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Q9
PostLcesarean delivery outpatient opioid consumption and perception of pain control following implementation of a restrictive opioid prescription protocol Nisha Lakhi, MD; Gabrielle Tricorico, BS; Tomi Kanninen, MD; Rahat Suddle, MD; Jane Ponterio, MD; Michael Moretti, MD
BACKGROUND: Cesarean delivery is the most common laparotomy
performed in the United States and can be the first exposure to opioids for many women. Unnecessary consumption of opioids may lead to long-term addiction and further perpetuate this national health crisis. OBJECTIVES: The primary objective of the study was to assess whether a quality improvement initiative by means of a restrictive opioid prescription policy decreases opioid consumption and maintains patient satisfaction after cesarean delivery. A secondary objective is to correlate opioid consumption with demographic and perioperative factors. MATERIALS AND METHODS: A Plan, Do, Check, Act model was used to implement a quality improvement initiative. A restrictive opioid prescribing policy was put in place in July 2017 preventing all physicians from prescribing opioids to their patients upon discharge after cesarean delivery; patients could call their providers from home to request additional analgesia (opioid or nonopioid) if pain was not sufficiently controlled. From August 2017 to February 2018, a postdischarge telephone interview assessing pain control satisfaction and opioid consumption was conducted for all English-speaking patients in our hospital who underwent a cesarean delivery. Statistical analysis was performed using IBM SPSS 22.0, with P < .05 reported as statistically significant.
T
he incidence rate of opioid-related death in women has increased 5fold over the past decade.1 From 1999 to 2010, deaths from prescription painkiller overdoses among women increased rapidly to more than 400% compared to 265% among men.2 It has also been estimated that approximately one-third of reproductive-aged women fill a prescription for an opioid medication each year.3 Over the past decade, the rate of cesarean delivery (CD) has increased to 31.9% of all births,4 with approximately 1.3 million women undergoing the procedure every year.5 Women are
Cite this article as: Lakhi N, Tricorico G, Kanninen T, et al. Postcesarean delivery outpatient opioid consumption and perception of pain control following implementation of a restrictive opioid prescription protocol. Am J Obstet Gynecol MFM 2019;XX:x.ex-x.ex. 2589-9333/$36.00 ª 2019 Elsevier Inc. All rights reserved. https://doi.org/10.1016/j.ajogmf.2019.100049
RESULTS: A total of 283 parturients were interviewed 8e33 days after cesarean delivery (mean, 16 days). After implementation of the restrictive opioid prescription policy, we observed a decrease in opioid prescriptions at discharge after cesarean delivery from 97.9% to 0%, with an 18% prescription rate after discharge. Patients reported high satisfaction with their pain control, with 89% (n ¼ 253) stating that their pain was adequately controlled upon discharge. Although 90% (n ¼ 256) reported that they did not need any pain medication other than ibuprofen or acetaminophen, opioids were prescribed to 18% of patients (n ¼ 51) after discharge, with only 51% of these women (n ¼ 27) consuming them. In response to the restrictive opioid prescribing policy, only 13% of the women (n ¼ 37) reported that they wished that a stronger pain medication had been prescribed after hospital discharge. Factors associated with opioid consumption postdischarge included white race/ethnicity, multiparity, and opioid consumption during inpatient hospitalization. CONCLUSION: Following implementation of the restrictive opioid prescribing policy, most women experienced adequate pain control after cesarean delivery. Patient satisfaction with pain control was high, showing that it is feasible to implement restrictive opioid prescription policies while Q2 maintaining a high satisfaction rate.
commonly prescribed opioids after CD to treat the acute postoperative pain. It has been shown that in opioid-naive patients, continuous opioid consumption over 72 hours increases these patients’ risk of developing a long-term opioid addiction.6 One recent study also showed that after a CD, 1 in 300 opiatenaive women may become addicted to opioids,1 but this number might be underestimated. Thus, even a short course of inpatient exposure to opioids after CD puts women at risk for longterm dependency. This risk may be further increased if opioids are prescribed after discharge in the outpatient setting. With CD being the most commonly performed surgery in the United States, it is important to know that undergoing this procedure may increase a woman’s risk of developing an opioid addiction. The Department of Obstetrics and Gynecology at Richmond University Medical Center (Staten Island, NY) implemented a restrictive opioid
prescription policy in July 2017 as part of a quality improvement initiative. As per this policy, patients were not to be prescribed opioid analgesia upon discharge after CD. The primary objective of this quality study was to investigate the efficacy of the restrictive outpatient opioidprescribing policy on reducing opioid consumption and its impact on patient satisfaction with pain control postdischarge. The secondary objective was to correlate opioid consumption with demographic and perioperative factors.
Materials and Methods This institutional review board approved initiative (2017-05-06RUMC) was conducted at Richmond University Medical Center (RUMC), Staten Island, New York, a high-risk tertiary care center for Obstetrics and Neonatology. Richmond University Medical Center is located on the North Shore of Staten Island, Community District I, which is home to a diverse population. Poverty affects 20.7% of MONTH 2019 AJOG MFM
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Original Research 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166
AJOG MFM at a Glance Why was this study conducted? This study was conducted to assess the efficacy of a restrictive opioid prescription policy on reducing postdischarge opioid consumption and maintaining patient satisfaction after cesarean delivery. Key findings Postdischarge pain was effectively managed with nonopioid analgesia while maintaining high patient satisfaction after implementation of a restrictive opioid prescription policy. What does this add to what is known? Previous studies have investigated methods for reducing opioid consumption postdischarge but have not attempted to completely stop opioid prescription at the time of discharge. This is the first study to take into consideration patient perceptions of pain control following a restrictive opioid prescribing policy in order to provide future pain management that is reasonable and effective.
Staten Island’s residents, most of which rely on RUMC for their healthcare needs. Community District I is home to a population in which 23.7% of residents are foreign born. Of the 175,800 residents of Community District I, 38.0% are white, 29.1% are Hispanic, and 22.5% are black. A Plan, Do, Check, Act model was used for this Quality Initiative. The Plan was to assess inpatient opioid consumption at our institution. Prior to July of 2017, customary practice at RUMC was for providers to send their patients home with opioids. The amount of opioids was determined by providers. We retrospectively reviewed opioid prescriptions at the time of discharge after CD from January 2017 to June 2017. We found that of 542 patients, prescriptions for opioid analgesia were dispensed to 531 patients. In response to this 97.9% opioid prescription rate post-CD at our institution, a restrictive opioid prescription policy was implemented in July 2017 as a quality improvement intervention, the Do portion of the Deming Cycle. The policy prohibited prescription of opioid analgesia upon discharge after CD. Instead, all patients were discharged home with a prescription for 30 tablets of ibuprofen (600 mg) to be taken every 6 hours as needed for pain. This was the only prescription given, as we do not routinely prescribe other medications (eg, simethicone, magnesium
citrate, docusate sodium) at discharge. Patients were instructed to contact their primary physician or RUMC’s Labor and Delivery Department if their pain was not well controlled. The physician could then assess pain and prescribe additional opioid or nonopioid analgesia if necessary. Patients were educated on the opioid epidemic in Staten Island and the possible effects of opioid use after CD through educational pamphlets provided by physicians as well as the Department of Obstetrics and Gynecology’s triage center. Providers were given in-service instruction on the protocol and were asked to educate their patients on the risks of opioid use and the benefits of nonopioid analgesia after CD. Our inpatient pain management was not modified with the introduction of the restrictive opioid prescription protocol. To determine the percentage of CD patients who were prescribed opioids prior to implementation of the restrictive prescription protocol, electronic discharge records were reviewed. It was found that 97.9% of our patients were prescribed opioids at discharge prior to the restrictive prescription protocol. To assess patient satisfaction and opioid consumption, a postdischarge telephone interview was conducted for all women who underwent CD at RUMC from August 2017 to February 2018, the Check part of the Deming cycle. All interviews were conducted in English by
the same research team member after obtaining verbal consent from each participant. The patients were asked 4 questions: (1) Did you need any pain medication other than Motrin or Tylenol after discharge? (2) Has your doctor prescribed any pain medication such as a Percocet or another strong pain killer? If so, what medication was prescribed? (3) Did you feel that your pain was adequately controlled upon discharge from the hospital? (patients were asked to respond with a dichotomous answer); (4) Do you wish you had been given a stronger pain medication? If opioids were prescribed, we also inquired as to whether the patient actually consumed the opioids (“consumed” was defined as taking at least 1 tablet). If the subject reported that she did not consume the opioids that were prescribed, we asked for the reason(s). Maternal demographic data including age, body mass index (BMI), marital status, race, and parity were collected. The attending surgeon, type and indication for CD, and use of opioids during hospitalization were also recorded. Statistical analysis was carried out using IBM SPSS 22.0. Univariate analysis for continuous variables was compared using the Student t test or the MannWhitney U test. Categorical data were compared using a c2 test or Fisher exact tests. Multivariate logistical regression analysis was performed to determine independent predictors of receiving an opiate prescription. A P value of <.05 was considered statistically significant. Risks for statistically significant variables are reported as odds ratios (OR) with 95% confidence intervals (95% CI).
Results All women who underwent CD from August 2017 to February 2018 were considered for inclusion, and a total of 567 eligible patients were identified. Women with a current or prior opioid use disorder were excluded from the study. Of the 567 eligible patients, 239 could not be reached by telephone, 42 could not be interviewed because of their limited English proficiency, and 3 declined participation. A total of 283
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Original Research 223 224 225 226 227 228 229 230 231 232 233 234 235 236 237 238 239 240 241 242 243 244 245 246 247 248 249 250 251 252 253 254 255 256 257 258 259 260 261 262 263 264 265 266 267 268 ½T1 269 270 271 272 273 274 275 276 277 278
TABLE 1
Demographic variables Prescribed outpatient opioids (n ¼ 51)
Not prescribed outpatient opioids (n ¼ 232)
P value
Age, y, mean SD (range)
33 4.21 (2440)
32 5.46 (1653)
.497
BMI, kg/m , mean SD (range)
32.1 6.64 (24.147)
33.4 6.70 (20.466.8)
.323
Variable 2
Parity, n (%) Nulliparous
13 (25.5)
99 (42.7)
Multiparous
38 (74.5)
133 (57.3)
White non-Hispanic
37 (72.5)
128 (55.2)
Black non-Hispanic
2 (3.9)
51 (22.0)
Hispanic
3 (5.9)
15 (6.5)
Other/unknown
9 (17.6)
38 (16.4)
Single
10 (19.6)
67 (28.9)
Married/
41 (80.4)
165 (71.1)
Primary cesarean delivery
24 (47.1)
125 (53.9)
Repeat cesarean delivery
27 (52.9)
107 (46.1)
.015
Race/ethnicity, n (%) .025a
Marital status, n (%) .560
Cesarean delivery type, n (%) .201
BMI, body mass index; SD, standard deviation. a 2 c Contingency table. Lakhi et al. Restrictive opioid prescribing postcesarean delivery. AJOG MFM 2019.
parturients were interviewed 8e33 days (mean, 16 days) after CD, depending on when the participant was able to be reached by phone. Using a Plan, Do, Check, Act model to assess the efficacy of our restrictive opioid prescription policy, we observed a decrease in opioid prescriptions postCD from 97.9% to 0% with an 18% (n ¼ 51) prescription rate after discharge. There were no statistical differences between patients who were prescribed outpatient opioids (n ¼ 51) and those who were not (n ¼ 232) with regard to age, BMI, and marital status (Table 1). Overall, 90% of the participants (n ¼ 256) reported that they did not need any pain medication other than ibuprofen or acetaminophen after hospital discharge. Similarly, 89% (n ¼ 253) reported that their pain was adequately controlled upon discharge. Oxycodone was prescribed to 49 of the 51 women, whereas the remaining 2 participants were prescribed acetaminophen with codeine. Only 27 of the 51 women (51%)
who were prescribed opioids reported consuming them. Of the 24 women who were prescribed opioids but did not consume them, 12 reported that they did not ask for the opioids, 5 reported that they asked for them but realized that they did not need them, and 7 reported that they did not use them because they did not want them to interfere with breastfeeding. In response to the restrictive opioid-prescribing policy, only 13% of the women (n ¼ 37) reported that they wished that a stronger pain medication had been prescribed after hospital discharge. Demographic factors of study population are shown in Table 1. In all, 37 of the 165 white women (22.4%, 2 of the 53 black women (3.7%), 3 of the 18 Hispanic women (16.7%), and 9 of the 47 women of other/unknown races (19.1%) were prescribed an opioid after discharge, and these differences were statistically significant (P ¼ .025). Of the 27 women who consumed the medication, 74% of them were white (n ¼ 20),
3.7% were black (n ¼ 1), and 9.5% were of other races (n ¼ 6). None of the Hispanic women reported consuming the prescription. Multiparous women (22.2%, 38 of 171), were significantly more likely to be prescribed opioids after discharge compared to nulliparous women (11.6%, 13 of 112; P ¼ .015l; OR, 2.15; 95% CI, 1.084.23). Interestingly, the type of CD was not statistically correlated with opioid prescribing, as 15.4% of women (23 of 149) who underwent a primary CD compared to 18.7% (25 of 134) who underwent a repeat CD required opioids at home (P ¼ .201). Inpatient opioid consumption was determined in order to find any possible correlations with outpatient opioid consumption. We found that during hospitalization after CD, 45% of the participants (n ¼ 127) consumed opioids. Of the 127 patients who required an opioid during inpatient hospitalization, 26% were also prescribed an opioid after MONTH 2019 AJOG MFM
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Original Research FIGURE 1
Opioid prescriptions dispensed by attending physicians, ALJ web 4C=FPO
335 336 337 338 339 340 341 342 343 344 345 346 347 348 349 350 351 352 353 354 355 356 357 358 359 360 361 362 363 364 365 366 367 368 369 370 371 372 373 374 375 376 377 378 379 380 381 382 383 384 385 386 387 388 389 390
Lakhi et al. Restrictive opioid prescribing postcesarean delivery. AJOG MFM 2019.
discharge (n ¼ 33). Thus, 64.7% of patients who were prescribed opioids upon discharge (33 of 51) were exposed to opioids during inpatient hospitalization. For the remaining 156 women who were not exposed to opioids during hospitalization, only 11.5% (n ¼ 18) were prescribed an opioid postdischarge. This demonstrates that women who were given opioids during the inpatient hospitalization were significantly more likely to be prescribed an opioid after discharge (P ¼ .002; OR, 2.69; 95% CI, 1.435.06) as well as to consume them (85.2% vs 14.8%; P < .001; OR, 8.40; 95% CI, 2.8225.01). Patient satisfaction with postdischarge pain control differed among women who used inpatient opioids, with 14.2% of these women (18 of 127) feeling that their pain was not adequately controlled, compared to 7.1% of their counterparts (11 of 156) who did not consume opioids. This trend fell just short of being statistically significant (P ¼ .051).
During the time the study was conducted, 22 providers performed CDs within our department. Interestingly, we found that of the 51 patients who received outpatient opioids in the study, 53.2% of them were prescribed by 2 physicians (Figure 1). After multivariate logistic regression analysis, we found that white race (RR, 13.1, 95% CI, 1.7102.8; P ¼ .015), multiparity (RR, 3.5; 95% CI, 1.29.3; P ¼ .013), and inpatient opioid consumption (RR, 3.1; 95% CI, 1.56.0; P ¼ .001) remained independent predictors of being prescribed opioids in the outpatient setting.
Comment
Our findings revealed that most of the women who participated in the interview had adequate pain control upon discharge using nonopioid analgesics. Implementation of a restrictive opioid prescribing policy was associated with high patient satisfaction, as 89.7% of
patients believed that their pain was adequately controlled upon discharge, and only 13.1% wished that stronger medications were prescribed. This suggests that pain after CD can be effectively managed with the use of nonopioid analgesics after hospital discharge. Other institutions have also been able to successfully lower opioid consumption while maintaining patient satisfaction. After implementation of an inpatient opioid-sparing policy, Peahl et al were able to decrease the number of patients requiring administration of unscheduled oxycodone from 60.45% to 13.28%, with a decrease in morphine milligram equivalents per patient from 25.5 to 10.0. However, no reduction in patients receiving scheduled oxycodone was noted. Patient satisfaction remained unchanged over protocol implementation, based on Press Ganey Q7 scores.8 Our data showed that a significant predictor of opioid prescription and consumption after discharge was the use of opioid analgesia in the inpatient setting following CD. The women who consumed opioids during hospitalization more often believed that their pain was not adequately controlled upon discharge, wished that they had stronger medications, and were more likely to consume the prescribed opioids, as compared to their counterparts who did not use opioids during their hospital admission. Several fac- ½F1 tors could account for this trend. Patients who consumed opioids in the Q3 hospital could have had more pain and could have actually required opioids after discharge. Some patients may have also assumed that because they received opioids in the hospital, they also required them at home, regardless of pain status. We also found that there was variability in physician prescription patterns. Given that 2 physicians were responsible for 52.2% of the prescribed opioids, we believe that this indicates that part of the opioid problem is provider induced. We found that this trend was not volume driven, as physicians with a similar volume of CDs had different
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391 392 393 394 395 396 397 398 399 400 401 402 403 404 405 406 407 408 409 410 411 412 413 414 415 416 417 418 419 420 421 422 423 424 425 426 427 428 429 430 431 432 433 434 435 436 437 438 439 440 441 442 443 444 445 446
Original Research 447 448 449 450 451 452 453 454 455 456 457 458 459 460 461 462 463 464 465 466 467 468 469 470 471 472 473 474 475 476 477 478 479 480 481 482 483 484 485 486 487 488 489 490 491 492 493 494 495 496 497 498 499Q4 500 501 502
TABLE 2
Inpatient and outpatient opioid consumption Required opioids during inpatient hospitalization (n ¼ 127)
Opioid prescription and consumption
Did not require opioids during inpatient hospitalization (n ¼ 156)
Prescribed opioid in outpatient setting, n (%)
P value .002
Yes (n ¼ 51)
33 (64.7)
18 (35.3)
No (n ¼ 232)
94 (40.5)
138 (59.5)
Yes (n ¼ 27)
23 (85.2)
4 (14.8)
No (n ¼ 256)
127 (44.9)
156 (55.1)
Consumed opioid in outpatient setting, if prescribed, n (%)
.002
Lakhi et al. Restrictive opioid prescribing postcesarean delivery. AJOG MFM 2019.
opioid prescribing rates. In addition, the 12 participants in this study who reported that they did not ask for opioids also reported that their providers called in a prescription in case they needed it, thereby circumventing the protocol. Opioid prescription discrepancies were also found in regard to race, with white women being prescribed more opioids than all other races (P ¼ .025). More privately insured patients in our institution were white, highlighting the necessity of provider education to eliminate disparities. Studies have suggested that physician training may help to control the nation’s opioid epidemic.7 One limitation of this quality study is the use of self-reported data, which may be subject to social desirability bias. Attempts to collect prescription data from the New York State Internet System for Tracking Over-PrescribingePrescription Monitoring Program (I-STOP/PMP) were made in order to corroborate patient reports; however data for our patient population were no longer available in the system at the time of data collection and analysis. Another limitation is that not all the women eligible to be included could be interviewed; only women who answered their telephone and were English speaking were included. Therefore, our participants represented a convenience sample population of women who underwent CD, which may be prone to selection bias. Poverty afflicts almost 20% of
our patient population. Many of these patients do not have mobile telephones, or used prepaid telephone plans, and thus were not reachable after hospital discharge. We made several attempts to call all of the patients’ stored numbers on the hospital database, but many times this was not successful. This could definitely be a confounding factor, as pain perception may vary across socioeconomic and demographic groups. Therefore, any generalizations should be made with caution. Although we tried to call all participants as soon as possible after their CD, not all patients were able to be contacted, which led to a large range in the time to telephone interview. This may have led to recall bias, as some patients were contacted very soon after surgery and may have been in more pain, and others were contacted as late as 33 days after surgery, which may have made it more difficult to accurately assess their satisfaction with pain control. In addition, the patients’ pain control satisfaction was not obtained using an objective method of assessment; rather, it was based the patients’ perception. This quality study also has several strengths. All of the subjects were interviewed by the same research team member, which eliminated interviewer bias. We took into consideration patient perceptions and feelings toward the restrictive opioid prescription initiative instead of only using opioid prescription as a primary endpoint.
Based on our findings, for the Act portion of the Deming cycle, we plan on developing and implementing a multimodal analgesia protocol that aims to reduce inpatient opioid consumption, given that it was an independent predictor of receiving an outpatient prescription. In addition, because providers can influence opioid use, we now give anonymized feedback to our physicians so that they can be aware of their opioidprescribing practices in comparison to those of their peers. We extract these data from the New York State I-STOP database. From September 15, 2018, to August 30, 2019, a total of 776 CDs were performed at our institution. Based on ISTOP data, our opioid prescription rate was 23% (186 of 776). Given the limitations described in our paper, these data do support that our improvement has persisted and applies to our entire patient population. In conclusion, this quality study demonstrated that most women had adequate pain control after CD and did not require any opioid analgesics after hospital discharge. Post-CD pain was effectively controlled at home with the use of nonopioid analgesics following the quality intervention. Our findings also revealed that use of opioids during inpatient hospitalization after CD was a significant predictor of opioid use after hospital discharge. We demonstrate that the use of a restrictive opioid prescription policy after CD is feasible. Thus, this may facilitate other institutions to establish protocols that encourage MONTH 2019 AJOG MFM
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503 504 505 506 507 508 509 510 511 512 513 514 515 516 517 518 519 520 521 522 523 524 525 526 527 528 529 530 531 532 533 534 535 536 537 538 539 540 541 542 543 544 545 546 547 548 549 550 551 552 553 554 555 556 557 558
Original Research 559 560 561 562 563 564 565 Q8 566 567 568 Q6 569 570½T2 571 572 573 574 575 576 577 578 579 580 581 582 583 584 585 586 587 588 589 590 591 592 593 594 595 596 597 598 599 600 601 602 603 604 605 606 607 608 609 610 611 612 613 614
discharging patients without opioid prescriptions. Future efforts should be aimed at provider and patient education eliminating opioid exposure during inpatient hospitalization, in order to complete the Deming cycle and to further perpetuate improvements for patients. n
Uncited Table Table 2 References 1. Bateman BT, Franklin JM, Bykov K, Avorn J, Shrank WH, Brennan TA, et al. Persistent opioid use following cesarean delivery: patterns and predictors among opioid-naive women. Am J Obstet Gynecol 2016;215:353-e1. 2. Centers for Disease Control and Prevention. Prescription painkiller overdoses: a growing
epidemic, especially among women. 2013. Available at http://www.cdc.gov/vitalsigns/ prescriptionpainkilleroverdoses/index.html. 3. National Institutes of Health, U.S. Department of Health and Human Services. Improve treatments for opioid misuse disorder and addiction. 2018. Available at: www.nih.gov/researchtraining/medical-research-initiatives/heal-initiative/ strategy-opioid-misuse-addiction. 4. Martin JA, Hamilton BE, Osterman MJK, Driscoll AK, Drake P. Births: final data for 2016. Natl Vital Stat Rep 2018;67:1–55. 5. Hamilton BE, Hoyert DL, Martin JA, Strobino DM, Guyer B. Annual summary of vital statistics: 2010-2011. Pediatrics 2013;131: 548–58. 6. Shah A, Hayes CJ, Martin BC. Characteristics of initial prescription episodes and likelihood of long-term opioid useeUnited States, 2006e 2015. MMWR Morbid Mortal Wkly Rep 2017;66: 265–9. 7. Woodrow Wilson School of Public and International Affairs. Addressing the opioid
epidemic: is there a role for physician education? 2018. Available at: http://wws.princeton. edu/faculty-research/research/item/addressing- Q5 opioid-epidemic-there-role-physician-education. 8. Peahl AF, Harvey S, Bradle A, Smith R. Reducing postpartum opioid use following cesarean delivery: the impact of opioid-sparing protocol. Obstet Gynecol 2019;133(Suppl 1). 215Se6S.
Author and article information From the Department of Obstetrics and Gynecology (Dr Lakhi, Ms Tricorico, and Drs Kanninen, Suddle, Ponterio, and Moretti), Richmond University Medical Center, Staten Island, NY; Department of Obstetrics and Gynecology (Drs Lahki, Ponterio, and Moretti), New York Medical College, Valhalla, NY. Received June 10, 2019; revised Sept. 15, 2019; accepted Sept. 17, 2019. The authors report no conflicts of interest. Corresponding author: Nisha Lakhi, MD nlakhi@ RUMCSI.org
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