Medical-Legal Considerations for Paramedics

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Questions and Answers

What is one of the main objectives of the Food and Drug Act?

  • To oversee the financial operations of drug companies
  • To regulate the manufacturing processes of all consumer goods
  • To protect consumers from food that is contaminated or unsafe for use (correct)
  • To establish international trade laws for pharmaceuticals

Which act clarifies the terms used in drug regulation in Canada?

  • Drug Quality Assurance Act
  • Food and Drug Act
  • Controlled Drugs and Substances Act (correct)
  • Health Products Regulation

What year was the Controlled Drugs and Substances Act enacted?

  • 2001
  • 1941
  • 1967
  • 1996 (correct)

Which of the following is NOT a focus of the Food and Drug Regulations?

<p>Transporting controlled substances (D)</p> Signup and view all the answers

Which entity is responsible for drug control in Canada according to the legislation?

<p>Department of National Health and Welfare (D)</p> Signup and view all the answers

What is one important aspect of the Controlled Drugs and Substances Act?

<p>It addresses the distribution and production of controlled drugs (D)</p> Signup and view all the answers

How does the Food and Drug Act protect consumers regarding food products?

<p>By preventing contamination and false labeling (C)</p> Signup and view all the answers

What aspect of drug administration do paramedics need to comply with according to Canadian legislation?

<p>The documentation and administration of medications (A)</p> Signup and view all the answers

What is the primary purpose of the Food and Drug Regulations?

<p>To ensure the safety and efficacy of health products (D)</p> Signup and view all the answers

What is a significant regulation under the Controlled Drugs and Substances Act?

<p>Limiting the quantities of controlled substances that can be prescribed (B)</p> Signup and view all the answers

What is the primary purpose of the Controlled Drugs and Substances Act (CDSA) classification system?

<p>To classify drugs according to their safety, risk of dependence, and medical use (A)</p> Signup and view all the answers

Which schedules of controlled substances are specifically mentioned as being repealed in the CDSA classification?

<p>Schedule VII and VIII (C)</p> Signup and view all the answers

What is the result of subsection 56(1) of the CDSA for designated paramedics in Ontario?

<p>It enables them to administer controlled substances under specific regulations (A)</p> Signup and view all the answers

Which of the following medications is NOT included in the exemptions outlined for paramedics under the CDSA?

<p>Aspirin (D)</p> Signup and view all the answers

Who can legally prescribe medication within the paramedic setting according to the content provided?

<p>Licensed physicians (B)</p> Signup and view all the answers

What is a potential consequence of a paramedic administering a medication outside of their scope of practice?

<p>Practicing medicine without a license (D)</p> Signup and view all the answers

Which of the following statements accurately describes medical directives and standing orders (MDSOs)?

<p>They outline the conditions under which a paramedic may administer a medication. (C)</p> Signup and view all the answers

What primary role do the schedules V and VI play in the CDSA classification system?

<p>They outline precursors required to produce controlled substances. (D)</p> Signup and view all the answers

With respect to the CDSA, which of the following activities is prohibited for paramedics without a specific exemption?

<p>Selling controlled substances to patients (C)</p> Signup and view all the answers

What must a paramedic ensure before administering medication according to the medical directives?

<p>Specific medical criteria are met (B)</p> Signup and view all the answers

What constitutes valid consent for treatment?

<p>The patient must understand relevant information and appreciate consequences. (C)</p> Signup and view all the answers

Which of the following is NOT considered part of informed consent?

<p>The financial cost associated with the treatment. (B)</p> Signup and view all the answers

In which scenario can a paramedic administer treatment without consent?

<p>In emergency situations with no available authorized person. (A)</p> Signup and view all the answers

What must a paramedic do if directed to perform an action outside their scope of practice?

<p>Notify the BHP and refuse to comply with the direction. (A)</p> Signup and view all the answers

What must a patient or caregiver do to ensure the paramedic can assist with a specific technology?

<p>Confirm they are trained in the use of the technology or medication. (D)</p> Signup and view all the answers

For consent to be informed, which of the following information is NOT required?

<p>The background of the medical provider. (D)</p> Signup and view all the answers

What condition must be met for a paramedic to assume a patient’s consent is valid in emergencies?

<p>The paramedic believes the patient is not capable of giving consent. (A)</p> Signup and view all the answers

When responding to a BHP's direction, what should a paramedic prioritize?

<p>Ensuring the action aligns with their authorized skill set. (C)</p> Signup and view all the answers

What does a patient need to understand for valid consent regarding treatment options?

<p>The risks involved and alternatives available. (B)</p> Signup and view all the answers

Which of the following is true regarding emergency consent procedures?

<p>Paramedics can act based on their assessment of the patient's capability. (D)</p> Signup and view all the answers

If a patient does not meet the MDSO for NTG, but a physician directs the paramedic to administer it, what is the primary legal concern for the paramedic?

<p>The paramedic should refuse to administer the medication unless the patient meets the MDSO criteria. (C)</p> Signup and view all the answers

According to the provided context, which statement accurately reflects the legal responsibility of a paramedic regarding medication administration?

<p>Paramedics are legally responsible for ensuring medications are administered within their scope of practice and according to established protocols. (A)</p> Signup and view all the answers

In the context of "Medical Delegation Case Studies," what is the key difference between Case 1 and Case 2 from a legal perspective?

<p>Case 1 involves a direct order from a physician, while Case 2 involves a request for advice from a non-medical professional. (B)</p> Signup and view all the answers

What does the term 'informed consent' mean in the context of paramedic treatment?

<p>Consent that is given by a patient who fully understands the risks and benefits of the treatment, as well as alternative options. (C)</p> Signup and view all the answers

What are the elements required for consent to treatment to be legally valid?

<p>The patient must be capable of giving consent, it must relate to the treatment, it must be provided voluntarily, and it must not be obtained through misrepresentation or fraud. (B)</p> Signup and view all the answers

What is the purpose of the medical directives mentioned in the text?

<p>To indicate when a patch for online medical control is required, ensuring proper communication and authorization for advanced interventions. (C)</p> Signup and view all the answers

Based on the provided content, what is the primary responsibility of a paramedic regarding medication administration?

<p>To administer medications according to established protocols and within their scope of practice. (B)</p> Signup and view all the answers

According to the provided content, what is an example of implied consent in a medical context?

<p>A patient who extends their arm when a paramedic asks for access to their vein for an IV. (C)</p> Signup and view all the answers

What is a potential consequence for a paramedic who administers medication outside of their scope of practice or established protocols, even with a physician's order?

<p>All of the above. (D)</p> Signup and view all the answers

What is the purpose of the "CARDIAC ISCHEMIA PROTOCOL (ALS PCS)" mentioned in the text?

<p>To ensure consistency and best practices in the management of cardiac ischemia by paramedics. (D)</p> Signup and view all the answers

Flashcards

Food and Drug Act

A Canadian law passed in 1941, safeguarding consumers from potentially harmful food and drugs.

Food and Drug Regulations

An accompanying document to the Food and Drug Act, providing specific guidelines for importing, manufacturing, labeling etc.

Controlled Drugs and Substances Act (CDSA)

A Canadian law passed in 1996, governing controlled drugs and substances like narcotics and stimulants.

Department of National Health and Welfare

The Canadian government department responsible for overseeing drug control and regulation in Canada.

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Medical Delegation

The process by which a qualified professional (like a physician) authorizes another healthcare professional (like a paramedic) to perform specific tasks.

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Medical Directive

A written document outlining specific medical procedures a paramedic is authorized to perform under the direction of a physician.

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Standing Order

Another name for a medical directive, where specific actions are pre-authorized by a physician for recurring situations.

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Legislation

A set of rules and regulations that govern a specific industry, profession, or activity.

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Medication Administration

The act of using a drug for a medical purpose.

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Controlled Substances

Substances that are restricted and regulated due to their potential for abuse and addiction.

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CDSA Exemption for Paramedics

A set of regulations that outline how paramedics can legally possess and administer certain medications under specific circumstances.

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Class Exemption for Primary Care Paramedics

A specific type of exemption granted to paramedics who meet certain qualifications, allowing them to legally possess and administer specific medications under the CDSA.

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Who Can Prescribe Medication?

The person who can prescribe medications in a pre-hospital setting. Only licensed physicians are legally authorized to prescribe medication.

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Medical Directives and Standing Orders (MDSOs)

A legal medical document that outlines the conditions under which paramedics can administer specific medications. They are specific to each province and ambulance service.

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Practicing Medicine Without a License

The practice of administering medication outside of the scope authorized by MDSOs and medical delegation. It is illegal and considered practicing medicine without a license.

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Schedule I - IV

A specific drug category within the CDSA that outlines the potential for abuse and addiction. This category includes drugs like morphine and fentanyl.

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Schedule V & VI

A specific drug category within the CDSA used to control the raw materials (precursors) needed to produce controlled substances.

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Schedule IX

A specific drug category within the CDSA focused on controlling equipment used to produce pills. This category has been repealed.

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Informed Consent

Consent that is given verbally or in writing, where the patient is informed about the treatment and agrees to it.

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Implied Consent

Consent that is assumed based on the patient's actions or behavior, such as nodding or reaching out for help.

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Capacity to Consent

The ability to make decisions about their own health care and understand the consequences of their decisions.

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Medication Administration Responsibility

The responsibility of paramedics to ensure they are knowledgeable about all medications they administer, including potential risks and interactions.

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Decision-Making Capacity

The ability to understand information relevant to a treatment decision and appreciate the potential outcomes.

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Informed Consent Information

Information a reasonable person would require to make a treatment decision, such as the nature, benefits, risks, and alternatives.

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Understanding

A patient understands the information provided about the treatment and its potential consequences.

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Appreciation

A patient recognizes and values the potential outcomes of a treatment decision.

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Emergency Consent Exception

A paramedic can provide treatment without consent in an emergency if the patient lacks capacity and delaying treatment will worsen their condition.

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Paramedic Scope of Practice

A paramedic can only perform actions within their authorized skills and training.

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Exceeding Scope of Practice

A paramedic must advise the physician and BHP if their request exceeds their scope of practice.

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Assumption of Training

A paramedic can assume a patient or caregiver knows how to use a technology or medication if they confirm their training.

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Paramedic Assistance

A paramedic can assist a patient or caregiver with technology or medications only within their scope of practice and based on confirmed training.

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Study Notes

  • Review the presentation "Medical-Legal Considerations" on Brightspace.
  • Read textbook chapters 2 (pp.18-20) and 3 (pp.37-48). Note that these chapters, while UK-specific, cover mirrored concepts in Canadian law.

Objectives

  • Identify regulations under the Food and Drug Act and Food and Drug Regulations applicable to paramedics.
  • Identify laws under which paramedics carry and dispense medications.
  • Identify special regulations for storage, transport, documentation, and administration of controlled substances under the Controlled Substances Act.
  • Discuss forms of medical delegation.
  • Explain how physicians may delegate to paramedics.
  • Discuss the structure of a medical directive or standing order.

Canadian Regulations and Legislation

  • Canadian legislation began in 1875.
  • Two acts of Parliament (Food and Drug Act [1941] and Controlled Drugs and Substances Act [1996]) form the basis of drug laws.
  • The Department of National Health and Welfare is responsible for drug control in Canada.

Canadian Regulations and Legislation (Specific Acts)

  • Food and Drug Act: Protects consumers from contaminated, adulterated or unsafe food and drugs; addresses falsely labelled or misleading products; and regulates drug manufacture & sale.
  • Food and Drug Regulation: An annex to the Food and Drug Act, explicitly defining terms used in the Act, and covering importing, preparing, treating, processing, labeling, advertising, and selling of food, drugs, cosmetics, natural health products (including herbal products), and medical devices.
  • Controlled Drugs and Substances Act (CDSA): Addresses drug possession, sale, manufacture, distribution, production, import, and export of controlled drugs, their precursors, and other controlled substances; and describes drug record keeping, documentation, and dispensing procedures.

CDSA Classification

  • CDSA classifies drugs into 8 categories based on safety risk, potential for dependence, and medical use.
  • Schedule V & VI: Precursors required to produce controlled substances.
  • Schedule VII & VIII: Repealed.
  • Schedule IX: Pill making equipment.
  • (See Table I, Schedules of Controlled Substances within the CSA for specific details on each schedule and examples.)*

CDSA Exemptions for Paramedics

  • Ontario paramedics (Primary Care, Advanced Care, and Critical Care) employed by certified ambulance services are exempted from some CDSA regulations, effective May 16, 2019 (subsect. 56(1)).
  • Exemptions pertain to possession of certain controlled substances (fentanyl, hydromorphone, ketamine, morphine, pethidine).
  • Also, exemptions regarding controlled substance selling, giving, transfer, etc. (diazepam, fentanyl, hydromorphone, ketamine, lorazepam, midazolam, morphine, pethidine).
  • Benzodiazepine possession also exempted (diazepam, lorazepam, midazolam).

Medical Delegation

  • Only physicians can prescribe medications in a clinical setting.
  • Paramedics are delegated the ability to administer certain medications, with specific medical criteria.
  • Administering medication outside their scope is considered practicing medicine without a license; MDSO's (Medical directives and standing orders) are crucial in such cases.

General Structure of a Medical Directive (MDSO)

  • Provides guidelines for when a paramedic may administer a medication.
  • Outlines conditions under which medication may be administered and specific clinical requirements.
  • Medical directives will indicate if/when a patch to online medical control is required.

Acute Coronary Syndrome (ACS) / Nitroglycerin Administration

  • For ACS, specific conditions must be met before initiating Nitroglycerin administration (e.g., patient age, MAP, heart rate, alertness),
  • Specific contraindications exist (e.g., nitrate allergy, use of phosphodiesterase-5 inhibitors within 48 hours).

Cardiac Ischemia Protocol (ALS PCS)

  • Protocol outlines conditions and considerations for treatment of cardiac ischemia, including potential use of ASA and nitroglycerin. Key considerations include age requirements, vital signs, and potential contraindications.

Responsibilities of the Paramedic

  • Maintain up-to-date information on medications and side effects.
  • Assess patient needs accurately and appropriately manage medication.
  • Employ appropriate interventions based on assessment.
  • Ensure accurate medication administration and maintain proper documentation.

Medical Delegation Case Studies

  • Case 1: Paramedic is asked to administer NTG, but patient does not meet MDSO criteria. Legal implications are discussed.
  • Case 2: Paramedic is asked for advice on a sick child. Legal responsibility is discussed.
  • Case 3: Paramedic tasked with escorting a patient with complex medical needs to a destination. Legal requirements are discussed.
  • Case 4: Paramedic called for an elderly patient with DNR. Patient refusing transport and wishes to die at home. Legal implications are discussed.
  • Paramedics must obtain consent prior to treating a patient, except in emergency situations. Informed or implied consent is acceptable.
  • Informed consent includes disclosing treatment nature, expected benefits, potential risks/side effects, alternatives, possible consequences of refusing treatment, and responding to patient questions/requests for further information.
  • Emergency situations allow for treatment without consent when the delay would prolong suffering/risk/bodily harm. Delay of treatment and ability to give consent should also be considered.

Determining Competence

  • Valid consent requires a patient's capacity to provide consent.
  • A patient is considered competent if able to understand relevant information, make decisions, and appreciate the consequences of their decisions/lack thereof.

Care Outside of Scope

  • Paramedics cannot provide care that exceeds their authorized skill set. Knowledge of technology/medication is assumed once it's verified the patient or caregiver has the corresponding training. Exceeding paramedic scope of practice must be communicated, and further direction requested of a higher medical authority.

Additional Notes

  • Information is based on the provided images.
  • Specific dosages, conditions, and examples are included where applicable.

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