Title: Restricted Antimicrobial Policy Designated Clinical Areas: All Inpatient Care areas ED and ED observation/short stay Level of Personnel: MD, PA, NP, RPh Applicable Policy Statement: 1) In collaboration with the Antimicrobial Stewardship Program (ASP) and the Infectious Disease Division, MESAC approves and maintains a list of restricted antibiotics and authorized prescribers (Refer to: Table 1 and Appendix). 2) Restricted antibiotics require approval from an authorized prescriber [member of the Infectious Disease Division or an affiliated member of ASP with approval privileges (Refer to: appendix). These restricted antibiotics will be prescribed and dispensed according to the guidelines and procedures outlined below. Procedure: Prescribing Guidelines General: 1. Empiric antimicrobial use should be limited to no more than 72hrs of therapy and subsequently guided by microbiological data. 2. Between 0800-2000, the ordering provider must obtain approval (verbal or written) from an authorized prescriber prior to ordering a restricted antimicrobial; the use of an authorized prescriber’s name in the ordering of a restricted antimicrobial without obtaining verbal or written approval constitutes a violation of hospital policy. Note: Approval cannot be transferred or obtained from previously approved antibiotic courses or when level of care changes. 3. Restricted antimicrobial approval can be obtained through: a. Restricted antimicrobial pager (p21884) i. The restricted antimicrobial pager service is active from 08:0020:00, 7 days a week ii. The restricted antimicrobial pager service shall not approve selected antimicrobials marked by an asterisk (see list below) b. Infectious Disease Consultation (p16136) c. Discussion with an authorized prescriber resulting in their specific approval (see Appendix) 4. Between the hours of 20:00 and 08:00, ID approval is not required: a. The pharmacist will dispense enough drug to cover all scheduled doses through 08:00. Note: doses after 08:00 will require ID approval as described above. b. A notice of this temporary approval and requirement for follow up approval will be provided to the overnight prescriber as an alert in POE when entering the order. The overnight prescriber must provide pass-off to the daytime prescriber to obtain approval to reorder the antimicrobial if the plan is to continue the antimicrobial. 5. Restricted antimicrobials included in approved ordering pathways do not require ID approval. 6. The restricted antimicrobial approval process applies to all inpatient floors, including the emergency room. Guidelines for selected restricted antimicrobials: 1. Moxifloxacin approval is restricted to treatment of tuberculosis 2. Posaconazole is restricted to approval by the transplant ID service. 3. Cystic fibrosis patients requiring ceftazidime or inhaled tobramycin can receive these agents through the cystic fibrosis pathway in POE. 4. Cefotaxime is restricted to ID approval in adults only; cefotaxime does not require approval in pediatrics. 5. Linezolid and voriconazole are highly bioavailable and oral formulations should be used as indicated by the IV:PO protocol. a. Linezolid oral suspension is restricted to pediatrics; oral tablets can be crushed for adults Dispensing Procedure 1. Between the hours of 0800 and 2000, all restricted antibiotics (below) require approval from an authorized prescriber. a. The name of the approving provider must appear in the “approval field” in each POE order (see appendix). 2. Between the hours of 20:00 and 08:00, ID approval is not required: a. The pharmacist will dispense enough drug to cover all scheduled doses through 08:00. Note: doses after 08:00 will require ID approval as described above. b. A notice of this temporary approval and requirement for follow up approval will be provided to the overnight prescriber as an alert in POE when entering the order. The overnight prescriber must provide pass-off to the daytime prescriber to obtain approval to reorder the antimicrobial if the plan is to continue the antimicrobial. c. Additionally, after 08:00, the designated floor/region pharmacist will identify temporary approval orders that were entered overnight through Sentri7 “Restricted Antimicrobial” rule and page the responding clinician prior to 10:00 to remind the prescriber to reorder the antimicrobial. i. The pharmacist will page the responding clinician with the following information: “Temporary doses for (name of restricted antimicrobial) have expired; please reorder with ID approval or will result in missed dose at (time of next dose).” ii. If the responding clinician does not change the antimicrobial order or fails to communicate the plan with the pharmacist within 1 hour after the page is sent, the pharmacist will page the attending physician with the same page above. iii. If a responding clinician fails to communicate the plan and does not reorder the antimicrobial, a safety report is strongly encouraged. Table 1: The following antimicrobials require verbal or written approval from an authorized prescriber (Refer to: Appendix). Amikacin* Amphotericin, liposomal Amphotericin (Inhaled) Artemether/lumefantrine Aztreonam Cefotaxime Ceftaroline Ceftazidime Cidofovir* Colistin (IV)* Daptomycin Ertapenem Fidaxomicin Foscarnet* Ganciclovir Imipenem Itraconazole Linezolid Maraviroc Meropenem Micafungin Moxifloxacin Nitazoxanide Posaconazole** Quinine Quinupristin/dalfopristin Ribavirin (Inhaled)* Rimantadine Sofosbuvir Ticarcillin/clavulanate Tigecycline Tobramycin (Inhaled) Voriconazole Unless specified, restriction applies to all routes of administration *Antimicrobials marked with a * shall not be approved by the restricted antimicrobial pager; due to cost or toxicity concerns; an Infectious Disease Consult is recommended **Approval privileges restricted to Transplant Infectious Disease Service Appendix: MEMBERS OF THE ANTIMICROBIAL STEWARDSHIP PROGRAMJULY 2014- JULY 2015 INFECTIOUS DISEASE DIVISION FACULTY/AFFILIATED FACULTY Kevin L. Ard Michael Aronoff Miriam Barshak Nesli O. Basgoz Ingrid V. Bassett Allyson Bloom Stephen B. Calderwood Michael Callahan Richelle C. Charles Andrea Ciaranello Benjamin T. Davis Marlene L. Durand Joseph El-Khoury Chadi El Saleeby (PEDI) Donna Felsenstein Jay A. Fishman Kenneth A. Freedberg Dahlene Fusco Rajesh T. Gandhi Jeffrey A. Gelfand Marcia B. Goldberg Jason Harris (PEDI) Howard M. Heller Elizabeth L. Hohmann David C. Hooper Rocio Hurtado Arthur Kim Dennis Kim Camille N. Kotton Douglas S. Kwon Regina C. LaRocque Cammie F. Lesser Alyssa Letourneau Lynn Luginbuhl (PEDI) Vandana Madhavan (PEDI) Lynn T. Matthews Sandra B. Nelson Bisola O. Ojikutu Mark S. Pasternack Virginia Pierce Mark Poznansky Gregory K. Robbins Eric S. Rosenberg Edward T. Ryan Erica S. Shenoy Mark J. Siedner Virginia Triant Athe Tsibris Jatin M. Vyas Rochelle P. Walensky Bruce D. Walker H. Shaw Warren Kimon C. Zachary AFFILIATED MEMBERS OF ASP WITH APPROVAL PRIVILEGES* Todd Astor (TRANS) Walter O’Donnell (MICU) Christy Varughese Marc DeMoya (SICU) Ulrich Schmidt (SICU) (Pharmacy) Samuel Moskowitz (CF) *The ASP Leadership determines minimum requirements for affiliates with approval privileges. These requirements include, but are not limited to, attendance and active participation in at least one of the biannual ASP/Pharmacy/Clinical Microbiology Meetings. Failure to meet stated requirements will result in termination of privileges. Aima A. Ahonkhai Amy K. Barczak Roby P. Bhattacharyya Laura K. Certain Brian T. Chan JUNIOR FACULTY Paul K. Drain Emily P. Hyle Anne G. Kasmar Mathias D. Lichterfeld Michael A. Lobritz Tariro Makadzange Tara M. Babu Kelly E. R. Bachta Lisa M. Bebell Taison Bell Daniel L. Bourque Daniel A. Caroff Justin J. Chan Jacqueline T. Chu CLINICAL & RESEARCH FELLOWS Boris D. Juelg Sanjat Kanjilal Philip A. Lederer Lenette L. Lu Anne Neilan Damaris D. Nou Ann L. Piantadosi Jonathan A. Robbins Michael K. Mansour Read Pukkila-Worley Jennifer L. Reedy Eileen P. Scully Pritha Sen Thomas F. Rogers Daniel A. Solomon Gustavo E. Velasquez Ana A. Weil Anne E. Woolley Cynthia R. Young Brian C. Zanoni Revision Detail SUBJECT : TITLE: APPROVED BY AND DATE: GENERAL POLICY AND PROCEDURE RESTRICTED ANTIMICROBIAL POLICY MESAC 3/2011, 10/2013 MESAC EXEC 5/2011, 9/2011 PENDING 6/2014