Use of Proprietary Names by Prescribers When Prescribing Over-the-Counter (OTC) Drug Products

2019 ◽  
Vol 53 (1) ◽  
pp. 132-137
Author(s):  
Chi-Ming Tu
Keyword(s):  
Over The Counter ◽  
Drug Products

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.

Final Report On the Safety Assessment of Benzoxiquine1

1997 ◽  
Vol 16 (1_suppl) ◽  
pp. 117-122
Author(s):  
F. Alan Andersen
Keyword(s):  
Safety Assessment ◽  
Safety Data ◽  
Metabolic Activation ◽  
Final Report ◽  
Cosmetic Products ◽  
Over The Counter ◽  
Drug Products ◽  
Ocular Irritation ◽  
Dermal Irritation ◽  
Mammalian System

Benzoxiquine is described as a biocide for use in cosmetic products. It is currently reported to be used in only one product. In a separate finding, the Food and Drug Administration determined that Benzoxiquine is not generally recognized as safe and effective in over-the-counter topical antifungal drug products. The only data available on the toxicity of Benzoxiquine indicates that it is mutagenic in the Ames test without metabolic activation. Because of the lack of data, the safety of Benzoxiquine could not be substantiated. The data needed to make a safety assessment include purity/impurities, ultraviolet absorption (if there is absorption, then photosensitization data will be needed), 28-day dermal toxicity, dermal teratogenicity, ocular irritation (if already available only), dermal irritation and sensitization, and two different genotoxicity studies (one using a mammalian system). If the latter data are positive, dermal carcinogenesis data using the methods of the National Toxicology Program will be needed. It cannot be concluded that Benzoxiquine is safe for use in cosmetic products until these safety data have been obtained and evaluated.

scholarly journals Knowledge, attitude, beliefs and use of over the counter drug products among medical undergraduates

2017 ◽  
Vol 6 (6) ◽  
pp. 1358
Author(s):  
Mamta Rani ◽  
M. C. Gupta
Keyword(s):  
Medical Students ◽  
Prescription Drugs ◽  
General Information ◽  
Drug Label ◽  
Medical Problems ◽  
Over The Counter ◽  
Drug Products ◽  
Validated Questionnaire ◽  
Medical Undergraduates ◽  
Day By Day

Background: Over the counter (OTC) drug products are available without prescription and considered safe, effective, affordable and easily accessible. Among medical students use of OTCs and even prescription drugs available as OTCs is increasing day by day. The objective of the study was carried out to assess the knowledge, attitude and beliefs about OTCs, their use, safety and regulatory issues of OTCs among medical undergraduates.Methods: A questionnaire-based study was conducted and 151 medical students participated in this study. A preformed and validated questionnaire consisting of 2 parts was used. Part 1 consisted of general information regarding OTCs and Part 2 consisted information about knowledge, attitude, beliefs and use of OTCs. Data were analyzed and the results were expressed as percentages.Results: 100% participating students were aware about OTCs. 70% used them a lot because of availability and belief on safety. Chemist was a good source of advice over minor medical problems according to 38% of students. Information to be read on drug label was known to 62.5% of them. Affordability and accessibility (84%) was the main reason for OTCs use. Common medications bought without prescription were antibiotics, antihistaminics (100%) and cough syrups (90%). Headache and fever (100%), acidity (91%) were common indications for OTC use. Common OTCs stored at home were painkiller, antacids and skin care products.Conclusions: All students though were aware of OTCs but had little knowledge of regulation and usage. Many prescription drugs were also available as OTCs. Medical students need to be educated and trained about OTCs and the related issues. 

scholarly journals Unusual Lysozyme-induced anaphylaxis in an egg-allergic child

2021 ◽  
Author(s):  
Charles Elbany ◽  
Delphine De Boissieu ◽  
CHANTAL KARILA ◽  
Marie-Alexandra Alyanakian ◽  
Claude PONVERT ◽  
...  
Keyword(s):  
Specific Ige ◽  
Over The Counter ◽  
Positive Skin ◽  
Allergenic Protein ◽  
Sublingual Tablet ◽  
Drug Products ◽  
Allergic Child ◽  
Egg Protein ◽  
Skin Prick Tests ◽  
A Minor

A nine-year-old egg allergic child developed anaphylaxis after ingesting the lysozyme-containing over-the-counter-drug Lysopaine®. He complained of a sore throat without fever or cough. His mother administered him one sublingual tablet of the over-the-counter drug Lysopaine®, containing 20 mg lysozyme hydrochloride. A few minutes after intake of the drug, he developed anaphylaxis and received 300 mg intramuscular epinephrine. HE was not exposed to other allergens. The responsibility of lysozyme was confirmed by positive skin prick tests for Lysopaïne® and the presence of specific IgE against lysozyme. When giving this treatment to her son, his mother had no idea that it could contain egg protein and she did not perceive lysozyme as an allergenic protein. However, the box mentioned the presence of lysozyme and also specified “contains lysozyme extracted from egg”. Lysozyme, a minor egg allergen, may induce anaphylaxis in egg-allergic patients. Lysozyme can be found in many commonly consumed industrial food and drug products and its labelling may be misleading. Our observation highlights the importance of properly educating allergic patients to recognize allergens, even minor ones.

Sign in / Sign up

Export Citation Format

Share Document