Evaluation of Benzene Presence and Formation in Benzoyl Peroxide Drug Products.

The potent carcinogen, benzene, is a known degradation product of benzoyl peroxide (BPO) and was recently reported to form when BPO drug products, used for acne and rosacea treatment, are incubated at body temperature and elevated temperatures expected during storage and transportation. This study provides evidence for a wide range of benzene concentrations (0.16 ppm to 35.30 ppm) detected by GC-MS in 111 over-the-counter BPO drug products tested and maintained at room temperature. A prescription encapsulated BPO drug product was stability tested at cold (2°C) and elevated temperature (50°C), resulting in no apparent benzene formation at 2°C, and high levels of benzene formation at 50°C, suggesting that encapsulation technology may not stabilize BPO drug products but cold storage may greatly reduce benzene formation. Face model experiments where BPO drug product was applied to PolyMethyl MethAcrylate (PMMA) photoprotection test skin plates and benzene was detected in surrounding air by SIFT-MS, showed detectable benzene through evaporation and substantial benzene formation when exposed to UV light at levels below peak sunlight. Results suggest that potential benzene exposure from formation during BPO drug product use poses significant risks independent of the starting benzene concentration.

A data-driven quality-score system for rating drug products and its implications for the health care industry.

The quality of drug products in the United States has been a matter of growing concern. Buyers and payers of pharmaceuticals have limited insight into measures of drug-product quality. Therefore, a quality-score system driven by data collection is proposed to differentiate between the qualities of drug products produced by different manufacturers. The quality scores derived using this proposed system would be based upon public regulatory data and independently-derived chemical data. A workflow for integrating the system into procurement decisions within health care organizations is also suggested. The implementation of such a quality-score system would benefit health care organizations by including the consideration of the quality of products while also considering price as a part of the drug procurement process. Such a system would also benefit the U.S. health care industry by bringing accountability and transparency into the drug supply chain and incentivizing manufacturers to place an increased emphasis on the quality and safety of their drug products.

Is P&T Ready to Add Rapid Cycle Analytics to Formulary?

Purpose: The intent of this article is to evaluate a novel approach, using rapid cycle analytics and real world evidence, to optimize and improve the medication evaluation process to help the formulary decision making process, while reducing time for clinicians. Summary: The Pharmacy and Therapeutics (P&T) Committee within each health system is responsible for evaluating medication requests for formulary addition. Members of the pharmacy staff prepare the drug monograph or a medication use evaluation (MUE) and allocate precious clinical resources to review patient charts to assess efficacy and value. We explored a novel approach to evaluate the value of our intravenous acetaminophen (IV APAP) formulary admittance. This new methodology, called rapid cycle analytics, can assist hospitals in meeting and/or exceeding the minimum criteria of formulary maintenance as defined by the Joint Commission Standards. In this particular study, we assessed the effectiveness of IV APAP in total hip arthroplasty (THA) and total knee arthroplasty (TKA) procedures. We assessed the correlation to same-stay opioid utilization, average length of inpatient stay and post anesthesia care unit (PACU) time. Conclusion: We were able to explore and improve our organization's approach in evaluating medications by partnering with an external analytics expert to help organize and normalize our data in a more robust, yet time efficient manner. Additionally, we were able to use a significantly larger external data set as a point of reference. Being able to perform this detailed analytical exercise for thousands of encounters internally and using a data warehouse of over 130 million patients as a point of reference in a short time has improved the depth of our assessment, as well as reducing valuable clinical resources allocated to MUEs to allow for more direct patient care. This clinically real-world and data-rich analytics model is the necessary foundation for using Artificial or Augmented Intelligence (AI) to make real-time formulary and drug selection decisions.

Medication utilization in patients in New York hospitals during the COVID-19 pandemic.

PURPOSE: Utilization of hydroxychloroquine, chloroquine, and supportive therapy drugs in hospitals in New York during the early weeks of the coronavirus disease 2019 (COVID-19) pandemic was analyzed. SUMMARY: Drug utilization trends for 7 medications used to treat patients with suspected or confirmed COVID-19 at 47 New York hospitals were identified. The data demonstrated sharp increases in aggregate utilization of hydroxychloroquine and chloroquine and the number of patients receiving either drug beginning on March 15, with a notable 20% median increase per day through March 31. The net quantity of drug charge units per day for midazolam, propofol, ketamine, cisatracurium, and fentanyl also increased during the study period. Following peak utilization, use of all study drugs decreased at different times throughout April 2020. The data were used to provide information to various stakeholders in the drug supply chain during the initial surge of the pandemic. CONCLUSION: This analysis describes the increased use, beginning in mid-March 2020, of hydroxychloroquine, chloroquine, midazolam, propofol, ketamine, cisatracurium, and fentanyl in 47 hospitals in New York State. The increased utilization of supportive therapy drugs was consistent with the surge in patients with presumed or confirmed COVID-19 during the study period. These data and observations can help clinicians, health-system leaders, manufacturers, wholesalers, and policymakers understand the impact of current and future pandemics on the drug supply chain.

COVID-19 pandemic preparedness: A practical guide from clinical pharmacists' perspective.

PURPOSE: To describe our hospital pharmacy department's preparation for an influx of critically ill patients during the coronavirus disease 2019 (COVID-19) pandemic and offer guidance on clinical pharmacy services preparedness for similar crisis situations. SUMMARY: Personnel within the department of pharmacy at a medical center at the US epicenter of the COVID-19 pandemic proactively prepared a staffing and pharmacotherapeutic action plan in anticipation of an expected surge in admissions of critically ill patients with COVID-19 and expansion of acute care and intensive care unit (ICU) capacity. Guidance documents focusing on supportive care and pharmacotherapeutic treatment options were developed. Repurposing of non-ICU-trained clinical pharmacotherapy specialists to work collaboratively with clinician teams in ICUs was quickly implemented; staff were prepared for these duties through use of shared tools to facilitate education and practice standardization. CONCLUSION: As challenges were encountered at the initial peak of the pandemic, interdisciplinary collaboration and teamwork was crucial to ensure that all patients were proactively assessed and that their respective pharmacotherapeutic regimens were optimized.

COVID-19 pandemic preparedness: A practical guide from an operational pharmacy perspective.

PURPOSE: To describe our medical center's pharmacy services preparedness process and offer guidance to assist other institutions in preparing for surges of critically ill patients such as those experienced during the coronavirus disease 2019 (COVID-19) pandemic. SUMMARY: The leadership of a department of pharmacy at an urban medical center in the US epicenter of the COVID-19 pandemic proactively created a pharmacy action plan in anticipation of a surge in admissions of critically ill patients with COVID-19. It was essential to create guidance documents outlining workflow, provide comprehensive staff education, and repurpose non-intensive care unit (ICU)-trained clinical pharmacotherapy specialists to work in ICUs. Teamwork was crucial to ensure staff safety, develop complete scheduling, maintain adequate drug inventory and sterile compounding, optimize the electronic health record and automated dispensing cabinets to help ensure appropriate prescribing and effective management of medication supplies, and streamline the pharmacy workflow to ensure that all patients received pharmacotherapeutic regimens in a timely fashion. CONCLUSION: Each hospital should view the COVID-19 crisis as an opportunity to internally review and enhance workflow processes, initiatives that can continue even after the resolution of the COVID-19 pandemic.

Multilayer Model of Pharmacy Participation in the Antimicrobial Stewardship Program at a Large Academic Medical Center.

Purpose: Leveraging pharmacy personnel resources for the purpose of antimicrobial stewardship program (ASP) operations presents a challenging task. We describe our experience integrating all pharmacists into an ASP, and evaluate the impact on ASP interventions, antimicrobial utilization, rate of selected hospital-onset infections and readmission. Summary: During a study period (January 1 to December 31, 2015), a total of 14 552 ASP-related pharmacy interventions were performed (ASP clinical pharmacotherapy specialists [CPS] n = 4025; non-ASP CPS n = 4888; hospital pharmacists n = 5639). Sixty percent of interventions by ASP CPS were initiated utilizing the dedicated ASP phone, and 40% through prospective audit and feedback. Non-ASP CPS performed interventions during bedside rounds (dose adjustment 23%, initiate new or alternative anti-infective 21%, discontinue antibiotic(s) 12%, therapeutic drug monitoring 11%, de-escalation 4%), whereas hospital pharmacists participated at the point of verification (dose adjustment 75%, restricted antibiotic verification 15%, and reporting major drug-drug interactions 4%). The acceptance rate of interventions by providers and clinicians was >90% for all groups. Annual aggregate antimicrobial use decreased by 6.4 days of therapy/1000 patient-days (DOT/1000 PD; P = 1.0). Ceftriaxone use increased by 8.4 DOT/1000 PD (P = .029) without a significant compensatory increase in the use of antipseudomonal agents. Sustained low rates of hospital-onset Clostridium difficile (CDI) and carbapenem-resistant Enterobacteriaceae (CRE) infections were observed in 2015 compared with the prior year (1.1 and 1.2 cases/1000 PD, 0.2 and 0.1 cases/1000 PD, respectively). Thirty-day readmission rate decreased by 0.6% (P = .019). Conclusions: Integration of all pharmacists into ASP activities based on the level of patient care and responsibilities is an effective strategy to expand clinical services provided by ASP.

Role of postgraduate year 2 pharmacy residents in providing weekend antimicrobial stewardship coverage in an academic medical center.

PURPOSE: The integration of pharmacy residents into an antimicrobial stewardship program (ASP) is described, and data on the residents' ASP interventions and outcomes are reported. SUMMARY: ASP coverage of nighttime, holiday, and weekend shifts is often provided by infectious diseases (ID) medical fellows and staff pharmacists, potentially leading to inconsistent stewardship practices. As part of an initiative by a large urban hospital to provide around-the-clock, comprehensive ASP services 7 days a week, postgraduate year 2 (PGY2) pharmacy residents in ID or critical care were assigned to provide ASP coverage on weekends. Over a 12-month period, residents providing ASP weekend coverage documented a total of 1,443 interventions, of which 1,000 (69%) were pursuant to 72-hour prospective audit and feedback review and 443 (31%) occurred during ASP phone coverage. A comparison of overall antimicrobial utilization (mean ± S.D. days of therapy [DOT] per 1,000 patient-days [PD]) before and after implementation of resident ASP coverage on weekends showed a decrease in aggregate antimicrobial use from 799.3 ± 46.8 to 740.7 ± 17.3 DOT/1,000 PD (a difference of 58.6 DOT/1,000 PD, p = 0.08), with a corresponding decline in the incidence of hospital-onset Clostridium difficile infection (from 1.18 cases to 0.9 case per 1,000 PD). CONCLUSION: By expanding the hospital's ASP services by assigning PGY2 pharmacy residents to weekend coverage, the institution was able to provide high-level clinical care 7 days per week, which benefited both patients and PGY2 pharmacy residents while meeting national ASP regulatory requirements.