Download MONTEFIORE MEDICAL CENTER DEPARTMENT OF PHARMACY

MONTEFIORE MEDICAL CENTER
DEPARTMENT OF PHARMACY
SUBJECT:
Restricted Drugs Policy, Antibiotic Restriction
MANUAL CODE:
PH-R-5
DATE ISSUED:
August, 1976
DATE REVISED:
September 2000, October 2003, September 2006, June 2009, May 2012
APPROVED BY:
Unified Director of Pharmacy
REVIEWED BY/DATE:
__________ _________
__________________________________
_________
_________
The Pharmacy and Therapeutics Committee, in approving the addition of certain antibiotics to the
Formulary, may restrict their use because of toxicity, and in an attempt tominimize antibiotic
resistance. Monitoring of the usage of these antibiotics is the responsibility of the Antibiotic
Subcommittee, the Division of Infectious Diseases, the Antibiotic Stewardship Program and the
Pharmacy Department.
1.
Prescribers wishing to prescribe any restricted antibioticsfrom 8AM to 11PM(Table 1) should
contact the person [a member of Infectious Diseases (ID) or Antimicrobial Stewardship
Program (ASP)] on call for antibiotic approval. The prescribersand member of ID/ASPwill
discuss the appropriateness of the request. If clinically indicated, member of ID/ASPwill call
the pharmacy and provide the following information:
a.
Name of patient
b.
Medical record number
c.
Location of patient
d.
Drug name, dosage, route, administration frequency, and duration of approval
1
e.
Name of antibiotic approver
If the restricted antibiotic has not been approved by a member of ID/ASP, pharmacists must
call the prescribers to inform them that the antibiotic requires ID approval.In instances when
prescribersare unable to reach ID/ASP within one hour, prescribers must call the pharmacy
and ask for two doses to be dispensed to allow for additional time to obtain approval. A list
of these incidents will be generated the following morning by pharmacy for follow up by a
member ID/ASP.
Pharmacists should not automatically dispense the two doses of antibiotic, but should wait for
the return call from prescribers indicating they were unable to reach ID/ASP. If prescribers
do not call back requesting the release of the two doses, no antibiotic should be dispensed.If
ID/ASP does not call the pharmacy to release the restricted antibiotics, no further medication
will be dispensed.
2.
One or two doses of designed restricted antibiotics (Table 1, Category III Antibiotics) can
be dispensed without approval from ID/ASP if requested between 11PM to 8AM.Requests
for these restricted antibioticsmade by Emergency Department prescribers during these
hours must include a Restricted Antimicrobial Request Form. Pharmacists should remind
prescribers that approval must be obtained (as outlined in Section 1) for continuation of
therapy.
3.
Upon receipt of an order for a restricted antibiotic, pharmacists should verify the order only
if ID approval has been obtained.
If ID approval is pending, the medication order should not be verified, and pharmacists
should follow the procedure outlined in Section1 above.
Once ID approval is obtained, the medication order should be verified by pharmacists, and
the appropriate number of doses sent to the patient unit. Pharmacists should modify the
antibiotic orders to match the dose, route, frequency, and duration of approval.
4.
The following adjustments in restricted antibiotic therapy are regarded as new orders and
will require new approval as described in Section 1:
a.
b.
c.
d.
5.
Increased dose of the drug
Increased frequency of administration
Increased (extended) duration
Changing from the oral to the parenteral route of administration.
The Director for Clinical and Educational Pharmacy Services will ensure that restricted
2
antibiotics are approved by the responsible departments through scheduled Pharmacy
Performance Improvement Initiatives.
5.1
It is the responsibility of pharmacists on duty to ensure each restricted antibiotic is
approved by ID or ASP in a timely fashion.
5.2
The list of Restricted Antibiotics (Table 1) is updated as necessary. It is distributed
to Department of Pharmacy staff, Division of Infectious Diseases and posted on
Formulary Advisor under “Pharmacy Information”.
Table 1. List of Antimicrobials Requiring Infectious Diseases Approval as of May 2012
ANTIMICROBIAL
ROUTE
COMMENTS
Category I - I.D. approval and consultation must be requested when given to adults.
These generally should not be started during the overnight hours.
ampho B deoxycholate
IV
None
ampho B lipid formulations IV
None
chloramphenicol
IV
The oral formulation is no longer made in the U.S., and is unavailable
cidofovir
IV
None
daptomycin
IV
None
fidaxomicin
Oral
None
flucytosine
Oral
None
foscarnet
IV
None
imipenem
IV
None
linezolid
IV and oral
Patients are automatically switched to the oral formulation when able to take oral medications
ID consultation is not required for 50 mg daily doses in allogeneic stem cell recipients who require
micafungin
IV
antifungal prophylaxis
Can also be approved by Pediatric Hematology-Oncology for prophylaxis of Pneumocystis jirovecii
pentamidine
IV
pneumonia
polymyxin B
IV
None
tigecycline
IV
None
amantadine
oseltamivir
rimantidine
acyclovir
albendazole
amikacin
Oral
Oral
Oral
Category II - I.D. approval must be requested when given to adults.
A consultation is suggested, but not required.
Approval is not required for Parkinson’s disease
None
None
Category III - I.D. approval must be requested from 8 A.M. to 11 P.M., but one or two doses may be
dispensed from 11 P.M. to 8 A.M. without approval when being given to adults.
Can also be approved by Dermatology; approval is not required for the oral formulation, or for 250
IV
mg IV q12h prophylaxis doses in stem cell recipients unable to take oral valacyclovir
Oral
None
IV and IM
None
3
azithromycin
aztreonam
cefepime
cefotaxime
ceftriaxone
IV
IV
IV
IV
IV
ciprofloxacin
IV
clarithromycin
Oral
fluconazole
IV and oral
ganciclovir
itraconazole
ivermectin
meropenem
IV
Oral
Oral
IV
moxifloxacin
IV
piperacillin-tazobactam
posaconazole
tobramycin
IV
Oral
Inhalation
IV, oral, and
rectal
IV and oral
vancomycin
voriconazole
Approval if not required for Pediatrics, and for the oral formulation.
None
Can also be approved by Oncology and Critical Care for their own patients
For Pediatrics only (ceftriaxone should be used for adults)
Approval is not required for doses up to 1000 mg per day
Approval is not required for peri-operative LVAD surgery prophylaxis for up to 48 hours, for
prophylaxis doses in stem cell recipients, and for the oral formulation; patients are automatically
switched to the oral formulation when able to take oral medications
Approval is not required for the treatment of patients with Mycobacterium avium and H. pylori
infections
Approval is not required for AIDS patients and for prophylaxis in stem cell recipients receiving up to
400 mg per day, for peri-operative LVAD surgery up to 200 mg per day and 48 hours, and for single
150 mg oral doses for candidal vaginitis; patients are automatically switched to the oral formulation
when able to take oral medications
Approval is not required for the oral formulation
Can also be approved by Dermatology; the intravenous formulation is non-formulary
None
For Pediatrics only (imipenem should be used for adults)
Approval is not required for the oral formulation; patients are automatically switched to the oral
formulation when able to take oral medications
Approval is required only for patients in the Emergency Room and on Vascular Surgery
None
Approval is not required for the IV and IM formulations
Approval is not required for the initial 72 hours of the IV formulation; after that, approval is required
and should be made only with confirmatory culture results or on strong clinical grounds
None
4