The Drug Approval Process

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Pharmacology
Chapter 6
Unit III - Chapter 6
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1

PHARMACOLOGY

STUDY OF THE EFFECTS OF CHEMICAL SUBSTANCES ON LIVING TISSUES

2

THE SET OF DRUG STANDARDS USED IN THE UNITED STATES OF AMERICA IS THE?

UNITED STATES PHARMACOPEIA OF 1820

3

THE UNITED STATES PHARMACOPEIA NATIONAL FORMULARY (USP-NF)

CURRENT 3 VOLUME AUTHORITATIVE SOURCE FOR DRUG STANDARDS, ANNUAL PUBLICATIONS WITH 2 SUPPLEMENTS. DRUGS INCLUDED HAVE MET HIGH STANDARDS FOR THERAPEUTIC USE, CLIENT SAFETY, QUALITY, PURITY, STRENGTH, PACKAGING SAFETY, AND DOSAGE FORM.
DESIGNATED BY THE U.S. FEDERAL FOOD, DRUG AND COSMETIC ACT.

4

DRUGS THAT MEET THERE STANDARDS HAVE _____ AFTER THEIR OFFICIAL NAME?

"USP"; DENOTING RECOGNITION GLOBALLY OF HIGH QUALITY.

5

INTERNATIONAL PHARMACOPEIA

1ST PUBLISHED 1951, BY WORLD HEALTH ORGANIZATION (WHO). IS THE BASIS FOR STANDARD USED THROUGHOUT THE WORLD.

6

PUBLIC IS PROTECTED FROM DRUGS THAT ARE IMPURE, TOXIC, INEFFECTIVE, OR NOT TESTED BEFORE PUBLIC SALE BY _______________________________?

FEDERAL LEGISLATION; ENSURES SAFETY

7

FEDERAL PURE FOOD AND DRUG ACT OF 1906

FIRST LAW TO REGULATE DRUGS, DID NOT INCLUDE DRUG EFFECTIVENESS AND DRUG SAFETY.

8

U.S. FOOD AND DRUG ADMINISTRATION (FDA)

MONITORS AND REGULATES THE MANUFACTURER AND AND MARKETING OF DRUGS. THEIR RESPONSIBILITY TO ENSURE ALL DRUGS ARE TESTED FOR HARMFUL EFFECTS, HAVE LABELS WITH ACCURATE INFORMATION, AND ENCLOSE WITH DRUG PACKAGE IS A DETAILED LITERATURE AND EXPLAINS ADVERSE EFFECTS. THE FDA CAN PREVENT THE MARKETING OF ANY DRUG.

9

1952: THE DURHAM-HUMPHREY AMENDMENT TO THE FOOD, DRUG, AND COSMETIC ACT OF 1938

DISTINGUISHES BETWEEN DRUGS THAT CAN BE SOLD WITH OR WITHOUT PRESCRIPTION. E.G. DRUGS THAT SHOULD NOT BE FILLED WITHOUT PRESCRIPTION SUCH AS NARCOTICS, HYPNOTICS, OR TRANQUILIZERS.

10

1962: THE KEFAUVER-HARRIS AMENDMENT TO THE FOOD, DRUG, COSMETIC ACT OF 1938

TIGHTENED CONTROL ON DRUG SAFETY, ESPECIALLY EXPERIMENTAL DRUGS, AND REQUIRED THAT ADVERSE REACTIONS AND CONTRADICTIONS MUST BE LABELED AND INCLUDED IN THE LITERATURE. INCLUDED EVALUATION OF TESTING METHODS OF MANUFACTURERS.

11

1970: THE CONTROLLED SUBSTANCE ACT

REMEDY THE ESCALATING PROBLEM OF DRUG ABUSE INCLUDED SEVERAL PROVISIONS:
1. PROMOTION OF DRUG EDUCATION AND RESEARCH TO PREVENTION AND TREATMENT FOR DRUG DEPENDANCE.
2. STRENGTHENING OF ENFORCEMENT AUTHORITY
3. ESTABLISHMENT OF TREATMENT AND REHABILITATION FACILITIES.
4. DESIGNATION OF SCHEDULES, OR CATEGORIES, FOR CONTROLLED SUBSTANCES ACCORDING TO ABUSE LIABILITY.

12

CONTROLLED SUBSTANCES

ARE DESCRIBED IN 5 SCHEDULES: SCHEDULE 1 DRUGS ARE NOT APPROVED FOR MEDICAL USE. AND SCHEDULE 2 - 5 DRUGS HAVE ACCEPTABLE MEDICAL USE. ABUSE POTENTIAL AND PHYSICAL/PSYCHOLOGICAL DEPENDANCE IS HIGHEST AT 5 AND DECREASES AS YOU MOVE THROUGH THE SCHEDULE. WITH 5 ONLY WITH LIMITED POTENTIAL.

13

SCHEDULE CATEGORIES OF CONTROLLED SUBSTANCES: SCHEDULE 1 (I)

EXAMPLES: HEROIN, HALLUCINOGENS (LSD, MARIJUANA *EXCEPT WHEN PRESCRIBED FOR CANCER TREATMENT*, MESCALINE, PEYOTE, PSILOCYBIN)
DESCRIPTION: HIGH POTENTIAL FOR DRUG ABUSE, NO ACCEPTABLE MEDICAL USE, LABELED C-I.

14

SCHEDULE CATEGORIES OF CONTROLLED SUBSTANCES: SCHEDULE 2 (II)

EXAMPLES: MEPERIDINE (DEMOROL), MORPHINE, HYDROCODONE, HYDROMORPHONE, METHADONE, OXYCODONE, CODEINE, AMPHETAMINES, SECOBARBITAL, PENTOBARBITAL
DESCRIPTION: HIGH POTENTIAL FOR DRUG ABUSE. ACCEPTED MEDICAL USE. CAN LEAS TO STRONG PHYSICAL AND PSYCHOLOGICAL DEPENDANCY. LABELED C-II

15

SCHEDULE CATEGORIES OF CONTROLLED SUBSTANCES: SCHEDULE 3 (III)

EXAMPLES: CODEINE PREPARATIONS, PAREGORIC, NONNARCOTIC DRUGS (PENTAZOCINE, PROPOXYPHENE)
DESCRIPTION: MEDICALLY ACCEPTED DRUGS. POTENTIAL ABUSE IS LESS THAN THAT FOR SCHEDULES I AND II. MAY CAUSE DEPENDENCE. LABELED C-III

16

SCHEDULE CATEGORIES OF CONTROLLED SUBSTANCES: SCHEDULE 4 (IV)

EXAMPLES: PHENOBARBITAL, BENZODIAZEPINES (DIAZEPAM, OXAZEPAM, LORAZEPAM, CHLORDIAZEPOXIDE), CHLORAL HYDRATE, MEPROBAMATE.
DESCRIPTION: MEDICALLY ACCEPTED DRUGS, MAY CAUSE DEPENDENCE. LABELED C-IV.

17

SCHEDULE CATEGORIES OF CONTROLLED SUBSTANCES: SCHEDULE 5 (V)

EXAMPLES: OPIOID-CONTROLLED SUBSTANCES FOR DIARRHEA AND COUCH (E.G. CODEINE, IN COUGH PREPARATIONS)
DESCRIPTION: MEDICALLY ACCEPTED DRUGS, VERY LIMITED POTENTIAL FOR DEPENDENCE. LABELED C-V.

18

NURSING INTERVENTIONS: CONTROLLED SUBSTANCES

1. ACCOUNT FOR ALL CONTROLLED DRUGS
2. KEEP SPECIAL CONTROLLED SUBSTANCE RECORD FOR REQUIRED INFORMATION
3. ENSURE DOCUMENTATION AND DRUGS ON HAND MATCH.
4. KEEP ALL CONTROLLED DRUGS IN LOCKED STORAGE AREA, NARCOTICS KEEP UNDER DOUBLE LOCK.
5. MAKE CERTAIN ONLY AUTHORIZED PERSONS HAVE ACCESS TO KEYS

19

AMERICAN NURSES ASSOCIATION (ANA) RECOGNIZES NURSE DRUG DIVERSION AND RECOMMENDS ALL STATES HAVE A ?

PEER-TO-PEER ASSISTANCE PROGRAM FOR ADDICTED NURSES. (MANDATORY REPORTING ON STAFF AND AGENCY IS SUSPECTED OR KNOWN DIVERSION OCCURS.

20

1983: DRUG ENFORCEMENT ADMINISTRATION (DEA) OF THE DEPARTMENT OF JUSTICE

WAS CHARGED WITH THE ROLE OF BEING THE NATIONS SOLE LEGAL DRUG ENFORCEMENT AGENCY.

21

1978: DRUG REGULATION REFORM ACT:

SHORTENED THE TIME IN WHICH NEW DRUGS COULD BE DEVELOPED AND MARKETED. PROTECTS PATIENTS' RIGHTS AND FACILITATES THE INVESTIGATIONAL PROCESS AND PROMOTES RESEARCH.

22

1992: DRUG RELATIONS ACT:

INCREASE THE APPROVAL RATE OF DRUGS USED TO TREAT ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS) AND CANCER. PHARMACEUTIC COMPANIES PAY A USER FEE AT THE TIME OF APPLICATION FOR THE NEW DRUG. THE FEE IS FOR THE FDA DRUG-APPROVAL PROCESS.

23

1997: THE FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT: (5 PROVISIONS)

1. REVIEW AND USE OF NEW DRUGS IS ACCELERATED
2. DRUGS CAN BE TESTED ON CHILDREN BEFORE MARKETING
3. CLINICAL TRIAL DATA ARE NECESSARY FOR EXPERIMENTAL DRUG USE FOR SERIOUS OR LIFE-THREATENING HEALTH CONDITIONS.
4. DRUG COMPANIES ARE REQUIRED TO GIVE INFORMATION ON "OFF LABEL" DRUGS (NON FDA APPROVED DRUGS) AND THEIR USES AND COSTS
5. DRUG COMPANIES THAT PLAN TO DISCONTINUE A DRUG MUST INFORM HEALTH PROFESSIONALS AND CLIENTS AT LEAST 6 MONTHS BEFORE STOPPING DRUG PRODUCTION.

24

2003: HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA) :

SETS THE STANDARDS FOR PRIVACY IF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION AS OF 2003. GIVES CLIENTS MORE CONTROL OVER THEIR HEALTH CARE INFORMATION, ADDS BOUNDARIES ON USE AND RELEASE OF HEALTH CARE RECORDS.

25

IMPLICATIONS OF HIPAA RELATED TO THE INDIVIDUALS THERAPEUTIC REGIMEN INCLUDE:

LIMITATION ON ACCESS TO INFORMATION FROM THE PHARMACY. (E.G. CLIENT HISTORY CAN ONLY BE RELEASED TO THE CLIENT) AND THE PHARMACIST MUST PROVIDE A PRIVATE AREA FOR CONSULTATION WITH THE CLIENT AND HAVE ALL CLIENT SIGN A STATEMENT THAT THEY HAVE RECEIVED A COPY OF THE PRIVACY STATEMENT.

26

2003: PEDIATRIC RESEARCH EQUITY ACT:

FDA REQUIRES TESTING BY DRUG MANUFACTURERS OF DRUGS AND BIOLOGIC PRODUCTS FOR THEIR SAFETY AND EFFECTIVENESS IN CHILDREN. *NEVER ASSUME A CHILD IS A SMALL ADULT*

27

2003: MEDICARE PRESCRIPTION DRUG IMPROVEMENT AND MODERNIZATION ACT (MMA):

PROVIDES FINANCIAL ASSISTANCE TO SENIORS TO PURCHASE NEEDED PRESCRIPTION MEDICATIONS.
- MONTHLY PREMIUM OF $35, $250 ANNUAL DEDUCTIBLE.
THIS WILL PAY 75% OF TOTAL COST OF DRUGS UP TO A MAX. OF $2250.
- THERE IS NO DRUG COVERAGE BETWEEN $2250 - $5100, SENIOR PAYS FULL COST OF DRUGS.
- MEDICARE WILL PAY 95% OF DRUG COST BEYOND $5100. MEDICARE SENIORS MAY HAVE A SUPPLEMENTAL INSURANCE FOR PRESCRIPTION MEDICATIONS, AND MUST CHOOSE TO CONTINUE SUPPLEMENTAL INSURANCE COVERAGE OR SIGN UP FOR MEDICARE DRUG BENEFITS. *DOUBLE COVERAGE IS NOT A OPTION*

28

NURSE PRACTICE ACTS:

-NURSES CANNOT PRESCRIBE OR ADMINISTER DRUGS WITHOUT A HEALTH PROVIDER'S ORDER (NURSES WHO ADMINISTER A DRUG WITHOUT PHYSICIAN ORDERS, CAN HAVE THEIR LICENSE REVOKED).
-PRACTICING NURSES SHOULD BE KNOWLEDGEABLE ABOUT NURSE PRACTICE ACT IN THE STATE THEY ARE LICENSED.

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MISFEASANCE:

NEGLIGENCE; GIVING THE WRONG DRUG OR DRUG DOSE THAT RESULTS IN THE CLIENT'S DEATH.

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NONFEASANCE:

OMISSION; OMITTING A DRUG DOSE THAT RESULTS IN THE CLIENT'S DEATH.

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MALFEASANCE:

GIVING THE CORRECT DRUG BUT BY THE WRONG ROUTE THAT RESULTS IN THE CLIENT'S DEATH.

32

CANADIAN DRUG REGULATION ACT I:
SCHEDULE F PRESCRIPTION DRUGS

ALL PRESCRIPTION DRUGS EXCEPT FOR NARCOTICS AND CONTROLLED SUBSTANCES ARE AVAILABLE ONLY WITH PRESCRIPTION (WRITTEN OR ORAL). MANUFACTURE'S LABEL ARE REQUIRED TO HAVE [Pr] PRINTED ON LABEL.

33

CANADIAN DRUG REGULATION ACT II:
CONTROLLED DRUG AND SUBSTANCE ACT (CDSA)

GIVES REGULATIONS ON CONTROL AND SALE OF NARCOTICS AND CONTROLLED SUBSTANCES. HAVE 8 SCHEDULES. LABELS MUST HAVE [C] FOR CONTROLLED AGENTS AND [N] FOR NARCOTICS PRINTED ON LABEL. LOW-DOSE CODEINE IS AN EXCEPTION AND CAN BE SOLD BY A PHARMACIST.

34

CANADIAN NONPRESCRIPTION DRUGS:

NONPRESCRIPTION DRUGS -CAN BE SOLD AT ANY RETAILER.
PHARMACY ONLY NONPRESCRIPTION DRUGS - PHARMACIST MUST BE AVAILABLE FOR REQUESTED ADVICE.
RESTRICTED ACCESS NONPRESCRIPTION DRUGS - AVAILABLE ONLY FROM THE PHARMACIST. CONSULATION IS REQUIRED.

35

CANADIAN DRUG REGULATION: NATIONAL ASSOCIATION OF PHARMACY REGULATORY AUTHORITY (NAPRA)

"HARMONIZE" REGULATION NATIONWIDE BY CREATING THE FOLLOWING THREE-SCHEDULE NATIONAL DRUG SCHEDULE:
-SCHEDULE I: ALL PRESCRIPTION DRUGS, INCLUDING NARCOTICS AND CONTROLLED SUBSTANCES.
-SCHEDULE II: RESTRICTED ACCESS OF PHARMACIST ONLY NONPRESCRIPTION DRUGS.
-SCHEDULE III: PHARMACY ONLY NON-PRESCRIPTION DRUGS.
-UNSCHEDULED DRUGS: ARE AVAILABLE AT A RETAIL OUTLET BUT NOT PLACED IN THE ABOVE CATEGORIES.

36

INITIATIVES TO COMBAT DRUG COUNTERFEITING = CONTRIBUTING REASONS FOR HIGHER NUMBERS OF DRUG COUNTERFEITING IS?

1. LACK OF MANDATORY REPORTING OF INCIDENTS
2. COUNTERFEITING IS THE "PERFECT CRIME", IN THAT MEDICINE IS TAKEN, EVIDENCE IS GONE.

37

FDA AND CONSUMER GROUPS ARE WORKING ON STRATEGIES TO COMBAT COUNTERFEITING OF DRUGS BY?

1. TOUGHER OVERSIGHT OF DISTRIBUTORS
2. A RAPID ALARM SYSTEM
3. BETTER-INFORMED CUSTOMERS
"IF ANY SUSPICION OF COUNTERFEITING ARISES, THE CLIENT/FAMILY/NURSE SHOULD CONTACT THE FDA"

38

THE ROLE OF THE NURSE IS CRITICAL IN CONSUMER EDUCATION. BOTH THE NURSE AND CLIENT MUST BE EVER VIGILANT. STRATEGIES INCLUDE: (IN REGARDS TO COUNTERFEITING)

1. BEING ALERT TO SLIGHT VARIATIONS IN PACKAGING OR LABELING (E.G. COLOR, PACKAGE SEAL)
2. ADVICE CLIENT TO REPORT ANY DIFFERENCE IN TASTE OR APPEARANCE OF THE DRUG OR PACKAGING.
3. NOTE ANY UNEXPECTED SIDE EFFECTS.
4. ADVISE ABOUT BUYING DRUGS FROM A REPUTABLE SOURCE.

39

REPUTABLE ONLINE PHARMACIES HAVE AN _______?

APPROVAL SEAL "VIPPS" VERIFIED INTERNET PHARMACY PRACTICE SITE.

40

CHEMICAL NAME

DESCRIBES THE DRUG'S CHEMICAL STRUCTURE

41

GENERIC NAME

IS THE "ACTUAL NAME", THE OFFICIAL OR NONPROPRIETARY NAME FOR THE DRUG. THEY MUST BE APPROVED BY THE FDA. THE NAME IS NOT OWNED BY THE ANY PHARMACEUTIC COMPANY AND IS UNIVERSALLY ACCEPTED. (MOST DRUGS ARE ORDERED BY GENERIC NAMES)

42

THE BRAND (TRADE) NAME

KNOWN AS THE PROPERTY NAME, THIS NAME IS CHOSEN BY THE DRUG COMPANY AND IS USUALLY A REGISTERED TRADEMARK OWNED BY THAT SPECIFIC MANUFACTURER. PHARMMACEUTIC COMPANIES MARKET THE COMPOUND USING THEIR GIVEN NAME (BRAND NAME)

EXAMPLE: NARCAN (BRAND NAME), naloxone HCI (GENERIC)

43

IF THE GENERIC DRUG IS FOUND TO BE BIO-EQUIVALENT TO THE BRAND NAME OR TRADE NAME DRUG THEN GENERIC DRUG IS CONSIDERED TO BE?

THERAPEUTICALLY EQUIVALENT AND IS GIVEN AN "A" RATING.

44

SPECIFICALLY WHAT MAKES A GENERIC DRUG EQUIVALENT TO A BRAND NAME DRUG?

WHEN THE PEAK SERUM CONCENTRATION (Cmax) & PLASMA-CONCENTRATION CURVE (AUC) OF THE GENERIC DRUG FALL BETWEEN 80% TO 125% OF THE BRAND NAME.

45

THE PRO'S AND CON'S OF GENERIC DRUGS:

PRO'S:
1. THEY ARE CHEAPER
2. SAME ACTIVE INGREDIENTS ANS BRAND/TRADE NAME.
CON'S:
1. SOME HAVE INERT FILLERS AND BINDERS THAT MAY RESULT IN VARIATIONS OF DRUG EFFECTIVENESS.
2. ARE LESS EXPENSIVE, ONLY BECAUSE MANUFACTURER'S DO NOT HAVE TO DO EXTENSIVE TESTING BECAUSE THEY WERE TESTED BY THE COMPANY THAT FIRST FORMULATED THE BRAND-NAME.

46

BRAND-NAME DRUGS ARE PREFERRED WHEN ORDERING WHAT TYPE OF DRUGS?

ANTICONVULSANTS FOR SEIZURES, ANTICOAGULANTS, MEDICATION FOR HEART FAILURE, AND ASPIRIN WHEN USED IN LARGE DOSES FOR RHEUMATOID ARTHRITIS.
(HEALTH CARE PROVIDER MUST NOTE ON PRESCRIPTION OR PAPER IF THE PHARMACIST MAY SUBSTITUTE THE GENERIC DRUG WHEN THE BRAND NAME IS PRESCRIBED.

47

GENERIC NAMES ARE GIVEN IN _______ LETTERS, AND THE BRAND NAMES ALWAYS BEGIN WITH A _________ LETTER.

1. lower case letters
2. Capital

48

AMERICAN HOSPITAL FORMULARY SERVICE (AHFS) DRUG INFORMATION

PUBLISHED YEARLY BY AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS IN BETHESDA, MARYLAND; IS UNBIASED; PROVIDES ACCURATE AND COMPLETE DRUG INFORMATION FOR DRUGS IN U.S. DRUGS LISTED ACCORDING TO THERAPEUTIC DRUG CLASSIFICATION.

49

AMERICAN HOSPITAL FORMULARY SERVICE (AHFS) DRUG INFORMATION, INCLUDES WHAT TYPE OF INFORMATION FOR EACH DRUG LISTED?

INFORMATION FOR EACH DRUG: CHEMISTRY AND STABILITY, PHARMACOLOGIC ACTIONS, PHARMACOKINETICS, USES, CAUTIONS PER BODY SYSTEM, PRECAUTIONS, CONTRAINDICATIONS, ACUTE TOXICITY, DRUG INTERACTIONS, DOSAGE AND ADMINISTRATION, AND PREPARATION

50

DRUG FACTS AND COMPARISONS (F & C):

INFORMATION ON ALMOST ALL DRUGS MARKETED IN THE U.S.
EXAMPLE: 2009 EDITION HAS OVER 22,000 PRESCRIPTION AND OVER 6,000 OTC DRUGS.

51

DRUG FACTS AND COMPARISONS (F & C), INCLUDES WHAT TYPE OF INFORMATION FOR EACH DRUG LISTED?

INFORMATION FOR EACH DRUG: DRUG ACTION, INDICATIONS, WARNINGS AND PRECAUTIONS, DOSAGE AND ROUTE FOR ADMINISTRATION, ADVERSE REACTIONS, CLIENT INFORMATION, OVER-DOSAGE, DRUG INTERACTIONS, CONTRAINDICATIONS, AND COMPARISON CHARTS AND TABLES.

52

THE UNITED STATES PHARMACOPIA - DRUG INFORMATION (USP-DI):

THREE VOLUME SET; VOLUME IA AND IB PROVIDE DRUG INFORMATION FOR THE HEALTH CARE PROVIDER. SECTIONS HERE INCLUDE: PHARMACOLOGY, PRECAUTIONS TO CONSIDER, SIDE AND ADVERSE EFFECTS, CLIENT CONSULTATION, GENERAL DOSING INFORMATION AND DOSAGE FORMS. VOLUME II IS FOR CLIENT, UNDERSTANDABLE FOR CLIENT, INCLUDES: ADMINISTRATION OF DRUG, DRUG EFFECTS, INDICATIONS, ADVERSE REACTIONS, DOSAGE GUIDELINES, AND WHAT TO DO FOR MISSED DOSES.

53

THE PHYSICIANS' DESK REFERENCE (PDR):

PUBLISHED YEARLY; SEVEN SECTIONS (TWO MOST USEFUL FOR NURSES, SECOND (PINK) SECTION IS THE DRUG NAME INDEX. SIXTH (WHITE) SECTION GIVES INFORMATION ABOUT THE DRUGS. A GOOD DRUG RESOURCE BUT DOES NOT PROVIDE COMPLETE: PHARMACEUTIC AND THERAPEUTIC INFORMATION AND DOES NOT INCLUDE NURSING INTERVENTIONS. THE DRUG INFORMATION IS REPRINTED FROM DRUG PACKAGE INSERTS SUPPLIED BY PHARMACEUTIC COMPANIES THAT PAT TO HAVE THEIR DRUGS LISTED IN THE PDR.

54

THE MEDICAL LETTER:

PUBLISHED BI-WEEKLY BY THE MEDICAL LETTER INC ROCHELLE, NEW YORK; NONPROFIT PUBLICATION FOR PHYSICIANS, NURSE PRACTITIONERS, AND OTHER HEALTH PROFESSIONALS. HAS 2 THEMES: DRUGS FOR TREATMENT OF DISEASE ENTITIES AND 2 OR 4 NEW DRUGS THAT HAVE BEEN APPROVED BY THE FDA. INFORMATION GIVEN FOR NEW DRUGS IS PHARMACOKINETICS, CLINICAL STUDIES, DOSAGE, ADVERSE EFFECTS, INTERACTIONS AND A CONCLUSION.

55

THE PRESCRIBER'S LETTER:

PUBLISHED MONTHLY BY THERAPEUTIC RESEARCH CENTER IN STOCKTON, CALIFORNIA. ADDRESSES NEW FDA APPROVED DRUGS, VARIOUS USES OF OLDER DRUGS, AND FDA WARNINGS.

56

THE HANDBOOK ON INJECTABLE DRUGS:

BY LAWRENCE A. TRISSEL; PUBLISHED BY THE AMERICAN SOCIETY OF HOSPITAL PHARMACISTS. EXCELLENT REFERENCE FOR INJECTABLE MEDICATIONS AND LIST DRUG COMPATIBILITY WITH OTHER DRUGS, BASE FLUIDS, AND DRUG AVAILABLE IN LARGE-VOLUME PARENTERALS. INCLUDES: pH OF EACH DRUG, DOSING ADMINISTRATION GUIDELINES.

57

NURSING DRUG REFERENCE BOOKS ARE UPDATED YEARLY SOME OF THESE BOOKS INCLUDE:

SAUNDERS NURSING DRUG HANDBOOK (ELSEVIER), NURSING DRUG GUIDE (PRENTICE HALL), AND NDR (DELMAR)

58

INTERNET IS ALSO A SOURCE FOR DRUG INFORMATION. ALWAYS NOTE?

DRUG INFORMATION CAN CAN BE POSTED ON THE INTERNET BUT ANYONE, SO INFORMATION MAY NOT ALWAYS BE ACCURATE, COMPREHENSIVE, OR UP-TO-DATE.

59

POISON CONTROL CENTERS (PCCs):

PRESENT IN MANY CITIES, WEBSITE IS WWW.AAPCC.ORG, TELEPHONE NUMBER USUALLY IN FRONT PAGES OF PHONE BOOK 1-800-222-1222; PROVIDE INFORMATION ABOUT DRUGS CHEMICAL COMPOUNDS AND IMMEDIATE ACTION THAT SHOULD BE TAKEN TO PREVENT INJURY OR DEATH.

60

PCCs CASES ARE MOSTLY BASED ON CHILDREN OVER-DOSES:

90% CASES ARE IN CHILDREN YOUNGER THAN 3 YEARS AND OCCURS AT HOME. IRON TABLETS, CHOCOLATE-COVERED LAXATIVES, FLAVORED ACETAMINOPHEN, AND FLAVORED LIQUID MEDICINE ARE COMMON DRUGS THAT CHILDREN INGEST. IN LARGE DOSES CAN BE TOXIC TO CHILDREN. CONSUMPTION OF CLEANING CHEMICALS AND INSECTICIDES POSE ADDITIONAL THREATS.

61

MORTALITY RATE FROM POISONING IN THE U.S. IS:

ABOUT 28,000 DEATHS PER YEAR. 70% FROM ACCIDENTS, AND 30% ARE FROM SUICIDES.

62

NURSES SHOULD BE _______ AND ________ RESPONSIBILITY FOR THE CLIENTS ___________.

MORALLY, ETHICALLY, TOTAL CARE.

63

NURSES PRIMARY __________ IS TO THE __________.

OBLIGATION, CLIENT

64

NURSES NEED TO ?

RESPECT THE RIGHTS, DIGNITY, AND WISHES OF CLIENTS.

65

CLIENT'S HAVE THE RIGHT TO ?

KNOW ABOUT THEIR DRUGS, DRUG ACTIONS, AND ANY SIDE EFFECTS. THEY HAVE THE RIGHT TO REFUSE DRUGS EVEN AFTER A THOROUGH EXPLANATION OF THE DRUGS AND DESIRED EFFECTS ARE GIVEN.

66

THE NURSE SAFE GUARDS:

CLIENT'S RIGHTS, SAFETY, DIGNITY, AND HEALTH CARE.

67

THE NURSE SEEKS:

CONSULTATION, ACCEPTS RESPONSIBILITY, AND DEMONSTRATES COMPETENCY IN NURSING CARE.

68

AMERICAN NURSES ASSOCIATION CODE OF ETHICS FOR NURSES: (1 - 3)

1. THE NURSE, IN ALL PROFESSIONAL RELATIONSHIPS, PRACTICES WITH COMPASSION AND RESPECT FOR THE INHERENT DIGNITY, WORTH, AND UNIQUENESS OF EVERY INDIVIDUAL, UNRESTRICTED BY CONSIDERATIONS OF SOCIAL OR ECONOMIC STATUS, PERSONAL ATTRIBUTES, OR THE NATURE OF HEALTH PROBLEMS.
2. THE NURSES PRIMARY COMMITMENT IS TO THE PATIENT, WHETHER AN INDIVIDUAL, FAMILY, GROUP, OR COMMUNITY.
3. THE NURSE, PROMOTES, ADVOCATES FOR, AND STRIVES TO PROTECT THE HEALTH, SAFETY, AND RIGHTS TOT HE PATIENT.

69

AMERICAN NURSES ASSOCIATION CODE OF ETHICS FOR NURSES: (4 - 6)

4. THE NURSE IS RESPONSIBLE AND ACCOUNTABLE FOR INDIVIDUAL NURSING PRACTICE AND DETERMINES THE APPROPRIATE DELEGATION OF TASKS CONSISTENT WITH THE NURSES OBLIGATION TO PROVIDE OPTIMUM PATIENT CARE.
5. THE NURSE OWES THE SAME DUTIES TO SELF AS TO OTHERS INCLUDING THE RESPONSIBILITY TO PRESERVE INTEGRITY AND SAFETY TO MAINTAIN COMPETENCE, AND TO CONTINUE PERSONAL AND PROFESSIONAL GROWTH.
6. THE NURSE PARTICIPATES IN ESTABLISHING, MAINTAINING, AND IMPROVING HEALTH CARE ENVIRONMENT AND CONDITIONS OF EMPLOYMENT CONDUCTIVE TO THE PROVISION OF QUALITY HEALTH CARE AND CONSISTENT WITH THE VALUES OF THE PROFESSION THOUGH INDIVIDUAL AND COLLECTIVE ACTION.

70

AMERICAN NURSES ASSOCIATION CODE OF ETHICS FOR NURSES: (7 - 9)

7. THE NURSE PARTICIPATES IN THE ADVANCEMENT OF THE PROFESSION THROUGH CONTRIBUTIONS TO PRACTICE, EDUCATION, ADMINISTRATION AND KNOWLEDGE DEVELOPMENT.
8. THE NURSE COLLABORATES WITH OTHER HEALTH PROFESSIONALS AND THE PUBLIC IN PROMOTING COMMUNITY, NATIONAL, AND INTERNATIONAL EFFORTS TO MEET HEALTH NEEDS.
9. THE PROFESSION OF NURSING, AS REPRESENTED BY ASSOCIATIONS AND THEIR MEMBERS, IS RESPONSIBLE FOR ARTICULATING NURSING VALUES, FOR MAINTAINING THE INTEGRITY OF THE PROFESSION AND ITS PRACTICE, AND FOR SHAPING SOCIAL POLICY.