One of the The Hospitalist newsmagazine’s features over the years is frequent articles educating physicians about Medicare reimbursement. Nothing wrong with that. Reimbursement for “sepsis” is better than for “urosepsis,” and that’s important for us to know.

However, I think it’s about time that we physicians take a stand and try to change some of the ridiculous word games going on in Medicare reimbursement circles. Why do we stand idly by and let some bureaucrat decree that if we write “urosepsis,” Medicare reimburses markedly less, even though we are treating exactly the same thing if we write “sepsis from UTI”? Why are we not fighting the asinine “bullet” system, in which we get substantially “downcoded” if we miss one trivial bullet in our physical exam that has no bearing on our assessment or plan for the patient? Why have we allowed this travesty to pass through unchallenged? Sure, this is the system now and has been, but do we need to continue to accept these inane reimbursement mechanisms?

I propose we develop a team from within SHM, maybe with some help from other physician organizations, to infiltrate, badger, or whatever it takes to advocate change to a reimbursement system that is more intuitive to physicians. The system should reimburse us for the value we add to the patient encounter. For example, how about reimbursement for nonprocedural visits measured not on history/exam bullets but on the complexity of your assessment and plan, including patient/family counseling and/ or care coordination?

Then we can read articles showing what we are doing to change/improve the Medicare reimbursement landscape instead of just learning how to comply with the current system.

Jim Fulmer, MD, site medical director,

Baptist Primary Care Hospitalist System,

Baptist Medical Center— Downtown Campus,

One of the The Hospitalist newsmagazine’s features over the years is frequent articles educating physicians about Medicare reimbursement. Nothing wrong with that. Reimbursement for “sepsis” is better than for “urosepsis,” and that’s important for us to know.

However, I think it’s about time that we physicians take a stand and try to change some of the ridiculous word games going on in Medicare reimbursement circles. Why do we stand idly by and let some bureaucrat decree that if we write “urosepsis,” Medicare reimburses markedly less, even though we are treating exactly the same thing if we write “sepsis from UTI”? Why are we not fighting the asinine “bullet” system, in which we get substantially “downcoded” if we miss one trivial bullet in our physical exam that has no bearing on our assessment or plan for the patient? Why have we allowed this travesty to pass through unchallenged? Sure, this is the system now and has been, but do we need to continue to accept these inane reimbursement mechanisms?

I propose we develop a team from within SHM, maybe with some help from other physician organizations, to infiltrate, badger, or whatever it takes to advocate change to a reimbursement system that is more intuitive to physicians. The system should reimburse us for the value we add to the patient encounter. For example, how about reimbursement for nonprocedural visits measured not on history/exam bullets but on the complexity of your assessment and plan, including patient/family counseling and/ or care coordination?

Then we can read articles showing what we are doing to change/improve the Medicare reimbursement landscape instead of just learning how to comply with the current system.

Jim Fulmer, MD, site medical director,

Baptist Primary Care Hospitalist System,

Baptist Medical Center— Downtown Campus,

One of the The Hospitalist newsmagazine’s features over the years is frequent articles educating physicians about Medicare reimbursement. Nothing wrong with that. Reimbursement for “sepsis” is better than for “urosepsis,” and that’s important for us to know.

However, I think it’s about time that we physicians take a stand and try to change some of the ridiculous word games going on in Medicare reimbursement circles. Why do we stand idly by and let some bureaucrat decree that if we write “urosepsis,” Medicare reimburses markedly less, even though we are treating exactly the same thing if we write “sepsis from UTI”? Why are we not fighting the asinine “bullet” system, in which we get substantially “downcoded” if we miss one trivial bullet in our physical exam that has no bearing on our assessment or plan for the patient? Why have we allowed this travesty to pass through unchallenged? Sure, this is the system now and has been, but do we need to continue to accept these inane reimbursement mechanisms?

I propose we develop a team from within SHM, maybe with some help from other physician organizations, to infiltrate, badger, or whatever it takes to advocate change to a reimbursement system that is more intuitive to physicians. The system should reimburse us for the value we add to the patient encounter. For example, how about reimbursement for nonprocedural visits measured not on history/exam bullets but on the complexity of your assessment and plan, including patient/family counseling and/ or care coordination?

Then we can read articles showing what we are doing to change/improve the Medicare reimbursement landscape instead of just learning how to comply with the current system.

Jim Fulmer, MD, site medical director,

Baptist Primary Care Hospitalist System,

Baptist Medical Center— Downtown Campus,

I would broaden the comment in the April 2012 article “10 Things Hospitalists Should Know about Infectious Diseases” regarding culturing decubitus ulcers to: “Do not swab any superficial dermatologic wound without sterilizing the surface and then subsequently expressing a sample from the underlying tissue.” I tell my trainees that, unless they sterilize, they might as well culture their ties and send that instead.

Clifford A. Kaye, MD, assistant professor,

Wayne State University SOM,

associate medical director of quality and hospital utilization,

Henry Ford Hospital, Detroit

I would broaden the comment in the April 2012 article “10 Things Hospitalists Should Know about Infectious Diseases” regarding culturing decubitus ulcers to: “Do not swab any superficial dermatologic wound without sterilizing the surface and then subsequently expressing a sample from the underlying tissue.” I tell my trainees that, unless they sterilize, they might as well culture their ties and send that instead.

Clifford A. Kaye, MD, assistant professor,

Wayne State University SOM,

associate medical director of quality and hospital utilization,

Henry Ford Hospital, Detroit

I would broaden the comment in the April 2012 article “10 Things Hospitalists Should Know about Infectious Diseases” regarding culturing decubitus ulcers to: “Do not swab any superficial dermatologic wound without sterilizing the surface and then subsequently expressing a sample from the underlying tissue.” I tell my trainees that, unless they sterilize, they might as well culture their ties and send that instead.

Clifford A. Kaye, MD, assistant professor,

Wayne State University SOM,

associate medical director of quality and hospital utilization,

Henry Ford Hospital, Detroit

ATLANTA – The incidence of Clostridium difficile infection in children in Monroe County, N.Y., was low, and most cases were mild and community acquired during 2009-2011, but a high proportion of children affected had underlying chronic medical conditions, surveillance data show.

Many cases in children followed exposure to traditional risk factors in the 2 weeks preceding C. difficile infection, including use of antibiotics in 48% of cases, and exposure to proton pump inhibitors in 15% of cases, Rebecca C. Smith reported in a poster at the International Conference on Emerging Infectious Diseases.

Photo courtesy CDC/D.Holdeman

Surveillance for C. difficile infection in Monroe County was part of a Centers for Disease Control and Prevention Emerging Infections Program project initiated because of an increase in infections in hospitalized children, as well as increases of severe disease acquired in the community in individuals with no known exposures to risk factors such as health care and antibiotics. These increases occurred following emergence of the highly toxic, epidemic BI/NAP1/027 strain of C. difficile, said Ms. Smith of the University of Rochester (N.Y.).

Of 3,351 cases of C. difficile infection identified during the 2-year surveillance conducted between October 2009, and October 2011, 115 (3%) were in children, for a yearly incidence of 33.5 cases per 100,000 population. The median age of pediatric patients in this study was 5 years, with those aged 12-23 months comprising 24% of cases, she noted.

Most pediatric cases (71%) were community acquired, and 4 (3%) of the 115 children were hospitalized for the C. difficile infection.

Stool samples were collected in 31 children, and of these 90% grew C. difficile, and 26% of those were NAP1, Ms. Smith said.

Recurrences occurred in 23% of cases, which was a rate similar to that seen in the adult population with C. difficile infection, she noted.

Importantly, 64% of the children had an underlying medical condition. The underlying medical conditions in children with C. difficile infection included asthma, malignancy, presence of a G-tube, or failure to thrive, and these conditions may have increased the likelihood of having true disease, Ms. Smith said.

The findings suggest that further investigation of the risk of C. difficile infection in children with no traditional risk factors is warranted, she concluded.

Ms. Smith said she had had no relevant financial disclosures.

ATLANTA – The incidence of Clostridium difficile infection in children in Monroe County, N.Y., was low, and most cases were mild and community acquired during 2009-2011, but a high proportion of children affected had underlying chronic medical conditions, surveillance data show.

Many cases in children followed exposure to traditional risk factors in the 2 weeks preceding C. difficile infection, including use of antibiotics in 48% of cases, and exposure to proton pump inhibitors in 15% of cases, Rebecca C. Smith reported in a poster at the International Conference on Emerging Infectious Diseases.

Photo courtesy CDC/D.Holdeman

Surveillance for C. difficile infection in Monroe County was part of a Centers for Disease Control and Prevention Emerging Infections Program project initiated because of an increase in infections in hospitalized children, as well as increases of severe disease acquired in the community in individuals with no known exposures to risk factors such as health care and antibiotics. These increases occurred following emergence of the highly toxic, epidemic BI/NAP1/027 strain of C. difficile, said Ms. Smith of the University of Rochester (N.Y.).

Of 3,351 cases of C. difficile infection identified during the 2-year surveillance conducted between October 2009, and October 2011, 115 (3%) were in children, for a yearly incidence of 33.5 cases per 100,000 population. The median age of pediatric patients in this study was 5 years, with those aged 12-23 months comprising 24% of cases, she noted.

Most pediatric cases (71%) were community acquired, and 4 (3%) of the 115 children were hospitalized for the C. difficile infection.

Stool samples were collected in 31 children, and of these 90% grew C. difficile, and 26% of those were NAP1, Ms. Smith said.

Recurrences occurred in 23% of cases, which was a rate similar to that seen in the adult population with C. difficile infection, she noted.

Importantly, 64% of the children had an underlying medical condition. The underlying medical conditions in children with C. difficile infection included asthma, malignancy, presence of a G-tube, or failure to thrive, and these conditions may have increased the likelihood of having true disease, Ms. Smith said.

The findings suggest that further investigation of the risk of C. difficile infection in children with no traditional risk factors is warranted, she concluded.

Ms. Smith said she had had no relevant financial disclosures.

ATLANTA – The incidence of Clostridium difficile infection in children in Monroe County, N.Y., was low, and most cases were mild and community acquired during 2009-2011, but a high proportion of children affected had underlying chronic medical conditions, surveillance data show.

Many cases in children followed exposure to traditional risk factors in the 2 weeks preceding C. difficile infection, including use of antibiotics in 48% of cases, and exposure to proton pump inhibitors in 15% of cases, Rebecca C. Smith reported in a poster at the International Conference on Emerging Infectious Diseases.

Photo courtesy CDC/D.Holdeman

Surveillance for C. difficile infection in Monroe County was part of a Centers for Disease Control and Prevention Emerging Infections Program project initiated because of an increase in infections in hospitalized children, as well as increases of severe disease acquired in the community in individuals with no known exposures to risk factors such as health care and antibiotics. These increases occurred following emergence of the highly toxic, epidemic BI/NAP1/027 strain of C. difficile, said Ms. Smith of the University of Rochester (N.Y.).

Of 3,351 cases of C. difficile infection identified during the 2-year surveillance conducted between October 2009, and October 2011, 115 (3%) were in children, for a yearly incidence of 33.5 cases per 100,000 population. The median age of pediatric patients in this study was 5 years, with those aged 12-23 months comprising 24% of cases, she noted.

Most pediatric cases (71%) were community acquired, and 4 (3%) of the 115 children were hospitalized for the C. difficile infection.

Stool samples were collected in 31 children, and of these 90% grew C. difficile, and 26% of those were NAP1, Ms. Smith said.

Recurrences occurred in 23% of cases, which was a rate similar to that seen in the adult population with C. difficile infection, she noted.

Importantly, 64% of the children had an underlying medical condition. The underlying medical conditions in children with C. difficile infection included asthma, malignancy, presence of a G-tube, or failure to thrive, and these conditions may have increased the likelihood of having true disease, Ms. Smith said.

The findings suggest that further investigation of the risk of C. difficile infection in children with no traditional risk factors is warranted, she concluded.

Ms. Smith said she had had no relevant financial disclosures.

The septate uterus is not only the most common Müllerian anomaly, it is the uterine malformation associated with the poorest reproductive outcomes, including recurrent pregnancy loss, preterm labor, malpresentation, and probably infertility. Although many patients with a uterine septum are asymptomatic and conceive and deliver without any difficulty, those who do have poor outcomes can benefit from transection of the septum.

The simplicity of hysteroscopic septoplasty, with its low rates of intraoperative complications and postoperative sequelae, provides experienced gynecologic surgeons with the opportunity to remarkably improve reproductive and obstetric outcomes for their patients with this anomaly.

The procedure has proven to be safe and effective for women with a history of recurrent miscarriage and other poor reproductive outcomes. Although a causal relationship between the septate uterus and infertility remains unproven, encouraging findings from numerous retrospective and observational studies are supporting the procedure’s use in patients with unexplained primary infertility as well.

Incidence and Effects

Müllerian anomalies are an embryologic phenomenon of the female reproductive tract. The anomalies are the result of a defect in the elongation, fusion, canalization, or septal reabsorption of the Müllerian/paramesonephric ducts.

Normally, at approximately 9 weeks’ gestation, these steps occur without incident and result in the creation of a single unified uterine cavity. In some cases, however, incomplete or failed reabsorption of the intervening partition of Müllerian products results in a persistent fibromuscular uterine septum. The extent of the septum varies; usually, it partially affects the uterine cavity rather than completely dividing it.

The septate uterus, the most common type of Müllerian anomaly, has been estimated to occur in 3%-7% of the general population. Its clinical sequelae include increased rates of spontaneous abortion, preterm delivery, intrauterine growth restriction, and malpresentation, compared with rates in women without a septum, as well as a higher rate of cesarean delivery.

Estimates of pregnancy rates in patients with a septate uterus have ranged from 5% to 40%, and miscarriage rates of 70%-90% have been reported. Thus, live birth rates in this population are poor.

Although uterine septa are closely related to recurrent miscarriage, the effect of the septate uterus on fertility is controversial. Some experts have proposed that the septate uterus may at least contribute to otherwise unexplained infertility by adversely affecting implantation. The endometrium overlying the septum may be different from the neighboring endometrium within the uterine cavity, it is believed, although this relationship is not yet directly correlated with primary infertility.

Dr. Luigi Fedele and his colleagues in Milan reported ultrastructural changes in biopsy sites from the septum, compared with the sites in the lateral uterine wall, using scanning electron microcopy. These histological factors included reductions in the number of glandular ostia, an irregular distribution of glandular ostia, incomplete ciliogenesis, and reductions in the ciliated cell ratio. The authors further concluded that septal tissue had decreased sensitivity to steroid hormones (Fertil. Steril. 1996;65:750-2).

Indications for Surgery

Currently, indications for surgical correction of a uterine septum include pelvic pain, endometriosis, an obstructing phenomenon, recurrent miscarriage, and history of preterm delivery.

Infertility is a controversial indication for surgery, as its association with the septate uterus has not been demonstrated by randomized studies. Several observational studies, however, have shown promising results with postoperative pregnancy rates of 25%-70% in patients with primary infertility, and there is consequently a movement to expand the use of hysteroscopic septoplasty to this subset of patients.

In one systematic review of 18 studies (including one retrospective cohort study of 64 women conducted by the review’s authors), the overall pregnancy rate after hysteroscopic septoplasty was 60% and the overall live birth rate was 45% (Reprod. Biol. Endocrinol. 2010;8:52-60).

A more recently published prospective study of women with unexplained primary infertility yielded remarkable results. Of 88 patients who underwent septoplasty, 48% conceived within a mean time to conception of approximately 7 months. Nearly 80% of these women conceived spontaneously, and more than 80% had live births. Approximately 71% of the deliveries were vaginal.

The only identifiable factor associated with reproductive failure in this study was a uterine septum. Patients had unexplained primary infertility for at least 48 months, and the study excluded patients with any history of miscarriage, abortion, or other factors that could contribute to infertility, such as endometriosis (Eur. J. Obstet. Gynecol. Reprod. Biol. 2011;155:54-7).

Diagnosis

Many imaging modalities have been used in the diagnosis of a uterine septum, including hysterosalpingogram (HSG), 2D and 3D ultrasound, saline infusion sonohysterography, and MRI. Müllerian anomalies may be paired with anomalies of the urinary tract, although the correlation with uterine septa is present less frequently than with other uterine anomalies. Nevertheless, evaluation of the urinary tract should be performed as part of the diagnostic work-up in patients with anomalies and thus may influence the diagnostic approach.

An HSG can elucidate the contour of the endometrial cavity and any communications including tubal patency. HSG is not universally considered a reliable diagnostic strategy, however, as the serosal surface of the uterus is not examined.

Images courtesy Dr. Megan Daw

By contrast, as Dr. Fedele has demonstrated, sensitivity and specificity may be up to 100% with the use of 3D sonography. Ultrasound also can provide an assessment of other pelvic structures, such as ovaries and kidneys, that may contribute to a patient’s symptoms or be associated with Müllerian anomalies.

MRI is another noninvasive diagnostic strategy for characterizing Müllerian anomalies. It is both sensitive and specific, and is considered a valuable strategy as it allows for thorough evaluation of both the internal and external contour of the uterus.

Although advancements in MRI and ultrasound have improved diagnostic accuracy, concurrent laparoscopy at the time of hysteroscopic treatment remains the standard in confirming the diagnostic impressions formed by initial imaging. At our institution, we employ a combination of in-office 2D and 3D ultrasound, as well as saline infusion sonohysterography, and then confirm our findings laparoscopically at the time of surgery.

Treatment, Complication Risk

Uterine septa classically were treated with abdominal surgery, but advances in operative hysteroscopy have led to equally efficacious treatment with the advantage of decreased morbidity.

Potential intraoperative complications of hysteroscopic transection of uterine septa include bleeding, distention media overload, and perforation, with an associated risk of damage to nearby structures. Generally, septa are avascular, making the risk of both hemorrhage and distention media overload quite minimal. These complications are on the order of less than 1%, and typically the procedure is performed without incident on an outpatient basis.

Delayed complications of hysteroscopic septoplasty include the formation of intrauterine adhesions and the risk of uterine rupture with subsequent pregnancies. Although case reports of uterine rupture after hysteroscopic septoplasty exist, rupture is a very rare event because the integrity of the myometrium is generally preserved.

Adhesion formation, however, has been reported in up to approximately 7% of cases following hysteroscopic transection of uterine septum, according to a review published last year (Semin. Reprod. Med. 2011;29:83-94). Adhesion formation can further compromise the gestational performance of these patients.

Operative Technique

In preparation for operative hysteroscopy, many surgeons recommend priming the endometrial lining to provide optimal visualization. Progestins, oral contraceptive pills (OCs), or a GnRH analog can be used for this purpose. Alternatively, the procedure may be coordinated or timed with the patient’s early proliferative phase.

Hysteroscopic treatment involves incising the uterine septum and allowing the fibromuscular tissue to retract to the level of the surrounding endometrium. Surgeons have used microscissors, electrosurgery, or even fiberoptic laser energy, although this latter technique is currently less common given its expense, manipulation difficulties, and requirement for specialized training.

Although energy-based techniques provide hemostasis and may offer greater ease to a procedure involving a thick septum, use of these techniques increases the risk of postoperative intrauterine adhesion formation from endometrial and myometrial thermal damage. The use of microscissors, an energy-free technique, avoids thermal damage to the surrounding tissue and the subsequent increased risk of intrauterine adhesive disease.

Images courtesy Dr. Megan Daw

A 12- or 25-degree lens provides accurate and continuous orientation of the ostia and instruments. A 5-7 Fr semi-rigid scissors offer sturdiness and maneuverability.

The surgical technique involves the incision of the septum equidistant between the anterior and posterior walls and traveling toward the fundus without inciting trauma to the myometrium of the fundus. Specifically, the septum is incised with both ostia in the visual field and midway between the anterior and posterior wall of the uterus. The incision is extended cephalad to the level of the uterine fundus.

If a broad septum limits visualization of both ostia, sequential thinning incisions are made along each side of the septum from the apex to the fundus. These incisions create a wedge that can ultimately be transected. The end point may be subtle, but continuous movement from one ostium to the other with the hysteroscope, and a uniform appearance of the uterine fundus, should be achieved. Bleeding may be an additional indication that the septum has been completely transected as this indicates myometrial disruption.

A complete septum is considered a rare phenomenon and may best be surgically treated only by providers with advanced hysteroscopic experience. In this case, visualization of the ectocervix must first be maximized. The initiation of the transection can be performed using a handheld instrument such as scissors, blade, or electrosurgical pencil and then continued hysteroscopically in a manner similar to transection of a partial septum.

Concomitant laparoscopic visualization can confirm prior findings revealed by imaging, provide assurance that the bowel is not adherent to the peritoneal surface of the uterus, and reveal proximity of the hysteroscopic instruments to the uterine serosal surface, thus decreasing risk of perforation during the procedure. Additionally, blanching of the uterine serosa or visualization of the hysteroscopic light can illustrate proximity to the serosal surface.

Coexisting pelvic pathology also can be diagnosed and treated at the time of the hysteroscopic procedure, as in the case of endometriosis.

Postop Care, Follow-Up

Postoperative care and follow-up must include strategies for preventing intrauterine adhesion formation and for confirming success of the procedure.

Multiple methods, from the placement of an intrauterine device or catheter to estrogen supplementation, have been proposed to minimize or prevent intrauterine adhesion formation following hysteroscopic septoplasty.

The IUD initially used for the purpose of separating endometrial surfaces over the operative site during healing was the Lippe’s loop – an inert device consisting of a thin polyethylene wire bent into a series of "S" shapes. It was removed from the U.S. market in the 1980s and is no longer widely available. The two currently approved IUDs – copper-based or progestin-containing – both raise concerns postoperatively, as copper can cause inflammation and progestins cause thinning of the endometrium lining.

For these reasons and in the setting of poor supportive data, IUDs are no longer used following hysteroscopic septoplasty.

Intrauterine catheters or stents are sometimes used following septoplasty under the same philosophy espoused by the IUD proponents – that adhesion formation can be prevented by the physical separation of endometrial surfaces during healing.

The surgeon should be extremely mindful of intrauterine pressure when a stent is placed, as the theoretical risk of uterine rupture exists if the myometrium is significantly disrupted during the procedure. Stents include a pediatric Foley balloon or specific intrauterine devices sold commercially.

Supplemental estrogen may be used to stimulate endometrial proliferation and, therefore, promote healing over the operative site. Multiple regimens exist and are sometimes paired with progestins. No standard regimen is reported in the literature and, thus, this choice depends on one’s familiarity and comfort.

Dr. Megan Daw is an AAGL/SRS fellow in minimally invasive gynecologic surgery at Advocate Lutheran General Hospital in Park Ridge, Ill. She matriculated at the University of North Carolina at Chapel Hill, then completed her residency in obstetrics and gynecology at the University of California at San Francisco in June 2010. Dr. Daw said that she has no disclosures to report.

The septate uterus is not only the most common Müllerian anomaly, it is the uterine malformation associated with the poorest reproductive outcomes, including recurrent pregnancy loss, preterm labor, malpresentation, and probably infertility. Although many patients with a uterine septum are asymptomatic and conceive and deliver without any difficulty, those who do have poor outcomes can benefit from transection of the septum.

The simplicity of hysteroscopic septoplasty, with its low rates of intraoperative complications and postoperative sequelae, provides experienced gynecologic surgeons with the opportunity to remarkably improve reproductive and obstetric outcomes for their patients with this anomaly.

The procedure has proven to be safe and effective for women with a history of recurrent miscarriage and other poor reproductive outcomes. Although a causal relationship between the septate uterus and infertility remains unproven, encouraging findings from numerous retrospective and observational studies are supporting the procedure’s use in patients with unexplained primary infertility as well.

Incidence and Effects

Müllerian anomalies are an embryologic phenomenon of the female reproductive tract. The anomalies are the result of a defect in the elongation, fusion, canalization, or septal reabsorption of the Müllerian/paramesonephric ducts.

Normally, at approximately 9 weeks’ gestation, these steps occur without incident and result in the creation of a single unified uterine cavity. In some cases, however, incomplete or failed reabsorption of the intervening partition of Müllerian products results in a persistent fibromuscular uterine septum. The extent of the septum varies; usually, it partially affects the uterine cavity rather than completely dividing it.

The septate uterus, the most common type of Müllerian anomaly, has been estimated to occur in 3%-7% of the general population. Its clinical sequelae include increased rates of spontaneous abortion, preterm delivery, intrauterine growth restriction, and malpresentation, compared with rates in women without a septum, as well as a higher rate of cesarean delivery.

Estimates of pregnancy rates in patients with a septate uterus have ranged from 5% to 40%, and miscarriage rates of 70%-90% have been reported. Thus, live birth rates in this population are poor.

Although uterine septa are closely related to recurrent miscarriage, the effect of the septate uterus on fertility is controversial. Some experts have proposed that the septate uterus may at least contribute to otherwise unexplained infertility by adversely affecting implantation. The endometrium overlying the septum may be different from the neighboring endometrium within the uterine cavity, it is believed, although this relationship is not yet directly correlated with primary infertility.

Dr. Luigi Fedele and his colleagues in Milan reported ultrastructural changes in biopsy sites from the septum, compared with the sites in the lateral uterine wall, using scanning electron microcopy. These histological factors included reductions in the number of glandular ostia, an irregular distribution of glandular ostia, incomplete ciliogenesis, and reductions in the ciliated cell ratio. The authors further concluded that septal tissue had decreased sensitivity to steroid hormones (Fertil. Steril. 1996;65:750-2).

Indications for Surgery

Currently, indications for surgical correction of a uterine septum include pelvic pain, endometriosis, an obstructing phenomenon, recurrent miscarriage, and history of preterm delivery.

Infertility is a controversial indication for surgery, as its association with the septate uterus has not been demonstrated by randomized studies. Several observational studies, however, have shown promising results with postoperative pregnancy rates of 25%-70% in patients with primary infertility, and there is consequently a movement to expand the use of hysteroscopic septoplasty to this subset of patients.

In one systematic review of 18 studies (including one retrospective cohort study of 64 women conducted by the review’s authors), the overall pregnancy rate after hysteroscopic septoplasty was 60% and the overall live birth rate was 45% (Reprod. Biol. Endocrinol. 2010;8:52-60).

A more recently published prospective study of women with unexplained primary infertility yielded remarkable results. Of 88 patients who underwent septoplasty, 48% conceived within a mean time to conception of approximately 7 months. Nearly 80% of these women conceived spontaneously, and more than 80% had live births. Approximately 71% of the deliveries were vaginal.

The only identifiable factor associated with reproductive failure in this study was a uterine septum. Patients had unexplained primary infertility for at least 48 months, and the study excluded patients with any history of miscarriage, abortion, or other factors that could contribute to infertility, such as endometriosis (Eur. J. Obstet. Gynecol. Reprod. Biol. 2011;155:54-7).

Diagnosis

Many imaging modalities have been used in the diagnosis of a uterine septum, including hysterosalpingogram (HSG), 2D and 3D ultrasound, saline infusion sonohysterography, and MRI. Müllerian anomalies may be paired with anomalies of the urinary tract, although the correlation with uterine septa is present less frequently than with other uterine anomalies. Nevertheless, evaluation of the urinary tract should be performed as part of the diagnostic work-up in patients with anomalies and thus may influence the diagnostic approach.

An HSG can elucidate the contour of the endometrial cavity and any communications including tubal patency. HSG is not universally considered a reliable diagnostic strategy, however, as the serosal surface of the uterus is not examined.

Images courtesy Dr. Megan Daw

By contrast, as Dr. Fedele has demonstrated, sensitivity and specificity may be up to 100% with the use of 3D sonography. Ultrasound also can provide an assessment of other pelvic structures, such as ovaries and kidneys, that may contribute to a patient’s symptoms or be associated with Müllerian anomalies.

MRI is another noninvasive diagnostic strategy for characterizing Müllerian anomalies. It is both sensitive and specific, and is considered a valuable strategy as it allows for thorough evaluation of both the internal and external contour of the uterus.

Although advancements in MRI and ultrasound have improved diagnostic accuracy, concurrent laparoscopy at the time of hysteroscopic treatment remains the standard in confirming the diagnostic impressions formed by initial imaging. At our institution, we employ a combination of in-office 2D and 3D ultrasound, as well as saline infusion sonohysterography, and then confirm our findings laparoscopically at the time of surgery.

Treatment, Complication Risk

Uterine septa classically were treated with abdominal surgery, but advances in operative hysteroscopy have led to equally efficacious treatment with the advantage of decreased morbidity.

Potential intraoperative complications of hysteroscopic transection of uterine septa include bleeding, distention media overload, and perforation, with an associated risk of damage to nearby structures. Generally, septa are avascular, making the risk of both hemorrhage and distention media overload quite minimal. These complications are on the order of less than 1%, and typically the procedure is performed without incident on an outpatient basis.

Delayed complications of hysteroscopic septoplasty include the formation of intrauterine adhesions and the risk of uterine rupture with subsequent pregnancies. Although case reports of uterine rupture after hysteroscopic septoplasty exist, rupture is a very rare event because the integrity of the myometrium is generally preserved.

Adhesion formation, however, has been reported in up to approximately 7% of cases following hysteroscopic transection of uterine septum, according to a review published last year (Semin. Reprod. Med. 2011;29:83-94). Adhesion formation can further compromise the gestational performance of these patients.

Operative Technique

In preparation for operative hysteroscopy, many surgeons recommend priming the endometrial lining to provide optimal visualization. Progestins, oral contraceptive pills (OCs), or a GnRH analog can be used for this purpose. Alternatively, the procedure may be coordinated or timed with the patient’s early proliferative phase.

Hysteroscopic treatment involves incising the uterine septum and allowing the fibromuscular tissue to retract to the level of the surrounding endometrium. Surgeons have used microscissors, electrosurgery, or even fiberoptic laser energy, although this latter technique is currently less common given its expense, manipulation difficulties, and requirement for specialized training.

Although energy-based techniques provide hemostasis and may offer greater ease to a procedure involving a thick septum, use of these techniques increases the risk of postoperative intrauterine adhesion formation from endometrial and myometrial thermal damage. The use of microscissors, an energy-free technique, avoids thermal damage to the surrounding tissue and the subsequent increased risk of intrauterine adhesive disease.

Images courtesy Dr. Megan Daw

A 12- or 25-degree lens provides accurate and continuous orientation of the ostia and instruments. A 5-7 Fr semi-rigid scissors offer sturdiness and maneuverability.

The surgical technique involves the incision of the septum equidistant between the anterior and posterior walls and traveling toward the fundus without inciting trauma to the myometrium of the fundus. Specifically, the septum is incised with both ostia in the visual field and midway between the anterior and posterior wall of the uterus. The incision is extended cephalad to the level of the uterine fundus.

If a broad septum limits visualization of both ostia, sequential thinning incisions are made along each side of the septum from the apex to the fundus. These incisions create a wedge that can ultimately be transected. The end point may be subtle, but continuous movement from one ostium to the other with the hysteroscope, and a uniform appearance of the uterine fundus, should be achieved. Bleeding may be an additional indication that the septum has been completely transected as this indicates myometrial disruption.

A complete septum is considered a rare phenomenon and may best be surgically treated only by providers with advanced hysteroscopic experience. In this case, visualization of the ectocervix must first be maximized. The initiation of the transection can be performed using a handheld instrument such as scissors, blade, or electrosurgical pencil and then continued hysteroscopically in a manner similar to transection of a partial septum.

Concomitant laparoscopic visualization can confirm prior findings revealed by imaging, provide assurance that the bowel is not adherent to the peritoneal surface of the uterus, and reveal proximity of the hysteroscopic instruments to the uterine serosal surface, thus decreasing risk of perforation during the procedure. Additionally, blanching of the uterine serosa or visualization of the hysteroscopic light can illustrate proximity to the serosal surface.

Coexisting pelvic pathology also can be diagnosed and treated at the time of the hysteroscopic procedure, as in the case of endometriosis.

Postop Care, Follow-Up

Postoperative care and follow-up must include strategies for preventing intrauterine adhesion formation and for confirming success of the procedure.

Multiple methods, from the placement of an intrauterine device or catheter to estrogen supplementation, have been proposed to minimize or prevent intrauterine adhesion formation following hysteroscopic septoplasty.

The IUD initially used for the purpose of separating endometrial surfaces over the operative site during healing was the Lippe’s loop – an inert device consisting of a thin polyethylene wire bent into a series of "S" shapes. It was removed from the U.S. market in the 1980s and is no longer widely available. The two currently approved IUDs – copper-based or progestin-containing – both raise concerns postoperatively, as copper can cause inflammation and progestins cause thinning of the endometrium lining.

For these reasons and in the setting of poor supportive data, IUDs are no longer used following hysteroscopic septoplasty.

Intrauterine catheters or stents are sometimes used following septoplasty under the same philosophy espoused by the IUD proponents – that adhesion formation can be prevented by the physical separation of endometrial surfaces during healing.

The surgeon should be extremely mindful of intrauterine pressure when a stent is placed, as the theoretical risk of uterine rupture exists if the myometrium is significantly disrupted during the procedure. Stents include a pediatric Foley balloon or specific intrauterine devices sold commercially.

Supplemental estrogen may be used to stimulate endometrial proliferation and, therefore, promote healing over the operative site. Multiple regimens exist and are sometimes paired with progestins. No standard regimen is reported in the literature and, thus, this choice depends on one’s familiarity and comfort.

Dr. Megan Daw is an AAGL/SRS fellow in minimally invasive gynecologic surgery at Advocate Lutheran General Hospital in Park Ridge, Ill. She matriculated at the University of North Carolina at Chapel Hill, then completed her residency in obstetrics and gynecology at the University of California at San Francisco in June 2010. Dr. Daw said that she has no disclosures to report.

The septate uterus is not only the most common Müllerian anomaly, it is the uterine malformation associated with the poorest reproductive outcomes, including recurrent pregnancy loss, preterm labor, malpresentation, and probably infertility. Although many patients with a uterine septum are asymptomatic and conceive and deliver without any difficulty, those who do have poor outcomes can benefit from transection of the septum.

The simplicity of hysteroscopic septoplasty, with its low rates of intraoperative complications and postoperative sequelae, provides experienced gynecologic surgeons with the opportunity to remarkably improve reproductive and obstetric outcomes for their patients with this anomaly.

The procedure has proven to be safe and effective for women with a history of recurrent miscarriage and other poor reproductive outcomes. Although a causal relationship between the septate uterus and infertility remains unproven, encouraging findings from numerous retrospective and observational studies are supporting the procedure’s use in patients with unexplained primary infertility as well.

Incidence and Effects

Müllerian anomalies are an embryologic phenomenon of the female reproductive tract. The anomalies are the result of a defect in the elongation, fusion, canalization, or septal reabsorption of the Müllerian/paramesonephric ducts.

Normally, at approximately 9 weeks’ gestation, these steps occur without incident and result in the creation of a single unified uterine cavity. In some cases, however, incomplete or failed reabsorption of the intervening partition of Müllerian products results in a persistent fibromuscular uterine septum. The extent of the septum varies; usually, it partially affects the uterine cavity rather than completely dividing it.

The septate uterus, the most common type of Müllerian anomaly, has been estimated to occur in 3%-7% of the general population. Its clinical sequelae include increased rates of spontaneous abortion, preterm delivery, intrauterine growth restriction, and malpresentation, compared with rates in women without a septum, as well as a higher rate of cesarean delivery.

Estimates of pregnancy rates in patients with a septate uterus have ranged from 5% to 40%, and miscarriage rates of 70%-90% have been reported. Thus, live birth rates in this population are poor.

Although uterine septa are closely related to recurrent miscarriage, the effect of the septate uterus on fertility is controversial. Some experts have proposed that the septate uterus may at least contribute to otherwise unexplained infertility by adversely affecting implantation. The endometrium overlying the septum may be different from the neighboring endometrium within the uterine cavity, it is believed, although this relationship is not yet directly correlated with primary infertility.

Dr. Luigi Fedele and his colleagues in Milan reported ultrastructural changes in biopsy sites from the septum, compared with the sites in the lateral uterine wall, using scanning electron microcopy. These histological factors included reductions in the number of glandular ostia, an irregular distribution of glandular ostia, incomplete ciliogenesis, and reductions in the ciliated cell ratio. The authors further concluded that septal tissue had decreased sensitivity to steroid hormones (Fertil. Steril. 1996;65:750-2).

Indications for Surgery

Currently, indications for surgical correction of a uterine septum include pelvic pain, endometriosis, an obstructing phenomenon, recurrent miscarriage, and history of preterm delivery.

Infertility is a controversial indication for surgery, as its association with the septate uterus has not been demonstrated by randomized studies. Several observational studies, however, have shown promising results with postoperative pregnancy rates of 25%-70% in patients with primary infertility, and there is consequently a movement to expand the use of hysteroscopic septoplasty to this subset of patients.

In one systematic review of 18 studies (including one retrospective cohort study of 64 women conducted by the review’s authors), the overall pregnancy rate after hysteroscopic septoplasty was 60% and the overall live birth rate was 45% (Reprod. Biol. Endocrinol. 2010;8:52-60).

A more recently published prospective study of women with unexplained primary infertility yielded remarkable results. Of 88 patients who underwent septoplasty, 48% conceived within a mean time to conception of approximately 7 months. Nearly 80% of these women conceived spontaneously, and more than 80% had live births. Approximately 71% of the deliveries were vaginal.

The only identifiable factor associated with reproductive failure in this study was a uterine septum. Patients had unexplained primary infertility for at least 48 months, and the study excluded patients with any history of miscarriage, abortion, or other factors that could contribute to infertility, such as endometriosis (Eur. J. Obstet. Gynecol. Reprod. Biol. 2011;155:54-7).

Diagnosis

Many imaging modalities have been used in the diagnosis of a uterine septum, including hysterosalpingogram (HSG), 2D and 3D ultrasound, saline infusion sonohysterography, and MRI. Müllerian anomalies may be paired with anomalies of the urinary tract, although the correlation with uterine septa is present less frequently than with other uterine anomalies. Nevertheless, evaluation of the urinary tract should be performed as part of the diagnostic work-up in patients with anomalies and thus may influence the diagnostic approach.

An HSG can elucidate the contour of the endometrial cavity and any communications including tubal patency. HSG is not universally considered a reliable diagnostic strategy, however, as the serosal surface of the uterus is not examined.

Images courtesy Dr. Megan Daw

By contrast, as Dr. Fedele has demonstrated, sensitivity and specificity may be up to 100% with the use of 3D sonography. Ultrasound also can provide an assessment of other pelvic structures, such as ovaries and kidneys, that may contribute to a patient’s symptoms or be associated with Müllerian anomalies.

MRI is another noninvasive diagnostic strategy for characterizing Müllerian anomalies. It is both sensitive and specific, and is considered a valuable strategy as it allows for thorough evaluation of both the internal and external contour of the uterus.

Although advancements in MRI and ultrasound have improved diagnostic accuracy, concurrent laparoscopy at the time of hysteroscopic treatment remains the standard in confirming the diagnostic impressions formed by initial imaging. At our institution, we employ a combination of in-office 2D and 3D ultrasound, as well as saline infusion sonohysterography, and then confirm our findings laparoscopically at the time of surgery.

Treatment, Complication Risk

Uterine septa classically were treated with abdominal surgery, but advances in operative hysteroscopy have led to equally efficacious treatment with the advantage of decreased morbidity.

Potential intraoperative complications of hysteroscopic transection of uterine septa include bleeding, distention media overload, and perforation, with an associated risk of damage to nearby structures. Generally, septa are avascular, making the risk of both hemorrhage and distention media overload quite minimal. These complications are on the order of less than 1%, and typically the procedure is performed without incident on an outpatient basis.

Delayed complications of hysteroscopic septoplasty include the formation of intrauterine adhesions and the risk of uterine rupture with subsequent pregnancies. Although case reports of uterine rupture after hysteroscopic septoplasty exist, rupture is a very rare event because the integrity of the myometrium is generally preserved.

Adhesion formation, however, has been reported in up to approximately 7% of cases following hysteroscopic transection of uterine septum, according to a review published last year (Semin. Reprod. Med. 2011;29:83-94). Adhesion formation can further compromise the gestational performance of these patients.

Operative Technique

In preparation for operative hysteroscopy, many surgeons recommend priming the endometrial lining to provide optimal visualization. Progestins, oral contraceptive pills (OCs), or a GnRH analog can be used for this purpose. Alternatively, the procedure may be coordinated or timed with the patient’s early proliferative phase.

Hysteroscopic treatment involves incising the uterine septum and allowing the fibromuscular tissue to retract to the level of the surrounding endometrium. Surgeons have used microscissors, electrosurgery, or even fiberoptic laser energy, although this latter technique is currently less common given its expense, manipulation difficulties, and requirement for specialized training.

Although energy-based techniques provide hemostasis and may offer greater ease to a procedure involving a thick septum, use of these techniques increases the risk of postoperative intrauterine adhesion formation from endometrial and myometrial thermal damage. The use of microscissors, an energy-free technique, avoids thermal damage to the surrounding tissue and the subsequent increased risk of intrauterine adhesive disease.

Images courtesy Dr. Megan Daw

A 12- or 25-degree lens provides accurate and continuous orientation of the ostia and instruments. A 5-7 Fr semi-rigid scissors offer sturdiness and maneuverability.

The surgical technique involves the incision of the septum equidistant between the anterior and posterior walls and traveling toward the fundus without inciting trauma to the myometrium of the fundus. Specifically, the septum is incised with both ostia in the visual field and midway between the anterior and posterior wall of the uterus. The incision is extended cephalad to the level of the uterine fundus.

If a broad septum limits visualization of both ostia, sequential thinning incisions are made along each side of the septum from the apex to the fundus. These incisions create a wedge that can ultimately be transected. The end point may be subtle, but continuous movement from one ostium to the other with the hysteroscope, and a uniform appearance of the uterine fundus, should be achieved. Bleeding may be an additional indication that the septum has been completely transected as this indicates myometrial disruption.

A complete septum is considered a rare phenomenon and may best be surgically treated only by providers with advanced hysteroscopic experience. In this case, visualization of the ectocervix must first be maximized. The initiation of the transection can be performed using a handheld instrument such as scissors, blade, or electrosurgical pencil and then continued hysteroscopically in a manner similar to transection of a partial septum.

Concomitant laparoscopic visualization can confirm prior findings revealed by imaging, provide assurance that the bowel is not adherent to the peritoneal surface of the uterus, and reveal proximity of the hysteroscopic instruments to the uterine serosal surface, thus decreasing risk of perforation during the procedure. Additionally, blanching of the uterine serosa or visualization of the hysteroscopic light can illustrate proximity to the serosal surface.

Coexisting pelvic pathology also can be diagnosed and treated at the time of the hysteroscopic procedure, as in the case of endometriosis.

Postop Care, Follow-Up

Postoperative care and follow-up must include strategies for preventing intrauterine adhesion formation and for confirming success of the procedure.

Multiple methods, from the placement of an intrauterine device or catheter to estrogen supplementation, have been proposed to minimize or prevent intrauterine adhesion formation following hysteroscopic septoplasty.

The IUD initially used for the purpose of separating endometrial surfaces over the operative site during healing was the Lippe’s loop – an inert device consisting of a thin polyethylene wire bent into a series of "S" shapes. It was removed from the U.S. market in the 1980s and is no longer widely available. The two currently approved IUDs – copper-based or progestin-containing – both raise concerns postoperatively, as copper can cause inflammation and progestins cause thinning of the endometrium lining.

For these reasons and in the setting of poor supportive data, IUDs are no longer used following hysteroscopic septoplasty.

Intrauterine catheters or stents are sometimes used following septoplasty under the same philosophy espoused by the IUD proponents – that adhesion formation can be prevented by the physical separation of endometrial surfaces during healing.

The surgeon should be extremely mindful of intrauterine pressure when a stent is placed, as the theoretical risk of uterine rupture exists if the myometrium is significantly disrupted during the procedure. Stents include a pediatric Foley balloon or specific intrauterine devices sold commercially.

Supplemental estrogen may be used to stimulate endometrial proliferation and, therefore, promote healing over the operative site. Multiple regimens exist and are sometimes paired with progestins. No standard regimen is reported in the literature and, thus, this choice depends on one’s familiarity and comfort.

Dr. Megan Daw is an AAGL/SRS fellow in minimally invasive gynecologic surgery at Advocate Lutheran General Hospital in Park Ridge, Ill. She matriculated at the University of North Carolina at Chapel Hill, then completed her residency in obstetrics and gynecology at the University of California at San Francisco in June 2010. Dr. Daw said that she has no disclosures to report.

Nearly five years ago, when Nasim Afsar, MD, SFHM, was launching her career as a hospitalist at the University of California Los Angeles Medical Center, she began to appreciate the importance of quality issues for the field of hospital medicine.

Dr. Afsar, who recently was elected to the SHM board of directors, says, "I realized that evidence-based medicine should be the standard of care in hospitals, but we were nowhere near where we should be in addressing that at a systemic level."

Believing that her medical training had not fully prepared her for quality work, Dr. Afsar attended the Advanced Training Program at Intermountain Healthcare in Salt Lake City. "With that foundation, my focus ever since has been on improvement initiatives," she says.

In the years since, Dr. Afsar's quality responsibilities have grown steadily. She is now associate medical director of quality and safety at UCLA, executive director for quality and safety in its department of medicine, and director of quality for neurosurgery. That means about 80% of her work week is devoted to quality improvement (QI). And while her time seeing patients is less, she says the "clinical work is what inspires and motivates me, gives me my best ideas, and keeps me grounded."

Among the more than 40 quality and safety projects she has implemented at UCLA is "The ABCs of Hospitalized Patients," a multidisciplinary checklist designed to reduce the risk of eight common hospital-acquired conditions. "Within three weeks of implementing it, we started seeing significant improvement in every area, and we have been able to sustain that," she says. In 2009, she implemented a systemwide QI curriculum for the residents and fellows at UCLA.

Dr. Afsar, chair of SHM's Hospital Quality and Patient Safety Committee, says HM is challenged to make these kinds of quality approaches the standard of practice nationwide.

"Different institutions are doing different pieces of the quality movement very well," and SHM and its leaders on the board need to find a way to disseminate those best practices and integrate them into hospital practice, she says. "There are no simple ways to do that, but we know there are a lot of solutions out there."

Nearly five years ago, when Nasim Afsar, MD, SFHM, was launching her career as a hospitalist at the University of California Los Angeles Medical Center, she began to appreciate the importance of quality issues for the field of hospital medicine.

Dr. Afsar, who recently was elected to the SHM board of directors, says, "I realized that evidence-based medicine should be the standard of care in hospitals, but we were nowhere near where we should be in addressing that at a systemic level."

Believing that her medical training had not fully prepared her for quality work, Dr. Afsar attended the Advanced Training Program at Intermountain Healthcare in Salt Lake City. "With that foundation, my focus ever since has been on improvement initiatives," she says.

In the years since, Dr. Afsar's quality responsibilities have grown steadily. She is now associate medical director of quality and safety at UCLA, executive director for quality and safety in its department of medicine, and director of quality for neurosurgery. That means about 80% of her work week is devoted to quality improvement (QI). And while her time seeing patients is less, she says the "clinical work is what inspires and motivates me, gives me my best ideas, and keeps me grounded."

Among the more than 40 quality and safety projects she has implemented at UCLA is "The ABCs of Hospitalized Patients," a multidisciplinary checklist designed to reduce the risk of eight common hospital-acquired conditions. "Within three weeks of implementing it, we started seeing significant improvement in every area, and we have been able to sustain that," she says. In 2009, she implemented a systemwide QI curriculum for the residents and fellows at UCLA.

Dr. Afsar, chair of SHM's Hospital Quality and Patient Safety Committee, says HM is challenged to make these kinds of quality approaches the standard of practice nationwide.

"Different institutions are doing different pieces of the quality movement very well," and SHM and its leaders on the board need to find a way to disseminate those best practices and integrate them into hospital practice, she says. "There are no simple ways to do that, but we know there are a lot of solutions out there."

Nearly five years ago, when Nasim Afsar, MD, SFHM, was launching her career as a hospitalist at the University of California Los Angeles Medical Center, she began to appreciate the importance of quality issues for the field of hospital medicine.

Dr. Afsar, who recently was elected to the SHM board of directors, says, "I realized that evidence-based medicine should be the standard of care in hospitals, but we were nowhere near where we should be in addressing that at a systemic level."

Believing that her medical training had not fully prepared her for quality work, Dr. Afsar attended the Advanced Training Program at Intermountain Healthcare in Salt Lake City. "With that foundation, my focus ever since has been on improvement initiatives," she says.

In the years since, Dr. Afsar's quality responsibilities have grown steadily. She is now associate medical director of quality and safety at UCLA, executive director for quality and safety in its department of medicine, and director of quality for neurosurgery. That means about 80% of her work week is devoted to quality improvement (QI). And while her time seeing patients is less, she says the "clinical work is what inspires and motivates me, gives me my best ideas, and keeps me grounded."

Among the more than 40 quality and safety projects she has implemented at UCLA is "The ABCs of Hospitalized Patients," a multidisciplinary checklist designed to reduce the risk of eight common hospital-acquired conditions. "Within three weeks of implementing it, we started seeing significant improvement in every area, and we have been able to sustain that," she says. In 2009, she implemented a systemwide QI curriculum for the residents and fellows at UCLA.

Dr. Afsar, chair of SHM's Hospital Quality and Patient Safety Committee, says HM is challenged to make these kinds of quality approaches the standard of practice nationwide.

"Different institutions are doing different pieces of the quality movement very well," and SHM and its leaders on the board need to find a way to disseminate those best practices and integrate them into hospital practice, she says. "There are no simple ways to do that, but we know there are a lot of solutions out there."

Hospitalist Ashish Jha, MD, MPH, doesn't want people to take his research on the value of pay-for-performance models the wrong way. Although a new study he worked on found no evidence that the Medicare Premier Hospital Quality Incentive Demonstration (HQID) led to decreased rates of 30-day mortality, he believes the program's structure—not its concept—is at issue.

"It's not that pay for performance doesn't work,” says Dr. Jha, associate professor of health policy and management at Harvard School of Public Health in Boston. "What we had in the HQID was pretty small incentives and mostly focused on processes of care, some of which are important, many of which are not. When you have that as your structure, it's not shocking to see in retrospect that it didn't have a big impact on outcomes."

The report, "The Long-Term Effect of Premier Pay for Performance on Patient Outcomes," showed that the composite 30-day mortality rates for patients with acute myocardial infarction, congestive heart failure, pneumonia, and coronary-artery bypass grafts were similar for Premier and non-Premier hospitals (12.33% and 12.40%, respectively; 95% confidence interval, -0.40 to 0.26).

Dr. Jha says the results were surprising, but he believes that HQID, value-based purchasing, and any pay-for-performance model can only succeed if they more narrowly focus on outcomes. For example, he says, HQID should not have weighed reductions in 30-day mortality rates on par with providing smoking-cessation worksheets to patients at discharge.

"You need much stronger incentives," he says. If hospitals focus on outcomes—and, specifically, on the right outcomes—they will figure out what processes they need to engage in and refine, he says. "Hospitalists are going to be the key people there. If they know that their mortality rates are high, they're going to work on trying to figure out why."

Hospitalist Ashish Jha, MD, MPH, doesn't want people to take his research on the value of pay-for-performance models the wrong way. Although a new study he worked on found no evidence that the Medicare Premier Hospital Quality Incentive Demonstration (HQID) led to decreased rates of 30-day mortality, he believes the program's structure—not its concept—is at issue.

"It's not that pay for performance doesn't work,” says Dr. Jha, associate professor of health policy and management at Harvard School of Public Health in Boston. "What we had in the HQID was pretty small incentives and mostly focused on processes of care, some of which are important, many of which are not. When you have that as your structure, it's not shocking to see in retrospect that it didn't have a big impact on outcomes."

The report, "The Long-Term Effect of Premier Pay for Performance on Patient Outcomes," showed that the composite 30-day mortality rates for patients with acute myocardial infarction, congestive heart failure, pneumonia, and coronary-artery bypass grafts were similar for Premier and non-Premier hospitals (12.33% and 12.40%, respectively; 95% confidence interval, -0.40 to 0.26).

Dr. Jha says the results were surprising, but he believes that HQID, value-based purchasing, and any pay-for-performance model can only succeed if they more narrowly focus on outcomes. For example, he says, HQID should not have weighed reductions in 30-day mortality rates on par with providing smoking-cessation worksheets to patients at discharge.

"You need much stronger incentives," he says. If hospitals focus on outcomes—and, specifically, on the right outcomes—they will figure out what processes they need to engage in and refine, he says. "Hospitalists are going to be the key people there. If they know that their mortality rates are high, they're going to work on trying to figure out why."

Hospitalist Ashish Jha, MD, MPH, doesn't want people to take his research on the value of pay-for-performance models the wrong way. Although a new study he worked on found no evidence that the Medicare Premier Hospital Quality Incentive Demonstration (HQID) led to decreased rates of 30-day mortality, he believes the program's structure—not its concept—is at issue.

"It's not that pay for performance doesn't work,” says Dr. Jha, associate professor of health policy and management at Harvard School of Public Health in Boston. "What we had in the HQID was pretty small incentives and mostly focused on processes of care, some of which are important, many of which are not. When you have that as your structure, it's not shocking to see in retrospect that it didn't have a big impact on outcomes."

The report, "The Long-Term Effect of Premier Pay for Performance on Patient Outcomes," showed that the composite 30-day mortality rates for patients with acute myocardial infarction, congestive heart failure, pneumonia, and coronary-artery bypass grafts were similar for Premier and non-Premier hospitals (12.33% and 12.40%, respectively; 95% confidence interval, -0.40 to 0.26).

Dr. Jha says the results were surprising, but he believes that HQID, value-based purchasing, and any pay-for-performance model can only succeed if they more narrowly focus on outcomes. For example, he says, HQID should not have weighed reductions in 30-day mortality rates on par with providing smoking-cessation worksheets to patients at discharge.

"You need much stronger incentives," he says. If hospitals focus on outcomes—and, specifically, on the right outcomes—they will figure out what processes they need to engage in and refine, he says. "Hospitalists are going to be the key people there. If they know that their mortality rates are high, they're going to work on trying to figure out why."

Are you aware that a significant change is coming to the way you prescribe opioid pain relievers for your patients? After 3 years of debate among the Food and Drug Administration (FDA), drug industry stakeholders, members of the pain and addiction communities, patient advocacy groups, and the public, the first large-scale, class-wide REMS is here. REMS is the acronym for Risk Evaluation and Mitigation Strategies. There is a good chance you are prescribing one or more of the affected medications, and adherence to the REMS requirements will be essential if you wish to continue prescribing them. 

Before getting into the fine points of the opioid REMS, a little background about how it came into being is in order. On March 25, 2008, the Food and Drug Administration Amendments Act went into effect, granting the FDA authority to require a REMS for any product or product class it deemed to be a public health, safety, or welfare threat.  Basically, REMS is an FDA-imposed “safety” program. The first medication to now have a single or class REMS is the class of extended-release (ER) and long-acting (LA) opioid analgesics.

Why opioid analgesics? In 2007, attempts to mitigate targeted risks associated with 30 drugs using RISKMaps were cited as inadequate by the FDA. RISKMaps are safety programs designed to minimize significant risks of certain medicines through FDA-approved labeling, reporting of adverse events, prescriber and patient education about risks, reminders, and performance-linked access systems that tie access to medications with documentation and laboratory testing.¹ Passage of the FDA Amendments Act allowed the FDA to use its REMS authority to “improve” existing risk plans.

Forces  for change

The FDA cites many good reasons for this change, primarily to ensure that the benefits of prescribing opioid analgesics outweigh the risks, and that patients in pain who need these drugs have access to them. Driving factors behind this move centered on the highly visible consequences associated with what FDA experts describe as misuse, abuse, and improper prescribing of 12 ER/LA opioid analgesics. According to FDA estimates,  in 2007 more than 33 million Americans age 12 and older misused ER/LA opioids. Of the almost 28,000 Americans who died from unintended consequences of drug use, nearly 12,000 were associated with prescription analgesics.²

In my opinion, voluntary continuing medical education (CME) and professional organization guidelines added to the problem by failing to decrease overdoses and unintended deaths. This may come as no surprise, as such deaths often stem from diversion, and diverters typically are not subject to a CME requirement.

The ER/LA  segment of the class was targeted for a variety of reasons. First,  higher doses of ER/LA opiates packed into single units are believed to pose a greater threat than the millions of short-acting, immediate-release (IR) opioid analgesics units abused annually.³ Another reason for the move focused on the burden to the health system caused by more than 24 similar individual REMS existing in this class. That alone created a virtual paper, regulatory, and health system encumbrance that is expected to be alleviated by a class-wide REMS. 

Increasing numbers of prescriptions were an additional consideration. The number of outpatient retail prescriptions dispensed for ER/LA and IR opiates rose dramatically between 2000 and 2009, from 9.3 million to 22.9 million ER/LA opioids and from 164.8 million to 234 million IR opioids [Figure 1].³ Who is prescribing them? You are. In 2009, primary care physicians were the top prescribers of ER/LA (43.8%) and IR (42.1%) opioid analgesics [Figure 2].³ Who are you prescribing them for? Not the elderly age group you might expect. The largest number of prescriptions were written for men and women between ages 50and 59 [Figure 3].³

And what are you prescribing them for? Data from a 2009 survey of the prescribing habits of 3200 office-based physicians in 30 specialties showed that most prescriptions written for ER/LA and IR opioids are associated with diagnoses related to pain in the musculoskeletal system and connective tissue (56% [ER/LA] and 30% [IR]). For ER/LA

prescriptions the second most common diagnoses were headaches and nerve pain (14%), while for IR prescriptions they were fractures, sprains, and contusions (23%) [Figure 4].³

According to Janet Woodcock, MD, Director of the FDA’s Center for Drug Evaluation and Research, some physicians may not be clear about who should receive these drugs or how to manage patients in pain. As a result, some physicians may be reluctant to prescribe opioid analgesics, leaving patients without adequate pain relief. At the same time, other physicians overprescribe them, putting patients—and anyone with access to the family medicine cabinet—at risk.⁴

A REMS by any other name

And so REMS was conceived. On February 6, 2009, manufacturers of certain opioid drug products received a letter from the FDA informing them that their drugs would be required to have a risk management program, and inviting them to meet to discuss the design and development of such a REMS.⁵

Two years later, on April 19, 2011, an alarm in the form of an action plan was released by the Obama administration through the Office of National Drug Control Policy. The plan,

Epidemic: Responding to America’s Prescription Drug Abuse Crisis, outlined a set of measures to remedy the problem through education, monitoring, proper disposal of prescription drugs, and enforcement.⁶

REMS for opioids was the FDA’s response in support of the President’s plan. On the same day in April, 32 manufacturers of ER/LA opioids received a letter from the FDA informing them that they must meet new safety requirements concerning these medications under a single shared, standardized system [Table].

As outlined in this REMS, manufacturers must provide for the training of prescribers of opioid medications—training that covers proper patient selection, patient counseling in specific product use and risk, and assessment for addiction and tolerance. Manufacturers must also develop factual, nonpromotional patient information and medication guides that will be FDA regulated and approved.  Finally, they will be asked to adhere to a timetable to assess whether REMS is meetings its goals.^4,5

In May 2011, the FDA met with  manufacturers to expand on how to coordinate and implement the REMS requirements.

Hope for a “new normal”

Will REMS for other large medication classes eventually reach beyond opioid analgesics, perhaps warranting practitioners to view REMS as being a good thing as opposed to a nuisance? Your decision to participate in REMS or pass and alter your care approach will need to be made soon. What will you do?

For you as an opioid prescriber, education is the focus, and you will soon be presented with voluntary prescriber education programs. The “hope” is that you will volunteer to take the opioid education program, fill out an electronic or fax form, and send it in to an administrator who will track all those who participate. Since “hope” will unlikely drive large-scale participation, when hope finally runs out the education will become mandatory. This will occur in a year or 2, and will likely become a Drug Enforcement Administration requirement for you to procure CII scheduling.

Unfortunately, there is no guarantee that deaths and overdoses will stop with the opioid REMS. The only guarantee is you will not be able to prescribe these medications at some point if you do not participate in the REMS.

So act now. To be notified when the opioid REMS training becomes available go to www.opioidREMS.com and register. It’s vital that you do ... and relatively painless.

REFERENCES

  1.    U.S. Department of Health and Human Services, Agency for Healthcare Research and Quality, Food and Drug Administration. Summary of public workshop. Implementation of risk minimization action plans (RiskMAPs) to support quality use of pharmaceuticals: opportunities and challenges. June 25-26, 2007.

  2.    US. Food and Drug Administration. FDA acts to reduce harm from opioid drugs. Consumer Updates. Available at: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm251830.htm.

  3.    Governale L. Outpatient Prescription Opioid Utilization in the U.S., Years 2000 – 2009. Food and Drug Administration, Division of Epidemiology. July 22, 2010. Avilable at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndLifeSupportDrugsAdvisoryCommittee/UCM220950.pdf

  4.    Marchand H, moderator. Opioid drugs and risk evaluation and mitigation strategies (REMS) Podcast/transcript. April 20, 2011. Available at: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm252649.htm.

  5.    U.S. Food and Drug Administration. Opioid drugs and risk mitigation strategies (REMS) Available at: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163647.htm.

  6.   Epidemic: responding to America’s prescription drug abuse crisis. Available at: http://www.whitehousedrugpolicy.gov/publications/pdf/rx_abuse_plan.pdf.

Are you aware that a significant change is coming to the way you prescribe opioid pain relievers for your patients? After 3 years of debate among the Food and Drug Administration (FDA), drug industry stakeholders, members of the pain and addiction communities, patient advocacy groups, and the public, the first large-scale, class-wide REMS is here. REMS is the acronym for Risk Evaluation and Mitigation Strategies. There is a good chance you are prescribing one or more of the affected medications, and adherence to the REMS requirements will be essential if you wish to continue prescribing them. 

Before getting into the fine points of the opioid REMS, a little background about how it came into being is in order. On March 25, 2008, the Food and Drug Administration Amendments Act went into effect, granting the FDA authority to require a REMS for any product or product class it deemed to be a public health, safety, or welfare threat.  Basically, REMS is an FDA-imposed “safety” program. The first medication to now have a single or class REMS is the class of extended-release (ER) and long-acting (LA) opioid analgesics.

Why opioid analgesics? In 2007, attempts to mitigate targeted risks associated with 30 drugs using RISKMaps were cited as inadequate by the FDA. RISKMaps are safety programs designed to minimize significant risks of certain medicines through FDA-approved labeling, reporting of adverse events, prescriber and patient education about risks, reminders, and performance-linked access systems that tie access to medications with documentation and laboratory testing.¹ Passage of the FDA Amendments Act allowed the FDA to use its REMS authority to “improve” existing risk plans.

Forces  for change

The FDA cites many good reasons for this change, primarily to ensure that the benefits of prescribing opioid analgesics outweigh the risks, and that patients in pain who need these drugs have access to them. Driving factors behind this move centered on the highly visible consequences associated with what FDA experts describe as misuse, abuse, and improper prescribing of 12 ER/LA opioid analgesics. According to FDA estimates,  in 2007 more than 33 million Americans age 12 and older misused ER/LA opioids. Of the almost 28,000 Americans who died from unintended consequences of drug use, nearly 12,000 were associated with prescription analgesics.²

In my opinion, voluntary continuing medical education (CME) and professional organization guidelines added to the problem by failing to decrease overdoses and unintended deaths. This may come as no surprise, as such deaths often stem from diversion, and diverters typically are not subject to a CME requirement.

The ER/LA  segment of the class was targeted for a variety of reasons. First,  higher doses of ER/LA opiates packed into single units are believed to pose a greater threat than the millions of short-acting, immediate-release (IR) opioid analgesics units abused annually.³ Another reason for the move focused on the burden to the health system caused by more than 24 similar individual REMS existing in this class. That alone created a virtual paper, regulatory, and health system encumbrance that is expected to be alleviated by a class-wide REMS. 

Increasing numbers of prescriptions were an additional consideration. The number of outpatient retail prescriptions dispensed for ER/LA and IR opiates rose dramatically between 2000 and 2009, from 9.3 million to 22.9 million ER/LA opioids and from 164.8 million to 234 million IR opioids [Figure 1].³ Who is prescribing them? You are. In 2009, primary care physicians were the top prescribers of ER/LA (43.8%) and IR (42.1%) opioid analgesics [Figure 2].³ Who are you prescribing them for? Not the elderly age group you might expect. The largest number of prescriptions were written for men and women between ages 50and 59 [Figure 3].³

And what are you prescribing them for? Data from a 2009 survey of the prescribing habits of 3200 office-based physicians in 30 specialties showed that most prescriptions written for ER/LA and IR opioids are associated with diagnoses related to pain in the musculoskeletal system and connective tissue (56% [ER/LA] and 30% [IR]). For ER/LA

prescriptions the second most common diagnoses were headaches and nerve pain (14%), while for IR prescriptions they were fractures, sprains, and contusions (23%) [Figure 4].³

According to Janet Woodcock, MD, Director of the FDA’s Center for Drug Evaluation and Research, some physicians may not be clear about who should receive these drugs or how to manage patients in pain. As a result, some physicians may be reluctant to prescribe opioid analgesics, leaving patients without adequate pain relief. At the same time, other physicians overprescribe them, putting patients—and anyone with access to the family medicine cabinet—at risk.⁴

A REMS by any other name

And so REMS was conceived. On February 6, 2009, manufacturers of certain opioid drug products received a letter from the FDA informing them that their drugs would be required to have a risk management program, and inviting them to meet to discuss the design and development of such a REMS.⁵

Two years later, on April 19, 2011, an alarm in the form of an action plan was released by the Obama administration through the Office of National Drug Control Policy. The plan,

Epidemic: Responding to America’s Prescription Drug Abuse Crisis, outlined a set of measures to remedy the problem through education, monitoring, proper disposal of prescription drugs, and enforcement.⁶

REMS for opioids was the FDA’s response in support of the President’s plan. On the same day in April, 32 manufacturers of ER/LA opioids received a letter from the FDA informing them that they must meet new safety requirements concerning these medications under a single shared, standardized system [Table].

As outlined in this REMS, manufacturers must provide for the training of prescribers of opioid medications—training that covers proper patient selection, patient counseling in specific product use and risk, and assessment for addiction and tolerance. Manufacturers must also develop factual, nonpromotional patient information and medication guides that will be FDA regulated and approved.  Finally, they will be asked to adhere to a timetable to assess whether REMS is meetings its goals.^4,5

In May 2011, the FDA met with  manufacturers to expand on how to coordinate and implement the REMS requirements.

Hope for a “new normal”

Will REMS for other large medication classes eventually reach beyond opioid analgesics, perhaps warranting practitioners to view REMS as being a good thing as opposed to a nuisance? Your decision to participate in REMS or pass and alter your care approach will need to be made soon. What will you do?

For you as an opioid prescriber, education is the focus, and you will soon be presented with voluntary prescriber education programs. The “hope” is that you will volunteer to take the opioid education program, fill out an electronic or fax form, and send it in to an administrator who will track all those who participate. Since “hope” will unlikely drive large-scale participation, when hope finally runs out the education will become mandatory. This will occur in a year or 2, and will likely become a Drug Enforcement Administration requirement for you to procure CII scheduling.

Unfortunately, there is no guarantee that deaths and overdoses will stop with the opioid REMS. The only guarantee is you will not be able to prescribe these medications at some point if you do not participate in the REMS.

So act now. To be notified when the opioid REMS training becomes available go to www.opioidREMS.com and register. It’s vital that you do ... and relatively painless.

REFERENCES

  1.    U.S. Department of Health and Human Services, Agency for Healthcare Research and Quality, Food and Drug Administration. Summary of public workshop. Implementation of risk minimization action plans (RiskMAPs) to support quality use of pharmaceuticals: opportunities and challenges. June 25-26, 2007.

  2.    US. Food and Drug Administration. FDA acts to reduce harm from opioid drugs. Consumer Updates. Available at: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm251830.htm.

  3.    Governale L. Outpatient Prescription Opioid Utilization in the U.S., Years 2000 – 2009. Food and Drug Administration, Division of Epidemiology. July 22, 2010. Avilable at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndLifeSupportDrugsAdvisoryCommittee/UCM220950.pdf

  4.    Marchand H, moderator. Opioid drugs and risk evaluation and mitigation strategies (REMS) Podcast/transcript. April 20, 2011. Available at: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm252649.htm.

  5.    U.S. Food and Drug Administration. Opioid drugs and risk mitigation strategies (REMS) Available at: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163647.htm.

  6.   Epidemic: responding to America’s prescription drug abuse crisis. Available at: http://www.whitehousedrugpolicy.gov/publications/pdf/rx_abuse_plan.pdf.

Are you aware that a significant change is coming to the way you prescribe opioid pain relievers for your patients? After 3 years of debate among the Food and Drug Administration (FDA), drug industry stakeholders, members of the pain and addiction communities, patient advocacy groups, and the public, the first large-scale, class-wide REMS is here. REMS is the acronym for Risk Evaluation and Mitigation Strategies. There is a good chance you are prescribing one or more of the affected medications, and adherence to the REMS requirements will be essential if you wish to continue prescribing them. 

Before getting into the fine points of the opioid REMS, a little background about how it came into being is in order. On March 25, 2008, the Food and Drug Administration Amendments Act went into effect, granting the FDA authority to require a REMS for any product or product class it deemed to be a public health, safety, or welfare threat.  Basically, REMS is an FDA-imposed “safety” program. The first medication to now have a single or class REMS is the class of extended-release (ER) and long-acting (LA) opioid analgesics.

Why opioid analgesics? In 2007, attempts to mitigate targeted risks associated with 30 drugs using RISKMaps were cited as inadequate by the FDA. RISKMaps are safety programs designed to minimize significant risks of certain medicines through FDA-approved labeling, reporting of adverse events, prescriber and patient education about risks, reminders, and performance-linked access systems that tie access to medications with documentation and laboratory testing.¹ Passage of the FDA Amendments Act allowed the FDA to use its REMS authority to “improve” existing risk plans.

Forces  for change

The FDA cites many good reasons for this change, primarily to ensure that the benefits of prescribing opioid analgesics outweigh the risks, and that patients in pain who need these drugs have access to them. Driving factors behind this move centered on the highly visible consequences associated with what FDA experts describe as misuse, abuse, and improper prescribing of 12 ER/LA opioid analgesics. According to FDA estimates,  in 2007 more than 33 million Americans age 12 and older misused ER/LA opioids. Of the almost 28,000 Americans who died from unintended consequences of drug use, nearly 12,000 were associated with prescription analgesics.²

In my opinion, voluntary continuing medical education (CME) and professional organization guidelines added to the problem by failing to decrease overdoses and unintended deaths. This may come as no surprise, as such deaths often stem from diversion, and diverters typically are not subject to a CME requirement.

The ER/LA  segment of the class was targeted for a variety of reasons. First,  higher doses of ER/LA opiates packed into single units are believed to pose a greater threat than the millions of short-acting, immediate-release (IR) opioid analgesics units abused annually.³ Another reason for the move focused on the burden to the health system caused by more than 24 similar individual REMS existing in this class. That alone created a virtual paper, regulatory, and health system encumbrance that is expected to be alleviated by a class-wide REMS. 

Increasing numbers of prescriptions were an additional consideration. The number of outpatient retail prescriptions dispensed for ER/LA and IR opiates rose dramatically between 2000 and 2009, from 9.3 million to 22.9 million ER/LA opioids and from 164.8 million to 234 million IR opioids [Figure 1].³ Who is prescribing them? You are. In 2009, primary care physicians were the top prescribers of ER/LA (43.8%) and IR (42.1%) opioid analgesics [Figure 2].³ Who are you prescribing them for? Not the elderly age group you might expect. The largest number of prescriptions were written for men and women between ages 50and 59 [Figure 3].³

And what are you prescribing them for? Data from a 2009 survey of the prescribing habits of 3200 office-based physicians in 30 specialties showed that most prescriptions written for ER/LA and IR opioids are associated with diagnoses related to pain in the musculoskeletal system and connective tissue (56% [ER/LA] and 30% [IR]). For ER/LA

prescriptions the second most common diagnoses were headaches and nerve pain (14%), while for IR prescriptions they were fractures, sprains, and contusions (23%) [Figure 4].³

According to Janet Woodcock, MD, Director of the FDA’s Center for Drug Evaluation and Research, some physicians may not be clear about who should receive these drugs or how to manage patients in pain. As a result, some physicians may be reluctant to prescribe opioid analgesics, leaving patients without adequate pain relief. At the same time, other physicians overprescribe them, putting patients—and anyone with access to the family medicine cabinet—at risk.⁴

A REMS by any other name

And so REMS was conceived. On February 6, 2009, manufacturers of certain opioid drug products received a letter from the FDA informing them that their drugs would be required to have a risk management program, and inviting them to meet to discuss the design and development of such a REMS.⁵

Two years later, on April 19, 2011, an alarm in the form of an action plan was released by the Obama administration through the Office of National Drug Control Policy. The plan,

Epidemic: Responding to America’s Prescription Drug Abuse Crisis, outlined a set of measures to remedy the problem through education, monitoring, proper disposal of prescription drugs, and enforcement.⁶

REMS for opioids was the FDA’s response in support of the President’s plan. On the same day in April, 32 manufacturers of ER/LA opioids received a letter from the FDA informing them that they must meet new safety requirements concerning these medications under a single shared, standardized system [Table].

As outlined in this REMS, manufacturers must provide for the training of prescribers of opioid medications—training that covers proper patient selection, patient counseling in specific product use and risk, and assessment for addiction and tolerance. Manufacturers must also develop factual, nonpromotional patient information and medication guides that will be FDA regulated and approved.  Finally, they will be asked to adhere to a timetable to assess whether REMS is meetings its goals.^4,5

In May 2011, the FDA met with  manufacturers to expand on how to coordinate and implement the REMS requirements.

Hope for a “new normal”

Will REMS for other large medication classes eventually reach beyond opioid analgesics, perhaps warranting practitioners to view REMS as being a good thing as opposed to a nuisance? Your decision to participate in REMS or pass and alter your care approach will need to be made soon. What will you do?

For you as an opioid prescriber, education is the focus, and you will soon be presented with voluntary prescriber education programs. The “hope” is that you will volunteer to take the opioid education program, fill out an electronic or fax form, and send it in to an administrator who will track all those who participate. Since “hope” will unlikely drive large-scale participation, when hope finally runs out the education will become mandatory. This will occur in a year or 2, and will likely become a Drug Enforcement Administration requirement for you to procure CII scheduling.

Unfortunately, there is no guarantee that deaths and overdoses will stop with the opioid REMS. The only guarantee is you will not be able to prescribe these medications at some point if you do not participate in the REMS.

So act now. To be notified when the opioid REMS training becomes available go to www.opioidREMS.com and register. It’s vital that you do ... and relatively painless.

REFERENCES

  1.    U.S. Department of Health and Human Services, Agency for Healthcare Research and Quality, Food and Drug Administration. Summary of public workshop. Implementation of risk minimization action plans (RiskMAPs) to support quality use of pharmaceuticals: opportunities and challenges. June 25-26, 2007.

  2.    US. Food and Drug Administration. FDA acts to reduce harm from opioid drugs. Consumer Updates. Available at: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm251830.htm.

  3.    Governale L. Outpatient Prescription Opioid Utilization in the U.S., Years 2000 – 2009. Food and Drug Administration, Division of Epidemiology. July 22, 2010. Avilable at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndLifeSupportDrugsAdvisoryCommittee/UCM220950.pdf

  4.    Marchand H, moderator. Opioid drugs and risk evaluation and mitigation strategies (REMS) Podcast/transcript. April 20, 2011. Available at: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm252649.htm.

  5.    U.S. Food and Drug Administration. Opioid drugs and risk mitigation strategies (REMS) Available at: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163647.htm.

  6.   Epidemic: responding to America’s prescription drug abuse crisis. Available at: http://www.whitehousedrugpolicy.gov/publications/pdf/rx_abuse_plan.pdf.

Before-and-after photographs are the stock in trade of house painters, auto repair shops, and, yes, plastic and reconstructive surgeons. But a new study may make the last group pause, since it hints that far more is at play in breast cancer patients’ definition of “successful’’ breast reconstruction surgery than how their breasts appear.

The study from Liverpool, England (J Plast Reconstr Aesthet Surg (2012): doi:10.1016/j.bjps.2012.03.005) sidestepped traditional measures used to evaluate outcomes of aesthetic breast surgery and instead asked open-ended questions of survivors who had undergone reconstruction 1-8 years previously.

What the researchers discovered, not surprisingly, is that reconstruction patients are quite unlike cosmetic surgery patients in fundamental and important ways.

©Lilli Day/iStockphoto.com

Of particular interest in the initial study cohort of 95 patients were 38 whose subjective evaluations of their surgical results completely contradicted objective ratings of cosmesis, the final appearance of the reconstructed breast(s) by surgeons and surgical nurses.

Incredibly, the association between women’s assessments and objective cosmesis ratings failed even to reach statistical significance.

In a structured data analysis of themes that arose in open-ended interviews with 27 of the survivors, the strongest link to women’s satisfaction with the procedure was the surgeon-patient relationship.

Next came the significance of reconstruction in what patients saw as the “completion of the cancer journey,” the authors wrote. “Patients who focused on this were positive about reconstruction that practitioners had rated negatively.”

A previous study asked patients about scarring, finding a correlation between scarring and dissatisfaction with reconstruction. But scarring wasn’t even a blip on the radar when, quoting from the Liverpool study, “we allowed patients to tell us what mattered to them rather than imposing our preconceptions.”

“It seems that surgeons and patients normally ‘talk different languages’; one technical and the other drawing more from relationships and patients’ sense of how normal they feel and appear and from their sense that reconstruction completes their cancer journey,” the investigators concluded. “In preoperative consultations, surgeons concentrate almost exclusively on the technical and cosmetic aspects of reconstruction: what can be achieved and what complications can occur.”

Of course, women who struggled with complications tended to factor that in to their assessments of their results, even if their final cosmetic outcome was considered by surgeons to be excellent.

Others were disappointed despite what seemed to surgeons to be  excellent cosmetic results because, as one said, “I was expecting to feel feminine again, but I don’t, I don’t at all.”

What is perhaps even more interesting is to eavesdrop on the comments of women whose surgeons judged their cosmetic result to be poor.

Said one, “I had a really good relationship with (the surgeon) and I just found it so reassuring to see her. That was part of the whole thing really. She was just so positive, and so, well, just understanding I think … I was really glad that I had chosen that form of reconstruction because I had this regular contact with her.”

Said another, who felt “normal” despite what her surgeon considered to be a poor result: “If I didn’t have it done, I wouldn’t have felt normal at all. It would always remind me of what had happened.”

A highly complex patient-surgeon dance occurs when breast surgery is performed for more than cosmetic reasons, the study found.

One woman, disappointed with the way her reconstructed breast fit in a bra, could not bring herself to voice her concern with the surgeon she credited with saving her life.

“It’s very difficult to come face to face with somebody who says, ‘You’ve had cancer but we can get rid of it,’ and does their best… without seeming ungrateful,” she said, tearfully.

The study concludes with a fascinating discussion about the potential clinical implications of the findings.

Considering the profound influence of the patient-surgeon relationship on these particular patients, the investigators offer a cautionary suggestion to avoid being overly effusive about the cosmetic result they may see. Patients, they explain, may not necessarily share their enthusiasm, if they continue to struggle with the sense that cancer has marred their bodies, their sense of self, or their security in relationships.

“Both patient and surgeon have invested physically and emotionally in the procedure and it is difficult for either to admit to the other that it was “not worth it,” they note.

Women, on the other hand, who appear to be disproportionately pleased with the result of surgery that objectively achieved a poor result may simply be expressing relief and gratitude. “Their apparent satisfaction,” they wrote, “should not excuse poor surgical practice.” Rather, routine assessments of reconstructive practice should be made by objective sources, not simply patient report.

On the other hand, in individual patients, the objective in reconstructive surgery is patient satisfaction, they suggest. An unhappy patient might spur a conscientious surgeon to keep trying, perhaps through repeated procedures, to achieve a better result – a strategy that could be inappropriate and pointless considering that in some cases, “the reason for disappointment with reconstruction include many that the surgeon cannot influence surgically.”

It all suggests that communication between surgeons and reconstruction candidates and patients needs to be deep and candidly honest, informed by the emotional, sexual, and existential meaning the surgery holds.

In a word, it’s complicated.

Betsy Bates Freed, Psych.D., is a clinical psychologist in Santa Barbara, Calif., and a medical journalist.

Before-and-after photographs are the stock in trade of house painters, auto repair shops, and, yes, plastic and reconstructive surgeons. But a new study may make the last group pause, since it hints that far more is at play in breast cancer patients’ definition of “successful’’ breast reconstruction surgery than how their breasts appear.

The study from Liverpool, England (J Plast Reconstr Aesthet Surg (2012): doi:10.1016/j.bjps.2012.03.005) sidestepped traditional measures used to evaluate outcomes of aesthetic breast surgery and instead asked open-ended questions of survivors who had undergone reconstruction 1-8 years previously.

What the researchers discovered, not surprisingly, is that reconstruction patients are quite unlike cosmetic surgery patients in fundamental and important ways.

©Lilli Day/iStockphoto.com

Of particular interest in the initial study cohort of 95 patients were 38 whose subjective evaluations of their surgical results completely contradicted objective ratings of cosmesis, the final appearance of the reconstructed breast(s) by surgeons and surgical nurses.

Incredibly, the association between women’s assessments and objective cosmesis ratings failed even to reach statistical significance.

In a structured data analysis of themes that arose in open-ended interviews with 27 of the survivors, the strongest link to women’s satisfaction with the procedure was the surgeon-patient relationship.

Next came the significance of reconstruction in what patients saw as the “completion of the cancer journey,” the authors wrote. “Patients who focused on this were positive about reconstruction that practitioners had rated negatively.”

A previous study asked patients about scarring, finding a correlation between scarring and dissatisfaction with reconstruction. But scarring wasn’t even a blip on the radar when, quoting from the Liverpool study, “we allowed patients to tell us what mattered to them rather than imposing our preconceptions.”

“It seems that surgeons and patients normally ‘talk different languages’; one technical and the other drawing more from relationships and patients’ sense of how normal they feel and appear and from their sense that reconstruction completes their cancer journey,” the investigators concluded. “In preoperative consultations, surgeons concentrate almost exclusively on the technical and cosmetic aspects of reconstruction: what can be achieved and what complications can occur.”

Of course, women who struggled with complications tended to factor that in to their assessments of their results, even if their final cosmetic outcome was considered by surgeons to be excellent.

Others were disappointed despite what seemed to surgeons to be  excellent cosmetic results because, as one said, “I was expecting to feel feminine again, but I don’t, I don’t at all.”

What is perhaps even more interesting is to eavesdrop on the comments of women whose surgeons judged their cosmetic result to be poor.

Said one, “I had a really good relationship with (the surgeon) and I just found it so reassuring to see her. That was part of the whole thing really. She was just so positive, and so, well, just understanding I think … I was really glad that I had chosen that form of reconstruction because I had this regular contact with her.”

Said another, who felt “normal” despite what her surgeon considered to be a poor result: “If I didn’t have it done, I wouldn’t have felt normal at all. It would always remind me of what had happened.”

A highly complex patient-surgeon dance occurs when breast surgery is performed for more than cosmetic reasons, the study found.

One woman, disappointed with the way her reconstructed breast fit in a bra, could not bring herself to voice her concern with the surgeon she credited with saving her life.

“It’s very difficult to come face to face with somebody who says, ‘You’ve had cancer but we can get rid of it,’ and does their best… without seeming ungrateful,” she said, tearfully.

The study concludes with a fascinating discussion about the potential clinical implications of the findings.

Considering the profound influence of the patient-surgeon relationship on these particular patients, the investigators offer a cautionary suggestion to avoid being overly effusive about the cosmetic result they may see. Patients, they explain, may not necessarily share their enthusiasm, if they continue to struggle with the sense that cancer has marred their bodies, their sense of self, or their security in relationships.

“Both patient and surgeon have invested physically and emotionally in the procedure and it is difficult for either to admit to the other that it was “not worth it,” they note.

Women, on the other hand, who appear to be disproportionately pleased with the result of surgery that objectively achieved a poor result may simply be expressing relief and gratitude. “Their apparent satisfaction,” they wrote, “should not excuse poor surgical practice.” Rather, routine assessments of reconstructive practice should be made by objective sources, not simply patient report.

On the other hand, in individual patients, the objective in reconstructive surgery is patient satisfaction, they suggest. An unhappy patient might spur a conscientious surgeon to keep trying, perhaps through repeated procedures, to achieve a better result – a strategy that could be inappropriate and pointless considering that in some cases, “the reason for disappointment with reconstruction include many that the surgeon cannot influence surgically.”

It all suggests that communication between surgeons and reconstruction candidates and patients needs to be deep and candidly honest, informed by the emotional, sexual, and existential meaning the surgery holds.

In a word, it’s complicated.

Betsy Bates Freed, Psych.D., is a clinical psychologist in Santa Barbara, Calif., and a medical journalist.

Before-and-after photographs are the stock in trade of house painters, auto repair shops, and, yes, plastic and reconstructive surgeons. But a new study may make the last group pause, since it hints that far more is at play in breast cancer patients’ definition of “successful’’ breast reconstruction surgery than how their breasts appear.

The study from Liverpool, England (J Plast Reconstr Aesthet Surg (2012): doi:10.1016/j.bjps.2012.03.005) sidestepped traditional measures used to evaluate outcomes of aesthetic breast surgery and instead asked open-ended questions of survivors who had undergone reconstruction 1-8 years previously.

What the researchers discovered, not surprisingly, is that reconstruction patients are quite unlike cosmetic surgery patients in fundamental and important ways.

©Lilli Day/iStockphoto.com

Of particular interest in the initial study cohort of 95 patients were 38 whose subjective evaluations of their surgical results completely contradicted objective ratings of cosmesis, the final appearance of the reconstructed breast(s) by surgeons and surgical nurses.

Incredibly, the association between women’s assessments and objective cosmesis ratings failed even to reach statistical significance.

In a structured data analysis of themes that arose in open-ended interviews with 27 of the survivors, the strongest link to women’s satisfaction with the procedure was the surgeon-patient relationship.

Next came the significance of reconstruction in what patients saw as the “completion of the cancer journey,” the authors wrote. “Patients who focused on this were positive about reconstruction that practitioners had rated negatively.”

A previous study asked patients about scarring, finding a correlation between scarring and dissatisfaction with reconstruction. But scarring wasn’t even a blip on the radar when, quoting from the Liverpool study, “we allowed patients to tell us what mattered to them rather than imposing our preconceptions.”

“It seems that surgeons and patients normally ‘talk different languages’; one technical and the other drawing more from relationships and patients’ sense of how normal they feel and appear and from their sense that reconstruction completes their cancer journey,” the investigators concluded. “In preoperative consultations, surgeons concentrate almost exclusively on the technical and cosmetic aspects of reconstruction: what can be achieved and what complications can occur.”

Of course, women who struggled with complications tended to factor that in to their assessments of their results, even if their final cosmetic outcome was considered by surgeons to be excellent.

Others were disappointed despite what seemed to surgeons to be  excellent cosmetic results because, as one said, “I was expecting to feel feminine again, but I don’t, I don’t at all.”

What is perhaps even more interesting is to eavesdrop on the comments of women whose surgeons judged their cosmetic result to be poor.

Said one, “I had a really good relationship with (the surgeon) and I just found it so reassuring to see her. That was part of the whole thing really. She was just so positive, and so, well, just understanding I think … I was really glad that I had chosen that form of reconstruction because I had this regular contact with her.”

Said another, who felt “normal” despite what her surgeon considered to be a poor result: “If I didn’t have it done, I wouldn’t have felt normal at all. It would always remind me of what had happened.”

A highly complex patient-surgeon dance occurs when breast surgery is performed for more than cosmetic reasons, the study found.

One woman, disappointed with the way her reconstructed breast fit in a bra, could not bring herself to voice her concern with the surgeon she credited with saving her life.

“It’s very difficult to come face to face with somebody who says, ‘You’ve had cancer but we can get rid of it,’ and does their best… without seeming ungrateful,” she said, tearfully.

The study concludes with a fascinating discussion about the potential clinical implications of the findings.

Considering the profound influence of the patient-surgeon relationship on these particular patients, the investigators offer a cautionary suggestion to avoid being overly effusive about the cosmetic result they may see. Patients, they explain, may not necessarily share their enthusiasm, if they continue to struggle with the sense that cancer has marred their bodies, their sense of self, or their security in relationships.

“Both patient and surgeon have invested physically and emotionally in the procedure and it is difficult for either to admit to the other that it was “not worth it,” they note.

Women, on the other hand, who appear to be disproportionately pleased with the result of surgery that objectively achieved a poor result may simply be expressing relief and gratitude. “Their apparent satisfaction,” they wrote, “should not excuse poor surgical practice.” Rather, routine assessments of reconstructive practice should be made by objective sources, not simply patient report.

On the other hand, in individual patients, the objective in reconstructive surgery is patient satisfaction, they suggest. An unhappy patient might spur a conscientious surgeon to keep trying, perhaps through repeated procedures, to achieve a better result – a strategy that could be inappropriate and pointless considering that in some cases, “the reason for disappointment with reconstruction include many that the surgeon cannot influence surgically.”

It all suggests that communication between surgeons and reconstruction candidates and patients needs to be deep and candidly honest, informed by the emotional, sexual, and existential meaning the surgery holds.

In a word, it’s complicated.

Betsy Bates Freed, Psych.D., is a clinical psychologist in Santa Barbara, Calif., and a medical journalist.