CSB601 Week 11: Complementary and Precision Medicine Comprehensive Study Notes

Learning Outcomes and Core Principles of Complementary and Precision Medicine

  • Primary Learning Outcome for Complementary Medicines (CM):

    • The goal for CSB601 Week 11 is to understand the issues related to the Quality Use of Medicines (QUM) concerning complementary medicines available for various health conditions.

  • Goal of Precision Medicine Learning:

    • To understand the application of precision medicine in therapeutic management within the healthcare system.

  • Critical Principle: "Natural does NOT always mean safe":

    • This is a critical concept for evaluating CM because it counters the common patient misconception that natural products lack toxicity or risks.

    • Natural products often contain potent pharmacological compounds that can interact with conventional medicines.

  • Definition of Pharmacogenomics (PGx):

    • The study of how genes affect a person's response to drugs.

  • Definition of Integrative Medicine:

    • An approach to care that puts the patient at the center and addresses the full range of physical, emotional, mental, social, spiritual, and environmental influences.

Quality Use of Medicines (QUM) in Complementary Medicines

  • The Four Pillars of CM Therapy:

    • To align with QUM, CM therapy should remain centered upon being:

      • Safe.

      • Effective.

      • Evidence-based.

      • Patient-centered.

  • Evidence vs. Perception:

    • Practitioners must consider that many CM products have limited scientific evidence supporting their claimed efficacy, despite public perception.

  • Practitioner Role in CM and QUM:

    • The primary role is to promote safe, informed, and evidence-based use of CM while respecting patient preferences.

    • Practitioners should maintain a non-judgmental approach when discussing CM to encourage patient disclosure and maintain the therapeutic relationship.

  • Initial Step in CM Evaluation:

    • When asked to evaluate a patient's CM use, the practitioner should focus on potential safety issues first.

Risks, Safety, and Clinical Interactions

  • Major Clinical Risks of Undisclosed CM Use:

    • Significant drug-herb interactions may occur and go undetected if the clinician is not informed.

  • Common Safety Risks and Interactions:

    • St John’s Wort:

      • Pharmacokinetic Risk: Causes CYP enzyme induction (especially CYP3A4), which can lead to reduced efficacy of co-administered drugs.

      • Pharmacodynamic Risk: Linked to serotonin syndrome, especially when used with other serotonergic agents.

    • Bleeding Risks: Supplements like Ginkgo biloba, Garlic, and Fish oil are associated with increased bleeding risk.

    • Hepatotoxicity: Black Cohosh is specifically noted for its potential risk of liver toxicity.

    • Hypersensitivity: Patients with documented seafood allergies taking brand-name fish oil may experience reactions such as chest tightness, shortness of breath, and flushing.

  • Specific Patient Populations and Considerations:

    • Narrow Therapeutic Range Drugs: Practitioners must be cautious with CM in patients taking drugs like Warfarin or Digoxin, as minor changes in drug levels due to interactions can lead to toxicity or treatment failure.

    • Surgery: It is generally recommended to cease CM use two weeks prior to admission for surgery.

    • Online Purchases: Major concerns include the risk of counterfeit products, contaminants, or poor manufacturing standards.

    • CM-Lab Interactions: This occurs when a complementary medicine interferes with the accuracy of laboratory test results.

  • Pharmacovigilance and Reporting:

    • In Australia, suspected Adverse Drug Reactions (ADRs) associated with CMs should be reported to the Therapeutic Goods Administration (TGA) and the drug sponsor.

Precision Medicine and Pharmacogenomics (PGx)

  • Core Concepts:

    • Individual Variability: Refers to the unique differences in how individual patients respond to the same medication.

    • Tailored Care: Unlike the "one-size-fits-all" approach, precision medicine considers genetics, biomarkers, lifestyle, and environment to optimize therapeutic outcomes and minimize harm.

    • Shared Decision-Making: This aligns tailored treatments with the patient's values and preferences.

  • Genetic Influences on QUM:

    • Genetics can determine both the efficacy of a drug and the likelihood of toxicity for a specific patient.

    • Clinicians must recognize situations where individual variability affects medicine choice, dosing, efficacy, or toxicity.

  • Clinical Specialty Areas Utilizing PGx:

    • Oncology.

    • Psychiatry.

    • Cardiovascular medicine.

  • Common PGx Guidance and Symbols:

    • Red 'X': Indicates the clinician should consider an alternative medication due to genetic factors.

    • Orange '!' in a circle: Indicates the medication should be used with caution.

    • Normal Metabolizer Status: Generally suggests using standard precautions and standard label-recommended dosages.

    • Poor Metabolizer Status: Typically implies a higher risk of toxicity at standard doses due to slow drug clearance.

  • Ethical Concerns:

    • The use of personalized care raises issues regarding equitable access to healthcare and testing, as high costs may not be affordable for all populations.

Specific PGx Case Studies and Dosing Adjustments

  • CYP2C19 Ultra-Rapid Metabolizer (URM):

    • Lansoprazole: Experience significantly decreased drug exposure following standard dosing. For H.pyloriH. pylori eradication, consider a 4-fold higher dose.

    • Pantoprazole: For H.pyloriH. pylori eradication, consider a 5-fold higher dose.

    • Omeprazole: Be alert to insufficient response and consider increasing the dose by 3-fold if needed.

    • Sertraline: Prescribe at standard dosage but consider an alternative if the patient does not respond to maintenance dosing.

  • CYP1A2 and Environmental Factors:

    • Olanzapine: Smoking can cause higher inducibility of the CYP1A2 enzyme, leading to lower drug levels and potential non-response.

  • OPRM1 Genotypes:

    • 118AA Wild-type: Associated with poorer outcomes and higher relapse rates in Naltrexone therapy for alcohol dependence compared to G allele carriers.

Decision-Making Frameworks and Models

  • PEACE Framework for CM Decision-Making:

    • P: Personal preferences (of both the practitioner and the patient).

    • E: Evidence and Expedience (refers to availability, accessibility, and immediacy of treatment).

    • A: Range of possible Alternatives.

    • C: Costs (associated costs and risk versus potential benefits).

    • E: Evaluation.

  • BEECH Principles of Integrative Medicine:

    • B: Balance between complementary aspects.

    • E: Empowerment and self-healing.

    • E: Education and Evidence.

    • C: Collaboration between practitioner and patient.

    • H: Holism (health is multi-dimensional) and Harm (First do no harm; prioritizing safety).

  • PLEM Model (Patients' Lived Experience with Medicine):

    • Medication-related burden: The effort of managing therapy.

    • Medication-related beliefs: Influenced by family, peers, and healthcare providers.

    • Medication taking practice: How the patient actually uses the medicine.

  • PICO Concept for Evaluation:

    • P: Population.

    • I: Intervention.

    • C: Comparison.

    • O: Outcome.

Complementary Medicines with Proven Efficacy

  • Cranberry: Proven efficacy for Urinary Tract Infection (UTI) prophylaxis.

  • Fish Oils: Proven efficacy for cardiovascular disease prevention and lipid lowering.

  • Glucosamine Sulphate: Used for symptom management and slowing disease progression in Osteoarthritis (OA).

  • Peppermint: Proven efficacy for Irritable Bowel Syndrome (IBS).

  • Saw Palmetto: Used for Benign Prostatic Hyperplasia (BPH).

  • Honey: Used for infection and wound control.

  • Hawthorne: Proven efficacy for Chronic Heart Failure.

  • St John’s Wort: Used to treat mild to moderate depression with evidence comparable to some standard antidepressants.

  • Turmeric: Evaluated for anti-inflammatory effects and pain reduction in Rheumatoid Arthritis (RA).

Complementary Medicine Resources

  • Natural Medicines (NatMed): Recognized as the most comprehensive CM resource worldwide; preferred for detailed monographs and interaction checkers. Limitation: US-based and does not recognize most Australian brand names.

  • Natural Standard Professional Database: Ranked by the NPS 2008 review as the highest quality (Tier 1) resource.

  • MedLine Plus Herbs and Supplements: Freely accessible to the public, hosted by the US National Library of Medicine.

  • Australian Pharmaceutical Formulary (APF): Recommended for pharmacy students to find 50 brief top-level CM monographs.

  • Special Populations Resources:

    • Pregnancy and Breastfeeding Medicines Guide (PBMG): For specific safety in pregnancy.

    • MotherToBaby (or OTIS): Provides info on medications (including CM) during pregnancy and breastfeeding.

  • Home Medicines Review (HMR): A clinical process to enhance understanding of medication-related problems and improve QUM in complex patients.

  • Naranjo Probability Scale: Used in clinical cases to determine the likelihood that a specific drug/substance caused an adverse clinical event.