6. Legal Aspects of IV Contrast Administration

Question 1

become more involved in medication administration

when medications are given for radiographic procedures

Answer 1

Radiographers

Question 2

are other typical emergencies seen by radiographers where

prompt administration of medication may be essential

Answer 2

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

Question 3

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

Answer 3

physician’s

Question 4

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

Answer 4

Orders

Question 5

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

Answer 5

Standing order

Question 6

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

Answer 6

Policy and Procedures Manual or Standing

Orders book

Question 7

affects the body as a result of tissue response to osmotic

pressure

Answer 7

Osmolality

Question 8

dehydration of blood cells, cells of blood vessels,

and surrounding tissues

Answer 8

Increased Osmolality contrast media

Question 9

causes reversal of this process, producing changes in

hemodynamics, in the RBCs and in the capillary lining

Answer 9

Circulation

Question 10

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

Answer 10

Circulation

Question 11

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

Answer 11

Ionization

Question 12

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

Answer 12

Central Nervous System

Question 13

The resulting risk includes the possibility of

Answer 13

seizures and cardiac dysfunction

Question 14

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

Answer 14

Generalized

Question 15

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

Answer 15

histamine

Question 16

causes the allergic reaction not the iodine

Answer 16

Tropomyosin

Question 17

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

Answer 17

Toxicity

Question 18

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

Answer 18

Toxicity

Question 19

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

Answer 19

diphenhydramine, papaverine hydrochloride, cimetidine, and protamine

Question 20

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

Answer 20

saline

Question 21

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

Answer 21

heart or kidney

Question 22

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

Answer 22

Urea and creatinine

Question 23

BUN

Answer 23

blood urea nitrogen

Question 24

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

Answer 24

6 to 20 mg/dl,

0.6 to 1.5 mg/dl

Question 25

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

Answer 25

2.0 mg/dl

Question 26

Patients with _____ must be identified because this disease | predisposes the patient to renal complications

Answer 26

diabetes

Question 27

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

Answer 27

metformin hydrochloride

Question 28

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

Answer 28

Metformin, | 48 hours

Question 29

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

Answer 29

acute renal failure

Question 30

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

Answer 30

metformin, | lactic acidosis

Question 31

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

Answer 31

vasodilation

Question 32

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

Answer 32

anaphylactoid reaction

Question 33

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

Answer 33

nonionic, | antihistamine or corticosteroid

Question 34

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

Answer 34

Common Reaction Signs and Symptoms

Question 35

Erythema, urticaria, bronchospasm

Answer 35

Intermediate reaction Signs and Symptoms

Question 36

Vasodilation, diaphoresis, hypotension, bradycardia

Answer 36

Vasovagal reaction (Intermediate) Signs and Symptoms

Question 37

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

Answer 37

Severe reaction, anaphylactic shock Signs and Symptoms

Question 38

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

Answer 38

Common Reaction Response

Question 39

Notify physician, prepare to administer antihistamine or epinephrine if ordered

Answer 39

Intermediate reaction Response

Question 40

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

Answer 40

Vasovagal reaction (Intermediate) Response

Question 41

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

Answer 41

Severe reaction, anaphylactic shock Response

Question 42

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

Answer 42

contrast media

Question 43

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

Answer 43

contrast media

Question 44

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

Answer 44

off-label use

Question 45

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

Answer 45

• 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

Question 46

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

Answer 46

clinical trials

Question 47

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

Answer 47

common

Question 48

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

Answer 48

regulatory system

Question 49

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

Answer 49

pharmacists, | nurses or midwives

Question 50

‘‘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’’

Answer 50

Article 5 of Directive 2001/83/ EC

Question 51

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 ______

Answer 51

negligence

Question 52

any response to a medicinal | product which is noxious and unintended

Answer 52

adverse drug reaction

Question 53

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

Answer 53

labeled-use

Question 54

SPC

Answer 54

Summary of Product Characteristics

Question 55

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

Answer 55

Summary of Product Characteristics (SPC)

Question 56

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

Answer 56

off-label use

Question 57

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)

Answer 57

compassionate use

Question 58

is a clinical use without marketing authorization

Answer 58

unlicensed use

Question 59

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)

Answer 59

contraindication

Question 60

describes the compound, including its chemical structure, | physicochemical data, and clinical pharmacology

Answer 60

label/SPC

Question 61

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

Answer 61

label/SPC

Question 62

to cause insensibility to pain

Answer 62

anesthetic agents

Question 63

to calm the patient or relieve pain during invasive | procedures and magnetic resonance imaging (MRI) examination

Answer 63

antianxiety or sedation agents