Nursing Pharmacology Lesson 1

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Questions and Answers

Which of the following is NOT a source of drugs?

  • Synthetic chemistry
  • Plants
  • Weather (correct)
  • Minerals

The discovery of penicillin marked a significant advancement in the use of medicines.

True (A)

What is the primary purpose of a prescription?

A prescription provides written instructions for the preparation and administration of a drug.

The six rights of medication administration ensure safe and effective medication use. These rights include the right drug, right dose, right time, right route, right patient and the ______.

<p>right documentation</p> Signup and view all the answers

Match the following historical advancements in medicine with their approximate year of discovery:

<p>Anaesthesia = 1846 Germ theory = 1861 Penicillin = 1928 Stem cell therapy = 1970s Immunotherapy and biologics = 1970s Artificial intelligence = 21st century</p> Signup and view all the answers

What is the term used to describe the process of testing new drugs before they are used in humans?

<p>All of the above (D)</p> Signup and view all the answers

Bedside nursing only involves administering medication to patients.

<p>False (B)</p> Signup and view all the answers

What are three reasons why new drugs are tested before being used in humans?

<p>New drugs are tested to ensure safety, efficacy, and determine the appropriate dosage.</p> Signup and view all the answers

What is the primary objective of Phase 1 clinical trials?

<p>Assess the drug's safety and optimal dosage (D)</p> Signup and view all the answers

Preclinical research is sufficient to determine how a drug will interact with the human body.

<p>False (B)</p> Signup and view all the answers

What is the role of the Botswana Medicines Regulatory Authority (BoMRA) in the drug development process?

<p>BoMRA is responsible for regulating and monitoring the safety of drugs post-marketing.</p> Signup and view all the answers

The drug development process typically involves _______ stages.

<p>five</p> Signup and view all the answers

Match the clinical trial phases with their primary objectives.

<p>Phase 1 = Determine efficacy and side effects Phase 2 = Assess safety and optimal dosage Phase 3 = Evaluate long-term effects and compare efficacy to existing treatments Phase 4 = Post-marketing surveillance and monitoring for rare side effects</p> Signup and view all the answers

Which of the following is NOT a primary concern in the drug development process?

<p>Biodegradability (D)</p> Signup and view all the answers

The success rate of a drug progressing through the development process is very high, with most drugs reaching the market.

<p>False (B)</p> Signup and view all the answers

What is the purpose of post-marketing surveillance?

<p>Post-marketing surveillance aims to monitor the long-term safety and effectiveness of drugs in a wider population after they have been approved for use.</p> Signup and view all the answers

What is the primary purpose of Phase 3 clinical trials in drug development?

<p>To evaluate the effectiveness of a drug compared to standard treatment (D)</p> Signup and view all the answers

Approximately 50% of drugs that successfully complete Phase 2 clinical trials advance to Phase 3.

<p>False (B)</p> Signup and view all the answers

Explain the key difference between preclinical and clinical phases in drug development in terms of the subjects involved.

<p>Preclinical trials use non-human subjects (animals) to assess the drug's safety and efficacy. Clinical phases involve human subjects, progressing through different stages to evaluate safety, effectiveness, and optimal dosage.</p> Signup and view all the answers

The ______ is the statutory body responsible for regulating and scheduling medicines in Botswana.

<p>Botswana Medicines Regulatory Authority (BoMRA)</p> Signup and view all the answers

Match the following medicine schedules in Botswana with their corresponding dispensing requirements:

<p>Schedule 1 = Controlled, requiring a doctor's prescription Schedule 2 = Available over-the-counter without prescription Schedule 3 = Available with a pharmacist's prescription Schedule 4 = Available with a doctor's prescription</p> Signup and view all the answers

Which of the following is NOT a general area covered by pharmaceutical laws?

<p>Patient education on alternative medicine practices (C)</p> Signup and view all the answers

Why are pharmaceutical laws and regulations considered essential?

<p>Pharmaceutical laws protect the public by ensuring the quality, safety, and efficacy of medicines. They provide guidance on the proper use of medications, contributing to public health and safety.</p> Signup and view all the answers

Counterfeit medicines, as defined by the WHO, are always clearly labelled with the correct source and identity.

<p>False (B)</p> Signup and view all the answers

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Flashcards

Historical Trends in Medicines

Patterns in the discovery and utilization of medicines over time.

Sources of Drugs

Various origins from which medications are derived including plants, animals, and synthetic compounds.

Drug Development Process

The steps involved in bringing a new drug to market, including testing and approval.

Legal Aspects in Medicine Sale

Regulations guiding the sale and supply of drugs, particularly in Botswana.

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Medication Definition

A substance used for diagnosis, cure, treatment, mitigation, or prevention of diseases.

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Prescription Guidelines

Written instructions for the preparation and administration of a drug to be valid.

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The Six Rights of Medication Administration

Guidelines ensuring safe drug delivery: right patient, drug, dose, route, time, and documentation.

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Testing New Drugs

The process of evaluating drugs for safety and efficacy before human use.

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Teratogenic Effects

The ability of a substance to cause birth defects.

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Carcinogenic Effects

The ability of a substance to cause cancer.

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Toxicity Studies

Research conducted to determine if a drug is harmful to body systems.

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Drug Development Stages

The process consisting of discovery, preclinical, clinical research, and registration.

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Phase 1 Clinical Trials

Early phase testing with 20-100 participants focusing on safety and dosage.

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Phase 2 Clinical Trials

Involves several hundred participants, assessing efficacy and side effects.

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Phase 3 Clinical Trials

Large-scale trials (300-3,000 participants) to confirm efficacy and monitor side effects.

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Post-Market Surveillance

Monitoring drug safety after approval to ensure ongoing efficacy and safety.

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Clinical Research Phases

Stages in drug development: Phase 1 tests safety, Phase 2 tests efficacy, Phase 3 compares to standard of care.

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Length of Clinical Studies

Typically takes 1 to 4 years to complete a clinical study.

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Success Rate of Drugs

Only 25-30% of drugs progress to the next phase after clinical trials.

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Pharmaceutical Laws

Regulations to protect the public and guide proper drug use and distribution.

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BoMRA

The body regulating medicines in Botswana, ensures compliance with safety and efficacy standards.

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Medicine Schedules

Classification of medicines in Botswana into 4 schedules based on safety and prescribing requirements.

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Counterfeit Medicines

Products that are mislabelled regarding their source or identity, posing risks to safety.

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Post-Marketing Surveillance

Monitoring of drug safety, quality, and efficacy after a drug is on the market.

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Study Notes

Lesson 1: Pharmacology

  • This lesson is part of Nursing Pharmacology 2025, taught by Matshediso Matome.
  • Learning objectives for Lessons 1 and 2 include:
    • Housekeeping (course outline, schedule, delivery method, assessments, quizzes, tests)
    • Understanding historical perspectives and pharmaceutical legislation/regulation
    • Describing historical trends in medicine discovery and use
    • Listing sources of drugs
    • Describing the drug development process
    • Describing legal aspects of medicine sale and supply in Botswana
    • Reading assignments
  • People have always sought to treat illness and cure disease.
  • The oldest known prescriptions date back to ancient times (BC).
  • Medicines have historically come from plants, herbs, and other natural sources.
  • Notable advancements include:
    • Anaesthesia (1846)
    • Germ theory (1861)
    • Penicillin (1928)
    • Stem cell therapy (1970s)
    • Immunotherapy and biologics (1970s)
    • Artificial intelligence (21st century)

Pharmacology and Medication

  • Medication is a substance used for diagnosis, cure, treatment, mitigation, or prevention of illness.
  • Prescriptions are written directions for preparing and administering medication.
  • Prescription validity may need specific information (e.g., in response to MRSA).

Pharmacology and the Nurse

  • In the 21st century, nurses' roles emphasize quality healthcare, administering medications in various settings (facilities, community, homes), and educating clients on self-medication.
  • Bedside nursing involves medication administration and monitoring.
  • Nurses must adhere to the six rights of medication administration and procedural rules of the institution.
  • Nurses may also be involved in prescribing select products (with required competencies).

Source of New Drugs

  • Drugs can originate from various sources:
    • Plants (digitalis, vincristine)
    • Animals (epinephrine, insulin, adrenocoticotrophic hormone)
    • Minerals (iron, iodine, zinc)
    • Synthetic chemistry
    • Biologics

Drug Development Process

  • All drugs undergo rigorous testing before human use.
  • Testing ensures drugs are not:
    • Teratogenic (causing birth defects)
    • Carcinogenic (causing cancer)
    • Harmful to the body system
  • Testing checks for specific action and desired effects.
  • The process includes 4 stages of drug development.

Stages of Drug Development Process

  • Drug development involves multiple steps:
    • Step 1: Discovery and Development
    • Step 2: Preclinical Research (safety testing; not a replacement for human interaction studies)
    • Step 3: Clinical Research (human trials, regulatory approval required)
    • Step 4: Drug registration
    • Step 5: Post-Market Drug Safety Monitoring (in Botswana, this is done by BOMRA)

Clinical Trials/Research

  • Clinical research involves studies/trials on people.
  • It is essential to understand how a drug interacts with the human body (preclinical research is not a substitute).
  • Links to external sources are omitted.

Clinical Research Phases

  • Clinical trial phases are outlined:
    • Phase 1: Safety and dosage, 20-100 healthy volunteers or those with the disease/condition, several months long
    • Phase 2: Efficacy and side effects, up to several hundred people with the disease/condition, several months to 2 years long.
    • Phase 3: Efficacy, comparing to standard of care, monitoring adverse reactions, 300-3,000 volunteers, 1-4 years long.

Summary Drug Development Process - Reflection

  • Discussion points about comparing pre-clinical and clinical phases.
  • Explanation of the purposes of Phases 1, 2 and 3 clinical research.
  • Why drug discovery/development is long and costly.
  • Pharmaceutical laws and regulations are vital for:
    • Public protection
    • Providing proper guidance on use
  • Laws typically cover:
    • Establishing effective regulatory authorities (e.g. BOMRA)
    • Manufacturing, Trade, and Use
    • Registration, Prescribing, Dispensing
    • Patient use, Advertising, Public access
  • All medicines sold/used in Botswana must be registered & meet standards.
  • Quality, safety, and effectiveness are key aspects.
  • BOMRA regulates and schedules medicines

Regulation of Medicines in Botswana - Relevant Provisions of MRSA

  • Key regulations surrounding medicine registration, complementary medicine, medical devices and veterinary medicine.
  • Medication registers for schedule 1, post-marketing surveillance, safety/quality/efficacy measures, counterfeit drug prevention measures, and storage/disposal guidelines.
  • Discussion points about contents of prescriptions and clinical trials control
  • Medicines in Botswana are categorized into 4 schedules based on safety/usage.
    • Schedule 1: Controlled substances
    • Schedule 2: Dr. prescription
    • Schedule 3: Pharmacy prescription
    • Schedule 4: General medicines

Regulation of Medicines in Botswana - Relevant Provisions of MRSA: Registers for Schedule 1 Medicines

  • Registration details for Schedule 1 medicines according to subsection 51/1,3, 5,6,7,8 (1043) and other relevant subsections.
  • Records correction procedures
  • WHO defines counterfeit medicines as those deliberately mislabeled concerning source or identity.
  • Counterfeits can apply to both generic and branded products.
  • Discussion points about potential related risks (omitted).

Identify Safety Protocols in Administering Medications, Including the "Six Rights"

  • Nurses' legal and ethical responsibilities in medication administration, including appropriate documentation.
  • The "six rights" of medication administration (patient, drug, dose, route, time, documentation).
  • Specific requirements regarding general schedule and HFD (schedule 1 controlled)medicines; and reasons for these requirements.

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