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20 October 2011 Follow-up to Previous Reviews Tramadol with SSRIs or SNRIs Potential for Serotonin Syndrome Pharmacy Provider Profiling Colchicine DUR Ketorolac DUR 2 Tramadol with SSRIs or SNRIs Potential for Serotonin Syndrome Pharmacy Provider Profiling Patients were selected if they had more than one tramadol fill, at least a 30 day overlap with the SSRI or SNRI, and had both a tramadol and an antidepressant claim within the most recent six weeks of data. Letters along with the Serotonin Syndrome Informational sheet were sent to 182 pharmacies about 552 patients on 7/18/2011. As of 9/27/2011, 45 responses have been received (25% response rate.) 3 Tramadol with SSRIs or SNRIs Potential for Serotonin Syndrome Response detail as of 9/27/2011 Note that providers may choose more than one selection per response. Reviewed and do not believe adjustment is needed Reviewed and have or will modify the treatment 19 10 I have previously discussed with the provider and their response was I attempted to modify the therapy, but the patient response was not favorable 3 1 4 Tramadol with SSRIs or SNRIs Potential for Serotonin Syndrome Response detail as of 9/27/2011 Note that providers may choose more than one selection per response. Information clinically useful: plan to monitor I will use this information in the care of future pts No longer my patient Somewhat useful to my practice Extremely useful to my practice Very useful to my practice 21 30 10 8 8 23 5 Tramadol with SSRIs or SNRIs Potential for Serotonin Syndrome Response detail as of 9/27/2011 “We are not a providing pharmacy for this patient.” “The patient has been on concurrent therapy for several years with no apparent serotonic toxicity” “Patients had a trial of Tramadol and other interacting meds since discontinued. Good reminder to watch for multiple offending drugs. This often gets over quickly on DURs.” “John is no longer on tramadol. Only on it for a week.” “I have previously discussed with the provider and their response was dosages not high enough to cause serotonin syndrome.” “Patient and family counseled on serotonin syndrome. Patient has not filled medication since April (only need if pain).” “Patient was taking Tramadol temporarily and hasn’t filled since. I have contacted providers several instances when they are adding Tramadol and they are currently taking 2 other serotonergic drugs. They always state they aren’t concerned about it.” 6 Tramadol with SSRIs or SNRIs Potential for Serotonin Syndrome Response detail as of 9/27/2011 “Patient has addiction programs by past hydrocodone and has not responded to past antidepressant treatment. He has been on this therapy for 9 years, continue with current therapy.” “Testing” “Patient moved from this area Aug 15, 2011.” “Both medications are prescribed by the same provider. Patient was counseled.” “We explained the signs and symptoms of SS to the patient or caregiver if they get the symptoms they are to contact their prescriber. Our computer flags drugs.” “Dr. switched Rx to Hydrocodone/APAP” “Tramadol was changed to other pain relievers in May 2011. The patient is not symptomatic” “Neither patient is currently taking tramadol at this time. The problem I find is the doctors are reluctant to change medication when you call them about a serotonin syndrome reaction. But refer to question 6.” 7 Tramadol with SSRIs or SNRIs Potential for Serotonin Syndrome Response detail as of 9/27/2011 “7 of 12 required contact with the doctor” “Patients are counseled to be aware of symptoms of Serotonin Syndrome. When taking more than one medication. Monitoring patient aware of interaction patient has been taking both Serotonergic drugs without problems. Will continue to remind patients of possible interaction with each refill. Helpful reminder reviewed with our pharmacist on staff also made copies of your hand out for educational purposes to give to patient at patient counseling.” “Serotonin Syndrome is rare and I would rather have her take Tramadol than hydrocodone. I appreciate the service you are offering, however I do not think Serotonin Syndrome is common enough to warrant Medicaid contacting pharmacies. This one interaction would keep you busy for a very long time. Thank You.” “I have counseled patient and she has been stable on both meds. She is aware of serotonin syndrome. Will f/u again.” 8 Tramadol with SSRIs or SNRIs Potential for Serotonin Syndrome Response detail as of 9/27/2011 “Patient has had concomitant therapy since August 16 2010 and has not reported the symptoms of serotonin syndrome.” “Not currently on this combination.” “We do counsel on the possibility of SS.” “Long standing regimen.” “She has been consulted on the risk. She has been on Tramadol since April 2010. Cymbalta since 11/2010 without incident.” “One patient no longer on Cymbalta. Other uses infrequently.” “Thank you very much for bringing this to my attention. I will speak with the provider directly and report his or her response back to you.” “To continue current regimen.” “I have reviewed the information and plan to follow up with the prescriber concerning the treatment regimen for the specified patient.” 9 Tramadol with SSRIs or SNRIs Potential for Serotonin Syndrome Response detail as of 9/27/2011 “She has been using this for awhile with no problem. I will let prescriber know of the issue again.” “I have previously discussed with Doctor and he has been watching the patient sees no indication of symptoms of Serotonin Syndrome. He is aware and watching.” “Continue therapy.” “Counsel patient and combine with current med. Patient received full interaction consult.” “Provider was notified about possible problems. No response.” “Watch for symptoms, patients are not taking Tramadol all the time. Thanks.” 10 Colchicine DUR Historical Perspective In June 2006, the FDA announced a new drug safety initiative to remove unapproved drugs from the market, including a final guidance entitled “Marketed Unapproved DrugsCompliance Policy Guide (CPG)”. Notice that any illegally marketed product is subject to FDA enforcement at any time Clarified that the FDA intends to use a risk-based approach to enforcement July 29, 2009: Colcrys® approved for Familial Mediterranean Fever (FMF) July 30, 2009: Colcrys® approved for Acute Gout Flares October 16, 2009: Colcrys® approved for Chronic Gout 11 Colchicine DUR October 1, 2010: FDA sent out a notice that it intends to initiate enforcement action against any marketed and listed unapproved single-ingredient oral colchicine product that is manufactured on or after November 15, 2010, or that is shipped on or after December 30, 2010. Use of Colcrys® Colcrys® colchicine May 2010 May 2011 No Rx’s 8 Rx’s $241.82/46 tabs 42 Rx’s (7 different NDCs) $23.25/46 tabs No Rx’s 12 Colcrys’® Place in Therapy Utilization Overview Number of Recipients Number of Claims Average Cost/Claim Allopurinol 172 432 $6.62 Colcrys® 16 29 $259.78 Probenecid 7 13 $25.26 Probenecidcolchicine 0 0 $0.00 Uloric® 9 25 $167.62 All information based on Idaho Medicaid Pharmacy Data 2nd Quarter 2011 (4/1/11-6/30/11). 13 Colcrys® - Summary 72.2% (13/18) of the Prior Authorization requests received were approved. Continue to require Prior Authorization for Colcrys® with the current therapeutic criteria (listed on next slide) Off-label use for treatment of chronic constipation was discovered Turned off Auto Pay rule which approved Colcrys® at point of sale if there was a paid colchicine claim in the past 90 days. 14 Therapeutic Criteria for Colcrys® Acute Gout 1. • Contra-indication and/or failure to NSAIDS or corticosteroids 2. Chronic Gout • Adjunct to allopurinol AND contra-indication or failure to NSAIDS 15 Ketorolac DUR Historical Perspective: Discovered that in the drug profiles the Maximum Quantity was set at 10 tablets per day. The Maximum Quantity was immediately changed to 4 tablets per day as recommended by the package insert. Report was generated to see how many patients have actually received doses higher than the recommended amount and based on this report it was felt that a Retrospective DUR would be appropriate. 16 Ketorolac DUR Patients were selected for evaluation if there was a paid claim for ketorolac > 40mg total daily dose or > 5 days duration over the 3 month period 3/1/20115/31/2011. A total of 29 patient profiles were evaluated Letters were sent to 9 prescribers about 9 patients on 6/20/2011. As of 9/26/2011, 4 responses have been received (44% response rate) 17 Ketorolac DUR Criteria Paragraph During a retrospective drug utilization review, it was noted that your patient, (Patient Name), received at least one prescription of more than 20 tablets and/or received multiple consecutive fills of ketorolac. The recommended maximum daily dose of oral ketorolac is 40mg per day (10mg tablet four times daily). Ketorolac is FDA approved for the short term (up to 5 days) management of moderately severe acute pain that requires analgesia at the opioid level and only as continuation treatment following IV or IM dosing of ketorolac. The total combined duration of use of injectable and oral ketorolac should not exceed 5 days. Increasing the dose beyond the recommended daily maximum of 40mg will not provide better efficacy, but will increase the risk of developing serious adverse events. Ketorolac has black box warnings addressing the following risks: Gastrointestinal, Cardiovascular, Renal, Risk of Bleeding, Risk During Labor and Delivery, Concomitant Use with NSAIDs, and in Special Populations. 18 Ketorolac DUR Response detail as of 9/26/2011 Note that providers may choose more than one selection per response. Information clinically useful: plan to monitor I will use this information for care of future patients. No longer my patient My patient, but I did not prescribe this My patient, but I have not seen him/her recently Somewhat useful to my practice 2 2 1 1 1 1 “The meds were being given in the ER and PCP I believe” “Will discuss Kadian and the use of other pain meds as an option for care” 19 Ketorolac DUR - Summary Maximum quantity per day reduced from 10 to 4 tablets on 5/24/2011 DUR letter sent on 6/20/2011 to 9 prescribers with 4 responses as of 9/26/2011 20 Auto Refill Practices Some pharmacies are instituting Auto Refill policies which allow them to automatically dispense refills based on days since last fill Issues Potential for stockpiling Potential for continued fill of discontinued medications Increase cost/waste Please see Survey in Packet 21 Auto Refill Practices Fax blast of survey went out to 318 pharmacies on July 8, 2011. As of 10/3/2011 a total of 78 surveys have been returned (25% response rate) 22 Auto Refill Practices – Results Does your pharmacy participate in an Auto Refill process? 27 Yes No 51 23 Auto Refill Practices – Results Do you exclude Auto Refill for any specific third party payers? If so which? ____See attached sheet for comments______ 5 Yes No 32 24 Auto Refill Practices – Results How are specific patients included in the Auto Refill process? 25 20 15 10 5 20 10 2 0 All patients are automatically enrolled in Auto Refill All patients are offered Auto Refill as a service option A patient must specifically request Auto refill All patients are included unless they specifically "opt out" of the program 25 Auto Refill Practices – Results Which medications does your pharmacy include in your Auto Refill? 25 22 20 15 10 5 5 2 0 All Medications Maintenance medications only Our Pharmacy has a specific list of medications or therapeutic classes (see attached sheet) 26 Auto Refill Practices – Results Which medications does your pharmacy include in your Auto Refill? Our Pharmacy has a list of excluded medications (please list), otherwise all are included in auto refill program 12 responses see attached sheet Does your system automatically flag all medications or does each RX have to be individually flagged? 22 responses see attached sheet Do you have a systematic method to discontinue an Auto Refill to prevent duplication of therapy when drugs or doses change? 20 responses see attached sheet How many days remain on the prescription when your system Auto fills the medication? 46 responses average 5 days 27 Auto Refill Practices – Results Does your system alert the patient that the prescription is ready for pick up? If so, how? 30 25 25 19 20 9 Yes 25 No 17 15 10 3 5 0 Phone Text Email Other (see attached sheet) 28 Auto Refill Practices – Results How long does the medication sit on the shelf before it is returned to stock? 39 responses with an average of 13 days How does your store handle medications not picked up? 40 33 30 20 7 10 11 0 Phone call to patient Mail out Other 29 Auto Refill Practices – Results Do you find the Auto Refill process beneficial for patients? 6 Yes No 24 30 Auto Refill Practices – Results Do you find the Auto Refill process potentially dangerous for patients? 13 Yes 17 No 31 Auto Refill Practices – Results Do you find the Auto Refill process has increased compliance by the patient? 7 Yes No 18 32 Auto Refill Practices – Results Do you have any other comments related to the Auto Refill process? 24 responses see attached sheet Comments/Questions/Recommendations? 33 Hepatitis C DUR Rationale for choosing this topic Multiple ribavirin products are available at very different costs. There is currently no therapeutic criteria required for ribavirin, so prescriptions pay at the pharmacy with prior authorization not needed. 34 Hepatitis C DUR – approximate cost of therapy for one month of therapy Ribavirin 200mg capsules Ribavirin 200mg tablets Ribasphere (400 and 600mg tablets) Ribapak 400mg twice daily $160 $120 $880 $1114 600mg in am and 400mg in pm $200 $150 $1105 $1273 600mg twice daily $240 $180 $1320 $1678 35 Hepatitis C DUR FDA Approved Indication Treatment of chronic hepatitis C in combination with interferon. Profiles Selected for Review Patients who had at least one paid claim for oral ribavirin between 5/01/2011 and 7/31/2011. N=29 Patient Demographics 16 female, 13 male Average age 46 yrs (Range 31-59) 36 Hepatitis C DUR Diagnosis for Hepatitis C in Electronic Profile Yes – 28 patients No – 1 patient (but called prescriber and this patient does have hepatitis C) Concomitant Therapy with Interferon Defined as at least one fill for interferon between 5/01/2011 and 7/31/2011. Yes – all 29 patients 7 of these patients are also on either Incivek or Victrelis for triple therapy. 37 Hepatitis C DUR Medication Possession Ratio (MPR) Definition: Total Days Supply of Dispensed Medication Total Days of Therapy Example e.g. Patient fills 30 tablets/30 days on January 1, March 1, and April 15 and then there are no more fills. Total days of therapy: 31 (January) + 28 (February) + 31 (March) + 30 (April) + 14 (May) = 134 days Note: last day of therapy is May 14th as patient has 30 days of medication to use from April 15 through May 14th. MPR = 30 (Jan fill) + 30 (Mar fill) + 30 (Apr fill) = 90 = 0.67 134 days 134 In general, MPR > 0.80 is considered good adherence to therapy. There are not specific standards for different drug classes. If a patient fills prescriptions early (e.g. opioids), then MPR will be greater than 1.0 38 Hepatitis C DUR Ribavirin MPR Average for all 29 patients: MPR = 0.904 (average days of filled ribavirin = 126, average days of ribavirin therapy 142 days) Subtracting out 8 patients with only one fill (who therefore had a MPR 1.0): Average MPR = 0.87 (average days of filled ribavirin = 163, average days of ribavirin therapy 186 days) 39 Hepatitis C DUR Interferon MPR Average for all 29 patients: MPR = 0.964 (average days of filled interferon = 138, average days of interferon therapy 145 days) Subtracting out 7 patients with only one fill (who therefore had a MPR 1.0): Average MPR = 0.96 (average days of filled interferon = 173, average days of interferon therapy 182 days) 40 Hepatitis C DUR Recommendations Ribavirin and interferon do not currently require prior authorization. All patients treated with oral ribavirin between May 1, 2011 and July 31, 2011 have a diagnosis of chronic hepatitis C and are on concomitant interferon therapy. Therefore, prior authorization for oral ribavirin with therapeutic criteria is NOT recommended at this time. 41 Hepatitis C DUR Potential for Cost Savings Currently 26 out of 29 patients are using generic ribavirin 200mg tablets or capsules which are the most cost effective dosage forms. Three (of the 26) of these patients switched from RibaPak to generic ribavirin during the time frame of this study. Three patients are still using Ribapak or Ribasphere (400mg or 600mg) tablets. 42 Hepatitis C DUR Cost Savings Example Patient switched from using Ribapak 600-600 (two 600mg tablets) to using six ribavirin 200mg tablets daily [same daily dose of 600mg twice daily]. Per 28 days of therapy: $1566 vs. $168 Per year of therapy: $20,414 vs. $2190 43 Hepatitis C DUR Incivek and Victrelis New class of medications recently approved by the FDA – Protease Inhibitors for chronic hepatitis C Triple combination with oral ribavirin and injectable interferon. Improves likelihood of attaining sustained virologic response (SVR). 44 Hepatitis C DUR Incivek – triple therapy with ribavirin and interferon for 12 weeks followed by double therapy with ribavirin and interferon for an additional 12-36 weeks depending on viral response and prior response status. Victrelis – triple therapy with ribavirin and interferon for 28-36 weeks with potential continuation of ribavirin and interferon through week 48 depending on viral response and prior response status 45 Hepatitis C DUR In treatment-naïve patients, incidence of achieving SVR (ADVANCE study) Triple therapy with Incivek – 79% Standard ribavirin/interferon therapy – 46% In treatment-naïve patients, incidence of achieving SVR (SPRINT-2 study) Triple therapy with Victrelis – 66% Standard ribavirin/interferon therapy – 38% Cost of therapy per month: Incivek $18,560 Victrelis $4,984 Currently requires prior authorization as a New Drug. Initial approval for 12 weeks Will be reviewed by P&T Committee in the future. 46 Hepatitis C DUR Prior Authorization requests from the FDA approval date of Victrelis (5/13/2011) and Incivek (5/23/2011) were reviewed. There were 17 approved requests. 2 for Victrelis 15 for Incivek 2 patients never filled any prescriptions. 1 for Victrelis 1 for Incivek Neither filled a prescription for ribavirin or interferon either. All patients that filled prescriptions for Victrelis/Incivek also filled prescriptions for ribavirin and interferon for the same timeframe. 47 Hepatitis C DUR Summary Not recommending prior authorization for generic ribavirin Recommend continuing to require prior authorization for Incivek and Victrelis 48 Transdermal Testosterone DUR Rationale for this DUR Project P&T Committee recommended implementing therapeutic criteria, including serum testosterone levels, for the Transdermal Testosterone drug class Patient Selection Patients with at least one paid claim for transdermal testosterone between June 1, 2010 and June 26, 2011 N=123 (122 male, 1 female with 1 fill) 49 Transdermal Testosterone DUR Patient Demographics 40 37 # of Patients 35 28 30 23 25 20 15 10 17 10 8 5 0 18-20 21-30 31-40 41-50 51-60 61-70 Age 50 Transdermal Testosterone DUR Product Selection Preferred agents Androgel Androderm Patches n=91 n=31 Non-preferred agents Testim Gel Fortesta Gel Axiron Underarm Solution n=1 n=0 n=0 51 Transdermal Testosterone DUR Patient Diagnoses ICD-9 257.x ICD-9 259.9 ICD-9 302.7x ICD-9 607.84 hypogonadism unspecified endocrine disorder low libido erectile dysfunction 52 Transdermal Testosterone DUR Patient Diagnoses # of patients 80 60 60 50 40 20 2 3 8 0 hypogonadism (2 patients also had ICD-9 for low libido and 4 patients also had ICD-9 for erectile dysfunction) unspecified endocrine disorder low libido (without hypogonadism diagnosis) erectile dysfunction (without hypogonadism diagnosis) no applicable diagnosis listed in electronic profile 53 Transdermal Testosterone DUR Potential Cost Savings $133,447 paid in claims for the study period If only paid claims for patients with diagnosis of hypogonadism (n=50), cost savings would be $79,200. Reference Testosterone Therapy in Adult Men with Androgen Deficiency Syndromes: An Endocrine Society Clinical Practice Guideline. Journal of Clinical Endocrinology & Metabolism, June 2010, Vol 95(6):2536-2559. Evidence based guideline was developed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system to describe the strength of recommendations and the quality of the evidence. 54 Transdermal Testosterone DUR Diagnosis of androgen deficiency in men Consistent symptoms and signs Note: Idaho Medicaid does not authorize payment for medications for sexual dysfunction so patient must be having other symptoms such as losing secondary sex characteristics, low bone mineral density, height loss Unequivocally low serum testosterone level 55 Transdermal Testosterone DUR More specific symptoms and signs of androgen deficiency in men As defined by the Endocrine Society Incomplete or delayed sexual development, eunuchoidism Reduced sexual desire (libido) and activity Decreased spontaneous erections Breast discomfort, gynecomastia Loss of body (axillary and pubic) hair, reduced shaving Very small (especially <5ml) or shrinking testes Inability to father children, low or zero sperm count Height loss, low trauma fracture, low bone mineral density Hot flushes, sweats Idaho Medicaid does not cover for the s/s underlined 56 Transdermal Testosterone DUR Less specific symptoms and signs of androgen deficiency in men As defined by the Endocrine Society Decreased energy, motivation, initiative, and self-confidence Feeling sad or blue, depressed mood, dysthymia Poor concentration and memory Sleep disturbance, increased sleepiness Mild anemia (normochromic, normocytic, in the female range) Reduced muscle bulk and strength Increased body fat, body mass index Diminished physical or work performance As these symptoms/signs are quite non-specific, need to have these in conjunction with at least one symptom/sign from previous slide. 57 Transdermal Testosterone DUR Diagnosis of androgen deficiency in men Consistent symptoms and signs Unequivocally low serum testosterone levels: Defined as a morning level below the normal range as defined by the testing laboratory (the lower limit of normal testosterone is approximately 280-300ng/dl but may vary slightly between laboratories). Serum testosterone levels exhibit a circadian variation with peak values in the morning. Confirm low testosterone concentration in men with an initial testosterone level in the mildly hypogonadal range because 30% of such men may have a normal testostosterone level on repeat measurement. 58 Transdermal Testosterone DUR Contra-indications to therapy with testosterone Breast or prostate cancer Palpable prostate nodule or prostate-specific antigen (PSA) > 4ng/ml [or > 3ng/ml in African Americans or men with first degree relative with prostate cancer] Hematocrit > 50% Untreated severe obstructive sleep apnea Severe lower urinary tract symptoms Uncontrolled or poorly controlled heart failure 59 Transdermal Testosterone DUR Follow-Up Laboratory Determination in 3-6 months Achieve testosterone level during treatment in the midnormal range; test 3-6 months after therapy has started Then Annual Monitoring Assess whether symptoms have responded to treatment Assess whether patient is suffering any adverse effects Assess adherence to therapy 60 Transdermal Testosterone DUR Duration of Therapy For patients with a start and stop date within this study period (defined as first fill after July 1, 2010 and last fill prior to May 26, 2011) N=65 61 Transdermal Testosterone DUR Number of Prescriptions 35 32 # of patients 30 25 20 15 11 11 10 5 2 1 3 4 4 1 1 1 1 0 1 2 5 6 7 8 9 10 11 12 # of fills 62 Transdermal Testosterone DUR # of patients Duration with respect to diagnosis 20 18 16 14 12 10 8 6 4 2 0 hypogonadism 1 2 3 4 low libido or ED 5 6 7 # of fills 8 No applicable diagnosis 9 10 11 12 63 Transdermal Testosterone DUR Recommendations Initiate therapeutic criteria for transdermal testosterone Diagnosis of hypogonadism At least one non-sexual dysfunction symptom Serum testosterone level below the lower limit of normal range (should we require a second level if the first level is barely under the lower limit of the normal range?) Contact prescribers of current patients receiving transdermal testosterone (prescription filled within the last 60 days?) informing them of the therapeutic criteria and requesting documentation of the points listed above. For study period, would be 35 Androgel patients and 18 Androderm patients but will run more recent list. 64 Transdermal Testosterone DUR Recommendations, continued Initial approval would be for six months Then follow-up serum testosterone level would be required (should be in mid-normal range). Subsequent approvals would be for one year. Requirements for annual renewal would be: Documentation that symptoms have responded to treatment Documentation that patient is not experiencing adverse effects Assessment of adherence to therapy 65 Transdermal Testosterone DUR Proposed testosterone DUR letter paragraph: Your patient, NAME, has a paid pharmacy claim for a topical testosterone agent within the last 60 days. Idaho Medicaid’s Pharmacy and Therapeutics Committee recommended that prior authorization with therapeutic criteria be added to the topical androgenic drug class. Idaho Medicaid’s Drug Utilization Review (DUR) Board reviewed usage from June 2010 to June 2011 and only 41% of the patients who received a topical testosterone agent had a documented diagnosis of hypogonadism in their electronic profile. Effective DATE, prior authorization with therapeutic criteria will be required for this drug class. Patients will be approved for therapy if they have (1) diagnosis of hypogonadism, (2) documented serum testosterone level that is below the lower limit of the normal range, and (3) clinical signs/symptoms of hypogonadism. If you wish for your patient to continue topical testosterone therapy, please complete the attached prior authorization form and submit to Idaho Medicaid. 66 Oral Terbutaline Utilization FDA Drug Safety Communication: New warnings against use of terbutaline to treat preterm labor On February 17, 2011, the Food and Drug Administration (FDA) released a Safety Announcement addressing the use of terbutaline for preterm labor and the potential adverse effects it can have on the mother. A review of Idaho Medicaid Recipients showed that between 5/1/2011 and 7/31/2011 there was a total of 28 female recipients between the ages of 10-55 who received prescriptions for terbutaline. 67 Oral Terbutaline Utilization Review of the data included female patients between the ages of 10-55, n=28. Female patients < 10 years or > 55 years: 1 - 62 year old No male patients 23/28 patients had a pregnancy diagnosis in the electronic profile. Average age 27 years (range 19-37) 1 fill – 22 2 fills – 5 3 fills – 1 Average fill was for 35 tablets (range 3-90) 68 Oral Terbutaline Utilization Prescribers 1 1 OB/GYN 7 Family Practice Legal Medicine 19 NP (works in OB?GYN office) 69 Oral Terbutaline Utilization For multiple patients per office 2 6 2 OB/GYN Boise OB/GYN Idaho Falls OB/GYN Twin Falls OB/GYN Coeur d'Alene 5 70 Oral Terbutaline Utilization All others were one patient per office: Family Practice in Cottonwood, Emmett, Mountain Home, Rexburg (2 different practices); Newport, WA OB/GYN in Boise, Montpelier, Pocatello; Logan, UT; Pullman, WA Legal Medicine in Twin Falls No address available for one office 71 Oral Terbutaline Utilization Based off this manual review of profiles by the State of Idaho Pharmacist, profiles were run for the time period of July 1, 2011 through September 30, 2011 and 24 patients were identified. Letters will be generated and sent out to those prescribers who have prescribed terbutaline along with the FDA Safety Announcement and specific detailed question form. (See packet) Currently there is no Therapeutic Criteria for oral terbutaline, only pays within the age/quantity limits. 72 Proposed Studies for Next Quarter: Citalopram high dose Oral Terbutaline Intervention Injectable Atypical Antipsychotics P&T Committee Narcotic Analgesic Studies Synagis 2010-2011 Season Update on the impact of using the 2009 revised American Academy of Pediatrics (AAP) recommendations for infants with gestational age between 32 to 35 weeks. Leukotrienes vs. inhaled corticosteroids in children with asthma 73 Citalopram High Dose DUR FDA Drug Safety Communication: Abnormal heart rhythms associated with high doses of Celexa (citalopram hydrobromide) On August 24, 2011, the Food and Drug Administration (FDA) released a Safety Announcement addressing the high dose of citalopram and potential adverse effects it can have on the heart. The maximum daily dose is now recommended to be 40 mg per day when it was previously 60 mg per day. A review of Idaho Medicaid Recipients showed that during the previous 3 months 234 recipients had received doses greater than 40 mg per day. 74 Citalopram High Dose DUR Letters were sent out on 10/6/2011 to 186 prescribers with a list of their patients along with the FDA Safety Announcement and Survey Response Form. (see Letter and Announcement in Packet) Results will be presented at the next DUR Board Meeting. 75 Injectable Atypical Antipsychotics Invega® Sustenna® and Risperdal® Consta® Indications Agent Indication Invega® Sustenna® Acute and Maintenance Treatment of Schizophrenia Risperdal® Consta® Treatment of Schizophrenia Risperdal® Consta® Mono or Adjunct therapy to Lithium or Valproate in Bipolar I Disorder Utilization Overview Agent Recipients Invega® Sustenna® 106 Risperdal® Consta® 148 Oral Agents 6936 Patients Receiving Both Oral and Injectable – 1st Quarter 2011 148 *Idaho Medicaid Data 4th Quarter 2010 (10/1/2010-12/31/2010) 76 Injectable Atypical Antipsychotics Invega® Sustenna® and Risperdal® Consta® Responsibilities of the parties involved Magellan Run reports to identify Prescribers, Pharmacies, and Patients Idaho Medicaid Pharmacy Unit Analyze reports and identify where intervention is needed Idaho Medicaid Program Integrity Send out letters requesting documentation of dose administration 77 P&T Committee Narcotic Analgesic Studies Committee Recommendation for Drug Utilization Review of Narcotic Analgesics The Committee recommended a comprehensive drug utilization review of short and long-acting narcotics. This was based on concern over the misuse/abuse of these agents that is not addressed through the preferred drug list. Components of the proposed review are outlined below. Patient Profiling Number of patients on monthly (chronic) narcotics Number of different agents used by individual patients Total (cumulative) monthly doses of all concurrent narcotics Number of prescribers per patient Analysis of multiple scripts from multiple providers 78 P&T Committee Narcotic Analgesic Studies Patient Profiling Continued Other addictive drugs prescribed concurrently Diagnosis/indication for narcotic use and data backing that diagnosis Patients with no relevant diagnosis for medication Evaluation for evidence of illicit drug use Relationships of long-acting narcotic use and breakthrough narcotics use (lack of long acting and/or breakthrough narcotics given continuously) Hospital and ER admissions for overdose Prescription fill history, including early refills 79 P&T Committee Narcotic Analgesic Studies Provider Profiling Prescribing pattern for non-pain clinic prescribers They also suggested utilizing several data sources outside Medicaid including outlier reports from the Board of Pharmacy Prescription Drug Monitoring Program, legal/arrest databases and hospital discharge medication records. 80 P&T Committee Narcotic Analgesic Studies Possible policy changes suggested for consideration after collection and analysis of the data Restriction of prescriptions to prescribers and pharmacies within Idaho state borders Stricter refill policies (90% rather than current 75% threshold) Expansion of lock-in program 81 P&T Committee Narcotic Analgesic Studies Please refer to Narcotic Spreadsheet in Packet for details. 82 Synagis Utilization Intervention Update using the 2010-2011 RSV season data on the impact of using the 2009 revised American Academy of Pediatrics (AAP) recommendations for infants with gestational age between 32 to 35 weeks. Profiles will be reviewed to assess outcomes Leukotrienes vs. inhaled corticosteroids in children with asthma Number of recipients < 18 years of age with paid claim for leukotriene from 7/1/2011 – 9/30/2011: 3,369 Number of recipients < 18 years of age with paid claim for Inhaled corticosteroid from 7/1/2011 – 9/30/2011: 1,595 Note: We do not have diagnosis data. 84 2010 Annual DUR Report State name abbreviation: ID Medicaid Agency Information Tami Eide, Pharm.D., BCPS Magellan Medicaid Administration Prospective DUR Comes from First Data Bank DUR criteria approved by DUR Board Currently reviewing criteria How do pharmacists handle ProDur messages? Early Refills (Prior Authorizations) Non-controlled as well as Controlled 85 2010 Annual DUR Report Prospective DUR, continued Therapeutic Duplications (Prior Authorizations) Prospective criteria reviewed by the Board (Table 1) Prospective DUR Review Summary (Attachment 1) Prospective DUR Pharmacy Compliance Report (Attachment 2) Retrospective DUR ISU College of Pharmacy/Magellan Medicaid Administration Retrospective DUR Board Approved Criteria (Attachment 3) 86 2010 Annual DUR Report Physician Administered Drugs Deficit Reduction Act requires collection of NDC numbers for covered outpatient physician administered drugs. Has MMIS been designed to incorporate this data into DUR for both Prospective and Retrospective DUR? DUR Board Activity Summary Report of activities/meetings (Attachment 4) DUR Board Involvement Disease Management Program Medication Therapy Management 87 2010 Annual DUR Report Generic Policy and Authorization Data Generic Drug Substitution Policies (Attachment 5) Generic Utilization Percentage: 70% Generic Expenditure Percentage: 17% Program Evaluation/Cost Savings Cost Savings Estimate (Attachment 6) Prospective DUR Retrospective DUR Total Savings $4,879,377 $463,187 $5,342,564 88 2010 Annual DUR Report Fraud, Waste, and Abuse Detection Does the State have ways to identify fraud or abuse of controlled drugs by recipients, prescribers, and/or providers? Prescription Drug Monitoring Program (Attachment 7) Innovative Practices E-Prescribing Executive Summary 89 Prospective DUR Report History Errors: • DD – drug-to-drug • PG – drug to pregnancy • TD – therapeutic duplication • ER – early refill • MC – drug-to-disease Non-History Errors: • PA – drug-to-age • HD – high dose • LD – low dose • SX – drug-to-gender 90 Prospective DUR Report Idaho Medicaid Program ProDUR Message Report Sep-11 ProDUR Message Drug To Drug Drug To Gender Drug To Known Diseas Drug To Pregnancy Duplicate Therapy Min Max Too Soon Clinical ALL ProDUR Severity 1 2 3 1 2 1 2 3 1 2 A B C D X 0 0 0 Message Count 4,812 11,760 55,682 117 37 57,898 217,811 249,187 22 6 10 71 153 34 26 102,499 34,089 19,391 Message Amount $710,509.70 $1,848,784.75 $8,568,836.29 $34,305.95 $2,836.30 $7,308,213.91 $31,264,134.87 $39,299,697.37 $419.72 $99.93 $174.59 $5,329.99 $12,086.68 $668.50 $1,436.76 $18,771,054.83 $5,130,125.40 $3,472,743.89 753,605 $116,431,459.43 Total Number of Claims with Messages 194,477 Average ProDUR Message Per Claim 3.88 91 Drug to Pregnancy Encounters Drug-to-Pregnancy Encounter User FDB Severity FDB Description Severity 1 Contraindicated or not recommended 1 User Severity Description Major 2 A Precautions or warnings Adequate and well controlled studies have failed to demonstrate a risk to the fetus in st the 1 trimester of pregnancy, and no risk in later trimesters. 2 3 Moderate Minor B Animal studies have failed to demonstrate a risk to fetus but there are no well controlled studies in pregnant women. 3 Minor C Studies in humans or animals have shown fetal abnormalities and/or there is positive evidence of fetal abnormalities. 2 Moderate D Positive evidence of human fetal risk based on investigation or marketing information but potential benefits may warrant use in pregnant women despite potential risks. Studies in humans or animals have shown fetal abnormalities and/or there is positive evidence of fetal abnormalities. 2 Moderate 1 Major X 92 Drug to Pregnancy Encounters Currently we report all severity levels for pregnancy and severity level 1 is set to reject Severity Level 1 = Major = Not Recommended in pregnancy Severity Level 2 = Moderate = Evaluate carefully if pregnant Severity Level 3 = Minor = No known risk in pregnancy Please see attached handout for specific details as it relates to specific medications 93 DUR Fall Newsletter Copy of Summer Newsletter in packet Brainstorm for new topics 94 Medicaid Update 95