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Psychopharmacology
Legal Issues
Ethics and Legal Issues in Pharmacology
ANA code of Ethics 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.
http://www.nursingworld.org/codeofethics
Ethics and Legal Issues in Pharmacology When it comes to pharmacotherapy:
The nurse needs to know and understand all information about the patient and each medication prescribed.
Errors can occur at any point during the process of dispensing medications. Including
Selecting, procuring storing, prescribing, ordering, filling the order, dispensing, administering, monitoring and documenting.
Ethics and Legal Issues in Pharmacology1- Nurses are responsible for administering
medications withintheir scope of practice.
2- Nurses are knowledgeable about the effects, side effects andinteractions of medications and take action as necessary.
3- Nurses adhere to “5 rights” of medication (a 6th and a7th sometimes included) administration: right medication, right client, right dose, right time, right route, right documentation, and right to refuse drugs.
4. Nurses determine all orders for an individual are clear,complete, current, legible and appropriate for the clientbefore administering any medication.
Ethics and Legal Issues in Pharmacology
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 frequencywith which the medication is to be administered.
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
Ethics and Legal Issues in Pharmacology5. If there is no alternative, nurses can administer a
medicationusing the pharmacy dispensing label as an order afterconfirming it is still appropriate.
6. Nurses act upon pre-printed orders when the authorizedhealth professional has made those orders client-specific byreviewing them, adding the client’s name, customizing them,signing, and dating them.
7. Nurses act upon verbal and telephone orders only whencircumstances require doing so and if there are no otherreasonable options.
Legal Issues in Pharmacology cont.
8. Nurses administer only medications they themselves or a pharmacist have prepared, except in an emergency.
9. Nurses educate clients about all the client’s medications.
10. Nurses understand the human and system factors that increase medication errors and near misses and take steps to prevent them.
Drug Legislationand Drug Agencies
• Laws were passed in the 1900s to protect the public from unscrupulous drug sellers worthless, or mislabeled, dangerous
medicines passage of The Food and Drugs Act of 1906,
the first federal drug law 1912 amendment required accurate labeling only drugs listed in the United States
Pharmacopeia or National Formulary could be prescribed
Drug Legislationand Drug Agencies• Sulfonamide National Tragedy
forced update of The Food and Drug Act of 1906
widely used anti-infective drug elixirs made from a sweetened alcohol base drug base was an industrial-strength liquid
solvent number of children died drug manufacturer did not need FDA
approval The Food, Drug, and Cosmetic Act of 1938
Drug Legislationand Drug Agencies
• 1951 Durham-Humphrey Amendment defined prescription drugs
• thalidomide FDA refused to approve U.S. use evidence against the safety began to
accumulate 8,000 babies born with deformed limbs passage of the 1962 Kefauver-Harris
Amendment
Drug Legislationand Drug Agencies1962 Kefauver-Harris Amendment
required drugs show that they are safe and effective
before being marketed manufacturers report adverse side effects
since that time, many drugs have been kept from the market or removed
Drug Legislationand Drug Agencies
• FDA (Food and Drug Administration) weigh the inherent risks against its benefits complete review process before it issues a
final approval (or rejection) 1994: Dietary Supplements and Health and
Education Act was passed FDA guidelines for herbal products and
dietary supplements
Drug Legislationand Drug Agencies• Early 1990s
34 month average for FDA approval of a new drug for certain critical drugs the process could be
much shorter 1987 first drug effective against HIV was approved in just
107 days
• Critics still pointed to a time lag some drugs were available in other countries
before FDA approved for use in United States took time before approved by the FDA for U.S. use
Drug Legislationand Drug Agencies
• Inderal hypertension and arrhythmias available in Europe for 10 years before
approval in U.S. (1967) response to criticism
FDA made a concerted effort to streamline the approval process
particularly with respect to drugs used to treat life-threatening diseases
Drug Legislationand Drug Agencies
• In 1996 indinavir (Crixivan) was approved by the FDA in a record 42 days
• 1997 Food and Drug Administration (FDA) Modernization Act gave authority to accelerate approval process
for certain types of drugs 2000 average review time less than 15 months critically needed drugs in as little as 6 months
Drug Legislationand Drug Agencies
• FDA allows physicians to prescribe some investigational drugs life-threatening diseases, no other
alternative therapy to prescribe
requires an Emergency Treatment Investigational New Drug (IND) application
Drug Legislationand Drug Agencies
• HIPAA (Health Insurance Portability and Accountability Act of 1996) verifies that health information, including all
drug information, is kept secure information only released to authorized
inquiries
Prescription and over-the-counter (OTC) Drugs• The FDA regulates prescription drugs
and OTC drugs Rx drugs
defined as those drugs that are not safe to use except under professional medical supervision
can only be obtained with a prescription by a healthcare provider whose license permits it
Prescription and over-the-counter (OTC) Drugs For many years, distinction was clear
between prescription and OTC drugs• over-the-counter (OTC) drugs
can be purchased without a prescription generally considered safe for consumers to
use if label directions and warnings are followed warnings are heeded
Prescription and over-the-counter (OTC) Drugs• Over-the-counter (OTC) drugs
OTC drug often the same as prescription drug
1992, the OTC Drugs Advisory Committee was created assist the FDA in reviewing drugs determining which ones were safe and
appropriate for OTC use
Prescription and over-the-counter Drugs• FDA approves a prescription drug being
reclassified as an OTC drug if the following criteria are met: the OTC drug has a low rate of side
effects/toxicity and a low potential for abuse
the use of the OTC drug does not require the patient to have any special monitoring or ongoing test.
Schedule Drugs
• Harrison Narcotics Act of 1914 Drugs with the potential for abuse and
dependence were first regulated established the legal framework for
controlling these drugs introduced the word narcotic Act was replaced in 1970 by The
Comprehensive Drug Abuse Prevention and Control Act
Schedule Drugs
• Harrison Narcotics Act of 1914 divided potentially addictive drugs into five
categories or schedules based on their potential for physical or psychological
dependence known as schedule drugs or controlled substances labeling and packaging for a controlled substance and
all of its advertisements must clearly show the drug’s assigned schedule
manufacturing, storage, dispensing, and disposal of controlled substances are strictly regulated by both federal and state laws.
Schedule Drugs
• Schedule II high potential for abuse and addiction currently accepted medical uses requires an official prescription form severe physical and psychological
dependence may result
Schedule Drugs
• Schedule III less potential for abuse and addiction than
Schedule II drugs currently accepted medical uses moderate physical and psychological
dependence may result.
Schedule Drugs
• Schedule IV less potential for abuse and addiction than
Schedule III drugs currently accepted medical uses limited-to-moderate physical or
psychological dependence may result
Schedule Drugs
Schedule V limited potential for abuse currently accepted medical uses
Orphan Drugs
• In 1983, The Orphan Drug Act was passed. purpose to facilitate the development of
new drugs to treat rare diseases. drug companies are reluctant to spend large
amounts of time and money to research and test a drug especially if it will have a limited market
Orphan Drugs
• In 1983, The Orphan Drug Act was passed. drugs for rare diseases were not being
developed The Orphan Drug Act provides special
incentives including: grants to offset drug development costs a tax credit that allows up to 75% deduction of
the cost of clinical trials streamlined process for obtaining FDA approval exclusive marketing rights for seven years
Testing of New Drugs
All drugs must be thoroughly tested Tested by the company before
marketing according to FDA guidelines Testing to determine:
drug’s effectiveness drug’s safety
Testing of New Drugs
in vitro testing in vitro is Latin for in glass chemical analysis laboratory test tubes
in vivo testing in vivo is Latin for in living animal testing human testing
Testing of New Drugs
Animal testing precedes testing on humans drug evaluated and noted for:
side effects toxic effects addictions cancerous tumors fetal deformities pharmacodynamics
Testing of New Drugs
Pharmacodynamics frequency distribution curve half-life median effect dose (ED50)
median toxicity dose (TD50) therapeutic index (TI)
“This drug was tested on 2000 white mice, and they had a ball.”
David W. Harbaugh.
Testing of New Drugs
After completion of animal studies company submits an IND (Investigational
New Drug) Application contains information about animal trials shows drug not a risk to humans includes information
chemistry of drug manufacturing process
Testing of New Drug
Phases of Human Testing (clinical trials) Phase I
10-100 healthy volunteers Informed consent mandatory evaluate side effects establish final, correct dosage pharmacokinetics studied generally takes 1½ years
Figure 2-4 Newpaper advertisement. A typical newspaper ad seeking volunteers to participate in clinical trials to test a new drug.
Testing of New Drug
Phases of Human Testing (clinical trials) Phase II
50-500 patients who have disease drug intended to treat
drug given on experimental basis determines therapeutic effect usually takes 2 years
Testing of New Drug
Phases of Human Testing (clinical trials) Phase III
several hundred or several thousand ill patients
Administered same way that it will be used on the market
performance compared with other drugs that are currently on the market
double-blind studies with placebo performed usually lasts 3 years
Testing of New Drug
Phases of Human Testing (clinical trials) Phase III
testing on children standardizes pediatric doses manufacturer receives 6 month extension on
standard 17 year patent
Testing of New Drug
Completion of Phase III drug company submits all documentation
to FDA in a New Drug Application (NDA) waits for final FDA decision
approval denial
only 20% NDA’s receive final FDA approval for marketing
Testing of New Drug
Once FDA approves ingredients, dosage, manufacturing
process, labeling, and packaging cannot change
can conduct further clinical trials expand the drug’s use example:
Propranolol (Inderal) Indomethacin (Indocin)