Drug adveisement letter is a necessary component of each drug formulation and contains various information about the drug like drug dosing, frequency and half-life. Which of the following information need not be given in the drug adveisement letter?
Research papers and other aicles proving efficacy of the drug
Date of expiry of the drug
Rare, but serious life threatening adverse-effects
Common, not so serious adverse-effects
Ans: B. Date of expiry of the drug(Ref Goodman Gilman 12/e p1883; Manual of Experimental and Clinical Pharmacology/p 345).Date of drug expiry need not to be given in drug adveisement letter.Regulated according to The Federal Food, Drug, and Cosmetic Act.Amended (Food and Drug Administration Modernization Act of 1997).Permits use of print & television adveising for prescription drugs.Drug adveisements:Contain summary information relating to side effects, contraindications & effectiveness.Current adveising regulations:Specify that this information disclosure needs to include all risk information in a product's approved labeling or must direct consumers to healthcare professionals to obtain this information.Print adveisements:Include reprinting of risk-related sections of product's approved labeling (package inse).Television adveising:Not includes reprinting of risk-related.Note:Adveisements cannot be false or misleading or omit material facts.Must present fair balance between effectiveness & risk information.