Lilley/Rainforth Collins/Snyder/Swart, Pharmacology for Canadian Health

Care Practice, 3rd Canadian Edition

Chapter 03: Legal and Ethical Considerations

Chapter Summary

 LEGAL CONSIDERATIONS

 Prescription medications are vital to treating and preventing illness. However, due to
safety reasons, their use is regulated by individual provincial or territorial laws that are
enforced by several agencies, including Health Canada and the Royal Canadian Mounted
Police (RCMP).
 Traditionally, only medical doctors and doctors of osteopathy had the privilege of
prescribing medications. Dentists and podiatrists are also allowed to prescribe medications
that are within the scope of their practice. In some provinces or territories, other health care
providers, including licensed physician’s assistants and nurse practitioners, may also
prescribe medications.
 Canadian drug legislation began in 1875.
 The Health Products Food Branch Inspectorate of Health Canada is the federal regulator
responsible for the administration and enforcement of the Food and Drugs Act, Food and
Drug Regulations, and the Controlled Drugs and Substances Act, the two Acts that form the
foundation for drug laws in Canada. The Therapeutic Products Directorate is the Canadian
federal authority that regulates these Acts. These Acts are designed to protect the Canadian
consumer from potential health hazards and fraud or deception in the sale and use of foods,
medications, cosmetics, and medical devices.
 The Personal Information Protection and Electronic Documents Act (PIPEDA) is the
federal law governing the collection, use, and disclosure of personal information. Some
provinces and territories have specific legislation that deals with this, such as Ontario’s
Personal Health Information Protection Act (PHIPA) of 2004.
 The Food and Drugs Act is the legislation that regulates foods, drugs, cosmetics, and
medical devices in Canada.
 The Controlled Drugs and Substances Act (CDSA), passed in 1997, sets out the
requirements for the control and sale of narcotics, controlled drugs, and substances of misuse.
The CDSA is based on eight schedules that list controlled drugs and substances, based on
their potential for misuse or harm. The Act is enforced by the RCMP and related sections of
the Criminal Code.
 The Therapeutic Products Directorate (TPD) of Health Canada is responsible for
approving drugs for clinical safety and efficacy before they are brought to the market.
 The TPD has made certain lifesaving investigational drug therapies available sooner than
usual by offering an expedited drug approval process, also known as “fast track” approval.

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 The collective goal of these drug-testing phases is to provide information on the safety,
toxicity, efficacy, potency, bioavailability, and purity of a new drug.
 Before any testing on humans, subjects must provide informed consent that is
documented.
o Informed consent involves carefully explaining to the research subject the purpose
of the study, the procedures to be used, the possible benefits, and the risks involved.
o Informed consent must be obtained from all patients (or their legal guardians)
before they can be enrolled in an investigational new drug study.
 Phase I studies involve small numbers of healthy subjects (normally fewer than 100)
rather than those who have the disease or ailment the new drug is intended to treat.
o An exception might be a study involving a very toxic drug used to treat a life-
threatening illness. In this case, the only study subjects might be those who already have
the illness and for whom other viable treatment options may be unavailable.
o The purpose of Phase I studies is to determine the potential adverse effects,
optimal dosage range, and pharmacokinetics of the drug (i.e., absorption, distribution,
metabolism, and excretion) and to determine if further testing is needed. Blood tests,
urinalyses, assessments of vital signs, and specific monitoring tests are also performed.
These trials usually last from a few days to a few weeks.
 Phase II studies involve small numbers of volunteers (usually 100 to 300) who
have the disease or ailment that the drug is designed to diagnose or treat.
o Study participants are closely monitored to determine the drug’s effectiveness and
to identify any adverse effects. Therapeutic dosage ranges are refined during this phase.
 Phase III studies involve large numbers of patients (normally 1 000 to 3 000) who are
followed by medical research centres and other types of health care entities.
o The purpose of this larger sample size is to provide information about infrequent
or rare adverse effects that may not yet have been observed during previous smaller
studies.
o The objective of phase III studies is to establish the drug’s clinical effectiveness,
safety, and dosage range.
 A placebo is an inert, nondrug substance that is given to a portion of the research subjects
to separate the real benefits of the investigational drug from the apparent benefits arising out
of researcher or subject bias regarding expected or desired results of the drug therapy. A
study incorporating a placebo is called a placebo-controlled study.
 If the study subject does not know whether the administered drug is a placebo or the
investigational drug but the investigator does know, the study is referred to as a blinded
investigational drug study.
 If neither the research staff nor the subjects being tested know which subjects are being
given the real drug and which are receiving the placebo, the study is known as a double-blind
investigational drug study.
 Phase IV studies are postmarketing studies voluntarily conducted by pharmaceutical
companies to obtain further proof of the therapeutic and adverse effects of the new drug.

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Chapter Summary 3-3

o Data from such studies are usually gathered for at least 2 years after the drug’s
release. Often, the safety and efficacy of the new drug is compared with another drug in
the same category.
o In rare cases, postmarketing studies are mandated by Health Canada.
 If a pattern of severe reactions to a newly marketed drug begins to emerge, Health
Canada may request that the manufacturer of the drug issue a black box warning or a
voluntary recall.
 There are three designated classes of drug recall based on Health Canada’s response to
postmarketing data for a given drug.
 Various pieces of federal legislation have been established to help ensure the safety and
efficacy of drug therapy and the nursing process.
 Federal and state legislation, standards of care, accrediting bodies, and nurse practice acts
provide the legal framework for safe nursing practice, including drug administration.
 Health Insurance Portability and Accountability Act guidelines have increased awareness
of patient confidentiality and privacy.
 The Controlled Substances Act of 1970 provides health care providers with information
on drugs that cause little to no dependence versus those that are associated with a high level
of misuse and dependency.
 In the investigational new drug research process, care providers must adhere to the study
protocol while also acting as a patient advocate and honouring the patient’s right to safe, quality
nursing care.
 Provincial and territorial legislation dictates the boundaries for professional nursing
practice.
 The Canadian Nurses Association (CNA) advances the practice and profession of nursing
to improve health outcomes and strengthen Canada’s health care system.

 ETHICAL CONSIDERATIONS

 Nurses must adhere to legal guidelines, ethical principles, and the CNA Code of Ethics
for Registered Nurses (2008) and the International Council of Nurses Code of Ethics for
Nurses (2012) as a guidelines for nursing care.
 The health care team must make a concentrated effort to recognize and understand its
own values and to be considerate, nonjudgemental, and respectful of the values and ethics of
others.
 The use of drug therapy has evolved from simply administering whatever was prescribed
to providing responsible drug therapy for the purpose of achieving defined outcomes that
improve a patient’s quality of life.
 Ethical nursing practice is based on fundamental principles, such as beneficence,
autonomy, justice, veracity, and confidentiality. Adhering to these ethical principles and
codes of ethics ensures that the nurse is acting on behalf of the patient and has the patient’s
best interests at heart.
 The nurse has the right to refuse to participate in any treatment or aspect of a patient’s
care that violates the nurse’s personal ethical principles, while not deserting the patient. In

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instances in which refusal of care is not an option, the nurse must always act in the best
interest of the patient while remaining an objective patient advocate.
 Inert placebos are administered frequently in experimental studies of new drugs in order
to evaluate and measure the pharmacological effects of a new medicine. However, placebo
use is often considered unethical and deceitful, possibly creating mistrust among the nurse,
the prescriber, and the patient.
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Copyright © 2017 Elsevier Canada, a division of Reed Elsevier Canada, Ltd.