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AIMS: The aim of this study was to assess the ChatGPT-4 (ChatGPT) large language model (LLM) on tasks relevant to community pharmacy. METHODS: ChatGPT was assessed with community pharmacy-relevant test cases involving drug information retrieval, identifying labelling errors, prescription interpretation, decision-making under uncertainty and multidisciplinary consults. Drug information on rituximab, warfarin, and St. John's wort was queried. The decision-support scenarios consisted of a subject with swollen eyelids and a maculopapular rash in a subject on lisinopril and ferrous sulfate. The multidisciplinary scenarios required the integration of medication management with recommendations for healthy eating and physical activity/exercise. RESULTS: The responses from ChatGPT for rituximab, warfarin, and St. John's wort were satisfactory and cited drug databases and drug-specific monographs. ChatGPT identified labeling errors related to incorrect medication strength, form, route of administration, unit conversion, and directions. For the patient with inflamed eyelids, the course of action developed by ChatGPT was comparable to the pharmacist's approach. For the patient with the maculopapular rash, both the pharmacist and ChatGPT placed a drug reaction to either lisinopril or ferrous sulfate at the top of the differential. ChatGPT provided customized vaccination requirements for travel to Brazil, guidance on management of drug allergies and recovery from a knee injury. ChatGPT provided satisfactory medication management and wellness information for a diabetic on metformin and semaglutide. CONCLUSIONS: LLMs have the potential to become a powerful tool in community pharmacy. However, rigorous validation studies across diverse pharmacist queries, drug classes and populations, and engineering to secure patient privacy will be needed to enhance LLM utility.
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AIMS: The management of patients treated with direct oral anticoagulants (DOACs) during hospitalization is a common challenge in clinical practice. Although bridging is generally not recommended, too often DOACs are switched to parenteral therapy with low molecular weight heparins. Our objectives were to update a local guideline for perioperative DOAC management and to develop a guideline for the anticoagulation management in non-surgical patients regarding temporary DOAC discontinuation. METHODS: We executed a two-step modified Delphi study in a 1000-bed university hospital in Belgium. The Delphi questionnaires were developed based on a literature review and a telephone survey of prescribers. Two expert panels were established: one dedicated to perioperative DOAC management and the other to DOAC management in non-surgical patients. Both panels completed two rounds, commencing with an individual and online round, followed by a face-to-face group session. RESULTS: After the two-round Delphi process, the updated perioperative guideline on DOAC management included reasons for delaying the resumption of DOACs following surgery, such as oral intake not possible, the probability of re-intervention within 3 days, and insufficient haemostasis (e.g. active clinically significant haematoma, haemorrhagic drains or wounds). Furthermore, a guideline for non-surgical hospitalized patients was developed, outlining possible reasons for interrupting DOAC therapy. Both guidelines offer clear anticoagulation therapy strategies corresponding to the identified scenarios. CONCLUSIONS: We have updated and developed guidelines for DOAC management in surgical and non-surgical patients during hospitalization, which aim to support prescribers and to enhance targeted prescription review by hospital pharmacists.
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With the continuous development of genetics in healthcare, there has been a significant contribution to the development of precision medicine, which is ultimately aimed at improving the care of patients. Generally, drug treatments used in Oncology are characterized by a narrow therapeutic range and by their potential toxicity. Knowledge of pharmacogenomics and pharmacogenetics can be very useful in the area of Oncology, as they constitute additional tools that can help to individualize patients' treatment. This work includes a description of some genes that have been revealed to be useful in the field of Oncology, as they play a role in drug prescription and in the prediction of treatment response.
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Drug information (DI) provided by hospital pharmacies aims to promote rational and safe drug therapy. While quality assessment for this task is recommended, more knowledge on the factors determining the quality is needed. We aimed to evaluate the impacts of different factors on the quality of DI provided by hospital pharmacies to healthcare professionals. Retrospectively, answers on fictitious enquiries about annual DI tests for German hospital pharmacies over five years were evaluated for content-related and structural requirements. Multivariate analysis was performed for the impact of the enquiry complexity, DI organization (specialized DI center; pharmacist responsible per day; DI on top of other routine tasks), and quality measures (second look; experience of answering pharmacist in DI/on ward; use of documentation database). In 2017-2021, 45, 71, 79, 118, and 122 hospital pharmacies participated. The enquiry complexity had a statistically significant impact on the content-related quality, with poor results for a higher complexity (years 2018/2021, OR 0.25/0.04, p < 0.01). The DI centers achieved better results regarding content-related quality than for a pharmacist responsible per day (OR 0.76/p = 0.65) or DI on top of routine tasks (OR 0.35/p = 0.02). The DI centers scored better in structural quality. The second look showed an overall trend of a better content-related and structural quality. In conclusion, specialized DI centers and second looks are recommended as quality-improving measures. Training for answering complex enquiries should be intensified.
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Background: Initiation of sacubitril-valsartan and mineralocorticoid receptor antagonists (MRA) during hospitalization for acute decompensated heart failure (ADHF) may be an ideal time to optimize guideline-directed medical therapy. However, there is limited research assessing the safety of combining these agents in the hospital. Methods: This was a multi-center, retrospective, propensity-score matched cohort study performed at 7 acute-care hospitals within a large health care system. All adult patients admitted with ADHF between January 1, 2019 to December 31, 2021 who received sacubitril-valsartan with MRA (MRA group) or without MRA (non-MRA group) and had a left ventricular ejection fraction (LVEF) < 40% were included in the study. Results: 220 patients were screened during the study time frame with 179 meeting inclusion criteria. Following propensity-score matching, 50 patients in the MRA group were matched to 50 patients in the non-MRA group. The overall incidence of adverse drug reactions (ADRs) was 24% in the non-MRA group compared to 20% in the MRA group (P = .629). There was a significantly greater incidence of hyperkalemia in the MRA group (0% vs 10%; P = .022). None of the patients in the non-MRA group were readmitted within 30 days due to an ADR compared to 6% in the MRA group (P = .079). Conclusion: The addition of spironolactone to sacubitril-valsartan in the hospital setting following stabilization of ADHF did not lead to a significantly greater incidence of overall ADRs, but patients were more likely to develop hyperkalemia and there was a numerically higher incidence of 30-day readmissions due to ADRs.
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OBJECTIVES: Adverse drug reactions (ADRs) are a major drug safety concern and a frequent topic of enquiries to hospital drug information services. Our goal was to analyse these enquiries regarding background, complexity, nature of ADR, and involved drug classes to improve in-hospital drug safety. METHODS: Retrospectively, ADR enquiries to a German university hospital pharmacy drug information 2018-2022 were analysed regarding enquirer (profession, medical specialty) and enquiry details (drugs, suspected ADR/enquiry prior to drug initiation, ADR system organ class, probable cause identified, and enquiry complexity). KEY FINDINGS: Of 543 enquiries, 516 (95%) were asked by physicians, 493 (91%) patient-specific, 390 (71%) on suspected ADRs, and 153 (28%) prior to drug initiation. Enquiries originated frequently from internal medicine (74/13.6%), paediatrics (71/13.1%), neurology (70/12.9%), and haemato-oncology (62/11.4%). Most frequent ADRs were haematologic (94/17%) and hepatic (72/13%). The median number of drugs per enquiry was three (range 0-37), 209 (38%) enquiries referred to one specific drug, 165 (30%) concerned ≥11 drugs. A probable cause for suspected ADRs was identified in 75 (36%) enquiries concerning one drug and 155 (94%) with ≥11 drugs. Most frequent drugs were antineoplastic (54/25.8%), nervous-system-drugs (42/20.1%), and anti-infective (40/19.1%). Most enquiries (342/63%) were complex (multiple/specialist resources). CONCLUSIONS: Enquiries were usually asked by physicians referring to suspected ADRs in specific clinical situations. A probable cause was identified in many cases pointing to a direct positive impact on patient care. Enquiries prior to drug initiation should be encouraged to increase drug safety. Information on main ADR effects and drug classes helps with targeted counselling.
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Serviços de Informação sobre Medicamentos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Serviço de Farmácia Hospitalar , Humanos , Estudos Retrospectivos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Serviço de Farmácia Hospitalar/organização & administração , Alemanha , Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Hospitais UniversitáriosRESUMO
Background: The advent of Large Language Models (LLMs) such as ChatGPT introduces opportunities within the medical field. Nonetheless, use of LLM poses a risk when healthcare practitioners and patients present clinical questions to these programs without a comprehensive understanding of its suitability for clinical contexts. Objective: The objective of this study was to assess ChatGPT's ability to generate appropriate responses to clinical questions that hospital pharmacists could encounter during routine patient care. Methods: Thirty questions from 10 different domains within clinical pharmacy were collected during routine care. Questions were presented to ChatGPT in a standardized format, including patients' age, sex, drug name, dose, and indication. Subsequently, relevant information regarding specific cases were provided, and the prompt was concluded with the query "what would a hospital pharmacist do?". The impact on accuracy was assessed for each domain by modifying personification to "what would you do?", presenting the question in Dutch, and regenerating the primary question. All responses were independently evaluated by two senior hospital pharmacists, focusing on the availability of an advice, accuracy and concordance. Results: In 77% of questions, ChatGPT provided an advice in response to the question. For these responses, accuracy and concordance were determined. Accuracy was correct and complete for 26% of responses, correct but incomplete for 22% of responses, partially correct and partially incorrect for 30% of responses and completely incorrect for 22% of responses. The reproducibility was poor, with merely 10% of responses remaining consistent upon regeneration of the primary question. Conclusions: While concordance of responses was excellent, the accuracy and reproducibility were poor. With the described method, ChatGPT should not be used to address questions encountered by hospital pharmacists during their shifts. However, it is important to acknowledge the limitations of our methodology, including potential biases, which may have influenced the findings.
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Background: Medication dosing in overweight and obese children often involves complex weight-based calculations, leading to higher dosing errors, particularly with intravenous drugs. Currently, tools to aid in dosage calculations are lacking for these patients, especially in Thai population. Objective: This study aimed to develop a mobile application with the intent of utilizing it as a tool to enhance the efficiency and accuracy of dosing calculations required for obese and overweight Thai children. Methods: The performance of the application was assessed in 3 key aspects using a sample of 30 healthcare professionals. These key aspects included: 1) the accuracy of dosage calculations, assessed through pre- and posttests comparing manual calculations to app-based calculations using a 10-item questionnaire, 2) the time taken for calculations before and after app usage, 3) user satisfaction, which was measured through a questionnaire. Results: The integration of applications into the calculation demonstrated a significant improvement when compared to the manual calculation in both accuracy (6.10 vs 9.33 out of 10, P < .001) and efficiency (10.40 vs 8.53 minutes per 10 questions, P = .008). Also, the application elicited high levels of satisfaction among users, as reflected by an overall mean satisfaction score of 4.57 on a 5-point scale. Conclusion: The integration of this application to assist in dosage calculations for overweight and obese pediatric Thai patients has yielded favorable outcomes concerning accuracy, efficiency, and user satisfaction. Further development should be pursued within a larger cohort, with an emphasis on real-world implementation in clinical settings.
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Background: Poison centers develop triage threshold guidelines for pediatric metformin ingestions. Our network uses 1700 mg, or 85 mg/kg. Objective: To describe the dose, clinical course, and outcomes for inadvertent metformin ingestions in children 5 years old and younger reported to our statewide poison center network. Methods: We searched the poison center database 2011 to 2021 for metformin ingestions in patients 5 years and younger. Variables included age, sex, weight, dose, symptoms, outcome, and more. We used descriptive statistics with medians and interquartile ranges (IQR) for continuous variables. Results: Of 669 cases, exposures by age were 208 (31.1%) 1 to 2 years, and 275 (41.1%) 2 years. Weight was recorded in 342 (51.1%) (median 13.5 kg; IQR: 3.7 kg), and dose in 149 (22.3%) (median 500 mg; IQR: 500 mg). Milligram/kilogram values were available for 103 (15.4%) with median 42.4 mg/kg, IQR: 39 mg/kg. Most (647, 98.5%) exposures were unintentional. Most (445/669, 66.5%) were managed at a non-healthcare facility, while 204 (30.7%) were already at or referred to a healthcare facility. Of these 204 patients, 169 (82.8%) were evaluated and treated at the emergency department and discharged. Four (2%) were admitted to critical care, and 7 (3.4%) to the ward. Medical outcomes by effect were 5 (0.7%) minor, 2 (0.3%) moderate, 253 (37.8%) none, 292 (43.6%) not followed (minimal effects possible), and no major effects or deaths. Of 20 clinical occurrences reported, vomiting was most common (8, 1.2%). Conclusion: Despite little recorded dosage information, pediatric metformin ingestions under 85 mg/kg had predominantly uneventful medical outcomes.
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Text summarization is crucial in scientific research, drug discovery and development, regulatory review, and more. This task demands domain expertise, language proficiency, semantic prowess, and conceptual skill. The recent advent of large language models (LLMs), such as ChatGPT, offers unprecedented opportunities to automate this process. We compared ChatGPT-generated summaries with those produced by human experts using FDA drug labeling documents. The labeling contains summaries of key labeling sections, making them an ideal human benchmark to evaluate ChatGPT's summarization capabilities. Analyzing >14000 summaries, we observed that ChatGPT-generated summaries closely resembled those generated by human experts. Importantly, ChatGPT exhibited even greater similarity when summarizing drug safety information. These findings highlight ChatGPT's potential to accelerate work in critical areas, including drug safety.
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Rotulagem de Medicamentos , United States Food and Drug Administration , Humanos , Estados Unidos , Processamento de Linguagem Natural , Efeitos Colaterais e Reações Adversas Relacionados a MedicamentosRESUMO
Background: In the healthcare field, there has been a growing interest in using artificial intelligence (AI)-powered tools to assist healthcare professionals, including pharmacists, in their daily tasks. Objectives: To provide commentary and insight into the potential for generative AI language models such as ChatGPT as a tool for answering practice-based, clinical questions and the challenges that need to be addressed before implementation in pharmacy practice settings. Methods: To assess ChatGPT, pharmacy-based questions were prompted to ChatGPT (Version 3.5; free version) and responses were recorded. Question types included 6 drug information questions, 6 enhanced prompt drug information questions, 5 patient case questions, 5 calculations questions, and 10 drug knowledge questions (e.g., top 200 drugs). After all responses were collected, ChatGPT responses were assessed for appropriateness. Results: ChatGPT responses were generated from 32 questions in 5 categories and evaluated on a total of 44 possible points. Among all ChatGPT responses and categories, the overall score was 21 of 44 points (47.73%). ChatGPT scored higher in pharmacy calculation (100%), drug information (83%), and top 200 drugs (80%) categories and lower in drug information enhanced prompt (33%) and patient case (20%) categories. Conclusion: This study suggests that ChatGPT has limited success as a tool to answer pharmacy-based questions. ChatGPT scored higher in calculation and multiple-choice questions but scored lower in drug information and patient case questions, generating misleading or fictional answers and citations.
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Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are available online to subscribers. Monographs can be customized to meet the needs of a facility. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service, contact Wolters Kluwer customer service at 866-397-3433.
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Background: Hypertension, a significant risk factor for cardiovascular diseases, demands proactive management as cardiovascular diseases remain the leading cause of death worldwide. Reducing systolic and diastolic blood pressure levels below recommended reference values of <140/90 mmHg can lead to a significant reduction of the risk of CVD and all-cause mortality. However, treatment of hypertension can be difficult and the presence of comorbidities could further complicate this treatment. Drugs used to manage these comorbidities may inadvertently have an impact on blood pressure, resulting in a phenomenon known as drug-disease interaction. This study aims to assess the safety of medication that can affect blood pressure in patients with hypertension and provide practical recommendations for healthcare professionals. Methods: For the development of recommendations for the drug-disease interaction (DDSI) hypertension, a six-step plan that combined literature selection and multidisciplinary expert opinion was used. The process involved (1) defining the scope of the DDSI and selecting relevant drugs, (2) collecting evidence, (3) data-extraction, (4) reaching of expert consensus, (5) publication and implementation of the recommendations in healthcare systems and (6) updating the information. Results: An increase of 10 mmHg in systolic blood pressure and 5 mmHg in diastolic blood pressure was defined as clinically relevant. Corticosteroids, danazol, and yohimbine caused a clinically relevant DDSI with hypertension. Several other drugs with warnings for hypertension in the official product information were assessed to have no clinically relevant DDSI due to minor influence or lack of data on blood pressure. Drugs with evidence for a relevant change in blood pressure which are prescribed under close monitoring of blood pressure according to clinical guidelines, were deemed to be not clinically relevant for signalling. Conclusion: This study provides specific recommendations that can be implemented directly in clinical practice, for example, in clinical decision support systems, potentially resulting in safer drug use in patients with hypertension and better healthcare by reducing alert fatigue. Future research should focus on evaluating the effectiveness of implementation strategies and their impact on reducing unsafe use of medication in patients with hypertension.
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Background: Toxicity or treatment failure related to drug-drug interactions (DDIs) are known to significantly affect morbidity and hospitalization rates. Despite the availability of numerous databases for DDIs identification and management, their information often differs. Oral anticoagulants are deemed at risk of DDIs and a leading cause of adverse drug events, most of which being preventable. Although many databases include DDIs involving anticoagulants, none are specialized in them. Aim and method: This study aims to compare the DDIs information content of four direct oral anticoagulants and two vitamin K antagonists in three major DDI databases used in Switzerland: Lexi-Interact, Pharmavista, and MediQ. It evaluates the consistency of DDIs information in terms of differences in severity rating systems, mechanism of interaction, extraction and documentation processes and transparency. Results: This study revealed 2'496 DDIs for the six anticoagulants, with discrepant risk classifications. Only 13.2% of DDIs were common to all three databases. Overall concordance in risk classification (high, moderate, and low risk) was slight (Fleiss' kappa = 0.131), while high-risk DDIs demonstrated a fair agreement (Fleiss' kappa = 0.398). The nature and the mechanism of the DDIs were more consistent across databases. Qualitative assessments highlighted differences in the documentation process and transparency, and similarities for availability of risk classification and references. Discussion: This study highlights the discrepancies between three commonly used DDI databases and the inconsistency in how terminology is standardised and incorporated when classifying these DDIs. It also highlights the need for the creation of specialised tools for anticoagulant-related interactions.
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Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are available online to subscribers. Monographs can be customized to meet the needs of a facility. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service, contact Wolters Kluwer customer service at 866-397-3433.
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The German weekly magazine DIE ZEIT (THE TIME) reaches more than one million readers per issue, mainly from high-income social classes. Pharmacological content is frequent in DIE ZEIT. As it therefore reaches many people who generally have no in-depth knowledge of pharmacology, it can be assumed that DIE ZEIT is an important primary source of information. It should be its task to depict the drugs widely used by the population and to present them correctly and comprehensibly. This study analyzes 71 articles from 2012 to 2022 in terms of form, content, and comprehensibility. The analysis shows that in DIE ZEIT, drug groups largely correspond to the prescription figures and disease prevalence in Germany, with cardiovascular, neuropsychiatric, and pain medications being frequently discussed. There are deviations in the case of oncological drugs, for example, which are discussed more frequently than prescribed. New drug approvals are reported less frequently, and when they are, it is usually about the research phase. DIE ZEIT often reports on findings that are less than a week old and frequently quotes trustworthy experts, but no scientific sources can be found in around a quarter of the articles. A COVID-19 effect can also be identified in the years 2020 to 2022, as reporting on drugs for the treatment of coronavirus disease 2019 (COVID-19) predominated. An important point of criticism was identified with regard to comprehensibility. Less than half of the articles achieved the cut-off value for general comprehensibility specified by the Textlab analysis program, and only one article achieved the value for target group-oriented comprehensibility. This analysis confirms the problem that science communication is often too complicated and incomprehensible. It discusses the tension between the prescribed drugs and the mission of DIE ZEIT to entertain and should serve as a basis for analyzing other newspapers. Finally, we make specific suggestions how presentation of pharmacological topics in lay media can be improved in the future.
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OBJECTIVE: To explore the pharmacy students' perception of the content and pedagogical strategies used for the delivery of drug information (DI) training. METHODS: An explanatory sequential mixed-methods study was conducted among BSc Pharmacy and PharmD students at the College of Pharmacy, Qatar University. The first phase consisted of a quantitative cross-sectional survey using a 34-item pretested questionnaire. The Donabedian framework guided the development of the questionnaire. This was followed by a phenomenological qualitative phase that was conducted based on the result of the first phase. Descriptive statistics and thematic content analysis were used for data analyses. RESULTS: The completion and usable rates were 88.7% (102 of 115) and 91.2% (93 of 102) respectively. The online resources used for the delivery of DI and the progressive structuring from year 1 to 4 were reported to be adequate by a majority of the respondents (93.55%). Ninety percent of the students opined that the use of simulation-based assessments improved their integration of the theoretical and practical aspects, and their preparedness to apply the DI concepts in practice. However, 20% of the participants reported inconsistency of the DI curricular content with some practices encountered during their experiential learning exposures. The themes identified from the focus group discussion included the perceived value and skills acquired from the DI content, availability and currency of DI resources, students' preparedness, curricular structuring of DI content, and reflection on and recommendations to improve DI coverage and delivery. CONCLUSION: The curricular structuring of the DI content across varieties of relevant undergraduate pharmacy courses from the lower to higher professional years and its focus on the progressive development of DI-related competencies appeared to have enhanced the students' perception of the relevance, appropriateness, and utility of the content, resources, and pedagogical strategies used for the delivery of DI education at the undergraduate level.
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Educação em Farmácia , Estudantes de Farmácia , Humanos , Currículo , Estudos Transversais , Educação em Farmácia/métodos , PercepçãoRESUMO
Purpose: Tamsulosin is formulated as sustained release beads within a capsule to prevent rapid absorption and associated hypotension. The package insert advises the capsule is swallowed whole; not crushed, chewed, or opened. To our knowledge, there are no current data on opening capsules for adults with enteral tube feeds. Given the unidentified safety and efficacy of administration via enteral tubes, alternative alpha blockers with less selectivity for alpha1A are often used. Methods: A single center retrospective chart review was conducted at two hospital sites. Adult patients that received at least one dose of tamsulosin or doxazosin while an enteral feeding tube was placed were included. Safety outcomes evaluated were the number of documented tube obstructions and incidence of medication associated hypotension. Results: 169 patients were included. Ten enteral feeding tube obstructions were reported, 4 of 110 (3.64%) in the tamsulosin arm and 6 of 59 (10.17%) in the doxazosin arm (RR .36, 95% CI .11 to 1.22, P = .099). At least 1 episode of medication associated hypotension occurred in 22 of 98 (22.45%) in the tamsulosin arm and 20 of 49 (40.82%) in the doxazosin arm (RR .55, 95% CI .33 to .91, P = .019). Conclusion: There was no statistically significant difference in the number of tube obstructions between patients receiving tamsulosin or doxazosin via enteral tube feeds. Patients receiving doxazosin were at increased risk of experiencing medication related hypotension. Tamsulosin capsules may be opened and administered via enteral feeding tubes if administered with content integrity intact.
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Cápsulas , Nutrição Enteral , Estudos de Viabilidade , Tansulosina , Humanos , Tansulosina/administração & dosagem , Estudos Retrospectivos , Masculino , Nutrição Enteral/métodos , Feminino , Pessoa de Meia-Idade , Idoso , Antagonistas de Receptores Adrenérgicos alfa 1/administração & dosagem , Doxazossina/administração & dosagem , Adulto , Hipotensão/prevenção & controle , Hipotensão/induzido quimicamente , Idoso de 80 Anos ou maisRESUMO
Statins are widely prescribed and highly susceptible to pharmacokinetic (PK)-based drug-drug interactions (DDIs). To date, there has not been a comprehensive analysis of the basis upon which statin DDI recommendations in US Food and Drug Administration (FDA) prescribing information (PI) are derived. We have conducted such an analysis. We also assessed the degree of concordance of statin DDI recommendations in FDA PI and those provided in common tertiary clinical resources. We catalogued statin DDI information, including PK data and management recommendations, for statin precipitant drugs approved from 2010 to 2021, available from FDA PI and tertiary clinical resource databases. Recommendations were categorized and mapped with associated PK data to assess consistency in the PK basis for labeling recommendations. From the 80 precipitant drugs evaluated, 180 statin DDIs were identified in FDA PI. Dedicated clinical DDI studies were conducted for 54% (n = 97) of these DDIs and 34% (n = 61) of DDI recommendations were extrapolated from clinical data with other statins. Overall, we found that PK-based statin recommendations were consistent across PI. These findings highlight regulatory precedence for translating information across statins without conducting dedicated clinical DDI studies, which may support future efforts toward streamlining the approach to investigation and labeling of statin DDIs. In addition, with the exception of some notable discrepancies, general concordance was observed between FDA and tertiary resources regarding "Dose Adjustment" and "Avoid Coadministration" recommendations. However, further analyses are warranted across other DDI pairs to determine whether discordance can routinely lead to different clinical recommendations depending on the drug information resource.
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Interações Medicamentosas , Rotulagem de Medicamentos , Inibidores de Hidroximetilglutaril-CoA Redutases , United States Food and Drug Administration , Humanos , Estados Unidos , Rotulagem de Medicamentos/normas , Inibidores de Hidroximetilglutaril-CoA Redutases/farmacocinética , Bases de Dados FactuaisRESUMO
Drug information tools help avoid medication errors, a common cause of avoidable harm in health care systems. We sought to describe the design, development process and architecture of an electronic drug information tool, as well as its overall use by health professionals. We developed a tool that can be accessed by all health professionals in a tertiary level university hospital. The functionalities of eDrugs are organized into two main parts: Drug Summary sheet, and Prescription Simulator. Most users accessed eDrugs to use the Drug summary sheet. Clinical information and antimicrobial drugs were the most accessed drug information and drug group. The analysis of log data provides insights into the information priorities of health professionals.