Implementation and Preliminary Clinical Outcomes of a Pharmacist‐managed Venous Thromboembolism Clinic for Patients Treated With Rivaroxaban Post Emergency Department Discharge

Objective

The objective was to describe the implementation, work flow, and differences in outcomes between a pharmacist‐managed clinic for the outpatient treatment of venous thromboembolism (VTE) using a non‐vitamin K oral anticoagulant versus care by a primary care provider (PCP).

Methods

Patients in the studied health system that are diagnosed with low‐risk VTE in the emergency department are often discharged without hospital admission. These patients are treated with a non‐vitamin K oral anticoagulant and follow‐up either in a pharmacist‐managed VTE clinic or with their PCP. Pharmacists in the VTE clinic work independently under a collaborative practice agreement (CPA). An evaluation of 34 patients, 17 in each treatment arm, was conducted to compare the differences in treatment‐related outcomes of rivaroxaban when managed by a pharmacist versus a PCP.

Results

The primary endpoint was a 6‐month composite of anticoagulation treatment‐related complications that included a diagnosis of major bleeding, recurrent thromboembolism, or fatality due to either major bleeding or recurrent thromboembolism. Secondary endpoints included number of hospitalizations, adverse events, and medication adherence. There was no difference in the primary endpoint between groups with one occurrence of the composite endpoint in each treatment arm (p = 1.000), both of which were recurrent thromboembolic events. Medication adherence assessment was formally performed in eight patients in the pharmacist group versus no patients in the control group. No differences were seen among other secondary endpoints.

Conclusions

The pharmacist‐managed clinic is a novel expansion of clinical pharmacy services that treats patients with low‐risk VTEs with rivaroxaban in the outpatient setting. The evaluation of outcomes provides support that pharmacist‐managed care utilizing standardized protocols under a CPA may be as safe as care by a PCP.

     

Slow Infusion of Low‐dose Ketamine Reduces Bothersome Side Effects Compared to Intravenous Push: A Double‐blind,Double‐dummy,Randomized Controlled Trial

Objective

We compared the analgesic efficacy and incidence of side effects when low‐dose (0.3 mg/kg) ketamine (LDK) is administered as a slow infusion (SI) over 15 minutes versus an intravenous push (IVP) over 1 minute.

Methods

This was a prospective, randomized, double‐blind, double‐dummy, placebo‐controlled trial of adult ED patients presenting with moderate to severe pain (numerical rating scale [NRS] score ≥ 5). Patients received 0.3 mg/kg ketamine administered either as a SI or a IVP. Our primary outcome was the proportion of patients experiencing any psychoperceptual side effect over 60 minutes. A secondary outcome was incidence of moderate or greater psychoperceptual side effects. Additional outcomes included reduction in pain NRS scores at 60 minutes and percent maximum summed pain intensity difference (%SPID).

Results

Fifty‐nine participants completed the study. A total of 86.2% of the IVP arm and 70.0% of the SI arm experienced any side effect (difference = 16.2%, 95% confidence interval [CI] = –5.4 to 37.8). We found a large reduction in moderate or greater psychoperceptual side effects with SI administration—75.9% reported moderate or greater side effects versus 43.4% in the SI arm (difference = 32.5%, 95% CI = 7.9 to 57.1). Additionally, the IVP arm experienced more hallucinations (n = 8, 27.6%) than the SI arm (SI n = 2, 6.7%, difference = 20.9%, 95% CI = 1.8 to 43.4). We found no significant differences in analgesic efficacy. At 60 minutes, the mean %SPID values in the IVP and SI arms were 39.9 and 33.5%, respectively, with a difference of 6.5% (95% CI = –5.8 to 18.7).

Conclusion

Most patients who are administered LDK experience a psychoperceptual side effect regardless of administration via SI or IVP. However, patients receiving LDK as a SI reported significantly fewer moderate or greater psychoperceptual side effects and hallucinations with equivalent analgesia.

     

Physical Compatibility of Sodium Glycerophosphate and Calcium Gluconate in Pediatric Parenteral Nutrition Solutions

Background: The solubility of inorganic calcium and phosphate in parenteral solutions can be complicated in pediatrics due to the dosing of calcium and phosphorus at the saturation point. The purpose of this study was to test the solubility of sodium glycerophosphate (NaGP) with calcium gluconate in pediatric parenteral nutrition (PN) solutions. Methods: Five PN solutions were compounded by adding calcium gluconate at 10, 20, 30, 40, and 50 mEq/L and corresponding concentrations of NaGP at 10, 20, 30, 40, and 50 mmol/L. Each of the 5 solutions was compounded using 1.5% and 4% amino acids, cysteines, and lipids. Compatibility was evaluated by visual inspection (precipitation, haze, and color change). Solutions were evaluated microscopically for any microcrystals and measured by a turbidimeter for changes in turbidity. Solutions were further analyzed using United States Pharmacopeia 788 standards. Six hundred seventy‐one PN solutions were compounded at various concentrations and evaluated for visual stability. Results: Compatibility testing showed no changes in the PN solution in any of the concentrations tested. Microscopically, no microcrystals were detected. The turbidimeter measurements had changes of ≤0.14 nephelometric turbidity units for all test solutions. There were no visual changes in any of the 671 PN solutions. Conclusion: It is recommended that NaGP replace sodium phosphate in PN solutions. This would eliminate the concern of calcium and phosphorus precipitation and the need of any saturation curves.