Pharmacology Ch 1 Nursing 205

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Stats on drugs . ..

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p3 more than 3 billion prescriptions are dispense ea. year in US. 1/2 of all Americans take 1 prescr. drug regularly, and at least one out of 6 persons takes at least 3!

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History of pharmacology . . .

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herbal medicine (oldest forms of health care) - dating to antiquity worldwide. Babylonians, Egyptians, Chinese. Little development in Dark Ages. Science had to become relevant in eyes of religious doctrines of era.

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1st reference to pharmacology

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"pharmacologia sen Manuductio and Materiam Medicum" by Samuel Dale in 1693. Before, study of herbal remedies was called "Materia Medica"

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Pharmacology began . ..

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early 1800's, chemists were isolating sp. substances fr complex mixtures. Morphine, colchicine, curare, cocaine and other agents fr natural products. studied it in animals. Some researchers used themselves -ie morphine Frederich Serturner

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Ph. as a distinct discipline recognized . . .

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1st dept. of ph. was established in Estonia in 1847. John Jacob Abel -Father of American ph - also founded 1st ph. dept in US in 1890 in Michigan

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20th Ph . . .

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pharmacologists could synthesize drugs in the laboratory. 100s of drugs could be synthesized and tested in a short time. It became possible to understand how drugs produce their effects, down to their molecular mechanism of action

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Early ph intention . . .
Today . ..

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to relieve human suffering!
focus on the client and to improve the quality of life.

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Ph means. . .

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p4 study of medicines. How drugs are administered, where they travel in the body, and actual responses of the body.
need firm understanding of all nursing pre-reqs that I took!!

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"off the label"

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a drug used for something other than what it was created for

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Drugs . . .

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more than 40,000 brand name drugs, generic drugs and combination agents on the market. Ea has its own characteristics, set of therapeutic appl. interactions, side effects, and mech of action. Many can be prescr. for more than one disease and produce multiple effects on the body.

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ALL nurses are directly involved w/client care and are active in . ..

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p4 educating, managing, monitoring the proper use of drugs

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Therapeutics


Pharmacotherapy or pharmacotherapeutics

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branch of medicine concerned w/ prevention of disease and treatment of suffering.
application of drugs for the purpose of disease prevention and treatment of suffering.

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Drug
Medication

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Synthesized in a laboratory, chemical agent capable of producing biological responses w/in body. Desirable or adverse. After it is administered it is called a ______. Different than foods, antiperspirants, etc. . .

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Biologics

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boost immune system, not synthesized. Naturally produced in animal cells, by microorganisms or the body itself. hormones, monoclonal antibodies, natural blood products, interferon, and vaccines. Used to treat a wide variety of illnesses and conditions

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Complementary and alternative therapies

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natural plant extracts, herbs, vitamins, etc . . acupuncture, hypnosis, biofeedback, massage

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Legal drugs

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by prescription or OTC. Prescription can become an OTC w/ a high margin of safety observed over many years. OTC can have a serious adverse effect if directions are not followed. Self treatment sometimes ineffective and potential for harm may increase if disease is allowed to progress

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Drug Reg. and Standards

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until 19th cent., there were few standards or guidelines to protect the public fr drug misuse. Some medicines contained hazardous levels of dangerous or addictive substances

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Formulary

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1st standard commonly used by pharmacists - list of drugs and drug recipes. 1st standard publication of drug standards - US pharmacopoeia (USP) in 1820. Pharmacopoeia is a medical reference summarizing standards of drug purity, strength and directions for synthesis.

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National Formulary (NF)
Us Pharmacopoeia

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(established by the APhA) 1852 -pharmaceutical ingredients

All drug products were covered in USP. 1820
The two merged into a single publication. 1975

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USP Labels

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verifying purity, strength, and exact amounts of ingredients found w/in container

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Early 1900s - laws for pharmacology

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1906 Pure Food and Drug Act- gave govt power to control the labeling of medicines. 1912 Sherley Amendment prohibited sale of drugs labeled w/false therapeutic claims that were intended to defraud consumer. 1938 - Food, Drug and Cosmetic Act - these must be thoroughly tested before marketing. 1994

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Later 1900's laws for ph.

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1986 Childhood Vaccine Act - authorized govt to obtain info about patients taking vaccines, to recall biologics, and penalties 1988 -FDA established as an agency of US Dept of Health and Human Services. 1992 Prescription Drug and User Act - required nongeneric drug and biologic manufacturers pay fees to be used for improvements in the drug review process.

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Dietary Supplement Health and Education Act (1994)

FDA Modernization Act

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- requires clear labeling of dietary supplements of dietary supplements. FDA has power now to remove supp. that cause sig. risk to public.
reauthorized PD User Fee Act -largest reform effort of drug review process since 1938

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Center for Drug Evaluation and Research (CDER)

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branch of FDA - exercise control over whether prescr. drugs and OTC drugs may be used for therapy. Mission - facilitate availability of safe, effective drugs, keeping unsafe/ineffective drugs off the market, improving health of Americans, providing clear, easily understandable drug info for safe use.

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Center for Biologics Evaluation and Research (CBER)
Center for Food Safety and Applied Nutrition (CFSAN)

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Regulates use of biologics inc. serums, vaccines and blood products.
Herbal products and dietary supplements are regulated by Act of 1994. DOES NOT provide same degree of protection for consumers as Food, Drug and Cosmetic Act (1938). Herbal and Dietary supplements MAY be marketed w/out prior FDA approval

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Preclinical Investigation

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1st stage involves extensive lab research on animals and cultured microbial cells. Uses diff. doses to examine drug's effectiveness to look for adverse effects. Always inconclusive! Range 1-3 years

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Clinical Investigation

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2nd stage - 3 phases - Clinical trial phases -longest part of drug approval process. Tests on HEALTHY volunteers to determine proper dosage and to assess for adverse effects. THEN, on selected clients w/ particular disease given medication. Range 2-10 years

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Clinical investigators

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address concerns such as whether the drug is effective, worsens other medical conditions, interacts unsafely w/existing medications, or affects one type of client more than others

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If drug appears to be effective and w/out serious side effects:

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Approval for marketing may be accelerated.

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NDA Review

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3rd stage clinical phase III trials and animal testing may continue. FDA is permitted 6 mos to initially review NDA. Average NDA review time for new med. 18-24 mos.

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Postmarketing surveillance

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Final Stage - Drug has already been approved. Looking for harmful drug effects in a larger population. FDA holds public meetings annually to receive feedback from clients and professional and pharmaceutical org.

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Reasons for delay in the FDA drug approval process:

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Outdated guidelines, poor communication, and insufficient staff to handle the workload. This improved with 1992 Presc Drug User Fee Act and its renewal in 1997.