1. Medication Overview Flashcards

1
Q

What is pharmacy?

A

Pharmacy is the science and practice of preparing, dispensing, and reviewing drugs, as well as providing additional clinical services to ensure safe and effective medication use.

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2
Q

How has pharmacy evolved over time?

A

Pharmacy has evolved from trial and error methods to a more scientific approach, with formal education and research becoming essential in the 17th century.

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3
Q

What were some major drug discoveries in the last 200-300 years?

A

1906: Vitamins (Fredrick Hopkins)
1921: Insulin (Frederick Banting and Charles Best)
1950: External cardiac pacemaker (John Hopps and Wilfred Bigelow)
1967: Propranolol (first beta blocker, James Black)
1999: The Edmonton Protocol (James Shapiro)

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4
Q

What are the sources of modern drugs?

A

Plants: e.g., digoxin from foxglove, morphine from opium poppy.
Animals: e.g., insulin from pig pancreas.
Minerals: e.g., calcium and iron.

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5
Q

What is pharmacology?

A

Pharmacology is the study of drugs and their effects on the body, focusing on how they can improve health or cause harm if misused.

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6
Q

What subjects are important for understanding pharmacology?

A

Knowledge in anatomy, physiology, chemistry, and pathophysiology is essential for the safe application of drugs.

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7
Q

How do pharmacology and therapeutics differ?

A

Pharmacology studies drugs and their effects, while therapeutics focuses on using drugs to treat diseases and alleviate suffering.

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8
Q

What are the classifications of drugs?

A

Traditional Drugs: Chemically produced in labs.
Biologics: Naturally produced substances (e.g., hormones, vaccines).
Natural Alternatives: Herbs, vitamins, and dietary supplements.

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9
Q

What are the responsibilities of pharmacy technicians?

A

Pharmacy technicians assist in dispensing medications, managing patient profiles, preparing products, and providing instructions on medical devices.

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10
Q

What is required to become a registered pharmacy technician in Canada?

A

Candidates must complete a CCAPP-accredited program, pass relevant certification exams, and accumulate 2000 hours of work or teaching experience within the past 36 months.

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11
Q

Why is understanding the history of pharmacy important?

A

Understanding the history helps contextualize current practices and the evolution of drug discovery and healthcare roles.

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12
Q

What is the significance of the 17th century in pharmacy?

A

The 17th century marked the beginning of better documentation and basic testing in pharmacy, leading to the requirement for pharmacists to have a university education.

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13
Q

What are the consequences of improper drug application?

A

Improper application of drugs can lead to devastating health consequences, including adverse reactions, ineffective treatment, and potential harm to patients.

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14
Q

What is the role of pharmacists in healthcare?

A

Pharmacists are experts in medication management, advising patients on drug interactions, side effects, and proper usage, and ensuring safe medication distribution.

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15
Q

How are drugs classified based on their sources?

A

Natural Sources: Derived from plants, animals, and minerals.
Synthetic Sources: Chemically manufactured in laboratories.

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16
Q

What is the difference between pharmacology and pharmaceutics?

A

Pharmacology focuses on the study of drugs and their effects, while pharmaceutics is the science of formulating and preparing medications.

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17
Q

What is pharmacotherapeutics?

A

Pharmacotherapeutics is the application of pharmacology to treat diseases, focusing on the therapeutic use of drugs.

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18
Q

Who are the healthcare providers that can prescribe drugs?

A

Physicians, dentists, advanced nurse practitioners, and, depending on provincial or territorial laws, some other healthcare providers.

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19
Q

What are the key components of the pharmacy team?

A

The pharmacy team includes pharmacists, pharmacy technicians, and pharmacy assistants, each with specific responsibilities and scopes of practice.

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20
Q

What is the importance of interdisciplinary knowledge in pharmacology?

A

Interdisciplinary knowledge enhances the understanding of drug interactions, patient care, and the overall effectiveness of treatment plans.

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21
Q

What are some examples of traditional drugs?

A

Traditional drugs are chemically produced in laboratories and include medications like antibiotics, analgesics, and antihypertensives.

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22
Q

What are biologics, and how do they differ from traditional drugs?

A

Biologics are naturally produced by living organisms and include substances like vaccines and hormones, differing from traditional drugs that are chemically synthesized.

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23
Q

What is the evolving role of pharmacy technicians?

A

Pharmacy technicians are increasingly involved in patient care, medication management, and ensuring the accuracy of prescriptions, reflecting a growing recognition of their expertise.

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24
Q

What is the process for becoming a registered pharmacy technician?

A

The process includes completing a CCAPP-accredited program, passing certification exams, and gaining relevant work experience.

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25
Q

What is the historical significance of pharmacy?

A

Pharmacy has existed for thousands of years, evolving through trial and error, and has become a distinct profession separate from medicine.

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26
Q

What are the major drug discoveries highlighted in the lecture?
A: Key discoveries include:

A

1906: Vitamins (Fredrick Hopkins)
1921: Insulin (Frederick Banting and Charles Best)
1951: Cobalt bomb for cancer (Harold Johns)
1967: Propranolol (first beta blocker, James Black)

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27
Q

What are the classifications of drugs based on their sources?

A

Plant-derived: e.g., digoxin from foxglove.
Animal-derived: e.g., insulin from pig pancreas.
Mineral-derived: e.g., calcium and iron supplements.

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28
Q

What is the definition of pharmacology?

A

Pharmacology is defined as “the study of medicine,” focusing on how drugs interact with biological systems.

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29
Q

What are the interrelated subject areas important for pharmacology?

A

Key areas include anatomy, physiology, chemistry, and pathophysiology, which are essential for understanding drug actions and effects.

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30
Q

How do pharmacology and therapeutics interconnect?

A

Pharmacology provides the knowledge of drug actions, while therapeutics applies this knowledge to treat diseases and manage patient care.

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31
Q

What are the roles of healthcare professionals in pharmacology?

A

Healthcare professionals, including pharmacists and pharmacy technicians, are involved in medication distribution, patient education, and adherence to drug laws.

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32
Q

What distinguishes traditional drugs from biologics and natural alternatives?

A

Traditional drugs are chemically synthesized, biologics are derived from living organisms, and natural alternatives include herbs and dietary supplements.

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33
Q

What is the role of the pharmacy technician in the healthcare team?

A

Pharmacy technicians handle technical aspects of dispensing, manage patient profiles, prepare medications, and provide device instructions.

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34
Q

What are the eligibility criteria for becoming a registered pharmacy technician in Canada?

A

Candidates must complete a CCAPP-accredited program, pass certification exams, and have 2000 hours of relevant work or teaching experience.

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35
Q

What is the importance of drug education in pharmacy?

A

Drug education is crucial for ensuring patients understand their medications, potential side effects, and the importance of adherence to prescribed therapies.

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36
Q

How has the role of pharmacy technicians evolved?

A

The role has expanded to include more patient interaction, medication management, and responsibilities that were traditionally held by pharmacists.

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37
Q

What are the consequences of improper drug application?

A

Misapplication can lead to adverse drug reactions, ineffective treatment, and increased healthcare costs due to complications.

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38
Q

Historical Context
- Evolution of Pharmacy:

A

Pharmacy has evolved significantly over thousands of years, transitioning from trial-and-error practices to a more scientific approach.

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39
Q

Historical Context - Seventeenth Century Developments:

A

This period saw the demand for better documentation and basic testing, leading to the establishment of formal education requirements for pharmacists.

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40
Q

Major Drug Discoveries
Significant Discoveries:

A

1906: Discovery of vitamins by Fredrick Hopkins.
1921: Insulin discovered by Frederick Banting and Charles Best.
1950s: Innovations like the external cardiac pacemaker and cobalt bomb for cancer treatment.

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41
Q

Drug Sources
Natural Sources:
Many modern drugs are derived from plants (e.g., digoxin from foxglove), animals (e.g., insulin from pigs), and minerals (e.g., calcium supplements).

A

Drug Sources
Examples of Plant-Derived Drugs:
Willow bark = aspirin
Opium poppy = morphine

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42
Q

Pharmacology and Therapeutics
Definitions:

A

Pharmacology: The study of drugs and their effects on the body.

Therapeutics: The application of pharmacology to treat diseases.

Pharmacotherapeutics: Focuses on the use of drugs to treat specific conditions.

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43
Q

Roles in Healthcare
Healthcare Providers:

A

Physicians, dentists, and advanced nurse practitioners can prescribe medications, while pharmacists and pharmacy technicians play crucial roles in medication management and patient education.

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44
Q

Pharmacy Team Dynamics
Team Composition:

A

The pharmacy team includes pharmacists, pharmacy technicians, and assistants, each with distinct responsibilities.

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45
Q
A
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46
Q

Pharmacy Team Dynamics

A

Evolving Roles: Pharmacy technicians are increasingly involved in patient care and medication management, reflecting a shift in the healthcare landscape.

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47
Q

Drug Classification
Types of Drugs:

A

Traditional Drugs: Chemically synthesized in laboratories.
Biologics: Naturally produced substances, including hormones and vaccines.
Natural Alternatives: Include herbs, vitamins, and dietary supplements.

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48
Q

Eligibility for Pharmacy Technicians
Requirements:

A

To become a registered pharmacy technician in Canada, candidates must complete a CCAPP-accredited program, pass relevant certification exams, and accumulate 2000 hours of work or teaching experience.

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49
Q

Summary
Pharmacy’s Historical Significance:

A

Pharmacy has a rich history, with many significant drug discoveries in the last 300 years.

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50
Q

Summary
Interconnectedness of Fields:

A

Understanding pharmacology is essential for effective therapeutics and patient care.

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51
Q

What is Pharmacy?

A

The study of medicine.

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52
Q

How has pharmacy evolved?

A

Pharmacy has a rich history, evolving alongside human civilization through a trial and error approach.

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53
Q

What significant changes occurred in pharmacy during the 17th century?

A

Better documentation and basic testing became requirements, and research was initiated. Pharmacists were required to have a university education to practice.

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54
Q

Name three major discoveries in medicine and pharmacy in the last 300 years and their discoverers.

A


1921: Insulin, discovered by Frederick Banting and Charles Best

1950: External cardiac pacemaker, discovered by John Hopps and Wilfred Bigelow

1999: The Edmonton Protocol (pancreatic islet cell transplantation for diabetes), discovered by James Shapiro

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55
Q

What are the three main sources from which drugs are derived?

A

Plants, animals, and minerals.

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56
Q

Give three examples of modern drugs derived from plants.

A


Foxglove (digoxin) for congestive heart failure

Willow bark (aspirin)

Opium poppy (morphine)

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57
Q

Give two examples of modern drugs derived from animals.

A


Dried thyroid gland tissue (thyroid supplements)

Ground-up pancreas of cows or pigs (insulin)

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58
Q

Provide three examples of drugs derived from minerals.

A


Calcium

Iron

Potassium

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59
Q

Define Pharmacology.

A

Pharmacology is the expansive study of medicine, encompassing its origins, properties, and uses.

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60
Q

Why is pharmacology considered a challenging field?

A

It requires knowledge across diverse areas like anatomy, physiology, chemistry, and pathophysiology. It also involves understanding complex concepts like drug names, interactions, side effects, mechanisms of action, and varying patient responses.

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61
Q

Define Therapeutics.

A

Therapeutics is the branch of medicine concerned with the treatment of disease and the alleviation of suffering.

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62
Q

What is Pharmacotherapeutics?

A

Pharmacotherapeutics is the application of pharmacological principles to the treatment of disease. It focuses on using medications to treat diseases.

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63
Q

Explain the connection between pharmacology and therapeutics.

A

Both fields are essential for providing effective healthcare. Pharmacology provides the scientific understanding of drugs, while therapeutics focuses on applying that knowledge to treat diseases.

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64
Q

Who are some healthcare providers who can prescribe drugs?

A

Physicians, dentists, and advanced nurse practitioners, with other groups potentially able to prescribe depending on provincial or territorial law.

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65
Q

What are the roles of pharmacists, pharmacy technicians, and nurses in medication management?

A

They are directly involved in dispensing, administering, educating patients about medications, managing, and/or enforcing drug laws.

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66
Q

Name the three main classifications of drugs.

A

Traditional drugs, biologics, and natural alternative therapies.

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67
Q

What are traditional drugs?

A

Traditional drugs are chemically produced in a laboratory and are routinely used by healthcare providers.

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68
Q

Define Biologics.

A

Biologics are substances naturally produced by the body itself, in animal cells, or in microorganisms. They include hormones and vaccines and are routinely used by healthcare providers.

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69
Q

What are Natural Alternative Therapies?

A

Natural alternative therapies are naturally produced substances such as herbs, extracts, vitamins, minerals, or dietary supplements.

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70
Q

Define Pharmaceutics.

A

Pharmaceutics is the science of pharmacy, encompassing all aspects of drug development, production, and dispensing.

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71
Q

Describe the role of pharmacists.

A

Pharmacists are medication experts who catalog signs, symptoms, side effects, drug interactions, and act as advisors to patients, guiding them on safe and effective medication use.

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72
Q

Who comprises the pharmacy team?

A

The pharmacy team includes pharmacists, pharmacy technicians, and pharmacy assistants, each with their own responsibilities and scope of practice.

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73
Q

Describe the evolving role of pharmacy technicians.

A

Pharmacy technicians play a key role in supporting pharmacists. Their responsibilities are expanding to include technical aspects of dispensing prescriptions, data entry, preparing products, performing final accuracy checks, and instructing patients on medical devices.

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74
Q

What is the status of registered pharmacy technicians in Canada?

A

Registered pharmacy technicians are recognized as regulated healthcare professionals in Canada. They are held to specific standards of practice and ethics.

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75
Q

Pablum:

A

Developed in 1930 by Canadian pediatricians, Pablum represented a major breakthrough in infant nutrition.

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76
Q

Hypothermia and Open-Heart Surgery:

A

The source mentions that Wilfred Bigelow’s pioneering work with hypothermia in 1952 was crucial for advancements in open-heart surgery.

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77
Q

Propranolol

A

The development of Propranolol, the first beta-blocker, in 1967 by James Black had a significant impact on cardiovascular medicine

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78
Q

Red Iron Oxide:

A

The source specifically mentions red iron oxide being used as an inert ingredient in quinapril (Accupril), highlighting the diverse applications of minerals in medications.

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79
Q

What is the definition of pharmacology?

A

Pharmacology is defined as the study of medicine. It is derived from the Greek words pharmakon, meaning “medicine,” and logos, meaning “study”.

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80
Q

Why is a strong knowledge of pharmacology important to properly educate and advise patients about their health care needs?

A

A strong knowledge of pharmacology is necessary to properly educate and advise patients about their healthcare needs. This knowledge is also essential to communicate effectively with health care providers, who rely heavily on health care professionals to gather medical data from their patients and to follow up on results of therapy.

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81
Q

What is the interconnectedness of pharmacology and therapeutics?

A

The interconnectedness of the fields of pharmacology and therapeutics is important to health care workers. Health care providers apply the discipline of pharmacology in their clinical practice because it contains knowledge of how drugs improve the health of the human body. If used properly, drugs can dramatically improve patients’ quality of life.

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82
Q

What is the difference between pharmacology and therapeutics?

A

Pharmacology is the study of medicine or drugs. Therapeutics is the science associated with the treatment and prevention of diseases.

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83
Q

What is pharmacotherapeutics?

A

Pharmacotherapeutics is the useful application of drugs for the purpose of fighting diseases. The study of pharmacology is important to health care professionals working in different fields of medicine. Pharmacotherapeutics is the use of medicine to treat disease.

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84
Q

What is pharmaceutics?

A

Pharmaceutics is the science of preparing and dispensing drugs and is a very important part of pharmacotherapy. Pharmaceutics is the science of pharmacy.

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85
Q

Why is dispensing medication safely a major challenge for health care professionals and patients?

A

Pharmaceutics involves the successful dispensing of drugs for therapeutic purposes. Dispensing medication safely is a major challenge for health care professionals and patients.

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86
Q

What are the three classifications of drugs?

A

Agents may be classified as traditional drugs, biologics, and natural alternatives.

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87
Q

What are the characteristics of traditional drugs?

A


Chemically produced in a laboratory

Routinely used by health care providers

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88
Q

What are the characteristics of biologics?

A


Naturally produced by the body itself, in animal cells, or in microorganisms

Include hormones and vaccines

Routinely used by health care providers

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89
Q

What are the characteristics of natural alternative therapies?

A


Naturally produced

Include herbs, extracts, vitamins, minerals, or dietary supplements

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90
Q

Why do natural alternative therapies not necessarily mean that the therapies are safe?

A

Just because the word “natural” is used when referring to natural alternative therapies, it does not necessarily mean that the therapies are safe. Natural alternative therapies can also cause drug–diet interactions.

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91
Q

Provide examples of biologics.

A

Biologics would include products such as insulin for diabetes, estrogen for hormone replacement therapy, and the influenza vaccine.

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92
Q

When did pharmacy begin?

A

Pharmacy has been in existence for thousands of years. It is believed that the origins of pharmacy almost coincide with the beginnings of human life itself. Early humans observed animals and used that knowledge to create medications from materials found throughout their environment.

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93
Q

How did pharmacy evolve?

A

The history of pharmacy is rich and exciting, filled with many discoveries and events. From beginnings as remote and simple as the caveman came the proud profession of pharmacy. Its development parallels that of humans. Ancient humans learned from instinct and from observation of birds and animals. Cool water, a leaf, dirt, or mud was humankind’s first soothing application.

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94
Q

Why were fatalities common in the early practice of pharmacy?

A

Ancient Egyptians compiled lists of drugs within formularies or pharmacopoeias. Medical information was documented on clay tablets around 2600 bce, and the Ebers Papyrus, written around 1500 bce, contained formulas for more than 800 remedies. Each tribe had a designated person who was the priest, pharmacist, and physician all in one. Little was known about the toxicity of drugs, however, so fatalities were common.

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95
Q

What contribution did the ancient Romans make to the history of pharmacy?

A

The ancient Romans and Greeks organized all of the medical and pharmaceutical knowledge existing at that time, converted theories into scientific rules, and soon took on the responsibility for preparing their own prescriptions. Around 100 ad, Dioscorides, known as the “father of pharmacology,” accompanied the Roman armies wherever they went in the known world. He recorded everything he observed and devised excellent rules for the collection, storage, and usage of drugs. His texts, including De Materia Medica, were considered basic science as late as the sixteenth century.

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95
Q

What is trepanation? Why was it performed?

A

Historically, there was a strong belief in a spiritual cause for disease, so the tribes relied extensively on their shamans, who removed evil spirits from the bodies of ill persons. Trepanation, a surgical procedure whereby a hole was drilled in the skull to create a portal for evil spirits to leave the body, was also practised. Later, Hippocrates, the “father of medicine,” liberated medicine from the belief that diseases were caused by spirits. Hippocrates introduced the concept of the four bodily humors—yellow bile, black bile, blood, and phlegm—which, when out of balance, produced disease.

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96
Q

What contribution did Galen make to the history of pharmacy?

A

Galen, a Greek physician, wrote On the Art of Healing and was very critical of physicians who did not prepare their own remedies. He practised and taught both pharmacy and medicine in Rome around 160 ad. His principles for preparing and compounding medicines were predominant in the Western world for the next 1500 years, and his name still is associated with galenicals, the class of pharmaceuticals compounded by mechanical means. Many of the procedures that Galen devised have their counterparts in the modern compounding laboratories of today. For example, he was the originator of the formula for a cold cream that is essentially similar to the product that we know today.

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97
Q

When did pharmacy become a separate discipline from medicine?

A

Pharmacy soon became a separate discipline from medicine. During the fourteenth century, there was still a strong belief that evil spirits caused some diseases, and treatments were still a process of trial and error—some were effective, but some caused death. New scientists emerged, and new methods were devised to test hypotheses, which led to more advancements in treatments for illnesses.

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98
Q

What contribution did Paracelsus make to pharmacy?

A

The seventeenth century saw the rise of alchemy or chemistry, which included basic testing and research. A Swiss physician, Paracelsus, challenged Galen’s botanically oriented approach to medicine with his own chemical-based theories. Better documentation of this new knowledge was initiated. Pharmacists were now required to have a university education to practise, and larger quantities of known and new drugs were imported from the New World and Asia; new chemical medicines were also introduced.

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99
Q

Who was Louis Hébert?

A

In 1605, the young Parisian apothecary Louis Hébert answered the call of the New World when he helped de Monts and Champlain build New France’s first settlement at Port Royal (Nova Scotia, Canada). Hébert looked after the health of the settlers, cultivated native drug plants, and supervised the gardens while learning about the native specimens of drug plants brought to him by the aboriginal Micmac population. Hébert was the first Canadian pharmacist.

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100
Q

What did pharmacists compound during the 1800s?

A

During the 1800s, pharmacists compounded many of the drugs ordered by physicians and also sold soda and ice cream in their establishments. Drugs were included as ingredients in commonly consumed products, for example, cocaine in Coca Cola and lithium in 7-Up.

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101
Q

When were many drugs and vaccines discovered?

A

Many drugs and vaccines were discovered in the last 200 to 300 years.

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102
Q

When was modern pharmacy born?

A

With the progress of the scientific era, the number of available medicines increased, as scientists all over the world discovered new chemicals to treat diseases. The turn of the twentieth century saw the growth of pharmaceutical manufacturing plants that mass-produced these new drugs. Increasingly, regulations were put in place to ensure public safety and to prevent false claims. The pharmacist’s focus turned to patient-centred care, and modern pharmacy was born.

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103
Q

Why is the interconnectedness of the fields of pharmacology and therapeutics important to health care workers?

A

More than 10 000 brand name and generic drugs, with different names, interactions, side effects, and complex mechanisms of action, are currently available. Thus, keeping abreast of current knowledge about these thousands of drugs is a huge challenge. Many of the drugs currently available may be prescribed for more than one disease, and most produce multiple effects in the body. Further complicating the study of pharmacology is the fact that drugs may cause different responses, depending on such factors as gender, age, health status, body mass, and genetics.

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104
Q

What did the pharmacy team consist of in its evolving role?

A

The pharmacy team includes pharmacists, pharmacy technicians, and pharmacy assistants, each with his or her own responsibilities and scope of practice.

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105
Q

How did the pharmacy technician’s role evolve?

A

As the practice of pharmacy evolved, so did the role of the pharmacy technician. At first, pharmacy technicians or assistants were family members who helped out in the pharmacy, often as cashiers or fulfilling administrative roles. However, with the expanded role of the pharmacist, a need arose for an expanded role for the technician, and a new regulated profession was born. The pharmacy technician can now perform all technical aspects associated with dispensing prescriptions, from entering patient profile information to preparing products and performing the final accuracy check on prescriptions. Pharmacy technicians are also becoming more actively involved in collecting patient medication information for the pharmacist and instructing patients on medical devices, such as blood glucose monitors.

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106
Q

What is a registered pharmacy technician?

A

For many years, pharmacy has been a regulated profession, requiring the attainment of specific educational and regulatory qualifications to be licensed to practise in Canada. Once these requirements have been met, the pharmacist may register with his or her provincial regulatory body on an annual basis. There is a movement throughout Canada toward regulating the pharmacy technician profession also because of the increased responsibility of this role and to ensure public safety. Several provinces have passed new legislation to protect the pharmacy technician title so that only individuals meeting registration requirements within the province can become registered pharmacy technicians.

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107
Q

What examination must candidates pass to become a registered pharmacy technician?

A

For registration, the candidate has to pass both parts of a national qualifying examination conducted by the Pharmacy Examining Board of Canada (PEBC). The two parts are the multiple-choice questions (MCQ) component and the Objective Structured Performance Examination (OSPE), which is the practical component. PEBC is the national certification body for the profession of pharmacy in Canada, and their website is the official source for information regarding the PEBC certification process for pharmacists and pharmacy technicians. Entry to that examination is via two routes: graduation from a college pharmacy technician program accredited by the Canadian Council for Accreditation of Pharmacy Programs (CCAPP), or passing a preliminary PEBC evaluating examination.

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108
Q

What does the CCAPP ensure?

A

The CCAPP is responsible for the accreditation of the professional degree program in pharmacy at the universities in Canada and of pharmacy technician programs in the college-level system, ensuring that these programs have met stringent national educational standards.

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109
Q

How else can a candidate be eligible to take the Pharmacy Technician Qualifying Examination?

A


Direct Completion of a CCAPP program

Pass OCP Cert. Exam (2008)

Pass PTCB-AB Cert. Exam (2008)

Pass Pharmacist Evaluating Examination

Completion of a pharmacist degree program in Canada or in the United States

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110
Q

What are the eligibility criteria for those that did not complete a CCAPP program?

A

2000 hours of work and/or teaching experience in the past 36 months

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111
Q

Besides the national qualifying examination, what other requirements for registration are there for pharmacy technicians?

A

Other requirements of registration include passing a provincial jurisprudence examination on the pharmacy laws and regulations of the province and carrying malpractice insurance. Registration occurs on an annual basis, along with continuing education

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112
Q

Where can more information about regulation be found?

A

More information about regulation can be found on provincial regulatory body websites, the PEBC website (www.pebc.ca), and the CCAPP website (www.ccapp-accredit.ca).

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113
Q

List some notable discoveries in medicine and pharmacy in the last 300 years.

A

Review Table 1.1 for a complete list of notable discoveries, but some notable ones are:

Digitalis (1785)

Smallpox vaccine (1798)

Morphine (1806)

Washing hands prevents the spread of disease (1847)

Germ theory of disease (1860)

Aspirin (1899)

Insulin (1921)

Penicillin (1928)

Pablum (1930)

The Edmonton Protocol (1999)

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114
Q

List some drugs derived from plants.

A

Review Table 1.2 for a complete list of drugs derived from plants, but some notable ones are:

Foxglove = digoxin (congestive heart failure)

Belladonna = atropine (dilate pupil) and scopolamine (motion sickness)

Yams = estrogen replacement therapy

Willow bark = aspirin

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115
Q

List some drugs derived from animals.

A


Dried thyroid gland tissue = thyroid supplements

Pregnant mares’ urine = Premarin (menopause)

Ground up pancreas of cows or pigs = insulin

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116
Q

List some drugs derived from minerals.

A


Calcium, iron

Copper, magnesium, selenium, zinc

Potassium

Red iron oxide as inert ingredient in quinapril (Accupril)

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117
Q

What does the new horizon in pharmacy hold?

A

The new horizon in pharmacy holds more research into gene therapy and genetic defects. New medications will be devised on the basis of patients’ genetic makeup. Research continues to pursue cures for major diseases, such as cancer.

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118
Q

How are some drugs still derived, even though most medications continue to be mass-produced synthetically?

A

Although most medications continue to be mass-produced synthetically, some drugs are still derived from natural sources, such as plants, animals, and minerals.

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119
Q


Pharmacy is an ancient profession that has existed for thousands of years. Early humans observed animals and used their knowledge to create medications.

A

Many drug and vaccine discoveries occurred in the last 200-300 years. As the scientific era progressed, so did the number of available medicines. For example, Canadians Banting and Best discovered insulin in 1921. This discovery had a significant impact on the lives of people with diabetes worldwide.

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120
Q


Pharmacology is a broad and challenging topic. It is the study of drugs and their effects on the human body. The subject encompasses how drugs enter and travel through the body, how they interact with the human body, and how they elicit different responses.

A


Pharmacology and therapeutics are interconnected fields that are crucial to healthcare workers. Therapeutics is the science of treating and preventing diseases. Pharmacotherapeutics is the application of drugs to fight diseases.

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121
Q


Drugs can be classified into three main categories: traditional drugs, biologics, and natural alternatives.

Traditional drugs are chemically produced in a laboratory.

Biologics are produced by the body, animals, or microorganisms. For example, biologics include insulin for diabetes and the influenza vaccine.

A


Natural alternative therapies include herbs, extracts, vitamins, minerals, or dietary supplements. Just because something is natural does not mean it is safe; natural therapies can also cause drug and diet interactions.

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122
Q


Pharmaceutics is the science of preparing and dispensing drugs. Pharmaceutics is a vital part of pharmacotherapy.

A


The pharmacy team includes pharmacists, pharmacy technicians, and pharmacy assistants. Each member has their own responsibilities and scope of practice. The role of the pharmacy technician has evolved and expanded over time. Pharmacy technicians now perform many tasks, including preparing and dispensing prescriptions, checking patient profiles, and instructing patients.

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123
Q


Becoming a registered pharmacy technician in Canada requires specific education and meeting regulatory requirements. This includes passing a national qualifying exam conducted by the Pharmacy Examining Board of Canada (PEBC).

A

What is the historical context of pharmacy?

Pharmacy has existed for thousands of years, evolving from early human practices of using natural materials and plants to treat illnesses.

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124
Q

What were some early practices in pharmacy?

A

Early humans learned from observing animals and nature, discovering which plants could help with various health issues.

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125
Q

Name a significant drug discovery and its impact.

A

Insulin (1921) - Discovered by Frederick Banting and Charles Best, it is crucial for managing diabetes and has transformed the lives of many patients.

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126
Q

What is pharmacology?

A

Pharmacology is the study of how drugs work in the body and how they can help treat diseases.

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127
Q

Why is pharmacology interdisciplinary?

A

It combines knowledge from biology, chemistry, and medicine, which is essential for safe and effective drug use in health care.

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128
Q

What is the connection between pharmacology and therapeutics?

A

Pharmacology informs therapeutics, which focuses on treating diseases using medications prescribed by health care providers.

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129
Q

How are drugs classified?

A

Drugs can be classified as:
Traditional Drugs: Chemically synthesized in labs.
Biologics: Naturally produced in living organisms (e.g., vaccines).
Natural Alternatives: Derived from plants and other natural sources.

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130
Q

What is pharmaceutics?

A

Pharmaceutics is the science of preparing and dispensing medications to patients.

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131
Q

What role do pharmacists play?

A

Pharmacists ensure patients receive the correct medications, provide information on usage, and educate about side effects and interactions.

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132
Q

Describe the pharmacy team and their roles.

A

Pharmacists: Responsible for patient care and medication management.
Pharmacy Technicians: Assist in preparing medications and managing inventory.
Pharmacy Assistants: Support administrative tasks and help the pharmacy team.

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133
Q

What is the evolving role of pharmacy technicians?

A

Pharmacy technicians are now a regulated profession in Canada, with expanded responsibilities including collecting patient information and providing instructions on medical devices.

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134
Q

What is the future of pharmacy?

A

Ongoing research in gene therapy and personalized medicine is shaping the future of pharmacology and therapeutics, aiming to tailor treatments to individual patients.

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135
Q

What are some major drug discoveries in the last 200-300 years?

A

Digitalis (1785) - William Withering
Smallpox Vaccine (1798) - Edward Jenner
Penicillin (1928) - Alexander Fleming

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136
Q

What is the significance of the smallpox vaccine?

A

Developed by Edward Jenner, it was the first vaccine that helped prevent a deadly disease, marking a major advancement in public health.

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137
Q

What are biologics?

A

Biologics are natural agents produced by living organisms, such as hormones and vaccines, used in medical treatments.

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138
Q

What is the definition of pharmacology?

A

Pharmacology is derived from Greek words meaning “medicine” (pharmakon) and “study” (logos), defined as the study of medicine and how drugs affect the body.

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139
Q

What are the core concepts of pharmacy?

A

1 - Pharmacy has existed for thousands of years.

2 - Many drugs and vaccines were discovered in the last 200-300 years.

3 - Pharmacology is expansive and challenging.

4 - Pharmacology and therapeutics are interconnected.

5 - Agents can be classified as traditional drugs, biologics, and natural alternatives.

6 - Pharmaceutics is the science of pharmacy.

7 - The pharmacy team includes pharmacists, pharmacy technicians, and pharmacy assistants.

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140
Q

What is the importance of understanding pharmacology for health care providers?

A

A thorough knowledge of pharmacology is essential for prescribing medications safely and effectively, as well as for educating patients about their treatments.

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141
Q

How do drugs produce biological responses?

A

Drugs are chemical agents that interact with the body’s systems to produce therapeutic effects, which can vary based on factors like age, gender, and health status.

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142
Q

What are the different sources of drugs?

A

Plants: e.g., foxglove for digoxin, willow bark for aspirin.

Animals: e.g., insulin from animal pancreas, thyroid supplements from dried thyroid tissue.

Minerals: e.g., calcium and iron supplements.

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143
Q

What is the role of the Pharmacy Examining Board of Canada (PEBC)?

A

The PEBC oversees the registration and certification of pharmacy technicians and pharmacists in Canada, ensuring they meet national standards.

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144
Q

What is the process for becoming a registered pharmacy technician in Canada?

A

Candidates must:

  1. Complete a CCAPP-accredited pharmacy technician program.
  2. Pass the national qualifying examination (MCQ and OSPE).
  3. Pass a provincial jurisprudence examination.
  4. Carry malpractice insurance and register annually.
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145
Q

What are some examples of traditional drugs?

A

Traditional drugs are chemically synthesized in laboratories, such as:
Aspirin
Antibiotics like amoxicillin
Antidepressants like fluoxetine

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146
Q

What are the responsibilities of pharmacy assistants?

A

Pharmacy assistants support the pharmacy team by handling administrative tasks, managing inventory, and assisting customers with basic inquiries.

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147
Q

Why is patient-centered care important in pharmacy?

A

Patient-centered care focuses on the individual needs of patients, ensuring they receive appropriate medications and education, which improves health outcomes.

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148
Q

What is the significance of the Ebers Papyrus?

A

Written around 1500 BCE, the Ebers Papyrus is one of the oldest medical texts, containing over 800 remedies and demonstrating early pharmacological knowledge.

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149
Q

How did the role of pharmacists evolve over time?

A

Pharmacists transitioned from compounding medications to becoming health care providers who focus on patient care, medication management, and education.

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150
Q

What are some challenges in studying pharmacology?

A

The vast number of available drugs, their interactions, side effects, and the need to stay updated with new discoveries make pharmacology a challenging field.

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151
Q

What is the relationship between drugs and the body?

A

Drugs can mimic or block natural substances in the body, leading to various therapeutic effects or side effects depending on the drug and the individual.

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152
Q

What is the significance of the germ theory of disease?

A

Proposed by Louis Pasteur in the 1860s, this theory revolutionized medicine by establishing that microorganisms cause diseases, leading to improved hygiene and treatment practices.

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153
Q

What is the historical significance of ancient Egyptian practices in pharmacy?

A

Ancient Egyptians documented medical knowledge in formularies, such as the Ebers Papyrus, which contained over 800 remedies, showcasing early pharmacological practices.

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154
Q

Who is considered the “father of pharmacology”?

A

Dioscorides, known for his work “De Materia Medica,” which laid the foundation for pharmacological knowledge in the Western world.

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155
Q

What was the role of shamans in early medicine?

A

Shamans were believed to remove evil spirits causing illness, reflecting the spiritual beliefs surrounding disease in ancient cultures.

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156
Q

How did Hippocrates contribute to the field of medicine?

A

Hippocrates shifted the understanding of disease from spiritual causes to natural explanations, introducing the concept of the four bodily humors.

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157
Q

What advancements occurred during the Middle Ages in pharmacy?

A

The emergence of apothecaries, development of dosage forms, and the establishment of the first pharmacy shops in Baghdad and hospital pharmacies in Marrakech.

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158
Q

What was the impact of the scientific era on pharmacy?

A

The scientific era led to the mass production of drugs, increased regulations for public safety, and a shift towards patient-centered care in pharmacy practice.

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159
Q

What are some examples of major drug discoveries and their significance?

A

Aspirin (1899): Revolutionized pain management.
Penicillin (1928): Marked the beginning of modern antibiotics.
Insulin (1921): Critical for diabetes management.

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160
Q

What is the difference between traditional drugs and biologics?

A

Traditional drugs are chemically synthesized, while biologics are derived from living organisms, such as hormones and vaccines.

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161
Q

What are the responsibilities of pharmacy technicians?

A

Pharmacy technicians perform technical tasks related to dispensing medications, collecting patient information, and assisting pharmacists in patient care.

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162
Q

What is the significance of the CCAPP?

A

The Canadian Council for Accreditation of Pharmacy Programs (CCAPP) ensures that pharmacy technician programs meet national educational standards.

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163
Q

How do drugs interact with the body?

A

Drugs can alter biological processes by mimicking or blocking natural substances, leading to therapeutic effects or side effects.

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164
Q

What are some natural sources of drugs?

A

Foxglove: Digoxin (for heart failure).
Cinchona bark: Quinine (for malaria).
Opium poppy: Morphine (for pain relief).

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165
Q

What is the role of the pharmacist in patient care?

A

Pharmacists assess patient needs, provide medication counseling, monitor therapy outcomes, and ensure safe medication use.

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166
Q

What is the importance of continuing education for pharmacy professionals?

A

Continuing education helps pharmacy professionals stay current with new drugs, therapies, and regulations, ensuring high-quality patient care.

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167
Q

What is the primary purpose of the drug review process in Canada?

A

To ensure the safety, efficacy, and quality of drugs available to Canadians.

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168
Q

Which branch of Health Canada is responsible for drug regulation?

A

Health Products and Food Branch (HPFB).

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169
Q

What constitutes a drug under the Food and Drugs Act?

A

Any substance for use in diagnosis, treatment, mitigation, or prevention of diseases in humans or animals, including pharmaceuticals, biologically-derived products, and disinfectants.

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170
Q

What are the initial steps in drug development?

A

Research and development of chemical or biological substances, followed by testing on tissue cultures and small animals.

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171
Q

What is the purpose of preclinical testing?

A

To assess the safety and determine the appropriate dosage of a substance before human trials.

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172
Q

What is the intent of clinical trials?

A

To gather information on a drug’s dose, effectiveness, and safety in humans.

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173
Q

What must a sponsor submit to HPFB to begin the drug review process?

A

A New Drug Submission containing data on safety, efficacy, and quality.

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174
Q

What are the key steps in the drug review process?

A
  1. New Drug Submission filed.
  2. Thorough review by HPFB.
  3. Evaluation of safety and efficacy data.
  4. Review of proposed information for healthcare practitioners.
  5. Issuance of Notice of Compliance (NOC) and Drug Identification Number (DIN) if approved.
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175
Q

How does HPFB ensure the thoroughness of the review process?

A

By sometimes consulting external experts and advisory committees.

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176
Q

What factors influence the duration of the drug review process?

A

The type of product, the size and quality of the submission, and HPFB’s workload.

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177
Q

What is the Special Access Program?

A

A program that allows physicians to access drugs not currently available in Canada for patients with unmet medical needs.

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178
Q

What happens after a drug is approved?

A

Ongoing monitoring of safety and efficacy, including reporting of serious side effects and regular inspections of production sites.

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179
Q

What is the role of distributors after a drug is on the market?

A

They must report any new safety information and serious side effects to HPFB.

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180
Q

Why might some drugs not be approved by HPFB?

A

If there is insufficient evidence to support their safety, efficacy, or quality claims.

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181
Q

What is a Notice of Compliance (NOC)?

A

An official approval issued by HPFB allowing a drug to be marketed in Canada.

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182
Q

What is a Drug Identification Number (DIN)?

A

A unique number assigned to a drug that indicates its official approval in Canada.

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183
Q

What is the name of the national authority in Canada that regulates drugs and health products?

A

Health Products and Food Branch (HPFB)

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184
Q

What Canadian government department is the HPFB a part of?

A

Health Canada

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185
Q

What is the name of the act that legally defines drugs in Canada?

A

Food and Drugs Act

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186
Q

List at least 5 categories of products that are considered drugs in Canada.

A


Prescription pharmaceuticals

Nonprescription pharmaceuticals

Biologically-derived products such as vaccines

Tissues and organs

Disinfectants

Radiopharmaceuticals

Natural health products that make therapeutic claims

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187
Q

List the 3 main criteria that HPFB uses to assess drugs.

A


Safety

Efficacy

Quality

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188
Q

What are the first steps in drug development, before clinical trials?

A

Scientists develop chemical or biological substances, isolate and purify them, and administer them to tissue cultures and small animals. If the results are promising, more animal and laboratory tests are conducted to study effects and determine dosages.

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189
Q

Who applies to HPFB for authorization to conduct a clinical trial in Canada?

A

The sponsor, which is the person or company that takes responsibility for the application.

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190
Q

What is the purpose of a clinical trial?

A

To research and gather information on a drug’s dose, effectiveness, and safety in humans.

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191
Q

What kind of document does a sponsor file with HPFB when they want to market a drug in Canada?

A

A New Drug Submission

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192
Q

What does HPFB issue if the drug review is successful and the benefits of the drug outweigh the risks?

A


Notice of Compliance (NOC)

Drug Identification Number (DIN)

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193
Q

What is the name of the process where Health Canada may test biological products before and after authorization to sell?

A

Lot Release Process

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194
Q

What are the options for a sponsor if HPFB decides not to grant marketing authorization for their drug?

A

They can supply additional information, re-submit their submission later with more data, or ask HPFB to reconsider their decision.

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195
Q

What is the name of the process that allows a faster review for promising drug products for life-threatening or severely debilitating conditions?

A

Priority Review Process

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196
Q

What is a monograph?

A

A scientific standard that contains information about an ingredient, product, or class of products, including its properties, acceptable use, dosage, duration of use, risk information, etc. It represents Health Canada’s knowledge about what is necessary for the safe and effective use of the ingredient, product, or class of products.

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197
Q

Why is the process to obtain approval faster if an applicant wants to market a product that follows a monograph exactly?

A

Because Health Canada has already pre-cleared the information in the monograph.

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198
Q

What is the name of the program that allows physicians to gain access to drugs that are not currently available in Canada?

A

Special Access Program

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199
Q

Who administers the Special Access Program?

A

HPFB

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200
Q

What must the distributor of a drug do once the drug is on the market?

A

Report any new information received concerning serious side effects, including failure of the drug to produce the desired effect. They must also notify HPFB about any studies that have provided new safety information and request approval for any major changes to the manufacturing processes, dose regime, or recommended uses for the drug.

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201
Q

What activities does HPFB conduct as part of its post-market surveillance of drugs?

A

Market surveillance, monitoring adverse reaction reports, investigating complaints and problem reports, managing recalls, licensing most drug production sites, and conducting regular inspections.

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202
Q

What is drug classification?

A

Drug classification is the organization of medications based on their therapeutic use and pharmacological action, helping healthcare professionals determine appropriate treatments.

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203
Q

What are the two main types of drug classification?

A
  1. Therapeutic Classification
  2. Pharmacological Classification
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204
Q

What does therapeutic classification focus on?

A

It focuses on what the drug does clinically, such as treating specific health conditions.

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205
Q

Give examples of therapeutic classifications and their uses.

A

Anticoagulants: Prevent blood clotting.
Antihypertensives: Lower blood pressure.
Antianginal drugs: Treat chest pain (angina).

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206
Q

What does pharmacological classification focus on?

A

It focuses on the mechanism of action, or how the drug produces its effects in the body.

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207
Q

Provide examples of pharmacological classifications and their mechanisms.

A

Diuretics: Lower plasma volume.

Calcium Channel Blockers: Block calcium channels in the heart.

ACE Inhibitors: Block hormonal actions that narrow blood vessels.

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208
Q

What is a prototype drug?

A

A prototype drug is the original model from which other drugs in a class are developed, such as Penicillin V for penicillin antibiotics.

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209
Q

What is the difference between prescription and over-the-counter (OTC) drugs?

A

Prescription drugs require a doctor’s approval and are stored in a dispensary, while OTC drugs can be purchased without a prescription.

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210
Q

What are the schedules for OTC drugs in Canada?

A

Schedule II: Requires pharmacist intervention.

Schedule III: Available without a prescription but with some restrictions.

Unscheduled: Sold without professional supervision.

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211
Q

What are the three names a drug can have?

A

Chemical Name: Describes the drug’s chemical structure.

Generic Name: The universally accepted name (e.g., acetaminophen).

Trade Name: The brand name given by the manufacturer (e.g., Tylenol).

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212
Q

Why are drug regulations important?

A

They protect public health by ensuring that drugs are tested for safety and efficacy before being marketed.

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213
Q

Who oversees drug regulations in Canada?

A

Health Canada is responsible for monitoring drug safety and effectiveness.

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214
Q

What are the four stages of the drug approval process?

A
  1. Preclinical Testing: Laboratory and animal studies.
  2. Clinical Trials: Testing in humans.
  3. New Drug Application (NDA): Submission for regulatory review.
  4. Post-Marketing Studies: Ongoing monitoring after approval.
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215
Q

What are controlled substances?

A

Controlled substances are drugs that have a potential for abuse and are regulated under the Controlled Drugs and Substances Act (CDSA).

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216
Q

What are the schedules of controlled substances in Canada?

A

Schedule I: High potential for abuse (e.g., opioids).

Schedule II: Cannabis and its derivatives.

Schedule III: Amphetamines and other stimulants.

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217
Q

What is the purpose of drug classification?

A

Drug classification helps healthcare professionals understand the uses, effects, and mechanisms of drugs, facilitating better treatment decisions.

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218
Q

What is the significance of the prototype approach in drug classification?

A

The prototype approach allows for easier understanding and comparison of new drugs to established ones, helping to predict their effects and uses.

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219
Q

Why are generic drug names preferred over trade names?

A

Generic names are universally accepted, easier to remember, and reduce confusion, ensuring consistent communication among healthcare providers.

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220
Q

What are the advantages of prescription drugs?

A

Professional diagnosis and monitoring.
Controlled dosage and frequency.
Detailed instructions on use and side effects.

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221
Q

What are the disadvantages of over-the-counter (OTC) drugs?

A

Potential for incorrect self-diagnosis.
Lack of professional guidance on use.
Risk of ineffective treatment or progression of disease.

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222
Q

What role does Health Canada play in drug approval?

A

Health Canada evaluates the safety, efficacy, and quality of drugs before they can be marketed, ensuring public health protection.

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223
Q

What is the Controlled Drugs and Substances Act (CDSA)?

A

The CDSA is Canadian legislation that regulates the possession, distribution, and use of controlled substances to prevent abuse and protect public health.

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224
Q

What are the key components of the preclinical testing stage?

A

Preclinical testing involves laboratory studies and animal testing to assess the drug’s safety and biological activity before human trials.

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225
Q

What happens during the clinical trials phase?

A

Clinical trials are conducted in multiple phases to evaluate the drug’s safety, effectiveness, and optimal dosing in human subjects.

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226
Q

What is included in the New Drug Application (NDA)?

A

The NDA includes data from preclinical and clinical studies, proposed labeling, and information on manufacturing processes for regulatory review.

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227
Q

What are post-marketing studies?

A

Post-marketing studies monitor the drug’s long-term effects and safety in the general population after it has been approved for use.

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228
Q

How are drugs scheduled under the CDSA?

A

Drugs are categorized into schedules based on their potential for abuse, with Schedule I having the highest potential and Schedule VIII the lowest.

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229
Q

What is the importance of bioavailability in drug comparison?

A

Bioavailability refers to the extent and rate at which the active ingredient or active moiety is absorbed and becomes available at the site of action, affecting drug effectiveness.

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230
Q

What are the implications of drug formulations on brand name vs. generic drugs?

A

Brand name drugs may have different formulations (e.g., fillers, coatings) compared to their generic counterparts, which can affect absorption and effectiveness.

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231
Q

What is the role of pharmacists in the dispensing of Schedule II and III drugs?

A

Pharmacists provide professional guidance, ensuring safe use and appropriate selection of these drugs, which may require their intervention.

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232
Q

What is the significance of a drug’s mechanism of action?

A

It describes how a drug produces its effects within the body, which is crucial f

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233
Q

How are prescription drugs classified in Canada?

A

Prescription drugs are classified as Schedule I drugs, requiring a prescription from a healthcare practitioner and must be stored in a dispensary.

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234
Q

What are the storage requirements for OTC drugs?

A

Schedule II: Stored in a pharmacy area with no public access.

Schedule III: Available in the self-selection area under pharmacist supervision.

Unscheduled: Can be sold from any retail outlet without supervision.

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235
Q

What are the advantages of prescription drugs over OTC drugs?

A

Prescription drugs are tailored to individual patient needs, with professional oversight ensuring proper use and monitoring for side effects.

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236
Q

What are the disadvantages of prescription drugs?

A

They may require time for a physician’s appointment and can be more costly compared to OTC options.

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237
Q

What is the role of Health Canada in drug regulation?

A

Health Canada oversees the safety and efficacy of drugs, ensuring they are thoroughly tested before being approved for public use.

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238
Q

What are the four stages of the drug approval process in Canada?

A

Preclinical Testing: Laboratory and animal studies.
Clinical Trials: Testing in human subjects.
NDA Submission: Review of the new drug application.
Post-Marketing Studies: Monitoring drug effects after approval.

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239
Q

What is the Controlled Drugs and Substances Act (CDSA)?

A

It is legislation that regulates drugs with potential for abuse, categorizing them into schedules based on their risk levels.

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240
Q

What are the characteristics of Schedule I drugs?

A

Schedule I drugs have the highest potential for abuse and include many prescription medications, requiring strict regulation.

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241
Q

What is the importance of distinguishing between chemical, generic, and trade names?

A

Understanding these names helps healthcare professionals communicate effectively and ensures proper medication administration.

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242
Q

Why is the prototype drug model beneficial?

A

It provides a reference point for understanding the effects and characteristics of other drugs within the same pharmacological class.

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243
Q

What are the implications of drug bioavailability?

A

Bioavailability affects how much of a drug reaches systemic circulation, influencing its therapeutic effectiveness and safety.

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244
Q

How do drug regulations protect public health?

A

They ensure that only safe, effective, and properly tested drugs are available to consumers, minimizing the risk of adverse effects.

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245
Q

Drug Classification

A

Therapeutic Classification: Focuses on the clinical use of drugs (e.g., anticoagulants, antihypertensives).

Pharmacological Classification: Focuses on the mechanism of action (e.g., diuretics, calcium channel blockers).

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246
Q

Drug Names

A

Chemical Name: The scientific name based on standard nomenclature (IUPAC).

Generic Name: The universally accepted name that describes the active ingredient.

Trade Name: The brand name given by the manufacturer, often easier to remember.

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247
Q

Drug Approval Process

A

Preclinical Testing: Involves laboratory and animal studies to assess safety and biological activity.

Clinical Trials: Conducted in phases (I, II, III) to evaluate safety and efficacy in humans.

NDA Submission: A comprehensive application for regulatory review, including all data from previous stages.

Post-Marketing Studies: Ongoing monitoring of the drug’s effects in the general population after approval.

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248
Q

Health Canada’s Role

A

Oversees drug approval and regulation to ensure public safety.

Works with provincial and territorial governments to maintain health standards.

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249
Q

Controlled Substances

A

Schedule I: High potential for abuse; includes many prescription drugs.

Schedule II: Requires professional intervention; available without a prescription but under pharmacist supervision.

Schedule III: Available without a prescription but may present risks to certain populations.

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250
Q

Advantages and Disadvantages of Drug Types

A

Prescription Drugs: Advantages include professional oversight and tailored treatment; disadvantages include cost and access issues.

OTC Drugs: Advantages include ease of access and lower cost; disadvantages include potential for misuse and lack of professional guidance.

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251
Q

Bioavailability

A

Refers to the proportion of a drug that enters circulation when introduced into the body, affecting its therapeutic effectiveness.

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252
Q

What are the two main ways drugs are classified?

A


Therapeutic Classification: Based on what the drug does clinically (its therapeutic usefulness). For example, antihypertensives are used to lower blood pressure.

Pharmacological Classification: Based on a drug’s mechanism of action, meaning how it produces its effect in the body. For example, diuretics lower blood pressure by reducing blood volume.

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253
Q

What is a prototype drug?

A

The original drug model within a pharmacological class, from which other drugs in that class were developed. For example, Penicillin V is the prototype for the penicillin class of antibiotics.

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254
Q

What are the key differences between prescription drugs and over-the-counter (OTC) drugs?

A


Prescription drugs require a doctor’s prescription and are Schedule I drugs.

OTC drugs can be purchased without a prescription and fall under Schedules II, III, or Unscheduled.

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255
Q

What are the three names a drug typically has, and what does each name tell us?

A


Chemical Name: Describes the drug’s chemical structure using IUPAC nomenclature.

Generic Name: The official, universally recognized name for the drug’s active ingredient. Preferred by healthcare professionals.

Trade Name: The brand name given to a drug by the company that markets it.

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256
Q

Give an example of a drug with its chemical, generic, and trade names.

A


Chemical Name: N-(4-hydroxyphenyl) acetamide

Generic Name: acetaminophen

Trade Name: Tylenol

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257
Q

Why are generic drug names preferred in healthcare settings?

A

Generic names are unique, universally accepted, and clearly identify the drug’s active ingredient. They avoid confusion caused by multiple brand names for the same drug.

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258
Q

What is the role of Health Canada in drug regulation?

A

Health Canada is the federal agency responsible for regulating drugs in Canada. They work to ensure the safety and efficacy of drugs available to Canadians.

259
Q

What are the four stages of the drug approval process in Canada?

A

1.
Preclinical testing: Laboratory and animal studies to evaluate safety and potential effectiveness.
2.
Clinical trials: Testing the drug on human volunteers to assess safety, dosage, effectiveness, and side effects.
3.
New Drug Application (NDA) submission and review: The drug company submits an NDA to Health Canada, which reviews the data collected in the previous stages.
4.
Post-marketing surveillance: Monitoring the drug’s effects after it is on the market to identify any long-term or rare side effects.

260
Q

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

A

The CDSA regulates drugs with a potential for abuse or addiction to protect public health and safety.

261
Q

How are drugs categorized under the CDSA?

A

Drugs are categorized into eight schedules (I-VIII) based on their potential for abuse. Schedule I drugs have the highest potential for abuse (like opioids), while Schedule VIII drugs have the lowest.

262
Q

What are some key differences between brand-name drugs and their generic equivalents?

A

While generic drugs have the same active ingredient as brand-name drugs, they may differ in:

Price: Generic drugs are typically much less expensive.

Formulation: Inactive ingredients, such as fillers and coatings, can vary.

Bioavailability: The extent and rate at which the active ingredient is absorbed by the body can be slightly different.

263
Q

List three advantages of prescription drugs.

A


Doctor’s diagnosis ensures appropriate treatment.

Dosage and frequency are controlled for safety and efficacy.

Instructions on use and side effects are provided by a healthcare professional.

264
Q

List three disadvantages of prescription drugs.

A


Require a doctor’s appointment, which can be time-consuming and costly.

Higher cost compared to OTC drugs.

May require ongoing monitoring or refills.

265
Q

List three advantages of OTC drugs.

A


Easily obtained without a prescription.

More convenient to purchase.

Less expensive than prescription drugs.

266
Q

List three disadvantages of OTC drugs.

A


Risk of self-misdiagnosis and choosing the wrong drug.

Potential for not knowing or understanding potential side effects and interactions.

Ineffective treatment if the wrong drug is used, leading to disease progression.

267
Q

Explain the concept of bioavailability.

A

Bioavailability refers to the extent and rate at which the active ingredient of a drug is absorbed into the bloodstream and becomes available to produce its effect. This can vary between different formulations of the same drug, such as brand-name versus generic versions.

268
Q

What are the three drug schedules for OTC drugs in Canada, and where can they be sold/stored?

A


Schedule II: Requires pharmacist intervention, no prescription required. Stored in an area of the pharmacy with no public access.

Schedule III: Risks for certain populations in self-selection. Available without a prescription but sold in the pharmacy’s “professional services area” under pharmacist supervision.

Unscheduled: Sold without professional supervision in any retail outlet.

269
Q

What is the National Association of Pharmacy Regulatory Authorities (NAPRA), and what role does it play?

A

NAPRA is the national organization responsible for developing and harmonizing pharmacy regulations across Canada. It establishes standards for drug scheduling, dispensing, and other aspects of pharmacy practice.

270
Q

What were the limitations of the Canadian Food and Drugs Act in the early 1900s?

A

The Act primarily aimed to prevent the marketing of untested drugs. However, it did not address issues such as drug efficacy (whether a drug actually worked) or the potential for drug abuse.

271
Q


Focus on the rationale behind drug scheduling.

A

The Controlled Drugs and Substances Act (CDSA) doesn’t just list drugs in categories; it’s designed to protect public health and safety by controlling access to substances with a potential for abuse and harm.

272
Q

Consider the implications of each schedule for dispensing and storage.

A

For example, Schedule I drugs (prescription only) are subject to stricter storage and record-keeping requirements compared to Schedule III OTC medications.

273
Q

Pharmacology is a constantly evolving field.

A

New drugs are being developed, and our understanding of existing medications continues to grow.

274
Q

Be prepared to apply the concepts of drug classification, regulation, and approval to new information and scenarios.

A

For example, you might encounter a news article about a new drug being approved by Health Canada or a discussion on the ethical considerations of drug pricing and availability.

275
Q

What is pharmacology?

A

The study of drugs, their properties, effects, and mechanisms of action.

276
Q

Why is pharmacology important?

A

It helps healthcare professionals ensure safe and effective medication management for patients.

277
Q

What are the two major ways to classify drugs?

A

Therapeutic classification and pharmacological classification.

278
Q

Define therapeutic classification.

A

Organizing drugs based on their clinical usefulness or what they do to help patients.

279
Q

Give examples of therapeutic classifications.

A

Anticoagulants (prevent blood clots)
Antihypertensives (lower blood pressure)
Antidysrhythmics (correct irregular heartbeats)

280
Q

Define pharmacological classification.

A

Organizing drugs based on their mechanism of action or how they work in the body.

281
Q

Give examples of pharmacological classifications.

A

Diuretics (lower plasma volume)
Calcium channel blockers (reduce heart contraction force)
ACE inhibitors (block hormonal pathways to lower blood pressure)

282
Q

What is a prototype drug?

A

The original drug model from which other drugs in a class are developed.

283
Q

Provide an example of a prototype drug.

A

Penicillin V is the prototype for penicillin antibiotics.

284
Q

What are the three types of drug names?

A

Chemical name, generic name, and trade name.

285
Q

Define chemical name.

A

The scientific name assigned using standard nomenclature (IUPAC).

286
Q

Define generic name.

A

The common name used for a drug, which is easier to remember.

287
Q

Define trade name.

A

The brand name given by the manufacturer, often designed to be catchy and memorable.

288
Q

What is the purpose of drug regulations?

A

To protect the public from drug misuse and ensure drug safety and efficacy.

289
Q

What is Health Canada’s role in drug regulation?

A

Health Canada ensures that drugs are safe, effective, and of high quality before they can be sold.

290
Q

What are the four stages of the drug approval process?

A

Preclinical testing
Clinical trials
Submission of New Drug Application (NDA)
Post-marketing studies

291
Q

Describe preclinical testing.

A

Laboratory and animal studies to assess the safety and biological activity of a drug.

292
Q

What happens during clinical trials?

A

The drug is tested on humans in three phases to evaluate its safety and effectiveness.

293
Q

What is the New Drug Application (NDA)?

A

A comprehensive application submitted to Health Canada for regulatory review after clinical trials.

294
Q

What are post-marketing studies?

A

Ongoing monitoring of the drug’s effects in the general population after it has been approved.

295
Q

What are controlled substances?

A

Drugs that have the potential for abuse and are categorized into schedules under the Controlled Drugs and Substances Act (CDSA).

296
Q

What is Schedule I in the CDSA?

A

Drugs with the highest potential for abuse, including narcotics.

297
Q

What is the difference between prescription and OTC drugs?

A

Prescription drugs require a doctor’s prescription, while OTC drugs can be purchased without one.

298
Q

What are the advantages of prescription drugs?

A

They are monitored by healthcare professionals, ensuring proper use and tailored treatment.

299
Q

What are the disadvantages of OTC drugs?

A

They can be misused, and individuals may choose the wrong medication without professional guidance.

300
Q

What is the difference between therapeutic and pharmacological classifications?

A

Therapeutic classification focuses on what a drug does clinically, while pharmacological classification focuses on how the drug works in the body.

301
Q

Why are prototype drugs important in pharmacology?

A

They serve as a model to understand the effects and side effects of other drugs in the same class.

302
Q

What is the significance of drug bioavailability?

A

Bioavailability measures how well and how quickly a drug reaches its target cells and produces its effects.

303
Q

What factors can affect a drug’s bioavailability?

A

Inactive ingredients, tablet compression, and the drug’s formulation can all influence absorption and effectiveness.

304
Q

What are the stages of drug approval in Canada?

A

Preclinical Investigation: Initial testing on cells and animals (1-3 years).

Clinical Investigation: Human trials in three phases (2-10 years).

NDA Submission and Review: Health Canada reviews the application (2 months to 7 years).

Postmarketing Studies: Ongoing monitoring after the drug is on the market.

305
Q

What is the role of Health Canada in drug approval?

A

Health Canada evaluates the safety, efficacy, and quality of drugs before they can be marketed.

306
Q

What is the Controlled Drugs and Substances Act (CDSA)?

A

A Canadian law that categorizes drugs based on their potential for abuse and regulates their use.

307
Q

How are drugs categorized under the CDSA?

A

Drugs are placed into schedules (I to VIII) based on their potential for abuse, with Schedule I being the most restrictive.

308
Q

What are the characteristics of Schedule III drugs?

A

These drugs can be sold without a prescription but may require pharmacist supervision for safe use.

309
Q

What is the importance of drug regulations?

A

Regulations ensure that drugs are safe, effective, and marketed responsibly to protect public health.

310
Q

What is the margin of safety in drug use?

A

The difference between the effective dose of a drug and the dose that causes severe side effects.

311
Q

What are the advantages of OTC drugs?

A

They are easily accessible, often cheaper, and do not require a doctor’s visit.

312
Q

What are the risks associated with OTC drugs?

A

Potential for misuse, interactions with other medications, and lack of professional guidance can lead to ineffective treatment or harm.

313
Q

What is the significance of the Canadian Food and Drugs Act?

A

It requires that drugs be tested for safety and efficacy before they can be marketed in Canada.

314
Q

What is the role of the Therapeutic Products Directorate (TPD)?

A

The TPD authorizes the marketing of pharmaceutical drugs after reviewing scientific evidence of safety and efficacy.

315
Q

What is the role of the Biologics and Genetic Therapies Directorate (BGTD)?

A

The BGTD regulates biological drugs and gene therapy products derived from living sources.

316
Q

What is the role of the Natural Health Products Directorate (NHPD)?

A

The NHPD regulates natural health products sold in Canada, ensuring their safety and quality.

317
Q

What is the difference between brand name drugs and generic drugs?

A

Brand name drugs are marketed under a proprietary name, while generic drugs use the chemical name and are usually less expensive.

318
Q

Why might a patient prefer a generic drug?

A

Generic drugs are often cheaper and can be just as effective as brand name drugs, depending on bioavailability.

319
Q

What is the primary purpose of drug classification?

A

To organize drugs for easier identification and understanding of their uses and effects.

320
Q

What are the two main categories of drug classification?

A

Therapeutic classification and pharmacological classification.

321
Q

How does therapeutic classification categorize drugs?

A

By their clinical usefulness or the conditions they treat.

322
Q

How does pharmacological classification categorize drugs?

A

By their mechanism of action or how they produce effects in the body.

323
Q

What is the prototype approach in drug classification?

A

Using a well-understood drug as a model to predict the actions and side effects of other drugs in the same class.

324
Q

What are the three names associated with drugs?

A

Chemical name, generic name, and trade name.

325
Q

Why are generic names preferred in pharmacology?

A

They are simpler, easier to remember, and reduce confusion among healthcare providers.

326
Q

What is the significance of drug regulations?

A

They protect the public from drug misuse and ensure the safety and efficacy of medications.

327
Q

They protect the public from drug misuse and ensure the safety and efficacy of medications.

A

Preclinical investigation
Clinical investigation
Submission of New Drug Application (NDA)
Post-marketing studies

328
Q

What occurs during the preclinical investigation stage?

A

Laboratory and animal testing to assess safety and biological activity.

329
Q

What happens during the clinical investigation stage?

A

The drug undergoes three phases of trials on human subjects to evaluate its safety and effectiveness.

330
Q

What is the purpose of the NDA submission?

A

To provide Health Canada with comprehensive data for review before a drug can be marketed.

331
Q

What is involved in post-marketing studies?

A

Ongoing monitoring of the drug’s effects in the general population to identify any long-term adverse effects.

332
Q

What is the Controlled Drugs and Substances Act (CDSA)?

A

A Canadian law that regulates drugs with potential for abuse, categorizing them into schedules.

333
Q

What are the characteristics of Schedule I drugs?

A

They have the highest potential for abuse and include narcotics and controlled substances.

334
Q

What is the difference between prescription and OTC drugs?

A

Prescription drugs require a doctor’s authorization, while OTC drugs can be purchased without one.

335
Q

What are the risks associated with OTC drugs?

A

Potential for misuse, interactions with other medications, and lack of professional guidance.

336
Q

What is the margin of safety in drug use?

A

The difference between the effective dose and the dose that causes severe side effects.

337
Q

What is the role of Health Canada in drug regulation?

A

To ensure that drugs are safe, effective, and of high quality before they can be sold.

338
Q

What is the significance of bioavailability in drug therapy?

A

It determines how effectively a drug reaches its target cells and produces its intended effects.

339
Q

What is the role of the Therapeutic Products Directorate (TPD)?

A

To authorize the marketing of pharmaceutical drugs after reviewing their safety and efficacy.

340
Q

What is the role of the Natural Health Products Directorate (NHPD)?

A

To regulate natural health products sold in Canada, ensuring their safety and quality.

341
Q

What is the importance of understanding drug interactions?

A

To prevent adverse effects and ensure safe and effective medication management.

342
Q

What are the potential consequences of drug misuse?

A

Increased risk of side effects, ineffective treatment, and potential for addiction or dependency.

343
Q

How can pharmacists assist patients with OTC medications?

A

By providing guidance on safe use, potential interactions, and appropriate choices for self-treatment.

344
Q

What is the primary goal of drug classification?

A

To provide a systematic way to categorize drugs based on their therapeutic effects and mechanisms of action.

345
Q

What are the two major methods of drug classification?

A

Therapeutic classification (based on clinical use) and pharmacological classification (based on mechanism of action).

346
Q

What is a therapeutic classification?

A

A system that categorizes drugs according to their intended therapeutic effects, such as treating hypertension or pain relief.

347
Q

What is a pharmacological classification?

A

A system that categorizes drugs based on their mechanism of action, such as diuretics or beta-blockers.

348
Q

What is a prototype drug?

A

A well-understood drug that serves as a model for understanding the effects and side effects of other drugs in the same class.

349
Q

Why is understanding a drug’s mechanism of action important?

A

It helps predict how the drug will behave in the body and its potential interactions with other medications.

350
Q

What are the three types of drug names?

A

Chemical name, generic name, and trade name.

351
Q

What is the significance of the chemical name?

A

It provides a precise description of the drug’s chemical structure but is often complex and difficult to remember.

352
Q

What is the role of Health Canada in drug regulation?

A

To ensure that drugs are safe, effective, and of high quality before they can be marketed in Canada.

353
Q

What are the four stages of drug approval in Canada?

A

Preclinical investigation
Clinical investigation
Submission of New Drug Application (NDA)
Post-marketing studies

354
Q

What occurs during the preclinical investigation stage?

A

Laboratory and animal testing to assess the drug’s safety and biological activity.

355
Q

What is involved in the clinical investigation stage?

A

Conducting three phases of trials on human subjects to evaluate the drug’s safety and efficacy.

356
Q

What is the purpose of the NDA submission?

A

To provide Health Canada with comprehensive data for review before a drug can be marketed.

357
Q

What is the significance of post-marketing studies?

A

They monitor the drug’s effects in the general population to identify any long-term adverse effects.

358
Q

How are drugs categorized under the Controlled Drugs and Substances Act (CDSA)?

A

Drugs are placed into schedules (I to VIII) based on their potential for abuse, with Schedule I being the most restrictive.

359
Q

What are the characteristics of Schedule II drugs?

A

They require professional intervention from a pharmacist but do not need a prescription.

360
Q

What is the difference between prescription and OTC drugs?

A

Prescription drugs require a doctor’s authorization, while OTC drugs can be purchased without one.

361
Q

What are the risks associated with OTC drugs?

A

Potential for misuse, interactions with other medications, and lack of professional guidance.

362
Q

What is the margin of safety in drug use?

A

The difference between the effective dose and the dose that causes severe side effects.

363
Q

What is the importance of understanding drug interactions?

A

To prevent adverse effects and ensure safe and effective medication management.

364
Q

What is the role of pharmacists in managing OTC medications?

A

They provide guidance on safe use, potential interactions, and appropriate choices for self-treatment.

365
Q

What is the significance of bioavailability in drug therapy?

A

It determines how effectively a drug reaches its target cells and produces its intended effects.

366
Q

What is the role of the Therapeutic Products Directorate (TPD)?

A

To authorize the marketing of pharmaceutical drugs after reviewing their safety and efficacy.

367
Q

What is the role of the Natural Health Products Directorate (NHPD)?

A

To regulate natural health products sold in Canada, ensuring their safety and quality.

368
Q

What are the potential consequences of drug misuse?

A

Increased risk of side effects, ineffective treatment, and potential for addiction or dependency.

369
Q

How can patients ensure safe use of OTC medications?

A

By following instructions, consulting with pharmacists, and being aware of potential interactions.

370
Q

What are the two main ways drugs are classified?

A


Therapeutic Classification: Classifies drugs based on their therapeutic usefulness in treating particular diseases.

Pharmacological Classification: Classifies drugs based on their mechanism of action, or how a drug produces its physiological effect in the body.

371
Q

Give an example of a therapeutic drug class and some drugs that belong to that class.

A


Therapeutic Class: Antihypertensives (drugs that lower blood pressure)

Examples:

Diuretics

Calcium Channel Blockers

Angiotensin-Converting Enzyme Inhibitors

Adrenergic Blockers

Vasodilators

372
Q

What is a prototype drug?

A

A prototype drug is the first drug in a class of drugs. It serves as a model or standard for other drugs developed later in the same class. Understanding the prototype drug can help predict the actions and side effects of other drugs within the same class.

373
Q

What is the main role of Health Canada in drug regulation?

A

Health Canada is responsible for protecting the public from drug misuse and ensuring that drugs marketed in Canada are safe, effective, and of high quality.

374
Q

What are the four stages of the drug approval process in Canada?

A

1.
Preclinical Investigation: Initial testing in a lab setting, often using cells or animals.
2.
Clinical Investigation: Testing the drug in human volunteers in three phases of clinical trials.
3.
Health Canada Review and Submission of New Drug Submission (NDS): Health Canada reviews the NDS, and if approved, grants a Notice of Compliance (NOC) and assigns a Drug Identification Number (DIN).
4.
Post-Marketing Surveillance: Monitoring the drug’s safety and effectiveness after it’s been released to the market.

375
Q

What are the three types of drug names?

A

Chemical Name: Describes the drug’s chemical structure using standard nomenclature.

Generic Name: The official, nonproprietary name of the drug. Usually simpler than the chemical name.

Trade Name/Brand Name: The name given by the company marketing the drug. Can be multiple trade names for the same generic drug.

376
Q

What is the main difference between a prescription drug and an over-the-counter (OTC) drug?

A


Prescription Drugs: Require a prescription from a healthcare professional because they may have a higher potential for side effects or require monitoring.

OTC Drugs: Deemed safe enough for self-medication and can be purchased without a prescription.

377
Q

What are the advantages of prescription drugs?

A


A healthcare professional can diagnose the condition and ensure the appropriate drug is prescribed.

The dosage and frequency can be tailored to the patient’s needs.

Instructions on proper use and potential side effects can be provided.

378
Q

What are the advantages of OTC drugs?

A


Convenience - no need for a doctor’s appointment.

Cost-effectiveness.

Accessibility.

379
Q

What is the difference between a brand-name drug and its generic equivalent?

A


They contain the same active ingredients but may have different inactive ingredients.

Generics are typically less expensive.

Bioavailability (the extent to which the drug is absorbed and reaches its target in the body) may vary slightly.

380
Q

What is the reason for the price difference between brand-name and generic drugs?

A

Pharmaceutical companies that develop new drugs are granted patent protection, giving them exclusive rights to market the drug for a set period. This allows them to recoup their investment. Once the patent expires, other companies can produce generic versions, leading to competition and lower prices.

381
Q

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

A

The CDSA regulates drugs with a potential for abuse or dependence, classifying them into eight schedules based on their potential for harm. Schedule I drugs have the highest potential for abuse, and Schedule VIII has the lowest.

382
Q

What is the difference between addiction and dependence?

A


Addiction: Overwhelming feeling that drives a person to repeatedly use a drug despite negative consequences.

Dependence: A physiological or psychological need for a substance. Physical dependence involves withdrawal symptoms when the drug is stopped. Psychological dependence involves an intense craving for the drug.

383
Q

Give examples of drugs in different CDSA schedules.

A


Schedule I: Opium, heroin, cocaine, methadone.

Schedule II: Cannabis, marijuana.

Schedule III: Amphetamines, LSD, psilocybin.

Schedule IV: Barbiturates, benzodiazepines, anabolic steroids.

384
Q

What is bioavailability?

A

Bioavailability is the physiological ability of the drug to reach its target cells and produce its effect.

385
Q

Define efficacy.

A

Efficacy is the ability to produce a desired effect.

386
Q

What is a formulary?

A

A formulary is a list of drugs and drug recipes.

387
Q

Define inert.

A

Inert means inactive.

388
Q

What is a pharmacopoeia?

A

A pharmacopoeia is a medical reference summary, indicating standards of drug purity and strength and directions for synthesis.

389
Q

What does the abbreviation CPS stand for, and what is it?

A


CPS: Compendium of Pharmaceuticals and Specialties

The Canadian drug reference.

390
Q

What are the three drug schedules used in Canada for drugs sold in pharmacies?

A


Schedule I: Prescription drugs, including controlled and narcotic drugs. These cannot be dispensed without a prescription.

Schedule II: Do not require a prescription but require pharmacist intervention. These drugs are stored in an area of the pharmacy where there is no public access.

Schedule III: Available without a prescription but present risks to certain populations if patients self-select. Sold from the self-selection area but within view of the pharmacist so the pharmacist can provide counseling.

391
Q

What is the requirement for Schedule I, II, and III drugs when a pharmacy is open, but the dispensary is closed?

A

These medications need to be in a lock-and-leave area to prevent customer access.

392
Q

What is a Schedule U drug?

A

A Schedule U drug can be sold in any establishment.

393
Q

What is an unscheduled drug?

A

An unscheduled drug can be sold without the intervention of a pharmacist.

394
Q

Provide some examples of drugs for each of the Canadian drug schedules.

A


Schedule I: Ranitidine greater than 150 mg per dose.

Schedule II: Tylenol #1 tablets (acetaminophen 325mg, codeine 8mg, and caffeine 65 mg).

Schedule III: Ranitidine 150 mg tablets in packages greater than 30 tablets, cough and cold products containing decongestants.

Unscheduled: Ranitidine (Zantac), acetaminophen (Tylenol).

395
Q

Which drug name is preferred in healthcare settings and why?

A

The generic name is preferred because it’s unique, universally applicable, and simpler than the chemical name. Using generic names promotes clear communication and reduces confusion among healthcare providers.

396
Q

What is the difference between a drug’s generic name and its generic version?

A


Generic Name: The official non-proprietary name of the drug ingredient. There is only one generic name for a specific drug ingredient.

Generic Version: A copy of the brand-name drug that becomes available after the patent expires.

397
Q

What was the first law in Canada to protect the public from drug misuse?

A

The Canadian Food and Drugs Act. It prevents the marketing of drugs that haven’t been thoroughly tested.

398
Q

What is the purpose of the U.S. Pharmacopoeia-National Formulary (USP-NF)?

A

The USP-NF sets standards for drug purity, strength, and directions for synthesis, ensuring the quality and consistency of medications.

399
Q

What is the Compendium of Pharmaceuticals and Specialties (CPS), and who publishes it?

A


CPS: The Canadian drug reference.

Published by: Published annually.

400
Q

What are the roles of the Therapeutic Products Directorate (TPD), the Biologics and Genetic Therapies Directorate (BGTD), and the Natural Health Products Directorate (NHPD) in regulating therapeutic products in Canada?

A


Therapeutic Products Directorate (TPD): Authorizes the marketing of pharmaceutical drugs and medical devices.

Biologics and Genetic Therapies Directorate (BGTD): Regulates drugs derived from living sources (like blood products and vaccines).

Natural Health Products Directorate (NHPD): Regulates natural health products sold in Canada.

401
Q

What are the three phases of clinical trials involved in the drug approval process? Briefly describe each.

A


Phase I: Tests the drug on a small group of healthy volunteers to evaluate safety, dosage, and side effects.

Phase II: Tests the drug on a larger group of patients with the target condition to determine effectiveness and further assess safety.

Phase III: Tests the drug on a much larger group of patients to confirm effectiveness, monitor side effects, and compare it to existing treatments. This is the longest phase of a clinical trial.

402
Q

How long does patent protection typically last for a new drug in Canada, and what does this mean for generic drug availability?

A

Patent protection lasts for 20 years from the time the patent application is filed. During this period, only the original drug developer can market the drug. After the patent expires, other companies can produce and sell generic versions.

403
Q

What is an Abbreviated New Drug Submission (ANDS), and when is it used?

A

An ANDS is used by companies to seek approval for a generic version of a drug after the original patent has expired. It provides evidence that the generic drug is bioequivalent to the brand-name drug.

404
Q

How are drugs with a high potential for abuse categorized in Canada?

A

They are categorized into eight schedules within the Controlled Drugs and Substances Act (CDSA). Schedule I has the highest potential for abuse, and Schedule VIII has the lowest.

405
Q

What is the difference between physical dependence and psychological dependence on a drug?

A


Physical Dependence: The body adapts to the drug’s presence, leading to withdrawal symptoms when use is stopped.

Psychological Dependence: Involves an intense craving for the drug and its effects, often without significant physical withdrawal symptoms.

406
Q

What are the penalties for unlawful activities involving controlled substances in Canada?

A

Individuals or companies convicted of unlawful manufacturing, distribution, or dispensing of controlled substances face severe penalties.

407
Q

Therapeutic Classification:

A

This system groups drugs based on their therapeutic use or clinical purpose. For example, “antihypertensives” are drugs used to lower blood pressure. This classification focuses on the intended effect of the drug.

408
Q

Pharmacological Classification:

A

This system categorizes drugs based on their mechanism of action — how the drug works at a molecular, cellular, or organ level. For instance, “diuretics” lower blood pressure by reducing plasma volume.

409
Q

Prototype Drug:

A

A prototype drug is a well-understood drug that serves as a model for other drugs in the same pharmacological class. Penicillin V is a prototype drug for the penicillin class of antibiotics. Learning about a prototype can help you predict the actions and potential side effects of other drugs in the same class. It’s important to note that prototypes are not always the most widely used drugs in their class.

410
Q

Prescription Drugs (Schedule I):

A

These require a physician’s order to obtain. The practitioner can diagnose the condition, determine the appropriate drug, and counsel the patient on proper use and side effects. This is the most tightly controlled category.

411
Q

Margin of Safety:

A

This refers to the difference between a drug’s effective dose and a dose that causes severe side effects. Drugs with a wide margin of safety are considered safer.

412
Q

OTC Drugs:

A

These are deemed safe enough for consumers to buy and use without a doctor’s diagnosis. OTC status is often granted to drugs after extensive use and a demonstrated wide margin of safety. It’s essential for patients to follow OTC drug instructions carefully, as improper use can still lead to serious side effects.

413
Q

Chemical Name:

A

Describes the drug’s chemical structure and is used in scientific settings. It’s based on rules from the International Union of Pure and Applied Chemistry (IUPAC). Chemical names are often complex and difficult to remember.

414
Q

Generic Name:

A

This is the official non-proprietary name of the drug, approved by regulatory bodies. Generic names are generally simpler than chemical names and widely used in healthcare settings.

415
Q

Trade Name:

A

This is the brand name given by the pharmaceutical company that developed the drug. A single drug can have many trade names.

416
Q

Bioavailability:

A

This is a crucial concept that refers to the extent and rate at which a drug enters the systemic circulation and reaches its site of action. It’s a key factor in determining a drug’s effectiveness.

417
Q

Factors Affecting Bioavailability:

A

Inert ingredients in the drug formulation, tablet compression, and anything that influences a drug’s absorption and distribution can affect its bioavailability.

418
Q

omparing Brand-Name vs. Generic:

A

While brand-name and generic drugs have the same active ingredients, variations in bioavailability are possible due to differences in formulation. This can be a significant consideration for drugs where a rapid onset of action is crucial.

419
Q

Purpose of Drug Regulations:

A

Drug regulations aim to protect the public from drug misuse by setting standards for safety, efficacy, and quality.

420
Q

Early Drug Regulations:

A

In the early 1900s, Canada introduced the Canadian Food and Drugs Act to ensure drugs were thoroughly tested before being marketed. This law requires drug companies to prove both the safety and effectiveness of their products.

421
Q

Health Canada’s Role:

A

Health Canada, specifically its Health Products and Food Branch (HPFB), plays a central role in regulating drugs in Canada. Various directorates within the HPFB, including the Therapeutic Products Directorate (TPD), the Biologics and Genetic Therapies Directorate (BGTD), and the Natural Health Products Directorate (NHPD), have specific responsibilities in ensuring the safety and quality of different types of therapeutic products.

422
Q

Controlled Drugs and Substances Act (CDSA):

A

This legislation classifies drugs with a potential for abuse into eight schedules. Schedule I drugs have the highest potential for abuse, while Schedule VIII drugs have the lowest. Hospitals and pharmacies face strict regulations when handling CDSA scheduled drugs.

423
Q

What are some precautions patients need to know when taking OTC drugs?

A

1) Self-treatment is sometimes ineffective.
2) OTC drugs may interact with foods, herbal products, prescription, or other OTC drugs.
3) Allowing disease progression increases potential for injury.
4) All of the above are important.

424
Q

What is typically the longest part of the drug approval process?

A

Clinical investigation, due to multiple testing phases for safety and efficacy.

425
Q

Which type of drug classification focuses on what a drug does clinically?

A

Therapeutic classification, which describes the drug’s clinical use or treatment purpose.

426
Q

What term describes how a medication produces its effects in the body?

A

Mechanism of action, which explains the biochemical process by which the drug exerts its effects.

427
Q

Which drug category has only one name assigned to it?

A

Generic name, which is unique and used universally for that drug.

428
Q

Why is the chemical name of a drug rarely used in pharmacotherapy?

A

Chemical names are complex and difficult to remember; they’re mainly useful for understanding the drug’s structure.

429
Q

What is the proprietary name of a drug?

A

It’s the trade name or brand name, suggesting ownership by the manufacturer.

430
Q

What might cause differences between brand name drugs and generic equivalents?

A

Bioavailability differences can make brand names preferable in specific cases, despite generics being cost-effective and generally safe.

431
Q

How are prescription drugs classified for sale in Canada?

A

They are classified as Schedule I drugs, meaning they require a prescription and pharmacist monitoring.

432
Q

What is pharmacotherapeutics?

A

The treatment of diseases by the use of drugs to relieve suffering or manage conditions.

433
Q

Why is there extensive “red tape” involved in drug authorization?

A

To ensure safety and prevent harm—regulations are in place to thoroughly assess a drug’s safety and efficacy before approval.

434
Q

What is an OTC drug?

A

Over-the-counter (OTC) drugs are medications available without a prescription for self-treatment.

435
Q

What is the preclinical investigation phase in drug approval?

A

The first phase, where a drug is tested in the lab and on animals for safety and efficacy before human trials.

436
Q

What are postmarketing studies in drug approval?

A

Also known as Phase IV trials, these studies continue after drug approval to monitor long-term effects and safety in the general population.

437
Q

Define therapeutic classification.

A

Classification based on a drug’s clinical use, like treating specific diseases or symptoms.

438
Q

Define pharmacological classification.

A

Classification based on the drug’s mechanism of action or how it affects the body.

439
Q

What is a trade name?

A

The brand or proprietary name of a drug, owned by a pharmaceutical company, often capitalized (e.g., Tylenol for acetaminophen).

440
Q

Why are generic names not capitalized?

A

Generic names are written in lowercase to standardize their universal usage and distinguish from brand names.

441
Q

What is bioavailability?

A

A measure of the rate and extent to which a drug’s active ingredient is absorbed and becomes available at the site of action.

442
Q

What is the NDA submission and review phase?

A

New Drug Application (NDA) submission is the formal proposal to the FDA to approve a drug for sale and marketing after clinical trials.

443
Q

What is drug administration?

A

The process of giving medications to patients safely and effectively.

444
Q

Why is proper drug administration important?

A

It ensures the right medication is given in the right way, leading to better health outcomes and fewer side effects.

445
Q

What are the learning outcomes of this chapter?

A

Understand safe drug administration.

Know the roles of pharmacy technicians.

Explain the six rights of drug administration.

Improve patient compliance.

Interpret drug abbreviations.

Compare measurement systems.

Explain administration methods.

Evaluate advantages and disadvantages of routes.

Recognize medication forms.

446
Q

What are the six rights of drug administration?

A

Right Patient
Right Medication
Right Dose
Right Route
Right Time
Right Documentation

447
Q

How does the “Right Patient” contribute to safety?

A

Ensures that the medication is given to the correct individual, preventing errors.

448
Q

What factors affect patient compliance?

A

Cost of medications
Forgetfulness
Side effects
Fear of dependence

449
Q

What strategies can improve patient compliance?

A

Educating patients
Simplifying dosing schedules
Providing reminders and support

450
Q

What are common drug administration abbreviations?

A

ac: before meals
bid: twice daily
prn: as needed
PO: by mouth
SL: sublingual

451
Q

What are the three systems of measurement in pharmacology?

A

Metric System
Apothecary System
Household System

452
Q

What is enteral administration?

A

Giving medications through the gastrointestinal tract, such as orally or rectally.

453
Q

What are the advantages of enteral administration?

A

Convenient, non-invasive, and cost-effective.

454
Q

What are the disadvantages of enteral administration?

A

First-pass metabolism can reduce drug effectiveness; not suitable for all patients.

455
Q

What is topical administration?

A

Applying medications directly to the skin or mucous membranes.

456
Q

What are the advantages of topical administration?

A

Localized effect and reduced systemic side effects.

457
Q

What are the disadvantages of topical administration?

A

Limited absorption for systemic effects; potential for skin irritation.

458
Q

What is parenteral administration?

A

Giving medications through injections, bypassing the gastrointestinal tract.

459
Q

What are the forms of parenteral administration?

A

Intravenous (IV)
Intramuscular (IM)
Subcutaneous (SC)

460
Q

What are the advantages of parenteral administration?

A

Rapid onset of action and avoids first-pass metabolism.

461
Q

What are the disadvantages of parenteral administration?

A

Requires sterile techniques; potential for infection or injury.

462
Q

What is the goal of pharmacotherapy?

A

To limit the number and severity of adverse drug events.

463
Q

Why is patient compliance crucial in pharmacotherapy?

A

Successful treatment depends on patients following their medication regimens.

464
Q

What protocols are common to all methods of drug administration?

A

Aseptic techniques, patient identification, and adherence to the six rights of drug administration.

465
Q

What is the significance of the “Three Checks” in drug administration?

A

They ensure accuracy in medication delivery by:
Checking the drug against the prescription.
Checking the drug during preparation.
Checking the drug before dispensing to the patient.

466
Q

What are the common forms of enteral drugs?

A

Tablets, capsules, liquids, and suspensions.

467
Q

What are enteric-coated tablets?

A

Tablets designed to dissolve in the small intestine rather than the stomach to protect the drug from stomach acid.

468
Q

What is sustained-release medication?

A

Medications designed to dissolve slowly, providing a prolonged effect.

469
Q

What are the characteristics of sublingual and buccal administration?

A

Sublingual: Placed under the tongue for rapid absorption.
Buccal: Placed between the gum and cheek for absorption.

470
Q

What are the advantages of nasogastric (NG) and gastrostomy administration?

A

Useful for patients who cannot swallow; allows for liquid medications.

471
Q

What are the disadvantages of NG and gastrostomy administration?

A

Tubes can become clogged; some medications may not be suitable for crushing.

472
Q

What types of topical medications are commonly used?

A

Creams, ointments, gels, patches, and sprays.

473
Q

What is the purpose of transdermal patches?

A

To deliver medication through the skin for systemic effects while avoiding first-pass metabolism.

474
Q

What are the common routes for parenteral administration?

A

Intradermal (ID): Injected into the dermis.
Subcutaneous (SC): Injected into the subcutaneous tissue.
Intramuscular (IM): Injected into the muscle.
Intravenous (IV): Injected directly into the bloodstream.

475
Q

What are the key aseptic techniques for parenteral administration?

A

Hand hygiene, using sterile equipment, and maintaining a clean environment.

476
Q

What is the first-pass effect?

A

The metabolism of a drug in the liver before it reaches systemic circulation, which can reduce its effectiveness.

477
Q

What are the potential risks of parenteral administration?

A

Infection, allergic reactions, and injury to blood vessels or nerves.

478
Q

How can healthcare providers enhance patient compliance?

A

By addressing barriers, providing education, and involving patients in their treatment plans.

479
Q

What is the role of pharmacy technicians in drug administration?

A

To assist in preparing and dispensing medications, ensuring safety and compliance with regulations.

480
Q

Why is documentation important in drug administration?

A

It provides a record of what medications were given, when, and to whom, which is essential for patient safety and legal accountability.

481
Q

What are the characteristics of various forms of medications?

A

Different forms (e.g., tablets, liquids, injections) have unique properties that affect absorption, onset of action, and patient preference.

482
Q

What is the importance of understanding drug interactions?

A

To prevent adverse effects and ensure that medications work effectively together.

483
Q

What is the primary goal of pharmacotherapy?

A

To limit the number and severity of adverse drug events.

484
Q

What are the responsibilities of pharmacy technicians regarding drug administration?

A

Understanding drug delivery principles, knowing various drug forms and routes, and ensuring safe medication practices.

485
Q

What are the advantages of oral (PO) drug administration?

A

Most common, convenient, least costly, and generally well-accepted by patients.

486
Q

What are the disadvantages of oral drug administration?

A

Requires the patient to swallow, potential inactivation by digestive enzymes, and variability in gastrointestinal motility.

487
Q

What is the significance of the “Three Checks” in medication administration?

A

They help prevent medication errors by ensuring the correct drug is given at the right time and in the right way.

488
Q

What are the characteristics of topical drug administration?

A

Applied locally to the skin or mucous membranes, with minimal systemic absorption.

489
Q

What types of medications are typically administered via inhalation?

A

Medications for respiratory conditions, delivered through inhalers or nebulizers.

490
Q

What are the key considerations for parenteral drug administration?

A

Aseptic technique is crucial, and the route chosen (ID, SC, IM, IV) affects the onset and duration of action.

491
Q

What is the role of patient education in medication compliance?

A

Educating patients about their medications can improve adherence and understanding of treatment plans.

492
Q

What are the common reasons for noncompliance in medication regimens?

A

Cost, forgetfulness, side effects, and fear of dependence.

493
Q

How can healthcare providers increase patient compliance?

A

By simplifying medication regimens, providing clear instructions, and addressing concerns about side effects.

494
Q

What are the three systems of measurement used in pharmacology?

A

Metric, apothecary, and household systems.

495
Q

Why is it important to understand drug abbreviations?

A

To accurately interpret prescriptions and avoid medication errors.

496
Q

What is the purpose of using abbreviations in drug administration?

A

To communicate directions and times for medication administration efficiently.

497
Q

What are the potential risks associated with parenteral administration?

A

Infection, allergic reactions, and complications from improper technique.

498
Q

What is the importance of documentation in drug administration?

A

It ensures accountability and provides a record for future reference regarding patient care.

499
Q

What factors influence the choice of drug form and route of administration?

A

Patient needs, drug properties, and the desired effect.

500
Q

What is the significance of patient compliance in pharmacotherapy?

A

It is essential for achieving the desired therapeutic outcomes and minimizing adverse effects.

501
Q

How do the six rights of drug administration enhance patient safety?

A

They provide a systematic approach to prevent medication errors and ensure the correct treatment is given.

502
Q

What are the common forms of medications?

A

Tablets, capsules, liquids, creams, ointments, and injections.

503
Q

What are the six rights of drug administration?

A

Right patient
Right medication
Right dose
Right route
Right time
Right documentation

504
Q

How do the six rights contribute to patient safety?

A

They help prevent medication errors, ensuring that patients receive the correct treatment tailored to their needs.

505
Q

What is the role of pharmacy technicians in ensuring safe drug administration?

A

They assist in preparing and dispensing medications, verify prescriptions, and educate patients about their medications.

506
Q

What are the advantages of using enteral routes for drug administration?

A

They are generally safer, less invasive, and more convenient for patients.

507
Q

What are the disadvantages of topical drug administration?

A

Limited systemic absorption and potential for local irritation.

508
Q

What is the significance of patient compliance in pharmacotherapy?

A

High compliance rates lead to better health outcomes and reduced risk of adverse drug events.

509
Q

What are some common abbreviations used in drug administration?

A

ac: before meals
bid: twice a day
prn: as needed
qid: four times a day

510
Q

What are the three systems of measurement in pharmacology?

A

Metric, apothecary, and household systems.

511
Q

Why is it important to compare and contrast different routes of drug administration?

A

To understand the advantages and disadvantages of each route, which can affect patient outcomes and treatment efficacy.

512
Q

What factors can affect patient compliance with medication regimens?

A

Cost, complexity of the regimen, side effects, and lack of understanding of the treatment.

513
Q

What is the purpose of using enteral, topical, and parenteral routes?

A

Each route is chosen based on the drug’s properties, the desired effect, and patient needs.

514
Q

How can healthcare providers improve patient compliance?

A

By simplifying medication regimens, providing clear instructions, and addressing any concerns or barriers.

515
Q

What is the first-pass metabolism, and why is it significant?

A

It refers to the metabolism of a drug in the liver before it reaches systemic circulation, which can reduce its effectiveness.

516
Q

What are the common forms of medications and their characteristics?

A

Tablets (solid, easy to swallow), liquids (fast absorption), creams (local application), and injections (rapid effect).

517
Q

What protocols are essential for parenteral drug administration?

A

Aseptic techniques, proper patient identification, and adherence to the six rights of drug administration.

518
Q

What is a major goal of pharmacotherapy?

A

To limit the number and severity of adverse drug events.

519
Q

What are adverse drug events?

A

Undesirable or harmful effects caused by medications.

520
Q

What are the key responsibilities of a pharmacy technician related to drug administration?

A


Understanding general principles of drug delivery.

Knowledge of various drug forms.

Understanding routes of administration.

521
Q

What is patient compliance in medication therapy?

A

Taking medication as prescribed, following instructions for dosage, frequency, and any special directions.

522
Q

Why is patient compliance important?

A

It’s essential for successful pharmacotherapy (drug treatment).

523
Q

What are some common reasons why patients might not comply with their medication regimen?

A


Expense of medications

Forgetting to take doses

Annoying side effects

Fear of dependence

524
Q

What are the Six Rights of Drug Administration?

A

1.
Right patient
2.
Right medication
3.
Right dose
4.
Right route
5.
Right time
6.
Right documentation

525
Q

What is the purpose of the Six Rights of Drug Administration?

A

They form the basis for safe and accurate drug delivery.

526
Q

What are the Three Checks in medication administration?

A

1.
Checking the drug against the prescription/order when selecting.
2.
Checking the drug during preparation (pouring, etc.).
3.
Checking the drug before dispensing it to the patient.

527
Q

Why are the Three Checks important?

A

They are a safety procedure to prevent medication errors.

528
Q

What does “ac” stand for in medication directions?

A

Before meals

529
Q

What does “bid” mean in medication instructions?

A

Twice per day

530
Q

Twice per day

A

Drop

531
Q

What does “hs” mean in medication instructions?

A

At bedtime

532
Q

What does “PO” stand for?

A

By mouth

533
Q

What does “prn” mean?

A

When needed/necessary

534
Q

What does “STAT” mean?

A

Immediately; at once

535
Q

What are the three systems of measurement used in pharmacology?

A

1.
Metric
2.
Apothecary
3.
Household

536
Q

Approximately how many milliliters (mL) are in a teaspoon?

A

5 mL

537
Q

How many teaspoons are in a tablespoon?

A

3 teaspoons

538
Q

How many fluid ounces are in a cup?

A

8 fluid ounces

539
Q

If a medication order is for 1 grain of a drug, approximately how many milligrams (mg) would that be?

A

60-65 mg

540
Q

What are the three main routes of drug administration?

A

1.
Enteral
2.
Topical
3.
Parenteral

541
Q

What is enteral drug administration?

A

Administering medication through the gastrointestinal (GI) tract.

542
Q

What are common methods of enteral drug administration?

A


Orally (PO)

Nasogastric (NG) tube

Rectally

543
Q

What are the advantages of oral drug administration?

A


Most common and convenient.

Least costly.

544
Q

Where are enteral drugs absorbed?

A


Oral mucosa

Stomach

Small intestine

545
Q

What are some disadvantages of enteral drug administration?

A


Patient must be able to swallow.

Some drugs are inactivated by digestive enzymes.

First-pass metabolism can reduce drug effectiveness.

Variations in GI motility can affect absorption.

Patients may dislike swallowing large pills.

546
Q

What is topical drug administration?

A

Applying medications locally to the skin or mucous membranes.

547
Q

Where are topical drugs commonly applied?

A


Skin

Membranous linings of the:

Eye

Ear

Respiratory tract

Urinary tract

Vagina

Rectum

548
Q

What are some types of topical drug applications?

A


Dermatologic preparations (creams, lotions, gels, etc.)

Instillations and Irrigations (into body cavities)

Inhalations (to the respiratory tract)

549
Q

What are transdermal drug delivery systems?

A

Patches that deliver medication through the skin over time, such as nitroglycerin, estrogen, or narcotics. They bypass the first-pass effect and digestive enzymes.

550
Q

Why is nasal drug administration (IN) sometimes preferred?

A

The nasal passages have an excellent absorptive surface. This route also avoids the first-pass effect and digestive enzymes.

551
Q

What is parenteral drug administration?

A

Administering medication by injection, bypassing the digestive tract.

552
Q

What are the four main types of parenteral injections?

A

1.
Intradermal (ID): Into the skin’s dermis.
2.
Subcutaneous (SC): Into the subcutaneous tissue (fat layer).
3.
Intramuscular (IM): Into the muscle.
4.
Intravenous (IV): Directly into the bloodstream.

553
Q

What is an important consideration when administering parenteral medications?

A

Aseptic techniques must be used because the skin barrier is bypassed, increasing the risk of infection.

554
Q

What are the advantages of parenteral drug administration?

A


Avoids first-pass metabolism in the liver.

Avoids breakdown by digestive enzymes.

555
Q

What is a key disadvantage of parenteral drug administration?

A

The possibility of introducing pathogens directly into the blood or body tissues.

556
Q

What are the advantages of tablets and capsules as oral dosage forms?

A


Easy to use

Often preferred by patients over other oral forms

557
Q

What does it mean if a tablet is “scored?”

A

It has a line indented on it, making it easier to break into smaller doses if needed.

558
Q

What are enteric-coated tablets, and what is important to know about administering them?

A


They have a special coating designed to prevent them from dissolving in the stomach.

Do not crush enteric-coated tablets.

They are designed to dissolve in the small intestine.

559
Q

What are sustained-release (SR, XR, LA) medications?

A


Tablets or capsules formulated to dissolve slowly over an extended period.

This extends the drug’s duration of action.

560
Q

What are the advantages of sublingual and buccal drug administration?

A


Fast absorption directly into the bloodstream from the mouth.

Avoids destruction by stomach acid.

May have a faster onset of action than oral medications.

561
Q

Where are sublingual medications placed?

A

Under the tongue

562
Q

Where are buccal medications placed?

A

Between the cheek and gum.

563
Q

What are some considerations when administering medications via a nasogastric (NG) or gastrostomy tube?

A


Medications are usually in liquid form.

Some tablets can be crushed, but always check for compatibility.

Tubes can easily become clogged.

The same physiological processes affect absorption as with oral administration.

564
Q

What is the “first-pass effect”?

A

When a drug absorbed from the GI tract is significantly metabolized (broken down) by the liver before reaching the systemic circulation.

565
Q

Why do some medications avoid the first-pass effect?

A

To ensure more of the active drug reaches the bloodstream and target tissues.

566
Q

What is the ISMP Canada, and what does it recommend regarding medication abbreviations?

A


ISMP Canada stands for the Institute for Safe Medication Practices Canada.

It recommends spelling out some abbreviations to avoid medication errors.

Use “daily” instead of “qd.”

Use “nightly” instead of “qhs.”

Use “every other day” instead of “qod.”

567
Q

Where can I find ISMP’s complete “Do Not Use” list of abbreviations?

A

http://www.ismp.org/tools/errorproneabbreviations.pdf

568
Q

How do you convert grains to grams?

A

Divide the number of grains by 15 or 16.

569
Q

How do you convert grams to grains?

A

Multiply the number of grams by 15 or 16.

570
Q

How do you convert minims to milliliters?

A

Divide the number of minims by 15 or 16.

571
Q

What are instillations?

A

Liquid medications introduced drop by drop into a body cavity, such as the eye or ear.

572
Q

What are irrigations?

A

Flushing a body cavity with a stream of liquid, often for cleaning or applying medication.

573
Q

Besides the skin, where else can topical medications be applied?

A

Topical medications can also be applied to the membranous linings of the:

Eye

Ear

Respiratory tract

Urinary tract

Vagina

Rectum

574
Q

What are the three main types of topical applications?

A


Dermatologic preparations (creams, lotions, gels, powders, and sprays)

Instillations and Irrigations

Inhalation (using inhalers, nebulizers, or positive-pressure breathing devices)

575
Q

What are the advantages of transdermal (patches) and transmucosal drug delivery systems?

A


They are effective for delivering certain medications.

Examples include nitroglycerin, estrogen, and narcotics.

They avoid the first-pass effect.

They bypass digestive enzymes.

576
Q

What is an advantage of nasal (IN) drug administration?

A


The nasal passages provide an excellent absorptive surface.

This route avoids the first-pass effect.

It bypasses digestive enzymes.

577
Q

What are the four main types of parenteral administration routes?

A


Intradermal (ID) – into the skin layers

Subcutaneous (SC) – into the subcutaneous tissue

Intramuscular (IM) – into the muscles

Intravenous (IV) – into the veins

578
Q

Why are aseptic techniques essential in parenteral administration?

A

Because the delivery system bypasses the skin’s protective barrier, increasing the risk of introducing pathogenic microbes directly into the bloodstream or body tissues.

579
Q

What are two advantages of parenteral drug administration?

A


Avoidance of the first-pass effect in the liver.

Bypassing digestive enzymes.

580
Q

What is a major goal in pharmacotherapy?

A

To limit the number and severity of adverse drug events.

581
Q

What are the “Six Rights” of drug administration?

A


Right patient

Right medication

Right dose

Right route

Right time

Right documentation

582
Q

What does “patient compliance” mean in the context of medication?

A


Taking the medication in the way it was prescribed.

Taking the medication according to the instructions provided.

Understanding the right to refuse medication.

583
Q

What are some common reasons for patient noncompliance with medications?

A


Expense

Forgetfulness

Annoying side effects

Fear of dependence

584
Q

What are the three systems of measurement used in pharmacology?

A


Metric

Apothecary

Household

585
Q

Why is it important for pharmacy technicians to understand the various forms of drugs and routes of administration?

A

This knowledge is essential for their responsibilities in ensuring the safe and effective delivery of medications.

586
Q

What is pharmacokinetics?

A

Pharmacokinetics is the study of how the body interacts with drugs. It focuses on how drugs move within the body and includes four main processes: absorption, distribution, metabolism, and excretion.

587
Q

Define absorption.

A

Absorption is the first step in how the body handles a drug. It is the movement of a drug from its site of administration across one or more body membranes to reach its target cells.

588
Q

What are some factors that affect the rate of drug absorption and/or distribution?

A


Particle size (smaller particles absorb faster)

State of matter (gas > liquid > solid)

Lipid solubility

Chemical neutrality

Temperature (warmer > room temperature)

Presence or absence of food

Membrane characteristics: thickness (thin > thick), surface area (larger > smaller), tightness of connections between membrane cells

Protein binding (reduced protein binding increases rate)

Body temperature (increased body temperature increases rate)

589
Q

What is distribution in pharmacokinetics?

A

Distribution is the process by which drugs are transported throughout the body. It involves the binding of drugs to substances in the blood (like proteins) and the concept of bioavailability, which refers to how much of the drug is actually available to reach its target cells.

590
Q

Why is the fact that only unbound drugs can reach their target cells important?

A

When a drug is bound to a protein in the bloodstream, it forms a complex that is too large to pass through the membranes of target cells. Only the free, unbound drug molecules can reach their site of action and exert a pharmacological effect.

591
Q

What are drug-drug interactions?

A

Drug-drug interactions can occur when two drugs compete for the same protein-binding sites in the blood. This competition can alter the distribution and effectiveness of one or both drugs.

592
Q

What are the three major anatomical barriers that prevent certain drugs from reaching specific organs?

A


Blood-brain barrier

Blood-placental barrier

Blood-testicular barrier

593
Q

What is metabolism in pharmacokinetics?

A

Metabolism is the process where drugs are made less or more active. It involves a series of chemical reactions that transform the drug into different forms, called metabolites.

594
Q

Where does metabolism primarily occur?

A

Metabolism occurs in almost every cell and organ, but the liver is the primary site. It uses the cytochrome P-450 enzyme system to metabolize many drugs.

595
Q

What are inducers and inhibitors in relation to the cytochrome P-450 system?

A


Inducers are drugs that speed up the activity of a specific isoenzyme within the cytochrome P-450 system.

Inhibitors are drugs that slow down the activity of a specific isoenzyme within the cytochrome P-450 system.

596
Q

Why is it important to consider the age of a patient when thinking about drug metabolism?

A

Metabolic enzymes are usually less active in very young and very old patients, impacting how they process drugs and potentially leading to different drug effects.

597
Q

What is biotransformation?

A

Biotransformation is the chemical conversion of a drug from one form to another by the body. It often results in increased or decreased activity of the drug.

598
Q

What is the significance of prodrugs?

A

Prodrugs are inactive in their administered form and require metabolism to become active. The products formed by the breakdown of prodrugs can sometimes produce a more intense response than the original drug. An example is codeine, which is metabolized to morphine, which has significantly greater analgesic capabilities.

599
Q

What is the first-pass effect?

A

The first-pass effect occurs when drugs absorbed in the intestinal wall first travel to the liver via the blood. The liver may extensively metabolize the drug before it reaches the rest of the body (systemic circulation), potentially reducing the drug’s effectiveness.

600
Q

What is excretion in pharmacokinetics?

A

Excretion, also called elimination, is the final step in pharmacokinetics. It is the process by which drugs are removed from the body.

601
Q

What are the methods of drug excretion?

A

The primary methods of excretion include:

Urination

Exhalation

Defecation

Sweating

602
Q

What organs are involved in drug excretion?

A

Drug excretion primarily involves the kidneys, but also the respiratory tract, bile, and glands.

603
Q

What is enterohepatic recirculation?

A

Enterohepatic recirculation is a process in which drugs are metabolized by the liver, excreted in the bile, reabsorbed from the intestine, and then recirculated back to the liver. This can prolong the duration of a drug’s action.

604
Q

What is half-life (t ½)?

A

Half-life is the length of time required for a drug’s concentration in the body to decrease by one-half. It is an important factor in determining the frequency of drug dosing.

605
Q

What is the therapeutic range?

A

The therapeutic range is the difference between the minimum effective concentration (MEC) and the minimum toxic concentration (MTC). Maintaining drug concentrations within this range is crucial for achieving the desired therapeutic effect without causing toxicity.

606
Q

What is a loading dose?

A

A loading dose is a larger initial dose of a drug given to quickly reach the therapeutic range. It might sometimes be double the usual dose.

607
Q

What is a maintenance dose?

A

A maintenance dose is the amount of drug given regularly to maintain the drug concentration within the therapeutic range once it has been achieved.

608
Q

What are some factors that can influence the effectiveness of drug therapy?

A

Some important factors include:

Concentration (dose) of the drug

Metabolic rate (lower in children and older patients)

Frequency of drug dosing

Genetics

Food-drug interactions

Excretion rate

Drug-drug interactions

Half-life

Absorption rate

Changing medical conditions (especially those affecting the liver or kidneys)

609
Q

What is pharmacokinetics?

A

The study of how the body processes drugs, focusing on the movement of drugs through absorption, distribution, metabolism, and excretion.

610
Q

What are the four major processes of pharmacokinetics?

A
  1. Absorption
  2. Distribution
  3. Metabolism
  4. Excretion
611
Q

What is absorption in pharmacokinetics?

A

The process by which drugs enter the bloodstream from the site of administration.

612
Q

What mechanisms are involved in drug absorption?

A
  1. Diffusion (movement from high to low concentration)
  2. Active Transport (requires energy to move against a concentration gradient)
613
Q

What factors affect drug absorption?

A
  1. Drug formulation (liquid vs. solid)
  2. Route of administration (oral, intravenous)
  3. Presence of food in the stomach
  4. Surface area of the absorption site
614
Q

What is distribution in pharmacokinetics?

A

The process by which drugs are transported throughout the body after absorption.

615
Q

What is bioavailability?

A

The proportion of the drug that enters circulation and is available for action in the body.

616
Q

How does plasma protein binding affect drug distribution?

A

Only unbound drugs can exert therapeutic effects; bound drugs are inactive and cannot reach target cells.

617
Q

What are the key barriers in drug distribution?

A
  1. Blood-Brain Barrier (protects the brain)
  2. Blood-Placenta Barrier (protects the fetus)
618
Q

What is metabolism in pharmacokinetics?

A

The process of chemically altering a drug, primarily occurring in the liver, to make it easier to eliminate.

619
Q

What is the first-pass effect?

A

The initial metabolism of a drug in the liver after oral administration, which can reduce its effectiveness.

620
Q

What factors influence drug metabolism?

A
  1. Age (younger and older patients metabolize differently)
  2. Genetics
  3. Presence of other medications (drug-drug interactions)
621
Q

What is excretion in pharmacokinetics?

A

The process of removing drugs from the body, primarily through urine.

622
Q

What is half-life (t½)?

A

The time required for the concentration of a drug in the bloodstream to decrease by half.

623
Q

What is the therapeutic range?

A

The range of drug concentration in the bloodstream that is effective without causing toxicity.

624
Q

What are the minimum effective concentration (MEC) and minimum toxic concentration (MTC)?

A

MEC is the lowest concentration needed for a drug to be effective, while MTC is the lowest concentration that can cause toxicity.

625
Q

What is a loading dose?

A

An initial higher dose of a drug given to quickly achieve therapeutic levels in the bloodstream.

626
Q

What is a maintenance dose?

A

The regular dose taken to maintain drug levels within the therapeutic range after the loading dose.

627
Q

Why is understanding pharmacokinetics important?

A

It helps healthcare professionals optimize drug therapy, ensuring efficacy and minimizing adverse effects.

628
Q

What is enterohepatic recirculation?

A

The process where drugs are metabolized by the liver, excreted into bile, and then reabsorbed into the bloodstream, prolonging their effects.

629
Q

How do metabolic enzymes differ in younger and older patients?

A

Enzymes are usually less active in very young and very old patients, which can impact drug effects and dosing requirements.

630
Q

What are prodrugs?

A

Drugs that require metabolism to become active; for example, codeine is metabolized to morphine, which has stronger effects.

631
Q

What is the significance of the blood-brain barrier in drug therapy?

A

It limits the types of drugs that can affect the central nervous system, making it crucial for treating neurological conditions.

632
Q

What factors influence the effectiveness of drug therapy?

A
  1. Concentration of the drug
  2. Metabolic rate
  3. Frequency of dosing
  4. Genetics
  5. Food-drug interactions
  6. Excretion rate
  7. Drug-drug interactions
  8. Half-life of the drug
  9. Absorption rate
  10. Changing medical conditions (e.g., liver or kidney disease)
633
Q

What is the relationship between rate of elimination and plasma half-life?

A

The rate of elimination affects how long a drug remains active in the body; a longer half-life means the drug stays in the system longer.

634
Q

How long does it typically take to reach a therapeutic plateau?

A

It takes about four half-lives to reach a steady state or therapeutic plateau of drug concentration in the bloodstream.

635
Q

What is the role of drug-drug interactions in pharmacokinetics?

A

When two drugs compete for the same metabolic pathways or protein-binding sites, it can alter the effectiveness and safety of one or both drugs.

636
Q

What is the importance of understanding the therapeutic range?

A

It helps healthcare providers ensure that drug concentrations are effective without reaching toxic levels, guiding safe and effective dosing.

637
Q

What is the significance of the first-pass effect?

A

It can significantly reduce the bioavailability of orally administered drugs, necessitating higher doses or alternative routes of administration.

638
Q

What are the methods of drug excretion?

A
  1. Urination
  2. Exhalation
  3. Defecation
  4. Sweating
639
Q

What is the relationship between drug concentration and therapeutic response?

A

Drug concentrations must remain within the therapeutic range to be effective without causing toxicity; concentrations below MEC are ineffective, while those above MTC can be toxic.

640
Q

How does temperature affect drug absorption?

A

Higher temperatures can increase the rate of absorption, while cooler temperatures may slow it down.

641
Q

What is the impact of food on drug absorption?

A

The presence of food can either enhance or inhibit drug absorption, depending on the drug’s properties and the type of food consumed.

642
Q

What is the role of the liver in drug metabolism?

A

The liver is the primary site for drug metabolism, utilizing enzyme systems like cytochrome P-450 to convert drugs into more water-soluble forms for excretion.

643
Q

What are the implications of drug-drug interactions on pharmacokinetics?

A

They can lead to altered absorption, distribution, metabolism, or excretion of drugs, potentially resulting in reduced efficacy or increased toxicity.

644
Q

What factors can increase the rate of drug absorption?

A
  1. Smaller particle size
  2. Lipid solubility
  3. Higher temperatures
  4. Larger surface area
  5. Thinner membranes
645
Q
A