Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
Download Emerging technologies in MAT care
Document related concepts
Transcript
EMERGING TECHNOLOGIES IN MAT MEDICATION DELIVERY William Roberts, RN, CRNA, MD, PhD Diplomat, American Board of Addiction Medicine Diplomat, American Board of Anesthesiology None CONFLICTS OF INTEREST THIS TALK IS ABOUT EXPENSIVE OPTIONS, SO LETS START WITH: WHY SOCIETY SHOULD CARE? LOST PRODUCTIVITY IS THE REAL COST DOES MAT WORK? AGONIST AND PARTIAL AGONIST OUTCOMES FOR OPIATE MISUSE DISORDER ARE REAL METHADONE AND BUPRENORPHINE DELIVERY SYSTEMS SHARE A COMMON FLAW: NON-COMPLIANCE UNDERMINES OUTCOMES WHEN TREATMENT IS A “PROBLEM” The “majority of buprenorphine-certified physicians (81%) stated that buprenorphine was easier to buy on the street than methadone”. MOST OFTEN DIVERSION IS A “GIFT” Potential Patients know that “treatment as usual” is time consuming Travel limits access to methadone, especially in rural settings Methadone is frankly less safe when used without guidance Buprenorphine access is rapidly expanding since DATA 2000 Compliance is less time consuming, but still limits employment The drugs are not the problem when delivered in a protocol Access while making an honest living while working is the problem METHADONE VS BUPRENORPHINE AND COMPLIANCE WHY NOT JUST BE PORTUGAL? Twenty-eight instances of IVDA of buprenorphine were detected in a population of 239 of my patients in a two year interval Urinary ratios of buprenorphine to nor-buprenorphine are an indicator of IVDA of buprenorphine* *when obtained consistently and reviewed serially The patients all agreed that they had an issue with injection IVDA OF BUPRENORPHINE IS NOT MAT IVDA OF BUPRENORPHINE IS DANGEROUS Variable uptake and distribution First pass metabolism Diversion Abuse IVDA Inventory Dependency The behavior of taking of a medication frequently PROBLEMS WITH SUBLINGUAL BUPRENORPHINE DELIVERY SYSTEMS So there has been a lot of activity directed at alternative delivery systems The emphasis has been identifying options that patients do not control Most of the issues have been shifted into the cost column Disposal becomes a larger issue Surgical techniques required Patients won’t like this LONG TERM DELIVERY SYSTEMS SOMETIMES IT IS JUST THE SAME OLD HORSE BUTRANS FEATURES 7-DAY TRANSDERMAL MATRIX TECHNOLOGY buprenorphine is delivered (5, 7.5, 10, 15, or 20 mcg/hour Issues: Residual drug content is high after use Inventory exchange necessary Delivery dose is low Expensive Lack of data regarding efficacy for opioid misuse disorder BUTRANS AS A 7 DAY MAT OPTION? Burtans may have a place in: the weaning and discontinuance of MAT transition to implants patients returning to households with theft risks Transition to naltrexone or antagonists care MAT “END OF CARE” CARE AND TRANSITIONS Endo Pharmaceuticals Inc., a subsidiary of Endo International plc (NASDAQ: ENDP) (TSX: ENL), Announced on June 3, 2016 “new data support the safety and tolerability of BELBUCA™ (buprenorphine) buccal film for the long-term management of chronic pain in patients requiring around-the-clock opioids” HEADLINE: “NEW DATA DEMONSTRATE SAFETY OF LONG-TERM, AROUND-THECLOCK TREATMENT WITH BELBUCA™ (BUPRENORPHINE) BUCCAL FILM FOR CHRONIC PAIN” EFFICACY IS REAL “ALTERNATE” DELIVERY SYSTEMS Eighty-nine (51 women and 38 men); 81 with malignant pain and 8 with benign "refractory" pain. Pumps delivering buprenorphine into the CSF through the skin High rates of infection Placement issues Refill issues Costs Clin J Pain. 1992 Dec;8(4):324-37. INTRATHECAL PUMPS LONGER TERM DELIVERY SYSTEMS Drug eluting implants Each implant consists of ethylene vinyl acetate copolymer and 90 mg buprenorphine HCl, and measures 26 mm in length and 2.4 mm in diameter. Steady-state release in-vitro was 0.5 mg/implant/day. In-vivo pharmacokinetics and safety were examined for up to 52 weeks. Plasma buprenorphine concentrations correlated with the number of implants administered. J Pharm Pharmacol. 2006 Mar;58(3):295-302. IN VITRO TESTING Peak buprenorphine concentrations were generally reached within 24 h after implantation. Steady-state plasma levels were attained between 3 and 8 weeks Steady-state plasma levels were maintained for study duration, with a calculated mean release rate of 0.14+/-0.04 mg/implant/day. J Pharm Pharmacol. 2006 Mar;58(3):295-302. BEAGLE DOGS RECEIVING 8, 16 OR 24 SUBCUTANEOUS IMPLANTS 90 mg buprenorphine HCl x 24 implants = 2.16 Grams of buprenorphine How will the delivery system be installed and by whom? What is the serum dose equivalency in humans to sublingual? Wound complication rates? Who takes the implant out? Disposal of residual drug? Patient selection? Costs? CON ARGUMENTS WARNING: IMPLANT MIGRATION, PROTRUSION, EXPULSION and NERVE DAMAGE ASSOCIATED WITH INSERTION and REMOVAL Risk associated with Insertion and Removal Insertion and removal of PROBUPHINE are associated with the risk of implant migration, protrusion, expulsion, and nerve damage resulting from the procedure. Serious but rare complications including nerve damage and migration resulting in embolism and death may result from improper insertion of drug implants inserted in the upper arm. Additional complications may include local migration, protrusion and expulsion. Incomplete insertions or infections may lead to protrusion or expulsion. All Healthcare Providers must successfully complete a live training program and become certified prior to performing insertion and/or removal of PROBUPHINE implants. Because of the risks associated with insertion and removal, PROBUPHINE is available only through a restricted program called the PROBUPHINE REMS Program. All Healthcare Providers must successfully complete a live training program on the insertion and removal procedures and become certified, prior to performing insertions or prescribing PROBUPHINE implants. Patients must be monitored to ensure that PROBUPHINE is removed by a healthcare provider certified to perform insertions. DEVICES ARE NOT SIMPLE NOR WITHOUT RISKS deterioration of the quality of the cervical mucus and sperm penetration is evident by 24 hours after insertion not to a level that would suggest adequate protection until 72 hours after insertion. Fertil Steril. 1998 Feb;69(2):258-66. THINK “NORPLANT” PROBUPHINE IS ONLY ONE OF FOUR PRODUCTS FROM ONE COMPANY Braeburn Pharmaceuticals: Probuphine The FDA previously rejected Probuphine in 2012, judging the delivered dose was too low to reliably help patients. Federal approval on Thursday, May 26, 2016 Six month implant “implantable format could help patients avoid dangerous relapses that can occur if they miss a medication” http://www.usnews.com/news/business/articles/2016-05-26/fdaapproves-first-drug-oozing-implant-to-control-addiction “FDA APPROVES FIRST DRUG-OOZING IMPLANT TO CONTROL ADDICTION” USNEWS AND WORLD REPORT “Probuphine is intended for patients who have already been stabilized on low-to-medium doses of buprenorphine for at least a half year.” “Braeburn estimates that one fourth, or 325,000, of the 1.3 million patients currently taking buprenorphine meet that criterion.” APPROVED INDICATIONS BRAEBURN IS NOT ALONE INDIVIOR HAS A PIPELINE WHAT IS THE REAL INNOVATION OPTION? Persons aged 65 years and older comprise only 13 percent of the population. Persons aged 65 years and older account for more than onethird of total outpatient spending on prescription medications in the United States. HTTPS://WWW.DRUGABUSE.GOV/PUBLICATIONS/RESEARCHREPORTS/PRESCRIPTION-DRUGS/TRENDS-IN-PRESCRIPTION-DRUGABUSE/OLDER-ADULTS PATTERNS OF PRESCRIPTION OPIOID ABUSE AND CO-MORBIDITY IN AN AGING TREATMENT POPULATION HTTP://WWW.NCBI.NLM.NIH.GOV/PMC/ARTICLES/PMC3217134/ A NEW LINE HAS BEEN DEFINED WHO HAS HAD THEIR PRESCRIPTIONS DISCONTINUED OR REDUCED? BOOMERS GET A POSITION ON THE PLAYING FIELD THIS HAS ALWAYS BEEN AN OLDER PERSON PROBLEM THIS HAS ALWAYS BEEN A PRESCRIPTION PROBLEM Moderate to severe non-withdrawal related bodily pain – that greatly limited social contacts and work – was common in most of those entering treatment: 45% of those 18–24 years reported moderate to severe pain. However, the incidence of this intense pain grew to well over 70% in individuals 45 or older. The huge surge of youthful opioid abusers who began using drugs in the 1993–2010 time-frame have not yet reached the age of 40. Therefore, the number of elderly people seeking treatment should continue to rise over the next 5–10 years HEROIN IS FOR YOUNG PEOPLE…. SO THE NEW TECHNOLOGY OF GREATEST VALUE IS…. Prevention Limit dependence of older patients Limit diversion from aged patients Monitor everyone that has access to opiates/opioids Judge no one, except perhaps ourselves as clinicians LONG TERM SUCCESS WILL BE BASED ON PRACTICE PATTERNS
