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.

     

Impact of Vendor Computerized Physician Order Entry in Community Hospitals

BACKGROUND

It is uncertain if computerized physician order entry (CPOE) systems are effective at reducing adverse drug event (ADE) rates in community hospitals, where mainly vendor-developed applications are used.

OBJECTIVE

To evaluate the impact of vendor CPOE systems on the frequency of ADEs.

DESIGN AND PATIENTS

Prospective before-and-after study conducted from January 2005 to September 2010 at five Massachusetts community hospitals. Participants were adults admitted during the study period. A total of 2,000 charts were reviewed for orders, medication lists, laboratory reports, admission histories, notes, discharge summaries, and flow sheets.

MAIN MEASURES

The primary outcome measure was the rate of preventable ADEs. Rates of potential ADEs and overall ADEs were secondary outcomes.

KEY RESULTS

The rate of preventable ADEs decreased following implementation (10.6/100 vs. 7.0/100 admissions; p?=?0.007) with a similar effect observed at each site. However, the associated decrease in preventable ADEs was balanced against an increase in potential ADEs (44.4/100 vs. 57.5/100 admissions; p?p?=?0.03), which was driven by non-preventable events (4.0/100 vs. 11.7/100 admissions; p?CONCLUSIONS Adoption of vendor CPOE systems was associated with a decrease in the preventable ADE rate by a third, although the rates of potential ADEs and overall ADEs increased. Our findings support the use of vendor CPOE systems as a means to reduce drug-related injury and harm. The potential ADE rate could be reduced by making refinements to the vendor applications and their associated decision support.     

Effects of androgens on bone in men and women

Although the beneficial effects of estrogen on bone have been proven in multiple well-designed clinical trials, with respect to testosterone and androgens, the data are less definitive. Testosterone appears to have a role in the development and maintenance of bone mass; however, the mechanism by which androgens exert their effects on bone is still not clearly understood. Despite the increasing use of testosterone supplementation in men and women for the prevention and treatment of osteoporosis, in sufficient evidence exists to support the widespread use of these agents for this indication at this time. The data supporting the beneficial effects of testosterone on bone mineral density are more convincing in hypogonadal men than in men with normal testosterone levels, or in women. The transdermal route of administration is often preferred for testosterone therapy because it avoids the first-pass metabolism associated with oral formulations and the pain experienced with intramuscular injections. Other androgens, including an abolic steroids and dihydroepiandrosterone, have also been used. In addition to monitoring for therapeutic response on initiation of androgen therapy, assessment for potential adverse events should be implemented. This should include assessment for adverse effects on the liver and alterations in the lipid profile in both men and women. Men should also be monitored for prostate growth, gynecomastia, priapism, decreased libido, and erythrocytosis, whereas women should be monitored for virilizing effects. Ongoing research into the pathophysiology and clinical effects of testosterone on bone will provide more insights regarding the utility of androgens in these populations.     

Zinc Deficiency in a Parenteral Nutrition–Dependent Patient During a Parenteral Trace Element Product Shortage

Parenteral nutrition product shortages are common and place vulnerable patients at risk for nutrient deficiencies. This case report describes a parenteral nutrition–dependent patient who was found to have zinc deficiency during a parenteral nutrition product shortage. The management of the patient's zinc deficiency is described.