Navigating the journey as a peer reviewer: a roadmap to success.

Peer review is an essential step in scientific progress and clinical improvement, providing opportunity for research to be critically evaluated and improved by one's colleagues. Pharmacists from all job settings are called to serve as peer reviewers in the ever-growing publication landscape of the profession. Despite challenges to engagement such as time and compensation, peer review provides considerable professional development for both authors and reviewers alike. This article will serve as a practical guide for peer reviewers, discussing best practices as well as the handling of different situations that may arise during the process.

Direct Oral Anticoagulants: Probability of Recurrent Venous Thromboembolism and Bleeding Risk in an Obese Population.

BACKGROUND: Direct-acting oral anticoagulants (DOACs) have become the preferred drugs for managing venous thromboembolism (VTE). Despite their advantages over vitamin K antagonists such as warfarin, their use in obese patients remains controversial with many providers reluctant to switch patients managed on warfarin. Outcome research that opts to increase provider confidence when prescribing DOACs for patients with obesity will be invaluable. OBJECTIVE: This investigation evaluated whether patients with a body mass index (BMI) 35 kg/m2 or greater who were prescribed a DOAC had a higher risk for a recurrent VTE or bleed event relative to warfarin. METHODS: The study was conducted in West Virginia which has the highest rate of obesity in the United States. RESULTS: Of the total study population (1633), 2.3% (37) had a recurrent thrombotic event, 5.5% (89) had a major bleed event, and 10.7% (174) had some type of bleeding event. No individual patient characteristic was associated with recurrent thrombosis-including BMI. Older age, antiplatelet use, and taking a medication with a theoretical risk of increasing the effect of DOACs were associated with any and major bleeding events. The use of warfarin was associated with major bleeding events more frequently versus a DOAC. Body mass index was not a predictor for recurrent VTE or any bleed or major bleed events. CONCLUSIONS: These findings support the conclusion that DOACs are an appropriate and effective drug class for the management of VTE in patients with obesity.

Levonorgestrel Emergency Contraception Information Accuracy From West Virginia Community Pharmacies: A Mystery Caller Approach.

BACKGROUND: To ensure access to effective levonorgestrel (LNG) emergency contraception (EC), pharmacies must keep medication in stock or available for quick delivery, and pharmacists must be knowledgeable about sales restrictions and the therapeutic window for EC. We conducted a mystery caller study to assess LNG EC availability and information accuracy provided by staff in West Virginia community pharmacies. METHODS: A female research team member posed as a 16-year-old caller to ask pharmacy staff questions about whether LNG EC was in stock, the requirements for purchase, and when it should be taken for effectiveness. Data were analyzed with SPSS using the Pearson's χ2 test to determine if there was a relationship between pharmacy type and response accuracy to our questions about point-of-sale requirements and timing for effectiveness for LNG EC. RESULTS: Of the 506 pharmacies in the sample, 275 (54.3%) were chain pharmacies and 231 (45.7%) were independent. Overall, chain pharmacies provided significantly more accurate answers than independent pharmacies on all point-of-sale requirements. Regarding timing for effectiveness, 49.2% of all pharmacies provided an accurate response (62.9% for chain pharmacies vs. 32.9% for independent pharmacies). CONCLUSIONS: Overall, availability and accuracy regarding LNG EC were poor in West Virginia pharmacies. Pharmacists, particularly those at independent pharmacies serving rural communities, are in a critical and powerful position to influence community health by providing accurate and timely information and access to all contraceptive options, including LNG EC.

The impact of caller characteristics on levonorgestrel emergency contraception access in West Virginia community pharmacies.

OBJECTIVE: Access to levonorgestrel (LNG) emergency contraception (EC) has increased since the FDA removed age restrictions on over-the-counter (OTC) LNG EC in 2013, but availability is highly variable and numerous barriers to access remain. The purpose of this study was to assess availability and accessibility of LNG EC at community pharmacies in West Virginia (WV). METHODS: A mystery caller cross-sectional study was conducted to assess availability and accessibility of LNG EC. Inquiries were made by identified 'research' staff and by staff presenting as a 16 y/o. RESULTS: Nearly half of community pharmacies reported having LNG EC in stock. Pharmacy staff were significantly more likely to tell research callers LNG EC was in stock (53%) and more likely to report willingness to order it (50%) than 'teen' callers (45% and 34%, respectively). There was no significant difference between caller types on the five barriers assessed. CONCLUSION: Lack of availability may contribute to teen and unintended pregnancies.

A Possible Case of COVID-19 Booster Vaccine-Associated Rhabdomyolysis and Acute Kidney Injury.

Background: Nearly 10 billion doses of the various messenger ribonucleic acid (mRNA) and viral vector vaccines against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) have been administered worldwide. Adverse drug reactions (ADRs) have been overwhelmingly mild to moderate in nature. Rare side effects have included myocarditis/pericarditis, thrombosis with thrombocytopenia syndrome (TTS), Guillain-Barré Syndrome (GBS), and death. However, vaccine-related ADR data are still being collected using a variety of reporting systems. Purpose: We will describe a case of suspected mRNA coronavirus disease 2019 (COVID-19) booster-related rhabdomyolysis in a woman who developed signs and symptoms 10 days after administration of the vaccine dose. With a Naranjo ADR probability score of 4, the vaccine was deemed to be a possible cause of our patient's rhabdomyolysis. Methods: A search of the VAERS (Vaccine Adverse Event Reporting System) mined in November 2021 revealed 386 reported cases of COVID-19 vaccine-related rhabdomyolysis. However, system limitations make the utility of the information problematic. Conclusions: It is vitally important that clinicians, scientists, and patients are aware of rhabdomyolysis as a potential side effect of vaccination. Suspected vaccine-related ADRs should be promptly and accurately reported via VAERS or other surveillance systems to support the ongoing effort to ensure vaccine safety.

The [underutilized] power of independent pharmacies to promote public health in rural communities: A call to action.

Independent community pharmacies are in a unique and powerful position to promote public and individual health in their communities. Independent pharmacies are particularly important in rural communities where there are few chain pharmacies and accessible health clinics. West Virginia received national attention recently when they opted out of the Federal Pharmacy Program collaborating with CVS and Walgreens and developed their own plan for COVID-19 vaccine distribution and administration, heavily relying on independent pharmacies and the infrastructure they already have in local communities. However, in other areas of public health with urgent, unmet need, such as pregnancy prevention, there is considerable room for independent pharmacies to improve. The pandemic has allowed independent pharmacies to shine during the vaccination effort and has demonstrated what can be accomplished when policymakers, providers, and pharmacists work together for the benefit of community health. Expanding such collaboration to include contraceptive provision and counseling in a timely, nonjudgmental manner could play a pivotal role in preventing unintended and unwanted pregnancies.

Harder to get than you think: Levonorgestrel emergency contraception access in West Virginia community pharmacies.

OBJECTIVES: Emergency contraception (EC) is the only noninvasive form of contraception available after risk exposure and is an important tool for preventing unintended pregnancy resulting from unprotected sex, sexual assault, or contraceptive failure. The U.S. Food and Drug Administration (FDA) removed age restrictions on levonorgestrel EC and made it available over-the-counter to everyone in 2013. Despite improved availability and accessibility since the change in FDA regulations, community pharmacies have not uniformly embraced the policy. West Virginia is a rural state with high rates of poverty and teen pregnancy. DESIGN: The investigators called community pharmacies in West Virginia to assess the availability and accessibility of levonorgestrel EC in addition to the pharmacy staff's knowledge of effectiveness for this cross-sectional study. SETTING AND PARTICIPANTS: The study sample consisted of 509 community pharmacies throughout the state. OUTCOME MEASURES: A structured script was employed to conduct phone calls to community pharmacies with items assessing availability, accessibility, and knowledge of effectiveness. RESULTS: At the time of the phone calls, levonorgestrel EC was reported to be available in 48.9% of the community pharmacies in West Virginia. Chain pharmacies were more likely to report EC as being in stock (0.76) than independent pharmacies (0.15.). Other measures of accessibility also favored chain pharmacies versus independent pharmacies. The overall accessibility of EC at West Virginia community pharmacies was derived from a binary composite variable of "completely accessible" or "not completely accessible" by combining 5 predetermined items. Overall, EC was completely accessible to callers in 0.27 of all pharmacies with significant differences by pharmacy type (0.47 of chain pharmacies as compared with 0.03 of independent pharmacies). CONCLUSION: Accessible EC could reduce unintended pregnancy and help break the state's generational cycle of poverty and poor educational, social, and health outcomes. Pharmacists will be instrumental in expanding access to EC.

Predictors of Transitioning to Incident Chronic Opioid Therapy Among Working-Age Adults in the United States.

BACKGROUND: Opioids have been prescribed and used for chronic noncancer pain at prolific rates in the United States during the past 2 decades. Patients who transition to incident chronic opioid therapy are at increased risk for significant negative health consequences, including cardiovascular risk, endocrine disorders, opioid use disorder, and death. OBJECTIVE: To identify the leading predictors associated with transitioning to incident chronic opioid therapy among working-age adults without cancer. METHOD: This retrospective observational cohort study is based on medical and pharmacy claims of a nationally representative sample of adults enrolled in commercial health insurance plans. Standard parametric (logistic regressions) and nonparametric methods based on a decision tree were used for prediction. To facilitate comparison with the available published literature, we also present adjusted odds ratios (AORs) and 95% confidence intervals (CIs). The 10% random sample of 491,442 patients included in the study who were working-age adults (age, 28-63 years) were insured in a commercial health plan, did not have cancer, and initiated opioid therapy between January 2007 and May 2015. Transition to incident chronic opioid therapy was defined as having claims for at least a 90-day supply of opioids within 120 days after the index date (ie, initiation of opioid therapy). Predictive models used for the analysis comprised a comprehensive list of factors available in the claims data, including opioid regimen characteristics, pain conditions, physical and mental health conditions, concomitant medications use (ie, benzodiazepine, stimulants, nonopioid analgesics, and polypharmacy), patient characteristics, and health insurance type. RESULTS: In our sample, the transition to incident chronic opioid therapy was 1.3% and pain-specific diagnoses were documented for only one-third (31.7%) of patients. The 4 leading predictors of chronic opioid therapy were opioid duration of action (AOR, 12.28; 95% CI, 8.06-18.72), the parent opioid compound (eg, tramadol vs codeine; AOR, 7.26; 95% CI, 5.20-10.13), the presence of conditions that are very likely to cause chronic pain (AOR, 5.47; 95% CI, 3.89-7.68), and drug use disorders (AOR, 4.02; 95% CI, 2.53-6.40). CONCLUSION: The initial opioid regimen's characteristics are powerful predictors of chronic opioid therapy. Predictive algorithms created from readily available claims data can be used to develop real-time predictions of the future risk for a patient's transition to chronic opioid use.

Cardiovascular Mortality of Oral Antidiabetic Drugs Approved Before and After the 2008 US FDA Guidance for Industry: A Systemic Review and Meta-Analysis.

BACKGROUND: Both diabetes and antidiabetic drugs (ADDs) increase the risk for cardiovascular (CV) diseases. Due to the increasing concern about CV safety associated with ADDs, the US FDA revised regulatory guidelines in 2008 to include CV safety as an endpoint. OBJECTIVE: The objective of the current study was to conduct a systematic review with meta-analysis to compare CV mortality of oral ADDs approved before and after the FDA's 2008 guidance. METHODS: Three electronic databases (PubMed, Scopus, and the Clinical Trial Registry) were searched to retrieve studies published up to 24 February 2017. Randomized clinical trials were included in this study if they (1) were published in the English language; (2) included adults with type 2 diabetes mellitus with or without CV risk factors, who were taking at least one oral antidiabetic drug; and (3) had at least one study outcome as CV mortality. Meta-analysis was performed using a random-effects model. Small-study effects were accessed using funnel plot symmetry. The primary outcome was CV mortality. RESULTS: We found that there was no significant increase in CV mortality for drugs approved before and after 2008. The overall odds ratio (OR) and the upper bound of the two-sided 95% confidence interval (CI) for all drugs approved after 2008 (OR 0.74, 95% CI 0.52-1.07) were lower than the overall OR for all drugs approved before 2008 (OR 1.03, 95% CI 0.89-1.19). In addition, the upper bounds of the two-sided 95% CI for both groups of drugs before and after 2008 were below 1.3. Empagliflozin, which was approved after the guidance, was significantly associated with a reduction in CV mortality. CONCLUSION: The 2008 FDA guidance appears to have a positive impact on CV risk assessment of recently marketed drugs for the management of diabetes.

Increased Healthcare Utilization and Expenditures Associated With Chronic Opioid Therapy.

OBJECTIVES: To assess the association of the transition from incident opioid use to incident chronic opioid therapy (COT) with the trajectories of healthcare utilization and expenditures. STUDY DESIGN: We used a longitudinal, retrospective cohort design, including seven 120-day time periods covering preindex (t1, t2, and t3), index (t4), and postindex (t5, t6, and t7) periods with data from adults aged 28 to 63 years at the index date, without cancer, and continuously enrolled in a primary commercial insurance plan (N = 20,201). METHODS: Multivariable analyses were performed on utilization (population-averaged [PA] logistic regression), expenditures (PA generalized estimating equations), and expenditure estimates (counterfactual prediction). The data used were from a commercial claims database (10% random sample from the IQVIA Real-World Data Adjudicated Claims - US database) from 2006-2015. RESULTS: Patients on COT were more likely to use inpatient services (adjusted odds ratio, 1.11; 95% CI, 1.01-1.21) compared with those who did not. Although expenditures peaked during the index period (t4) for all users, differences in unadjusted average 120-day expenditures between COT and non-COT users were highest in t4 for total ($4607) and inpatient ($2453) expenditures. COT users had significantly higher total (ß = 0.183; P <.01) and inpatient (ß = 0.448; P <.001) expenditures. CONCLUSIONS: The period after incident opioid prescription but before transition to COT is an important time for payers to intervene.

Laboratory and Clinical Monitoring of Direct Acting Oral Anticoagulants: What Clinicians Need to Know.

The direct acting oral anticoagulants (DOACs), including dabigatran, rivaroxaban, apixaban, and edoxaban, have favorable pharmacokinetic and pharmacodynamic properties and equal or superior efficacy and an improved safety profile compared with warfarin. Noted shortcomings with DOACs are shorter half-lives requiring stricter adherence, lack of standardized laboratory monitoring, lack of anticoagulation reversal agents, and loss of routine coagulation monitoring leading to fewer patient-clinician interactions. This review addresses many of these limitations including monitoring of DOACs for efficacy and toxicity, an assessment of selected qualitative and quantitative tests, and development of monitoring strategies for special populations. Coagulation monitoring is generally recommended only in overdose situations, but once standardized assays are readily available, they could be helpful to ensure efficacy, assess bleeding, and aid in drug selection in a number of other patient scenarios. Coagulation tests that may provide qualitative assessment include activated partial thromboplastin time, prothrombin time, and thrombin time. Methods with potential utility for quantitative assessment of DOACs include plasma drug concentrations, ecarin clotting time, dilute thrombin time, and anti-factor Xa concentrations. Noncoagulation laboratory monitoring should include serum creatinine, liver function tests, and complete blood counts. Clinical monitoring of the DOAC-treated patient should include routine assessment of adherence, bleeding risks, and drug interactions. Frequency of monitoring should be 1-3 months after initiation and then at least every 6 months, with more frequent follow-up (i.e., 3 months) based on patient specific characteristics such as age, renal impairment, hepatic impairment, and concomitant drug therapy. The authors provide a practical tool to assist in DOAC monitoring and recommend that pharmacists collaborate with physicians in selecting appropriate patients and tailoring patient-specific monitoring plans.

The perceived value of clinical pharmacy service provision by pharmacists and physicians: an initial assessment of family medicine and internal medicine providers.

BACKGROUND: Few publications have addressed the perceptions of pharmacists and physicians regarding the value of clinical pharmacist services. A survey-based study was conducted to determine whether Internal Medicine (IM) and Family Medicine (FM) pharmacists and physicians differed in their attitudes regarding the benefits of collaboration in an acute care setting. OBJECTIVES: The primary objective was to evaluate perceived differences regarding self-assessment of value between IM and FM pharmacists. The secondary objective was to evaluate perceived differences of clinical pharmacist benefit between IM and FM physicians. METHODS: An eight-item questionnaire assessed the attitudes and beliefs of pharmacists and physicians regarding the value of clinical pharmacy services. Surveys were emailed and participants marked their responses using a 7-point Likert scale for each item. Demographic data and overall comments were collected from each participant. KEY FINDINGS: Overall, 167 surveys were completed. When comparing cumulative physician and pharmacist responses, none of the eight questions showed significant differences. Statistically significant differences were noted when comparing IM and FM clinical pharmacists on five of the eight survey items; for each of these items, FM pharmacists had more favourable perceptions than their IM counterparts. No statistically significant differences were noted when comparing responses of IM and FM physicians. CONCLUSIONS: This study found that FM pharmacists perceived a greater benefit regarding participation in inpatient acute care rounds when compared to their IM pharmacist counterparts. Future studies are necessary to determine if other medical specialties' perceptions of clinical pharmacy provision differ from our findings and to evaluate the rationale behind specific attitudes and behaviours.

Attitudes and knowledge about pain: an assessment of West Virginia family physicians.

BACKGROUND AND OBJECTIVES: This study's objective was to determine the attitudes/beliefs and knowledge of West Virginia's family physicians regarding evaluation and treatment of patients with pain. METHODS: A 20-item instrument (10 attitudinal/behavioral and 10 knowledge items) was mailed to 537 members of the West Virginia Chapter of the American Academy of Family Physicians in October 2002. Five percent of the surveys were mailed to out-of-state members. No follow-up questionnaire was mailed. RESULTS: A total of 186 surveys (186/537, 34.6%) were returned. The typical respondent was a male ages 30-54 graduating in 1983 or later and having 15.5 years of practice experience. The majority of respondents were in a solo or group practice. There were no differences in response rates according to age, gender, years in practice, and practice setting. Chronic nonmalignant pain and assessing pain in the elderly are problematic for many physician providers. Perceived regulatory scrutiny does impact physician prescribing of opioids for patients in pain. Knowledge gaps were uncovered in the areas of fentanyl administration, the use of propoxyphene in the elderly, the management of opioid-induced constipation, laxative prescription, and the use of oxygen to manage opioid-induced respiratory depression. The majority of respondents felt that their formal medical training did not prepare them to effectively manage pain. CONCLUSIONS: This survey provides valuable insight into the attitudes/behaviors and knowledge about pain and its management by West Virginia family physicians. A national sample, using a revised instrument, is needed to more fully characterize and validate the findings from this statewide survey.