Podcast
Questions and Answers
Which of the following is NOT a source of drugs?
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.
The discovery of penicillin marked a significant advancement in the use of medicines.
True (A)
What is the primary purpose of a prescription?
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 ______.
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 ______.
Match the following historical advancements in medicine with their approximate year of discovery:
Match the following historical advancements in medicine with their approximate year of discovery:
What is the term used to describe the process of testing new drugs before they are used in humans?
What is the term used to describe the process of testing new drugs before they are used in humans?
Bedside nursing only involves administering medication to patients.
Bedside nursing only involves administering medication to patients.
What are three reasons why new drugs are tested before being used in humans?
What are three reasons why new drugs are tested before being used in humans?
What is the primary objective of Phase 1 clinical trials?
What is the primary objective of Phase 1 clinical trials?
Preclinical research is sufficient to determine how a drug will interact with the human body.
Preclinical research is sufficient to determine how a drug will interact with the human body.
What is the role of the Botswana Medicines Regulatory Authority (BoMRA) in the drug development process?
What is the role of the Botswana Medicines Regulatory Authority (BoMRA) in the drug development process?
The drug development process typically involves _______ stages.
The drug development process typically involves _______ stages.
Match the clinical trial phases with their primary objectives.
Match the clinical trial phases with their primary objectives.
Which of the following is NOT a primary concern in the drug development process?
Which of the following is NOT a primary concern in the drug development process?
The success rate of a drug progressing through the development process is very high, with most drugs reaching the market.
The success rate of a drug progressing through the development process is very high, with most drugs reaching the market.
What is the purpose of post-marketing surveillance?
What is the purpose of post-marketing surveillance?
What is the primary purpose of Phase 3 clinical trials in drug development?
What is the primary purpose of Phase 3 clinical trials in drug development?
Approximately 50% of drugs that successfully complete Phase 2 clinical trials advance to Phase 3.
Approximately 50% of drugs that successfully complete Phase 2 clinical trials advance to Phase 3.
Explain the key difference between preclinical and clinical phases in drug development in terms of the subjects involved.
Explain the key difference between preclinical and clinical phases in drug development in terms of the subjects involved.
The ______ is the statutory body responsible for regulating and scheduling medicines in Botswana.
The ______ is the statutory body responsible for regulating and scheduling medicines in Botswana.
Match the following medicine schedules in Botswana with their corresponding dispensing requirements:
Match the following medicine schedules in Botswana with their corresponding dispensing requirements:
Which of the following is NOT a general area covered by pharmaceutical laws?
Which of the following is NOT a general area covered by pharmaceutical laws?
Why are pharmaceutical laws and regulations considered essential?
Why are pharmaceutical laws and regulations considered essential?
Counterfeit medicines, as defined by the WHO, are always clearly labelled with the correct source and identity.
Counterfeit medicines, as defined by the WHO, are always clearly labelled with the correct source and identity.
Flashcards
Historical Trends in Medicines
Historical Trends in Medicines
Patterns in the discovery and utilization of medicines over time.
Sources of Drugs
Sources of Drugs
Various origins from which medications are derived including plants, animals, and synthetic compounds.
Drug Development Process
Drug Development Process
The steps involved in bringing a new drug to market, including testing and approval.
Legal Aspects in Medicine Sale
Legal Aspects in Medicine Sale
Regulations guiding the sale and supply of drugs, particularly in Botswana.
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Medication Definition
Medication Definition
A substance used for diagnosis, cure, treatment, mitigation, or prevention of diseases.
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Prescription Guidelines
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
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
Testing New Drugs
The process of evaluating drugs for safety and efficacy before human use.
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Teratogenic Effects
Teratogenic Effects
The ability of a substance to cause birth defects.
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Carcinogenic Effects
Carcinogenic Effects
The ability of a substance to cause cancer.
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Toxicity Studies
Toxicity Studies
Research conducted to determine if a drug is harmful to body systems.
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Drug Development Stages
Drug Development Stages
The process consisting of discovery, preclinical, clinical research, and registration.
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Phase 1 Clinical Trials
Phase 1 Clinical Trials
Early phase testing with 20-100 participants focusing on safety and dosage.
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Phase 2 Clinical Trials
Phase 2 Clinical Trials
Involves several hundred participants, assessing efficacy and side effects.
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Phase 3 Clinical Trials
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
Post-Market Surveillance
Monitoring drug safety after approval to ensure ongoing efficacy and safety.
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Clinical Research Phases
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
Length of Clinical Studies
Typically takes 1 to 4 years to complete a clinical study.
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Success Rate of Drugs
Success Rate of Drugs
Only 25-30% of drugs progress to the next phase after clinical trials.
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Pharmaceutical Laws
Pharmaceutical Laws
Regulations to protect the public and guide proper drug use and distribution.
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BoMRA
BoMRA
The body regulating medicines in Botswana, ensures compliance with safety and efficacy standards.
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Medicine Schedules
Medicine Schedules
Classification of medicines in Botswana into 4 schedules based on safety and prescribing requirements.
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Counterfeit Medicines
Counterfeit Medicines
Products that are mislabelled regarding their source or identity, posing risks to safety.
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Post-Marketing Surveillance
Post-Marketing Surveillance
Monitoring of drug safety, quality, and efficacy after a drug is on the market.
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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
Historical Trends
- 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.
Legal Aspects Pertaining to Sale and Supply of Medicines
- 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
Legal Aspects Pertaining to Sale and Supply of Medicines - Statutes (MRSA)
- 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
Legal Aspects Pertaining to Sale and Supply of Medicines - Medicine Schedules
- 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
Legal Aspects Pertaining to Sale and Supply of Medicines - Counterfeit Medicines
- 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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