Pharmacy Orientation PP150 Associate professor of Pharmaceutics Faculty of Pharmacy-Mansoura University
Lecture 1 Over-the-Counter (OTC) and Prescription Drugs
Categories of Medicinal Products Three categories of medicinal substances are available for purchase: 1.Prescription drugs 2.Over-the-counter (OTC) drugs 3.Dietary supplements
The U.S. Food and Drug Administration (FDA) sets standards of safety, effectiveness, and honesty in labeling for prescription drugs and OTC drugs. Cosmetics are also regulated by the FDA Dietary supplements are not regulated as drugs.
Abuse of OTC products Nonprescription products that can be severely habit-forming: decongestants, laxatives, antihistamines, sleep aids, antacids and ephedrine.
The active ingredients in OTC drugs have been classified and placed in category I (considered safe and effective). However, as recently as 1992, the FDA has banned over 400 ingredients from 7 categories of OTC products.
Criteria for OTC Designation Low toxicity and low risk of serious adverse reactions Not to mask any underlying condition or increase resistance Correct self-assessment of the condition Limited risk to public health in case of misuse.
OTC Labels Required label information includes: Approved uses of the product Detailed instructions on safe and effective use Cautions or warnings to those at greatest risk when taking the medication
Label information When to use Product name Identity Active ingredients Quantity Manufacturer Indications Warnings: Precautions: Expiration date: What to watch for Possible drug interactions When drug should no longer be used
Types of OTC drugs Cold, allergy and cough remedies Decongestants Antitussives Expectorants Vitamin C Sleep aids Diet aids Skin products Acne medications Sun products OTC herbal products Gastrointestinal medication Antacids and antiheartburn
Switching policy of the FDA The FDA is attempting to make more drugs available to the public by switching some frequently used and safe prescription medications to OTC.
Switching policy of the FDA This policy is in response to public demand to have obtain effective drugs for self-medication and has resulted in over 63 ingredients, such as ulcer and hair-growing medications.
How Prescription Drugs Become OTC Drugs? Drugs are usually approved as prescription only first and just after they prove safety in clinical use they are recategorized as OTC. The drug has been marketed as a prescription drug for 3 years.
The use of the drug has been relatively high during this time. Potential adverse effects are printed on the label, and frequency of side effects has not increased during the time it was available to the public.
Discuss Procedures for Approving Prescription and OTC Drugs All OTC drugs have been required by the FDA to be Generally Recognized As -Safe (GRAS) -Effective (GRAE) -Honestly Labeled (GRAHL).
Prescription drugs There are currently more than 10,000 prescription products sold in the United States, representing Approximately 1500 different drugs With 20 to 50 new medications approved each year by the FDA
Drug Nomenclature 1. Chemical Name 2. Non-Proprietary/Generic/Approved Name 3. Proprietary/Trade/Brand Name
acetaminophen. 1. Chemical Name: It depicts the chemical/molecular structure of the drug. It states the structure in terms of atoms and molecules. They are long and can be clumsy and are useful to a few technically trained personnel. For example, acetyl-p-amino-phenol is for
2. Non-Proprietary/Generic/Approved Name: It is the abbreviated and approved name of the drug. It is the official medical name assigned by the producer in collaboration with the Food and Drugs Board and Nomenclature Committee.
The generic name may be used by any interested party and it removes the confusion of giving several names to the same drug regardless of who manufactures them once they have the same chemical structure (like acetaminophen). It is not subject to trademark rights.
3. Proprietary/Trade/Brand Name: These are names given to the drug by the manufacturing and marketing company. They are copyrighted terms selected by a manufacturer to designate a product. Copyright laws prevent any other person from using the name.
In most cases one drug could have so many trade/brand names For example: Acetaminophen has about 30 trade names. Some are Paracetamol, Tylenol, Paramol, Panadol, Capol etc.
Acetyl-p-aminophenol Acetaminophen Paracetamol, Tylenol, Paramol, Panadol, Capol Chemical Name Non- Proprietary /Generic/Approved Name Proprietary/Trade/ Brand Name
Common categories of prescription drugs Analgesics, Bronchodilators Antidepressants, Antidiabetics Antibiotics, Antiulcer drugs Cardiovascular drugs Antihypertensive agents Antianginal agents Drugs to treat CHF Sedative-hypnotics
Common categories of prescription drugs Antiepileptic drugs lipid-lowering drugs. Hormone-related drugs Drugs to treat HIV HIV, human immunodeficiency virus
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