CHAPTER 6 THE DRUG APPROVAL PROCESS pharmacology = study of effects of chemical substances on living tissues o Early drugsderived for

r plants, animals and minerals that date back to the Middle East and China (emetics and laxatives) o Egyptians wrote empirical observations of drug therapy on what has come to be known as Ebers Medical Papyrussuggestion of moldy bread being applied to wounds and bruises (3500 years before the discovery of penicillin!!) o Roman physician and writer Galen was considered an authority in medicine and pharmacy for hundreds of yearsinitiated common use of prescriptions and several ingredients o Christian monks kept information on medicine and pharmacy in their monasteries o Arabic doctorsfirst set of drug standards and measurements known as apothecary system o Eighteenth century, vaccine for smallpox o Nineteenth century, morphine and codeine were extracted from opium, atropine, bromides, and iodine o Twentieth centuryaspirin, phenobarbital, insulin and sulfonamides, antibiotics

DRUG STANDARDS AND LEGISLATION The United States Pharmacopeia National Formulary (USP-NF) o Drugs that are included have met high standards for therapeutic use, client safety, quality, purity, strength, packaging safety and dosage form o Drugs in this category have the initials USP following their official name

Federal Legislation primary purpose is to ensure safety o FDA did not include drug effectiveness and drug safety and so these legalized standards were put in place

1938: Food, Drug and Cosmetic Act Food, Drug and Cosmetic Act empowered a governing body: the U.S. Food and Drug Administration (FDA) to monitor and regulate the manufacture and marketing of drugs o It is the FDAs responsibility to ensure that all the drugs are tested for harmful effects, have labels with accurate information, and enclose the drug with packaging with detailed literature that explains adverse effects Prevent marketing of any drug it judges to be incompletely tested or dangerous Only drugs considered safe by the FDA are approved for marketing

1952: Durham-Humphrey Amendment to the 1938 Act Durham-Humphrey Amendment to the Food, Drug and Cosmetic Act of 1938 distinguished between drugs that can be sold with or without prescription and those that shouldnt be refilled without a new prescription o Drugs that shouldnt be refilled: Narcotics Hypnotics Tranquilizers

1962: Kefauver-Harris Amendment to the 1938 Act resulted from the widely publicized thalidomide tragedy o pregnant women took the sedative during their first trimester of pregnancy gave birth to infants with extreme limb deformities o this amendment tightened controls on drug safety, especially experimental drugs and required that adverse reactions and provisions were included in the literature for the evaluation of testing methods used by manufacturers, the process for withdrawal of approved drugs when safety and effectiveness were in doubt, and the establishment of the effectiveness of new drugs before marketing

1970: The Controlled Substances Act act was designed to remedy the escalating problem of drug abuse, included several provisions: o promotion of drug education o strengthening of enforcement authority o establishment of treatment and rehabilitation facilities o designation of schedules or categories for controlled substances according to abuse liability controlled substances = described in five schedules or categories: I. heroin, hallucinogens II. meperidine, morphine, hydrocodone, etc. III. codeine preparations IV. phenobarbital, benzodiazepines V. opioid-controlled substances dependency decreases as one moves through the schedule

Nursing Interventions: Controlled Substances account for all controlled drugs keep a special controlled-substance record for required information countersign all discarder or wasted medication ensure that documentation and drugs on hand match keep all controlled drugs in a locked storage area; narcotics must be kept under double lock o Pixis system = biodentical identifiers are used for access Be certain that only authorized persons have access to keys The Drug Enforcement Administration (DEA) of the department of Justice was charged with the role of being the nations sole legal drug enforcement agency o Bureau of Narcotics and Dangerous Drugs which preceded the DEA is defunct

1978: Drug Regulation Reform Act shortened the time in which new drugs could be developed and marketed o act protects patients rights and at the same time facilitates the investigational process and promotes research

1992: Drug Relations Act increase the approval rate of drugs used to treat acquired immunodeficiency syndrome and cancer o pharmaceutical companies pay a user fee at the time of application for the new drug o fee is for the FDA drug approval-process

1997: The Food and Drug Administration Modernization Act five provisions in this act include: o review and use of new drug is accelerated

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drugs can be tested in children before marketing clinical trial data are necessary for experimental drug use for serious or life-threatening health conditions are drug companies are required to give information on off-label drugs and their uses and costs drug companies that plan to discontinue drugs must inform health professionals and clients at least six months before stopping drug production

2003: Health Insurance Portability and Accountability Act (HIPAA) sets the standards for the privacy of individually identifiable health information as of 2003 o rule gives client more control over their health information, including boundaries on the use and release of health records Implications of HIPAA related to the individuals therapeutic regimen include limitation on access to information from the pharmacy

2003: Pediatric Research Equity Act FDA is authorized to require testing by rug manufacturers of drugs and biologic products for their safety and effectiveness in children DO NOT ASSUME THAT CHILDREN ARE SMALL ADULTS

2003: Medicare Prescription Drug Improvement and Modernization provides financial assistance to seniors to purchase needed prescription medications o may have supplement insurance coverage for prescription medications o choose whether to continue or to sign up for Medicaredouble insurance is not an option

NURSE PRACTICE ACTS Every state has its own laws regarding drug administration by nurses o Nurses cannot prescribe or administer drugs without a healthcare providers order o Practicing nurses must request a copy and be knowledgeable about he nurse practice act in the state in which they are licensed Nurse can be prosecuted for giving the wrong drug or dosage, omitting a drug dose or giving the drug by the wrong route o Misfeasance = negligence; giving the wrong drug or drug dose that results in clients death o Nonfeasance = omission; omitting a drug dose that results in the clients death o Malfeasance = giving the correct drug that but by the wrong route that results in the client death

CANADIAN DRUG REGULATION Health Protection Branch, Department of National Health and Welfare is responsible for the administration of the two acts that are foundation of national drug laws o Manufacture, distribution, and sale of drugs are controlled by the Canadian Food and Drug Act amended in 1953 Drugs sold in Canada are assigned to the following schedules: o Schedule F Prescription Drugs o Controlled Drug and Substances Act Schedule I: Opium, poppy and all the derivatives Schedule II: Cannabis and derivatives Schedule III: amphetamines, methylphenidate Schedule IV: sedative-hypnotic agent o Covers select codeine preparations

Nonprescription drugs are assigned to one of three categories: o Nonprescription drugs are sold at any retailer o Pharmacy-only nonprescription drugs o Restricted access nonprescription drugs Three-schedule national drug schedule using the same nomenclature and numbering as the controlled substances: o Schedule I: All prescription drugs including narcotics and controlled substances o Schedule II: Restricted access of pharmacist only nonprescription drugs o Schedule III: Pharmacy only nonprescription drugs o Unscheduled drugs: drugs that are available at a retail outlet and not placed in the above categories Therapeutic and toxic levels are monitored according to the International System of Units (SI); also true in many European countries

INITIATIVES USED TO COMBAT DRUG COUNTERFEITING The numbers of counterfeit and adulterated prescription drugs are on the rise o Lack of mandatory reporting of counterfeit incidents and that counterfeiting has features Strategies to overcome this problem: o Tougher oversight of distributors o Rapid alert system o Better-informed consumers

DRUG NAMES Each drug may have several names: o Chemical name: describes drugs chemical structure o Generic name: official or nonproprietary name of the drug o Brand (trade) name: proprietary name, chosen by drug company; usually a registered trademar owned by tat specific manufacturer Pros and Cons to generic drug usage: o Generic drugs must be approved by FDA before marketing o FDA publishes a list of approved generic drugs that are bioequivalent to brand-name drugs o Cheaper and usually have the same active incredients Sometimes the generics have inert fillers and binders that may result in variations in drug effectiveness Less expensive because no extensive testing is needed Certain types of medicine require the use of the brand-name rather than the generic; make sure youre aware of that!

DRUG RESOURCES many resource reference books on drugs: o American Hospital Formulary Services Drug Information Published yearly by the American Society of Health-System Pharmacists in Bethesda Excellent reference that provides accurate and complete drug information Contains drugs listed according to therapeutic drug classification Info given on each drug: Chemistry and stability Pharmacologic action Pharmacokinetics Uses Cautions per body system

Precautions Contraindications Acute toxicity Drug interactions Dosage and administration preparations Drug Facts and Comparisons Contains info on almost all drugs marketed in the United States Prescription and over-the-counter (OTC) products reference consists of: drug actions indications warnings and precautions dosage and route adverse reactions client info overdosage drug interactions contraindications comparison charts and tables U.S. PharmacopeiaDrug Information Three-volume set 1A and 1B = drug information for healthcare provider Volume 2 = client information Physicians Desk Reference Several thousand drugs with complete drug info Seven sections Two = most useful to nurses Pink = drug names index White = information about the drugs Other periodicals also are published at different intervals regarding drugs and their usage: The Medical Letter Prescribers Letter The Handbook on Injectable Drugs

U.S. FOOD AND DRUG ADMINISTRATION PREGNANCY CATEGORIES described in chapter 3 (check tables) o classification system that relates to the effects of drugs on the fetus

POISON CONTROL CENTERS PCC o Provide information about the drug or toxic chemical compounds and what immediate action should be taken

ETHICAL CONSIDERATIONS ethical values related to drug administration: o Code of Ethics for Nurses (ANA ANDCNA) Primary obligation of a nurse is to the client Must respect rights, dignity and wishes of clients.

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Clients 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 drug and its desired effects Nurse safeguards clients and their rights, safety, dignity and healthcare Seeks consolation, accepts responsibility and demonstrates competency in nursing care

reduced prices of drugs are a problem availability of expensive drugs to those who cannot afford them is also an issue Many drugs can be bought in Canada at a reduced rate o Sometimes drugs are counterfeit AIDS patients in Africa cannot afford AIDS medication o WTO (World Trade Organization) has made changes and now permit a generic form in emergency situations