Pharmacy students' interprofessional experience and performance in advanced pharmacy practice experience rotations amid COVID-19 pandemic.

Introduction: Interprofessional education (IPE) is essential in pharmacy training, providing students with vital collaborative skills for real-world healthcare. Advanced Pharmacy Practice Experience (APPE) is integral to IPE, allowing students to apply their knowledge in diverse healthcare settings. The COVID-19 pandemic has disrupted healthcare education and raised concerns about its impact on IPE during APPE rotations. Our study investigates the pandemic's influence on pharmacy students' interprofessional interactions and APPE performance. Objective: To assess the interprofessional experiences of fourth-year pharmacy students before and during the COVID-19 pandemic in the context of APPE. Methods: This retrospective observational study examined the experiences of P4 pharmacy students in the United States during APPEs before and during the pandemic. We employed electronic surveys with 21 questions to gauge interactions and interprofessional team effectiveness, employing Likert scale response options. We compared responses between the 2019-2020 and 2020-2021 APPE rotations using statistical tests. Results: Our study encompassed 83 and 86 students for the 2019-2020 and 2020-2021 APPE rotations, respectively, achieving a 100% response rate. Amid the pandemic, written communications between pharmacy students and healthcare providers in general medicine rotations increased, while in-person engagement decreased. Pre-COVID, students reported higher colleague referrals and greater interprofessional utilization during ambulatory care rotations. Conclusion: COVID-19 shifted interactions from in-person to written communication between pharmacy students and healthcare providers. Students reported decreased satisfaction with their interprofessional experiences. This research offers insights into the changing landscape of pharmacy education, helping students prepare for evolving challenges in healthcare delivery and education.

Patient motivators to use opioids for acute pain after emergency care.

Introduction: Patients are stakeholders in their own pain management. Factors motivating individuals to seek or use opioids therapeutically for treatment of acute pain are not well characterized but could be targeted to reduce incident iatrogenic opioid use disorder (OUD). Emergency departments (EDs) commonly encounter patients in acute pain for whom decisions regarding opioid therapy are required. Decision-making is necessarily challenged in episodic, unscheduled care settings given time pressure, limited information, and lack of pre-existing patient provider relationship. Patients may decline to take prescribed opioids or conversely seek opioids from other providers or non-medical sources. Methods: Using a framework analysis approach, we qualitatively analyzed transcripts from 29 patients after discharge from an ED visit for acute pain at a large, urban, academic hospital in the midwestern United States to describe motivating factors influencing patient decisions regarding opioid use for acute pain. A semi-structured interview guide framed participant discussion in either a focus group or interview transcribed and analyzed with conventional content analysis. Results: Four major themes emerged from our analysis including a) pain management literacy, b) control preferences, c) risk tolerance, and d) cues to action. Discussion: Our findings suggest targets for future intervention development and a framework to guide the engagement of patients as stakeholders in their own acute pain management.

Physician-approved protocols increase naloxone dispensing rates.

OBJECTIVE: To measure the impact of the implementation of a law that allows pharmacists to provide naloxone under a physician-approved protocol on naloxone dispensing rates in an all-payer population across the United States. METHODS: Prescription claims from a national grocery chain for 31 states and Area Heath Resource File were used for this retrospective study. The study sample included all patients who filled at least one naloxone prescription during the study period from July 16, 2014 to January 16, 2017. A stepwise autoregression was performed for 30 consecutive months to evaluate the change in naloxone prescription dispensing rate. The primary independent variable was "implementation of the physician-approved protocol." The primary outcome measure was the rate of naloxone prescriptions dispensed per month per state. Secondary outcome measures were naloxone dispensing rates by each payer. RESULTS: Number of patients who received naloxone prescriptions in the states with physician-approved protocol was 423% higher compared to states without the protocol. The overall model showed that the naloxone dispensing rate was 6 times higher in the states with a physician-approved protocol. In the payer-based models, comparing states with and without protocol, the dispensing rate was highest for Medicare (9.0 times) followed by Private (4.6 times), Medicaid (3.2 times), and Cash (3.1 times). The number of prescriptions dispensed in the low-employment states with the protocol was 17.59 times higher compared to states without the protocol. CONCLUSIONS: Implementation of physician-approved protocol was strongly associated with an increase in naloxone dispensing rates, especially in the low-employment states.

Association Between a State Law Allowing Pharmacists to Dispense Naloxone Without a Prescription and Naloxone Dispensing Rates.

Importance: Between 2015 and 2017, Ohio had the second highest number of opioid-related deaths. In July 2015, the Ohio General Assembly approved a law allowing pharmacists to dispense naloxone without a prescription in accordance with a physician-approved protocol. This change in the law allowed pharmacists to have more opportunity to participate in the management of patients who were addicted to opioids. Objective: To determine the association between the implementation of an Ohio law allowing pharmacists to dispense naloxone without a prescription in accordance with a physician-approved protocol and naloxone dispensing rates. Design, Setting, and Participants: A segmented regression analysis of an interrupted time series was performed for 30 consecutive months to evaluate the change in the naloxone dispensing rate before and after the implementation of the state law. Ohio Medicaid naloxone claims and Kroger Pharmacy naloxone claims for all 88 counties in Ohio were examined. Any patient 18 years or older with at least 1 naloxone order dispensed through Ohio Medicaid or by a Kroger Pharmacy in Ohio during the study period of July 16, 2014, to January 15, 2017, was included in the study. Data were analyzed from April 23, 2018, to July 7, 2019. Exposures: The primary independent variable was implementation of an Ohio law allowing pharmacists to dispense naloxone without a prescription in accordance with a physician-approved protocol, which took effect in July 2015. Main Outcomes and Measures: The primary outcome measure was the naloxone dispensing rate per month per county. Results: In the Ohio Medicaid population, the number of naloxone orders dispensed after the policy was implemented increased by 2328%, from 191 in the prepolicy period to 4637 in the postpolicy period. The rate of naloxone orders dispensed per month per county after the policy was implemented increased by 4% in the Ohio Medicaid population and 3% in the Kroger Pharmacy population compared with the prepolicy period. The rate of naloxone orders dispensed after the policy was implemented increased by 18% per month in low-employment counties compared with high-employment counties in the Ohio Medicaid population. Conclusions and Relevance: The implementation of a state law allowing pharmacists to dispense naloxone without a prescription in accordance with a physician-approved protocol was associated with an increase in the number of naloxone orders dispensed in the Ohio Medicaid and Kroger Pharmacy populations. Moreover, a significant increase was observed in the naloxone dispensing rate among the Ohio Medicaid population in counties with low employment and high poverty.

Emergency Physicians' Perception of Barriers and Facilitators for Adopting an Opioid Prescribing Guideline in Ohio: A Qualitative Interview Study.

BACKGROUND: Ohio has the fifth highest rate of prescription opioid overdose deaths in the United States. One strategy implemented to address this concern is a state-wide opioid prescribing guideline in the emergency department (ED). OBJECTIVE: Our aim was to explore emergency physicians' perceptions on barriers and strategies for the Ohio ED opioid prescribing guideline. METHODS: Semi-structured interviews with emergency physicians in Ohio were conducted from October to December 2016. Emergency physicians were recruited through the American College of Emergency Physicians Ohio State Chapter. The interview guide explored issues related to the implementation of the guidelines. Interview data were transcribed and thematically analyzed and coded using a scheme of inductively determined labels. RESULTS: In total, we conducted 20 interviews. Of these, 11 were also the ED medical director at their institution. Main themes we identified were: 1) increased organizational responsibility, 2) improved prescription drug monitoring program (PDMP) integration, 3) concerns regarding patient satisfaction scores, and 4) increased patient involvement. In addition, some physicians wanted the guidelines to contain more clinical information and be worded more strongly against opioid prescribing. Emergency physicians felt patient satisfaction scores were perceived to negatively impact opioid prescribing guidelines, as they may encourage physicians to prescribe opioids. Furthermore, some participants reported that this is compounded if the emergency physicians' income was linked to their patient satisfaction score. CONCLUSIONS: Emergency physicians interviewed generally supported the state-wide opioid prescribing guideline but felt hospitals needed to take additional organizational responsibility for addressing inappropriate opioid prescribing.

Statewide cross-sectional survey of emergency departments' adoption and implementation of the Ohio opioid prescribing guidelines and opioid prescribing practices.

STUDY OBJECTIVE: To evaluate the implementation of the Ohio Emergency and Acute Care Facility Opioids and Other Controlled Substances Prescribing Guidelines and their perceived impact on local policies and practice. METHODS: The study design was a cross-sectional survey of emergency department (ED) medical directors, or appropriate person identified by the hospital, perception of the impact of the Ohio ED Opioid Prescribing Guidelines on their departments practice. All hospitals with an ED in Ohio were contacted throughout October and November 2016. Distribution followed Dillman's Tailored Design Method, augmented with telephone recruitment. Hospital chief executive officers were contacted when necessary to encourage ED participation. Descriptive statistics were used to assess the impact of opioid prescribing policies on prescribing practices. RESULTS: A 92% response rate was obtained (150/163 EDs). In total, 112 (75%) of the respondents stated that their ED has an opioid prescribing policy, is adopting one or is implementing prescribing guidelines without a specific policy. Of these 112 EDs, 81 (72%) based their policy on the Ohio ED Opioid Prescribing Guidelines. The majority of respondents strongly agreed/agreed that the prescribing guidelines have increased the use of the prescription drug monitoring programme (86%) and have reduced inappropriate opioid prescribing (71%). CONCLUSION: This study showed that the Ohio ED Opioid Prescribing Guidelines have been widely disseminated and that the majority of EDs in Ohio are using them to develop local policies. The majority of respondents believed that the Ohio opioid prescribing guidelines reduced inappropriate opioid prescribing. However, prescribing practices still varied greatly between EDs.

Mandatory review of a prescription drug monitoring program and impact on opioid and benzodiazepine dispensing.

BACKGROUND: The purpose of this study is to determine whether Ohio House Bill 341, which mandated the use of Ohio's Prescription Drug Monitoring Program (PDMP), was an effective regulatory strategy to reduce opioid and benzodiazepine dispensing. METHOD: Secondary analysis of Ohio's PDMP data on prescription opioids and benzodiazepines dispensed from November 2014 to March 2017. An interrupted time series analysis was conducted to determine if there was a significant change in the quantity of opioids and benzodiazepines dispensed. RESULTS: After HB341 became effective in April 2015, there was a statistically significant decrease in the monthly quantity (number of pills) opioids and benzodiazepines dispensed in Ohio. There was a modest increase in the mean days' supply of opioids and no change in the mean morphine equivalent dose. CONCLUSIONS: Legislation in Ohio requiring prescribers to check the PDMP was effective in reducing the quantity of opioids and benzodiazepines dispensed.

Structured Multi-Stakeholder Workshops to Advance a Global Transformative Roadmap for Pharmaceutical Workforce.

In November 2016, the International Pharmaceutical Federation (FIP) endeavored to create an environment to foster a shared vision to lead a transformative pharmaceutical workforce roadmap. Three milestone documents were developed and presented at the Global Conference on Pharmacy and Pharmaceutical Education. Workshops with the key themes and connecting Pharmaceutical Workforce Development Goals (PWDG) were conducted and analyzed. This Note serves to summarize the key aspects of these workshops, reporting on the innovative approaches used to generate guidance for stakeholders regarding implementation. INNOVATION: Seven workshops with a uniform structure were developed. These were designed to improve communication, harmonise outcome-generation, and allow for aggregate analysis. A team of seven conducted each workshop, each team consisted of: a Chair, a facilitator, one rapporteur, and four speakers purposively selected from FIP member organisations and other key stakeholders with expertise for sharing a variety of perspectives. Guidelines and templates were developed for all roles and each team was briefed in advance. KEY FINDINGS: Approximately 200 personnel participated in the seven workshops, with around 20 country representatives per workshop, covering all six World Health Organisation regions. Three key aspects of workforce transformation, using the PWDGs, were explored in each workshop: drivers for implementation; challenges to implementation; and ways of encouraging implementation. Drivers for implementation mentioned were enhancing collaboration and engagement. Challenges to implementation were identified as variance in terminology. Several ways of encouraging implementation were acknowledged, such as communication strategies, advocating for workforce development and sharing best practices to foster partnerships. NEXT STEPS: The unique format of the workshops, the innovative approach to include stakeholders across an array of settings and the parallel structure in all the seven workshops, aided in creating reliable findings. The achievability of the PWDGs depends on several factors. Engagement with stakeholders and engagement from and between professional associations are important factors to achieving workforce development goals.

Strategies and policies to address the opioid epidemic: A case study of Ohio.

OBJECTIVE: To describe the strategies and policies implemented in Ohio to improve opioid safety and to discuss the role that pharmacists can play in implementing, promoting, and enhancing the effectiveness of these policies. SETTING: Ohio has the fifth highest rate of drug overdose deaths (24.6 deaths per 100,000) in the United States. Unintentional drug overdose has become the leading cause of injury-related death in Ohio. In 2015, there were 3050 overdose deaths in Ohio, and in 2014 there were an estimated 12,847 overdose events reversed by emergency medical services with naloxone. PRACTICE DESCRIPTION: Not applicable. PRACTICE POLICY INNOVATION: In 2011, the Governor's Cabinet Opiate Action Team was created to implement a multifaceted strategy, in part (1) to promote the responsible use of opioids, (2) to reduce the supply of opioids, and (3) to support overdose prevention and expand access to naloxone. Innovations to assist these goals include the development of Ohio guidelines on the responsible use of opioids, mandatory use of Ohio's prescription drug monitoring program, closing pill mills, promotion of drug take-back programs and increased access to naloxone and public health campaigns. EVALUATION: Not applicable. RESULTS: Since the development of the Governor's Cabinet Opiate Action Team, there were 81 million fewer doses of opioids dispensed to Ohio patients in 2015 compared with 782 million doses dispensed in 2011. As such, the proportion of unintentional drug overdose deaths involving prescription opioids has reduced from 45% in 2011 to 22% in 2015. CONCLUSION: Strong political support was crucial in Ohio to facilitate the rapid implementation opioid overdose prevention programs and the promotion of public awareness campaigns. However, the misuse and abuse of prescription opioids are complex problems requiring a comprehensive and multifaceted approach. Pharmacists are identified as a crucial component of the state strategy to addressing opioid abuse by promoting responsible prescribing and adopting prevention practices.

Provision of Recommended Chronic Pain Assessment and Management in Primary Care: Does Patient-Centered Medical Home (PCMH) Recognition Make a Difference?

BACKGROUND: Chronic pain (CP) care in the patient-centered medical home (PCMH) model has not been well studied. We assessed whether PCMH recognition is associated with increased provision of key practice recommendations for CP assessment and management. METHODS: Chart reviews were completed for 12 primary care practices affiliated with one health system in the Cincinnati Area Research and Improvement Group (CARInG). Recommendations were abstracted and compared based on PCMH status: 3 practices had received prior PCMH level 3 recognition, 5 were in an ongoing process of applying, and 4 had no recognition and were not applying. RESULTS: A total of 485 charts were reviewed from 65 PCPs. Eight of 10 key recommendations were documented more often in the prior and ongoing PCMH cohorts, including assessing pain severity, function, psychosocial distress, and substance abuse, and using structured instruments for these assessments. There were fewer differences between the cohorts in the management of chronic opioids, with only the ongoing PCMH cohort having higher documentation for 5 of the 7 recommendations, including performing urine drug screens and using a structured instrument to assess for misuse. CONCLUSIONS: These findings support the usefulness of the PCMH model in managing patients with CP, but patient outcomes need to be addressed in future studies.

TransitionRx: Impact of community pharmacy postdischarge medication therapy management on hospital readmission rate.

OBJECTIVES: To determine if a community pharmacy-based transition of care (TOC) program that included the full scope of medication therapy management (MTM) services (TransitionRx) decreased hospital readmissions, resolved medication-related problems, and increased patient satisfaction. DESIGN: Prospective, quasi-experimental study. SETTING: Nine Kroger Pharmacies located in Western Cincinnati. PATIENTS: Patients older than 18 years of age and discharged from two local hospitals with a diagnosis of congestive heart failure, chronic obstructive pulmonary disease, or pneumonia. Patients were recruited from two local hospitals and referred to the community pharmacy for MTM services with the pharmacist within 1 week of discharge. MAIN OUTCOME MEASURES: Pharmacists reconciled the patients' medications, identified drug therapy problems, recommended changes to therapy, and provided self-management education. At 30 days after discharge, research personnel conducted telephone surveys, using a previously validated survey instrument, to assess hospital readmissions and patient satisfaction. Pharmacist interventions and medication-related problems were documented. RESULTS: A total of 90 patients completed the study. Of these, 20% of patients in the usual care group were admitted to the hospital within 30 days compared with 6.9% of patients in the intervention group (P = 0.019). In the 30 patients who received MTM services from the pharmacist, 210 interventions were made. The overall mean patient satisfaction with the TOC process was not significantly different between patients who were seen by the pharmacist and those who were not seen by the pharmacist. CONCLUSION: Community pharmacies successfully collaborated with hospitals to develop a referral process for TOC interventions. Patients who received MTM services from the pharmacist experienced significantly fewer readmissions than patients who received usual care.

Is there an association between immunosuppressant therapy medication adherence and depression, quality of life, and personality traits in the kidney and liver transplant population?

OBJECTIVES: To measure the association of transplant patients' personality, depression, and quality of life with medication adherence in kidney and liver transplant recipients. METHODS: A cross-sectional study of liver and kidney transplant recipients greater than 1 year post-transplant was conducted. Patients' adherence with medications was assessed using the Immunosuppressive Therapy Adherence Scale. Personality and depression were assessed using the NEO Five-Factor Inventory Scale and Patient Health Questionnaire 9, respectively. Quality of life was assessed using the Short Form-36, and functional status was determined using the Karnofsky Performance Status Scale. RESULTS: A total of 86 kidney and 50 liver transplant patients completed the surveys. Logistic regression analysis demonstrated an association between depression and adherence with immunosuppressive medications in kidney transplant recipients. Kidney transplant patients who exhibited "low openness" scores were 91% more likely to be nonadherent. Kidney transplant patients' physical functional status was strongly associated with nonadherence, and for each point increase in functionality the patients' adherence increased by 4%. In the liver sample, age was associated with adherence. For every year increase in age, adherence increased by 7%. CONCLUSION: The presence of low openness as a personality trait, poor physical functional status, and depression were associated with adherence in the kidney transplant population. In the liver transplant population, younger age was associated with nonadherence.

Long-term Medicaid excess payments from alleged price manipulation of generic lorazepam.

BACKGROUND: Cost savings from the use of generic drugs versus brand-name drugs are well known. Both private and public prescription drug plans encourage the use of generic drugs through a variety of mechanisms. The magnitude of cost savings for a given generic drug is dependent on the degree to which the generic market is competitive. Should the competitive structure become compromised, higher prices and reduced cost savings may result. An alleged conspiracy between Mylan Laboratories and its active-ingredient suppliers in 1997 was associated with an increase in seller concentration in the generic lorazepam market. The Federal Trade Commission (FTC) alleged that Mylan raised costs to consumers by $120 million because of price increases for generic lorazepam from March through December 1998 and for generic clorazepate from January through December 1998. In November 2002, a settlement with Mylan was approved by the FTC, and a federal district court required Mylan to pay $147 million, including $28.2 million to state agencies including Medicaid. OBJECTIVES: To (a) describe the seller concentration in the national Medicaid generic lorazepam market over a 19-year period from January 1991 through December 2009, (b) estimate the excess payments for generic lorazepam by Medicaid between 1998 and 2009, and (c) investigate potentially increased utilization and prices of 2 substitute pharmaceuticals: branded lorazepam (Ativan) and generic alprazolam (another widely used intermediate-acting benzodiazepine). METHODS: Using Medicaid State Drug Utilization Data from the Centers for Medicare Medicaid Services, we calculated the 4-firm concentration ratio (CR4) and the Herfindahl-Hirschman Index (HHI) for the Medicaid generic lorazepam market, along with pre-rebate reimbursement for pharmacy claims, number of claims (utilization), and average pre-rebate reimbursement per claim (average "price") for generic lorazepam, from 1991 through 2009. Medicaid's excess payments were estimated under 2 different assumptions regarding what the average generic lorazepam price would have been in the absence of the alleged conspiracy. To find counterfactual prices, the average per-claim reimbursement for lorazepam for the 4 quarters prior to the alleged conspiracy, $6.80, was inflated using (a) the quarterly change in the average per-claim reimbursement for generic alprazolam and (b) the Consumer Price Index (CPI) for all urban consumers, all goods. Potential impact of the alleged conspiracy on the branded lorazepam and generic alprazolam markets was investigated. RESULTS: The average pre-rebate reimbursements per claim for generic lorazepam were $10.25, $23.12, and $8.48 in 1991, 1998, and 2009, respectively. For the same 3 years, CR4 = 52.80, 76.02, and 86.74, while HHI = 905.71, 2,166.25, and 2,233.36. Medicaid's excess payments from 1998-2009 were estimated at approximately $625-$657 million. The data also suggest the possibility of small impacts on the utilization of branded lorazepam and the price of generic alprazolam. CONCLUSIONS: Prior to the alleged conspiracy in 1997, average pre-rebate reimbursement per claim for generic lorazepam was declining, while seller concentration was rising. After a jump in average payment per claim in the years immediately following the alleged conspiracy, prices have gradually returned to their pre-1998 levels. However, the generic lorazepam market was more concentrated in 2009 than prior to the alleged conspiracy.

Utilization, spending, and price trends for benzodiazepines in the US Medicaid program: 1991-2009.

BACKGROUND: Although it is well-known that drug costs in the US have risen precipitously over the last 25 years, what is much less appreciated is how this rise in cost has occurred across so many seemingly distinct drug markets. OBJECTIVE: To describe trends in the utilization, spending, and average per-prescription cost of benzodiazepines individually, in subgroups, and overall, in the Medicaid program. Medicaid has been the primary public payer for benzodiazepines over the past 2 decades. METHODS: A retrospective, descriptive analysis was performed for the years 1991-2009 using the publicly available national Summary Files from the Medicaid State Drug Utilization Data maintained by the Centers for Medicare & Medicaid Services. Quarterly prescription counts and reimbursement amounts were calculated for all benzodiazepines reimbursed by Medicaid. Average per-prescription spending as a proxy for drug price was found by dividing reimbursement by the number of prescriptions. RESULTS: Prescriptions for benzodiazepines among Medicaid beneficiaries increased from 8.0 million in 1991 to 17.1 million in 2009. Expenditures rose from $131.6 million to $171.1 million over the same time period. The average per-prescription price was a little over $10 in 2009. Whereas utilization of intermediate- and long-acting agents increased over time, prescriptions for short-acting drugs fell from 1.1 million to 0.3 million (1991-2009). The percentage rise in Medicaid spending on benzodiazepines since 1991 (30.0%) was less than the general rate of inflation (57.5%), as measured by the percentage change in the consumer price index over the same time period. CONCLUSIONS: Relative to the rise in the number of Medicaid beneficiaries (more than doubled over the study period), there is no evidence of an extraordinary rise in the utilization of benzodiazepines. Moreover, both nominal and real average prices of benzodiazepines have fallen, primarily because of generic entry over the last 2 decades.

Evidence-based prediction of statin use with lipid-panel data from the National Health and Nutrition Examination Survey.

OBJECTIVES: This study compared actual use of individual statin drugs to expected use based on their efficacy and safety profiles. METHODS: Five panels covering the years 1999 to 2008 from the National Health and Nutrition Examination Survey provided interview, demographic, and laboratory data for 8769 (365,503,838 weighted) people aged 20 years or older who were not taking a statin medication. An individual's risk for coronary heart disease and low-density lipoprotein (LDL) cholesterol goal were determined, following the Adult Treatment Panel III Cholesterol Guidelines. The percentage LDL cholesterol lowering required to reach his/her LDL cholesterol level goal was calculated. Depending on the amount of LDL cholesterol lowering needed and on if the individual had a liver condition (i.e., enhanced risk of rhabdomyolysis) statins were hypothetically prescribed. Predicted use was compared to actual use by U.S. Medicaid beneficiaries in the third quarter of 2009, obtained from the Medicaid State Drug Utilization Data maintained by the Centers for Medicare and Medicaid Services. RESULTS: Results showed that 72.34% of the population was in the lowest coronary heart disease risk group and that 86.30% required no statin therapy. Among the people who did require LDL cholesterol lowering, a significant majority (37.3 million or 10.22% of the population) needed 30% lowering or less. Only 314,784 (0.09%) required LDL cholesterol lowering of greater than 60%. Utilization shares based on safety and efficacy were estimated at 19.26% (rosuvastatin), 18.67% (atorvastatin), 16.48% (simvastatin), 16.30% (lovastatin), 14.93% (pravastatin), and 14.36% (fluvastatin). CONCLUSIONS: Actual statin use differed substantially from predicted use. It may be appropriate to develop and maintain policies that encourage use of less costly products that have essentially equivalent safety profiles and efficacy.

The impact of a change in tacrolimus monitoring immunoassay techniques on clinical decision making.

CONTEXT: Tacrolimus is an immunosuppressant that undergoes therapeutic drug monitoring. The laboratory at our institution changed its immunoassay techniques from the fluorescence polarization immunoassay to the cloned enzyme donation immunoassay. OBJECTIVE: To evaluate the relationship between the 2 assays and to determine the impact of the change on clinical decision making. DESIGN: A retrospective study of patients admitted to the hospital during the assay transition period. Tacrolimus values for the 2 assays were collected for 4 weeks and compared. SETTING: An academic health center. PATIENTS: Liver transplant patients hospitalized from February 18, 2008, to March 18, 2008. MAIN OUTCOME MEASURE: The primary outcome was the agreement between the results of the 2 immunoassays. Secondary outcome was agreement of clinical decision making with established patient-specific therapeutic ranges or with a 30% difference in absolute values between the assays. RESULTS: Seventy-nine pairs of tacrolimus concentrations were collected from 21 liver transplant patients. The mean (SD) tacrolimus concentrations were 7.36 (4.21) microg/L for the fluorescence polarization immunoassay and 9.00 (5.30) microg/L for the cloned enzyme donation immunoassay (P = .03). A clinically different decision would have been made if the fluorescence polarization immunoassay value had not been reported 51% of the time. A Bland-Altman plot indicated no relationship between the assay results. CONCLUSION: A change in tacrolimus monitoring assay would have resulted in different clinical decisions 51% of the time. Awareness of changes in assay technology must be heightened to enhance clinical decision making and prevent potential impact on morbidity among liver transplant patients.