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Laws and Ethics > Questions > Flashcards

Questions Flashcards

0
Q

what is the FDA? explain.

A

The food and drugs act

  • Controls production, import, export, transport and sale of food, drugs, contraceptive devices and cosmetics.
  • ensures that Drug products sold in Canada are safe and effective
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1
Q

as regulated HCP’s, pharmacy technicians must respect patients autonomy. what does this mean?

A

we recognize that our patients have the ethical and legal right to make decisions about their health care, based on their value system

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3
Q

what is a schedule II Drug?

A
  • RX is not required
  • Pharmacist professional intervention is required at the point of sale(POS)
  • Kept we’re public doesn’t have access
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4
Q

what is the liquor control act-nonportable alcohol regulation?

A

States rubbing alcohol may only be sold at pharmacies by a pharmacist

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5
Q

explain: public administration

A

Insurance plans are to be administered by nonprofit authorities

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6
Q

explain schedule B of the FDA

A

List of Drug standards publications

example: British Pharmacopoiea (BP); United States Pharmacopoiea (USP)

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7
Q

what are the five principles of the Canada Health Act(CHA)?

A
  • public administration
  • comprehensiveness
  • universality
  • portability
  • Accessability
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8
Q

what is the Manitoba interchangeability formulary?

A
  • List of drugs which pharmacists may substitute
  • also the maximum prices that maybe charged per unit
  • purpose is to save money on drug costs for the government
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9
Q

explain: universality

A

all insured residents are entitled to services

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10
Q

pharmacy technician tells Ms. Smith little white lie about her prescription to help ease her fear of side effects. What ethical principle has the pharmacy technician violated?

A

veracity

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11
Q

explain: accessability

A

provide reasonable access and reasonable compensation to cover cost insured

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12
Q

what is the CDSA? explain.

A

controlled drugs and substances act
-Controls the import, production, export, distribution and possession of substances classified as narcotic and controlled

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13
Q

what regulations are included in the FDA?

A
  • Food and drug regulations

- Natural health product’s regulations

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14
Q

what is PIPEDA?

A

personal information protection and electrical documents act

  • protect the collection, storage, access and destruction of personal information collected about customers
  • applies to all businesses
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15
Q

what regulations are included in the CDSA?

A
  • Benzodiazepines and other targeted substance regulations
  • Marihuana medical access regulations
  • Narcotic controlled regulations
  • Precursor controlled regulations
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16
Q

what gives federal government authority to regulate prices?

A

patent medicine regulations of the patent act.

-The patent medicine prices review board (PMPRB) is an independent body authorized to carry this out.

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17
Q

what is PHIA? explain

A

personal health information act

-Controls collection, storage, access and destruction of personal health information collected by healthcare.

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18
Q

explain: comprehensiveness

A

ensure all health services

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19
Q

explain the medical device regulations

A
  • defined in the FDA, covers wide range of health/medical instruments used in treatment, mitigation, diagnosis/prevention, of abnormal/physical condition
  • pharmacies must be involved in the sale
  • do not require RX, RX is required for third-party billing
  • establishment license is required to sell these(except pharmacy to pharmacy)
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20
Q

Explain: portability

A

residents covered by home province when moving

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22
Q

what is a schedule III Drug?

A
  • RX is not required
  • Available for self-selection BUT product must be sold in a pharmacy
  • pharmacist must be available for consultation (lock and leave)
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23
Q

what is the patent register database?

A

an alphabetical list of patented medicine I Canada

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24
Q

what is the drug product database?

A

List all products approved for use

-includes: vet, disinfectant products, pharmaceuticals and biologicals

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25
Q

name 4 important drug advisories

A

-advisories, warnings and recall

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26
Q

what is Part C of the FDR?

A

drugs (contains what was schedule F)

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27
Q

how often is the CARN published?

A

quarterly

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29
Q

what is Med-effect e-notice?

A

A free email service that distributes CARN

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30
Q

explain the special access program

A

Health Canada allows doctors to gain access to non-marketed drugs and medical devices that have not yet been approved for sale in Canada.

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31
Q

what kind of vitamins require an RX?

A
  • Vitamin A greater than 10,000 IU/dosage form
  • vitamin D greater than 1000 IU/””
  • vitamin K greater than 120 mg/””
  • folic acid greater than 1 mg/””
  • extended release niacin 500 mg preparations (Niaspan®)
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32
Q

what is an unscheduled drug?

A
  • RX is not required
  • May be sold at any retail outlet
  • Professional intervention is not required
  • label is deemed sufficient for self-selection
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33
Q

explain schedule A of the FDA.

A

condition for which a cure cannot be advertised to the public

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35
Q

explain schedule D of the FDA

A

biopharmaceuticals

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36
Q

what is the Manitoba pharmaceutical act??

A
  • regulates practice of pharmacy in Manitoba
  • regulates pharmacies and pharmacist
  • NDS are mandated under the MPA
  • regulations for the drug interchangeability in connection with the Manitoba interchangeability formulary
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37
Q

what is part G of the FDR?

A

controlled drugs

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38
Q

explain part C of the food and drug regulations.

A
  • includes regulations for RX drugs
  • prescription drug list is divided into two lists: 1. List of medical ingredients that require a RX for human use, 2. List of medical ingredients that require at RX for veterinary use.
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39
Q

explain veterinary drug directorate

A

through this health Canada monitors safety, quality, effectiveness, set standards & promote use administered to food producing and companion animals

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40
Q

explain schedule F of the FDA

A

scheduled either, ask, G, H have all been repealed

- schedule F used to be most pharmaceuticals

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41
Q

Who issues establishment licenses?

A

Health Canada

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42
Q

name 2 useful resources.

A
  • patent register database

- drug product database (DPD)

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43
Q

what are good manufacturing practices?

A

manufacturing facilities must be open to inspection by health Canada inspectors, even if the product is made in another country and imported into Canada.
-testing, sanitation, stability, equipment checked.

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44
Q

explain schedule D drug regulations

A
  • animals used as a source of drugs
  • preparation of vaccines
  • preparation from human sources(blood)
  • preparation of insulin product
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45
Q

standards of potency have been set for some natural substances including..(4)

A
  • conjugated estrogens (mixture of female hormones concentrated and purified from pregnant mares urine)
  • digoxin
  • Gelatin
  • Thyroid
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46
Q

New drugs..

A

manufacturers must submit a new drug submission to health Canada, as well as finished product labels, inserts and proposed date of release
-Health Canada will issue a notice of compliance (NOC) & DINs for each drug product and strength.

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47
Q

what are the divisions of schedule G drugs?

A

part I- straight controlled drugs/preparation
part II- barbiturates and their salts and derivatives
part III- anabolic steroids and derivatives

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48
Q

where are schedule G Drugs regulated?

A

-regulated in schedules III and IV of the CDSA

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49
Q

what is excluded schedule G part II drugs?

A

secobarbital and pentobarbital

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50
Q

what is part J of the FDR?

A

restricted drugs

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51
Q

A pharmacist show not refill an RX for a controlled drug unless…

A

A practitioner issued a prescription in writing or oral

-RX to be refilled, number of times to be refilled and date for intervals between s

52
Q

what devices are listed in the medical device regulations?

A

condoms, pacemakers, breast implants, dentures, toothbrushes

53
Q

explain the FDR part J

A

restricted drugs, restricted to license dealers, qualified research investigators and law enforcement officials.
-also listed in schedule III of CDSA

54
Q

what does natural health product mean?

A

A substance set out in the schedule I or a combination of substances set out and schedule I or a homeopathic or traditional medicine that is manufactured, sold or represented for use in: 1. diagnosis, treatments etc., 2. restoring or correcting organ functions, 3. modifying organic functions

55
Q

what does schedule I of NHP regulations include?

A
  • Plants, plant material, algae, bacteria, fungi or their extracts
  • Vitamins
  • Amino acids
  • Essential fatty acids
  • Minerals
  • Probiotics
56
Q

how are vitamins regulated?

A

under three categories.

  1. require an RX-will have Pr symbol
  2. do not require an RX-must be labeled “therapeutic use only”
  3. do not require RX or therapeutic use only label
57
Q

what are the two components to the NHP definition?

A

A medical ingredient component and a functional component.

58
Q

what kind of vitamins do not require an RX or therapeutic use only label?

A

small doses, usually multivitamin

59
Q

what kind of vitamins do not require an RX but must be labeled therapeutic use only?

A

all but vitamin a and vitamin K have doses that fall in the therapeutic use only range

60
Q

what is schedule I drug?

A
  • RX is required

- Have a Pr, N, C or T/C symbol

65
Q

what is part D of the FDR?

A

vitamins, minerals and amino acids

67
Q

explain schedule C of the FDA

A

Radiopharmaceuticals

70
Q

Labeling requirement regulations

A
  • Drug schedule
  • Label not misleading
  • Generic/chemical name must proceed and no less than 1/2 size of trade name.
  • Company info
  • Lot number, expiry date, DIN, quantity
  • Ingredients
  • directions for use
  • standards the drug has met (BP, USP, CF, NF)
73
Q

what are amino acids?

A

protein supplements (used in TPN)

74
Q

what are some amino acids?(8)

A

Leucine, isoleucin, lysine, methionine, phenylalanine, threonine, tryptophan, tyrosine

75
Q

what are essential fatty acids?

A
  • body cannot make
  • required for healthy functioning
  • four energy production and to manufacture hormones & eicosanoids
76
Q

what are some essential fatty acids?

A

omega 3 fatty acids
omega 6 fatty acids
omega 9 fatty acids

77
Q

what are some omega-3 fatty acids?

A
  • alpha linolenic acid
  • eicosapentanoic acid (EPA)
  • docosahexanoic acid (DHA)
78
Q

what are some Omega-6 fatty acids?

A
  • linolenic acid

- gamma linolenic acid

79
Q

what are some omega-9 fatty acids?

A

oleochemicals acid

80
Q

what kind of product’s contain essential fatty acids?(3)

A
  • Fish oil products
  • flaxs products
  • borage products
81
Q

what fatty acid supplement contains 1 g EPA/DHA?

A

Omacor®- RX only

–for lipid regulation

82
Q

what are minerals?

A

Central nonorganic nutrients

83
Q

what are macronutrients?(6)

A

calcium, chloride, magnesium, phosphorus, potassium and sodium

84
Q

what are trace elements?

A

copper, fluoride, iodine, iron, zinc & selenium

85
Q

what are probiotics?

A

contain live bacteria cells

example: lactobacillus products (restore G.I. functioning) -yogurt

86
Q

what is a controlled substance

A
  • any drug that the federal government has scheduled under CDSA (schedules I-VIII)
  • these drugs have a higher than average potential for abuse or addiction & are divided into 4 categories based on their potential for abuse
  • range from illegal street drugs to RX meds
87
Q

what is the controlled drug?

A
  • Any drug listed in part G, schedule G of the FDA
  • Part I-straight controlled drugs/preparations (includes secobarbital and pentobarbital)
  • Part II-barbiturates and their salts and derivatives
  • Part III-anabolic steroids and derivatives
88
Q

definition of a precursor Drug

A

chemicals that are essential to the production of a controlled substance.

89
Q

what is an example of a precursor drug?

A

ephedrine and pseudoephedrine

-common in decongestant medication, also precursor chemicals that are used to produce methamphetamine.

90
Q

definition of a narcotic drug

A

any substance set out in the narcotic control regulations schedule or anything containing a substance listed in in
-three classifications

91
Q

what are the three classifications of a narcotic drug?

A
  • straight narcotic
  • verbal RX narcotic
  • exempted narcotic (no RX required)
92
Q

what are some examples of schedule I of the CDSA?

A
  • opium
  • cocaine
  • methadone
  • morphine
  • fentanyl
93
Q

what are some examples of schedule II of the CDSA?

A

-marihuana and cannabis products

94
Q

what are some examples of schedule III drugs of the CDSA?

A
  • amphetamines

- methylphenidate

95
Q

what are some examples of schedule IV drugs of the CDSA?

A
  • barbiturates
  • anabolic steroids
  • benzodiazepines
96
Q

what are some examples of schedule V drugs of the CDSA?

A

-propylhexedrine and its derivatives

97
Q

what are some examples of schedule VI drugs of the CDSA?

A

precursors to the drugs of abuse

-ephedrine and pseudoephedrine

98
Q

what are some examples of schedule VII drugs of the CDSA ?

A

cannabis resin (3kg); cannabis (3kg)-must be in conjunction with schedule II

99
Q

what are some examples of schedule VIII drugs of the CDSA?

A

cannabis resin (1g); cannabis (1g)-in conjunction with schedule II

100
Q

what components make up the narcotic control regulations?

A

-interpretation (general definitions), possession, test kits containing narcotics, dealers licenses and licensed dealers, pharmacists, practitioners, hospitals, general, narcotic control regulations schedule

101
Q

what is a verbal narcotic?

A

medication that

  • contains, in addition to a narcotic, two or more medical ingredients other than the narcotic
  • not intended for paternal administration
  • does not contain diacetylomorphine (heroin), hydrocodone, methadone, oxycodone, Pentazodrine
102
Q

what is a straight narcotic?

A

defined by what they are not-this is done by applying the definition for verbal backwards

  • contain a single ingredient or only one medical ingredient other than narcotic in a single therapeutic dose
  • intended for parenteral administration
  • contained heroin, hydrocodone, methadone, oxycodone or pentazocine
103
Q

what is an RX?

A

authorization given by practitioner, that a stated amount of the narcotic to be pissed dispensed, for the person named in the prescription.

104
Q

definition of possession

A

A person is permitted to possess on my product if:

  • for business or profession(MD,RPh)
  • received it pursuant to an RX
  • RCMP, inspector, police constable, peace officer
105
Q

what does section 31 of the NCR regarding pharmacist sale of narcotics say?

A
  • may so/provide narcotic other than methadone
  • if the person is exempted under section 56 of the act with respect to possession of that narcotic
  • pharmacy first received a written order
106
Q

can narcotics be refilled?

A

no verb refill after RX quantity is dispensed

107
Q

within how long should a loss or theft of a narcotic be reported?

A

within 10 days of discovery

108
Q

pharmacist: destruction of narcotics

A
  • two witnesses while destroying

- need authorization first

109
Q

how are opioids used?

A
  • used as analgesic, to treat pain

- also used to treat cough and diarrhea

110
Q

how is cocaine used?

A

used medicinally to stop severe nosebleeds in ER

111
Q

methadone regulations

A
  • only can be given by pharmacist
  • used to treat pain where other narcotics are no longer appropriate
  • most commonly used for maintenance in opioids dependency
112
Q

controlled drug regulations

A
  • found in the FDA regulations under part G
  • drug labels must have c in diamond symbol
  • 3 sections 1. straight C.Ds& preps 2.barbiturates & salts 3. anabolic steroids
113
Q

destruction of targeted control substances

A
  • do not require authorization
  • quantity to be destroyed must be recorded
  • must have a witness
114
Q

what does it mean to be diligent?

A
  • always do your best and follow practice standards and guidelines
  • be reliable, thoughtful and prepared
  • look for ways to improve
115
Q

it mean to be conscientious?

A

-do the right thing because it’s the right thing

116
Q

practices that keep us integrity

A
  • sincerely, honesty
  • see what you mean, mean what you say
  • for your patience the way you want to be treated
  • actor patients rights to autonomy, privacy and confidentiality
117
Q

what is ethics?

A

firmly established standards that define right and wrong for us in terms of obligations and duties

118
Q

what are values?

A

values provide the basis for ranking the worth of one thing over another
-personal values and professional values

119
Q

what are personal values?

A

personal beliefs about the right and wrong which we have acquired through life experience

120
Q

what are professional values?

A

beliefs which we share with our colleagues which define our ethical commitment to healthcare

121
Q

where do values come from?

A
  • personal experience
  • taught
  • learned
122
Q

what is Altruism?

A

-unselfish concern for the welfare of others

123
Q

what is Fidelity?

A

faithful devotion to duty or obligation, Waelti to your patient

124
Q

what is veracity?

A

truthfulness and honesty

125
Q

what is law?

A

The principles and regulations established by the government and applicable to people, whether in the form of legislation or of policies recognized and enforced by judical decision

126
Q

what is ethics?

A

A systematic and reflective approach to providing good reasons (sound arguments) for our moral beliefs and opinions

127
Q

what are ethical principles??

A

Basic general rules which define right and wrong in the practice of healthcare

128
Q

what is the scope of practice for a regulated pharmacy technician?

A

accountable, responsible and liable for the technical aspects of products preparation and processing including the final check of that product/preparation.

129
Q

what is the scope of practice for pharmacists?

A

accountable, responsible and liable for assessing the appropriateness of drug therapy (patient assessment, confirm dose and interval, check patient record and identify any drug related problems) and providing all patients consultation.

130
Q

what is professional misconduct?

A

an act or omission, a failure to do something that we know or should have know we must do

  • unlawful behavior
  • dishonest or bad management

Laws and Ethics (3 decks)

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