The impacts of national centralized drug procurement policy on drug utilization of medical institutions: an empirical study in a county-level hospital in China.

PURPOSE: Under the background of the regular implementation of the National Centralized Drug Procurement (NCDP) policy, this study aimed to assess the impacts of the NCDP policy on drug utilization of county-level medical institutions, and probe into the influencing factors of the changes in drug utilization. METHOD: A pre-post study was applied using inpatient data from a county-level medical institution in Nanjing. Drug utilization behavior of medical institutions of 88 most commonly used policy-related drugs (by generic name, including bid-winning and bid-non-winning brands) was analyzed, and the substitution of bid-winning brands for brand-name drugs after policy intervention was evaluated. RESULTS: After policy intervention, 43.18% of policy-related drugs realized the substitution of bid-winning brands for bid-non-winning brands (6.82% of complete substitution, 36.36% of partial substitution). Meanwhile, 40.90% of policy-related drugs failed to realize brand substitution. Multiple factors affected brand substitution, including: (1) Policy effect: brand substitution was more obvious after the intervention of the first and third round of NCDP. (2) Drug market competition: the greater the price reduction of bid-non-winning brands, the more the drugs for the same indication, the more likely that medical institutions keep using the same brands as they did before policy intervention. (3) Previous drug utilization of medical institutions: brand substitution was more obvious in drugs with large number of prescriptions and weak preference for brand-name drugs. CONCLUSION: The NCDP policy promoted the substitution of bid-winning brands for bid-non-winning brands. However, the NCDP policy remained to be further implemented in county-level medical institutions. Policy implememtation efforts, drug market competition and drug utilization of medical institutions would affect the implementation of the NCDP policy.

Effect of methenamine hippurate shortage on antibiotic prescribing for urinary tract infections in Norway-an interrupted time series analysis.

BACKGROUND: Despite a lack of conclusive evidence of effect, methenamine hippurate is widely prescribed as preventive treatment for recurrent urinary tract infections (UTIs) in Norway. A national discontinuation of methenamine hippurate treatment due to a 4-month drug shortage in 2019 presented an opportunity to evaluate its preventive effect on UTIs among regular users. OBJECTIVE: To estimate the impact of the methenamine hippurate drug shortage on prescription frequency of UTI antibiotics. METHODS: Data from The Norwegian Prescription Database was analysed using an interrupted time series design. The time series consisted of 56 time periods of 14 days. The model included two naturally occurring interruptions: (i) the methenamine hippurate drug shortage, and (ii) reintroduction of the drug. The study population were 18 345 women ≥50 years receiving ≥2 prescriptions of methenamine hippurate in the study period before the shortage. Main outcome measure was number of prescriptions of UTI antibiotics per 1000 methenamine hippurate users. Prescription rates of antibiotics for respiratory tract infections were analysed to assess external events affecting antibiotic prescribing patterns. RESULTS: We found a significant increase of 2.41 prescriptions per 1000 methenamine hippurate users per 14-day period during the drug shortage (95%CI 1.39, 3.43, P < 0.001), followed by a significant reduction of -2.64 prescriptions after reintroduction (95%CI -3.66, -1.63, P < 0.001). CONCLUSIONS: During the methenamine hippurate drug shortage, we found a significant increase in prescribing trend for UTI antibiotics followed by a significant decrease in prescribing trend after reintroduction. This change in trend seems to reflect a preventive effect of the drug on recurrent UTIs.

Assessing the Trends of Tramadol Utilization in the Medicare Part D Population in Rhode Island.

OBJECTIVE: To assess the trends in tramadol dispensing among Medicare Part D patients in Rhode Island. METHODS: An analysis was conducted of the Medicare Part D Provider Utilization and Payment Data Public Use File for the years 2013-2021. Chi squared tests were conducted to assess statistical significance of annual changes in proportions. RESULTS: Following tramadol becoming a controlled substance in 2014, the number of dispensed tramadol prescriptions and patients with a tramadol prescription decreased every subsequent year through 2021 (prescriptions: 42,157 to 33,026; patients: 12,654 to 9,653). The percentage of opioid prescriptions that were tramadol increased from 16.32% in 2013 to 21.19% in 2020. CONCLUSION: Tramadol utilization has been decreasing among the Medicare Part D population in Rhode Island while the percentage of opioid dispensings that were tramadol have been increasing. Future studies are needed to assess whether patients utilizing tramadol are at a higher risk for adverse outcomes.

Retrospective review of medicine utilization for noncommunicable diseases in three public sector pharmacies in Jamaica / Revisión retrospectiva del uso de medicamentos para enfermedades no transmisibles en tres farmacias del sector público de Jamaica / Revisão retrospectiva do uso de medicamentos para doenças não transmissíveis em três farmácias da rede pública na Jamaica

[ABSTRACT]. Objective. The rational use of medicines offers a cost-saving strategy to maximize therapeutic outcomes for developing and developed countries. The aim of this study was to evaluate the rational use of medicines for selected noncommunicable diseases (NCDs) at three pharmacies at public hospitals in Jamaica using the World Health Organization’s (WHO’s) prescribing indicators. Methods. In this retrospective cross-sectional study, prescriptions for adult outpatients containing at least one medicine for cardiovascular disease, diabetes, cancer, chronic obstructive pulmonary disease or asthma that were filled between January and July 2019 were reviewed using WHO’s prescribing indicators for the rational use of medicines. Data were analyzed and expressed as descriptive and inferential statistics. For all analyses conducted, significance was determined at P < 0.05. Results. A total of 1500 prescriptions covering 5979 medicines were reviewed; prescriptions were mostly written for female patients aged 42–60 years. Polypharmacy was observed in 35.6% (534) of prescriptions, and there was an average of 4 medicines per prescription, with a maximum of 17. Most of the prescriptions at each site were filled, with the main reason for not dispensing a medicine being that it was out of stock. Generic prescribing was high for all sites, accounting for more than 95% (5722) of prescribed medicines. There was full compliance with prescribing according to the WHO Model List of Essential Medicines at two of the sites, but it was just off the target at Site 1, by 1.4%. Conclusions. The WHO guidelines for the rational use of medicines were followed with respect to the proportion of medicines prescribed from the WHO Model List and the proportion of antibiotics prescribed. The number of medicines per prescription and the proportion of medicines prescribed by generic name did not meet the WHO criteria. However, prescribing was aligned with treatment guidelines for the selected NCDs.

[RESUMEN]. Objetivo. El uso racional de los medicamentos proporciona una estrategia de ahorro de costos para maximizar los resultados terapéuticos tanto en los países en desarrollo como en los países desarrollados. El objetivo de este estudio fue evaluar el uso racional de medicamentos para algunas enfermedades no transmisibles (ENT) seleccionadas en tres farmacias de hospitales públicos de Jamaica, usando los indicadores de prescripción de la Organización Mundial de la Salud (OMS). Métodos. En este estudio transversal retrospectivo se examinaron las prescripciones realizadas a pacientes ambulatorios adultos que incluían al menos un medicamento para enfermedades cardiovasculares, diabetes, cáncer, enfermedad pulmonar obstructiva crónica o asma, dispensadas entre enero y julio del 2019, utilizando los indicadores de prescripción para el uso racional de medicamentos de la OMS. Los datos se analizaron y expresaron mediante estadística descriptiva e inferencial. Para todos los análisis realizados se estableció un nivel de significación de p <0,05. Resultados. Se examinó un total de 1 500 prescripciones que incluían 5 979 medicamentos; la mayor parte de ellas correspondían a pacientes de sexo femenino de 42 a 60 años. Se observó que había polimedicación en el 35,6% (534) de las prescripciones, con un promedio de 4 y un máximo de 17 medicamentos por receta. En todos los centros se dispensó la mayor parte de los medicamentos prescritos, y el motivo principal para no hacerlo fue la falta de existencias del medicamento en cuestión. La prescripción de genéricos fue elevada en todos los centros y supuso más del 95% (5 722) de los medicamentos prescritos. En dos centros la prescripción se realizó en su totalidad de acuerdo con la Lista Modelo de Medicamentos Esenciales de la OMS, pero en el centro 1 no se alcanzó el objetivo por un 1,4%. Conclusiones. Se siguieron las directrices de la OMS para el uso racional de medicamentos en cuanto a la proporción de medicamentos prescritos de la Lista Modelo de la OMS y la proporción de antibióticos prescritos. El número de medicamentos por receta y la proporción de medicamentos prescritos mediante su nombre genérico no cumplieron con los criterios de la OMS. Sin embargo, las prescripciones estaban en consonancia con las directrices de tratamiento de las enfermedades no transmisibles seleccionadas.

[RESUMO]. Objetivo. O uso racional de medicamentos é uma estratégia de contenção de custos para maximizar os resultados terapêuticos em países desenvolvidos e em desenvolvimento. O objetivo deste estudo foi avaliar o uso racional de medicamentos para algumas doenças não transmissíveis selecionadas em três farmácias de hospitais públicos na Jamaica a partir dos indicadores de prescrição preconizados pela Organização Mundial da Saúde (OMS). Métodos. Estudo transversal retrospectivo que avaliou receitas médicas de pacientes ambulatoriais adul- tos contendo pelo menos um medicamento prescrito para doença cardiovascular, diabetes, câncer, doença pulmonar obstrutiva crônica ou asma e dispensadas entre janeiro e julho de 2019. A avaliação foi realizada a partir dos indicadores de prescrição preconizados pela OMS para o uso racional de medicamentos. Os dados obtidos foram analisados por meio de estatísticas descritivas e inferenciais. O nível de significância de p <0,05 foi adotado em todas as análises. Resultados. Ao todo, foram analisadas 1 500 receitas médicas compreendendo 5 979 medicamentos. Em sua maioria, as receitas foram prescritas para pacientes do sexo feminino com idades entre 42 e 60 anos. A polifarmácia foi observada em 35,6% (534) das receitas; em média, foram prescritos 4 medicamentos, até um máximo de 17. As farmácias estudadas dispensaram a maior parte dos medicamentos receitados. O principal motivo para não fornecer algum medicamento foi o desabastecimento. O percentual de medicamentos genéricos foi alto em todos os locais, representando mais de 95% (5 722) do volume receitado. Houve plena observância da Lista Modelo de Medicamentos Essenciais da OMS nas receitas analisadas em dois dos locais estudos, e observância quase completa (diferença de 1,4%) no local 1. Conclusões. As diretrizes da OMS de uso racional de medicamentos foram cumpridas no que se refere ao percentual de medicamentos receitados de acordo com a Lista Modelo da OMS e o percentual de antibióticos receitados. Os critérios da OMS não foram cumpridos quanto ao número de medicamentos por receita e ao percentual receitado usando o nome genérico. Porém, os medicamentos foram receitados de acordo com as diretrizes terapêuticas para as doenças não transmissíveis selecionadas.

Drug utilization in patients starting haemodialysis with a focus on cardiovascular and antidiabetic medications: an epidemiological study in the Lazio region (Italy), 2016-2020.

BACKGROUND: Entering dialysis is a critical moment in patients' healthcare journey, and little is known about drug therapy around it. A study funded by the Italian Medicines Agency offered the opportunity to leverage data from the Lazio Regional Dialysis and Transplant Registry (RRDTL) and perform an observational study on drug use patterns before and after initiating chronic dialysis. METHODS: Individuals initiating dialysis in 2016-2020 were identified from RRDTL, excluding patients with prior renal transplantation, stopping dialysis early, or dying within 12 months. Use of study drugs, predefined by clinicians, in the two years around the index date was retrieved from the drug claims register and described by semester. For each drug group, proportions of users (min 2 claims in 6 months) by semester, and intensity of treatment in terms of Defined Daily Doses (DDDs) for cardiovascular and antidiabetic agents were compared across semesters, stratifying by sex and age. RESULTS: In our cohort of 3,882 patients we observed a general increase in drug use after initiating dialysis, with the mean number rising from 5.5 to 6.2. Cardiovascular agents accounted for the highest proportions, along with proton pump inhibitors and antithrombotics over all semesters. Dialysis-specific therapies showed the most evident increase, in particular anti-anaemics (iron 4-fold, erythropoietins almost 2-fold), anti-parathyroids (6-fold), and chelating agents (4-fold). Use of cardiovascular and antidiabetic drugs was characterised by significant variations in terms of patterns and intensity, with some differences between sexes and age groups. CONCLUSIONS: Entering dialysis is associated with increased use of specific drugs and goes along with adaptations of chronic therapies.

Medicare Part D Plans Greatly Increased Utilization Restrictions On Prescription Drugs, 2011-20.

Drug utilization management tools can be employed to ensure that medicines are prescribed cost-effectively, but they can also be implemented in ways that reduce adherence and harm patient health. We examined trends in the prevalence of utilization restrictions on non-protected-class compounds in Medicare Part D plans during the period 2011-20, including prior authorization and step therapy requirements as well as formulary exclusions. Part D plans became significantly more restrictive over time, rising from an average of 31.9 percent of compounds restricted in 2011 to 44.4 percent restricted in 2020. The prevalence of formulary exclusions grew particularly fast: By 2020, plan formularies excluded an average of 44.7 percent of brand-name-only compounds. Formulary restrictions were more common among brand-name-only compared with generic-available compounds, among more expensive compounds, and in stand-alone compared with Medicare Advantage prescription drug plans.

Design and statistical analysis reporting among interrupted time series studies in drug utilization research: a cross-sectional survey.

INTRODUCTION: Interrupted time series (ITS) design is a commonly used method for evaluating large-scale interventions in clinical practice or public health. However, improperly using this method can lead to biased results. OBJECTIVE: To investigate design and statistical analysis characteristics of drug utilization studies using ITS design, and give recommendations for improvements. METHODS: A literature search was conducted based on PubMed from January 2021 to December 2021. We included original articles that used ITS design to investigate drug utilization without restriction on study population or outcome types. A structured, pilot-tested questionnaire was developed to extract information regarding study characteristics and details about design and statistical analysis. RESULTS: We included 153 eligible studies. Among those, 28.1% (43/153) clearly explained the rationale for using the ITS design and 13.7% (21/153) clarified the rationale of using the specified ITS model structure. One hundred and forty-nine studies used aggregated data to do ITS analysis, and 20.8% (31/149) clarified the rationale for the number of time points. The consideration of autocorrelation, non-stationary and seasonality was often lacking among those studies, and only 14 studies mentioned all of three methodological issues. Missing data was mentioned in 31 studies. Only 39.22% (60/153) reported the regression models, while 15 studies gave the incorrect interpretation of level change due to time parameterization. Time-varying participant characteristics were considered in 24 studies. In 97 studies containing hierarchical data, 23 studies clarified the heterogeneity among clusters and used statistical methods to address this issue. CONCLUSION: The quality of design and statistical analyses in ITS studies for drug utilization remains unsatisfactory. Three emerging methodological issues warranted particular attention, including incorrect interpretation of level change due to time parameterization, time-varying participant characteristics and hierarchical data analysis. We offered specific recommendations about the design, analysis and reporting of the ITS study.

Not surprising: a rebound in antibacterial consumption in Europe, with Cyprus and Greece on the podium.

Recent European-wide data place Cyprus and Greece in the highest positions of total antimicrobial consumption. While this level of consumption might be partly attributed to the high rates of infections due to MDR bacteria in these countries, several other reasons should be sought to help apply local measures, to decrease inappropriate and excess antimicrobial use. The present viewpoint aims to provide a roadmap for interventions, by briefly discussing the various factors that underlie antimicrobial use and prescribing practices in Greece and Cyprus.

Factors Related to the Evaluation of Essential Medicines Use in Health Facilities in Indonesia

Background: Indonesia has recently implemented a national policy to ensure equitable access to medicines, promote their rational use, and maintain a reliable and quality supply, specifically for essential medicines. Several organizations have conducted evaluations on essential medicines use but have yielded varying results and cannot reflect the actual situation. Objectives: This study aims to discover the current situation regarding essential medicines and identify the most important factors to be considered during future indicator-based evaluations in health facilities in Indonesia. Methods: This qualitative study was carried out using FGDs and interview from January to February 2022. The sample population consisted of ten experts selected based on predetermined criteria. The discussions were recorded and transcribed verbatim in the original language, thematically coded with Nvivo, and analyzed for common themes. Results: This study found 32 factors related to the use of essential medicines in Indonesia, divided into three categories of components, namely access, medicine handling quality, and rational use. Furthermore, a total of 10, 8, and 14 main factors were related to access, handling quality, and rational use, respectively. The discussion provided various perspectives on measuring drug use, specifically essential medicines. Based on expert opinions, evaluating the utilization of essential medicines by relying on existing guidelines was insufficient due to superficiality and irrelevance within the Indonesian health system. Conclusion: Based on the results, one of the crucial factors to consider during evaluation was the accessibility of medicines, which encompassed their availability in health facilities and affordability to patients... (AU)

Optimal assessment share structured of Pharmacoeconomics for medical drugs according to minimax criterion

Objective: To develop a comprehensive methodology for the optimal assessment of the share of the use of medicines, based on the procedure for ranking drugs according to the pharmacoeconomic point scale and the minimax criterion was applied. Methods: The author’s approach is based on the minimax principle and allows solving the problem of optimizing the pharma drug portfolio based on available data, without the need to obtain the parameters of the Markowitz model associated with correlation analysis of data. Results: The authors obtained the optimal distribution of medicines in group A, B: 37% to 63%, which the authors consider a promising recommendation for a pharmaceutical company. The use of a similar approach, which does not contradict the Markowitz methodology, but allows us to reasonably accept the parameters of the model and give the optimal solution for the share distribution of drugs in medical practice. Conclusion: These mathematical tools, justified and equipped with an alternative confirmation, the minimax task can and should take a significant place in the complex pharma-analytical methodology of the management of large companies supplying concomitant drugs to the Russian and foreign market. (AU)

Assessing medication use patterns by clinical outcomes severity among inpatients with COVID-19: A retrospective drug utilization study.

PURPOSE: This study assessed medication patterns for inpatients at a central hospital in Portugal and explored their relationships with clinical outcomes in COVID-19 cases. METHODS: A retrospective study analyzed inpatient medication data, coded using the Anatomical Therapeutic Chemical classification system, from electronic patient records. It investigated the association between medications and clinical severity outcomes such as ICU admissions, respiratory/circulatory support needs, and hospital discharge status, including mortality (identified by ICD-10-CM/PCS codes). Multivariate analyses incorporating demographic data and comorbidities were used to adjust for potential confounders and understand the impact of medication patterns on disease progression and outcomes. RESULTS: The analysis of 2688 hospitalized COVID-19 patients (55.3% male, average age 62.8 years) revealed a significant correlation between medication types and intensity and disease severity. Cases requiring ICU admission or ECMO support often involved blood and blood-forming organ drugs. Increased use of nervous system and genitourinary hormones was observed in nonsurvivors. Corticosteroids, like dexamethasone, were common in critically ill patients, while tocilizumab was used in ECMO cases. Medications for the alimentary tract, metabolism, and cardiovascular system, although widely prescribed, were linked to more severe cases. Invasive mechanical ventilation correlated with higher usage of systemic anti-infectives and musculoskeletal medications. Trends in co-prescribing blood-forming drugs with those for acid-related disorders, analgesics, and antibacterials were associated with intensive interventions and worse outcomes. CONCLUSIONS: The study highlights complex medication regimens in managing severe COVID-19, underscoring specific drug patterns associated with critical health outcomes. Further research is needed to explore these patterns.

Pharmacological treatment of obesity in adults in Norway 2004-2022.

AIMS: To describe trends in the use of anti-obesity drugs in Norway during the period 2004-2022. MATERIALS AND METHODS: We assessed the annual utilization of any available drug indicated for obesity recorded in the nationwide Norwegian Prescribed Drug Register for adults (age 18-79 years) from 1 January 2004 to 31 December 2022. Prevalence was stratified by sex and age group (18-29 years and 10-year age groups thereafter). Additional analyses were performed in individuals initiating treatment with an anti-obesity drug and on the cost of the anti-obesity drugs since 2017. RESULTS: The prevalence of anti-obesity drug use decreased from 2009, when sibutramine and rimonabant were withdrawn from the market, and increased again after the approval of bupropion-naltrexone in 2017 and liraglutide in 2018. The use of the peripheral-acting anti-obesity drug orlistat decreased from 2004. In 2022, 1.04% of the adult Norwegian population (72.8% women) filled at least one prescription of bupropion-naltrexone, 0.91% used liraglutide (Saxenda; 74.2% women), and semaglutide without reimbursement was used by 0.68% (76.7% women). The prevalence increased with age, peaking in the age group 50 to 59 years, and decreased in older age groups. From 2017 to 2022, 2.8% of the adult residents initiated treatment with an anti-obesity drug. The total sale of those drugs increased from 1.1 million euros in 2017 to 91.8 million euros in 2022. CONCLUSIONS: The use of anti-obesity drugs in Norway has increased substantially in recent years, especially among women aged 40 to 59 years. Changes in availability and reimbursement have influenced the use of these drugs in recent years.

Real-World evidence revelations: The potential of patient support programmes to provide data on medication usage.

Patient Support Programmes (PSPs) are used by the pharmaceutical industry to provide education and support to consumers to overcome the challenges they face managing their condition and treatment. Whilst there is an increasing number of PSPs, limited information is available on whether these programmes contribute to safety signals. PSPs do not have a scientific hypothesis, nor are they governed by a protocol. However, by their nature, PSPs inevitably generate adverse event (AE) reports. The main goal of the research was to gather all Novartis-initiated PSPs for sacubitril/valsartan, followed by research in the company safety database to identify all AE reports emanating from these PSPs. Core data sheets (CDS) were reviewed to assess if these PSPs contributed to any new, regulatory-authority approved, validated signals. Overall, AEs entered into the safety database from PSPs confirmed no contribution to CDS updates. Detailed review of real-world data revealed tablet splitting or taking one higher dose tablet a day instead of twice daily. This research, and subsequent analyses, revealed that PSPs did not impact safety label changes for sacubitril/valsartan. It revealed an important finding concerning drug utilisation i.e. splitting of sacubitril/valsartan tablets to reduce cost. This finding suggests that PSPs may contribute important real-world data on patterns of medication usage. There remains a paucity of literature available on this topic, hence further research is required to assess if it would be worth designing PSPs for collecting data on drug utilisation and (lack of) efficacy. Such information from PSPs could be important for all stakeholders.

Servicio de Dispensación: un servicio esencial brindado desde la Farmacia Comunitaria que permite reforzar la Seguridad del Paciente. A propósito de un caso / Dispensing Service: An Essential Service Provided by Community Pharmacy to Enhance Patient Safety. A Case Study

Paciente de 38 años, diagnosticado de asma y ansiedad que utilizaba 2 medicamentos (salbutamol 100 mcg inhalador (2 pulv. cada 6 horas) y diazepam 5 mg (0-0-1)), acude a la Farmacia Comunitaria (FC) para retirar un tratamiento prescrito por el Médico de Atención Primaria (MAP) tras diagnóstico de un cuadro ansioso-depresivo. Desde el Servicio de Dispensación (SD) se detectó un Problema Relacionado con el Medicamento (PRM) de un potencial error en la prescripción, que podría tener asociado un Resultado Negativo asociado a la Medicación (RNM) ante uso concomitante de desvenlafaxina y mirtazapina, así como un PRM de Problema de Salud (PS) insuficientemente tratado ante una propuesta de suspensión de uso de diazepam, que podría derivar en un RNM de Necesidad de Tratamiento ante el riesgo de empeoramiento de episodios de ansiedad. Desde la FC, se elaboró un informe de derivación con recomendaciones que fueron aceptadas por el MAP. Se llevó a cabo un seguimiento del caso que permitió realizar un mejor control de los PS presentados por el paciente, así como la resolución de los PRM y RNM detectados, garantizando así un uso racional, seguro y eficaz del medicamento. (AU)

A 38-year-old patient diagnosed with asthma and anxiety, who takes two medications (salbutamol 100 mcg inhaler (2 puffs every 6 hours), and diazepam 5 mg (0-0-1), visited the Community Pharmacy to pick up a treatment prescribed by the Primary Care Physician (PCP) following a diagnosis of anxious-depressive symptoms. During the Dispensing Service, a potential Drug-Related Problem (DRP) of prescription error is detected, which could be related with a Negative Outcomes Releated to Medicines (NOM) due to the concurrent use of desvenlafaxine and mirtazapine. Additionally, a Health Problem (HP)-related DRP was detected, as the proposal to discontinue the use of diazepam could result in an Insufficiently Treated HP, potentially leading to a NOM of Treatment Necessity due to the risk of worsening anxiety episodes. From de Community Pharmacy, a report was prepared with recommendations that were accepted by the PCP. Subsequent case monitoring revealed an improved management of the patient’s health problems, as well as the resolution of the identified DRP and NOM. This ensured a rational, safe, and effective use of the medication. (AU)

Drug Utilization Studies in Pregnant Women for Newly Licensed Medicinal Products: A Contribution from IMI ConcePTION.

Purpose: Studies focusing on safety outcomes typically require large populations to comprehensively characterise the patient groups exposed to the medicines under investigation. However, there is often less information for subpopulations, such as pregnant or breastfeeding women, particularly when new medicines are considered. It is important to understand what information can be obtained from drug utilization studies (DUS) involving pregnant women in the early years postmarketing to provide supportive information for safety studies. The aims of this literature review are to (1) identify and review DUS for new medicines in pregnancy and breastfeeding and (2) list and summarise key information items to be reported in a DUS for new medicines in pregnancy. Methods: To identify postmarketing DUS of new prescription medicines or enantiomers in pregnancy, a systematic literature review was undertaken in PubMed and Embase between January 2015 and June 2022. In addition, the complete database of the ENCePP EU PAS Register was systematically searched to June 2022. Results: We identified 11 published DUS on new medicines in pregnancy from the ENCePP EU PAS Register and none from other sources. No studies on breastfeeding were identified. The 11 identified publications reported the medicine's use for the first 3 to 5 years after marketing approval. No reports assessed utilization in the first 3 years of approval. It was usual to issue interim reports annually (7 studies). All studies concerned conditions managed in ambulatory care (primary care and outpatient facilities) and included some primary care prescribing. Most (n = 8) only had prescribing/dispensing data available at individual level for ambulatory care; outpatient prescribing was included in three of these studies Three studies held a limited amount of in-hospital prescribing data. A DUS can confirm at an early stage whether there are sufficient exposed pregnancies in available data sources to ensure a safety study is powered to detect a difference in the prevalence of adverse pregnancy or infant outcomes or if additional data from other databases are needed. A DUS may also help address methodological considerations such as selection of comparators. DUS can be performed embedded in a DUS in the general population, in a cohort of women of childbearing age, or in a cohort of pregnant women. Conclusion: This review summarises key aspects of a DUS for new medicines in pregnancy. DUS for new medicines in pregnancy should be planned before marketing, scheduled for the first 3 to 5 years after release, with annual interim/progress reports, and reported in peer-reviewed journals. By offering detailed information on data sources, exposure timing, prevalence and location, coprescribing, comorbidities, coexposures, and demographics, a DUS will offer a firm foundation for safety studies and will help to contextualize spontaneous reporting of serious adverse events.

Impact of COVID-19 on patterns of drug utilization: A case study at national hospital.

BACKGROUND: The Coronavirus disease of 2019 (COVID-19) pandemic and the corresponding mitigation measures have had a discernible impact on drug utilization among outpatients. However, limited research exists on the prescription trends in the elderly population during the pandemic period in Viet Nam. OBJECTIVES: This study aims to analyze the effects of COVID-19 on outpatient drug utilization patterns at a national geriatric hospital in Ho Chi Minh City before and after the early onset of the pandemic. METHODS: Data was collected from the prescriptions and administration claims, encompassing the period from January 2016 to December 2022. The dataset was divided into two periods: Period 1: January 2016 to December 2020 and Period 2: January 2021 to December 2022. The drug utilization was measured using DDD/1000P (defined daily doses-DDD per 1000 prescriptions) on a monthly basis. The analysis employed interrupted time series using Autoregressive Integrated Moving Average (ARIMA) to detect changes in drug use levels and rates. RESULTS: A total of 1,060,507 and 644,944 outpatient prescriptions from Thong Nhat Hospital were included in Period 1 and Period 2, respectively. The median age of the patients were 58 in Period 1 and 67 years old in Period 2. The most common comorbidities were dyslipidemia, hypertension, and diabetes mellitus. In terms of medication utilization, cardiovascular drugs were the most frequently prescribed, followed by drugs active on the digestive and hormonal systems. The study observed significant surges in the number of prescriptions and the average number of drugs per prescription. However, there were no significant changes in the overall consumption of all drugs. Among the drug groups related to the cardiovascular system, three subgroups experienced a sudden and significant increase: cardiac therapy, beta-blocking agents, and antihypertensives, with increasing consumption levels of 1,177.73 [CI 95%: 79.29; 2,276.16], 73.32 [CI 95%: 28.18; 118.46], and 36.70 [CI 95%: 6.74; 66.66] DDD/1000P, respectively. On the other hand, there was a significant monthly decrease of -31.36 [CI 95%: -57.02; -5.70] DDD/1000P in the consumption of anti-inflammatory and antirheumatic products. Interestingly, there was a significant increase of 74.62 [CI 95%: -0.36; 149.60] DDD/1000P in the use of antigout preparations. CONCLUSION: COVID-19 resulted in a sudden, non-significant increase in overall drug consumption levels among outpatients. Notably, our findings highlight significant increases in the utilization of three drug groups related to the cardiovascular system, specifically cardiac therapy, beta-blocking agents, and antihypertensives. Intriguingly, there was a statistically significant increase in the consumption of antigout preparations, despite a decline in the monthly consumption rate of non-steroidal anti-flammatory drugs (NSAIDs). Further studies in the following years are necessary to provide a more comprehensive understanding of the impact of COVID-19 on outpatient drug utilization patterns.

A six years trend analysis of systemic antibiotic consumption in Northwest Ethiopia.

BACKGROUND: Consumption of antibiotics, a major global threat to public health, is perhaps the key driver of antibiotic resistance. Monitoring antibiotic consumption is crucial to tackling antimicrobial resistance. This study assessed antibiotic consumption trends during the last six years in the Bahir Dar branch of the Ethiopian pharmaceutical supply agency (EPSA), Northwest Ethiopia, in 2022. METHODS: Retrospective data were collected in August 2022 based on antibiotic distribution data from the Bahir Dar Brach of EPSA from July 2016 to June 2022. Data were analyzed according to the Anatomic Therapeutic Classification (ATC) developed by the World Health Organization (WHO). We measured antibiotic consumption using a defined daily dose per 1000 inhabitants per day (DIDs) based on the Agency's catchment population. Descriptive statistics and trend analyses were conducted. RESULTS: About 30.34 DIDs of antibiotics were consumed during the six years. The consumption of antibiotics decreased by 87.4%, from 6.9 DIDs in 2016/17 to 0.9 DIDs in 2021/22. Based on the WHO AWaRe classification, 23.39 DIDs (77.1%) of the consumed antibiotics were from the Access category. Consumption of Access category antibiotics was decreased by 72.7% (from 5 to 0.5 DIDs) but Watch antibiotics decreased by 54.3% (from 1.8 to 0.4 DIDs). Oral antibiotics accounted for 29.19 DIDs (96.2%) of all consumed systemic antibiotics. The average cost expenditure per DDD for all antibiotics was 54.1 birr/DDD (0.4-482.3 birr/DDD). Only seven antibiotics accounted for DU90% and the cost expenditure per DDD for the DU90% antibiotics ranged from 0.4/DDD for Doxycycline to 232.8 birr/DDD for Piperacillin/tazobactam. Overall, during the last six years, the most commonly used antibiotic was Amoxicillin (10.1 DIDs), followed by Doxycycline (5.3 DIDs) and Ciprofloxacin (3.4 DIDs). CONCLUSION: In this study, we found that antibiotic usage was low and continuously declining over time. Minimizing unnecessary antibiotic usage is one possible approach to reduced AMR. However, a shortage of access to important medicines can compromise the quality of treatment and patient outcomes. A prospective study is needed to evaluate the balance of patient outcomes and reduce AMR by optimizing the community consumption of systemic antibiotics.

Interruptions in Insurance Coverage and Prescription Drug Utilization: Evidence from Kentucky.

This study examined how interruptions in insurance coverage affect purchases of prescription drugs for young adults. It used data spanning 2014 to 2018 from Kentucky's prescription drug monitoring program, which tracked the universe of federally-regulated (Schedule II-V) prescription drugs dispensed in the state. The study employed a regression discontinuity design based on the age limit at 26 for dependent insurance coverage for children. At age 26, the probability of purchasing a prescription decreased by 5%, with all subcategories of prescriptions affected. The share of generic prescriptions increased for stimulants (the only category observed with substantial branded prescriptions). By age 27, prescription purchases returned to levels observed at 25, but the share purchased with public insurance and the generic share for stimulants remained higher. The findings suggest that interruptions in insurance coverage decrease prescription drug utilization by young adults and that public insurance programs such as Medicaid are important for resuming treatment.

Use of molnupiravir: A Danish nationwide drug utilization study.

PURPOSE: To describe utilization patterns, characteristics of users and prescribers of the new oral antiviral medication, molnupiravir, indicated for mild-to-moderate COVID-19. METHODS: Using nationwide registries, we identified all Danish adults who filled a prescription for molnupiravir from December 16th, 2021, to August 31st, 2022. We described weekly incidence rates and patient characteristics over time, prescriber characteristics as well as time between molnupiravir initiation and a positive SARs-CoV-2 test. Patient characteristics were compared to matched, untreated SARS-CoV-2 positive reference groups. RESULTS: By August 31st, 2022, 5847 individuals had filled a prescription for molnupiravir. The incidence rate gradually increased to 16 weekly prescriptions per 1000 RT-PCR SARS-CoV-2 positives. Users of molnupiravir were most often men (55% vs. 45% women). The majority (81%) had a positive RT-PCR SARS-CoV-2 test and few (2.9%) redeemed molnupiravir outside the recommended window of 5 days from the positive test result. Compared to matched, untreated SARS-CoV-2 positive reference groups, users of molnupiravir had a median age of 74 years versus 49 years, a higher proportion resided in a nursing home (12% vs. 1.5%) and had a higher number of comorbidities (median of 3 vs. 0); most commonly hypertension (38%), chronic lung disease (35%), diabetes (20%) and mood disorders (20%). General practitioners were the primary prescribers of molnupiravir (91%). CONCLUSIONS: Molnupiravir was mainly prescribed by general practitioners to RT-PCR SARS-CoV-2 positive individuals who had a potentially increased risk of severe COVID-19. Though some off-label prescribing occurred, our study indicates a high level of adherence to contemporary guidelines.