Pharmacist optimization of lipid therapy in patients with peripheral vascular disease.

DISCLAIMER: In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. PURPOSE: American College of Cardiology/American Heart Association guidelines recommend high-intensity statin therapy and consideration for nonstatin therapy for patients with peripheral vascular disease (PVD); however, utilization rates remain suboptimal. The primary objective of this study was to determine whether pharmacist intervention for patients with PVD could improve the percentage of patients discharged on a high-intensity statin. METHODS: The study used a single-center pre/post design and included patients with PVD who underwent peripheral bypass during their admission. Postintervention patients managed with an order set including a preselected consult for a pharmacy lipid protocol were compared to preintervention patients managed using the order set without the consult. The primary outcome was the percentage of patients discharged on a high-intensity statin. Secondary outcomes included intensification of statin therapy, the addition of ezetimibe, and referral to an outpatient lipid clinic. RESULTS: A total of 175 patients were included in the analysis, with 94 patients in the preintervention group and 81 patients in the postintervention group. The primary outcome met statistical significance, with an increase in the percentage of patients discharged on a high-intensity statin in the postintervention group (70.4%) compared to the preintervention group (38.3%) (P < 0.001; 95% confidence interval, 1.37-2.46). Secondary outcomes that met statistical significance included an increase in the percentage of patients with any increase in statin intensity (35.8% vs 20.2%; P = 0.02). CONCLUSION: The addition of a pharmacist consult led to an increase in the percentage of patients discharged on a high-intensity statin and an increase in overall statin intensification.

Prospective Evaluation of a Fixed-Dose 4-Factor Prothrombin Complex Concentrate Protocol for Urgent Vitamin K Antagonist Reversal.

BACKGROUND: Four-factor prothrombin complex concentrate (4F-PCC) is the standard of care for reversal of vitamin K antagonists (VKAs). Research has demonstrated noninferior efficacy with the use of lower, fixed-dose strategies for 4F-PCC dosing. OBJECTIVES: We compared a fixed-dose 4F-PCC protocol to weight-based dosing at our institution. METHODS: This was a multicenter, noninferiority, interventional, quasiexperimental cohort study including subjects who were administered 4F-PCC for VKA reversal. The retrospective cohort consisted of subjects given a weight-based dose of 4F-PCC dependent on international normalized ratio (INR). The prospective cohort was managed with a fixed-dose protocol. The fixed dose was 1500 units of factor IX unless subjects weighed >100 kg or had a baseline INR >7.5, in which case the dose was 2000 units of factor IX. The primary endpoint was achievement of a postinfusion INR of <2. Secondary endpoints included achievement postinfusion INR <1.5, mean 24-h INR, 7-day mortality, and 7-day venous thromboembolic events. RESULTS: Twenty-four subjects were enrolled in the prospective cohort and 30 in the retrospective cohort. A postinfusion INR <2 was achieved in 96% of subjects in the retrospective cohort and 95% in the prospective cohort (p = 0.0035 for noninferiority). A postinfusion INR <1.5 occurred in 90% of subjects in the retrospective cohort and 75% in the prospective cohort (p > 0.4 for noninferiority). There were no significant differences in 24-h postinfusion INRs, mortality, or venous thromboembolic events. CONCLUSION: The use of a fixed-dose 4F-PCC protocol is safe and effective for the rapid reversal of VKA-associated anticoagulation.

A Review on the Use of Cystic Fibrosis Transmembrane Conductance Regulator Gene Modulators in Pediatric Patients.

The literature surrounding the use of cystic fibrosis transmembrane conductance regulator-targeted pharmacotherapies in pediatric patients continues to evolve. These therapies represent a departure from symptom management and infection prevention, which have been the mainstay of cystic fibrosis management in pediatrics, to targeting the genetic defect present within these patients. This article reviews the clinical studies evaluating the safety and efficacy of ivacaftor, ivacaftor/lumacaftor, and ivacaftor/tezacaftor. These medications were initially studied in adults and adolescents but have begun to be studied in younger populations. Further investigation into the use of these drugs with different CFTR mutations and in younger age groups will continue to expand the number of patients who can benefit from these therapies.

The effect of counseling on willingness to use a hypothetical medication and perceptions of medication safety.

BACKGROUND: Poor medication adherence is an ongoing issue, and contributes to increased hospitalizations and healthcare costs. Although most adverse effects are rare, the perceived risk of adverse effects may contribute to low adherence rates. OBJECTIVES: The objective of this study was to determine how adverse effect likelihood and pharmacist counseling on adverse effect prevention affects individuals': (1) willingness to use a hypothetical medication and (2) perceptions of medication safety. METHODS: This study used a 3 × 3 experimental design. Participants (n = 601) viewed a hypothetical scenario asking them to imagine being prescribed an anti-asthma medication that could cause fungal infections of the throat. Participants were randomized to 1 of 9 scenarios that differed on: probability of developing an infection (5%, 20%, no probability mentioned) and whether they were told how to reduce the risk of infection (no prevention strategy discussed, prevention strategy discussed, prevention strategy discussed with explanation for how it works). Participants were recruited through Amazon Mechanical Turk. RESULTS: Participants were less willing to take the medication (F = 12.86, p < 0.0001) and considered it less safe (F = 13.11, p < 0.0001) when the probability of fungal infection was presented as 20% compared to 5% or when no probability information was given. Participants were more willing to take the medication (F = 11.78, p < 0.0001) and considered it safer (F = 11.17, p < 0.0001) when a prevention strategy was given. Finally, there was a non-statistically significant interaction between the probability and prevention strategy information such that provision of prevention information reduced the effect of variation in the probability of infection on both willingness to use the medication and perceived medication safety. CONCLUSIONS: Optimal risk communication involves more than informing patients about possible adverse effects. Pharmacists could potentially improve patient acceptance of therapeutic recommendations, and allay medication safety concerns, by counseling about strategies patients can implement to reduce the perceived risk of adverse effects.

Communicating information concerning potential medication harms and benefits: What gist do numbers convey?

OBJECTIVES: Fuzzy trace theory was used to examine the effect of information concerning medication benefits and side-effects on willingness to use a hypothetical medication. METHODS: Participants (N=999) were recruited via Amazon Mechanical Turk. Using 3×5 experimental research design, each participant viewed information about medication side effects in 1 of 3 formats and information about medication benefits in 1 of 5 formats. For both side-effects and benefits, one format presented only non-numeric information and the remaining formats presented numeric information. RESULTS: Individuals in the non-numeric side-effect condition were less likely to take the medication than those in the numeric conditions (p<0.0001). In contrast, individuals in the non-numeric benefit condition were more likely to take the medication than those in the numeric conditions (p<0.0001). CONCLUSIONS: Our findings suggest that non-numeric side-effect information conveys the gist that the medication can cause harm, decreasing willingness to use the medication; whereas non-numeric benefit information has the opposite effect. PRACTICE IMPLICATIONS: Presenting side-effect and benefit information in non-numeric format appears to bias decision-making in opposite directions. Providing numeric information for both benefits and side-effects may enhance decision-making. However, providing numeric benefit information may decrease adherence, creating ethical dilemmas for providers.