scholarly journals The Institute of Medicine, the Food and Drug Administration, and the calcium conundrum

2014 ◽  
Vol 17 (8) ◽  
pp. 1865-1867 ◽  
Author(s):  
Shristi Neupane ◽  
Stephen J Knohl
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Age Group ◽  
Institute Of Medicine ◽  
Over The Counter ◽  
Health And Nutrition ◽  
Upper Limit ◽  
Diet Supplements ◽  
Us Government ◽  
The Usa

AbstractIn the present article we aim to bring forward the apparent disconnect between two US government-sponsored entities – the Institute of Medicine (IOM) and the Food and Drug Administration (FDA) – regarding the safe upper limit of Ca intake.In light of the 2011 US Congress-appointed IOM report indicating an upper limit of elemental Ca intake of 2000–2500 mg/d in adults (based on age group), it is perplexing that the FDA has not yet required a change on the labelling of over-the-counter Ca-containing antacids, some of which indicate an upper limit of elemental Ca intake of 2800–3000 mg/d. Even more concerning is that Ca intake is rarely from supplementation in isolation. National Health and Nutrition Examination Survey (NHANES) data from 2003–2006 indicate that mean dietary Ca intakes for males ranged from 871 to 1266 mg/d and for females from 748 to 968 mg/d depending on the age group. The estimated total Ca (diet + supplements) intake exceeded the upper limit in 5 % of the population older than 50 years. Furthermore, NHANES data from 1999–2000 indicate that when Ca is taken as part of an antacid preparation, patients often fail to report this as Ca intake. Thus, individuals taking the maximum allowable dose of supplemental Ca as antacids are at high risk for complications associated with excess Ca intake.Our hope is that by describing Ca homeostasis and highlighting the risks and dangers of Ca overload, the FDA will align its recommendation with the IOM and solve the current Ca conundrum in the USA for the sake of patient safety.

scholarly journals Hearables: eLearning in the Workplace

2019 ◽  
pp. 97-102
Author(s):  
Rory McGreal
Keyword(s):  
Artificial Intelligence ◽  
Drug Administration ◽  
Hearing Aids ◽  
Hearing Aid ◽  
Food And Drug Administration ◽  
Personal Digital Assistant ◽  
Hearing Impaired ◽  
The Internet ◽  
Over The Counter ◽  
The Usa

Hearables, a term first coined by Hunn (2014), are wireless smart micro-computers with artificial intelligence that incorporate both speakers and microphones. They fit in the ears and can connect to the internet and to other devices; they are designed to be worn daily. These devices, such as the Bragi Dash, Vinci and Bose Hearphone are now appearing on the market, which is expected to exceed $40 billion in the USA by 2020 (Omnicom, 2018). Hearables are not headphones, nor hearing aids, nor ear plugs, although they could take on the affordances of any of these devices (Banks, 2018). Headphones are designed for listening to music. Hearing aids are designed as an aid for the hearing impaired. Ear plugs reduce unwanted sounds by cancelling noise. Hearables offer comparable features and additionally provide users with a microphone and connectivity to the internet supporting telephony and personal digital assistant (PDA) services (Computational Thinkers, n.d.). Prior to 2017, in the USA, such devices required the approval of the Food and Drug Administration. This approval is no longer required for hearables, as they are no longer considered to be medical hearing aids (Over the Counter Hearing Aid Act, 2017). This paves the way for the expansion in the market of significantly lower-priced hearables, undercutting the expensively-priced hearing aid market.

Unapproved Uses of Approved Drugs: The Physician, the Package Insert, and the Food and Drug Administration: Subject Review

PEDIATRICS ◽  
1996 ◽  
Vol 98 (1) ◽  
pp. 143-145 ◽  
Author(s):  
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Age Groups ◽  
Package Insert ◽  
Age Group ◽  
Off Label Use ◽  
Off Label ◽  
Fda Approval ◽  
Approved Drugs

Physicians who prescribe a new drug that has not been approved for a specific indication or a specific age group frequently find themselves in a quandary. Physicians who prescribe "old," time-honored drugs usually do not consult the package insert or search for US Food and Drug Administration (FDA) approval. This statement was written to clarify the legal and informational status of the package insert and the role of the FDA in approving or not approving drugs for specific indications or specific age groups. The unapproved use of approved drugs, or so-called "off-label" use, is extremely prevalent among physicians who care for children. It is important that such use of compounds be brought up to date with current FDA policies and to emphasize the responsibility of the prescribing physician in the use of these compounds.

Podophyllum–A Dangerous Laxative

PEDIATRICS ◽  
1976 ◽  
Vol 57 (3) ◽  
pp. 419-421
Author(s):  
Gladys Rosenstein ◽  
Herman Rosenstein ◽  
Martha Freeman ◽  
Nathan Weston
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Antiemetic Drug ◽  
Review Panel ◽  
Over The Counter ◽  
Drug Products ◽  
Bilateral Absence ◽  
Independent Evaluation ◽  
Available Information ◽  
Intensive Search

A physician asked the Food and Drug Administration (FDA) for information regarding podophyllum. He had under his care an infant born with phocomelia manifested by bilateral absence of the radii. During her pregnancy, the child's mother had occasionally taken a laxative which contained podophyllum as one of its active ingredients. This inquiry led to an intensive search for available information on this subject. The discussion below is a summary of this information. From the data it was determined that podophyllum is too toxic a drug to be used as a laxative, especially since much safer laxatives are available. The FDA Advisory Review Panel on Over-the-Counter (OTC) Laxative, Antidiarrheal, Emetic and Antiemetic Drug Products, in a recently completed independent evaluation, similarly concluded that podophyllum resin is an unsafe laxative.

Comprehension Testing for OTC Drug Labels: Goals, Methods, Target Population, and Testing Environment

1998 ◽  
Vol 17 (1) ◽  
pp. 86-96 ◽  
Author(s):  
Louis A. Morris ◽  
Karen Lechter ◽  
Michael Weintraub ◽  
Debra Bowen
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Target Population ◽  
Low Literacy ◽  
Over The Counter ◽  
Testing Environment ◽  
Complex Products ◽  
Drug Products ◽  
Label Information

Drug products may be switched from precription (Rx) to over-the-counter (OTC) status if labeling can be written that ensures that the label information is comprehensible to ordinary consumers, including persons with low literacy ability, under normal conditions of purchase and use. The Food and Drug Administration has been working with sponsors to develop methods to test consumer comprehension of proposed OTC product labels. The authors discuss several conceptual and operational elements of comprehension testing, focusing on the goals, methods, appropriate target audience, and testing environment. The authors also examine areas in need of further research and debate. As more complex products are considered for OTC status, it is even more important to ensure that OTC labels are comprehensible. As understanding and the validity of methods to evaluate consumer comprehension improve, so should the quality of labels offered to consumers.

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