DEPARTMENT OF PHARMACY MONTEFIORE MEDICAL CENTER SUBJECT: MANUAL CODE: Restricted Drugs Policy, Antibiotic Restriction PH-R-5 DATE ISSUED: August, 1976 DATE REVISED: September 2000, October 2003, September 2006, June 2009, May 2012, May 2015, July 2015, August 2015, May 2016, November 2016, January 2017 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 to minimize 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 antibiotics during designated hours of restriction (see Table 1 for hours of restriction according to division) should contact the designated person [a member of Infectious Diseases (ID) or Antimicrobial Stewardship Program (ASP)] on call for antibiotic approval. Table 1. Hours of Restriction by Division Division / Patient Population Days of Restriction Hours of Restriction Moses and Einstein 7 days per week 8 AM to 11PM Wakefield Weekdays* (excluding official holidays) 9:30 AM to 5 PM Pediatric and NICU Patients 7 days per week 8 AM to 11 PM *ID consultation must still be obtained for drugs requiring mandatory consult within 24 hours The prescribers and member of ID/ASP will discuss the appropriateness of the request. If clinically indicated, member of ID/ASP will either place approval note under stewardship ABX approval note in Epic or 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 e. Name of antibiotic approver 1
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 and enter as intervention (Ivent) in Epic. In instances when prescribers are 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 of 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. A limited number of doses (i.e. sufficient to maintain patient until stewardship hours resume) of designated, restricted antibiotics (Table 3, Category III Antibiotics at Moses and Einstein Divisions) can be dispensed without approval from ID/ASP if requested during non-stewardship hours (see table 2). Pharmacists should remind prescribers that approval must be obtained (as outlined in Section 1) for continuation of therapy. Table 2. Hours During Which Limited Doses May Be Dispensed Division / Patient Population Day Time Moses and Einstein 7 days per week 11PM 8AM Wakefield Monday Friday Weekends Holidays 5:00PM 9:30 AM All hours All hours CHAM 7 days per week 11PM 8AM 3. Upon receipt of an order for a restricted antibiotic, pharmacists should verify the order only if ID approval has been obtained as per ABX approval note in Epic. If ID approval is pending, the medication order should not be verified, and pharmacists should follow the procedure outlined in Section 1 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. Increased dose of the drug b. Increased frequency of administration c. Increased (extended) duration d. Changing from the oral to the parenteral route of administration. 2
5. The Director for Clinical and Educational Pharmacy Services will ensure that restricted 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 lists of Restricted Antibiotics (Tables 3-6) are updated as necessary. They are distributed to Department of Pharmacy staff, Division of Infectious Diseases and posted on pharmacy and Infectious Diseases intranet sites Reviewed by: Yi Guo, PharmD Nidhi Saraiya, PharmD Philip Lee, PharmD Belinda Ostrowsky, MD Priya Nori, MD Vijaya Soma, MD 3
Table 3. Restricted Antimicrobial List for Moses and Einstein (Adults) as of March 2017 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 Ampho B lipid formulations Artemether/lumefantrine PO Ceftaroline Ceftazidime/avibactam Ceftolozane/tazobactam Chloramphenicol (The oral formulation is no longer made in the U.S.) Cidofovir Daptomycin Fidaxomicin PO Flucytosine PO Foscarnet Fosfomycin PO IG Need ID approval/consult for any infectious diseases indications (i.e. C. difficile colitis, group A streptococcal or MRSA toxic shock syndrome). Linezolid, PO (Patients are automatically switched to the oral formulation when able to take oral medications) Meropenem Micafungin ID consultation/approval is not required for 50 mg daily doses in allogeneic stem cell recipients who require antifungal prophylaxis. Pentamidine Polymyxin B Pyrimethamine PO Ribavirin Inhalation Tigecycline Voriconazole, PO Category II - I.D. approval must be requested when given to adults. A consultation is suggested, but not required. Oseltamivir Oral 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. Acyclovir Approval is not required for 250 mg q12h prophylaxis doses in stem cell recipients unable to take oral valacyclovir. Albendazole PO Amikacin, IM Azithromycin Approval not required for 1 st dose ordered via Severe Sepsis Protocol Aztreonam Approval not required for 1 st dose ordered via Severe Sepsis Protocol Cefepime Approval is exempt for oncology patients in NW 2 (Moses) and 11S (Einstein) and patients in critical care units (not step-down patients). Approval is not required for 1 st dose ordered via Severe Sepsis Protocol. Cefotaxime For Pediatrics only (ceftriaxone should be used for adults) Ceftriaxone Approval is not required for doses up to 1000 mg per day. 1 st dose of > 1 gm is exempt from approval if ordered via Severe Sepsis Protocol. Ciprofloxacin Approval is not required for peri-operative LVAD surgery prophylaxis for up to 48 hours, for prophylaxis doses in stem cell recipients, or for 1 st dose ordered via Severe Sepsis Protocol. Patients are automatically switched to the oral formulation when able to take oral medications. Clarithromycin PO Approval is not required for the treatment of Mycobacterium avium and H. pylori infections. Fluconazole, PO Approval is not required for H patients, for prophylaxis in stem cell recipients receiving up to 400 mg/day, for peri-operative LVAD surgery up to 200mg/day x 48 hours, and for single 150mg PO dose for candidal vaginitis. Patients are automatically switched to the oral formulation when able to take oral medications. Ganciclovir Itraconazole PO Ivermectin PO Levofloxacin, PO Approval is not required for oral doses 500 mg daily. Patients are automatically switched to the oral formulation when able to take oral medications. Penicillin G benzathine (Bicillin LA) IM Piperacillin/tazobactam Approval is required only for patients in the Emergency Room and on Vascular Surgery, however 1 st dose ordered via Severe Sepsis Protocol is exempt from approval. Posaconazole PO (Please note suspension and extended-release tablet dosing is NOT interchangeable) Tobramycin Inhalation Vancomycin, PO, and Approval is not required for the initial 72 hours of the therapy. Approval is not required for therapy for rectal per-operative LVAD surgery prophylaxis x 48 hours. 4
Table 4. Restricted Antimicrobial List for Wakefield Inpatients as of March 2017 Category I - I.D. stewardship approval and ID consultation must be requested within 24 hours. From 5:01 p.m. 9:29 a.m. on M-F, on weekends, or holidays, pharmacy will authorize a sufficient duration of therapy until an ID consult can be obtained (24 hours) Non-formulary antimicrobials require ID consultation and approval prior to dispensing. Ampho B deoxycholate Ampho B lipid formulations Artemether/lumefantrine PO Ceftaroline Ceftazidime/avibactam Ceftolozane/tazobactam Chloramphenicol (The oral formulation is no longer made in the U.S.) Cidofovir Daptomycin Fidaxomicin PO Flucytosine PO Foscarnet Fosfomycin PO IG Need ID approval/consult for any infectious diseases indications (i.e. C. difficile colitis, group A streptococcal or MRSA toxic shock syndrome). Meropenem Micafungin ID consultation/approval is not required for 50 mg daily doses in allogeneic stem cell recipients who require antifungal prophylaxis. Pentamidine Polymyxin B Pyrimethamine PO Ribavirin Inhalation Tigecycline Voriconazole, PO Category II - I.D. stewardship approval must be requested from 9:30 a.m. 5:00 p.m. From 5:01 p.m. 9:29 a.m. M-F, on weekends, or holidays, pharmacy will authorize a sufficient duration of therapy until the next antimicrobial stewardship business day. ID consultation may be suggested, but is not required. Oseltamivir Oral Category III A - I.D. stewardship approval must be requested from 9:30 am to 5:00 pm From 5:01 p.m. 9:29 a.m. M-F, on weekends, or holidays, pharmacy will authorize a sufficient duration of therapy until the next antimicrobial stewardship business day. ID consultation may be suggested, but is not required. Acyclovir Approval is not required for 250 mg q12h prophylaxis doses in stem cell recipients unable to take oral valacyclovir. Albendazole PO Amikacin, IM Azithromycin Approval not required for 1 st dose ordered via Severe Sepsis Protocol Aztreonam Approval not required for 1 st dose ordered via Severe Sepsis Protocol Cefotaxime For Pediatrics only (ceftriaxone should be used for adults) Ceftriaxone Approval is not required for doses up to 1000 mg per day. 1 st dose of > 1 gm is exempt from approval if ordered via Severe Sepsis Protocol. Ciprofloxacin Approval is not required for prophylaxis doses in stem cell transplant recipients or for 1 st dose ordered via Severe Sepsis Protocol. Patients are automatically switched to the oral formulation when able to take oral medications. Clarithromycin PO Approval is not required for the treatment of Mycobacterium avium and H. pylori infections. Fluconazole, PO Approval is not required for H patients and for prophylaxis in stem cell recipients receiving up to 400 mg per day. Approval is not required for prophylaxis doses in stem cell recipients, for single 150 mg oral doses for candidal vaginitis, or in neonates using doses of 3 mg/kg Q 72 hours; patients are automatically switched to the oral formulation when able to take oral medications Ganciclovir Itraconazole PO Ivermectin PO Levofloxacin, PO Approval is not required for oral doses 500 mg daily. Patients are automatically switched to the oral formulation when able to take oral medications Penicillin G benzathine (Bicillin LA) IM Posaconazole PO (Please note suspension and extended-release tablet dosing is NOT interchangeable) Tobramycin Inhalation Vancomycin PO, rectal Category III B - I.D. approval required to continue past the initial 72 hours of therapy. From 5:01 p.m. 9:29 a.m. M-F, on weekends, or holidays, pharmacy will authorize a sufficient duration of therapy until the next antimicrobial stewardship business day. ID consultation is suggested, but not required. Cefepime Approval not required for 1 st dose ordered via Severe Sepsis Protocol Piperacillin/tazobactam Approval not required for 1 st dose ordered via Severe Sepsis Protocol Vancomycin *Antimicrobial Stewardship reserves the right to restrict antimicrobials whose supply is critically short (i.e. nationwide drug shortage)* **Approvals for patients 21 years of age should be directed to the adult stewardship pager, while approvals for patients < 21 years of age should be directed to the pediatric stewardship pager** 5
Table 5. Restricted Antimicrobial List for (CHAM Pediatrics) As Of January 2017 Acyclovir, Oral One dose exceptions are the emergency room for fever in baby < 8 weeks, severe sepsis and possible meningitis Albendazole Oral Amantadine Oral Amikacin, IM One dose exception for severe sepsis Ampho b dexoycholate Ampho b lipid complex Aztreonam One dose exception for severe sepsis. Cefepime Approvals are exempt on CHAM 9 and CHAM 10. One dose exceptions are for severe sepsis, possible meningitis, and febrile neutropenia (in ER only) Ceftaroline Chloramphenicol The oral formulation is no longer made in the U.S., and is unavailable. Cidofovir Ciprofloxacin Oral, One dose exception for severe sepsis Clarithromycin Oral Colistin Nebulizer Inhalation Daptomycin Fluconazole Oral, Flucytosine Oral Foscarnet Ganciclovir Itraconazole Oral Levofloxacin Oral, One dose exception for severe sepsis Linezolid Oral, One dose exception for severe sepsis Meropenem One dose exception for severe sepsis Micafungin Oseltamivir Oral For treatment, answer choices in the EPIC ordering set are mandatory Palivizumab IM,, must be evaluated by an ASP member from 8 a.m. 5 p.m. Monday through Friday Pentamidine, Inhalation Polymyxin B Ribavirin Oral, Inhalation Posaconazole Oral, Rimantidine Oral Tigecycline Tobramycin, IM, Inhalation Valganciclovir PO Vancomycin, oral, rectal One dose exceptions are for severe sepsis and possible meningitis Voriconazole Oral, 6
Table 6. Restricted Antimicrobial List for (Einstein and Wakefield NICU) as of January 2017 Acyclovir One dose exception for severe sepsis Albendazole Oral Amantadine Oral Amikacin and IM One dose exception for severe sepsis Ampho b deoxycholate Ampho b lipid complex Aztreonam Cefepime Chloramphenicol The oral formulation is no longer made in the U.S., and is unavailable. Cidofovir Ciprofloxacin One dose exception for severe sepsis Clarithromycin Oral Daptomycin Fluconazole and oral Approval is not required in neonates using doses of 3mg/kg q72h. Flucytosine Oral Foscarnet Ganciclovir Itraconazole Oral Imipenem Levofloxacin One dose exception for severe sepsis Linezolid and oral One dose exception for severe sepsis Meropenem One dose exception for severe sepsis Micafungin Oseltamivir Oral For treatment, answer choices in the EPIC ordering set are mandatory Pentamidine Polymyxin B Ribavirin Oral, Inhalation Rimantadine Oral Tigecycline Tobramycin Inhalation Approval is not required for the and IM formulations. Valganciclovir PO Vancomycin, One dose exception for severe sepsis Vancomycin PO and Rectal Voriconazole and oral 7