Psych 3303 1nd Edition Lecture 6 Outline of Last Lecture I. Brain Function and Structure cont.A. Forebrain B. Cerebral Cortex: Frontal, Temporal, Occipital, Parietal C. Association Cortex, Unilateral Neglect, Broca’s Area, Wernicke’s Area, LateralizationD. NeuroplasticityII. Drug DevelopmentA.Over The Counter (OTC)B.Process For Approving Prescription and OTC DrugsOutline of Current Lecture III. Drug Postmarketing phaseA. Pharmaceutical repsB. Specific Procedures of OTCIV. FDAA. GRAS, GRAE, GRAHLB. PackagingC. Standardizing labelsV. Major OTC (analgesics)A. AspirinB. AcetaminophenC. IbuprofenD. Cold and Allergy MedsThese notes represent a detailed interpretation of the professor’s lecture. GradeBuddy is best used as a supplement to your own notes, not as a substitute.Current LectureIII. Drug Postmarketing PhaseA. Pharmaceutical reps:Drugs are protected by pattern for a while then generics can come out. Pharmaceutical reps try to get physicians to prescribe their drugs.70%-80% pharmaceutical companies budget money goes into marketing.B. Specific procedures for OTC:In 1962, there was the Kafauver-Harris Amendment so that all OTC drugs need to be evaluated to be safe by the FDA. Children were being born with birth defects due to the mothers taking Thalidomide found in OTC drugs for morning sickness (not in North America). Was never tested in non-human primates. Now used for anemia but is NEVER given to a woman in child-bearing years OR to a man living with a female in child-bearing years.IV. FDAAfter that event the FDA started testing all OTC drugs by grouping them into categories and testing the active ingredients.A. GRAS, GRAE, GRAHL:GRAS: Generally Regarded As SafeGRAE: Generally Regarded As EffectiveGRAHL: Generally Regarded As Honestly LabeledB. Packaging:FDA is also involved in simplifying labels and ensuring safe packaging.In 1982 the FDA started implementing tamper-resistant packaging for all drugs following a Tylenol poisoning event where the Tylenol packaging was tampered with and cyanide was put into the drug resulting in various fatalities.C. Standardizing labels:Before standardization the labels were very confusing and people had difficulty reading them, especially the elderly. Now, they are much more clear.V. Major OTCAnalgesics:A. Aspirin:Dr Felix Hoffman discovered the effects of salicylic acid. Alone though, it messes up the stomachso he added acetyl, which decreases stomach problems. Therefore it became Acetylsalicylic Acid, ASA(aspirin).Use: - Analgesic (strain leg)- Antipyretic (fever reducer)- Anti-inflammatory (rheumatoid)How it works:It blocks synthesis of prostaglandins so block pain and inflammation. Prostaglandins act on hypothalamus to elevate body temp so, if blocked- fever-reducing effect.Side-effects:- Thins blood so increases bleeding time so no aspirin if surgery a week to ten days later.- Induces gastrointestinal bleeding 70% of normal people- Reye’s syndrome (pronounced mental/neurological probs if taken when viral infection under 20)- Overdose (in kids)B. Acetaminophen (Tylenol):- Analgesic- Fever-reducing- No anti-inflammatorySide- effects:- Liver and kidney damage (more serious issues than heroin)- Enhancing anti-clottingC. Ibuprofen (advil)Not sure how it works. NSAID. 200mg recommended.Use:- Reduce fever- Reduce pain- Reduce inflammation- Menstrual crampsSide effects:- Kidney damage- Minor stomach issues D. Cold and Allergy:Treat cold by decreasing symptoms.Three common ingredients:1. Antihistamines (for itching , teary eyes etc.)2. Decongestant (For blocked sinuses)3. Analgesic and antipyretic (relief aches and pains, fever)Side effects:- Drowsiness- Alcohol- Abuse (because of alcohol)- Health risk for children (under 4)- Dextromethorphan (abuse, get “high”) 1 in 16 10th graders and 1 out of 20 high school seniors
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