Spuriously elevated testosterone measurements caused by application of testosterone gel at or near the phlebotomy site.

OBJECTIVE: To report 2 cases of spuriously elevated testosterone measurements caused by contamination of blood samples by testosterone gel applied near the phlebotomy site. CASE SUMMARIES: A 21-year-old male with primary hypogonadism and a 67-year-old male with secondary hypogonadism were prescribed standard replacement doses of testosterone gel. The patients' symptoms improved without adverse effects. However, their measured testosterone levels rose above the target range and paradoxically increased further despite decreasing the testosterone dose. In both cases, the gel had been applied near the site of venipuncture on the day of blood sampling. Subsequent testosterone measurements from blood obtained after the gel was applied away from the upper/mid arms were in therapeutic range. DISCUSSION: To our knowledge, falsely elevated testosterone concentrations due to contamination of blood samples by testosterone gel have been reported only once (PubMed search, 1966-September 2012). In the cases we describe, application of the Naranjo probability scale suggests a probable likelihood that sample contamination caused the falsely elevated testosterone measurements. Health care professionals should recognize and take measures to prevent this problem, which could lead to inappropriate dose changes in hypogonadal patients. CONCLUSIONS: The application of testosterone gel at or near the site of venipuncture can markedly increase the measured serum testosterone concentration.

A proactive medical necessity review program reduces revenue loss associated with outpatient medical benefit drugs.

PURPOSE: A common denial trend that occurs with "outpatient medical benefit drugs" (ie, medications covered by a medical benefit plan and administered in an outpatient visit) is payers not requiring or permitting prior authorization (PA) proactively, yet denying the drug after administration for medical necessity. In this situation, a preemptive strategy of complying with payer-mandated requirements is critical for revenue protection. To address this need, our institution incorporated a medical necessity review into its existing closed-loop, pharmacy-managed precertification and denials management program. SUMMARY: Referrals for targeted payers and high-cost medical benefit drugs not eligible for PA and deemed high risk for denial were incorporated into the review. Payer medical policies were evaluated and clinical documentation assessed to confirm alignment. This descriptive report outlines the medical necessity workflow as a component of the larger precertification process, details the decision-making process when performing the review, and delineates the roles and responsibilities for involved team members. A total of 526 drug orders were evaluated from September 2018 to August 2019, with 146 interventions completed. Of the 761 individual claims affected by proactive medical necessity review, 99.2% resulted in payment and less than 1% resulted in revenue loss, safeguarding more than $5.3 million in annual institutional drug reimbursement. At the time of analysis, there were only 3 cases of revenue loss. CONCLUSION: Our institution's pharmacy-managed medical necessity review program for high-cost outpatient drugs safeguards reimbursement for therapies not eligible for payer PA. It is a revenue cycle best practice that can be replicated at other institutions.

Prescribing pharmacists in the ambulatory care setting: Experience at the University of North Carolina Medical Center.

PURPOSE: The prescribing authorities, clinical activities, and productivity documentation strategies of ambulatory care clinic-based pharmacists practicing within a large academic health system are described. SUMMARY: North Carolina law encourages progressive pharmacy practice through acquisition of the clinical pharmacist practitioner (CPP) designation. Qualified CPPs are authorized to provide collaborative drug therapy management services, including medication prescribing and ordering of laboratory tests, according to defined protocols and under physician supervision. The University of North Carolina Medical Center has approximately 30 CPPs deployed across a wide range of ambulatory care clinical practice sites. This article describes (1) the pharmacy department's implementation of an ambulatory care practice model, (2) the credentialing and privileging process leading to granting of prescribing privileges, (3) metrics used to demonstrate the impact of CPP activities, (4) recommended general criteria for ambulatory care practice site identification, and (5) strategies for overcoming barriers to successful implementation of ambulatory care-focused clinical pharmacist services. Aggregated intervention-tracking data compiled by seven of the medical center's CPP ambulatory care practice sites indicate extensive CPP involvement in direct patient care encounters and patient or provider consultations, with large numbers of medication-related interventions to support institutional cost-avoidance and revenue goals. CONCLUSION: CPPs deployed at the medical center's ambulatory care clinics have had a positive impact on clinical and cost outcomes, improving patient care through interventions, contributing to readmission reduction efforts, generating indirect revenue through cost avoidance, and generating new revenue through billing for patient visits.

Prospective study of supplemental vitamin K therapy in patients on oral anticoagulants with unstable international normalized ratios.

BACKGROUND: It is not known whether patients on oral vitamin K antagonists who have unstable INRs achieve more stable INRs with daily vitamin K supplementation. We sought to determine whether vitamin K supplementation may decrease INR variability in patients with a history of unstable INRs, how soon the INR decreases after vitamin K therapy is initiated, the time to reach a therapeutic INR after vitamin K initiation, and how much of an increase in oral anticoagulant dose is needed to maintain the INR in the desired range. METHODS: This is a prospective open label crossover study of patients on warfarin with a history of fluctuating INRs. A 9 week observation phase was followed by an 8 week period with patients receiving 500 microg of oral vitamin K daily. INRs were determined once weekly with a home point of care monitoring instrument. RESULTS: Vitamin K supplementation led to a decrease in INR variability in five of the nine patients studied (56%). INR decrease occurred 2-7 days after initiation of vitamin K. Therapeutic INRs were achieved 2-35 days after vitamin K therapy was initiated and an increase in warfarin dose of 6-95% was required to bring the INR back into the therapeutic range. CONCLUSIONS: INR fluctuations may decrease in selected patients with unstable INRs who receive vitamin K supplementation. A study with a larger sample size and longer follow-up period is needed. The results of the present study can help design such a study.

Bioterrorism web sites for pharmacists.

OBJECTIVE: To identify Internet Web sites for ease of accessibility to bioterrorism-related information, comprehensive provision of bioterrorism-related information, and provision of bioterrorism information that specifically pertains to the pharmacy profession. DATA SOURCES: Web sites of national pharmacy organizations, US government agencies, and medical organizations, as well as Web sites related to bioterrorism. DATA SYNTHESIS: Pharmacists need access to relevant bioterrorism information in a timely manner. An evaluation of Web sites was performed to identify those that include a discussion of the potential infectious microorganisms and prevention and treatment methods, as well as unique features for pharmacy practice. RESULTS: The American Society of Health-System Pharmacists and American Pharmaceutical Association Web sites provide pharmacy-specific recommendations. The Centers for Disease Control and Prevention provides biological agent information and health department contact numbers. Additional agent-specific data are provided by the American Medical Association, The Johns Hopkins University, and the Food and Drug Administration (FDA) Web sites. Information addressing food safety is provided by the FDA. CONCLUSIONS: Pharmacy-specific bioterrorism information is available only at selected national pharmacy organization Internet Web sites. However, other Web sites provide comprehensive bioterrorism information useful for pharmacists.