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VOLUME 30 NUMBER 10 APRIL 1 2012<br />

JOURNAL OF CLINICAL ONCOLOGY E D I T O R I A L S<br />

<str<strong>on</strong>g>Time</str<strong>on</strong>g> <str<strong>on</strong>g>to</str<strong>on</strong>g> <str<strong>on</strong>g>Focus</str<strong>on</strong>g> <strong>on</strong> <strong>Inpatient</strong> <strong>Safety</strong>: Revisi<strong>on</strong> <strong>of</strong> the<br />

<strong>American</strong> <strong>Society</strong> <strong>of</strong> <strong>Clinical</strong> Oncology/Oncology<br />

Nursing <strong>Society</strong> Chemotherapy Administrati<strong>on</strong><br />

<strong>Safety</strong> Standards<br />

Joseph O. Jacobs<strong>on</strong>, Dana-Farber Cancer Institute, Bos<str<strong>on</strong>g>to</str<strong>on</strong>g>n, MA<br />

Therese Marie Mulvey, Southcoast Hospitals Group, Fall River, MA<br />

See related article in J Oncol Pract 8:2-6, 2012<br />

In 2009, the <strong>American</strong> <strong>Society</strong> <strong>of</strong> <strong>Clinical</strong> Oncology<br />

(ASCO) and the Oncology Nursing <strong>Society</strong> (ONS) jointly published<br />

a comprehensive set <strong>of</strong> chemotherapy safety standards. 1<br />

The project was the end result <strong>of</strong> a highly structured multistakeholder<br />

process and the sole focus was <strong>on</strong> outpatient chemotherapy<br />

administrati<strong>on</strong> in the facilities in which most adult cancer<br />

chemotherapy is administered. 2,3 In 2011, ASCO and ONS c<strong>on</strong>vened<br />

a workgroup <str<strong>on</strong>g>to</str<strong>on</strong>g> revise the standards. The revised standards<br />

are published in the January 2012 issue <strong>of</strong> Journal <strong>of</strong><br />

Oncology Practice (JOP). 4 In additi<strong>on</strong> <str<strong>on</strong>g>to</str<strong>on</strong>g> clarifying language, the<br />

workgroup voted unanimously <str<strong>on</strong>g>to</str<strong>on</strong>g> extend the standards <str<strong>on</strong>g>to</str<strong>on</strong>g> encompass<br />

the inpatient setting. <strong>Inpatient</strong> chemotherapy administrati<strong>on</strong>,<br />

especially in the community setting, is believed <str<strong>on</strong>g>to</str<strong>on</strong>g><br />

pose a silent but growing threat <str<strong>on</strong>g>to</str<strong>on</strong>g> patient safety.<br />

Most patients with cancer prefer <str<strong>on</strong>g>to</str<strong>on</strong>g> be managed as outpatients,<br />

and ambula<str<strong>on</strong>g>to</str<strong>on</strong>g>ry management <strong>of</strong> cancer is more costeffective<br />

than inpatient management. 5-8 Indeed, some insurers<br />

now require justificati<strong>on</strong> <str<strong>on</strong>g>to</str<strong>on</strong>g> admit a patient <str<strong>on</strong>g>to</str<strong>on</strong>g> the hospital solely <str<strong>on</strong>g>to</str<strong>on</strong>g><br />

receive chemotherapy. 9 The trend, then, <strong>of</strong> shifting adult medical<br />

<strong>on</strong>cology care from the hospital <str<strong>on</strong>g>to</str<strong>on</strong>g> the outpatient setting reflects<br />

patient-centered, cost-effective care. It has occurred gradually during<br />

the last decades <strong>of</strong> modern cancer chemotherapy, accompanied by<br />

shifts in care from academic centers <str<strong>on</strong>g>to</str<strong>on</strong>g> the community, where it is<br />

estimated that at least 80% <strong>of</strong> adult cancer care is provided. 2,3 The<br />

change reflects at least three major advances. First, medical <strong>on</strong>cologists<br />

have become skilled in the management <strong>of</strong> highly <str<strong>on</strong>g>to</str<strong>on</strong>g>xic agents. Predictable<br />

<str<strong>on</strong>g>to</str<strong>on</strong>g>xicities <strong>of</strong> chemotherapeutic agents have been defined and<br />

risk fac<str<strong>on</strong>g>to</str<strong>on</strong>g>rs have been identified, allowing for the preventi<strong>on</strong> or ameliorati<strong>on</strong><br />

<strong>of</strong> most serious adverse effects. Pretreatment assessment <strong>of</strong><br />

renal functi<strong>on</strong> in c<strong>on</strong>juncti<strong>on</strong> with aggressive hydrati<strong>on</strong>, for example,<br />

has allowed cisplatin <str<strong>on</strong>g>to</str<strong>on</strong>g> be routinely administered in the outpatient<br />

setting. 10,11 Sec<strong>on</strong>d, the availability <strong>of</strong> highly active antiemetics and<br />

better-<str<strong>on</strong>g>to</str<strong>on</strong>g>lerated chemotherapeutic agents has additi<strong>on</strong>ally reduced<br />

the need for inpatient administrati<strong>on</strong>. Third, technologic advances<br />

that enable the safe delivery <strong>of</strong> c<strong>on</strong>tinuous chemotherapy infusi<strong>on</strong>s in<br />

the home permit the ambula<str<strong>on</strong>g>to</str<strong>on</strong>g>ry administrati<strong>on</strong> <strong>of</strong> complex regimens<br />

that previously required supervisi<strong>on</strong> in an inpatient setting. 5,6<br />

Community <strong>on</strong>cology practices have also become adept at<br />

managing the c<strong>on</strong>sequences <strong>of</strong> cancer and cancer treatment <strong>on</strong><br />

an ambula<str<strong>on</strong>g>to</str<strong>on</strong>g>ry basis. They have developed comprehensive care<br />

systems that rely <strong>on</strong> highly experienced nursing and pharmacy<br />

staff. Certificati<strong>on</strong> requirements for nursing and pharmacy staff<br />

al<strong>on</strong>g with the availability <strong>of</strong> supportive services that include<br />

nutriti<strong>on</strong>ists and social workers complement these practices.<br />

Patients who experience venous thromboembolic events, for<br />

example, are routinely managed with low molecular weight<br />

heparin as outpatients. Patients with low-risk chemotherapyinduced<br />

fever and neutropenia are managed with close observati<strong>on</strong><br />

and oral antibiotics. Patients who experience treatmentrelated<br />

GI <str<strong>on</strong>g>to</str<strong>on</strong>g>xicity are managed with ambula<str<strong>on</strong>g>to</str<strong>on</strong>g>ry or home fluid<br />

resuscitati<strong>on</strong>, and those with hypercalcemia receive potent<br />

parenteral bisphosph<strong>on</strong>ates. 12-15 Each <strong>of</strong> these patient groups<br />

are now routinely spared the risks and inc<strong>on</strong>venience <strong>of</strong><br />

hospitalizati<strong>on</strong>.<br />

The c<strong>on</strong>sequence <strong>of</strong> these advances in the ambula<str<strong>on</strong>g>to</str<strong>on</strong>g>ry care<br />

<strong>of</strong> patients with cancer is the disintegrati<strong>on</strong> <strong>of</strong> trained, cohesive<br />

chemotherapy teams in many hospitals; this problem is compounded<br />

by flaws in the transfer <strong>of</strong> data between outpatient and<br />

inpatient systems. 3,16 The advances made in ambula<str<strong>on</strong>g>to</str<strong>on</strong>g>ry practices<br />

(electr<strong>on</strong>ic chemotherapy order entry, for example) are<br />

inc<strong>on</strong>sistently reflected in the inpatient setting. Fundamental<br />

changes in hospital staffing have occurred, with fewer dedicated<br />

nurses and pharmacists who are skilled in chemotherapy pro<str<strong>on</strong>g>to</str<strong>on</strong>g>cols<br />

and more hospitalists providing inpatient cancer care.<br />

Because <strong>of</strong> declining inpatient censuses and declining revenue,<br />

many hospitals have had <str<strong>on</strong>g>to</str<strong>on</strong>g> eliminate dedicated inpatient <strong>on</strong>cology<br />

units. 3 This scenario may create a perfect s<str<strong>on</strong>g>to</str<strong>on</strong>g>rm in which<br />

very ill hospitalized patients are exposed <str<strong>on</strong>g>to</str<strong>on</strong>g> high-risk procedures<br />

(chemotherapy) that are provided by staff with diminishing<br />

expertise and without the needed infrastructure.<br />

Journal <strong>of</strong> <strong>Clinical</strong> Oncology, Vol 30, No 10 (April 1), 2012: pp 1021-1029<br />

© 2012 by <strong>American</strong> <strong>Society</strong> <strong>of</strong> <strong>Clinical</strong> Oncology 1021<br />

Informati<strong>on</strong> downloaded from jco.ascopubs.org and provided by at ASCO <strong>on</strong> March 19, 2013 from 206.205.123.242<br />

Copyright © 2012 <strong>American</strong> <strong>Society</strong> <strong>of</strong> <strong>Clinical</strong> Oncology. All rights reserved.


Academic and comprehensive cancer centers have been<br />

somewhat insulated from the changes that have affected community<br />

practices. Because these centers rely <strong>on</strong> referral <strong>of</strong> rare<br />

or refrac<str<strong>on</strong>g>to</str<strong>on</strong>g>ry cancers, and because such cases <strong>of</strong>ten require more<br />

intensive management, they have been less affected by the shift<br />

<strong>of</strong> chemotherapy administrati<strong>on</strong> <str<strong>on</strong>g>to</str<strong>on</strong>g> the outpatient setting.<br />

However, with the increasing ability <str<strong>on</strong>g>to</str<strong>on</strong>g> manage highly complex<br />

therapies <strong>on</strong> an outpatient basis, academic and comprehensive<br />

cancer centers are not immune from c<strong>on</strong>cerns related <str<strong>on</strong>g>to</str<strong>on</strong>g> reduced<br />

use <strong>of</strong> inpatient chemotherapy services. 17-21<br />

Patients who are managed in the ambula<str<strong>on</strong>g>to</str<strong>on</strong>g>ry setting have also<br />

benefitted from the availability <strong>of</strong> <str<strong>on</strong>g>to</str<strong>on</strong>g>ols that are designed <str<strong>on</strong>g>to</str<strong>on</strong>g> make their<br />

care as safe as possible. The Quality Oncology Practice Initiative,<br />

available as a free service for ASCO members, allows practices <str<strong>on</strong>g>to</str<strong>on</strong>g><br />

measure the care that is provided <str<strong>on</strong>g>to</str<strong>on</strong>g> their patients and <str<strong>on</strong>g>to</str<strong>on</strong>g> compare<br />

themselves against nati<strong>on</strong>al benchmarks. 22,23 A Quality Oncology<br />

Practice Initiative Certificati<strong>on</strong> Program has been in place since January<br />

2010; 92 practices achieved certificati<strong>on</strong> as <strong>of</strong> September 2011. 24<br />

Certificati<strong>on</strong> is a rigorous process that requires practices <str<strong>on</strong>g>to</str<strong>on</strong>g> dem<strong>on</strong>strate<br />

that they reliably deliver high-quality cancer care in a safe envir<strong>on</strong>ment.<br />

These <str<strong>on</strong>g>to</str<strong>on</strong>g>ols, which provide standards for documentati<strong>on</strong>,<br />

assessment, treatment, and m<strong>on</strong>i<str<strong>on</strong>g>to</str<strong>on</strong>g>ring, must now be implemented<br />

for inpatient cancer care.<br />

The January issue <strong>of</strong> JOP c<strong>on</strong>tains the first revisi<strong>on</strong> <strong>of</strong> the ASCO/<br />

ONS Chemotherapy Administrati<strong>on</strong> <strong>Safety</strong> Standards (http://jop<br />

.ascopubs.org/c<strong>on</strong>tent/8/1/2.full). Each standard has been modified <str<strong>on</strong>g>to</str<strong>on</strong>g><br />

be applicable <str<strong>on</strong>g>to</str<strong>on</strong>g> the inpatient setting. The ASCO/ONS workgroup<br />

recognizes that implementati<strong>on</strong> <strong>of</strong> the standards in hospitals will pose<br />

challenges. Community medical <strong>on</strong>cologists <strong>of</strong>ten admit patients <str<strong>on</strong>g>to</str<strong>on</strong>g><br />

multiple instituti<strong>on</strong>s and have variable direct influence over the processes<br />

that lead <str<strong>on</strong>g>to</str<strong>on</strong>g> the delivery <strong>of</strong> care. Most US hospitals are accredited<br />

by the Joint Commissi<strong>on</strong> and many are certified by the <strong>American</strong><br />

College <strong>of</strong> Surgery Commissi<strong>on</strong> <strong>on</strong> Cancer. To date, these bodies have<br />

not focused attenti<strong>on</strong> <strong>on</strong> the safety <strong>of</strong> patients who are receiving<br />

chemotherapy. The modified ASCO/ONS Chemotherapy Administrati<strong>on</strong><br />

<strong>Safety</strong> Standards serve as a call-<str<strong>on</strong>g>to</str<strong>on</strong>g>-acti<strong>on</strong> <str<strong>on</strong>g>to</str<strong>on</strong>g> these organizati<strong>on</strong>s.<br />

We encourage medical <strong>on</strong>cologists <str<strong>on</strong>g>to</str<strong>on</strong>g> bring the standards <str<strong>on</strong>g>to</str<strong>on</strong>g> the<br />

attenti<strong>on</strong> <strong>of</strong> medical and administrative leaders in their hospitals and<br />

<str<strong>on</strong>g>to</str<strong>on</strong>g> <strong>of</strong>fer their expertise <str<strong>on</strong>g>to</str<strong>on</strong>g> assist in their implementati<strong>on</strong>. ASCO, ONS,<br />

and other organizati<strong>on</strong>s must also take the lead <str<strong>on</strong>g>to</str<strong>on</strong>g> develop quality<br />

metrics that are focused <strong>on</strong> the unique aspects <strong>of</strong> inpatient medical<br />

<strong>on</strong>cology care.<br />

AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST<br />

The author(s) indicated no potential c<strong>on</strong>flicts <strong>of</strong> interest.<br />

AUTHOR CONTRIBUTIONS<br />

Manuscript writing: All authors<br />

Final approval <strong>of</strong> manuscript: All authors<br />

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DOI: 10.1200/JCO.2011.40.9409; published <strong>on</strong>line ahead <strong>of</strong> print at<br />

www.jco.org <strong>on</strong> February 6, 2012<br />

1022 © 2012 by <strong>American</strong> <strong>Society</strong> <strong>of</strong> <strong>Clinical</strong> Oncology JOURNAL OF CLINICAL ONCOLOGY<br />

Informati<strong>on</strong> downloaded from jco.ascopubs.org and provided by at ASCO <strong>on</strong> March 19, 2013 from 206.205.123.242<br />

Copyright © 2012 <strong>American</strong> <strong>Society</strong> <strong>of</strong> <strong>Clinical</strong> Oncology. All rights reserved.

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