1. Introduction to Pharmacology Prepare by Assistant Prof /Dr.Amira Yahia

2. Learning outcomes By the end of this session the student will be able to : 1.Explain history of pharmacology 2.Discuss the classification of therapeutic agents 3.Define terms related to pharmacology 4.Explain drug regulation and standards

3. Introduction History of pharmacology: The story of pharmacology is rich and exciting,filled with accidental discoveries and landmark events. It began when humans first used plants to relieve symptoms of diseases. One of the oldest forms of health care,herbal medicine. Herbal medicine continued to practice,few historical events related to topic were recorded. The first recorded reference to word pharmacology was found in text entitled “pharmacologia sen manuduction and materiam medicum by Samuel Dale 1693”

4. Cont…… Pharmacology as discipline was officially recognized when the first department of pharmacology established in Estonia in 1847. The current practice of pharmacology is extremely complex and far advanced compared with its early primitive history. Nurses who consult with pharmacists in the use of pharmacologic substance and other health professionals who practice it must never forget it early roots. The main focus on the patient and to improve the quality of life.

5. Pharmacology :The Study of Medicine : The word Pharmacology is Derived from two Greek words, Pharmakon, which mean “medicine” and logos mean “study” Thus,pharmacology is most simply defined as the study of medicine. More than 10.000 brand –name drugs, generic drugs and combination are currently available. Each has its own characteristic set of therapeutic applications, interactions,side effects and mechanism of action.

6. Pharmacology and Therapeutics: Nurses are most often health care providers directly involved with patient care and are active in educating, managing, and monitoring the proper use of drugs.this application not only to nurses working in health care setting but also for students entering nursing profession. Another important area of study for nurse,sometimes,challenging to distinguish from pharmacology,is study of therapeutics. Therapeutics is slightly different from field of pharmacology.

7. Cont… Therapeutics is branch of medicine concerned with the prevention of disease and treatment of suffering. Pharmacotherapy or pharmacaotherapeutics is application of drugs for the purpose of disease prevention and treatment of suffering.

8. Classification of therapeutic agents : Drug: is chemical agent capable of producing biologic responses With in the body. Medication: a drugs after is administered. Biologics : are the agents naturally produced in animal cells,by microorganisms,or by the body itself. Complementary and alternative therapies: This involve natural plants extracts,herbs, vitamins, minerals, dietary supplements.

9. Definition of terms Pharmacopeias: are the total of all authorized drugs available within the country Prescription: the written direction for the preparation and the administration of the drug The therapeutic effect: is the primary effect intended that is the reason the drug is prescribed such as morphine sulfate is analgesia. Side effect: secondary effect of the drug is one that unintended, side effects are usually predictable and may be either harmless Drug toxicity: deleterious effect of the drug on an organism or tissue, result from overdose or external use. Drug allergy: is immunological reaction to a drug.

10. Drug interaction: occur when administration of one drug before or after alter effect of one or both drug. Drug misuse: Is the improper use of common medications in way that lead to acute and chronic toxicity for example laxative, antacid and vitamins. Drug abuse: is an inappropriate intake of substance either continually or periodically. Drug dependence: is a persons reliance on or need to take drug or substance there are two type of dependence: Cont …..

11. Drug regulation and standards : The first standard commonly used by pharmacists was the formulary,or list of drugs and drugs recipes. In 1820 a pharmacopoia is a medical reference summarizing standards of drug, strength and direction for synthesis. 1906 Pure Food & Drug Act Empowered federal government to enforce standards set by US Pharmacopoeia and National Formulary Drugs must meet standards of strength & purity Type & amount of narcotics must be listed on label of opiate mixture

12. Cont…. 1914 Harrison Narcotic Act: Legally defines the term “narcotic” Regulates manufacture, import, sale, and use of cocaine and opiates.Revision to Harrison Act regulates the use of marijuana and synthetic opiates 1938 Food, Drug and Cosmetic Act: Requires drugs & products be tested for harmful effects Drug labels and literature must be complete & accurate, setting dose, manufacturer’s name & address, names & amounts of potentially harmful ingredients, a warning if habit forming, direction for use, and contraindications.Medical devices must be safe & effective and cosmetics must be safe

13. Cont… 1997 FDA Modernization Act Updated regulation of biologic products increased client access to experimental drugs and medical devices accelerated review of important new drugs allowed drug companies to disseminate info about off-label (non-FDA approved) uses and costs of drugs extended user fees FDA (Federal Drug Administration) General safety standards Approval & removal of products on market DEA (Drug Enforcement Administration) Controlled substances Only enforces laws against illegal drug use Monitors need for changing schedules of abused drugs

14. Controlled Substances Groups of medications that have potential for abuse or physical & psychological dependence Proper handling of controlled substances is essential Violations may result in suspension of your nursing license 5 Schedules

15. Controlled Substances (cont.) Schedule I – CI Highest risk for abuse Not acceptable for prescription use May be available for investigational use Include: Hallucinogens (LSD, heroin, & mescaline )

16. Controlled Substances (cont.) Schedule II - CII Medically useful, but carry high potential for abuse and may lead to physical & psychological dependence Includes certain barbiturates, narcotics (opiates), and stimulants (MS, codeine, meperidine) Prescriptions may not be refilled Medically useful drugs with high abuse potential Includes pure preparations of narcotics (opiates) Includes stimulants (uppers) Includes stimulants (uppers) used for treatment of hyperactive children

17. Controlled Substances (cont.) Schedule III - CIII Lesser abuse potential that schedule I or II Includes nonbarbiturate sedatives, narcotics in combination with other drugs, stimulants, anabolic steroids & paregoric (Tylenol with codeine)

18. Controlled Substances (cont.) Schedule IV - CIV Low potential for abuse, with psychological dependence more common that physical dependence Includes benzodiazepines, propoxyphene (Darvon), and chlordiazepoxide (Librium)

19. Controlled Substances (cont.) Schedule V - CV Least abuse potential Have a small amount of narcotic combined with an antitussive or antidiarrheal

20. Controlled Substances (cont.) Scheduled Drugs in Hospital & Nursing. Home II, III, and IV Nurses All are “signed for” with patient’s name, date, time, reason, nurses’ signature. While student, controlled substances must have a second signature of licensed nurse. All are counted at change of work shift, with two nurses: leaving and arriving Records and signatures may be written or on computer. Locked with two different “keys”, either actual or virtual

21. Controlled Substances (cont.) Scheduled Drugs in Hospital & Nrsg Home II, III, and IV Doctors and nurses Schedule II drug prescriptions/orders in effect only 72 hours Schedule III drug prescriptions/orders in effect for up to one month Nurses must not give drug if order is out of date Nurses remind doctors with regular visit Rules change

22. Controlled Substances (cont.) Five pregnancy categories established by FDA (Federal Drug Administration)

23. Controlled Substances (cont.) Cat A No demonstrated risk to fetus in first trimester of pregnancy No evidence of risk in second and third trimester

24. Controlled Substances (cont.) Cat B Animal studies have not demonstrated risk to fetus or have demonstrated adverse effect, but adequate studies on pregnant women have not demonstrated a risk to fetus during 1st, 2nd, or 3rd trimesters

25. Controlled Substances (cont.) Cat C Animal studies have shown adverse effects on fetus, but there are no adequate studies on humans

26. Controlled Substances (cont.) Cat D Evidence indicates a risk to the human fetus Potential benefit from use of drug may outweigh the risk to the fetus

27. Controlled Substances (cont.) Cat X Studies in animals and humans demonstrated fetal abnormalities or reports indicate evidence of fetal risk