Medicines and Medication Regulation and Policies

Medicines and Medication Regulation in Australia

  • The topic for the week is medicines and medication-related content.
  • Will cover the regulation of medicines in Australia and related policies.

What are Medications?

  • Substances that provide a therapeutic benefit when taken.\

Forms of Medicines

  • Tablets
  • Injections
  • Liquids
  • Patches

Regulation of Medications

  • TGA (Therapeutic Goods Administration): Responsible for regulating medications and medical devices.

Federal vs. State Regulation

  • Federal Government (TGA):
    • Regulates the approval, registration, and scheduling of medicines.
    • Medicines must be approved by the TGA to be registered on the market.
    • Medicines are placed in schedules that determine how they are supplied, prescribed, or used.
  • State Government:
    • Regulates the practice components.
    • Includes who can prescribe what, how medications are dispensed, where and how medications are stored, and who checks these aspects.
  • Practice requirements can vary significantly based on location.

Responsibility

  • It is the individual's responsibility to know what they can and cannot do regarding medication practices when crossing state borders.
  • Ignorance is not a defense.

National Medicines Policy

  • A comprehensive document governing the approach to medications in Australia at the federal level.
  • It addresses various medication-related aspects.
    • Four Pillars: Quality use of medicines, equitable access, meeting of standards and quality, collaborative and sustainable medicines industry.

Four Pillars:

  • Quality Use of Medicines: Focus on three principles to be explored:
  • Equitable, Timely, Safe, and Reliable Access to Medicines:
    • Addresses the cost of medications.
    • Involves schemes like PBS (Pharmaceutical Benefits Scheme), RPBS, CTG (Closing the Gap), and others to ensure equitable access.
    • Includes incentives for suppliers to ensure medication availability across Australia, typically within one to two business days.
  • Medicines That Meet Required Standards, Quality, Safety, and Efficacy:
    • Related to the regulatory powers of the TGA.
    • The TGA regulates the approval process of medications.
    • Requires evidence and clinical trials before registration and supply in Australia.
    • The TGA also regulates manufacturing facilities, including overseas audits, to ensure quality.
  • Collaborative, Innovative, Sustainable Medicines Industry and Research Sectors:
    • Refers to initiatives that subsidize research and development.
    • Supports vaccination research and generic drug production.

Additional Initiatives

  • The Australian Commission on Safety and Quality in Health Care producing guidance documents.
  • Local areas generating guidance based on the National Medicines Policy.
  • National frameworks guide additional research; research should aim to be at least as equitable, timely, safe, and reliable as current standards.

Quality Use of Medicines (QUM) and Medicine Safety

  • QUM principles apply to healthcare professionals, individuals, carers, and family members.
  • The degree of application varies by profession due to different roles and interactions with medications.

Three Core Principles of QUM

  • Selecting Treatment Options.
  • Choosing Suitable Medicines.
  • Using Medicines Safely and Effectively.
Selecting Treatment Options
  • Involves choosing between pharmacological and non-pharmacological approaches.
  • Medication may not always be the best treatment option.
  • Considerations include the need to differentiate between medicines.
Choosing Suitable Medicines
  • The term "choosing" is used because not all healthcare professionals prescribe medicines; they may administer or supply them.
  • Pharmacists dispense medicines, but also check that the medicine is appropriate.
  • Deprescribing is also a part of this principle.
Using Medicines Safely and Effectively
  • This principle involves clinical monitoring through clinical observations to checking patient response.
  • It is important to document and do clinical handover.
Adverse Drug Reactions (ADR)
  • Type A: Predictable, based on the pharmacology of the medication (85% of ADRs).
  • Type B: Idiosyncratic, with no clear reason (15% of ADRs).
  • The best way to avoid ADR is not to administer a drug if possible.
  • Non-pharmacological approaches should be considered.
  • Judicious and appropriate use is crucial.

Paramedic Application of QUM Principles

  • Selecting Treatment Options:
    • Considering non-pharmacological approaches before medication.
    • Choosing between different medicines (e.g., morphine vs. fentanyl).
  • Choosing Suitable Medicines:
    • Considering the formulation (e.g., fentanyl patch vs. nasal spray).
    • Different formulations act quicker.
    • Considering patient's ability to take medication.
    • Take into account any pre existing medical conditions.
    • Considering a person's age, as certain medicines aren't applicable to children.
    • Considering side effects alongside comorbidities.
    • Being aware of potential drug integrations, such as drug and disease integrations.
  • Using Medicines Safely and Effectively:
    • Monitoring the patient through clinical observations (obs).
    • Looking for respiratory depression and blood pressure when administering painkillers.
    • Assessing the route of medication administration.
    • Inhalation vs. IV administration.
    • Clinical handover, communication, and documentation of how much was given when handing a patient over into care.

Pharmacist Application of QUM Principles

  • Selecting Treatment Options:
    • Having more time to understand a patient's lifestyle.
    • Providing advice on lifestyle modifications.
  • Choosing Suitable Medicines:
    • Worrying about the cost of medicines.
    • Considering generic medicines.
    • Considering route of medication and if the person can swallow the medicine.
  • Using Medicines Safely and Effectively:
    • Access to a patient's continuity of care.
    • Checking on patient's safety across the continuum and effectiveness of medicines.
    • Checking blood pressure.
    • Take time making sure all information is accurate.
    • Look into non adherence.

Podiatrist Application of QUM Principles

  • Prescribing rights after extra study.
  • Formulary driven.
  • Referring to someone if something becomes out of field for scope of practice.
  • Administering medicines as well.

Radiographers and Radiation Therapists Application of QUM Principles

  • Contrast administration.
  • Considering alternative action besides contrast administration.
  • Educating the patients.

Additional Points Emphasized

  • The Qum principles work alongside healthcare providers and organisations.
  • Patient is important when encouraging medication treatment.
  • Proper communication.
  • Risk management.
  • Information resources.
  • Medicine disposal.
  • More healthcare professionals get prescribing rights and they are going to be initiating meds.
  • Polyclinicianism: patients that are seeing more than one healthcare professional.

Therapeutic Goods Administration (TGA) Regulatory Functions

  • Medicines bought online may have to have the prescription approved by the TGA before they can be shipped over.

AUST L vs. AUST R

  • AUST L:
    • Lower risk.
    • Complementary medicines, vitamin formulations.
    • Ingredients will fall under pre approved ingredient only.
  • AUST R:
    • Assessed for pre market effectiveness.
  • Both make sure the ingredient is actually in the product.
  • Registered products have been assessed for safety and efficacy.
  • Listed products are not necessarily assessed for efficacy.

Scheduling of Medicines

  • TGA is responsible for scheduling medicines.
  • Schedule 1 doesn't exist.
  • Schedules that are relevant in general practice are 2,3,4, and 8.
    • Two and 3 medication can be accessed without prescription.
    • Schedule Four requires a prescription.
    • Schedule 8 required a prescription and has monitoring requirements.
    • There is a bit of controversy whether ibuprofen should be unscheduled.

Activity Three Scenario involving Sarah

  • Sarah wants to access medication from overseas.
  • If customs picks up medication from overseas, you may have to provide an actual prescription to it.
  • Likely diagnosis is migraine.
  • Currently takes Ibuprofen.

Therapeutic Guidelines

  • Access therapeutic guidelines through the library access.
  • There is an approach to treatments.
  • She is drinking a lot of coffee.