BNS 200 Introduction to Pharmacology Lesson 1 2025 PDF

Nursing Pharmacology 2025 Matshediso Matome  House keeping  Note learning objective relating historical perspective and pharmaceutical legislation and regulation ◦ Describe historical trends in medicines discoveries and use ◦ List source of drugs ◦ Describe t...

Nursing Pharmacology 2025 Matshediso Matome  House keeping  Note learning objective relating historical perspective and pharmaceutical legislation and regulation ◦ Describe historical trends in medicines discoveries and use ◦ List source of drugs ◦ Describe the drug development process ◦ Describe legal aspects relating to sale and supply of medicines in Botswana  Reading assignment  House keeping ◦ Course Outline, ◦ Schedule, ◦ Delivery method, ◦ Assessments.  Quiz – Contribution, when, how many  Tests – How many and when  Since the beginning people search to treat illness and cure disease the oldest known prescription dates to BC.  Era of plants, herbs and medicinal  Some of the notable advances in the use of medicines ◦ Anaesthesia (1846)... ◦ Germ theory (1861)... ◦ Penicillin (1928)... ◦ Stem cell therapy (1970s)... ◦ Immunotherapy and biologics(1970s)... ◦ Artificial intelligence (21st century)  Medication: is a substance administered for diagnosis, cure, treatment, mitigation or prevention  Prescription: the written direction for the preparation and the administration of the drug. ◦ Take home: According to MRSA, what information should be contained on a prescription for it to be valid?  In twenty first century, the emphasis on providing quality health care & nursing role included administering medication in health care facility, community and home care setting, teaching client safe and effective self administration to better care for their clients. ◦ Bedside nursing – administration and monitoring  The six rights of medication administration by the Nurse – list and ensure you are aware of the procedural rules within the institution, that are required to achieve the five rights. ◦ Prescribing of select products  Required competencies for prescribing 1. Plants: such as digitalis, vincristine. 2. Human and animals: such as epinephrine, insulin and adrenocoticotrophic hormone. 3. Minerals: as iron, iodine and zinc 4. Synthetic chemistry 5. Biologics Note all drugs are tested before they can be used in humans – part of the drug development process Some reasons for testing new drugs before use.  To ensure that they are not teratogenic ( causes birth defect)  To ensure that they are not carcinogenic ( causes cancer)  To conduct toxicity studies to ensure that they are not harmful to body system  To ensure that they are specific in action and check whether they produce the desired therapeutic effects.  To optimise route of administration Therefore , 4 stages of the drug development process Note all drugs are tested before they can be used in humans – part of the drug development process 4 stages of the drug development process  Step 1: Discovery and Development.  Step 2: Preclinical Research. ◦ answers basic questions about a drug’s safety, it is not a substitute for studies of ways the drug will interact with the human body1  Step 3: Clinical Research – note need for regulatory approval ◦ refers to studies, or trials, that are done in people  Step 4: Drug registration. In Botswana BoMRA Importance of stage 5 post marketing surveillance  Step 5: BoMRA Post-Market Drug Safety Monitoring. Cost, success rate and duration on drug discovery and drug development process  “Clinical research” refers to studies, or trials, that are done in people. While preclinical research answers basic questions about a drug’s safety, it is not a substitute for studies of ways the drug will interact with the human body1 1. https://www.fda.gov/patients/dr ug-development-process/step-3- clinical-research  Phase 1 ◦ Objectives to be met/Purpose ◦ Number of participants ◦ Type of participants  Phase 2 – Objectives to be met/purpose – Number of participants – Type of participants  Phase 3 – Objectives to be met/Purpose – Number of participants – Type of participants – Type of study design  Study Participants: 20 to 100 healthy volunteers or people with the disease/condition.  Length of Study: Several months  Purpose: Safety and dosage   Approximately 70% of drugs move to the next phase  Study Participants: Up to several hundred people with the disease/condition.  Length of Study: Several months to 2 years  Purpose: Efficacy and side effects   Approximately 33% of drugs move to the next phase  Study Participants: 300 to 3,000 volunteers who have the disease or condition.  Compares the IND to standard of care  Length of Study: 1 to 4 years  Purpose: Efficacy, compare standard of care and monitoring of adverse reactions   Approximately 25-30% of drugs move to the next phase 1. Compare preclinical phase and clinical phase in terms of subjects used? 2. Explain the purpose of phase 1, phase 2 and phase 3 clinical research in drug development 3. Explain why drug discovery and development is such a long and costly process.  Why pharmaceutical laws and regulations are necessary ◦ Public protection ◦ Guidance on proper use  What do pharmaceutical laws generally cover? ◦ Establishment of effective regulatory authorities to ensure appropriate regulation of  Manufacturing  Trade and Use  Registration  Prescribing  Dispensing  Patient use  Advertising etc  Public access to accurate information  The MRSA ◦ All medicines sold/used in Botswana must be registered ◦ and must comply with certain standards including  Quality  Safety  Effectiveness  The statutory body that decides on regulation and scheduling of medicines = BoMRA  Registration and regulation ◦ Medicines ◦ Cosmetics ◦ Complementary medicines ◦ Medical devices ◦ Veterinary medicine  Scheduling of medicines (1,2,3,4) ◦ Registers for schedule 1 medicines (Take home exercise)  Post marketing surveillance – healthcare provider reporting of any safety, quality and efficacy issues to the authority  Counterfeit medicines and risk management plan to prevent circulation of counterfeit medicines  Storage of medicines  Guidelines for disposal of medicines ◦ General ◦ HFD (schedule 1 meds)  Product information for medicines that require caution – see word content (C1042)  Contents of a prescription (Take home exercise)  Control of clinical trials  Medicine schedules in Botswana consist of 4 major schedules according to the safety with which they can be used ◦ Schedule 1 - Controlled ◦ Schedule 2 – Dr prescription ◦ Schedule 3 – Pharmacy prescription ◦ Schedule 4 – General medicines  Registers for schedule 1 medicines (Take home exercise subsection 51/1,3, 5, 6,7 and 8 (1043) registers kept by the dispenser of medicines in schedule 1A,1B, and 1C ◦ Correction of records  Counterfeit medicines: as per WHO ◦ A product that is: deliberately and fraudulently mislabelled with respect to source and/or identity. ◦ Counterfeiting can apply to both generic and branded products. ◦ Counterfeit products may include:  products with the correct ingredients or  with the wrong ingredients,  without active ingredients,  with incorrect quantities of active ingredients or  with fake packaging. What do you think are risks associated with counterfeit medicines? Discuss the nurses’ legal responsibilities in administering medications, including proper documentation.  Right patient,  Right drug,  Right dose,  Right route,  Right time, and  Right documentation ◦ General schedule medicines ◦ HFD (schedule 1/controlled) medicines that is received and supplied in the ward – what are the requirements and why?