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RT 208 > 6. Legal Aspects of IV Contrast Administration > Flashcards

6. Legal Aspects of IV Contrast Administration Flashcards

1
Q

become more involved in medication administration

when medications are given for radiographic procedures

A

Radiographers

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2
Q

are other typical emergencies seen by radiographers where

prompt administration of medication may be essential

A

acute angina attack, a sudden asthmatic episode, or an insulin
reaction

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3
Q

No medication should ever be given without a _____ order and supervision

A

physician’s

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4
Q

may be written or verbal and may sometimes be in the form of a
standing order

A

Orders

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5
Q

consists of written directions for a specific
medication or procedure, signed by a physician, and used only under
the specific conditions stated in the order

A

Standing order

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6
Q

Such orders are found in a _______ available for immediate reference in the radiology
department

A

Policy and Procedures Manual or Standing

Orders book

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7
Q

affects the body as a result of tissue response to osmotic

pressure

A

Osmolality

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8
Q

dehydration of blood cells, cells of blood vessels,

and surrounding tissues

A

Increased Osmolality contrast media

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9
Q

causes reversal of this process, producing changes in

hemodynamics, in the RBCs and in the capillary lining

A

Circulation

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10
Q

This may cause adverse changes in pulmonary artery pressure, blood volume,
and cardiac output

A

Circulation

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11
Q

also affects toxicity and is a factor to be considered when using ionic media

A

Ionization

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12
Q

is sensitive to increased levels of ions in the blood, which may interfere with the
normal electrical activity of the body

A

Central Nervous System

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13
Q

The resulting risk includes the possibility of

A

seizures and cardiac dysfunction

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14
Q

______ effects frequently seen in response to ionic media include a sensation of warmth
spreading throughout the body, light-headedness, nausea, and vomiting

A

Generalized

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15
Q

The release of _______ in response to contrast injections causes allergic or anaphylactoid (anaphylactic-like) responses, but is not usually the result of antigens in the
blood as is the case with other allergic reactions

A

histamine

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16
Q

causes the allergic reaction not the iodine

A

Tropomyosin

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17
Q

may occur as a result of excessive dose or failure of the renal
system to excrete the media

A

Toxicity

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18
Q

It may also result when a contrast medium is combined with an
incompatible medication

A

Toxicity

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19
Q

Precipitate formation has been noted with some combinations of
contrast media and the following common medications:

A

diphenhydramine, papaverine hydrochloride, cimetidine, and protamine

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20
Q

To avoid the possibility of this complication, flush the IV or arterial catheter
with _____ both before and after the injection of the contrast medium

A

saline

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21
Q

Toxic responses, either mild or severe, may occur in patients with poor _______
function, or may result from an overdose of the contrast agent

A

heart or kidney

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22
Q

are products of cellular metabolism that are excreted by
the kidneys, and high blood levels of these substances indicate impaired renal
function

A

Urea and creatinine

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23
Q

BUN

A

blood urea nitrogen

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24
Q

The usual normal ranges for adults are considered to be approximately _____ mg/dl for BUN, and _____ for
creatinine

A

6 to 20 mg/dl,

0.6 to 1.5 mg/dl

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25
Q

Creatinine levels of _____ or greater may constitute a contraindication for
administration of iodine contrast agents

A

2.0 mg/dl

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26
Q

Patients with _____ must be identified because this disease

predisposes the patient to renal complications

A

diabetes

27
Q

It is especially
important to be alert for the possibility that diabetic patients may be
taking medications containing ______, such as
Glucophage, Glucovance, Metaglip, or Avandamet, which are agents prescribed to manage hyperglycemia

A

metformin hydrochloride

28
Q

______ products must be withheld on the day the contrast medium is
administered and for at least ____ afterward

A

Metformin,

48 hours

29
Q

Diabetic patients may suffer ______ as a result of the contrast
medium

A

acute renal failure

30
Q

With inadequate kidney function, ______ could build to dangerous levels in the blood, causing ______, a potentially fatal
change in blood pH

A

metformin,

lactic acidosis

31
Q

Contrast agents cause ______, which may produce dangerous changes in
blood pressure and cardiac output

A

vasodilation

32
Q

Patients who have experienced asthmatic attacks in the past are three times more likely than others to respond to contrast with an ______

A

anaphylactoid reaction

33
Q

If the patient’s history suggests a high risk of
adverse response, a ______ contrast medium
may be indicated and/or the procedure may be
preceded by the administration of an
_______ drug to reduce the risk of reaction

A

nonionic,

antihistamine or corticosteroid

34
Q

Feeling of warmth, flushing, metallic taste, nausea, vomiting, coughing

A

Common Reaction Signs and Symptoms

35
Q

Erythema, urticaria, bronchospasm

A

Intermediate reaction Signs and Symptoms

36
Q

Vasodilation, diaphoresis, hypotension, bradycardia

A

Vasovagal reaction (Intermediate) Signs and Symptoms

37
Q

Respiratory or cardiac arrest, seizures, hypotension, Onset characterized by warmth, tingling, itching palms, throat constriction, feeling of doom, followed by expiratory wheeze and laryngeal and bronchial edema. May be fatal if not treated promptly

A

Severe reaction, anaphylactic shock Signs and Symptoms

38
Q

No treatment necessary, symptoms resolve rapidly. Prevent aspiration of emesis if patient vomits

A

Common Reaction Response

39
Q

Notify physician, prepare to administer antihistamine or epinephrine if ordered

A

Intermediate reaction Response

40
Q

Notify physician, place patient in dorsal recumbent position with feet elevated 20 degrees; elevate head slightly if breathing is a problem, be prepared to administer intravenous fluids or atropine if ordered

A

Vasovagal reaction (Intermediate) Response

41
Q

Maintain airway and call a code, treat as for shock respiratory or cardiac arrest, as symptoms require

A

Severe reaction, anaphylactic shock Response

42
Q

As diagnostic agents, ______ fall within the definition of a
medicine in European law, since the definition includes:
Any substance or combination of substances which may be used in or administered to human
beings … with a view to … making a medical diagnosis

A

contrast media

43
Q

The legislation also encompasses radiopharmaceuticals:
Any medicinal product which, when ready for use, contains one or more radionuclides
(radioactive isotopes) included for a medicinal purpose

A

contrast media

44
Q

applies to prescribing or administration outside any
of the terms of the marketing authorization, generally in relation to
indications, dosage, or contra-indications

A

off-label use

45
Q

In the light of the regulatory framework, there are a number of situations where off-label use or the use of unlicensed medicines occurs:

A

• Products for which a marketing authorization application or variation has yet to be made. These
include drugs in development and undergoing clinical trials.
• Medicines for which a marketing authorization application or variation has been refused.
• Medicines which no longer have a relevant marketing authorization because it has been
suspended, revoked, not renewed, or compulsorily varied.
• Products prepared in formulations specially adapted to special populations such as lower strengths
for children or liquids for the elderly, or without particular excipients for patients allergic to them

46
Q

The use of unlicensed medicines, and off-label use, may also occur in _____; i.e., where use of the drug for a particular indication is still under
development

A

clinical trials

47
Q

Off-label prescribing of medicines, and the prescribing of unlicensed
medicines, is _____ in the areas of oncology, obstetrics, and
infectious disease in particular in HIV/AIDS and is particularly common
in the pediatric population

A

common

48
Q

The _____ aims to control the activities of pharmaceutical
companies manufacturing, selling, or supplying medicines. It is not
intended to impact on the practice of medicine

A

regulatory system

49
Q

Medicines prescribed outside the terms of the marketing authorization may be dispensed by _____ and administered by

A

pharmacists,

nurses or midwives

50
Q

‘‘A Member State may, in
accordance with the legislation in force and to fulfil special needs, exclude
from the provisions of this Directive medicinal products supplied in
response to a bona fide unsolicited order, formulated in accordance with
the specifications of an authorized health-care professional and for use by
an individual patient under his direct personal responsibility’’

A

Article 5 of Directive 2001/83/ EC

51
Q

A doctor is also responsible for obtaining the consent of the patient to the treatment in question. Failure to obtain fully informed consent
may amount to ______

A

negligence

52
Q

any response to a medicinal

product which is noxious and unintended

A

adverse drug reaction

53
Q

is a clinical use within a label as approved for given indications, doses,
and route of administration

A

labeled-use

54
Q

SPC

A

Summary of Product Characteristics

55
Q

is used in some countries rather than the term ‘label’, provides identical information

A

Summary of Product Characteristics (SPC)

56
Q

is a clinical use of an approved drug in a manner which has not
been approved, or has not been addressed in the package insert, such as administering liver specific MR contrast agents to patients under the age of 18 years

A

off-label use

57
Q

is a clinical use of a medicine that is not yet authorized, and is
in the development process, which is made available to patients when there is no
satisfactory alternative (EMEA 2010; Whitfield et al. 2010)

A

compassionate use

58
Q

is a clinical use without marketing authorization

A

unlicensed use

59
Q

is a potential indication which is clearly stated as a contraindication by the manufacturer in the label/Summary of Product
Characteristics approved by the Medicines Agency (Dresser 2008; Reimer and Vosshenrich 2008)

A

contraindication

60
Q

describes the compound, including its chemical structure,

physicochemical data, and clinical pharmacology

A

label/SPC

61
Q

gives guidance for the use of a contrast agent with specific information on the dose range and indications such as imaging of a particular organ system

A

label/SPC

62
Q

to cause insensibility to pain

A

anesthetic agents

63
Q

to calm the patient or relieve pain during invasive

procedures and magnetic resonance imaging (MRI) examination

A

antianxiety or sedation agents

RT 208 (16 decks)

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