PHARMACOLOGY: Introduction to Drugs

BSN2-B | Lesson 1

BASIC TERMS
GUIDELINES THAT CAN HELP ENSURE CORRECT
CLINICAL PHARMACOLOGY ADMINISTRATION:
• the study of drugs in humans (Burchum and • Read the medication order carefully. If the order
Rosenthal, 2019) is unclear, verify it with the prescriber.
• Verify the identity of the patient by comparing the
THERAPEUTICS/PHARMACOTHERAPEAUTICS name on the wristband with the name on the drug
• use of drugs to diagnose, prevent, or treat order or medication administration record.
disease or to prevent pregnancy. • Read the medication label carefully. Verify the
identity of the drug, the amount of drug (per
tablet, volume of liquid, etc.) and its suitability for
NURSING RESPONSIBILITIES administration by the intended route.
• Administering drugs • Verify dose calculations.
• Assessing drug effects • Implement any special handling the drug may
• Intervening to make the drug regimen more require.
tolerable • Don’t administer any drug if you don’t understand
• Providing patient teaching about drugs and the reason for its use.
drug regimens
AS AN EDUCATOR, THE NURSE MUST GIVE THE
• Monitoring the overall patient care plan to FOLLOWING INFORMATION
prevent medication errors
• Drug name and therapeutic category (e.g.,
penicillin: antibiotic)
SOURCES OF DRUGS
• Dosage
• Natural and synthetic • Dosing schedule
• Natural sources (Plants, Animals, inorganic • Route and technique of administration
compounds) • Expected therapeutic response and when it
• Synthetic sources (refers to the origin or should develop
production method of pharmaceutical • Nondrug measures to enhance therapeutic
substances used in medications) responses

8 ASPECTS OF DRUG THERAPY DRUG DEVELOPMENT PROCESS

(FOCUSING ON PATIENT CARE)
5 Steps (FDA, 2018)
1. Pre-administration assessment
1. Discovery and Development
2. Dosage and administration 2. Pre-Clinical research
3. Promoting therapeutic effects 3. Clinical Research
4. FDA Review
4. Minimizing adverse effects 5. FDA Post-Market, Safety Monitoring
5. Minimizing adverse interactions
6. Making “as needed” (PRN) decisions
7. Evaluating responses to medication DISCOVERY AND DEVELOPMENT
Discovery
8. Managing toxicity
• New insights into a disease process that allow
researchers to design a product to stop or
PRE-ADMINISTRATION ASSESSMENT HAS 4 BASIC
reverse the effects of the disease.
GOALS:
• Many tests of molecular compounds to find
• Collection of baseline data needed to evaluate possible beneficial effects against any of a large
therapeutic effects. number of diseases.
• Collection of baseline data needed to evaluate • Existing treatments that have unanticipated
adverse effects. effects.
• Identification of high-risk patients. • New technologies, such as those that provide
• Assessment of the patient’s capacity for self- new ways to target medical products to specific
care. sites within the body or to manipulate genetic
material.
RIGHTS OF DRUG ADMINISTRATION
1. Right Drug 6. Right Assessment
2. Right Patient 7. Right Documentation
3.Right Dose 8. Right Evaluation
4. Right Route 9. Patient’s Right to Education
5. Right Time 10.Patient’s Right of Refusal
PRE-CLINICAL RESEARCH • Proposed labeling
Before testing a drug in people, researchers must find out • Safety updates
whether it has the potential to cause serious harm, also • Drug abuse information
called toxicity. The two types of preclinical research are: • Patient information
• In Vitro (it describes medical procedures, tests, • Any data from studies that may have been
and experiments that researchers perform conducted outside the United States
outside of a living organism) • Institutional review board compliance
• In Vivo (research or work is done with or within information
an entire, living organism. Examples can include • Directions for use
such studies in animal models or human clinical
trials) COMPARISON OF GENERIC, BRAND, AND
CHEMICAL NAME
CLINICAL RESEARCH
• Clinical research refers to studies, or trials, that Brand Name
are done in people.
• Researchers design clinical trials to answer • name given to a drug by the pharmaceutical
specific research questions related to a medical company that developed it; also called a trade
product. name or proprietary name.
• These trials follow a specific study plan, called Generic Name
protocol, that is developed by the researcher or
manufacturer. • the original designation that a drug is given when
the drug company that developed it applies for
Clinical Research Phase Studies the approval process.

Phase I Chemical Name

• Study participants: 20 to 100 healthy • name that reflects the chemical structure of a
volunteers or people with the disease / condition drug.

• Length of Study: several months Generic Name Brand Name Chemical Name
• Purpose: safety and dosage Tylenol, N-(4-hydroxyphenyl)
Paracetamol
Panadol acetamide
Phase II
(RS)-4-[2-(tert-
• Study participants: Up to several hundred Ventolin,
butylamino)-1-
Salbutamol Proventil,
people with the disease / condition hydroxyethyl] -2-
Albuterol
(hydroxymethyl)phenol
• Length of Study: several months to 2 years
2-(2,3-dimethylphenyl)
Mefenamic Acid Dolfenal
• Purpose: efficacy and side effects aminobenzoic acid

2-(diphenylmethoxy)-
Phase III Diphenhydramine Bendaryl
N,N-dimethylethanamine
• Study participants: 300 to 3,000 volunteers
who have the disease of condition

• Length of Study: 1 to 4 years OVER THE COUNTER DRUGS (OTC)

• Purpose: efficacy and monitoring of adverse
reactions
Phase IV
• Study participants: several thousand
volunteers who have the disease or condition
• Length of Study: several months to 2 years
• Purpose: safety and efficacy
• Defined as drugs that can be purchased without
a prescription.
• These agents are used for a wide variety of
complaints, including mild pain, motion sickness,
allergies, colds, constipation, and heartburn.
• Nurses must be aware of OTC drugs and the
implications of their use.
• OTC drugs provide both advantages and
potential serious complications for the consumer.

FDA DRUG REVIEW

New Drug Application
A new drug application (NDA) tells the full story of a drug.
Its purpose is to demonstrate that a drug is safe and
effective for its intended use in the population studied.
Developers must include reports on all studies, data, and
analyses. Along with clinical results, developers must
include:
STEPS IN NEW DRUG DEVELOPMENT Sources of Drug Labels
Pre-clinical Testing (in animals) • drug labels
• package inserts
Toxicity • reference books
Pharmacokinetics • journals
Possible Useful Effects • internet information

Investigational New Drug (IND) Status

Clinical Testing (in humans)

Phase I
Subjects: Healthy volunteers
Tests: metabolism, pharmacokinetics, and
biologic effects

Phase II
Subjects: Patients
Tests: therapeutic utility and dosage range

Phase III
Subjects: Patients
Tests: safety and effectiveness

Conditional Approval of New Drug Application

(NDA)

Phase IV: Post-marketing Surveillance

THE PREGNANCY AND LACTATION

LABELING RULE (PLLR)

• It is a comprehensive system implemented by the

U.S Food and Drug Administration (FDA) to
provide more detailed and specific information on
drug use during pregnancy and lactation.
• It replaced the previous Pregnancy Categories (A
B, C, D and X), which were less informative and
sometimes confusing for both healthcare
providers and patients.
• The goal of the PLLR is to offer clearer guidance
to healthcare professionals and pregnant or
breastfeeding individuals about the risks and
benefits of using medications during these critical
periods.

KEY FEATURES OF PLLR:

Lactation Labeling
• the PLLR also requires drug manufacturers to
provide information about using medications
while breastfeeding.

Removal of Pregnancy Categories

• the PLLR eliminates the old Pregnancy
Categories (A,B,C,D,X) that were based on
limited data and often led to confusion. Instead,
the new labeling provides more context and
clarity about the risks and benefits of a specific
medication during pregnancy lactation.