Improve Medication Safety Research Articles

‘Making it Meaningful’: Co-designing an intervention to improve medication safety for people from culturally and linguistically diverse backgrounds accessing cancer services.

‘Making it Meaningful’: Co-designing an intervention to improve medication safety for people from culturally and linguistically diverse backgrounds accessing cancer services.

Walking the line: Mindfulness with IT in hospital medication routines

This paper addresses the dilemma that organizations face when they introduce information technology (IT) to standardize and guide operations and improve performance, while also supporting staff mindfulness in using IT and questioning it, to safeguard against errors. People are warned to be mindful in using the information provided by IT, yet IT may contribute to their mindlessness. Organizational operations involve routine work, where work is distributed across roles, in space and time. To fully understand mindfulness or mindlessness with IT at work it is necessary to consider the routines in which they are embedded. We sought to investigate what factors might influence mindfulness or mindlessness with IT in the context of organizational routines. We carried out an in-depth study of clinicians using technology during medications routines in a UK hospital. The IT in this context aimed to guide and standardize clinical work to improve medication safety. The study uncovered several factors influencing mindfulness and mindlessness with IT: not only the IT design but also task design, individual experience and history of IT use, distribution of work, and the situation at hand. These are interacting influences on mindfulness and mindlessness with IT, each embodying a tension, as each may influence both mindfulness and mindlessness. The distribution of work and the dynamics of the routine over time mean that individuals in the routine may (mindlessly) entrust mindfulness in using IT to others, or to other moments in time. The study highlights the complexity of achieving mindfulness with IT in organizations, and a nuanced relation between mindfulness and IT in a routine work context.

The Extent of Medication Errors During Hajj in the Kingdom of Saudi Arabia.

Background Medication errors are frequently identified in healthcare institutions and pose a risk to patients. The mass gathering during Hajj may expose the pilgrims to numerous health risks. No study has reported the extent of medication errors during Hajj in Saudi Arabia.Weinvestigated the rate, nature, reporting, severity, and causes of medication errors in Hajj pilgrims. Methodology A retrospective analysis of medication errors reported by healthcare professionals was conducted from July 5, 2022, to July 15, 2022, at Mina Al Wadi Hospital, Saudi Arabia. This study included all medication error report forms collected during the Hajj season. The National Coordinating Council for Medication Error Reporting and Prevention Index was used to classify the severity of medication errors. Results There were reports of 43 medication errors in 3,210 prescriptions. The medication error incidence rate was 1.5% (43/3,210). The highest proportion of medication errors (83.72%, 95% confidence interval (CI) = 72.69-94.75) occurred during the prescribing phase, and 97% (95% CI = 93.16-100.0) of medication errors were classified as near misses. Wrong drugs (23.25%) and frequency (18.60%) were responsible for nearly half of the medication errors. Lack of drug information was the leading cause of reported medication errors (58.14%), followed by environmental, personnel, and workload issues (23.25%), and look-alike/sound-alike medication issues (18.60%). Conclusions This study found that the incidence of medication errors was consistent with the global standard, and many of them did not reach pilgrims and were preventable. This highlights the importance of targeted interventions. Incorrect medication was the common type of medication error, highlighting a crucial area for intervention and improvement. Lack of drug information was the primary underlying factor in the occurrence of medication errors. Pharmacists were more likely than other healthcare professionals to report medication errors, highlighting the importance of their involvement in improving medication safety among pilgrims. Future research needs to focus on examining the effectiveness of interventions (e.g., provision of education regarding medicines and medication review) in reducing medicine-related events during Hajj.

Patient, Caregiver, and Clinician Experience with a Technologically Enabled Pillbox: A Qualitative Study

Abstract Objectives As part of a study to assess whether a technologically enabled pillbox prescribed to patients at hospital discharge can improve medication safety, we sought to assess participant experiences with the intervention. Methods We conducted a series of semi-structured phone interviews with patients, patient caregivers, and inpatient and outpatient clinicians who participated in the Smart Pillbox Transition Study. We developed an interview guide using the Systems Engineering Initiative for Patient Safety (SEIPS) framework, which included the a priori domains of (1) barriers to implementation, (2) facilitators of the intervention, and (3) general feedback regarding experience with the intervention. Within these domains, we employed SEIPS-informed themes of environment and organization, logistics and tasks, personnel and patients, and technology and tools. Interviews were conducted between May 2018 and January 2019. We used content analysis to interpret findings. Results We interviewed 6 patients, 2 caregivers, and 5 inpatient and 2 outpatient clinicians. Patient-endorsed barriers in the theme of technology and tools included signal issues, inappropriate alarms, and portability. Barriers in the theme of logistics and tasks included coordination with pharmacists in the event of a prescription change. Barriers mentioned by clinicians included patients who were poor fits for the intervention (theme: personnel and patients) and competing demands at discharge (theme: logistics and tasks). Facilitators that were frequently mentioned by patients and caregivers in the theme of technology and tools included useful alarms and ease of use. Clinicians stated that communication with pharmacy and study staff helped facilitate the intervention (theme: personnel and patients). Conclusion We identified several key barriers and facilitators from patients, caregivers, and clinicians to successful implementation of this intervention. Reconciling these sometimes contrasting viewpoints will be crucial if the Smart Pillbox or similar health information technology interventions are to be adopted as tools to improve medication safety during care transitions.

Improving Medication Safety in an ICU

ABSTRACT Reported medication errors in an ICU at an academic teaching hospital raised concerns about adherence to safety protocols, including barcode scanning before medication administration. A group of nurse leaders, bedside nurses, and pharmacists formed a medication safety task force to increase compliance with barcode scanning and reduce reported medication errors in which failure to scan was a contributing factor. Three task force members observed nurses' workflow in ICU medication administration. The members observed three nurses administer medications before scanning the barcode and three other nurses scan medications in a location where they were unable to see alerts on the computer. After the observations, the task force implemented three interventions: medication tables to provide a surface in front of the computer where medications could be placed when scanning; standardized workflow; and nursing staff education. Task force members then conducted postimplementation observations to evaluate improvement in barcode scanning compliance. In the postintervention observations, all medications were scanned in front of the computer before administration, an increase of 27.3 percentage points (from 72.7% preintervention) in the barcode scanning compliance rate. The ICU also went 17 months in the postintervention period without a reported medication administration error in which failure to scan was a contributing factor. The task force's observation of medication administration led to interventions that made it easier for nurses to adhere to best practice. Medication tables were a simple, sustainable intervention that used human factors principles to increase barcode scanning compliance.

Relationship between assertiveness in community pharmacists and pharmacist-initiated prescription changes

BackgroundDespite the usefulness of assertiveness by healthcare professionals in improving patient safety, few studies have evaluated the assertiveness of community pharmacists. Community pharmacists’ assertiveness might be associated with pharmacist-initiated prescribing changes to improve medication safety. ObjectivesOur objective was to examine which types of assertiveness-related self-expression are associated with community pharmacist-initiated prescribing changes while adjusting for possible confounding factors. MethodsWe conducted a cross-sectional survey in Japan between May and October 2022 in 10 prefectures. Community pharmacists belonging to a large pharmacy chain were recruited. The outcome variable was the frequency of community pharmacist-initiated prescription changes over 1 month. Community pharmacists' assertiveness was assessed using the Interprofessional Assertiveness Scale (IAS) and 3 sub-domains (nonassertive, assertive, and aggressive self-expression). Participants were classified into 1 of 2 categories based on medians. Demographic and clinical characteristics were compared by group with univariate analysis. A generalized linear model (GLM) was used to investigate the association between pharmacist-initiated prescription changes as an ordinal variable and pharmacists' assertiveness. ResultsOf 3346 community pharmacists invited, 963 were included in the analysis. Participants with high assertive self-expression scores had a significantly higher frequency of pharmacist-initiated prescription changes. There was no association between nonassertive or aggressive self-expression and pharmacist-initiated prescription changes. After adjustments, high assertive self-expression remained associated with a high frequency of community pharmacist-initiated prescription changes (odds ratio, 1.34; 95% confidence interval, 1.02–1.74; p = 0.032). ConclusionsHigher assertive self-expression among community pharmacists is associated with higher frequency of pharmacist-initiated prescription changes.

Medicines use issues perceived by Arabic-speaking patients living in English-speaking countries: A systematic review.

Quality use of medicines, or rational medicines use, requires patients' adherence to the quality principles of medication use. There is a limited number of reviews about quality medication use among migrant patients. This review aims to fill this gap by exploring medication-related issues experienced by Arabic-speaking patients living in English-speaking countries. The searched databases included WebMD, EMBASE, Scopus, CINHAL, PubMed/Medline and Web of science. The initial search retrieved 2071 publications and 23 publications met the inclusion criteria. Our review found that the most frequently reported medication-related issues among Arabic-speaking patients residing in English-speaking countries were problems related to decision-making regarding treatment options, inappropriate counselling and lack of information about medicines and diseases, lack of monitoring and follow-up, and intentional and unintentional medication non-adherence. Informed by the bio-psycho-socio-systems model, contributing factors to the medication issues included used coping strategies, ethno-cultural and religious beliefs and ineffective relationships with healthcare providers. Our review suggests that cultural factors can significantly influence individuals' perceptions and actions around the use of medication. Thus, healthcare providers need to be mindful of the specific cultural affiliations of ethnic minorities and exhibit cultural sensitivity when prescribing medication to migrant patients to foster a better relationship between patients and healthcare providers. Applying a patient-centred approach using shared decision-making can help. Our findings also suggest that pharmacy practice is critical in improving medication safety among Arabic-speaking patients.

Strategies for improving medication safety in healthcare facilities in Nigeria

Strategies for improving medication safety in healthcare facilities in Nigeria

Clinical pharmacist intervention to improve medication safety for hip fracture patients through secondary and primary care settings: a nonrandomised controlled trial

BackgroundHip fracture patients face a patient safety threat due to medication discrepancies and adverse drug reactions when they have a combination of high age, polypharmacy and several care transitions. Consequently, optimised pharmacotherapy through medication reviews and seamless communication of medication information between care settings is necessary. The primary aim of this study was to investigate the impact on medication management and pharmacotherapy. The secondary aim was to evaluate implementation of the novel Patient Pathway Pharmacist intervention for hip fracture patients.MethodsHip fracture patients were included in this nonrandomised controlled trial, comparing a prospective intervention group (n = 58) with pre-intervention controls who received standard care (n = 50). The Patient Pathway Pharmacist intervention consisted of the steps: (A) medication reconciliation at admission to hospital, (B) medication review during hospitalisation, (C) recommendation for the medication information in the hospital discharge summary, (D) medication reconciliation at admission to rehabilitation, and (E) medication reconciliation and (F) review after hospital discharge. The primary outcome measure was quality score of the medication information in the discharge summary (range 0–14). Secondary outcomes were potentially inappropriate medications (PIMs) at discharge, proportion receiving pharmacotherapy according to guidelines (e.g. prophylactic laxatives and osteoporosis pharmacotherapy), and all-cause readmission and mortality.ResultsThe quality score of the discharge summaries was significantly higher for the intervention patients (12.3 vs. 7.2, p < 0.001). The intervention group had significantly less PIMs at discharge (− 0.44 (95% confidence interval − 0.72, − 0.15), p = 0.003), and a higher proportion received prophylactic laxative (72 vs. 35%, p < 0.001) and osteoporosis pharmacotherapy (96 vs. 16%, p < 0.001). There were no differences in readmission or mortality 30 and 90 days post-discharge. The intervention steps were delivered to all patients (step A, B, E, F = 100% of patients), except step (C) medication information at discharge (86% of patients) and step (D) medication reconciliation at admission to rehabilitation (98% of patients).ConclusionThe intervention steps were successfully implemented for hip fracture patients and contributed to patient safety through a higher quality medication information in the discharge summary, fewer PIMs and optimised pharmacotherapy.Trial registration: NCT03695081.

Pharmacist Experiences with Electronic Health Records (EHR) Integration: Understanding Pharmacists’ Experiences, Challenges, and Perceived Benefits of Integrating EHR Systems into Their Workflow

This qualitative study explores 15 pharmacists' experiences with integrating Electronic Health Records (EHR) systems into their workflow. Through in-depth interviews, the study investigates the challenges faced by pharmacists, as well as the perceived benefits of EHR integration. Findings reveal that while EHR systems offer potential advantages such as improved medication safety and enhanced communication with healthcare teams, pharmacists encounter various challenges including usability issues, time constraints, and workflow disruptions. The study underscores the need for tailored EHR solutions and comprehensive training to optimize pharmacist engagement and integration within healthcare settings.

Understanding the medication safety challenges for patients with mental illness in primary care: a scoping review

BackgroundMental illness and medication safety are key priorities for healthcare systems around the world. Despite most patients with mental illness being treated exclusively in primary care, our understanding of medication safety challenges in this setting is fragmented.MethodSix electronic databases were searched between January 2000-January 2023. Google Scholar and reference lists of relevant/included studies were also screened for studies. Included studies reported data on epidemiology, aetiology, or interventions related to medication safety for patients with mental illness in primary care. Medication safety challenges were defined using the drug-related problems (DRPs) categorisation.ResultsSeventy-nine studies were included with 77 (97.5%) reporting on epidemiology, 25 (31.6%) on aetiology, and 18 (22.8%) evaluated an intervention. Studies most commonly (33/79, 41.8%) originated from the United States of America (USA) with the most investigated DRP being non-adherence (62/79, 78.5%). General practice was the most common study setting (31/79, 39.2%) and patients with depression were a common focus (48/79, 60.8%). Aetiological data was presented as either causal (15/25, 60.0%) or as risk factors (10/25, 40.0%). Prescriber-related risk factors/causes were reported in 8/25 (32.0%) studies and patient-related risk factors/causes in 23/25 (92.0%) studies. Interventions to improve adherence rates (11/18, 61.1%) were the most evaluated. Specialist pharmacists provided the majority of interventions (10/18, 55.6%) with eight of these studies involving a medication review/monitoring service. All 18 interventions reported positive improvements on some medication safety outcomes but 6/18 reported little difference between groups for certain medication safety measures.ConclusionPatients with mental illness are at risk of a variety of DRPs in primary care. However, to date, available research exploring DRPs has focused attention on non-adherence and potential prescribing safety issues in older patients with dementia. Our findings highlight the need for further research on the causes of preventable medication incidents and targeted interventions to improve medication safety for patients with mental illness in primary care.

Understanding an epidemiological view of a retrospective audit of medication errors in an intensive care unit

BackgroundMedication errors in the intensive care setting continue to occur at significant rates and are often associated with adverse events and potentially life-threatening repercussions. Aim/objectiveThe aim of this study was to (i) determine the frequency and severity of medication errors reported in the incident management reporting system; (ii) examine the antecedent events, their nature, the circumstances, risk factors, and contributing factors leading to medication errors; and (iii) identify strategies to improve medication safety in the intensive care unit (ICU). MethodA retrospective, exploratory, descriptive design was selected. Retrospective data were collected from the incident report management system and electronic medical records over a 13-month period from a major metropolitan teaching hospital ICU. ResultsA total of 162 medication errors were reported during a 13-month period, of which, 150 were eligible for inclusion. Most medication errors occurred during the administration (89.4%) and dispensing phases (23.3%). The highest reported errors included incorrect doses (25.3%), incorrect medications (12.7%), omissions (10.7%), and documentation errors (9.3%). Narcotic analgesics (20%), anaesthetics (13.3%), and immunomodifiers (10.7%) were the most frequently reported medication classes associated with medication errors. Prevention strategies were found to be focussed on active errors (67.7%) as opposed to latent errors (32.3%) and included various and infrequent levels of education and follow-up. Active antecedent events included action-based errors (39%) and rule-based errors (29.5%), whereas latent antecedent events were most associated with a breakdown in system safety (39.3%) and education (25%). ConclusionThis study presents an epidemiological view and understanding of medication errors in an Australian ICU. This study highlighted the preventable nature of most medication errors in this study. Improving administration-checking procedures would prevent the occurrence of many medication errors. Approaches aimed at both individual- and organisational-level improvements are recommended to address administration errors and inconsistent medication-checking procedures. Areas for further research include determining the most effective system developments for improving administration-checking procedures and verifying the risk and prevalence of immunomodifier administration errors in the ICU as this is an area not reported previously in the literature. In addition, the impact of single- versus two-person checking procedures on medication errors in the ICU should be prioritised to address current evidence gaps.

Patient safety in prisons: a multi-method analysis of reported incidents in England.

Prisoners use healthcare services three times more frequently than the general population with poorer health outcomes. Their distinct healthcare needs often pose challenges to safe healthcare provision. This study aimed to characterise patient safety incidents reported in prisons to guide practice improvement and identify health policy priorities.Design: We carried out an exploratory multi-method analysis of anonymised safety incidents from prisons. Safety incidents had been reported to the National Reporting and Learning System by prisons in England between April 2018 and March 2019. Reports were reviewed to identify any unintended or unexpected incident(s) which could have, or did, lead to harm for prisoners receiving healthcare. Free-text descriptions were examined to identify the type and nature of safety incidents, their outcomes and harm severity. Analysis was contextualised with subject experts through structured workshops to explain relationships between the most common incidents and contributory factors. Of 4112 reports, the most frequently observed incidents were medication-related (n = 1167, 33%), specifically whilst administering medications (n = 626, 54%). Next, were access-related (n = 559,15%), inclusive of delays in patients accessing healthcare professionals (n = 236, 42%) and managing medical appointments (n = 171, 31%). The workshops contextualised incidents involving contributing factors (n = 1529, 28%) into three key themes, namely healthcare access, continuity of care and the balance between prison and healthcare priorities. This study highlights the importance of improving medication safety and access to healthcare services for prisoners. We recommend staffing level reviews to ensure healthcare appointments are attended, and to review procedures for handling missed appointments, communication during patient transfers and medication prescribing.

Application of Multidisciplinary Teamwork in Medication Safety Guidance for Elderly Population with Chronic Diseases in Community

[Objective] A randomized controlled trial was conducted to investigate a systematic intervention to improve medication safety among elderly people in the community. [Methods] 150 community elderly patients with chronic diseases were randomly selected and divided into intervention group and control group. In addition to conventional medication safety guidance methods, multidisciplinary team cooperation mode was added to the intervention group. After 2 months of intervention, the knowledge, belief and practice of elderly patients with chronic diseases in the two groups were compared and analyzed. [Results]After intervention, inter-group and intra-group comparison of the intervention results showed that the total scores of knowledge, attitude and behavior KAP of the elderly with chronic diseases in the intervention group were higher than those in the control group, with statistical significance (p < 0.05), and the overall drug safety of the elderly in the community increased from a low level (47.3%) before intervention to a high level (95.8%) after intervention.. [Conclusion] The overall level of medication safety of the elderly in the chronic disease clinic of a town health center in Zhuhai is low. The drug safety guidance program of multidisciplinary team cooperation can effectively improve the medication safety of the elderly with chronic diseases in the community, and has a wide popularization.

The clinical and financial impact of remote clinical oncology pharmacist engagement in community-based practices within The US Oncology Network.

The integration of clinical oncology pharmacists into multidisciplinary healthcare teams is not well-described in the community practice setting. This study aims to analyze the clinical and financial impact of a remote-based clinical oncology pharmacist in four community oncology practices within The US Oncology Network. Oncology-trained clinical pharmacists electronically reviewed chemotherapy orders for clinical optimization and financial stewardship within four community oncology practices. Each pharmacist was appointed at 0.5 full-time equivalents per practice. Financial, clinical, and workload metrics were tracked to monitor the impact of pharmacist engagement. Over 12 months, 5716 order reviews were completed with an intervention rate of 57%. The most common interventions identified by the pharmacists were interventions with clinical impact on the patient (36%), followed by dose rounding (35%) and therapeutic interchange (30%). Overall, interventions improved the cumulative practice margins by $1,455,033 and reduced total medication costs by $5,962,551. The average program return on investment was 415% (range 100-915%). Community oncology practices seek to provide high-value care in a lean, resource-constrained model. An oncology clinical pharmacist is a cost-effective and clinically invaluable care team member in community oncology practice. Pharmacists in this setting identified opportunities to improve medication safety and regimen optimization and demonstrated a significant tremendous financial impact on small-scale budgets in community oncology.

Using a checklist-based electronic calculation aid and contextual cues to assist medication dose calculation and calculation resumption after interruptions

ObjectivesTo examine whether (1) the use of a checklist-based electronic calculation aid enhanced medication dose calculation and reduced the negative effects of interruptions on calculation, and (2) the use of contextual cues facilitated the resumption of calculation after an interruption. MethodsSixty students in healthcare majors participated in two computer-based laboratory experiments. Experiment 1 examined the effects of the calculation aid and interruptions on calculation error rate, calculation completion time, and perception outcomes. Experiment 2 assessed the effects of contextual cues on resumption error rate, calculation error rate, calculation completion time, and perception outcomes. ResultsIn Experiment 1, calculation error rates were lower for participants who received the calculation aid versus those who did not, and for uninterrupted calculations versus interrupted calculations, although the differences were not statistically significant.The participants spent significantly less time completing the calculation task with the use of the calculation aid than without the use of the calculation aid, and in the case without interruptions than in the case with interruptions. In Experiment 2, the use of contextual cues associated with previous actions significantly reduced the resumption error rate and the completion time of the medication dose calculation. Both experiments showed that the use of the calculation aid and contextual cues was associated with positive attitudes toward the aid and cues, reduced mental effort, and/or higher confidence in task performance. ConclusionsThe use of the checklist-based electronic calculation aid and contextual cues facilitated medication dose calculation and resumption after interruptions and thus has the potential to improve medication safety and work efficiency in healthcare.

Implementation of a Patient Questionnaire in Community Pharmacies to Improve Care for Patients Using Combined Antithrombotic Therapy: A Qualitative Study.

For several indications or combinations of indications the use of more than one antithrombotic agent is required. The duration of combined antithrombotic therapy depends on indication and patient characteristics. This study investigated the use of an antithrombotic questionnaire tool that had been developed for pharmacists to detect patients with possible incorrect combined antithrombotic therapy. The objective of this study was to identify potential barriers and facilitators that could influence the implementation of the developed antithrombotic questionnaire tool in daily community pharmacy practice. A qualitative study was conducted at 10 Dutch community pharmacies in which the antithrombotic questionnaire tool had been used with 82 patients. Semi-structured interviews were conducted with pharmacy staff who used the antithrombotic questionnaire tool. The interview questions to identify barriers and facilitators were based on the Consolidated Framework for Implementation Research. The interview data were analysed using a deductive thematic analysis. Ten staff members from nine different pharmacies were interviewed. Facilitators for implementation were that the questionnaire was easily adaptable and easy to use, as well as the relative short duration to administer the questionnaire. A possible barrier for using the questionnaire was a lower priority for using the questionnaire at moments when the workload was high. The pharmacists estimated that the questionnaire could be used for 70-80% of the patient population and they thought that it was a useful addition to regular medication surveillance. The antithrombotic questionnaire tool can be easily implemented in pharmacy practice. To implement the tool, the focus should be on integrating its use into daily activities. Pharmacists can use this tool in addition to regular medication surveillance to improve medication safety in patients who use combined antithrombotic therapy.

Reducing Medication Errors by Adopting Automatic Dispensing Cabinets in Critical Care Units

Medication errors can have severe consequences and threaten patient safety. The patient safety-related benefits of automated dispensing cabinets (ADCs) have been reported by several previous studies, including a reduction in medication errors in intensive care units (ICUs) and emergency departments. However, the benefits of ADCs need to be assessed, given the different healthcare practice models. This study aimed to compare the rates of medication errors, including prescription, dispensing, and administrative, before and after using ADCs in intensive care units. The prescription, dispensing, and administrative error data before and after the adoption of ADCs were retrospectively collected from the medication error report system. The severity of medication errors was classified according to the National Coordinating Council for Medication Error Reporting and Prevention guidelines. The study outcome was the rate of medication errors. After the adoption of ADCs in the intensive care units, the rates of prescription and dispensing errors reduced from 3.03 to 1.75 per 100,000 prescriptions and 3.87 to 0 per 100,000 dispensations, respectively. The administrative error rate decreased from 0.046 to 0.026%. The ADCs decreased National Coordinating Council for Medication Error Reporting and Prevention category B and D errors by 75% and category C errors by 43%. To improve medication safety, multidisciplinary collaboration and strategies, such as the use of automated dispensing cabinets, education, and training programs from a systems perspective, are warranted.

Mortality and Hospitalizations Among Patients Enrolled in an Interprofessional Medication Management Program-Results of the Medicines Initiative Saxony- Thuringia (Arzneimittelinitiative Sachsen-Thüringen, ARMIN).

Measures for improving medication safety in outpatient care are often complex and involve medication reviews. Over the period 2016-2022 (with a preceeding one-year pilot phase), an interprofessional medication management program-the Medicines Initiative Saxony-Thuringia (Arzneimittelinitiative Sachsen-Thüringen, ARMIN)-was implemented in two German federal states. More than 5000 patients received a medication review by the end of 2019 by a team composed of physicians and pharmacists and were provides with joint, continuous care thereafter. In the framework of a retrospectively registered cohort study, the mortality and hospitalizations of this population (5033 patients) were studied using routine data from a statutory health insurer (observation period 2015-2019) and compared with those of a control group (10 039 patients) determined from the routine data by propensity score matching. Mortality was compared by survival analysis (Cox regression), and hospitalization rates were compared in terms of event probabilities within two years of enrollment in the medication management program. Robustness was tested in multiple sensitivity analyses. Over the observation period, 9.3% of the ARMIN participants and 12.9% of persons in the control group died (hazard ratio of the adjusted Cox regression, 0.84; 95% confidence interval [0.76; 0.94], P = 0.001). In the first two years after inclusion, the ARMIN participants were hospitalized just as often as the persons in the control group (52.4% versus 53.4%; odds ratio from the adjusted model, 1.04 [0.96; 1.11], P = 0.347). The effects were consistent in sensitivity analyses. In this retrospective cohort study, participation in the ARMIN program was associated with a lower risk of death. Exploratory analyses provide clues to the potential origin of this association.

395 Hindering Generic Antiretroviral Treatment Competition for Human Immunodeficiency Virus: Anti-Competitive Agreements and HIV Disease Management Concerns

OBJECTIVES/GOALS: To understand the implications of minimal HIV generic drug availability on long-term HIV disease management, including anti-competitive agreements and patent strategies that hinder (ART) competition and ART medication safety and efficacy improvement. METHODS/STUDY POPULATION: Individuals living with Human Immunodeficiency Virus (HIV) require sustained ART treatment. Despite excessive ART costs, the treatments use active ingredients known to be toxic, causing bone and renal impairments. A review of pharmaceutical legal cases examined the role of strategic patenting–product hopping–and anti-competitive agreements, which prevent generic competition and contribute to minimal ART improvement. A literature review explored the long-term safety effects of ART medications on HIV patients and disease management. A cost analysis of HIV disease management assessed the implications of using treatments with known toxins and their contribution to comorbidities and their effect on the cost of overall HIV disease management. RESULTS/ANTICIPATED RESULTS: Ongoing lawsuits of major ART medication manufacturers demonstrate the intentional agreements made to hinder generic competition, which is an inherently anti-competitive strategy. Thus, prices for ART medications remained high, causing treatment costs to be a significant barrier to treatment access. Further, the entry of a new ART, Tenofovir Alafenamide Fumarate (TAF), was delayed despite knowing the key active ingredient in Tenofovir Disoproxil Fumarate (TDF) was toxic to patients long-term. As a result, patients were more likely to experience comorbidities, significantly increasing the cost of HIV care. The average cost of HIV care without comorbidities is $30,312. However, HIV care is $46,000 for two comorbidities and about $219,000 for people with 11 or more. DISCUSSION/SIGNIFICANCE: Abuse of patent rights prevents more effective HIV medication and generic option development. Thus, HIV disease management is inhibited. The only method of HIV disease management is patient adherence to ARTs. Patients taking less effective medications increase the development of comorbidities from toxic treatments, magnifying the cost of HIV care.