6. Legal Aspects of IV Contrast Administration Flashcards
become more involved in medication administration
when medications are given for radiographic procedures
Radiographers
are other typical emergencies seen by radiographers where
prompt administration of medication may be essential
acute angina attack, a sudden asthmatic episode, or an insulin
reaction
No medication should ever be given without a _____ order and supervision
physician’s
may be written or verbal and may sometimes be in the form of a
standing order
Orders
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
Standing order
Such orders are found in a _______ available for immediate reference in the radiology
department
Policy and Procedures Manual or Standing
Orders book
affects the body as a result of tissue response to osmotic
pressure
Osmolality
dehydration of blood cells, cells of blood vessels,
and surrounding tissues
Increased Osmolality contrast media
causes reversal of this process, producing changes in
hemodynamics, in the RBCs and in the capillary lining
Circulation
This may cause adverse changes in pulmonary artery pressure, blood volume,
and cardiac output
Circulation
also affects toxicity and is a factor to be considered when using ionic media
Ionization
is sensitive to increased levels of ions in the blood, which may interfere with the
normal electrical activity of the body
Central Nervous System
The resulting risk includes the possibility of
seizures and cardiac dysfunction
______ effects frequently seen in response to ionic media include a sensation of warmth
spreading throughout the body, light-headedness, nausea, and vomiting
Generalized
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
histamine
causes the allergic reaction not the iodine
Tropomyosin
may occur as a result of excessive dose or failure of the renal
system to excrete the media
Toxicity
It may also result when a contrast medium is combined with an
incompatible medication
Toxicity
Precipitate formation has been noted with some combinations of
contrast media and the following common medications:
diphenhydramine, papaverine hydrochloride, cimetidine, and protamine
To avoid the possibility of this complication, flush the IV or arterial catheter
with _____ both before and after the injection of the contrast medium
saline
Toxic responses, either mild or severe, may occur in patients with poor _______
function, or may result from an overdose of the contrast agent
heart or kidney
are products of cellular metabolism that are excreted by
the kidneys, and high blood levels of these substances indicate impaired renal
function
Urea and creatinine
BUN
blood urea nitrogen
The usual normal ranges for adults are considered to be approximately _____ mg/dl for BUN, and _____ for
creatinine
6 to 20 mg/dl,
0.6 to 1.5 mg/dl
Creatinine levels of _____ or greater may constitute a contraindication for
administration of iodine contrast agents
2.0 mg/dl
Patients with _____ must be identified because this disease
predisposes the patient to renal complications
diabetes
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
metformin hydrochloride
______ products must be withheld on the day the contrast medium is
administered and for at least ____ afterward
Metformin,
48 hours
Diabetic patients may suffer ______ as a result of the contrast
medium
acute renal failure
With inadequate kidney function, ______ could build to dangerous levels in the blood, causing ______, a potentially fatal
change in blood pH
metformin,
lactic acidosis
Contrast agents cause ______, which may produce dangerous changes in
blood pressure and cardiac output
vasodilation
Patients who have experienced asthmatic attacks in the past are three times more likely than others to respond to contrast with an ______
anaphylactoid reaction
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
nonionic,
antihistamine or corticosteroid
Feeling of warmth, flushing, metallic taste, nausea, vomiting, coughing
Common Reaction Signs and Symptoms
Erythema, urticaria, bronchospasm
Intermediate reaction Signs and Symptoms
Vasodilation, diaphoresis, hypotension, bradycardia
Vasovagal reaction (Intermediate) Signs and Symptoms
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
Severe reaction, anaphylactic shock Signs and Symptoms
No treatment necessary, symptoms resolve rapidly. Prevent aspiration of emesis if patient vomits
Common Reaction Response
Notify physician, prepare to administer antihistamine or epinephrine if ordered
Intermediate reaction Response
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
Vasovagal reaction (Intermediate) Response
Maintain airway and call a code, treat as for shock respiratory or cardiac arrest, as symptoms require
Severe reaction, anaphylactic shock Response
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
contrast media
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
contrast media
applies to prescribing or administration outside any
of the terms of the marketing authorization, generally in relation to
indications, dosage, or contra-indications
off-label use
In the light of the regulatory framework, there are a number of situations where off-label use or the use of unlicensed medicines occurs:
• 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
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
clinical trials
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
common
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
regulatory system
Medicines prescribed outside the terms of the marketing authorization may be dispensed by _____ and administered by
pharmacists,
nurses or midwives
‘‘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’’
Article 5 of Directive 2001/83/ EC
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 ______
negligence
any response to a medicinal
product which is noxious and unintended
adverse drug reaction
is a clinical use within a label as approved for given indications, doses,
and route of administration
labeled-use
SPC
Summary of Product Characteristics
is used in some countries rather than the term ‘label’, provides identical information
Summary of Product Characteristics (SPC)
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
off-label use
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)
compassionate use
is a clinical use without marketing authorization
unlicensed use
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)
contraindication
describes the compound, including its chemical structure,
physicochemical data, and clinical pharmacology
label/SPC
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
label/SPC
to cause insensibility to pain
anesthetic agents
to calm the patient or relieve pain during invasive
procedures and magnetic resonance imaging (MRI) examination
antianxiety or sedation agents
