Costs associated with United States pharmacopeia compliant infusion clinics.

PURPOSE: As costs continue to rise in oncology, a strategy that has been implemented to limit these costs is use of alternative sites of care. However, there are differences in regulatory standards between common sites of care such as freestanding infusion clinics and hospital outpatient departments. The costs associated with United States Pharmacopeia compliance were evaluated in order to better understand the cost of universally compliant hospital outpatient departments. METHODS: Annual operational costs associated with United States Pharmacopeia compliance were estimated for a 30-chair infusion clinic with United States Pharmacopeia <797> and <800> pharmacy cleanrooms for non-hazardous and hazardous drugs, respectively. Annual United States Pharmacopeia compliance costs included: competency assessments, personal protective equipment, closed system transfer devices, labels, cleaning supplies, and environmental monitoring. One-time costs included initial cleanroom construction and renovations. Published information and benchmarks provided baseline assumptions for patient volume, staffing, and unit costs. If no published data was available, prices were estimated based on a similarly sized clinic. RESULTS: Recurring annual costs for a 30-chair fully compliant infusion clinic were calculated to be $785,207. One-time costs associated with initial construction and renovations were estimated to be $1,365,207-$1,535,207 and $965,207-$1,005,207, respectively. CONCLUSIONS: Costs associated with increased operational oversight and regulatory standards are a major contributing factor to the facility fee of hospital outpatient departments. Ultimately, all sites of care share in the goal to provide optimal patient care while considering all aspects of patient care, including cost. Therefore, a move towards consistent regulatory standards across all settings would aid in preventing discrepancies in care.

Patterns and characteristics associated with surface contamination of hazardous drugs in hospital pharmacies.

PURPOSE: The surface contamination levels of 5 commonly used hazardous drugs in hospital pharmacies are summarized, identifying practice patterns associated with contamination. METHODS: Contamination testing data were compiled to evaluate surface contaminants of 5 hazardous drugs (docetaxel, paclitaxel, cyclophosphamide, ifosfamide, and 5-fluorourcil). Data from 5,842 wipes over 6 years were collected from 338 hospital pharmacies. The contamination level for each drug was categorized as nondetectable (ND; ≤10 ng/ft2), low (between 10 and ≤100 ng/ft2), medium (between 100 and ≤1,000 ng/ft2) or high (>1,000 ng/ft2). Surface exposures for each drug were summarized based on location, contamination at first and subsequent wipe events, and the use of a closed system transfer device (CSTD). RESULTS: The majority of contamination results corresponded to locations at or near hazardous drug preparation, but also occurred in areas where hazardous drugs were not prepared. There was a higher incidence of contamination levels (high, medium, and low, respectively) at first wipe event (10.2%, 17.4%, and 17.7%) compared to subsequent wipe events (5.8%, 12.2%, and 13.6%) (p < 0.0001). There was a lower incidence of contamination levels at institutions that used CSTDs (6.3%, 12.8%, and 14.4%) compared to institutions that did not use CSTDs (14.2%, 17.9%, and 17.3%) (p < 0.0001). CONCLUSIONS: The majority of highest contamination levels corresponded to locations where hazardous drugs were prepared. While the rate of contamination was lower at subsequent wipe events and at institutions that used CSTDs, contamination was not completely eliminated in either scenario.

Application of the 2015 proposed NIOSH vapor containment performance protocol for closed system transfer devices used during pharmacy compounding and administration of hazardous drugs.

PURPOSE: The National Institute for Occupational Safety and Health (NIOSH) released a proposed protocol in 2015 to evaluate the vapor containment abilities of closed system transfer device technologies in order to provide meaningful comparisons between products. This study assessed the vapor containment ability of closed system transfer devices when following the methodology as outlined by the 2015 NIOSH proposed protocol. METHODS: This study evaluated six closed system transfer device brands following the draft NIOSH vapor containment protocol. The testing evaluated each closed system transfer device brand during both compounding (Task 1) and administration (Task 2). Five pre-specified steps for each task were repeated for a total of four manipulations per device. The Thermo Scientific™ MIRAN SapphIRe XL Infrared Analyzer was used to detect isopropyl alcohol vapor levels after each step. RESULTS: For Task 1, two closed system transfer device products (PhaSeal™ and Equashield®) adequately contained the isopropyl alcohol vapor and passed the predefined testing criteria. The same two products, plus one additional product (ChemoLock™), contained the vapor for Task 2 manipulations. Based on the results of this study, only two out of the six closed system transfer device brands passed testing criteria for both tasks, functioning as truly closed systems. CONCLUSION: To improve employee safety in chemotherapy preparation, closed system transfer devices that demonstrate no leakage should be the preferred choices of healthcare systems. In this study, PhaSeal™ and Equashield® proved to be adequately closed in both Task 1 and Task 2, while ChemoLock™ proved to be closed in Task 2 but not in Task 1. All other products failed both tasks when measuring for isopropyl alcohol vapor release.

Discrepancies in Lesbian, Gay, Bisexual, and Transgender Patient Care and How Pharmacists Can Support an Evolved Practice.

We live in an increasingly multicultural society with people from different ethnicities and beliefs. In recent years, we have witnessed a growing group of people who identify as having diverse sexual orientations and gender identities. Members of the lesbian, gay, bisexual, and transgender (LGBT) community have historically been marginalized by the health care industry. The disproportionate prevalence of LGBT health concerns and cultural prejudices may be overlooked by many practitioners. As pharmacists, we are in an optimal position to affect meaningful changes in how we treat, counsel, and interact with all our patients, including with those whose sexual orientation or gender identity differ from ours. It is important for student and practicing pharmacists alike to receive adequate education and training that identifies the role of a pharmacist in LGBT health and fosters culturally competent and equitable patient care. Clinical and cultural competence should be reflective of inclusive pharmacy programs that embrace and incorporate LGBT health. The objectives of this commentary are to identify the role of a pharmacist in LGBT health, recognize specific concerns with mental and sexual health, describe gender-transitioning pharmacotherapy, and discuss the current stance of LGBT health in pharmacy education.