DOCSLIB.ORG

2/16/2015 1 Disclosures Objectives

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
2/16/2015 1 Disclosures Objectives 2/16/2015 Women with Epilepsy: Seizures in Pregnancy and Maternal/Fetal Outcomes 40th Annual Progress in OBGYN February 19, 2015 Jennifer L. DeWolfe, DO Associate Professor UAB Epilepsy Center Director, BVAMC Sleep Center Disclosures Research Funding Marinus Pharmaceuticals, Inc. NINDS -- No bearing on this presentation Objectives • Identify maternal outcomes in pregnant women with epilepsy • Identify fetal outcomes related to antiepileptic drug use in pregnant women with epilepsy • Describe neurodevelopmental effects of antiepileptic drug use during pregnancy and breastfeeding in women with epilepsy • Describe approach to managing seizures during pregnancy 1 2/16/2015 Goal in Epilepsy Management • Seizure freedom on the lowest dose of the least number of antiepilpetic drugs (AEDs) with the least amount of side effects Maternal Outcomes • Cesarean Delivery • Change in Seizure Frequency • Postpartum Depression Cesarean Section Risk • Most women with epilepsy have vaginal delivery 1 • Pregnancy registries demonstrate no increased rates of cesarean section compared to general population 2 • Planned c-section solely based on history of epilepsy may result in increased number of unnecessary procedures • If signs of fetal distress – cesarean section 1. Nakken KO, et al. Tidsskr Nor Laegeforen. 2006;126(19):2507-10. 2. EURAP Study Group. Neurology. 2006;66(3):354-60. 2 2/16/2015 Seizure Control during Pregnancy Seizure Frequency • Unchanged for most women (1-4,6) • Some increased st • especially 1 trimester (1,6) • 17% EURAP (2) • Some decreased (1) • 15% EURAP (2) • 3.5% seizures during childbirth (7) More likely to have seizures during pregnancy if higher # seizures prior to pregnancy (1, 5) (1) http://www.mayoclinic.com/health/pregnancy/PR00123. (2) Pennell, P. Epilepsy Currents. Nov/Dec 2006;6(6):186-188. (3) Bardy AH. Acta Neurol Scand. 1987 May;75(5):356-60. (4) Tomson T et al. Epilepsia. 1994 Jan-Feb;35(1):122-30. (5) Gjerde IO, et al. Acta Neurol Scand. 1988 Sep;78(3):198- 205. (6) Epilepsia. 2013 Sep;54(9):1621-7. (7) (1) EURAP Study Group. Neurology. 2006;66(3):354-60 Seizure Control during Pregnancy Seizure Frequency • 84–92% seizure-free during pregnancy if seizure-free 9 months prior to pregnancy Epilepsia. 2009;50(5):1229-36 Seizure Control during Pregnancy • Generalized epilepsy higher rate seizure freedom (73% vs 59%) • Lamotrigine • Less likely to be seizure-free, 58.2% • More convulsions, 21.1% • More seizures from 1st to 2nd or 3rd trimesters, 19.9% • More likely to require an increase in drug load, 47.7% Thus, more frequent Lamotrigine levels should be evaluated and proactive increases should be performed during pregnancy Epilepsia. 2013 Sep;54(9):1621-7. 3 2/16/2015 Postpartum Depression Postpartum Depression • General population: 11% • Women with Epilepsy: 25-29% • Risk factors include multiparity and AED polytherapy 1. Turner K, et al. Epilepsy Behav. 2006 Sep 9;9(2):293-7. 2. Epilepsy and Behav. 2009 Nov;16(3):426-430. Fetal Outcomes • Teratogenicity • Neurodevelopmental Effects FDA Pregnancy Categories for Medications • Category A: Controlled studies in pregnant women demonstrate no evidence fetal risk. The possibility of harm appears remote. • Category B: Presumed safety based on animal studies, with no controlled studies in pregnant women, or animal studies have shown an adverse effect that was not confirmed in controlled studies in women. • Category C: Studies in women and animals are not available or studies in animals have revealed adverse effects on the fetus and no controlled studies in women. Give if potential benefits justify potential risks. • Category D: Evidence of human fetal risk (unsafe), however in some cases such as a life- threatening illness the potential risk may be justified if there are no other alternatives • Category X: Highly unsafe: risk of use outweighs any potential benefit. Contraindicated in women who are or may become pregnant. US Code of Federal Regulations. 21CFR, 201.57. 4 2/16/2015 Generalized Seizure during Delivery • Seizures increase risk of morbidity and mortality, thus need for AEDs during pregnancy for some WWE • Fetal heart rate tracing during a maternal generalized tonic clonic seizure demonstrated bradycardia, reduced short-term and long-term variability, and late decelerations suggesting asphyxia Hiilesmaa VK, et al. Am J Obstet Gynecol. 1985;152(5):499-504. Teratogenicity Major malformations Minor malformations • ~3% general population (1,3) • 5-10% general population (1) • Higher WWE on AED • 10-15% WWE on AED monotherapy (1) monotherapy (1) • Increased with 1st trimester AED exposure (2) • Higher AED doses and polytherapy associated with increased risk (2) (1) www.epilepsyfoundation.org/answerplace/Life/adults/women/Professional/pregnancy.cfm. (2) Perucca E. Lancet Neurol. 2005 Nov;4(11):781-6. (3) CDC. MMWR. January 6, 2006 / 54(51&52);1301-1305 Folic Acid • Folate may decrease birth defect risks by overcoming defect in homocysteine metabolism • Cooking and enzyme inducing AEDs reduce folic acid levels ~90% • folic acid supplementation in epilepsy • 1mg daily • 4mg daily (enzyme inducing AEDs and valproate) (1) Morrell MJ. Epilepsy Currents, 2002, 2:31-34. (2) Wilson RD, et al. J Obstet Gynaecol Can. 2003 25:959-73. (3) Ono H, et. al. Metabolism. 1997;46:959- 962. (4) Schwaninger M, et. al. Epilepsia 1999;40:345-350. (7) Werler MM, et al. JAMA 1993;269:1257-1261. (8) Medical Research Council Vitamin Research Group. Lancet 1991;338:131-137. 5 2/16/2015 Major Malformation Rates • Valproate 9-20% (Neural tube defects, hypospadias, cardiac defects, oral clefts) • Dose dependent effect > 800 – 1000 mg • Phenobarbital: 6% (cardiac defects, oral clefts) • Topiramate: 4.5% (oral clefts) • Carbamazepine: 3.1% • Phenytoin: 2.9% • Levetiracetam: 2.2% • Lamotrigine: 2.0% • Gabapentin: 1.2% • Zonisamide: none 1. Neurology. 2012 May 22;78(21):1692-9. 2. Arch Neurol. 2011 Oct;68(10):1275-81. 2. Birth Defects Res A Clin Mol Teratol. 2012 Aug;94(8):599-606. 3. Meador KJ. Neurology 2006 Aug ;67(3):407-12. 4. Neurology. 2013 Jan 22;80(4):400-5. NAED Pregnancy Registry Fall 2014. Neurodevelopmental Effects of AEDs : VPA, CBZ, LTG, PHT 3 y/o • Verbal abilities were lower than non-verbal in children exposed in utero to each drug • Preconceptional folate use was associated with higher verbal outcomes • Valproate was associated with poorer cognitive outcomes, lower verbal and non-verbal scores • Carbamazepine: Lower verbal performance Epilepsy Behav. 2011 Jun;21(2):147-52. Meador KJ. Neurology 2006 Aug ;67(3):407-12. Neurodevelopmental Effects of AEDs: 195 children – CBZ, PHT, LTG, VPA 6 y/o Adaptive & Emotional/Behavioral Cognitive Outcomes • Dose-related performance decline Valproate and Phenytoin • Valproate vs. Lamotrigine and Phenytoin: • Significantly lower scores on General Adaptive Composite • More atypical behaviors and inattention • Greater risk of ADHD Epilepsy Behav. 2013 Nov;29(2):308-15. 6 2/16/2015 Neurodevelopmental Effects of AEDs: 6 y/o Cognitive Outcomes Breastfeeding Outcomes • Valproate worse by 7-13 IQ points (P < .001 vs. other drugs) • IQ higher if breastfed (106 vs. 94) • Drug dosage: higher dosage worse (P = 0.01) • Maternal IQ: higher child IQ with higher maternal IQ (P = .01) • Periconception folate use: IQ 6 points higher (P = .005) • Breastfeeding: IQ 4 points higher (P = .045) JAMA Pediatr. 2014 Aug 1;168(8):729-36. Seizures and Pregnancy My Approach 1. Epileptologist visit in family planning stage Review diagnosis Optimize seizure control Folic acid: 1mg daily, 4 mg if enzyme inducing antiepileptic drug 2. Patient education Expectations during family pregnancy, postpartum Educational handouts, websites 3. High Risk OB referral 2nd trimester targeted ultrasound Genetics counselor 7 2/16/2015 My Approach 4. Frequent office visits Every 2-3 months 5. AED levels Monthly levels Lamotrigine doses need to be increased throughout pregnancy Neurologist/Epileptologist adjust meds 6. Breakthrough seizures Call Epileptologist for any seizures, obtain AED levels Check for infection, reduce stress, increase sleep ER for any convulsions My Approach 7. Pregnancy Registries North American Antiepileptic Drug Pregnancy Registry 1-800-233-2334 8. Breastfeeding Encouraged, discuss literature Husband/family 3 AM feedings 9. Postpartum visit 2 months Aim for pre-pregnancy AED dosages by 7-10 days postpartum Ask about postpartum depression Baby safety (changing, carrying child, bathing, night feeds) Ongoing Research 8 2/16/2015 Maternal Outcomes and Neurodevelopment Effects of AEDs • Pregnant Women w/epilepsy vs. Pregnant Women w/out Epilepsy • Outcomes • Seizure frequency during pregnancy • C-section rate • Rate of depression • Small for gestational age • Child verbal ability • Childhood IQ • Breastfeeding effects • Epilepsy Center Office: 934-1654, Cheryl Hall, LPN Summary Summary • Most women with epilepsy have normal pregnancies delivered via vaginal delivery • Pregnancy Seizure frequency is unchanged for most WWE • High likelihood of remaining seizure free during pregnancy if seizure free 9 months prior to pregnancy • All AEDs are Pregnancy Category C or D, thus increased teratogenicity potential 9 2/16/2015 Summary • Valproate monotherapy and polytherapy have highest rate of teratogencity followed by Phenobarbital and Topiramate • Dose dependent negative effects for teratogenic and cognitive outcomes • VPA and higher AED doses are associated with lower IQ, and attention/behavior problems • Breastfeeding, use of folic acid, higher maternal IQ associated with higher IQs and verbal cognitive abilities Summary • Preconception visit: Review diagnosis, Obtain seizure control, Optimize AEDs, Add folic acid (1 mg, 4 mg), High Risk OB referral • During Pregnancy: monthly levels, increase AED doses for levels trending down, High Risk OB, review postpartum depression, 2nd Trimester Structural US, breastfeeding data, postpartum care of infant • Encourage enrollment in Pregnancy Registry • Epilepsy Center Office: 934-1654, Cheryl Hall, LPN for MONEAD Study 10 .
Load more

Recommended publications
  • FDA Guidance on Establishing Pregnancy Exposure Registries
    Guidance for Industry Establishing Pregnancy Exposure Registries U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) August 2002 Clinical/Medical Guidance for Industry Establishing Pregnancy Exposure Registries Additional copies are available from: Office of Training and Communications Division of Communications Management Drug Information Branch, HFD-210 5600 Fishers Lane Rockville, MD 20857 (Tel) 301-827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Communication, Training, and Manufacturers Assistance (HFM-40) Center for Biologics Evaluation and Research (CBER) 1401 Rockville Pike, Rockville, MD 20852-1448 http://www.fda.gov/cber/guidelines.htm (Fax) 888-CBERFAX or 301-827-3844 (Voice Information) 800-835-4709 or 301-827-1800 U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) August 2002 Clinical/Medical TABLE OF CONTENTS I. INTRODUCTION................................................................................................................. 1 II. BACKGROUND ...................................................................................................................1 III. WHAT IS A PREGNANCY EXPOSURE REGISTRY? .................................................. 2 IV. WHAT MEDICAL PRODUCTS MAKE GOOD REGISTRY CANDIDATES?........... 3 V. WHEN SHOULD SUCH A REGISTRY BE ESTABLISHED?......................................
    [Show full text]
  • Australian Product Information – Panadol Night (Paracetamol 500Mg, Diphenhydramine Hydrochloride 25Mg) Tablets
    AUSTRALIAN PRODUCT INFORMATION – PANADOL NIGHT (PARACETAMOL 500MG, DIPHENHYDRAMINE HYDROCHLORIDE 25MG) TABLETS 1 PANADOL NIGHT 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: Paracetamol Contains: potassium sorbate as preservative Excipients: For full list of excipients, see section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Panadol Night is a film coated, blue caplet (capsule shaped tablet) with “PANADOL” printed on one face and “NIGHT” on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the temporary relief of pain when associated with sleeping difficulty, for example: headache, migraine, backache, arthritis, rheumatic and muscle pain, neuralgia, toothache or period pain. Relief of fever. 4.2 DOSE AND METHOD OF ADMINISTRATION Adults and children over 12 years: take 1 - 2 tablets with water or other fluid only at bedtime. Maximum of two tablets in 24 hours. Do not exceed the stated dose. Do not use in children under 12 years of age. Other products containing paracetamol may be taken during the day but the total daily dose of paracetamol must not exceed 4,000 mg in any 24 hour period. Allow at least four hours between taking any paracetamol-containing product and Panadol Night. For adults, paracetamol should not be taken for more than a few days at a time except on medical advice. For children, paracetamol should not be taken for more than 48 hours except on medical advice. Do not exceed the stated dose. To be taken at bedtime. Should not be used with other anti-histamine containing preparations, including those used on the skin (see Warnings and Precautions). The lowest dose necessary to achieve efficacy should be used for the shortest duration of treatment.
    [Show full text]
  • 00005721-201907000-00003.Pdf
    2.0 ANCC Contact Hours Angela Y. Stanley, DNP, APRN-BC, PHCNS-BC, NEA-BC, RNC-OB, C-EFM, Catherine O. Durham, DNP, FNP-BC, James J. Sterrett, PharmD, BCPS, CDE, and Jerrol B. Wallace, DNP, MSN, CRNA SAFETY OF Over-the-Counter MEDICATIONS IN PREGNANCY Abstract Approximately 90% of pregnant women use medications while they are pregnant including both over-the-counter (OTC) and prescription medications. Some medica- tions can pose a threat to the pregnant woman and fetus with 10% of all birth defects directly linked to medications taken during pregnancy. Many medications have docu- mented safety for use during pregnancy, but research is limited due to ethical concerns of exposing the fetus to potential risks. Much of the information gleaned about safety in pregnancy is collected from registries, case studies and reports, animal studies, and outcomes management of pregnant women. Common OTC categories of readily accessible medications include antipyretics, analgesics, nonsteroidal anti- infl ammatory drugs, nasal topicals, antihistamines, decongestants, expectorants, antacids, antidiar- rheal, and topical dermatological medications. We review the safety categories for medications related to pregnancy and provide an overview of OTC medications a pregnant woman may consider for management of common conditions. Key words: Pharmacology; Pregnancy; Safety; Self-medication. Shutterstock 196 volume 44 | number 4 July/August 2019 Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved. he increased prevalence of pregnant women identifi ed risks in animal-reproduction studies or completed taking medications, including over-the-counter animal studies show no harm. The assignment of Category (OTC) medications presents a challenge to C has two indications; (1) limited or no research has been nurses providing care to women of childbear- conducted about use in pregnancy, and (2) animal studies ing age.
    [Show full text]
  • Use of Prescribed Psychotropics During Pregnancy: a Systematic Review of Pregnancy, Neonatal, and Childhood Outcomes
    brain sciences Review Use of Prescribed Psychotropics during Pregnancy: A Systematic Review of Pregnancy, Neonatal, and Childhood Outcomes Catherine E. Creeley * and Lisa K. Denton Department of Psychology, State University of New York at Fredonia, Fredonia, NY 14063 USA; [email protected] * Correspondence: [email protected]; Tel.: +1-716-673-3890 Received: 19 July 2019; Accepted: 9 September 2019; Published: 14 September 2019 Abstract: This paper reviews the findings from preclinical animal and human clinical research investigating maternal/fetal, neonatal, and child neurodevelopmental outcomes following prenatal exposure to psychotropic drugs. Evidence for the risks associated with prenatal exposure was examined, including teratogenicity, neurodevelopmental effects, neonatal toxicity, and long-term neurobehavioral consequences (i.e., behavioral teratogenicity). We conducted a comprehensive review of the recent results and conclusions of original research and reviews, respectively, which have investigated the short- and long-term impact of drugs commonly prescribed to pregnant women for psychological disorders, including mood, anxiety, and sleep disorders. Because mental illness in the mother is not a benign event, and may itself pose significant risks to both mother and child, simply discontinuing or avoiding medication use during pregnancy may not be possible. Therefore, prenatal exposure to psychotropic drugs is a major public health concern. Decisions regarding drug choice, dose, and duration should be made carefully, by balancing severity, chronicity, and co-morbidity of the mental illness, disorder, or condition against the potential risk for adverse outcomes due to drug exposure. Globally, maternal mental health problems are considered as a major public health challenge, which requires a stronger focus on mental health services that will benefit both mother and child.
    [Show full text]
  • FDA Downgrades Efavirenz to Pregnancy Category D
    32 Clinical Rounds Women’s Health I NTERNAL M EDICINE N EWS • July 15, 2005 D RUGS, PREGNANCY, FDA Downgrades Efavirenz A ND L ACTATION To Pregnancy Category D Migraine Drugs BY JANE SALODOF MACNEIL live births after second- or third-trimester igraine symptoms improve in around the time of conception, and ex- Southwest Bureau exposures. Dr. Lewis-Hall did not de- up to 70% of women during posure in the third trimester is associ- scribe the birth defects, except to say Mpregnancy, usually during the ated with premature closure of the he Food and Drug Administration they were not neural tube defects, which, second and third trimesters. But in 4%- ductus arteriosus with the risk of per- has downgraded efavirenz to preg- so far, have only been seen in retrospec- 8% of women, migraines worsen, and sistent pulmonary hypertension of the Tnancy category D, “Positive Evi- tive reports. as many as 16% of all migraine cases newborn. dence of Fetal Risk,” and is urging women “Although a causal relationship of these during pregnancy may be new onset. Since aspirin causes irreversible inhi- to avoid becoming pregnant while taking events to the use of Sustiva has not been A 2002 review identified drugs or drug bition of platelet function and other the antiretroviral drug. established, similar defects have been ob- classes used for preventing migraine at- clotting disorders, its use near term The new package label stems from four served in preclinical studies of efavirenz,” tacks (N. Engl. J. Med. 2002;346:257-70), may enhance maternal blood loss at de- retrospective reports of women who gave she wrote.
    [Show full text]
  • Beta-Blockers and Fetal Growth Restriction in Pregnant Women with Cardiovascular Disease
    Circulation Journal ORIGINAL ARTICLE Official Journal of the Japanese Circulation Society http://www.j-circ.or.jp Pediatric Cardiology and Adult Congenital Heart Disease Beta-Blockers and Fetal Growth Restriction in Pregnant Women With Cardiovascular Disease Kayo Tanaka, MD; Hiroaki Tanaka, MD; Chizuko Kamiya, MD, PhD; Shinji Katsuragi, MD, PhD; Masami Sawada, MD; Mitsuhiro Tsuritani, MD, PhD; Masashi Yoshida, MD, PhD; Naoko Iwanaga, MD; Jun Yoshimatsu, MD, PhD; Tomoaki Ikeda, MD, PhD Background: The effects of β-adrenergic blockers on the fetus are not well understood. We analyzed the maternal and neonatal outcomes of β-adrenergic blocker treatment during pregnancy to identify the risk of fetal growth restric- tion (FGR). Methods and Results: We retrospectively reviewed 158 pregnancies in women with cardiovascular disease at a single center. Maternal and neonatal outcomes were analyzed in 3 categories: the carvedilol (α/β-adrenergic blocker; α/β group, n=13); β-adrenergic blocker (β group, n=45), and control groups (n=100). Maternal outcome was not significantly different between the groups. FGR occurred in 1 patient (7%) in the α/β group, in 12 (26%) in the β group, and in 3 (3%) in the control group; there was a significant difference between the incidence of FGR between the β group and control group (P<0.05). The β group included propranolol (n=22), metoprolol (n=12), atenolol (n=6), and bisoprolol (n=5), and the individual incidence of FGR with these medications was 36%, 17%, 33%, and 0%, respectively. Conclusions: As a group, β-adrenergic blockers were significantly associated with FGR, although the incidence of FGR varied with individual β-blocker.
    [Show full text]
  • Evidence of Drug Safety in Pregnancy
    DRUGS IN PREGNANCY Evidence of drug safety in pregnancy For an area as complex as prescribing in pregnancy, unfortunately, there is very little information in the literature to support practice. Newer antimicrobials are trialled excluding pregnant women for reasons of risk-avoidance and, therefore, prescribers must rely on post-marketing surveillance data. For some medications, this takes the form of a formal registry (for example, the antiretroviral pregnancy registry). Obviously, prospective safety data from Phase I/II clinical trials is preferable, but in the absence of this, registry data provides some reassurance. Older antibiotics, on the other hand, may have many years of practical experience to suggest their safety, but little robust scientific evidence to support their safe use. Evidence of treatment efficacy in pregnancy Large prospective trials of treatment in pregnancy are conspicuously absent from the literature. There have been a number of Cochrane reviews on different topics in the treatment of infections in pregnancy – from asymptomatic bacteriuria to bacterial vaginosis. All of the reviews have in common very heterogeneous primary articles and cautious recommendations based on lack of data. In general, antibiotics are effective at treating the infection in question, but studies are underpowered to provide information on optimum therapy or fetal safety. 1 Done by : Pharm.D –Neda'Rwashdeh Infection and pregnancy Immune tolerance’ in pregnancy is widely discussed and there are some data to suggest that pregnant women are at slightly higher risk of developing disease from some infections (including poliomyelitis, smallpox, hepatitis A and falciparum malaria). Also, the risk of severe disease and death are increased for some infections.
    [Show full text]
  • Composition: Each
    ______________________________________________________________________________________________________________ Composition: Each Triptolol Tablet contains: Amitriptyline Hydrochloride IP 10mg Propranolol Hydrochloride IP 40mg Pharmacokinetic properties: Amitriptyline is readily absorbed from the gastrointestinal tract, peak plasma concentrations occurring within about 6 hours after oral doses. Amitriptyline undergoes extensive first-pass metabolism and is demethylated in the liver by the cytochrome P450 isoenzymes CYP3A4, CYP2C9, and CYP2D6 to its primary active metabolite, nortriptyline. Other paths of metabolism of amitriptyline include hydroxylation (possibly to active metabolites) by CYP2D6 and N-oxidation; nortriptyline follows similar paths. Amitriptyline is excreted in the urine, mainly in the form of its metabolites, either free or in conjugated form. Amitriptyline and nortriptyline are widely distributed throughout the body and are extensively bound to plasma and tissue protein. Amitriptyline has been estimated to have an elimination half-life ranging from about 9 to 25 hours. Propranolol is almost completely absorbed from the gastrointestinal tract, but is subject to considerable hepatic-tissue binding and first-pass metabolism. Peak plasma concentrations occur about 1 to 2 hours after an oral dose. Plasma concentrations vary greatly between individuals. Propranolol has high lipid solubility. It crosses the blood-brain barrier and the placenta, and is distributed into breast milk. Propranolol is about 90% bound to plasma proteins. It is metabolised in the liver and at least one of its metabolites (4-hydroxypropranolol) is considered to be active, but the contribution of metabolites to its overall activity is uncertain. The metabolites and small amounts of unchanged drug are excreted in the urine. The plasma half-life of propranolol is about 3 to 6 hours.
    [Show full text]
  • 02-2012 DUR Packet
    Drug Utilization Review Board Oklahoma Health Care Authority 2401 N.W. 23rd Street, Suite 1A Oklahoma City, Oklahoma 73107 Ponca Room Wednesday February 8, 2012 6:00 p.m. The University of Oklahoma Health Sciences Center COLLEGE OF PHARMACY PHARMACY MANAGEMENT CONSULTANTS MEMORANDUM TO: Drug Utilization Review Board Members FROM: Shellie Keast, Pharm.D., M.S. SUBJECT: Packet Contents for Board Meeting – February 8, 2012 DATE: February 2, 2012 NOTE: The DUR Board will meet at 6:00 p.m. The meeting will be held in the Ponca Room at the Oklahoma Health Care Authority Offices in Shepherd Mall. (North Entrance) Enclosed are the following items related to the February meeting. Material is arranged in order of the Agenda. Call to Order Public Comment Forum Action Item – Approval of DUR Board Meeting Minutes – See Appendix A. Update on DUR / MCAU Program – See Appendix B. Action Item – Vote to Prior Authorize Select Prenatal Vitamins – See Appendix C. Action Item - Vote to Prior Authorize Soliris® – See Appendix D. Action Item – Vote to Prior Authorize Onfi™ – See Appendix E. Action Item – Annual Review of Erythropoietin Stimulating Agents – See Appendix F. Action Item – Annual Review of Narcotic Analgesics and 30 Day Notice to Prior Authorize Abstral®, Lazanda®, Nucynta® ER, and Oxecta® – See Appendix G. 30 Day Notice to Prior Authorize Xgeva® – See Appendix H. 30 Day Notice to Prior Authorize Makena™ – See Appendix I. Action Item – Questions Regarding Annual Review of Mozobil®, Nplate®, Arcalyst®, and Ilaris® – See Appendix J. FDA and DEA Updates – See Appendix K. Future Business Adjournment ORI-4403 • P.O. BOX 26901 • OKLAHOMA CITY, OKLAHOMA 73126-0901 • (405) 271-9039 • FAX: (405) 271-2615 Oklahoma Health Care Authority Drug Utilization Review Board (DUR Board) Meeting – February 8, 2012 @ 6:00 p.m.
    [Show full text]
  • Tuberculosis and Pregnancy
    Tuberculosis and pregnancy Susanna Capone, MD, MIH University Department of Infectious Diseases and Tropical Medicine WHO Collaborating Center for TB/HIV collaborative activities and for the TB elimination Strategy University of Brescia Brescia, Italy © by author ESCMIDESCMID Postgraduate Education Online Course Lecture Library Infectious Diseases of Pregnant Woman, Fetus and Newborn 29th September 2016 Bertinoro Summary From the mother’s point of From the newborn’s point of view: TB and Pregnancy view: Congenital Tuberculosis 1. Epidemiology 1. Congenital and 2. How pregnancy can perinatal affect TB 2. Epidemiology 3. Diagnosis 3. Diagnosis 4. Active TB © by author4. Treatment Management 5.ESCMID Managment Online of LTBI Lecture Library 6. TB and HIV hints From the mother’s point of view: TB and Pregnancy © by author ESCMID Online Lecture Library Epidemiology Tuberculosis affected an estimated 9.6 million people (3.2 million women and 1 million children) and caused 1.5 million deaths globally in 2014, including about half©‐million by author women and at least 140.000 children. ESCMID Online Lecture Library TB is one of the top killers of women worldwide rd World Health Organization. Global tuberculosis Report 2015 (3 cause). Geneva, Switzerland: WHO, 2016. TB incidence: countries and regions Europe 3% Americas 3% E. Mediterranean 8% South‐East Asia Africa 28% 41% © by author 23% in India 10% each:ESCMID Indonesia & China Online Lecture Library 5% each: Nigeria & Pakistan Prevalence of active TB in pregnant and post partum women <20 cases per 100 000 population per year in LBC >60 cases per 100 000© population by perauthor year in HBC ESCMID Online Lecture Library Mathad & Gupta, CID, 2012: 55 (11): 1532-1549 Prevalence of LTBI in pregnant and post partum women © by author ESCMID Online Lecture Library Mathad & Gupta, CID, 2012: 55 (11): 1532-1549 2.
    [Show full text]
  • Auspar Attachment 1. Product Information for Methotrexate
    Attachment 1: Product information for AusPAR - TREXJECT & TREXJECT IN - Methotrexate - Link Medical Products Pty Ltd T/A Link Pharmaceuticals - PM-2014-01050-1-3 FINAL 7 June 2017. This Product Information was approved at the time this AusPAR was published. TREXJECT IN, methotrexate (as sodium) Injection Version: DRAFT 0.9 PRODUCT INFORMATION TREXJECT IN, methotrexate (as sodium) Solution for subcutaneous or intramuscular injection, pre-filled syringe 7.5 mg/0.15 mL, 10 mg/0.2 mL, 12.5 mg/0.25 mL, 15 mg/0.3 mL, 17.5 mg/0.35 mL, 20 mg/0.4 mL, 22.5 mg/0.45 mL and 25 mg/0.5 mL WARNING Methotrexate must only be prescribed by physicians experienced in anti-metabolic therapy and the treatment of severe rheumatoid arthritis or psoriasis. Patients should be fully informed of the risk of fatal or severe toxic reactions involved with the administration of methotrexate and should be under constant supervision of the physician. Deaths have been reported with the use of methotrexate. In the treatment of psoriasis and rheumatoid arthritis, methotrexate should be restricted to severe, recalcitrant, disabling disease which is not adequately responsive to other forms of therapy and only when the diagnosis has been established. Methotrexate may produce depression of the bone marrow, anaemia, aplastic anaemia, leukopenia, neutropenia, thrombocytopenia and bleeding. At high or prolonged doses, methotrexate may be hepatotoxic. Liver atrophy, necrosis, cirrhosis, fatty changes and periportal fibrosis have been reported. Since changes may occur without previous signs of gastro-intestinal or haematological toxicity, it is imperative that hepatic function be determined prior to initiation of treatment and monitored regularly throughout therapy.
    [Show full text]
  • Substance Use and Addiction During Pregnancy: Identifying Unvoiced Needs
    SUBSTANCE USE AND ADDICTION DURING PREGNANCY: IDENTIFYING UNVOICED NEEDS JASSIN M. JOURIA, MD DR. JASSIN M. JOURIA IS A MEDICAL DOCTOR, PROFESSOR OF ACADEMIC MEDICINE, AND MEDICAL AUTHOR. HE GRADUATED FROM ROSS UNIVERSITY SCHOOL OF MEDICINE AND HAS COMPLETED HIS CLINICAL CLERKSHIP TRAINING IN VARIOUS TEACHING HOSPITALS THROUGHOUT NEW YORK, INCLUDING KING’S COUNTY HOSPITAL CENTER AND BROOKDALE MEDICAL CENTER, AMONG OTHERS. DR. JOURIA HAS PASSED ALL USMLE MEDICAL BOARD EXAMS, AND HAS SERVED AS A TEST PREP TUTOR AND INSTRUCTOR FOR KAPLAN. HE HAS DEVELOPED SEVERAL MEDICAL COURSES AND CURRICULA FOR A VARIETY OF EDUCATIONAL INSTITUTIONS. DR. JOURIA HAS ALSO SERVED ON MULTIPLE LEVELS IN THE ACADEMIC FIELD INCLUDING FACULTY MEMBER AND DEPARTMENT CHAIR. DR. JOURIA CONTINUES TO SERVES AS A SUBJECT MATTER EXPERT FOR SEVERAL CONTINUING EDUCATION ORGANIZATIONS COVERING MULTIPLE BASIC MEDICAL SCIENCES. HE HAS ALSO DEVELOPED SEVERAL CONTINUING MEDICAL EDUCATION COURSES COVERING VARIOUS TOPICS IN CLINICAL MEDICINE. RECENTLY, DR. JOURIA HAS BEEN CONTRACTED BY THE UNIVERSITY OF MIAMI/JACKSON MEMORIAL HOSPITAL’S DEPARTMENT OF SURGERY TO DEVELOP AN E- MODULE TRAINING SERIES FOR TRAUMA PATIENT MANAGEMENT. DR. JOURIA IS CURRENTLY AUTHORING AN ACADEMIC TEXTBOOK ON HUMAN ANATOMY & PHYSIOLOGY. Abstract All healthcare professionals involved in the prenatal care of women should be observant to the unvoiced needs of the pregnant patient. This includes ongoing evaluation of the expectant mother’s knowledge of labor and delivery, emotional state and health risks. Screening for the risk and the diagnosis of a substance use disorder during pregnancy, as well as correlating socioeconomic and other environmental stressors; and, treatment and follow-up of the mother’s recovery and the child’s development in utero and after birth are discussed.
    [Show full text]