Glyco D opyrrolate Drug Sho e (Robinu ortage Ale ul®) Solut ert

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