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    • 1
    • DRUG EVALUATION Process of classifying drugs as either therapeutic or non-therapeutic and are approved by a governing agency 2
    • DRUG APPROVAL PROCESS1. Food and Drug Administration (FDA) - US  Agency in-charge of monitoring the use of drugs as well as its development.2. Bureau of Food and Drug Administration (BFAD) – Philippines Concerns of these agencies are 2-fold:  Whether the drugs are effective  Whether the drug is safe for human use 3
    • Drugs for approval should pass through 4 Stages of New Drug Development. 4
    • Stages of New Drug Development1. Preclinical Study2. Clinical Study 1. Phase I 2. Phase II 3. Phase III3. New Drug Application (NDA) review4. Post Clinical Study 5
    • Stages of New Drug Development1. Preclinical Study Starts with the discovery, synthesis and purification of drug Functions:  To know if with therapeutic value  Safe in animals 6
    • Stages of New Drug Development2. Clinical Study “testing in humans” stage. 3 phases:  Phase I ○ Tested in small # of healthy volunteers. ○ Initial info on the effects in humans  Phase II ○ Tested in small, selected population (10-150 subjects) ○ To evaluate the therapeutic effect in treating specific disease/pathologic condition.  Phase III ○ More cients (several hundredths-thousands) ○ Provides info on proper dosing and safety. 7
    • Stages of New Drug Development3. New Drug Application (NDA) Review  the drug is submitted to FDA for new drug application. 8
    • Stages of New Drug Development4. Post Clinical Study Known as “postmarketing surveilance” Final stage of drug approval process It surveys the drug’s harmful effects. 9
    • 10
    • Drug Classifications1. Therapeutic Use/Clinical Indications2. Physiologic/Chemical Action3. Prescribed (Ethical) Drug4. Non-prescription (Non-Ethical) Drugs5. Illegal Drugs 11
    • Drug Classifications1. Therapeutic Use/ Clinical Indications Examples:  Antibiotics ○ cefuroxime, penicillin, erythromycin  Laxatives ○ Bulk-forming  Sterculia [Normacol], methylcellulose (Citrucel) ○ Stool softeners  (Colace, Diocto) ○ Lubricants or emollient  Diuretics  Antacids 12
    • Drug Classifications2. Physiologic/ Chemical Action Examples: 1. Beta-adrenergic blockers ○ management of cardiac arrhythmias ○ block the action of epinephrine and norepinephrine ○ Ex. propanolol 13
    • Drug Classifications2. Physiologic/ Chemical Action Examples: 2. Anticholinergics ○ inhibit parasympathetic nerve impulses  responsible for the involuntary movements of smooth (GI, urinary, etc) ○ Ex. Atropine sulfate 14
    • Drug Classifications2. Physiologic/ Chemical Action Examples: 3.Cholinergics ○ drug that functions to enhance the effects mediated by acetylcholine 4. Calcium channel blockers ○ to decrease blood pressure ○ Antiepileptics ○ Ex. Dihydropyridine 15
    • Drug Classifications3. Prescribed (Ethical) Drug Requiring prescriptions Ordered/dispensed only by an authorize practitioner 16
    • Drug Classifications4. Non-prescription (Non-Ethical) Drugs Drugs available over the counter Not requiring any prescription for use Can be purchased directly by consumer Used to treat relatively minor problems and conditions Judged to be safe for used by the consumer without direct medical supervision 17
    • Drug Classifications5. Illegal Drugs Use for non-therapeutic purposes. Also referred as “recreational drugs” Drugs not approved by FDA/BFAD 18
    • 19
    • #10SOLVENT 20
    • #9 Psychedelic Mushrooms(hallucinogenic mushrooms ) 21
    • #8 Opium(addictive painkiller ) 22
    • #7 LSD(Lysergic Acid Diethylamide)most powerful hallucinogenic 23
    • #6Barbiturates / Benzodiazepines (a prescription medicine) 24
    • #5 Amphetaminesaffecting the amount of dopamine and serotonin in the brain 25
    • #4 Ecstasy Psycho therapeutic drugproduces euphoria and a feeling of well being, decreased levels of fear and anxiety and a physical stimulant and sensational effect in users. 26
    • #3 Cocaine (Coca plan)powerful stimulant, appetite suppressant and anesthetic 27
    • #2 Heroin/Diamorphinepowerful painkiller and users experience exhilaration, euphoria and a sense of well being. 28
    • #1Cannabis or Marijuana, Grass, Hemp, Weed, Pot, Hash, Dope slightly drunken but euphoric sensation 29
    • 30
    • Drug Standards and Legislation Drug Standards  The United Pharmacopoeia National Formulary (USP NF) ○ the current authoritative source for drug standards (revised every 5 years by a group of experts in nursing: pharmaceutics, pharmacology, chemistry, and microbiology) ○ Drugs included in the USP-NF have the standards for:  therapeutic use  client safety  quality  purity  strength  packaging  dosage form 31
    •  Drug Standards  International Pharmacopoeia – first published in 1951 by WHO ○ provides basis for standards in strength and composition of drugs worldwide ○ published in English, Spanish, and French (revised every 5 years) 32
    •  FEDERAL LEGISLATION  Purpose – to ensure safety (drugs that are impure, toxic, ineffective, or not tested before public sale)  do not include drug effectiveness and drug safety 1938: Food, Drug, and Cosmetic Act  empowered a governing body—the Food and Drug Administration (FDA) and Cosmetic Act of 1938  Purpose: to monitor and regulate the manufacture and marketing of drugs  FDA’s responsibility is to ensure that all drugs are tested for harmful effects, have labels with accurate information, drug literature that explains adverse effects 33
    •  FEDERAL LEGISLATION 1952: Durham-Humphrey Amendment  amendment to the FDA and Cosmetic Act of 1938  distinguished between drugs that be sold with or without prescription and those that should not be refilled without a new prescription (ex. Narcotics, hypnotics, or tranquilizers; must be labeled)  It also specified that all other drugs are approved for use to be considered non-prescription drugs 34
    •  1962: Kefauver-Harris Amendment  tightened controls on drug safety, especially experimental drugs, and required that adverse reactions and contraindications must be labeled and included in the literature  it added requirements that both prescription and non-prescription drugs be shown to be effective as well as safe  thalidomide tragedy1950 – pregnant European women who took the sedative-hypnotic thalidomide during their first trimester of pregnancy gave birth to infants with extreme limb deformities. 35
    • A German pharmaceutical company, Chemie Grünenthal at Stolberg,synthesized thalidomide inWest Germany in 1953.It had accidentally been discovered during a search for cheap antibiotics, but was soon marketedwith little evidence as a sedative.In 1961 the drug was found to be harmful to the unborn children of pregnant women 36
    • 1978: Drug Regulation Reform Act This reform act shortened the time in which new drugs could be developed and marketed.1992: Drug Relations Act The regulations were changed to increase the approval rates of drugs used to treat AIDS and cancer The pharmaceuticals pay a users fee at the time they file the application for the new drugs (for FDA approval process). 37
    • 1997: The Food and Drug Administration Modernization Act 5 Provisions included in this act: Review and use of new drugs is accelerated. Drugs can be tested in children before marketing. Clinical trial data is necessary for experimental drug for serious or life- threatening health conditions. Drug companies are required to give information on “off-label” drugs (non- FDA approved drugs) and their uses and costs Drug companies that plan to discontinue drug must inform health professionals and clients at least 6 months before stopping drug production 38
    • LEGAL REGULATIONS OF DRUGS1. Pregnancy Categories Reviews drug labeling information on pregnancy and risk effects to the fetus 39
    • Drug Pregnancy Categories CATEGORY A: No risk to fetus. Studies have not shown evidence for fetal harm. CATEGORY B: No risk in animal studies, and well-controlled studies in pregnant women are not available. It is assumed there is little to no risk in pregnant women. CATEGORY C: Animal studies indicate a risk to the fetus. Controlled studies on pregnant women are not available. Risk versus benefit of the drug must be determined. CATEGORY D: A risk to the human fetus has been proven. Risk versus benefit of the drug must be determined. It could be used in life-threatening conditions. CATEGORY X: A risk to the human fetus has been proven. Risk outweighs the benefits and drug should be avoided during pregnancy. 40
    • LEGAL REGULATIONS OF DRUGS2. Controlled Substances  Comprehensive Drug Abuse Prevention and Control Act of 1970 known as “Controlled Substance Act” ○ To improve the administration and regulation of manufacturing, distribution, and dispensing of drugs found necessary to be controlled ○ Consist of 5 classifications or schedules of controlled substance ○ The degree of control, the condition of record keeping, and the particular order form required, and other regulation depends on these classifications. 41
    • LEGAL REGULATIONS OF DRUGS2. Controlled Substances Drug Enforcement Administration (DEA)  Organize to enforce the Controlled Substance Act  To gather intelligence, train and conduct research in the area of dangerous drug and drug abuse 42
    • LEGAL REGULATIONS OF DRUGS3. Generic Drugs Drug which is produced and distributed without patent protection. Drugs which may still have a patent on the formulation but not on the active ingredient It must contain the same active ingredients as the original formulation Identical/bioequivalent to the brand name counterpart since these drugs should be identical in dose, strength, route of administration, safety, efficacy and intended use. 43
    • LEGAL REGULATIONS OF DRUGS4. Orphan Drugs Drugs that have been discovered but not financially viable and therefore have not been “adopted” by any drug company. 44
    • Drug Nomenclature Chemical Name  describes the drug’s chemical structure  Chemical constitution of the drug & the exact placing of its atoms or molecular groupings. Generic Name (nonpropriety names)  Common name or non-proprietary name for the drug ○ this name is not owned by any pharmaceutical (drug) company and is universally accepted Brand Name or Trade Name (proprietary name) ○ also chosen by the drug company and is usually a registered trademark owned by that specific manufacturer ○ Uses the symbol ® 45
    • Drug NameChemical Name: 0-[(2S)-3-mercapto-2- methylpropionyl]-L- proline[MW217.29]Generic Name: captoprilTrade Name: CapotenOfficial Name: captopril 46
    • Drug Uses1. Symptomatic treatment.  ANTI-EMETIC DRUGS2. Preventive drug  helps the body avoid disease.  VACCINES & TOXOIDS3. Diagnostic drugs  help the physician determine whether a disease is present4. Curative drugs  eliminate the disease.  ANTICANCER AGENT & ANTIBIOTICS5. Health maintenance drugs  help the body to function normally.  VITAMINS & MINERALS6. Contraceptive drugs  prevent pregnancy.  ORAL CONTRACEPTIVES/SPERMICIDAL AGENTS 47
    • Properties of Ideal Drug1. Effectiveness:  A drug that elicits the response it was meant to.  It is the most important property.  No effect=no justification of use (FDA approved with appropriate experiments). 48
    • Properties of Ideal Drug2. Safety:  Pharmakon = poison in Greek  Safe even at high concentrations and for long periods of administration (no such thing as a safe drug) ○ Reduced by proper administration (iv, im, sc, etc…) ○ No habit forming aspects ○ No side effects  ( excessive dosage of opoid analgesics carries a risk of respiratory failure, cancer drugs increase infections, aspirin causes gastric ulcer etc…) 49
    • Properties of Ideal Drug3. Selectivity:  One that elicits only the response for which it is given  Selective for specific reaction with no side effects (there is no such thing) ○ Drowsiness can be caused by antihistamines ○ Morning sickness, cramps, and depression can be caused by oral contraceptives ○ Constipation, urinary hesitance, and respiratory depression can be caused by morphine 50
    • Additional Properties of Ideal Drug (no drug is ideal!)1. Reversible action  Effects be reversible, i.e., removal/subside w/i specific time (1/2 life is short but potent during that time)  Example: General Anesthetic; Contraceptives 51
    • Additional Properties of Ideal Drug (no drug is ideal!)2. Predictability  Know how patient will respond3. Ease of Administration  Number of doses should be low and easy to administer  increase compliance & decrease errors ○ Diabetic patient: Multiple daily injection of insulin ○ Intravenous infusion 52
    • Additional Properties of Ideal Drug (Continued)4. Freedom from drug interactions  Should not augment or decrease action of other drugs or have adverse combined effects ○ Respiratory depression caused by diazepam (Valium), which is normally minimal, can greatly be intensified by alcohol. ○ Antibacterial effects of Tetracycline can be greatly reduced by taking iron or calcium supplements 53
    • Additional Properties of Ideal Drug (Continued)5. Low Cost  Easy to afford (especially with chronic illness) ○ Growth hormone (somatrem) costs between $10,000 and $20,000 ○ Lifelong medication: hypertension, arthritis, diabetes 54
    • Additional Properties of Ideal Drug (Continued)6. Chemical Stability  No lose of effectiveness with storage7. Possession of a simple generic name  Easy to remember and pronounce ○ Example: Viagra (sildenafil); Tylenol (acetaminophen) 55
    • Because No Drug is Ideal…….. Because no drug is ideal…….  No medications are ideal  No drug is safe  All drugs produce side effects  Drug responses may be difficult to predict  Drugs may be expensive  Drugs may be hard to administer All members of health care team must exercise care to promote therapeutic effects and minimize drug induced harm 56
    • Therapeutic Objective To provide maximum benefit with minimum harmFactors that determine Intensity of Response Administration- dosage size and route Pharmacokinetic processes Pharmacodynamics Individual Variations 57
    • Therapeutic Objective1. Administration- dosage size and route - Because of errors in administration routes and dosage and at wrong time there are many discrepancies in what patient gets and could cause more harm than good - Errors could be made by pharmacists, physicians, or nurses - Should give patients complete instruction about their medication and how to take it 58
    • Therapeutic Objective2. Pharmacokinetic processes - Determines how much of an administered dose gets to its sites of action ○ 1) drug absorption ○ 2) drug distribution ○ 3) drug metabolism ○ 4) drug excretion 59
    • 60
    • Therapeutic Objective (continued)3. Pharmacodynamics pharmacodynamic processes determine the type of response and intensity Once a drug has reached its site of action, it must first bind to its specific target site at (RECEPTOR)Receptor  may be a chemical, a protein on a cell or in blood or tissue spaces, or on a bacteria or virus  Ex. heparin, antibody, leukotriene receptor (new), penicillin, etc 61
    • Therapeutic Objective (continued)3. Pharmacodynamics Series of events that result in response such as inhibition of: 1. Clotting 2. Peptidoglycan synthesis 3. Inflammation 4. Blocking of virus 62
    • Therapeutic Objective (continued)4. Sources of individual variation Each patient is unique in ability to respond and to how they each respond, but formation of “IDEAL DRUG” will lessen this variation ○ Age- very important factor ○ Sex- due to hormonal differences ○ Weight  less effective and longer lasting in obese individuals (storage in fat) ○ Kidney & liver functions - elimination of drug ○ Genetic variables- tolerance, allergy (though not always genetic) 63
    • Factors that determine the intensity of drug response 64
    • Summary To promote desired effects and minimize adverse effects, we need to understand  Pharmakokinetics  Pharmacodynamics  In addition ○ Sources of individual variation in drug response 65
    • Key Points The most important properties of an ideal drug are: effectiveness, safety, and selectivity. If the drug is not effective, it should not be used. There is no such drug as safe drug: all drugs can cause harm. There is no such thing as selective drug: all drugs can cause side effects. The objective of drug therapy is to provide maximum benefit within minimum harm. Because all patients are unique, drug therapy must be tailored to each individual. 66