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Minerva Anestesiologica Jul 2020There is largely an absence of validated evidence-based therapies in term- and preterm newborn infants, due to a lack of pharmacological clinical trials. As a... (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION
There is largely an absence of validated evidence-based therapies in term- and preterm newborn infants, due to a lack of pharmacological clinical trials. As a consequence, the drugs and doses used in clinical practice are extrapolated from dose-ranging trials performed in older patients. Drugs administered to the preterm infant are invariably off-label. The aim of this current review is to identify commonly used anesthetic and analgesic agents in this patient population, assess the existing evidence base, in terms of safety, efficacy, pharmacokinetics and pharmacodynamics, current indications and doses.
EVIDENCE ACQUISITION
We searched the PubMed, Google Scholar, Web of Science, U.S. Food and Drug Administration and World Health Organization databases and analyzed any studies for general anesthesia; analgo-sedation; regional anesthesia; pharmacokinetics, pharmacodynamics and pharmacogenomics in this patient population.
EVIDENCE SYNTHESIS
A total of 412 studies (meta-analysis, systematic reviews, randomized controlled trial (RCT), and observational) were identified and analyzed.
CONCLUSIONS
Preterm infants are characterized by remarkable metabolic and developmental differences when compared with adults. It is not possible to derive guidelines or clinical recommendations based on the existing evidence.
Topics: Adult; Aged; Analgesia; Anesthesia, Conduction; Humans; Infant; Infant, Newborn; Infant, Premature; Pain Management; Pharmaceutical Preparations; Randomized Controlled Trials as Topic
PubMed: 32000473
DOI: 10.23736/S0375-9393.20.14073-2 -
The Journal of Pediatrics Jan 2022To provide up-to-date medication prescribing patterns in US neonatal intensive care units (NICUs) and to examine trends in prescribing patterns over time.
OBJECTIVE
To provide up-to-date medication prescribing patterns in US neonatal intensive care units (NICUs) and to examine trends in prescribing patterns over time.
STUDY DESIGN
We performed a cohort study of 799 016 infants treated in NICUs managed by the Pediatrix Medical Group from 2010 to 2018. We used 3 different methods to report counts of medication: exposure, courses, and days of use. We defined the change in frequency of medication administration by absolute change and relative change. We examined the Food and Drug Administration (FDA) package insert for each medication to determine whether a medication was labeled for use in infants and used PubMed to search for pharmacokinetics (PK) studies.
RESULTS
The most frequently prescribed medications included ampicillin, gentamicin, caffeine citrate, poractant alfa, morphine, vancomycin, furosemide, fentanyl, midazolam, and acetaminophen. Of the top 50 medications used in infants with extremely low birth weight, only 20 (40%) are FDA-labeled for use in infants; of the 30 that are not labeled for use in infants, 13 (43%) had at least 2 published PK studies. The medications with the greatest relative increase in use from 2010 to 2018 included dexmedetomidine, clonidine, rocuronium, levetiracetam, atropine, and diazoxide. The medications with the greatest relative decrease in use included tromethamine acetate, pancuronium, chloral hydrate, imipenem + cilastatin, and amikacin.
CONCLUSION
Trends of medication use in the NICU change substantially over time. It is imperative to identify changes in medication use in the NICU to better inform further prospective studies.
Topics: Cohort Studies; Databases, Factual; Drug Utilization; Humans; Infant, Newborn; Intensive Care Units, Neonatal; Pharmaceutical Preparations; United States
PubMed: 34481808
DOI: 10.1016/j.jpeds.2021.08.075 -
Yakugaku Zasshi : Journal of the... 2017The practice of regulatory science (RS) for drug development is described. In the course material for education in pharmaceutical sciences drafted by the RS Division of... (Review)
Review
The practice of regulatory science (RS) for drug development is described. In the course material for education in pharmaceutical sciences drafted by the RS Division of the Pharmaceutical Society of Japan, RS for pharmaceuticals is defined as the science of predicting, assessing, and judging the quality, efficacy, and safety of pharmaceutical products throughout their lifespan. RS is also described as an integrated science based on basic and applied biomedical sciences, including analytical chemistry, biochemistry, pharmacology, toxicology, genetics, biostatistics, epidemiology, and clinical trial methodology, and social sciences such as decision science, risk assessment, and communication science. The involvement of RS in drug development generally starts after the optimization of lead compounds. RS plays important roles governing pharmaceuticals during their entire life cycle management phase as well as the drug development phase.
Topics: Biomedical Research; Consumer Product Safety; Drug Discovery; Education, Pharmacy; Equipment Safety; Hazard Analysis and Critical Control Points; Humans; Japan; Pharmaceutical Preparations; Risk Assessment; Risk Management; Science; Societies, Pharmaceutical; Teaching Materials
PubMed: 28381719
DOI: 10.1248/yakushi.16-00244-2 -
Clinical Medicine (London, England) Dec 2013The likelihood of a general physician encountering a patient with compensated and decompensated liver disease is increasing. This article provides an overview of... (Review)
Review
The likelihood of a general physician encountering a patient with compensated and decompensated liver disease is increasing. This article provides an overview of pharmaceutical agents currently used in the management of cirrhosis and is designed to allow a better understanding of the rationale for using certain drugs in patients with often complex pathology.
Topics: Disease Management; Humans; Liver Diseases; Pharmaceutical Preparations
PubMed: 24298107
DOI: 10.7861/clinmedicine.13-6-585 -
Pediatrics Aug 2011Although pediatric electronic prescribing systems are increasingly being used in pediatric care, many of these systems lack the clinical decision-support infrastructure... (Comparative Study)
Comparative Study Review
BACKGROUND
Although pediatric electronic prescribing systems are increasingly being used in pediatric care, many of these systems lack the clinical decision-support infrastructure needed to calculate a safe and effective rounded medication dose. This infrastructure is required to facilitate tailoring of established dosing guidance while maintaining the medication's therapeutic intent.
OBJECTIVE
The goal of this project was to establish best practices for generating an appropriate medication dose and to create an interoperable rounding knowledge base combining best practices and dose-rounding information.
METHODS
We interviewed 19 pediatric health care and pediatric pharmacy experts and conducted a literature review. After using these data to construct initial rounding tolerances, we used a Delphi process to achieve consensus about the rounding tolerance for each commonly prescribed medication.
RESULTS
Three categories for medication-rounding philosophy emerged from our literature review: (1) medications for which rounding is used judiciously to retain the intended effect; (2) medications that are rounded with attention to potential unintended effects; and (3) medications that are rarely rounded because of the potential for toxicity. We assigned a small subset of medications to a fourth category-inadequate data-for which there was insufficient information to provide rounding recommendations. For all 102 medications, we were able to arrive at a consensus recommendation for rounding a given calculated dose.
CONCLUSIONS
Results of this study provide the pediatric information technology community with a primary set of recommended rounding tolerances for commonly prescribed drugs. The interoperable knowledge base developed here can be integrated with existing and developing electronic prescribing systems, potentially improving prescribing safety and reducing cognitive workload.
Topics: Child; Dose-Response Relationship, Drug; Drug Therapy, Computer-Assisted; Drug-Related Side Effects and Adverse Reactions; Electronic Prescribing; Health Care Surveys; Humans; Medical Order Entry Systems; Medication Errors; Pediatrics; Pharmaceutical Preparations
PubMed: 21788218
DOI: 10.1542/peds.2011-0760 -
The Oncologist Feb 2020Urine drug test (UDT) is an effective tool used in chronic opioid therapy to ensure patient adherence to treatment and detect nonmedical opioid use. The two main types... (Review)
Review
Urine drug test (UDT) is an effective tool used in chronic opioid therapy to ensure patient adherence to treatment and detect nonmedical opioid use. The two main types of UDT used in routine clinical practice are the screening tests or immunoassays and the confirmatory tests or laboratory-based specific drug identification tests such as gas chromatography-mass spectrometry, liquid chromatography-mass spectrometry, or tandem mass spectrometry. UDT produces objective data on some nonmedical opioid use that may otherwise go undetected, such as the use of undisclosed medications, the nonuse of prescribed medications, and the use of illegal drugs. It allows clinicians to initiate an open and effective conversation about nonmedical opioid use with their patients. However, the test has certain limitations that sometimes compromise its use. Its interpretation can be challenging to clinicians because of the complexity of the opioid metabolic pathways. Clear guidelines or recommendations regarding the use of UDT in cancer pain is limited. As a result, UDT appears to be underused among patients with cancer pain receiving opioid therapy. More studies are needed to help standardize the integration and use of UDT in routine cancer pain management. IMPLICATIONS FOR PRACTICE: Despite its potential benefits, urine drug testing (UDT) appears to be underused among patients with cancer pain receiving opioid therapy. This is partly because its interpretation can be challenging owing to the complexity of the opioid metabolic pathways. Information regarding the use of UDT in opioid therapy among patients with cancer is limited. This review article will improve clinician proficiency in UDT interpretation and assist oncologists in developing appropriate treatment plans during chronic opioid therapy.
Topics: Analgesics, Opioid; Humans; Neoplasms; Opioid-Related Disorders; Pain Management; Pharmaceutical Preparations; Substance Abuse Detection
PubMed: 32043770
DOI: 10.1634/theoncologist.2019-0525 -
European Journal of Pharmaceutical... Aug 2023Older adults are the main users of medicine and due to common multimorbidity they are often confronted with a complex medication management. This review article provides... (Review)
Review
Older adults are the main users of medicine and due to common multimorbidity they are often confronted with a complex medication management. This review article provides a brief overview on aspects of medication management, i.e., maintaining a stock of the required medicine, understanding and following the instructions for use, coping with the primary and secondary packaging, as well as the preparation prior to use. However, the main focus is on the drug intake itself and the review provides an overview of the current understanding of real life dosing conditions in older adults and geriatric patients. It elaborates the acceptability of dosage forms, in particular solid oral dosage forms as they represent the majority of dosage forms taken by this patient population. An improved understanding of the needs of older adults and geriatric patients, their acceptability of various dosage forms, and the circumstances under which they manage their medications will allow for the design of more patient-centric drug products.
Topics: Aged; Humans; Dosage Forms; Medication Review; Pharmaceutical Preparations
PubMed: 37149104
DOI: 10.1016/j.ejps.2023.106453 -
Boletin Medico Del Hospital Infantil de... 2017With the appearance of Homo sapiens, the biological order was gradually replaced by the anthropocentric cultural order (CO), in which traditions, appreciations,... (Review)
Review
With the appearance of Homo sapiens, the biological order was gradually replaced by the anthropocentric cultural order (CO), in which traditions, appreciations, preferences and desires for possession and domination guided their interactions with nature (predation or care), within the group (ranks, classes) and with others groups (commerce, wars). Current CO, characterized by unlimited profit interests, extreme wealth concentration and inequality where moral degradation hits rock bottom and planetary ecosystem is devastated, shows a collapsed civilization with a background of a global media controlled anesthetized societies. Regarding the health field, control works by prevalent ideas and practices: sickness as a strange object to the body, health as an imperative vital ideal and technologically based suppressive medicine shaping life's medicalization, main control "device" and health industry support. Other alternative ideas and practices are discussed: sickness as an inner harmony disturbance or as a differentiated and particular way of human beings, and stimulating medicine, that targets sick people with the purpose of strengthening and harmonizing them so they may recover, alleviate or appease. Considerations about possibilities and significance of stimulating medicine are made at the end.
Topics: Cultural Characteristics; Delivery of Health Care; Disease; Humans; Medicalization; Socioeconomic Factors
PubMed: 29382523
DOI: 10.1016/j.bmhimx.2017.06.002 -
The American Journal of Managed Care Jan 2017In this article, we consider the problem of financing highly effective and cost-effective prescription drugs within a value-based pricing system. Precisely because these... (Review)
Review
In this article, we consider the problem of financing highly effective and cost-effective prescription drugs within a value-based pricing system. Precisely because these drugs are highly effective, their value-based prices may be quite expensive; and moreover, the value-based price of a cure ought to be set high enough to create incentives for innovation, otherwise these beneficial therapies may be underdeveloped. However, in our fragmented health insurance system, where patients move frequently between payers, these payers generally lack the incentives to pay value-based prices for cures because they cannot ensure that they will reap the long-term economic benefits. Therefore, we argue that there is a need for mechanisms to spread the burden of financing of cures across payers to maximize patient access and the public good. We suggest that risk adjustment, reinsurance, and risk corridors are familiar policy options that merit consideration to address the problem and create incentives for value-based pricing.
Topics: Cost-Benefit Analysis; Drug Costs; Drug Industry; Fee-for-Service Plans; Health Policy; Humans; Insurance, Pharmaceutical Services; Needs Assessment; Outcome Assessment, Health Care; Pharmaceutical Preparations; United States; Value-Based Purchasing
PubMed: 28141931
DOI: No ID Found -
Neurocritical Care Feb 2020Drug shortages have become all too familiar in the health care environment, with over 200 drugs currently on shortage. In the wake of Hurricane Maria in September 2017,... (Review)
Review
Drug shortages have become all too familiar in the health care environment, with over 200 drugs currently on shortage. In the wake of Hurricane Maria in September 2017, hospitals across the USA had to quickly and creatively adjust medication preparation and administration techniques in light of decreased availability of intravenous (IV) bags used for compounding a vast amount of medications. Amino acid preparations, essential for compounding parenteral nutrition, were also directly impacted by the hurricane. Upon realization of the impending drug shortages, hospitals resorted to alternative methods of drug administration, such as IV push routes, formulary substitutions, or alternative drug therapies in hopes of preserving the small supply of IV bags available and prioritizing them for them most critical needs. In some cases, alternative drug therapies were required, which increased the risk of medication errors due to the use of less-familiar treatment options. Clinical pharmacists rounding with medical teams provided essential, patient-specific drug regimen alternatives to help preserve a dwindling supply while ensuring use in the most critical cases. Drug shortages also frequently occur in the setting of manufacturing delays or discontinuation and drug recalls, with potential to negatively impact patient care. The seriousness of the drug shortage crisis reached public attention by December 2017, when political and pharmacy organizations called for response to the national drug shortage crisis. In this article, we review institutional mitigation strategies in response to drug shortages and discuss downstream effects of these shortages, focusing on medications commonly prescribed in neurocritical care patients.
Topics: Analgesics, Opioid; Anticonvulsants; Antifibrinolytic Agents; Antihypertensive Agents; Central Nervous System Diseases; Cooperative Behavior; Critical Care; Drug Compounding; Drug Substitution; Humans; Intensive Care Units; Pharmaceutical Preparations; Pharmaceutical Solutions; Pharmacy Service, Hospital; Rehydration Solutions; Solutions
PubMed: 31077080
DOI: 10.1007/s12028-019-00730-7