Ethics chapter

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


• 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


• 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


• 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


• 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


• 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


• 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


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


Animal testing precedes testing on humans drug evaluated and noted for:

side effects toxic effects addictions cancerous tumors fetal deformities pharmacodynamics


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.


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)

Health & Medicine

Ethics chapter