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Goods and consumer issues
Published in Michael Weir, Law and Ethics in Complementary Medicine, 2023
An Advisory Committee on Complementary Medicines (ACCM) evaluates and reports on the registration or listing of complementary medicines. Complementary medicines are specifically defined under the Therapeutic Goods Regulation section 2 and would be considered to be therapeutic goods based upon the definition of that term. For the purpose of the establishment and membership of the ACCM and for issues relevant to listing and exemptions associated with complementary medicine, it is defined in the Therapeutic Goods Regulation section 2 as therapeutic goods ‘consisting wholly or principally of one or more designated active ingredients, each of which has a clearly established identity and a traditional use’. The type of complementary medicine product includes traditional medicines, herbal medicines; homoeopathic medicines; anthroposophic medicines; essential oils and nutritional supplements.4
Statistical Approaches in the Development of Digital Therapeutics
Published in Oleksandr Sverdlov, Joris van Dam, Digital Therapeutics, 2023
Oleksandr Sverdlov, Yevgen Ryeznik, Sergei Leonov, Valerii Fedorov
The development of a new medicinal product consists of a sequence of studies, logically structured from small early development (exploratory) trials to larger, more definitive (confirmatory) trials.16 A statistician provides strategic input to the clinical development plan, identifying critical uncertainties within the clinical program and ways to address these uncertainties through carefully designed and analyzed experiments. Statistical input is essential when a project reaches strategic transition points, e.g., early to full development. On a study level, the statistician helps the study team select a statistical design to answer the research questions of interest reliably, calibrates sample size, chooses appropriate statistical analysis methodologies, performs data analysis, etc.
A Functional Approach to Gynecologic Pain
Published in Sahar Swidan, Matthew Bennett, Advanced Therapeutics in Pain Medicine, 2020
For years, amitriptyline and nortriptyline were considered first-line therapy. They are not approved for the treatment of pain but have been widely used in a variety of pain syndromes to alter neurotransmission, even independent of a diagnosis of a depression. In fact, the TCAs can be used to treat pain at a dose much lower than that required for depression.83 Amitriptyline can be started at 10 mg at bedtime and increased by 10 mg weekly until either satisfactory effect or dissatisfaction with its anticholinergic side effects. Doses higher than 100 mg have been associated with sudden cardiac death, though it is rare that such a high dose is required with the availability of topical options discussed below. More recently, the SNRIs have taken on a prominent role in the treatment of pain syndromes. Duloxetine is typically started at 20 mg and can be increased as needed to 60 mg, which is the typical treatment dose for depression. Side effects include nausea, headache, and dizziness, as well as the potential for a withdrawal syndrome on stopping the medicine.
Defining and enhancing collaboration between community pharmacists and primary care providers to improve medication safety
Published in Expert Opinion on Drug Safety, 2022
Annesha White, Kimberly G. Fulda, Rachel Blythe, Michelle A. Chui, Emily Reeve, Richard Young, Anna Espinoza, Noah Hendrix, Yan Xiao
Community pharmacists are highly accessible as 90% of people within the U.S. live within 5 miles of a community pharmacy [5]. In this review, we refer to community pharmacies who do not typically have access to an electronic health record and tend not to have affiliation with health systems or clinics, such as traditional drug stores, supermarkets, and mass merchants with pharmacies. Community pharmacists’ roles in medication safety in dispensing are well adopted among pharmacists, ensuring the right dose of the right medicine reaches the right patient at the right time by the right route [6]. Beyond dispensing-related safety roles, studies have shown that community pharmacists are under-utilized in reducing ADEs such as through improving prescribing decision-making, inpatient education, in disease state monitoring, and in functioning as a safety net [7]. Due to their proximity to patients and frequency of interactions, a wider view of community pharmacist in patient care has been recognized. For example, more comprehensive lists of roles include evaluating medication appropriateness, improving medication adherence, providing health and wellness services, performing medication management services, assessing patients’ health status, and coordinating care transition [7].
Localized, on-demand, sustained drug delivery from biopolymer-based materials
Published in Expert Opinion on Drug Delivery, 2022
Junqi Wu, Sawnaz Shaidani, Sophia K. Theodossiou, Emily J. Hartzell, David L. Kaplan
The field of medicine depends on therapeutics to treat or cure diseases. In 2020, it was estimated that $1.3 trillion was spent globally on prescription drugs [1]. As more therapeutics are developed, there is an opportunity for refined modes of delivery to increase safety and efficacy. With any mode of drug delivery, the active pharmaceutical ingredient (API) should be delivered at a concentration that reaches the therapeutic index, which describes the dose range where a medication is effective without causing adverse effects [2]. This concentration can be challenging to achieve due to unpredictable drug release rates, the inability to precisely target the desired tissues, renal/hepatic clearance of the delivered drugs, and unreliable stability of the therapeutic [3]. As a result, when therapeutics are delivered systemically, they often must be delivered at much higher concentrations than the target requirements to achieve an effective dose (Figure 1), leading to adverse side effects or harm to other organs.
Limitations on the Capability of the FDA to Advise
Published in The American Journal of Bioethics, 2022
Leah Z. Rand, Aaron S. Kesselheim
In the case of tobacco, Svirsky, Howard, and Berman argue that when the FDA advises by offering evidence in support of a product, it does not merely provide information but recommends one action over another, legitimizing that action and making it the “right” thing to do. Since 1938, the FDA has been responsible for ensuring that new drugs are adequately tested for safety (efficacy was added in 1962). When it approves a new medicine, the FDA specifies what clinical indication the drug is intended to treat, the approved dose strength and frequency, and safety warnings that are derived from testing the drug at those parameters. As a result, FDA approval is supposed to serve an important advice-like function for prescribers, for whom the labeling (or information sources derived from labeling) exists to guide their use of the drug.