251 Pharma Study Cards - Midterm to Quiz #2 Flashcards
(178 cards)
1
Q
What historical event spurred stricter drug legislation and regulation in Canada?
A
The thalidomide catastrophe.
2
Q
What does the Health Products Food Branch Inspectorate (HPFB) of Health Canada do?
A
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)
3
Q
What does the Therapeutic Product Directorate do?
A
Regulates the following Acts:
- Food and Drugs Act and Food and Drug Regulations
- Controlled Drugs and Substances Act
4
Q
In Canada, who can prescribe medications?
A
- 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.
5
Q
When did Canadian drug legislation begin?
A
It began in 1875.
6
Q
What Act is the legislation that regulates foods, drugs, cosmetics, and medical devices in Canada?
A
The Food and Drugs Act
7
Q
What does the Controlled Drugs and Substances Act (CDSA) do?
A
- 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.
8
Q
True or false: The Controlled Drugs and Substances Act is enforced by the RCMP and related sections of the Criminal Code.
A
True
9
Q
When did recreational use of cannabis become legal in Canada?
A
October 17, 2018
10
Q
What group is responsible for approving drugs for clinical safety and efficacy before they are brought to the market?
A
The Therapeutic Products Directorate (TPD) of Health Canada
11
Q
What is involved in ‘fast track approval’?
A
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.
12
Q
Define alpha 1 blocker.
A
Drugs that primarily cause arterial and venous dilation through their action on peripheral sympathetic neurons.
13
Q
Define antihypertensive drugs.
A
Medications used to treat hypertension.
14
Q
Define cardiac output.
A
The amount of blood ejected from the left ventricle, measured in litres per minute.
15
Q
Define centrally acting adrenergic drugs.
A
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.
16
Q
Define essential hypertension.
A
Elevated systemic arterial pressure for which no cause can be found; also called primary or idiopathic hypertension.
17
Q
Define hypertension.
A
A common, often asymptomatic disorder in which blood pressure persistently exceeds 140 mm Hg or diastolic pressure exceeds 90 mm Hg.
18
Q
Define malignant hypertension.
A
Extremely high blood pressure, usually above 180/120.
19
Q
Define orthostatic hypotension.
A
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.
20
Q
Define prodrug.
A
An inactive drug dosage form that is converted to an active metabolite by various biochemical reactions once it is inside the body.
21
Q
Define secondary hypertension.
A
High blood pressure caused by another disease, such as kidney, pulmonary, endocrine, or vascular disease.
22
Q
Define bias.
A
Any systematic error in a measurement process. One common effort to avoid bias in research studies involves the use of blinded study designs.
23
Q
What are benzodiazepines and other targeted substances regulations?
A
Implemented in 2000, these regulations specify the requirements for producing, assembling, importing, exporting, selling, providing, transporting, delivering, or destroying benzodiazepines and other targeted substances.
24
Q
What is a blinded investigational drug study?
A
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.
25
What is the Act called that legislates publicly funded health insurance?
The Canada Health Act.
26
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.
27
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).
28
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.
29
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.
30
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.
31
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.
32
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.
33
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.
34
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.
35
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.
36
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.
37
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.
38
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.
39
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.
40
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.
41
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.
42
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.
43
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
44
Where is the prevalence of hypertension highest globally?
* Africa
* low-and-middle income nations
45
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
46
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
47
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.
48
Who are Beta clockers and ACE inhibitors more effective in?
More effective in people who are White than people who are Black
49
Who are calcium channel blockers and diuretcis more effective in?
More effective in patients who are Black than in patients who are White
50
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
51
What determines blood pressure?
Cardiac output and systemic vascular restriction (SVR)
52
What is the average cardiac output
4 - 8 L/min
53
What is the mean arterial pressure?
A product of CO and SVR. Calculated at ⅓ (SBP -DBP) + DBP.
54
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.
55
Define cardiac output.
the amount of blood ejected from the left ventricle and is measured in litres for minute.
56
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.
57
What is angiotensin II?
A potent vasoconstrictor and induces aldosterone secretion by the adrenal glands.
58
What is prehypertension?
Systolic blood pressure of 120 to 139 mm HG or diastolic blood pressure of 80 to 89 mm Hg, or both.
59
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
60
What normally causes the sneeze reflex?
Irritation of nasal mucosa often triggers the sneeze reflex.
61
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.
62
What is involved in the treatment of the common cold?
Combined use of antihistamines, nasal decongestants, antitussives, and expectorants.
63
True of false: Treatment of the common cold cures the causative pathogen.
False: Treatment is symptomatic only and does not cure the causative pathogen.
64
What is “empirical therapy”?
Treating the most likely cause.
65
In 2009, what minimum age did Health Canada advise for the use of over-the-counter cough and cold products?
6 years old
66
How do antihistamines work?
Compete with histamine for specific receptor sites (Histamine **_Ant_**agonist)
* Bind to histamine receptors on mast cells & basophils
* Prevent further release of histamine & actions
67
What are two examples of antihistamines?
**Loratadine and Diphenhydramine**
68
What are H1 blockers?
* **H1** blockers are associated with antihistamines
* **H1** are in areas such as smooth muscle surrounding blood vessels and bronchioles
69
What secretions do antihistamines affect?
Lacrimal, salivary and respiratory mucous glands
**Primary anticholinergic actions (dry mouth, etc.)**
70
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**
71
What else can antihistamines be used to treat?
* Vertigo
* Insomnia
* Motion sickness
* Cough
72
When are antihistamines most effective?
Most effective when given early in histamine mediated reactions.
73
True or false: Antihistamines should be used as the sole therapy in acute asthma attacks.
False. Should not be used as the sole therapy.
74
What are contraindications for antihistamines.
* Narrow angle glaucoma
* Heart disease
* Hypertension
* COPD
* Peptic ulcer disease
* Seizure disorders,
* BPH (enlarged prostate)
* Pregnancy
75
What is a pediatric alert for antihistamines?
* Fexofenadine (Allegra) is not recommended in children under 6yrs*
* Desloratadine (Aerius) is not recommended in children*
* Loratadine (Claritin) is not recommended in children under 2 yrs*
76
What are adverse effects of antihistamines?
Drowsiness (varies amongst drug class)
“Drying” effects:
* Dry mouth
* Difficulty urinating
* Constipation
* Change in vision
77
What interactions are there for antihistamines?
* Ketoconazole, cimetidine and erythromycin increase concentrations of fexofenadine & loratadine
* Alcohol, CNS depressants, MAOs increase depressant effects of certirizine (Reactine) and diphenhydramine (Benadryl)
78
What is nasal congestion and what are its primary causes?
* Excessive nasal secretions
* Inflamed and swollen nasal mucosa
* Primary causes
* Allergies
* Upper respiratory infection (common cold)
79
List the 3 separate groups of decongestants.
* Adrenergics (sympathomimetics)
* Anticholinergics (parasympatholyitcs)
* Corticosteroids
80
Name 2 adrenergic (sympathomimetics) decongestants.
* Pseudoephedrine (Sudafed) oral
* Oxymetazoline HCl (Dristan) nasal spray
81
List 1 anticholinergic decongestant (parasympatholytics).
•Ipratropium bromide (Atrovent) nasal spray
82
List 3 corticosteroid decongestants.
* Fluticasone propionate (Flonase) nasal spray
* Beclomethasone dipropionate (Rivanase) (nasal spray)
* Budenoside (Pulmicort, pulmicort turbohaler, symbicort turbohaler)
83
What does a negative inotropic drug do?
Decreases cardiac contractility.
84
What is a negative chronotropic effect?
Decreased heart rate.
85
What is a negative dromotropic effect?
Decreased conduction.
86
What does a person taking guaifesin (Robitussin) need to do?
Increase fluid intake
87
How do adrenergic decongestants mainly work?
•Constrict small arterioles due to URI to cause constriction to reduce swelling and allow secretions to drain
88
How do corticosteroid decongestants typically work?
Target inflammatory response; “turn off” cell response
89
How do anticholinergic decongestants mainly work?
Inhibits secretions of the serous and serous-mucous membranes of the nasal passages.
90
What else can antihistamines be used to treat?
vertigo, motion sickness, insomnia, and cough
91
What are the general characteristics of the antihistamine diphenhydramine hydrochloride?
* High anticholinergic
* High sedative effect
* Drowsiness occurs in about 50% of patients
* Also used as an antiemetic
92
What are the general characteristics of loratadine?
* Few adverse anti-cholinergic or sedative effects
* Can be used during the day
* Longer acting
* Fewer adverse effects than other classes of drugs
93
What is the effect of antihistamine on the cardiovascular system?
Reduces dilation of blood vessels and increases permeability.
94
What are antihistamines indicated for?
Primarily:
* Nasal allergies
* Seasonal or perennial allergic rhinitis
* Symtoms of common cold
Others:
* allergic reactions
* motion sickness
* Parkinson's disease
* vertigo
* Can sometimes be used for sleep aids
95
True or false. Antihistamines should be used as the sole drug therapy during acute asthma attacks.
False. Would need a rapid acting broncholdilator such as salbutamol
96
What are contraindications of adrenergic decongestants?
* Narrow angle glaucoma
* Uncontrolled cardiovascular disease
* Hypertension
* Diabetes
* Hyperthyroidism
* Prostatitis, BPH
* Inability to close eyes (stroke patients)
* TIAs
* AsthmaDrugs allergy
97
What are the adverse effects of adrenergic decongestants?
* Nervousness
* Insomnia
* Palpitations
* Tremor
\****MAOIs may result in additive pressor effect with adrenergics decongestants***
98
What are the adverse effects of corticosteroid decongestants?
ØLocalized dryness, nose bleeds, mucosal thinning
99
What are the adverse effects of anticholinergic decongestants?
Excessive dryness, nose bleeds
100
What phase of an investigational drug study involves studies of small numbers (100 - 300) of volunteers who have the disease or ailment that the drug is designed to diagnose or treat?
Phase II
101
What phase of an investigational drug study involves studies that are voluntarily conducted by pharmaceutical companies to obtain more information about the therapeutic and adverse effects.
Phase IV
102
What phase of an investigational drug study involves studies that involve small numbers of healthy subjects who do not have the disease or ailment that the drug is intended for?
Phase 1
103
What phase of an investigational drug study involves studies of large numbers of patients who have the disease that the drug is intended to treat; these studies establish the drug's clinical **effectiveness, safety and dosage range.**
Phase III
104
What are the main categories of antihypertensive drugs?
* Adrenergic drugs
* Angiotensin-converting enzyme (ACE) inhibitors
* Angiotensin II receptor blockers (ARBs)
* Calcium channel blockers
* Diuretics
* Vasodilators
* Direct renin inhibitors
105
How many Canadians does hypertension affect?
7.5 million
106
Which antihypertensive drugs have their effect on cardiac factors (e.g. heart rate, contractility)?
* Beta blockers
* Calcium channel blockers
* Centrally acting andrenergics
107
Which antihypertensive drugs have their effect on circulating volume?
* ACE inhibitors
* Diuretics
108
Which antihypertensive drugs have their effect on hormones (vasodilators, vasoconstrictors)?
* Vasodilators
* Prostaglandins
* ACE inhibitors
* Calcium channel blockers
* Angiotensin II blockers
109
90 - 95% of cases is what kind of hypertension?
Essential hypertension (idiopathic, primary)
110
What is secondary hypertension most commonly caused by?
pheochromocytoma, pre-eclampsia, renal artery disease, sleep apnea, thyroid disease, or parathyroid disease
111
What are the goals of antihypertensive therapy?
* Reduction of cardiovascular and renal morbidity
* Achieve pressure less than 140/90 mmHg
* Hypertension + diabetes: \< 130/80 mmHg
* Hypertension + chronic kidney disease: \< 140/90 mmHg
112
What are the 5 subcategories of adrenergic drugs?
* Adrenergic neuron blockers (central and peripheral)
* α2-Receptor agonists (central)
* α1-Receptor blockers (peripheral)
* β-Receptor blockers (peripheral)
* Combination α1- and β-receptor blockers (peripheral)
113
Which ACE inhibitors are not prodrugs?
Captopril and lisinopril are _not_ prodrugs.
114
Which ACE inhibitors can be use by a patient with liver dysfunction and why?
Captopril and lisinopril can be used if a patient has liver dysfunction, unlike other ACE inhibitors that are prodrugs
115
What drugs may be used to treat pulmonary hypertension?
* bosentan (Tracleer®)
* epoprostenol
* treprostinil
* ambrisentan
* sildenafil and tadalafil
116
What are key nursing implications in the administration of antihypertensives?
* Monitor BP and HR _prior_ to administration of antihypertensives (client _and_ patient).
* Need specific parameters. General rule: If **apical** HR \<60 or SBP \< 90 contact their HCP; medication **_will be held_** if BP and/or HR parameters are lower than above
* Monitor lab values (K+, possibly other electrolytes such as Na+ and Cl-, blood glucose, kidney function, liver function)
* Before beginning therapy, obtain a thorough health history and perform a head-to-toe physical examination.
* Assess for contraindications.
* Assess for conditions that require cautious use.
* Educate patients re: importance of not missing a dose and taking the medications exactly as prescribed. Never double up.
* Not be stopped abruptly; can cause rebound hypertensive crisis
* Oral forms should be given with meals
* Administer IV forms with extreme caution; must use an IV pump
* Remind patients that medication is only part of therapy. Encourage patients to watch their diet, stress level, weight, and alcohol intake.
* Instruct patients to avoid smoking and to avoid eating foods high in sodium.
* Encourage supervised exercise.
* Teach patients to change positions slowly to avoid syncope from postural hypotension.
* Hot tubs, showers, or baths; hot weather; prolonged sitting or standing; physical exercise; and alcohol ingestion may aggravate low BP, leading to fainting and injury.
* Patients should not take any other medications, including over-the-counter drugs, without first getting the approval of their health care provider.
* Monitor for adverse effects (dizziness, orthostatic hypotension, fatigue) and for toxic effects.
* Monitor for therapeutic effects.
*
117
What lab values are important to know related to ACE Inhibitors?
* ACE inhibitors can cause **renal impairment**, which can be identified by **serum creatinine**.
* ACE inhibitors can also cause **hyperkalemia**, so **potassium levels** need to be monitored.
* Monitor **serum sodium** during therapy.
118
What are 4 examples of **Angiotensin-converting enzyme (ACE) inhibitors (-pril)?**
* **captopril (Capoten®)**
* **enalapril (Vasotec®)**
* **perindopril (Coversyl®)**
* **ramipril (Altace®)**
119
What are 2 examples of **Angiotensin II receptor blockers (ARBs) (-tan)?**
**losartan (Cozaar®)**
**telmisartan (Micardis®)**
120
List two diseases of the lower respiratory tract.
* Chronic obstructive pulmonary disease
* Asthma (persistent and present most of the time despite treatment)
121
Recurrent and reversible shortness of breath
Occurs when the airways of the lungs become narrow as a result of:
* Bronchospasms
* Inflammation of the bronchial mucosa
* Edema of the bronchial mucosa
* Production of viscous mucus
Bronchial asthma
122
Symptoms of bronchial asthma.
* Wheezing
* Difficulty breathing
123
What is a prolonged asthma attack that does not respond to typical drug therapy is known as?
Status asthmaticus
124
What are the characteristics of status asthmaticus?
* Prolonged asthma attack that does not respond to typical drug therapy
* May last several minutes to hours
* Medical emergency
125
Progressive respiratory disorder that is characterized by chronic airflow limitation, systematic manifestations, and significant comorbidities.
Chronic Obstructive Pulmonary Disease
126
Presence of cough and sputum for at least 3 months in each of 2 consecutive years; separate disease from chronic obstructive pulmonary disease.
Chronic bronchitis
127
What are the steps of the asthma management continuum?
* Confirm diagnosis; environmental control, self-management education plus a written action plan
* Step 1: Mild intermittent: SABA as needed; low dosage inhaled glucosteroid
* Step 2: Moderate intermittent: SABA as needed; medium-dosage inhaled glucosteroid and long acting beta agonist combo
* Step 3 - 4: Severe uncontrolled: In addition to the above, oral prednisone, anti-IgE antagonist
128
Nonselective adrenergics: mode and example.
* Stimulate ß-, ß1- (cardiac), and ß2- (respiratory) receptors
* Example: epinephrine (EpiPen®)
129
Nonselective ß-adrenergics: mode and example.
* Stimulate both ß1- and ß2-receptors
* Example: isoproterenol hydrochloride
130
Selective ß2 drugs: mode and example
* Stimulate only ß2-receptors
* Example: salbutamol
131
What are indications of B-Andrenergic Agonists?
* **Relief of bronchospasm** related to asthma, chronic obstructive pulmonary disease (COPD), and other pulmonary diseases
* Used in treatment and prevention of **acute attacks**
* Used in **hypotension** and **shock**
132
What are contraindications of B-Andrenergic Agonists?
* Known drug allergy
* Uncontrolled cardiac dysrhythmias
* High risk of stroke (because of the vasoconstrictive drug action)
133
Adverse effects of α and ß (epinephrine)
* Insomnia
* Restlessness
* Anorexia
* Vascular headache
* Hyperglycemia
* Tremor
* Cardiac stimulation
134
ß1 and ß2 adverse effects.
* Cardiac stimulation, tachycardia
* Tremor
* Anginal pain
* Vascular headache
135
What routes can salbutamol be used?
oral, parenteral, and inhalation (includes metered-dose inhalers as well as solutions for inhalation (aerosol nebulizers))
136
Adverse effects of salbutamol.
* Hypotension or hypertension
* Vascular headache
* Tremor
137
True or false. An increase in blood glucose levels can occur as an interaction with B-Andrenergic Agonists?
True
138
What should Salmeterol always be used in combination with?
In combination with an inhaled glucocorticoid steroid
139
What are OTC drugs?
* Nonprescription drugs
* Use for short-term treatment of common minor illnesses.
* More than 300 000 over-the-counter (OTC) drugs available
* Use should be for short-term treatment of common minor illnesses
* Interactions with current prescription medications may occur
140
Who regulates OTC's and what are they regulating?
.Health Canada’s Food and Drug Regulations. Regulating:
* Safety and efficacy
* Appropriate labelling standards
* Reclassification
141
What percentage of Canadians use OTCs?
* More than 80% of Canadians use OTCs
* Most are unscheduled drugs that can be sold without professional supervision
142
restricted access such as behind counter
Schedule II
143
schedule # for prescription
schedule I
144
Schedule: pharmacy only, nonprescription, pharmacist must be available for assistance
Schedule III
145
Schedule: those that may be prescribed by a pharmacist
Schedule IV
146
What are the criteria for OTC status?
147
What is the process for reclassification to an OTC?
* Submission of a “switch” application to National Drug Scheduling Advisory Committee (NDSAC)
* Review of clinical-trial results and safety data submitted to Health Canada
* Approval of active ingredient for nonprescription status
* Removal from Schedule F of the Food and Drug Regulations
148
List 4 OTC analgesics.
* acetaminophen, codeine 8 mg, caffeine (Tylenol No.1®)
* acetylsalicylic acid, codeine 8 mg, caffeine (222®, AC&C®)
* ibuprofen (Advil®, Motrin®)
* naproxen sodium (Aleve®, Anaprox®, Naprelan®, Naproxen®)
149
What are two OTC smoking deterrents?
* nicotine gum (Nicorette®)
* nicotine transdermal patch (Nicoderm®, Habitrol®)
150
What are some advantages of OTCs?
* Convenience of self treatment of minor ailments
* Decreased health care costs when drug is paid out of pocket
* Fewer visits to health care provider
151
What are disadvantages of OTCs?
* May postpone effective treatment of serious or life-threatening disorders
* May delay treatment of serious or life-threatening disorders
* May relieve symptoms of a disorder but not the cause
152
What are potential hazards of OTCs?
* Toxicity
* May have their own toxicity profiles
* Possible interactions with current prescription medications
* Misuse
153
What are Natural Health Products?
* Therapeutic agents for treatment and prevention of diseases
* Proactively to preserve health and wellness and “boost” one’s immune system
* Adjunct therapy to support conventional pharmaceutical therapies
154
List the different types of Natural Health Products.
* Dietary Supplements: Vitamin and mineral supplements – health food bars, shakes
* Herbs – teas, oils, ointments, dried extract
* Homeopathy – microdose of substance thought to cause disease
* Traditional Chinese, Ayurvedic, and other traditional medicines
* Probiotics
* Other products like amino acids and essential fatty acids
155
What are the requirements of Natural Health Products to be marketed towards consumers?
* Require a product licence from Health Canada
* Regulated by the Natural Health Products Directorate
* Homeopathic Meds receive a DIN – HM followed by a product number
* Classified according to level of risk
* Also have labelling requirements: product name, amount of product, conditions for use or purpose, dose amount, warnings, cautionary statements, contraindications, possible adverse reactions
156
What % of Canadians regularly take vitamins and minerals, herbal products, and homeopathic medicines?
71%
157
True or false: Natural Health Products treat major illnesses.
False. Natural health products treat minor conditions and illnesses (e.g., coughs, colds, stomach upset)
158
Define complementary medicine.
Complementary medicine (integrative medicine): simultaneous use of both conventional and alternative medicine
159
NCCAM
National Center for Complementary and Alternative Medicine (NCCAM)
160
What are some commonly used herbal products?
* Aloe
* Feverfew
* Gingko biloba
* Goldenseal
* St. John’s wort
* Valerian
* Chamomile
* Echinacea
* Garlic
* Ginseng
* Hawthorn
* Saw palmetto
* Black cohosh
* Ginger
161
What are safety considerations with Natural Health Products?
* Caution for allergic reactions, toxic reactions, and adverse effects
* Drug interactions
* Under-reporting of natural health products (NHPs) to health care providers
* NHP Canada’s Vigilance Program
* Indiscriminate or excessive use of NHPs potentially dangerous
162
What are the potential drug interactions for chamomile?
Increased potential for bleeding with anticoagulants
163
What are the potential drug interactions for cranberry?
Decreased elimination of many drugs excreted by the kidneys
164
What are the potential drug interactions for echinacea?
Possible interference with or counteraction to immunosuppressant drugs and antivirals
165
What are the potential drug interactions for evening primrose?
Possible interaction with antipsychotic drugs
166
What are the potential drug interactions for garlic?
Possible interference with hypoglycemic therapy and the anticoagulant warfarin sodium (Coumadin®)
167
What are the potential drug interactions for gingko biloba?
May increase risk of bleeding with use of anticoagulants (warfarin sodium, heparin sodium) and antiplatelets (aspirin, clopidrogrel)
168
What are the potential drug interactions for ginger root?
At high dosages, possible interference with cardiac, antidiabetic, or anticoagulant drugs
169
What are the potential drug interactions for Grapefruit?
* Decreases metabolism of drugs used for erectile dysfunction
* Decreases metabolism of estrogens and some psychotherapeutic drugs (benzodiazepines, sertraline)
* Increases risk of toxicity of immunosuppressants, HMG-CoA reductase inhibitors, and of some psychotherapeutic drugs (pimozide, escitalopram)
* Increases intensity and duration of effects of caffeine
170
Oldest and most commonly used anticholinergic bronchodilator. Available both as a liquid aerosol for inhalation and as a multidose inhaler. Usually dosed twice daily
Anticholinergic respiratory medication: Ipratropium bromide
171
What are 3 examples of inhaled corticosteroids?
* beclomethasone dipropionate (Qvar®)
* budesonide (Pulmicort Turbuhaler®)
* fluticasone propionate (Flovent Dickus®)
172
What are contraindications of inhaled corticosteroids?
* Drug allergy
* Not intended as sole therapy for acute asthma attacks
* Hypersensitivity to glucocorticoids
* Patients whose sputum tests are positive for *Candida* organisms
* Patients with systemic fungal infection
173
What are the adverse effects of inhaled corticosteroids?
* Pharyngeal irritation
* Coughing
* Dry mouth
* Oral fungal infections
* Systemic effects are rare because low doses are used for inhalation therapy.
174
What are some nursing considerations for B-andrenergic agonists?
* Salbutamol, if used too frequently, loses its ß2-specific actions at larger doses.
* As a result, ß1-receptors are stimulated, causing nausea, increased anxiety, palpitations, tremors, and increased heart rate.
* Ensure that patients take medications exactly as prescribed, with no omissions or double doses.
* Inform patients to report insomnia, jitteriness, restlessness, palpitations, chest pain, or any change in symptoms.
175
What are some nursing considerations for leukotriene receptor agonists?
* Ensure that the medication is being used for long-term management of asthma, not acute asthma.
* Teach the patient the purpose of the therapy.
* Improvement should be seen in about 1 week.
* Assess liver function before beginning therapy and throughout therapy.
* Teach patients to take medications every night on a continuous schedule, even if symptoms improve.
176
What are nursing considerations for xanthine derivatives?
* Contraindications: history of peptic ulcer disease or gastrointestinal disorders
* Cautious use: cardiac disease
* Timed-release preparations should not be crushed or chewed (causes gastric irritation).
* Report to prescriber
* Nausea
* Vomiting
* Restlessness
* Insomnia
* Irritability
* Tremors
* Be aware of drug interactions with cimetidine, oral contraceptives, allopurinol, certain antibiotics, influenza vaccine, and others.
* Cigarette smoking enhances xanthine metabolism.
* Interacting foods include charcoal-broiled, high-protein, and low-carbohydrate foods.
* These foods may reduce serum levels of xanthines through various metabolic mechanisms.
177
What are nursing considerations for inhaled corticosteroids?
* Teach patients to gargle and rinse the mouth with lukewarm water afterward to prevent the development of oral fungal infections.
* If a ß-agonist bronchodilator and corticosteroid inhaler are both ordered, the bronchodilator should be used several minutes before the corticosteroid to provide bronchodilation before administration of the corticosteroid.
* Teach patients to monitor disease with a peak flow meter.
* Encourage the use of a spacer device to ensure successful inhalations.
* Teach the patient how to keep inhalers and nebulizer equipment clean after use.
178
What patient education is relevant for proper inhaler use?
* Provide a demonstration and a return demonstration.
* Ensure that the patient knows the correct time intervals for inhalers.
* Provide a spacer if the patient has difficulty coordinating breathing with inhaler activation.
* Ensure that the patient knows how to keep track of the number of doses in the inhaler device
