251 Pharma Study Cards - Midterm to Quiz #2 Flashcards
What historical event spurred stricter drug legislation and regulation in Canada?
The thalidomide catastrophe.
What does the Health Products Food Branch Inspectorate (HPFB) of Health Canada do?
Administers and enforces the
- Food and Drugs Act and the Food and Drug Regulations
- Controlled Drugs and Substances Act
- Consumer protection from fraud, health hazards (food, drugs, cosmetics, medical devices)
What does the Therapeutic Product Directorate do?
Regulates the following Acts:
- Food and Drugs Act and Food and Drug Regulations
- Controlled Drugs and Substances Act
In Canada, who can prescribe medications?
- Medical doctors and doctors of osteopathy
- Dentists and podiatrists are also allowed to prescribe medications that are within the scope of their practice.
- In some provinces or territories, other health care providers, including licensed physician’s assistants and nurse practitioners, may also prescribe medications.
When did Canadian drug legislation begin?
It began in 1875.
What Act is the legislation that regulates foods, drugs, cosmetics, and medical devices in Canada?
The Food and Drugs Act
What does the Controlled Drugs and Substances Act (CDSA) do?
- sets out the requirements for the control and sale of narcotics, controlled drugs, and substances of misuse. The CDSA is based on eight schedules that list controlled drugs and substances, based on their potential for misuse or harm. The Act is enforced by the RCMP and related sections of the Criminal Code.
True or false: The Controlled Drugs and Substances Act is enforced by the RCMP and related sections of the Criminal Code.
True
When did recreational use of cannabis become legal in Canada?
October 17, 2018
What group is responsible for approving drugs for clinical safety and efficacy before they are brought to the market?
The Therapeutic Products Directorate (TPD) of Health Canada
What is involved in ‘fast track approval’?
The TPD (Therapeutic Products Directorate) has made certain lifesaving investigational drug therapies available sooner than usual by offering an expedited drug approval process, also known as “fast track” approval.
Define alpha 1 blocker.
Drugs that primarily cause arterial and venous dilation through their action on peripheral sympathetic neurons.
Define antihypertensive drugs.
Medications used to treat hypertension.
Define cardiac output.
The amount of blood ejected from the left ventricle, measured in litres per minute.
Define centrally acting adrenergic drugs.
Drugs that modify the function of the sympathetic nervous system in the brain by stimulating alpha2 receptors. Alpha2 receptors are inhibitory in nature and thus have a reverse sympathetic effect and cause a decrease in blood pressure.
Define essential hypertension.
Elevated systemic arterial pressure for which no cause can be found; also called primary or idiopathic hypertension.
Define hypertension.
A common, often asymptomatic disorder in which blood pressure persistently exceeds 140 mm Hg or diastolic pressure exceeds 90 mm Hg.
Define malignant hypertension.
Extremely high blood pressure, usually above 180/120.
Define orthostatic hypotension.
A common adverse effect of adrenergic-blocking drugs involving a sudden drop in blood pressure when patients change position, especially when rising from a seated or horizontal position.
Define prodrug.
An inactive drug dosage form that is converted to an active metabolite by various biochemical reactions once it is inside the body.
Define secondary hypertension.
High blood pressure caused by another disease, such as kidney, pulmonary, endocrine, or vascular disease.
Define bias.
Any systematic error in a measurement process. One common effort to avoid bias in research studies involves the use of blinded study designs.
What are benzodiazepines and other targeted substances regulations?
Implemented in 2000, these regulations specify the requirements for producing, assembling, importing, exporting, selling, providing, transporting, delivering, or destroying benzodiazepines and other targeted substances.
What is a blinded investigational drug study?
A research design in which subjects in the study are purposely made unaware of whether the substance they are administered is the drug under study or a placebo. This method serves to minimize bias on the part of research subjects in reporting their body’s responses to investigational drugs.
What is the Act called that legislates publicly funded health insurance?
The Canada Health Act.
What is the Controlled Drugs and Substances Act?
A Health Canada act that makes it a criminal offence to possess, traffic, produce, import, or export controlled substances.
Define controlled substances.
Any drugs listed on one of the “schedules” of the Controlled Drugs and Substances Act (also a called scheduled drug if it is an item under the Food and Drug Regulations Part G).
What is a double-blind, investigated drug study?
A research design in which both the study investigator(s) and the subjects are purposely made unaware of whether the substance administered to a given subject is the drug under study or a placebo. This method minimizes bias on the part of both the investigator and the subject.
What is a drug identification number (DIN)?
A computer-generated number assigned by Health Canada, placed on the label of prescription and over-the-counter drug products that have been evaluated by the Therapeutic Products Directorate (TPD) and approved for sale in Canada.
Define ethics.
A set of principles, rights and responsibilities, and duties governing the moral values, beliefs, actions, and behaviours of human conduct and the rules and principles that ought to govern them.
What is the Food and Drug Act?
The main piece of drug legislation in Canada that protects consumers from contaminated, adulterated, and unsafe drugs and labelling practices; also addresses appropriate advertising and selling of drugs, foods, cosmetics, and therapeutic devices.
What are Food and Drug Regulations?
An adjunct to the Food and Drugs Act, these regulations clarify terms used in the Act and state the processes that companies must carry out to comply with the Act in terms of importing, preparing, treating, processing, labelling, advertising, and selling foods, drugs, cosmetics, natural health products including herbal products, and medical devices.
Define informed consent.
Written permission obtained from a patient consenting to a specific procedure (e.g., receiving an investigational drug), after the patient has been given information regarding the procedure deemed necessary for the patient to make a sound or “informed” decision.
What is an investigational new drug?
A drug not yet approved for marketing by the Therapeutic Products Directorate of Health Canada but available for use in experiments to determine its safety and efficacy.
Define malpractice.
Improper or unethical conduct or unreasonable lack of skill that results in harm and where compensation may be sought. All malpractice involves negligence.
Define negligence.
The failure to act in a reasonable and prudent manner or failure of the nurse to give the care that a reasonably prudent (cautious) nurse would render or use under similar circumstances.
What is a new drug submission?
The type of application that a drug manufacturer submits to the Therapeutic Products Directorate of Health Canada following successful completion of required human research studies.
What is a Notice of Compliance?
A notification issued when Health Canada decides that a drug and its manufacturing process are safe and effective, allowing the pharmaceutical company to sell the product by prescription to the Canadian population.
What is a placebo?
An inactive (inert) substance (e.g., saline, distilled water, starch, sugar) that is not a drug but is formulated to resemble a drug for research purposes.
What are Precursor Control Regulations?
A scheme intended to allow Canada to fulfill its international obligations and meet its domestic needs with respect to the monitoring and control of precursor chemicals such as methamphetamine, gamma-hydroxybutyric acid (GHB), and other drugs listed in Schedules I, II, and III of the Controlled Drugs and Substances Act, across Canadian borders and within Canada.
What is a Special Access Programme?
A program that allows health care providers to apply for access to drugs currently unavailable for sale in Canada.
What does health information privacy legislation involve?
Deals with the collection, use, and disclosure of personal health information. Requires that all health care providers, health insurance and life insurance companies, public health authorities, employers, and schools to maintain patient privacy regarding protected health information.
What are the factors that determine the schedule under which a controlled substance should be placed?
- international requirements
- the dependence potential
- the likelihood of abuse of the substance
- the extent of its abuse in Canada
- the danger it represents to the safety of the public
- the usefulness of the substance as a therapeutic agent
Where is the prevalence of hypertension highest globally?
- Africa
- low-and-middle income nations
Who is at greatest risk in Canada for the development of hypertension?
- People who are Black
- Indigenous people
- People with South Asian heritage
- People with low socioeconomic status
What is hypertension a major risk factor for?
- Coronary artery disease
- Cardiovascular disease
- Death resulting from cardiovascular causes
- Most important risk factor for stroke and heart failure
- Major risk factor for kidney failure and peripheral artery disease
Between 40 and 70 years old, how high is the risk of cardiovascular disease in relation to hypertension?
The risk of developing cardiovascular disease doubles with each 20 mm Hg increase in systolic blood pressure or 10 mm Hg increase in diastolic blood pressure.
Who are Beta clockers and ACE inhibitors more effective in?
More effective in people who are White than people who are Black
Who are calcium channel blockers and diuretcis more effective in?
More effective in patients who are Black than in patients who are White
What feature of the physiology of Black people affect the effectiveness of certain hypertension medications?
They are considered to have lower renin levels than the general treatment public
What determines blood pressure?
Cardiac output and systemic vascular restriction (SVR)
What is the average cardiac output
4 - 8 L/min
What is the mean arterial pressure?
A product of CO and SVR. Calculated at ⅓ (SBP -DBP) + DBP.
Why might MAP be a better indicator of tissue perfusion?
Because two thirds of the cardiac cycle are spent in diastole; a MAP of > or equal to 60 is believed to be necessary to to maintain adequate tissue perfusion.
Define cardiac output.
the amount of blood ejected from the left ventricle and is measured in litres for minute.
Define systemic vascular resistance (SVR).
Also known as afterload, is the resistance to blood flow that is determined by the diameter of the blood vessel and the vascular musculature. Calculated by dividing blood pressure by cardiac output.
What is angiotensin II?
A potent vasoconstrictor and induces aldosterone secretion by the adrenal glands.
What is prehypertension?
Systolic blood pressure of 120 to 139 mm HG or diastolic blood pressure of 80 to 89 mm Hg, or both.
How is the common cold usually caused and what effect does it have?
- Most are caused by viral infection (rhinovirus or influenza virus).
- Virus invades tissues (mucosa) of upper respiratory tract, causing upper respiratory infection.
- Excessive mucus production results from the inflammatory response to this invasion.
- Fluid drips down the pharynx into the esophagus and lower respiratory tract, causing cold symptoms: sore throat, coughing, upset stomach
What normally causes the sneeze reflex?
Irritation of nasal mucosa often triggers the sneeze reflex.
What does mucosal irritation from the common cold cause?
Mucosal irritation also causes the release of several inflammatory and vasoactive substances, dilating small blood vessels in the nasal sinuses and causing nasal congestion.
What is involved in the treatment of the common cold?
Combined use of antihistamines, nasal decongestants, antitussives, and expectorants.
True of false: Treatment of the common cold cures the causative pathogen.
False: Treatment is symptomatic only and does not cure the causative pathogen.
What is “empirical therapy”?
Treating the most likely cause.
In 2009, what minimum age did Health Canada advise for the use of over-the-counter cough and cold products?
6 years old
How do antihistamines work?
Compete with histamine for specific receptor sites (Histamine Antagonist)
- Bind to histamine receptors on mast cells & basophils
- Prevent further release of histamine & actions
What are two examples of antihistamines?
Loratadine and Diphenhydramine
What are H1 blockers?
- H1 blockers are associated with antihistamines
- H1 are in areas such as smooth muscle surrounding blood vessels and bronchioles
What secretions do antihistamines affect?
Lacrimal, salivary and respiratory mucous glands
Primary anticholinergic actions (dry mouth, etc.)
What characteristics of the inflammatory response do antihistamines mediate?
- Rhinitis: hay fever, mold, dust
- Anaphylaxis
- Angioedema
- Drug fevers
- Insect bite reactions
- Uritcaria (itching)
-
Symptoms of common cold
- Sneezing
- Runny nose
What else can antihistamines be used to treat?
- Vertigo
- Insomnia
- Motion sickness
- Cough