The first national standards for safe administration of chemotherapy have been issued jointly by the American Society of Clinical Oncology and the Oncology Nursing Society. They are published online ahead of print in ASCO's Journal of Clinical Oncology and in the November issue of ONS's Oncology Nursing Forum.
This is the first time ASCO has issued any standards, said the Society's CEO and Executive Vice President, Allen S. Lichter, MD. Past collaborative efforts with other professional societies have been limited to guidelines, including those issued with the American Urological Association on finasteride, with the American Society of Hematology on the use of erythropoietin, and with the College of American Pathologists on HER-2 testing.
ASCO's entrance into standards setting is also part of a larger societal strategy that will ultimately allow clinicians greater clout in dealing with payers (see below).
The 31 safety standards cover the following seven areas, and are intended to serve as a benchmark for treating adult cancer patients by reducing the risk of errors, and providing a context for best cancer care practices:
* Reviewing clinical information and selecting treatment regimens.
* Planning treatment and informed consent.
* Ordering treatment.
* Preparing drugs.
* Assessing treatment compliance.
* Administrating and monitoring.
* Assessing response and monitoring toxicity.
Both ASCO and ONS also recommended use of electronic medical record systems to improve the safety and quality of outpatient chemotherapy administration by reducing errors in ordering drugs.
The standards were developed by ASCO and ONS through consensus by a multidisciplinary workgroup including 40 oncologists, nurses, pharmacists, social workers, practice administrators, and patient advocates, who met in 2008.
A steering committee was co-chaired by ASCO representative Joseph O. Jacobson, MD, Chief of Medicine at North Shore Medical Center in Salem, MA. and Associate Clinical Professor at Harvard Medicine School; and ONS representative Marty Polovich, MN, RN, AOCN, Associate Director of Clinical Practice of the Duke Oncology Network in Durham, NC.
Dr. Jacobson is Chair of ASCO's Quality Oncology Practice Initiative (QOPI), and Immediate-Past Chair of its Quality of Care Committee. Ms. Polovich is co-editor of the ONS Chemotherapy and Biotherapy Guidelines and Recommendations for Practice and editor of ONS's Safe Handling of Hazardous Drugs.
The group originally proposed 64 draft standards, which were reduced to 35 after subsequent conference calls and electronic voting, and the 35 were posted online for six weeks of open public comment, resulting in some 300 written responses.
Interestingly, only 11% of the respondents were physicians, as contrasted with 77% nurses, 6% pharmacists, 3% social workers, 1% patient advocates, and the remaining 2% combined as others.
The disproportionate number of nurses to physicians was explained by some of those interviewed as perhaps being due to nurses being selected to respond for an entire practice.
The final list included 31 standards, although none of those who spoke to OT could recall any specifics about the four standards that did not make the final cut.
‘One of Most Effective Collaborations Ever Had’
Dr. Jacobson said the process of working with ONS was one of the most effective collaborations he had ever taken part in.
“It was great fun and moved very quickly, and would have been impossible without the support of the staffs of both ASCO and ONS, who cooperated incredibly well.”
He said that although a body of literature about chemotherapy safety had been published during the last decade by various professional organizations, none encompassed the total spectrum of administration from ordering the drugs through patient follow-up, and that late in the development of the ASCO/ONS standards the Clinical Oncology Society of Australia published similar safety recommendations that addressed the roles of various oncology professionals.
Dr. Jacobson noted that ASCO created its Quality of Care Committee three years ago to address the growing needs of members, surveys of whom showed that they wanted better definitions of what constituted high-level care.
The QOPI program, opened to ASCO members in 2006, now has more than 500 practices enrolled, with about half successfully submitting their data semi-annually, and the other half doing so on an annual basis.
A 2004 ASCO position paper outlined minimum-level criteria for outpatient chemotherapy administration but did not address the growing rise in oral chemotherapy or bridge the various professions involved.
‘Cushioned by Nurses…Need to Feel More Responsible”
“The current generation of medical oncologists expects that all they need to do is write the order and then everything unfolds, and they've been cushioned by nurses,” Dr. Jacobson said. “We need to feel more responsible, since it's no longer acceptable for oncologists to be unaware of the practices involving others in the administration of chemotherapy. This needs to be done for patient-centered care.”
Chemotherapy administration must be a team-based undertaking, and in 2009 the oncologist is just another member of that team, as is the patient, he said.
Ms. Polovich said that the joint standards were long overdue and an important project.
“ONS has had recommendations for chemotherapy administration for many years, but we've never called them standards—rather, they were recommendations or guidelines for practice. These standards now offer a higher level of expectation for performance.”
She stressed the importance of the standards applying to all those involved in the process including writing orders, preparing drugs, gaining consent, administrating the drugs, and monitoring the patient after treatment to identify toxicity and response.
“When chemo moved into the outpatient setting, the bureaucracy didn't move with it,” she said. “We need to pay more attention to patient safely, and this is what it means to do it right.”
“I teach ONS biochemistry and chemotherapy courses, and many students say we [our practices] are too small to take all these steps. But these standards are applicable to any setting where chemotherapy is delivered. It's a good step forward, especially since it has the stamp of approval from two professional organizations that are well respected.”
ONS President Brenda Nevidjon, RN, MSN, FAAN, Clinical Professor and Chair of the Master's Program at Duke University School of Nursing, said that although cancer care is inter-professional, most disciplines focused on their own domains, and that the handoff in chemotherapy was often an issue that caused problems.
“The inter-professional focus is key, and we've always partnered across disciplines, but these new national standards now address the continuum of care, not just the individual components.”
The idea of joint standards grew out of staff-to-staff discussions between ASCO and ONS about two years ago, she noted.
“Standards carry weight, in the parlance of the Joint Commission. They deal with measurable outcomes. In the past, many guidelines coming out of various organizations were often voluntary, but here is the evidence of our best practices so far. These standards represent our expectation of what we need to do to achieve them and how it can be measured.”
The ASCO-ONS collaboration represented a longstanding relationship between both organizations and in retrospect, setting joint chemotherapy-safety standards seemed to be a no-brainer.
Comment from ASHP
When asked if the standards would have been even stronger if they also had the imprimatur of the American Society of Health-System Pharmacists (ASHP), those interviewed for this article said that individual pharmacists had been part of the consensus process.
I called ASHP, which represents pharmacists working in all medical specialties, not just oncology, and spoke with Cynthia Reilly, BSPharm, Director of the society's Practice Development Division, who said, though, that she hadn't been aware the standards had been published until asked about it for this article.
“We were formally invited [by ASCO and ONS] to participate in the review process, and that's pretty standard for most guideline publishers with a transparent process that invites peer-review comments. I don't know that ASHP necessarily appointed the pharmacists on the team, or if they are members, but we did provide comment on a draft of the document, and in general we appreciate getting the opportunity to comment on our part of the peer-review process and appreciate that the organizations reached out for our perspective.”
She said she still had to review the standards to see if they had addressed ASHP's recommendations, but as of press time a few weeks later that still hadn't happened, an ASHP spokesperson said, due to the document's length and complexity.
Additional Online Resources
In addition to the publication of the standards in JCO and Oncology Nursing Forum, related online resources from both organizations are posted at http://www.asco.org/safety and http://www.ons.org/clinical/Treatment/Chemotherapy/news.shtml