Quantitative and qualitative evaluation of antimicrobial usage: the first step for antimicrobial stewardship.

The identification of antimicrobial use patterns is essential for determining key targets for antimicrobial stewardship interventions and evaluating the effectiveness thereof. Accurately identifying antimicrobial use patterns requires quantitative evaluation, which focuses on measuring the quantity and frequency of antimicrobial use, and qualitative evaluation, which assesses the appropriateness, effectiveness, and potential side effects of antimicrobial prescriptions. This paper summarizes the quantitative and qualitative methods used to evaluate antimicrobials, drawing insights from overseas and domestic cases.

Implementing antimicrobial stewardship: lessons and perspectives from a university-affiliated tertiary hospital in Korea.

Antimicrobial stewardship programs (ASPs) can lower antibiotic use, decrease medical expenses, prevent the emergence of resistant bacteria, and enhance treatment for infectious diseases. This study summarizes the stepwise implementation and effects of ASPs in a single university-affiliated tertiary care hospital in Korea; it also presents future directions and challenges in resource-limited settings. At the study hospital, the core elements of the ASP such as leadership commitment, accountability, and operating system were established in 2000, then strengthened by the formation of the Antimicrobial Stewardship (AMS) Team in 2018. The actions of ASPs entail key components including a computerized restrictive antibiotic prescription system, prospective audit, post-prescription review through quantitative and qualitative intervention, and pharmacy-based interventions to optimize antibiotic usage. The AMS Team regularly tracked antibiotic use, the effects of interventions, and the resistance patterns of pathogens in the hospital. The reporting system was enhanced and standardized by participation in the Korea National Antimicrobial Use Analysis System, and educational efforts are ongoing. Stepwise implementation of the ASP and the efforts of the AMS Team have led to a substantial reduction in the overall consumption of antibiotics, particularly regarding injectables, and optimization of antibiotic use. Our experience highlights the importance of leadership, accountability, institution-specific interventions, and the AMS Team.

Willingness to pay for community pharmacies-based medication review service: perspectives of private health insurance firms

Background: The medication review service (MRS) is a valuable community pharmacies-based health service to patients, ensuring optimal medication use and reducing medication errors. Nevertheless, it remains limited in scope and empowerment without remuneration for providing the service. Objective: This study aimed to assess private health insurance (PHI) and third-party administration (TPA) firms' perspectives regarding the MRS offered by community pharmacies in Jordan and the extent of their willingness to pay for this service. Method: The research was an observational, cross-sectional study conducted using a constructed and validated Arabic questionnaire that was distributed electronically to the key health insurance decision-makers (general managers, operational managers, medical network managers, directors, and supervisors) among all the (22) PHI and TPA active firms that are members of the Jordan Insurance Federation (JIF) and licensed under the insurance administration in the Ministry of Industry and Trade. Participants provided their consent electronically before filling out the questionnaire. Results: 50 health insurance decision-makers agreed to participate in this study. 48% partially (42%) or completely (6%) heard about the medication review service. Most respondents (n=35, 70%) believed the medication review service is expected to reduce the cost of medications. Furthermore, they believed the service is expected to reduce the cost of the medical bill by ensuring the medication is not repeated within a short time unless advised by the doctor, checking the exact dosage regimen of each drug, and using alternative medicines at lower cost (74%, 64%, and 60%) of respondents respectively. Half of the respondents were eager to remunerate for the medication review service, with the majority willing to pay less than 10 Jordanian Dinars (JODs) per patient (AU)

Drug Utilization Review: Our Patients Deserve Our Very Best.

In 1990, the Omnibus Budget Reconciliation Act included requirements for Medicaid patients in an effort to save the federal government money. The requirements included a prospective drug utilization review, patient counseling, and maintenance of patient records. Subsequently, in 1993, when the pharmacy practice requirements went into effect, this federal regulation became the standard of care for pharmacists and part of their professional duty. This article suggests that the pharmacy should review all active pharmaceutical ingredients and excipients that are dispensed at the pharmacy and list all interactions or potential side effects in the review, so that a proper drug utilization review can be performed.

Guidelines on optimizing the use of proton pump inhibitors: PPI stewardship.

Proton pump inhibitors (PPIs) have been available for over three decades and are among the most commonly prescribed medications. They are effective in treating a variety of gastric acid-related disorders. They are freely available and based on current evidence, use of PPIs for inappropriate indications and duration appears to be common. Over the years, concerns have been raised on the safety of PPIs as they have been associated with several adverse effects. Hence, there is a need for PPI stewardship to promote the use of PPIs for appropriate indication and duration. With this objective, the Indian Society of Gastroenterology has formulated guidelines on the rational use of PPIs. The guidelines were developed using a modified Delphi process. This paper presents these guidelines in detail, including the statements, review of literature, level of evidence and recommendations. This would help the clinicians in optimizing the use of PPIs in their practice and promote PPI stewardship.

Impact of Oncology Drug Review Times on Public Funding Recommendations.

New oncology drugs undergo detailed review prior to public funding in a single-payer healthcare system. The aim of this study was to assess how cancer drug review times impact funding recommendations. Drugs reviewed by the pan-Canadian Oncology Drug Review (pCODR) between the years 2012 and 2020 were included. Data were collected including Health Canada approval dates, initial and final funding recommendations, treatment intent, drug class, clinical indications, and incremental cost-effectiveness ratios (ICER). Univariable and multivariable analyses were used to determine the association between funding recommendations and review times. Of the 164 applications submitted, 130 received a positive final recommendation. Median time from Health Canada (HC) approval to final recommendation was longer for drugs indicated for the treatment of gastrointestinal (GI) and lung cancer compared to breast, genitourinary (GU), and other tumours (205 vs. 198 vs. 111 vs. 129 vs. 181 days, respectively; Kruskal-Wallis p = 0.0312). Drugs with longer review times were more likely to receive a negative pCODR recommendation, even when adjusting for tumour type, drug class, and intent of therapy (157 vs. 298 days; Wilcoxon p = 0.0003, OR 1.002 95% CI [1.000-1.004].). There was no association between funding recommendation and tumour type or class of drug. The exploration of factors associated with variance in review times will be important in ensuring timely patient access to cancer drugs.

Prescription Patterns of New Use of Fixed-Dose Combination Inhalers in Patients with Chronic Obstructive Pulmonary Disease: Long-Acting ß2 Agonists Plus Long-Acting Muscarinic Antagonists versus Long-Acting ß2 Agonists Plus Inhaled Corticosteroids.

Background: The clinical guideline recommends use of long-acting ß2 agonists/long-acting muscarinic antagonists (LABA/LAMA) or long-acting ß2 agonists/inhaled corticosteroids (LABA/ICS) combination therapies for patients with severe chronic obstructive pulmonary disease (COPD). The fixed-dose combination (FDC) inhalers of LABA/LAMA and LABA/ICS were reimbursed in Taiwan in 2015 and in 2002, respectively. This study aimed to examine prescription patterns of new use of either FDC therapy in real-world practice. Methods: We identified COPD patients who initiated LABA/LAMA FDC or LABA/ICS FDC between 2015 and 2018 from a population-based Taiwanese database with 2 million, randomly sampled beneficiaries enrolled in a single-payer health insurance system. We compared number of LABA/LAMA FDC and LABA/ICS FDC initiators in each calendar year, from different hospital accreditation levels, and cared for by different physician specialties. We also compared baseline patient characteristics between LABA/LAMA FDC and LABA/ICS FDC initiators. Results: A total of 12,455 COPD patients who initiated LABA/LAMA FDC (n=4019) or LABA/ICS FDC (n=8436) were included. Number of LABA/LAMA FDC initiators increased apparently (n=336 in 2015 versus n=1436 in 2018), but number of LABA/ICS FDC initiators decreased obviously (n=2416 in 2015 versus n=1793 in 2018) over time. The preference of use of LABA/LAMA FDC varied across clinical environments. The proportions of LABA/LAMA FDC initiators were more than 30% in the setting of non-primary care clinics (eg, medical centers) and in the services of chest physicians; but were only less than 10% in primary care clinics and non-chest physicians' services (eg, family medicine physicians). LABA/LAMA FDC initiators appeared to be older, male, to have more comorbidities, and to utilize resources more frequently compared to LABA/ICS FDC initiators. Conclusion: This real-world study found evident temporal trends, variations in healthcare provider, and differences in patient characteristics among COPD patients who initiated LABA/LAMA FDC or LABA/ICS FDC.

Impact of Hospital-based Multidisciplinary Anticoagulation Stewardship Programs.

Antithrombotic therapies, especially anticoagulants, are high-risk medications with increased potential for adverse events. The development and implementation of a well-functioning, designated, multidisciplinary anticoagulation stewardship program (MASP), tailored to each hospital-center's needs, has the primary objectives of improving patient-centered outcomes, minimizing undesirable anticoagulation-related adverse events and minimizing hospital length of stay (LOS) and other patient-related costs. Such stewardship programs are pivotal in supporting busy clinicians with consultation on challenging clinical case scenarios, ensuring appropriate use of valuable healthcare resources, achieving compliance with anticoagulant-associated accreditation standards, and positively impacting patient-specific morbidity/mortality outcomes. Herein, we review and discuss the critical need for antithrombosis stewardship and the benefit of formalized MASP in optimizing use of antithrombotic therapies.

Community pharmacists' attitudes towards, and experiences of, providing medication reviews after hospital discharge: a questionnaire survey.

OBJECTIVES: To investigate the attitudes and experiences of community pharmacists providing medicines-use review (MUR) and post-discharge medicines-use review (PD-MUR) services. METHODS: An online survey for community pharmacists who had experience providing the MUR service. KEY FINDINGS: In total, 495 community pharmacists responded to the survey. A total of 89% (n = 382) of community pharmacists wanted to receive the patient's full discharge summary and 79% (n = 363) preferred electronic communication. Community pharmacists thought they could build trusted relationships with patients and felt that patients were willing to discuss post-discharge medicines-related issues with them. Less experienced pharmacists conducted more MURs than more experienced pharmacists (P = 0.004), and pharmacists working in large multiples (>50 pharmacies) conducted more MURs than those working in independent pharmacies (<5 pharmacies) (P = 0.001). Community pharmacists working in independent pharmacies conducted more PD-MURs than those working in large multiples (P = 0.004). Community pharmacists working in rural areas also thought they were best placed to provide PD-MURs while those working in urban areas thought that practice pharmacists were best suited to provide this service (P = 0.007). CONCLUSIONS: Community pharmacists believe they have a vital role in supporting patients after hospital discharge. They can build long-lasting, trusted relationships with patients and patients are willing to discuss medication issues with them. By providing community pharmacists in all locations with timely access to accurate discharge information, they could use their knowledge and skills to better support patients after hospital discharge.

Principles for the Prevention of Medication-Induced Nephrotoxicity.

Medications are a common cause of injury to the kidney and can contribute to the increased progression of disease, poorer outcomes, and increased health care costs. Improved prescribing practices can decrease the risk for the development of acute kidney injury and the progression to end-stage kidney disease. KDIGO Clinical Practice Guidelines recommend the use of caution when prescribing potentially nephrotoxic medications for patients with kidney disease. More than 50-72% of individuals across all stages of kidney disease utilized potentially nephrotoxic medications contributing to poorer outcomes. Annually, 1.5 million adverse drug events causing medication-induced nephrotoxicity occur in the US. Medication-induced nephrotoxicity accounts for 14-26% of cases of AKI in adults and 16% of hospitalized children. It is imperative that nurses and all health care providers are practicing nephrotoxic stewardship to prevent medication-induced nephrotoxicity.

Pediatric drug utilization evaluation of cefepime and piperacillin/tazobactam.

BACKGROUND: Drug utilization evaluation (DUE) is a systematic, criteria-based assessment of medicine that aims to optimize the appropriateness of antibiotic prescription. This study aimed to evaluate the performance of the DUE on prescriptions of two commonly used antibiotics in a pediatric population, cefepime and piperacillin/tazobactam, in a tertiary care hospital. METHODS: This quasi-experimental study was conducted at the Department of Pediatrics, Ramathibodi Hospital, between March 2020 and August 2021. All hospitalized children aged 1 month to 20 years who received at least one dose of cefepime or piperacillin/tazobactam were enrolled. Before implementing the DUE, cefepime and piperacillin/tazobactam prescriptions were retrospectively evaluated using the DUE criteria. During the 6 month DUE implementation period, physicians voluntarily chose to use DUE to assess the prescriptions' appropriateness. Demographic data, antibiotic use, and clinical data were recorded. RESULTS: There were 304 prescriptions of cefepime and piperacillin/tazobactam, with 108 empirical prescriptions (72 patients) in the DUE group and 158 prescriptions (138 patients) in the non-DUE group. The appropriateness of empirical prescriptions of cefepime and piperacillin/tazobactam was significantly higher in the DUE group (93.5% vs. 83.5%; P = 0.003). Drug utilization evaluation was significantly associated with appropriate empirical prescriptions (adjusted OR 5.32: 95% CI 1.80-15.73; P = 0.003). Prescriptions in critical care wards and urinary tract infections (UTIs) were associated with not fulfilling the DUE criteria for appropriateness. CONCLUSIONS: Drug utilization evaluation could improve the appropriateness of empirical use of cefepime and piperacillin/tazobactam in pediatric patients. Patients in critical care units and with UTIs appeared to be associated with inappropriate empirical treatment.

Regulatory reliance pathways during health emergencies: enabling timely authorizations for COVID-19 vaccines in Latin America

[ABSTRACT]. Objectives. To map the timing and nature of regulatory reliance pathways used to authorize COVID-19 vaccines in Latin America. Methods. An observational study was conducted assessing the characteristics of all COVID-19 vaccine authorizations in Latin America. For every authorization it was determined whether reliance was used in the authorization process. Subgroups of reference national regulatory authorities (NRAs) and non-reference NRAs were compared. Results. 56 authorizations of 10 different COVID-19 vaccines were identified in 18 countries, of which 25 (44.6%) used reliance and 12 (21.4%) did not. For the remaining 19 (33.0%) it was not possible to determine whether reliance was used. Reference agencies used reliance less often (40% of authorizations with a known pathway) compared to non-reference agencies (100%). The median review time was just 15 days and does not meaningfully differ between reliance and non-reliance authorizations. Conclusions. This study demonstrated that for these vaccines, despite reliance pathways being associated with numerous rapid authorizations, independent authorization review times were not considerably longer than reliance reviews; reliance pathways were not a prerequisite for rapid authorization. Nevertheless, reliance pathways provided rapid authorizations in response to the COVID-19 emergency.

[RESUMEN]. Objetivos. Determinar dónde y cuándo se usaron las decisiones de autoridades regulatorias de otras jurisdicciones y la naturaleza de estos mecanismos para autorizar vacunas contra la COVID-19 en América Latina. Métodos. Se realizó un estudio observacional para evaluar las características de todas las autorizaciones de vacunas contra la COVID-19 en América Latina. Para cada autorización se determinó si se emplearon las decisiones de autoridades regulatorias de otras jurisdicciones en el proceso de autorización. Se compararon subgrupos de autoridades regulatorias nacionales (ARN) consideradas de referencia con otras ARN no usadas como referencia. Resultados. Se determinó dónde se otorgaron 56 autorizaciones de 10 vacunas diferentes contra la COVID–19 en 18 países; de estas 56 autorizaciones, 25 (44,6%) hicieron uso de las decisiones de autoridades regulatorias de otras jurisdicciones y 12 (21,4%), no. Para las 19 restantes (33,0%) no fue posible determinar si se hizo uso de las decisiones de autoridades regulatorias de otras jurisdicciones. Los organismos de referencia utilizaron las decisiones de autoridades regulatorias de otras jurisdicciones con menos frecuencia (40% de las autorizaciones con un mecanismo conocido) en comparación con los organismos no usados como referencia (100%). El plazo medio de revisión fue de tan solo 15 días y no difiere significativamente entre las autorizaciones que emplearon decisiones de autoridades regulatorias de otras jurisdicciones y las que no las emplearon. Conclusiones. En este estudio se demostró que, a pesar de que los mecanismos de utilización de las decisiones de autoridades regulatorias de otras jurisdicciones se asocian en muchos casos con autorizaciones rápidas, para estas vacunas los plazos de revisión independiente para la autorización no fueron considerablemente mayores que los de las revisiones que emplearon decisiones de autoridades regulatorias de otras jurisdicciones. También se demostró que para obtener una autorización rápida no se requería la utilización de las decisiones de autoridades regulatorias de otras jurisdicciones. Sin embargo, estos mecanismos proporcionaron autorizaciones rápidas en respuesta a la emergencia por la COVID–19.

[RESUMO]. Objetivos. Mapear a tempestividade e a natureza do uso de decisões regulatórias de outras autoridades (reliance regulatório) para autorização de vacinas contra a COVID-19 na América Latina. Métodos. Em um estudo observacional, foram avaliadas as características de todas as autorizações de vacinas contra COVID-19 na América Latina. Para cada autorização, foi determinado se foram utilizadas decisões de outras autoridades regulatórias para embasar o processo de autorização. Foram comparados subgrupos de autoridades reguladoras nacionais (ARN) de referência (ARNr) e ARN não consideradas de referência. Resultados. Foram identificadas 56 autorizações de 10 vacinas diferentes contra a COVID-19 em 18 países, das quais 25 (44,6%) utilizaram decisões de outras ARN como base para o registro e 12 (21,4%) não. Para as 19 (33,0%) autorizações restantes, não foi possível determinar se decisões de outras ARN foram utilizadas. As ARNr utilizaram decisões de outras autoridades com menos frequência (40% das autorizações com via regulatória conhecida) em comparação com as ARN não consideradas de referência (100%). A mediana do tempo de tramitação foi de apenas 15 dias, sem diferença significativa entre processos nos quais foram utilizadas decisões de outras agências e processos que não as utilizaram. Conclusões. Este estudo demonstrou que, para estas vacinas, apesar de o uso do reliance regulatório estar associado a várias autorizações rápidas, os tempos de tramitação não foram consideravelmente maiores em autorizações independentes do que quando foram utilizadas decisões de outras ARN; o reliance regulatório não foi um pré-requisito para autorização rápida. No entanto, o uso de tais processos viabilizou autorizações rápidas em resposta à emergência de COVID-19.

Clinical and Cost-Saving Effects of the Drug Utilization Review Modernization Project in Inpatient and Outpatient Settings in Korea.

OBJECTIVES: Korea's national health insurance authority introduced a drug utilization review modernization pilot project in which health professionals provided follow-up services to monitor adverse drug events. We aimed to evaluate the effects of the project on clinical and economic outcomes. METHODS: We conducted difference-in-differences analysis using National Health Insurance claims data from the Health Insurance Review and Assessment Service. We calculated the number of adverse drug events and allergic reactions as a clinical indicator and medical costs incurred to manage these events as an economic indicator. Absolute difference in each outcome measure was defined as the value after the project minus the value before the project. Difference-in-differences was defined as a difference in absolute differences between the intervention group and the control group. RESULTS: Overall, difference-in-differences were -43 and -826 for the number of drug-related adverse events and allergic reactions and -$198,700 and $53,318 for medical costs in the inpatient and outpatient settings, respectively. For outpatients, the monthly number of adverse drug events and allergic reactions has grown higher for the control group than for the intervention group after implementation of the pilot project. CONCLUSIONS: Implementation of the pilot project lowered the number of adverse drug events and allergic reactions in the inpatient and outpatient setting. The project also lowered medical costs incurred to manage these events in the inpatient setting only. Based on our findings, we recommend that the pilot project be expanded on a nationwide level at least in the inpatient setting.

Retrospective drug utilization review of meropenem and role of infectious disease pharmacist in specialized cancer care hospital.

OBJECTIVES: Carbapenem antimicrobials are considered for the treatment of serious bacterial infections. The objective of this study was to review the use of meropenem in cancer patients and to evaluate the impact of clinical pharmacist's intervention in this practice to reduce possible risks associated with use of meropenem. METHODS: This retrospective study was conducted among 100 patients who received meropenem at hospital. A structured questionnaire was used to collect data. Descriptive statistics was used to analyze the collected data. RESULTS: A total of 100 patients were included in this retrospective study with aim to review rationality and possible side effects associated with meropenem use in our study population. It was revealed that meropenem used was associated with rise in bilirubin in many of our study patients. Pharmacist were found to be instrumental in placing timely interventions for either de-escalation or switch of meropenem to imipenem/cilastatin to reduce that risk. Interventions were accepted by physicians in most of the cases. CONCLUSION: De-escalation and switching were performed in accordance with pharmacist recommendations in more than half of study population with empirically started/ study population in which meropenem was used.

[Clinical Research in Communities and the Importance of Patient Information].

In collaboration with community pharmacists, we have conducted research including drug utilization reviews since 2009 and patient registry and long-term follow-up since 2013. The results of these projects have influenced the establishment of healthcare policies and pharmacists' roles. Moreover, the number of clinical studies using electronic medical records by hospital pharmacists has increased. Findings from real-world clinical practice provide useful evidence to improve the quality of patient care provided by clinical pharmacists. When comparing research between community and hospital pharmacists, differences are observed in the efficiency of using patients' information. In hospitals, patients' medical records are important for sharing information among healthcare providers. However, in communities, the importance of maintaining patients' information tends to follow dispensing medications and counseling. This practice results in a lack of data for clinical research. Studies in community pharmacies would deepen our understanding of the needs for patient records and improve the quality of patient care.

Mandatory nonmedical switching from originator to biosimilar infliximab in patients with inflammatory arthritis and psoriasis in British Columbia: a cohort study.

BACKGROUND: In 2019, British Columbia's public drug plan, PharmaCare, was the first in Canada to implement a nonmedical switching policy from originator infliximab to its biosimilar, for patients with inflammatory arthritis or psoriasis. We aimed to detect signals of impact on health services utilization during the first year of policy implementation and to provide early data to policy-makers. METHODS: We constructed cohorts of users of originator infliximab: 3 historical cohorts (2016-2018) and 1 policy cohort (2019). We extracted data from BC Ministry of Health databases from 2015 to 2020, as we followed each cohort for 365 days from May 27 of each cohort's respective year. We excluded patients with gastrointestinal conditions and those not covered by PharmaCare. We examined the cumulative incidence of infliximab prescription refills, switching to other biologic drugs and use of additional health services. A log-likelihood ratio of 1.96 compared with the null hypothesis was used as the threshold for differences between the policy cohort and the historical cohorts. RESULTS: The study included a total of 572 unique patients: 520 in the 2016 historical cohort, 461 in the 2017 historical cohort, 423 in the 2018 historical cohort and 377 in the policy cohort (with some patients included in multiple cohorts; 335 [58.6%] were included in all 4 cohorts). During months 8 and 9 of follow-up, a transient signal was observed in infliximab refills (7.2% decrease in refilling infliximab for the fourth time for the policy cohort, log-likelihood ratio > 1.96). An anticipated increase in visits to specialists was observed from month 4 forward (15.0%, log-likelihood ratio > 1.96). No signal was observed for increased use of other health services (log-likelihood ratio < 1.96). INTERPRETATION: Early monitoring did not detect signals of negative impacts on health services use during the first year of the policy. Detailed, longer-term cohort studies and hypothesis-testing methods could provide additional assurance about the safety of the policy.

Drug Utilization Evaluation of Medications Used by Hypertensive Patients in Hospitals in Nigeria.

Drug utilization studies in developing countries is evolving. Rising medication cost for hypertensive patients is a major cause of noncompliance to therapy. The study was a cross-sectional drug utilization review involving outpatients in two purposively selected hospitals (secondary and tertiary) in Abeokuta, Southwestern Nigeria. Data and relevant information were obtained from the patients' medical records domiciled in the outpatients' hospital records department. Descriptive and inferential statistics were used at p < 0.05. Total medication cost to patients was USD$48,575; out of which antihypertensive medications accounted for 46% (USD$21,588) in two referral hospitals. Ramipril was the most prescribed in both hospitals. Generic drugs were cheaper than their branded alternatives. Study outcomes are beneficial for managing costs for hypertensive patients.