Inside This Issue New Oral Over-the-Counter HIV Test: OraQuick

GregoryRx Press
Lloyd L. Gregory School of Pharmacy
September 2012
Volume 7 Issue 2
New Oral Over-the-Counter HIV Test: OraQuick®
Inside This Issue
®
On July 3, 2012, the FDA approved OraQuick , an OTC
HIV testing kit that is scheduled to arrive in stores in
October of this year, and will cost approximately $40 per
kit. This is the first in-home testing product available for
patients, which allows for immediate viewing of results,
instead of having to mail out the sample and wait to
receive the results. This test uses a small amount of
saliva and is recommended by the manufacturer for those
over the age of 17 that has engaged in sexual contact
that could have exposed them to bodily fluids containing
HIV. Included in the package information are
explanations of who should and should not use the test. If
the patient is within the three-month window of the potential exposure, the manufacturer warns
that the test may not yield accurate results. According to the package insert, the reliability and
accuracy of this home test are similar to professionally administered tests. The manufacturer
®
reports that the OraQuick kit is 99.6% sensitive if used correctly. It is important that patients read
the package insert and directions before using the test, as the correct collection of the sample is a
critical part of the test’s successful function. In order to ensure a pure sample without contamination patients should be
counseled not to eat, drink, or smoke for 30 minutes before using the test, and should be counseled to use the kit in a
clean, dry, smoke-free environment. Proper reading of the test results should be no sooner than 20 minutes and no later
than 40 minutes after placing the sample in the test area. One line (“C”, the control) should always appear indicating that
the test is functioning properly, which is also the indicator for a negative result. Two lines, (“C” and “T”), where “T” is the
active test line, indicates a positive result. Pharmacists should explain that negative results do not definitively rule out HIV
infection. A false negative result can be caused by several factors including: continual risky behavior surrounding the time
of taking the test, testing during the three-month time period after exposure, and use of improper technique when
collecting saliva. The package insert states that the risk of a false negative with this test is approximately 1 in 12, while
the risk of a false positive is 1 in 5000. The manufacturer has a toll-free line for consumers, which is available 24/7 in
English and Spanish. For those that receive a positive result, pharmacists should strongly encourage them to seek
®
medical attention for a confirmatory test at their clinic or doctor’s office. With OraQuick being accessible as an OTC,
pharmacists have an opportunity to provide education and assistance to patients at a potentially pivotal point in their
health.
 Oraquick®: New Oral OTC
HIV Test
 October: Health Literacy
Month
 2012 Updated STD
Guidelines From CDC
 Review of Complementary
Alternative Medicines for
Men’s Health
 FDA Approval: StribildTM
(Emtricitabine/Tenofovir/
Elvitegravir/Cobicistat) for
Treatment-Naïve HIV
October is Health Literacy Month… What Does This Mean To A Pharmacist?
Health literacy has been defined by the National Library of Medicine as the “Ability to obtain, process, and understand
basic health information and services needed to make appropriate health decisions.” In 2003, the U.S. Department of
Education held a survey assessing the health literacy of more than 19,000 American adults. Over half of the adults
surveyed (53%) were found to have intermediate health literacy. An additional 22% of adults had basic health literacy, and
14% had below basic health literacy. The survey also showed that adults who were aged 65 and older had lower average
health literacy than adults in younger age groups. Patients with lower levels of health literacy have an increased rate of
medication and treatment errors, are less adherent to therapy, and have worse health outcomes compared with those with
higher health literacy. For this reason it is important that healthcare providers ensure that patients are receiving, and more
importantly understanding, information about their healthcare. Specific interventions pharmacists can make when serving
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patients with limited health literacy are detailed in Table 1. Something to keep in
mind is that easy to understand and less complex written materials are beneficial
to all patients, not just those with limited literacy. It is not always evident in talking
with a patient that they have limited health literacy or that there is a language
barrier present. With this said, pharmacists should strive to provide all patients the
same valuable healthcare information in a relatively universal format. For more
information, patients can visit bemedwise.org to learn more about understanding
*Information from US Department of Education
prescription and OTC labeling, as well as how to choose and use OTC
medications safely. This website also offers a quiz for patients, educational materials and tools that pharmacists can
purchase. Other websites that contain similar information pertaining to safe medication use for pharmacists and patients
are talkaboutrx.org and learnaboutrxsafety.org.
Below basic level- Able to circle date of
upcoming medical appointment
Basic level- Able to read clearly written
pamphlet and explain value of screening test
Intermediate level- Able to read OTC
medication label, identify drug interactions
Proficient level- Able to define medical term
after reading complex document
Table 1: Health Literacy Barriers and Actions Pharmacists Can Make to Improve Literacy Gap
Areas Of Concern
Labels
(Primary, Auxiliary)
Patient Information
and Medications
Potential Barriers
What Pharmacists Can Do
 Multiple studies have confirmed
 Labels and instructions should be written in 6th grade or lower
patient’s difficulty interpreting both
reading level in a patient’s native language
types of labels
 Auxiliary labels should be limited to 1 to 2 labels to reduce
 One study showed the average
mixed messages perceived by patients
comprehension of the primary and  Patient instructions regarding medication dosing on the primary
auxiliary labels were 54% and 47%,
label should be as specific as possible and include key details
respectively (ACP Foundation
as for better understanding
2007)
o For example, avoid using terms such as “twice” and instead
use “1 tablet in the morning and 1 tablet at night, 12 hours
apart”
o Always specify the route of administration and time frame
o Always spell out measurements instead of using
abbreviations
 Current labels on prescription vials  Use visual examples and demonstrations of instructions
draw attention to text that will assist
o One option is to create a medication list for the patient
the pharmacist instead of the
using an AHRQ pill card specially designed for low literacy
patient, and often detract from the
patients (www.ahrq.gov/qual/pillcard/pillcard.htm)
patient’s grasp of the information
 Ask patients to explain and/or demonstrate the information you
 Patients often take multiple
just presented to them using the teach back method
medications, therefore they must
o For example, when teaching the patient how to properly
recall and be able to decipher the
use an inhaler, have them demonstrate to you how they
information later on at home
use the inhaler
 Patients with limited health literacy  Limit the information provided to the patient to the most
may need more information
relevant information and repeat all information at least once to
clarified. However, they tend to ask
enhance recall
fewer questions and may hide their  Ask open-ended questions to assess their full understanding
limited understanding for fear of
 Read key information with them and circle or highlight key
embarrassment
points to remember
 Patients with limited health literacy  Educate technicians and other pharmacy staff on how to
not only have trouble interpreting
better communicate health information to patients
words but also have trouble
 If possible, translate patient handouts and other information
remembering and understanding
into their native language
numerical values, such as goals of
o MedlinePlus is a free internet website which provides
treatment
translation in Spanish to numerous drug and disease
monographs http://www.nlm.nih.gov/medlineplus/
o Healthinfotranslations.org is another useful tool for
translating health topics into a multitude of languages
o The Lexi-comp drug resource offers 19 languages for
translation
 Explain to patients how to keep a log of their medications, as
well as readings (BP, glucose) to determine if goals are met
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CDC Updates Sexually Transmitted Diseases Treatment Guidelines
On August 10, 2012, the Centers for Disease Control and Prevention (CDC) updated the 2010 STD treatment guidelines.
According to the updated guidelines, the oral antibiotic, cefixime, is no longer recommended as a first line treatment
option for gonorrhea. Treatment of gonorrhea has been complicated by the ability of N. gonorrhoeae to develop resistance
to cefixime. Based on this increased resistance, the new recommended treatment is ceftriaxone 250 mg IM plus either
azithromycin PO or doxycycline for N. gonorrhoeae and Chlamydia trachomatis. A cost comparison showed that,
azithromycin orally in a single dose costs more than doxycycline twice daily for 7 days. However, for patients who have
poor medication adherence or unpredictable follow-up, azithromycin would be a more cost-effective alternative. Table 2
details the specific dosing recommendations for uncomplicated gonococcal infections of the cervix, urethra, and rectum as
well as the pharynx. The most effective and updated treatment for patients with gonorrhea is essential to reduce the
transmission of gonorrhea, prevent complications, and slow the emergence of resistance.
Table 2: Updated Guideline Recommendations for Gonococcal Infections
Site of Infection
Recommended Treatment Regimens

Uncomplicated
Gonococcal
Infections of the
Cervix, Urethra, and
Rectum
Uncomplicated
Gonococcal
Infections of the
Pharynx
Persistent infection
after treatment with
recommended
regimen


Alternative regimens
If ceftriaxone is not available: Cefixime 400 mg in a single oral dose PLUS Azithromycin 1 g orally in a
single dose or doxycycline 100 mg orally twice daily for 7 days PLUS Test-of-cure in 1 week
If the patient has severe cephalosporin allergy: Azithromycin 2 g in a single oral dose PLUS Test-ofcure in 1 week

Recommended regimen
Ceftriaxone 250 mg in a single intramuscular dose PLUS Azithromycin 1 g orally in a single dose or
doxycycline 100 mg orally twice daily for 7 day

Recommendation
Culture clinical specimens; perform antimicrobial susceptibility testing of N. gonorrhoeae isolates, and
tailor therapy accordingly.

For all patients with
gonorrhea
Recommended regimen
Ceftriaxone 250 mg in a single intramuscular dose PLUS Azithromycin 1 g orally in a single dose or
doxycycline 100 mg orally twice daily for 7 days

Recommendation
The patients' sexual partners from the preceding 60 days should be evaluated and treated for N.
gonorrhoeae with a recommended regimen.
If a heterosexual partner of a patient cannot be reached for evaluation and treatment, therapy
consisting of cefixime 400 mg and azithromycin 1 g should be delivered to the partner by the patient, a
disease investigation specialist, or a collaborating pharmacy.
MMWR 2012;61(31):590-594
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Complementary Alternative Medicines Review for Men’s Health
Complementary alternative medicines (CAMs) have grown in popularity and it is important as pharmacists to be familiar
with medications and supplements that patients may ask questions about. Table 3 provides information on several
supplements commonly inquired about by men. When counseling on CAMs, patients should be reminded that the FDA
does not regulate the quality or safety of these therapies. CAMs are rated based on data about their safety and their
efficacy. The term “Likely safe” describes that a CAM has a high level of reliable clinical data showing “safety,” which
describes a product safe to suggest to patients. The terms “Effective” and “Likely effective” products have clinical data to
support its use for a specific symptom or disease state. These designations are provided by the Natural Medicines
Comprehensive Database and are used in all their analyses of the safety and efficacy of alternative medicines and
supplements. In addition, patients should be counseled that alternative therapies should always be discussed with their
doctor and pharmacist to prevent interactions with their current prescription medications.
Table 3: Commonly Used Complementary Alternative Medicines in Men’s Health*
Name
Safety
Efficacy
Oral
Dosing
50-240
mg/day
Potential Uses
Co-enzyme
Q10
“Ubiquinone”
Likely
Safe
Likely
Effective
CHF; statin-induced
cardiomyopathy
Ginseng
“Panax
ginseng”
Possibly
Safe,
short term
Possibly
Unsafe,
long term
Possibly
Effective
200 mg
BID to 900
mg TID
Improve stamina,
memory, cognitive
function, erectile
dysfunction,
diabetes, stress
relief
Guarana
“Paullinia
cupana”
Possibly
Safe,
short term
Possibly
Unsafe,
long term
Insufficient
Evidence
200-800
mg/day
Improving athletic
performance, weight
loss, mental and
physical fatigue,
ingredient of energy
drinks
Lycopene
“All-trans
lycopene”
Likely
Safe
Likely
Effective
15 mg BID
Saw Palmetto
“Serenoa
repens”
Likely
Safe
Possibly
Ineffective
320
mg/day,
may split
dose
Atherosclerosis,
CVD, prevent
cancer of the
prostate, breast,
pancreas, lung,
ovaries, and colon,
may lower PSA
Alopecia, BPH
symptoms:
(frequency, flow,
hesitancy, urgency,
nocturia), prostatitis
Common Side
Effects
N/V/D, loss of
appetite, heartburn
Cautions and
Warnings
↓Effects of warfarin
DI: warfarin,
antihypertensives
Insomnia,
mastalgia,
tachycardia,
vaginal bleeding,
diarrhea,
hypotension,
vertigo, edema,
headache
Hypertension,
diuresis, headache,
N/V, stimulation,
anxiety, agitation,
tachycardia,
insomnia,
nervousness, GI
irritation
↓Effects of warfarin
↓blood sugar
DI: alcohol,
antiplatelets, CYP2D6
substrates, insulin,
MAOIs, warfarin
None reported to
date
N/V/D, dizziness,
headache
↑Risk of bleeding;
alcohol prolongs
effects, caution
combining energy
drinks with alcohol
DI: stimulants,
anticoagulants,
antipsychotics,
antihypertensives
None reported to date
↑Risk of bleeding
Does not appear to
effect PSA
DI: anticoagulants,
antiplatelets
*Information acquired from National Comprehensive Medicines Database. Abbreviations: CYP: Cytochrome P450; D: Diarrhea; DI: Drug
Interactions; GI: Gastrointestinal; MAOIs: Monoamine Oxidase Inhibitors; N: Nausea; PSA: Prostate-Specific Antigen; V: Vomiting
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New FDA Drug Approval: StribildTM (Emtricitabine/Tenofovir/Elvitegravir/Cobicistat) for the Treatment of HIV
TM
On August 27, 2012, Stribild also known as the “Quad
Pill,” a combination of two already existing antivirals –
emtricitabine and tenofovir, one new - elvitegravir and an
antiviral pharmacologic booster - cobicistat, was approved
by the FDA for the treatment in antiretroviral-naïve adults
only with HIV-1 infection. It is the only combination of
reverse transcriptase inhibitors and an integrase inhibitor. It
is available as a tablet formulation
with the recommended dose of
one
tablet/day
with
food
(150mg/day
cobicistat,
150
mg/day elvitegravir, 200 mg/day
emtricitabine and 300 mg/day
tenofovir).
This
dosage
represents
the
usual
and
maximum dose for all four
ingredients, making Stribild a
monotherapy option.
Tablets
should be dispensed in original
container and stored at room
temperature. It is classified as a
pregnancy category B. It is
contraindicated in patients taking
drugs that are dependent on
CYP3A4 for clearance (eg.
rifampin, ketoconazole, triazolam,
etc…) and patients with creatinine clearance (CrCl) less
than 70 mL/min. Health care providers should monitor
patients’ white blood cells, liver enzymes, serum chemistry
levels, and renal function while taking Stribild. Black box
warnings include lactic acidosis with severe hepatomegaly
and severe exacerbation of HBV, in HIV and HBV
confected individuals, following discontinuation of therapy.
Pharmacists should counsel patients that in the case of a
missed dose, patients should take that missed dose as
soon as they remember but if close to the next dose then
only take the next dose. Taking two tabs at once to make
up for missed dose is not recommended. The efficacy and
safety of Stribild was studied in a pivotal non-inferiority
phase 3 trial comparing Stribild to atazanavir/ritonavir +
tenofovir/emtricitabine
(ATV/RTV+FTC/TDF)
in
708
treatment-naïve HIV-1 patients, which subsequently led to
its FDA approval. This randomized, double-blind, parallel,
and non-inferiority clinical trial included patients only if they
had a HIV RNA concentration of 5000 copies per mL or
higher, a GFR > 70 mL/min, liver enzymes < 5 times the
upper limit of normal, total bilirubin of 0.46 mg/dL or less,
and no AIDS defining infections, such as candidiasis of
upper-respiratory tract and lungs, extra-pulmonary or
disseminated coccidioidomycosis, cytomegalovirus retinitis,
pneumocystis jirovecii pneumonia
and toxoplasmosis of brain, within
the past 30 days. The primary
outcome was the difference
between treatments in the
proportion of patients achieving
viral suppression, defined as HIV
RNA concentration of 50 copies
per mL or less after 48 weeks.
The non-inferiority margin was
set at 12%. Results showed
Stribild to be non-inferior to
ATV/RTV+FTC/TDF:
89.5%
(316/353) patients in the Stribild
arm and
86.8% (308/355)
patients
in
the
ATV/RTV+FTC/TDF group had
HIV-RNA viral suppression of
less than 50 copies/mL (p =
0.048, 95% CI 3% (-1.9 to 7.8). Additionally, 94% of
patients in Stribild group were adherent to their medication
regimen compared with 78% of the ATV/RTV + FTC/TDF
arm. Common adverse events noted in the study were
diarrhea: 22% (77/353) in the Stribild group vs 27%
(97/355) in the ATV/RTV+FTC/TDF group (p=0.097).
Current guidelines recommend atazanavir/ritonavir +
emtricitabine/tenofovir (the control arm) as one of four
possible first line regiments for treatment-naïve HIV-1
infected non-pregnant adults. Stribild is a potential
alternative in the treatment of antiretroviral-naïve adults with
HIV-1 infection and has potential to increase adherence
compared with an established first-line therapy. Further
studies comparing the efficacy and adverse events of
Stribild to other antiretrovirals need to be reviewed,
however, before authenticating this new drug as first-line
treatment in antiretroviral-naïve patients.
Lancet 2012;379:2429-38
“The one who guards a fig tree will eat its fruit, and whoever protects their master will be honored. As water reflects the
face, so one’s life reflects the heart.” Proverbs 27:18-19 (New International Version)
The Drug Information Center is operated as a training site for experiential purposes. Students, under supervision of a
pharmacy faculty member, are available to answer questions from preceptors and facilities who are PBA partners. The
Center is open Monday to Friday, 8:30 am to 4:30 pm. Phone: 561-803-2728 or 800-468-6722 ext. 32728, Fax: 561-8032703. You can also e-mail your questions to: [email protected]
This issue was written by Andrea Barham, Jee Lee, Nat Mulugeta, and Kristina Retcho, PharmD Candidates 2013. Edited
by Faculty Preceptors: Dr. Krisy Thornby and Dr. Ashley Johnson
*Partners of GSOP: Our mission statement and strategic plan are posted on the PBA website. We
invite your review and feedback. *
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