Infectious Diseases Society of America Emerging Infections Network Report for Query: Antimicrobial Drug Shortages 2016 Overall response rate: 701/1,597 (44%) physicians responded from 3/22/16 to 4/13/16. Note: The denominator includes only members who have ever responded to an EIN survey; 150 members who joined the EIN but have not yet responded to any surveys so far are excluded. Note: Not all respondents answered all questions, so totals for individual questions vary. Responders as percent of overall members in each category: Practice: Adult only 511 (42% of 1214 members) Pediatric only 166 (50% of 331 members) Both adult and pediatric* 24 (46% of 52 members) Region: New England 51 (48% of 107 members) Mid Atlantic 107 (48% of 224 members) East North Central 105 (44% of 236 members) West North Central 66 (43% of 155 members) South Atlantic 121 (43% of 280 members) East South Central 36 (44% of 81 members) West South Central 42 (42% of 101 members) Mountain 44 (45% of 97 members) Pacific 119 (41% of 292 members) Puerto Rico 2 (67% of 3 members) Canada 8 (38% of 21 members) Years experience since ID fellowship: <5 years 161 (42% of 387 members) 5-14 207 (38% of 543 members) 15-24* 161 (50% of 323 members) 25 172 (50% of 344 members) Employment: Hospital/clinic 208 (43% of 489 members) Private/group practice 169 (42% of 398 members) University/medical school 276 (44% of 623 members) VA and military 42 (55% of 77 members) State gov t 6 (60% of 10 members) Primary hospital type: Community Non-university teaching University VA hospital or DOD City/county 157 (38% of 414 members) 178 (44% of 409 members) 292 (47% of 625 members) 45 (52% of 87 members) 29 (47% of 62 members) *Respondents were significantly more likely than non-respondents to have at least 15 years of ID experience (p=0.0004), have pediatric practices (p=0.03), and not work at community hospitals (p=0.04). Page 1
Agents in Short Supply and Clinical Outcomes Question 1. Have you needed to modify your antimicrobial choice for treating or preventing an infectious disease because of a drug shortage within the past 2 years? Yes 491 (70%) No 210 (30%) Answered by 701 respondents Most of the 210 respondents who responded No opted out of answering any further questions, but data from the 5 who did answer the remaining questions are included below. Respondents who were least likely to report needing to modify their antimicrobial choice because of a drug shortage worked: --for the federal government, U.S. military, or state/local government (p=0.01), or --in a VA or Dept of Defense hospital or a community hospital (p=0.048). Question 2. The top antimicrobial agent(s) in short supply within the past 2 years: [Answers were typed into an open-text field, and are shown here in order of frequency mentioned] piperacillin-tazobactam (Zosyn) 298 ampicillin-sulbactam (Unasyn) 103 meropenem 98 cefotaxime 77 (70/77 have pediatric practices) cefepime 63 trimethoprim-sulfamethoxazole (Bactrim) 56 doxycycline 41 imipenem 40 acyclovir 40 amikacin 22 pyrimethamine 18 penicillin 16 cefazolin 14 vancomycin 13 aztreonam 11 tigecycline 10 Agents each mentioned by fewer than 10 respondents: albendazole, amoxicillin-clavulanate suspension, ampicillin, anidulafungin, atovaquone (Malarone), azithromycin, cefixime, cefotetan, cefoxitin, ceftaroline, ceftazidime, ceftazidime-avibactam, ceftriaxone, cefuroxime, cephalexin, chloramphenicol, chloroquine, cidofovir, clindamycin, daptomycin, doripenem, ertapenem, ethambutol, fluconazole IV, flucytosine, foscarnet, ganciclovir, gentamicin, isoniazid, levofloxacin IV, linezolid oral, mebendazole, metronidazole IV, moxifloxacin, mupirocin, nafcillin, Odefsey (emtricitabine/tenofovir/alafenamide), oseltamivir suspension, pentamidine (inhaled), peramivir, polymyxin, praziquantel, rifampin IV, rifapentine, telavancin, tetracycline, ticarcillin-clavulanate, tobramycin, voriconazole IV Page 2
Question 3. Has this shortage(s) and any resulting change in treatment affected patient care or outcomes in your opinion? Yes 358 (73%) No 132 (27%) Answered by 490 respondents Adverse effects that occurred because of the shortage(s): [Instructions were to select all that apply; numbers add to more than 100%; 358 respondents] Use of broader-spectrum antimicrobials than would have been optimal 268 (75%) Use of more costly agents 209 (58%) Use of second-line / less effective therapy 161 (45%) Use of more toxic antimicrobials than would have been optimal 132 (37%) Delayed treatment 54 (15%) Longer hospitalization 43 (12%) Slower clinical response 37 (10%) Use of compounded agents 22 (6%) Long-term morbidity from inadequate treatment of infection 16 (4%) Transfer patients to other facilities 10 (3%) Patient contracted disease that agent in short supply should have prevented 8 (2%) Other* 12 (3%) Most common response (by 57) was use of a broader-spectrum agents + use of more costly agents. *In open-text field, other adverse events listed were: two drugs instead of one (cefepime/flagyl) (by 3 respondents); actually, has facilitated time-outs that we prefer, limiting use of broadspectrum abx; except doxycycline which required alt agents determined but not necessarily less effective; pyrimethamine COULD affect us but has not to date ; C diff (by 1); changing surgical abx prophylaxis regimen (by 1); use of less tested agent in children (by 1), readmission to hospital when outpatient/long term care facility could not provide drug (by 1) Question 4. Have price increases for an antimicrobial agent resulted in your inability to prescribe an agent? Yes 176 (36%) No 319 (64%) Answered by 495 respondents *In open-text field, 157 respondents specified agent(s) or offered comments: Daraprim/pyrimethamine (by 38), doxycycline (by 34), linezolid (by 16), daptomycin (by 8), ribavirin (by 7), albendazole (by 6), ceftaroline (by 6), flucytosine (by 4), penicillin (by 3), primaquine (by 3), fidaxomicin (by 2), meropenem (by 2), minocycline (by 2) By 1 respondent each: atovaquone, cycloserine, erythromycin, Harvoni, hepatitis C drugs, itraconazole, ivermectin, mebendazole, moxifloxacin, oritavancin/dalbavancin, oxacillin, praziquantel, Tamiflu, telavancin, vancomycin oral A patient who received copay assistance for Baraclude is now unable to afford generic entecavir ; Encouraged to not use ampicillin for CAP in favor of cheaper ceftriaxone ; the insane price of albendazole makes therapy for patients without insurance unobtainable ; flucytosine - in hospital cost and out of hospital cost- pharmacies won t fill as Medicare reimburses only 600$ ; linezolid price isn't new, but we often can't prescribe it when we think it's the best drug Page 3
Question 5. Have you experienced a shortage of any vaccine within the past 2 years? Yes 94 (19%) No 401 (81%) Answered by 495 respondents *In open-text field, 89 respondents specified agent(s): or offered comments: Yellow fever (by 39), typhoid (by 15), influenza (by 8), influenza high dose (by 6), rabies (by 6), Pentacel (by 4), TDaP (by 3), Japanese encephalitis (by 3), influenza nasal/flumist (by 3), shingles/zoster (by 3), polio/ipv (by 2), Prevnar (by 2), meningococcal, including Menomune and Menactra (by 2) At the Federally Qualified Health Center, Vaccines for Children cannot be ordered in advance; you can restock but not order for any anticipated surge. This results in sending children home without scheduled vaccines when reordering is delayed or more patients than usual arrive. We don't have a solution. Communication about Agents in Short Supply Question 6. How do you currently learn about shortages? [Instructions were to select all that apply; numbers add to more than 100%; 493 respondents] Hospital/system notification (via pharmacy, P&T committee, stewardship) 377 (76%) Other communication from a colleague (MD, PharmD, etc) 277 (56%) Contact from a pharmacy after I tried to prescribe a drug in short supply 259 (53%) Listserv or social media (EIN, FDA MedWatch Safety Alerts, Twitter) 153 (31%) Website (FDA Drug Shortages or ASHP) 115 (23%) Mobile app (FDA Drug Shortages, RxShortages 26 (5%) Other 8 (2%) Most common response (by 70) was notification only from their hospital/system. *In open-text field, other sources of information were: Sanford mobile app, AAP email, local health department, VA central / VISN pharmacy administration Question 7. Are current communications about drug shortage issues sufficient for your practice? Yes 349 (71%) No 142 (29%) Answered by 491 respondents Question 8. Has your institution developed any guidelines for prioritizing use of agents in short supply, or restrictions who can get an agent in short supply? Yes 408 (83%) No 50 (10%) Not sure 36 (7%) Answered by 494 respondents If yes, who was involved in the process? [Instructions were to select all that apply; numbers add to more than 100%; 377 respondents] You 195 (52%) Antimicrobial stewardship program 351 (93%) Page 4
Question 9. Does your institution a. switch to nonformulary agents when the formulary agent is in short supply? Yes 307 (62%) No 113 (23%) Not sure 74 (15%) Answered by 494 respondents b. seek supplies from other hospitals to provide agents in short supply? Yes 384 (78%) No 40 (8%) Not sure 70 (14%) Answered by 494 respondents Question 10. In the period since January 1, 2013 a. have you perceived any improvements in FDA s communication / notification about drug shortages? Yes 64 (13%) No 216 (44%) Not sure 214 (43%) Answered by 494 respondents b. have shortages for your practice become More frequent 298 (60%) Less frequent 36 (7%) No change 116 (24%) Not sure 44 (9%) Answered by 494 respondents Page 5