Treating Alcoholism for Optimal Results Treating Alcoholism for Optimal Results

114 Pages·2012·15.14 MB·English

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Indication Prophylactic therapy (i.e. - NSAIDs or colchicine)
upon initiation of treatment may be benefi cial for
ULORIC is a xanthine oxidase (XO) inhibitor indicated for
up to six months.
the chronic management of hyperuricemia in patients
with gout. ULORIC is not recommended for the treatment • Cardiovascular Events: In randomized controlled studies,
of asymptomatic hyperuricemia. there was a higher rate of cardiovascular thromboembolic
events (cardiovascular deaths, non-fatal myocardial
Important Safety Information infarctions, and non-fatal strokes) in patients treated
with ULORIC [0.74 per 100 P-Y (95% CI 0.36-1.37)] than
• ULORIC is contraindicated in patients being treated allopurinol [0.60 per 100 P-Y (95% CI 0.16-1.53)]. A causal
with azathioprine, mercaptopurine, or theophylline. relationship with ULORIC has not been established.
• An increase in gout fl ares is frequently observed Monitor for signs and symptoms of MI and stroke.
during initiation of anti-hyperuricemic agents, • Liver Enzyme Elevations: In randomized controlled studies,
including ULORIC. If a gout fl are occurs during transaminase elevations greater than 3 times the upper
treatment, ULORIC need not be discontinued. limit of normal (ULN) were observed (AST: 2%, 2%, and
ULORIC® is a registered trademark of Teijin Pharma Limited and used under license by Takeda Pharmaceuticals America, Inc.
©2009 Takeda Pharmaceuticals North America, Inc. TXF-00319 08/09
ULORIC powerfully lowers
serum uric acid levels for long-term
control of gout.
Powerfully lowers serum uric acid1
• In the largest phase 3 study (6 months):
- 45% of patients who received ULORIC 40 mg achieved serum uric acid
levels of <6 mg/dL (N=757) compared to 42% of patients who received
allopurinol 300 mg (N=755; p=0.233)
- 67% of patients who received ULORIC 80 mg achieved serum uric acid
levels of <6 mg/dL (N=756) compared to 42% of patients who received
allopurinol 300 mg (N=755; p<0.001)
Extensively studied safety profi le1
• The safety profi le of ULORIC has been evaluated2
- In more than 4000 patients
- In some for more than 5 years
Simple, once-daily dosing1
• Available in 40- and 80-mg tablets for once-daily dosing with a starting
dose of 40 mg
• No dose adjustments required in patients with mild to moderate renal
or hepatic impairment*
* There are insuffi cient data in patients with severe renal dysfunction, and no
studies have been conducted in patients with severe hepatic impairment.
Caution should be exercised in these patients.
ALT: 3%, 2% in ULORIC and allopurinol-treated patients, For more information,
respectively). No dose-effect relationship for these
please visit www.ULORIC.com.
transaminase elevations was noted. Laboratory
assessment of liver function is recommended at, for
example, 2 and 4 months following initiation of ULORIC
and periodically thereafter.
• Adverse reactions occurring in at least 1% of ULORIC-treated
patients, and, at least 0.5% greater than placebo, are liver
function abnormalities, nausea, arthralgia, and rash.
Individual results may vary based on factors such as baseline
serum uric acid levels.
Please see brief summary of complete Prescribing Information
on adjacent pages.
References:
1. ULORIC® (febuxostat) full prescribing information, February 2009.
2. Data on fi le, Takeda Pharmaceuticals North America, Inc.
BRIEF SUMMARY OF FULL PRESCRIBING INFORMATION for Blood and Lymphatic System Disorders: anemia, idiopathic thrombocytopenic
ULORIC® (febuxostat) tablets purpura, leukocytosis/leukopenia, neutropenia, pancytopenia, splenomegaly,
throm bo cytopenia; Cardiac Disorders: angina pectoris, atrial fibrillation/flutter,
INDICATIONS AND USAGE
cardiac murmur, ECG abnormal, palpitations, sinus bradycardia, tachycardia;
ULORIC® is a xanthine oxidase (XO) inhibitor indicated for the chronic management
Ear and Labyrinth Disorders: deafness, tinnitus, vertigo; Eye Disorders: vision
of hyperuricemia in patients with gout.
blurred; Gastrointestinal Disorders: abdominal distention, abdominal pain,
ULORIC is not recommended for the treatment of asymptomatic hyperuricemia. constipation, dry mouth, dyspepsia, flatulence, frequent stools, gastritis,
CONTRAINDICATIONS gastro esophageal reflux disease, gastrointestinal discomfort, gingival pain,
ULORIC is contraindicated in patients being treated with azathioprine, mercapto- haematemesis, hyperchlorhydria, hematochezia, mouth ulceration, pancreatitis,
purine, or theophylline [see Drug Interactions]. peptic ulcer, vomiting; General Disorders and Administration Site Conditions:
asthenia, chest pain/discomfort, edema, fatigue, feeling abnormal, gait
WARNINGS AND PRECAUTIONS
disturbance, influenza-like symptoms, mass, pain, thirst; Hepatobiliary
Gout Flare Disorders: cholelithiasis/cholecystitis, hepatic steatosis, hepatitis, hepatomegaly;
After initiation of ULORIC, an increase in gout flares is frequently observed. This Immune System Disorder: hypersensitivity; Infections and Infestations: herpes
increase is due to reduction in serum uric acid levels resulting in mobilization of zoster; Procedural Complications: contusion; Metabolism and Nutrition Disorders:
urate from tissue deposits. anorexia, appetite decreased/increased, dehydration, diabetes mellitus, hyper-
cholesterolemia, hyperglycemia, hyperlipidemia, hypertriglyceridemia, hypokalemia,
In order to prevent gout flares when ULORIC is initiated, concurrent prophylactic
weight decreased/increased; Musculoskeletal and Connective Tissue Disorders:
treatment with an NSAID or colchicine is recommended.
arthritis, joint stiffness, joint swelling, muscle spasms/twitching/tightness/weakness,
Cardiovascular Events musculoskeletal pain/stiffness, myalgia; Nervous System Disorders: altered
In the randomized controlled studies, there was a higher rate of cardiovascular taste, balance disorder, cerebrovascular accident, Guillain-Barré syndrome, headache,
thrombo embolic events (cardiovascular deaths, non-fatal myocardial infarctions, hemiparesis, hypoesthesia, hyposmia, lacunar infarction, lethargy, mental
and non-fatal strokes) in patients treated with ULORIC [0.74 per 100 P-Y impairment, migraine, paresthesia, somnolence, transient ischemic attack,
(95% CI 0.36-1.37)] than allopurinol [0.60 per 100 P-Y (95% CI 0.16-1.53)] [see tremor; Psychiatric Disorders: agitation, anxiety, depression, insomnia, irritability,
Adverse Reactions]. A causal relationship with ULORIC has not been established. libido decreased, nervousness, panic attack, personality change; Renal and
Monitor for signs and symptoms of myocardial infarction (MI) and stroke. Urinary Disorders: hematuria, nephrolithiasis, pollakiuria, proteinuria, renal
Liver Enzyme Elevations failure, renal insufficiency, urgency, incontinence; Reproductive System and
During randomized controlled studies, transaminase elevations greater than 3 times Breast Changes: breast pain, erectile dysfunction, gynecomastia; Respiratory,
the upper limit of normal (ULN) were observed (AST: 2%, 2%, and ALT: 3%, 2% Thoracic and Mediastinal Disorders: bronchitis, cough, dyspnea, epistaxis,
in ULORIC and allopurinol-treated patients, respectively). No dose-effect nasal dryness, paranasal sinus hypersecretion, pharyngeal edema, respiratory
relationship for these transaminase elevations was noted. Laboratory tract congestion, sneezing, throat irritation, upper respiratory tract infection;
assessment of liver function is recommended at, for example, 2 and 4 months Skin and Subcutaneous Tissue Disorders: alopecia, angio edema, dermatitis,
following initiation of ULORIC and periodically thereafter. dermographism, ecchymosis, eczema, hair color changes, hair growth abnormal,
hyperhidrosis, peeling skin, petechiae, photosensitivity, pruritus, purpura, skin
ADVERSE REACTIONS
discoloration/altered pigmentation, skin lesion, skin odor abnormal, urticaria;
Clinical Trials Experience Vascular Disorders: flushing, hot flush, hypertension, hypotension; Laboratory
Because clinical trials are conducted under widely varying conditions, adverse Parameters: activated partial thromboplastin time prolonged, creatine increased,
reaction rates observed in the clinical trials of a drug cannot be directly compared bicarbonate decreased, sodium increased, EEG abnormal, glucose increased,
to rates in the clinical trials of another drug and may not reflect the rates observed cholesterol increased, triglycerides increased, amylase increased, potassium
in practice. increased, TSH increased, platelet count decreased, hematocrit decreased, hemoglobin
decreased, MCV increased, RBC decreased, creatinine increased, blood urea
A total of 2757 subjects with hyperuricemia and gout were treated with ULORIC
increased, BUN/creatinine ratio increased, creatine phosphokinase (CPK) increased,
40 mg or 80 mg daily in clinical studies. For ULORIC 40 mg, 559 patients
alkaline phosphatase increased, LDH increased, PSA increased, urine output
were treated for (cid:114) 6 months. For ULORIC 80 mg, 1377 subjects were treated for
increased/decreased, lymphocyte count decreased, neutrophil count decreased,
(cid:114) 6 months, 674 patients were treated for (cid:114) 1 year and 515 patients were treated
WBC increased/decreased, coagulation test abnormal, low density lipoprotein
for (cid:114) 2 years.
(LDL) increased, prothrombin time prolonged, urinary casts, urine positive for
Most Common Adverse Reactions white blood cells and protein.
In three randomized, controlled clinical studies (Studies 1, 2 and 3), which were
Cardiovascular Safety
6 to 12 months in duration, the following adverse reactions were reported by
Cardiovascular events and deaths were adjudicated to one of the pre-defined
the treating physician as related to study drug. Table 1 summarizes adverse
endpoints from the Anti-Platelet Trialists’ Collaborations (APTC) (cardiovascular
reactions reported at a rate of at least 1% in ULORIC treatment groups and at
death, non-fatal myocardial infarction, and non-fatal stroke) in the randomized
least 0.5% greater than placebo.
controlled and long-term extension studies. In the Phase 3 randomized controlled
studies, the incidences of adjudicated APTC events per 100 patient-years of exposure
Table 1: Adverse Reactions Occurring in (cid:114) 1% of ULORIC-Treated
were: Placebo 0 (95% CI 0.00-6.16), ULORIC 40 mg 0 (95% CI 0.00-1.08),
Patients and at Least 0.5% Greater than Seen in Patients
Receiving Placebo in Controlled Studies ULORIC 80 mg 1.09 (95% CI 0.44-2.24), and allopurinol 0.60 (95% CI
0.16-1.53).
Placebo ULORIC allopurinol*
In the long-term extension studies, the incidences of adjudicated APTC events were:
40 mg 80 mg ULORIC 80 mg 0.97 (95% CI 0.57-1.56), and allopurinol 0.58 (95% CI 0.02-3.24).
daily daily
Overall, a higher rate of APTC events was observed in ULORIC than in allopurinol-
Adverse Reactions (N=134) (N=757) (N=1279) (N=1277)
treated patients. A causal relationship with ULORIC has not been established.
Liver Function 0.7% 6.6% 4.6% 4.2% Monitor for signs and symptoms of MI and stroke.
Abnormalities
DRUG INTERACTIONS
Nausea 0.7% 1.1% 1.3% 0.8%
Xanthine Oxidase Substrate Drugs
Arthralgia 0% 1.1% 0.7% 0.7% ULORIC is an XO inhibitor. Drug interaction studies of ULORIC with drugs that
are metabolized by XO (e.g., theophylline, mercaptopurine, azathioprine) have
Rash 0.7% 0.5% 1.6% 1.6%
not been conducted. Inhibition of XO by ULORIC may cause increased plasma
* Of the subjects who received allopurinol, 10 received 100 mg, 145 received concentrations of these drugs leading to toxicity [see Clinical Pharmacology].
200 mg, and 1122 received 300 mg, based on level of renal impairment. ULORIC is contraindicated in patients being treated with azathioprine,
mercaptopurine, or theophylline [see Contraindications].
The most common adverse reaction leading to discontinuation from therapy
was liver function abnormalities in 1.8% of ULORIC 40 mg, 1.2% of ULORIC Cytotoxic Chemotherapy Drugs
80 mg, and in 0.9% of allopurinol-treated subjects. Drug interaction studies of ULORIC with cytotoxic chemotherapy have not been
conducted. No data are available regarding the safety of ULORIC during
In addition to the adverse reactions presented in Table 1, dizziness was reported
cytotoxic chemotherapy.
in more than 1% of ULORIC-treated subjects although not at a rate more than
0.5% greater than placebo. In Vivo Drug Interaction Studies
Based on drug interaction studies in healthy subjects, ULORIC does not have
Less Common Adverse Reactions
clinically significant interactions with colchicine, naproxen, indomethacin,
In phase 2 and 3 clinical studies the following adverse reactions occurred in less
hydrochlorothiazide, warfarin or desipramine. Therefore, ULORIC may be used
than 1% of subjects and in more than one subject treated with doses ranging from
concomitantly with these medications.
40 mg to 240 mg of ULORIC. This list also includes adverse reactions (less than
1% of subjects) associated with organ systems from Warnings and Precautions.
USE IN SPECIFIC POPULATIONS No dose adjustment is necessary in patients with mild to moderate renal
impairment [see Dosage and Administration and Use in Specific Populations].
Pregnancy
The recommended starting dose of ULORIC is 40 mg once daily. For patients
Pregnancy Category C: There are no adequate and well-controlled studies in
who do not achieve a sUA less than 6 mg per dL after 2 weeks with 40 mg,
pregnant women. ULORIC should be used during pregnancy only if the potential
ULORIC 80 mg is recommended. There is insufficient data in patients with
benefit justifies the potential risk to the fetus.
severe renal impairment; caution should be exercised in those patients [see Use
Febuxostat was not teratogenic in rats and rabbits at oral doses up to 48 mg per kg in Specific Populations.
(40 and 51 times the human plasma exposure at 80 mg per day for equal body
ULORIC has not been studied in end stage renal impairment patients who are
surface area, respectively) during organogenesis. However, increased neonatal
on dialysis.
mortality and a reduction in the neonatal body weight gain were observed when
pregnant rats were treated with oral doses up to 48 mg per kg (40 times the Hepatic Impairment: Following multiple 80 mg doses of ULORIC in patients
human plasma exposure at 80 mg per day) during organogenesis and through with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic
lactation period. impairment, an average of 20-30% increase was observed for both Cmax and
AUC (total and unbound) in hepatic impairment groups compared to subjects
Nursing Mothers 24
with normal hepatic function. In addition, the percent decrease in serum uric
Febuxostat is excreted in the milk of rats. It is not known whether this drug is
acid concentration was comparable between different hepatic groups (62% in
excreted in human milk. Because many drugs are excreted in human milk, caution healthy group, 49% in mild hepatic impairment group, and 48% in moderate
should be exercised when ULORIC is administered to a nursing woman. hepatic impairment group). No dose adjustment is necessary in patients with
Pediatric Use mild or moderate hepatic impairment. No studies have been conducted in
Safety and effectiveness in pediatric patients under 18 years of age have not subjects with severe hepatic impairment (Child-Pugh Class C); caution should
been established. be exercised in those patients [see Use in Specific Populations.
Geriatric Use NONCLINICAL TOXICOLOGY
No dose adjustment is necessary in elderly patients. Of the total number of subjects Carcinogenesis, Mutagenesis, Impairment of Fertility
in clinical studies of ULORIC, 16 percent were 65 and over, while 4 percent were Carcinogenesis: Two-year carcinogenicity studies were conducted in F344 rats
75 and over. Comparing subjects in different age groups, no clinically significant and B6C3F1 mice. Increased transitional cell papilloma and carcinoma of urinary
differences in safety or effectiveness were observed but greater sensitivity of bladder was observed at 24 mg per kg (25 times the human plasma exposure
some older individuals cannot be ruled out. The Cmax and AUC24 of febuxostat at maximum recommended human dose of 80 mg per day) and 18.75 mg per
following multiple oral doses of ULORIC in geriatric subjects ((cid:114) 65 years) were kg (12.5 times the human plasma exposure at 80 mg per day) in male rats and
similar to those in younger subjects (18-40 years). female mice, respectively. The urinary bladder neoplasms were secondary to
Renal Impairment calculus formation in the kidney and urinary bladder.
No dose adjustment is necessary in patients with mild or moderate renal Mutagenesis: Febuxostat showed a positive mutagenic response in a chromosomal
impairment (Cl 30-89 mL per min). The recommended starting dose of ULORIC aberration assay in a Chinese hamster lung fibroblast cell line with and without
cr
is 40 mg once daily. For patients who do not achieve a sUA less than 6 mg per metabolic activation in vitro. Febuxostat was negative in the in vitro Ames assay
dL after 2 weeks with 40 mg, ULORIC 80 mg is recommended. and chromosomal aberration test in human peripheral lymphocytes, and L5178Y
mouse lymphoma cell line, and in vivo tests in mouse micronucleus, rat
There are insufficient data in patients with severe renal impairment (Cl less
cr unscheduled DNA synthesis and rat bone marrow cells.
than 30 mL per min); therefore, caution should be exercised in these patients.
Impairment of Fertility: Febuxostat at oral doses up to 48 mg per kg per day
Hepatic Impairment
(approximately 35 times the human plasma exposure at 80 mg per day) had no
No dose adjustment is necessary in patients with mild or moderate hepatic
effect on fertility and reproductive performance of male and female rats.
impairment (Child-Pugh Class A or B). No studies have been conducted in
patients with severe hepatic impairment (Child-Pugh Class C); therefore, caution Animal Toxicology
should be exercised in these patients. A 12-month toxicity study in beagle dogs showed deposition of xanthine crystals
and calculi in kidneys at 15 mg per kg (approximately 4 times the human plasma
Secondary Hyperuricemia
exposure at 80 mg per day). A similar effect of calculus formation was noted in
No studies have been conducted in patients with secondary hyperuricemia (including
rats in a six-month study due to deposition of xanthine crystals at 48 mg per kg
organ transplant recipients); ULORIC is not recommended for use in patients whom
(approximately 35 times the human plasma exposure at 80 mg per day).
the rate of urate formation is greatly increased (e.g., malignant disease and its
treatment, Lesch-Nyhan syndrome). The concentration of xanthine in urine PATIENT COUNSELING INFORMATION
could, in rare cases, rise sufficiently to allow deposition in the urinary tract. [see FDA-Approved Patient Labeling in the full prescribing information]
General Information
OVERDOSAGE
Patients should be advised of the potential benefits and risks of ULORIC. Patients
ULORIC was studied in healthy subjects in doses up to 300 mg daily for seven should be informed about the potential for gout flares, elevated liver enzymes and
days without evidence of dose-limiting toxicities. No overdose of ULORIC was adverse cardiovascular events after initiation of ULORIC therapy.
reported in clinical studies. Patients should be managed by symptomatic and
Concomitant prophylaxis with an NSAID or colchicine for gout flares should
supportive care should there be an overdose.
be considered.
CLINICAL PHARMACOLOGY
Patients should be instructed to inform their healthcare professional if they
Pharmacodynamics develop a rash, chest pain, shortness of breath or neurologic symptoms
Effect on Uric Acid and Xanthine Concentrations: In healthy subjects, ULORIC suggesting a stroke. Patients should be instructed to inform their healthcare
resulted in a dose dependent decrease in 24-hour mean serum uric acid professional of any other medications they are currently taking with ULORIC,
concentrations, and an increase in 24-hour mean serum xanthine concentrations. including over-the-counter medications.
In addition, there was a decrease in the total daily urinary uric acid excretion.
Distributed by
Also, there was an increase in total daily urinary xanthine excretion. Percent Takeda Pharmaceuticals America, Inc.
reduction in 24-hour mean serum uric acid concentrations was between 40% to Deerfield, IL 60015
55% at the exposure levels of 40 mg and 80 mg daily doses.
U.S. Patent Nos. - 6,225,474; 7,361,676; 5,614,520.
Effect on Cardiac Repolarization: The effect of ULORIC on cardiac repolarization
as assessed by the QTc interval was evaluated in normal healthy subjects and in ULORIC® is a registered trademark of Teijin Pharma Limited and used under
patients with gout. ULORIC in doses up to 300 mg daily, at steady state, did not license by Takeda Pharmaceuticals America, Inc.
demonstrate an effect on the QTc interval. All other trademark names are the property of their respective owners
Special Populations ©2009 Takeda Pharmaceuticals America, Inc.
Renal Impairment: Following multiple 80 mg doses of ULORIC in healthy subjects
February 2009
with mild (Cl 50-80 mL per min), moderate (Cl 30-49 mL per min) or severe
renal impairmcrent (Cl 10-29 mL per min), the Ccr of febuxostat did not change For more detailed information, see the full prescribing information for
relative to subjects wcirth normal renal function (Cmla xgreater than 80 mL per min). ULORIC (febuxostat) tablets (PI1114 R1; February 2009) or contact
AUC and half-life of febuxostat increased in subcjrects with renal impairment in Takeda Pharmaceuticals America, Inc. at 1.877.825.3327.
comparison to subjects with normal renal function, but values were similar PI1114 R1-Brf; February 2009
among three renal impairment groups. Mean febuxostat AUC values were up to
L-TXF-0209-3
1.8 times higher in subjects with renal impairment compared to those with
normal renal function. Mean C and AUC values for 3 active metabolites
max
increased up to 2- and 4-fold, respectively. However, the percent decrease in
serum uric acid concentration for subjects with renal impairment was
comparable to those with normal renal function (58% in normal renal function
group and 55% in the severe renal function group).
Straight Talk
Pharmacy Technicians:
Truth and Consequences
W
ith the flu season quickly posed to check each and every prescrip-
approaching, imagine an tion before it is dispensed.
absolutely unbearable work- A doomsday scenario, you say, that
day in your pharmacy. Anticipating the would never happen in your pharmacy?
worst, you call in extra pharmacists and Maybe, but the truth is, it does hap-
pharmacy technicians to help fill what pen, and it is more than likely that the
are expected to be some of the busiest pharmacist, not the technician, will pay
prescription days of the year. Sure the consequences of any error. Depend-
enough, on a typical day during the flu ing on its severity, the error could result
outbreak, a line starts early at the pre- in a hefty fine and prison time for the
scription drop-off counter and contin- pharmacist. While the above scenario
ues to build throughout the day. Cars may be fictitious, a case reported by
are stacked up at the drive-through pre- U.S. Pharmacist’s legal contributor, Jesse
scription window as though McDonald’s C. Vivian, BS Pharm, JD, in this
were giving out free Big Macs. As physi- month’s Legal Considerations column
cians’ offices open, the pharmacy’s (page 66), is unfortunately all too real.
phones ring incessantly with new pre- In that case of a fatal error, the tech-
scription orders and permissions to refill nician was charged with negligent
older prescriptions. Everyone is working homicide but was given a “get out of
to their fullest capacity, which necessi- jail free” card by the court, wasn’t even
tates extra effort from all pharmacy per- fined, and actually went back to work
sonnel. Pharmacists’ and technicians’ in a retail pharmacy. The pharmacist,
fingers are furiously tapping the com- however, was found guilty of involun-
puter keyboards trying to input data as tary manslaughter and faced up to 5
quickly as possible while making sure important infor- years in prison and a $10,000 fine. His license was
mation is accurately recorded into patients’ medical revoked, and he will probably never work again as a
records. Medication stock bottles are being pulled pharmacist. All this because he did not check the
from every shelf in the pharmacy, with their tablets accuracy of a prescription filled by the technician.
and capsules ready to be poured out into the smaller The column should be a wake-up call for every
prescription containers and bottles lined up on the pharmacist who works closely with one or more phar-
prescription counter, each awaiting a label with macy technicians. While it is true that each case of
instructions to be affixed to it. Once filled, the pre- negligence involving a technician will be judged on
scriptions will be checked by a pharmacist before the merits of the case, the message is clear. The truth
being dispensed to the patient. The pharmacy counter is that if a pharmacist is not diligent about checking a
is a mess and resembles the trading floor of the New technician’s work, the consequences could be dire.
York Stock Exchange after a busy day, with notes on
scrap paper strewn everywhere. Pharmacy technicians
and pharmacists line up to fill the waiting prescription
bottles and vials like a General Motors assembly line.
And then it happens...a pharmacy technician pre-
pares a prescription that contains a fatal dose of the Harold E. Cohen, RPh
medication. Because of the craziness in the pharmacy, Editor-in-Chief
the error gets passed over by a pharmacist who is sup- [email protected]
4
U.S. Pharmacist (cid:129) November 2009 (cid:129) www.uspharmacist.com
What’s News
U.S.Pharmacist
Editorial Board of Advisors
Joseph Bova, RPh
Community Pharmacy Owner, FDA Approves Gardasil for Genital Warts in Men and Boys
Cary’s Pharmacy,
Silver Spring, MD — The FDA approved the vaccine Gardasil for the
Dobbs Ferry, New York;
prevention of genital warts resulting from the human papillomavirus (HPV)
Member, NYS Board of Pharmacy
types 6 and 11 in boys and men age 9 through 26 years. A randomized trial of
Carmen Catizone, RPh
4,055 males age 16 through 26 showed that Gardasil was 90% effective in
Executive Director, National Association
of Boards of Pharmacy preventing genital warts, and studies measuring the immune response of males
age 9 through 15 were equally positive. Each year, about two out of every
John M. Coster, PhD, RPh
1,000 men in the United States are diagnosed with genital warts. Gardasil
Senior VP of Government Affairs
currently is approved for use in girls and women age 9 through 26 for the
National Community Pharmacists Assoc.
prevention of cervical, vulvar, and vaginal cancer caused by HPV types 16 and
Hewitt (Ted) W. Matthews, PhD
18; precancerous lesions caused by types 6, 11, 16, and 18; and genital warts
Dean, Southern School of Pharmacy,
Mercer University, Atlanta caused by types 6 and 11. Most genital warts are caused by HPV infection,
which is the most common sexually transmitted infection in the U.S.
David G. Miller, RPh
Pharmacy Affairs, Merck & Co., Inc.,
West Point, Pennsylvania IMS Predicts 4% to 6% Global Pharma Market Growth Next Year
Norwalk, CT — IMS Health reported that the value of the global
Mario F. Sylvestri, PharmD, PhD
Senior Director, Medical Science Liai- pharmaceutical market in 2010 is expected to grow 4% to 6% on a
sons, Amylin Pharmaceuticals constant-dollar basis, exceeding $825 billion. The forecast predicts global
pharmaceutical market sales to grow at a 4% to 7% compound annual rate
Ray A. Wolf, PharmD
Medical Education, Sanofi Aventis through 2013, and considers the impact of the global macroeconomy, the
changing mix of innovative and mature products, and the rising influence of
Mary Ann E. Zagaria,
PharmD, MS, CGP health care access and funding on market demand. The value of the global
Senior Care Consultant and pharmaceutical market is expected to expand to $975+ billion by 2013.
President, MZ Associates, Inc., “Overall, market growth is expected to remain at historically low levels, but
Norwich, New York
stronger-than-expected demand in the U.S. is lifting both our short- and
long-term forecasts,” said Murray Aitken, senior vice president, Healthcare
Contributing Editors Insight, IMS Health.
Loyd V. Allen, Jr., PhD FDA Warns About Illegal H1N1 Vaccines on the Web
Connie Barnes, PharmD Silver Spring, MD — The FDA warned consumers about purchasing any
Bruce Berger, PhD products over the Internet that claim to diagnose, prevent, treat, or cure the
R. Keith Campbell, RPh, CDE H1N1 influenza virus. The warning comes after the FDA recently purchased
Patrick N. Catania, PhD, RPh and analyzed several products represented online as Tamiflu (oseltamivir) that
R. Rebecca Couris, PhD, RPh may pose risks to patients. One of the orders, which arrived in an unmarked
Ed DeSimone, PhD, RPh envelope with a postmark from India, consisted of unlabeled white tablets
Ronald W. Maddox, PharmD taped between two pieces of paper. When analyzed by the FDA, the tablets
Somnath Pal, BS (Pharm), MBA, PhD were found to contain talc and acetaminophen, but none of the active
W. Steven Pray, PhD, DPh ingredient oseltamivir. The Web site disappeared shortly after the FDA placed
M. Saljoughian, PharmD, PhD the order.
Jesse C. Vivian, BS Pharm, JD
Smoking Bans Reduce Heart Attack Risk
Washington, DC — A report from the Institute of Medicine says that
Send your comments via
smoking bans are effective at reducing the risk of heart attacks and heart
[email protected] disease associated with secondhand smoke. The report also provides evidence
that breathing secondhand smoke boosts the risk for heart problems in
Mail: 1 60 Chubb Avenue, Suite 306 nonsmokers, adding that there is evidence that relatively brief exposures could
Lyndhurst, NJ 07071
lead to a heart attack. About 43% of nonsmoking children and 37% of
Telephone: [phone]
nonsmoking adults are exposed to secondhand smoke in the U.S., according
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to public health data.
Internet: www.uspharmacist.com
5
U.S. Pharmacist (cid:129) November 2009 (cid:129) www.uspharmacist.com
1
No. 1 PATDIENiBTs TioEpACrHodINlGea AIrDr
4
NOVEMBER 2009 The Journal HfoEArLT HP ShYSaTErMmS EDaITcIOiNsts’ Education Vol. 3 TEAR ALONG PERFORATION
U.S. PharmaciFst isE a PAeer-TReviUewedR JouErnaSl CmitTolThpypaewihe hrynwbmftt orneiolehcthaoWitoirLb coabgDuhetneeTwoguahrhurai iitdofmtraabshnt o l s ae has1emptrlJer tdduaylho enofyh % o .b aaloiciw uoace mafcsatsoyme fDm ot io sbud l cdonvu ititomisosumfhvw aalrcrp e nMioeeehrlerat eaoi adsdlihiaMo stnt elpynet.h fhitaeohd t dm tmiga if ryiDpbobinp gci ouaetiebeands hooinphnyo ntlgbatafpece imhoo. thtIprecrgeum ls,neeikt tnnra eipolrwasdfes ab etro.oetc ssaausd otreidsest digrmpieeimoiddaiosooanc iot n anstuanaissld aoot.tdnaH trnti, e rac hio hTr y,pdmtdobSt nf, aeihee newh dvi isintesrLle esiesiihiil biddswtrgLxniztitroeyanhesisCthec ,mr arpe f gemado,ernhlgtey s.intmeihi2 an t to erTfoh d0etaconosn eal f ht0eichisres dp arist. 9 aeelt s esabgsish xg. taDw lkntciaoehoi ipleno ensieruadaloe npssonydseruvael,sgu atib de insad’ nfsgctreni lan il gh raw mioidpm r o tsn inaimiihtaumocitscit,stiolhetontr iiawiisyBub xrncedh tsng ntd aobpariui h ogbanimepreseiftlpn aee arpeory rgoc oed,oodh m i noslio olfoe moaam ealep cntfnfaerdrbrvshevt adn isbsc reo miiadnstwtee iniptaoikaitndxt iaedoeorl e i nshstaai,i lnoooe losr sbndiardnk,ndroteafig recr sd lmsrcr hnata ll baadeedthundat idnh ersineonr(edreiot,ps draams edis. fpe,osot csm t mc o sPr r l rbfaoht bamiotuwdaihaoafrngehenbrtnatnetemtghieie aiilrdi iladettnledeact alnhiiiir)mn i , ivmctvcs nsndisyaat,stci iasocs esca uoodehag l e nrrlassrtmdwicauneaud i dt roomcteolradaiiedieah ansmnultrl tn celygialh,c eosc orscnl uipelttda oewigsfanyb hnsimbrtdnm,ralw ggeo i etatsoe dfpnn (s rb mvdmiuffptmdpai ofn eseeh pees,nawtecl aroga cocoaei,tpo snanshn tsd ioutorn ra inmtiu.,i gdfifenghac ndzr nd sA hsi og po osioddosgt eipfts omlpewtsr tmloo te redof uhhtthnrpoeair soph.edecdrnhtoaiw )mr lttrieaToeu bitgeeiruonnydgm-rm -s sgehua il.ihiss. hmi nsai otgie v s ioo tgohs aeoo f nd sn y ,
COVER IMAGE: PPTTAA00991111 BBiippoollaarr 1100__1144ssccbboo..iinndddd 11
MI PATIENT TEACHING10/15/09 12:2A4 PM ID
C
A, Bipolar Disorder. See page 17
M
ott, Senior Care Pharmacologic Management
m
Der Progressive Supranuclear Palsy ...20 of Alcohol Dependence .............60
Mc Difficulty looking up without extending the Several medications are available that may help
9 Teri J. nsyemckp toorm tr oouf bthleis u csoinndg itthioen s.tairs may be an initial pKartiniean Hts .a Pcahtieelv, eP haabrsmtinDence and avoid relapse.
0 Mary Ann E. Zagaria, PharmD, MS, CGP
0
2
© Pharmacy Law
n: So Many Options, So Little Criminalization of
o
ati Difference in Efficacy: What Is the Medication Errors ............66
Illustr TeriMcDermott.com Appropriate Antidepressant? ......26 A recent case equating a pharmacist’s mistake
These agents are equal in effectiveness, but it with manslaughter raises the question of pharmacy
As part of the reward pathway in alcohol
use, endorphins are released. Naltrexone is hard to predict which one will work best for technician responsibility.
blocks the binding of endorphins to opioid a given patient. Jesse C. Vivian, BS Pharm, JD
receptors, preventing dopamine release. Marjorie Rochette DeLucia, PharmD, MS, ●2 CE Credits
and Michael J. Schuh, PharmD, MBA
CE CREDITS Emergency Contraception:
Emergency Contraception:
Medications Used in Opioid An Update of Clinical and
An Update of Clinical and
Regulatory Changes. See page 70 Maintenance Treatment ............40 Regulatory Changes ................70
It is important to keep abreast of current Current information about levonorgestrel-based
THIS MONTH
Editorial Focus: Psychotropics therapeutic options as increasingly more emergency birth control and strategies for educating
patients are treated for dependence. consumers are discussed.
NEXT MONTH
Editorial Focus: Christie Choo, PharmD, BCPS Kathleen H. Besinque, PharmD, MSEd
Gastroenterologic Diseases
Earn additional CE credits online. Visit: HEALTH SYSTEMS EDITION
www.uspharmacist.com
Schizophrenia: A Review of Pharmacologic and
CE PROGRAMS ON THE Nonpharmacologic Treatments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . HS-2
U.S. PHARMACIST WEB SITE
Pharmacists should play an active role in the management of this complicated form of mental illness.
New:
Emergency Contraception: An Update Stacy Eon, PharmD, and Jennifer Durham, PharmD
of Clinical and Regulatory Changes
Prophylactic Therapies in Traumatic Brain Injury Management . . . . . HS-10
Recent:
Ovarian Cancer: One of the Clear guidelines for the proper administration of drugs used to treat this condition are lacking.
Common Gynecologic Malignancies Jennifer Confer, PharmD, and Jon Wietholter, PharmD
Perimenopause: Management
of Common Symptoms During Newly Approved mTOR Inhibitors for the Treatment of
the Menopausal Transition Metastatic Renal Cell Carcinoma . . . . . . . . . . . . . . . . . . . . . . . . . . HS-20
An Update on the Current Temsirolimus and everolimus are now indicated as therapy for this type of cancer.
Treatment of HIV
Diana Hey Cauley, PharmD, BCOP
If you have any questions about our
CE programs, call [phone], In-Service Primers
fax [phone], or e-mail
Nutrition and Clinical Depression . . . . . . . . . . . . . . . . . . . . . . . . . . HS-28
[email protected].
Manouchehr Saljoughian, PharmD, PhD
U.S. PHARMACIST® (ISSN 01484818; USPS No. 333-490) is published monthly by Jobson Medical Information LLC, 100 Avenue of the Americas, New York, NY 10013-1678. Periodicals postage
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6
U.S. Pharmacist (cid:129) November 2009 (cid:129) www.uspharmacist.com
Q.
Which Global Generic Company’s Transdermal
Patches Were Most Dispensed in the U.S.
Last Year?
A.
Mylan Pharmaceuticals.
*
With one of the most advanced transdermal development and manufacturing facilities in the
United States—brand or generic—Mylan is well-recognized as an innovator in transdermal
drug delivery technology. In fact, last year 65% of all generic patches dispensed in the U.S.
carried the Mylan name.*
We have developed more generic transdermal patches than any company in the U.S. and all
of our patches are designed with patient safety in mind. None have a bulky, liquid, gel-filled
reservoir, which eliminates any concern about the dangers associated with leakage, and
none have aluminum or other metals in their backing, which may cause potential burns in
MRI patients. So when you need generic transdermal patches…think Mylan.
*IMS National Prescription Audit. 12 months ending December 2008.
©2009 Mylan Pharmaceuticals Inc. MYNMKT308
U.S.Pharmacist
1
1
A Jobson Publication No.
Senior Vice President–Editor-in-Chief 34
HERxoaebrcoeulrtditv EDe .E aCdviiotdohsreonn, RPh NOVEMBER 2009 The Journal for Pharmacists’ Education Vol.
Senior Editor
Bonnie Ostrowski
U.S. Pharmacist is a Peer-Reviewed Journal
Senior Associate Editor
Marjorie Borden
Projects Editor
Nancy Robertson, MS
Consulting Clinical Editor
Mary Gurnee, PharmD, RPh
Senior Vice President–Publisher
Harold E. Cohen, RPh [phone] D E PA R T M E N T S
Associate Publisher
Jack McAleer [phone]
East Coast Regional Sales Manager
Mark Hildebrand [phone]
Straight Talk Consult Your Pharmacist
Midwest/West Regional Sales Manager
Pharmacy Technicians: Fatigue and Drowsiness:
Megan Conley [phone]
Truth and Consequences . . . . . . 4 Everyday Exhaustion
Marketing Manager
Deborah Mortara [phone] Harold E. Cohen, RPh and Beyond . . . . . . . . . . . . . . 12
Classified Advertising Sales Prolonged tiredness and sleepiness are a
What’s News. . . . . . . . . . . . . . 5
Heather Brennan [phone] x106 concern for many people.
W. Steven Pray, PhD, DPh
TrendWatch
Design Director
Sharyl Sand Carow Acute Negative Feelings FDA Fast Facts . . . . . . . . . . . 24
Among Adults . . . . . . . . . . . . 10
Production Manager
Dina Romano [phone] Nonpositive beliefs and emotions generally Generic Trends . . . . . . . . . . . 54
Corporate Production Director occur to a similar degree across age groups.
Contemporary
John Anthony Caggiano
Somnath Pal, BS (Pharm), MS, MBA, PhD Compounding
Director, Continuing Education Processing Ketamine Hydrochloride
Regina Combs [phone] Prevalence of Selected Acute Negative Feelings
10-mg Troches . . . . . . . . . . . 58
VEimcee lPdrae sBidaerenat, Circulation Director Worthlessness2.9 3.1 3.0 2.6 18-44 years In lozenge form, this analgesic and
45-64 years
anesthetic agent can be prepared to suit
Vice President, Helplessness 3.7 4.2 3.5 2.7 65-74 years
Creative Services and Production 75+ years the patient’s individual flavor preference.
Monica Tettamanzi
Restlessness 5.2 4.9 3.9 3.1 Loyd V. Allen, Jr, PhD
Classified Advertising . . . . . . 80
Sadness 6.7 7.3 7.9 7.5
Career and business opportunities, products,
“Everaynth einffgo rits” 7.9 7.4 7.9 7.4 and services for the pharmacist.
Chief Executive Officer
Product News . . . . . . . . . . . . 82
Jeff MacDonald Nervousness 10.1 9.6 8.4 8.4
Chief Financial Officer 0 5 10 15 20 25 30 35 40
Derek Winston Percentage of adults surveyed
© JUPITERIMAGES
CEO, Information Services Division
Marc Ferrara
Senior Vice President, Operations
Jeff Levitz
Vice President, Human Resources
Lorraine Orlando
U.S. Pharmacist
160 Chubb Avenue, Suite 306
Lyndhurst, NJ 07071
Tel: [phone] New Products in This Issue
Fax: [phone] Afinitor / Novartis Pharmaceuticals Corporation (cid:129) Authorized Generics / Greenstone LLC (cid:129)
E-mail: [email protected] Embeda / King Pharmaceuticals (cid:129) Kapidex / Takeda Pharmaceuticals (cid:129) Onglyza / AstraZeneca (cid:129)
Web: www.uspharmacist.com Uloric / Takeda Pharmaceuticals (cid:129) Welchol / Daiichi-Sankyo
Printed on paper containing an Health Systems Edition: Distinctive Labeling / Baxter Healthcare (cid:129) Injectables / Pfizer Injectables (cid:129)
average of 96 percent post-consumer
Product Labeling / Teva Pharmaceuticals
recycled waste.
8
U.S. Pharmacist (cid:129) November 2009 (cid:129) www.uspharmacist.com