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The following is a brief summary for TRUVADA ® (emtricitabine/tenofovirdisoproxil fumarate [DF]) tablets. Before prescribing, see full PrescribingInformation, including boxed WARNINGS.WARNINGS: LACTIC ACIDOSIS, SEVERE HEPATOMEGALY WITHSTEATOSIS and POST TREATMENT ACUTE EXACERBATION OFHEPATITIS B.Lactic acidosis and severe hepatomegaly with steatosis, includingfatal cases, have been reported with the use of nucleoside analogs,including VIREAD, a component of TRUVADA, in combination withother antiretrovirals [See Warnings and Precautions].TRUVADA is not approved for the treatment of chronic hepatitis B virus(HBV) infection and the safety and efficacy of TRUVADA have not beenestablished in patients coinfected with HBV and HIV-1. Severe acuteexacerbations of hepatitis B have been reported in patients who arecoinfected with HBV and HIV-1 and have discontinued TRUVADA.Hepatic function should be monitored closely with both clinical andlaboratory follow-up for at least several months in patients who arecoinfected with HIV-1 and HBV and discontinue TRUVADA. Ifappropriate, initiation of anti-hepatitis B therapy may be warranted[See Warnings and Precautions].INDICATIONS AND USAGETRUVADA, a combination of EMTRIVA ® (emtricitabine) and VIREAD ® (tenofovirdisoproxil fumarate), is indicated in combination with other antiretroviral agents (suchas non-nucleoside reverse transcriptase inhibitors or protease inhibitors) for the treatmentof HIV-1 infection in adults.The following points should be considered when initiating therapy with TRUVADA forthe treatment of HIV-1 infection:• It is not recommended that TRUVADA be used as a component of a triplenucleoside regimen.• TRUVADA should not be coadministered with ATRIPLA ® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), EMTRIVA, VIREAD, orlamivudine-containing products [See Warnings and Precautions].• In treatment experienced patients, the use of TRUVADA should be guided by laboratorytesting and treatment history.DOSAGE AND ADMINISTRATIONThe dose of TRUVADA is one tablet (containing 200 mg of emtricitabine and 300 mg oftenofovir disoproxil fumarate) once daily taken orally with or without food.Dose Adjustment for Renal Impairment: Significantly increased drug exposuresoccurred when EMTRIVA or VIREAD were administered to patients with moderate to severerenal impairment [See EMTRIVA or VIREAD Package Insert]. Therefore, the dosing intervalof TRUVADA should be adjusted in patients with baseline creatinine clearance 30–49mL/min using the recommendations in Table 1. These dosing interval recommendationsare based on modeling of single-dose pharmacokinetic data in non-HIV-1 infectedsubjects. The safety and effectiveness of these dosing interval adjustmentrecommendations have not been clinically evaluated in patients with moderate renalimpairment, therefore, clinical response to treatment and renal function should be closelymonitored in these patients [See Warnings and Precautions].No dose adjustment is necessary for patients with mild renal impairment (creatinineclearance 50–80 mL/min). Routine monitoring of calculated creatinine clearance and serumphosphorus should be performed in patients [See Warnings and Precautions].Table 1.Dosage Adjustment for Patients with Altered Creatinine ClearanceRecommendedDosing IntervalCreatinine Clearance (mL/min)*≥50 30–49
JuvenilevoiceEmergency Contraception in MarylandIn this column, Judith Robbins, LCSW, JD, CCHP-A, talkswith a team of health professionals from the MarylandDepartment of Juvenile Services about an emergencycontraception program in DJS facilities.JR: What is emergency contraception?DJS: EC is a safe, effective method to prevent unintendedpregnancy after sexual intercourse. The most common typeof EC is oral hormonal medication, often called the “morningafter pill.” The most widely used product of this type isPlan B, which consists of 1.5 mg of levonorgestrel (availableeither as two 0.75 mg tablets taken together or a single pill)taken up to 120 hours (five days) after intercourse. Plan Bworks to prevent pregnancy by thickening cervical mucus,preventing ovulation and affecting sperm or ova movementthrough the uterus. Plan B does not harm an existing pregnancynor cause an abortion.Women may choose Plan B in many situations, such assex without a condom, condom breakage, rape, unprotectedsex with inconsistent use of hormonal birth control(or during the first month of hormonal birth control) andunprotected sex while impaired by drugs or alcohol.Plan B is approved by the FDA for over-the-counter salesto those age 17 and older. For those younger than 17, it isavailable by prescription.JR: Why did you start an EC program at your secure juvenilejustice facilities?DJS: In the United States, nearly 1 million teenagersbecome pregnant each year and approximately four out offive of those pregnancies are unwanted. Girls in the juvenilejustice system are at an even greater risk due to inconsistentcondom use, early sexual activity, prostitution, substanceabuse, gang involvement, mental illness and histories ofsexual or physical abuse.Secure juvenile justice facilities have a prime opportunityto link youth to reproductive health services, including EC.The Maryland DJS recognized an opportunity to preventunintended pregnancies and also wanted DJS girls to haveaccess to the same services available in the community. TheEC screening process also starts an important conversationabout family planning options and sexual health in general.JR: How does your EC program work?DJS: The program is nurse directed and integrated intothe nursing intake assessment. Upon admission, all girlsare offered testing for pregnancy, HIV, syphilis, gonorrheaand chlamydia. We also obtain a reproductive health historythat includes questions about the date of last sexualintercourse, contraception use and pregnancy concerns. Ifa youth has had possibly unprotected sexual intercourse inthe past 120 hours and doesn’t want to become pregnantfrom that encounter, the EC protocol is initiated.Among the forms we developed to facilitate EC administrationare a fact sheet, consent form and protocol flowsheet. When youth qualify for EC, the nurse initiates discussionguided by the fact sheet. If the youth wants EC, thenurse proceeds to the protocol flow sheet, which outlinesthe process for determining eligibility, obtaining consent,getting a physician’s verbal order, administering EC andscheduling follow-up.JR: How did you introduce the program and train thestaff? Were there any challenges?DJS: During the planning phase, we sought feedbackfrom stakeholders including health care staff, facility superintendentsand DJS legal counsel. We developed a comprehensivenurse training module that discussed backgroundon EC, the protocol and documentation, potential ethicalconcerns and strategies for communicating with youth. Thetrainings included a PowerPoint lecture, interactive scenariosand case studies.Initially, some nurses had misconceptions about EC, confusingit with “the abortion pill” or thinking it could harmexisting pregnancies. Others felt that DJS youth would notbe interested in EC. The training addressed these concerns.We assessed knowledge through pre- and post-trainingtests. Test scores improved dramatically from an average62.9% before training to an average 98.6% after training.JR: What have you learned through program evaluation?DJS: Program evaluation strategies include chart reviews,observation of intake assessments, and nurse and youthsurveys. Our goals are to ensure that EC materials are youthfriendly,that nurses feel comfortable counseling youth onthese issues and that girls who receive EC get appropriatefollow-up. Nurses have reported high efficacy in using theEC protocol. Our greatest challenge has been ensuring consistentscreening within the 120-hour window.Judith Robbins, LCSW, JD, CCHP-A, directs the JuvenileDetention Mental Health Program of Yale BehavioralHealth, Department of Psychiatry, Yale Medical School, NewHaven, CT. She represents the <strong>National</strong> Association of SocialWorkers on NCCHC’s board of directors and chairs the juvenilehealth committee.At the Maryland DJS, Jennifer Maehr, MD, is the medicaldirector and a board-certified pediatrician and adolescentmedicine specialist. Jessica Burns, RN, MSN/MPH, is a nursingprogram consultant. Alison Smith, RN, BSN, is a JohnsHopkins University graduate student intern.For additional resources, including the DJS EC protocolforms and references, please visit the CorrectCare archive atwww.ncchc.org/pubs.www.ncchc.org<strong>Fall</strong> 2009 • CorrectCare23
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