrotoxicity During Outpatient Intravenous Vancomycin Administration / Karen M. Krueger, Lisa LaCloche, Amy Buros Stein, Ryan Kates, Milena Murray and Michael P. Angarone, p. 10-17]

Abstract:

Background: Many studies have described an association between intravenous vancomycin and nephrotoxicity; however, the majority have evaluated incidence and risk factors among hospitalized patients. Outpatient administration of intravenous antibiotics is a growing practice and presents its own set of unique challenges.

Objective: The aim of this study was to identify risk factors for vancomycin-associated nephrotoxicity in the outpatient setting.

Methods: A case-control study of patients who received intravenous vancomycin through an Outpatient Parenteral Antimicrobial Therapy (OPAT) program was conducted. Patients were identified who developed an acute kidney injury (AKI) during treatment. The primary outcome was the incidence of AKI during treatment.

Results: A total of 37 out of 130 patients (28.5%) met the criteria for AKI. AKI was more likely to occur in patients with a longer duration of therapy, higher maximum trough concentration, co-administration of a fluoroquinolone or metronidazole, and those who received another potentially nephrotoxic medication. Co-administration of a fluoroquinolone (OR = 5.96, P = 0.009, [CI: 1.59, 24.38]), any nephrotoxic medication (OR = 11.17, P < 0.001, [CI 3.14, 51.23]), and a higher maximum vancomycin trough (OR = 1.29, P < 0.001, [CI 1.17, 1.44]) were all indicative of a higher odds of an AKI.

Conclusion: In this cohort, vancomycin-associated nephrotoxicity was common during outpatient intravenous antibiotic therapy. Co-administration of a fluoroquinolone, any nephrotoxic medication, and a higher maximum vancomycin trough were associated with AKI development. Further study is needed to determine how this impacts long-term clinical outcomes and what measures can be taken to reduce nephrotoxicity risk.

https://doi.org/10.1177/87551225211054378

[Article Title: A Continuing Education Activity Durably Addressed Knowledge Gaps Related to Penicillin Allergies Among Pharmacists and Pharmacy Technicians / Elizabeth W. Covington, Spencer H. Durham, Christopher M. Bland, P. Brandon Bookstaver, Elias B. Chahine, Jonathan C. Cho, Fernando Diggs, Bruce M. Jones, Jeffrey A. Kyle, Kayla R. Stover, Jamie L. Wagner and Peter J. Hughes, p. 18-25]

Abstract:

Background: Penicillin allergy is one of the most frequent self-reported allergies; however, only about 10% of reported allergies are accurate.

Objectives: Through the creation of a continuing pharmacy education (CPE) activity, we sought to assess knowledge gaps and comfort levels in the management of penicillin allergies.

Methods: A 1-hour enduring-content CPE activity was offered as an interactive course from September 20, 2019, to September 20, 2020. Participants completed 3 surveys (pre-survey, post-survey, and follow-up survey). Participants were pharmacists and pharmacy technicians who completed, at a minimum, the activity and both pre- and post-surveys. The primary outcome was the percentage of participants scoring >80% on knowledge-based questions on the post-survey compared with the pre-survey. Secondary outcomes included pre-post comparisons on knowledge-based questions, participants’ self-report of an allergy, and comfort levels dispensing cephalosporins in a patient with a self-reported penicillin allergy.

Results: A total of 389 participants completed the CPE activity, with 176 included for analysis. Significantly more participants scored >80% on knowledge-based questions on the post-survey compared with the pre-survey (71.6% vs 22.7%, P < .001). There was no significant difference between the percentage of participants scoring >80% on the post-survey and the follow-up survey (71.6% vs 65%, P = .119). The majority of participants (74%) felt comfortable dispensing a cephalosporin in a patient with a penicillin allergy on the pre-survey, with similar percentages on the post- and follow-up surveys (77% and 90%, respectively).

Conclusion: A targeted continuing education program improved overall knowledge, which was sustained for up to 2 months.

https://doi.org/10.1177/87551225211051015

[Article Title: Examination of the Effectiveness of Direct Oral Anticoagulants in Comparison to Warfarin in an Obese Population / Rachel M. Watson, Carmen B. Smith, Erica F. Crannage and Laura M. Challen, p. 26-30]

Abstract:

Background: While commonly prescribed today, direct oral anticoagulants (DOACs) have historically been avoided in patients with class III obesity or a weight >120 kg due to limited literature regarding the efficacy and safety in this population.

Objective: The overall objective was to examine the effectiveness of DOACs compared to warfarin in a population with obesity.

Methods: Patients with a diagnosis of venous thromboembolism (VTE) or atrial fibrillation and a body mass index (BMI) ≥35 kg/m2 from August 1, 2015, to August 1, 2020, were included in this retrospective cohort study. Patients receiving a DOAC were matched in a 1:2 ratio to warfarin. The primary outcome was a composite of stroke or recurrent VTE. Secondary outcomes included the individual components of the primary outcome, hospitalization for bleed, and the primary outcome in patients with a BMI ≥40 kg/m2.

Results: A total of 162 patients were included, with 54 and 108 in the DOAC and warfarin groups, respectively. Baseline BMI was similar between groups (45.7 kg/m2 for DOACs vs 43.8 kg/m2 for warfarin), with approximately 70% of patients having a BMI ≥40 kg/m2. The primary outcome occurred in 1 patient (1.9%) in the DOAC group and 2 patients (1.9%) in the warfarin group. The DOAC group had a higher, nonsignificant incidence of bleeding (5.6% vs 0.9%, P = 0.11). There was no difference between groups in incidence of deep vein thrombosis (DVT), pulmonary embolism (PE), or stroke in patients with a BMI ≥40 kg/m2.

Conclusion: DOACs may be as efficacious as warfarin in the prevention of stroke or recurrent VTE in patients with a BMI of ≥35 kg/m2. Prospective, randomized trials are warranted to further assess the efficacy and safety of DOACs in this population.

https://doi.org/10.1177/87551225211064113

[Article Title: Pharmacist Hypertension Management Quality Review at an Ambulatory Care Clinic / Kayla Chonko, Sandra Axtell and Bianca Mayzel, p. 31-38]

Abstract:

Background: A reduction of 10 mm Hg in systolic blood pressure (SBP) significantly decreases the risk of major cardiovascular disease events. Pharmacists’ management of blood pressure may assist with this reduction.

Objective: Assess the impact of pharmacist management of hypertension via a collaborative practice agreement with physicians in an ambulatory care clinic.

Methods: The first phase of this study was a retrospective chart review of physician/nurse hypertension visits from October 2019 to August 2020. The second prospective phase consisted of pharmacist managed hypertension visits from December 2020 to January 2021. The primary outcome was the change in SBP from the beginning to the end of the study period in the prospective group. Secondary outcomes included the proportion of patients achieving their blood pressure goal and the proportion of patients adherent to all antihypertensive medications at their follow-up visits in both groups. This study was institutional review board approved.

Results: Forty-seven patients were included and analyzed (24 in the retrospective group and 23 in the prospective group). Patients in the prospective group had an average SBP lowering of 10.83 mm Hg (P = .0035). Thirteen patients (56.5%) met their blood pressure goal of <130/80 mm Hg in the prospective group, compared to 5 patients (20.8%) in the retrospective group (P = .012). One adverse event occurred during this study. Limitations included small sample size and short duration of study.

Conclusion: Patients had an average SBP lowering of >10 mm Hg. More patients reached a goal blood pressure of <130/80 mm Hg when managed by pharmacists.

https://doi.org/10.1177/87551225211064240

[Article Title: Media Generation and Pharmacy Regulatory Authority Awareness / Todd A. Boyle and Thomas Mahaffey, p. 39-45]

Abstract:

Background: Professional regulatory authorities play a critical role in protecting public interest. Yet, there is a growing view that trust in regulatory authorities may be on the decline.

Objective: Awareness has been identified as important for maintaining trust. However, research that examines public awareness and trust in pharmacy regulatory authorities (PRAs) is lacking. This research explores public awareness and trust of PRAs and presents recommendations to enhance PRA communication strategies.

Methods: An online survey was conducted with the Nova Scotia (Canada) public in 2020. Adopting classifications from the Communications literature, 3 media generations were explored: newspaper, television, and the Internet. The χ2 test of independence and Kruskal-Wallis H test were adopted to explore differences between the generations.

Results: Six hundred sixty-two usable surveys were obtained. Over 80% of those surveyed were aware of the existence of the PRA. Those who had heard of the PRA were most aware of its operational responsibilities and less aware of its governance. The Internet Generation was more aware that the PRA includes members of the public in its decision making than expected and showed increased trust toward the PRA versus the other media generations.

Conclusion: The findings should help inform PRA communication plans and set baselines to assess whether such plans enhance awareness. Future studies should explore additional aspects of PRA awareness and trust, perform comparisons across pharmacy jurisdictions, and develop and test models of the relationship between PRA awareness and various dimensions of institutional trust.

https://doi.org/10.1177/87551225211051593

[Article Title: The Comparative Dosing and Glycemic Control of Intermediate and Long-Acting Insulins in Adult Patients With Type 1 and 2 Diabetes Mellitus / Anna Kabakov and Andrew Merker, p. 46-53]


Abstract:

Objective:
The various basal insulin products possess differences in pharmacokinetics that can significantly impact glycemic control and total daily basal insulin dosing. In addition, there will be instances where transitions between the different long-acting insulins will need to be made. Because every basal insulin product is not interchangeable on a 1:1 unit-to-unit basis, it is important for health care providers to understand the expected dose adjustments necessary to maintain a similar level of glycemic control.

Data Sources:
A Medline and Web of Science search was conducted in September 2021 using the following keywords and medical subjecting headings: NPH, glargine, detemir, type 1 diabetes mellitus, and type 2 diabetes mellitus.

Study Selection and Data Extraction:
Included articles were those that followed adult patients with type 1 diabetes mellitus and/or type 2 diabetes mellitus and compared the following types of insulin: “NPH and glargine,” “NPH and detemir,” and “glargine and detemir” for at least 4 weeks, had documented basal insulin (BI) doses, and excluded pregnant patients.

Data synthesis:
Twenty-five articles were found that include adult type 1 and/or type 2 diabetes mellitus patients. Once daily NPH can be converted unit-to-unit to glargine or detemir. Twice daily NPH converted to glargine or detemir requires an initial 20% reduction in BI dose. An increase in dose of BI is recommended when transitioning from glargine to detemir. Glargine and detemir consistently resulted in improved glycemic control with lower incidence of hypoglycemic events compared with NPH.

Conclusions:
When transitioning between long-acting insulins, the doses are not always interchangeable on a 1:1 basis. Unit dose adjustments are likely if transitioning between BIs and can influence short-term parameters in the acute care setting and long-term parameters in the outpatient setting.

https://doi.org/10.1177/87551225211055700

[Article Title: Opioids and the Risk of Motor Vehicle Collision: A Systematic Review / Silvia J. Leon, Aaron Trachtenberg, Derek Briscoe, Maira Ahmed, Ingrid Hougen, Nicole Askin, Reid Whitlock, Thomas Ferguson, Navdeep Tangri, Claudio Rigatto and Paul Komenda, p. 54-62]

Abstract:

Background: Opioid analgesics are among the most commonly prescribed medications, but questions remain regarding their impact on the day-to-day functioning of patients including driving. We set out to perform a systematic review on the risk of motor vehicle collision (MVC) associated with prescription opioid exposure.

Method: We searched Medline, PubMed, EMBASE, Scopus, and TRID from January 1990 to August 31, 2021 for primary studies assessing prescribed opioid use and MVCs.

Results: We identified 14 observational studies that met inclusion criteria. Among those, 8 studies found an increased risk of MVC among those participants who had a concomitant opioid prescription at the time of the MVC and 3 found no significant increase of culpability of fatal MVC. The 3 studies that evaluated the presence of a dose-response relationship between the dose of opioids taken and the effects on MVC risk reported the existence of a dose-response relationship. Due to the heterogeneity of the different studies, a quantitative meta-analysis to sum evidence was deemed unfeasible. Our review supports increasing evidence on the association between motor vehicle collisions and prescribed opioids. This research would guide policies regarding driving legislation worldwide.

Conclusion: Our review indicates that opioid prescriptions are likely associated with an increased risk of MVCs. Further studies are warranted to strengthen this finding, and investigate additional factors such as individual opioid medications, opioid doses and dose adjustments, and opioid tolerance for their effect on MVC risk.

https://doi.org/10.1177/87551225211059926