Ppt chapter 02

Chapter 2
Pharmaceuticals: Development,
Safeguards, and Delivery
Copyright © 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins

Sources of Drugs
• Plants
• Animals
• Synthetic chemicals
• Genetically engineered chemicals

Plants
• Date to primitive times
• Classified according to their physical and chemical
properties
– Alkaloids
– Glycosides
– Gums
– Oils
– Resins

Question
• The advantage of genetically engineered drugs over
those made from animals is less drug reactions.
– A. True
– B. False

Answer
• A. True
• Rationale: Genetically engineered drugs are
considered to be purer, thereby causing less adverse
drug reactions.

Animals
• Traditionally, drugs from animal sources include agents
such as insulin.
• Today, genetically engineered hormones are rapidly
replacing animal-based drugs.
• The advantage of genetically engineered drugs is their
purity.

Synthetic Chemicals
• Most drugs used today are either partially or wholly
synthetic chemical compounds.
• A partially synthetic agent contains a derivative of a
natural substance combined with a pure chemical.
• An advantage of synthetic drugs is that they are pure
chemicals.

Genetically Engineered Chemicals
• Genetically engineered drugs are drugs developed using
DNA technologies.
• Genomics is the study and identification of genes and
gene function.
• This new knowledge has enabled researchers to
manipulate the chemical formulas of drugs to produce
more specifically targeted drugs with fewer adverse
effects.
• Proteomics is the study of protein structure and function.
• Proteomic technology is essential in biomarker discovery.

Genetically Engineered Chemicals (cont.)
• Transcriptomics is the study of the transcriptome.
• Transcriptomics aids in understanding the development
and differentiation of a cell.
• Metabonomics is the study of metabolic responses to
drugs, environmental changes, and diseases.
• In pharmacotherapy, metabonomics can possibly predict
an individual patient’s response to drug treatment.

Drug Nomenclature
• Chemical name
– Precisely describes the drug’s atomic and molecular
structure
• Generic name
– Nonproprietary name; identifies the drug’s active
ingredient
• Trade name
– Brand or proprietary name

Drug Nomenclature (cont.)

Implications for Nursing
• A drug should be ordered by the generic name.
• Many trade names sound alike.
• The nurse should check the drug name at least three
times.
• Pharmacy bar code system

Question
• For the drug furosemide (Lasix), furosemide is the _____
name of the drug.
– A. Chemical
– B. Trade
– C. Generic
– D. Therapeutic class

Answer
• C. Generic
• Rationale: Lasix is the trade name of the medication,
and furosemide is the generic name of the
medication.

Drug Classifications
• Drugs that share similar characteristics are classified as a
pharmacologic group or family.
• Allows for increased understanding of medications
• Drugs that share similar characteristics can be classified
by
– Chemical classification
– Physiologic classification
– Therapeutic classification

Sources of Drug Information
• New drugs are continually being developed.
• Nurses need reliable and up-to-date drug reference.
• Where can nurses obtain information:
– Drug publications
– Pharmacists
– Internet-based drug guides

Question
• As a new nurse, what would be the most appropriate
action to take when you administer a medication you are
unfamiliar with?
– A. Go ahead and give the drug in an emergency
situation and look the drug up later
– B. Ask a co-worker to give the medication
– C. Ask the patient why he or she is taking the
medication
– D. Look up the drug prior to administration

Answer
• D. Look up the drug prior to administration
• Rationale: As the nurse, you are responsible for the
medication you are administering. You need to know
the purpose of the medication, dosage, and side
effects prior to giving the medication. Many sources
are available to you as a nurse to obtain information
about medications.

Standards for Drug Purity and Content
• Pure Food and Drug Acts
• Federal Food, Drug, and Cosmetics Act of 1938
• Kefauver-Harris Amendment

Procedure for Drug Development and
Approval
• The first step is in the discovery of a potential new drug
molecule.
• Preclinical trials are designed to provide basic safety,
bioavailability, pharmacokinetic, and initial efficacy data
about the drug.
• Clinical trials are performed on humans in several
phases.
• Only about 10% of new drugs that begin clinical trials
are approved.

Procedure for Drug Development and
Approval (cont.)

Question
• In this phase of clinical trials, the majority of the risks
associated with the new drug therapy are identified.
– A. Phase I
– B. Phase II
– C. Phase III
– D. Phase IV

Answer
• C. Phase III
• Rationale: In phase III of drug trials, 1,000 to 3,000
patient volunteers are enrolled in double-blind
studies and crossover design studies. These studies
are monitored closely to evaluate the safety and
effectiveness of the drug.

Legislation to Promote Truth in
Advertising
• In 1912, Congress passed the Sherley Amendment.
• The FFDCA of 1938 provided labeling requirements for
the first time.
• Today, the Federal Trade Commission regulates the
advertisement of medications aimed at the general
public.

Legislation Regarding Controlled
Substances
• Harrison Narcotic Law of 1914
– Provided regulation regarding the manufacture and
distribution of certain drugs
• The 1970 Comprehensive Drug Abuse Prevention and
Control Act
– Established the Drug Enforcement Agency (DEA)
– Five categories, known as schedules, were
established.

Controlled Substances

Nursing Management of Controlled
Substances
• The prescribing, dispensing, and storing of controlled
substances is subject to governmental control.
• Procedures are precisely defined by law for every step,
from manufacture to administration to wasting or
discarding.
• Many hospitals use an automated system to
electronically track the use of stock drugs.

Legislation Regarding Drug Distribution
• The Durham-Humphrey amendments (1952)
– Nonprescription drugs (over-the-counter drugs)
– Legend (prescription) drugs
• Labeled properly
• Procedures for the distribution of legend drugs

Online Pharmacies
• Increased usage of online pharmacies
• Not all online pharmacies are regulated
• The Ryan Haight Internet Pharmacy Consumer Protection
Act of 2005

Nongovernmental Institutional Controls
• Additional regulations may be implemented by the
institution.
• Accrediting bodies play an additional role in institutional
controls.

Effect of Legal and Institutional Controls
on Nursing Management of Drug Therapy
• Drug laws and nurse practice acts vary from state to
state.
• Nurses must be familiar with the current regulations in
their states and in their practice settings.
• In professional practice, nurses must adhere to and obey
established drug control laws and protocols.
• Nurses cannot provide drug therapy without proper
authorization.
• Nurses are responsible for drug security and safe
administration.

Patient Education as a Safeguard in Drug
Therapy
• Educating patients is a key safeguard in drug therapy.
• Patient learning needs
• Teaching focus and content
• Evaluating and documenting educational outcomes
• Consumer drug information on the Internet

Importance of Nursing Management of
Drug Therapy
• Nurses are legally responsible for the drugs they
administer.
• Safe drug administration requires a thorough
understanding of therapeutic drug actions and adverse
drug reactions.
• In some clinical settings, nurses are allowed to modify
drug regimens.
• Application of the nursing process to the pharmacologic
aspects of patient care is especially important because
long-term use of drug therapy is frequently necessary to
control chronic disease processes.
• Nursing management of drug therapy may be considered
an applied science.

Ppt chapter 02

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