Ethics chapter


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Ethics chapter

  1. 1. Psychopharmacology Legal Issues
  2. 2. Ethics and Legal Issues in Pharmacology <ul><li>ANA code of Ethics </li></ul><ul><ul><li>The Code of Ethics for Nurses was developed as a guide for carrying out nursing responsibilities in a manner consistent with quality in nursing care and the ethical obligations of the profession.  </li></ul></ul><ul><ul><li> </li></ul></ul>
  3. 3. Ethics and Legal Issues in Pharmacology <ul><li>When it comes to pharmacotherapy: </li></ul><ul><ul><li>The nurse needs to know and understand all information about the patient and each medication prescribed. </li></ul></ul><ul><ul><li>Errors can occur at any point during the process of dispensing medications. </li></ul></ul><ul><ul><ul><li>Including </li></ul></ul></ul><ul><ul><ul><ul><li>Selecting, procuring storing, prescribing, ordering, filling the order, dispensing, administering, monitoring and documenting. </li></ul></ul></ul></ul>
  4. 4. Ethics and Legal Issues in Pharmacology <ul><li>1- Nurses are responsible for administering medications within </li></ul><ul><li>their scope of practice. </li></ul><ul><li>2- Nurses are knowledgeable about the effects, side effects andinteractions of medications and take action as necessary. </li></ul><ul><li>3- Nurses adhere to “5 rights” of medication (a 6 th and a7th sometimes included) administration: right medication, right client, right dose, right time, right route, right documentation, and right to refuse drugs. </li></ul><ul><li>4. Nurses determine all orders for an individual are clear, </li></ul><ul><li>complete, current, legible and appropriate for the client </li></ul><ul><li>before administering any medication. </li></ul>
  5. 5. Ethics and Legal Issues in Pharmacology <ul><li>11. Nurses verify that medication orders, pharmacy labels and/or medication administration records are complete and include the name of the client, the name of the medication, the medication strength and the dosage, route and frequency </li></ul><ul><li>with which the medication is to be administered. </li></ul><ul><li>12. When a medication error or near miss occurs at any point inthe process of prescribing, compounding, dispensing or administering a medication, nurses take appropriate </li></ul>
  6. 6. Ethics and Legal Issues in Pharmacology <ul><li>5. If there is no alternative, nurses can administer a medication </li></ul><ul><li>using the pharmacy dispensing label as an order after </li></ul><ul><li>confirming it is still appropriate. </li></ul><ul><li>6. Nurses act upon pre-printed orders when the authorized </li></ul><ul><li>health professional has made those orders client-specific by </li></ul><ul><li>reviewing them, adding the client’s name, customizing them,signing, and dating them. </li></ul><ul><li>7. Nurses act upon verbal and telephone orders only when </li></ul><ul><li>circumstances require doing so and if there are no other </li></ul><ul><li>reasonable options. </li></ul>
  7. 7. Legal Issues in Pharmacology cont. <ul><li>8. Nurses administer only medications they themselves or a pharmacist have prepared, except in an emergency. </li></ul><ul><li>9. Nurses educate clients about all the client’s medications. </li></ul><ul><li>10. Nurses understand the human and system factors that increase medication errors and near misses and take steps to prevent them. </li></ul>
  8. 8. Drug Legislation and Drug Agencies <ul><li>Laws were passed in the 1900s to protect the public </li></ul><ul><ul><li>from unscrupulous drug sellers </li></ul></ul><ul><ul><li>worthless, or mislabeled, dangerous medicines </li></ul></ul><ul><ul><li>passage of The Food and Drugs Act of 1906, the first federal drug law </li></ul></ul><ul><ul><ul><li>1912 amendment required accurate labeling </li></ul></ul></ul><ul><ul><ul><li>only drugs listed in the United States Pharmacopeia or National Formulary could be prescribed </li></ul></ul></ul>
  9. 9. Drug Legislation and Drug Agencies <ul><li>Sulfonamide National Tragedy </li></ul><ul><ul><li>forced update of The Food and Drug Act of 1906 </li></ul></ul><ul><ul><li>widely used anti-infective drug </li></ul></ul><ul><ul><li>elixirs made from a sweetened alcohol base </li></ul></ul><ul><ul><li>drug base was an industrial-strength liquid solvent </li></ul></ul><ul><ul><li>number of children died </li></ul></ul><ul><ul><li>drug manufacturer did not need FDA approval </li></ul></ul><ul><ul><li>The Food, Drug, and Cosmetic Act of 1938 </li></ul></ul>
  10. 10. Drug Legislation and Drug Agencies <ul><li>1951 Durham-Humphrey Amendment </li></ul><ul><ul><li>defined prescription drugs </li></ul></ul><ul><li>thalidomide </li></ul><ul><ul><li>FDA refused to approve U.S. use </li></ul></ul><ul><ul><li>evidence against the safety began to accumulate </li></ul></ul><ul><ul><li>8,000 babies born with deformed limbs </li></ul></ul><ul><ul><li>passage of the 1962 Kefauver-Harris Amendment </li></ul></ul>
  11. 11. Drug Legislation and Drug Agencies <ul><li>1962 Kefauver-Harris Amendment </li></ul><ul><ul><li>required </li></ul></ul><ul><ul><ul><li>drugs show that they are safe and effective before being marketed </li></ul></ul></ul><ul><ul><ul><li>manufacturers report adverse side effects </li></ul></ul></ul><ul><ul><li>since that time, many drugs have been kept from the market or removed </li></ul></ul>
  12. 12. Drug Legislation and Drug Agencies <ul><li>FDA (Food and Drug Administration) </li></ul><ul><ul><li>weigh the inherent risks against its benefits </li></ul></ul><ul><ul><li>complete review process before it issues a final approval (or rejection) </li></ul></ul><ul><ul><li>1994: Dietary Supplements and Health and Education Act was passed </li></ul></ul><ul><ul><ul><li>FDA guidelines for herbal products and dietary supplements </li></ul></ul></ul>
  13. 13. Drug Legislation and Drug Agencies <ul><li>Early 1990s </li></ul><ul><ul><li>34 month average for FDA approval of a new drug </li></ul></ul><ul><ul><li>for certain critical drugs the process could be much shorter </li></ul></ul><ul><ul><ul><li>1987 first drug effective against HIV was approved in just 107 days </li></ul></ul></ul><ul><li>Critics still pointed to a time lag </li></ul><ul><ul><li>some drugs were available in other countries before FDA approved for use in United States </li></ul></ul><ul><ul><li>took time before approved by the FDA for U.S. use </li></ul></ul>
  14. 14. Drug Legislation and Drug Agencies <ul><li>Inderal </li></ul><ul><ul><li>hypertension and arrhythmias </li></ul></ul><ul><ul><li>available in Europe for 10 years before approval in U.S. (1967) </li></ul></ul><ul><ul><li>response to criticism </li></ul></ul><ul><ul><ul><li>FDA made a concerted effort to streamline the approval process </li></ul></ul></ul><ul><ul><ul><li>particularly with respect to drugs used to treat life-threatening diseases </li></ul></ul></ul>
  15. 15. Drug Legislation and Drug Agencies <ul><li>In 1996 indinavir (Crixivan) was approved by the FDA in a record 42 days </li></ul><ul><li>1997 Food and Drug Administration (FDA) Modernization Act </li></ul><ul><ul><li>gave authority to accelerate approval process for certain types of drugs </li></ul></ul><ul><ul><li>2000 average review time less than 15 months </li></ul></ul><ul><ul><li>critically needed drugs in as little as 6 months </li></ul></ul>
  16. 16. Drug Legislation and Drug Agencies <ul><li>FDA allows physicians to prescribe some investigational drugs </li></ul><ul><ul><li>life-threatening diseases, no other alternative therapy </li></ul></ul><ul><ul><li>to prescribe </li></ul></ul><ul><ul><ul><li>requires an Emergency Treatment Investigational New Drug (IND) application </li></ul></ul></ul>
  17. 17. Drug Legislation and Drug Agencies <ul><li>HIPAA (Health Insurance Portability and Accountability Act of 1996) </li></ul><ul><ul><li>verifies that health information, including all drug information, is kept secure </li></ul></ul><ul><ul><li>information only released to authorized inquiries </li></ul></ul>
  18. 18. Prescription and over-the-counter (OTC) Drugs <ul><li>The FDA regulates prescription drugs and OTC drugs </li></ul><ul><li>Rx drugs </li></ul><ul><ul><li>defined as those drugs that are not safe to use except under professional medical supervision </li></ul></ul><ul><ul><li>can only be obtained with a prescription by a healthcare provider whose license permits it </li></ul></ul>
  19. 19. Prescription and over-the-counter (OTC) Drugs <ul><li>For many years, distinction was clear between prescription and OTC drugs </li></ul><ul><li>over-the-counter (OTC) drugs </li></ul><ul><ul><li>can be purchased without a prescription </li></ul></ul><ul><ul><li>generally considered safe for consumers to use if </li></ul></ul><ul><ul><ul><li>label directions and warnings are followed </li></ul></ul></ul><ul><ul><ul><li>warnings are heeded </li></ul></ul></ul>
  20. 20. Prescription and over-the-counter (OTC) Drugs <ul><li>Over-the-counter (OTC) drugs </li></ul><ul><ul><li>OTC drug often the same as prescription drug </li></ul></ul><ul><ul><li>1992, the OTC Drugs Advisory Committee was created </li></ul></ul><ul><ul><ul><li>assist the FDA in reviewing drugs </li></ul></ul></ul><ul><ul><ul><li>determining which ones were safe and appropriate for OTC use </li></ul></ul></ul>
  21. 21. Prescription and over-the-counter Drugs <ul><li>FDA approves a prescription drug being reclassified as an OTC drug if the following criteria are met: </li></ul><ul><ul><li>the OTC drug has a low rate of side effects/toxicity and a low potential for abuse </li></ul></ul><ul><ul><li>the use of the OTC drug does not require the patient to have any special monitoring or ongoing test. </li></ul></ul>
  22. 22. Schedule Drugs <ul><li>Harrison Narcotics Act of 1914 </li></ul><ul><ul><li>Drugs with the potential for abuse and dependence were first regulated </li></ul></ul><ul><ul><li>established the legal framework for controlling these drugs </li></ul></ul><ul><ul><li>introduced the word narcotic </li></ul></ul><ul><ul><li>Act was replaced in 1970 by The Comprehensive Drug Abuse Prevention and Control Act </li></ul></ul>
  23. 23. Schedule Drugs <ul><li>Harrison Narcotics Act of 1914 </li></ul><ul><ul><li>divided potentially addictive drugs into five categories or schedules </li></ul></ul><ul><ul><ul><li>based on their potential for physical or psychological dependence </li></ul></ul></ul><ul><ul><ul><li>known as schedule drugs or controlled substances </li></ul></ul></ul><ul><ul><ul><li>labeling and packaging for a controlled substance and all of its advertisements must clearly show the drug’s assigned schedule </li></ul></ul></ul><ul><ul><ul><li>manufacturing, storage, dispensing, and disposal of controlled substances are strictly regulated by both federal and state laws. </li></ul></ul></ul>
  24. 24. Schedule Drugs <ul><li>Schedule II </li></ul><ul><ul><li>high potential for abuse and addiction </li></ul></ul><ul><ul><li>currently accepted medical uses </li></ul></ul><ul><ul><li>requires an official prescription form </li></ul></ul><ul><ul><li>severe physical and psychological dependence may result </li></ul></ul>
  25. 25. Schedule Drugs <ul><li>Schedule III </li></ul><ul><ul><li>less potential for abuse and addiction than Schedule II drugs </li></ul></ul><ul><ul><li>currently accepted medical uses </li></ul></ul><ul><ul><li>moderate physical and psychological dependence may result. </li></ul></ul>
  26. 26. Schedule Drugs <ul><li>Schedule IV </li></ul><ul><ul><li>less potential for abuse and addiction than Schedule III drugs </li></ul></ul><ul><ul><li>currently accepted medical uses </li></ul></ul><ul><ul><li>limited-to-moderate physical or psychological dependence may result </li></ul></ul>
  27. 27. Schedule Drugs <ul><li>Schedule V </li></ul><ul><ul><li>limited potential for abuse </li></ul></ul><ul><ul><li>currently accepted medical uses </li></ul></ul>
  28. 28. Orphan Drugs <ul><li>In 1983, The Orphan Drug Act was passed. </li></ul><ul><ul><li>purpose to facilitate the development of new drugs to treat rare diseases. </li></ul></ul><ul><ul><li>drug companies are reluctant to spend large amounts of time and money </li></ul></ul><ul><ul><ul><li>to research and test a drug </li></ul></ul></ul><ul><ul><ul><li>especially if it will have a limited market </li></ul></ul></ul>
  29. 29. Orphan Drugs <ul><li>In 1983, The Orphan Drug Act was passed. </li></ul><ul><ul><li>drugs for rare diseases were not being developed </li></ul></ul><ul><ul><li>The Orphan Drug Act provides special incentives including: </li></ul></ul><ul><ul><ul><li>grants to offset drug development costs </li></ul></ul></ul><ul><ul><ul><li>a tax credit that allows up to 75% deduction of the cost of clinical trials </li></ul></ul></ul><ul><ul><ul><li>streamlined process for obtaining FDA approval </li></ul></ul></ul><ul><ul><ul><li>exclusive marketing rights for seven years </li></ul></ul></ul>
  30. 30. Testing of New Drugs <ul><li>All drugs must be thoroughly tested </li></ul><ul><li>Tested by the company before marketing according to FDA guidelines </li></ul><ul><li>Testing to determine: </li></ul><ul><ul><li>drug’s effectiveness </li></ul></ul><ul><ul><li>drug’s safety </li></ul></ul>
  31. 31. Testing of New Drugs <ul><li>in vitro testing </li></ul><ul><ul><li>in vitro is Latin for in glass </li></ul></ul><ul><ul><li>chemical analysis </li></ul></ul><ul><ul><li>laboratory test tubes </li></ul></ul><ul><li>in vivo testing </li></ul><ul><ul><li>in vivo is Latin for in living </li></ul></ul><ul><ul><li>animal testing </li></ul></ul><ul><ul><li>human testing </li></ul></ul>
  32. 32. Testing of New Drugs <ul><li>Animal testing </li></ul><ul><ul><li>precedes testing on humans </li></ul></ul><ul><ul><li>drug evaluated and noted for: </li></ul></ul><ul><ul><ul><li>side effects </li></ul></ul></ul><ul><ul><ul><li>toxic effects </li></ul></ul></ul><ul><ul><ul><li>addictions </li></ul></ul></ul><ul><ul><ul><li>cancerous tumors </li></ul></ul></ul><ul><ul><ul><li>fetal deformities </li></ul></ul></ul><ul><ul><ul><li>pharmacodynamics </li></ul></ul></ul>
  33. 33. Testing of New Drugs <ul><li>Pharmacodynamics </li></ul><ul><ul><li>frequency distribution curve </li></ul></ul><ul><ul><li>half-life </li></ul></ul><ul><ul><li>median effect dose (ED 50 ) </li></ul></ul><ul><ul><li>median toxicity dose (TD 50 ) </li></ul></ul><ul><ul><li>therapeutic index (TI) </li></ul></ul>
  34. 34. <ul><li>“ This drug was tested on 2000 white mice, and they had a ball .” </li></ul><ul><li> David W. Harbaugh. </li></ul>
  35. 35. Testing of New Drugs <ul><li>After completion of animal studies </li></ul><ul><ul><li>company submits an IND (Investigational New Drug) Application </li></ul></ul><ul><ul><ul><li>contains information about animal trials </li></ul></ul></ul><ul><ul><ul><li>shows drug not a risk to humans </li></ul></ul></ul><ul><ul><ul><li>includes information </li></ul></ul></ul><ul><ul><ul><ul><li>chemistry of drug </li></ul></ul></ul></ul><ul><ul><ul><ul><li>manufacturing process </li></ul></ul></ul></ul>
  36. 36. Testing of New Drug <ul><li>Phases of Human Testing (clinical trials) </li></ul><ul><ul><li>Phase I </li></ul></ul><ul><ul><ul><li>10-100 healthy volunteers </li></ul></ul></ul><ul><ul><ul><li>Informed consent mandatory </li></ul></ul></ul><ul><ul><ul><li>evaluate side effects </li></ul></ul></ul><ul><ul><ul><li>establish final, correct dosage </li></ul></ul></ul><ul><ul><ul><li>pharmacokinetics studied </li></ul></ul></ul><ul><ul><ul><li>generally takes 1½ years </li></ul></ul></ul>
  37. 37. <ul><li>Figure 2-4 Newpaper advertisement. A typical newspaper ad seeking volunteers to participate in clinical trials to test a new drug. </li></ul>
  38. 38. Testing of New Drug <ul><li>Phases of Human Testing (clinical trials) </li></ul><ul><ul><li>Phase II </li></ul></ul><ul><ul><ul><li>50-500 patients who have disease drug intended to treat </li></ul></ul></ul><ul><ul><ul><li>drug given on experimental basis </li></ul></ul></ul><ul><ul><ul><li>determines therapeutic effect </li></ul></ul></ul><ul><ul><ul><li>usually takes 2 years </li></ul></ul></ul>
  39. 39. Testing of New Drug <ul><li>Phases of Human Testing (clinical trials) </li></ul><ul><ul><li>Phase III </li></ul></ul><ul><ul><ul><li>several hundred or several thousand ill patients </li></ul></ul></ul><ul><ul><ul><li>Administered same way that it will be used on the market </li></ul></ul></ul><ul><ul><ul><li>performance compared with other drugs that are currently on the market </li></ul></ul></ul><ul><ul><ul><li>double-blind studies with placebo performed </li></ul></ul></ul><ul><ul><ul><li>usually lasts 3 years </li></ul></ul></ul>
  40. 40. Testing of New Drug <ul><li>Phases of Human Testing (clinical trials) </li></ul><ul><ul><li>Phase III </li></ul></ul><ul><ul><ul><li>testing on children </li></ul></ul></ul><ul><ul><ul><ul><li>standardizes pediatric doses </li></ul></ul></ul></ul><ul><ul><ul><ul><li>manufacturer receives 6 month extension on standard 17 year patent </li></ul></ul></ul></ul>
  41. 41. Testing of New Drug <ul><li>Completion of Phase III </li></ul><ul><ul><li>drug company submits all documentation to FDA in a New Drug Application (NDA) </li></ul></ul><ul><ul><li>waits for final FDA decision </li></ul></ul><ul><ul><ul><li>approval </li></ul></ul></ul><ul><ul><ul><li>denial </li></ul></ul></ul><ul><ul><li>only 20% NDA’s receive final FDA approval for marketing </li></ul></ul>
  42. 42. Testing of New Drug <ul><li>Once FDA approves </li></ul><ul><ul><li>ingredients, dosage, manufacturing process, labeling, and packaging cannot change </li></ul></ul><ul><ul><li>can conduct further clinical trials </li></ul></ul><ul><ul><ul><li>expand the drug’s use </li></ul></ul></ul><ul><ul><ul><li>example: </li></ul></ul></ul><ul><ul><ul><ul><li>Propranolol (Inderal) </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Indomethacin (Indocin) </li></ul></ul></ul></ul>