Nursing Pharmacology Lesson 1

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.