Background: Anaesthetic drugs may cause neuroapoptosis in children and are routinely used off-label in specific age groups. Techniques that reduce anaesthetic drug dose requirements in children may thus enhance the safety of paediatric sedation or anaesthesia. Brainwave entrainment, notably in the form of auditory binaural beats, has been shown to have sedative effects in adults. We evaluated the influence of brainwave entrainment on propofol dose requirements for sedation in children.
The dose is the amount of drug taken at any one time. This can be expressed as the weight of drug (e.g. 250 mg), volume of drug solution (e.g. 10 mL, 2 drops), the number of dosage forms (e.g. 1 capsule, 1 suppository) or some other quantity (e.g. 2 puffs).
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The dosage form is the physical form of a dose of drug. Common dosage forms include tablets, capsules, creams, ointments, aerosols and patches. Each dosage form may also have a number of specialized forms such as extended-release, buccal, dispersible and chewable tablets. The strength is the amount of drug in the dosage form or a unit of the dosage form (e.g. 500 mg capsule, 250 mg/5 mL suspension).
There are many factors taken into consideration when deciding a dose of drug - including age of the patient, weight, sex, ethnicity, liver and kidney function and whether the patient smokes. Other medicines may also affect the drug dose.
In the absence of data, the use of many drugs in children, especially neonates, is often off label. The off-label use of drugs is associated with an increased risk of adverse effects, particularly in patients under the age of two years.2 It is particularly difficult to predict pharmacological effects in neonates as development occurs quickly, resulting in rapid changes in drug metabolism over short periods of time which create difficulty in predicting doses.3,4
Dosing information for obese children is limited and has been identified as an area for research. Obese children can be dosed using ideal body weight and the dose adjusted based on clinical effect. They are at higher risk of toxicity from drugs such as paracetamol that do not distribute into fat, if actual weight is used to calculate the dose.
Dosing information is difficult to determine in children as traditional pharmacokinetic studies are hard to conduct in children and are subject to a greater range of ethical considerations. These studies require large amounts of blood to be taken over periods of time and this is not considered ethical in children. The development of population pharmacokinetic modelling has allowed paediatric-specific dosing information to be developed.13 These new techniques will assist in developing safer dosing information for children over time by reducing the burden of pharmacokinetic studies. Although improving, no mathematical method of dose estimation can replace clinical studies using actual outcomes, surrogate measures or therapeutic drug monitoring.14
Weight-based and surface-area-based dosing regimens are simple and are used in most clinical situations. However, with the lack of specific paediatric data, these dosing equations are often based on adult data and then scaled based on size and age as an approximation for drug activity in children. Paediatric growth and development is not a linear process. Scaling from adult doses based on weight alone is not adequate for determining doses across the range of developmental processes that occur throughout childhood.7 While this method may have some value in older children and adolescents, who have similar values to adults for body composition and organ function, it lacks utility in toddlers and neonates.
Drug consumption can be expressed in cost, number of units, number of prescriptions or by the physical quantity of drugs. However these variables can vary between regions and countries over time. This limits comparisons of drug consumption at an international level. To address this, a technical unit of measurement, the Defined Daily Dose (DDD) was created.
DDDs are only assigned for medicines given an ATC codes. The DDDs are allocated to drugs by the WHO Collaborating Centre in Oslo, working in close association with the WHO International Working Group on Drug Statistics Methodology.
Only one DDD is assigned per ATC code and route of administration (e.g. oral formulation). The DDD is sometimes a dose that is rarely or never prescribed because it is an average of two or more commonly used doses.
DDDs are not established for all medicines with an ATC code. Major drug groups without DDDs are topical products (most products in ATC group D), sera (ATC group J06), vaccines (ATC group J07), antineoplastic agents (ATC group L01), general and local anesthetics (ATC group N01), ophthalmologicals and otologicals (most products in ATC group S), allergen extracts (ATC group V01) and contrast media (ATC group V08).
The DDD is a unit of measurement and does not necessarily correspond to the recommended or Prescribed Daily Dose (PDD). Therapeutic doses for individual patients and patient groups will often differ from the DDD as they will be based on individual characteristics such as age, weight, ethnic differences, type and severity of disease, and pharmacokinetic considerations.
Drug utilization data presented in DDDs give a rough estimate of consumption and not an exact picture of actual use. DDDs provide a fixed unit of measurement independent of price, currencies, package size and strength enabling the researcher to assess trends in drug utilization and to perform comparisons between population groups.
The prescribed daily dose (PDD) is defined as the average dose prescribed according to a representative sample of prescriptions. The PDD can be determined from studies of prescriptions, medical or pharmacy records, and it is important to relate the PDD to the diagnosis on which the drug is used. The PDD will give the average daily amount of a drug that is actually prescribed. When there is a substantial discrepancy between the PDD and the DDD, it is important to take this into consideration when evaluating and interpreting drug utilization figures.
For drugs where the recommended dosage differs for different indications (e.g. antipsychotics) it is important that diagnosis is linked to the prescribed daily dose given. Pharmacoepidemiological information (e.g. sex, age and mono/combined therapy) is also important in order to interpret a PDD. The PDD can vary according to both the illness treated and national policies and practices. For example, the PDDs of anti-infectives may vary according to the severity of the infection. There are also international differences between PDDs, which can be up to four or five fold higher/lower. PDDs in Asian populations are often lower than in Caucasian populations.
- The World Health Organization: The WHO endorsed the ATC/DDD methodology for global use in 1996 as an international standard for drug utilization studies in an effort to ensure universal access to essential drugs and to stimulate rational use of drugs particularly in middle/low income countries.
CBP is on the frontline of stopping illegal narcotics, such as fentanyl and heroin, from entering the U.S. The interactive dashboard shows Office of Field Operations (OFO) seizures of fentanyl and heroin by the number of doses seized, the estimated value of drugs seized, and weight beginning in fiscal year 2023. For more data on CBP drug seizures, please visit the CBP drug seizure statistics dashboard.
Chronic kidney disease affects renal drug elimination and other pharmacokinetic processes involved in drug disposition (e.g., absorption, drug distribution, nonrenal clearance [metabolism]). Drug dosing errors are common in patients with renal impairment and can cause adverse effects and poor outcomes. Dosages of drugs cleared renally should be adjusted according to creatinine clearance or glomerular filtration rate and should be calculated using online or electronic calculators. Recommended methods for maintenance dosing adjustments are dose reductions, lengthening the dosing interval, or both. Physicians should be familiar with commonly used medications that require dosage adjustments. Resources are available to assist in dosing decisions for patients with chronic kidney disease.
Inappropriate dosing in patients with chronic kidney disease can cause toxicity or ineffective therapy. In particular, older patients are at a higher risk of developing advanced disease and related adverse events caused by age-related decline in renal function and the use of multiple medications to treat comorbid conditions. Chronic kidney disease can affect glomerular blood flow and filtration, tubular secretion and reabsorption, and renal bioactivation and metabolism. Drug absorption, bioavailability, protein binding, distribution volume, and nonrenal clearance (metabolism) also can be altered in these patients. Physicians should pay careful attention when considering drug therapies with active or toxic metabolites that can accumulate and contribute to exaggerated pharmacologic effects or adverse drug reactions in patients with chronic kidney disease. Table 2 includes resources for more information about dosing adjustments in patients with chronic kidney disease.
Dosages of drugs cleared renally are based on renal function (calculated as GFR or creatinine clearance; Table 3). These calculations are valid only when renal function is stable and the serum creatinine level is constant.
Loading doses usually do not need to be adjusted in patients with chronic kidney disease. Published guidelines suggest methods for maintenance dosing adjustments: dose reduction, lengthening the dosing interval, or both.4 Dose reduction involves reducing each dose while maintaining the normal dosing interval. This approach maintains more constant drug concentrations, but it is associated with a higher risk of toxicities if the dosing interval is inadequate to allow for drug elimination. Normal doses are maintained with the extended interval method, but the dosing interval is lengthened to allow time for drug elimination before redosing. Lengthening the dosing interval has been associated with a lower risk of toxicities but a higher risk of subtherapeutic drug concentrations, especially toward the end of the dosing interval. 17dc91bb1f
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