1. OVER THE COUNTER MEDS 4-19-16

2. INTRODUCTION No prescriptions are necessary and no questions need to be answered to attain these drugs OTC med use saves the health care system millions and the consumer hundreds annually –Patients don’t have to see doctor in order to obtain OTC meds so that saves money Consumers want to be involved in their own treatment; OTC medications give them this capability OTC meds are more easily obtainable then prescriptions because you can buy them after hours when pharmacy is closed

3. OTC Issues –Patient can mis-diagnose issue therefore buy wrong meds –Tampering of OTC meds cause so easily accessible –Age restrictions (pediatrics) –Identical ingredients –Special diets restrictions, allergies, diabetes –Pregnancy or breastfeeding

4. FDA characteristics for OTCs Their benefits outweigh the risk Their potential for misuse and abuse is low Consumers can use them for self-diagnosed conditions They can be adequately labeled for proper use Health practitioners are not needed for the safe and effective use of the products

5. 3 FDA catergories Before OTC meds are allowed to enter the market the FDA classifies them during data review according to one of the following 3 categories –Category 1: Generally Recognized as Safe and Effective (GRASE) for the claimed therapeutic indication –Category 2: Not GRASE –Category 3: Cannot determine GRASE; additional data must be acquired to determine whether the drug is safe and effective Which category should the drug fall under to be considered for approval?

6. FDA Regulations To determine which category proposed OTC drugs fall, the FDA regulated five major areas concerning the safety of OTC medications. The following five areas are explored individually 1. Purity 2. Potency 3. Bioavailability 4. Efficacy 5. Safety and toxicity

7. PURITY The purity of a product represents the lack of contamination from environmental factors of the chemical (drug) contained in the product Any food, drug, or product that contains any avoidable, added, poisonous, or deleterious substance is unsafe and is considered adulterated Few agents are pure because many meds are prepared on a large scale and dust particles are present in the mix. A certain amount of dust is allowed by government standards

8. PURITY Purity is also affected by other additives Various ingredients are used in preparation of medications to make the appropriate dosage forms, to alter drug absorption characteristics and to make medications taste better

9. Types of Additives Filers –Enable manufactures to make tablets or capsules large enough to ingest Dyes –Used to color tablets and coatings for more aesthetic appearance Solvents –Mixtures used along with chemical agents as a dissolvent Buffers –Used to adjust pH of medication Waxes –Used to mold various medications, such as suppositories

10. POTENCY The potency of a medication refers to the strength of the drug This measure is done by chemical analysis and is measured in grams, milligrams, micrograms, or milliequivalents If the drug cannot measured in a laboratory by such analytical methods then it is tested on research animals and the strength of the drug is measured in units All medications measured in units require a prescription

11. BIOAVAILABILTY Bioavailability is the percentage and rate of a drug that is absorbed and transported to the site of action Oral medications are low in solubility or have slow absorption properties that affect its overall bioavailability; this is due to the drug having to pass through the gastrointestinal tract, liver and intestines The total bioavailability is measured by the concentration of the drug in the blood or tissue at a specific time of administration Patients medical history, genetics, age and gender as well as concurrent medications being taken have an effect on bioavailability

12. EFFICACY Efficacy is the ability of the drug to produce the desired effect in the body for intended use. Clinical trials of the drug, which includes the use of a placebo are conducted to judge the effectiveness Many variances may affect the end result; these variances may be caused by other influences on a person, such as unknown health conditions, age, weight, lifestyle, gender, and genetics

13. SAFETY and TOXICITY Safety and toxicity represent opposite effects of the drug being studied. All drugs can be toxic if not taken correctly The difference between dosages that produce toxic effects and those that produce desirable effects is documented Trial testing is done on laboratory animals first before it is done on human beings.