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 1 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 2 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 3 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 4 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. * 5