Peak Development for ...

Medication Administration

Vol. 16 Issue 2
February 2015

Overview: New Drugs of 2014

Peak Development Resources
P.O. Box 13267
Richmond, VA 23225
Phone: (804) 233-3707
Fax: (804) 233-3705
Email: editor@peakdev.com

Peak Development for Medication

Administration and Competency
Assessment Tool for Medication
Administration are components of
a site license for the Peak
Development Resources
Competency Assessment System
for Medication Administration
and may be reproduced for this
individual facility only. Sharing
of these components with any
other freestanding facility within
or outside the licensees corporate
entity is expressly prohibited.

The information contained in

Peak Development for Medication
Administration is intended only as
a guide for the practice of
licensed nursing personnel who
administer medications. Every
effort has been made to verify the
accuracy of the information
herein. Because of rapid changes
in the field of drug therapy, the
reader is advised to consult the
package insert, facility pharmacist
or patients physician for relevant
information. This is particularly
important for new or seldom used
drugs. Use of professional
judgment is required in all patient
care situations. It is the readers
responsibility to understand and
adhere to policies and procedures
set forth by the employing
institution. The editor and
publisher of this newsletter
disclaim any liability resulting
from use or misuse of
information contained herein.
Copyright 2015

After completion the learner should be able to:

1. Identify newly-approved drugs, their
indications, actions, and common adverse
effects.
2. Discuss nursing responsibilities related to
new medications.
According to the US Food and Drug
Administration (FDA), 41 new drugs were
approved in 2014. This is the largest number of
novel drugs approved annually since 1996, and
significantly more than the 27 new drugs
approved in 2013. Over 40% of these new
approvals were first in class drugs, meaning
they represent development of a new drug that
works to treat a condition in a novel and
innovative way. Also, over 40% of approvals
were orphan drugs, used to treat rare
conditions for which treatment options are
usually limited. This is the highest number of
orphan drugs ever approved by the FDA in a
year. This is notable, since, due to the small
number of users, these drugs may not be
commercially successful for the company,
which decreases the likelihood of their
development. Several new antibiotics were also
approved, which is an area of drug
development that has been slow. Selected drug
approvals for 2014 are highlighted:
-Belsomra (suvorexant), oral prescription drug
approved August 2014: Belsomra is approved
for treatment of insomnia, to promote falling
asleep and staying asleep. It is a first-in-class
orexin receptor inhibitor. Orexin is a neurotransmitter thought to promote wakefulness.
Sleep is promoted by blocking these receptors.
Adverse effects include somnolence, impaired
next-day driving, altered thoughts or behavior,
respiratory impairment, and increased risk of
depression and suicidal thoughts.
-Dalvance (dalbavancin), IV injection
prescription drug, approved May 2014: This

new antibiotic is approved to treat infections of

the skin and skin structure. Like vancomycin,
Dalvance is a member of the glycopeptide class
of antibiotics. It is used for treatment of
susceptible strains of gram-positive bacteria,
such as Strep and Staph (including MRSA).
Adverse effects include nausea, diarrhea, rash,
headache and hypersensitivity reaction. A
similar drug, Orbactiv (oritavancin), was
approved in August 2014.
-Esbriet (pirfenidone) and Ofev (nintenanib),
oral prescription drugs, both approved in
October 2014. These two orphan drugs are
indicated for the treatment of idiopathic
pulmonary fibrosis, a chronic condition
characterized by progressive lung scarring.
These drugs block multiple pathways that may
be involved in the lung scarring. Both drugs
may cause elevated liver enzymes, nausea,
abdominal pain, diarrhea and weight loss.
-Farxiga (dapagliflozin), oral prescription drug
approved January, 2014: Farxiga is indicated to
improve glycemic control in adults with type 2
diabetes, either alone or in combination with
other hypoglycemic agents. It is an SGLT-2
inhibitor, related to Invokana (canagliflozin).
Farxiga blocks reabsorption of glucose by the
kidneys, increasing urinary glucose excretion.
Adverse effects include renal impairment,
hypotension, female fungal genital infection and
bladder cancer. A similar drug, Jardiance
(empagliflozin), was approved in August 2014.
-Harvoni (ledipasvir/sofosbuvir), oral
prescription drug approved October 2014: This
drug is indicated for the treatment of chronic
hepatitis C genotype 1 infection. It is a first-inclass drug, and the first and only drug to treat
hepatitis C with a single daily tablet. Other oral
treatments have required co-administration of
drugs such as interferon or ribavirin. Adverse
effects include fatigue, headache, nausea and
insomnia.

-Keytruda (pembrolizumab), IV injection prescription drug

approved September 2014: Keytruda is a first-in-class drug
approved for treatment of melanoma that is advanced or not
responding to previous treatment. It is an antibody that blocks
certain substances to promote the function of the immune
system in fighting cancer cells. Adverse effects include cough,
fatigue, joint pain, pruritus, colitis, pneumonitis and liver injury.
-Movantik (naloxegol), oral prescription drug approved
September 2014: Movantik is indicated for the treatment of
opioid-induced constipation in patients with chronic non-cancer
pain. This drug is an opioid receptor antagonist that decreases
the action of opioids on the GI tract. It doesnt cross the bloodbrain barrier easily, and so has minimal effect on the desired
analgesic action of opioids. Adverse effects include abdominal
pain, nausea, flatulence and possible opioid withdrawal.
-Rapivab (peramivir), IV injection prescription drug approved
December 2014: Rapivab is an anti-viral drug, indicated for the
treatment of uncomplicated influenza in adults. It is a
neuraminidase inhibitor, in the same class with Tamiflu
(oseltamivir). Rapivab is administered as a single IV infusion
within 2 days of symptom onset. Adverse effects include
diarrhea, rash, severe skin and hypersensitivity reactions,
abnormal behavior and hallucination.
-Sivextro (tedizolid), IV injection and oral prescription drug
approved June 2014: This new antibiotic is approved to treat
infections of the skin and skin structure. Like linezolid (Zyvox),
Sivextro is a member of the oxazolidinone class of antibiotics.
It is used for treatment of susceptible strains of gram-positive
bacteria, such as Strep and Staph (including MRSA). Adverse
effects include nausea, diarrhea, headache and dizziness.
-Striverdi Respimat (olodaterol), inhalation spray
prescription drug approved July 2014: This bronchodilator drug
is indicated for maintenance treatment of COPD. It is a longacting beta-agonist in the class with salmeterol, and is not for
use as a rescue inhaler for acute symptoms. Striverdi
Respimat carries a black box warning due to increased risk of
asthma-related death, and should not be used in patients with
asthma. Adverse effects include upper respiratory infection,
bronchospasm, hyperglycemia, increased blood pressure,
hypokalemia, dizziness and joint pain.
-Tanzeum (albiglutide) subcutaneous injection prescription
drug approved April 2014: Tanzeum is indicated to improve
glycemic control in adults with type 2 diabetes, either alone or
in combination with other hypoglycemic agents. It is a GLP-1
receptor agonist, in the same class with Byetta (exenatide) and
Victoza (liraglutide). Tanzeum is a once-weekly injection that
may cause nausea, diarrhea, upper respiratory tract infection,
pancreatitis and renal impairment. This drug carries a black

box warning due to risk of thyroid cancer. A similar drug,

Trulicity (dulaglutide), was approved in September 2014.
-Zerbaxa (ceftolozane/tazobactam), IV injection prescription
drug approved December 2014: This antibiotic is a
combination of the previously-approved beta-lactamase
inhibitor, tazobactam, and the new cephalosporin, ceftolozane.
It is approved for treatment of complicated intra-abdominal and
urinary tract infections. When used for abdominal infections,
the drug is administered concurrently with metronidazole.
Zerbaxa is effective against gram-negative and gram-positive
organisms that include strains of Klebsiella, Proteus, Staph,
Strep, Pseudomonas and E coli. Adverse effects include fever,
diarrhea, nausea, headache and hypersensitivity reactions.
-Zontivity (vorapaxar), oral prescription drug approved May
2014: This anti-platelet agent is indicated for prevention of MI,
stroke, and cardiovascular death in patients with a history of
MI or peripheral artery disease. It is a first-in-class proteaseactivated receptor 1 (PAR-1) antagonist. The drug is
administered with aspirin or clopidogrel, and carries a black
box warning due to increased risk of bleeding.
Working with New DrugsRole of the Nurse
The pharmaceutical field is constantly changing, with the
development of new drugs, approval of currently-marketed
drugs for different indications, and classification of some
prescription drugs to OTC status. Therefore, the nurses drug
knowledge base must remain current in order to provide safe
care. This is especially important when newly-approved or
unfamiliar drugs are being administered. For any drugs
administered, the nurse must be knowledgeable regarding the
indications, recommended dosage, route, therapeutic and side
effects, and precautions/contraindications. When administering
newly-approved drugs, the nurse must be particularly watchful
for possible adverse effects, since all of these may not have
been apparent during clinical trials. The FDA has set up the
MedWatch program to encourage the voluntary reporting of
serious adverse effects caused by drugs or medical devices
once they are FDA-approved and in general use. Health
professionals are encouraged to report any suspected effects
that result in death, disability, birth defects, life-threatening
events, or hospitalization. If the FDA determines that the drug
or device is unsafe, it may be removed from the market. The
reporting of confusing or unclear packaging is also
encouraged.
Nurses play an important role in the process of new drug
development by assisting with research, following the
development of new drugs, maintaining a current knowledge
base, and reporting serious adverse reactions.

Peak Development for Medication Administration

Overview: New Drugs of 2014

Page 2

Peak Development for ...

Medication Administration
Competency Assessment Tool

Vol. 16 Issue 2
February 2015

Overview: New Drugs of 2014

NAME:

DATE:

UNIT:

Directions: Place the letter of the one best answer in the space provided.
_____1. In 2014, more new drugs were approved by the FDA than in any year since 1996.
A. True
B. False
_____2. Orphan drugs are best defined as drugs that:
A. are the only drug in their class
B. have unique modes of action
C. are used to treat rare conditions
D. are produced only in generic form
_____3. Belsomra (suvorexant) is a first-in-class drug approved to treat:
A. arthritis
B. insomnia
C. heartburn
D. rosacea
_____4. Tanzeum (albiglutide) is a new diabetes drug that carries a black box warning due to risk of:
A. paralytic ileus
B. hypoglycemia
C. thyroid cancer
D. osteoporosis
_____5. Rapivab (peramivir) is a new anti-viral drug indicated for the treatment of:
A. influenza
B. hepatitis C
C. HIV
D. all of the above

_____6. Striverdi Respimat (olodaterol) is an inhalation spray indicated for:

A. maintenance treatment of asthma
B. rescue treatment for acute symptoms of COPD or asthma
C. maintenance treatment of COPD
D. all of the above
_____7. All of the following are newly-approved antibiotics EXCEPT:
A. Dalvance (dalbivancin)
B. Zerbaxa (ceftolozane/tazobactam)
C. Sivextro (tedizolid)
D. Movantik (naloxegol)
_____8. Which of the following drugs carries a black box warning due to risk of bleeding:
A. Sivextro (tedizolid)
B. Trulicity (duliglutide)
C. Ofev (nintenanib)
D. Zontivity (vorapaxar)
_____9. Which of the following is the first and only single-tablet treatment for Hepatitis C:
A. Keytruda (pembrolizumab)
B. Harvoni (ledipasvir/sofosbuvir)
C. Zerbaxa (ceftolozane/tazobactram)
D. Farxiga (dapagliflozin)
_____10. Esbriet (pirfenidone) is an orphan drug approved for the treatment of pulmonary fibrosis.
A. True
B. False

Competency Assessment Tool

Overview: New Drugs of 2014

Page 2

Peak Development for ...

Medication Administration

Month: February 2015

Issue:
Overview: New Drugs of 2014

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Overview: New Drugs of 2014

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