D Drug Sho ortage Aleert: Glyco opyrrolatee (Robinu ul®) Soluttion for In njection Background1‐3 Glycopyrrolate is an anticholinergic medication used in hospice and ppalliative care tto manage secretions, including piratory secretions, as well ass to reduce sym mptoms of coliicky pain/gastrrointestinal (GI) spasm and secretions terminal resp associated w with malignant bowel obstrucctions. Many prresentations, bboth branded aand generic, off glycopyrrolatte (Robinul®) so olution for injection are curre ently in shortagge. Manufactuurers of glycopyyrrolate have n not provided a specific reason for th he shortage, bu ut ongoing consolidations in tthe generic inj ectables marketplace have b been a root cau use of shortages of generic injectaables used in o oncology practiice, and hospicce and palliativve care in recent years. Price impactt: average wholesale price (AW WP) and whole esale acquisitioon cost (WAC) for glycopyrro olate products have greatly increaased as the sho ortage progressses; expect this trend to con tinue into 20155. Supply inform mation: neithe er West‐Ward n nor American Regent have p rovided estimaated resupply dates. Glycopyrrola ate Products A Affected by Sho ortage & Curre ently Unavailabble G Glycopyrrolate 0 0.2 mg/mL injecttion, A American Regent 11 mL vial (NDC 00517‐4601‐25) 22 mL vial (NDC 00517‐4602‐25) Glycopyrrrolate 0.2 mg/m mL injection, Weest‐Ward 20 mL vial (NDC 00143‐9 9679‐10) Robinul 0.2 mg//mL injection, W West‐Ward 1 mL vial (NDC 000641‐6104‐25)) 2 mL vial (NDC 000641‐6105‐25)) 5 mL vial (NDC 000641‐6106‐25)) 20 mL vial (NDC C 00641‐6107‐100) Glycopyrrola ate Products A Available in Lim mited Supply G Glycopyrrolate 0 0.2 mg/mL injecttion, American R Regent 55 mL vial (NDC 00517‐4605‐25) 220 mL vial (NDC 00517‐4620‐25)) Glyco opyrrolate 0.2 m mg/mL injection, West‐Ward 1 mL vial (NDC 001433‐9682‐25) 2 mL vial (NDC 001433‐9681‐25) 5 mL vial (NDC 001433‐9680‐25) Recomme endations2‐7 M Malignant Bow wel Obstruction n: The go oal of medical management ffor patients with an intestinaal obstruction iis to decrease pain, nausea aand distention by decreaasing the amou unt of secretion ns flowing intoo the bowel. Fo or irreversible aand complete bowel obstru uction, a trial o of an anticholin nergic/antispassmodic may deecrease bowel contractions aand provide pain relief. Parenteral opioids, corticostteroids, and an nti‐emetics shoould be added to relieve pain n and nausea. ntinue medicattions which maay affect GI mo otility or worseen symptoms: sstimulant laxattives, lactulosee, Discon polyetthylene glycol. Continue or in nitiate metoclo opramide (Regllan®) only if a ppartial obstrucction is suspectted; docusate (Colace®) m may also be usseful in the settting of partial oobstructions. omatostatin an nalog octreotid de (Sandostatin n®) has shown benefit for pattient symptom ms refractory to o The so other therapies. Octreotide may be ineffective as a sole pharm macotherapy an nd may have im mproved efficaacy in n anticholinerggic medication and/or corticoosteroids. combiination with an TTerminal Secretions: Drugs that decrease secretions are e best initiated at the first siggn of death rattle as they do not affect existing respiraatory secretion ns. These agents have limited d or no impact t when the secrretions are seccondary to pneeumonia or pulmonary edemaa. No medication will dry exissting secretionns, but may red duce accumulaation of new seecretions. holinergic drugs remain the standard of the erapy for preveention and treaatment of term minal secretion ns due to Antich their aability to effecttively reduce secretions. All drugs used forr this indication n are similar ph harmacologicaally; select by antticholinergic po otency, onset o of action, route e of administraation, alertness of patient, an nd cost. While shorta age of glycopyrrrolate continu ues, reserve usse of glycopyr rolate for man nagement of syymptoms of m malignant bowel obstru uction. Use mo ore cost effecttive anticholine ergic medicatiion options if n needed to man nage terminal secretions. SSee chart on ne ext page. Please conta act your HospiSScript clinical p pharmacist forr assistance in managing pattient symptom ms and for recommenda ations of thera apeutic alterna atives should yyou encounter supply shorta ages of necessa ary medication ns. Non Pharrmacologic Trreatment of TTerminal Secrretions3 Inform and e educate the fam mily about whaat to expect du uring the dyingg process. Always continue good mou uth care – genttle swabbing w with moistened oral swabs (To oothettes®) ass needed. Position the patient on his//her side or in a semi‐prone p position to fac ilitate drainingg of secretions. Oropharynge eal suctioning iis not usually recommended as it may be d isturbing to bo oth the patientt and visitors. © 2014, HospiScript Servvices druginformatiion@hospiscrip pt.com w www.hospiscrip pt.com D Drug Sho ortage Aleert: Glyco opyrrolatee (Robinu ul®) Soluttion for In njection C Commonly Ussed Anticholinergic Mediccations2‐6 Med dication Usual Dosing Preparaations Hyosccyamine (Levsin/SL®, max‐SL®) Hyom 0.125mg SL evvery 4 hours as needed 0.125mgg SL tabs 0.125mgg PO tabs 0.125mgg/ml oral drops 0.125mgg/5ml elixir Atrop pine 1% Ophth (Isoptto® Atropine) Averagee AWP $0.85/S L tab $39.80//15mL ($2.655/dose) $105/4773mL ($1.100/dose) 2 drops SL eve ery 4 hours as needed 1% ophthalmic solution 0.4mg/m mL soln for injecttion Glyco opyrrolate (Robinul®, Cuvposa®) 0.1‐0.2mg SQ Q/IV every 6 hourss as needed 1mg tabs 2mg tabs 0.2mg/m mL soln for injecttion 1mg/5m mL oral solution (OS) Scopo olamine (Tran nsderm‐Scop®) 1‐2 patches every 72 hours 1.5mg trransdermal patch 0.4mg/m mL soln for injecttion $16.80//5mL ($0.333/dose) $0.80/00.4mg inj $14.40//0.2mg inj $1.30/11mg tab $2.20/22mg tab $5.40/55mL OS $17.95//patch $7.95/00.4mg inj Co omments U Use of SL tabs is ccurrently the mo ost cost eeffective treatmeent option for teerminal seecretions, unless ordering 20 orr more SL tabs Iff patient’s mouth is dry and hypopharyngeal seecretions persist, may give SL taab with few ddrops of water to o help dissolve tabs TTends to be easieest for caregiverrs to use M Must clearly instrruct not to placee drops in eye 22 drops is approxx. 1mg of atropin ne when using on at 20 drops/m mL 11% ophth. solutio M MOST INJECTABLLE PRODUCTS IN N SHORTAGE Low bioavailabilitty via oral or sub blingual routes; nnot recommendeed for terminal ssecretions Sublingual use off injectable not rrecommended O Oral solution (1m mg/5mL) is brand d only M MOST INJECTABLLE PRODUCTS IN N SHORTAGE D Delayed onset off action (4‐6 hou urs) for trransdermal patcch can reduce efffectiveness of trreatment D Do NOT cut patch hes Averagee Wholesale Price (AWP) P) current as of Novembeer 10, 2014 5 O Octreotide (Sandostatin®)): Basic Drug Information5‐7 Med dication Usual Dosing Preparattions Avverage AWP Commentts Octreeotide (Sand dostatin®, Sando ostatin® LAR) Off‐la abel use for pallia ation of malig gnant bowel obstrruction7 50‐100mcg SQ//IV every 8 hours; may titrate to 100‐300mcg urs; every 8‐12 hou Continuous SQ Q infusion: 10‐40mcg/hour 50mcg/mL (1mL) 100mcg/m mL (1mL) 200mcg/m mL (5mL) 500mcg/m mL (1mL) 1000mcg//mL (5mL) $5.40/50mcg $ $9.50/100mcg $ $2 23.90/200mcg $2 24.50/500mcg $1 119.25/1000mcgg Octreotidee mimics naturaal somatostatin b by inhibiting release off serotonin and iinhibiting secrettion of gastrin, VIP, insulin, glucagon, seccretin, motilin an nd pancreatic polypeptidde LAR depott injection is nott recommended for acute symptom management off malignant bow wel obstruction LAR depott injection for inttramuscular adm ministration only y SQ: Use cooncentration witth smallest volume to deliver dose to reeduce injection ssite pain. Rotatee injection site; bring to rooom temperaturre prior to injecttion Averagee Wholesale Price (AWP) P) current as of Novembeer 10, 2014 References merican Society of Health‐systems Pharmacists (ASHP). Drug shhortages: Currennt shortages. Acccessed Novembeer 10, 1. Am 20 014. Available att: http://www.asshp.org/DrugShortages/Currentt/Bulletin.aspx?iid=385 2. Jaackson KC. Bowe el obstruction. In n: Grauer P, Shusster J, Protus BM M. Palliative Caree Consultant.3rd ed. Ohio Hospicce and Paalliative Care Orgganization: Kend dall/Hunt; 2008::56‐61 3. Prrotus BM, Graueer PA, Kimbrel JM M. Evaluation of atropine 1% op hthalmic solutioon administered sublingually forr the management of t m erminal respirattory secretions. A Am J Hosp Palliaat Med 2013; 300(4):388‐392 4. Do olan E. Malignan nt bowel obstrucction: a review o of current treatm ment strategies. Am J Hosp Pallia at Med 20 011;28(8):576‐58 82 5. vo on Gunten CF, M Muir JC. Medical management off bowel obstructtion, 2nd ed. Fastt Facts and Conccepts. August 20005;45. Avvailable at: http:://www.eperc.m mcw.edu/EPERC//FastFactsIndex//ff_045.htm 6. Le exi‐Drugs Online e. Hudson, OH:Le exi‐Comp, Inc. Accessed Novembber 10, 2014. 7. Naational Compreh hensive Cancer N Network (NCCN)). NCCN clinical ppractice guidelinnes in Oncology (NCCN guidelinees). Paalliative care. V1 1.2014. Available e at: http://www w.nccn.org/profeessionals/physiccian_gls/f_guidelines.asp#suppo ortive © 2014, HospiScript Servvices druginformatiion@hospiscrip pt.com w www.hospiscrip pt.com
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