Volume 25, Number 2 February 2011 Drugs & Therapy

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Volume 25, Number 2 February 2011 Drugs & Therapy

Transcript Of Volume 25, Number 2 February 2011 Drugs & Therapy

Volume 25, Number 2

February 2011   

Drugs & Therapy
BN U N LN LN EN T N IN N

FORMULARY UPDATE
The Pharmacy and Therapeutics Committee met January 18, 2011. 3 drugs were added in the Formulary, and 2 dosage forms were deleted. 6 products were designated nonformulary and not available. 4 interchanges and 3 restrictions were approved.
◆ ADDED Dabigatran (Pradaxa® by Boehringer Ingelheim)
Iron Sucrose (Venofer® by American Regent)
Minocycline Oral (Generic) and IV (Minocin® by Triax)* *IV Restricted
◆ DELETED Cisplatin Powder (Platinol® Powder)†
†Nonformulary and Not Available
Phenytoin Injection (Generic) †Nonformulary and Not Available and Interchanged to Fosphenytoin
◆ NONFORMULARY AND NOT AVAILABLE Baclofen Injection (Gablofen®)‡
‡Lioresal® is just NF, not NFNA
Ferumoxytol (Feraheme®)
Tesamorelin (Egrifta®)
Tolvaptan (Samsca®)
◆ INTERCHANGES DTaP (Tripedia®) for Daptacel® and Infanrix®
Fosphenytoin for Phenytoin Injection§ §Same dose in Phenytoin Equivalents
Iron Sucrose Injection for Sodium Ferric Gluconate Complex Tdap (Adacel®) for Boostrix®
(continued on next page)

NEWS
Abandoned prescriptions?

D rugs do not work if patients do not take them. Noncompliance is an impediment to quality patient care. Therefore, identifying reasons patients do not take their prescriptions is important in order to improve adherence to the drugs that have been prescribed.
Shrank and colleagues recently published an interesting study examining why patients with “good” insurance (mostly employer-based insurance) and reasonable incomes (median income greater than $60,000) failed to pick up their prescriptions from their pharmacy. Examining characteristics of this “prescription abandonment” might alert prescribers and pharmacists of predictors of poor compliance.
Overall, only 1 out of every 30 prescriptions was abandoned in this population. However, remember these patients were well-insured and had incomes that should not prohibit copays for most patients. This could be a bigger problem in patients without insurance and/or with lower incomes.
This study showed that drugs for cough, cold, and allergy or asthma had the highest rate of abandonment. The information on asthma medications was disturbing considering the importance of compliance in controlling a patient’s condition. Interestingly, opiates and anti-platelet drugs had the lowest rates of abandonment.
Patients with the lowest incomes (as indicated by the median incomes of their zip codes) were more likely to abandon prescriptions. The higher the co-pay (ie, out of pocket costs), the higher rates of abandonment.
There was also a higher rate of abandonment for electronic prescriptions. This may be a harbinger of another problem that will increase in the future. With electronic medical records (EMRs) used for medication reconciliation, prescribers may assume that since an electronic prescription has been “written,” that patients are taking that medication…when they may not. It will be important to determine what medications patients are actually taking, not

what we think they are taking based on the EMR.
There is also a higher rate of abandonment for first prescriptions compared with refills. Patients who get their first prescription refilled are more likely to pick up additional refills.
New electronic prescriptions for patients between 18 and 34 years of age with high co-pays are most likely to be abandoned. Understanding why patients do not pick up their prescriptions could help improve patient compliance and, hopefully, patient outcomes.
Abandoned drugs also cause problems for the Shands outpatient pharmacies. Each abandoned prescription is twice the work with no associated revenue. When a prescription is filled, it has to be electronically processed, so the third-party payer (eg, insurance company) authorizes payment. When a prescription is not picked up, the label has to be carefully removed, and the drug returned to stock. The prescription has to be re-processed to give the third-party payer their money back.
Third-party payers audit pharmacies to make sure they get their money back when a prescription is not picked up. If a pharmacy cannot show documentation of a written prescription and that the filled prescription was picked-up (eg, your signature when you get your prescription), the pharmacy must reimburse the payer.
Over a 2-3 week period, 114 prescriptions were abandoned at our outpatient pharmacies. Roughly, 10% of these were employee prescriptions, and half of these had co-pays of $10 or less. This reinforces that written prescriptions do not mean compliance, regardless of the cost of the drug.
REFERENCES
1. Shrank WH, Choudhry NK, Fischer MA, et al. The epidemiology of prescriptions abandoned at the pharmacy. Ann Intern Med 2010;153:633-40.

INSIDE THIS ISSUE
◆ New drugs in 2011

Formulary update, from page 1

with non-valvular atrial fibrillation

same time. Ferumoxytol was evalu-

compared to warfarin. The primary out- ated as a possible alternative to iron

◆ CRITERIA-FOR-USE CHANGES

come was time to stroke and systemic embolism; the safety outcome was

dextran, which is the only parenteral iron product that can be given as a

Eribulin (Halaven®)*
*Nonformulary Drug Restricted to Chemotherapy Order Form
Fluoroquinolone-Macrolide Combinations*

major hemorrhage. It was concluded that dabigatran 150 mg was superior in efficacy and similar in safety, while the 110-mg dose was noninferior in efficacy and superior in safety. Beyond hemorrhage, other adverse events of note are

total dose infusion (TDI) of iron. Due to its individual physiochemical
properties, ferumoxytol has less free iron in vitro than the other intravenous iron preparations available for the treatment of anemia in chronic kidney

*Restricted: Stop the quinolone or

myocardial infarction (MI) and dyspep- disease. The release of free iron into

l macrolide.

sia. Dabigatran was associated with a

the extracellular space of a cell is asso-

Sodium Ferric Gluconate Complex higher risk of MI, but the significance

ciated with many adverse effects seen

(Ferrlecit®)*

of this is currently unknown. Dyspepsia with other intravenous iron therapies.

l

was seen in a much greater amount

Due to its unique properties, feru-

*Restricted to Outpatient Dialysis

of patients on dabigatran and is most

moxytol may avoid unwanted adverse

Center

likely due to the tartaric acid core of the effects, and it is suggested that those

capsule, which is needed to promote

that do occur are not as severe. This

Dabigatran is the first oral direct

absorption.

has not been validated in head-to-

thrombin inhibitor approved for use

The current cost of dabigatran is

head studies.

in the United States. It has a labeled $5.07 per day, significantly higher than

In 3 ferumoxytol clinical trials, 2

indication to reduce the risk of stroke warfarin, which costs approximately $1 doses of 510 mg were administered

and systemic embolism in patients

a day. The increased drug cost for dabi- as an IV injection, given 3 to 8 days

with non-valvular atrial fibrillation.

gatran is somewhat offset by the costs apart. The recommended administra-

It offers an alternative to warfarin in of INR tests associated with the use

tion rate is up to 30 mg-per-second

this patient population.

of warfarin. However, it is estimated

so each individual dose is adminis-

Unlike warfarin, dabigatran does

that dabigatran is about 3 times more

tered over 17 seconds. The phase III

not require INR laboratory monitoring, expensive than warfarin, even with the open-label randomized clinical trials

does not interact with foods, and is

laboratory tests included.

analyzing the efficacy and safety of

less susceptible to drug-drug interac-

Safety remains an issue with dabiga- ferumoxytol used oral iron as a com-

tions. Its ease of use and convenience tran. The lack of a monitoring param-

parison. The greatest increase in the

compared with warfarin make it a

eter, like INR with warfarin, makes it

mean hemoglobin at day 35 was seen

possible replacement for anticoagula- difficult to determine when patients

with ferumoxytol in comparison to the

tion in some patients. However, until may be over-anticoagulated and are at oral iron.

more is known about the safety of

risk for bleeding. Patients with a creati-

Ferumoxytol was well-tolerated in

this product, use should be limited to nine clearance below 30 mL/min are at clinical trials. The main adverse effects

patients who cannot be adequately

increased risk. A dosage reduction to

experienced were diarrhea, nausea,

controlled with warfarin.

75 mg BID for patients with a creatinine hypotension, constipation, peripheral

Dabigatran etexilate mesylate is

clearance between 15-30 mL/min may

edema, and dizziness. Fewer patients

a prodrug that is rapidly converted

avoid problems. Patients who bleed

experienced adverse events while

to its active form by serum ester-

while on dabigatran should be treated taking ferumoxytol in comparison to

ases. It is a specific and reversible

with fresh-frozen plasma or blood. The oral iron. Ferumoxytol did have higher

direct thrombin inhibitor. By inhibit- official labeling should be consulted for incidences of hypotension and dizzi-

ing thrombin, fibrinogen cannot be

guidelines on stopping therapy before a ness. Nevertheless, there was a lower

converted to fibrin, inhibiting the

surgical procedure.

incidence of gastrointestinal adverse

formation of a clot. Due to its mecha-

Iron sucrose is now the primary

effects when compared to oral iron.

nism of action, there is no antidote for injectable iron product listed in the

As with most IV iron preparations,

dabigatran, which is a disadvantage. Formulary. Sodium ferric gluconate

serious hypersensitivity reactions

Dabigatran has a half-life of 12 to 17

complex will no longer be used in the

may be experienced with ferumoxytol

hours, which requires twice-daily

inpatient setting and will be automati- administration (eg, anaphylaxis). This

dosing—another disadvantage. Dabi- cally interchanged to the closest avail- is why it is important for patients to

gatran is not a substrate, inhibitor, or able dose of iron sucrose based on vial be monitored closely for signs and

inducer of CYP450.

size. Sodium ferric gluconate complex

symptoms of hypersensitivity for at

Dabigatran is available in 150-mg

will continue to be used in the outpa-

least 30 minutes after administration,

and 75-mg capsules. The dosage in-

tient dialysis unit, since iron sucrose

as described in the clinical trials.

dicated for reduction in risk of stroke would too expensive in this setting.

Ferumoxytol costs more than twice

or systemic embolization is 150 mg

All of the currently marketed paren- the cost of the most commonly used

twice daily. The dose indicated for

teral iron products, including iron dex- IV iron preparation currently used

patients with a creatinine clearance

tran, sodium ferric gluconate complex, inpatient at Shands per equivalent

of 15-30 mL/min is 75 mg twice daily. iron sucrose, and ferumoxytol, are effec- iron dose. The potential increase in

Dabigatran was not used in patients tive at providing iron supplementation. pharmaceutical expenditures led to

with a creatinine clearance under 30 The decision regarding which products ferumoxytol being designated nonfor-

mL/min, a criterion for exclusion in

to use is driven by safety, economics,

mulary and not available for inpatient

the large trial of dabigatran in non-

and convenience.

use. It remains available as a 2-dose

valvular atrial fibrillation (RE-LY);

Ferumoxytol is a super paramagnetic option in the outpatient setting.

hence, there is a lack of outcome data iron oxide. Ferumoxytol has a labeled

Iron sucrose may have advantages

to support this low-dose regimen. The indication for the treatment of iron

over sodium ferric gluconate complex

110-mg dose in the RE-LY trial was

deficiency anemia in adult patients with and ferumoxytol in that it can be

not approved.

chronic kidney disease. The patients

diluted in saline and infused over

The RE-LY trial examined the safety who receive this treatment may or may a short period (ie, 15 minutes for a

2

and efficacy of dabigatran in patients not be receiving hemodialysis at the

(continued on next page)

Formulary update, from page 2

serum, although sputum-to-serum ratios used to provide this product through

100-mg dose). There have been anec- in bronchitis patients are 0.6:1. Penetra- the Platinol® Powder Restricted Access

dotal reports of patients not tolerating tion into the CNS is poor.

Program. The powder has never been

Ferrlicit® but tolerating iron sucrose.

Minocycline is generally well-tolerat- approved by the FDA for this indica-

Further, there is published information ed. The most common adverse effects

tion. Carboplatin may be substituted.

on off-labeled doses of as high as 500 are gastrointestinal (nausea, vomiting),

Intravenous phenytoin was deleted

mg of iron sucrose being given at one CNS effects (dizziness, vertigo, light-

from the Formulary and was desig-

time [diluted in 250 mL normal saline headedness, tinnitus), skin discolor-

nated nonformulary and not available

and given over 4 hours]. Giving two,

ation, and photosensitivity. Serious

in August 2008. After that decision,

500-mg doses of iron sucrose could

adverse effects generally occur with

orders were automatically changed to

be used instead of ferumoxytol. The

long-term oral therapy or high doses.

fosphenytoin, a water-soluble prodrug

labeled iron sucrose dose is 100 mg

These include autoimmune hepatitis,

of phenytoin with some advantages

given over 10 doses for a total dose of vasculitis, and lupus-like syndrome. A

over parenteral phenytoin (eg, less

1 gram.

report published in 2005 concluded that irritating to veins and can be adminis-

Since sodium ferric gluconate

minocycline may cause more and differ- tered more rapidly).

complex will no longer be available

ent adverse events than doxycycline,

A shortage of fosphenytoin required

for inpatient use after February 1,

although other studies contradict this. the re-addition of IV phenytoin in the

2011, the P&T Committee approved an

Tetracycline resistance is primarily

Formulary, and, temporarily (during

automatic interchange to iron sucrose. mediated through the acquisition of

the shortage), fosphenytoin orders

Typical adult doses of sodium ferric

genes that code for efflux pumps and

were automatically interchanged to

gluconate complex 125 mg IV will be ribosomal protective mechanisms. The phenytoin. The fosphenytoin shortage

changed to iron sucrose 100 mg IV. If resistance mechanisms have variable

has been resolved; therefore, inter-

8 doses are ordered, the duration will effects on the different tetracycline

change to fosphenytoin will be done

be changed to 10 doses (ie, same total molecules. Therefore, minocycline may using the same “Phenytoin Equivalent

amount of iron). For children, sodium retain activity when doxycycline is inac- (PE)” doses.

ferric gluconate complex doses of 1.5 tive. Minocycline may be inactive when

Gablofen® does not differ much

mg/kg to a maximum dose of 125 mg tigecycline is active.

from the other currently available

will be changed to iron sucrose 1 mg/

The acquisition cost per day for

intrathecal baclofen formulations, but

kg to a maximum of 100 mg per dose. minocycline IV is twice that of doxycy- its manufacturer claims its ease of

Oral and IV minocycline were

cline, yet slightly less than tigecycline. administration for refills as the primary

added in the Formulary. IV minocy-

Compared to other selected therapies

advantage over competitors. Gablofen®

cline will be restricted to approval by for MRSA (linezolid or daptomycin), the was recently approved for the treat-

Infectious Diseases or the Antimicro- cost is much less. Compared to other

ment of severe spasticity; however,

bial Management Program.

therapies for resistant A. baumannii,

intrathecal baclofen was first approved

Minocycline was reviewed for pos- the cost is moderately higher. Published in 1992 as an orphan drug and is now

sible addition in the Formulary due to clinical trials are lacking to compare

considered a standard of care for the

the 2009 re-release of the injectable

minocycline to non-tetracyclines.

treatment of severe spasticity (eg, as-

formulation and nonformulary use of

Use of tigecycline and doxycycline at sociated with spinal cord injury).

the oral product.

Shands at UF has been low. It is antici-

Gablofen® is compatible with

Minocycline is a tetracycline deriva- pated that use of minocycline would be Medtronic’s SynchroMed® II, a pro-

tive originally introduced in 1972. The limited to niche situations. Using this

grammable drug pump. It does not

IV formulation was voluntarily with-

agent for certain MRSA infections may differ from the currently available

drawn from the US market in 2005 and decrease pressure, preserve activity for baclofen injection, Lioresal® Intrathe-

reintroduced in 2009 at the request

other agents, and provide cost benefit

cal, which is exclusively marketed by

of the US military. Minocycline, like

to the institution as well. Minocycline

Medtronic and manufactured by No-

other tetracyclines, is thought to exert may also be a less expensive alterna-

vartis. When the pumps are implanted,

bacteriostatic activity against a broad tive to tigecycline or other antibiotics

Lioresal® comes with the pump, so

range of gram-positive and gram-

for infections caused by susceptible

Gablofen® is used only for refills.

negative organisms through inhibition Stenotrophomonas, Enterococcus, or

Gablofen® comes in ready-to-use

of protein synthesis. Recently the IV

ESBL producing organisms. Additional vials for ease of administration as

formulation has been described in the sensitivity testing (E test) may be re-

well as pre-filled syringes, which may

treatment of infections due to resis-

quired for gram-negative infections. The reduce both refill preparation time.

tant Acinetobacter baumannii and

new Staph microbiology panel will list

Tesamorelin is a growth hormone

methicillin-resistant Staphylococcus

sensitivities to minocycline. Sensitivi-

releasing factor (GHRF) analog with a

aureus (MRSA).

ties to minocycline and tigecycline do

labeled indication for the reduction of

The oral bioavailability of minocy-

not always correlate.

excess abdominal fat in HIV-infected

cline is 95-100% and food does not ap-

Because oral minocycline can cause

patients with lipodystrophy. Long-term

pear to affect absorption. Thus, there esophagitis when not administered

cardiovascular benefit and safety have

is no dosing adjustment when chang- correctly (ie, with enough fluid and

not been studied. It is not indicated

ing from IV to oral administration.

with the patient sitting up or the bed

for weight-loss management and has

The recommended dosing scheme for elevated), appropriate administration

a weight-neutral effect. There are no

minocycline is a 200-mg loading dose instructions should be considered.

data to support improved compliance

followed by 100 mg every 12 hours.

Cisplatin powder is no longer provid- with antiretroviral therapies in HIV-

The maximum daily dose should not

ed for patients undergoing transhepatic positive patients taking tesamorelin.

exceed 400 mg. Pediatric dosing for

arterial chemoembolization (TACE) for

This agent is given once daily as a

children above 8 years of age is 4 mg/ the treatment of hepatocellular cancers. SQ injection. The onset and offset of

kg load followed by 2 mg/kg every 12 Cisplatin is an alkylating agent that is

action of tesamorelin are not well-

hours.

available in an injectable form and used described in the literature. However

Minocycline is widely distributed

for various types of cancer (eg, testicu- a clinical benefit was not seen until

in the tissues and generally achieves lar cancer). The powder is no longer be- 26 weeks of therapy. Thus, it can be

higher concentrations in tissue than

ing manufactured. Bristol-Myers Squibb

(continued on next page) 3

Formulary update, from page 3

concomitant use of hypertonicFsoarlimneulary upwdialltbee, firnotmercphaagneg3ed to the brand that

inferred, until data refute this assump- should be avoided.

is currently available at Shands at

tion, that missing a few doses of tesa-

Conivaptan is the only other VRA

UF, regardless of the brand that the

morelin while a patient is hospitalized available in the US; it is administered

patient has previously received per a

should not be significant. Therefore,

parenterally and targets the V1a and V2 P&T-approved interchange.

tesamorelin was designated nonfor-

receptors. Conivaptan use must be

Eribulin is a microtubule inhibi-

mulary and not available for inpatient approved for the management of

tor with a labeled indication for the

use.

patients with euvolemic and hyper-

treatment of patients with metastatic

Tolvaptan is an oral non-peptide

volemic hyponatremia.

breast cancer who have previously

selective vasopressin V2-receptor

Conivaptan differs from tolvaptan in received at least 2 chemotherapy regi-

antagonist (VRA) that causes an

that it must be administered for the full mens for the treatment of metastatic

increase in urine water excretion,

course of treatment in a hospital and

disease. Prior therapy should have in-

resulting in a decrease in urine osmo- may cause hypotension or hypertension. cluded an anthracycline and a taxane

lality and an increase in free water

It is, however, doubtful that tolvaptan

in either the adjuvant or metastatic

clearance and serum sodium concen- would be used outside of a hospital

setting.

trations. It has a labeled indication for setting. Also, tolvaptan has more drug-

Eribulin was added in the Chemo-

the treatment of clinically significant drug interactions than conivaptan. Both therapy Policy, [requiring the use of

hypervolemic and euvolemic hypona- drugs are contraindicated with potent

a Chemotherapy Order Form], but

tremia (serum sodium less than 125

CYP3A inhibitors like ketoconazole,

remains a nonformulary drug. It is

mEq/L or less marked hyponatremia clarithromycin, ritonavir, nelfinavir, sa- anticipated that it will be used mostly

that is symptomatic and has resisted quinavir, nefazodone, and indinavir.

in the outpatient setting.

correction with fluid restriction),

A disadvantage of tolvaptan is cost.

Azithromycin is the primary macro-

including patients with heart failure, Each tolvaptan tablet (either 15 or 30

lide listed in the Formulary. Ciproflox-

cirrhosis, and Syndrome of Inappropri- mg) is $240.87, which is taken every

acin and levofloxacin are the primary

ate Antidiuretic Hormone (SIADH).

day for an indefinite time until hypo-

fluoroquinolones. After reviewing

Although tolvaptan has been

natremia resolves. Off-labeled use is a the evidence regarding the use of

studied in patients with chronic heart concern.

fluoroquinolones in combination with

failure, it did not improve all-cause

Tolvaptan was designated nonfor-

macrolides for community-acquired

mortality or the combined events of

mulary and not available. Conivaptan

pneumonia (CAP) and Legionnaire’s

cardiovascular mortality or heart fail- is available to increase serum sodium

disease, the P&T Committee empow-

ure morbidity. Hyponatremia studies levels temporarily in the inpatient set- ered the Antimicrobial Management

showed that tolvaptan significantly

ting. Use must be approved by a clinical Program to discontinue one of these

improved serum sodium to normal lev- pharmacist. Patients may qualify for

agents when they are being used

els. However, hyponatremia recurred conivaptan therapy if they are in an

together to treat a bacterial infection.

after discontinuation of tolvaptan

ICU or IMC and have low serum sodium

The IDSA/ATS pneumonia guide-

but improved once therapy was re-

levels that prevent them from going

lines and a preponderance of data sup-

initiated after a week. A peak increase to the operating room for a procedure.

port monotherapy for the management

of approximately 6 mEq/L in serum

All other measures to increase serum

of Legionnaire’s disease. Clinical trials

sodium is achieved with tolvaptan.

sodium must have failed prior to initia- evaluating the efficacy of a fluoroqui-

Patients with mild hyponatremia (se- tion of conivaptan therapy. Due to a

nolone or macrolide have consistently

rum sodium concentration of 130-134 high incidence of injection-site reac-

demonstrated that either regimen

mmol/L) and patients with marked

tions, conivaptan can be infused via

results in high cure rates. There are

hyponatremia (serum sodium concen- a peripheral line for a maximum of 12

in-vitro data supporting combina-

tration of < 130 mmol/L) had a mean hours. A central line must be placed

tion macrolide and fluoroquinolone

increase in serum sodium levels of 4 after this period for further therapy to

against L. pneumophila, but no clinical

mmol/L and 8 mmol/L, respectively, on be approved.

evidence exists to support this com-

day 30.

DTaP is diphtheria, tetanus, and

bination therapy. In addition, there is

Tolvaptan’s most common adverse acellular pertussis vaccine, which is

an increased risk for adverse events,

reactions include thirst, dry mouth,

used routinely in young children. Tdap including Torsade de pointes.

and polyuria/pollakiuria. Tolvaptan

is tetanus, diphtheria, and acellular

Based on these data, the Anti-Infec-

contains a black-box warning indicat- pertussis vaccine and is used as a

tive Subcommittee recommended that

ing that too-rapid correction of serum booster in older children and adults.

the combination of fluoroquinolones

sodium (eg, greater than 12 mEq/L

According to Centers for Disease Con- and macrolides be avoided in patients

over 24 hrs) may result in osmotic

trol’s (CDC) Advisory Committee on Im- with CAP and patients suspected of

demyelination syndrome. During ini- munization Practices (ACIP), the same having Legionnaire’s disease.

tiation and titration, close monitoring manufacturer of the DTaP and Tdap

Healthcare providers can continue

of serum sodium and volume status is vaccines should be used for the entire

to prescribe a fluoroquinolone-mac-

necessary in patients receiving tolvap- series “whenever feasible;” however,

rolide combination in the following

tan. Tolvaptan is contraindicated in

the vaccine should not be deferred if the scenarios with a warning for concerns

patients who have an urgent need

previously used brand is not available

for adverse events: cystic fibrosis and

to increase sodium, those who are

or unknown. Data on the safety and im- bronchiolitis obliterans when levo-

unable to autoregulate thirst, patients munogenicity of interchanging vaccines floxacin or ciprofloxacin may be used

with hypovolemic hyponatremia, pa- from different manufacturers is limited. in combination with azithromycin

tients on concomitant potent CYP3A4

There are three different brands of

(ie, azithromycin is being used as an

inhibitors, and anuric patients. Tolvap- the DTaP vaccine: Daptacel® and Tripe- anti-inflammatory agent) and when

tan can induce copious aquaresis

dia® by Sanofi Pasteur, and Infanrix®

azithromycin is used for gastrointes-

causing dehydration and hypovolemia, by GlaxoSmithKline. There are 2 Tdap

tinal motility issues in combination

especially in volume-depleted patients vaccine brands: Adacel® by Sanofi Pas- with levofloxacin or ciprofloxacin (ie,

who may be on diuretics or who are

teur, and Boostrix® by GlaxoSmithKline. azithromycin is used as a prokinetic

fluid-restricted. Fluid restriction dur- Shands at UF currently carries Tripedia® agent).

4

ing the first 24 hours of therapy and

and Adacel®. DTaP and Tdap vaccines

4

55

NEW DRUGS, BIOLOGICALS, & SELECTED DOSAGE FORMS APPROVED BY THE FDA IN 2010

GENERIC NAME
Acetaminophen Injection† Alcaftadine^ Alglucosidase alfa^ Aliskiren-Amlodipine†‡ Aliskiren-Amlodipine-Hydrochlorothiazide† Alpha-1-protease Inhibitor Baclofen Injection†‡ Buprenorphine Transdermal†‡ Cabazitaxel^ Calcipotriene Foam†‡ Carglumic acid^ Ceftaroline^ Clindamycin-Tretinoin†‡ Collagenase Clostridium Histolyticum‡ Dabigatran^ Dalfampridine^ Denosumab^‡ Dextromethorphan-Quinidine† Donepezil† Doxepin†‡ Dutasteride-Tamsulosin†‡ Eribulin^ Esomeprazole-Naproxen†‡ Ethinyl estradiol, Drospirenone, Levomefolate‡ Ethinyl estradiol, Drospirenone, Levomefolate‡ Ethinyl estradiol, Norethindrone, Ferrous fumarate‡ Estradiol valerate, Dienogest^‡ Everolimus^ Fibrin Sealant Patch† Fingolimod^ Gatifloxacin Ophth† Glycopyrrolate†‡ Hexaminolevulinate Hydromorphone ER†‡ Immune Globulin, SQ†‡ IncobotulinumtoxinA‡ Influenza Virus Vaccines Ketorolac Nasal Spray†‡ Lamotrigine ER†‡ Liraglutide^ Lurasidone^ Mannitol† Memantine ER†‡ Meningococcal Vaccine‡ Mometasone-Formoterol† Moxifloxacin Ophth† Olmesartan-Amlodipine-Hydrochlorothiazide†‡ Ondansetron Film†‡ Paliperidone Palmitate†‡ Pancrelipase* Pegloticase^‡ Pneumococcal Vaccine* Polidocanol^ Pramipexole ER†‡ Risedronate†‡ Ritonavir Tablet*† Saxagliptin-Metformin† Sipuleucel-T^‡ Sodium & Potassium sulfate – Magnesium Citrate† Tesamorelin^‡ Testosterone, Topical†‡ Testosterone, Topical†‡ Toclizumab^ Trazodone ER†‡ Triptorelin Pamoate‡ Ulipristal acetate^ Vardenafil†‡ Velaglucerase alfa^‡
^New Molecular Entities (NMEs) *Listed in the Formulary †New Dosage Form, Combination, or Indication ‡Nonformulary and not available

TRADE NAME
Ofirmev® Lastacaft® Lumizyme® Tekamlo® Amturnide® Glassia® Gablofen® Butrans® Jevtana® Sorilux® Carbaglu® Teflaro®
Xiaflex® Pradaxa® Ampyra® Prolia® Nuedexta® Aricept® Silenor® Jalyn® Halaven® Vimovo® Beyaz® Safyral® Lo Loestrin® FE Natazia® Zortress® TachoSil® Gilenya® Zymaxid® Cuvposa® Cysview® Exaglo® Hizentra® Xeomin® Various Sprix® Lamictal® XR Victoza® Latuda® Aridol® Namenda® XR Menveo Dulera® Moxeza® Tribenzor® Zuplenz® Invega® Sustenna Pancreaze® Krystexxa® Prevnar-13® Asclera® Mirapex® ER Atelvia® Norvir® Kombiglyze® XR Provenge® Suprep® Egrifta® Axiron® Fortesta® Actemra® Oleptro® Trelstar® Ella® Staxyn® Vpriv®

INDICATION
Pain and Fever Conjunctivitis, Allergic Pompe Disease Hypertension Hypertension Emphysema Spasticity Chronic Pain Cancer: Prostate Psoriasis N-acetylglutamate Deficiency Antibiotic Acne Dupuytren’s Contracture Anticoagulant: Atrial Fibrillation Multiple Sclerosis Osteoporosis Pseudobulbar Affect Alzheimer’s Disease Insomnia Benign Prostatic Hypertrophy Cancer: Breast Pain: Arthritis Oral Contraceptive Oral Contraceptive Oral Contraceptive Oral Contraceptive Transplant Organ Rejection Cardiovascular Surgery Multiple Sclerosis Conjunctivitis, Bacterial Drooling Diagnostic: Bladder Cancer Pain Primary Immunodeficiency Cervical Dystonia & Blepharospasm Influenza Prevention Pain Seizures Diabetes Schizophrenia Asthma Diagnostic Alzheimer’s Disease Prevention of Meningococcal Infection Asthma Conjunctivitis, Bacterial Hypertension Nausea and Vomiting Schizophrenia Pancreatic Insufficiency Gout Prevention of Pneumococcal Infections Spider Veins Parkinson’s Disease Osteoporosis HIV Diabetes Cancer: Prostate Laxative: Bowel Prep HIV Lipodystrophy Hypogonadism Hypogonadism Rheumatoid Arthritis Depression Cancer: Prostate Oral Contraceptive, Emergency Erectile Dysfunction Gaucher Disease

Drugs & Therapy
BN U N LN LN EN T N IN N

Volume 25, No. 2

February 2011

This publication is produced by the

Drug Information and Pharmacy Re-

source Center under the direction of

the Department of Pharmacy Services

and the Pharmacy and Therapeutics

Committee.

EDITOR, DRUGS & THERAPY BULLETIN Randy C. Hatton, PharmD

DIRECTOR, PHARMACY SERVICES Alan Knudsen, MS, RPh

CHAIRMAN, PHARMACY & THERAPEUTICS COMMITTEE Ricardo Gonzalez-Rothi, MD

EDITING, DESIGN, & PRODUCTION Shands HealthCare’s Publication Svcs. © Copyright 2011. All rights reserved. No portion of the Drugs & Therapy Bulletin may be reproduced without the written consent of its editor.

FOR MORE INFORMATION, VISIT US ONLINE http://shands.org/professionals/ druginfo/bulletin.asp

SHANDS Shands at the University of Florida DRUG INFORMATION SERVICE PO Box 100316 Gainesville, FL 32610-0316

NON-PROFIT ORG. U.S. POSTAGE PAID
GAINESVILLE, FL PERMIT NO. 94

NEWS

New drugs in 2010

T here were 21 new unique drugs (ie, New Molecular Entities) approved in 2010 (see table on page 5). This was a decrease compared with 25 last year. The year started out with many new approvals, but the number of new approvals slipped at the end of the year. Several drugs that were reviewed near the end of the year were delayed requiring additional information. There also appeared to be a slight decrease in the number of new biologicals approved. There were many new dosage forms or combinations approved.
The trend of approving boutique drugs also continues. For example, carglumic acid was approved for N-acetylglutamate deficiency, alglucosidase for Pompe disease, and valaglucerase for Gaucer disease.
There were several drugs approved for the treatment or prevention of cancer. Manufacturers seek approval of drugs used for the treatment of cancer, since usually these drugs are covered by third-party payers.

Four new oral contraceptives were approved, 2 with levomefolate.
Three combination antihypertensive agents were approved, continuing the trend of marketing combinations for the treatment of hypertension.
Five new extended-release versions of drugs were approved as the patents expired on the immediate-release dosage forms.
2010 was another big year for first-time generics approvals. Generic versions of blockbuster drugs continue to be marketed as patents expire. Many third-party payers encourage patients to use generics by requiring much lower co-pays. Some plans now have no co-pays for some generics, and Walmart and many other retailers offer many generics for $4 for a 1-month supply, and $10 for 3 months’ supply. At least 2/3 of all prescriptions filled are now generic drugs, yet they account for less than 1/4 of all expenses.
Important first-time generic versions of brand name drugs approved in 2010 included generic versions of

common drugs used in the ambulatory setting like Ambien CR® (zolpidem ER), Effexor® XR (venlafaxine ER), Strattera® (atomoxetine), Temodar® (temozolomide), and Yasmin®. Other important generics used in health systems include Azactam® (aztreonam), Cosmegen® (dactinomycin), Gemzar® (gemcitabine), Hycamtin® (topotecan), Keppra® IV (levetiracetam), Lovenox® (enoxaparin), Merrem® (meropenem), and Vfend® tablets (voriconazole). New generics expected for 2011 include Lipitor® (atorvastatin), Uroxatral® (alfuzosin), Xalatan® (latanoprost), and Zyprexa® (olanzapine).
The growing arsenal of generics makes it easier to find a less expensive option in many therapeutic categories. After generics have been on the market for several months, the cost to health systems can drop by as much as 70% or more.

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PatientsDrugsDabigatranMinocyclineTreatment