Drug Standard & Drug Information Part 1

Drug Standards and Information Overview

Introduction to Online Learning and Module Objectives

• The speaker addresses student nurses, encouraging them to adapt to online learning during the "New Normal" and emphasizes the importance of attentive listening and note-taking.

• The session will cover drug information, phases of drug evaluation, drug legislations, standards, and cultural/ethical considerations in pharmacology.

Learning Outcomes

• By the end of the session, students should be able to identify different sources of drugs and their information, describe types of drug preparations, and understand phases of drug evaluation.

• Students are expected to relate drug legislation and standards in nursing care while adhering to cultural and ethical considerations for safe practice.

Phases of Drug Evaluation

Overview of Drug Development Process

• Drug development involves several stages: preclinical testing on laboratory animals followed by clinical trials on humans. The process is regulated by the FDA for safety assurance.

Preclinical Testing

• Initial tests are conducted on laboratory animals (e.g., guinea pigs) to assess toxicity and pharmacokinetics before human trials begin. This phase ensures that potential therapeutic effects are evaluated safely.

Clinical Trials Phases

1. Phase One: Involves healthy volunteers (typically young males) to test metabolism, pharmacokinetics, and biological effects. Positive outcomes lead to further testing in patients with specific diseases.

• Focuses on establishing safety profiles for new drugs through controlled environments.

2. Phase Two: Conducted with patients who have the disease targeted by the drug; this phase assesses therapeutic utility and effective dosage ranges.

• Aims at determining how well a drug works in real-world conditions among affected individuals.

3. Phase Three: Expands testing across hospitals or clinics; evaluates safety and effectiveness before market approval.

• Involves larger populations to ensure comprehensive data collection regarding efficacy versus risk factors associated with new medications.

4. Phase Four: Post-marketing surveillance monitors adverse reactions once drugs are available publicly; healthcare professionals report any negative effects observed in patients.

• Ensures ongoing assessment of long-term safety after widespread use begins post-FDA approval processes.

Drug Legislation and Standards

Importance for Nursing Practice

• Nurses must familiarize themselves with rules governing pharmaceuticals as they may work internationally; understanding local regulations is crucial for safe practice.

• Researching guidelines from regulatory bodies like the FDA is recommended for up-to-date knowledge on medication management practices globally.

Black Box Warnings

• These warnings indicate severe risks associated with newly marketed drugs; prescribers must inform patients about potential dangers linked with these medications.

• Resources such as blackboxrx.com provide lists of drugs under scrutiny due to serious adverse effects reported post-market release by manufacturers or healthcare providers.

Pregnancy Categories

• New drugs undergo classification based on their teratogenic effects—potential harm they may cause a fetus during pregnancy.

Pregnancy Categories and Drug Labeling Updates

Overview of Pregnancy Categories

• Discussion on the importance of understanding pregnancy categories for emergency cases, particularly in administering medications to pregnant mothers.

• Reference to a YouTube link provided for further reading on pregnancy categories to enhance comprehension.

Changes in Drug Labeling Regulations

• Update on the Food and Drug Administration (FDA) regarding the Pregnancy and Lactation Labeling Rule; previous pregnancy letter categories were deemed overly simplistic and misinterpreted as a grading system.

• Clarification that drugs with adverse animal information could be categorized similarly to those without any animal data, leading to potential misinterpretations.

Implementation Timeline

• Effective date for changes: June 30, 2015; all prescription drugs are required to remove pregnancy letters by June 2020 as part of a gradual process.

• New labeling aims to provide clearer descriptions of available data, aiding healthcare providers in counseling patients about prescription drug use during pregnancy.

Focus Areas in New Labels

• Emphasis on new labels addressing females and males of reproductive potential, including considerations for infertility.