Processes and perceptions of chemotherapy supply chain in Ethiopia: A mixed-method study.

BACKGROUND: The impact and downstream effects of the chemotherapy supply chain in Ethiopia are not well understood. The purpose of this study was to identify perceived gaps in supply chain and characterize their impact on patient care. METHODS: A concurrent mixed-method study was conducted at a large academic cancer center in Ethiopia. In-depth interviews (IDIs) and surveys were completed in collaboration with external stakeholders with knowledge about chemotherapy supply chain in Ethiopia. Thematic coding was used for qualitative analysis of IDI and descriptive statistics were used to summarize quantitative survey data. RESULTS: Six stakeholders participated in the IDIs and seven completed surveys. IDIs revealed that most chemotherapeutic agents are purchased by the Ethiopian Pharmaceutical Supply Agency (EPSA) and are distributed to cancer treatment centers. A free-market purchasing option also exists, but for chemotherapy obtained outside of government-subsidized channels, the potential for substandard or falsified chemotherapy was a concern. Participants expressed confidence that the correct treatment was administered to patients, but viewpoints on reliability and consistency of medication supply were variable. Quantitative data from the survey showed that participants were not confident that medications are prepared safely and correctly. Improper storage and manipulation of high-risk medications remain a significant risk to staff. CONCLUSIONS: This study provides insight from a healthcare staff perspective on how gaps in the chemotherapy supply chain process impact patient care in a low-income country. Inventory management, disruptions in supply chain, and product integrity were perceived as the largest gaps in the current chemotherapy supply chain structure.

Considerations When Transitioning From Health-System Pharmacy Administration and Leadership Resident to Pharmacy Leader.

A key part to assimilating into an organization in a leadership role is managing transitions. Health-System Pharmacy Administration and Leadership (HSPAL) Residency Programs focus on laying the foundation for continued growth in management and leadership skills. This article focuses on keys for transitioning from HSPAL Pharmacy Resident to Pharmacy Leader. Managing transitions is and will continue to be an important topic for all leaders. As HSPAL Residents transition to new pharmacy leaders, understanding pharmacy practice building relationships, maintaining them, and having a thoughtful strategy through this transition will allow for a more complete understanding of the organization to navigate complexities, develop people, and complete projects and initiatives. While this article is specific to HSPAL residents, these concepts can apply to the transition to pharmacy leaders.

Impact of an electronic health record transition on chemotherapy error reporting.

BACKGROUND: Incident reporting systems allow for frontline employees to report errors and are a critical component of healthcare patient safety programs. Although incident reporting systems cannot quantify total errors, organizations can utilize incident reporting systems to help identify risks and trends to act upon. The objective of this article is to utilize incident reporting systems to evaluate trends in medication error reporting before and after implementation of a new electronic health record system. METHODS: A five-month pre- and post-analysis was completed in a cancer hospital following electronic health record conversion by reviewing medication errors reported via the institution's voluntary incident reporting systems. Error reports included medication error category, date error was reported/occurred, patient location at time of error, harm severity score, medication(s) involved, medication use system node error originated/discovered in, medication source, narrative summary, and contributing factors. Data were analyzed using descriptive statistics within Office Excel. RESULTS: Oncology medication error reports submitted pre- and post-electronic health record were 68 vs. 57, respectively. During the pre- and post-electronic health record conversion, a majority of errors had a harm severity index of 0 or 1; 12 (18%) in pre-electronic health record and 3 (5%) in post-electronic health record were level 2, and one (1%) in pre-electronic health record vs. 0 in post-electronic health record were level 3. Reported medication errors originated most commonly during the prescribing, administration, and preparation/dispensing phase and were primarily identified in the administration phase of the medication use process. The most frequently reported error category was 'wrong dose' followed by 'other' and 'overdose' in the pre-electronic health record phase and 'missing dose/delayed delivery' and 'order incorrect' in the post-electronic health record phase. The most frequently reported medications included methotrexate, chemotherapy (unspecified), and cisplatin. CONCLUSION: Analyzing data from incident reporting system reports allowed our institution to understand different trends of reporting in the cancer hospital following electronic health record adoption. Utilization of incident reporting systems must be combined with proactive risk identification approaches to enable systems-focused improvements to improve patient safety.

A chemotherapy privileging process for advanced practice providers at an academic medical center.

PURPOSE: Nurse practitioners, physician assistants, and pharmacists are advanced practice providers who are highly trained and qualified healthcare professionals that can help support traditional demands on oncologists' increased time in direct patient care. The purpose of this study was to detail and assess the creation of a privileging process for this group of medical professionals within an academic medical center. Obtaining the designation of limited oncology practice provider (LOPP) gives the right to modify chemotherapy orders and to order supportive care medications. METHODS: An interdisciplinary team developed a comprehensive training process inclusive of required educational domains, knowledge goals, and educational activities to become an LOPP. In 2018, five years after the implementation of the privileging process, a survey was distributed to assess perceptions of the training process and integration of LOPPs within oncology practice. RESULTS: Most oncologists noted that working with LOPPs is beneficial to oncology practice (94%) and that they make modifying chemotherapy orders more efficient (87%). Greater than 82% of LOPPs also reported that their privileges streamline the chemotherapy process and make them feel valuable. CONCLUSION: The creation of the LOPP designation is an effective way to integrate nurse practitioners, physician assistants, and pharmacists within oncology practice. The inclusion of a focused privileging process ensures the safety of cancer care provided and has created a streamlined process for chemotherapy modifications and supportive care.

Evaluation of Targeted Pharmacist Interventions to Reduce Length of Stay in an Acute Care Practice Model.

BACKGROUND: Despite widespread recognition of the need for innovative pharmacy practice approaches, the development and implementation of value-based outcomes remains difficult to achieve. Furthermore, gaps in the literature persist because the majority of available literature is retrospective in nature and describes only the clinical impact of pharmacists' interventions. OBJECTIVE: Length of stay (LOS) is a clinical outcome metric used to represent efficiency in health care. The objective of this study was to evaluate the impact of pharmacist-driven interventions on LOS in the acute care setting. METHODS: A separate samples pretest-posttest design was utilized to compare the effect of pharmacist interventions across 3 practice areas (medicine, hematology/oncology, and pediatrics). Two time periods were evaluated: preimplementation (PRE) and a pilot period, postimplementation of interventions (POST). Interventions included targeted discharge services, such as discharge prescription writing (with provider cosignature). Participating pharmacists completed semistructured interviews following the pilot. RESULTS: A total of 924 patients (466 PRE and 458 POST) were included in the analysis. The median LOS decreased from 4.95 (interquartile range = 3.24-8.5) to 4.12 (2.21-7.96) days from the PRE versus POST groups, respectively ( P < 0.011). There was no difference in readmission rates between groups (21% vs 19.1%, P = 0.7). Interviews revealed several themes, including positive impact on professional development. Conclusion and Relevance: This pilot study demonstrated the ability of pharmacist interventions to reduce LOS. Pharmacists identified time as the primary barrier and acknowledged the importance of leaders prioritizing pharmacists' responsibilities. This study is novel in targeting LOS, providing a value-based outcome for clinical pharmacy services.

Patient engagement in first cycle comprehensive chemotherapy consultation pharmacist services and impact on patient activation.

BACKGROUND: Healthcare systems and policy makers worldwide are demonstrating interest in shared decision making, which requires patient activation. Patient activation can be measured using a validated tool called the patient activation measure-10. First cycle comprehensive chemotherapy consultation services (3CS) is provided by an oncology pharmacy team member during a patient encounter at the beginning of the patient's treatment for cancer. METHODS: This was a single center, prospective, non-randomized, observational clinical study in patients with cancer who required a new chemotherapy plan. A baseline patient activation measure-10 survey was administered and a pharmacy team member met with the patient to complete the first cycle 3CS encounter. Within two business days of that encounter, a second patient activation measure-10 survey was administered, and thus, patients served as their own control. RESULTS: Forty-nine patients who met the inclusion criteria were enrolled, of which 36 completed the study. Mean patient activation measure-10 scores measured at baseline and two business days after the 3CS encounter were significantly different (68.5 ± SD 14.7 vs. 75.0 ± SD 14.3, p = 0.001). This difference persisted when evaluated by gender (female: 70.0 ± SD 14.8 vs. 81.6 ± SD 10.5, p = 0.001; male: 66.1 ± SD 14.8 vs. 70.8 ± SD 14.7, p = 0.022). CONCLUSION: This study demonstrates that cancer patients had significantly increased patient activation scores after engagement in a 3CS encounter provided by an oncology pharmacy team. Further studies are needed to verify these data in a larger population, different healthcare settings, and to evaluate for patients who have solid tumor malignancies.

Continuous Care Provided Through Comprehensive Medication Management in an Acute Care Practice Model.

BACKGROUND: Pharmacy practice models that foster pharmacists' accountability for medication-related outcomes are imperative for the profession. Comprehensive medication management (CMM) is an opportunity to advance patient care. OBJECTIVE: The objective of this study was to evaluate the impact of a CMM practice model in the acute care setting on organizational, patient, and financial outcomes. METHODS: Three adult service lines focused on at-risk patients identified using internal risk stratification methodology were implemented. Core CMM elements included medication reconciliation, differentiated clinical pharmacy services, inpatient MTM consultations, discharge services, and documentation. Mixed methods compared the effect of the CMM model before and after implementation. Historical patients served as comparative controls in an observational design. Pharmacists completed a 60-minute interview regarding their experiences. Qualitative data were analyzed using thematic coding to characterize perception of the model. RESULTS: Three pharmacists implemented the model on cardiology, hematology/oncology, and surgery transplant services and provided services to 75 patients during the study. A total of 145 medication-related problems were identified and resolved. CMM was associated with a nonsignificant reduction of 8.8% in 30-day hospital readmission rates ( P = 0.64) and a 24.9% reduction in 30-day hospital utilization ( P = 0.41) as well as a significant reduction of 86.5% in emergency department visits ( P = 0.02). Patients receiving discharge prescriptions from our outpatient pharmacies increased by 21.4%, resulting in an 11.3% increase in discharge prescription capture and additional revenue of $5780. Themes identified from qualitative interviews included CMM structure, challenges, value, and resources. CONCLUSION: This study demonstrated successful implementation of a CMM model that positively affected organizational, patient, and financial outcomes.

Impact of an integrated oral chemotherapy program on patient adherence.

As the use of oral chemotherapy continues to rise, the issue of patient adherence is a concerning aspect of cancer treatment. In this concurrent prospective and retrospective study, we assessed oral chemotherapy adherence in patients receiving their prescriptions at an institutional specialty pharmacy, with an integrated oral chemotherapy program. The primary endpoint is medication possession ratio. Secondary endpoints include self-reported adherence comparing survey data before and after the introduction of the oral chemotherapy program to assess the impact of the comprehensive pharmacy services provided. Patients receiving their oral chemotherapy from the institutional specialty pharmacy have a mean medication possession ratio of 0.92, indicating excellent adherence rates. The oncology clinical pharmacist, in collaboration with the specialty pharmacy, has also decreased the rates of patient-reported non-adherence.

Challenges and Solutions to New Manager Onboarding.

This article outlines challenges and solutions to new managers onboarding within a department of pharmacy.

Financial Effect of a Drug Distribution Model Change on a Health System.

Background: Drug manufacturers change distribution models based on patient safety and product integrity needs. These model changes can limit health-system access to medications, and the financial impact on health systems can be significant. Objective: The primary aim of this study was to determine the health-system financial impact of a manufacturer's change from open to limited distribution for bevacizumab (Avastin), rituximab (Rituxan), and trastuzumab (Herceptin). The secondary aim was to identify opportunities to shift administration to outpatient settings to support formulary change. Methods: To assess the financial impact on the health system, the cost minus discount was applied to total drug expenditure during a 1-year period after the distribution model change. The opportunity analysis was conducted for three institutions within the health system through chart review of each inpatient administration. Opportunity cost was the sum of the inpatient administration cost and outpatient administration margin. Results: The total drug expenditure for the study period was $26 427 263. By applying the cost minus discount, the financial effect of the distribution model change was $1 393 606. A total of 387 administrations were determined to be opportunities to be shifted to the outpatient setting. During the study period, the total opportunity cost was $1 766 049. Conclusion: Drug expenditure increased for the health system due to the drug distribution model change and loss of cost minus discount. The opportunity cost of shifting inpatient administrations could offset the increase in expenditure. It is recommended to restrict bevacizumab, rituximab, and trastuzumab through Pharmacy & Therapeutics Committees to outpatient use where clinically appropriate.

Evaluating the Sensitivity of a Media-Fill Challenge Test Under Various Situations as a Reliable Method for Recommended Aseptic Technique Competency Assessment.

Background: Microbial contamination of compounded medications is a serious concern within hospital pharmacies as it can lead to severe patient injury. The United States Pharmacopeia <797> mandates that pharmacy personnel responsible for preparing compounded sterile preparations must annually demonstrate competency in aseptic technique by performing a media-fill challenge test. Objective: The purpose of this study is to evaluate the sensitivity of a commonly used media-fill test through proper and improper compounding techniques. Methods: Two aseptically trained pharmacy technicians performed media-fill challenge testing by carrying out 5 separate manipulations 5 times each for a total of 25 trials. Sterile vials, syringes, and intravenous bags were prepared. The first manipulation followed best-practice aseptic technique and sterile compounding procedures. Each of the following 4 manipulations removed one aspect of best-practice aseptic technique. The prepared products were incubated at 20°C to 25°C. A positive result for microbial contamination is indicated by visible turbidity within the vials, syringes, and intravenous bags at the following check points: 24 hours, 72 hours, 7 days, 14 days, 21 days, and >30 days. Results: Twenty-five trials, each containing 10 distinct admixtures, resulted in a total of 250 compounded preparations. No single preparation showed signs of turbidity, sedimentation, or visible microbial growth at any of the 6 checkpoints yielding a 0% contamination rate. However, the positive controls inoculated with bacteria did have positive microbial growth results. Conclusion: A more sensitive test needs to be developed to provide assurances that all poor aseptic practices are detected in compounding personnel.

Eliminating sexual harassment in pharmacy: Role of the chief pharmacy officer.

In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time.

Evaluating the effects of a global pandemic on the operation of an investigational drug service.

PURPOSE: This study is an analysis of the changes to workload and operations of UNC Health's investigational drug service (IDS) brought about by the coronavirus disease 2019 (COVID-19) pandemic. METHODS: Workload statistics were collected and analyzed for trend changes to illustrate operational changes necessitated by the COVID-19 pandemic within the IDS pharmacy at UNC Health. RESULTS: Multiple workload metrics declined at the beginning of the COVID-19 pandemic, followed by an increase in the metrics for many categories as the pandemic continued. Notably, monthly inventory added initially decreased by 37.5%, later leveling off but showing increased variability. Fills dispensed and monitoring visits both decreased by 34.5% from the first quarter (Q1) to Q2 of 2020. Both metrics returned to or slightly exceeded prepandemic levels by the end of the study period in March 2021. Patient enrollment decreased 76% from February to May 2020 before dramatically increasing in Q3 of 2020 and Q1 of 2021 with the initiation of COVID-19 vaccine studies. The average time to study startup increased for trials not related to COVID-19 and decreased for COVID-19-related trials. There has been no major impact on the number of open protocols throughout the course of the pandemic. CONCLUSION: Despite initial decreases in workload following the start of the COVID-19 pandemic, IDS operations returned to and, in some cases, exceeded prepandemic levels.

Establishing a pharmacy revenue integrity team: A blueprint for increasing pharmacy's role in health-system revenue cycle.

PURPOSE: An increasing focus on driving margin has pushed health-system pharmacy departments to find new ways of generating new or protecting existing revenue. At UNC Health, a dedicated pharmacy revenue integrity (PRI) team has been operating since 2017. This team has been able to significantly reduce revenue loss from denials, increase billing compliance, and improve revenue capture. This article provides a framework for establishing a PRI program and reports results generated from it. SUMMARY: The activities of a PRI program can be grouped into 3 main pillars: minimizing revenue loss, optimizing revenue capture, and ensuring billing compliance. Minimizing revenue loss is accomplished primarily through management of pharmacy charge denials and can be an ideal first step in establishing a PRI program due to the tangible value generated. Optimizing revenue capture involves a combination of clinical expertise and understanding of billing operations to ensure medications are being billed and reimbursed appropriately. Finally, ensuring billing compliance, including ownership of the pharmacy charge description master and maintenance of electronic health record medication lists, is vital in preventing charge and reimbursement errors. CONCLUSION: Successfully bringing traditional revenue cycle functions into the department of pharmacy can be a daunting task but provides significant opportunities to create value for a health system. Key factors to the success of a PRI program include robust data access, hiring individuals with financial and pharmacy expertise into PRI positions, strong relationships with the existing revenue cycle teams, and a progressive model that allows for incremental expansion of services.

Embedding an Advanced Pharmacy Technician in an Adult Specialty Pulmonary Clinic to Complete Prior Authorizations Improves Efficiency and Provider Satisfaction.

PURPOSE: The purpose of this study is to assess the impact of a clinic embedded Medication Assistance Program (MAP) specialist on the prescription benefit prior authorization (PA) process and provider satisfaction in an adult pulmonary clinic. METHODS: In this mixed methods study, a retrospective cohort analysis was done to determine the turnaround time for the PA process from initial referral to approval or final denial in an adult pulmonary clinic. Additionally, a pre- and post-implementation survey to providers was conducted to assess provider satisfaction and perceptions around the prescription benefit PA process. The first study aim assessed PA efficiency by summarizing PA approval rate and PA turnaround time using descriptive statistics. Any prescriptions written by a clinic provider requiring a PA during the timeframe of June 2018 through August 2018 were included. The second study aim assessed change in provider satisfaction, analyzed via the Mann-Whitney U test. RESULTS: The MAP specialist completed 110 PAs over 3 months for 110 unique patients. Median turnaround time was 3 hours, with 76% of PAs approved in less than 24 hours. Initial approval rate was 82.7%, and overall approval rate following the appeals process was 87.3%. A significant difference between the pre- and post-survey responses were identified in 2 of the 17 questions. CONCLUSION: Implementation of a clinic embedded MAP specialist to complete PAs demonstrated an efficient process while also improving provider satisfaction.

Evaluation of density variations to determine impact on sterile compounding.

PURPOSE: To determine the density variation between (1) the measured density and manually calculated density, (2) density variation of different lots, and (3) density variation of different drug manufacturers in order to support institutions using gravimetric compounding methods. SUMMARY: Seventeen sterile injectable ingredient (drug) vials frequently used to make compounded sterile products (CSPs) were identified based on the ability to ensure that for each drug there were vials produced by 2 different manufacturers and 2 lots produced by the same manufacturer. Each drug's density was measured using a density meter and by manual calculation using the institution's density formula. Density differences were compared between the 2 different methods. Overall, the average drug density difference between the measured versus calculated density was determined to be 0.022. Further analysis revealed the average difference between the different lot numbers of the same manufacturers was 0.005 for the nonhazardous drugs and 0.0001 for the hazardous drugs. The average difference between the different manufacturers of the same drug was determined to be 0.008 for the nonhazardous drugs and 0.001 for hazardous drugs. CONCLUSION: No clinically meaningful difference exists when manually calculating a drug's density compared to measuring a drug's density using a density meter. In addition, there does not appear to be a sizeable density variation between the same drugs in separate lots or produced by different manufacturers.

Descriptive Report of Individual State Responses to Personal Protective Equipment Shortages for Pharmacy Practice During the Covid-10 Pandemic.

The objective of this study was to describe the response by state boards of pharmacy pertaining to personal protective equipment shortages during the early phase of the COVID-19 pandemic. All webpages of state boards of pharmacy were independently reviewed for written guidance pertaining to personal protective equipment conservation strategies in sterile compounding and deviations from United States Pharmacopeia General Chapter <797> standards; each guidance was then reviewed for referenced sources. Of 52 state pharmacy regulatory bodies, 38 (73.08%) provided guidance to modifying personal protective equipment use during sterile compounding activities to mitigate supply shortages. The references for each guidance varied, however, most referenced CriticalPoint, LLC or the United States Pharmacopeia. A few of the guidance documents from boards also permitted other deviations from United States Pharmacopeia Chapter <797> standards. Early in the pandemic, pharmacists within sterile compounding practices had to conserve personal protective equipment while mitigating contamination risk. Pharmacists looked to state boards of pharmacy for guidance. This report shows a high level of state response to the personal protective equipment shortage induced by the pandemic.

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.

Effectiveness and impact of a structured research approach for health-system pharmacy administration and leadership residents.

PURPOSE: Required competency areas, goals, and objectives for both postgraduate year 1 (PGY1) pharmacy residencies and postgraduate year 2 (PGY2) health-system pharmacy administration and leadership (HSPAL) residencies indicate the importance of research in the residency program by specifying it as a required part of the training process. Research is critical in the field of health-system pharmacy administration, which is built upon the principles of evaluation and assessment, ensuring that all activities implemented in an organization are evaluated through data collection and assessment to determine their impact. Additionally, the research structure provides residents the opportunity to share research broadly, and it also provides the platform for other institutions to implement successful ideas of interest to them. SUMMARY: This article describes the impact of having a structured, publication-focused research program in an HSPAL residency. The research process has provided follow-up projects (n = 7) and grant participation (n = 6). Additionally, the process has yielded a 66% publication rate, with 21 of 32 thesis substitutes published in various journals. The department of pharmacy at the residency site has noticed that the continued refinement, scoping, and robust methodologies of projects have been essential to their impact in the literature and in dissemination of the accumulated body of knowledge. CONCLUSION: A structured residency research program has provided direction to HSPAL residents and ensured successful scoping and completion of their research. Intentionality in this aspect has provided HSPAL residents with opportunities for publications, grants, and strong research experiences. Overall, the department of pharmacy has been positively impacted through implementation of services that were evaluated through a structured HSPAL pharmacy residency research program.

Report on 2020 Safe to Touch Consensus Conference on Hazardous Drug Surface Contamination.

PURPOSE: The 2020 Safe to Touch Consensus Conference on Hazardous Drug Surface Contamination was convened in order to gather subject matter experts in the field of hazardous drug (HD) handling to develop consensus statements regarding surface contamination monitoring for adoption by stakeholders in the drug supply chain, policy, and healthcare arenas. SUMMARY: The Safe to Touch conference convened virtually on September 22, 24, and 26, 2020. An expert panel of healthcare providers with experience in HD handling, monitoring, and research; pharmacy and nursing operations; and medication safety led the conference. An experienced audience of approximately 25 reaction panel members provided feedback to the panel via a preconference survey, during the conference, and at a postconference virtual town hall. Additionally, expert speakers presented on a range of issues, including the impact of HD surface contamination on health, current regulations and standards, surface contamination monitoring technologies, and variables impacting surface contamination testing. CONCLUSION: At the end of the conference, the expert panel developed 11 consensus statements and corresponding recommendations that should be widely disseminated in order to educate individuals regarding the impact of HD surface contamination and increase the scope of HD surface contamination monitoring. Institutions involved in the handling of HDs should set short- and long-term goals for implementation of applicable consensus statements.